NOTICES 38573-38609 thence along the Amelia County-Powha Each applicant (except as otherwise The subject application under section tan County line to junction ^Powhatan specifically noted) states that there will 212(b) of the Interstate Commerce Act County-Cumberland County line, thence be no significant effect on the quality of is to be assigned for hearing at a time along the Powhatan County-Cumberland the human environment resulting from and place to be fixed, along with directly County line to junction U.S. Highway 60, approval of its application in compliance related conversion and gateway elimina thence along U.S. Highway 60 to junction with the requirements of 49 CFR 1100.- tion applications in No. MC 120879 (Sub- Virginia Highway 622rtbence along Vir 250. Nos. 2 and 3). Interested parties have 30 ginia Highway 622 to junction U.S. High Protest to the granting of the re days from the date of this publication in way 15, thence along U.S. Highway 15 to quested authority must be filed with the which to file petitions for leave to in the Virginia-Maryland State line. The Commission within 30 days after the tervene. Such petitions should state the purpose of this filing is to eliminate the date of this F ederal R egister notice (un treason or reasons for the intervention, gateways of the plant site and warehouse less otherwise specified). Failure season where the petitioner wishes the hearing facilities of the Abitibi Corporation near ably to file a protest will be construed as to be held, the number of witnesses to Roaring River, N.C. and the plant site a waiver of opposition and participation be presented, and the estimated time re and warehouse facilities of the Celotex in the proceeding. A protest should com quired for the presentation of evidence. Corporation in Wayne County, N.C. ply with section 247(d) (4) or section 240 R obert L. Oswald, No. MC-115322 (Sub-No. E88), filed (c)(4) as appropriate of the Commis Secretary. May 14,1974. Applicant : REDWING RE sion’s general rules of practice which re FRIGERATED, INC.,- P.O. Box 10177, quires that it set forth specifically the [FR Doc.76-26541 Filed 9-9-76;8:45 am] Taft, Fla. 32809. Applicant’s representa grounds upon which it is made, contain tive: Lawrence E. Lindeman, Suite 1032 a detailed statement of protestant’s in [Notice No. 27] Pennsylvania Building, Pennsylvania terest in the proceeding (including a copy Avenue and 13th St., NW„ Washington, of the portions of its authority which MOTOR CARRIER TRANSFER D.C. 20004. Authority sought to operate Protestant believes to be in conflict with PROCEEDiNGS that sought in the application, and a August 10, 1976. as a common carrier, by motor vehicle, detailed description of the method— over irregular routes, transporting: whether by joinder, interline, or other Application filed for temporary au frozen foods, from points in Florida, on means—by which protestant would use thority under section 210a(b) in connec and south of Florida Highway 40, to such authority to provide all or part of tion with transfer application under Sec points in Tennessee (except Nashville). the service proposed), and shall specify tion 212(b) and Transfer Rules, 49 C.F.R The purpose of this filing is to eliminate with particularity the facts, matters and Part 1132: the gateway of Hot House, N.C. things relied upon, but shall not include No. MC-FC-76724. By application filed No. MC FEDERAL REGISTER, VOL. 4 ), NO. 177— FRIDAY, SEPTEMBER 10, 1976 — I M M M FRIDAY, SEPTEMBER 10, 1976 'PART II: DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Administration on Aging MULTIPURPOSE SENIOR CENTERS Acquisition, Alteration or Renovation of Facilities; Interim Regulations 38612 RULES AND REGULATIONS Title 45— Public Welfare to facilities supported under this pro that facilities shall be in close proximity gram. The areas of concern are—health, to the majority of individuals eligible to CHAPTER IX— ADMINISTRATION ON AG fire, zoning, safety, and sanitation. use the multipurpose senior center. Sec ING, DEPARTMENT OF HEALTH, EDU The Act requires that the Commis tion 911.13 of the interim regulations say CATION, AND WELFARE sioner on Aging consult with the Secre the same thing. However, another point PART 911— MULTIPURPOSE SENIOR tary of the Department of Housing and made in connection with § 911.13 deals CENTERS Urban Development with regard to the with the special emphasis given to the Acquisition, Alteration or Renovation of technical adequacy of any application proximity of the facility to low income Facilities; Interim Regulations for alteration or renovation. Negotiations and minority elderly individuals of the with the Department of Housing and community. Special emphasis to low- Interim regulations are hereby pro Urban Development are still in process. income and minority older persons with mulgated by the Commissioner on Aging In the meantime, to facilitate the statu regard to Older Americans Act programs, and the Assistant Secretary for Human tory requirerpent for consultation, ap has been in effect since the passage of the Development with the approval of the plicants were instructed to send one copy Nutrition Program for the Elderly in Secretary of Health, Education, and Wel of the application'to the Department of 1972 (Pub. L. 92-258), and additionally fare. The purpose of these interim regula Housing and Urban Development Area when the Older Americans Comprehen tions is to establish procedures for imple Office at the same time that they submit sive Services Amendments of 1973 were menting the provisions of sections 501- their application to the' Administration enacted. 505 of Title V of the Older Americans on Aging, through the Area Agency on In legislation establishing the Nutri Comprehensive Services Amendments of Aging. The representatives of the Area tion Program for the Elderly, low income 1973 (Pub. L. 93-29), hereafter referred Office of the Department of Housing and and minority older persons are singled to as “Title V.” The program is admin Urban Development will decider within out as groups with particular need for istered by the Administration on Aging seven working days, whether or not to this program. Nutrition sites are located in the Office of Human Development. comment on the application. If they do near heavy concentrations of such groups , Title V is designed to provide facilities comment within this period of time, of older persons, and after every effort that will serve as a focal point in com their comments should be transmitted at is made to reach and attract minority munities for the development and deliv once by the applicant agency to the Ad and low-income older persons to the pro ery of social services and nutritional ministration on Aging through the Area gram, all older persons 60 years of age or services designed primarily for older Agency on Aging and/or the State older are eligible to participate. persons. The programs to be conducted Agency on Aging, together with a state In addition to the Declaration of Ob in such facilities shall be coordinated ment as to what changes, if any, the ap jectives of the Older Americans Act, the with State and Area Agencies on Aging, plicant is making in the - application in 1973 Amendments to the Older Ameri who are charged under the Older Ameri light of the Department of Housing and cans Act added several objectives in sec cans Act, with the responsibility for de Urban Development comments. The De tion 101. One of these objectives states— veloping comprehensive systems of serv partment of Housing and Urban Devel “(2) give full and special consideration ices for older Americans. The Title V opment may advise that an application to older citizens with special needs in program will be an integra1, part of the for acquisition or for structural modifi planning such programs, and pending the overall planning and service delivery cation of an existing facility should not availability of such programs for all scheme of State and Area Agencies on be approved unless additional supporting older citizens, give priority to the el Aging. Title V applications will be re material is submitted. If it is determined derly with the greatest economic and viewed by both Area and State Agen that the proposal is one which merits social need.” Title I of the Older Amer cies, who shall transmit such applica funding, a conditional approval will be icans Act is, in a real sense, the preamble tions to the Commissioner after first given. This means, however, that no Title to all provisions contained within the . having recommended and ranked them. V funds can be spent until the additional Act. Therefore, it follows that special There are five terms defined in the in materials are submitted and approved. consideration, though not exclusive con terim regulations, one of which, “mul The Architectural Barriers Act appli sideration, should be given to low-income tipurpose senior center,” is defined in cability is stated as in the Act. The and minority older persons in the Title the statute. The other four terms are— Davis-Bacon Act applicability, while in V program'. “acquisition,” “alter,” “existing facility,” cluded in the Act, was interpreted Another condition under Subpart D, and “renovate.” With only minor excep broadly in the interim regulations. The § 911.14, relates to information about tions, they are standard definitions. Act, under section 502(a) (4) states that the program which is to be conducted As indicated earlier, the Title V pro-, grants or contracts for purchase shall be within the facility. The authority in the gram is to be coordinated through State covered by the Architectural Barriers Act supporting the request for this pro and Area Agencies on Aging. In this re Act. The Act does not state “purchase of gram information is found in section gard, seé Subpart C of the interim regu facility,” it says “purchase.” We do not 502(a)(1)(c) of the Act, “sufficient lations, whereby a portion of the funds believe the Act meant “purchase of fa funds will be available when purchase is appropriated under Title V have been cility” for applicability of the Davis- completed, for effective use of the facility designated to" States in the same way Bacon Act, because the Davis-Bacon Act, for the purpose for which it is being that allocations are made under the Ad which deals with wage rates paid to la purchased.” While most of the content ministration on Aging formula grant borers and mechanics, would not be ap contained in the interim regulations deal program. The State in turn shall desig plicable to the purchase of a facility. with facilities, this section relates ex nate a portion of its amount to each Clearly, Davis-Bacon applicability per clusively to the program to be conducted. planning and service area, where appli tains to alteration and renovation, where The other major reference to program is cations from such areas will be consid contracting work will require the service found in Subpart E, § 911.15(1), which ered and grants made (by the Commis of laborers and mechanics. gives priority to the applicants who pro sioner) up to a given amount within the 'A section in the interim regulations pose to operate the program in close overall amount designated for the State. (911.10) discusses shared facilities in coordination with the comprehensive Title V applications will be transmitted that Title V funds shall pay only for that service systems for older persons being to the Commissioner on Aging through portion of the shared facility to be used developed by State and Area Agencies Area and State Agencies on Aging. for older persons. on Aging under Title n i of the Older Under Subpart D of the interim regu The Act under section 502(a)(1)(D) Americans Act. Section 502(b) (1) of the lations, required conditions for facilities prohibits the use of the facility for sec Act provides the basis for the relation are identified. One section dealing with tarian instruction or religious worship. ship between such facilities and coordi the applicability of State and local laws The interim regulations state this pro nated systems under Title HI of the Act. is not required by statute. It is reason hibition in § 911.12. The second citation under § 911.5 refers able to require that all State and local Accessibility to the facility is noted in to broadening the base of financial sup laws, which are applicable, should apply the Act in section 501(a) when it states port for the program to be conducted in FEDERAL REGISTER, VOL. 41, N O . 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38613 the facility. Again the authority to sup demonstrated by the requests from 3. Request revision that would allow port this citation rests with the “effec community groups to State and only State Agencies on Aging to be Title tiveness” clause found in section 502 Area Agencies on Aging for assistance in V grantees. (a) (c). Subpart P deals with general re establishing a senior center in their com Action Taken: Rejected. The Title V quirements. Allowable expenditures in munity. In a 1975 national study of senior statute does not permit this approach. § 911.17, are identified as being those cus group programs in: the United States, 4. Public Hearings, § 905.21, to be held tomarily associated with acquiring, al conducted by the National Council on the prior to the acquisition, alteration, or tering, or renovating facilities. The un Aging, “inadequate senior center facili renovation of facilities would be too allowable costs, in § 911.18 are associated ties were found to have serious program time-consuming and duplifcative in terms with—■ matic implications." Another finding of of potential benefit. (1) Administrative costs by State or the report noted, "* • * that communi Action Taken: Concur. Section 905.21— Area Agencies—because the Administra ties and their older citizens were increas Public Hearings—was removed. How tion on Aging provides funds, under ingly by accepting senior centers as “so ever, to assure citizen involvement, other authority, to State and Area Agen-> cial utilities” for older adults, i.e., re § 911.4(d) of the revised draft adds the cies to administer Older Americans Act sources and facilities - directed to the requirement of Area Agency Advisory programs; needs of older persons (not just their Council participation in the review and (2) Additional floor space or cubage— problems) and accessible to all who ranking of applications. because this is contrary to standard De need and want them. 5. State specifically whether applicants partment of Health, Education, and Wel Good cause exists to dispense with no are to send applications to the Depart fare interpretation of this type of stat tice of Proposed Rulemaking in order to ment of Housing and Urban Develop utory language; inform the public of the Title V program ment’s Regional Office or to the Area (3) Demolition of existing facilities— in light of the September 30 deadline. To Office. because the Act clearly calls for acquir apprise representatives of the aging net Action Taken: Further consultation ing, altering or renovating existing fa work constituency of our plans, the Ad with the Department of Housing and cilities, not demolishing them; ministration on Aging sent a draft of Urban Development has resulted in the (4) Purchase of land not related to these regulations to State and Area decision that applications are to be sent facility—because the Act speaks to fa Agencies on Aging, national organiza only to Area Offices, and is so reflected cilities, not land without a facility; tions of older persons, and to relevant in § 911.7 of the revised draft. (5) Program operational costs, rent, Congressional staff persons. A revised 6. Remove § 905.3 concerning program leasing etc.—because Part B would have draft of tiie interim regulations, which participant’s dues or contributions, covered most of these items. Part B of included an application kit and addi since this suggests that the Federal Gov Title V of the Act was not authorized tional explanatory materials was trans ernment is encouraging such dues or for appropriation. mitted to State and Area Agencies on contributions in the senior center pro Monitoring of the progress of activi Aging, and to prospective Title V appli grams to be held in the facility. ties carried but under this program is cants who have indicated an interest in Action Taken: Concur. Section 905.3 covered in § 911.22. State or Area Agen applying for funds under the Title V pro removed. cies on Aging are requested by the Com gram. In the interest of expediting the 7. Add a section relative to “non-Fed- missioner on Aging to conduct the mon implementation of the Title V program, eral contributions" to the revised draft, itoring activities, since these agencies will State and Area Agencies and potential stating that such contribution is required be more knowledgeable about progress applicants were advised that the revised to be identified in the Title V application and developments at the local level of draft of the regulations, pending ap form. these grant programs. In those cases proval by the Secretary, would be used Action Taken: A new § 911.16 was where State or Area Agencies on Aging as a basis for review of applications and added to the revised draft as recom are unable or unwilling to conduct such award of grants during the period end mended. monitoring activities, the Commissioner ing September 30, 1976. The revised draft 8. Add a new subsection under § 905.48 on Aging will direct that these activities of the interim regulations reflect some of which more accurately informs the ap be carried out by the Administration on the comments received from the field plicants of acquisition and procurement Aging. ; and from within the Department of policies. Section 504 of the Older “Americans Health, Education, and Welfare. Action Taken: A new § 911.19(a) was Act provides for the recapture of pay Comments received from State and added to the revised draft as recom ments, if within ten years after purchase Area Agencies and others in the field, mended. of any facility for which funds have been and from the Department of Health, The authorization to extend Title V, paid, the sponsorship changes from pub Education, and Welfare, who reviewed Part B—Initial Staffing—was not en lic or nonprofit, or the facility ceases to the early draft of the interim regulations, acted when Part A was extended in the be used for the purpose fgr which it was are listed below with the following ac 1975 Older Americans Act Amendments. purchased. In § 911.23 of the interim tions taken—• Part B, therefore, is not included in these regulations, an exception to this recap 1. Clarify or remove § 905.6 in the early interim regulations. ture clause is stated, allowing the De draft which deals with a priority to be Funds to implement sections 506 and partment of Health, Education, and Wel given to applicants who possess title to a 507 of Title V of the Act. which deal with fare to permit the sale of such a fa facility, and to applicants with facili mortgage insurance a”d annual interest cility when that facility is no longer ties that require less alteration or reno grants, were not included in the 1976 adequate in which to provide the level vation. Second Supplemental Appropriations Bill and quantity of services required. The Action Taken: Section 905.6 was (Pub. L>. 94-303). These sections are not amount of money realized from the sale dropped, and is not included in the re included in these interim regulations. must then be used to purchase another Prior to amending thase interim regu facility in the community which meets vised draft of interim regulations. lations, consideration will be given to any the standards of these interim regula 2. Concerning procedures for making comments, suggestions, or objections tions. awards in the early draft found in § 905.7 thereto which are submitted in writing - A project period of 12 months has (a), there was ambiguity concerning the to the Commissioner, Administration on been established as the time period when phrasing of the 10% maximum amount Aging, Office of Human Development, the activities to be paid for by this pro gram will be completed, and when the for each State under the Title V Department of Health, Education, and senior center program within the fa appropriation. Welfare, 400 6th Street, SW., Washing cility will have been developed. The ur Action Taken: Concur, section 911.4- ton, D.C. 20201, on or before November 9, gent need: for additional facilities to (a) was revised to more accurately de 1976. Comments received will be available be used as multipurpose senior cen scribe the statutory limitation found in for public inspection in Room 4853, 400 ters for older persons has been section 501(b) of the Act. 6th Street, SW., Washington, D.C. 20201, FEDERAL REGISTER, VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 38614 RULES AND REGULATIONS on Monday through Friday of each week of acquiring, altering, or renovating ex (c) In order to be considered for fund from 9:00 a.m. to 5:30 p.m. (202.245- isting facilities to serve as multipurpose ing under this part, all applications must 0011). senior centers (including the initial be submitted on forms prescribed for N o t e .—It is hereby certified that this pro equipment of such centers) which will this purpose by the Commissioner. posal has been screened pursuant to Execu provide focal points in communities for (d) All applications submitted to the tive Order No. 11821, and does not require an the development and delivery of social Commissioner from planning and serv Inflation Impact Evaluation. services and nutritional services de ice areas that have a designated Area (Catalog of Federal Domestic-Assistance Pro signed primarily for older persons. Agency on Aging shall be transmitted gram No. 13.609 Special Programs for the Subpart B— Definitions through the Area Agency to the State Aging.) Agency. In transmitting the applications § 911.2 Definitions. to the State Agency on Aging, the Area Dated: August 16,1976. In addition to the definitions set forth Agency shall include, as proposed rec Arthur S. F lemming, in §§ 901.2 and 903.2 of this chapter, the ommendations to the Commissioner, a Commissioner on Aging. following definitions are applicable for ranking of the applications in order Dated: August 18,1976. the purposes of this part: of priority. Such recommendations and (a) “Acquisition” means obtaining ranking shall be consistent with the ob S tanley B. T homas, Jr., ownership of an existing facility based jectives established by the Area Agency Assistant Secretary for upon a consideration. in the Area Plan. The Advisory Council Human Development. (b) “Alter” means the making of rea to the Area Agency shall participate in Approved: September 1,1976. sonable changes or modifications in an the review of applications, the making existing facility necessary to its more of recommendations and the ranking of D avid Mathews, effective utilization as a multipurpose applications in order of priority. Secretary. senior center. (e) All applications submitted to the Subpart A— Purpose (c) “Existing facility” means an exist Commissioner from planning and service Sec. ing building together with necessary land areas that do not have a designated Area 911.1 Purpose. and appurtenances which is, or which Agency on Aging shall be through the Subpart B— Definitions. may be, with reasonable alteration or State Agency on Aging. renovation, suitable for utilization as a (f) The State Agency on Aging shall 911.2 Definitions. multipurpose senior center. , transmit all applications to the Commis Subpart C— Grants Authorized (d) “Multipurpose senior center” sioner on Aging grouped by planning and 911.3 Eligibility. means a community facility for the or service areas and ranked in order of pri 911.4 Procedures for making awards. ganization and provision of a broad ority. Such recommendations and rank 911.5 Availability of facilities for leasing. spectrum of services (including the pro ing shall be consistent with the objec Subpart D— Required Conditions for Facilities vision of health, social and educational tives established by the State Agency in Acquired, Altered or Renovated Under This Part services and provision of facilities for the State Plan. If the State Agency on 911.6 Applicability of State and local laws. recreational activities) for older persons. Aging decides that changes should be 911.7 Determination of technical adequacy (e) “Renovate” means the reasonable made in the order of priority recom of activities by the Department of repair, renewal or restoration of an exist mended by an Area Agency on Aging, it Housing and Urban Development. ing facility necessary to its more effec shajl provide the Commissioner with its 911.8 Applicability of the Architectural Barriers Act. tive utilization as a multipurpose senior reasons for recommending such changes. 911.9 ApplicabUity of the Davis-Bacon Act. center. (g) All applications to thev Commis 911.10 Costs of shared facilities. Subpart C— Grants Authorized sioner received under this part by State 911.11 Length of time facilities must be and' Area Agencies shall be forwarded to used. § 911.3 Eligibility. the Commissioner for consideration for 911.12 Religious worship in facilities. The Commissioner is authorized to funding. 911.13 Accessibility of facilities. make grants to units of general purpose (h) If approvable projects in any State 911.14 Multipurpose senior center program. local government or other public or non do not require the amount designated for Subpart E— Priority Consideration for Funding profit private agencies or organizations the State in § 911.4(a), the amount not Under This Part for paying part of the costs of acquiring, required shall be available for grants in 911.15 Funding Priorities. altering, or renovating existing facilities other States up to the 10 percent maxi designed to carry out the purpose of this mum. Subpart F— General Requirement part. Funds may not be used for the con 911.16 Non-Federal contributions. § 911.5 Availability of facilities for leas 911.17 Allowable expenditures. struction of new facilities. In making ing. 911.18 UnaUowable expenditures. such grants the Commissioner will con The applicant shall assure that in the 911.19 Grantee acquisition and procure sider the recommendations of State case of applications for acquisition that ment. agencies and Area agencies as provided there are no existing facilities in the 911.20 Reports and records. in this part. 911.21 Civil rights. community suitable for leasing as a mul 911.22 Monitoring activities. § 911.4 Procedures for making awards. tipurpose senior center. 911.23 Recapture of payments. (a) The Commissioner will notify each Subpart D— Required Conditions for Facili 911.24 Notification of action taken on pro State Agency on Aging that he will make ties Acquired, Altered or Renovated posals. grants up to a specified amount in that Under This Part 911.25 Project period. State. The amount designated for each 911.26 Payments. §911.6 Applicability of State and local State shall be determined in the same laws. Subpart G— Contract Authority way that allocations are made each year 911.27 Authority. under section 303 of the Act, except that As a condition to acquire, alter or total funds awarded to any State in any renovate a facility to serve as a multi A u t h o r it y : Secs. 501-505, Title V, Older fiscal year shall not exceed ten percent purpose senior center, the applicant shall Americans Comprehensive Services Amend of the funds appropriated by the Con assure that all such facilities, when all ments of 1973 (Pub. L. 33-29). gress for the nation for that fiscal year. activities under this part are completed, Subpart A— PurposeN (b) Each State Agency on Aging shall will comply with all applicable State and notify Area Agencies on Aging, and local health, fire, zoning, safety and § 911.1 Purpose. through the Area Agencies, other agen sanitation codes. ' The purpose of these regulations is to cies and organizations in each planning § 911.7 Determination of technical ade establish procedures for implementing and service area, that applications from quacy of activities by the Department sections 501-505 of Title V of the Older the area shall be considered and grants of Housing and Urban Development. Americans Act which provide for the made up to a given amount within thè The applicant shall assure that repre making of grants to pay part of the costs over-all amount designated for the State. sentatives of Area Offices of the U.S. De- FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38615 partment of Housing and Urban Devel ity elderly individuals of the commu §911.18 Unallowable expenditures. opment have been provided the opportu nity. The following expenditures are un nity to comment on the technical §911.14 Multipurpose senior center allowable; adequacy of any proposed alteration or program. renovation of a facility. Such comments, (a) Administrative expenses incurred The application shall provide in by State or Area Agencies in carrying out If any, shall be transmitted to the activities under this part; Commissioner. formation on the following points: (a) Services to be available in the (b) Use of funds for additional floor § 911.8 Applicability of the Architec facility; space or cubage beyond the existing tural Barriers Act* (b>~ Leadership and staffing of the ^facility; The applicant shall assure that all facility; " (c) The demolition of existing facil facilities to be acquired under this part (c) Involvement of elderly partici ities; shall meet the Architectural Barriers Act pants in decisions relating to center pro (d) The purchase of land not related of 1968,41 CFR 101-17.703. grams; to acquisition of an existing facility; and (d) Days and hours per week the cen (e) Any cost associated with the op § 911.9 Applicability of the Davis-Bacon ter facility will be accessible to the eration of the multipurpose senior cen Act. elderly; ter, including: Rent, maintenance, leas The application for acquisition, alter (e) Training plans for professional ing costs, personnel and supplies. ation, or renovation of a facility shall be senior center personnel; and § 911.19 Grantee acquisition and pro supported by adequate assurance that (f) A financial plan demonstrating curement. any laborer or mechanic employed by any that when the facility has been ac contractors or subcontractors in the per The applicable provisions of Part 74 quired, altered, or renovated, sufficient of this title shall apply to all acquisition, formance uf work on the facility will be funds will be available for effective use alteration or renovation activities ap paid wages at rates not less than those of the facility. prevailing for similar work in the locality proved by the Commissioner under this as determined by the Secretary of Labor Subpart E— Priority Consideration for part. in accordance with the Davis-Bacon Act, Funding Under This Part § 911.20 Reports and records. as amended (40 U.S.C. 276a-276a5). § 911.15 Funding priorities. (a) Agencies receiving funds under § 911.10 Costs o f shared facilities. Priority will be given by the Com this part shall make such reports in such If the facility to be acquired, altered missioner to applications submitted by form and containing such information or renovated will be shared with other eligible applicant agencies or or x as the Commissioner may determine. age groups, the applicant shall assure ganizations which: (b) Grantee agencies shall maintain that funds under this part will be used (a) Plan to operate, in accordance such records anu afford such access only for that portion of the facility that with the Congressional intent, a multi thereto as the Commissioner may find will be used by older persons. Where the purpose senior center program that will necessary to assure the correctness and be closely coordinated with, and made verification of such reports. same floor space is to be shared with dif part of, the comprehensive service sys ferent age groups, funds under this part tem for older persons being developed by § 911.21 Civil rights. may be used proportionately to acquire, State and Area Agencies on Aging under (a) . The applicant shall assure that alter or renovate the facility only to the Title III of the Act; and all activities undertaken under this part extent that such floor space will be used (b) Have developed a plan, including shall conform to the Civil Rights Act of by older persons. written commitments, under which other 1964 and all applicable policies and pro §911.11 Length of time facilities must Federal, State, local, or private agencies cedures established relating to such Act, be used. will utilize the facility for the purpose including the development and imple (a) An application for acquisition of a of delivering services to older persons, or mentation of an affirmative action plan facility under this part shall provide rea will contribute resources in such a man in the area of employment, and the de sonable assurances that for not less than ner as to broaden the service base of the velopment and implementation of a plan ten years after acquisition, the facility facility. designed to provide maximum opportu will be used for the purposes for which Subpart F— Genera! Requirements nity for participation in the service pro it is to be purchased. grams operating out of the center by low (b) An application for alteration or § 911.16 Non-Federal contributions. income and minority personnel. renovation of a facility shall set forth The Commissioner is authorized to pay (b) The applicant shall also give as the arrangements that have been made, up to 75 per centum of the costs of ac surance that, subject to merit employ or are contemplated, relative to the quiring, altering or renovating facilities ment systems of State and local govern length of time the facility will be used to serve as multipurpose senior centers. ments, preference shall be given to per for the purposes intended under this The non-Federal share of proposed costs sons 60 or over for any staff position part. under this part shall be identified by the (full time or part-time) related to the applicant in the application. acquisition, renovation or' alteration of § 911.12 Religious worship in facilities. the facility or to service programs oper Applications for a grant or contract § 911.17 Allowable expenditures. ated out of the facility by the applicant. for acquisition shall be supported by (a) In acquiring facilities, Federal § 911.22 Monitoring activities. reasonable assurances that, “the facility funds may be used to meet costs custom will not be used, and is not intended to arily associated with the acquisition of (a) The State Agency on Aging will be used for sectarian instruction or as real estate in the locality, such as: Costs be requested by the Commissioner to a place for religious worship” (Section of title search, title insurance, attorney regularly monitor" the progress of all 502(a) (l) (2) of this Act). > fees, recording fees and other related acquisition, alteration or renovation ac costs. tivities undertaken in those planning and § 911.13 Accessibility of facilities. (b) In altering or renovating facilites, service areas not having approved Plans The applicant shall assure that any costs customarily associated with alter under Title HI of the Act. facility to be acquired, altered or ren ing or renovating a facility in the locality (b) The Area Agency on Aging will ovated under this part wiE be in close be requested by the Commissioner to reg Proximity, within walking distance is permissible, including:^ Consultant ularly monitor the progress of all acqui 5“ Possible, to the majority of in- fees, architectural fees, charges for plan sition, alteration or renovation activi mviduals eligible to use the multipurpose development and other related costs. ties undertaken in those planning and senior center, with special emphasis on (c) The cost of initial equipment and service areas haying approved area Plans ns proximity to low-income and minor furnishings is allowable. under Title IH of the Act. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38616 RULES AND REGULATIONS §911.23 Recapture of payments. § 9X1.24 Notification of action taken on amount so reserved may be paid in ad If within ten years after the acquisi proposals. vance or by way of reimbursement, and tion of the facility, under this part, Applicants will be notified in writing in such installments consistent with either the owner of the facility ceases of the final action taken by the Com progress in alteration or renovation, as to be a public or nonprofit private agency missioner on each application. For those the Commissioner may determine. The or organization, or the facility ceases to applications approved by the Commis Commissioner’s reservation of any be used for the purpose for which it was sioner, this notification shall set forth amount under this section may be acquired, the Department shall be en the amount of fUnds awarded, and shall amended by him, either upon approval titled to recover from the agency or other constitute for such amounts"the incum of an amendment of the application or owner of the facility an amount, which brance of Federal funds for such pro upon revision of the estimated cost of bears to the then value of the facility, or posal on the date of the award. altering pr renovating the facility. so much thereof as constituted an ap § 911.25 Project period. Subpart G— Contract Authority proved project award or awards, the same ratio as the amount of such Fed Except in those instances where an § 911.27 Authority. eral funds bore to the,cost of the fa exemption is approved by the Commis (sO The Commissioner is authorized to cility financed with the aid/ of such sioner: make contracts to carry out the purposes funds. Such value shall be determined (a) The period of a grant award ap of this part with any agency or organiza by agreement of the parties or by action proved in any fiscal year may not ex tion to pay not to exceed 75 per centum brought in the United States District ceed 12 months following the effective of the costs of such program, subject to date of the “Notice of Grant Awarded” Court for the district in which such fa the ten per centum maximum payments cility is situate. Release by the Depart relating tosuch grant. ment from recapturing the payment may (b) All activities relating to the ac in any State in any fiscal year. occur if the facility as originally, ac quisition, alteration or renovation of a (b) Any contract under this part shall quired is no longer adequate as a setting facility under this part shall be com be entered into in accordance with and to provide the type and level of services pleted, and the multipurpose program shall conform to all of the relevant regu operational, within 12 months following now required by older persons in the lations relating to grants under this title community, and therefore, the facility, the approval of the grant relating to that as originally acquired, altered .or reno activity. as well as to all other applicable laws, regulations and Department policy. vated, will be sold at a price, determined § 911.26 Payments. as reasonable by the Department, and (c) Payments may be made in advance that such funds resulting from the sale Upon approval of any application for a or by way of reimbursement, and in such grant or contract under this part, the of the original facility will be used to installments and on such conditions as purchase another facility in the com Commissioner shall reserve, frsom any munity which meets the standards of appropriation available therefor, the the Commissioner may determine. this part. amount of such grant or contract. The [FR Doc.76-26338 Filed 9-9-76;8:45 am] \ \ FEDERAL REGISTER, VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 FRIDAY, SEPTEMBER 10, 197S PART lit: DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration RECODIFICATION 38618 RULES AND REGULATIONS Title 21— Food and Drugs in §§ 1.8c and 501.8 are provided for chapter B, which will be recodified in the solely by the Fair Packaging and Label near future and be limited to just hu CHAPTER I— FOOD AND DRUG ADMIN ing Act. The other requirements of this man food. New Partis 501, 503, 507, 508, ISTRATION, DEPARTMENT OF HEALTH, part are issued under both the Fair Pack 509, 564/570, 571, 573, and 582 are taken EDUCATION, AND WELFARE aging and Labeling Act and the Federal from Parts 1,* 3,10, 90,102,121,122,128b, [Docket No. 76N-0320] Food, Drug, and Cosmetic Act, or by the and the sectio»*pumbers are keyed to the Recodification Editorial Amendments latter act solely, and are not limited projected new human food section num in their application by section 10 of the bers wherever possible. The texts of the The Foodvand Drug Administration is Fair Packaging and Labeling Act. sections are editorially modified'to re in the proces^of recodifying all of Chap * * * * * flect animal applicability. ter I of Title 21 of the Code of Federal This document merely recodifies exist Regulations, for the purposes of provid ing regulations and does not represent ing orderly development of such regula PART 8— COLOR ADDITIVES a change in current requirements for tions, furnishing ample room for expan § 8.301 [Amended] animal feed or pet food. sion in the years ahead, and providing The following table shows the relation the public and affected industries with 2. Section 8.301(b) (2) (ii) is amentied by changing the reference “§ 121.202” ship of the CFR section numbers under regulations that are easy to find, read Subchapters A and B to this redesigna and understand. to read “§ 573.380.” tion reflected in Parts 501, 503, 507, 508, The fourteenth in a series of recodi § 8.306 [Amended] 509, 564, 570, 571, 573, and 582: fication documents, which reorganize and 3. Section 8.306(c) (2) (ii) is amended Old sec.: New see. recodify sections of the general regula by changing the reference “§ 121.202” to 1 .7 ------1—...... 501.1 tions of Subchapter A and the general read “§ 573.380.” 1 . 8------— . 501.3 food regulations under Subchapter B 1 .8 a ______— 501.5 that have applicability to animal drugs, 1 .8b ------_:T— ------501.105 feeds, and related products, is published PART 121— FOOD ADDITIVES 1 .8c — ______501.8 elsewhere in this issue of the F ederal 1 .8 d _____ S------501.2 § 121.1001 [Amended] 501.15 R egister. These regulations are now in 1 .9 ------4. Section 121.1001(b) is amended by 1 . 1 0 ...... 501.4 Parts 501, 503, 507, 508, 509,. 564, 570, 501.100 571, 573, and 582 of Subchapter E. changing the reference “§§ 121.201 and 1 .10 a ______—...... a 121.202” to read “§§ 573.380 and 573.400.” 1 .10 b ...... - ...... - 501.103 To provide uniformity and continuity 1 . 1 2 ______*...... 501.22 during the recodification, the Commis The changes being made are nonsub 1.13______U------— 501.17 sioner concludes that the references to stantive in nature and for this reason 1.15 ------501.18 the recodified material should be notice and public procedure are not pre 1.16 ______501.110 amended at this time. requisites to this promulgation. 3 .9 3 ______509.15 10 .1 -f-...... - ...... - 564.3 Due to tiie complexity and volume of Dated: September 2,1976. 10 .2 ...... 564.5 cross-references involved in the recodi 564.8 J oseph P. H ile, 10.3 ____ ------fication of these regulations, if neces 10.4 __ '.______--- 56420 Acting Associate Commissioner 564.17 sary, supplemental documents will be for Compliance. 10.5 ______issued at a later date. 10 .6 _>______< 564.12 Therefore, Chapter I of Title 21 of [PR Doc.76-26298 Piled 9-9-76;8:45 am] ,10.7 ______564.14 1 0 . 8 ______—V’ 564.6 the Code of Federal Regulations is 508.3 SUBCHAPTER E— ANIMAL DRUGS, FEEDS, 90 .1 ______amended as follows: AND RELATED PRODUCTS 9 0 .2 ...... — ___ - 508.19 PART 1— REGULATIONS FOR THE EN 90.3 ______- ...... 508. 5 [Recodifl.cation Docket No. 14; Docket No. 9 0 .4 ______—- 1' 508.7 FORCEMENT OF THE FEDERAL FOOD, 76N-0320] 508.10 DRUG, AND COSMETIC ACT AND THE 90.5_____ —— ...... *...... REORGANIZATION ANQ REPUBLICATION 9 0 .6 ...... ;...... 508.6 FAIR PACKAGING AND LABELING ACT 9 0 .7 ______L ______: ------508.12 The Food and Drug Administration is 90.20 ...... —...... 508.35J 1. Section 1.1 is amended by revising 10 2 .1______503.20 paragraph • FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38619 Old sec.: New sec. Old sec.: New sec. Subpart B— Specific Animal Food Labeling 121.74 ______„ 671.130 121.246 573.680 Requirements 121.75 —___ 570.17 121.247 573. 580 601.22 Animal foods; labeling of spices, 1 2 1 . 1 0 1 except table in (d) and 121.250 573.260 flavorings, colorings, and chemi (e) through (i)------582.1 121.261 673. 720 cal preservatives. 121.101(d) ...... 582.1005, 121.265 573.320 Subparts C Through E-— [Reserved) 582.1009, 582.1033, 582.1057, 582.1061, 121.271 573.360 582.1069, 582.1073, 582.1077, 582.1087, 121.272 573.960 Subpart F— Exemptions From Animal Food 582.1091, 582.1095, 582.1099, 582.1125, 121.273 573.900 Labeling Requirements 582.1127, 682.1129, 582.1131, 582.1135, 121.275 573.520 601.100 Animal food; exemptions from label 582.1137, 582.1139, 582.1141, 582.1143, 121.277 573.740' ing. 582.1155, 582,1165, 582.1191, 582.1193, 121.282 573.560 501.103 Petitions requesting exemptions 582.1195, 582.1199, 582.1205, 582.1207, 121.283 673. 980 from or special requirements 582.1210, 582.1217, 582.1235, 582.1240, 121.284 573.1020 for label declaration of ingredi 582.1275, 582.1320, 582.1324, 582.1355, 121.285 573.160 ents. 582.1366, 582.1400, 582.1425, 582.1428, 121.286 573.620 501.105 Declaration of net quantity of con 582.1431, 582.1480, 582.1500, 582.1516, 121.288 573. 120 tents when exempt. 582.1540, 582.1585, 582.1613, 582.1619, 121.295 673. 760 501.110 Animal feed labeling; collective 582.1625, 582.1631, 582.1643, 582.1655, 121.298 573.440 names for feed ingredients. 573. 540 582.1666, 582.1685, 582.1711, 582.1721, 121.301 A u t h o r it y : Secs. 4, 6 , 80 Stat. 1297, 1299, 582.1736, 582.1742, 582.1745, 582.1748, 121.302 573.200 1300 (15 U.S.C. 1453, 1455) and secs. 403, 682.1751, 582.1763, 582.1775, 582.1778, 121.306 673. 280 602, 701, 62 Stat. 1047-1048 as amended, 1054- 582.1781, 582.1792, 582.1804, 582.1810, 121.307 573.880 1056 as amended (21 U.S.C. 343, 362, 371), 582.1901, 582.1973, 582.1975, 682.1978, 121.313 573.240 unless otherwise noted. 582.2122, 582.2227, 582.2437, 582.2727, 121.319 673.140 582.2729, 582.2906, 582.3013, 582.3021, 121.320 573. 800 Subpart A— General Provisions 582.3041, 582.3081, 582.3089, 582.3109, 121.322 573.340 582.3149, 582.3169, 582.3173, 582.3189, 121.325 573.920 § 501.1 Principal display panel of pack 582,3221, 582.3225, 582.3280, 582.3336, 121.328 573.220 age form animal food. 682.3490, 582.3616, 582.3637, 582.3640, 121.329 573.460 The term “principal display panel” as 582.3660, 582.3670, 582.3731, 582.3733, 122.1 609.3 it applies to food in package form and as 582.3739, 582.3766, 582.3784, 582.3795, 122.10 509.30 used in this part, means the part of a 582.3798, 582.3845, 582.3862, 582.3890, 128b. 1 507.3 582.4101, 582.4505, 582.4521, 582.4666, 128b.2 507.1 label (hat is most likely to be displayed, 582.5013, 582.5017, 582.5049, 582.5065, 128b.3 507.81 presented, shown, or examined under 682.5118, 582.5145, 582.5159, 582.5191, 128b.4 507.83 customary conditions of display for re 582.5195, 582.5201, 582.5210, 582.5212, 128b.5 507.87 tail sale. The principal display panel 682.5217, 582.5223, 582.5230, 582.5245, 128b.0 507.40 shall be large enough to accommodate all 582.5250, 582.5252, 582.5260, 582.5271, 128b.7 507.60 the mandatory label information re 582.5273, 582.5301, 582.5304, 582.5306, 128b.8 607.110 quired to be placed thereon by this part 582.5308, 582.5311, 582.5315, 582.5361, 128b.9 507.89 with clarity and conspicuousness and 582.5370, 582.5375, 582.5381, 582.5406, 128b.10 507.10 without obscuring design, vignettes, or 582.5411, 582.5431, 582.5434, 582.5443, 582.5446, 582.5449, 582.5452, 582.5455, The changes being made are nonsub crowding. Where packages bear alternate 582.5458, 582.5461, 582.5464, 582.5470, stantive and editorial; and for this rea principal display panels, information re 582.5475, 582.5477, 582.5530, 582.5535, son, notice and public procedure are not quired to be placed on the principal dis 582.5580, 682.5590, 582.5622, 582.5628, prerequisites to this promulgation. For play panel shall be duplicated on each 582.5634, 582.5650, 582.5676, 582.5695, the convenience of the user, the entire principal display panel For the purpose 582.5697, 682.5701, 582.5772, 582.5778, text of Parts 501, 503, 507, 508, 509, 564, of obtaining uniform type size in declar 582.5835, 582.5875, 582.5878, 582.5881, 570,571,573, and 582 is set forth below. ing the quantity of contents for all pack 582.5890, 582.5892, 582.5915, 582.5920, ages of substantially the same size, the 582.5925, 582.5930, 582.5933, 582.5936, Dated; September 2,1976. 