Guidelines for Obtaining Authorization of Compounds to Be Used in Meat and Poultry Plants

•^ ^""^i^ ^

■//>

U.S. Department of Agriculture Food Safety and Quality Service Agriculture Handbook No. 562 September 1979

Preface

This publication is intended to assist manufacturers or distributors in applying for authorization to use certain chemicals or other materials in establishments operating under the USDA Meat and Poultry Inspection Program. Compliance with the requirements set forth in this publication does not, in itself, constitute authorization. On receipt of applications, consideration will be given to the suitability of preparations and their safety for use as directed.

Users of this publication are cautioned that some chemicals or other materials referred to herein may be the subject of outstanding U.S. patents. The use of trade names in this publication does not imply endorsement by the U.S. Department of Agriculture.

Supersedes "Guidelines for Obtaining Authorization of Compounds to be Used in Meat and Poultry Plants," MPI-10, October 1974.

For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, D. C. 20402 Stock Nmnber 001-000-04058-8 Contents

Page

Introduction 1 Part 1.—Compounds which must be evaluated 2 Section 1.1 Maintenance and cleaning chemicals; sanitizers; pesticides; and all other substances referred to in Part 5 of this publication 2 Section 1.2 Packaging materials; marking and branding inks; coatings applied to equipment or structural members prior to installation in the plant; and all materials such as metal alloys, plastics, belting, hose, etc., proposed for use in association with processing facilities and equipment 2 Section 1.3 Other chemicals proposed for use in meat and poultry plants 2 Section 1.4 Shell egg cleaning, defoaming, destaining, and sanitizing compounds 3 Section 1.5 Chemicals or materials proposed for uses other than those previously specified 3 Part 2.—Compounds which do not require evaluation 4 Section 2 .1 Dénaturants 4 Section 2.2 Outdoor pest control substances 5 Section 2.3 Compounds used in offices and other similar non- processing areas 5 Section 2.4 Compounds used in cafeterias or other retail food service areas 5 Section 2.5 - Compounds used in heating systems 5 Section 2.6 - Compounds used in the treatment of certain inedible materials 5 Section 2.7 - Compounds used in holding pens 6 Part 3.—Compounds which are not applicable for evaluation 6 Section 3.1 - Compounds used in sewage or waste water systems outside the plant 6 Section 3.2 - Compounds used in secondary cooling loops 6 Section 3.3 - Compounds used on the exterior of buildings or immediate surrounding areas 6 Section 3.4 - Compounds used for cleaning or maintaining of the exterior of vehicles 7 Part 4.—Procedures for the evaluation of compounds 7 Section 4.1 - Use of forms 7 Section 4.2- Labeling requirements 16 Section 4.3 - Preparation and submission of samples 17 page

Section 4,4 - Types of compounds requiring additional supporting data 18 Section 4.5 - Specific exceptions to the identification of other adjuvants (detergents, emulsifiers, surfactants, etc . ) > t)y brand name and manufacturer • 19 Section 4.6 - Obtaining temporary authorization 20 Section 4.7 - Notification of progress of evaluation 21 Section 4.8 - Notification of the outcome of evaluation 24 Section 4.9 - Publication listing authorized compounds 27 Section 4.10 - Reasons for termination of authorization 27 Part 5.—Compounds and their acceptable uses 28 Section 5.1- Cleaning compounds 28 Section 5.2 - Compounds for laundry use 29 Section 5.3 - Compounds used in inedible product processing areas and/or nonprocessing areas 30 Section 5.4- Sanitizing compounds 30 Section 5.5 - Compounds for employee hand care 34 Section 5.6- Pesticides 35 Section 5.7 - Potable water treatment compounds 40 Section 5.8 - Cooling and retort water treatment compounds.... 41 Section 5.9 - Boiler treatment compounds 42 Section 5.10 - Compounds for steamlines or primary cooling water loops 44 Section 5.11 - Poultry scald media 45 Section 5.12 - Hog scald media 46 Section 5.13 - Tripe processing compounds 46 Section 5.14 - Fruit and vegetable washing compounds 47 Section 5.15 - Lubricants 48 Section 5.16 - Sewer and drain treatment compounds 50 Section 5.17 - Absorbant/anti-slip compounds 50 Section 5.18 - Paints or other resinous or polymeric coatings. 50 Section 5.19 - Solvents 51 Part 6.—Compounds restricted by specific Federal regulations.... 52 Section 6.1- USDA regulations 52 Section 6.2 - Environmental Protection Agency regulations 53 Section 6.3 - Concurrent registration with EPA and authorization with USDA 53 Section 6.4 - Food and Drug Administration regulations 54 Part 7.—Compounds not permitted as ingredients 55 Section 7.1- Hazardous substances 55 Section 7.2 - Potentially harmful compounds 55 Section 7.3- Odorous compounds 55

ni HigmigtLts

Following are the significant changes in this revised edition of the "Guidelines For Obtaining Authorization..."

* Changes in the definition of water treatment compounds (See Section 3.2, Section 5.7 and Section 5.10)

-k More information on labeling requirements (See Section 4.2)

* More information on tests for enz3niiatic drain cleaners and hand washing and/or sanitizing compounds (See Section 4.4)

* Information on obtaining temporary authorization (See Section 4.6)

'^ Examples of additional forms and letters used by the Compounds Evaluation Unit (See Section 4.7 and Section 4.8)

"^ Information about the "List Of Chemical Compounds" and how to obtain it (See Section 4.9)

^' More information about reasons for termination of authorizations (See Section 4.10)

■^ A complete rewrite of the section on use of pesticides (See Section 5.6)

"^ Addition of a list of accepted antimicrobial agents for paints (See Section 5.18 (B) (3)

'^ Information on the procedure for petitioning for changes in USDA regulations (See Section 6.1)

"^ More information about compounds restricted as ingredients (See Part 7)

IV Guidelines for Obtaining Authorization of Compounds to Be Used in Meat and Poultry Plants Introduction

Two Federal laws require the maintenance of safe and sanitary conditions in federally inspected meat and poultry plants. These two laws are the Federal Meat Inspection Act as amended by the Wholesome Meat Act of 1967 and the Poultry Products Inspection Act as amended by the Wholesome Poultry Products Act of 1968. These Acts are enforced by the Food Safety and Quality Service through the Meat and Poultry Inspection Program (MPI).

The Inspection Program calls for authorization of the use of substances and compounds in the plants, because misuse of such material may result in adulteration or unwholesomeness of meat and poultry being processed. Food Ingredient Assessment Division, Science evaluates compounds proposed for use in plants and authorizes, where appropriate, the use of safe compounds.

The scope of the compound evaluation program is national and international in significance. All chemicals produced anywhere within the United States for marketing to federally inspected meat and poultry plants must be evaluated by USDA. In addition, chemicals produced outside of the United States for marketing to U.S. plants or to plants exporting meat or poultry products to the United States may require such evaluation. Though we deal mainly with firms supplying chemicals to federally inspected meat and poultry plants, our primary responsibility is to the Federal inspectors in those plants. In that respect, our primary consideration is to provide inspectors with continual assurance that chemicals used in federally inspected plants are authorized for use and that their proper use will not result in the adulteration or contamination of food products. Part 1.—Compounds Which Must Be Evaluated

Section 1.1 - Maintenance and cleaning chemicals; sanitizers; pesticides; and all other substances referred to in Part 5 of this publication

(A) Send requests for such evaluation to:

Compounds Evaluation Unit, CPS Product Safety Branch Food Ingredient Assessment Division, Science, FSQS U.S. Department of Agriculture Building 306, Room 300, BARC-East Beltsville, MD 20705 Telephone (301) 344-2566

(B) All preparations to be evaluated by the Compounds Evaluation Unit must be submitted using the appropriate application form. A description of the forms and their use is provided in Section 4.1 of these guildlines.

DO NOT USE THESE FORMS FOR ANY PREPARATIONS OTHER THAN THOSE SUBMITTED TO THE COMPOUNDS EVALUATION UNIT. OBTAIN BLANK FORMS FROM THAT UNIT.

Section 1.2 - Packaging materials; marking and branding inks; coatings applied to equipment or structural members prior to installation in the plant; and all materials such as metal alloys, plastics, belting, hose, etc., proposed for use in association with processing facilities and equipment Send requests for such evaluation to:

Packaging Evaluation Unit, CPS Product Safety Branch Food Ingredient Assessment Division, Science, FSQS Food Safety and Quality Service U.S. Department of Agriculture Washington, DC 20250 Telephone (202) 447-7680

Section 1.3 - Other chemicals proposed for use in federally inspected meat and poultry plants

Send requests or inquiries to the Chief of:

Product Safety Branch Food Ingredient Assessment Division, Science, FSQS Food Safety and Quality Service U.S. Department of Agriculture Washington, DC 20250 Telephone (202) 447-7680 Section 1.4 - Shell egg cleaning, defoaming, destaining, and sanitizing compounds

(A) Although such compounds are included in the "List of Chemical Com- pounds," their evaluation is not the responsibility of Food Ingredient Assessment Division, Science.

Send all requests and inquiries concerning such compounds to:

Poultry Grading Branch, PDQ Food Safety and Quality Service U.S. Department of Agriculture Washington, DC 20250 Telephone (202) 447-7510

(B) Copies of authorization issued by the Poultry Grading Branch are sent to the Compounds Evaluation Unit by PDQ, and the compounds are subsequently inserted in the "List of Chemical Compounds."

Section 1.5 - Chemicals or materials proposed for uses other than those previously speci fied

The evaluation of such preparations is not the responsibility of Food Ingredient Assessment Division, Science, nor can it be performed by that group. Requests or inquiries concerning such evaluation should not be directed to the addresses given above. Part 2.—Compounds Which Do Not Require Evaluation

The compounds referred to in this part may be used under the conditions described in the following paragraphs without being evaluated or authorized by USDA« Any such compounds which are classified as economic poisons must be registered with the Registration Division, Office of Pesticides Program, EPA and must be used according to label directions. Any compounds governed by FDA regulations must be used in accordance with those regulations. All compounds must be used in a manner which, in the opinion of the Inspector in Charge, will not result in the direct or indirect contamination of food products.

Section 2.1 Dénaturants

(A) Dénaturants formulated and labeled according to the following sub- paragraphs require no evaluation or authorization by USDA prior to their designated use. (1) Preparations consisting only of the substances listed below may be used for denaturing carcasses, parts thereof, meat and meat food products (other than rendered animal fat) condemned for pathology and intended for disposal only as tankage. The dénaturant must be deposited in all portions of the carcass or product to the extent necessary to prevent its use for food purposes. The container label must identify all ingredients present. Crude carbolic acid A formula consisting of: Cresylic disinfectant 1 part FD&C Green No. 3, 40 parts oil of citronella, 40 parts liquid detergent, and 40 parts water. (2) Preparations consisting only of the substances listed below may be used for denaturing carcasses, parts thereof, meat and meat food products intended for disposal for purposes other than human food. Preparations marketed as aqueous solutions may also contain chemical preservatives and/or emulsifying agents regulated under the Food Additive Regulations (CFR Title 21, Parts 172, 182 & 184). The dénaturant must be deposited in all portions of the carcass or product to the extent necessary to prevent its use as human food. The container label must identify all ingredients present.

Charcoal (finely powdered) FD&C Blue No. 2 FD&C Blue No. 1 FD&C Green No. 3

(3) Preparations consisting only of substances listed below may be used for denaturing poultry and poultry products condemned for pathology and intended for disposal only as tankage. The dénaturant must be deposited in all portions of the carcass or product to the extent necessary to prevent its use for food purposes. The container label must identify all ingredients present.

Crude carbolic acid Phenolic disinfectants conforming Fuel oil to commercial standards Kerosene CS 70-41 or CS 71-41 Used crankcase oil

(4) Preparations consisting only of substances listed below may be used for denaturing poultry and poultry products intended for disposal for purposes other than human food. Preparations marketed as aqueous solutions may also contain chemical preservatives and/or emulsifying agents regulated under the Food Additive Regulations (CFR Title 21, Parts 172, 182 & 184). The dénaturant must be deposited in all portions of the carcass or product to the extent necessary to prevent its use as human food. The container label must identify all ingredients present.

FD&C Blue No. 1 FD&C Red No. 3 FD&C Blue No. 2 FD&C Red No. 40 FD&C Green No. 3 Ultramarine Blue

(B) Dénaturants including ingredients other than those listed in Section 2.1(A), or those identified only by proprietary name, must be submitted for evaluation according to Section 1.1 of these guidelines prior to use.

Section 2.2 - Outdoor pest control substances

Compounds such as herbicides, bird control compounds, insect repellants and other pest control substances labeled for outdoor use only may be used around the outside of the premises of federally inspected plants without evaluation or authorization by USDA, provided that they are registered by the Registration Division, Office of Pesticide Programs, EPA; and they are used in accordance with label directions and in a manner which prevents the direct or indirect contamination of food products.

Section 2.3 - Compounds used in offices and other similar non-processing areas

Compounds such as dusting aids, furniture waxes or polishes, wall or floor finishes or waxes, wax strippers, rug or upholstery shampoos or cleaners, rug anti-static treatments, window or glass cleaners, and other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to use in such areas. They may not be used in any processing area of a federally inspected plant.

Section 2.4 - Compounds used in cafeterias or other retail food services areas

Compounds such as rinse additives to prevent spotting and streaking of dishes and utensils, utensil tarnish removers, some hand dishwashing soaps or detergents, and other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to use in those areas. They may not be used in any processing area of a federally inspected plant.

Section 2.5 - Compounds used in heating systems

Compounds such as fuel additives, firebox or flue treatments or cleaners, and other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to their intended use.

Section 2.6 - Compounds used in the treatment of certain inedible materials

Compounds used to treat inedible materials such as hides, hair, feathers, or other similar materials specified by the Compounds Evaluation Unit, require no evaluation or authorization by USDA prior to their intended use.

Section 2.7 - Compounds used in holding pens, trucks, transporting cages, etc.

Compounds such as pesticides, disinfectants, or cleaners used in transporting or holding facilities for animals prior to slaughter, or on animals being trans- ported or held prior to slaughter; chemicals for deodorizing or dissolving animal waste; or other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to their intended use.

Part 3.—Compounds Which are Not Applicahle for Evaluation

None of the compounds referred to in this part may be used in a processing area of the plant. However, they may be used under the conditions described in the following paragraphs without being evaluated or authorized by USDA. They may be stored within the plant provided that such storage is in a designated non- processing area acceptable to the Inspector in Charge. Any such compounds which are classified as economic poisons must be registered with the Registration Division, Office of Pesticide Programs, EPA and must be used according to label directions. Any compounds governed by FDA regulations must be used in accordance with those regulations. All compounds must be used in a manner which, in the opinion of the Inspector in Charge, will not result in the direct or indirect contamination of food products.

Section 3.1 - Compounds used in sewage or waste water systems outside of the plant

Compounds such as grease solvents for traps or lines, sewage odor control compounds, compounds to maintain biological balance in sewage lagoons or holding ponds, or other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to their intended use.

Section 3.2 - Compounds used in secondary cooling loops.

Algaecides, corrosion inhibitors, compounds for cleaning and maintenance, or other similar compounds specifically designated by the Compounds Evaluation Unit, to be added to water used to cool gases or liquids which do not contact food products require no evaluation or authorization by USDA prior to their intended use. An example of a secondary cooling loop is the cooling system used to condense hot ammonia gas in an ammonia chilling system.

Section 3.3 - Compounds used on the exterior of buildings or immediate surrounding areas

Compounds such as exterior coatings; mortar cleaning or etching compounds; tar, asphalt, or mortar removers; driveway patching or finishing compounds; or other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to their intended use.

Section 3,4 - Compounds used for the cleaning or maintenance of the exterior of vehicles

Compounds such as car washes or shampoos, tire cleaners, truck body brighteners, or other similar compounds specifically designated by the Compounds Evaluation Unit require no evaluation or authorization by USDA prior to their intended use. Compounds used on the interior of vehicles for transporting meat and poultry products are applicable for evaluation under conditions set forth in Section 1.1 of this publication.

