Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations 26785 such suspension, revocation, sugar, dragees for cooking and baking, 13. Section 2011.206 is amended by modification or addition of further fondant (a creamy blend of sugar and revising paragraph (c) to read as follows: limitations will not have the effect of glucose), ti light sugar (99.2% sugar modifying the allocation of sugar made with the residual comprised of the § 2011.206 Suspension or revocation of individual certificates. pursuant to the provisions of artificial sweeteners aspartame and subdivision (b) of additional U.S. Note acesulfame K), caster sugar, golden * * * * * 5. syrup, ferdiana granella grossa, golden (c) The determination of the granulated sugar, muscovado, molasses Certifying Authority under paragraph (a) * * * * * that the importer has failed to comply sugar, sugar decorations, sugar cubes, 9. Section 2011.201 is revised to read with the requirements of this subpart and other sugars, as determined by the as follows: may be appealed to the Director, Import United States Trade Representative, that Policy and Trade Analysis Division, § 2011.201 General. would be considered specialty sugar Foreign Agricultural Service (FAS), U.S. This subpart sets forth the terms and products within the normal commerce Department of Agriculture, Washington, conditions under which certificates will of the United States, all of which in D.C. 20250, within 30 days from the be issued to U.S. importers for addition: date of suspension or revocation. The importing specialty sugars from (1) are sugars, syrups, or molasses request for reconsideration shall be specialty sugar source countries. described in subheading 1701.11.10, presented in writing and shall Specialty sugars imported from 1701.12.10, 1701.91.10, 1701.99.10, specifically state the reason or reasons specialty sugar source countries may not 1702.90.10, or 2106.90.44 of the why such determination should not be entered unless accompanied by a Harmonized Tariff Schedule of the stand. The Director shall provide such specialty sugar certificate. This subpart United States, person with an opportunity for an applies only to the ability to enter (2) are the product of a specialty sugar informal hearing on such matter. A specialty sugar at the in-quota tariff source country, and further appeal may be made to the rates of the quota (subheadings * * * * * Administrator, FAS, U.S. Department of 1701.11.10, 1701.12.10, 1701.91.10, (j) ‘‘Specialty sugar source country’’ Agriculture, Washington, D.C. 20250, 1701.99.10, 1702.90.10, and 2106.90.44 means any country or area to which the within five working days of receipt of of the HTS). Nothing in this subpart United States Trade Representative has the notification of the Director’s shall affect the ability to enter articles at allocated an amount of the quantity decision. The Certifying Authority may the over-quota tariff rate (subheadings reserved for the importation of specialty take action under paragraph (b) during 1701.11.50, 1701.12.50, 1701.91.30, sugars under additional U.S. Note 5 to the pendency of any appeal. 1701.99.50, 1702.90.20, 2106.90.46). chapter 17 of the Harmonized Tariff 14. Section 2011.207(a) is revised to 10. Section 2011.202 is amended by Schedule of the United States. read as follows: removing paragraph (g), redesignating 11. Section 2011.203 is amended by paragraphs (h) through (j) as paragraphs § 2011.207 Suspension of the certificate revising paragraphs (a) and (c) to read as system. (g) through (i), respectively, revising follows: paragraphs (b), (c), (f), (g), and (i), as (a) Suspension. The U.S. Trade redesignated, and adding a new § 2011.203 Issuance of specialty sugar Representative may suspend the paragraph (j) as follows: certificates. provisions of this subpart whenever he (a) Specialty sugars imported into the or she determines that the quota is no § 2011.202 Definitions. United States from specialty sugar longer in force or that this subpart is no * * * * * source countries may be entered only if longer necessary to implement the (b) ‘‘Certificate’’ means a specialty such specialty sugars are accompanied quota. Notice of such suspension and sugar certificate issued by the Certifying by a certificate issued by the Certifying the effective date thereof shall be Authority permitting the entry of Authority. published in the Federal Register. specialty sugar. * * * * * * * * * * (c) ‘‘Certifying Authority’’ means the 15. Subpart B of part 2011 is amended (c) Subject to quota availability, an Team Leader, Import Quota Programs, by adding § 2011.208 to read as follows: unlimited number of complying Foreign Agricultural Service, U.S. shipments may enter under a given Department of Agriculture, or his or her § 2011.208 Paperwork Reduction Act certificate and a given certificate may assigned number. designee. cover more than one type of specialty The Office of Management and Budget * * * * * sugar. Issuance of a certificate does not (OMB) has approved the information (f) ‘‘Person’’ means any individual, guarantee the entry of any specific collection requirements contained in the partnership, corporation, association, shipment of specialty sugar, but only regulations in this subpart in estate, trust, or other legal entity, and, permits entry of such sugar if the accordance with 44 U.S.C. Chapter 25 wherever applicable, any unit, amount allocated to the specialty sugar and OMB control number 0551–0014 instrumentality, or agency, of a source country is not already filled. has been assigned with corresponding government, domestic or foreign. 