582.5945, 582.5950, 582.5953, 582.5985, term “area of the principal display 582.5988, 582.5991, 582.5994, 582.5997, J oseph P. H ile, panel” means the area of the side or 582.6033, 582.6085, 582.6099, 582.6185, Acting Associate Commissioner surface that bears the principal dis 582.6193, 582.6195, 582.6197, 582.6199, for Compliance. play panel, which area shall be; 582.6203, 582.6215, 582.6219, 582.6285, Therefore, 21 CFR is amended by re (a) In the case of a rectangular pack 582.6290, 582.6386, 582.6511, 582.6540, age where one entire side properly can 582.6651, 582.6754, 582.6757, 582.6760, designating animal food provisions under be considered to be the principal display 582.6769, 582.6778, 582.6787, 582.6789, Parts 1 and 3 of Subchapter A and Parts panel side, the product of the height 582.6801, 582.6804, 582.6807, 582.6810, 10, 90, 102, 121, 122, and 128b of Sub times the width of that side; 582.6851, 582.7115, 582.7133, 582.7187, chapter B as Parts 501, 503, 507, 508, 509, 582.7255, 582.7330, 582.7333, 582.7339, 564, 570, 571, 573, and 582 of Subchapter (b) In the case of a cylindrical or 582.7343» 582.7349, 582.7351, 582.7610, E—Animal Drugs, Feeds» and Related nearly cylindrical container, 40 percent 582.7724 Products and republished to read as fol of the product of the height of the con 1 2 1 .1 0 1 (e )( 1 ) lows: tainer times the circumference; 1 2 1 .1 0 1 (e)(2 ) - . ------582.20 (c) In the case of any otherwise 121.101(e)(3) ------582.30 shaped container, 40 percent of the total 121.101(e)(4) _ PART 501— ANIMAL FOOD LABELING surface of the container: Provided, 121.101(e)(5) ------582.50 Subpart A— General Provisions however, That where such container 1 2 1 .1 0 1 if) Sec. 1 2 1 .1 0 1 (g) ------682.60 501.1 Principal display panel of package presents an obvious “principal display 1 2 1.1 0 2 _____ form animal food. panel” such as the top of a triangular 12 1.2 0 1 ______501.2 Information panel of package for or circular package, the area shall consist 12 1.2 0 2 ____ animal food. of the entire top surface. In determining 121.203 _ 501.3 Identity labeling of animal food in the area of the principal display panel, 121.206 __ package form. exclude tops, bottoms, flanges at tops and 121.209 ___ 501.4 Animal food, designation of Ingre bottoms of cans, and shoulders and necks 121.219 ___ dients. 12 1.2 2 2 _ of bottles or jars. In the case of cylindri 121.223 _ 501.5 Animal food; name and place of cal or nearly cylindrical containers, in 121.224 _ business of manufacturer, packer, 121.229 or distributor. formation required by this part to ap 121.230 __ 501.8 Labeling of animal food with num pear on the principal display panel shall 121.231___ ber of servings. appear within that 40 percent of the cir 121.234 _ 501.15 Animal food; prominence of re cumference which is most likely to be dis 121.235 _ quired' statements. 121.236 501.17 Animal food labeling warning played, presented, shown, or examined 121.239 statements. under customary conditions of display 121.242 501.18 Misbranding of animal food. for retail sale FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38620 RULES AND REGULATIONS §501.2 Information panel of package (ii) The area of surface available for (b) Such statement of identity shall for animal food. labeling on the principal display panel be in terms of: (a) The term “information panel'’ as of the package as this term is defined in (1) The name now or hereafter speci it applies to packaged food means that § 501.1 is less than 12 square inches and fied in or required by any applicable part of the label immediately contiguous bears all labeling appearing on the pack Federal law or regulation; or, in the age. absence thereof, / \ and to the right of the principal display (iii) The label information includes (2) The common or usual name of panel as observed by an individual fac a full list of ingredients in accordance the food; or, in the absence thereof, ing the principal display panel with the with regulations in this part. (3) An appropriately descriptive term, following exceptions: | (iv) The information required by par or when the nature of the food is obvious, (1) If the part of the label immedi agraph (b) of this section appears on a fanciful name commonly used by the ately contiguous and to the right of the the single, obvious principal display pan public for such food. principal display panel is too small to el in accordance with the provisions of (c) Where a food is marketed in vari accommodate the necessary information ous optional forms (whole, slices, diced, or is otherwise unusable label space, e.g., this paragraph (c) except that the type size is not less than Y32 inch in height. etc.), the particular form shall be con folded flaps or can ends, the panel im (3) Packaged foods are exempt fromsidered to be a necessary part of the mediately contiguous and to the right the type size requirements of this para statement of identity and shall be de of this part of the label may be used. graph: Provided, That: clared in letters of a type size bearing (2) If the package has one or more (i) The package is designed such that a reasonable relation to the size of the alternate principal display panels, the it has a total surface area available to letter^ forming the other components of information panel is immediately con bear labeling of less than 12 square the statement of identity; except that if tiguous and to the right of any principal inches. the optional form is visible through the display panel. (ii) The label information includes a container or is depicted by an appropri (3) If the top of the container is the full list of ingredients in accordance ate vignette, the particular form need principal display panel and the pack with regulations in this part. not be included in the statement. This age has no alternate principal display (iii) The information required by par specification does not affect the required panel, the information panel is any pan agraph (b) of this section appears on declarations of identity under definitions el adjacent to the principal display the principal display panel or informa- / and standards for foods promulgated panel. tion panel label in accordance with the pursuant to section 401 of the act. (b) All information required to ap (d) This statement of identity shall pear on the label of any package of food provisions of this paragraph (c) except that the type size is not less than % 2 be presented in bold type on the principal pursuant to §§ 501.4, 501.5, 501.8 and inch in height. display panel, shall be. in a size reason 501.17 shall appear either on the princi (d) All information required to appear ably related to the most prominent pal display panel or on the information on the principal display panel or on the printed matter on such panel, and. shall panel, unless otherwise specified by reg information panel pursuant to this sec be in lines generally parallel to the base ulations in this chapter. tion shall appear on the same panel un on which the package rests as it is (c) All information appearing on the less there is insufficient space. In deter designed to be displayed. principal display panel or the informa mining the sufficiency of the available (e) Under the provisions pf section tion panel pursuant to this section shall space, any vignettes, design, and other 403(6) of the Federal Food, Drug, and appear prominently and conspicuously, nonmandatory label information shall Cosmetic Act, a food shall be deemed but in no case may the letters and/or not be considered. If there is insufficient to be misbranded if it is an imitation of numbers be less than 1/16 inch in height space for all of this infomiation to appear another food unless its label bears, in unless an exemption pursuant to para on a single panel, it may be divided, be type^of uniform size and prominence, graph (f) of this section is established. tween these two panels except that the the word “imitation” and, immediate’y The requirements for conspicuousness information required pursuant to any thereafter, the name of the food imi and legibility shall include the specifica given section or part shall all appear on tated. tions of §§ 501.15 and 501.105(h) (1) and the same panel. A food whose label is (1) A food shall be deemed to be an (2). required to bear the ingredient statement imitation and thus subject to the re (1) Packaged foods are exempt fromon the principal display panel may bear quirements of section 403(c) of the act the type size requirements of this para all other information specified in para if it is a substitute for and resembles graph: Provided, That: graph (b) of this section on the informa another food but is nutritionally inferior (1) The package is designed such that to that food. it has a surface area that can bear an tion panel. (e) All information appearing on the (2) A food that is a substitute for and information panel and/or an alternate resembles another food shall not be principal display panel. information panel pursuant to this sec tion shall appear in one place without deemed to be an imitation provided it (ii) The area of surface available for other intervening material. meets each of the following require labeling on the principal display panel ments: of the package as this term is defined in (f ) If the label of any package of food (i) It is not nutritionally inferior to § 501.1. is less than 10 square inches. is too small to accommodate all of the the food for which it substitutes and (iii) The label information includes a information required by §§ 501.4, 501.5, 501.8, and 501.17, the Commissioner may which it resembles. full list of ingredients in accordance with ** (ii) Its label bears a common or usual regulations in this part. establish by regulation an acceptable al ternative method of disseminating such name that complies with the provisions (iv) The information required by information to the public, e.g., a type size of § 503.20 of this chapter and that is not paragraph (b) of this section appears on smaller than one-sixteenth inch in false or misleading, or in the absence of the principal display panel or informa height, or labeling attached to or inserted an existing common or usual name, an tion panel label in accordance with the in the package or available at the point appropriately descriptive term that is not provisions of this paragraph (c) except of purchase. A petition requesting such a false or misleading. The label may,, in that the type size is not less than 3/64 regulation, as an amendment to this addition, bear a fanciful name which is inch in height. paragraph, shall be submitted to the not false or misleading. (2) Packaged foods are exempt from Hearing Clerk in the form established in (3) A food for which a common or the type size requirements of this para § 2.65 of this chapter. usual name is established'ey regulation graph: Provided,^That: (e.g., in a standard of identity pursuant (i) The package is designed such that§ 501.3 Identity labeling of animal food to section 401 of the act, in a common it has a single “obvious principal dis in package form. or usual name regulation pursuant to play panel” as this term is defined in (a) The principal display panel of afalse or misleading. The label may, in § 501.1 and has no other available sur food in package form shall bear as one addition, bear a fanciful name which is face area for an information panel or al of its principal features a statement of part 503 of this chapter), and which ternate principal display panel. the identity of title commodity. complies with all of the applicable re- FEDERAL REGISTER, VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38621 quirements of such regulation (s), shall (4) Milk, concentrated milk, reconsti § 501.5 Animal food; name and place not be deemed to be an imitation. tuted milk, and dry whole milk may be of business of manufacturer, packer, (4) Nutritional inferiority includes: declared as "milk”. or distributor. (i) Any reduction in the content of an (5) Bacterial cultures may be declared (a) The label of a food in packaged essential nutrient that is present in a by the word "cultured” followed by the form shall specify conspicuously the measurable amount. \ name of the substrate, e.g., "made from name and place of business of the manu (ii) If the Commissioner coricludescultured skim milk or cultured butter facturer, packer, or distributor. that a food is a substitute for and re milk”. (b) The requirement for declaration of sembles another food but is inferior to (6) Sweetcream buttermilk, concen the name of the manufacturer, packer, or the food imitated for reasons other than trated sweetcream buttermilk, reconsti distributor shall be deemed to be satis those set forth in this paragraph, he may tuted sweetcream buttermilk, and dried fied, in the case of a corporation, only by propose appropriate revisions to this sweetcream buttermilk may be declared the actual corporate name, which may regulation or he may propose a separate as “buttermilk”. be preceded or followed by the name of regulation governing the particular food. (7) Whey, concentrated whey, recon the particular division of the corpora (f) A label may be required to bear the,stituted whey, and dried whey may be de tion. In the case of an individual, part percentage(s) of a characterizing ingre clared as “whey”. nership, or association, the name under dientes) or information concerning the (8) Cream, reconstituted cream, dried which the business is conducted shall presence or absence of an ingredient(s) cream, and plastic cream (sometimes be used. or the need to add an ingredient(s) as known as concentrated milk fat) may be (c> Where the food is not manufac part of the common or usual name of the declared as “cream”. tured by the person whose name appears food pursuant'to Part 503 of this chapter. (9) Butteroil and anhydrous butterfat on the label, the name shall be qualified (Secs. 403, 701(a), 52 Stat. 1047-1048, as may be declared as "butterfat”. by a phrase that reveals the connection a m e n d e d , 1055; 21 U.S.C. 343, 371 (a )) (10) Dried whole eggs, frozen whole such person has with such food; such as eggs, and liquid whole eggs may be de “Manufactured for ______,” “Dis § 501.4 Animal food; designation of in clared as “eggs”. tributed by'_____:_____,” or any other gredients. (11) Dried egg whites, frozen egg wording that expresses the facts. (a) Ingredients required to be declared whites, and liquid egg whites may be (d) “The statement of the place of on the label of a food, including foods declared as "egg whites”. business shall include the street address, that comply with standards of identity (12) Dried ess yolks, frozen egg yolks, city, State, and ZIP Code; however, the that require labeling in compliance with and liquid egg yolks may be declared as street address may be omitted if it is this Part 501, except those exempted by “egg yolks”. shown in a current city directory or tele § 501.100, shall be listed by common or (13) A livestock or poultry feed may phone directory. The requirement for usual name in descending order of pre be declared by a collective name listed inclusion of the ZIP Code shall apply dominance by weight on either the prin in § 501.110 if it is an animal feed within only to consumer commodity labels de cipal-display panel or the information the meaning of section 201 (x) of the act veloped or revised after the effective date panel in accordance with the provisions and meets the requirements for the use of this section. In the case of noncon of § 501.2. of a collective name as prescribed in sumer packages, the ZIP Code shall ap (b) The name of an ingredient shall be §501.110 for certain feed ingredients. pear either on the label or the labeling a specific name and not a collective (ge (14) [Reserved] (including invoice). neric) name, except that: (15) When all the ingredients of a (e) If a person manufactures, packs, (1) Spices, flavorings, colorings and wheat flour are declared in an ingredient or distributes a food at a place other than chemical preservatives shall be declared statement, the principal ingredient of his principal place of business, the label according to the provisions of § 501.22. the flour shall be declared by the may state the principal place of business (2) An ingredient which itself contains name(s) specified in §§ 15.1, 15.40, 15.80 in lieu of the actual place where such two or more ingredients and which has and 15.100 of this chapter, i.e., the first food was manufactured or packed or is an established common or usual name, ingredient designated in the ingredient to be distributed, unless such statement conforms to a standard established pur list of flour, or bromated flour, or en would be misleading. suant to the Meat Inspection or Poultry riched flour, or self-rising flour is "flour”, Products Inspection Acts by the U.S. De “white flour”, "wheat flour”, or “plain § 501.8 Labeling of animal food with partment of Agriculture, or conforms to flour”; the first ingredient designated in number of servings^ a definition and standard of identity es the ingredient list of durum flour is (a) The label of any package of a food tablished pursuant to section 401 of the “durum flour”; the first ingredient desig which bears a representation as to the Federal Foodu Drug, and Cosmetic Act, nated in the ingredient list of whole number of servings contained in such shall be designated in the statement of wheat flour, or bromated whole wheat package shall bear in immediate con ingredients on the label of such food by flour is “whole wheat flour”, “graham junction with such statement, and in the either of the following alternatives: flour”, or “entire wheat flour” ; and the same size type as is used for such state (i) . By declaring the established comfirst ingredient designated in the in ment, a statement of the net quantity mon or usual name of the ingredient fol gredient list of-whole durum wheat flour (in terms of weight, measure, or numeri lowed by a parenthetical listing of all in is “whole durum wheat flour”. cal count) of each such serving; how gredients contained,therein in descend (c) When water is added to reconever, such statement may be expressed in ing order of predominance except that, stitute, completely or partially, an in terms that differ from the terms used in if the ingredient is a food subject to a gredient permitted by paragraph (b) of the required statement of net quantity definition and standard of identity estab this section to be declared by a class of contents (for example, cupfuls, table lished in this subchapter E, only the name, the position of the ingredient class spoonfuls, etc.) when such differing term ingredients required to be declared by name in the ingredient statement shall is common to cookery and describes a the definition and standard of identity constant quantity. Such statement may need be listed; or be determined by the weight of the un not be misleading in any particular. A (ii) By incorporating into the state reconstituted ingredient plus the weight statement of the number of units in a ment of ingredients in descending order of the quantity of water added to re package is not in itself a statement of of predominance in the finished food, the constitute that ingredient, up to the the number of servings. common or usual name of every com amount of water needed to reconstitute (b) If there exists a voluntary prod ponent of the ingredient without listing uct standard promulgated pursuant to the ingredient-itself. the ingredient to single strength Any water added in excess of the amount of the procedures found in 15 CFR Part 10 (3) Skim milk, concentrated skim milk, by the Department of Commerce, quan reconstituted skim milk, and nonfat dry water needed to reconstitute the ingredi titatively defining the meaning of the milk may be declared as "skim milk” or ent to single strength shall be declared term “serving” with respect to a particu nonfat milk”. as “water” in the ingredient statement. lar food, then any label representation FEDERAL REGISTER, VOL. 41, NO, 177— FRIDAY, SEPTEMBER TO, 1976 38622 RULES AND REGULATIONS as to the number of servings in such ever, That in the case of articles dis § 501.18 Misbranding of animal food. packaged food shall correspond with tributed solely in the Commonwealth of (a) Among representations in the such quantitative definition. (Copies of Puerto Rico or in a Territory where the labeling of a food which render such food published standards are available upon predominant language is one other than misbranded is a false or misleading rep request from the National Bureau of English, the predominant language may resentation yvith respect to another food Standards, Department of Commerce, be substituted for English. or a drug, device, or cosmetic. Washington, DC 20234.) (2) If the label contains any repre (b) The labeling of a food which con sentation in a foreign language, all § 501.15 Animal food; prominence of tains two or more ingredients may be required statements. words, statements, and other informa misleading by reason (among other rea tion required by or under authority of sons) of the designation of such food in (a) A word, statement, or other in the act to appear on the label shall such labeling by a name which includes formation required by or under authority appear thereon in the foreign language. or suggests the name of one or more but of the act to appear on the label may lack- (3) If any article of labeling (other not all such ingredients, even though the that prominence and conspicuousness re than a label) contains any representa names of all such ingredients are stated quired by section 403(f) of the act by tion in a foreign language, all words, elsewhere in the labeling. reason (among other reasons) of: statements, and other information re (c) Among representations in the la (1) The failure of such word, state quired by or under authority of the act beling of a food which render such food ment, or information to appear on the to appear on the label or labeling shall misbranded is any representation that part or panel of the label which is pre appear on such article of labeling. expresses or implies a geographical ori sented or displayed under customary § 501.17 Animal food labeling warning gin of the food or any ingredient of the conditions of purchase; statements. ' food except when such representation is (2) The failure of such word, state either: ment, or information to appear on two (a) Self-pressurized containers. (1) The label of a food packaged in a self- Cl) A truthful representation of geo or more parts or panels of the label, each graphical origin. of which has sufficient space therefor, pressurized container and intended to be expelled from the package under pres (2) A trademark or trade name pro and each of which is so designed as to vided that as applied to the article in render it likely to be, under customary sure shall bear the following warning: W arning.—Avoid spraying in eyes. question its use is not deceptively mis- conditions of purchase, the part or panel descriptive. A trademark or trade name displayed; Contents under pressure. Do not punc ture or incinerate. Do not store at tem comprised in whole or in part of geo (3) The failure of the label to extend perature above 120° P. Keep out of reach graphical words shall not be considered over the area of the container or pack of children. deceptively misdescriptive if it: age available for such extension, so as to (2) In the case of products intended (1) Has been so long and exclusively provide sufficient label space for the for use by children, the phrase “except used by a manufacturer or distributor prominent placing of such word, state under adult supervision” may be added at that it is generally understood by the ment, or information; the end of the last sentence in the warn consumer to mean thé product of a par (4) Insufficiency of label space (for ing required by paragraph (a) (1) of this ticular Manufacturer or distributor; or the prominent placing of such word, section. (ii) Is so arbitrary or fanciful that it statement, or information) resulting . (3) In the case of products packaged is not generally understood by the con from the use of label space for any word, in glass containers, the word “break” sumer to suggest geographic origin. statement, design, or device which is not may be substituted for the word “punc (3) A part of the name required by required by or under authority of the ture” in the warning , required by para applicable Federal law or regulation. act to appear on the label; graph (a) (1) of this section. (4) A name whose market significance (5) Insufficiency of label space (for (4) The words “Avoid spraying in is generally understood by the consumer the prominent placing of such word, eyes” may be deleted from the warning to connote a particular class, kind, type, statement, or information) resulting required by paragraph (a)(1) of this or style of food rather than to indicate from the use of label space to give ma section in the case of a product not ex geographical origin. terially greater conspicuousness to any pelled as a spray. Subpart B— Specific Animal Food other word, statement, or information, (b) Self-pressurized containers toith Labeling Requirements or to any design or device; or halocarbon or hydrocarbon propellants. §501.22 Animal foods; labeling o f (6) Smallness or style of type in (1) in addition to the warning required spices, flavorings, colorings, a n d which such word, statement, or informa by paragraph (a) of this section, the la chemical preservatives. tion appears, insufficient background bel of a food packaged in a self-pressur contrast, obscuring designs or vignettes, ized container in which the propellant (a) (1) The term “artificial flavor” or or crowding with other written, printed, consists in whole or in part of a halo- “artificial flavoring” means any sub or graphic matter. carbon or a hydrocarbon shall bear the stance, the function of which is to im (b) No exemption depending on in following warning: part flavor, which is not derived from a sufficiency of label space, as prescribed W arning.—Use only as directed. Inten spice, fruit or fruit juice, vegetable or in regulations promulgated under sec tional misuse by deliberately concentrat vegetable juice, edible yeast, herb, bark, tion 403 (e) or (i) of the act, shall apply ing and inhaling the contents can be bud, root, leaf or similar plant material, if such insufficiency is caused by : harmful or fatal. meat, fish, poultry, eggs, dairy products, (2) The warning required by paraor fermentation products thereof. Ar (1) The use of label space for any tificial flavor includes the substances word, statement, design, or device which graph (b) (1) of this section is not re quired for the following products: listed in §§ 582.60 and 121.1164(b) of is not required by or under authority of this chapter except where these are de the act to appear on the label; (i) Products expelled in the form of a rived from natural sources. (2) The use of label space to give foam or cream, which contain less than (2) The term “spice” means any aro- greater conspicuousness to any word, 10 percent propellant in the container. matip vegetable substance in the whole, statement, or other information than is (ii) Products in a container with a broken, or ground form, except for those required by section 403(f) of the act; or physical barrier that prevents escape of substances which have been traditionally (3) The use of label space for any rep the propellant at the time of use. regarded as foods, such as onions, garlic resentation in a foreign language. (iii) Products of a net quantity of and celery; whose significant function in (c) (1) All words, statements, and contents of less than 2 ozs that are de food is seasoning rather than nutri other information required by or under signed to release a measured amount of tional; that is true to name; and from authority of the act to appear on the product with each valve actuation. which no portion of any volatile oil or label or labeling shall appear there n (iv) Products of a net quantity of con other flavoring principle has been re in the English language: Provided, how- tents of less than y2 oz. moved. Spices include the spices ^listed FEDERAL REGISTER, VOL. 41, N 0 7 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38623 in Subpart A of Part 582 of this chapter, (e) A food shall be exempt while held (4) Any salt (sodium chloride) used such as the following : for sale from the requirements of section as an ingredient in food shall be declared Allspice Marjoram 403(k) of the act (requiring label state by its common or usual name “salt.” Anise Mustard flour ment of any artificial flavoring, artificial (5) Any monosodium glutamate used Basil Nutmeg coloring, or chemical preservatives) if as an ingredient in food shall be declared Bay leaves Oregano said food, having been received in bulk by its common or usual name “mono Caraway seed Paprika containers at a retail' establishment, is sodium glutamate.” Cardamon Parsley displayed to the purchaser with either (6) Any pyroligneous acid or other ar Celery seed Pepper, black (1) the labeling of the bulk container tificial smoke flavors used as an ingredi ChervU Pepper, white ent in a food may be declared as artificial Clnnamoii Pepper, red plainly in view or (2) a counter card, Cloves Rosemary sign, or other appropriate device bearing flavor or artificial smoke flavor. No repre Coriander Saffron prominently and conspicuously the infor sentation may be made, either directly Cumin seed Sage ^ mation required to be stated on the label or implied, that a food flavored with py Dill seed Savory pursuant to section 403 (k) of the Act. roligneous acid or other artificial smoke\ Fennel seed Star aniseed (f) A fruit or vegetable shall be flavor has been smoked or has a true Fenugreek Tarragon smoked flavor, or that a seasoning sauce Thyme exempt from compliance with the re Ginger quirements of section 403 (k) of the act or similar product containing pyroligne Horseradish Turmeric ous acid or other artificial smoke flavor Mace with respect to a chemical preservative applied to the fruit or vegetable as a and used to season or flavor other foods Paprika, tumeric, and saffron or other pesticide chemical prior to harvest. will result in a smoked product or one spices which are also colors, shall be having a true smoked flavor. declared as “spice and coloring” unless (g) A flavor shall be labeled In the (i) If the label, labeling, or advertising declared by their common or usual name. following way when shipped to a food of a food makes any direct or indirect (3) The term “natural flavor” or manufacturer or processor (but not a representations with respect to the pri “natural flavoring” means the essential consumer) for use in the manufacture mary recognizable flavor(s), by word, oil, oleoresin, essence or extractive, pro of a fabricated food, unless it is a flavor vignette, e.g., depiction of a fruit, or other tein hydrolysate, distillate, or any prod for which a standard of identity has been means, or if for any other reason the uct of roasting, heating or enzymolysis, promulgated, in which case it shall be manufacturer or distributor of a food which contains the flavoring constituents labeled as provided in the standard: wishes to designate the type of flavor in derived from a spice, fruit or fruit juice, (1) If the flavor consists of one in the food other than through the state vegetable or vegetable juice, edible yeast, gredient, it shall be declared by its com ment of ingredients, such flavor shall be herb, bark, bud, root, leaf or similar plant mon or usual name. considered the characterizing flavor and material, meat, seafood, poultry, eggs, (2) If the flavor consists of two or shall be declared in the following way: dairy products, or fermentation products more ingredients, the label either may (1) If the food contains no artificial thereof, whose significant function in declare each ingredient by its common or flavor which simulates, resembles or rein food is flavoring rather than nutritional. usual name or may state “All flavor in forces the characterizing flavor, the name Natural flavors, include the natural es gredients contained in this product are of the food on the principal display panel sence or extractives obtained from plants approved for use in a regulation of the or panels of the label shall be accom listed in Subpart A of Part 582 of this Pood and Drug Administration.” Any panied by the common or usual name of chapter, and the substances listed in flavor ingredient not contained in one the characterizing flavor in letters not § 121.1163 of this chapter. of these regulations, and any nonflavor less than one-half the height of the let (4) The term “artificial color” or “ar ingredient, shall be separately listed on ters used in the name of the food, except tificial coloring” means any “color addi the label. that: tive” as defined in § 8.1(f) of. this (3) In cases where the flavor contains (1) If the food is one that is commonly chapter. a solely natural flavor(s), the flavor shall expected to contain a characterizing (5) The term “chemical preservative” be so labeled, e.g., “strawberry flavor,” food ingredient, and the food contains means any chemical that, when added to “banana flavor,” or “natural strawberry natural flavor derived from such ingredi food, tends to prevent or retard deterio flavor.” In cases where the flavor con ent and an amount of characterizing ration thereof, but does not include com tains both a natural flavor and an arti ingredient insufficient to independently mon salt, sugars, vinegars, spices, or oils ficial flavor, the flavor shall be so labeled, characterize the food, or the food con extracted from spices, substances added e.g., “natural and artificial strawberry tains no such ingredient, the name of the to food by direct exposure thereof to flavor.” In cases where the flavor con characterizing flavor may be imme wood smoke, or chemicals applied for tains a solely artificial flavor(s), the diately preceded by the word “natural” their insecticidal or herbicidal properties. flavor shall be so labeled, e.g., “artificial and shall be immediately followed by the (b) A food which is subject to the re strawberry flavor.” word “flavored” in letters not less than quirements of section 403 (k) of the act (h) The label of a food to which flavor one-half the height of the letters in the shall bear labeling, even though such is added shall declare the flavor in the name of the characterizing flavor. food is not in package form. (ii) 'If none of the natural flavor used statement of ingredients in the following in the food is derived from the product (c) A statement of artificial flavoring, way: whose flavor is simulated, the food in artificial coloring, or chemical preserva (1) Spice, natural flavor, and artificial which the flavor is used shall be labeled tive shall be placed on the food, or on flavor may be declared as “spice,” “nat either with the flavor of the product from its container or wrapper, or on any two ural flavor,” or “artificial flavor,” or any which the flavor is derived or as “artifi or all of these, as may be necessary to combination thereof, as the case may be. cially flavored.” render such statement likely to be read (2) .An incidental additive in a food, (iii) If the food contains both a char by the ordinary individual under cus originating in a spice or flavor used in acterizing flavor from the product whose tomary conditions of purchase and use the manufacture of the food, need not flavor is simulated and other natural of such food. be declared in the statement of ingredi flavor which simulates, resembles or rein (d) A food shall be exempt from com ents if it meets the requirements of forces the characterizing flavor, the food pliance with the requirements of section § 501.100(a) (3). shall be labeled in accordance with the 403 (k) of the act if it is not In package (3) Substances obtained by cutting, introductory text and paragraph (i) (1) form and the units thereof are so small grinding, drying, pulping, or similar proc (i) of this section and the name of the that a statement of artificial flavoring, essing of tissues derived from fruit; food shall be immediately followed by the artificial coloring, or chemical preserva vegetable, meat, fish, or poultry, e.g., words “with other natural flavor” In let tive, as the case may be, cannot be placed powdered or granulated onions, garlic ters not less than one-half the height of on such units with such conspicuousness powder, and celery powder, are com the letters used in the name of the char as to render it likely to be read by the monly understood by consumers to be acterizing flavor. ^ a r y Individual under customary food rather than flavor and shall be de (2) If the food contains any artificial onditions of purchase and use. clared by their common or usual name. flavor which simulates, resembles or re- FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38624 RULES AND REGULATIONS inforces the characterizing flavor, the Food and Drug Administration as re label declaration stating both the com name of the food on the principal dis ports to the government and as guar mon or usual name of the ingredient(s) play panel or panels of the label shall antees or other undertakings within the and a separate description of its func be accompanied by the common or usual meaning of section 301(h) of the act and tion, e.g., “preservative,” “to retard name(s) of the characterizing flavor, in subject the certifying party to the penal spoilage,” “a mold inhibitor,” “to help letters not less than one-half the height ties for making any false report to the protect flavor” or “to promote color re of the letters used in the name of the government under T8 U.S.C. 1001 and tention.” food and the name of the characterizing any false guarantee or undertaking (Secs. 402, 403, 409, 701(a), 702, 703, 704, 52 flavor shall be accompanied by the under section 303(a) of the act. Hie Stat. 1046, 1047, 1048-1049 as amended, 1055, word is) “artificial” or “artificially defenses provided under section 303(c) 1056-1057 as amended; 21 U.S.C. 342, 343, 348, flavored,” in letters not less than one- (2) of the act shall be applicable to the 371(a), 372, 373, 374.) half the height of the letters in the name certifications provided for in this sec Subparts C-E— [Reserved] of the characterizing flavor. tion. (3) Wherever the name of the char (ii) Wherever possible, the Food and Subpart F— Exemptions From Animal Food acter izing flavor appears on the label Drug Administration shall verify the ac Labeling Requirements (other than in the statement of ingredi curacy of a reasonable number of certifi § 501.100 Animal food; exemptions ents) so conspicuously as to be easily cations made pursuant to this section, , from labeling. seen under customary conditions of pur constituting a representative sample of (a) The following foods are exempt chase, the words prescribed by this par such certifications, and shall not request from compliance with the requirements agraph shall immediately and conspicu all such certifications. of section 403(i) (2) of the act (requir ously precede or follow such name, with (iii) Where no person authorized to ing a declaration on the label of/ the out any intervening written, printed, or provide such information is reasonably common or usual name of each ingredi graphic matter, except: r - available at the time of inspection, ther ent when the food is fabricated from two (i) Where the characterizing flavor certifying party shall arrange to have or more ingredients). and a trademark or brand are presented such person and the relevant materials (1) An assortment of different items together, other written, printed, or and records ready for verification as soon of food, when variations in the items graphic matter that is a part of or is as practicable; provided that, whenever that make up different packages packed associated with the trademark or brand the Food and Drug Administration has from such assortment normally occur in may intervene if the required words are reason to believe that the supplier or user good packing practice and when such in such relationship with the trademark may utilize this period to alter invento variations result in variations in the in or brand as to be clearly related to the ries or records, such additional time shall gredients in different packages, with characterizing flavor; and not be permitted. Where such additional respect to any ingredient that is not (ii) If the finished product contains time is provided, the Food and Drug Ad common to all packages. Such exemp more than one flavor subject to the re ministration may require the certifying tion, however, shall be on the condition quirements of this, paragraph, the state party to certify that relevant inventories that the label shall bear, in conjunction ments required by this paragraph need have not been materially disturbed and with the names of such ingredients as appear only once in each statement of relevant records have not been altered or are common to all packages, a statement characterizing flavors present in such concealed during such period. (in terms that are as informative as food. (iv) The certifying party shall pro practicable and that are not mislead (iii) If the finished product contains vide, to an officer or representative duly ing) indicating by name other^ ingredi three or more distinguishable character^- designated by the Secretary, such quali ents which may be present. izing flavors, or a blend of flavors with no tative statement of the composition of (2) A food having been received in primary recognizable flavor, the flavor the flavor or product covered by the cer bulk containers at a retail establish may be declared by an t appropriately tification as may be reasonably expected ment, if displayed to the purchaser with descriptive generic term in lieu of nam to enable the Secretary’s representatives either (i) the labeling of the bulk con ing each flavor. to determine which relevant raw and tainer plainly in view or (ii) a counter (4) A flavor supplier shall certify, in finished materials and flavor ingredient card, sign, or other appropriate device writing, that any flavor he supplies which records are reasonably necessary to bearing prominently and conspicuously is designated as containing no artificial verify the certifications. The examination the information required to be stated on flavor does not, to ttie best of his knowl conducted by the Secretary’s represent the label pursuant to section 403(i) (2) edge and belief, contain any artificial ative shall be limited to inspection and of the act. flavor, and that he has added no artificial review of inventories and ingredient rec (3) Incidental additives that are pres flavor to it. The requirement for such ords for those certifications which are to ent in -a food at insignificant levels and certification may be satisfied by a guar be verified. do not have any technical or functional antee under section 303(c) (2) of the act (v) Review of flavor ingredient records effect in that food. For the purposes of which contains such a specific statement. shall be limited to the qualitative formu this paragraph (a) (3), incidental addi A flavor used shall be required to make la and shall not include the quantitative tives are: - such a written certification only where formula. The person verifying the cer (i) Substances that have no technical he adds to or combines another flavor tifications may make only such notes as or functional effect but are present in a with a flavor whichhas been certified by are necessary to enable him to verify food by reason of havimg been incorpo- a flavor supplier as containing no artifi such certification. Only such notes or ra ted-into the food as an ingredient of cial flavor, but otherwise such user may such flavor ingredient records as are nec another food, in which the substance did rely upon the supplier’s certification and essary to verify such certification or to have a functional or technical effect. need make no separate certification. show a potential or actual violation may (ii) Processing aids,- which are as All such certifications shall be retained be removed or transmitted Trom the cer follows: by the certifying party throughout the tifying party’s place of business '.^Pro (a) Substances that are added to a period in which the flavor is supplied and vided, That, where such removal or food during the processing of such food for a minimum of 3 years thereafter, and transmittal is necessary for such pur but are removed in seme manner from shall be subject to the following condi poses the relevant records and notes the food before it is packaged in its tions: shall beretained as separate documents finished form. (i) The certifying party shall makein Food and Drug Administration files, (b) Substances that are added to a such certifications available upon request shall not be copied in other reports, and food during processing, are converted at all reasonable hours to any duly au shall not be disclosed publicly other than into constituents normally presen ï in the thorized office or employee of the Food in a judicial proceeding brought pursu food, and do not significantly increase and Drug Administration or any other ant to the act or 18 U.S.C. 1001. ttie amount of the constituents naturally employee acting on behalf of the Secre (j) A food to which a chemical prefound in the food. tary of Health, Educationrand Welfare. servative^) is added shall, except .when (c) Substances that are added to a Such certifications are regarded by the exempt pursuant to §501.100, bear a food for their technical or functional ex- FEDERAL REGISTER, VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38625 feet in the processing but are present adulterated or misbranded within the amend § 501.4 to specify the manner in in the finished food at insignificant levels meaning of the act upon completion of which an ingredient(s) shall be declared, and do not have any technical or func such processing, labeling, qr repacking. i.e., by specific or class name, or § 501.100 tional effect in that food. Such person and such operator shall each to exempt an ingredient (s) from the re (iii) Substances migrating to food keep a copy of such agreement until 2 quirements for label declaration. from equipment or packaging or other years after the final shipment or delivery § 501.105 Declaration of net quantity of wise affecting food that are not food ad of such food from such establishment, contents when exempt. ditives as defined in section 201 (s) of and shall make such copies available the act; or if they are food additives as for inspection at any reasonable hour to (a) The principal display panel of a so defined, they are used in conformity any oLicer or employee of the Depart food in package form shall bear a dec with regulations established pursuant to ment who requests them. laration of the net quantity of contents. section 409 of the act. (e) Conditions affecting expiration of This shall be expressed in the terms of (b) A food repackaged in a retail esexemptions. (1) An exemption of a ship weight, measure, numerical count, or a tablishment is exempt from the following ment or other delivery of a food under combination of numerical count and provisions of the act if the conditions paragraph (d) (1) of this section shall, weight or measure. The statement shall specified are met. at the beginning of the act of removing be in terms of fluid measure if the food (1) Section 403(e)(1) of the act (re such shipment or delivery, or any part is liquid, or in terms of weight if the quiring a statement on the label of the thereof, from such establishment become food is solid, semisolid, or viscous, or a name and place of business of the manu void ab initio if the food comprising such mixture of solid and liquid; except that facturer, packer, or distributor). shipment, delivery, or part is adulterated such statement may be in terms of dry (2) Section 403(g) (2) of the act (re or misbranded within the meaning of the measure if the food is a fresh fruit, fresh quiring the lâbel of a food which pur act when so removed. vegetable, or other dry commodity that ports to be or is represented as one for (2) An exemption of a shipment or is customarily sold by dry measure. If which a definition and standard of iden other delivery of a food under paragraph there is a firmly established general con tity has been prescribed to bear the name (d) (2) of this section shall become void sumer usage and trade custom of declar of the food specified in the definition and ab initio with respect to the person who ing the contents of a liquid by weight, or standard and, insofar as may be required introduced such shipment or delivery a solid, semisolid, or viscous product by by the regulation establishing the stand into interstate commerce upon refusal fluid measure, it may be used. When ard the common names of the optional by such person to make available for ever the Commissioner determines that ingredients present in the food), if the inspection a copy of the agreement, as an existing practice of declaring net food is displayed to jthe purchaser with required by paragraph (d) (2) of this quantity of contents by weight, measure, its interstate labeling clearly in view, or section. numerical count, or a combination in with a counter card, sign; or other appro (3) An exemption of a shipment or tifie case of a specific packaged food does priate device bearing prominently and other delivery of a food under paragraph not facilitate value comparisons by con conspicuously the information required (d) (2) of this section shall expire; sumers and offers opportunity for con by these provisions. (i) . At the beginning of the act of resumer confusion, he will by regulation (3) Section 403 (i) (1) of the act (re moving 6uch shipment or delivery, or designate the appropriate term or terms quiring the label to bear the common or any part thereof, from such establish to be used for such commodity. usual name of the food), if the food is ment if the food comprising such ship (b) (1) Statements of weight shall be displayed to the purchaser with its inter ment, delivery, or part is adulterated in terms of avoirdupois pound and ounce. state labeling clearly in view, or with a or misbranded within the meaning of (2) Statements of fluid measure shall counter card, sign, or other appropriate the act when so removed; or be in terms of the UJ5. gallon of 231 cubic device bearing prominently and con (ii) Upon refusal by the operator of inches and quart, pint, and fluid ounce spicuously the common or usual name of the establishment where such food is to subdivisions thereof, and shall; the food, or if the common or usual name be processed, labeled, or repacked, to (i) In the case of frozen food that is of the food is clearly revealed by its make available for inspection a copy of sold and consumed in a frozen state, appearance. the agreement as required by such express the volume at the frozen (c) [Reserved] paragraph. temperature. (ii) In the case of refrigerated food (d) Except as provided by paragraphs (f) [Reserved] (e) and (f) of this section, a shipment (g) The label declaration of a harm that is sold in the refrigerated state, ex less marker used to identify a particular press the volume at 40° F (4° C). or other delivery of a food which is, in (iii) In the case of other foods, ex accordance with the practice of the trade, manufacturer’s product may result in to be processed, labeled, or repacked in unfair competition through revealing a press the volume at 68° F (20° C). substantial quantity at an establishment trade secret. Exemption from the label (3) Statements of dry measure shall other than that where originally proc declaration of such a marker is granted, be in terms of the U.S. bushel of 2.150.42 essed or packed, shall be exempt, during therefore, provided that the following cubic inches and peck, dry quart, and the time of introduction into and move conditions are met: dry pint subdivisions thereof. ment in interstate commerce and the (1) The person desiring to use the (c) When the declaration of quantity time of holding in such establishment, marker without label declaration of its of contents by numerical count does not from compliance with the labeling re presence has submitted to the Commis give adequate information as to the quirements of section 403 (c), (e), (g), sioner of Food and Drugs full informa quantity of food in the package, it shall (h), (i), (j> anji (k) 0f the acf if; tion concerning the proposed usage and be combined with such statement of the reasons why he believes label decla weight, measure, or size of the individual (1) The person who introduced such ration of the marker should be subject to units of the foods as will provide such in shipment or delivery into interstate com formation. merce is the operator of the establish this exemption; and ment where such food is to be processed, (2) The person requesting the exemp (d) The declaration may contain com labeled, or repacked ; or tion has received from the Commissioner mon or decimal fractions. A common of Food and Drugs a finding that the fraction shall be in terms of halves, quar (2) In case such person is not such marker is harmless and that the ex ters, eighths, sixteenths, or thirty-sec operator, such shipment or delivery is emption has been granted. onds; except that if there exists a firmly to such establishment under a established general consumer usage and written agreement, signed by and con- § 501.103 Petitions requesting exemp trade custom of employing different com aining the post office addresses of such tions -from or special requirements mon fractions in the net quantity dec Person and such operator, and contain for label declaration of ingredients. laration of a particular commodity, they ing such specie rations for the process- The Commissioner of Food and may be employed. A common fraction g, labeling, or repacking, as the case Drugs, either on his own initiative or on shall be reduced to its lowest terms; a may be, of such food in such establish- behalf of any interested person who has decimal fraction shall not be carried out ment as will ensure, if such specifications submitted a petition pursuant to Part 2 to more than two places. A statement e followed, that such food will not be of this chapter may issue a proposal to that includes small fractions of an ounce FEDERAL REGISTER, VOL. 41, N O . 