Part 4.—Procedures for Evaluation of Compounds

Section 4.1 - Use of forms

A brief description of the MP Forms and their use follows. Instructions for the completion of the forms is provided on the back of each form. In some cases more detailed instructions are required and instructions are provided below. (A) MP Form 26 - Application for Authorization of New Products This form is intended for the submission of products for which authorization has not been previously requested or granted. Also, it must be used for the submission of products for temporary authorization under the provisions of Section 4,6. When the same compound is to be marketed by the same firm under more than one product name, submit an MP Form 26 for one name, and an MP Form 27 for each of the others.

it U.S. GOVeRNfMMT fWlNTING OFFICE 1978-2M-002 USE A SEPARATE APPLICATION FOR EACH PROOUQ Submit ConfiUtMl ApplicaHon (Original and 3 CopiM) With CaiiKMi Intoct-Ratain "Applicant's Copy" No «valuation for authorizad ut« may b« mod« uni«» a compl«t«d oppi¡cation form has b««n r«c«iv«d 19 CFB 381.60). FOIM APMOVEO: OMB NO 40-«M51 U.S. DEPARTMENT OF AGRICULTURE 1 DATE OF APPLICATION Î. PAGE FOOD SAFETY AND QUALITY SERVICE January 27, 1978 MEAT AND POULTRY INSPECTION PROGRAM 3. NAME-OF. PRODUCT - (MuH b» lomt ptoduci nomt ai on fab«' RELTSVILLE, MARYLAND and not to »MC—d 40 characttrt) APPLICATION K» AUTHORIZATION OF | NEW | PRODUa RCS » 37-MP-71 (Under the Meat & Poultry Inspection Program) Compound X IMPORTANT: R«od inttrucHons on r«v«rio. 4 NAME & MAILING ADDRESS OF MANUFACTUKING FIRM . INCLUDE ZIf CODE FOR USDA USE ONLY ÍTfp, (MIOW a, bttw^i, doH,- inifructio« 4 on rtyrt») • • XYZ Chemical Co. 123 Main Street BeltsvUle, MD 20705

5. TYPE OF PRODUCT (Brm' d»ichption of propofd uiM ■ i

General cleaner

6 WHO WILL MARKET THE PRODUCT? fChccl on* box -

MANUFACTURING FIRM l—l DISTRIBUTOR (—1 ONLY D ONLY LJ )5I 8. IS THE PRODUCT INTENDED FOR USE AS A SCALD, TRIPE PROCESSING, OR COOLING AND RETORT WATER TREATMENT COMPOUND! ÍSM YES O NO 0 9. DO NECESSARY DIRECTIONS FOR USE APPEAR ON THE PRODUCT LAiELf (S— in$truetion 9 on rto»ri»)

YES □ NO [2 Y ADDITIONAL PERTINENT INFORMATION (Oo NOT »ntm ConUdtntml Formuh hurt ■ <•• ih n»»d»d, atlach additional t^

C] CONTINUED ON ATTACHMENT (Submit 2 cops of «och $h—t)

n. THE FOLLOWING MUST BE SUBMITTED WITH THIS APPLICATION This is to certify that the product as proposed for use will have no deleterious effect on meat and poultry being processed. o. 7 copies of proposed lob«! or st«ncil. Must include at least product nome and supplier s name. Copy must be legible and must include all printed matter 12 SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE which will oppear on final label. Sec items 6, 7, 8 & 9 above for further instructions. b. 1 completed set of MP Form 29, Confidential Statement of Formula. (This in- ^1304, ^ formation 1$ treated confidentially) 1. TELEPHONE NO. OF FIRM REP

c. 1 product sample (See mitruction Vc on reverse^ 555-2566 d. 2 copies of supporting doto (5— instruction Ud on r»v0ri») \i TYPE NAME & TITLE OF PERSON SIGNING IN ITEM 17

flflV* An iiKOiit|»l«t« opiklkatien will b* r*fwrn«d for cempi*** detail« John Jones, Chemist .0,5, r'SO" f» ^- - Q p '^SUBMISSION OR RETURN OF THIS APPLICATION DOES NOT CONSTITUTE AUTHORIZATION 16 DATf RECEIVED BY USDA \r DATE ACK BY USDA 18 DATE RETURNED BY USDA kTEpF FINAL ACTION 4V. USDA USE -i -in . l97li ONLY FcB I <:j7il PREVIOUS EDITION OBSOLETE ORIGINAL Instructions for MP Form 26 (Application for Authorization of New Product) This form is intended for the submission of products proposed for use in federally inspected meat and poultry plants for which authorization has not previously been requested or issued. This form is intended only to be used for products covered under Part 1, Section 1.1 of the "Guidelines For Obtaining Authorization of Compounds To Be Used In Meat and Poultry Plants". When the same compound is to be marketed by the same firm under more than one product name, submit on MP Form 26 for one name and on an MP Form 27 for each of the others. NOTE: Following instructions are numbered according to the item number to which they apply. 2. Enter total number pages used to complete this Application (this form is Page 1, and number each attached sheet with subsequent numbers). 4. Enter the name and mailing address of the firm or person manufacturing the product. The address given in item 4 will be the mailing address permanently on our record unless changed by the firm whose name appears in item 4. The manufacturing firm may designate an agent to act in his behalf. If so, this application and a letter designating the agent must be sent to the agent and forwarded by him to USDA. The agent's name and complete mailing address must accompany the letter and application on an attached sheet. Include on the attached sheet: MP Form No. 26, Date of Application (Item 1), Page number (Item 2), Name of Product (Item 3), Name and Mailing Address of Manufacturing Firm (Item 4).

5. Do not attempt to categorize the product according to currently established categories (ie. A, CC, etc.) State the use(s) for which the product is applicable in federally inspected meat and poultry plants. 6. If the product is marketed by firm in item 4 that firm name must appear on the product labels submitted with this application. If the firm name on the product labels submitted with this application is different from firm name in item 4 (as with a "house brand" for marketing company), correlate the 2 firm names in item 10. Distributor labels should not be submitted with this application, they must accompany the MP Form 28, Application For Authorization of Distributor Product, submitted by the Distributor. 7. If the product is an economic poison, (i.e. pesticide, algaecide, fungicide, sanitizer, germicide, etc.), the label must be registered with the Registration Division, Office of Pesticide Programs, Environmental Protection Agency, Washington, D.C. 20460. If product is being concurrently submitted for Registration by EPA, see the "Guidelines For Obtaining Authorization" for details. 8. If the product is intended as a scald, tripe processing, or filled can cooling and retort water treatment compound, the label must include a qualitative statement of ingredients. If the product contains an ingredient restricted as to maximum amount permitted, the label must also include the maximum allowable concentration of the product in the treated water. 9. If necessary directions, including proposed use dilutions and/or precautions for use do not appear on the product label, provide such information under item 10 of this application. 10. If attached sheet(s) are used, they must be identified by: • Form number (MP Form 26) • Date of Application (Item 1) • Page number (Item 2). (Page 2 of (total pages) and subsequent numbers for each additional sheet). • Name of Product (Item 3) • Name and Mailing Address of Manufacturing Firm (Item 4) 11c. PRODUCT SAMPLE: • For resinous or polymeric coatings, provide a 2x4 inch panel of the finished coating on an appropriate substrate. • For ail other products, provice a 4-fluid-ounce portion or equivalent thereof. (Do not provide larger samples as environmental impact is prohibitive to disposal of the excess). • The sample MUST be identified by: • Date of application (Item 1) • Name of Product (Item 4) • Name & Mailing Address of Manufacturing Firm (Item 5) The sample MUST accompany this application lid. SUPPORT DATA: • The following types of products require additional supporting data as indicated in the "Guidelines For Obtaining Authoriza- tion:" • Poultry scald media • Bacterial/enzyme drain and sewer treatments • Hand washing and sanitizing compounds • Hand sanitizing compounds • Coatings for application to food contact surfaces,

>U.S. Department of Agriculture Food Safety and Quality Service Meat and Poultry Inspection Program Building 306, BARC-East Beltsville, Maryland 20705 MORE DETAILED INFORMATION AND INSTRUCTIONS ARE PROVIDED IN THE "GUIDELINES FOR OBTAINING AUTHORIZATION." (B) MP Form 27 - Application for Authorization of Amended Products This form must be used when: * Permanent authorization was previously granted and one or more revisions listed in item 6 of this form are desired. * Temporary authorization was previously granted and permanent authorization is desired (See Section 4.6 (A.2) of this publication). * Authorization was denied within the past year and reconsideration is desired. (See Section 4.8 (B) of this publication).

vr w).a. ^uvt.r

NO No evaluation for authorized use may be made unless a complet««! application forr n ha s been received (9 CFR 381.60) FORM A PPRO V ED 40 - R 3 3S2 1. DATE OF APPLICATION 2 PAoe U.S. DEPARTMENT OF AGRICULTURE 1 Of -^ FOOD SAFETY AND QUALITY SERVICE May 17, 1978 MEAT AND POULTRY INSPECTION PROGRAM 3.DATE OF ORIGINAL iSee instruction j on ">*ars», RCS Í-37-MP-72 BELTSVILLE, MARYLAND APPLICATION FOR AUTHORIZATION OF /AMENDED/ PROI3UCT A.AUTHORIZATION B APPLICATION lUndtr f^• P*

• . FOR USDA USE ONLY Cleaning Products, Inc. 1234 Haln Street Beltsville, MD 20705

6, NATURE OF REVISION (See instruction 6 on reverse)

IS Additional Product Name (Give Old name in item 7 and other name in item 4 - also attach 2 copies of label)

n Change in Product Name (Give old name in item 7 and new name in item 4 - also attach 2 copies of revised label)

D Change in Company Name (Give old name in item 7 and new name in item 5 - also attach 2 copies of revised label)

D Chanye in Label Text - other than product name (Attach 2 copies of revised label)

n Change in formula (Attach completed MP Form 29)

□ Request for additional/changed authorized use(s) (Specify in item 7. Attach 2 copies of revised label only if additional use(s) results in revision of label text)

7. DETAILS REQUIRED BY REVISIONS CHECKED IN ITEM 5 iDo MOT enter revised formula here use MP fomn ?9 Attach additional sheet it more space is needed)

Final Action Concentrate-Cleaner

□ CONTINUED ON ATTACHMENT (Sut)mit 2 copies ot each sheet)

. IS PRODUCT ALSOCURRENTLY MARKETED THRU DISTRIBUTORS USING THEIR OWN LABEL?

YESD NOKI YES n NO E (If "YES," attach list of

10. THE FOLLOWING MUST BE SUBMITTED WITH THIS APPLICATION This IS to certify that the product as proposed for use will have no (As applicable) deletenous effect on meat and poultry being processed a. 2 copies of revised Label or Stencil b. 1 set MP Form 29, Confidential Statement of Formula (See instruction 11. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE 6 on reverse) c. 1 product sample (see instruction 6 on reverse) d. J copies of supporting data (see instruction lOd on reverse! e. 2 copies of a List of Distributors required in item 8 above. 12. ^TE SIGNED 7j 13. TELEPHONE NO. OF FIRM REP. May 17, 1978 I 51^^:2566 C3Q1) 14. TYPED NAME & TITLE OF PERSON SIGNING IN ITEM 11

^An incomplete application will be returned for complete details. John Jones, Chemist SUBI^ISSION Oß RETURN OF THIS APPLICATION DOES NOT CONSTITUTE AUTHORIZATION 16. DATE ACK. BY USDA 17. DATE RETURNED BY USDA USDA USE-»^ ONLY PREVIOUS EDITION OBSOLETE ORIGINAL

10 Instructions for MP Form 27 (Application for Authorization of Amended Products) This form is intended for the submission of products for which authorization has been previously granted or requested and denied. It should also be used to request the authorization of the same compound to be marketed by the same firm under additional product names. NOTE: Following instructions are numbered according to the item number to which they apply. 2. Enter total number of pages used to complete this Application (this form is Page 1, and number each attached sheet with subsequent numbers). 3. If the ()roduct is currently authorized, enter the date of the letter of authorization in item 3A. If there is another current application, or a [)fior application which ciid not result in authorization, enter tfie date of that application in item 3B. 5. Enter the name and mailing address of the firm or person manufacturing the product. The address given in item 5 will be the mailing address permanently on our record unless changed by the firm whose name appears in item 5. The manufacturing firm may designate an agent to act in his behalf. If so, this application and a letter designating the agent must be sent to the agent and forwarded by him to USDA. The agent's name and complete mailing address must accompany the letter and application on an attached sheet. Include on the attached sheet: MP Form No. 27, Date of Application (Item 1), Page number (Item 2), Name of Pro duct (Item 3), Name and Mailing Address of Manufacturing Firm (Item 5),

6. Any change in label text or formulation of a product registered with the Registration Division, Office of Pesticide Programs, EPA, requires reregistration of the product with that agency prior to submission of this application to USDA. • When the identical formula is to be marketed by the same firm under an additional product name the labels submitted must reflect'the new product or company name. • When the label text changes, the new labels submitted must reflect those changes. • When the product formula changes, the revised formula must be submitted on MP Form 29, Confidential Statement of For- mula. A revised product sample must be provided. For resinous or polymeric coating, provide a 2 x 4 panel of the finished coating on an appropriate substrate. For all other products, provide a four (4) fluid ounce portion or equivalent thereof. (Do not provide larger samples as environmental impact is prohibitive to disposal of the excess). • The sample MUST be identified by: • Date of application (Item 1) • Name of Product (Item 4) • Name b Mailing Address of Manufacturing Firm (Item 5) The sample must accompany this application • When the application submitted is to request additions to or changes in product authorization, specify in item 7 whether the desired action is a change in use or an additional use and specify the use desired. 7. If attached sheet(s) are used, they must be identified by: • Form number (MP Form 27) • Date of Application (Item 1) • Page number (Item 2).(Page 2 of - (total pages) and subsequent numbers for each additional sheet). • Name of Product (Item 3) • Name and Mailing Address of Manufacturing Firm (Item 5) 8. If yes, attach 2 copies of a list showing the distributor's company name and product name for those authorized by USDA. lOd.SUPPORTING DATA • The following types of products require additional supporting data as indicated in the "Guidelines For Obtaining Authoriza- tion." • Poultry Scald Media • Bacterial/enzyme drain and sewer treatments • Hand washing and sanitizing compounds •' Hand sanitizing compounds ^ • Coatings for application to food contact surfaces.

Order blank forms from and U.S. Department of Agriculture send the completed application Food Safety and Quality Service and sample to Meat and Poultry Inspection Program Building 306. BARC - East Beltsviile. Maryland 20706

MORE DETAILEO INFORMATION AND INSTRUCTIONS ARE PROVIDED IN THE GUIDELINES FOR OBTAINING AUTHORIZATION

11 (C) MP Form 28 - Application for Authorization of Distributor Products. This form is intended for the submission of products being distributed by a firm other than the manufacturer where the composition of the distributor's product is identical to that of the manufacturer's product. Use of this form should not be limited to strict distributor-manufacturer relationships: it should be used in any situation where the firm name appearing on the label is different than the manufacturing firm name. The product may be repackaged; but if the product is diluted or altered in any other way, it must be submitted using MP Form 26 - Application of Authorization of New Product, by the firm responsible for the change in product composition.

■j:^' U.S. GOVERNMENT PRINTING OFFICE 1978-258-073 USE A SEPARATE APPLICATION FOR EACH PRODUCT Submit Completed Application (Original & 3 Copies) With Carbon Intact - Retain "Applicant's Copy" No evaluation for authorized use nr i be made unless a completed a| n form has been received (9 CFR 381.60).