12. Section 2011.204 is revised to read clearance effective through April 30, (g) ‘‘Quota’’ means the tariff-rate quota as follows: 1997. on imports of sugar provided in additional U.S. Note 5 to chapter 17 of § 2011.204 Entry of specialty sugars. Subpart CÐ[Removed] the Harmonized Tariff Schedule of the An importer or the importer’s agent 16. Subpart C of part 2011 is removed. United States. must present a certificate to the * * * * * appropriate customs official at the date Signed at Washington, D.C. on May 15, (i) ‘‘Specialty sugar’’ means brown of entry of specialty sugars. Entry of 1996. slab sugar (also known as slab sugar specialty sugars shall be allowed only in Charlene Barshefsky candy), pearl sugar (also known as perl conformity with the description of Acting United States Trade Representative sugar, perle sugar, and nibs sugar), sugars and other conditions, if any, [FR Doc. 96–12807 Filed 5–28–96; 8:45 am] vanilla sugar, rock candy, demerara stated in the certificate. BILLING CODE 3190±01±M 26786 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations

DEPARTMENT OF HEALTH AND wine, dealcoholized wine, and low (ppm) in sports drinks and fruit or juice HUMAN SERVICES alcohol wine (53 FR 41325, October 21, sparklers are consistent with these 1988; and 58 FR 6088, January 26, 1993) findings. Specifically, data from a study Food and Drug Administration and in ready-to-drink tea beverages (59 of sparkling juice drink formulated with FR 5317, February 4, 1994) (hereinafter 250 ppm DMDC showed no detectable 21 CFR Part 172 referred to as the October 1988 final amount of the additive (limit of [Docket No. 94F±0189] rule, the January 1993 final rule, and the detection (LOD) = 40 parts per billion February 1994 final rule, respectively). (ppb)) after 4 hours (Ref. 1). A study of Food Additives Permitted for Direct As discussed below, FDA has water with 250 ppm DMDC added Addition to Food for Human evaluated data in the petition and other yielded the same result (Ref. 1). Based Consumption; Dimethyl Dicarbonate relevant material and concludes that on these data and data incorporated DMDC is efficacious in preventing the from the petition that resulted in the AGENCY: Food and Drug Administration, growth of yeasts and molds in sports October 1988 final rule (FAP 2A3636), HHS. drinks and fruit or juice sparklers and the agency concludes that there will be ACTION: Final rule. that the proposed use of DMDC is safe. virtually no consumer exposure to II. Determination of Safety DMDC, per se, from the use of the SUMMARY: The Food and Drug additive in sports drinks and fruit or Administration (FDA) is amending the Under the so-called ‘‘general safety juice sparklers. Therefore, FDA food additive regulations to provide for clause’’ in section 409(c)(3)(A) of the concludes that DMDC itself presents no the safe use of dimethyl dicarbonate Federal Food, Drug, and Cosmetic Act hazard to the consumer. (DMDC) as a yeast inhibitor in sports (the act) (21 U.S.C. 348(c)(3)(A)), a food drinks and fruit or juice sparklers. This additive cannot be approved for a IV. Safety of Substances That May be action is in response to a petition filed particular use unless a fair evaluation of Present in Sports Drinks and Fruit or by Miles, Inc. (now Bayer Corp.). the data available to FDA establishes Juice Sparklers Due to the Use of the Additive DATES: Effective May 29, 1996; written that the additive is safe for that use. objections and requests for a hearing by FDA’s food additive regulations (21 CFR DMDC is unstable in aqueous solution June 28, 1996. 170.3(i)) define safe as ‘‘a reasonable and breaks down almost immediately ADDRESSES: Written objections may be certainty in the minds of competent after addition to beverages. In aqueous sent to the Dockets Management Branch scientists that the substance is not liquids, the principal breakdown (HFA–305), Food and Drug harmful under the intended conditions products are methanol and carbon Administration, 12420 Parklawn Dr., of use.’’ dioxide. Dimethyl carbonate (DMC) may rm. 1–23, Rockville, MD 20857. The food additive anticancer or be present as an impurity in DMDC. Delaney clause in section 409(c)(3)(A) of Section 172.133 sets a specification of FOR FURTHER INFORMATION CONTACT: the act (21 U.S.C. 348(c)(3)(A)) further 0.2 percent DMC in DMDC. DMDC also Martha D. Peiperl, Center for Food provides that no food additive shall be may react with traces of ammonium Safety and Applied Nutrition (HFS– deemed to be safe if it is found to induce ions in beverages to produce methyl 217), Food and Drug Administration, cancer when ingested by man or animal. carbamate (MC), a known carcinogen. 