177-r-FRIDÁY, SEPTEMBER 10, 1976 38626 RULES AND REGULATIONS shall be deemed to permit smaller varia in relationship to the area of the princi Jk) On packages containing 4 pounds tions than one which does not include pal display panel of thè package and or 1 gallon or more and labeled in terms such fractions. shall be uniform for all packages of sub of weight or fluid measure, the declara (e) The declaration shall be located stantially the same size by complying tion shall be expressed, in pounds for on the principal display panel of the with the following type specifications: weight units with any remainder in label, and with respect to packages bear (1) Not less than inch in height on terms of^punces or common or decimal ing alternate principal panels it shall be packages the principal display panel of fraction of the pound, or in the case of duplicated on each principal display which has an area of 5 square inches or fluid measure, it shall be expressed in panel. less. the largest whole unit (gallons followed (f) The declaration shall appear as a (2) Not less than Vs inch in height on by common or decimal fraction of a gal distinct item on the principal display packages the principal display panel of lon or by the next smaller whole unit or panel, shall be separated (by at least a which has an area of more than 5 but units (quarts, or quarts and pints)) with space equal to the height of the lettering not more than 25 square inches. any remainder in terms of fluid ounces used in the declaration) from other (3) Not less than inch in height on or common or decimal fractions of the printed label information appearing packages the principal display panel of pint or quart (see paragraph (m) (6) of above or below the declaration and (by at which has an area of more than 25 but this section). least.a space equal to twice the width of hot more than 100 square inches. (l) [Reserved] the letter “N” of the style , of type used (4) Not less than % inch in height on (m) Examples: in the quantity of contents statement) packages the principal display panel of (1) A declaration of 1V2 pounds weight from other printed label information ap which has an area of more than 100 shall be expressed as “Net Wt. 24 oz. (1 pearing to the left or right of the dec square inches, except not less than Vz lb. 8 oz.),” “Net Wt. 24 oz. (1 Vz lb.),” or laration. It shall not include any term inch in height if the area^ is more than “Net Wt. 24 oz. (1.5 lb.) qualifying a unit of weight, measure, or 400 square inches. (2) A declaration of % pound avoir count (such as “jumbo quart” and “full Where the declaration is blown, em dupois weight shall be expressed as “Net gallon”) that tends to exaggerate the bossed, or molded on a glass or plastic Wt. 12 oz.” amount of the food in the container. It surface rather than by printing, typing, (3) A declaration of 1 quart liquid shall be placed on the principal display or coloring, the lettering sizes specified measure shall be expressed as “Net 32 panel within the bottom 30 percent of in paragraph (i) (1) through (4) of this fl. oz. (1 qt.) the area of the label panel in lines gen section shall be increased by of an (4) A, declaration of 1% quarts liquid erally parallel to the base on which the measure shall be expressed as “Net inch. contents 56 fluid ounces (1 quart IV2 package rests as it is designed tc be dis (j) On packages containing less than played: Provided, That on packages hav pints) ” or as “Net 56 fluid oz. (1 qt. 1 pt. 4 pounds or 1 gallon and labeled in terms 8 oz.),” but not in terms of quart and ing a principal display panel of 5 square of weight or fluid measure: inches or less, the requirement for place ounce such as “Net 56 fluid oz. (1 quart ment within the bottom 30 percent of the (1) The declaration shall be expressed 24 ounces)”. area of the label panel shall not apply both in ounces, with identification by Hv(5> On a random package, declaration when the declaration of net quantity of weight or by liquid measure and, if ap of % pound avoirdupois may be ex contents meets the other requirements plicable (1 pound or 1 pint or more) fol pressed as “Net Wt. .75 lb.” lowed in parentheses by a declaration (6) A declaration of 2Vz gallons liquid of this part. in pounds for weight units, with any re (g) The declaration shall accurately measure shall be expressed as “Net con mainder in terms of ounces or common tents 2 V2 gallons,” “Net contents 2.5 gal reveal the quantity of food ir. the pack or decimal fractions of the pound (see lons,” or “Net contents 2 gallons 2 age exclusive of wrappers and other ma examples set forth in paragraph (m) (1) quarts” and not as “2 gallons 4 pints”. terial packed therewith; provided that and (2) of this section), or in the case (n) For quantities, the^ following ab In the case of foods packed in containers of liquid measure, in the largest whole breviations and none other may be em designed to deliver the food under pres Units (quarts, quarts and pints, or pints, ployed (periods and plural forms are sure, the declaration shall state the net as appropriate) with any remainder in optional): quantity of the contents that will be ex terms of fluid ounces or common or deci weight wt. " pint pt. pelled when the instructions for use as mal fractions of the pint or quart (see ounce oz. quart qt. shown on the container are followed. examples in paragraph (m) (3) and (4) pound lb. fluid fl. „ The propellant is included in the net of this section). gallon gal. quantity declaration. ' _ (2) If the net quantity of contents dec (o) Nothing in this section shall pro (h) The declaration shall appear in laration appears on a random package, hibit supplemental statements at loca conspicuous and easily legible boldface that is a package which is one of a lot, tions other than the principal display print or type in distinct contrast (by shipment, or delivery of packages of the typography, layout, color, embossing, or panel (s) describing in nondeceptive same consumer commodity with varying terms the net quantity of contents; pro molding) to other matter on the package; weights and with no fixed weight pattern, except that a declaration of net quantity vided, that such supplemental statements it may, when the net weight exceeds T. of net quantity of contents shall not in blown, embossed, or molded on a glass pound, be expressed in terms of pounds clude any term qualifying a unit of or plastic surface is permissible when all and decimal fractions of the pound car label information is so formed on the weight, measure, or count that tends to ried out to not more than two decimal exaggerate the amount of the food con surface. Requirements of conspicuous places. When the net weight does not ex tained in the package; for example, ness and legibility shall include the speci ceed i pound^the declaration on the ran “jumbo quart” and “full gallon”. Dual fications that: v dom package may be in decimal fractions or combination declarations of net quan (1) The ratio of height to width (of of tiie pound in lieu of ounces (see ex tity of contents as provided for in para the letter) shall not exceed a differential ample in paragraph (m) (5) of this graphs (a), (c),, and (3) of this section of 3 units to 1 unit (no more than 3 times section). (for example, a combination of net as high as it is wide). (3) The declaration may appear in weight plus numercial count, net con (2) Letter heights pertain to upper more than one line. The term “net tents plus dilution directions of a con case or capital letters. When upper and weight” shall be used when stating the centrate, etc.) are not regarded as sup lower case or all lower case letters are net quantity of contents in terms of plemental net quantity statements ana used, it is the lower case letter “o” or its weight. Use of the terms “net” or “net may be located on the principal display equivalent that shall meet the minimum contents” in terms of fluid measure or panel. - . standards. numerical count is optional. It is suffi (p) A separate statement of the net (3) When fractions are used, each cient to distinguish avoirdupois ounce quantity of contents in terms of the met component numeral shall meet one-half from fluid ounce through association of ric system is not regarded as a supple-, the minimum height standards. terms; for example, “Net vft. 6 oz." or mental statement and an accurate state (i) The declaration shall be in letters “6 oz. Net wt.” and “6 fl. oz.” or “Net ment of the net quantity of contents in and numerals in a type size established contents 6 fl. oz.” terms of the metric system of weight or FEDERAL REGISTER, VOL. 41, N O . 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38627 measure may also appear on the prin that any subsequent distribution by him (1) “Animal protein products” include cipal display panel or on other panels. of said product except for his own insti one or more of the following: Animal (q) The declaration of net quantity of tutional use is unlawful. This statement products, marine products, and milk contents shall express an accurate state shall be kept on file at the principal place products. ment of the quantity of contents of the of business of the manufacturer or proc (2) “Forage products” include one or package. Reasonable variations caused essor for 2 years subsequent to the date more of the following: Alfalfa meals, en by loss or gain of moisture during the of shipment of the product and shall be tire plant meals, hays, and stem meals. course of good distribution practice or available to thé Food and Drug Admin (3) “Grain products” include one or by unavoidable deviations in good manu istration upon request. more of the following: Barley, grain sor facturing practice will be recognized. (2) The product shall be labeled on ghums, maize (com), oats, rice, rye, and Variations from stated quantity of con the outside of its shipping container with wheat. tents shall not be unreasonably large. the statement(s) : (4) “Plant protein products” include (r) [Reserved] (i) When the variation concerns netone or more of the following: Algae (s) On a multiunit retail package, a weight and/or drained weight of vo'- meals, coconut meals (copra), cottonseed ume—“Product Mislabeled. Actual net meals, guar meal, linseed meals, peanut statement of the quantity of contents meals, safflower meals, soybean meals, shall appear on the outside of the pack weight (drained weight or volume where age and shall include the number of in appropriate) may be as low a s ___ % sunflower meals, and yeasts. below labeled quantity. This Product Not (5) “Processed grain byproducts” in dividual units, the quantity of each in clude one or more of the following: dividual unit, and, in parentheses, the for Retail Distribution”, the blank to be filled in with the maximum percentage Brans, brewers dried grains, distillers total quantity of contents of the multi grains, distillers solubles, flours, germ unit package in terms of avoirdupois or variance between the labeled and actual weight or volume of contents of the in meals, gluten feeds, gluten meals, grits, fluid ounces, except that such declara groats, hominy feeds, malt sprouts, mid tion of total quantity need not be fol dividual packages in the shipping con tainer, and dlings, pearled, polishings, shorts, and lowed by an additional parenthetical wheat mill nm. declaration in terms of the largest whole FEDERAL REGISTER, V O L 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 38628 RULES AND REGULATIONS 02> The percentage of a characteriz name of the food required by paragraphs packing of low-acid foods in hermet ing ingredient or component shall be (a) and (b) of this section, in easily ically sealed containers are operated or declared by the words “containing to r legible bold face print or type in distinct administered in a manner adequate to contains)___ percent (or % ) ____ ” on contrast to other printed or graphic protect the public health. “___ percent (or %) ___” with the first matter, and in a height not less than the blank filled in with the percentage ex larger of the alternatives established § 507.3 Definitions. pressed as a whole number not greater under paragraph (b) (2) (i) and (ii) of (a) “Aseptic processing and packag than the actual percentage of the in this section. ing” means the filling of a commercially gredient or component named and the (d) A common or usual name of a"sterilized cooled product into presteril second blank filled in with the common food may be established by common us ized containers, followed by aseptic her- or usual name of the ingredient or com age or by establishment of a regulation, metical sealing, with a presterilized clo ponent. The word “containing” (or “con- fn this part, in a standard of identity, or sure, in an atmosphere free of micro tains”) , when used, shall appear on a in other regulations in this chapter. organisms. (b) “Bleeders” means openings used line immediately below the part of the § 503.22 Petitions, common or usüal name of the food re to remove air, that enters with steam, quired by paragraph (a) of this section. (a) The Commissioner of Food and from retorts and steam chambers and to For each characterizing ingredient or Drugs, either on his own initiative or on promote circulation of steam in such re component, the words “__ < percent (or behalf of any interested person who has torts and steam chambers. Bleeders may %) __” shall appear following or di submitted a petition, may publish a pro serve as a means of removing condensate. rectly below the word “containing” (or posal to establish or amend, under this (c) “Cdming-up-time” means the time “contains”), or directly below the part of part, a regulation prescribing a common which elapses between the introduction the common or usual i. ame of the food or usual name for a food. Any such peti of steam into the closed retQrt and the required'by paragraph (a) of this section tion shall include an adequate factual time when the retort reaches the required when the word “containing” (or “ con basis to support the petition, shall be in processing temperature. tains”) is not used, in easily legible bold the form set forth in § 2.65 of this chap (d) “Commercial processor” shall in face print or type in distinct contrast to ter, and will be published io r comment if clude any person engaged in commercial other printed or graphic matter, and in it contains reasonable grounds for the custom, and so-called sportsman process a height not less than the larger of the proposed regulation. ing ox institutional processing of food. following alternatives i (b) If the principal display panel of a (e) "Commercial sterility” of food (i) Not less than one-sixteenth inch in food for which a common or usual name means the condition achieved by appli height on packages having a principal regulation is established is too small to cation of heat which renders such food display panel with an area of 5 square accommodate all mandatory require free of viable forms of microorganisms inches or less and not less than one- ments, the Commissioner may establish having public health significance, as well eighth inch in height if the area of the by regulation an acceptable alternative as any microorganisms of nonhealth principal display panel is greater than (e.g., a smaller type size). A petition re significance capable of reproducing in 5 square inches; or questing such a regulation, which would the food under normal nonrefrigerated amend the applicable regulation, shall conditions of storage and distribution. (ii) Not less than one-half the height be submitted to the office of the Hearing of the largest |ype appearing in the part “Commercial sterility” of equipment and Clerk in the form set forth in § 2.65 of containers used for aseptic processing of j-he common or usual name of the food this chapter. required by paragraph (a) of this section. -and packaging of food means the condi tion achieved by application of heat, (c) The common or usual name of aPART 507— THERMALLY PROCESSED chemical sterilant(s), or other appropri food shall include a statement of the LOW-ACID ANIMAL FOODS PACKAGED ate treatment which renders such equip presence or absence of any characteriz IN HERMETICALLY SEALED CON ment and containers free of viable forms ing ingredient(s) or component(s) and/ TAINERS of microorganisms having public health or the need for the user to add any char Subpart A— General Provisions significance as well as any micro acterizing ingredient (s) or component(s) organisms of nonhealth Significance ca when the presence or absence of such Sec. 607.1 Current good manufacturing prac pable of reproducing in the food under ingredientes) /or component(s) in the tice. normal nonrefrigerated conditions of food bras a material bearing on price or 607.3 Definitions. storage and distribution. consumer acceptance or when the label 607.10 Personnel. Cf) “Flame sterilizer” means an ap ing or the appearance of the food may Subpart B— [Reserved] paratus in which hermetically sealed otherwise create an erroneous impres containers are agitated at atmospheric sion that such ingredient(s) or compo Subpart C— Equipment pressure, by either continuous, discon nents) is present when it it not, and 5Q7.40 Equipment and procedures. tinuous, or reciprocating movement, over consumers may otherwise be misled Subpart D— Control of Components, Food Product gas flames to achieve sterilization tem about the presence or absence of the in Containers, Closures, and In-Process Materials peratures. A holding period in a heated gredients) or component(s) in the food. 607.60 Containers. section may follow the Initial heating The following requirements shall apply Subpart E— Production and Process Controls period. unless modified by a specific regulation in (g) “Headspace, gross” is the vertical this part. 507.81 Product preparation. 607.83 Establishing scheduled processes.' distance between the level of the product (1) The presence or absence of a char 507.87 Operations In the thermal proc (generally the liquid surface) in an up acterizing ingredient or component shall essing room. 5 -! v right rigid container and the top edge be declared by the words “containing (or 607.89 Deviations in processing. of the container (the top of the double contains)___.______” or “containing Subpart F— Records and Reports seam of a can or the top edge of a glass (or contains) n o ______” or “no jar). ______” or “does not contain 607.110 Processing and production records. (h) “Headspace, net” of a container ______,” with the blank being filled Authority: Secs. 402(a)(4), 701(a), 52 having a double seam, such as a can, is in with the common or usual name of Stat. 1046,1065 ( 21 U.S.C. 342(a) (4), 371(a)). the vertical distance between the level of the ingredient or component. Subpart A— General Provisions the product (generally the liquid sur (2) The need for the user of a food face) in the upright rigid container and to add any characterizing ingredient (s) § 507.1 Current good manufacturing the inside surface of the lid. or component(s) shall be declared by an practice. (I) “Hermetically sealed container^ appropriate informative statement. The criteria in § § 507.10 through 507.- means a container which is designed and N (3) The statement(s) required under 110 shall apply in determining whether intended to be secure against the entry paragraph (c)(l> and/or (2) of this the facilities, methods, practices, and of microorganisms and to maintain the section shall appear following or directly controls used by the commercial proces commercial sterility of its contents aft«: below -the part of the common or usual sor in the manufacture, processing, or processing. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38629 (j) “Incubation” means the holding Subpart B— [Reserved] may be a recording-controlling instru of a sample(s) at a specified temperature Subpart C— Equipment ment when combined with a recording for a specified period of time before thermometer. examination. § 507.40 Equipment and procedures. (5) Steam inlet. The steam inlet to (k) “Initial temperature” means the (a) Equipment and procedures foreach still retort shall be large enough average temperature of the contents of pressure processing in steam in still re to provide sufficient steam for proper op the coldest container to be processed at torts—(1) Indicating mercury-in-glass eration of the retort. Steam may enter the time the sterilizing cycle begins, as thermometer. Each retort shall be either the top portion or the bottom por determined after thorough stirring or equipped with at least one mercury-in tion of the retort but, in. any case, shall shaking of the filled and sealed container. glass thermometer with a temperature enter the portion of the retort opposite (l) “Lot” means the product produced range of not more than 100° P in th e v the vent; for example, steam inlet in during the period of time indicated by a processing range on a scale at least 7 bottom portion and vent in top portion. specific code. inches in length. The scale divisions shall (6) Crate supports. A bottom crate (m) “Low-acid foods” means any be no more than 2° P. Thermometers support shall be employed in vertical foods, other than alcoholic beverages, shall be tested for accuracy against a still retorts. Baffle plates shall not be with a finished equilibrium pH value known accurate standard thermometer used in the bottom of still retorts. greater than 4.6 and a water activity upon installation and at least once a (7) Steam spreaders. Steam spread greater than 0:85 and -also includes any year„4hereafter or more frequently as ers, which are perforated or other style normally low-acid fruits, vegetables, or may be necessary to ensure their ac continuations of the steam line inside the vegetable products ih which for the pur curacy. Bulbs of indicating thermome retort, should not be larger than the pose of thermal processing the pH value ters shall be installed either within the steam inlet line., Horizontal still retorts is reduced by acidification. Tomatoes, retort shell or in external wells attached shall be equipped with steam spreaders pears, and pineapples, or the jmces to the retort. External wells or pipes shall that extend along the bottom for the thereof, having a pH of less than 4*.7and be connected to thé retort through at length of the retort; the perforations figs having a pH of 4.9 or below shall not least a %-inch diameter opening, and should be along the top 90° of this pipe. be classed as low-acid foods. shall be equipped 'with a 1/16 inch or Horizontal still retorts over 30 feet long (n) “Minimum thermal process” larger bleeder opening so located should have two steam inlets connected means the application of heat to food, as to provide a full flow of steam past to the spreader. In vertical still retorts either before or after sealing, in a her the length of the thermometer bulb. The the steam spreaders, if used, should be metically sealed container, for a period bleeder for external wells shall emit in the form of a cross with the perfora steam continuously during the entire tions along the top or sides of the pipe. of time and at a temperature scien The number of perforations in spreaders tifically determined to be adequate to processing period. Thermometers shall be installed where they can be accurately for both horizontal and vertical still ensure destruction of microorganisms retorts should be such that the total of public health significance. and easily read. A thermometer that has a divided mercury column or that devi cross-sectional area of the perforations (o) “Retort” means any closed vessel is equal to 1 to 2 times the cross- or other equipment used for the thermal ates more than 1° F from the standard shall be repaired or replaced. The mer sectional area of the steam inlet line. processing of foods. (8) Bleeders. Bleeders, except those (p) “Scheduled process” means the cury thermometer—not the recorder chart—shall be the reference instrument for thermometer wells, shall be one- process selected by the processor as ade eighth inch or larger and shall be wide quate under the conditions of manufac for indicating the processing tempera ture. open during the entire process, includ ture for a given product to achieve com ing the coming-up-time. For horizontal mercial sterility. This process may be in (2) Temperature recording device. There shall be an accurate temperature retorts, bleeders shall be located within excess of that necessary to ensure de approximately 1 foot of each end; addi struction of microorganisms of public recording device for each still retort ad justed to agree within 1 ° P of the known tional bleeders shall be located not more health significance. accurate mercury-in-glass thermometer. than 8 feet apart along the top. Vertical (q) "Shall” and “should.” As used in A means of preventing unauthorized retorts shall have at least one bleeder' this part, “shall” refers to mandatory changes in adjustment shall be provided. opening located in that portion of the requirements and “should” refers to rec The chart graduations shall not exceed retort opposite the steam inlet. In re ommended or advisory procedures or 2° P within a range of 10° P of the torts having top steam inlet and bottom equipment. processing temperature. Each chart shall venting, a bleeder shall be installed in (r) “Vents’* means openings controlled have a working scale of not more than the bottom of the retort to ensure by gate, plug cock, or other adequate 50° F per inch within a range of 20° P removal of condensate. All bleeders shall valves used for the elimination of air of the processing temperature. This re be arranged in such a way that the during the venting period. corder may be combined with the steam operator can observe that they are func (s) “Water activity” or “a„” means the controller and may bé a recording-con tioning properly. vapor pressure of the food product dir trolling instrument. The temperature re (9) Stacking equipment and position vided by the vapor pressure of pure water corder bulb shall be installed either of containers. Crates, trays, gondolas, under identical conditions of pressure within the, retort shell or in a wéH at etc., for holding containers shall be and temperature. tached to the shell. Each temperature made of strap iron, adequately perfo § 507.10 Personnel. recorder bulb well shall have a l/HR rated sheet metal, or other suitable ma inch or larger bleeder opening emitting terial. When perforated sheet metal is All operators of retorts, processing sys steam continuously during the process used for the bottoms, the perforations tems, and aseptic processing and pack ing period. should be approximately the equivalent aging systems, and container closure in (3) Pressure gages. Each retort shall of 1-inch holes on 2-inch centers. If spectors shall be under the operating be equipped with a pressure gage. The dividers are used between the layers of supervision of a person who has attended gage should be graduated in divisions containers,"tbey should be perforated as a school approved by the Commissioner of 2 pounds or less, should be connected above. When there is stratification of for giving instruction in retort opera to the retort shell, or external well by a the product tot the containers, the con tions, processing systems operations, short gooseneck tube, and should be not tainers should be processed in such a aseptic processing and packaging sys more than 4 inches higher than the position that the plane of stratification tems operations, and container closure gooseneck. The gage should be checked is vertical. inspections, and has been identified by for accuracy at least once a year. (10) Vents. Vents shall be installed in that school as having satisfactorily (4) Steam controller. Each retort shall such a way that air is removed from the completed the prescribed course of be equipped with a steam controller to retort before timing of the process is instruction. maintain the retort temperature. This started. Vents shall fcj controlled by FEDERAL REGISTER. VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 38630 RULES AND REGULATIONS gate, plug cock, or other adequate type (&) Venting through multiple 1-inch valves which shall be fully open to per vents discharging through a manifold Overflow Pipe as Vent mit rapid discharge of air from the re to atmosphere. tort during the venting period. Vents shall not be connected directly to a Gate Valve closed drain system. If the overflow la used as a vent, there shall be an atmos pheric break in the line before it con nects to a closed drain. The vent shall be located in that portion of the retort op posite the steam inlet; for example, steam inlet in bottom portion and vent in top portion. Where a retort mani fold connects several vent pipes from a single still retort, it shall be controlled by a gate, plug cock, or other adequate type valve. The retort manifold shall be Specifications. One 1-inch vent for every of a size such that the cross-sectional 5 feet of retort length; end vents not over area of the pipe is larger than the total 2 % feet from ends of retort; size of mani cross-sectional area of all connecting fold—for retorts less than 15 feet in length, vents. The discharge shall not be di 2% inches; for retorts 15 feet and over in rectly connected to a closed drain with length, 3 inches. Specifications. A 1 y2 -inch overflow pipe out an atmospheric break in the line. Venting method. Manifold vent gate or equipped with a 1 1 4 -inch gate or plug cock A manifold header connecting vents or plug cock valve should be wide open for at valve and With' not more than 6 feet of manifolds from several still retorts shall least 6-minutes and to at least 225° F, or for 1 %-inch pipe beyond the vafve before break lead to the atmosphere. The manifold at least 8 minutes and to at least 220° F. to the atmosphere or to a manifold header. header shall not be controlled by a valve (c) Venting through water spreaders. Venting method. Vent gate or plug cock and shall be of a size such that the valve should be wide open for at least 4 cross-sectional area is at least equal to Vent Globe Valve minutes and to at least 218° F, or for at the total cross-sectional area of all con least 5 minutes and to at least 215° F. necting retort manifold pipes from all Sate Valve —’{LxZL— W ater (&) Venting through a single 1-inch retorts venting simultaneously. Timing side or top vent. of the process shall not begin until the retort has been properly vented and the Water Spreader processing temperature has bee:i Steam Spreader reached. Retorts using air for pressure cooling shall be equipped with a ball or globe valve or suitable valve and piping Inlet arrangement on the air line to prevent Size of water inlet, vent pipe, and vent air leakage into the retort during proc valve. For retorts less than 15 feet in length, essing. Some typical installations and 2 Inches; for retorts 15 feet and over in operating procedures reflecting the re length, 2 % inches. quirements of this section for venting Size of watep-epreader. For retorts less than still retorts are given in paragraph 15 feet in length, 1% Inches; for retorts 15 feet and over in length, 2 Inches. FEDERAL REGISTER, V O L 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38631 (iii) Such measurements and recordto the retort shell or external well by a (11) Retort headspace, The headspace ings should be made at intervals not to short gooseneck tube, and should be not necessary to control the air pressure exceed 15 minutes. more than 4 inches higher than the should be maintained between the water (b) Equipment and procedures for gooseneck. The gage should be checked level and the top of the retort shell. pressure processing in water in still re- for accuracy at least once a year. (12) Vertical and horizontal still re torts—(1) Indicating mercury-in-glass (il) An adjustable pressure relief, or torts. Vertical and horizontal still retorts thermometer. Each retort shall be control valve of a capacity sufficient to should follow the arrangements in the equipped with at least one mercury-in prevent uffdiesired increase in retort following diagrams or be equivalent. glass thermometer that has a tempera pressure when the water valve is wide Vertical Retorts ture range of not more than 100° F in open and should be installed in the over the processing range on a scale at least flow line. 7 inches in length or a temperature (4) Steam introduction. The distribu range of not more than 150* F on a tion of steam in the bottom of the retort scale at least 9 inches in length. The shall be accomplished in a manner ade scale divisions shall be no more than quate to provide uniform heat distribu 2' F. Thermometers shall be tested for tion throughout the retort In vertical accuracy against a known accurate retorts, uniform steam distribution can standard thermometer upon installation be achieved by any of several methods. and at least once a year thereafter or In horizontal retorts, the steam distrib more frequently as may be necessary to utor shall run the length of the bottom ensure their accuracy. Bulbs of indi of the retort with perforations distrib cating thermometers shall be located in uted uniformly along the upper part of such a position that they are beneath the pipe. the surface of the water throughout the (5) Crate supports. A bottom crate process. On horizontal retorts this entry support shall be employed in vertical should be made in the side at the cen still retorts. Baffle plates shall not be ter, and the thermometer bulbs shall used in the bottom of the retort. Center be inserted directly into the retort shell. ing guides should be installed so as to In both vertical and horizontal retorts, ensure that there be about 1%-inches the thermometer bulbs shall extend di clearance between the side wall of the rectly into-the water a minimum of at crate and the retort wall. least 2 inches without a separable well or (6) Stacking equipment. Crates, trays, sleeve. Thermometers shall be installed gondolas, etc., for holding containers where they can be accurately and easily shall be made of strap iron, adequately read. A thermometer that has a divided perforated sheet metal, or other suitable material. When perforated sheet metal mercury column or that deviates more L e g e n d f o b V e r t i c a l ” a n d H o r i z o n t a l S t i l l is used for the bottoms, the perforations than 1° F from the standard shall be R e t o r t s repaired or replaced. The mercury should be approximately the equivalent A—Water line., thermometer—not the recorder chart— of 1-inch holes on 2-inch centers. If B—Steam line. shall be the reference instrument for in divider plates are used between the lay C—Temperature control. dicating the processing temperature. ers of containers, they should be per D—Overflow line. forated as above. Ei—Drain line. (2) Temperature recording device. (7) Drain valve. A nonclogging, water Es—Screens. There shall be an accurate temperature F—Check valves. recording device for each still retort tight valve shall be used. Screens should G—Line from hot water storage. adjusted to agree within 1° F of the be installed over all drain openings. H—Suction line and manifold. (8) Water level indicator. There shall I—Circulating pump. known accurate mercury-in-glass ther be a means of determining the water J—Petcocks. mometer. A means of preventing un level in the retort during operation (e.g., K—Recirculating line. authorized changes in adjustment shall by using a gage water glass or pet- L—Steam distributor. — be provided. The chart graduations shall cock (s)). Water shall cover the top layer M—Temperature controller bulb. not exceed 2° F within a range of 10° F of containers during the entire coming- N—Thermometer. of the processing temperature. Each up-time and processing periods and O—Water spreader. chart shall have a working scale of not P—Safety valve. should cover the top layer of containers Q—Vent valve for steam processing. more than 50° F per inch within a range during the cooling periods. R—Pressure gage. of 20° F of the processing temperature. (9) Air supply and controls. In both S—Inlet air control. This recorder may be combined with horizontal and vertical still retorts for T—Pressure control. the steam controller and may be a re pressure processing in water, a means TJ—Air line. cording-controlling instrument. The re shall be provided for introducing com V—To pressure control instrument. cording thermometer bulb should be pressed air at the proper pressure and W—To temperature control instrument. located adjacent to the bulb of the mer- rate. The proper pressure shall be con X—Wing nuts. cury-in-glass thermometer except in the Yi—Crate support. trolled by an automatic pressure control Y2—Crate guides. case of a vertical retort equipped with a unit. A check valve shall be provided in Z—Constant flow orifice valve. combination recorder-controller. In such the air supply line to prevent water from Zi—Constant flow orifice valve used during vertical retorts the temperature record Mitering the system. Air or water circu come-up. er-control bulb shall be located at the lation shall be maintained continuously Za—Constant flow orifice valve used during bottom of the retort below the lowest cook. crate rest in such a position that the during the coming-up-time, processing, steam does not strike it directly. In hori and cooling periods; if air is used to pro (13) Water circulation. When a water zontal retorts the temperature recorder- mote circulation it shall be introduced circulating system is used for heat dis control bulb shall be located between into the steam line at a point between tribution it shall be installed in such a the water surface and the horizontal the retort and the steam control valve manner that water will be drawn from Plane passing through the center of the at the bottom of the retort. the bottom of the retort through a suc retort so that there is no opportunity (10) Cooling water supply. In vertical tion manifold and discharged through a lor direct steam impingement upon the retorts the cooling water should be in spreader which extends the length of the control bulb. troduced at the top of the retort between top of the retort. The holes in the water the water and container levels; in hori spreader shall be uniformly distributed . ^ Pressure gages. (4) Each retort zontal retorts the cooling water should and should have an aggregate area not hall be equipped with a pressure gage. be introduced into the suction side of greater than the cross section area of the The gage should be graduated in divi the pump. A checkrvalve should be in outlet line from the pjjmp. The suction sions of 2 lbs or less, should be connected cluded in the cooling water line. outlets should be protected with nonclog- FEDERAL REGISTER; VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38632 RULES AND REGULATIONS ging screens to keep debris from entering the shell. Each temperature recorder bulb required in this chapter. If the alterna the circulating system. The pump shall well shall have a He-inch or larger bleed tive procedure of prompt cooling is fol be equipped with a pilot light or other er opening emitting steam continuously lowed, the subsequent handling meth signaling device to warn the operator during the processing period. ods used for the containers in the retort when it is not running, and with a bleed (3) Pressure gages. Each retort shall at the time of stopping and cooling shall er to remove air when starting opera be equipped with a pressure gage. The be entered on the production records. tions. gage should be graduated in divisions of (9) Temperature drop. If the tempera (14) Critical factors, (i) Where maxi2 pounds or less, should be connected to ture of the continuous retort drops be mum drained weight is specified in the the retort shell or external well by a low the temperature specified in the scheduled process it shall be measured short gooseneck tube, and should be not scheduled process while containers are and recorded at intervals of sufficient more than 4 inches higher than the in the retort, the retort reel shall be frequency to ensure that the weight of gooseneck. The gage should be checked stopped promptly. An automatic device the product does not exceed the maxi for accuracy at least once a year. should be used to stop the reel when the mum for the given container size speci (4) Steam controller. Each retort shall temperature drops below the specified fied in the scheduled process. be equipped .with an automatic steam process temperature. Before the reel is (ii) Closing machine vacuum (in vac controller to maintain the retort tem restarted, all containers in the retort uum-packed products) shall be observed perature. This may be a recording-con shall be given a complete still retort and recorded at intervals of sufficient trolling instrument when combined with process if the temperature drop was 10° frequency to ensure that the vacuum is a recording, thermometer. F or more below the specified tempera as specified in the scheduled process. (5) Bleeders. Bleeders, except those ture. Alternatively, container entry to (iii) Such measurements and record for thermometer wells, shall be %-inch the retort shall be stopped and the reel ings should be made at intervals not to or larger and shall be wide open during shall be restarted to empty the retort. exceed 15 minutes. the entire process, including the coming- The discharged containers shall be either (c) Equipment and procedures forup-time. Bleeders shall be located within reprocessed, repacked and reprocessed, pressure processing in steam in continu approximately 1 foot of each end; addi or discarded. Both the time at which the ous agitating retorts—(1)/ Indicating tional bleeders shall be located not more reel stopped and the time the retort was mercury-in-glass thermometer. Each re than 8 feet apart along the top of the re used for a still retort process, if so used, tort shall be equipped with at least one tort. All bleeders shall be arranged in shall be marked on the, recording chart mercury-in-glass thermometer that has such a way that the opera toucan observe and entered on the other production a temperature range of not more than that they are functioning properly. records required in this chapter. If the 100° F in the processing range on a scale (6) Venting and condensate removal. alternative procedure of emptying the at least 7 inches in length. The scale di Vents shall be located in that portion of retort is followed, the subsequent han visions shall be no more than 2° F. Ther the retort opposite the steam inlet. Air dling methods used for the containers in mometers shall be tested for accuracy shall be removed before processing is the retort at the time of the tempera against a known accurate standard ther started. At the time steam is turned on, ture drop shall be entered on the pro mometer upon installation and at least the drain should be opened for a time duction records. If the temperature drop once a year thereafter or more frequently sufficient to remove steam condensate was less than 10° F, an authorized emer as may be necessary to ensure their^accu- from the retort and provision shall be gency still process approved by a quali racy. Bulbs of indicating thermometers made for continuing drainage of con fied person(s) having expert knowledge shall be installed either withinrthe retort densate during the retort operation. The of thermal processing requirements may shell or in external wells attached to the condensate bleeder in the bottom of the be used before restarting the retort reel. retort. External wells or pipes shall be shell serves as an indicator of continuous Alternatively, container entry to the re connected to the retort through at least condensate removal. tort shall be stopped and an authorized a %-inch diameter opening, and shall be (7) Retort speed timing. The rota emergency agitating process may be used equipped with a Hß-toch or larger bleeder tional speed of the retort shall be speci before container entry to the retort is opening so located as to provide a full fied in the scheduled process. The speed restarted. If any emergency process and flow of steam past the length of the ther shall be adjusted and recorded when the procedure is utilized, no containers shall mometer bulb. The bleeders for external retort is started, at any time a speed enter the retort during this time and the wells shall emit steam continuously dur change is made, and at intervals of suffi process and procedures used shall be en ing the entire processing period. Ther cient frequency to ensure that the retort tered on the production records. mometers shall be installed where they speed is maintained as specified in the (10) Critical factors. The minimum scheduled process. These adjustments headspace of containers, if specified in can be accurately and easily read. A ther the scheduled process, shall be measured mometer that has a divided mercury col and recordings should be made every 4 hours or less. Alternatively, a recording and récorded at intervals of sufficient fre umn or that deviates more than 1° F quency to ensure that the headspace is from the standard shall be repaired or tachometer may be usecT to provide a continuous record of the speed. A means as specified in the scheduled process. The replaced. The mercury thermometer— headspace of solder-tipped, lap seam not the recorder chart—shall be the ref of preventing unauthorized speed (vent hole) cans may be measured by erence instrument for indicating the changes on retorts shall be provided. net weight determinations. Where the processing temperature. (8) Emergency stops. If a retort jams product consistency is specified in the (2) Temnerature recording device. or breaks down during processing opera - scheduled process, the consistency of the There shaU be an accurate temperature . tions, necessitating cooling the retort for product shall be .determined by objec recording device for each retort adjusted repairs, the retort shall either be op tive measurements on the product taken to agree within 1° F of the known accu erated as a still retort, with all con from the filler before processing and re rate