U.S. DEPARTMENT OF AGRICULTURE FORM APPROVED OM8. NO. 40'R3850 FOOD SAFETY AND QUALITY SERVICE 1. DATE APPLICATION BY DISTRIBUTOR MEAT AND POULTRY INSPECTION PROGRAM RCS »37-MP-70 BELTSVILLE, MARYLAND May 16, 1978 APPLICATION FOR AUTHORIZATION OF /DISTRIBITTOR/ PRODUCT 1 OF \ {Under the Meat and Poultry Inspection Program) IMPORTANT: Read instructions on reverse. DISTRIBUTING FIRM'S AUTHORIZED REPRESENTATIVE (Complete items 1 thru 11 and submit with attachments to USDA) FOR USDA USE ONLY

Humphries, Ltd 789 E. River Road Beltsville, MD 20705

4. DISTRIBUTOR'S PRODUCT NAME A^ i 5 ISMANUFACTURERSPRODUCT ■ REPACKAGED BY DISTRIBUTOR' (If "Yes," see instruction 5 on revei Andy's Super H.D. Cleaning Concentrate YESD 6. ANY ADDITIONAL PERTINENT INFORMATION (If n^ore space is needed, attach 2 copies of each additional sheet)

This submission is being made as a result of a change in our source Qf .qupply. DiSJMBUlOR'S CERTIFICATION This is to certify that the manufacturer's product is not altered in any way prior to marketing by the Distributor, and that the Distributor will not change Suppliers without prior notification to USDA. 8. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE

a. Two (2) labels or stencils for product as marketed by A=J-^- -ypi ^^ Distributor 9. C/ATE SIGNED /O. TELEPHONE NO. OF FIRM REP. b. One (1) product sample, if product is repackaged by Distributor ¡See instruction 5 on reverse! ¿ay 16, 1978 555-2466 11. TYPED NAME & TITLE OF PERSON SIGNING ITEM 8 c. 2 copies of EPA Form 8570-5, if applicable (See instructions 13 thru 19 on reverse) WÊ^^^ An incomplete application will be returned for complete J. F. Humphries, Marketing V.P. ^^^ details. MANUFACTURING FIRM'S AUTHORIZED REPRESENTATIVE (Complete items 12 thru 19 prior to completion and submission by the Distributor) 12. NAME & MAILING ADDRESS OF MANUFACTURER (Indi 13. MANUFACTURER'S PRODUCT NAME (Must be same as product nan under which authorization is currently granted or applied for Not to exceed 4 characters -See instructions 13 thru 19 on reverse) Cleaning Products, Inc. 1234 Main Street Final Action Concentrate-Cleaner Beltsville, MD 20705

15. DATE OF MANUFACTURER'S (Seem A. AUTHORIZATION B. APPLICATION îD DE May 17, 1978 16. ANY ADDITIONALPERTINENT INFORM AT ION (If more space is needed, attach 2 copies of each additional shee t)

MANUFACTURER'S CERTIFICATION This is to certify that the formula of the product supplied to the Distributor is identical to that of the Manufacturer's product entered in item 13 above, and that the manufacturer will notify USDA if he changes the Product Formula or ceases to supply the product to the Distributor named in item 3 above. 18. DATE SIGNED 19. TYPED NAME & TITLE OF PERSON SIGNING I REPRESENTATIVE May 16, 1978 John Jones, Chemist ( \ SU^ISSIONl/SSiON OR RETURNR OF THIS APPLICATION DOES NOT CONSTITUTE AUTHORIZATION ^ on riATP nprpivpn RV OI . DATE ACK. BY USDA 22. DATE RETURNED BY USDA USDA USE—I ONLY

PREVIOUS EDITION OBSOLETE ORIGINAL COPY

12 Instructions for MP Form 28 (Application for Authorization of Distributor Products) This application is intended for the submission of products being distributed by a supplier other than the manu facturer where the product composition of the distributor's product is identical to that of the manufacturer s product The product may be repackaged; but, if it is diluted or altered in any other way, it must be submitted using MP Form 26, Application for the Authorization of New Products, by the firm responsible for the change in product composition. NOTE: The following instructions are numbered according to the number of the item to which they apply. 2. Enter total number pages used to complete this application (this Form is Page 1, and number each attached sheet with subsequent number(s). 3 Enter the name and address of the firm or person to whom authorization is to be issued. The address given in item 3 will be the mailing address permanently on our record unless changed by the firm whose name appears in item 3. The distributing firm may designate an agent to act in his behalf. If so, this application and a letter designating the agent must be sent to the agent and forwarded by him to USDA. The agent's name and complete mailing address must accompany the letter and application on an attached sheet. Include on the attached sheet. Include on the attached sheet: MP Form No. 28, Date of Application (Item 1), Page number (Item 2), Name of Product (Item 4), Nahne and Mailing Address of Distributing Firm (Item 3). If the firm name on the product labels submitted with this application is different from firm name in item 3 (as with a "house brand" for marketing company), correlate the 2 firm names in item 6.

A firm located outside of the United States must designate an authorized agent within the United States to represent them in all matters pertaining to product evaluation. This application and a letter designating the agent must be sent to the agent and forwarded by him to USDA. The agent's name and complete mailing address must accompany the letter and application on an attached sheet. Include on the attached sheet: MP Form No. 28, Date of Application (Item 1), Page number (Item 2), Name of Product (Item 4), Name and Mailing Address of Distributing Firm (Item 3). 5. If the product is repackaged, the distributor MUST submit a sample with this application. For resinous or polymeric coatings, provide a 2x4 inch panel of the finished coating on an appropriate substrate. For all other products, provide a four (4) fluid ounce portion or the equivalent thereof.(Do not provide larger sample as environmental impact is prohibitive to disposal of the excess). • The sample MUST be identified by: • Date of application (Item 1) • Name of Product (Item 4) • Name & Mailing Address of Distributing Firm (Item 3) The sample must accompany this application 13 thru 19 • If the manufacturer's product, entered in item 13, is registered with EPA's Office of Pesticides Program, the manufacturer MUST submit 2 copies of EPA Form 8570-5, Application For Supplemental Registration Of Distributors (Photo copy acceptable), which indicates acceptance by EPA of the distributor's product named in item 4. • If the manufacturer's product entered in item 13 is currently authorized by USDA, enter date of current authorization in item 15A. The manufacturer must complete items 17, 18, and 19 on this form, but no technical information is required. • If the manufacturer's product entered in item 13 is not currently authorized by USDA, the manufacturer must concurrently supply information on his product, using MP Form 26, Appli- cation for the Authorization of NEW Products. Enter the date of the manufacturer's application in item 15B. Complete items 17, 18, and 19 on this form. • If the manufacturer's product entered in item 13 is not currently authorized by USDA, but be_ ing revised the manufacturer must concurrently supply information on his product, using MP Form 27 Application for the Authorization of AMENDED Products. Enter the date of current authorization in item 15A and the date of application for amended product authorization m item 15B. Complete items 17, 18, and 19 on this form. • If attached sheet(s) are used, they must be identified by: • Form number (MP Form 28) • Date of Application (Item 1) , ^ . ..- • Page number (Item 2). Page 2 of (total pages) and subsequent numbers for each additional sheet). • Name and Mailing Address of Manufacturing Firm (Item 12) • Name of Product (Item 13) U.S. Department of Agriculture Order blank forms from and ^^~~^--~--~._^^ Food Safety and Quality Service send the completed application ^I> Meat and Poultry Inspection Program and sample to: ^.^-^-""""^ Building 306, BARC - East Beltsville, Maryland 20705

MORE DETAILED INFORMATION AND INSTRUCTIONS ARE PROVIDED IN THE "GUIDELINES FOR OBTAINING AUTHORIZATION"

13 (D) MP Form 29 - Confidential Statement of Formula.

This form is intended for reporting the ingredients used in the formulation of a product. It must be completed and submitted with each MP Form 26 - Application for Authorization of New Product; and with each MP Form 27 - Application for Authorization of Amended Product, if the revision involves a formula change.

'{r U.S. QO^ERNMENT PRINTING OFFICE 1978-258-577 USE A SEPARATE FORM FOR EACH FORMULA EACH FORM MUST BE AHACHED TO A COMPLETED APPLICATION Submit Original and Copy with Application (Carbon Intact) - Retain **Applicant's Copy"

No evaluotion for outhorizad use may be mode unless mpleted opplicotion form hos been received (9 CFR 381.60).

U.S. DEPARTMENT OF AGRICULTURE FORM APPROVED OMB NO 40.R3e49

FOOD SAFETY AND QUALITY SERVICE 2 PAGE MEAT AND POULTRY INSPECTION PROGRAM BELTSVILLE, MARYLAND 1 OF 2 CONFIDENTIAL STATEMENT OF FORMULA January 27, 1978 (Under the Federal Meat and Poultry Inspection Program)

IMPORTANT: R*ad in.trucliom on ravtrit b.for. compl.flng form An mcompl.t. form w.ll b* r.tum.d for corKpUt« daloili FSQS ho. d.t.rmin.d (!■ providad in ;t«m> 6 ond 7 ii «xcmpl from mandatory ditclotur* undar the Fraadom of Informotion Act, S U.S.C. SS2!b) 14;

3 REASON FOR SUBMISSION

APPLICATION FOR , , SUBMISSION OF APPLICATION FOR AUTHORIZATION (TH AUTHORIZATION OF CORRECTED/ADDITIONAL OF NEW PRODUCT LJÜ AMENDED PRODUCT ' ' INFORMATION n 4. NAME & MAILING ADDRESS OF APPLICANT . INCLUDE ZIP CODE f/Mu 1 b* loma 01 5. NAME OF PRODUCT fMusf ba Jo ma product narr» OS on /aba/ and not >o êMC»ed 40 chara '*"' XYZ Chemical Co. 123 Main Street Beltsville, MD 20705 Compound X

6 NAME EACH ACTIVE AND EACH INERT INGREDIENT USED IN THE FORMULATION AND NUMBER CONSECUTIVELY

(Lifl both ffia common noma ond th» prtcis» chamico/ noma of aocfi Ir n nof nacaisorx ro diffaranfio'a b»tw»»n octiva ond in»rt mgraditnlt Ui» additional sfiaart if n»»d*dl

INGREDIENT NAME OF INGREDIENT PERCENT OF EACH NO BY WEIGHT B C

1 Sodium dodecylbenzenesulfonate 9.5

2 Sodium hydroxide 1.5

3 Water 79.0

4 Tergon S-7 10.0

5 Dye - Acid Violet 9, C.I. /M5190 trace

All ingradian 1 liitad m II im 6 abo« ond on oddilio nal ihaati mull 100% r~l CONTINUED Ohi ATTACHMENTS {Svbm,t 3 cop.a< of aocfi ifiaarj . tolol * YES □ NO □

MAMt Of ium.m

Tergon S-7 H. Allen Chemicals

D CONTINUED ON ATTACHMENT (Svbm.r 2 copiai of aocfi ¡hnt)

8 SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE 10 TYPED NAME & TITLE OF PERSON SIGNING IN ITEM 6

9 DATEéVGNED / 1 John Jones, Chemist January 27, 1978 SUBMISSK ON OR RETURN OF THIS FORMULA DOES NOT CONSTITUTE AUTHORIZATION n DATE RECEIVED BY USDA 12 DATt AC«. BY USDA 13 DATE BETUSNED BY USDA 14 DATE OF F NAL ACTION USOA BY USDA USE —^■ ONLY

MP FORM 29 (■ütviOub fDiTiC N OBSOLETE -^_,_,-,. , ORIGINAL

14 Inttnictlons for MP Form 29 (Confi

In order to evaluate a product for use in federally inspected meat and poultry plants, the complete chemical composition must be known. This information is necessary to determine the status of ingredients, both active and inert,under existing regulations and policies of the federal Meat and Poultry Inspection Program, the Federal Insecticide. Fungi- cide, and Rodenticide Act. and the Federal Food. Drug, and Cosmetic Act. This form is designed for reporting the ingredients used in the formulation of a product proposed for use in federally inspected meat or poultry plants, it must be completed and submitted with each "Application for Authorization of NEW Products", MP Form 26; or with each "Application for Authorization of AMENDED Products". MP Form 27. if revision involves a formula change. NOTE: The following instructions are numbered according to the number of the item to which they apply 2. Enter total number pages used to complete this Statement (this form is Page 1. and number each attached sheet with subsequent number(s). 6. If the Statement of Ingredients requires more space than is available in item 6, it may be recorded partly in item 6. or entirely on separate sheet(s). If it is partly in item 6 and continued on additional sheet(s) check the box "Con- tinued on Attachment(s)". If it is entirely on additional sheet(s), enter in item 6 "See Attached Sheet(s)". When additional sheet(s) are used identify each with: • Form number (MP Form 29) • Date of Application Accompanying This Formula (Item 1) • Page number (Item 2). (Page 2 of — (total pages) and subsequent numbers for each additional sheet). • Name and Mailing Address of Applicant (Item 4) • Name of Product (Item 5) Col. A - Each ingredient must be numbered consecutively (1, 2. 3, ..) Col. B - Each active and each inert ingredient must be identified by common name and precise chemical name with the following exceptions: (1) Dyes, pigments, and fluorescent brighteners must be identified by Colour Index (C.I.) référer,:e. The Colour Index is a group of reference books published by the Society of Dyers and Colourists, Yorkshire, England, and the American Association of Textile Chemists and Colorists, Research Triangle Park. North Carolina, which lists dyes.pigments, and associated materials commercially available References may be given by C. I. Commercial Name, C. I. Generic Name, or C. I. Constitution Number. Identification by manufacturer's trade name is insufficient. If such materials have no C. I. reference, they must be identified by specific chemical name and chemical structure. If this information is not available to you, it may be sent directly to USDA by your supplier. In that case, the ingredient should be listed in item 7. (2) Proprietary perfumes must be identified by trade name and manufacturer. Essential oils may be identified by common or chemical name. (3) Other adjuvants (detergents, emulsifiers, surfactants, etc.) may be identified by trade name and manufacturer when the specific chemical name is not known. Caution: Do not confuse the identification of a classi- fication of materials (eg. alkyl aryl polyethoxy alcohols) with the specific chemical name (eg. octyl phenoxy polyethoxy (9 moles E.G.) ethanol). In most cases, materials listed in McCutcheon's Detergents and Emulsifiers Annual (Published by the Allured Publishing Corporation, Ridgewood. N.J.) require no further identification. Specific exceptions are noted in the "Guidelines for obtaining Authorization." Col. C -All formulations must add up to 1(X).0%. Round off percentages of all ingredients to the nearest tenth of a percent. Ingredients present in amounts of 0.05% or less should be expressed as "trace". Do not use units of liquid or dry measure (lbs., gals., etc.). 7. When adjuvants are identified only by trade name, if no information on the adjuvants is in USDA reference flies. USDA will require that you provide the specific chemical name or composition or request it from the supplier. If necessary, the information may be sent directly to USDA by the supplier. When information is being sub mitted by another source, enter the name of the ingredient(s) and thesupplier(s) in item 7. If the Ingredi'ent(s) and Supplier(s) require more space than is available in item 7. it may be recorded partly in item 7 or entirely on separate sheet(s). If it is partly in. item 7 and continued on additional sheet(s) check the box '^Continued on Attachments". If it is entirely on additional sheet(s). enter in item 7 "See Attached Sheet(s). When additional sheet(s) are used identify each with: • Form number (MP Form 29) • Date of Application Accompanying This Formula (Item 1) • Page number (Item 2). (Page 2 of — (total pages) and subsequent numbers for each additional sheet). • Name and Mailing Address of Applicant (Item 4) • Name of Product (Item 5) MORE DETAILED INFORMATION AND INSTRUCTIONS ARE PRQVIOÇD IN THE "QUIOELINES FOR OBTAINING AUTHORIZATION •

15 Section 4.2 - Labeling Requirements

(A) Two copies of product labeling MUST always accompany each application. In cases where printed labels in fl^t form with approximately 8 1/2-by 11-inch dimensions are not available, they should be converted to those dimensions by mounting or by photographic reduction, where reduction would not significantly impair readibility. When screen printing is used to print labeling directly on the container, do not submit the container; copies may be made by taping a piece of paper on the container as it goes through the printing process. If labeling is printed on a bag or drum, or is otherwise difficult to provide in flat form, a 35mm black and white negative transparency may be supplied instead. If shading or contrast make the black and white transparency unreadable, a 35mm color positive transparency must be substituted. In cases where none of these methods are feasible, draft labeling may be submitted. It should be submitted as either typewritten text on 8 1/2 by 11 inch paper or a legible mock-up of the label with the same approximate dimensions.