mercury-in-glass thermometer. A tainers being given a full still retort corded at intervals of sufficient frequency means of preventing unauthorized process before the retort is cooled, or the to ensure that the consistency is as speci changes in adjustment shall be provided. retort shall be cooled promptly and all fied in the scheduled process. Minimum The chart graduations shall not exceed containers shall be either reprocessed, closing machine vacuum (in vacuum- 2° F within a ranee of 10° F of the proc repacked and reprocessed, or discarded. packed products), maximum drained essing temnerature. Each chart shall (i) Any containers in the retort in weight, minimum net weight, and per have a working scale of not more than take valve of a continuous retort at the cent solids shall be as specified in the 50° F per inch within a range of 20° F time of breakdown shall either be re scheduled process for all products where of the processing temperature. This re processed, repacked and reprocessed, or deviations from such specifications may corder may be combined with the steam discarded. affect the scheduled process. Measure (ii) Both the time at which the reel ments of these critical factors shall be controller and may be a recording-con stopped and the time the retort was used made and recorded at intervals of sui- trolling instrument. The temperature re for a still retort process, if so used, shall flcient frequency to ensure that they are corder bulb shall be installed either with be marked on the recording chart and as specified in the scheduled process. An in the retort shell-or in a well attached to entered on the other production records measurements and recordings of criticai FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38633 factors should be made at intervals not or larger and shall be wide open during accuracy against a known accurate to exceed 15 minutes. the entire process, including the coming- standard thermometer upon installation (d) Equipment and procedures forup-time. Bleeders shall be located within and at least once a year thereafter or pressure processing in steam in discon approximately 1 foot of each end; addi more frequently as may be necessary to tinuous agitating retorts—(1) Indicating tional bleeders shall be located not more ensure their accuracy. Bulbs of indicating mercury-in-glass thermometer. Each re than 8 feet apart along the top of the thermometers shall be installed either tort shall be equipped with at least one retort. In retorts having top steam inlet within the retort shell or in external mercury-in-glass thermometer that has and bottom venting, a bleeder shall be in wells attached to the retort. Thermom a temperature range of not more than stalled in the bottom of the retort to en eters shall be installed where they can 100° F in the processing range on a scale sure removal of condensate. All bleeders be accurately and easily read. A ther at least 7 inches in length. The scale divi shall be arranged in such a way that the mometer that has a divided mercury sions shall be no more than 2° F. Ther operator can observe that they are func column or that deviates more than 1° F mometers shall be tested for accuracy tioning properly. from the standard shall be repaired or against a known accurate standard ther (6) Venting and condensate removal. replaced. The mercury thermometer— mometer upon installation and at least The air in each retort shall be removed not the recorder chart—shall be the ref once a year thereafter or more frequently before processing is started. At the time erence instrument for indicating the as may be necessary to ensure their ac steam is turned on, the drain should be processing temperature. curacy. Bulbs of indicating thermom- opened for a time sufficient to remove "—(2) Temperature recording device. i eters shall be installed either within the steam condensate from the retort and There shall be an accurate temperature retort shell or in external wells attached provision should be made for continuing recording device for each retort adjusted to the retort. External wells or pipes shall drainage of condensate during the retort' to agree within 1° F of the known ac be connected to the retort through a t v operation. curate mercury-in-glass thermometer. least a %-inch diameter opening, and (7) Retort speed timing. The rota A means of preventing unauthorized Shall be equipped with a ^ -in c h or tional speed of the retort shall be changes in adjustment shall be provided. larger bleeder opening so located as to specified in the scheduled process. The The chart graduations shall not exceed provide a full flow of steam past the rotational speed shall be adjusted, as 2° F within a range of 10° F of the length of the thermometer bulb. The necessary, to ensure that the speed is as processing temperature. Each chart shall bleeder for external wells shall emit specified in the scheduled process. The bave a working scale of not more than steam continuously during the entire rotational speed as well as the process 50° F per inch within a range of 20° F processing period. Thermometers shall time shall be recorded for each retort of the processing temperature. This re be installed where they can be accurately load processed. Alternatively, a recording corder may be combined with the steam and easily read. A thermometer with a tachometer may be used to provide a con controller and may be a recording divided mercury column or that deviates tinuous record of the speed. A means of controlling instrument. The temperature more than 1° F from the standard shall preventing unauthorized speed changes recorder bulb shall be installed either be repaired or replaced. The mercury on’retorts shall be provided. within the retort shell or in a well at thermometer—not the recorder chart— , (8) Critical factors. The minimum tached to the shell. shall be the reference instrument for in headspace of containers in each retort (3) Pressure gages. Each retort shall dicating the processing temperature. load to be processed, if specified in the be equipped with a pressure gage. The (2) Temperature recording device. scheduled process, shall be measured and gage should be graduated in divisions of There shall be an accurate temperature recorded at intervals of sufficient fre 2 pounds or less, should be connected to recording device for each retort adjusted quency to ensure that the headspace is the retort shell or external well by a to agree within 1° F of the known ac as specified in the scheduled process. The short gooseneck tube, and should be not curate mercury-in-glass thermometer. A headspace of solder-tipped, lap seam more than 4 inches higher than the means of preventing unauthorized (vent hole) cans may J?e measured by gooseneck. The gage should be checked changes in adjustment shall be provided. net weight determinations. Where the for accuracy at least once a year. The chart graduations shall not exceed product consistency is specified in the. (4) Steam controller. Each retort shall 2° F within a range of 10° F of the proc scheduled process the consistency of the be equipped with an automatic steam essing temperature. Each chart shall product shall be determined by objective controller to maintain the retort tem have a working scale of not more than measurements on the product taken perature. This may be a recording-con 50° F per inch within a range of 20° F from the filler before processing and re trolling instrument when combined with of the processing temperature. This re corded at intervals of sufficient frequency a recording thermometer. „ corder may be combined with the steam to ensure that the consistency is as spec (5) Retort speed timing. The rota controller and may be a recording-con ified in the scheduled process. Mini tional speed of the retort shall be speci trolling instrument. The temperature re mum closing machine vacuum (in fied in the scheduled process. The rota corder bulb shall be installed either vacuum-packed products), maximum tional speed shall be adjusted, as neces?- within the retort shell or in a well at drained weight, minimum net weight, sary, to ensure that the speed is as tached to the shell. Each temperature and percent solids shall be as specified specified in the scheduled process. The recorder bulb well shall have a Vte-inch in the scheduled process for all products rotational speed as well as the process or larger bleeder opening emitting steam where deviations from such specifica time shall be recorded for each retort continuously during the processing tions may affect the scheduled process. load processed. Alternatively, a recording Period. Measurements of these critical factors tachometer may be used to provide a (3) Pressure gages. Each retort shall shall be made and recorded at intervals continuous record of the speed. A means be equipped with a pressure gage. The of sufficient frequency to ensure that of preventing unauthorized speed ' | ase should be graduated in divisions of they are as specified in the scheduled changes shall be provided. 2 Pounds, or less, should be connected to process. All measurements and record (6) Air supply and controls. Means the retort shell or external well by a ings of critical factors should be made shall be provided for introducing com short gooseneck tube, and should be not at intervals not to exceed 15 minutes. pressed air at the proper pressure and wore than 4 inches higher than the (e) Equipment and procedures for rate. The proper pressure shall be con gooseneck. The gage should be checked pressure processing in water in discon trolled. by an automatic pressure control for accuracy at least once a year. tinuous agitating retorts—(1) Indicating unit. A cheek valve shall be provided in Steam controller. Each retort shall mercury-in-glass thermometer. Each re the air supply line to prevent water from ho equipped with an automatic steam tort shall be equipped with at least one entering the system. controller to maintain the retort tem mercury-in-glass thermometer that has (7) Critical factors. The minimum perature. This may be a recording a temperature range of not more than headspace of containers in each retort controlling instrument when combined 100° F in the processing range on a load to be processed, if specified in the with a recording thermometer, scale at least 7 inches in length. Hie scheduled process, shall be measured and t 5i ^feeders. Bleeders, except those scale divisions shall be no more than recorded at intervals of sufficient fre for thermometer wells, shall be % inch 2° F. Thermometers shall be tested for quency to ensure that the headspace is FEDERAL REGISTER, VOL. 41, N O . 177— FRIDAY, SEPTEMBER 10, 1976 38634 RULES AND REGULATIONS as specified in the scheduled process. The continuously during the entire processing ature indicating device shall be no more headspace of solder-tipped, lap seam period. Additional temperature recorder than 2° F within the range of 10° F (vent hole) cans may be measured by net bulbs shall be installed in the hydro of the product sterilization operating weight determinations. Where the prod static water legs if the scheduled process range. The device shall be installed in uct consistency is specified in the sched specifies maintenance of particular tem the product at the holding tube outlet uled process the consistency of the prod peratures in the hydrostatic water legs. between the holding tube and the inlet uct shall be determined by objective (3) Recording of temperatures. Tem to the cooler. The temperature indicat measurements on the product taken peratures indicated by the mercury-in ing device shall be tested for' accuracy from the filler before processing and glass thermometer or thermometers shall against a known accurate standard recorded at intervals of sufficient fre be entered on a suitable form during thermometer upon installation and at quency to ensure that the consistency is processing operations. Temperatures least once a year thereafter or more as specified in the scheduled process. shall be recorded by an accurate auto frequently as may be necessary to en Minimum closing machine vacuum (in matic recorder or recorders at the follow sure its accuracy. The device shall be vacuum-packed products), maximum ing points: - installed so that it can be accurately and drained weight, minimum net weight, (i) In the steam chamber between the easily read. A thermometer that has a and percent solids shall be as specified steam-water interface and the lowest divided mercury column or a device that in the scheduled process for all products container position. deviates more than 1° F from the stand where deviations from such specifications (ii) Near the top and the bottom of ard shall be repaired or replaced. The may affect the scheduled process. Meas each hydrostatic water leg if the sched temperature indicating device shall be urements of these critical factors shall uled processi specifies maintenance of the reference instrument for indicating be made and recorded at intervals of suf particular temperatures in the legs. the processing temperature. ficient frequency to ensure that they are (4) Venting. Before the start of proc FEDERAL REGISTER, VOL. 41, N O . 177— -FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38635 3 months of operation thereafter or mpre tion time of containers, and- closures if ensure that the methods and controls frequently as may be necessary to en applicable, in the sterilizing environ used for the manufacture, processing, sure its accuracy. One pressure sensor ment as specified in the scheduled proc and/or packing of such foods are oper shall be installed at the sterilized prod ess, or to controls the sterilization cycle ated or administered in a manner ade uct regenerator outlet, and the other at the rate as specified in the scheduled quate to achieve^commercial sterility. pressure sensor shall be installed at the process. A means of preventing unau Subpart D— Controls of Components, Food unsterilized product regenerator inlet. thorized speed changes shall be provided. Product Containers, Closures, and In- (/) Metering pump. A metering pump (ii) Operation—(a) Startup. Prior to Process Materials shall be located upstream from the hold the start of packaging operations, both ing tube and shall be operated to main the container and closure sterilizing § 507.60 Containers. tain the required rate of product flow. A system and the product filling and clos (a) Closures. Regular observations means of preventing unauthorized speed ing system shall be brought to a condi shall be maintained during production changes shall be provided. tion of commercial sterility. runs for gross closure defects. Any such (g) Product holding tube. The prod (b) Loss of sterility. In the event of defects shall be recorded, and corrective uct sterilizing holding tube shall be de loss of sterility, the system (s) shall be action shall be taken and recorded. At signed to give continuous holding of returned to a condition of commercial intervals of sufficient frequency to ensure every particle of food for at least the sterility before resuming packaging proper closure, the operator, closure su minimum holding time specified ih the operations. pervisor, or other qualified container scheduled process. The holding tube shall (c) Records. Observations and meas closure inspection person shall visually be designed so that no portion between urements of operating conditions shall examine either the top seam of a can the product inlet and the product out be made and recorded at intervals of randomly selected from each seaming let can be heated, and it shall be sloped sufficient frequency to ensure that com head or the closure of any other type of upward at least 0.25 inch per foot. ' mercial sterility of the food product is container being used, and shall record (ii) Operation—(a) Startup. Prior to beings achieved; such measurements his observations. Such measurements the start of aseptic processing operations,., shall include the sterilization media flow and recordings should be made at inter the product sterilizer shall be brought to rates and/or temperatures, the container vals not to exceed 30 minutes. Additional a condition of commercial sterilility. and closure rates (if applicable) through visual closure inspections shall be made (b) Temperature drop in product ster the sterilizing system, and the steriliza immediately following a jam in a closure ilizing holding tube, when product tem tion conditions if a batch system is machine, after closing machine adjust perature in the holding tube drops be used for container sterilization. The ment, or after startup of a machine fol low the temperature specified in the measurements and recordings should be lowing a prolonged shutdown. All perti scheduled process, the product holding made at intervals not to exceed 1 hour. nent observations shall be recorded. tube and any further system portions (3) Incubation. Incubation tests shallWhere irregularities are found, the cor affected shall be returned to a condition be conducted on a representative sample rective action shall be recorded. of commercial sterility before flow is re of containers of product from each code; (1) Teardown examinations for dou sumed to the filler. ; records of the tests shall be maintained. ble seam cans shall be performed by a (c) Loss of proper pressures in the re (h) Equipment and procedures for qualified Individual and the results generator. Where a regenerator is used flame sterilizers. The container conveyor therefrom shall be recorded at intervals the product may lose sterility whenever speed shall be specified in the scheduled of sufficient frequency onv enough .con the pressure of sterilized product in the process. The container conveyor speed tainers from each seaming station to regenerator is less than 1 lb. per square shall be measured and recorded at the ensure maintenance of seam integrity. in, greater than the pressure of unsteri start of operations and at intervals of Such examinations and recordings lized product in the regenerator. Product sufficient frequency to ensure that the should be made at intervals not to ex flow to the filler shall not be resumed conveyor speed is as specified in the ceed 4 hours. The results of the teardown until the cause of the improper pressure scheduled process. Such measurements examinations shall be recorded and the relationships in the regenerator has been and recordings should be done at 1-hour corrective action taken, if any, shall be corrected and the affected system (s) has intervals. Alternatively, a recording been returned to a condition of conimer- tachometer may be used to provide a noted. ■... cial sterility. continuous record of the speed. A means /' (i) Required and optional can seam (d) Records. Readings at the follow of * preventing unauthorized speed measurements: ing points shall be observed and recorded changes on the conveyor shall be pro (a) Micrometer measurement system: at the start of aseptic packaging opera vided. The surface temperature of at Required Optional tions and at intervals of sufficient fre least one container from each conveyor Cover hook. Overlap (by calcula- quency to ensure that these values are channel shall be measured and recorded, Body hook. ' tlon ). as specified in the scheduled process: at the end of the holding period at in Width (length, Countersink. Temperature indicating device in holding tervals of sufficient frequency to ensure height). Thickness. tube outlet; temperature recorder in that the temperatures specified in the Tightness (observa holding tube outlet; temperature record scheduled process are maintained. Such tion for wrinkle). er-controller at final heater outlet; dif measurements and recordings should be (b) Seam scope or projector : ferential pressure recorder-controller, if ^one at intervals not to exceed 15 Required Optional a product-to-product regenerator is minutes. Body hook. Width (length, used; and product flow rate as estab (i) New systems. The development of Overlap. s height). lished by the metering pump or as deter new systems for the thermal processing Tightness (observa- Cover hook, mined by filling and closing rates. Such of low-acid foods in hermetically sealed tion for wrinkle). Countersink. ■v measurements and recordings should be containers shall conform to the appli Thickness. made at intervals not to exceed 1 hr. \ cable requirements of this part and shall ' (c) Can double seam terminology; (2) Container sterilizing, filling, and closing operation—(i) Equipment—(a) RUST OPERATION MU SUM SECOND OPERATION MU SCAM Recording device. The container and closure sterilization system and product fljflug and closing system shall be in strumented to show that commercial sterility is being achieved. Automatic recording devices shall be used to record, where applicable, the,sterilization media flow rates and/or temperatures. Where a batch system is used for container ster ilization, the sterilization conditions shall be recorded. Timing method is), A method (s) shall be used either to give the reten FEDERAL REGISTER, VOL. 41, N O # 177— FRIDAY, SEPTEMBER 10, 1976 y 38636 RULES AND REGULATIONS FEDERAL REGISTER, VOL. 41, NO . 1 ff— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38637 product regenerator is used; product flow Sec. public health significance. Such evalua 508.19 Establishment of requirements for tion shall be made by a competent proc rate, as determined by the metering exemption from section 404 of the essing authority and shall be in accord pump or by filling and closing rates; act. sterilization media flow rate and/or ance with procedures recognized by Subpart B— Specific Requirements and Condi competent processing authorities as temperature; retention time of contain tions for Exemption From or Compliance With being adequate to detect any potential ers, and closures where applicable, in the an Emergency Permit hazard to public health. Unless such sterilizing environment; and, where a 508.35 Thermal processing of low-acid ani evaluation demonstrates that the product batch system is used for container and/ mal foods packaged in hermetically had been given a thermal process that or closure sterilization, sterilization cycle sealed containers. rendered it free of microorganisms of times and temperatures. Authority: Secs. 402, 404, 701, 52 Stat. potential public health significance, the (5) Flame sterilizers. Container con 1046-1047 as amended, 1048, 1055-1056 as product set aside either shall be fully re veyor speed; surface temperature at the amended by 70 Stat. 919 and 72 Stat. 948;v processed to render it commercially ster end of the holding period; nature of con 21 U.S.C. 342, 344, 371. * • ile or it shall be destroyed. A record shall tainer. Subpart A— General Provisions be made of the evaluation procedures (b) Recording thermometer charts used and the results. Either upon comple shall be identified by date, and other § 508.3 Definitions. tion of full reprocessing and the attain data as necessary, so they can be corre (a) The definitions contained in sec ment of commercial sterility or after the lated with the written record of lots tion 201 of the Federal Food, Drug, and determination that no significant poten processed. Each entry on the record shall Cosmetic Act are applicable to such tial for public health hazard exists, thalr be made by the retort or processing sys terms when used in this part. portion of the production involved may tem operator, or other designated per (b) “Commissioner’' means the Com be shipped in normal distribution. Other son, at the time the specific retort or missioner of Food and Drugs. wise, the portion of the production in processing system condition or opera (c) “Act” means the Federal Food, volved shah be destroyed. tion occurs, and the retort or processing system operator or such designated per Drug, and Cosmetic Act, as amended. Subpart F— Records and Reports (d) “Permit” means an emergency son shall sign or initial each record permit issued by the Commissioner pur § 507.110 Processing and production ^ form. Not later than 1 working day after suant to section 404 of the act for such records»-'5 the actual process, and prior to shipment or release for distribution, a representa temporary period of time as mav be nec (a) Processing and production infortive of plant management who is qual essary to protect the public health. mation shall be entered by the retort or ified by suitable training or experience (e) “Manufacture, processing, or pack processing system operator, or other des shall review all processing and produc ing of food in any locality” means activ ignated person, on forms which shall in tion records for completeness and»'to ities conducted in a single plant or clude the product, the code number, the ensure that the product received the establishment, a series of plants under retort or processing system number, the scheduled process. The records, includ a single management, or all plants in size of container, the approximate num ing the recording thermometer chart(s), an industry or region, by a manufac ber of containers per coding interval, the shall be signed or initialed by the per turer, processor, or packer. minimum initial temperature, the actual, son conducting the review. § 508.5 Determination of the need for a processing time and temperature, the (c) Written records of all container permit. mercury-in-glass and recording ther closure examinations shall specify the mometer readings ,imd other appropriate (a) Whenever the Commissioner de product code, the date and time of con termines after investigation that a man processing data. Closing machine vac tainer closure inspections, the measure uum (in vacuum-packed products), ufacturer, processor, or packer of a food ments obtained, and all corrective ac for which a regulation has been promul maximum drained weight, or other criti tions taken. Records shall be signed or cal factors specified in the scheduled gated in Subpart B of this part does not initialed by the container closure inspec meet’the mandatory conditions and re process shall also be recorded. In addi tor and shall be reviewed by manage tion, the following records shall be ment with sufficient frequency to assure quirements established in such regula maintained: tion, he shall issue to such manufacturer, that the containers are hermetically processor, or packer an order determin (1) Still retorts. Time steam on; time sealed. temperature up to processing tempera (d) Copies of all records provided for ing that a permit shall be required before ture; time steam off; venting time and/or in this part except those required under the food may be introduced or delivered temperature to which vented, (as ap § 507.83 establishing scheduled processes, for introduction into interstate commerce plicable) . shall be retained at the processing plant by that person. The order shall specify (2) Agitating retorts. Functioning of for a period of not less than 1 year, and the mandatory conditions and require condensate bleeder; retort speed; and, ments with which there is a lack of at the processing plant or other reason compliance. where specified in the scheduled proc ably accessible location for an additional (1) The manufacturer, processor, or ess, headspace, consistency, maximum 2 years. If during the first year of the drained weight, minimum net weight, 3-year record retention period the packer shall have 3 working days after and percent solids. receipt of such order within which to file processing plant is closed for a prolonged objections. Such objections may be filed (3) Hydrostatic retorts. The tempera period between seasonal packs, the rec by telegram, telex, or any Either mode of ture in the steam chamber between the ords may be transferred to some other steam-water interface and the lowest written communication addressed to thé container position; spqed of the con reasonably accessible location at the end Food and Drug Administration, Bureau of the seasonal pack. of Foods, 200 C St. SW., Washington, tainer conveyor chain; and, where the DC 20204. If such objections are filed, scheduled process specifiei maintenance the determination is stayed pending à of particular temperatures in the hydro PART 508—rEMERGENCY PERMIT hearing to be held within 5 working days static water legs, the temperatures near CONTROL the top and the bottom of each hydro after the .filing of objections on the Subpart A— General Provisions issues involved unless the Commissioner static water leg. Sec. X4) Aseptic processing and packaging 508.3 Definitions. determines that the objections raise no systems. Product temperature in the 508.5 Determination of the nçed for a genuine and substantial issiie of fact to holding tube outlet as indicated by the permit. justify a hearing. temperature indicating device and the 508.6 - Revocation of determination of need * (2) If the Commissioner finds that temperature recorder; product tempera for permit. there is an imminent hazard to health, 506.7 Issuance or denial of permit. the order shall contain this finding and ture in the final heater outlet as indi 508.10 Suspension and reinstatement of cated by the temperature recorder- permit. the reasons therefor, and shall state that controller; differential pressure as 508.12 Manufacturing, processing, or pack the determination of the need for a per indicated by the differential pressure ing without a permit or in viola mit is effective immediatëly pending an recorder-controller, if a product-to- tion of a permit. expedited hearing. Iltet , ; ' FEDERAL REGISTER, VOL. 41, N G . 177— FRIDAY, SEPTEMBER 10, 1976 38638 RULES AND REGULATIONS (b) A hearing under this section shallthis part are met and, in particular, shall § 508.12 Manufacturing, processing, or be conducted by the Commissioner or his show that the deviations specified in the packing without a permit or in vio designee at a location agreed upon by Commissioner’s determination of the lation of a permit. the objector and the Commissioner or, if need for a permit have been corrected or (a) A manufacturer, processor, or such agreement cannot be reached, at a suitable interim measures established. packer may continue a t his~ own risk to location designated by the Commissioner. Within 10 working days after receipt of manufacture, process, or pack without a The manufacturer, processor, or packer such application, (except that the Com permit a food for which the Commis shall have the right to cross-examine the missioner may extend such time an ad sioner has determined that a permit is Food and Drug Administration’s wit ditional 10 working days where neces required. All food so manufactured, proc nesses and to present witnesses on his sary) , the Commissioner shall Issue a essed, _or packed during such period own behalf. permit, deny the permit, or offer the ap without a permit shall be retained by the ic) Within 5 working days after the plicant a hearing conducted in accord manufacturer, processor, or packer and hearing, and based on the evidence pre ance with § 508.5 (b) and (c) as to may not be introduced or delivered for sented at the hearing, the Commissioner whether the permit should be issued. The introduction into interstate commerce shall determine whether a permit is re Commissioner shall issue such a permit without the advance written approval of quired and shall so inform the manu to which shall be attached, in addition the Food and Drug Administration. Such facturer, processor, or packer in writ to the mandatory requirements and con approval may be granted only upon an ing, with the reasons for his decision. ditions of Subpart B of this part, any ad adequate showing that such food is free (d) The Commissioner’s determinaditional Requirements or conditions from microorganisms of public health tion of the need for a permit constitutes which mav be necessary to protect the significance. The manufacturer, proc final agency action from which appeal public health if he finds that all manda essor, or packer may provide to the Com lies to the courts. The Commissioner tory requirements and conditions of Sub missioner, for his consideration in mak will not stay a determination of the need part B of this part are met or suitable ing any such determination, an evalua for a permit pending court appeal ex interim measures are established. tion of the potential public health sig cept in unusual, circumstances, but will (c) Denial of a permit constitutes finalnificance of such food by a competent participate in expediting any such agency action from which appeal lies to authority m accordance with procedures appeal. the courts. The Commissioner will not recognized' as being adequate to detect § 508.6 Revocation of determination of stay Such denial pending court appeal any potential hazard to public health. need for permit. except in unusual circumstances, but will Within 20-working days after receipt of participate in expediting any such ap a written request for such written ap (a) A permit shall be required only peal. during such temporary period as is nec proval the Food and Drug Administra essary to protect the public health. § 508.10 Suspension and reinstatement tion shall either issue such written ap of permit. proval or deny the request. If the request (b) Whenever the Commissioner has is denied, the applicant shall, upon re reason to believe that a permit holder is (a) Whenever the Commissioner finds quest, be afforded a prompt hearing con in compliance with the mandatory re that a permit holder is not in compliance ducted in accordance with §508.5 (b) quirements and conditions established in with the mandatory requirements and and(c). . v Subpart B of this part and is likely to re conditions established by the peimit, he main in compliance, he shall, on his own shall immediately suspend the permit (b) Except as provided in paragraph initiative or on the application of the (a) of this section, no manufacturer, and so. inform the permit holder, with processor, or packer may introduce or de permit holder, revoke both the deter the reasons for the suspension. mination of need for a permit and the liver for introduction into interstate permit that had been issued. If deniedr (b) Upon application for reinstatement commerce without a permit or in viola the applicant shall, upon request, be af of a permit, the Commissioner shall, tion of a permit a food for which the forded a hearing conducted in accord within 10 working days, reinstate the Commissioner has determined that a ance with § 508.5 (b) and (c) as soon as permit if he finds that the person is in permit is required. Where a manufac practicable. Such revocation is without compliance with the mandatory require turer, processor, or packer utilizes a con ments and conditions established by the solidation warehouse or other storage prejudice to the initiation of further permit or deny the application. permit proceedings with respect to the facility under his control, interstate ship same manufacturer, processor, or packer (c) Any person whose permit has been ment of any spch food from the point of should later information again show the suspended or whose application for re production to that warehouse or storage need for a permit. instatement has been denied may re facility shall not violate this paragraph, quest a hearing. The hearing shall he provided that no further introduction or § 508.7 Issuance or denial of permit. conducted by the Commissioner or his delivery for introduction into interstate (a) After a determination and notifidesignee within 5 working days of receipt commerce is made from that consoli cation by the Commissioner in accord of the request at a location agreed upon dated warehouse or storage facility ex ance with the provisions of § 508.5 that a by the objector and the Commissioner or, cept as provided in paragraph (a) of this manufacturer, processor, or packer re if an agreement cannot be reached, at a section. quires a permit, such manufacturer, location designated by the Commissioner. § 508.19 Establishment of requirements processor, or packer may not thereafter The. permit holder shall have the right for exemption from section 404 of introduce or deliver for introduction into to present witnesses on his own behalf the act, interstate commerce any such food man and to cross-examine the Food and Drug ufactured, processed, or packed by him Administration’s witnesses. (a) Whenever the Commissioner finds unless he holds a permit issued by the (d) Within 5 working days after the after investigation that the distribution Commissioner er obtains advance written hearingr and based on the evidence pre in interstate ■-commerce of any class of approval of the Food and Drug Admin sented at the hearing, the Commissioner food may, by reason of contamination istration pursuant to § 508.12(a). shall determine whether the permit shall with microorganisms during the manu FEDERAL REGISTER, V O L 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38639 proposed by the Commissioner on his the processing method in terms of the processor shall, at the time the existing own initiative or in response to a petition type of processing equipment employed, information is provided to the Food and from any interested person. Petitions re and a list of the low-acid foods so proc Drug Administration request in writing questing promulgation of regulations in essed in each such establishment. These an extension of time for submission of Subpart B of this part shall be in the forms are available from the Food and such information, specifying what addi form specified in § 2.65 of this chapter. Drug Administration, Bureau of Foods, tional information is to be supplied and (b) A manufacturer, processor, orIndustry Guidance Branch, HFF-326, the date by which it is to be submitted. packer of a food for which a regulation 200 C St. SW., Washington, DC 20204, Within 30 working days after receipt of has been promulgated in Subpart B of or at any Food and Drug Administration such request the Food and Drug Admin this part shall be exempt from the re district office. The completed form shall istration shall either grant or deny such quirement for a permit only if he meets be submitted to the Food and Drug Ad request in writing. all of the mandatory requirements and ministration, Bureau of Foods, Division (ii) If a packer intentionally makes a conditions established in that regulation. of Food Technology, HFF-419, 200 C St. change in a previously filed scheduled SW., Washington, DC 20204. Commer process by reducing the initial tempera Subpart B— Requirements and Conditions cial processors presently so engaged shall ture or retort temperature, reducing the for Exemption From or Compliance With register not later than July 13, 1973. time of processing, or changing the prod an Emergency Permit Commercial processors duly registered in uct formulation, the container, or any § 508.35 Thermal processing of low-acid accordance with this section shall no other condition basic to the adequacy of foods packaged in hermetically tify the Food and Drug Administration scheduled process, he shall prior to using sealed containers. not later than 90 days after such com such changed process obtain substantia (a) Inadequate or improper manufac mercial processor ceases or discontinues tion by qualified scientific authority as ture, processing, or packing of thermally tiie manufacture, processing, or packing to its adequacy. Such substantiation may processed low-acid foods in hermet of thermally processed foods in any es be obtained by telephone, telegram, or ically sealed containers may result in tablishment: Provided, That such notifi other media, but must be promptly re the distribution in interstate commerce cation shall not be required as to the corded, verified in writing by the authôr- of processed foods that may be injurious temporary cessation necessitated by the ity, and contained in the packer’s files to health. The harmful nature of such seasonal character of the particular es for review by the Food and Drug Ad foods cannot be adequately determined tablishment’s production or caused by ministration. Within 30 days after first after these foods have entered into in temporary conditions including but not use, the packer shall submit to the Food terstate commerce. The Commissioner of limited to strikes, lockouts, fire, or acts and Drug Administration, Bureau of Pood and Drugs therefore finds that, in of God. Foods, 200 C St. SW., HFF-419, Wash order to protect the public health, it may (2) Process filing. A commercial procington, DC 20204 a complete description be necessary to require any commercial essor engaged in the thermal processing of the modifications made and utilized, processor, in any establishment engaged of low-acid foods packaged in hermeti together with a copy of his file record in the manufacture, processing, or pack cally sealed containers shall, not later showing prior substantiation by a quali ing of thermally processed low-acid foods than 60 days after registration and prior fied scientific authority as to the safety in hermetically sealed containers, to ob to the packing of a new product, provide of the changed process. Any intentional tain and hold a temporary emergency the Food and Drug Administration in change of a previously filed scheduled permit provided for under section 404 of formation as to the scheduled processes process or modification thereof in which the Federal Pood, Drug, and Cosmetic including but not limited to the proc the change consists solely of a higher Act. Such a permit may be required essing method, type of retort or other initial temperature, a higher retort tem whenever the Commissioner finds, after thermal processing equipment employed, perature, or a longer processing time, investigation, that the commercial proc minimum initial temperatures, times shall not be considered a change subject essor has failed to fulfill all the require and temperatures of processing, steriliz to this paragraph, but if thereafter that ments of this section, including registra ing value (F0), or other equivalent sci modification is to be regularly scheduled, entific evidence of process adequacy, crit the modified process shall be promptly tion and the filing of process ical control factors affecting heat pene information, and the mandatory portions filed as a scheduled process, accompanied tration, and source and date of the estab by full information on the specified forms of Part 507 of this chapter. These re lishment of the process, for each such quirements are intended to ensure safe as provided in this paragraph. low-acid food in each container size: (iii) Many packers employ an “oper manufacture, processing, and packing Provided, That the filing of such infor procedures and to permit the Food and ating” process in which retort operators mation does not constitute approval of are instructed to use retort temperatures Drug Administration to verify that these the information by the Food and Drug procedures are being followed. Such and/or processing times slightly in ex Administration, and that information cess of those specified in the scheduled failure shall constitute a prima facie concerning processes and other data so basis for the immediate application of process as a safety factor to compensate filed shall be regarded as trade secrets for minor fluctuations in temperature or the emergency permit control provisions within the meaning of 21 U.S.C. 331(j) of section 404 of the act to th at establish time to assure that the minimum times and 18 U.S.C. 1905. This information and temperatures in the scheduled proc ment, pursuant to the procedures estab shall be submitted on the following forms lished in Subpart A of this part. ess are always met. This would not con as appropriate: Form FD-2541a (food stitute a modification of the scheduled (b) The definitions in § 507.3 of this canning establishment and process filing process. chapter are applicable when such terms for still retort processes), form FD-2541b (3) Process adherence and informa are used in this section. (food canning establishment and process tion. (i) A commercial processor engaged (c) Registration and process filing: filing for agitating processes), or form in the thermal processing of low-acid (1) Registration. A commercial proces FD-2541c (food canning establishment foods packaged in hermetically sealed sor when first engaging in the manufac and process filing for other than still re containers in any registered establish ture, processing, or packing of thermally tort and agitating processes). These ment shall process each low-acid food processed low-acid foods in hermetically forms are available from the Food and in each container size in conformity with sealed containers in any state, as defined Drug Administration, Bureau of Foods, at least the scheduled processes and in section 201(a)(1) of the act, shall, Industry Guidance Branch, HFF-326,200 modifications filed pursuant to paragraph not later than 10 days after first so C St. SW., Washington, DC 20204, or at (c) (2) of this section. any Food and Drug Administration dis (ii) Process information availability: engaging, register with the Food and trict office. The completed form(s) shall Drug Administration on Form FD-2541 When requested by the Food and Drug be submitted to the Food and Drug Ad Administration in writing, a commercial (food canning establishment registra ministration, Bureau of Foods, Division processor engaged in thermal processing tion) information including (but not lim of Food Technology, HFF-419, 200 C St. of low-acid foods packaged in hermeti bed to) his name, principal place of busi SW., Washington, DC 20204. cally sealed containers shall provide the ness, the location of each establishment (i) If all the necessary information isFood and Drug Administration with any m which such processing is carried on, not available for existing products, the information concerning processes and FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38640 RULES AND REGULATIONS procedures which is deemed necessary a prolonged period between seasonal the Commissioner may determine that by the Food and Drug Administration packs, the records may be transferred to the commercial processor offering the to determine the adequacy of the process: some other reasonably accessible loca food for import is in compliance with Provided, That the furnishing of such tion at the end of the seasonal pack. Up the requirements and conditions of this information does not constitute approval on written demand during the course of a section and that such food is not injuri of the information by the Food and Drug factory inspection pursuant to section ous to health. For the purpose of making Administration, and that the information 704 of the act by a duly authorized em such determination, the Commissioner concerning processes and other data so ployee of the Food and Drug Administra reserves the right for a duly authorized furnished shall be regarded as trade se tion, a commercial processor shall permit employee of the Food and Drug Adminis crets within the meaning of 21 U.S.C. 331 the inspection and copying by such em tration to inspect the commercial proc (j) and 18 U.S.C. 1905. ployee of these records to verify the ade essor’s manufacturing, processing, and (d) A commercial processor engaged in quacy of processing, the integrity of con packing facilities. the thermal processing of low-acid foods tainer closures, and the coding of the (1) The following data and informa packaged in hermetically sealed con products. tion submitted to the Food and Drug Ad tainers shall promptly report to the Food (1) This section shall not apply to the ministration pursuant to this section are and Drug Administration any instance commercial processing of any food proc not available for public disclosure unless of spoilage or process deviation the na essed under the continuous inspection of they have been previously disclosed to ture of which indicates potential health the meat and poultry inspection program the public as defined in § 4.81 of this significance where any lot of such food of the Animal and Plant Health Inspec chapter or they relate to a product or has in whole or in part entered distribu tion Service of the Department of Agri ingredient that has been abandoned and tion. culture under the Federal Meat Inspec they no longer represent a trade secret (e) A commercial processor engaged tion Act (34 Stat. 1256, as amended by 81 or confidential commercial or financial in thermal processing of low-acid foods Stat. 584 (21 U.S.C. 601 et seq.) ) and information as defined in § 4.61 of this packaged in hermetically sealed con the Poultry Products Inspection Act (71 chapter : tainers shall promptly report to the Food Stat. 441, as amended by 82 Stat. 791; 21 (1) Manufacturing methods or proc and Drug Administration any instance U.S.C. 451 et seq.). esses, including quality control infor wherein any lot of such food, which may (j) Compliance with State regulations: mation. be injurious to health by reason of con (1) Wherever the Commissioner finds (2) Production, sales, distribution, and tamination with microorganisms, has in that any State regulates the commercial similar data and information, except whole or in part entered distribution. thermal processing of low-acid foods in that any compilation of such data and (f ) A commercial processor engaged in accordance with effective regulations information aggregated and prepared in the thermal processing of low-acid foods specifying at least the requirements of a way that does not reveal data or infor packaged in hermetically sealed con Part 507 of this chapter, he shall issue mation which is not available for public tainers shall have prepared and in his a notice stating that compliance with disclosure under this provision is avail files a current procedure which he will such State regulations shall constitute able for public disclosure. use for products under his control and compliance with Part 507 of this chapter. (3) Quantitative or semiquantitative which he will ask his distributor to fol However, the provisions of this section formulas. low, including plans for effecting recalls shall remain applicable to the commer of any product that may be injurious to cial processing of low-acid foods in any PART 509— UNAVOIDABLE CONTAMI health: for identifying, collecting, ware such State, except that, either the State NANTS IN ANIMAL FOOD AND FOOD- housing, and controlling the product; for through its regulatory agency or each PACKAGING MATERIAL determining the effectiveness of such re processor of low-acid, foods in such State Subpart A— General Provisions call; for notifying the Food and Drug shall file with the Bureau of Foods the Sec. Administration of any such recall; and registration information and the proc 509.3 Definitions and interpretations. for implementing such recall program. essing information prescribed in para 509.15 Use of polychlorinated b ip h en y ls graph (c) of this section. (PCB’s) in establishments manu (g) All operators of retorts, thermal facturing food-packaging mate processing systems, aseptic processing (2) The Commissioner finds that the rials. and packaging systems, or other thermal regulations adopted by the State of Cali fornia under the laws relating to cannery Subpart B— Tolerances for Unavoidable processing systems, and container clo Poisonous or Deleterious Substances sure inspectors shall be under the operat inspections governing thermal processing ing supervision of a person who has at of low-acid foods packaged in hermeti 509.30 Temporary tolerances for p o ly ch lo tended a school approved by the Com cally sealed containers satisfy the re rinated biphenyls (PCB’s). missioner for giving instruction in re quirements of Part 507 of this chapter. A u t h o r i t y : Secs. 402(a), 406, 409, 701, 52 tort operations, aseptic processing and Accordingly, processors, who under the Stat. 1046 as amended, 1049, 1055-1056 as packaging systems operations or other laws relating to cannery inspections are amended by 70 Stat. 919 and 72 Stat. 948, 72 licensed by the State of California and Stat. 1785-1788 as amended; 21 U.S.O. 342(a), thermal processing systems operations, 346, 348, 371. and container closure inspections, and who comply with such state regulations, has satisfactorily completed the pre shall be deemed to comply with the re Subpart A— General Provisions scribed course of instruction: Provided, quirements of Part 507 of this chapter. § 509.3 Definitions and interpretations. That this requirement shall not apply in (k) Imports: (1) This section shall (a) The definitions and interpreta the State of California as listed in para apply to any foreign commercial proc tions of terms contained in section 201 graph (j) of this section and shall not essor engaged in the thermal processing of the Federal Food, Drug, and Cosmetic apply until March 25, 1975 in any other of low-acid foods packaged in hermeti cally sealed containers and offering such Act shall be applicable to such terms State. The Commissioner will not with when used in this part. hold approval of any school qualified to foods for import into the United States (b) Unavoidable natural, environ give such instruction. except that, in lieu of providing for the mental, or industrial contaminants in (h) A commercial processor engaged issuance of an emergency permit under paragraph (a) of this section, the Com clude any poisonous or deleterious sub in the thermal processing of low-acid stance added to any food where such foods packaged in hermetically sealed missioner will request the Secretary of the Treasury to refuse admission into the substance cannot be avoided by good containers shall prepare, review, and re manufacturing practice. tain at the processing plant for a period United States, pursuant to section 801 of of not less than 1 year, and at the proc the act, of any such low-acid foods which § 509.15 Use of polychlorinated bi essing plant or other reasonably acces the Commissioner determines, after in phenyls (PCB’s) in establishments sible location for an additional 2 vestigation, may result in the distribu manufacturing food-packaging ma years, all records of processing, devia tion in interstate commerce of processed terials. tions in processing, container closure in foods that may be injurious to.health as (a) Polychlorinated biphenyls (PCB’s) spections, and other records specified in set forth in paragraph (a) of this sec represent a class of toxic industrial Part 507 of this chapter. If during the tion. chemicals manufactured and sold under first year of the 3-year record retention (2) Any such food refused admissiona variety of trade names, including: period the processing plant is closed for shall not be admitted until such time as Aroclor (United States) ; Phenoclor FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38641 (France) ; Colphen (Germany) ; and wherever there is a reasonable expecta (5) 0.2 part per million in finished Kanaclôr (Japan). PCB’s are highly tion that such articles could cause food animal feed for food-producing animals stable, heat resistant, and nonflamma packaging materials to become contam (except the following finished, animal ble chemicals. Industrial uses of PCB’s inated with PCB’s either^ as a result of feeds: feed concentrates, feed supple include, or did include in the past, their normal use or as a result of accident, ments, and feed premixes). use as electrical transformer and capaci breakage, or other mishap. (6) 2 parts per million in animal feed tor fluids, heat transfer fluids, hydraulic (iii) The toxicity and other characcomponents of animal origin, including fluids, and plasticizers, and in formula teristics of fluids selected as PCB replace fishmeal and other by-products of ma tions of lubricants, coatings, and inks. ments must be adequately determined so rine origin and”~in finished animal feed Their unique physical and chemical that the least potentially hazardous re concentrates, supplements, and premixes properties and widespread, uncontrolled placement is used. In making this deter intended for food-producing animals. industrial applications have caused mination with respect to a given fluid, (7) 5 parts per million in fish and PCB’s to be a persistent and ubiquitous consideration should be given to (a) its shellfish (edible portion). The edible por contaminant in the environment, caus toxicity: (b) the maximum quantity that tion of fish excludes head, scales, viscefa, ing the contamination of certain foods. could be spilled onto a given quantify of and inedible bones. In addition, incidents have occurred in food before it would be noticed, taking (8) [Reserved] which PCB’s have directly contaminated into account its color and odor; (c) pos (9) 10 parts per million in paper food animal feeds as a result of industrial sible signaling devices in the equipment packaging material intended for or used accidents (leakage or spillage of PCB to indicate a loss of fluid, etc.; and (d) with finished animal feed and any com fluids from plant equipment). These ac its environmental stability and tendency ponents intended for animal feeds. The cidents in turn caused the contamina to survive and be concentrated through tolerance shall not apply to paper food tion of food products intended for human the food chain. The judgment as to packaging material separated from the consumption (meat, milk and eggs). In whether a replacement fluid is suffi food therein by a functional barrier vestigations by the Food and Drug Ad ciently non-hazardous is. to be made on which is impermeable to migration of ministration have revealed that a sig an individual installation and operation nificant percentage of paper food-pack- basis. PCB’s. aging material contains PCB’s which can (c) The provisions of jthis section do (b) A compilation entitled “Analytical migrate to the packaged food. The origin not apply to electrical transformers and Methodology for Polychlorinated Bi of PCB’s in such material is not fully condensers containing PCB’s in sealed phenyls, February 1973” for determining understood. Reclaimed fibers containing containers. compliance^ with the tolerances estab carbonless copy paper (contains 3 to 5 lished in this section is available from Subpart B— Tolerances for Unavoidable the Hearing Clerk, Food and Drug Ad percent PCB’s) have been identified as Poisonous or Deleterious Substances a primary souce of PCB’s in paper prod ministration, Room 4-65, 5600 Fishers ucts. Some virgin paper products have § 509.30 Temporary tolerances for poly Lane, Rockville, MD 20852. also been found to contain PCB’s, the chlorinated biphenyls (PCB’s). Note: At^8 PR 22794, Aug. 24, 1973, the source of which,is generally attributed (a) Polychlorinated biphenyls (PCB’s) following appeared concerning § 509.30(a) to direct contamination from industrial are toxic, industrial chemicals. Because (9): accidents from the use of PCB-contain- of their widespread, uncontrolled indus * * * § 509.30(a) (9) is hereby stayed pending ing equipment and machinery in food trial applications, PCB’s have become a full review of the objections and requests packaging manufacturing establish persistent and ubiquitous contaminant in for hearing. * * * ments. Since PCB’s are toxic chemicals, the environment. As a result, certain In the interim, as stated in the final order the PCB contamination of food-packag foods and animal feeds, principally those (38 PR 18098) the Food and Drug Adminis ing materials as a result of industrial tration will enforce the temporary tolerance of animal and marine origin, contain level established by § 509.30(a) (9) by seizing accidents, which can cause the PCB con PCB’s as unavoidable, environmental any paper food-packaging material shipped tamination of food, represents a hazard contaminants. PCB’s are transmitted to in interstate commerce after September 4, to public health. It is therefore necessary the food portion (meat, milk, and eggs) 1973 containing higher than the specified to place certain restrictions on the in-- of food producing animals ingesting PCB level of PCB’s as adulterated in violation of dustrial uses of PCB’s in establishments contaminated animal feed. In addition, a sec. 402 of the act. manufacturing food-packaging mate significant percentage of paper food rials. packaging materials contain PCB’s which (b) The following special provisionsmay migrate to the packaged food. The PART 564— DEFINITIONS AND are necessary to preclude the accidental source of PCB’s in paper food-packaging STANDARDS FOR ANIMAL FOOD PCB contamination of food-packaging materials is primarily of certain types of- Subpart A— General Provisions materials: . Sec. carbonless copy paper (containing 3 to 5 564.3 Definitions and interpretations. . (1) New equipment or machinery for percent PCB’s) in waste papei stocks 564.5 Procedure for establishing food manufacturing food-packaging matérials used for manufacturing recycled paper. standards under the Federal Food, shall not contain or use PCB’s. Therefore, temporary tolerances for res Drug, and Cosmetic Act. (2) On or before September 4, 1973, idues of PCB’s as unavoidable environ 564.6 Review of Codex Alimentarius Food the management of establishments man mental or industrial contaminants are Standards. 564.8 Conformity to definitions and stand ufacturing food-packaging materials established for a sufficient period of time ards of identity. shall : ■ ^ v^ ' . ‘ _ xfl.. ~~ following the effective date of this para 564.12 General methods for water capacity (i) Have the heat exchange fluid used graph to permit the elimination of such and fill of container. in existing equipment for manufacturing contaminants at the earliest practicable 564.14 General statements of substandard food-packaging materials sampled and time. For the purposes of this paragraph, quality and substandard fill of tested to determine whether it contains the term “polychlorinated biphenyls oohtainer. (PCB’s)” is applicable to mixtures of 564.17 Temporary permits for interstate PCB’s or verify the absencéf of PCB’s in shipment of experimental packs of such formulations by other appropriate chlorinated biphenyl compounds, irre animal food varying from the re means. On or before Sept. 4, 1973, any spective of which mixture of PCB’s is quirements of definitions and such fluid formulated with PCB’s must present as the residue. The temporary standards of identity. to the fullest extent possible commen tolerances'for residues of PCB’s are as Subpart 8— Food Additives in Standardized surate with current good manufacturing follows; i Animal Food Practices be replaced with a heat ex (1) 2.5 parts per million in milk (fat 564.20 Food additives proposed for use in change fluid that does not contain PCB’s. basis). animal foods for which definitions (ii) , Eliminate to the fullest extent pos (27 2.5 parts per million in ihanufac- and standards of identity are es sible commensurate with current good tured dairy products (fat basis). tablished. manufacturing practices from the estab (3) 5 parts per million in poultry (fat Au t h o r it y : The provisions of this Part 10 lishment any other PCB-containing basis). ' issued under secs. 401, 701, 52 Stat. 1046, 1055 equipment, machinery and materials (4) 0.5 part per million in eggs. as amended; 21 U.S.C. 341,371. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38642 RULES AND REGULATIONS § 564.3 Definitions and interpretations. (b) Practical administration of the desirability and need for the stand (a) The definitions and interpretations law requires that there be a substantial ard, on the specific provisions of the of terms contained, in section 201 of the showing of merit before any proposal is standard, on additional or different Federal Food, Drug, and Cosmetic Act published. In passing on proposals sub provisions that shquld be included in shall be applicable also tp. such terms mitted by petitioners for initiating ac the standard, and on any other perti when used in regulations promulgated tions, it will be the policy of the Food nent points. After reviewing all such under the act. and Drug Administration to consider comments, the Commissioner either shall (b) If a regulation prescribing a defi that reasonable grounds have been fur publish a proposal to establish a food nition and standard of identity for a nished when: standard pursuant to section 401 of the food has been promulgated under section (1) The proposal includes or is ac act covering the food involved,„or shall 401 of the act and the name therein companied by a statement of the facts publish a notice terminating considera specified for the food is used in any other that the petitioner asserts he is in a tion of such a standard. regulation under section 401 or any other position to substantiate by evidence in (c) All interested persons are encour provision of the act, such name means the event the proceedings lead to a pub aged to confer with different interest the fdod which conforms to such defini lic hearing. groups (consumers, industry, the tion and Standard, except as otherwise (2) The facts declared furnish sub academic community, professional or specifically provided in such other regu stantial support of the proposal and ganizations, and others) in formulating lation. warrant a conclusion that the proposal petitions or comments pursuant to para (c) No provision of any regulation is reasonable. graph (b) of this section. All such peti prescribing a definition and standard of (3) The proposal, if adopted, would tions or comments are requested to in identity or s'tandard of quality or fill of promote honesty and fair dealing in the clude a statement of any meetings and container under section 401 of the act interest of consumers. discussions that have been held with shall be construed as in any way affect (c) Opportunity will be given to other interest groups. Appropriate weight ing the concurrent applicability of the amend petitions regarded as inadequate. will be given by the Commissioner to general provisions of the act and the (d) At any time prior to the issuance petitions or comments that reflect a con regulations thereunder relating to adul of an order acting on his proposal under sensus of different interest groups. teration and misbranding. For example, section 701(e)(1) of the act, the peti tioner may withdraw his petition with § 564.8 Conformity to definitions and all regulations under ¡section 401 of the standards of identity. act contemplate that the food and all ar out prejudice to a future filing. Notice of ticles used as components or ingredients withdrawal of the petition and termina ~ In the following conditions, among thereof shall not be poisonous or dele tion of the rulemaking proceeding will others, a food does not conform to the be published in the F ederal R egister. definition and standard of identity terious and shall be clean, sound, and therefor: fit for food. A provision in such regula § 564.6 Review of Codex Alimentarius tions for the use of coloring or flavoring Food Standards. (a) If it contains an ingredient for does not authorize such use under cir which no provision is made in such def cumstances or in a manner whereby (a) All food standards adopted by the inition and standard, Unless such in damage or inferiority is concealed or Codex Alimentarius Commission will be gredient is an incidental additive intro whereby the food is made to appear bet reviewed by the Food and Drug Adminis duced at a nonfunctional and insignifi ter or of greater value than it is. tration and will be accepted without cant level as a result of its deliberate and (d) “Safe and suitable” means that the change, accepted with change, or not. purposeful addition to another ingredi ingredient: accepted. ent permitted by the terms of the appli (1) Performs an appropriate function (b) Review of Codex standards will be cable, standard and the presence of such 'in the food in which it is used. accomplished in one of the following incidental additive in unstandardized (2) Is used at a level no higher than three ways: foods has been exempted from label dec necessary to achieve its intended pur (1) Any interested person may peti laration as provided in § 501.100 of this tion the Commissioner to adopt a Codex •chapter. . pose in that food. standard, with or without change, by (b) If it fails to contain any one or (3) Is not a food additive or color proposing a new standard or an appro more ingredients required by such defi additive as defined in section 201 (s) or. priate amendment of an existing stand nition and standard;' (t) of the act as used in that food, or is ard, pursuant'to section 401 of the act. (c) If the quantity of any ingredient a food additive or color additive as so Any such petition shall specify any devi or component fails to conform to the defined and is used in conformity with ations from the Codex standard, and the limitation, if any, prescribed therefor by regulations established pursuant to se6- reasons for any such deviations. The such definition and standard. tion 409 or 706 of the act. Commissioner shall publish such a peti § 564.12s General methods for water ca § 564.5 Procedure for establishing food tion in the F ederal R egister as a pro pacity and fill of container. standards under the Federal Food, posal, with an opportunity for comment, Drug, and Cosmetic Act. if reasonable grounds are provided in For the purposes of regulations pro Section 401 of the Federal Food, Drug, the petition. Any published proposal shall mulgated under section 401 of the act: and Cosmetic Act provides for the for state any deviations from the Codex (a) The term “general method fqr mulation of definitions and standards of standard and the stated reasons there water capacity of containers” means the identity and standards of quality and fill for. following method: of container for foods. This procedure (2) The Commissioner may on his own (1) In the case of a container with lid initiative propose by publication in the attached by double seam, cut out the lid is condensed as follows: without removing or altering the height (a) If the petitioner shows that he is F ederal R egister the adoption of a Codex standard, with or without change, of the double seam. an interested person and furnishes rea (2) Wash, dry, and weigh the empty sonable grounds for his proposal, it is through a new standard or an appropri the duty of the Commissioner to publish ate amendment to an existing standard, container. the proposal and afford opportunity for pursuant to section 401 of the act. Any (3) Fill-the container with distilled other interested persons to comment on such proposal shall specify any devia water-at 68° F to 3/16 inch vertical dis it. After a study of all the facts avail tions from the Codex standard, and the tance below the top level of the container, able and of the comments .received, the reasons for any such deviations. and weigh the container thus filled. Commissioner will act upon the proposal (3) Any Codex standard not han (4) Subtract the weight found in para and publish an order, to which objection dled under paragraph ^(b) (1) or (2) of graph (a) (2) of this section from the may be taken by persons who would be this section may be published in the weight found in paragraph (a) (3) of this adversely affected. Thus the issues in F ederal R egister for review and in section. The difference shall be con controversy are singled out for a public formal comment. Interested persons sidered to be the weight of water required hearing. shall be requested to comment on the to fill the container: -/ FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES ANO REGULATIONS 38643 In the case of a container with lid at ground, and is sn placed as to be easily merce but no later than 3 months after tached otherwise than by double seam, seen when the name of the food or any notice of the issuance of the permit is remove the lid and proceed as directed in pictorial representation thereof is viewed, published in the F ederal R egister. The paragraph (a) (2) to (4) of this section, wherever such name or representation Commissioner shall be notified in writing except that under paragraph (a) (3) of appears so conspicuously as to be easily of the date on which the test period this section, fill the container to the level seen under customary conditions of begins as soon as it is determined. of the top thereof. purchase. , > (c) Any person desiring a permit may (b) The term “géneral method for fill (b) The term “general statement offile with the Commissioner a written ap of containers” means the following substandard fill” means the statement plication in triplicate containing as part method: "Below Standard in Fill” printed in thereof the following: (1) In the case of a container with lid Cheltenham bold condensed caps. If (1) Name and address of the appli-' attached by double seam, cut out the lid the quantity of the contents of the con cant. without removing or altering the height tainer is less than 1 pound, the state (2) A statement of whether or not the of the double seam. ment is in 12-point type; if such quantity applicant is regularly engaged in produc (2) Measure the vertical distance from is 1 pound or more, the statement is in ing the food involved. the top level of the container to the top 14-point type. Such statement is en (3) A reference to the applicable defi level of the food. closed within lines, not less than 6 points nition and standard of identity (citing (3) Remove the food from the con in width, forming a rectangle; but if the applicable section of regulations). tainer; wash, dry. and weigh the con statement specified in paragraph (a) of (4) A full description of the proposed tainer. this section is also used, both state variation from the standard. (4) Pill the container with water to ments (one following the other) may be (5) The basis upon which the food so %6 inch vertical distance below the top enclosed within the same rectangle. varying is believed to be wholesome and level of the container. Record the tem Such statement or statements, with en nondeleterious. perature of the water, weigh the con closing lines, are on aL strongly contrast (6) The amount of any new ingredient tainer thus filled, and determine the ing, uniform background, and are so to be added; the amount of any ingredi weight of the water by subtracting the placed as to be easily seen when the ent, required by the standard, to be weight of the container found in para name of the food or any pictorial repre eliminated; any change of concentra graph^) (3) of this section. sentation thereof is viewed, wherever tion not contemplated by the standard; (5) Maintaining the water at the tem such name or representation appears so or any change in name that would more perature recorded in paragraph (b) (4) of conspicuously as to be easily seen under appropriately describe the new product this section, draw off water from the con customary conditions of purchase. under test. If such new ingredient- is not a commonly known food ingredient, a de tainer as filled in paragraph (b)(4) of § 564.17 Temporary permits for inter this section to the level of the food found state shipment of experimental packs scription of its properties and basis for in paragraph (b)(2) of this section, of food varying from the require concluding that it is not a .deleterious weigh the container with remaining ments of definitions and standards of substance. water, and determine the weight of the identity. \ (7) The purpose of effecting the varia remaining water by subtracting the tion. weight of the container found in para (a) The Food and Drug Administra (8) A statement of how the variation graph (b) (3) of this section. tion recognizes that before petitions to is of potential advantage to consumers. (6) Divide the weight of water found amend food standards can be submitted, The statement shall include the reasons in paragraph (b) (5) of this section by appropriate investigations of potential why the applicant does not consider the the weight of water found in paragraph advances in food technology sometimes data obtained in any prior investigations (b) (4) of this section, and multiply by require tests in interstate markets of which may have been conducted sufficient 100. The result shall be considered to be the advantages to and acceptance by to support a petition to amend the stand the percent 'of the- total capacity of the consumers of experimental packs of food ard. container occupied by the food. varying from applicable definitions and (9) The proposed label (or an accurate standards of identity prescribed under draft) to be used on the food to be mar In the case of a container with lid at section 401 of the act. ket tested. The label shall conform in all tached otherwise than by double seam, (b) It is the purpose of the Adminis respects to the general requirements of remove the lid and proceed as directed in tration to permit such tests when itjcan the act and shall provide a means where paragraph (b) (2) to (6) of this section, be ascertained that the sole purpose of by the consumer can distinguish between except that under paragraph (b) (4) of the tests is to obtain data necessary for the food being tested and sUch food com this section, fill the container to the level reasonable grounds in support of a peti plying with the standard. of the top thereof. tion to amend food standards, that the (10) The period during which the ap § 564.14 General statements of sub tests are necessary to the completion or plicant desires to introduce such food standard quality and substandard fill conclusiveness of an otherwise adequate into interstate commerce, with a state of container. investigation, and that the interests of ment of the reasons supporting the need For the purposes of regulations consumers are adequately safeguarded; for such period. If a period longer than promulgated under section 401 of the permits for such tests shall normally be 15 months is requested, a detailed ex act: for a period not to exceed 15 months. The planation of why a 15-month period is (a) The term'"general statement of Commissioner, for good cause shown by inadequate shall be provided. substandard quality” means the state- the applicant, may provide for a longer (11) The probable amount of such ,ment "Below Standard in Quality Good test market period. The Administration food that will be distributed. The amount will therefore refrain from recommend distributed should be limited to the Food—Not High Grade” printed in two ing regulatory proceedings under the act smallest number of units reasonably re lines.of Cheltenham bold condensed caps. on the charge that a food does not con quired for a bona fide market test. Jus The words "Below Standard in Quality” form to an applicable standard, if the tification for the amount requested shall constitute the first line, and the second person who introduces or causes the in be included. immediately follows. If the quantity of troduction of the food,into interstate (12) The areas of distribution. the contents of the container is less than commerce holds an effective permit from (13) The address at which such food 1 pound, the type of the first line is 12-' the Commissioner providing specifically will be manufactured. Point and of the second, 8-point. If for those variations in respect to which (14) A statement of whether or not such quantity is 1 pound or more, the the food fails to conform to the appli such food has been or is to be distributed type of the first line is 14-point, and of cable definition and standard of identity. in the State in which it was manu the second, 10-point. Such statement The test period will begin on the date factured. is enclosed within lines, not less than 6 the person holding an effective permit (15X If it has not been or is not to be Points in width, forming a rectangle. from the Commissioner introduces or so distributed, a statement showing why. Such statement, with enclosing lines, is causes the introduction of the food cov X16) If it has been or is to be so dis on a strongly contrasting, uniform back- ered by the permit into interstate com tributed, a statement of why it is deemed FEDERAL REGISTER, VOL. 41. NO. 177— FRIDAY, SEPTEMBER 10, 1976 38644 RULES AND REGULATIONS necessary to distribute such food in other test shall notify the Commissioner in writing of that fact, the amount to be 570.35 Aflirmatioh of generally recognized States. as safe (GRAS) status. (d) The Commissioner may require distributed, and the area of distribution; 570.38 Determination of food additive the applicant to furnish samples, of the and along with such notification, he shall status. food varying from the standard and to submit the labeling under which the food furnish such additional information as is to be distributed. A u t h o r it y : Secs. 409, 701, 52 Stat. 1055- may be deemed necessary for action on (j) Notice of the granting or revoca 1056 as amended, 72 Stat. 1785-1788 as the application. tion of any permit shall be published in amended (21 U.S.C. 348, 371), unless other (e) If the Commissioner concludes the F ederal R egister. wise noted. that the variation may be advantageous (k) All applications for a temporary Subpart A— General Provisions to consumers and will not result in fail permit, applications for an extension of ure of the food to conform to any pro a temporary permit, and related records § 570.3 Definitions. vision of the act except section 403(g), are available for public disclosure when (a) “Secretary” means the Secretary a permit shall be issued to the applicant the notice of a permit or extension of Health, Education, and Welfare. for interstate shipment of such food. The thereof is published in the F ederal R eg (b) “Department” means the Depart terms and conditions of the permit shall ister. Such disclosure shall be in ac ment o t Health, Education, and Welfare. be those set forth in the application with cordance with the rules established in (c) “Commissioner” means the Com such modifications, restrictions, or quali Part 4 of this chapter. missioner of Food and Drugs. fications as the Commissioner may deem Subpart B— Food Additives in Standardized (d) As used in this part, the term necessary and state in the permit. Animal Food “act” means the Federal Food, Drug, and (f) The terms and conditions of. the Cosmetic Act approved June 25, 1936 (52 permit may be modified at the discretion § 564.20 Food additives proposed for Stat. 1040 et seq., as amended; 21 U.S.C. of the Commissioner or upon application use in animal foods for which defini 301-392)1 of the permittee during the effective pe tions and standards of identity are (e) “Food additives” includes all sub riod of the permit. , established. stances not exempted by section 201 (s) (g) The Commissioner may revoke a (a) Where a petition is received for of the act, the intended use of which re permit for cause, which shall include but the issuance or amendment of a regula sults or may reasonably be expected to not be limited to the following: tion establishing a definition and stand result, directly or indirectly, either in (1) That the permittee has introduced ard of identity for a food under section their becoming a component of food or a food into interstate commerce con 401 of the act, which proposes the inclu otherwise affecting the characteristics of trary to the terms and conditions of the sion of a food additive in such definition food. A material used in the production permit. j and standard of identity, the provisions sof containers and packages is subject to (2) That the application for a permit of the regulations in this subchapter the definition if it may reasonably be ex contains an untrue statement of a mate E shall apply with respect to the pected to become a component, or to af rial fact. information that must be submitted with fect the characteristics, directly or in (3) That the need therefor no longer respect to the food additive. Since sec directly, of food packed in the container. exists. tion 409(b) (5) of the act squires that “Affecting the characteristics of food” (h) During the period within which the Commissioner publish notice of a does not include such physical effects, as any permit is effective, it shall be deemed petition for the establishmentrof a food- protecting contents of packages, pre to be included within the terms of any additive regulation within 30 days after serving shape, and preventing moisture guaranty or undertaking otherwise ef filing, notice of a petition relating to a loss. If there is no migration of a pack fective pursuant to the provisions of sec definition and standard of identity shall aging component from the package to the tion 303(c) of the act. also be published within that time limi food, it does not become a component of (i) if an application is made for an tation if it includes a request, so desig~x the food and thus is not a food additive. extension of the permit, it shall be ac nated, for the establishment of a^regula- A substance that does., not become a com companied by a description of experi tion pertaining to a food additive. ponent of food, but that, is used, for ex ments conducted under the permit, ten (b) If a petition for a definition and ample, ifi preparing an ingredient of the tative conclusions reached, and reasons standard of identity contains a proposal food to give a different flavor, texture, or why further experimental shipments for a food-additive regulation, and the other characteristic in the food, may be are considered necessary. The applica petitioner fails to designate it as such, a food additive. ; tion for an extension shall be filed not the Commissioner, upon determining (f) “Cqmmon use in food” refers to later than 3 months prior to the expira that the petition includes a proposal for consumption of a substance by animals, tion date of the permit and shall be ac a food-additive regulation, shall so no regardless of the number of manufactur companied by a petition to amend the tify the petitioner and shall thereafter ers who may produce it. affected food standard. If the Commis proceed in accordance with the regula (g) Thef word “substance” in the defi sioner concludes that it will be in the tions in this subchapter E. nition of the term “food additive” in interest of consumers to issue an exten cludes a food or feed or a component of sion of x the time period for the market a food or feed coiisisting of one or more test, a notice will be published in the PART 570— FOOD ADDITIVES ingredients. F ederal R egister stating that fact. The Subpart A— General Provisions Sec. (h) “Scientific procedures” include not notice will include an invitation to all 570.3 Definitions. only original animal, analytical, and interested persons to participate in the 570.6 Opinion letters on food additive - other scientific studies, but also an market test under the same conditions status. unprejudiced compilation of reliable in that applied to the initial permit holder, 570.15 Adoption of regulation on initiative formation, both favorable a n d unfavor including labeling and the amount to be of Commissioner. able, drawn from the scientific literature. distributed, except that the designated 570.17 Exemption for investigational use (i) “Safe” means that after reviewing area of distribution shall not apply. The and procedure for obtaining au all available evidence, including; extended market test period shall not thorization tp market edible prod ucts from experimental animals. (1) The probable consumption of the begin prior to the publication of a notice 570.18 Tolerances for related food additives. substance and of any substance formed in in the F ederal R egister granting the ex 570.19 Pesticide chemicals in processed or on food because of its use; tension and shall terminate either on the foods. (2) The cumulative effect of the sub effective date of an affirmative order rul Subpart B— Food Additive Safety stance in the diet, taking into account ing on the proposal or ,30 days after a any chemically or pharmacologically re- negative order ruling on the proposal, 570.20 General principles for evaluating the' 1 o tori suhct.ancA nr Riihstfl.nceS in SUCh safety of food additives. whichever the case may be. Any inter 570.22 Safety factors to be considered. diet; and ^ ested person who accepts the invitation 570.30 Eligibility for classification as gen . (3) Safety factors which in the to participate in the extended market erally recognized as safe (GRAS). opinion of experts qualified by scientific FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38645 training and experience to evaluate the recognized as safe for their intended use, search animals or for tests in vitro. Not for safety of food and feed and food and or to have prior sanction or approval, or use in humans. feed ingredients are generally recognized not to be food additives under the con (b) If intended for use in animals as appropriate in the use of animal ex ditions of intended use, must be re- other than laboratory research animals perimentation data; the Pood and Drug examined in the light of current scien and if the edible products of the animals Administration can conclude that no sig tific information and current principles are to be marketed as food, permission nificant risk of harm will result when the for evaluating the safety of food addi for the marketing of the edible products substance is used as intended. tives if their use is to be continued. as food has been requested by the spon (j) The term “nonperishable proc (d) Because of the time span involved, sor, and authorization has been granted essed food” means any processed food copies of many of the letters in which by the Food and Drug Administration not subject to rapid decay or deteriora the Food and Drug Administration has in accordance with § 511.1 of this chap tion that would render it unfit for con expressed an informal opinion concern ter or by the Department of Agriculture sumption. Not included are hermetically ing the status of such articles may no in accordance with 9 CFR 309.17, and it sealed foods and other processed foods longer be in the file of the Food and bears a label which states prominently, requiring refrigeration. Drug Administration. In the absence of in addition to the other information re (k) “Generally recognized as safe” information concerning the names and quired by the act, the warning: means general recognition of safety by uses made of all the articles referred to Caution. Contains a new food additive for experts qualified by scientific training in such letters, their safety of use can usé only in investigational animals. Not for and experience to evaluate the safety of not be reexamined. For this reason all use in humans. such a substance, as determined through food additive status opinions of the kind Edible products of investigational ani the procedure prescribed by § 570.30 described in paragraph (c) of this sec mals are not to be used for food unless (b)(2). On the basis of scientific data tion given by the Food and Drug Admin authorization has been granted by the U.S. derived from published literature, avail istration are hereby revoked. Food and Drug Administration or by the able to experts generally, reporting on (e) The prior opinions of the kind U.S. Department of Agriculture. credible toxicological testing, or for those described in paragraph (c) of this sec § 570.18 Tolerances for related food substances used in food prior to January tion will be replaced by qualified and additives. 1,1958, on the basis of a reasoned judg current opinions if the recipient of each (a) Food additives that cause similar ment founded in experience with com such letter forwards a copy of each to or related pharmacological effects will mon food use, the substance is recog the Department of Health, Education, be regarded as a class, and in the absence nized to have no significant risk of harm and Welfare, Food and Drug Adminis of evidence to the contrary, as having if used as intended, taking into account tration, Bureau of Veterinary Medicine, additive toxic effects and will be consid in either case: Office of Compliance (HFV-200), 5600 ered as related food additives. (l) Reasonably anticipated patterns Fishers Lane, Rockville, MD 20852, along (b) Tolerances established for such re of consumption of the substance and of with a copy of his letter of inquiry, on or lated food additives may limit the any substance formed in or on food be before July 23,1970. amount of a common component that cause of the use of the substance; (f ) This section does not apply to food may be present, or may limit the amount (2) The cumulative effect of the sub additive status opinion letters pertaining of biological activity (such as cholines stance, and any chemically or pharma to articles that were considered by the terase inhibition) that may be present cologically related substance, in the diet Food and Drug Administration to be food or may limit the total amount of related of man or animals; and additives nor to articles included in reg food additives that may be present. (3) Safety factors appropriate for the ulations in this subchapter E if the arti (c) Where food additives from two on utilization of animal experimentation cles are used in accordance with the re more chemicals in the same class are data. quirements of such regulations. present in or on a food, the tolerance § 570.6 Opinion letters on food additive (Sec. 201, 72 Stat. 1784-88, as amended; 21 for the total of such additives shall be status. U.S.C. 321) the same as that for the additive having the lowest numerical tolerance in this (a) Over the years the Food and Drug § 570.15 Adoption of regulation on initiative of Commissioner. class, unless there are available methods Administration has given informal writ that permit quantitative determination ten opinions to inquirers as to the safety (a) The Commissioner upon his own of the amount of each food additive pres of articles intended for use as compo initiative may propose the issuance of a. ent or unless it is shown that a higher nents of, or in contact with, food. Prior regulation prescribing, with respect to tolerance is reasonably required for the to the enactment of the Pood Additives any particular use of a food additive, the combined additives to accomplish the Amendment of 1958 (Public Law 85-929, conditions under which such additive physical or technical effect for which Sept. 6, 1958), these opinions were given may be safely used. Notice of such pro such combined additives are intended pursuant to section 402(a)(1) of the posal shall be published in the F ederal and that the higher tolerance will be Federal Food, Drug, and Cosmetic Act, R egister and shall state the reasons for safe. which reads in part: “A food shall be the proposal. (d) Where residues from two or more deemed to be adulterated if it bears or (b) Action upon a proposal made by additives in the same class are present contains any poisonous or deleterious the Commissioner shall, after publica in or on a food and there are available substance which may render it injurious tion of the notice, proceed as provided methods that permit quantitative de to health;”. in §§ 571.1 and 571.100 and section 409 termination of each residue, the quantity - (b) Since enactment of the Food Ad of the act. of combined residues that are within the ditives Amendment, the Food and Drug tolerance may be determined as follows: Administration has advised such in § 570.17 Exemption for investigational (1) Determine the quantity of each quirers that an article: use and procedure for obtaining au thorization to market edible products residue present. (1) Is a food additive within the from experimental animals. (2) Divide the quantity of each residue meaning of section 201 (s) of the act; or by the tolerance that would apply if it (2) Is generally recognized as safe A food additive or food containing a occurred alone, and multiply by 100 to (GRAS); or food additive intended for investigational determine the percentage of the per (3) Has prior sanction or approval use by qualified experts shall be exempt mitted amount of residue present. hnder that amendment; or from the requirements of section 409 of (3) Add the percentages so obtained the act under the following conditions: for all residues present. (4) Is not a food additive under the (a) If intended for investigational use conditions of intended use. (4) The sum of the percentages shall in vitro or in laboratory research ani not exceed 100 percent. (c) In the interest of the public health,mals, it bears a label which states promi articles which have been considered nently, in addition to the other informa § 570.19 Pesticide chemicals in proc m the past by the Food and Drug Admin- tion required by the act, the warning : essed foods. c a tio n to be safe under the provisions Caution. Contains a new food additive for When pesticide chemical residues oc * section 402(a) (1), or to be generally investigational use only in laboratory re- cur in processed foods due to the use of FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 38646 RULES AND REGULATIONS raw agricultural commodities that bore (b) Upon written request describingcant degree the nutritive value or the or contained a pesticide chemical in the proposed use of an additive and the concentration of toxic constituents conformity with an exemption granted proposed experiments to determine its therein. or a tolerance prescribed under section safety, the Commissioner will advise a (iii) , Distillates, isolates, extracts, con 408 of the act, the processed food will not person who wishes to establish the safety centrâtes of extracts, or reaction prod be regarded as adulterated so long as of a food additive whether he believes ucts of substances considered as GRAS. good manufacturing practice has been the experiments planned will yield data (iv) Substances not of natural biologi followed in removing any residue from adequate for an evaluation of the safety cal origin including those for which evi the raw agricultural commodity in the of the additive. dence is offered that they are identical processing (such as by peeling or wash with a GRAS counterpart of natural ing) and so long as the concentration of § 570.22 Safety factors to be considered. biological origin. the residue in the processed food when In accordance with section 409(c) (5) (v) Substances of natural biological ready to eat is not greater than the tol (C) of the act, the following safety fac origin intended for consumption for erance prescribed for the raw agricul tors will be applied in determining other than their nutrient properties. tural commodity. But when the con whether the proposed use of a food addi (c) Substances that do not meet the centration of residue in the processed tive will be safe: Except where evidence criteria of paragraph (b) of this section food when ready to eat is higher than the is submitted which justifies use of a dif are not eligible for GRAS status and tolerance prescribed for the raw agricul ferent safety factor, a safety factor in hence require a food additive regulation tural commodity, the processed food is applying animal experimentation data promulgated under section 409 of the act, adulterated unless the higher concen to man of 100 to 1, will be used; that is, and no substance will be eligible for tration is permitted by a tolerance ob a food additive for use by man will not GRAS status if it has no history of food tained under section 409 of the act. For be granted a tolerance that will exceed use or requires prescribed limitations for example, if fruit bearing a residue of 7 1/100th of the maximum amount dem safe use. parts per million of DDT permitted on onstrated to be without harm to experi (d) Any substance used in food must the raw agricultural commodity is dried mental animals. be of