(B) All products must be labeled to show at least the name of the product and the name of the firm marketing the product. The firm name on the application forms and all labels must be in complete agreement. The firm name must also agree with that given on labeling for any previously authorized products. The product name on the application form must be limited to 40 characters including spaces in order to be incorporated into our computerized printing system. However, efforts should be made to have the name on the form agree with that on the label to the greatest degree possible considering the 40 character limitation. When abbreviation is necessary, efforts should be made to abbreviate similar product names in the same way. Consistent placement of words and symbols (. , - & # etc.) is very important because of our computerized printing system. Such inconsistencies can cause your product or firm to be listed incorrectly or out of normal alphabetical sequence in the "List Of Chemical Compounds."

(C) Only one formulation may be marketed under one product name. If more than one formulation is proposed for a preparation, there must be some modification to the brand name to distinguish between the formulations.

(D) If a preparation is authorized by USDA and reference is made to such authorization on the labeling or other printed material, the statement must be specific, indicating that the preparation is "Authorized by USDA for use in federally inspected meat and poultry plants." Such statements may not be given undue prominence on the label. Use of "USDA Approved" or a similar statement is not acceptable since it may connote an endorsement of the preparation by USDA. Reference to a specific agency (MID, C&MS,APHIS,FSQS) or category code letter from the "List Of Chemical Compounds" is discouraged since they are subject to change without public notification.

(E) Regulations under the Federal Insecticide, Fungicide, and Rodenticide Act (FÏFRA) require a preparation for which economic poison claims (i.e. pesticidal, algaecidal, fungicidal, germicidal, sanitizing, etc.) are made, to bear a label showing the active ingredients and to be appropriately registered with the Registration Division, Office of Pesticides Programs, Environmental Protection Agency (EPA). In order to be applicable for use in meat and poultry

16 plants, the label must also include directions and precautions for such use as required by those regulations. Accordingly, any such preparation offered for use in federally inspected meat and poultry plants must be labeled in compliance with those requirements.

(F) To assure safe use of boiler water additives, or fruit and vegetable washing compounds, regulations under the Federal Food, Drug and Cosmetic Act require that labels for such products include the common or chemical name for each ingredient and directions for use adequate to insure compliance with those regulations. Where additives are prepared to custom specifications of individual customers, or where for other reasons it is not feasible to include an ingredient statement and use directions on the container label, that information may be supplied to users in such forms as control charts, technical bulletins, service reports, or other written communications. In those cases, two copies of the supplementary information must be supplied to USDA along with an explanation of how they are provided to users.

(G) Because of the possibility of residues remaining in food products as a result of using chemicals in washing canned items, in denuding or otherwise processing tripe, or in scalding hog or poultry carcasses, the container labels for such preparations must include a qualitative statement of all chemicals present. For those chemicals restricted by a maximum amount permitted, the percentage must also be shown. Labels for products containing restricted chemicals must provide dilution directions which reflect the maximum allowable concentration of use for the preparation in addition to any recommended dilution direction which may be on the label.

(H) Unless otherwise stated in paragraphs (E), (F), or (G) of this Sec- tion, labeling is not required to include a statement of ingredients or directions for use. However, in most cases a description of the nature or purpose of the preparation and directions for its use are beneficial to the user. If applicable directions for use are not provided on the labeling or on an accompanying data sheet, they must be provided to USDA in the space designated for additional information on the application form. An explanation of how users are given directions for use must also be provided. The use of all cleaning compounds must be followed by a potable water rinse (see Section 5.1 (B) (1)). Labeling for such preparations may not carry general directions stating that no rinse is necessary unless the directions also state that rinsing with potable water IS required when the preparation is used in a federally inspected meat or poultry plant.

(I) To provide a means for USDA to correlate lots or batches of material supplied to federally inspected plants with reports supplied to them by formulators, labels for bacterial/enzyme sewer and drain treatments must have the product lot or batch number displayed so that it is easily identifiable as such.

Section 4.3 - Preparation and submission of samples

(A) The product sample must be submitted with the application form. Failure to do so will result in the application being returned or the sample being discarded.

17 (B) Samples of resinous or polymeric coatings must be provided as the cured film or coating on an appropriate substrate. The sample dimensions should approximate 2" x 4" whenever possible to facilitate handling and storage. Standard drawdowns are also acceptable for structural coatings inmost cases. Only where unusual physical requirements are to be examined would a more representative sample be required.

(C) Samples of all other compounds should be the equivalent of 4 fluid ounces whenever possible. Please do not send larger samples. Environmental considerations make disposal of the excess very difficult. Shipment of such samples in a 4 ounce, square, wide-mouth glass bottle, our standard storage container, will facilitate handling and storage. Shipment of aerosol packages should be avoided if possible. Such products may be shipped in a standard container in the concentrate form minus the propellants. Under those circumstances reference must be made, in the space available for additional information on the application, that the sample is being shipped in concentrate form. Some corrosive materials are classified as unmailable by the U.S. Postal Service. Such samples must be shipped by Express or other suitable means of air or surface transportation.

(D) The requirement for a sample may be waived by USDA if the compound is extremely toxic or hazardous. If you feel that your preparation falls into that group, contact USDA for an opinion prior to submission of an application for authorization.

Section 4.4 - Types of compounds requiring additional supporting data

(A) Bacterial/Enzyme drain and sewer treatments

(1) Manufacturers of compounds containing bacterial cultures are required to provide USDA a taxonomic identification (identification by genus and species) of the cultures. No pathogenic bacteria are permitted.

(2) Manufacturers must provide USDA with a record of salmonellae analysis for each lot of the finished enz3nmic treatment proposed for sale to federally inspected meat and poultry plants. Testing must be performed by a qualified microbiologist. A confirming analysis will be made on the sample submitted to the Compounds Evaluation Unit by the Microbiology Division, Science. The method that they use is adapted from Section 4.5(2) of the "Microbiology Laboratory Guidebook". That publication is available upon request by writing to the following address:

Microbiology Division, Science Food Safety and Quality Service U.S. Department of Agriculture Washington, DC 20250

The method used is the same as that for pre-cooked frozen foods with the following exceptions:

(a) In paragraph (a), blending is omitted and 0.6% (1.5ml) undiluted

18 Tergitol 7 is added in all cases. (b) In paragraph (d), only TT broth is used.

(B) Hand washing and/or sanitizing compounds

Compounds proposed for sanitizing or washing and sanitizing employees* hands need not be registered with the Environmental Protection Agency; however, data supporting their effectiveness must be provided USDA. The method for determining such effectiveness, "Available Chlorine Germicidal Equivalent Con- centration," is outlined in Sections 4.012 -^.014 of the "Official Methods of Analysis of the Association of Official Analytical Chemists -Twelveth Edition 1975." Use the operating procedure given in Section 4.014 with the following changes :

Test the compound with both Staphylococcus aureus ATCC No. 6538 and Saltnonella typhöse ATCC No. 6539.

The NaOCl control will have a concentration of 50 ppm available chlorine and the neutralizing culture medium will be 10 ml of thioglycollate broth.

The hand washing and/or sanitizing compound will be tested at the use dilution and the neutralizing culture medium must be appropriate in kind and volume for the compound tested. Quaternary ammonium compounds and parachlorometaxylenol (PCMX) are neutralized by letheen broth; halogens by thioglycollate medium. If 10 ml. is not sufficient for neutralization, it may be necessary to use 100 ml. If 10 negative subcultures are obtained, data must be obtained to show that the neutralization was effective.

Quaternary ammonium compounds must be tested in the presence of 400 ppm of hardness or diluted in hard water so the final concentation is 400 ppm.

Modifications may also be required to make the test valid for other compounds which possess considerable bacteriostatic activity; but a modified procedure is not available from USDA. In those cases, evidence must be presented which proves that the activity indicated by the test results is bactericidal rather than bacteriostatic in nature.

Formulators of such coatings must provide data to USDA to substantiate compliance of the coatings with FDA regulations. (See Section 6.4 (F) of these guidelines.) The protocol for gathering such data depends on the type of resin or polymer in the coating, the conditions of use of the coated surface, and the type of food in contact with the coated surface. All testing criteria are specifically described in the appropriate FDA regulation.

Section 4.5 - Specific exceptions to the identification of other adjuvants (detergents, emulsifiers, surfactants, etc.) by brand name and manufacturer

(A) Adjuvants used in any compound governed by USDA regulations, EPA regulations, or FDA regulations must be identified by specific chemical name or composition. See Part 6 of these guidelines for types of products involved.

19 (B) Adjuvants not identified in the current edition of "McCutcheon's De- tergents and Emulsifiers Annual" must be identified by specific chemical name or composition.

(C) If necessary, the required information may be sent directly to USDA by the manufacturer of the adjuvant. When such information is submitted to USDA by a source other than the applicant, the applicant must enter the name of the adjuvant(s) and manufacturer(s) in Item 7, MP Form 29.

Section 4.6 - Obtaining temporary authorization

Under the following circumstances, firms may request temporary authorization to market a compound to federally inspected plants.

(A) For experimental purposes

When a firm wishes to test an experimental compound under actual plant conditions, they may request authorization for experimental purposes for a 6-month period. Such an authorization allows the firm to vary the percent of any ingredient over a stated range. The authorization will not be indicated in the "List Of Chemical Compounds."

(1) For these requests, the MP Form 26 must be completed according to directions and the phrase "Authorization for experimental purposes requested" must be inserted in Item 9 on the form. On the accompanying MP Form 29, each ingredient name must be given in Item 6B according to directions; but in Item 6C the percent of each by weight may be expressed as a range (eg. 10-30%). In most cases, a sample is not required. However, where the acceptability of the compound for the proposed use is in question, USDA may require a sample to be sent.

(2) If the firm wishes to maintain the authorization, they must request either a renewal of the temporary authorization or a permanent authorization no later than 4 weeks prior to the termination date of the experimental period. A renewal of temporary authorization may be requested by letter. A permanent authorization must be requested using an MP Form 27. Any change must be noted as required in the directions. If there is no change in labeling or formulation, no block should be checked in Item 6 and the statement "No change in labeling or formulation since previous authorization" must be inserted in Item 7. Whether or not there has been a change in labeling and/or formulation, the statement "Authorization for experimental purposes previously granted" must always be inserted in Item 7. Also a sample and an MP Form 29 completed according to directions must always accompany the MP Form 27.

(B) To maintain plant operations

In cases where a federally inspected plant needs a specific compound to correct a deficiency or to otherwise maintain a phase of operations, the firm which markets the needed compound may request authorization for its use at the plant in question for a period of 90 days. The firm or processing plant must also arrange for the Federal inspector or other responsible Federal official at the plant to contact the Compounds Evaluation Unit to confirm the need.

20 (1) Depending on the urgency of the request, the Compounds Evaluation Unit may, at their discretion, accept information about the compound by telephone, telegram, letter, or appropriate application forms; but, in each case, the exact formula must be provided by the firm. To confirm the information, the firm must also submit the compound for evaluation according to the procedure stated in Section.1.1 of the "Guidelines For Obtaining Authorization Of Compounds..." at the earliest possible date.

(2) As urgency dictates, USDA may reply to the firm by collect telegram. It is the responsibility of the firm receiving the authorization to provide the Federal inspector or official at the plant with a copy of the proof of authorization.

Section 4.7 - Notification of progress of evaluation

(A) Upon receipt, applications are given an initial review for procedural completeness and correctness. If complete and correct, the acknowledgement copy will be returned with the date of acknowledgement stamped on it along with an indication of the additional time required to complete the substantive review.

21 FORM APPROVED: OMB NO. 40-R3851

U.S. DEPARTMENT OF AGRICULTURE 1. DATE OF APPLICATION 2. PAGE lOF FOOD SAFETY AND QUALITY SERVICE JmnutLTj 27 > 1978 MEAT AND POULTRY INSPECTION PROGRAM 3. NAME-OF- PRODUCT - (Must b« samé product nom« os on lab«l BELTSVILLE, MARYLAND and not to exc««d 40 characters) APPLICATION FOR AUTHORIZATION OF I NEW | PRODUQ RCS # 37-MP-71 (Under the Meat & Poultry Inspection Program) IMPORTANT: Read instructions on reverse. 1. NAME & MAILING ADDRESS OF MANUFACTURING FIRM -INCLUDE ZIP CODE FOR USDA USE ONLY (Type be/ow & befw»«n dof$-i«« instruction 4 on re>f»rsa)

ZTZ Chcnical Co. 123 Hftin StrMt l«lt«Tille, MD 20705

5. TYPE OF PRODUCT (Bri»f description of proposed us0s • tM instruction 5 on r«v«ri«J

G«nftral cleaner

6. WHO WILL MARKET THE PRODUCT? (Ch»ck on« box-t«« instruction 6 on rtvrst)

MANUFACTURING FIRM m□ DISTRIBUTORDIbiKIBUrOR 1—1 ONLY ONLY l—J 8. IS THE PRODUCT INTENDED FOR USE AS A SCALD, TRIPE PROCESSING, O« COOLING AND RETORT WATER Tl

9. DO NECESSARY DIRECTIONS FOR USE APPEAR ON THE PRODUCT LABEL» (SM instructioi

I I CONTINUED ON ATTACHMENT (Submit 2 copies of «ach sheet)

11. THE FOLLOWING MUST BE SUBMITTED WITH THIS APPLICATION This is to certify that the product as proposed for use will have no deleterious effect on meat and poultry being processed. a. 2 copies of proposed label or stencil. Must include at least product name and supplier's nome. Copy must be legible and must include oil printed matter 13. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE which will pppeor on final label. See items 6, 7, 8 & 9 above for further instructions. b. 1 completed f»t of MP Form 29, Confidential Statement of Formula. (This in- V)^'^n^^X^ formation is treated confidentially) E SIGNED [ 1 14.14 TELEPHONE NO. OF FIRM REP. c. 1 product sample fSe« instruction lie on reverse) CT 27> 197S 555-2566 d. 2 copies of supporting data (See instruction lid on reverse) 15 TYPE NAME & TITLE OF PERSON SIGNING IN ITEM 12

' An iiKompUt« opplkotio« will b« r«tvm«d for compl«»« d«*oiU

SUBMISSION OR RETURN i atlISj'ül^ftigJM'fiJMUKIZATIUN DATE THIS APPLICATION RECEIVED BY USDA DUE TO THE NUMBER OF (Refer to item 1 APPUCATIONS WE RECEIVE in corresponfmm ^/v IT WILL TAKE APPROXIMATELY on.this prodJclP J^V TO PROCESS THIS APPLICATION PREVIOUS EDITION OBSOLETE ACKNOWLEDGMENT COPY,

22 (B) A procedurally incomplete or incorrect application will be returned to the applicant for more information accompanied by MP Form 33, Application Re- turned For Additional Information, indicating the specific information required to process the application. An application which has been determined procedurally complete and correct may also be returned for more information if errors are found during the substantive review.

1.MP FORMS RETURNED 2.DATE OF FORM U.S. DEPARTMENT OF AGRICULTURE ,MP FORM 26 MEAT AND POULTRY INSPECTION PROGRAM v/' MP FORM 27 .5-/7- 7P

APPLICATION RETURNED MP FORM 29 LABEL 3. REASON FOR RETURN Tlic attached application is returned for the reasons checked below (otily the items checked are applicable). For details see the applicable pa^cs ot the "Guidelines For Obtaining Authorization . . ." or other reference noted in Column C, below.

REASONS ITEMS IN APPLICABLE PAGES IN GUIDELINES (Only applicable if checked in Col. A) APPLICATION OR OTHER REFERENCE — A

/ (1) The information required in the items indicated was omitted /¿> cu ¿"ec^/z^'/r ^.J^CS) (2) The information provided in the items indicated is incorrect

(3) Provide the specific chemical name or brand name and manufacturer for Ingredient Nos.:

(4) We have no information in our reference files for Ingredient Nos. :

Follow directions in item 7 on MP Form 29 1—_ (5) Product label must be amended to comply with USDA requirements

(6) Product not applicable for use in Federally inspected meat and poultry plants

(7)

4. ACTipN TO BE TAKEN BY APPLICANT Lia The information noted above must be entered on/returned with the attached original MP Form(s). inui application and this signed form must be returned to USDA.

I I A new copy of the MP Form{s) _ must be prepared, including the information noted above, as well as all the information on the original application. The new application and this signed form must be returned to USDA.

I—I This constitutes final action. You may not resubniit this application for further evaluation.

5. SIGNATURE OF USDA REPRESENTATIVE 6. DATE SIGNED

£^^^.>w¿^ £, {le ¿if Qr^^^- a. J97S^ if fünfter action is required in item 4, this form must a/ways be signed by an Auttiorized Firm Representative, dated, and returned to USDA with the application form. (If you wish a copy for your files, it may be photo copied.)

7. SIGNATURE OF AUTHORIZED FIRM REPRESENTATIVE 8. TYPED NAME AND TITLE OF PERSON SIGNING IN ITEM 7

9. DATE SIGNED

RECEIPT OB RETURN OF THIS FORM DOES NOT CONSTITUTE AUTHORIZA TION USDA 10. DATE RETURNED TO USDA 11.DATE RETURNED BY USDA 12.DATE OF FINAL ACTION BY USDA USE ONLY

MP FORM 33 PREVIOUS EDITIONS ARE OBSOLETE MAR. 1978

23 Section 4.8 - Notification of the outcome of evaluation

(A) When a compound is found acceptable for the proposed use, a letter of authorization is issued to the applicant by USDA referring to the compound by brand name. The type of authorization issued depends on the acceptable use(s) of the compound.

(1) Compounds classified in the categories described in the "List Of Chemical Compounds" are authorized by letter from Science, FSQS, USDA. Copies of the letters must be supplied to Federal inspectors as proof of authorization until the compounds appear in the next revision of the publication. Once a compound appears in the publication, the letter is no longer valid as proof of authorization.

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND QUALITY SERVICE

SCIENCE BLIILDiNG 306 RARC EAST BELTSVILLE, MD. 20705

April 1, 1979

Mr. John Jones XYZ Chemical Company 123 Main Street Beltsville, MD 20705

Dear Mr. Jones:

This is in reply to your request for compound authorization received on February 1, 1979.

Your product Compound X is acceptable as a general cleaning agent on all surfaces, or for use with steam or mechanical cleaning devices in all departments of official establishments operating under the Federal meat, poultry, shell egg grading, and egg products inspection programs.

Before using this compound, food products and packaging materials must be removed from the room or carefully protected. After using this compound, surfaces must be thoroughly rinsed with potable water.

Acceptance of this compound by this Department is in no way to be construed as an endorsement of the compound or of any claims made for it.

If any change is made in the labeling information or formulation, the authorization for use in official plants becomes void immediately.

Sincerely,

Chemis t-In-Charge Compounds Evaluation Unit, CPS Food Ingredient Assessment Division Science

24 (2) Compounds such as degreasers, paints, solvents, etc«, which are not classified in categories in the "List Of Chemical Compounds" are also authorized by letter indicating continuing authorization. Copies of such letters must be supplied to Federal inspectors as proof of authorization at all times since the compounds do not appear in the "List Of Chemical Compounds." The letters remain valid until terminated by USDA.

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND QUALITY SERVICE

SCIENCE RUILr::NG306 BARC EAST BELTSVILLE, MD. 20705

April 1, 1979

Mr. John Jones XYZ Chemical Company 123 Main Street Beltsville, MD 20705

Dear Mr. Jones:

This is in reply to your request for compound authorization received on February 1, 1979.

Your product Compound X is acceptable as a degreaser or carbon remover for food cooking or smoking equipment, utensils, or other associated surfaces in official establishments operating under the Federal meat, poultry, rabbit, shell egg grading, and egg products inspection programs.

Before using this compound, food products and packaging materials must be removed from the are.r or carefully protected. After using this compound, all surfaces must be thoroughly rinsed with potable water. This compound must be used in a manner so that all odors associated with the compound are dissipated before food products or packaging materials are re-exposed in the area.

Acceptance of compounds by this Department is in no way to be construed as an endorsement of the compounds or of any claims made for them.

If any change is made in the labeling information or formulation, the authorization for use in official plants becomes void immediately.

The above acceptance of this compound will not be indicated in the publication, "List of Chemical Compounds." This letter acts as continuing authorization for its use under the conditions stated above.

Sincerely,

Chemist-In-Charge Compounds Evaluation Unit, CPS Food Ingredient Assessment Division Science

25 (B) When a product is found unacceptable for the proposed use, the application will be returned to the applicant along with a copy of MP Form 30, Product Unacceptable For Use In Federally Inspected Establishments, shown below. The form specifically explains the reason(s) for unacceptability and the procedure for reconsideration.

U.S. DEPARTMENT OF AGRICULTURE 1.MP FORMS RETURNED 2.DATE OF FORM FOOD SAFETY AND QUALITY SERVICE MEAT AND POULTRY INSPECTION PROGRAM ¡XT^MP FORM 26 /-^7- /r BELTSVILLE. MARYLAND 20705 MP FORM 27 PRODUCT UNACCEPTABLE FOR USE IN MP FORM 28 FEDERALLY INSPECTED ESTABLISHMENTS l^/^MP FORM 29 j- zp-iS" LABEL

3. REASON FOR REJECTION The product is unacceptable for the reasons checked below {only the items checked are applicable). For details see the applicable pages of the "Guidelines For Obtaining Authorization . . ." or other reference noted in Column B, below. REASONS APPLICABLE PAGES IN GUIDELINES • (Only applicable if checked in Col. A} OR OTHER REFERENCE

(1) Product not in compliance with Meat and Poultry Inspection Regulations (2) Product not in compliance with Federal Food, Drug, and Cosmetic Act (3) Product not in compliance with Federal Insecticide, Fungicide, and Rodcnticidc Act (4) Product contains chemical(s) which is improperly dccharacterizcd

(5) Product contains a potentially hazardous substance

(6) Product has a strong characteristic odor or fragrance at the use ^ dilution .?ec^77/^/i/ 7 3 C/9) (7) Product has a perfume or chemical which leaves a residual fragrance on the hands after rinsing (8)Other

A. REMARKS

YOU MAY NOT RESUBMIT THIS APPLICATION FOR FURTHER EVALUATION It you wish to revise this product and resubmit for evaluation, always use MP Form 27, accompanied by a 4oz sample, 2 copies of the label, and if a formula change is involved a MP Form 29. 7. DATE RETURNED BY USDA 5. SIGNATURE A/>^/7Í

^r 'IP'ÎÎÎ.Î® 1/ PREVIOUS EDITIONS AR E OBSOLETE MAR. 1978 '-^

26 Section 4.9 - Publication listing authorized compounds

(A) Official use

The "List Of Chemical Compounds'* lists compounds authorized by Science, Food Safety and Quality Service for use in slaughtering and processing plants operating under the USDA Poultry, Meat, Rabbit and Egg Products Inspection Programs. The publication also lists compounds authorized by the Poultry Grading Branch, Poultry and Dairy Quality Division for use on shell eggs. The National Marine Fisheries Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce also recognizes the publication as an official list of compounds accepted for use in plants operating under their Fishery Products Inspection Program. There may be other government agencies or segments of the food industry that use the publication as a reference, but the preceding agencies are the only official users of the publication.

(B) Purpose

The purpose of the "List Of Chemical Compounds" i s to provide Federal inspectors and management of federally inspected plants with a means of confirming whether or not a compound offered for use is authorized by USDA for that use. It is not intended to be a reference for sources of supply of authorized compounds nor as a listing of compounds recommended or endorsed by USDA. For that reason, mailing addresses and/or telephone numbers of firms supplying authorized compounds are not provided.

The "List Of Chemical Compounds" is offered for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20401. It is revised annually with a supplement issued once between the annual revisions. If you wish to be notified when new revisions or supplements are issued, write to the following address and request your name to be put on Notification Key N-504:

Superintendent of Documents U.S. Government Printing Office Attn: Mail List, Stop SSOM Washington, DC 20401

Section 4.10 - Reasons for termination of authorization

(A) Any change in the composition or labeling of a product voids the authorization of the product unless the changes are submitted to the Compounds Evaluation Unit for review prior to the change.

(B) Any attempt by a proponent to mislead USDA as to the identity of constituents present in a product or to its accepted use through labeling, data sheets, or advertising media, may result in termination of the authorization of the product.

(C) Samples from supplies of bacterial/enz5mie drain and sewer treatment compounds in federally inspected meat and poultry plants are taken at

27 unspecified intervals. If analysis of those samples shows the presence of Salmonellae and/or other pathogenic microorganisms, authorization of the subject compound will be terminated. To apply for reinstatement of a bacterial/enzyme drain and sewer treatment compound found contaminated with pathogenic microorganisms, suppliers must proceed as follows:

1. The original source of contamination must be identified and removed.

2. The manufacturer of the compound must provide a statement of composition including the taxonomic identification (by genus and species) of the bacterial cultures for the revised compound.

3. An 8-ounce sample of the revised compound must be sent to the Compounds Evaluation Unit for examination.

4. The supplier of the compound must agree to provide the Compounds Evaluation Unit with a record of Salmonellae analysis for each new lot prepared for use in official establishments. Analyses must be conducted by a qualified microbiological laboratory.

The evaluation will be performed upon receipt of all the information indicated above. Authorization wil1 be issued if the above information indicates that the compound is free from pathogenic microorganisms and will be contingent upon continuing compliance with item four above.

(D) Any transaction which results in the sale, transfer, or merger of a firm, or sale or transfer of formulations of their authorized compounds, voids the authorization previously issued. In order to maintain continuity of authorizations, the firms involved must notify USDA of the transaction which has occurred. Notification may be: (1) a letter from each of the firms involved stating the transaction which has occurred, or (2) a copy of the legal document which records the transaction accompanied by a letter of explanation from the firm which has acquired the assets. In addition, the acquiring firm must confirm that there has been no change in formulation for the compounds in. question and it must provide labels for the compounds as it will market them. For any compound which has previous registration with EPA, the acquiring firm must also provide a copy of an acknowledgement from EPA confirming that EPA has transferred the registration for the compound to the acquiring firm.

Part 5.—Compounds and Their Acceptable Uses

Section 5.1 - Cleaning compounds

(A) General use criteria

(1) Neutral or mildly alkaline preparations consisting of any combination of soaps, detergents, wetting agents, emulsifiers, solubilizers, and common inorganic builders may be used on any surface in any department.

28 (2) Strongly alkaline preparations (those containing in excess of 20 percent caustic soda or other ingredients with the equivalent causticity thereof) may be used only in soak tanks or with steam or mechanical cleaning devices in any department.

(3) Acidic preparations consisting of mineral acids, organic acids, or acidic salts may be used in any department for the removal of rust, corrosion, scale, or other deposits which are not readily removed by alkaline preparations .

(B) Restrictions of use

(1) Before using any cleaning preparation, food products and packaging materials must be removed from the room or carefully protected. After using such preparations, all surfaces must be thoroughly rinsed with potable water.

(2) Preparations having a characteristic odor or fragrance as diluted for use which may, in the opinion of USDA, interfere with the sanitary inspection of food contact surfaces may not be used on food contact surfaces. They may be authorized for limited use on floors and walls only.

(3) Preparations containing abrasive materials such as silica, pumice, etc., may be used on food contact surfaces only if care is taken to remove all odors or residues resulting from their use by thorough rinsing with potable water. (4) Boric acid and salts thereof, may be used in such preparations only at concentrations up to 90 percent in association with strong acids, strong alkalis, soaps, or synthetic detergents.

Section 5.2 - Compounds for laundry use

(A) For all fabrics

Preparations consisting of soaps, synthetic detergents, alkaline builders, or any combination thereof are permitted for laundering shrouds, uniforms, aprons, or other fabrics used in the plant. Fluorescent dyes or optical bleaches may also be added if USDA has sufficient information on them to assure their safe use. Sours consisting of acetic acid, sodium bisulfate, or other acceptable acidic materials are permitted to neutralize excess alkalinity in all laundered fabrics. Acidic substances specifically unacceptable for such use are listed in Part 7 of these guidelines. Chlorine or oxygen bleaches are permitted to remove stains or maintain whiteness of all fabrics. In all cases, the final operation of the laundry cycle must be a potable water rinse sufficient to remove all added substances from the laundered fabric.

(B) For fabrics other than shrouds

In addition to the preparations referred to above, fabric softeners, or antistatic agents, and starches may be used on uniforms, aprons, or other wearing apparel. Also, the presence of a perfume or other odorant in a laundry compound may exclude its use on shrouds.

29 Section 5-3 - Compounds used in inedible product processing areas, and/or nonprocessing areas

The following compounds are limited to use in areas of federally inspected meat and poultry plants where edible products are neither processed nor stored in open containers. Their use on loading docks or other similar areas is left to the discretion of the Inspector in Charge at the plant.

(A) Compounds such as odor control compounds; air deodorants or sanitizers; cleaning or sanitizing compounds containing heavy perfume, pine oil, isomers of dichlorobenzene, etc.; or other similar compounds containing odorous substances are not acceptable for use in edible product processing areas because they may mask an odor resulting from poor sanitation rather than correct the situation. Compounds containing isomers of dichlorobenzene or other substances toxic by inhalation may be used only in areas where there is adequate ventilation to prevent the accumulation of hazardous vapors.

(B) So called "spray and wipe" cleaners, or other similar compounds are not acceptable for use in edible product proccessing areas because they are designed for use without a rinse. The use of all cleaning compounds in edible product processing areas must be followed by a potable water rinse.

Section 5.4 - Sanitizing compounds

(A) Equipment and utensils (hard, non-porous food contact surfaces)

Sanitizing solutions may be used on hard non-porous food contact surfaces such as equipment and utensils without a following potable water rinse under these conditions :

(1) Such surfaces are thoroughly drained and any collection of liquid removed therefrom before contact with food products is made.

(2) The sanitizing solutions are used in accordance with label directions.

(3) The sanitizing solutions consist of one of the following, to which may be added components generally recognized as safe (GRAS) and components which are permitted by prior sanction or approval. (Also see Section 6.4(A))

IMPORTANT NOTE: In order to be acceptable for use without a rinse, solutions must contain ALL ingredients required in the applicable sub-paragraph of this paragraph and may not contain any ingredients which are not GRAS, prior-sanctioned, or covered in the applicable sub-paragraph of this paragraph.

(a) An aqueous solution containing potassium, sodium, or calcium hypochlorite, with or without the bromides of potassium, sodium, or calcium.

(b) An aqueous solution containing dichloroisocyanuric acid, trichloroisocyanuric acid, or the sodium or potassium salts of these acids, with or without the bromides of potassium, sodium, or calcium.

30 (c) An aqueous solution containing potassium iodide, sodium p-toluenesulfonchloroamide, and sodium lauryl sulfate.

(d) An aqueous solution containing iodine, butoxy monoether of mixed (ethylene-propylene) polyalkylene glycol having a cloud-point of 90°C.-100°C in 0.5 percent aqueous solution and an average molecular weight of 3,300, and ethylene glycol monobutyl ether. Additionally, the aqueous solution may contain diethylene glycol monoethyl ether as an optional ingredient.

(e) An aqueous solution containing elemental iodine, hydriodic acid, alpha-(p-nonylphenyl)-omega-hydroxypoly(oxyethylene) (having a maximum average molecular weight of 748 and otherwise complying with appropriate FDA regulations) and/or polyoxethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 1,900). Additionally, the aqueous solution may contain isopropyl alcohol as an optional ingredient.

(f) An aqueous solution containing elemental iodine, sodium iodide, sodium dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 1,900).