food-grade quality. The Commis and a residue in excess of 7 parts per § 570.30 Eligibility for classification as sioner regards the applicable specifica million of DDT results on the dried fruit, generally recognized as safe (GRAS). tions in the current edition of “Food the dehydrated fruit is adulterated un Chemicals Codex’’ as establishing food less the higher tolerance for DDT is (a) To provide assurance that any grade unless he has by F ederal Register authorized by the regulations in this part. substance is absolutely safe for human promulgation established other-specifi Food that is itself ready to eat, and which or animal consumption is impossible. cations. contains a higher residue than allowed (b) A substance used as food, or the (e) If the Commissioner has not af for the raw agricultural commodity, may intended use of which results or may firmed a given substance as GRAS on his not be legalized by blending or mixing reasonably be expected to result directly own initiative, such affirmative ruling with other foods to reduce the residue in or indirectly in its becoming a compo may be sought by submitting to the Com the mixed food below the tolerance pre nent of food or affecting the characteris missioner a request containing all rele scribed for the raw agricultural com tics of food, may be eligible for classifi vant usage and safety data. modity. cation as generally recognized as safe (f) Substances listed as GRAS may (GRAS) under the following criteria: require reclassification either because of Subpart B— Food Additive Safety (1) Substances that will be considered the criteria established by this section § 570.20 General principles for evaluat as GRAS and for which a promulgation or because of new information regarding ing the safety of food additives. in the F ederal R egister is not required: safety. The initial results of a new in (a) In reaching a decision on any peti (1) Any substance of natural biological vestigation, even if not convincing with origin that has been widely consumed respect to potential harm, may establish tion filed under section 409 of the act, the for its nutrient properties in the United Commissioner will give full consideration that the substance in question can no States prior to January 1, 1958, without longer be considered as GRAS. Newly re to the specific biological properties of detrimental effect when used under rea the compound and the adequacy of the ported information will be caréfully sonably anticipated patterns of con evaluated by the Commissioner, along methods employed to demonstrate safety sumption. for the proposed use, and the Commis with other available information, to de sioner will be guided by the principles (ii) Substances defined in paragraph termine whether or not there has been and procedures for establishing the (b) (1) (i) of this section that have been a significant increase in risk to the pub modified by conventional processing as lic health from using the substance as safety of food additives stated in current practiced prior to January 1, 1958. publications of the National Academy intended. No change will be made in of Sciences-National Research Council. (2) Substances that will be affirmed existing GRAS status until the Commis as GRAS by the Commissioner after he sioner determines that the substance re A petition will not be denied, however, has given notice in the F ederal R egister by reason of the petitioner’s having fol quires evaluation. that the status of such substance (and (g) If a responsible and substantial lowed procedures other than those out limitations, if any) is under considera lined in the publications of the National question of safety has been raised re tion, invited experts qualified by scien garding a substance previously listed as Academy of Sciences-National Re tific training and experience to evalu search Council if, from available evi GRAS, but the main weight of the scien ate the safety of foods and food ingredi tific evidence still establishes safety dence, the Commissioner finds that the ents to submit comments, reviewed all procedures used give results as reliable within certain limits, an interim food ad available evidence and the comments ditive regulation may be proposed in the as, or more reliable than, those reason received, and found convincing evidence ably to be expected from the use of the F ederal R egister. This will permit fur of its general recognition of safety: ther scientific investigations to define the outlined procedures. In reaching a de ■ (i) Substances defined in paragraph cision, the Commissioner will give due conditions of safe use for a food additive (b) (1) (i) of this section that have regulation of indefinite duration. weight to the anticipated levels and pat been modified by processes proposed for terns of consumption of the additive introduction into commercial use after § 570.35 Affirmation of generally recog specified or reasonably inferable. For January 1, 1958, whqre such processes nized as safe (GRAS) status. the purposes of this section, the princi may reasonably be expected to signifi (a) The Commissioner, either on his ples for evaluating safety of additives cantly alter the composition of the initiative or on the petition of an inter set forth in the above-mentioned publi substance. ested person, may affirm the GRAS cations will apply to any substance that (ii) Substances that have had signifi status of substances that directly or in may properly be classified as a food addi cant alteration of composition by breed directly become components of food. tive as defined in section 201 (s) of the ing or selection and the change may rea (b) (1) If the Commissioner proposes act. sonably be expected to alter to a signifi on his own initiative that a substance is FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38647 entitled to affirmation as GRAS, he will dence that the substance is identical to office of the Hearing Clerk and will in place all of the data and information on a GRAS counterpart of natural bio clude in the F ederal R egister notice the which he relies on public file in the office logical origin, and other data may be sub name of the substance, its known uses, of the Hearing Clerk and will publish in mitted to support safety. Any adverse and a summary of the basis for the the F ederal R egister a notice giving the information or consumer complaints determination. name of the substance, its proposed uses, shall be included. Complete bibliographic (2) The F ederal R egister notice will and any limitations proposed for pur references shall be provided where a allow a periotSkof 60 days during which poses other than safety. copy of the article is not provided. any interested person may review the (2) The F ederal R egister notice will (v) A statement signed by the persondata and information and/or file com allow a period of 60 days during which responsible for the petition that to the ments with the Hearing Clerk. Copies any interested person may review the best of his knowledge it is a represent of all comments shall be made available data and information and/or file com ative and balanced submission that in for examination in the Heading Clerk’s ments with the Hearing Clerk. Copies of cludes unfavorable information, as'well office. all comments received shall be made as favorable information, known to him (3) The Commissioner will evaluate available for examination in the Hearing pertinent to the evaluation of the safety all comments received. If he concludes Clerk’s office. and functionality of the substance. that there is a lack of convincing evi (3) The Commissioner will evaluate all (2) Within 30 days after the date of dence that the substance is GRAS or is comments received. If he concludes that filing the petition, the Commissioner will otherwise exempt from the definition of there is convincing evidence that the place the petition on public file in the a food additive in section 201 (s) of the substance is GRAS as defined in § 570.3 office of the Hearing Clerk and will pub act, he will publish a notice thereof in (k), he will publish a notice in the Fed lish a notice of filing in . the F ederal the F ederal R egister. If he concludes eral Register listing the substance in R egister giving the name of the petition that there is convincing evidence that this" subchapter E as GRAS. er and a brief description of the petition the substance is GRAS, he will publish (4) ' If, after evaluation of the comincluding the name of the substance, its an order in the F ederal R egister listing ments, the Commissioner concludes that proposed use, and any limitations pro-" the substance in this subchapter E as there is a lack of convincing evidence^ posed for reasons other than safety. A GRAS. that the substance is GRAS and that it copy of the notice will be mailed to the (c) A F ederal R egister notice deter should be considered a food additive petitioner at the time the original is sent mining that a substance is a food addi subject to section 409 of the act, he shall to the F ederal R egister. tive shall provide for the use of the publish a notice thereof in the F ederal (3) The notice of filing in the F ederal additive in food or food-contact surfaces Register in accordance with § 570.38. R egister will allow a period of 60 days as follows: (c) (1) Persons seeking the affirmaduring which any interested person may Cl) Itjmay promulgate a food additive tion of GRAS status of substances as review the petition and/or file comments regulation governing use of the additive. provided for in § 570.30(e), except those with the Hearing Clerk. Copies of all (2) It may promulgate an interim subject to the NAS-NRC GRAS list sur comments received shall be made avail food additive regulation governing use vey (36 FR 20546), shall submit to the able for examination in the bearing of the additive. Commissioner of Food and Drugs a peti Clerk’s office. (3) It may require discontinuation of tion for GRAS affirmation in quadrupli (4) The Commissioner will evaluate the use of the additive. cate. Such petition shall contain infor the petition and all available informa (4) It may adopt any combination of mation to establish that the GRAS cri tion including all comments received. If teria as set forth in § 370.30 (b) have the above three approaches for different the petition and such information pro uses or levels of use of the additive. been met, in the following form: vide convincing evidence that the sub (i) Description of the substance, stance is GRAS as defined in § 570.3, (Sec. 201, 72 Stat. 1784-1788; 21 U.S.C. 321) including: he will publish an order in the. F ederal (a) Common or usual name. V R egister listing the substance in this PART 571— FOOD ADDlflVE PETITIONS (b) Chemical name. subchapter E as GRAS. (c) Chemical Abstract Service (CAS) Subpart A— General Provisions registry number. (5) If, after evaluation of the petition Sec. and all available information, the Com 571.1 Petitions. (d) Empirical formula. missioner concludes that there is a lack 571.6 Amendment of petition. (e) Structural formula. of convincing evidence that the sub 571.7 Withdrawal of petition without (/) Specifications for food grade ma stance is GRAS and that lit should be prejudice. terial, including arsenic and heavy considered a food additive subject, to Subpart B— Administrative Actions on metals. (Recommendation for any Applications change in. the Food Chemicals Codex section 409 of the act, he sha,U publish a notice thereof in the F ederal R egisters 571.100 Regulation based on petition. monograph should be included where in accordance with § 570.38. 571.102 Effective date of regulation. applicable.) 571.110 Objection to regulation and request (0) Quantitative compositions. (Sec. 201, 72 Stat. 1784-1788; 21 U.S.C. 321) for hearing. (h) Manufacturing process (excluding 571.120 Request for a stay of effective date § 570.38 Determination of food additive of regulation pending a hearing. any trade secrets). status. (ii) Use of the substance, including: 571.130 Procedure for amending and repeal (a) The Commissioner may, in ac ing tolerances or exemptions from (a) Date wlien use began. tolerances. (b) Information and reports or other cordance with § 570.35(b) (4) or (c) (5), data on past uses in food. publish a noticeLin the F ederal R egister Subpart C— Hearing Procedures (c) Foods in which used, and levels of determining that a substance is not 571.200 Notice of public hearing. use in such foods, and for what pur GRAS and is a food additive subject to 571.202 Appearances and burden of proof at poses. section 409 of the act. public hearings. (b) (1) The Commissioner may, on his 571.203 Administrative Law Judge. (iii) Methods for detecting the sub 571.204 Prehearing and other conferences. stance in food, including: own initiative, or on the basis of a peti 571.205 Transcript of the testimony. tion establishing reasonable grounds 571.206 Oral and written arguments. (o) References to qualitative and therefor in accordance with §571.130 571.208 Index of hearing record. quantitative methods for determining of this chapter filed in quadruplicate by 571.210 Certification of hearing record. the substance(s) in food,^including the an interested person, publish a notice in 571.212 Filing of hearing record. type of analytical procedures used. the F ederal R egister proposing to de 571.21T4 Copies of hearing record. (b) Sensitivity and reproducibility of termine that a substance is not GRAS Subpart D— Evidence such method(s). and is a food additive subject to section 571.220 Submission of documents in ad (iv) Information to establish the safe 409 of the act. The Commissioner will vance of hearing. ty and functionality of the substance in place all of the data and information on 571.221 Excerpts from documents. food. Published scientific literature, evi which he relies on public file in the 571.222 Submission and receipt of evidence. FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 38648 RULES AND REGULATIONS Sufopart E— Findings of Facts and Order of manufacturing, processing, or packing of include detailed data derived from appro 571.230 Proposed order after public bearing. the food additive which are relied upon to priate animal and other biological experi 571.232 Final order after public bearing. establish that it is a substance of repro ments in which the methods used and the ducible composition. Alternative methods Subpart F— Judicial Review results obtained are clearly set forth. The and controls and variations in methods and petition shall not omit without explanation 571.235 Judicial review. controls within reasonable limits that do not any reports of investigations that would bias affect the characteristics of the substance or an evaluation of the safety of the food Authority: Secs. 409, 701, 52 Stat. 1055- the reliability of the controls may be 1056 as amended, 72 Stat. 1785-1788 as additive.) specified. * F. Proposed tolerances for the food addi amended (21 U.S.C. 348, 371), unless other If the food additive is a mixture of chemi wise noted. tive, if tolerances ai^e required in order to cals, the petition shall supply a Pst of all ensure its safety. A petitioner may include Subpart A— General Provisions substances used in the synthesis, extraction, a proposed regulation. or other method of preparation, regardless of § 571.1 Petitions. whether they undergo- chemical change in G. If submitting petition to modify an the process. Each substance should be existing regulation issued pursuant to sec (a) Petitions to be filed with the Com identified by its common English name and tion 409(c)(1)(A) of the act, full informa missioner under the provisions of section complete chemical name, using structural tion on each proposed change that is to be 409(b) of the act shall be submitted in formulas when necessary for specific identifi made in the original regulation must be triplicate. If any part of the material cation. If any proprietary'-preparation is submitted. The petition may omit state used as a component, the proprietary name ments made in the original petition concern submitted is in a foreign language, it ing which no change is proposed. A supple shall be accompanied by an accurate and should be followed by a complete quantita tive statement of composition. Reasonable mental petition must be submitted for any complete English translation. The peti alternatives for any listed substance may be change beyond the variations provided for tion shall state petitioner’s post office specified. in the original petition and the regulation address to which published notices or If the petitioner does not himself perform issued on the basis of the original petition. orders issued or objections filed pur all the manufacturing, processing, and pack H. .The petitioner is required to submit an suant to section 409 of the act may be ing operations for a food additive, the peti environmental impact analysis report analyz sent. tion shall identify each person who will per ing the environmental impact of the manu (b) Pertinent information may be in form a part of such operations and designate facturing process and the ultimate use or the part. consumption of the food additive pursuant corporated in, and will be considered as The petition shall include stability data, to § 6 .1 of this chapter. • part of, a petition on the basis of spe and, if the data indicate that it is needed Tours very truly, cific reference to such information subr to ensure the identity, strength, quality, or Petitioner______■_ mitted to and retained in the files of the purity of the additive, the expiration date B y------...... Food and Drug Administration. How that will be employed. (Indicate authority) ever, any reference to unpublished B. The amount of the food additive pro (d) The petitioner will be notified of information furnished by a person other posed for use and the purposes for which it the date on which his petition is filed, than the applicant will not be considered is proposed, together with all directions, recommendations, an^ suggestions regarding and an incomplete petition, or one that unless use of such information is au the proposed Use, as well as specimens of the has not been submitted in triplicate, will thorized in a written statement signed by labeling proposed for the food additive and usually be retained but not filed as a pe the person who submitted it. Any ref any labeling that will be required by appli tition under sectibn 409 of the act. The erence to published information offered cable provisions of the Federal Food, Drug, petitioner will be notified in what re in support of a food-additive petition and Cosmetic Act on the finished food by spects his petition is incomplete. should be accompanied by reprints or reason of the use of the food additive. If the (e) The petition must be signed by the photostatic copies of such references. additive results or may reasonably be ex pected to result from the use of packaging petitioner or by his attorney or agent, or (c) Petitions shall include the follow material, the petitioner shall show how this (if a corporation) by an authorized ing data and be submitted in the follow may occur and what residues may reasonably official. ing form: be anticipated. (f) The data specified under the sev (Typewritten or other draft-labeling copy eral lettered headings "should be sub v (Date) will be accepted for consideration of the peti mitted on separate sheets or sets of Name of petitioner------„— ------tion, provided a statement is made that final Post office address------pointed labeling identical in content to the sheets, suitably identified. If such data D a te _____ - ______.>------—------draft copy will-be submitted as soon as avail have already been submitted with an Name of food additive and proposed u s e ----- able and prior to the marketing of the food earlier application, the present petition additive. may incorporate it by specific reference. If the food additive is one for which a to the earlier. If part of the data have tolerance limitation Is required to assure its Food and Drug Administration , safety, the level of use proposed should be no been submitted by the manufacturer of B ureau of Veterinary Medicine, higher than the amount reasonably required the food additive as a master file, the Associate Director for Scientific Evaluation_ to accomplish the intended physical or other petitioner rhay refer to the master file (HFV-100), Rockville, MD 20852. technical effect, even though the safety data if and to the extent he obtains the manu D ear Sir s: The undersigned,------may support a higher tolerance.) facturer’s written permission to do so. submits this petition pursuant to section C. Data establishing that the food additive The manufacturer may authorize spe 409(b) (1) of the Federal Food, Drug, and will have the intended physical or other cific reference to the ddta without dis Qosmetic Act with respect t o ------— technical effect or that it may reasonably be closure to the petitioner. Nothing'herein expected to become a component, or to affect (Name of the food additive and proposed use) the characteristics, directly or indirectly, of shall prevent reference to published data. Attached hereto, in triplicate, and consti food and the amount necessary to accomplish (g) A petition shall be retained but tuting a part of this petition, are the this. These data should include information shall not be filed if any of the data pre following : in sufficient detail to permit evaluation with scribed by section 409(b) of the act are A. The name and all pertinent informationcontrol data. lacking or are not set forth so as to be D. A description of practicable methods to readily understood. concerning the food additive, including determine the amount of the food additive chemical identity and composition of the in th e raw, processed, and/or finished food *?■ (h) (1) The following data and infor food additive, its physical, chemical, and and of any substance formed in or on such mation in a food additive petition are biological properties, and specifications pre available for public disclosure, unless scribing the minimum content of the desired food because of its use. The test proposed component(s) and identifying and limiting shall be one that can be used for food-control extraordinary circumstances are shown, the reaction byproducts and other Impurities. purposes and that can be applied with con after the notice of filing of the petition Where such information is not available, a sistent results by any properly equipped and is published in the F ederal Register statement as to the reasons why, it 4s not trained laboratory personnel. or, if the petition is not promptly filed should be submitted. E. Full reports of investigations made with because of deficiencies in it,; after the When the chemical identity and composi respect to the safety of the food additive. petitioner is informed that it will not be tion of the food additive is not known, the (A petition may be regarded as incomplete filed because of the deficiencies involved. unless it includes full reports of adequate petition shall contain information in suf data ficient detail to permit evaluation regarding tests reasonably applicable to show whether All safety and functionality the method of manufacture and the analyti or not the food additive will be safe for its and information submitted with or in cal controls used during the various stages intended use. The reports ordinarily should corporated by reference in the petition. FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38649 (ii) A protocol for a test or study, supplement a deficient petition after the substantive amendment proposes a unless it is shown to fall within the ex being notified regarding deficiencies. If substantial change to the petition which emption established for trade secrets the supplementary material or explana may affect the quality of the human en and confidential commercial information tion of the petition is deemed acceptable, vironment, the petitioner is required to in § 4.61 of this chapter. petitioner shall be notified. The date of submit an environmental impact analysis (iii) Adverse reaction reports, product such notification becomes the date of report pursuant to § 6.1 of this chapter. experience reports, consumer complaints, filing. If the petitioner does not wish § 571.7 Withdrawal of petition without and other similar data and information, to supplement or explain the petition and -- prejudice. after deletion of: requests in writing that it be filed as sub (a) Names and any information that mitted, the petition shall be filed and the (a) In some cases the Commissioner would identify the' person using the petitioner so notified. The date of such will notify the petitioner that the peti product. notification becomes the date of filing. tion, while technically complete, is in (b) Names and any information that (2) The Commissioner will publish inadequate to justify the establishment of would identify any third party involved theFEDERAL R egister within 30 days from a regulation or the regulation requested with the report, such as a physician or the date of filing of such petition, a by petitioner. This may be due to the hospital or other institution. notice of the filing, the name of the peti fact that the data are not sufficiently (iv) A list of all ingredients contained tioner, and a brief description of the pro clear or complete. In such cases, the peti in a food additive, whether or not it is posal in general terms. In the case of a tioner may withdraw the petition pending in descending order of predominance. A food additive which becomes a compo its clarification or the obtaining of addi particular ingredient or group of ingre nent of food by migration from packag tional data. This withdrawal will be with dients shall be deleted from any such list ing material, the notice shall include the' out prejudice to a future filing. Upon re prior to public disclosure if it is shown name of the migratory substance, and filing, the time limitation will begin to to fall within the exemption established where it is different from that of one of run anew from the date of refiling. in § 4.61 of this chapter, and a notation the original components, the name of the (b) At any time before the order pro shall be made that any such ingredient parent component, the maximum quan vided for in § 571.100(a) has been for list is Incomplete. tity of the migratory substance that is warded to the F ederal R egister for pub (v) An assay method or other ana proposed for use in food, and the physi lication, the petitioner may withdraw lytical method, unless it serves no regu cal or other technical effect which the the petition without prejudice to a future latory or compliance purpose and is migratory substance or its parent com filing. Upon refiling the time limitation shown to fall within the exemption es ponent is intended to have in the pack will begin to run anew. tablished in § 4.61 of this chapter. . aging material. A copy of the notice Subpart B— Administrative Actions on (2) The following data and informawill be mailed to the petitioner when the Applications original is forwarded to the F ederal R eg tion in a food additive" petition are not § 571.100 Regulation based on petition. available for public disclosure unless they ister for publication. have been previously disclosed to the (j) The Commissioner may request a .(a) The Commissioner will forward for public as defined in § 4.81 of this chapter full description of the methods used in, publication in'* the F ederal R egister, or they relate to a product or ingredient and the facilities and controls used for, within 90 days after filing of the petition that has been abandoned and they no the production of the food additive, or (or within 180 days if the time is ex longer represent a trade secret or confi a sample of the food additive, articles tended as provided for in section 409(c) dential commercial or financial infor used as components thereof, or of the (2> of the act), a regulation prescrib mation as defined in § 4.61 of this food in which the additive is proposed to ing the conditions under which the food chapter: be used, at ahy time while a petition is additive may be safely used (including, (i) Manufacturing methods or proc under consideration. The Commissioner but not limited to, specifications as to the esses, including quality control proce shall specify in the request for a sample particular food ov classes of food in or dures. of the food additive, or articles used as on which such additive may be used, the (ii) Production, sales, distribution, components thereof, or of the food in or maximum quantity that may be used nr and similar data and information, except on which the additive is proposed to be permitted to remain in or on such food, that any compilation of such data and used, a quantity deemed adequate to the manner in which such additive may information aggregated ancUprepared in permit tests of analytical methods to de be added to or used in or on, such food, a way that does not reveal data or infor termine quantities of the food additive and any directions or other labeling or mation which is not available for public present in foods for which it is intended packaging requirements for such additive disclosure under this provision is avail to be used or adequate for any stu£y or deemed necessary by him to assure the able for public disclosure. investigation reasonably required with safety of such use) ; and prior to the for (iii) Quantitative or semiquantitative respect to the safety of the food additive warding of the order to the F ederal R eg formulas. or the physical or technical effect it pro ister for publication shall notify the pe . (3) All correspondence and written duces. The date used for computing the titioner of such order and the reasons summaries of oral discussions relating to 90-day limit for the purposes of section for such action; or by order deny the a food additive petition are available for 409(c) (2) of the act shall be moved for petition, and shall notify the petitioner public disclosure in accordance with the ward 1 day for each day after the mailing of such order and of the reasons for provisions of Part 4 of this chapter when date of the request taken by the peti such action. the food additive regulation is published tioner to submit the sample. If the in (b) If the Commissioner determines in the Federal R egister. formation or sample is requested a that additional time is needed to study (4) For purposes of this regulation,reasonable time in advance of the 180 and investigate the petition, he shall by safety and functionality data include all days, but is not submitted within such written notice to the petitioner extend studies and tests of a food additive on 180 days after filing of the petition, the the 90-day period for not more than 180 animals and humans and all studies and petition will be considered withdrawn days after the filing of the petition. tests on a food additive for identity, sta without prejudice. bility, purity, potency, performance, and §571.102 Effective date of regulation. usefulness: § 571.6 Amendment of petition. (i) (1) Within 15 days after After a petition has been filed, the A regulation published in accordance receipt, the Commissioner will notify the petitioner may submit additional infor with § 571.100(a) shall become effective Petitioner of acceptance or nonaccept mation or data in support thereof. In upon publication in the F ederal R eg ance of a petition, and if not accepted such cases, if the Commissioner deter ister. the reasons therefor. If accepted, the mines that the additional information or § 571.110 Objection to regulation and date of the notification letter sent to data amounts to a substantive amend request for hearing. petitioner becomes the date of filing for ment, the petition as amended will be the purposes of section 409(b) (5) of the given a new filing date, and the time (a) Objections to an order promul act. if the petitioner desires, he may limitation will begin to run anew. Where gated pursuant to section 409(f) (1) of FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 38G50 RULES AND REGULATIONS the act shall be submitted in quintupli- ence with the existing regulation or ex objections on which he wishes, to be cate to the Hearing Clerk, Food and Drug emption may justify its amendment or heard. No person shall be heard if he Administration, at the address specified repeal. New data should be furnished failed to file notice of his appearance in such order. Each objection to a pro in the form specified in § 571.1 for sub within the time prescribed, in the ab vision of the regulation shall be sepa mitting petitions. sence of a clear showing of good cause rately numbered. Subpart C— Hearing Procedures why the notice of appearance was not (b) A statement of objections shall filed.'All present ai the hearing shall not be accepted for filing if: § 571.200 Notice of public hearing. conform to all reasonable standards of (1) It is received for filing more than ' If the objections and statements filed orderly and ethical conduct. 30 days after the date of publication of by any person when they are considered § 571.203 Administrative Law Judge. 'the order in the F ederal R egister. with the record in the proceeding (in (2) It fails to establish that the ob cluding any reply to the objections that The hearing shall be conducted by an jector will be adversely affected by the the petitioner may have filed), show that Administrative Law Judge, who shall be regulation. the person filing the objections is ad an Administrative Law Judge appointed (3) It does not specify with particu versely affected and that the grounds as provided in the Administrative Pro larity the provisions of the regulation to stated in support of the objections are cedure Act (sec. 11, 60 Stat. 244, as which objection is taken. reasonable, and a public hearing on the amended; 5 U.S.C. 1010 et seq.). and des (4) It does not state reasonable objections is requested, the Commis ignated by the Commissioner for con grounds for each objection raised. sioner shall cause to be published in the ducting the hearing. Any such designa Grounds that it is reasonable to conclude F ederal R egister a notice reciting the tion may be made or revoked by the are capable of being established by reli objections and announcing a public Commissioner at any time: Hearings able evidence at the hearing, and which hearing to receive evidence on them. shall be conducted in an informal but if proved would call for changing the The notice shall designate the place orderly manner in accordance with the provisions specified in the objections, where the hearing will be held, specify regulations in this part and the require will be deemed reasonable grounds. the time-within which appearances must ments of the Administrative Procedure (c) If the statement of objections may be filed, and specify the time (not earlier Act. The Administrative Law Judge shall not be filed, the Commissioner shall in-, than 30 days after the date of publica have the power to administer oaths and form the objector of the reasons. tion of the notice in the F ederal R eg affirmations, to rule upon offers of proof Cd) If objections to a regulation ister) when the hearing will commence. arid admissibility of evidence, to receive issued pursuant to the filing of a petition The hearing will convene at the place relevant evidence, to examine witnesses, are filed by a person other than the and time announced in the notice, but to regulate the course of the hearing, petitioner, the Food and Dryig Adminis thereafter it may be moved to a different to hold conferences for the simplification tration shall send a copy of the objec place and may be continued from day to of the issues, and to dispose pi procedural tions by certified mail to the petitioner day or recessed to a later day without requests, but he shall not have power at the address given in the petition. Peti other notice than announcement thereof to decide any motion that involves tioner shall have 2 weeks from the date by the presiding officer at the hearing. final determination of the merits of the of receipt by him of the objections to Included in such notice shall be a state proceeding. make written reply. ment indicating whether the regulation § 572.204 Prehearing and other confer § 571.120 Request for stay of effective to which objection was taken shall be ences. date of regulation pending a hearing. stayed pending the outcome of the (a) The Administrative Law Judge, on When a hearing is requested under hearing. his own motion or on the motion of any § 571.110, the request may also include a § 571.202 Appearances and burden of party or his representative, may direct request for a stay of effectiveness of the proof at public hearing. all parties or their representatives to ap order, in whole or in part, which request pear at a specific time and place for a shall include the reasons for the stay At the hearing, the person whose ob prehearing conference to consider: together with' a showing that the stay jections raised the issues to be deter (1) The simplification of the issues. involves no hazard to the public health. mined shall be, within the meaning of (2) The possibility of obtaining stipu section 7(c) of the Administrative Pro lations, admissions of facts, and § 571.130 Procedure for amending and cedure Act, the proponent of the order documents. repealing, tolerances or exemptions sought, and accordingly shall have the from tolerances. ■*< (3) The possibility of the limitation of, burden of proof. Any interested person the number of witnesses. (a) The Commissioner or any inter shall be given an opportunity toappear (4) The-scheduling of witnesses to be ested person may propose the issuance at the hearing, either in person or by his called. of a regulation amending or repealing a authorized representative, and to be (5) The^ advance submission of all regulation pertaining to a food additive heard with respect to matters relevant documentary evidence. or granting or repealing an exemption to the issues raised by the objectionsr (6) Such other matters as may aid in for such additive. Such a proposal by Any interested person who desires to be the disposition of the proceeding. an interested person' shall be in writing. heard at the hearing in person' or If such proposal by an interested person through a representative shall, within The Administrative Law Judge shall lumishes reasonable grounds therefor the time specified in the notice of hear make an order reciting the action taken the Commissioner will publish a notice ing, file with the presiding officer a writ at the conference, the agreements made announcing the proposal. Proposals ini ten notice of appearance setting forth by the parties or their representatives, tiated by the Commissioner will likewise his name, address, and employment. and the scheduling of witnesses, and lim be published. Following such publication, If such person desires to be heard iting the issues for hearing to those not the proceedings shall be the same as through a representative, such person disposed of by admissions or agreements. prescribed by section 409 of the act or such representative shall file with the Such order shall control the subsequent and the regulations in this part for the presiding officer a written appearance course of the proceeding unless m odified promulgation of a regulation. setting forth the name, address, and em for good cause by subsequent order. (b) “Reasonable grounds” shall in ployment of such person. Any person or (b) The Administrative Law Judge clude an explanation showing wherein representative shall state with particu may also direct all parties and their the person has a substantial interest in larity in the notice of appearance his representatives to appear at conferences such regulation and an assertion of facts interest in the proceeding and shall set at any time during the hearing with a (supported by data if available) showing forth the specific provisions of the regu view to simplification, clarification, or that new information exists with respect lation concerning which objections have shortening of the hearing. to the food additive or that new uses been made on which such person desires § 572.205 Transcript of the testimony. have been developed or old uses aban to be heard. The notice of appearance doned, that ndw data are available as to shall also set forth with particularity the Testimony given at a public hearing toxicity of the chemical, or that experi position to be taken concerning the shall be reported verbatim. All written FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38651 statements, charts, tabulations, and sim § 571.210 Certification of hearing rec § 571.221 Excerpts from documents. ilar data offered in evidence at the hear ord. When portions only of a document are ing shall be marked fpir identification At the close of the hearing, the Ad to be relied upon, the offering party shall and, upon a showing satisfactory to the ministrative Ldw Judge shall afford wit prepare the pertinent excerpts, ade presiding officer of their authenticity, nesses and their counsel a short time (not quately identified, and shall supply relevancy, and materiality, shall be re longer than 30 days, except in unusual copies of such excerpts, together with a ceived in evidence subject to the Ad cases) in which to point out errors that statement indicating the purpose for ministrative Procedure Act (sec. 7(c), 60 n\ay have been made in transcribing the which such materials will be offered, to Stat. 238; 5 U.S.C. 1008(c)). Exhibits testimony. The Administrative Law the Administrative Law Judge and to the shall if practicable, be submitted in Judge shall promptly thereafter order other parties. Only the excerpts, so pre quintuplicate. In case the required num such corrections made as in his judgment pared and submitted, shall be received in ber of copies are not made available, the are required to make the transcript con the record. However, the whole of the Administrative Law Judge shall exercise form to the testimony and he shall cer original document should be made avail his discretion in determining whether tify the transcript of testimony and the able for examination and for use by op said exhibit shall be read in evidence or exhibits to the Commissioner. posing counsel for purposes of cross- whether additional copies shall be re examination. quired to be submitted within a time to §571.212 Filing of hearing record. be specified by the Administrative Law As spon as practicable after the close § 571.222 Submission and receipt of evi Judge. Where the testimony of a witness of the hearing, the complete record of dence. T refers to a statute, or to a report or docu the hearing shall be filed in the office of (a) Each witness shall, before pro ment, the Administrative Law Judge the Hearing Clerk. The record shall in ceeding to testify, be sworn or make af shall, after inquiry relating to the clude the transcript of the testimony, all firmation. identification of such statute, report, or exhibits, and any written arguments that (b) When necessary to prevent undue document, determine whether the same may have been filed. prolongation of the hearing, the Admin shall be produced at the hearing and istrative Law Judge may limit the num physically be made a part of the evidence § 571.214 Copies of hearing record. ber of times any witness may testify, the by reference. Where relevant and mate _ The Department will make provision repetitious examination and cross- rial matter offered in evidence is em for a stenographic record of the testi examination of Witnesses, or the amount braced, in a report or document con mony and for such copies of the tran of jcorroborative or cumulative evidence. taining Immaterial and irrelevant mat script thereof as it requires for its own (c) The Administrative Law Judge ter, such immaterial and irrelevant purposes. Any person desiring a copy of shall admit only evidence which is matter shall be excluded and shall be the record of the hearing or of any part relevant, material, and not unduly segregated insofar as practicable, sub thereof shall be entitled to the same upon repetitious. ject to the direction of the Administra payment of the costs thereof. (d) Opinion evidence shall be ad tive Law Judge. —^ Subpart D— Evidence mitted when the Administrative Law Judge is satisfied that the witness is § 571.206 Oral and written arguments. § 571.220 Submission of documents in properly qualified. ' (a) Unless the Administrative Law advance of hearing. (e) The Administrative Law Judge Judge issues an announcement at the (a) All documents to be offered at the shall file as an exhibit a copy of the hearing authorizing ' oraf argument be hearing shall he. submitted to the Ad F ederal R egister promulgating the reg fore him, it shall not be permitted. ministrative Law Judge and to the in ulation to which objections were taken (b) The Administrative Law Judge terested parties sufficiently in advance and the objections that form the basis shall announce at the hearing a reason of the offer of such documents for in for the hearing. All documents constitut able period within which interested per troduction into the record to permit ing the record bearing on the point in sons may file written arguments based study and preparation of cross-exami controversy, and not entitled to protec solely upon the evidence received at the nation and rebuttal evidence. tion under section 301 (j) of the act, ac hearing, citing the pages of the transcript (b) The Administrative Law Judge, af cumulated up to the start of the hear of the testimony or properly identified ter consultation with the parties at a con ing shall be open for inspection by in exhibits where such evidence occurs. ference called in accordance with terested persons during office hours in § 571.208 Index of hearing record. § 571.204, shall make an order specifying the office of the Hearing Clerk, Food and the time at which documents shall be Drug Administration, Parklawn Bldg., (a) Whenever it -appears to the Ad submitted., He shall also specify in his Rm. 465, 5600 Fishers Lane, Rockville, ministrative Law Judge that the record order the time within which objection Md. 20852. of hearing will be of such length that an to the authenticity of such documents (f) If any person objects to the ad index to the record will permit a more must be made to comply with paragraph mission or rejection of any evidence or to orderly analysis of the evidence and re (d) of this section. other limitation of the scope of any ex duce delay, the Administrative Law Judge (c) Documents not submitted in ad amination or cross-examination, he shall shall require counsel for the parties to vance in accordance with the require state briefly the grounds for such ob prepare a daily topical index, which will ments of paragraphs (a) and (b) of this jection, and the transcript shall riot in be available to the Administrative Law section shall not be received in evidence clude extended argument or debate Judge and all parties. Preparation of in the absence of a clear showing that the thereon except as ordered by the pre such an index shall be apportioned offering party had good cause for his siding officer. A ruling of the Adnfinis- among all counsel present in such man failure to produce the documents sooner. trative Law Judge on any such objection ner as appears just and proper in the (d) The authenticity of all documents shall be a part of the transcript, together circumstances. submitted in advance shall be deemed with such offer of proof as has been (b) The index shall include each topic admitted unless written objection thereto made. of testimony upon which evidence is is filed with the Administrative Law Subpart E— Findings of Facts and Order token, the name of each witness testify Judge upon notice to the other parties ing upon the topic, the page of the record within the time specified by the Admin § 571.230 Proposed order after public at which each portion of his testimony istrative Law Judge in accordance with hearing. appeared, and the number of each exhibit paragraph (b) of this section, except As soon as practicable after the time relating to the topic. The index shall that a party will be permitted to chal for filing written arguments has ended also contain the name of each witness, lenge such authenticity at a later time the Commissioner shall prepare and followed by the topics upon which he upon a clear showing of good cause for cause to be. published in the F ederal testified and the page of the record at failure to have filed such written R egister a proposed order which shall which such testimony appears. objection. ^ set forth in detail the findings of fact v FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPtEMBER 10, 1976 38652 RULES AND REGULATIONS and conclusions, and recommend de Sec. (2) The maximum percentage of equiv cision on the objections that were the 573.660 Methyl glucoside-coconut oil ester. alent crude protein from the nonprotein 573.680 Mineral oil. nitrogen. subject of the hearing and tentative reg 573.700 Sodium nitrite. ulations. The proposed order shall spec 573.720 Petrolatum. (3) Directions for use to provide not ify a reasonable time, ordinarily not to 673.740 Odorless light petroleum-hydrocar more than 20 percent of the additive in exceed 60 days, within which any inter bons. the total ration, ested person may file exceptions. The 573.760 Poloxalene. (4) A statement: exceptions shall point out with particu 573.780 Polyethylene. (i) That not more than one-third of larity the alleged errors in said proposed 573.800 Polyethylene glycol (400) monq- , the total protein in the feed should come ... and dioleate. from nonprotein nitrogen sources. order and shall contain a specific refer 573.820 Polyoxyethylene glycol (400) mono- ence to the pages of the transcript of the and dioleates. (ii) That the additive is not to be testimony or to the exhibits on which 673.840 Polysorbate 60. given to debilitated or starved animals. each exception is based. Such excep 573.860 Polysorbate 80. (iii) “Warning—This feed should be tions may be accompanied by a memo 573.880 Normal propyl alcohol. used only in accordance with directions randum or brief. 573.900 Pyrophyllite. furnished on the label.” 573.920 Selenium § 571.232 Final ordei* after publichear 573.940 Silicon dioxide. § 573.160 Ammoniated rice hulls. ing. 573.960 Sorbitan monostearate. The food additive ammoniated rice 573.980 Taurine. hulls may be safely used in accordance As soon as practicable after the time 573.1000 Verxite. for filing exceptions has passed, the rec 573.1020 Yellow prussiate of soda. with the following prescribed conditions: ord and the exceptions shall be presented (a) The food additive is the product to the Secretary and he shall cause to Authority: Sec. 409, 72 Stat. 1785-1788 as obtained by the treatment of ground rice amended (21 U.S.C. 348) unless otherwise be published in the F ederal R egister hulls with monocalcium phosphate and his final order promulgating the regula noted. anhydrous ammonia at a temperature tion, which shall specify the date on Subpart A— [Reserved] of 350° F and a pressure of 175 pounds which the order shall take effect. Subpart B— Food Additive Listing per square inch. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38653 (5) A statement that silage treated (1) The name of the additive. (a) The food additive is the product with the additive is to be fed to cattle (ii) The maximum percentage of resulting from the neutralization of only. equivalent crude protein from nonpro feeding-phosphoric-acid or defluorinated (6) A statement that additional pro tein nitrogen. wet-process phosphoric acid with anhy tein should not be fed to lactating dairy (iii) The statement “Do not feed to drous ammonia. It contains not less cows producing less than 32 pounds of animals producing milk for human than 106.25 percent equivalent crude milk per day, or beef cattle consuming consumption.” protein (nitrogen X 6.25) and 20 per less than 1 percent of body weight daily (2) The label shall recommend that cent phosphorus. It contains not more in shelled corn. the diet be balanced to provide adequate than the following: (7) A warning statement to read as nutrients when equivalent crude protein 1 part fluorine to 100 parts phosphorus. follows: “Warning—Use only as di from all forms of nonprotein nitrogen 75 parts per million or arsenic (as As). rected; additional trace mineral supple exceed one-third of the total crude pro 30 parts per million of heavy metals, as lead mentation should not be fed with treated tein in the total daily ration. (Eb). silage.” § 573.240 Calcium periodate. (b) It is used in ruminant feeds as a § 573.200 Condensed animal protein The food additive calcium periodate source of phosphorus and nitrogen in an hydrolysate. may be safely used in accordance with amount that supplies not more than 2 (a) Identity. The condensed animal the following prescribed conditions: percent of equivalent crude protein in protein hydrblysate is produced from (a) The additive is produced by react the total daily ration. the meat byproducts scraped from cured ing calcium iodate with calcium hydrox Cc) To assure safe use of the additive, (salted) hides taken from cattle slaugh ide or calcium oxide to form a substance the label and labeling of the additive tered for food consumption. The meat consisting of not less than 60 percent by and that of any feed additive supple byproduct is hydrolyzed with heat and weight of penta calcium orthoperiodate ment, feed additive concentrate, feed phosphoric acid. containing 28 to 31 percent by weight of additive premix, or complete feed pre (b) Specifications. The additive shall iodine. pared therefrom shall contain, in addi conform to the following percent-by- (b) It is used or intended for use in tion to other information required by weight specifications: salt for livestock as a source of iodine. the act, the following: (1) The name of the additive. Moisture, not less than 45 percent nor more § 573.260 Calcium silicate; than 50 percent. «. (2) The maximum percentage of Protein, not less than 24 percent. Calcium silicate, including synthetic equivalent crude protein from the non Salt (NaCl), not more than 15 percent. calcium silicate, may be safely used'as protein nitrogen. Phosphorus, not less than 2 25 percent. an anticaking agent in animal feed, pro (3) If the feed additive premix, feed vided that the amount of calcium silicate additive concentrate, or feed additive (c) Uses. It is used or intended for use does not exceed 2 percent. supplement contains more than 2 per as a source of animal protein, phos cent equivalent crude protein from di phorus, and salt (NaCl) as follows: § 573.280 Feed-grade calcium stearate. ammonium phosphate, adequate direc (1) In poultry and swine feed in an Feed-grade calcium stearate may be tions for use and a prominent statement, amount not to exceed 5 percent by weight safely used in an animal feed in accord “Warning—This feed should be used only of the feed. ance with the following prescribed in accordance with directions furnished (2) In feed concentrates for cattle in conditions: on the label.” an amount not to exceed 10 percent by (a) Feed-grade calcium stearate is the weight of the concentrate. calcium salt of a fatty acid mixture that § 573.340 Diatomaceous earth. (d) Labeling. The label and labeling is predominately stearic acid. Associated (a) Identity. The additive consists of shall bear, in addition to the other in fatty acids, including palmitic acid and siliceous skeletal material derived from formation required by the act: minor amounts of lauric, myristic, pen- various species of diatoms. (1) The name of -the additive, con tadecanoic, margaric, arachidic, and (b) Specifications. Hie additive shall densed animal protein hydrolysate. other fatty acids may be contained in the conform to the following specifications: (2) Adequate directions for use in mixture, but such associated fatty acids Lead, not more than 15 parts per million. cluding maximum quantities permitted in aggregate do not exceed 35 percent by Arsenic (as As), not more than 20 parts per for each species and a guaranteed analy weight of the mixture. The fatty acids million sis of the additive. may be derived from feed-grade fats or Fluorine, not more than 600 parts per million. § 573.220 Feed-grade biuret. oils. (b) The additive meets the following (c) Uses. It is used or intended for use The food additive feed grade biuret specifications: as an inert carrier or anticaking agent may be safely used in ruminant feed in (1) Unsaponifiable matter does not in animal feeds in an amount not to accordance with the following prescribed exceed 2 percent. exceed s percent by weight of the total conditions: (2) It is free of chick-edema factor. ration. (a) The food additive is the product (c) The additive is manufactured so § 573.360 Disodium EDTA. resulting from the controlled pyrolysis that in aqueous solution it is exposed for of urea -conforming to the. following 1 hour or longer to temperature in excess The food additive disodium EDTA specifications: of 180° F. (disodium ethylenediaminetetraacetate) Percent (d) It is used as an anticaking agent may be safely used in animal feeds, in Biuret------5 5 minimum. in animal feeds in accordance with good accordance with the following prescribed Urea ------_■____ 15 maximum. manufacturing practice. conditions: Cyanuric acid and triurpt- 30 maximum. (a) The food additive contains a mini Mineral oll______0.5 maximum. § 573.300 Choline xanthate. Total nitrogen (equivalent mum of 99 percent disodium ethylene to 218.75 pet crude pro Choline xanthate may be safely used diaminetetraacetate dihydrate (CicHi408 tein). 35 minimum. as a component of animal feed as an NJSTa,2H,0). (b) It is used in ruminant feeds as a added source of choline to supplement (b) It is used to solubilize trace min the diets of poultry, ruminants, and erals in aqueous solutions, which are source of nonprotein nitrogen. swine in accordance with good feeding FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38654 RULES AND REGULATIONS (2) Adequate mixing directions to enSudan grass ______Sorghum vulgare su- § 573.460 Formaldehyde. sure that the chelated trace-mineral mix danense. Wheat______—______Triticum aestivum. The food additive formaldehyde may is uniformly blended throughout the feed. be safely used in the manufacture of an § 573.380 Ethoxyquin in animal feeds. or any mixture of such forage crops, for imal feeds in accordance with the follow use only as an animal feed. ing conditions: Ethoxyquin (1,2-dihydro - 6 - ethoxy- (b) Such additive is used only as a (a) The additive is used, or intended 2.2.4- trimethylquinoline) may be safely chemical preservative for the purpose of for use, to improve the handling charac used in animal feeds, when incorporated^ retarding oxidative destruction of nat teristics of animal fat in combination therein in accordance with the following urally occurring carotenes and vitamin with certain oilseed meals by producing prescribed conditions. E in the forage crops. therefrom a dry, free-flowing product as (a) It4s intended for use only: (1) As (c) It is added to the dehydrated for follows: a chemical preservative for retarding age crops in an oil mixture containing (1) An aqueous blend of soybean and oxidation of carotene, xanthophylls, and only suitable animal or suitable vege sunflower meals in a ratio of 3: 1, respec vitamins A and E in animal feed and table oil, prior to grinding and mixing. tively, is mixed with animal fat such that fish food and, (2) as an aid in prevent (d) The maximum quantity of the ad the oilseed meals and animal fat are in a ing 4he development of organic perox ditive permitted to be used and to remain ratio of 3: 2. The feed ingredients are ides in canned pet food. in or on the dehydrated forage crop shall those defined by the “Official Publica (b) The maximum quantity of the not exceed 150 parts per million. tion” of the Association of American additive permitted to be used and to re (e) To assure the safe use of the addi Feed Control Officials, Inc., 1976 ed., main in or on the treated article shall tive, the label of the market package pages 86,103, and 109.1 not exceed 150 parts per million. shall contain, in addition to other in (2) .Formaldehyde (37 percent solu (c) To assure safe use of the additive, formation required by the act: tion) is added to the mixture at a level the label and labeling of the food addi (1) The name of the additive as speci of 4 percent of the dry matter weight of tive container and that of any inter fied in this section. the oilseed meals and animal Tat. This mediate premixes prepared therefrom (2) Directions for the incorporation mixture, upon drying, contains not more shall contain, in addition to other infor of the additive in the forage crops, as than 1 percent formaldehyde and not mation required by the act: specified in paragraph (c) of this sec more than 12 percent moisture. (1) The name of the additive, ethoxy tion, with the directive that only suitable (b) The dried mixture described in quin. animal or suitable vegetable oils are to paragraph (a) of this section is used, or (2) A statement of the concentration be used in the oil mix. intended for use, as a component of dry, or strength contained therein. (f) The label of any dehydrated for nonpelleted feeds for beef and nonlactat- ,(3) Adequate use directions to provide age crops treated with the additive or ing dairy cattle. for a finished article with the proper the label of an animal-feed supplement (c) To assure safe use of the additive, concentration of the additive as provided containing such treated forage crops, in addition to the other information re in paragraph (b) of this section, whether shall, in addition to other information quired by the act, the label and labeling or not intermediate premixes are to be required by the act, bear the following of the dried mixture described in para used. statements: graph (a) of this section shall bear: (d) The label of any animal feed con (1) The name Of the additive. taining the additive shall, in addition (1) “Ethoxyquin, a preservative,” or (2) Adequate directionsfor use provid to the other information required by the “Ethoxyquin added to retard the oxida ing that feed as consumed is not to con act, bear the statement “Ethoxyquin, a tive destruction of carotene and vitamin tain more than 25 percent of the mixture. preservative” or “Ethoxyquin added to E.” retard the oxidative destruction of caro (2) The statement “For use in animal § 573.480 Formic acid. tene, xanthophylls, and vitamins A and feed only.” , Formic acid may be safely used as a E.” § 573.420 Ethyl cellulose. preservative in hay crop silage in an amount not to exceed 2.25 percent of the § 573.400 Ethoxyquin in certain dehy The food additive ethyl cellulose may silage on a dry weight basis or 0.45 per drated forage crops. be safely used in animal feed in accord cent when direct-cut. The top foot of Ethoxyquin (l,2-dihydro-6-ethoxy- ance with the following prescribed silage stored should not contain formic 2.2.4- trimethylquinoline) may be safely conditions: acid and silage should not be fed to live used in the dehydrated forage crops (a) The food additive is a cellulose stock within 4 weeks of treatment. listed in paragraph (a) of this section ether containing ethoxy (OC2H5) groups § 573.500 Condensed, extracted glu when incorporated therein in accordance attached by an ether linkage and con tamic acid fermentation product. with the conditions prescribed in this taining on an anhydrous basis not more section: than 2.6 ethoxy groups per anhydroglu- Condensed, extracted glutamic acid (a) It may be added to dehydratedcose unit. fermentation product may be safely used forage prepared from: (b) It is used or intended for use as a in animal feed under the following con binder or filler in dry vitamin prepara ditions : Alfalfa______Medicago sativa. concentrated Barley______Hordeum vulgare. tions to be incorporated into animal feed. (a) The additive is a Clovers: mixture of the liquor remaining from Alsike clover_____ - Trifolium hybridum. § 573.440 Ethylene dichloride. the extraction -of glutamic acid, com Crimson clover_____ Trifolium incarna- The food additive ethylene dichloride bined with the cells of Corynebacterium tum. may be safely used in the manufacture of lilium used to produce the glutamic acid. Red clover______Trifolium pratense. animal feeds in accordance with the fol (b) It is used or intended for use as White clover (in- Trifolium repens, eluding Ladino)-- lowing prescribed conditions: follows: White sweetclover_Melilotus alba. (a) It is used as a solvent in the ex (1) In poultry feed as a source of pro Yellow sweetclover- Melilotus officinalis. traction processing of animal byproducts tein in an amount not to exceed 5 per Coastal Bermudagrass. Cynodon dactylon. for use in animal feeds. cent of the total ration. Corn______Zea mays. (b) The maximum -quantity of the Fescue______.______Festuca sp. additive permitted to remain in or on the (2) In cattle feed as a source of pro Oats______Avena sativa. tein in an amount not to exceed 10 per Orchardgrass;_____ — Dactylis glomerata. extracted byproducts shall not exceed Beed canarygrass__ _ Pharlaris arundi- 300 parts per million. cent of the feed. nacea. (c) The extracted animal byproduct (c) In order to assure safe use, the Byegrass (annual and ' Elymus sp. and Lo- is added as a source of protein to a total perennial) liumperenne. ration at levels consistent with good 1 Sorghums—...... Sorghum vulgare Copies may be obtained from: Ern®f* vars, f eterita, shal- feeding practices, but in no event at Epps, Jr., Treasurer, Division of Agricmtu lu, kaoliang, levels exceeding 13 percent *of the total Chemistry, P.O. Box 16390-A, Baton Bouge* broomcorn. ration. LA 70803. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38655 label and labeling of the additive shall limitations prescribed in paragraph (b) acids: Docosahexanoic acid, eicosapen- bear, in addition to the other informa of this section. tanoic acid, linoleic acid, myristic acid, tion required by the act, the following: § 573.580 Iron-choline citrate complex. oleic acid, palmitic acid, palmitoleic acid, ( 1 ) The name of the additive. and stearic acid, and lesser amounts of (2) A statement of the concentration Iron-choline citiate complex made by the associated acid esters. of the additive contained in any mixture. reacting approximately equimolecular (b) The food additive meets the fol (3) Adequate directions for use. quantities of ferric hydroxide, choline, lowing specifications: § 573.520 Hemicellulose extract. and citric acid may be safely used as a (1) Free methyl alcohol not to exceed source of iron in animal feed. Hemicellulose extract may be safely 150 parts per million. § 573.600 Lignin sulfonates. (2) Unsaponifiable matter not to ex used in animal feed when incorporated ceed 2 percent. therein in accordance with the follow Lignin sulfonates may be safely used ing conditions: (3) It is free of Chick-edema factor or in animal feeds in accordance with the other factors toxic to chicks, as evi (a) The additive is produced from the following prescribed conditions: denced during the bioassay method for aqueous extract obtained by the treat (a) For the purpose of this section, determining the check-edema factor as ment of wood with water at elevated thè food additive is either one, or. a com prescribed in paragraph (b) (4) (ii) of temperatures (420°-535° F) and pressure bination of, the ammonium, calcium, this section. (300-900 pounds per square inch) and magnesium, or sodium salts of the ex contains primarily pentose and hexose tract of spent sulfitè liquor derived from (4) For the purposes of this section: sugars. the sulfite digestion of wood or of abaca (i) Unsaponifiable matter shall be de (b) The additive may be used in a (Musa textilis) or of sisal (Agave si~ termined by the method described in liquid or dry state with the liquid prod satana) in either a liquid form (moisture section 26.049, Official Methods of Analy uct containing not less than 55 percent not to exceed 50 percent by weight) or sis of the Association of Official Agricul carbohydrate and the dry product con dry form (moisture not to exceed 6 per-? tural Chemsits, 9th Ed. (I960).1 taining not less than 84 percent carbo cent by weight). (ii) The chick-edema factor bioassay hydrate. (b) It is used or intended for use in an method described in the Journal of the . (c) The additive is used as a source of amount calculated on a dry weight basis, Association of Official Agricultural metabolizable energy in animal feed in as follows: Chemists, Volume 44, page 146 (1961),1 accordance with good manufacturing (1) As a : pelleting aid in the liquid or shall be employed. The presence of and feeding practices. dry form in an amount not to exceed 4 chick-edema factor shall be determined § 573.540 Hydrolyzed leather meal. percent of the finished pellets. by a comparison between the mean log (2) As a binding aid in the liquid form of the pericardial fluid volumes of a test (a) Identity. Hydrolyzed leather meal in the flaking of feed grains in an group and of a concurrent negative con is produced from leather scraps that are amount not to exceed 4 percent of the trol group. The significance of the dif treated with steam for not less than 33 flaked grain. ference in pericardial fluid volumes be minutes at a pressure of not less than (3) As a surfactant in molasses used in tween the test group and the negative 125 pounds per square inch. feeds, as liquid lignin sulfonate, in an control group is determined by calculat (b) Specifications. The additive shall amount not to exceed 11 percent of the ing a “t" value according to the conform to the following percent-by- molasses. formula: weight specifications : (4) As a source of metabolizable en Moisture, not less than 5 percent nor more ergy, in the liquid or dry fo^m, in an than 10 percent. amount not to exceed 4 percent of the Crude protein, not less than 60 percent. finished feed. Crude fat, not less than 5 percent. w here: Crude fiber, not more than 6 percent. § 573.620 Menadione dimethylpyrimidi- Chromium, not more than 2 .7 5 percent. x t and xc are the means of the logs of the nol bisulfite. pericardial fluid volumes of-the test (c) Use. It is used or intended for use The food additive, menadione dimeth- and control groups, respectively; as a source of protein in swine feeds in ylpyrimidinol bisulfite, may be safely n't and nc are the number of chicks in the an amount not to exceed 1.0 percent by used in accordance with the following respective groups; weight of the finished feed. conditions: *r and Sc2 are the variances of the test (d) Labeling. The labels and labeling (a) The additive is the 2-hydroxy-4, 6- and control groups, respectively. shall bear, in addition to the other in dimethylpyrimidinol salt of menadione The variances are calculated as follows: formation required by thè act: (CuHisOoNaS). , (1) The name of the additive, hydro (b) The additive is used or intended ^ _ n(T,x2) — (2 > ) 2 lyzed leather meal. • n(n— 1) for use as a nutritional supplement for w here: (2) Adequate directions to provide fin the prevention of vitamin K deficiency ished feeds complying with paragraph as follows: is the sum of the logs of the peri (c) of this section. cardial fluid volumes; (1) In chicken and turkey feed at a is the sum of the squares of the logs § 573.560 Iron ammonium citrate. level not to exceed 2 grams per ton of of the pericardial fluid volumes for complete feed. either the test t or control c group data. Iron ammonium citrate may be safely (2) In the feed of growing and finish wsed in animal feed in accordance with ing swine at a level not to exceed 10 The test sample is judged to contain the following prescribed conditions: grams per ton of feed. chick-edema factor if the calculated “i” (a) The additive is+he chemical green (c) To assure safe use, the label and exceeds +1.3 and the mean log of the ferric ammonium citrate. labeling of the additive shall bear ade pericardial fluid volume obtained from (b) The additive is used or intended quate directions for use. the negative control group multiplied by ior use as an anticaking agent in salt for 100 is less than 1.1461. animal consumption so that the level of § 573.640 Methyl esters of higher fatty acids. (iii) “Other factors toxic to chicks” jron ammonium citrate does not exceed referred to in paragraph (b) (3) of this 4-u ^>ar^s Per million (0.0025 percent) in The food additive methyl esters of section shall be determined during the the finished salt. higher fatty acids may be safely used in course of the bioassay test described in fK(c.) assure safe use of the additive animal feeds in accordance with the fol paragraph (b) (4)(H) of this section, on ine label or labeling of the additive shall lowing prescribed conditions: the basis of chick deaths or other abnor- ear, in addition to the other information (a) The food additive is manufactured required by the act: by reaction of methyl alcohol with feed- ro? name of the additive, 1 Copies are available from: Association of grade fats or oils and consists of not Official Analytical Chemist, P.O. Box 540, Ben fin i Ade(luate directions to provide a less than 70 percent methyl esters of the jamin Franklin Station, Washington, D.C. a i product that complies with the following straight-chain monocarbox-ylic 20044. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38656 RULES AND REGULATIONS malities not attributable to chick-edema (b) To assure safe use of the additive, (a) The additive consists of polyoxy- factor or to the experimental conditions in addition to the other information re propylene-polyoxyethylene glycol non of the test. quired by the act: ionic block polymer meeting the follow (c) It is used or intended for use as (1) The label of the additive shall ing specifications: a supplementary source of fat for animal bear: (1) Molecular weight range: 2,850- feed. (1) The name of the additive. 3,150. (d) To assure safe use of the additive, (ii) A statement of the concentration (2) Hydroxyl number: 35.7-39.4. in addition to the other information of the additive in any mixture. (3) Cloud point (10 percent solution) : required by the act: (2) The label or labeling shall bear 42° C-46° C. (1) The label and labeling of the ad adequate directions to provide a final (4) Structural formula: ditive, and any feed additive supple product that complies with the limita H O (CH j—C H j—O) 01-13) ment, feed additive concentrate, feed ad tions prescribed in paragraph (a) of this ditive premix, or complete feed prepared .section. C H —CHj—0(33-3«) (C H r-C H j—0 ) FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38657 safely used as an emulsifier in calf-milk (f) Feeds containing added seleniumrier for the incorporation of nutrients in replacer formulations. may not be admiriisteted to hens laying poultry, swine, dog, or ruminant feeds, eggs for human consumption. in ah amount not to exceed that neces § 573.840 Polysorbate 60. sary to accomplish its intended effect The food additive polysorbate 60 (poly § 573.940 Silicon dioxide. and in no case to exceed 1.5 percent of oxyethylene (20) sorbitan monostea The food additive silicon dioxide may the dog feed or 5 percent of the final rate) may be safely used in animal feeds be safely used in animal feed in accord feed for other animals. in accordance with the following pre-' ance with the following conditions: (2) (i) Verxite flakes: The additive Scribed conditions: (a) The food additive is manufactured contains a minimum of 98 percent of hy- (a) It is used alone or in combination by vapor phase hydrolysis or by other drobiotite; it has a bulk density of from with sorbitan monostearate as an emul means whereby the particle size is such 20 to 30 pounds per cubic foot. sifier in mineral premixes and dietary as to accomplish the intended effect. supplements for animal feeds. (b) It is used or intended for u£e in (ii) It is used or intended for use as (b) It is used as an emulsifier in milk- feed components as an anticaking an anticaking or blending agent in ru replacer formulations for calves. agent, and/or grinding aid, as follows: minant feeds in an amount noMo exceed that necessary to accomplish its intended § 573.860 Polysorbate 80. • Limitations effect and in no case to exceed 1 percent Feed component: (percent) by weight of the final feed for ruminants. The food additive polysorbate 80 (poly BHT (butylated hydroxytolu- oxyethylene (20) sorbitan monooleate) e n e ) ______2 (3) (i) yerxtte grits: The additive con may be safely used as an emulsifier in Methionine hydroxy analog and its tains a minimum of 80 percent of hydro- milk-replacer formulations for calves. calcium salts__Z______1___ 1 biotite; it has a bulk density of from 40 Piperazine, piperazine salts_____ 0. 8 § 573.880 Normal propyl alcohol. to 50 pounds per cubic foot. Sodium propionate______r__ 1 (ii) It is used or intended for use as Normal propyl alcohol may be safely U rea______1 Vitam ins______3 a partial roughage replacement in rumi used in feeds and feed supplements for nant feeds in an amount not to exceed cattle as a source of metabolizable en (c) It is used in feed as an anticakingthat necessary} to-accomplish its intended ergy. It is incorporated in the feed or agent in an amount not "to exceed that effect and in no case to,, exceed 1 per feed supplement in an amount which reasonably required to accomplish its in cent by weight of the final feed. provides not more than 54.5 grams of the tended effect and in no case in an amount (b) To assure safe use of the additive, v additive per head per day. to exceed 2 percent by weight of the fin the label of any feed additive supple § 573.900 Pyrophyllite. ished feed. ment, feed additive concentrate, feed ad Pyrophyllite (aluminum silicate mono § 573.960 Sorbitan monostearate. ditive premix, or complete feed prepared hydrate) may be safely used as the sole The food additive sorbitan monostea therefrom shall bear, in addition to the anticaking aid, blending agent, pelleting rate may be safely used alone or in com other information required by the act, aid, or carrier in animal feed when incor bination with polysorbate 60 as an emul the name of the additive (verxite gran porated therein in an amount not to ex sifier in mineral premixes and dietary ules, verxite flakes, or verxite grits), ade ceed 2 percent in complete animal feed. quate directions for use, and, when the supplements for animal feeds. additive is present in excess of 1 percent, § 573.920 Selenium. , § 573.980 Taurine. a statement of the quantity of the addi The food additive selenium may be The food additive taurine (2-amino- tive contained therein an the term safely used in accordance with the fol ethanesulfonic acid) may be safely used “nonnutritive” in juxtaposition there lowing prescribed conditions: in feed in accordance with the following with. (a) The additive is used in animal prescribed conditions: § 573.1020 Yellow prussiate of soda. feed as a nutrient in the fqrm of sodium (a) It is used as a nutritional supple selenite or sodiùm selenate. ment in the feed of growing chickens. Yellow prussiate of soda (sodium fer- . (b) It is added to the complete feed of (b) It is added to complete feeds so rocyanide decahydrate; Na«FE(Cn) B° growing chickens up to 16 weeks of age -that the total taurine content does not lOHsO) may be safely used as an anti and to the complete feed of swine at a exceed 0.054 percent of the feed. caking agent in salt for animal consump level not to exceed 0.1 part per million (c) ' i d assure safe use of the additive,tion at a level not to exceed 13 parts per of added selenium; it is added to the ^the label and labeling shall bear in ad million. The additive contains a mini complete feed of turkeys afr a level not dition to the other information required mum of 99.0 percent by weight of sodium to exceed 0.2 part per million of added by the act: ferrocyanide decahydrate. selenium. (1) The name of the additive. (c) The additive shall be incorporated (2) The quantity of the additive into each ton of the complete feed of contained therein. PART 582— SUBSTANCES GENERALLY growing chickens up to 16 weeks of age (3) Adequate directions for use. RECOGNIZED AS SAFE and of swine by a premix containing no Subpart A— General Provisions more than 90.8 milligrams of added sele § 573.1000 Verxite. Sec. 582.1 Substances that are generally rec nium and weighing not less than 1 pound. The food additive verxite may be safely ognized as safe. The additive shall be incorporated into used in animal feed in accordance with 582.10 Spices and other natural season each ton of the complete feed of tur the following prescribed conditions: ings axid flavorings. / x keys by a premix containing no more (a) The additive, is a magnesium-alu 582.20 Essential oils, oleoresins (solvent- than 181.6 milligrams of added selenium minum-iron silicate conforming to one free), and natural extractives and weighing not less than 2 pounds. of the following: (including distillates). (d) The premix manufacturer shall (1) (i) Verxite granules: The additive 582.30 Natural substances used in con analyze each production batch of sele contains a minimum of 98 percent of hy- junction with spices and other natural seasonings and flavor nium premix and shall establish by such drobiotite; it is thermally expanded and ings. analysis that the levels of selenium speci has a bulk density of from 5 to 9 pounds 582.40 Natural extractives (solvent-free) fied in paragraph (c) of this section are per cubic foot. used in conjunction with spices, not exceeded. (ii) It is used or intended for use: seasonings, and flavorings. . te) The label or labeling of any sele (a) In poultry feed at a level not to 582.50 Certain other spices, seasonings, nium premix shall bear adequate direc exceed 5 percent of the weight of the essential oils, oleoresins, and tions and cautions for use including this. finished feed as a nonnutritive bulking' natural extracts. 582.60 'Synthetic flavoring substances and statement : “Caution : Follow label direc sagent for restricting calorie intake in adjuvants. tions. The addition to feed of higher pullet replacement feeds, 582.80 Trace minerals added to animal levels of this premix containing selenium f (b) As an anticaking or ‘ blending foods. !s not permitted.” ■ agent, pelleting aid, or nonnutritive car 582.99 Adjuvants for pesticide chemicals. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38658 RULES AND REGULATIONS Subpart B— General Purpose Food Additives Subpart D— Chemical Preservatives Sec. Sec. Sec. 582.5446 Manganese chloride. 582.1005 Acetic acid. 582.3013 Ascorbic acid. 582.5449 Manganese citrate. 582.1009 Adipic acid. 582.3021 Benzoic acid. 582.5452 Manganese gluconate. 582.1033 Citric acid. 582.3041 Erythorbic acid. 582.5455 Manganese glycerophosphate. 582.1057 Hydrochloric acid.. 582.3081 Propionic acid. 582.5458 Manganese hypophosphite. 582.1061 Lactic acid. 582.3089 Sorbic acid. 582.5461 Manganese sulfate. 582.1069 Malic acid. 582.3109 Thiodipropionic acid. 582.5464 Manganous oxide. 582.1073 Phosphoric acid. 582.3149 Ascorbyl palmitate. 582.5470 Mannitol. 582.1077 Potassium acid tartrate. 582.3169 Butylated hydroxyanisole. 582.5475 Methionine. 582.1087 Sodium acid pyrophosphate. 582.3173 Butylated hydroxytoluene. 582.5477 Methionine hydroxy analog and its 582.1091 Succinic acid. 582.3189 Calcium ascorbate. % calcium salts. 582.1095 Sulfuric acid. 582.3221 Calcium propionate. 582.5530 Niacin. 582.1099 Tartaric acid. 582.3225 Calcium sorbate. 582.5535 Niacinamide. 582.1125 Aluminum sulfate. 582.3280 Dllauryl thiodipropionate, 582.5580 D-Pantothenyl alcohol. 582.1127 Aluminum ammonium sulfate. 582.3336 Gum guaiac. 582.5590 Phenylalanine. 582.1129 Aluminum potassium sulfate. 582.3490 Methylparaben. 682.5622 Potassium ehloride. 582.1131 Aluminum sodium sulfate. 582.3616 Potassium bisulfite. “582.5628 Potassium glycerophosphate. 582.1135 Ammonium bicarbonate.. . 582.3637 Potassium metabisulfite. 582.5634 Potassium iodide. 582.1137 Ammonium carbonate. 582.3640 Potassium sorbate. 582.5650 Proline. 582.1139 Ammonium hydroxide. 582.3660 Propyl gallate. 582.5676 Pyridoxine hydrochloride. 582.1141 Ammonium phosphate. 582.3670 Propylparaben. 582.5695 Riboflavin. 582.1143 Ammonium sulfate. 582.3731 Sodium ascorbate. 582.5697 Ribofiavin-5-phosphate. 582.1155 Bentonite. 582.3733 Sodium benzoate. 582.5701 Serine. 582.1165 Butane. 582.3739 Sodium bisulfite. 582.5772 Sodium pantothenate. 582.1191 Calcium carbonate. 582.3766 Sodium metabisulfite. 582.5778 Sodium phosphate. 582.1193 Calcium chloride. 582.3784 Sodium propionate. 582.5835 Sorbitol. 582.1195 Calcium citrate. 582.3795 Sodium sorbate. 582.5875 Thiamine hydrochloride. 582.1199 Calcium .gluconate. 582,3798 Sodium sulfite. 582.5878 Thiamine mononitrate. 582.1205 Calcium hydroxide. 582.3845 _Stannous chloride. 582.5881 Threonine. 582.1207 Calcium lactate. 582.3862 Sulfur dioxide. 582.5890 Tocopherols. 582.1210 Calcium oxide. 582.3890 Tocopherols. 582.5892 a-Tocopherol acetate. 582.5915 Tryptophane. 582.1217 Calcium phosphate. Subpart E— Emulsifying Agents 582.1235 Caramel. 582.5920 Tyrosine. 582.1240 Carbon dioxide. 582.4101 Diacetyl tartaric acid esters of 582.5925 Valine. 582.1275 Dextrans. mono- and diglycerides of edible 582,5930 Vitamin A. 582.1320 Glycerin. fats or oils, or edible fat-forming 582.5933 Vitamin A acetate. 582.1324 Glyceryl monostearate. fatty acids. v- : 582.5936 Vitamin A palmitate. 682.1355 Helium. 582,4505 Mono- and diglycerides of edible 582.5945 Vitamin Bu. 582.1366 Hydrogen peroxide. fats or oils, or edible fat-forming 582.5950 Vitamin D2. 582.1400 Lecithin. acids^ 582.5953 Vitamin Dg. 582.1425 Magnesium carbonate. 582.4521 Monosodium phosphate derivatives 582.5985 "Zinc chloride. 582.1428 Magnesium hydroxide. of mono- and diglycerides of 582.5988 Zinc gluconate. 582.1431 Magnesium oxide. edible fats or oils, or edible fat 582,5991 Zinc oxide. 582.1480 Methylcellulose. forming fatty acids. 582.5994 Zinc stearate. 582.1500 Monoammonium glutamate. 582.4666 Propylene glycol 582.5997 Zinc sulfate. 582.1516 Monopotassium glutamate. Subpart F— Nutrients and/or Dietary Subpart G— Sequestrants 582.1540 Nitrogen. ___ Supplements Papain. 582.6033 Citric acid. 582.1585 582.5013 Ascorbic add. 582.6085 Sodium acid phosphate. 582.1613 Potassium bicarbonate. 582,5017 Aspartic acid. Potassium carbonate. , 582.6099 Tartaric acid. 582.1619 582.5049 Aminoacetic acid. 582.6185 Calcium acetate. 582.1625 Potassium citrate. 582.5065 Linoleic acid. Potassium hydroxide. 582.6193 Calcium chloride. 582.1631 582.5118 Alanine. 582.6195 Calcium citrate. 582.1643 Potassium sulfate. 582.5145 Arginine. Propane. 582.6197 Calcium diacetate. 582.1655 682.5159 Biotin. 582.6199 Calcium gluconate. 582.1666 Propylene glycol, 582.5191 Calcium carbonate. 582.6203 Calcium hexametaphosphate. 582.1685 Rennet. 582.5195 Calcium citrate. Silica aerogel. 582.6215 Monobasic calcium phosphate. 582.1711 582.5201 Calcium glycerophosphate. 5826219 Calcium phytate. 582.1721 Sodium acetate. 582.5210 Calcium oxide. 582.6285 Dipotassium phosphate. 582.1736 Sodium bicarbonate. 582.5212 Calcium pantothenate. Sodium carbonate. 582.6290 Disodium phosphate. 582.1742 582.5217 Calcium phosphate. 582.6386 Isopropyl citrate. 582.1745 Sodium carboxymethylcellulose. 582.5223 Calcium pyrophosphate. Sodium caseinate. 582.6511 Monoisopropyl citrate. 582.1748 582.5230 Calcium sulfate. 582.6540 Potassium citrate. 582.1751 Sodium citrate. 582.5245 Carotene^ 582.6651 Sodium citrate. 582.1763 Sodium hydroxide. 582.5250 Choline bitartrate. 582.6754 Sodium dlacetate. 582.1775 Sodium pectinate. 582.5252 Choline chloride, 582.6757 Sodium gluconate. 582.1778 Sodium phosphate. 582.5260 Copper gluconate. Sodium hexametaphosphate. Sodium aluminum phosphate. 582.6760 582.1781 582.6271 Cysteine. 582.6769 Sodium metaphosphate. 582.1792 Sodium sesquicarbonate. 582.5273 Cystine. Sodium potassium tartrate. 582.6778 Sodium phosphate. 582.1804 582.5301 Ferric phospljate. 582.6787 Sodium pyrophosphate. 582.1810 Sodium tripolyphosphate. 582.5304 Ferric pyrophosphate. 582.6789 Tetra sodium pyrophosphate. 582.1901 Triacetin. 582.5306 Ferric sodium pyrophosphate. 582.6801 Sodium tartrate. 582.1973 Beeswax. 582.5308 Ferrous gluconate. ^ 582.6804 Sodium potassium tartrate. 582.1975 Bleached beeswax. 582.5311 Ferrous lactate. 582.6807 Sodium thiosulfate. 582.1978 Carnauba wax. 582.5315 Ferrous sulfate. 582.6810 Sodium tripolyphosphate. Subpart C— Anticaking Agents 582.5361 Histidine. 582.6851 Stearyl citrate. 582.5370 Inositol. 582.2122 Aluminum calcium silicate. 582.5375 Iron reduced. Subpart H— Stabilizers 582.2227 Calcium silicate. 582.5381 Isoleucine. 582.7115 Agar-agar. 582.2437 Magnesium silicate. 582.5406 Leucine. 582.7133 Ammonium alginate. 582.2727 Sodium aluminosilicate. 582.5411 Lysine. 582.7187 Calcium'' alginate. 582.2729 Hydrated sodium calcium alumi 582.5431 Magnesium oxide. 582.7255 Chrondrus extract. nosilicate. 582.5434 Magnesium phosphate. 582.7330 Gum arable. 582.2906 Tricalcium silicate. 582.5443 Magnesium sulfate. 582.7333 Gum ghatti. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS s 3B659 tion. Such notation will apply only to the and will not affect its status for other 582.7339 Guar gum. 582.7343 Locust bean gum. specific use covered by the review, e.g., uses not specified in the referenced regu- 582.7349 Sterculla gum. direct animal food use and/or indirect, lation, pending a specific review of such 582.7351 Gum tragacanth. animal food use and/or animal feed use other uses. 582.7610 Potassium alginate. § 582.10 Spices and other natural seasonings and flavorings. 582.7724 Sodium alginate^ Spices and other natural seasonings ahd flavorings that are generally recognized A u t h o r i t y : Secs. 2Ql(s), 409, 701, 52 Stat. 1055-1056 as amended, 72 Stat. 1784-1788 as as safe for their intended use, within the meaning of section 409 of the act, are amended (21 U.S.C. 321 (s), 348, 371), unless as follows: otherwise noted. Common name Botanical name of plant source Subpart A— General Provisions Alfalfa herb and seed______Medicago sativa L. Allspice______'i___ Pimenta officinalis Lindl. § 582.1 Substances that are generally Ambrette seed______Hibiscus abelmoschus L. recognized as safe. A ngelica__)______Angelica archangelica L. or other spp. of An (a) It is impracticable to list all sub gelica. Angelica root______,____ _ Do. stances that are generally recognized as Angelica seed______Do. safe for their intendedUse. However, by Angostura (cusparia bark)______Galipea officinalis Hancock. way of illustration, the Commissioner A n ise____ .______.______Pimpinella anisum L. regards such common food ingredients as Anise, star______Illicium verum Hook. t. salt, pepper, sugar, vinegar, baking pow Balm (lemon balm)______Melissa officinalis L. der, and monosodium glutamate as safe Basil, bush______Ocimum minimum L. for their intended use. The lists in Sub Basil, sweet______r.______Ocimum basilicum L.. parts B through H of this part include Bay _____ — ------Laurus nobilis L. additional substances that, when used Calendula ______'______,___ __ Calendula officinalis L. for the purposes indicated, in accordance Camomile (chamomile), English or Anthemis nobilis L. with good manufacturing or feeding Roman. practice, are regarded by the Commis Camomile (chamomile), German or Matricaria chamomilla L. sioner as generally recognized as safeTor Hungarian. such uses. Capers______Capparis spinosa L. Capsicum ______Capsicum frutescens L. or Capsicum annuum L. (b) For the purposes of this section, Caraway ______Carum carvi L. good manufacturing or feeding practice Caraway, black (black cum in)______- Nigella sativa L. shairbe defined to include the following Cardamom (cardamon)______'.______Elettaria cardamomum Maton. restrictions: V Cassia, Chinese.______Cinnamomum cassia Blume. (1) The quantity of a substance added Cassia, Padang or Batavia______Cinnamomum burmanni Blume. to animal food does not exceed the Cassia,' Saigon______Cinnamomum loureirii Nees. amount reasonably required to accom Cayenne pepper______Capsicum frutescens L. or Capsicum annuum L. plish its intended physical, nutritional, Celery seed______Apium graveolens L. or other technical effect in food; and Chervil ______Anthriscus cerefolium (L.) Hoffm, (2) The quantity of a substance that Chives ______AUium schoenoprasum L. becomes a component of animal food as Cinnamon, Ceylen______,______Cinnamomum zeylanicum Nees. a result of its use in the manufacturing, Cinnamon, Chinese _____¿1______Cinnamomum cassia Blume. processing, or packaging of food, and* Cinnamon, Saigon—______Cinnamomum loureirii Nees. which is not intended to accomplish any Clary (clary sage)______Salvia sclarea L. physical or other technical effect in the Clover ______Trifolium spp. Cloves ______Eugenia caryophyllata Thunb. food itself, shall be reduced to the extent Coriander______Coriandrum sativum L. > — reasonably possible. Cumin (cummin )______Cuminum cyminum L. (3) The substance is. of appropriate Cumin, black (black caraway)______Nigella sativa L. grade and is prepared and handled as a Dill ______:------— Anethum graveolens L. food ingredient. Upon request the Com Elder flowers------;—*—- Sambucus canadensis L. missioner will offer an opinion, based on Fennel, common______.___ __ Foeniculum vulgare MiU. specifications and, intended use, as to Fennel, sweet (nnocchio, Florence Foeniculum vulgare Mill. var. duice (DC.) Alex. whether or not a particular grade or lot fennel). of the substance is of suitable purity Fenugreek ______Trigonelia foenum-graecum L. , for use in food and would generally be Galanga (galangal) ------*------— Alpina officinarum Hance. regarded as safe for the purpose in Garlic ______ii______Allium sativum L. tended, by experts qualified to evaluate Geranium ______...------Pelargonium ------spp.-— its safety. Ginger______------— Zingiber officinale Rose. Glycyrrhiza ______Glycyrrhiza glabra L. and other spp. of (c) The inclusion of substances in the Glycyrrhiza. list of nutrients does not constitute a Grains of paradise____ j,______Amomum melegueta Rose. finding on the part of the Department Horehound (hoarhound)______Marrubium vulgare L. that the substance is useful as a supple Horseradish______... ______Armoracia lapathifolia Gilib. ment to the diet for animals. ' Hyssop ______£ ------Hyssopus officinalis L. (d) Substances that are generally rec Lavender ______Lavandula officinalis Chaix. ognized as safe for their intended use Licorice ______Glycyrrhiza glabra L. and other- spp. of within the meaning of section 409 of the Glycyrrhiza. act are listed in Subparts B through H of Linden flowers______Tilia spp. this part. When the status of a sub Mace ______Myristica fragrans Houtt. Marigold, pot______Calendula officinalis L. stance has been reevaluated and affirmed Marjoram, pot______Major ana onites (L.) Benth. as GRAS or deleted from Subparts B Marjoram, sweet______Majorana hortensis Moench. through H of this part, an appropriate Mustard, black or brown.______Brassica nigra (L.) Koch. explanation will be noted, e.g., “affirmed Mustard, brown______Brassica juncea (L.) Coes. ff? GRAS,” “food additive regulation,” Mustard, white or yellow______Brassica hirta Moench. ^interim food additive regulation,” or N utm eg______._____ Myristica fragrans Houtt. Prohibited from use in food,” with a Oregano (oreganum, Mexican oregano, Lippia spp. reference to the appropriate new regula - Mexican sage, origan). / FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38660 RULES AND REGULATIONS Common name Botanical name of plant source Paprika______Capsicum annuum L. P a rsley __—------1------Petroselinum crispum (Mill.) Mansf. . Pepper, black------Piper nigrum L. Pepper, cayenne------Capsicum frutescens L. or Capsicum annuum L. Pepper, rpd_— ------—— Do. Pepper, white------— Piper nigrum L. Peppermint p-----:------Mentha piperita L. Poppy seed------Papaver somniferum L. Pot marigold_I_—------— Calendula officinalis L. Pot marjoram__ ;------Majorana onites (L.) Benth. Rosemary------—------Rosmarinus officinalis L. R u e — —------Ruta graveolens L. Saffron ------.— ----- Crocus sativus L. Sage —------—-- Salvia officinalis L. Sage, Greek— — ------— Salvia triloba L. Savory, summer------Satureia hortensis L. (Satureja). Savory, winter------Satureia montana L. (Satureja). Sesame ------Sesamum indicum L. Spearmint — ______Mentha spicata L. Star anise— 2------Illicium verum Hook, f. Tarragon .— _—----- Artemisia dracunculus L>. Thyme i l — -----:— Thymus vulgaris L. Thyme, wild or creeping---- Thymus serpyllum b. T urm eric__.*------Curcuma longa L. Vanilla______—- Vanilla planifolia Andr. or Vanilla tahltensis J. W. Moore Zedoary ------■------Curcuma zedoaria Rose. 582.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates). Essential oils, oleoresins (solvent-free), and natural extractives (including^dis tillates) that are generally'Tecognized as safe for their intended use, within the meaning of section 409 of the act, are as follows: Common name Bûtanical name of plant source . Alfalfa Medicagö sativa L. Allspice ______—------— Pimenta officinalis Lindl. , Almond, bitter (free from prussic acid) — Prunus amygdalus Bätsch, Prunus armeniaca L., or Prunus persica (L.) Bätsch. Ambrette (seed)------— Hibiscus moschatus Moench. Angelica root------— Angelica archangelica L. Angelica seed------Do. ■ x,Z- Angelica stem------Do*. Angostura (cusparia bark)------Galipea officinalis Hancock. A n ise______Pimpinella anisum L. • Asafetida ------Ferula assa-foetida L. and related spp. of Ferula. Balm (lemon balm)------,------.— — Melissa officinalis L. Balsam of Peru ------—•------— Myroxylon pereirae Klotzsch. Basil ______— .------— Ocimuni basilicum L. Bay leaves___,__ ._____ —.------Laurus nobilis L. Bay (myreia oil)------Pimenta racemosa (Mill.) J. W. Moore. Bergamot (bergamot orange)------— ■Citrus aurantium L. subsp. bergamia Wright et Arn. Bitter almond (free from prussic acid) Prunus amygdalus Bätsch, Prunus armeniaca L., or Prunus persica (L.) Bätsch. Bois de rose------\— ------i?------Aniba rosaeodora Ducke. Cacao ______Theobroma cacao L. * - Camomile (chamomile) flowers, Hun Matricaria chamomilla L. garian. Camomile (chamomile) flowers, Roman Anthemis nobilis L. or English. Oananga £------—-— Cananga odorata Hook. f. and Thoms. Capsicum______Capsicum frutescens L. and Capsicum annuum Xi. Caraway__—-— ------—- Carum carvi L. Cardamom seed (cardamon)------Elettaria cardamomum Maton. Carob bean____^.------Çeratania siliqua L. C arrot------—-- Daucus carota L. Cascarilla bark------— Croton eluteria Benn. Cassia bark, Chinese------Cinnamomum cassia Blume. Cassia bark, Padang or Batavia.^------Cinnamomum burmanni Blume. Cassia bark, Saigon— r_----:------>------Cinnamomiifftr loureirii Nees. . Celery seed------— Apium graveolens L. Cherry, wild, bark------—----- Prunus serotina Ehrh. Chervil------Anthriscus cerefolium (L.) Hoffm. Chicory______:— Cichorium intybus L. Cinnamon bark, Ceylon------Cihnamomum zeylanicum Nees. Cinnamon bark, Chinese------Cinnamomum cassia Blume. Cinnamon bark,Saigon ------— Cinnamomum loureirii Nees. Cinnamon leaf, Ceylon— — ------Cinnamomum zeylanicum Nees. Cinnamon leaf, Chinese------—-b------'Cinnamomum cassia Blume. ■- Cinnamon leaf_Saigon—s------Cinnamomum loureirii Nees. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38661 Common name Botanical name of plant source Citronella____.