(g) An aqueous solution containing dodecylbenzenesulfonic acid and polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 2,800).

(h) An aqueous solution containing elemental iodine, butoxy monoether of mixed (ethylene-propylene) polyalkylene glycol (having a minimum average molecular weight of 2,400), and alpha-lauroyl-omega-hydroxypoly (oxyethylene) with an average 8-9 moles of ethylene oxide and an average molecular weight of 400.

(i) An aqueous solution containing n-alkyl (C]^2"Cl8) benzyldimethylammonium chloride compounds having average molecular weights of 351-380 and consisting principally of alkyl groups with 12-16 carbon atoms with or without not over 1 percent each of groups with 8 and 10 carbon atoms. Additionally, the aqueous solution may contain isopropyl alcohol as an optional ingredient.

(j) An aqueous solution containing trichloromelamine and either sodium lauryl sulfate or dodecylbenzenesulfonic acid.

(k) An aqueous solution containing equal amounts of n-alkyl (C22"C-j^g) benzyldimethylammonium chloride and n-alkyl (Ci2'"^18) dimethylethylbenzylammonium chloride (having an average molecular weight of 384).

(1) An aqueous solution containing the sodium salt of sulfonated oleic acid and polyoxyethylene-polyoxyproplyene block poljrmers (having an average molecular weight of 2,000 and 27 to 31 moles of polyoxypropylene). All equipment and utensils treated with this sanitizing solution shall have a drainage period of 15 minutes prior to use in contact with food.

(m) An aqueous solution containing elemental iodine and alkyl (Ci2""^15) monoether of mixed (ethylene-propylene) polyalkylene glycol.

31 having a cloud point of 70°-77°C in 1 percent aqueous solution and an average molecular weight of 807.

(n) An aqueous solution containing iodine, butoxy monoether of mixed (ethylene-propylene) polyalkylene glycol, having a cloud point of 90°-100°C in 0.5 percent aqueous solution and an average molecular weight of 3,300, and polyoxyethylene-polyoxypropylene block polymers (having a minimum molecular weight of 2,000).

(o) An aqueous solution containing lithium hypochlorite.

(p) An aqueous solution containing equal amounts of n-alkyl(C22"CjL8) benzyl dimethyl ammonium chloride and n-alkyl(C22"Ci4) dimethyl ethylbenzyl ammonium chloride (having average molecular weights of 377-384), with the optional adjuvant substances tetrasodium ethylenediaminetetraacetate and/or alpha-(p-nonylphenol)-omega-hydroxypoly (oxyethylene) having an average poly(oxyethylene) content of 11 moles. Alpha-hydro-omega-hydroxy-poly(oxyethylene) poly(oxypropylene)(15 to 18 mole minimum) poly(oxyethylene) block copolymer, having a minimum molecular weight of 1,900, may be used in lieu of alpha-(p-nonylphenol)-omega-hydroxypoly (oxyethylene) having an average poly(oxyethylene) content of 11 moles.

(q) An aqueous solution containing di-n-alkyl (Cg-Cj^Q) dimethyl ammonium chlorides, having average molecular weights of 332-361 and isopropyl alcohol.

(r) An aqueous solution containing n-alkyl(C-j^2"^18^ benzyldimethylammonium chloride, sodium metaborate, alpha-terpineol and alpha[p-(l,l,3,3-tetramethylbutyl) phenyl]-omega-hydroxypoly(oxyethylene) produced with one mole of the phenol and 4 to 14 moles ethylene oxide.

(s) An aqueous solution containing sodium dichloroisocyanurate and tetrasodium ethylenediaminetetraacetate.

(t) An aqueous solution containing ortho-phenylphenol, ortho-benzyl-para-chlorophenol, para-tertiaryamylphenol, sodium-alpha-alkyl (C22""CjL5)-omega-hydroxypoly(oxyethylene) sulfate with the poly(oxyethylene) content averaging one mole, potassium salts of coconut oil fatty acids, and isopropyl alcohol or hexylene glycol.

(u) An aqueous solution containing sodium dodecylbenzenesulfonate.

(4) The solutions identified in paragraph (3) must not exceed the following concentrations:

(a) Solutions identified in sub-paragraphs (3) (a) and (3) (o) will provide not more than 200 parts per million of available halogen determined as available chlorine.

(b) Solutions identified in sub-paragraph (3) (b) and (3)(s) will provide not more than 100 parts per million of available halogen determined as available chlorine.

32 (c) Solutions identified in sub-paragraphs (3)(c), (3)(d), (3)(e), (3)(f), (3)(h), (3)(m), and (3)(n) will contain iodine to provide not more than 25 parts per million of titratable iodine. The adjuvants used with the iodine will not be in excess of the minimum amount required to accomplish the intended technical effect.

(d) Solutions identified in sub-paragraph (3)(g) will provide not more than 400 parts per million of dodecylbenzenesulfonic acid and not more than 80 parts per million of the block polymers identified in the sub-paragraph.

(e) Solutions identified in sub-paragraphs (3)(i), (3)(k) and (3)(p) will provide no more than 200 parts per million of the active quaternary compound when ready to use.

(f) Solutions identified in paragraph (3)(j) will not provide more than sufficient trichloromelamine to produce 200 parts per million of available chlorine and either sodium lauryl sulfate at a level not in excess of the minimum required to produce its intended functional effect or not more than 400 parts per million of dodecylbenzenesulfonic acid.

(g) Solutions identified in sub-paragraph (3)(1) will not provide more than 200 parts per million of sulfonated oleic acid, sodium salt.

(h) Solutions identified in sub-paragraph (3)(q) will not provide more than 150 parts per million of the active quaternary compound when ready to use.

(i) Solutions identified in sub-paragraph (3)(r) will not provide more than 200 parts per million of active quaternary compound and not more than 66 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl)phenyl]- omega-hydroxypoly(oxyethy lene).

(j) Solutions identified in sub-paragraph (3)(t) are for single use applications only and will provide, when ready to use, a level of 800 parts per million of total active phenols consisting of 400 parts per million ortho-phenyl-phenol, 320 parts per million ortho-benzyl-para-chlorophenol and 80 parts per million para-tertiaryamylphenol.

(k) Solutions identified in sub-paragraph (3)(u) will not provide more than 430 parts per million and not less than 25 parts per million of sodium dodecylbenzenesulfonate.

(5) The use of sanitizing solutions (other than those described in paragraphs (3) and (4) above) or combination cleaner-sanitizers on hard non-porous food contact surfaces, such as equipment and utensils, must be followed by a potable water rinse. Such solutions must be used in a manner which does not result in the contamination of food products subsequently processed.

(B) Equipment and utensils (porous and semi-porous surfaces).

Concentrations of sanitizing solutions considerably higher than those described

33 in paragraph (A)(4) above are necessary to provide efficacy in sanitizing porous and semiporous surfaces. Any sanitizing solution or combination cleaner- sanitizer may be used on such food contact surfaces at the concentration recommended on the label provided that such use is followed by a potable water rinse and does not result in the contamination of food products subsequently processed.

Sanitizing solutions described in paragraph (A)(3) may be used for mold control on such surfaces at concentrations considerably higher than those described in paragraph (A)(4) without a potable water rinse unless, in the judgement of the Inspector in Charge at the plant, such use results in residues which may contaminate food products subsequently processed or be otherwise objectionable. The use of other sanitizing solutions or combination cleaner/sanitizers must be followed by a potable water rinse.

Section 5.5 - Compounds for employee hand care

(A) General use criteria

(1) Only liquid soaps or detergents in suitable dispensing devices are allowed for hand washing in the slaughtering or food processing areas of the plant.

(2) Powdered or abrasive hand cleaners in suitable dispensing devices may be used in toilets and dressing rooms and other non-processing areas. Such cleaners may contain up to 90 percent sodium borate (borax), or other abrasive material, in combination with soaps or detergents and other adjuvants common to such preparations.

(3) Waterless hand cleaners and hand lotions or creams may also be used in toilets and dressing rooms or other non-processing areas. However, employees who handle food products may use them only when leaving the plant for the day.

(4) Those solutions described in Section 5.4(A) of these guidelines which are applicable for the purpose may be used to sanitize the hands of employees handling meat food products without a subsequent rinse provided that they are germicidally equivalent to 50 ppm chlorine. (See Section 4.4(B) for method.) Hand sanitizing is not a substitute for hand washing. Accordingly, such sanitizing solutions may be used only after thorough hand washing with soaps or detergents and water followed by rinsing with potable water.

(5) Combination detergent-germicides (single step preparations designed to combine hand washing and sanitizing) will be considered for authorization on the basis of their ability to effectively clean the hands as well as their equivalency to 50 ppm available chlorine. (See Section 4.4(B) for method.) The hands need not be washed with soap or detergent prior to use of such preparations. However, the hands must be rinsed with potable water after use of the preparations and before handling food again.

34 (B) Restrictions of use

CD The intent of the requirement that employees wash and sanitize their hands is to provide for quick and effective removal of transient bacteria which may contaminate the hands as a result of handling raw meat or poultry products, or using lavatory facilities. To insure that preparations for which hand sanitizing claims are made meet that intent, data must be provided to determine that the preparations are germicidally equivalent to 50 ppm available chlorine. The protocol for gathering such data is given in Section 4.4(B) of these guidelines. The germicidal equivalency must be confirmed by USDA as a prerequisite to authorization.

(2) Preparations which leave a residual fragrance on the hands after rinsing, which in the opinion of USDA, may interfere with the inspection of food products, may not be used in food processing areas or by employees who handle food products.

Section 5.6 - Pesticides

Elimination of vermin in and around plants is vital to the maintenance of good sanitation. Such pests are most effectively controlled by preventing their breeding and/or preventing their entrance into plants. This may be accomplished only through a program designed to eliminate all areas outside the plant where these pests may breed or be sheltered. The construction of the plant itself should, insofar as possible, prevent the pests from gaining entrance. When vermin do gain entrance, in spite of vigorous attempts to keep them out, certain eradication methods are permitted. A brief outline of methods used and specific substances permitted follows.

(A) Insecticides

(1) Contact sprays, space sprays, and aerosols

(a) Nonresidual

So-called "knockdown" sprays containing pyrethrum extracts or other substances not having residual killing action may be used in places where edible products are handled, provided that exposed edible products are removed, covered or stored in closed containers. Facilities and equipment must be thoroughly washed with an effective cleaning compound and rinsed with potable water after spraying. (i) The following nonresidual insecticides may be used: Allethrins Lethanes Pyrethrins Pyrethrum extract Synthetic pyrethroids (ii) The following synergists, singly or in combination, may be used in conjunction with the insecticides in Section 5.6 (A)(1)(a)(i):

Piperonyl butoxide Piperonal bis[2-(butoxyethoxy)ethyl] acetal (Tropital)

35 N-Octyl bicycloheptane dicarboximide (MGK 264) n-Propyl isome Sulfoxide

In contact and space sprays, the concentration of total synergists in the insecticide may not exceed one (1) percent based on the active content of the synergists. The concentration of synergists may be increased to a maximum of 5 percent, if the insecticide is dispensed as an aerosol spray from an adequate fogging device. An aerosol spray is defined by the Office of Pesticide Programs, EPA, as one in which none of the droplets exceeds 50 microns in diameter and 80 percent of the droplets are less than 30 microns in diameter.

(b) Residual

In contrast to nonresidual substances, there are residual insecticides which kill insects over an extended period of time. They are effective when used in conjunction with sound sanitation and maintenance programs. However, affected insects may fall into food products since there is no practical way to protect food products during operations. Therefore, the use of residual insecticides as contact sprays, space sprays, or aerosol sprays is restricted to inedible product areas or outside premises where exposed food products are neither processed nor stored in open containers. Also, precautions must be taken to prevent insecticide mist or affected insects from entering edible product processing or storage areas through open windows, ventilating systems, moveable equipment, clothing, etc. The following residual insecticides may be used:

Baygon Dipterex Carbaryl (Sevin) Fenthion (Entex) Chlordane Kepone Chlorpyrifos (Dursban,Dowco 179) Lindane Diazinon Malathion Dichlorvos (DDVP, Vapona) Methoxychlor Dimethoate Ronnel

(2) Crack and crevice treatment

The insecticides referred to in paragraph (A)(1)(a) and (A)(1)(b) of this section may be used for a single crack and crevice treatment in edible product processing areas; warehouse areas where edible product, ingredients, and packaging material are stored in sealed containers; and nonprocessing areas such as office, maintenance areas, employee locker room, etc.; provided that the following conditions are met:

(a) Production operations are not conducted in the area at time of treatment.

(b) All exposed edible product and packaging materials are removed, covered, or stored in closed containers.

36 (c) Plant management informs the Inspector in Charge of the treatment schedule. The Inspector in Charge will determine to what extent an inspector must be present during the chemical application based on past experience with the insecticide applicator and the degree of control exercised by plant management. The need for the presence of an inspector during the chemical application may be minimized if experience has demonstrated the reliability of plant management and insecticide applicator. When the Inspector in Charge does not assign an inspector to be present during treatment, he may require the plant to identify the proposed treatment sites in advance to permit review during an inspector's normal tour of duty. He may also permit the treatment sites to be recorded at the time of treatment for later review by the inspector.

(d) They are not used for area treatment such as misting or fogging, or for surface treatment such as at floor-wall junctions in rooms where their use is restricted to crack and crevice treatment.

(e) When used in offices, welfare areas, etc., insecticides must be used so that they will not be transferred to employees* clothing or other materials that may contact product.

(g) After treatment, the areas are ventilated to remove insecticide odors, and the facilities and equipment are throughly washed with an acceptable detergent solution and rinsed with potable water to remove all traces of contamination.

(h) The treated cracks and crevices are sealed with appropriate material within a reasonable period of time after treatment. The Inspector in Charge may include major projects in a plant improvement program.

If adherance to all above provisions does not result in elimination of the insect infestation, the inspector in charge may permit repeated treatments under the same provisions. However, he must continue to require sound construction, sanitation, and maintenance programs to avoid hazards related to chemical use.

Requests by plant management for residual insecticide treatment programs not covered by this section must be submitted through the inspector in charge to the Facilities, Equipment, and Sanitation Staff, Technical Services.

(3) Automatic insecticide dispensing systems

(a) The insecticides referred to in paragraph (A)(1)(a) of this section may be dispensed automatically in all areas of plants. They may be dispensed automatically in edible product processing or storage areas only when food products are not being processed or stored in open containers. The use of nonresidual insecticides on an intermittent basis (less than 24-hours a day) may significantly affect the efficacy of the insecticides. Therefore, registered

37 labels for nonresidual insecticides proposed for automatic dispensing in edible product areas must include directions for less than 24-hour operations to substantiate their efficacy under those conditiuons. Nonresidual insecticides may be dispensed automatically in inedible product areas 24 hours a day provided that precautions are taken to prevent entry of the insecticide mist or affected insects into edible product areas through open windows, ventilating systems, moveable equipment, clothing, etc.

(b) The residual insecticides referred to in paragraph (A)(1)(b) of this section may be dispensed automatically only in inedible product areas of plants. They may be dispensed 24 hours a day provided that precautions are taken to prevent entry of the insecticide mist or affected insects into edible product areas through open windows, ventilating systems, moveable equipment, clothing, etc. (4) Powdered or granular insecticides

(a) The insecticides referred to in paragraph (A)(1)(a) or A(l)(b) of this section, as well as borax, boric acid, derris or cube root, silica aerogel, and sodium fluoride mixed with inert ingredients such as clay, sugar, or talc, may be used for the control of flies, roaches, or other insects in inedible product areas or outside premises under circumstances which absolutely prevent contact with food products.

(b) To minimize the possibility of undetected contamination of food products, all powdered or granular insecticides, except those marketed exclusively in labeled dispenser containers, must be colored a definite blue or green. Any dye or pigment which imparts a definite blue or green color to the mixture may be used.