___ *______Cymbopogon nardus Rendle. Citrus peels______;___ __ Citrus spp. Clary (clary sage)______Salvia sclarea L. Clove bud______Eugenia caryophyllata Thunb. Clove leaf______Do. Clove stem______. Do. C lover______:______Trifolium spp. Coca (decocainized)______Erythroxylum coca Lam. and other spp. of ♦ Ery thr oxylum. Coffee______Coffea spp. Cola nut______—_ Cola acuminata Schott and Endl., and other spp. of Cola. Coriander______Coriandrum sativum L. Corn silk______:______Zea mays L. Cumin (cummin)______Cuminum cyminum L. Curacao orange peel (orange, bitter Citrus aurantium L. peel). Cusparia bark______i __ Galipea officinalis Hancock. Dandelion______Taraxacum officinale Weber and T. laevigatum DC. Dandelion root______]_____:______Do. D ill______Anethum graveolens L. Dog grass (quackgrass, triticum) ____ _ Agropyron repens (L.) Beauv. Elder flowers.______... ___ !____ Sambucus canadensis L. and S. nigra L. Estragóle (esdragol, esdragon, tar Artemisia dracunculus L. ragon) . Estragón (tarragon)__ .______Do. Fennel* sweet.______Foeniculum vulgare Mill. Fenugreek______Trigonella foenum-graecum L. Galanga (galangal)______Alpinia officinarum Hance. G a rlic______Allium sativum L. Geranium______¿____ _ Pelargonium spp. Geranium, East Indian______Cymbopogon martini Stapf. Geranium, rose______Pelargonium graveolens L’Her. Ginger___ i ______Zingiber officinale Rose. Glycyrrhiza ______Glycyrrhiza glabra L. and other spp. of Glycyr rhiza. Glycyrrhizin, ammoniated______Do. Grapefruit ______:______Citrus paradisi Macf. Guava ______Psidium spp. Hickory bark______r______Cary a spp. Horehound (hoarhound)______*_ Marrubium vulgare L. Hops______Humulus lupulus L. H orsem int______^______Monarda punctata L. Hyssop______Hyssopus officinalis L. Immortelle______Helichrysum augustifolium DC. Jasmine ______Jasminum officinale L. and other spp. of Jasminum. Juniper (berries). . . ______Juniper us communis L. Kola nut__.______Cola acuminata Schott and Endl., and other spp. of Cola. Laurel berries______Laurus nobilis L. Laurel leaves______Laurusspp. Lavender______Lavandula officinalis Chaix. Lavender, spike______Lavandula latifolia Vill. Lavandin ______;______Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill. Lem on______¡______Citrus limon (L.) Burm. f. Lemon balm (see balm). Lemon grass______Cymbopogon ciiratus DC. and Cymbopogon flexuosus Stapf. Lemon peel______Citrus limon (L.) Burm. f. Licorice ______Glycyrrhiza glabra L. and other spp. of Glycyrrhiza. Lime ______* Citrus aurantifolia Swingle. Linden flowers______Tilia spp. Locust bean______Ceratonia siliqua L. Lupulin ______-____ Humulus lupulus L. Mace ______Myristica fragrans Houtt. Malt (extract)______Hordeum vulgare L., or other grains. Mandarin ______Citrus reticulata Blanco. Marjoram, sweet______Majorana hortensis Moench. Maté ______Ilex paraguariensis St. Hil. Melissa (see balm). Menthol ______Mentha spp. Menthyl acetate______]______Do. Molasses (extract) _____ ¡ _____ Saccharum officinarum L. M ustard______Brassica spp. Naringin______;______Citrus paradisi Macf. Neroli, blgarade______Citrus aurantium L. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38662 RULES AND REGULATIONS Common name Botanical name of plant source N utm eg------.— ------Myristica fragrans Houtt. Onion ______Allium cepa L. Orange, bitter, flowers------— Citrus aurantium L. Orange, bitter, peel------Do.. Orange leaf------.------Citrus sinensis (L.) Osbeck. Orange, sweet______Do. Orange, sweet, flowers______Do. Orange, sweet, peel------Do. Origanum ______Origanum spp. Palmarosa______Cymbopogon martini Stapf. Paprika______Capsicum annuum L. Parsley______-— Petroselinum crispum (Mill.) Mansf. Pepper, black______Piper nigrum L. Pepper, white------Do. Pepperm int______Mentha piperita L. , Peruvian balsam___ .______Myroxylan pereirae Klotzsch. Petitgrain ------Citrus aurantium L. Petitgrain lemon______Citrus limon (L.) Burm. f. Petitgrain mandarin or tangerine— Citrus reticulata Blanco. P im en ta______Pimenta officinalis Lindl. Pimenta leaf______— Primenta officinalis Lindl. Pipsissewa leaves______Chimaphila umbellata Nutt. Pomegranate______Punica granatum L. Prickly ash bark______Xanthoxylum (or Zanthoxylum) Americanum Mill, or Xanthoxylum clava-herculis L. Hose absolute______Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp. Rose (otto of roses, attar of roses) Do. Rose buds______Do. Rose flowers______Do. Rose fruit (hips)______Do. Rose geranium______Pelargonium graveolens L’Her. Rose leaves______Rosa spp. Rosemary ______— Rosmarinus officinalis L. Rue ______Ruta graveolens L. Saffron ______I------Crocus sativus L. Sage ______Salvia officinalis L. Sage, Greek______Salvia triloba L. Sage, Spanish______Salvia lavandulaefolia Vahl. St. John’s bread______—:— Ceratonia siliqua L. Savory, summer______Satureia hortensis L. Savory, winter______Satureia montana L. Schinus molle______Schinus molle L. Sloe berries (blackthorn berries) — Prunus spinosa L. Spearmint ______Mentha spicata L. Spike lavender______Lavandula latifolia Vill. Tamarind______Tamarindus indica L. Tangerine______Citrus reticulata Blanco. * Tannic acid______Nutgalls of Quercus infectoria Oliver and related spp. of Quercus. Also in many other plants. Tarragon ------Artemisia dracunculus L. Tea ______Thea sinensis L. Thyme ______Thymus vulgaris L. and Thymus zygis var. gracilis Boiss. Thyme, white______Do. Thyme, wild or creeping______Thymus serpyllum L. Triticum (see dog grass). Tuberose______Polianthes tuberosa L. Turmeric ______Curcuma longa L. Vanilla ______Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore. Violet flowers______Viola odorata L. Violet leaves______Do. Violet leaves absolute______Do. Wild cherry bark_-______Prunus serotina Ehrh. Ylang-ylang______Cananga odorata Hook. f. and Thoms. Zedoary bark______:------Curcuma sedoaria Rose. § 582.30 Natural substances used in conjunction with spices and other natural sea sonings and flavorings. Natural substances used in conjunction with spices and other natural seasonings and flavorings that are generally recognized as safe for their Intended use, within the meaning of section 409 of the act, are as follows: Common name Botanical name of plant source• Algae, brown (kelp)______- ___ Laminaria spp. and Nereocystis spp. Algae, red______Porphyra spp. and Rhodymenia palmata (L.) Grev. D u lse______- ______Rhodymenia palmata (L.) FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38663 § 582.40 Natural extractives (solvent-free) used in conjunction with spices, season Element Source compounds ings, and flavorings. Manganese____ Manganese acetate. Manganese carbonate. Natural extractives (solvent-free) used in conjunction with spices, seasonings, Manganese citrate (sol and flavorings that are generally recognized as safe for their intended use, within uble) . the meaning of section 409 of the act, are as follows: Manganese chloride. Manganese gluconajfe. Common name Botanical name of plant source Manganese orthophos Algae, brown------Laminaria spp. and Nereocystis spp. phate. Algae, red------Porphyra spp. and Rhodymenia palmata (L.) Manganese phosphate (di Grev. basic) . Apricot kernel (persic o il)______Prunus armeniaca L. Manganese sulfate. Dulse------Rhodymenia palmata (L.) Grev. Manganous oxide. Kelp (see algae, brown). Z in c ______Zinc acetate. Peach kernel (persic oil)______Prunus persica Sieb, et Zucc. Zinc carbonate. Peanut stearine______Arachis hypogaea L. Zinc chloride. Persic oil (see apricot kernel and peach Zinc oxide. kernel). Zinc sulfate. Quince seed______Cydonia oblonga Miller. § 582.99 Adjuvants for pesticide chemi cals. § 582.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts. Adjuvants, identified and used in ac cordance with 40 CFR 180.1001 (c) and Certam other spices, seasonings, essential oils, oleoresins, and natural extracts (d), which are added to pesticide use that are generally recognized as safe for their intended use, within the meaning of dilutions by a grower or applicator prior section 409 of the act, are as follows: to application to the raw agricultural commodity, are exempt from the re Common name Derivation quirement of tolerances under section Ambergris______Physeter macrocephalus L. 409 of the act. C astoreum ______Castor fiber L. and C. canadensis Kuhl. Civet (zibeth, zibet, zibetum) Civet cats, Viverra civetta Schreber and Viverra (Sec. 409, 72 Stat. 1785; 21 U.S.C. 348) zibetha Schreber. Subpart B— General Purpose Food Cognac oil, white and green------Ethyl oenanthate, so-called. Additives Musk (Tonquin musk)------Musk deer, Moschus moschiferus L. § 582 .1005 Acetic acid. § 582.60 Synthetic flavoring substances § 582.80 Trace minerals added to animal (a) Product. Acetic acid. and adjuvants. feeds. (b) Conditions of use. This substance is generally recognized as safe when-used Synthetic flavoring substances and These substances added to animal feeds adjuvants that are generally recognized in accordance with good manufacturing as nutritional dietary supplements are or feeding practice. as safe for their intended use, within the generally recognized as safe when added meaning of section 409 of the act, are § 582.1009 Adipic acid. as follows: at levels consistent with good feeding practice.1 (a) Product. Adipic acid. Acetaldehyde (ethanal). (b) [Reserved] Acetoin (acetyl methylcarbinol). Element Source compounds Aconitic acid (equisetic acid, citridic acid, Cobalt------Cobalt acetate. (c) Limitations, restrictions, or ex achillelc acid) . Cobalt carbonate. planation. This substance la cenerallv Anethole (parapropenyl anisole). Cobalt chloride. recognized as safe when used as a buffer Benzaldehyde (benzoic aldehyde). Cobalt oxide. W-Butyric acid (butanoic acid). Cobalt sulfate. and neutralizing agent in accordance d- or Z-Carvone (carvol). Copper------Copper carbonate. with good manufacturing or feeding Cinnamaldéhyde (cinnamic aldehyde). Copper chloride. practice. Citral (2,6-dimethyloctadlen-2,6-oZ-8, géra Copper gluconate. nial, neral). Copper hydroxide. § 582.1033 Citric acid. Decanal (JV-decylaldhehyde, capraldéhyde, Copper orthophosphate. (a) Product. Citric acid. capric aldehyde, cafrinaldehyde, aldehyde Copper oxide. C-10). Copper pyrophosphate. (b) Conditions of use. This substance is Diacetyl (2,3-butandeione). Copper sulfate. generally recognized as safe when used Ethyl acetate. Iodine------Calcium lodate. Ethyl butyrate. Calcium lodobehenate. in accordance with good manufacturing 3-Methyl-3-phenyl glycidic acid ethyl ester Cuprous Iodide. or feeding practice. 3,5-Dilodosalicyllc acid. (ethyl-methyl-phenyl-glycidate, so-called § 582.1057 Hydrochloric acid. strawberry aldehyde, C-16 aldehyde). Ethylenediamine dihydrol Ethyl vanillin. odlde. (a) Product. Hydrochloric acid. Eugenol. Potassium lodate. (b) [Reserved] Geraniol (3,7-dimethyl-2,6 and 3 ,6 -octadien- Potassium iodide. 1 -oZ). Sodium lodate. (c) Limitations, restrictions, or ex Geranyl acetate (geraniol acetate). Sodium Iodide. planation. This substance is generally Glycerol (glyceryl) tributyrate (tributyrin, Thymol iodide. recognized as safe when used as a buffer butyrin). Iron------Iron ammonium citrate. Limonene ) d-, I-, and dl-). Iron carbonate. and neutralizing agent in accordance Iron chloride. with good manufacturing or feeding hinalool (linalol, 3,7-dimethyl-l,6-octadien- Iron gluconate. 3-oZ). Iron oxide. practice. Linalyl acetate (bergamol). Iron phosphate. § 582.1061 Lactic acid. 1-Malic acid. Iron pyrophosphate. (a) Product. Lactic acid. Methyl anthranilate (methyl-2 -aminoben- Iron sulfate. zoate). . ' Reduced Iron. (b) Conditions of use. This substance Piperonal ( 3,4-methylenedioxy-benzaldehyde, is generally recognized as safe when used heliotropin). * All substances listed may be In anhydrous in accordance with good manufacturing Vanillin. or hydrated form. or feeding practice. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38664 RULES AND REGULATIONS § 582.1069 Malic acid. (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Malic acid. in accordance with good manufacturing (b) Conditions of use. This substance § 582.1205 Calcium hydroxide. is generally recognized as safe when used or feeding practice. (a) Product. Calcium hydroxide. in accordance with good manufacturing §582.1135 Ammonium bicarbonate. (b) Conditions of use. This substance or feeding practice. (a) Product. Ammonium bicarbonate. is generally recognized as safe when used § 582.1073 Phosphoric acid. (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Phosphoric acid. in accordance with good manufacturing § 582.1207 ' Calcium lactate. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) Product. Calcium lactate. in accordance with good manufacturing § 582.1137 Ammonium carbonate. (b) Conditions of use. This substance or feeding practice. (a) Product. Ammonium carbonate. is generally recognized as safe when used § 582.1077 Potassium acid tartrate. (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Potassium acid tartrate. in accordance with good manufacturing § 582.1210 Calcium oxide. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) Product. Calcium oxide. in accordance with good manufacturing § 582.1139 Ammonium hvdroxide. (b) Conditions of use. This substance or feeding practice. (a) Product. Ammonium hydroxide. is generally recognized as safe when used § 582.1087 Sodium acid pyrophosphate. (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Sodium acid pyrophos in accordance with good manufacturing § 582.1217 Calcium phosphate. phate. or feeding practice. (b) Conditions of use. This substance (a) Product. Calcium phosphate is generally recognized as safe when used § 582.1141 Ammonium phosphate. (mono-, di-, and tribasic). in accordance with good manufacturing (a) Product. Ammonium phosphate (b) Conditions of use. This substance or feeding practice. (mono- and dibasic). is generally recognized as safe when used in accordance with good manufacturing § 582.1091 Succinic acid. (b) Conditions of use. This substance is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Succinic acid. in accordance with good manufacturing § 582.1235 Caramel. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) Product. Caramel. in accordance with good manufacturing § 582.1143 Ammonium sulfate. (b) Conditions of use. This substance or feeding practice. (a) Product. Ammonium sulfate. is generally recognized as safe when used in accordance with good manufacturing § 582.1095 Sulfuric acid. (b) Conditions of use. This substance is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Sulfuric acid. in accordance with good manufacturing § 582.1240 Carbon dioxide. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) Product. Carbon dioxide. in accordance with good manufacturing § 582.1155 Bentonite. (b) Conditions of use. This substance or feeding practice. (a) Product. Bentonite. is generally recognized as safe when used § 582.1099 Tartaric acid. (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) P ro d u ct. Tartaric acid. in accordance with good manufacturing § 582.1275 Dextrans. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) Product. Dextrans of average in accordance with good manufacturing § 582.1165 Butane. molecular weight below 100,000. or feeding practice. (a) Product. Butane. (b) Conditions of use. This substance § 582.1125 Aluminum sulfate. (b) Conditions of use. This substance is generally recognized as safe when used is generally recognized as safe when used in accordance with good manufacturing (a) P ro d u ct. Aluminum sulfate. in accordance with good manufac or feeding practice. (b) Conditions of use. This substance turing or feeding practice. is generally recognized as safe when used § 582.1320 Glycerin. in accordance with good manufacturing §582.1191 Calciumcarbonate. (a) Product. Glycerin. or feeding practice. - (a) Product. Calcium carbonate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when used § 582.1127 Aluminum ammonium sul in accordance with good manufacturing fate. is generally recognized as safe when used in accordance with good manufacturing or feeding practice. (a) P ro d u ct. Aluminum ammonium or feeding practice. sulfate. * § 582.1324 Glyceryl monostearate. (b) Conditions of use. This substance §582.1193 Calcium chloride. (a) Product. Glyceryl monostearate. is generally recognized as safe when used (a) Product. Calcium chloride. (b) Conditions of use. This substance in accordance with good manufacturing (b) Conditions of use. This substance is generally recognized as safe when used or feeding practice. is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing § 582.1129 Aluminum potassium sul or feeding practice. or feeding practice. fate. § 582.1195 Calcium citrate. § 582.1355 Helium. (a) P ro d u ct. Aluminum potassium (a) Product. Calcium citrate. (a) Product. Helium. sulfate. (b) Conditions of use. This substance (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when used is generally recognized as safe when use is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing in accordance with good manufacturing or feeding practice. or feeding practice. or feeding practice. § 582.1199 Calcium gluconate. § 582.1366 Hydrogen peroxide. § 582.1131 Aluminum sodium sulfate. (a) Product. Calcium gluconate. (a) Product. Hydrogen peroxide. (b) Conditions of use. This substance (a) P ro d u ct. Aluminum sodium sul (b) [Reserved! fate. is generally recognized as safe when used FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38665 (c) Limitations, restrictions, or exin accordance with good manufacturing § 582.1742 Sodium carbonate. planation. This substance is generally or feeding practice. recognized as safe when used as a bleach (a) Product. Sodium carbonate. ing agent in accordance with good manu § 582.1619 Potassium carbonate. (b) Conditions of use. This substance facturing or feeding practice. (a) Product. Potassium carbonate. is generally recognized as safe when used (b) Conditions of use. This substance in accordance with good manufacturing § 582.1400 Lecithin. is generally recognized as safe when used or feeding practice. (a) Product. Lecithin. in accordance with good manufacturing § 582.1745 Sodium carboxymethylcellu- (b) Conditions of use. This substance or feeding practice. lose. is generally recognized as safe when used (a) Product. Sodium carboxymethyi- in accordance with good manufacturing § 582.1625 Potassium citrate. or feeding practice. (a) Product. Potassium citrate. cellulose is the sodium salt of carboxy- (b) Conditions of use. This substance methylcellulose not less than 99.5 percent § 582.1425 Magnesium carbonate. is generally recognized as safe when used on a dry-weight basis, with maximum (a) Product. Magnesium carbonate. in accordance with good manufacturing substitution of 0.95 carboxymethyl (b) Conditions of use. This substance or feeding practice. groups per anhydroglucose unit, and with is generally recognized as safe when used a minimum viscosity of 25 centipoises for in accordance with good manufacturing § 582.1631 Potassium hydroxide. 2 percent by weight aqueous solution at or feeding practice. (a) Product. Potassium hydroxide. 25° C. (b) Conditions of use. This substance (b) Conditions of use. This substance § 582.1428 Magnesium hydroxide. is generally recognized as safe when used is generally recognized as safe when used (a) Product. Magnesium hydroxide. in accordance with good manufacturing in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. or feeding practice. is generally recognized as safe when used § 582.1643 Potassium sulfate. § 582.1748 Sodium caseinate. in accordance with good manufacturing or feeding practice. (a) Product. Potassium sulfate. (a) Product. Sodium caseinate. (b) Conditions of use. This substance (b) Conditions of use. This substance § 582.1431 Magnesium oxide. is generally recognized as safe when used is generally recognized as safe when used (a) Product. Magnesium oxide. in accordance with good manufacturing in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. or feeding practice. is generally recognized as safe when used § 582.1655 Propane. § 582.1751 Sodium citrate. in accordance with good manufacturing or feeding practice. (a) Product. Propane. (a) Product. Sodium citrate. (b) Conditions of use. This substance (b) Conditions of use. This substance § 582.1480 Methylcellulose. is generally recognized as safe when used is generally recognized as safe when used (a) Product. U.S.P. methylcellulose, in accordance with good manufacturing in accordance with good manufacturing except that the methoxy content shall or feeding practice. or feeding practice. not be less than 27.5 percent and not § 582.1666 Propylene glycol. § 582.1763 Sodium hydroxide. more than 31.5 percent on a dry-weight basis. (a) Product. Propylene glycol. (a) Product. Sodium hydroxide. (b) Conditions of use. This substance (b) Conditions of use. This substance Cb) Conditions of use. This substance is generally recognized as safe when used is generally recognized as safe when used is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing in accordance with good manufacturing or feeding practice. or feeding practice. or feeding practice. § 582.1500 Monoammonium glutamate. § 582.1685 Rennet. § 582.1775 Sodium pectinate. (a) Product. Monoammonium gluta (a) Product. Rennet (rennin). (a) Product. Sodium pectinate. mate. (b) Conditions of i~se. This substance (b) Conditions of use. This substance > (b) Conditions of use. This substance is generally recognized as safe when used is generally recognized as safe when used is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing in accordance with good manufacturing or feeding practice. or feeding practice. or feeding practice. § 582.1711 Silica aerogel. § 582.1778 Sodium phosphate. § 582.1516 Monopotassium glutamate. (a) Product. Silica aerogel as a finely (a) Product. Sodium phosphate (a) Product. Monopotassium gluta powdered microcellular silica foam hav (mono-, di-, and tribasic). mate. ing a minimum silica content of 89.5 per (b) Conditions of use. This substance cent. (b) Conditions of use. This substance is generally recognized as safe when used is generally recognized as safe when used (b) [Reserved] in accordance with good manufacturing in accordance with good manufacturing (c) Limitations, restrictions, or ex or feeding practice. or feeding practice. planation. This substance is generally § 582.1781 Sodium aluminum phos recognized as safe when used as a com phate. § 582.1540 Nitrogen. ponent of antifoaming agents in accord (a) Product. Nitrogen. ance with good manufacturing or feeding (a) Product. Sodium aluminum phos practice. phate. (b) Conditions of use. This substance (b) Conditions of use. This substance generally recognized as safe when used § 582.1721 Sodium acetate. m accordance with good manufacturing is generally recognized as safe when used or feeding practice. (a) Product. Sodium acetate. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. § 582.1585 Papain. is generally recognized as safe when used § 582.1792 Sodium sesquicarbonate. (a) Product. Papain. in accordance with good manufacturing (a) Product. Sodium sesquicarbonate. (b) Conditions of use. This substance or feeding practice. in ^enera^y recognized as safe when used (b) Conditions of use. This substance accordance with good manufacturing § 582.1736 Sodium bicarbonate. is generally recognized as safe when used or feeding practice. (a) Product. Sodium bicarbonate. in accordance with good manufacturing § 582.1613 Potassium bicarbonate. (b) Conditions of use. This substance or feeding practice. Product. Potassium bicarbonate, is generally recognized as safe when used § 582.1804 Sodium potassium tartrate. is {.Aw c °nditions of use. This substance in accordance with good manufacturing (a) Product. Sodium potassium tar generally recognized as safe when used or feeding practice. trate. FEDERAL REGISTER, VOL. 41, NO . 177— FRIDAY, SEPTEMBER 10, 1976 38666 RULES AND REGULATIONS - (b) Conditions of use. This substance with good manufacturing or feeding § 582.3169 Butylated hydroxyanisole. is generally recognized as safe when used practice. (a) Product. Butylated hydroxyani in accordance with good manufacturing § 582.2729 Hydrated sodium calcium sole. or feeding practice. aluminosilicate. (b) Tolerance. This substance is gen erally recognized as safe for use in food § 582.1810 Sodium tripolyphosphate. (a) Product. Hydrated sodium calcium when the total content of antioxidants (a) Product. ¡Sodium tripolyphosphate. aluminosilicate (sodium calcium silico is not over 0.02 percent of fat or oil con (b) Conditions of use. This substance aluminate) . tent, including essential (volatile) oil is generally recognized as safe when used (b) Tolerance. This substance is gen content of food provided the substance in accordance with good manufacturing erally recognized as safe for use at a level is used in accordance with good manu or feeding practice. not exceeding 2 percent in accordance facturing or feeding practice. with good manufacturing or feeding § 582.1901 Triàcetin. practice. § 582.3173 Butylated hydroxytoluene. (a) Product. Triacetin (glyceryl tri § 582.2906 Tricalcium silicate. (a) Product. Butylated hydroxytolu acetate) . ene. (b) Conditions of use. This substance (a) Product. Tricalcium silicate. (b) Tolerance. This substance is gen is generally recognized as safe when (b) Tolerance, 2 percent. erally recognized as safe for use in food used in accordance with good manufac (c) Limitations, restrictions, or ex when tiie total content of antioxidants turing or feeding practice. planation. This substance is generally is not over 0.02 percent of fat or oil con recognized as safe when used in table tent, including essential (volatile) oil § 582.1973 Beeswax. salt in accordance with good manufac content of food provided the substance (a) Product. Beeswax (yellow wax). turing or feeding practice. is used in accordance with good manu (b) Conditions of use. This substance Subpart D— Chemical Preservatives facturing or feeding practice. is generally recognized as safe when used in accordance with good manufacturing § 582.3013 Ascorbic acid. § 582.3189 Calcium ascorbate. or feeding practice. (a) Product. Ascorbic acid. (a) Product. Calcium ascorbate. (b) Conditions of use. This substance (b) Conditions of use. This substance § 582.1975 Bleached beeswax, is generally recognized as safe when used is generally recognized as safe when used (a) Product. Bleached beeswax (white in accordance with good manufacturing in accordance with good manufacturing wax). or feeding practice. or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when used § 582.3021 Benzoic acid. § 582.3221 Calcium propionate. in accordance with good manufacturing (a) Product. Benzoic acid. (a) Product. Calcium propionate. or feeding practice. (b) Tolerance. This substance is gen (b) Conditiom of me. This substance § 582.1978 Carnauba wax. erally recognized as safe for use at a is generally recognized as safe when used level not exceeding 0.1 percent in ac in accordance with good manufacturing (a) Product. Carnauba wax. or feeding practice. (b) Conditions of use. This substance cordance with good manufacturing or is generally recognized as safe when used feeding practice. § 582.3225 Calcium sorbate. in accordance with good manufacturing § 582.3041 Erythorhic acid. (a) Product. Calcium sorbate. or feeding practice. (a) Product. Erythorbic acid. (b) Conditions of use. This substance Subpart C— Anti caking Agents (b) Conditions of me. This substance is generally recognized as safe when used is generally recognized as safe when used in accordance with good manufacturing § 582.2122 Aluminum calcium silicate. in accordance with good manufacturing or feeding practice. (a) Product. Aluminum calcium sili or feeding practice. § 582.3280 Dilauryl thiodipropionate. cate. (b) Tolerance. 2 percent. § 582.3081 Propionic acid. (a) Product. Dilauryl thiodipropio (c) Limitations, restrictions, or expla (a) Product. Propionic acid. nate. nation. This substance is generally recog (b) Conditions of use. This substance (b) Tolerance. This substance is gen nized as safe when used in table salt in is generally recognized as safe when used erally recognized as safe for use in food accordance with good manufacturing or in accordance with good manufacturing when the total content of antioxidants feeding practice. or feeding practice. is not over 0.02 percent of fat or oil con tent, including essential (volatile) oil § 582.2227 Calcium silicate. § 582.3089 Sorbic acid. content of the food, provided the sub (a) Product. Calcium silicate. (a) Product. Sorbic acid. stance is used in accordance with good (b) Tolerance. 2 percent and 5 per (b) Conditions of me. This substance manufacturing or feeding practice. cent. is generally recognized as safe when used § 582.3336 Gum guaiac. (c) Limitations, restrictions, or expla in accordance with good manufacturing nation. This substance is generally recog or feeding practice. (a) Product. Gum guaiac. nized as safe when used at levels not ex (b) Tolerance. 0.1 percent (equivalent ceeding 2 percent in table salt and 5 per § 582.3109 Thiodipropionic acid. antioxidant activity 0.01 percent). cent in baking powder in accordance with (a) Product. Thiodipropionic acid. (c) Limitations, restrictions, or ex good manufacturing or feeding practice. (b) Tolerance. This substance is gen planation. This substance is generally erally recognized as safe for use in food recognized as safe when used in edible § 582.2437 Magnesium silicate. when the total content of antioxidants fats or oils in accordance with good (a) Product. Magnesium silicate. is not over 0.02 percent of fat or oil con manufacturing or feeding practice. (b) Tolerance. 2 percent. § 582.3490 Methylparaben. (c) Limitations, restrictions, or expla tent including essential (volatile) oil nation. This substance is generally recog content of the food, provided the sub (a) Product. Methylparaben (methyl nized as safe when used in table salt stance is used in accordance with good p-hydroxy benzoate). in accordance with good manufacturing manufacturing or feeding practice. (b) Tolerance. This substance is gen or feeding practice. erally recognized as safe for use at a § 582.3149 Ascorbyl palmitate. level not exceeding 0.1 percent in ac § 582.2727 Sodium aluminosilicate. (a) Product. Ascorbyl palmitate. cordance with good manufacturing 0 (a) Product. Sodium aluminosilicate (b) Conditions of me. This substance feeding practice. (sodium silicoaluminate). § 582.3616 Potassium bisulfite. (b) Tolerance. This substance is gen is generally recognized as safe When used erally recognized as safe for use at a level in accordance with good manufacturing (a) Product. Potassium bisulfite. not exceeding 2 percent in accordance or feeding practice. (b) [Reserved] FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38667 (c) Limitations, restrictions, or expractice, except that it is not used in § 582.4521 Monosodium phosphate de planation. This substance is generally meats or in food recognized as source of rivatives of mono- and digylcerides of recognized as safe when used in accord vitamin Bi. edible fats or oils, or edible fat- ance with good manufacturing or feed forming fatty acids. § 582.3784 Sodium propionate. ing practice, except that it is not used in (a) Product. Monosodium phosphate meats or in food recognized as source (a) Product. Sodium propionate. derivatives of mono- and diglycerides of of vitamin B*. - (b) Conditions of use. This substance edible fats or oils, or edible fat-forming is generally recognized as safe when used fatty acids. § 582.3637 Potassium metabisulfite. in accordance with good manufacturing (a) Product. Potassium metabisulfite. or feeding practice. (b) Conditions of use. This substance (b) [Reserved] is generally recognized as safe when used (c) Limitations, restrictions, or ex § 582.3795 Sodium sorbate. in accordance with good manufacturing planation. This substance is generally (a) Product. Sodium sorbate. or feeding practice. recognized as safe when used in accord (b) Conditions ,of use. This substance § 582.4666 Propylene glycol. ance with good manufacturing or feed is generally recognized as safe when used (a) Product. Propylene glycol. ing practice, except that it is not used in in accordance with good manufacturing FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38668 RULES AND REGULATIONS § 582.5370 Inositol. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when used Is generally recognized as safe when (a) Product. Inositol. in accordance with good manufacturing used in accordance with good manufac (b) Conditions of use. This substance or feeding practice. turing or feeding practice. is generally recognized as safe when used § 582.5260 Coppér gluconate. in accordance with good manufacturing § 582.5191 Calcium carbonate. or feeding practice. (a) P ro d u ct. Calcium carbonate. (a) Product. Copper gluconate. § 502.5375 Iron reduced. (b) Conditions of use. This substance (b) Tolerance. This substance is gen is generally recognized as safe when used erally recognized as safe fbr use at a, (a) Product. Iron reduced. in accordance with good manufacturing level not exceeding 0.005 percent in ac (b) Conditions of use. This substance or feeding practice. cordance with good manufacturing or is generally recognized as safe when used feeding practice. in accordance with good manufacturing § 582.5195 Calcium citrate. § 582.5271 Cysteine. or feeding practice. (a) P rodu ct. Calcium citrate. § 582.5381 Isoleucine. (b) Conditions of use. This substance (a) Product. CysteineJL-forms). is generally recognized as safe When used (b) Conditions of use. This substance (a) Product.' Isoleucine (L- and DL- in accordance with good manufacturing is generally recognized as safe when ' forms). or feeding practice. used in accordance with good manufac (b) Conditions of use. This substance turing or feeding practice. § 582.5201 Calcium glycérophosphate. is generally recognized as safe when used § 582.5273 Cystine. in accordance with good manufacturing (a) P ro d u ct. Calcium glycerophos or feeding practice. phate. (a) Product. Cystine, (L- and DL- (b) Conditions of use. This substance forms). § 582.5406 Leucine. is generally recognied as safejvhen used (b) Conditions of use. This substance (a) Product. Leucine (L- and DL- in accordance with good manufacturing is generally recognized as safe when forms). or feeding practice. used in accordance with good manufac (b) Conditions of use. This substance turing or feeding practice. ,is generally recognized as safe when used § 582.5210 Caleium oxide. § 582.5301 Ferric phosphate. in accordance with good manufacturing .fa) P ro d u ct. Calcium oxide. or feeding practice. (b) Conditions of use. This substance (a) Product. Ferric phosphate. is generally recognized as safe when (b) Conditions of use. This substance § 582.541L Lysine. - used in accordance with good manufac is generally recognized as safe when used r (a) / Product. Lysine (L- and DL- turing or feeding4practice. in accordance with good manufacturing forms). or feeding practice. § 582.5212 Calcium pantothenate. (b) Conditions of use. This substance § 582.5304 Ferric pyrophosphate. is generally recognized as safe when used (a) P ro d u ct. Calcium pantothenate. in accordance with good manufacturing (b) Conditions of use. This substance (a) Product. Ferric pyrophosphate. or feeding practice. "‘s- \ is generally recognized as safe when used (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used * § 582.5431 Magnesiuni oxide. or feeding practice. in accordance with good manufacturing (a) Product. Magnesium oxide. or feèding practice. (b) Conditions of use. This substance § 582.5217 Calcium phosphate. § 582.5306 Ferric sodium pyrophos is generally recognized ad safe when used (a) P ro d u ct. Calcium phosphate phate. in accordance with good manufacturing (mono-, di-, and tribasic). or feeding practice. (b) Conditions of use. This substance (a) Product. Ferric sodium pyrophos is generally recognized as safe when used phate. § 582.5434 Magnesium phosphate. in accordance with good manufacturing (b) Conditions of «se. This substance (a) Product. Magnesium phosphate or feeding practice. is generally recognized as safe when used (di- and tribasic). in accordance with good manufacturing (b) Conditions of use. This substance § 582.5225 Calcium pyrophosphate. or feeding practice. is generally recognized as safe when used . (a) P ro d u ct. Calcium pyrophosphate. § 582.5308 Ferrous gluconate. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when (a) Product. Ferrous gluconate. used in accordance with good manufac (b) Conditi&ns of use. This substance § 582.5443 Magnesium sulfate. turing or feeding practice. is"generally recognized as safe when used (a) Product. Magnesium sulfate. in accordance with good manufacturing (b) Conditions of use. This substance § 582.5230 Calcium sulfate. or feeding practice. is generally recognized as safe when used (a) P ro d u ct. Calcium sulfate. §582.5311 Ferrous lactate. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when (a) Ptbduct. Ferrous lactate. used in accordance with good manufac (b) Conditions of use. This substance § 582.5446 Manganese chloride. turing^ feeding practice. is generally recognised as safe when used (a) Product. Manganese chloride. in accordance with good manufacturing (b) Conditions of use.. This substance § 582.5245. Carotene. or feeding practice. < is generally recognized as safe when used (a) P ro d u ct. Carotene. § 582.5315 Ferrous sulfate. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when (a) Product. Ferrous sulfate. used in accordance with good manufac (b) Conditions of use. This substance § 582.5449 Manganese citrate. turing or feeding practice. is generally recognized as safe when used (a) Product. Manganese citrate. in accordance with good manufacturing § 582.5250 Choline bitartrate. (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when used (a) P ro d u ct. Choline bitartrate. § 582.5361 Histidine. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. is generally recognized as safe when (a) Product. Histidine (L- and DL- used in accordance with good manufac forms). § 582.5452 Manganese gluconate. turing or feeding practice. (b) Conditions of use. This substance (a) Product. Manganese gluconate. is generally recognized as safe when used § 582.5252 Choline chloride. in accordance with good manufacturing (b) Conditions of use. This substance is generally recognized as safe when used (a) P ro d u ct. Choline chloride. or feeding practice. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY*, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38669 in accordance with good manufacturing in accordance with good manufacturing § 582.5778 Sodium phosphate. or feeding practice. or feeding practice. (a) Product. Sodium phosphate § 582.3455 Manganese glycerophos § 582.5590 Phenylalanine. (mono-, di-, and tribasic). phate. (a) Product. Phenylalanine (L- and (b) Conditions of use. This substance is (a) Product. Manganese glycerophos DL-forms). generally recognized as safe when used phate. (b) Conditions of use. This substance in accordance with good manufacturing (b) Conditions of usé. This substance is generally recognized as safe when used or feeding practice. is generally recognized as safe when used in accordance with good manufacturing § 582.5835 Sorbitol. in accordance with good manufacturing or feeding practice. or feeding practice. (a) Product. Sorbitol. § 582.5622 Potassium chloride. (b) Conditions of use. This substance is § 582.5458 Manganese hypophosphite. (a) Product. Potassium chloride. generally recognized as safe when used (a) Product. Manganese hypophos (b) Conditions of use. This substance in accordance with good manufacturing phite. is generally recognized as safe when used or feeding practice. (b) Conditions of use. This substance in accordance with good manufacturing §582.5875 Thiamine hydrochloride. is generally recognized as safe when used or feeding practice. in : accordance with good manufacturing (a) Product. Thiamine hydrochloride. or feeding practice. § 582.5628 Potassium glycerophosphate. (b) Conditions of use. This substance (a) Product. Potassium glycerophos is generally recognized as safe when used § 582.5461 Manganese sulfate. phate. in accordance with good manufacturing (a) Product. Manganese sulfate. (b) Conditions of use. This substance or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when used § 582.5878 Thiamine mononitrate. is generally recognized as safe when use4 in accordance with good manufacturing in accordance with good manufacturing or feeding practice. (a) Product. Thiamine mononitrate. or feeding practice. (b) Conditions of use. This substance § 582.5634 Potassium iodide. is generally recognized as safe when used § 582.5464 Manganous oxide. (a) Product. Potassium iodide. in accordance with good manufacturing (a) Product. Manganous oxidè. Ob) Tolerance. 0.01 percent, or feeding practice. E (b) Conditions of use. This substance Oe)* Limitations, restrictions, or expla § 582.5881 Threonine. is generally recognized as safe When used nation. This substance is generally rec in accordance with good manufacturing ognized as safe when used in table salt (a) Product. Threonine (L- and DL- or feeding practice. forms) . as a source of dietary iodine in accord (b) Conditions of use. This substance §582.5470 Mannitol. ance with good manufacturing or feeding practice. is generally recognized as safe when used (a) Product. Mannitol. in accordance with good manufacturing (b) Conditions of use. This substance § 582.5650 Proline. or feeding practice. is generally recognized as safe when used (a) Product. Proline (L- and DL- § 582.5890 Tocopherols. in accordance with good manufacturing forms). or feeding practice. (a) Product. Tocopherols. .(b) Conditions of use. This substance (b) Conditions of use. This substance § 582.5475 Methionine. is generally recognized as safe when used is generally recognized as safe when used (a) Product. Methionine. in accordance with good manufacturing in accordance with good manufacturing (b) [Reserved], or feeding practice. or feeding practice. (c) Limitations, restrictions, or ex § 582.5676 Pm doxine hydrochloride. § 582.5892 a-Tocopherol acetate. planation. This substance is generally (a) Product. Pyridoxine hydrochloride. recognized as safe when used in animal (b) Conditions of use. This substance- (a) Product. a-Tocopherol acetate. feeds in accordance with good manu is generally recognized as safe when used (b) Conditions of use. This substance facturing or feeding practice. ' is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing § 582.5477 Methionine hydroxy analog or feeding practice. or feeding practice. -and its calcium salts. § 582.5695 Riboflavin. (a) Product. Methionine hydroxy ana § 582.5915 Tryptophane. log and its calcium salts. (a) Prodttcf.'Riboflavin. (ay Product. Tryptophane (L- and DL- (b) Conditions of use. This substance forms) , (b) [Reserved]. is generally recognized as safe when used (c) Limitations, restrictions, or ex in accordance with good manufacturing (b) Conditions of use. This substance planation. This substance is generally or feeding practice. is generally recognized as safe when used recognized as safe whqn used in animal in accordance with good manufacturing feeds in accordance with good manufac §582.5697 Riboflavin-5-phosphate. or feeding practice. turing or feeding practice. (a) Product. Riboflavin-5-phosphate. § 582.5920 Tyrosine. § 582.5530 Niacin. Cb) Conditions of use. This substance (a) Product. Tyrosine (L- and DL- is generally recognized as safe when used forms). (a) Product. Niacifi. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. (b) Conditions of use. This substance Is generally recognized as safe when used is generally recognized as safe when used m accordance with good manufacturing § 582.5701 Serine. in accordance with good manufacturing or feeding practice. (a) Product. Serine (L- and DL- or feeding practice. § 582.5535 Niacinamide. ■ forms). § 582.5925 Valine. (a) Product. Niacinamide. (b) Conditions of use. This substance (a) Product. Valine (L- and—DL- is generally recognized as safe when used forms) . . Conditions of use. This substam in accordance with good manufacturing . generally recognized as safe when use or feeding practice. (b) Conditions of use. This substance m accordance with good manufacturir is generally recognized as safe when used or feeding practice. § 582.5772 Sodium pantothenate. in accordance with good manufacturing or feeding practice. * § 582.5580 D-Pantothenyl alcohol. (a) Product. Sodium pantothenate. (b) Conditions of use. This substance § 582.5930 Vitamin A. (a) Product. D-Pantothenyl alcohol, is generally recognized as safe when used 'o) Conditions of use. This substance (a) Product. Vitamin A. in accordance with good manufacturing (b) Conditions of use. This substance generally recognized as safe when used or feeding practice. is generally recognized as safe when used FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 38670 RULES AND REGULATIONS in accordance with good manufacturing § 582.6033 Citric acid. in accordance with good manufacturing or feeding practice. (a) Product.Citric acid. or feeding practice. § 582.5933 Vitamin A acetate. (b) Conditions of use. This substance § 582.6285 Dipotassihm phosphate. is generally recognized as safe when used (a) Product. Dipotassium phosphate. (a) Product. Vitamin A acetate. in accordance with, good manufacturing (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when used dr feeding practice. is generally recognized as safe when used in accordance with good manufacturing § 582.6085 Sodium acid phosphate. in accordance with good manufacturing or^eeding practice. (a) Product. Sodium acid phosphate. or feeding practice. § 582.5936 Vitamin A palmitate. (b) Conditions of use. This substance § 582.6290 Disodium phosphate. is generally recognized as safe when used (a) Product. Disodium phosphate. FEDERAL REGISTER, VOL. 41, NO. 177— FRIDAY, SEPTEMBER 10, 1976 RULES AND REGULATIONS 38671 in accordance with good manufacturing § 582.6851 Stearyl citrate. in accordance with good manufacturing or feeding practice. (a) Product. Stearyl citrate. or feeding practice. § 582.6787 Sodium pyrophosphate. (b) Tolerance. This substance is gen § 582.7339 Guar gum. (a) Product. Sodium pyrophosphate. erally recognized as safe for use at a level not exceeding 0.15 percent in accordance (a) Product. Guar gum. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when used with good manufacturing or feeding practice. is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing or feeding practice. Subpart H— Stabilizers or feeding practice. § 582.6789 Tetra sodium pyrophos § 582.7115 Agar-agar. § 582.7343 Locust bean gum. phate. (a) Product. Agar-agar. (a) Product. Locust (carob) bean (a) Product. Tetra sodium pyrophos (b) Conditions of use. This substance gum. phate. is generally recognized as safe when used (b) Conditions of use. This substance (b) Conditions of use. This substance in accordance with good manufacturing is generally recognized as safe when used is generally recognized as safe when -used or feeding practice. in accordance with good manufacturing in accordance with good manufacturing or feeding practice. or feeding practice. § 582.7133 Ammonium alginate. (a) Product. Ammonium alginate. § 582.7349 Sterculia gum. § 582.6801 Sodium tartrate. (b) Conditions of use. This substance (a) Product. Sterculia gum (karaya (a) Product. Sodium tartrate. is generally recognized as safe when used gum). (b) Conditions of use. This substance in accordance with good manufacturing (b) Conditions of use. This substance is generally recognized as safe when used or feeding practice. is generally recognized as safe when used in accordance with good manufacturing § 582.7187 Calcium alginate. in accordance with good manufacturing or feeding practice. or feeding practice. (a) Product. Calcium alginate. § 582.6804 Sodium potassium tartrate. (b) Conditions of use. This substance § 582.7351 Gum tragacanth. (a) Product. Sodium potassium tar is generally recognized as safe when used (a) Product. Tragacanth (gum tra trate. in accordance with good manufacturing gacanth) . (b) Conditions of use. This substance or feeding practice. (b) Conditions of use. This substance is generally recognized as safe when used § 582.7255 Chondrus extract. is generally recognized as safe when used in accordance with good manufacturing in accordance with good manufacturing or feeding practice. (a) Product. Chondrus extract (car- or feeding practice. rageenin). § 582.6807 Sodium thiosulfate. ' (b) Conditions of use. This substance § 582.7610 Potassium alginate. (a) Product. Sodium thiosulfate. is generally recognized as safe when used (a) Product. Potassium alginate. (b) Tolerance. 0.1 percent. in accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. (c) Limitations, restrictions, or ex is generally recognized as safe when used planation. This substance is generally § 582.7330 Gum arabic. recognized as safe when used in salt in in accordance with good manufacturing accordance with good manufacturing or (a) Product. Acacia (gum arabic). or feeding practice. feeding practice. (b) Conditions of use. This substance is generally recognized as safe when used § 582.7724 Sodium alginate. § 582.6810 Sodium tripolyphosphate. in accordance with good manufacturing (a) Product. Sodium alginate. (a) Product. Sodium tripolyphosphate. or feeding practice. (b) Conditions of use. This substance (b) Conditions of use. This substance § 582.7333 Gum ghatti. is generally recognized as safe when used is generally recognized as safe when used (a) Product. Ginn ghatti. in accordance with good manufacturing In accordance with good manufacturing (b) Conditions of use. This substance or feeding practice. or feeding practice. is generally recognized as safe when used [FR Doc.76-26299 Filed 9-9-76;8:45 am] FEDERAL REGISTER, VOL. 41, NO. 177—FRIDAY, SEPTEMBER 10, 1976
Thence Along the Amelia County-Powha Tan County Line To