(B) Fumigants

(1) Hydrocyanic acid gas, methyl bromide gas, or phosphinç gas generated from aluminum phosphide may be used for the eradication of insects specified on the registered pesticide label. Hydrocyanic acid gas and methyl bromide gas may also be used for the eradication of rodents specified on the registered pesticide label. Raw uncured meat and poultry product must be removed from the room before fumigating. Uncooked cured hams and bacon, cooked sausage, or packaged product need not be removed.

(2) Gases other than those referred to in paragraph (B) (1) of this section may be used for purposes specified by USDA according to directions specified on the registered pesticide label. All edible products and their packaging materials must be removed from rooms to be fumigated. All food contact surfaces must be rinsed with potable water before products are returned.

(3) Since all gases referred to in paragraphs (B)(1) and (B)(2) of this section are extremely poisonous to man as well as vermin, permission for their use must first be obtained from the Inspector in Charge; and a competent, experienced person must be placed in direct charge of the fumigating operation. After fumigating, the room must be well ventilated before inspectors or plant personnel reenter the room. Ventilation must also be sufficient to assure

38 complete removal of the gas from the surfaces contacted. The fumigating equipment used must be so constructed and controlled as to positively prevent any of the liquid or powdered fumigant from escaping. Only the gas should be permitted to escape from the fumigating equipment.

In general, rodenticides are not allowed to be placed in edible product departments until operations have ceased for the day and all uncovered products have been removed from the area. Strict account must be kept of the location and number of stations in the area and the floor plan layout must be approved by the Inspector in Charge. Rodenticides may not be placed in dry salt cellars. They may remain in areas containing sealed, packaged meats, but care must be taken to place them so as to prevent contamination of the meat. All rodenticides and their containers must be removed from edible product departments before operations are resumed. All rodenticides and associated supplies must be stored in a separate place designed by the Inspector in Charge.

(1) The following rodenticides may be used:

3-(alpha-AcetonyIfurfuryl)-4-hydroxycoumarin (Fumarin) 3-(alpha-Acetonylfurfuryl)-4-hydroxycoumarin, sodium salt (Fumarin) alpha-Naphthyl-thiourea (ANTU) 2-[p-Chlorophenyl)phenylacetyl]"l,3-indandione (Chlorophacinone, Rozol) Diphacinone (Diphacin) Diphacinone, sodium salt 2-Isovaleryl-l,3-indandione (PMP, Valone) 2-Pivalyl-l,3-indandiane (Pival) 2-Pivalyl-l,3-indandione, sodium salt (Pivalyn) Prolin Red squill Vacor (DLP 787) Warfarin [3-alpha-(Acetonylbenzyl)-"4-hydroxycoumarin] Warfarin, sodium salt Zinc phosphide

(2) Baits

(a) The rodenticides referred to in paragraph (C)(1) of this section may be mixed with dry inert materials such as grains, meals, or flours to form dry baits. All dry baits must be secured in bait boxes in order to be used anywhere in meat or poultry plants. Liquid formulations may also be used if contained in a bait fountain and placed in a bait box.

(b) To minimize the possibility of undetected contamination of food products, all liquid baits, and dry baits in which the inert ingredients consist mainly of meal or flour, must be colored a definite blue or green. Where inert ingredients consist mainly of whole or cracked grain, or flour or meal pressed into cakes or pellets that do not have characteristics of food products, no addition of color is necessary.

39 (3) Tracking powders

Tracking powders consisting of the rodenticides listed in paragraph (c)(1) of this section and inert materials colored a definite blue or green may be used in all departments, provided that processing operations have ceased, all exposed products are removed, and their use does not create a nuisance. After the powders are removed, floors must be washed with an effective cleaning compound and/or rinsed with potable water to remove all evidence of the tracking powders before operations are resumed.

(4) St icky boards

Board strips covered with extremely adhesive resinous material may be used to capture rodents. Since the adhesive does not contain a rodenticide, board strips may be used in all departments provided that their use does not create a nuisance.

Section 5.7 - Potable water treatment compounds

In general, substances recognized as safe for the treatment of drinking water may be used for the treatment of water which may be incorporated into food products or directly contact food. [Examples of operations requiring potable water are cooking, fluming, and washing food.] Substances used in such treatment should not remain in the water in concentrations greater than required by good practice and may not remain at concentrations greater than the maximum stated in the EPA "National Interim Primary Drinking Water Standards." Substances which may subsequently result in the adulteration or contamination of meat or poultry products may not be introduced into the system. Specific limitations on substances are as follows:

(A) The concentration of phosphates may not exceed 10 parts per milllion calculated as phosphate ion.

(B) The concentration of silicates may not exceed 10 parts per million calculated as silicon dioxide.

(C) Chlorine used in the system may be derived only from chlorine gas; sodium, potassium, or calcium hypochlorite; or chlorine dioxide.

(1) Chlorine may be present in process water of meat plants at concentrations up to 5 parts per million calculated as available chlorine. Under reliable controls, the chlorine level may be increased in water used on meat carcasses. Requests for such use should be directed to the Ante-mortem and Post-mortem Inspection Staff, Technical Services, FSQS, USDA, Washington, DC 20250.

(2) Chlorine may be present in process water of poultry plants at levels acceptable to plant management, recognizing the self-limiting factors of effect on product, corrosion of equipment, and acceptability by plant personnel. Plant management must notify the Inspector in Charge when the chlorine level is increased above 20 parts per million. Chlorine must be dispensed at a constant and uniform level and the method or system must be such that a controlled rate i s maintained.

40 (D) Coagulant aids may be added to the system provided that they are listed in the current "Report On Coagulant Aids For Water Treatment"^ published by EPA, and provided that their concentration of use does not exceed the maximum concentration recommended in that publication.

(E) Ion-exchange resins may be used in the treatment of process water provided that they are formulated and used in compliance with Section 173.25 of the Food Additives Regulations [Also see Section 6.4(E)].

Note: 1. Information on these references may be obtained from EPA, Office of Water and Hazardous Substances, Office of Water Supply, Washington, DC 20460.

Section 5.8 -Cooling and retort water treatment compounds

Preparations containing one or more of the substances listed below, or others subsequently appearing in the appropriate regulations, may be used in the retort water, washing spray, or cooling water for canned products. Unless a limitation is otherwise stated, the preparation should be used in the minimum amount sufficient for the purpose.

Substances Limitations

Calcium chloride Citric acid Dioctyl Sodium Sulfosuccimate Maximum of 0.05% in water Disodium-calcium ethylenediaminetetraacetate Disodium ethylenediaminetetraacetate Disodium phosphate Ethylenediaminetetraacetic acid Isopropanol Maximum of 0.002% in water Potassium pyrophosphate Propylene glycol Sodium n-alkylbenzene sulfonate Maximum of 0.05% in water (alkyl group predominantly Cj^2 ai^

41 Sodium nitrite See note below Sodium pyrophosphate Maximum of 0.05% in water Sodium tripolyphosphate Ditto Zinc oxide Maximum of 0.01% in water Zinc sulfate Ditto

Note:

The use of sodium nitrite in meat establishments is limited to 600 parts per million of the treated water. The dry nitrite must be decharacterized with 0.05 percent powdered charcoal. Bulk decharacterized sodium nitrite, when in cook room, shall be held in locked metal bin or container conspicuously labeled "Decharacterized Sodium Nitrite—to be used by authorized personnel only."

Section 5.9 - Boiler treatment compounds

(A) Preparations containing one or more of the substances listed below are permitted for the treatment of water in boilers for producing steam that may contact food products. [Also see Section 6.4 (B)]

Substances Limitations

Acrylamide-sodium acrylate resin Contains not more than 0.05% by weight of acrylamide monomer Ammonium alginate Cobalt sulfate (as catalyst) Lignosulfonic acid Monobutyl ethers of polyethylene- Minimum mol. wt. 1,500 polypropylene glycol produced by random condensation of 1:1 mixture by weight of ethylene oxide and propylene oxide with butanol Polyoxyethylene glycol Mean mol. wt. 200-9,500 Polyoxypropylene glycol Minimum mol. wt. 1,000 Potassium carbonate Potassium hydroxide Potassium tripolyphosphate Sodium acetate Sodium alginate Sodium alumínate Sodium bisulfate Sodium bisulfite See notes (1) and (2) below Sodium carbonate

42 Sodium carboxymethylcellulose Contains not less than 95 percent sodium carboxymethylcellulose on a dry weight basis, with maximum substitution of 0.9 carboxy- methyl groups per anhydro- glucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25^C.; such determinations to be made by methods pre- scribed in Food Chemicals Codex (Second Edition) mono- graph for sodium carboxymethylcellulose Sodium glucoheptonate Sodium hexametaphosphate Sodium húmate Sodium hydroxide Sodium lignosulfonate Sodium metabisulfite See notes (1) and (2) below Sodium metasilicate Sodium nitrate See Note (1) below Sodium phosphate (mono-, di-, tri) Sodium polyacrylate Sodium polymethacrylate Sodium silicate Sodium sulfate Sodium sulfite See notes (1) and (2) below Sodium tripolyphosphate Tannin (including Quebracho extract) Tetrasodium EDTA Tetrasodium pyrophosphate

Notes :

(1) To promote handling of preparations containing sodium nitrate, sodium sulfite, sodium bisulfite, and sodium metabisulfite in a manner as to prevent their use in meat products, such preparations must be adequately decharacterized. The preparation is considered to be acceptable if the nitrate, sulfite, bisulfite, or metabisulfite present is decharacterized by 33 percent of its weight of sodium hydroxide; by 50 percent of its weight of trisodium phosphate; by 100 percent of its weight of sodium carbonate; or if the preparation contains not less than 5 percent tannin, lignin, sodium lignosulfonate, or sodium húmate.

(2) Compounds containing sulfite ion may not be added to meat or other foods recognized as a source of vitamin B^. Therefore, precautions must be taken to ensure that compounds containing sulfite ion are not entrained or otherwise carried over in steam that will contact meat products.

43 (B) Preparations containing one of the substances listed below, alone or in combination with the substances listed in paragraph (A) of this section, are permitted in systems where steam is used for cooking food products, or rendering and deodorizing fats.

Substances Limitations

Cyclohexylamine Not to exceed 10 ppm in steam Diethylaminoethanol Not to exceed 15 ppm in steam Hydrazine Zero ppm in steam Morpho line Not to exceed 10 ppm in steam (Also see note below) Octadecylamine Not to exceed 3 ppm in steam Trisodium nitrilotriacetate Not to exceed 5 ppm in boiler feedwater

Note:

There is pending at this time a proposal to revoke the use of morpholine as a boiler treatment chemical. Therefore, the status of that material is subject to change depending on the final action taken by FDA.

Section 5.10 - Compounds for steam lines or primary cooling water loops

There is no specific list of substances which may be used to treat water in boilers or steam lines which produce or carry steam for purposes other than direct food contact, or water in cooling systems which indirectly cool food products or substances that may be incorporated into a food product. Examples are water or steam therefrom used in a steam jacketed kettle, or cooling water which passes through a jacketed kettle. Most substances generally used for that purpose would be acceptable. However, there are the following restrictions:

(A) Compounds containing sodium borate, sodium nitrite, sodium nitrate, or any combination thereof may be used only if they are decharacterized by the addition of a blue or green dye at 2.5 percent of the sodium borate or sodium nitrite present. If both sodium borate and sodium nitrite are present, the decharacterization must be based on the concentration of sodium nitrite. If both sodium nitrite and sodium nitrate are present, the decharacterization must be based on the concentration of sodium nitrite present including that resulting from the reduction of sodium nitrate.

(B) Compounds containing sodium sulfite, sodium bisulfite, or sodium metabisulfite may be used only if they are decharacterized by one of the methods specified in Section 5.9 (A)(1) of this publication.

44 (C) Compounds containing salts of chromic acid may not be used.

(D) There may be other compounds which would be unacceptable or restricted because of unfavorable toxicity or considerations. Each compound submitted will be evaluated on its own merit.

Section 5.11 - Poultry scald media

Preparations containing one or more of the substances listed below, or others subsequently appearing in the appropriate regulation, are permitted for the defeathering of poultry carcasses. Unless a limitation is otherwise stated, the preparation may be used at a level sufficient for the purpose provided that added substances are removed by subsequent rinsing.

Substances Limitations

DimethyIpolysiloxane Dioctyl sodium sulfosuccinate Dipotassium phosphate Ethylenediamine tetraacetic acid, sodium salts alpha-Hydro-omega-hydroxy- 0.05 percent in the poly(oxyethylene)/poly(oxy- scald water propylene)(minimum 15 moles)/ poly(oxyethylene) block copolymer, (Poloxamer) Lime (calcium hydroxide, calcium oxide) Polyoxyethylene (20) 0.017 5 percent in the sorbitan monooleate scald water Potassium bicarbonate Potassium carbonate Potassium hydroxide Propylene glycol Sodium acid phosphate Sodium acid pyrophosphate Sodium bicarbonate Sodium carbonate Sodium dodecylbenzenesulfonate Sodium 2-ethylhexylsulfate Sodium hydroxide Sodium lauryl sulfate Sodium metaphosphate Sodium phosphate (mono-, di-, tribasic) Sodium pyrophosphate Sodium sesquicarbonate Sodium sulfate Sodium tripolyphosphate Tetrasodium pyrophosphate

45 Section 5.12 - Hog scald media

Preparations containing one or more of the substances listed below, or others subsequently appearing in the appropriate regulation, are permitted for the dehairing of hog carcasses at a level sufficient for the purpose providing that they are removed by subsequent rinsing operations.

Caustic soda (sodium hydroxie) Sodium n-alkylbenzene sulfonate Dimethyl polysiloxane (alkyl group predominantly Dioctyl sodium sulfosuccinate C]^2 ^^^ ^13 ^^^ ^ot less Disodium calcium ethylene- than 95 percent CIQ to Cj^g). diaminetetraacetate Sodium lauryl sulfate Disodium ethylenediamine- Sodium metasilicate tetraacetate Ethylene diaminetetraacetic acid Sodium pyrophosphate Lime (calcium oxide, calcium hydroxide) Propylene glycol Sodium sulfate Soap (prepared by reaction of Sodium tripolyphosphate calcium, potassium, or sodium Sucrose hydroxide with rosin or fatty acids of natural fats or oils). Sodium acid pyrophosphate Trisodium phosphate Sodium carbonate Sodium dodecylbenzene sulfonate Sodium hexametaphosphate

Section 5.13 - Tripe processing compounds

Preparations containing one or more of the substances listed below, or others subsequently appearing in the appropriate regulation, are permitted for the denuding, bleaching, or neutralizing of tripe at a level sufficient for the purpose providing that they are removed by subsequent rinsing operations.

Citric acid Hydrogen peroxide Lime (calcium oxide, calcium hydroxide) Sodium carbonate Sodium gluconate Sodium hydroxide Sodium metasilicate Sodium persulfate Trisodium phosphate

46 Section 5.14 - Fruit and vegetable washing compounds

Preparations containing one or more of the substances listed below, others subsequently appearing in the appropriate regulation, or those generally recognized as safe (CFR, Title 21, Part 182) may be used to wash or to assist in the lye peeling of fruits or vegetables which will become a part of a meat or poultry product. Unless a limitation is otherwise stated, the preparation should be used in the minimum amount sufficient for the purpose. [Also see Section 6.4(C)]

Substances Limitations

A mixture of alkylene oxide adducts Not to exceed 0.2 percent in of alkyl alcohols and phosphate lye peeling solution. esters of alkylene oxide adducts of alkyl alcohols consisting of: alpha-alkyl (C]^2"'^l8)"^^^ê^"" hydroxy-poly (oxyethylene)(7.5- 8.5 moles)/poly (oxypropylene) block copolymer having an average mol. wgt. of 810; alpha- alkyl (C]L2"^l8)"^™^êa-hydroxypoly (oxyethylene)(3.3-3.7 moles) pol3niier having an average mol. wgt. of 380, and subsequently esterified with 1.25 moles phosphoric anhydride; and alpha-alkyl (C]^o"^12)"^™^ê^ hydroxypoly (oxyethylene)(11.9-12.9 moles)/poly (oxypropylene) copol3rmer, having an average mol. wgt. of 810, and subsequently esterified with 1.25 moles phosphoric anhydride. Aliphatic acid mixture consisting of Not to exceed one (1) valeriescaproic, enanthic, percent in lye peeling caprylic, and pelargonic acids solution. Polyacrylamide Not to exceed 10 ppm in wash water. Contains not more than 0.2 percent acrylamide monomer Potassium bromide Sodium hypochlorite Sodium n-alkylbenzene sulfonate Not to exceed 0.2 percent (alkyl group predominantly in wash water or lye a2 and C-j^3 and not less than peeling solution. 95 percent CIQ to C^g). Sodium dodecylbenzenesulfonate (alkyl Ditto group predominantly C-|^2 ^^^ ^^^ less than 95 percent CIQ to C]^5). Sodium 2-ethylhexyl sulfate Ditto Sodium mono-and dimethyl naphthalene Ditto sulfonates (mol. wt. 245-260).

47 Section 5.15 - Lubricants

(A) Preparations consisting of one or more of the materials listed below, others subsequently appearing in the appropriate regulation, or those generally recognized as safe (CFR, Title 21, Part 182) are permitted for use as lubricants and anti-rust agents, or as release agents on gaskets or seals of tank closures, where there is a possibility of incidental food contact. The amount used should be the minimum required to accomplish the required technical effect on the equipment so treated. [Also see Section 6.4(D)]

Substances Limitations

Acetylated monoglycerides Aluminum stéarate Aluminum stearoyl benzoyl For use as a thickening hydroxide agent in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil BHA BHT alpha-Butyl-omega-hydroxypoly Addition to food not to exceed (oxye thylene)poly(oxypropylene) 10 parts per million. Must having a minimum molecular comply with CFR, Title 21, weight of 1500. Part 178, Section 178.3570(a)(3). alpha-Butyl-omega-hydroxypoly Addition to food not to exceed (oxypropylene) having a minimum 10 parts per million. molecular weight of 1500. Castor oil Castor oil, dehydrated Castor oil, partially dehydrated Dialkyldimethylammonium aluminum For use only as a gelling silicate where the alkyl groups agent in mineral oil are derived from hydrogenated tal- lubricants at a level low fatty acids (C^^^-C^g) and not to exceed 7 per- where the aluminum silicate is cent by weight of the derived from bentonite mineral oil Dimethylpolysiloxane (viscosity greater than 300 centistokes) Fatty acids derived from animal or vegetable sources, and the hydrogenated forms of such fatty acids alpha-Hydro-omega-hydroxypoly Addition to food not to (oxye thylene)poly(oxypropylene exceed 10 parts per having a minimum molecular weight million. Must comply of 1500. with CFR, Title 21, Part 178, Section 178.3570(a)(3)

48 12-Hydroxystearic acid Isopropyl oléate For use only as an adjuvant to improve lu- bricity in mineral oil lubricants Magnesium ricinoleate For use only as an adjuvant in mineral oil lubricants at a level not to exceed 10 percent by weight of the mineral oil. Mineral oil Must comply with CFR, Title 21, Part 178, Section 178.3620 (a) or (b) Petrolatum Must comply with CFR, Title 21, Part 178 Section 178.3700 Phenyl-alpha- and/or phenyl-beta- For use only singly or naphthylamine in combination, as antioxidants in mineral oil lubricants at a level not to exceed a total of one (1) percent by weight of the mineral oil Polybutene (minimum average molecular weight 80,000) Polybutene, Hydrogenated Must comply with CFR, Title 21, Part 178 Section 178.3740(b) Polyethylene Polyisobutylene (average molecular For use only as a thick- weight 35,000-140,000) ener in mineral oil lubricants Polysorbate 60 As a thickener and sta- bilizer, at a level not to exceed 2 percent by weight of lubricants. Must comply with CFR, Title 21, Part 178, Section 178.3400 Polyurea, having a nitrogen content For use as an adjuvant 9-14 percent based on the dry in mineral oil lub- polyurea weight, produced by re- ricants at a level not acting toluene diisocyanate with to exceed 10 percent by tall oil fatty acid (C-j^g and Cj^g) weight of the mineral amine and ethylene diamine in a oil 2:2:1 molar ratio Sodium nitrite For use only as a rust preventative in mineral oil lubricants at a level not to exceed 3 percent by weight of the mineral oil

49 Sorbí tan monooleate For use as a rust preventative in mineral oil lubricants Must comply with CFR, Title 21, Part 178, Section 178.3400 Tetrafluoroethylene fluorocarbon Must comply with CFR, Title 21, polymers Part 177, Section 177.1550

(B) There is no specific list of substances which may be used as lubricants where there is no possibility of food contact. Most substances generally used for the purpose in industry would be acceptable. Substances which are categorically unacceptable for such use are listed among the substances in Part 7 of this publication. There may be other substances which are not acceptable because of unfavorable toxicology or other considerations. Therefore, each preparation will be evaluated on its own merit.

Section 5.16 - Sewer and drain treatment compounds

Preparations containing strong acids, strong alkalis, and those containing enzymes, bacteria or a combination thereof, may be used for the treatment of drains, sewers, or connecting lines in any department. Special requirements concerning bacterial/enzjnne preparations are given in Section 4.4 (A) of this publication.

Section 5.17 - Absorbant/Anti-slip compounds

Preparations consisting primarily of clays, diatomaceous earth, or other naturally occurring mineral substances appropriate for the purpose are permitted for spot application on floors to correct a hazardous condition. Their use is limited to that portion of the floor area where the condition exists and may not result in dusting, tracking, or other objectionable conditions. Such preparations may not be used as a substitute for good sanitation. They must be regularly removed during the operation as a part of the routine floor cleaning operation.

Section 5.18 - Paints or other resinous or polymeric coatings

All coatings, whether used as a primer or as a finish coat, are evaluated according to the following criteria:

(A) Coatings for use on food contact surfaces.

Coatings proposed for this use must be formulated in compliance with the appropriate food additive regulation, and must meet applicable extraction requirements, if they are specified by FDA. Specific references are given in Section 6.4 (F) of these guidelines.

50 (B) Coatings for use on incidental food contact surfaces.

Coatings proposed for use on structural surfaces or other incidental food contact surfaces such as parts of machinery or equipment where meat or poultry would not be in repeated or continuous contact need not be formulated in strict compliance with FDA regulations. However, they may not contain heavy metals or other toxic substances. Substances which are categorically unacceptable for such use are listed among the substances in Part 7 of this publication. The following exceptions to categorical unacceptability have been established:

(1) Pigments Chromic oxide (Cr203) may be used as a pigment in primers or finish coats because it is water insoluble.

(2) Lead driers Lead driers may be used at concentrations up to 0.5 percent calculated as elemental lead based upon the weight of the dry film.

(3) Antimicrobial agents The antimicrobial agents listed below may be added to protect the coating. If the purpose of the antimicrobial agent is just to prevent microbial growth in the paint before application or on the paint film after application and no antimicrobial claims other than these are made on the container label, the paint does not require registration with the U.S. Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act.

Barium metaborate (Busan 11~M1) o-Benzyl-p-chlorophenol (Santophen-1) l-(3-Chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride (Dowicil 100) Copper-8-qui noli noleate (Cunilate) 2,4-Dichloro-6-(o-chloroaniline)~s-triazine (Nuozene) Pentachlorophenol (Dowicide 7) Pentachlorophenol, sodium salt (Dowicide G) o~Phenylphenol, sodium salt (Dowicide A) Tetrachloroisophthalonitrile (Nopcocide N-96) 2,3,5,6--Tetrachloro-4-(methylsulfonyl)-pyridine (Dowicil S-13) Tetrachlorophenol (Dowicide 6) N-Tr i chlor ome thy Ime reap to-4-cyclohexane-l ,2'-dicarboximide (Vancide #89) N-(Trichloromethylthio)-phthalamide (Fungitrol II, Ortho phalten)

Section 5.19 - Solvents

Preparations consisting of hydrocarbon, chlorinated hydrocarbon, or other water immiscible solvents and other appropriate adjuvants are permitted for the removal of grease, oil, wax, resinous materials, or other substances not readily removable using acidic or alkaline cleaning agents. Their use is limited to non-processing areas where there is no possibility of solvent vapors entering a processing area. Food processing equipment or utensils treated with such preparations must be washed and thoroughly rinsed with potable water before being returned to a processing area.

51 Part 6.—Compounds Restricted by Specific Federal Regulations

Section 6.1 - USDA regulations

Compounds used in association with hog scalding, tripe processing, or in the treatment of water used in cooking or cooling filled cans must be formulated in compliance with CFR. Title 9, Part 318, Section 318.7 or Part 381, Section 381.147. Section 318.1 and Section 381.145 also require that labels for such compounds identify the chemicals present. For those chemicals having a re- striction as to the maximum amount permitted, the percentage present must also be shown. Specific lists of acceptable ingredients are given in Part 5 of these guidelines. Requests to use ingredients not presently covered under Section 318.7 or Section 381.147 shall be submitted as follows:

(A) Submit the petition and any subsequent correspondence to:

Chief Product Safety Branch Food Ingredient Assessment Division, Science Food Safety and Quality Service U.S. Department of Agriculture Washington, DC 20250

(B) Include the following information:

(1) Name and mailing address of the petitioner.

(2) The chemical name or composition of the substances and their physical and chemical properties.

(3) The proposed use of the substances including proposed concentration of use; and directions, recommendations and/or suggestions for use.

(4) A statement of the intended physical or technical effect of the substances including data to substantiate the claimed effect. If such data are not currently available, arrangements can be made for a supervised practical test of the substances in a federally inspected plant provided all other information submitted indicates that the substances will be safe and effective as proposed for use.

(5) A description of a practical method for determining residual amounts of the substances in meat or poultry food products if available.

(6) Reference to applicable sections if the substance is regulated under other applicable Federal regulations.

(7) Data demonstrating that the substances are safe as proposed for use. The data must be derived from applicable animal or other biological test methods and must include a complete description of the method used and the results obtained. Copies of previously

52 performed test methods and results may be submitted to be reviewed for applicability. However, before new tests are performed, a protocol should be submitted for USDA review to see that the proposed tests will produce applicable and valid data. If you have questions on the development or presentation of applicable data, contact the office in paragraph (A) of this section and an opportunity will be provided for you to discuss the questions with a USDA toxicologist.

Section 6.2 - Environmental Protection Agency regulations

Compounds classified as economic poisons (pesticides, algaecides, fungicides, germicides, sanitizers, etc.) must comply with (CFR, Title 162, Parts 162-164) regulations under the Federal Insecticide, Fungicide, and Rodenticide Act. These regulations require that such compounds must bear a label showing an ingredient statement, directions, and precautions for use. They must be appropriately registered with the Registration Division, Office of Pesticide Programs, EPA and the label must include the registration number. Lists of ingredients acceptable for such use are given in Part 5 of these guidelines.

Section 6.3 - Concurrent registration with EPA and authorization with USDA

The registration of a preparation with EPA and the authorization of the same preparation with USDA may be pursued concurrently. In order to do so, submit the appropriate USDA application form as described in Section 4.1 of these guidelines. On the application form indicate that concurrent registration with EPA and authorization with USDA is being pursued. A copy of the proposed label which is being submitted to EPA must accompany the application. Labeling claims for use(s) in federally inspected meat and poultry processing establishments must have the acceptance of USDA before the label can be accepted by EPA.

(A) If there are no specific claims for use(s) in federally inspected meat and poultry processing plants, the registration process can proceed according to EPA's established procedures. When registration with EPA is accomplished, send USDA a copy of the acceptance letter and a copy of the registered label. Upon receipt of that information, USDA will complete their evaluation of the product.

(B) In the event the labeling makes specific claims for use(s) in federally inspected meat and poultry processing plants, the EPA Product Manager (PM) will contact USDA to confirm that the registrant has also filed the appropriate application with USDA relative to the use of their product in federally inspected meat and poultry processing establishments.

(1) If the affected registrant has not filed the apropriate USDA applications, the PM will immediately notify the registrant of the necessity to contact USDA before their product (i.e. use patterns for federally inspected meat and poultry processing establishments) can be considered for registration.

(2) If the affected registrant has filed the appropriate application with USDA, the PM will hold the registration application in abeyance, pending receipt of notification from USDA indicating their acceptance or denial for use of the product in federally inspected meat and poultry processing establishments .

53 (a) If the preparation is acceptable to USDA and there are no other problems in registering the product, the PM will send the registrant a letter of acceptance and a copy of the acceptable labeling. The PM will also provide USDA with a copy of the EPA acceptance letter and labeling. Upon receipt of that information, USDA will complete their evaluation of the product.

(b) If the preparation is unacceptable to USDA, the PM will inform the registrant that the claims for use(s) in federally inspected meat and poultry processing establishments is not acceptable according to the evaluation conducted by USDA, and the registration of this product can continue only if these claims are deleted from the labeling. USDA will inform the affected registrant as to the specific reasons the preparation is unacceptable.

Section 6.4 - Food and Drug Administration regulations

(A) Sanitizing solutions proposed for use on food contact surfaces without a potable water rinse must be formulated in compliance with CFR, Title 21, Part 178, Section 178.1010. That section also requires that such solutions bear labeling meeting the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act. The list of solutions acceptable for such use is given in Sec- tion 5.4 (A)(3) of these guidelines.

(B) Boiler water treatment compounds, where the steam produced may contact food products, must be formulated in compliance with CFR, Title 21, Part 173, Section 173.310. That section also requires that the label for the preparation include the common or chemical name of each ingredient and directions for use adequate to insure compliance with the law. The list of ingredients acceptable for such use is given in Section 5.9 of these guidelines.

(C) Chemicals for washing or lye peeling fruits or vegetables must be formulated in compliance with CFR, Title 21, Part 173, Section 173.315. That section also requires that the label for the preparation include a statement of ingredients and directions for use adequate to insure compliance with the law. The list of ingredients acceptable for such use is given in Section 5.14 of these guidelines.

(D) Lubricants for use where there is the possibility of incidental food contact must be formulated in compliance with CFR, Title 21, Part 178, Section 178.3570. The list of ingredients acceptable for such use is given in Section 5.15 of these guidelines.

(E) Ion-exchange resins for the treatment of potable water must be formulated in compliance with CFR, Title 21, Part 173, Section 173.25. That section also requires that such resins be accompanied by label or labeling including directions for use consistent with the intended functional purpose of the resin. [See Section 5.7 (E)]

(F) Coatings for application to food contact surfaces must be formulated in compliance with CFR, Title 21, Parts 175 and 177. The specific section(s) applicable depend(s) on the basic resin or resins in the coating and the additives used. (See Section 5.18)

54 Part 7.—Compounds Not Permitted as Ingredients

Section ?•! - Hazardous substances

Preparations containing antimony, arsenic, cadmium, lead, mercury, selenium, or other materials such as carcinogens, mutagens, and teratogens classified as hazardous substances may not be used for any purpose anywhere within a plant. Specific exceptions, such as the use of lead in solders or other alloys used in the fabrication and/or maintenance of plant facilities and/or equipment, may be granted by USDA if data are presented which demonstrate that the addition of the substance does not significantly change the toxicity of the formulated compound.

Section 7.2 - Potentially harmful compounds

Certain potentially harmful compounds, like chromic acid, hydrofluoric acid, hydrofluosilicic acid, oxalic acid, or the salts of those acids, are not generally permitted for use within a federally inspected plant. Specific exceptions may be granted by USDA if a need can be demonstrated and the use can be controlled so that there is no human hazard and no opportunity for food products to become contaminated.

Section 7.3 - Odorous compounds

(A) Preparations containing heavy perfumes, isomers of dichlorobenzene, pine oil, etc., are not permitted in areas where edible products are handled.

(B) Employee hand care preparations which leave a residual fragrance on the hands after rinsing are not permitted for use in food processing or slaughtering areas or for use by employees who handle food products.

55 TÛr U& GOVERNMENT PRINTING OFFICE : 1979 O—280-916 (345)