200 C St. SW., Washington, DC 20204, Importantly, however, the Delaney In previous evaluations of DMDC, the 202–418–3077. clause applies to the additive itself and agency, in accordance with § 171.1 (21 SUPPLEMENTARY INFORMATION: not to the impurities in the additive. CFR 171.1), reviewed the safety not only I. Background That is, where an additive itself has not of DMDC but also of its decomposition been shown to cause cancer, but products in aqueous beverages. The In a notice published in the Federal contains a carcinogenic impurity, the results of the agency’s analysis of the Register of June 28, 1994 (59 FR 33299), additive is properly evaluated under the additive’s use in wine and wine FDA announced that a food additive general safety clause using risk substitutes were discussed extensively petition (FAP 4A4420) had been filed by assessment procedures to determine in the October 1988 and January 1993 Miles, Inc., Mobay Rd., Pittsburgh, PA whether there is a reasonable certainty final rules, and its use in ready-to-drink 15205–9741 (now Bayer Corp., 100 that no harm will result from the tea beverages was discussed in the Bayer Rd., Pittsburgh, PA 15205–9741), proposed use of the additive, Scott v. February 1994 final rule. The agency proposing that the food additive FDA, 728 F.2d 322 (6th Cir. 1984). applied the same type of analysis as in regulations in § 172.133 Dimethyl past reviews to its review of the dicarbonate (21 CFR 172.133) be III. Safety of DMDC in Sports Drinks petitioned use of DMDC. Aspects of the amended to provide for the safe use of and Fruit or Juice Sparklers safety evaluation that were not DMDC as a yeast inhibitor in sports DMDC is currently permitted as a previously addressed in final rules for drinks and fruit or juice sparklers. The yeast inhibitor in wine and wine other uses of DMDC are discussed petition defines sports drinks as substitutes (dealcoholized wine and below. carbonated or noncarbonated, nonjuice- low-alcohol wine) and in ready-to-drink containing (less than or equal to 1 tea beverages under § 172.133. In the A. Methanol percent juice), flavored or unflavored October 1988, January 1993, and As stated in previous final rules on beverages containing added electrolytes February 1994 final rules, the agency DMDC, the tolerable (safe) level of (5–20 milliequivalents (meq)/liter concluded that, because DMDC exposure to methanol is 7.1 to 8.4 sodium ion (Na+) and 3–7 meq/liter decomposes almost immediately after milligrams per kilogram body weight potassium ion (K+)). Fruit or juice addition to aqueous beverages, there per day (mg/kg body weight/day), or sparklers are defined as carbonated, will be virtually no exposure to the approximately 426 to 504 mg/person/ dilute beverages containing juice, fruit additive from the consumption of the day for a 60 kg adult. FDA estimates that flavor, or both, with juice content not to above-listed beverages. the cumulative methanol exposure for a exceed 50 percent. Data submitted in the petition to consumer at the 90th percentile from its DMDC is currently approved in support the proposed use of the additive presence naturally in untreated fruit § 172.133 for use as a yeast inhibitor in at levels up to 250 parts per million juice and wine and from all uses of Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations 26787

DMDC, including its currently regulated available for inspection at the Center for waiver of the right to a hearing on that uses and the proposed use in sports Food Safety and Applied Nutrition by objection. Each numbered objection for drinks and fruit or juice sparklers, is 59 appointment with the information which a hearing is requested shall mg/person/day (Ref. 2). This estimate is contact person listed above. As include a detailed description and based on a maximum level of methanol provided in § 171.1(h), the agency will analysis of the specific factual that can be derived from DMDC of 48.7 delete from the documents any information intended to be presented in ppm methanol per 100 ppm DMDC materials that are not available for support of the objection in the event used. This level is less than one-seventh public disclosure before making the that a hearing is held. Failure to include of the tolerable safe level. The agency, documents available for inspection. such a description and analysis for any therefore, concludes that there is an VI. Environmental Impact particular objection shall constitute a adequate margin of safety between total waiver of the right to a hearing on the methanol consumption from all sources, The agency has carefully considered objection. Three copies of all documents including the petitioned use of DMDC, the potential environmental effects of shall be submitted and shall be and the amount of methanol that can be this action. FDA has concluded that the identified with the docket number safely ingested. action will not have a significant impact found in brackets in the heading of this on the human environment, and that an B. Methyl Carbamate document. Any objections received in environmental impact statement is not response to the regulation may be seen The reaction of ammonium ions in required. The agency’s finding of no in the Dockets Management Branch beverages with DMDC produces MC, a significant impact and the evidence between 9 a.m. and 4 p.m., Monday known carcinogen. The petitioner supporting that finding, contained in an through Friday. provided data showing that MC was environmental assessment, may be seen detected at a level of 3.7 ppb in a fruit in the Dockets Management Branch VIII. References sparkler formulated with 250 ppm (address above) between 9 a.m. and 4 The following references have been DMDC. MC was not detected in DMDC- p.m., Monday through Friday. placed on display in the Dockets The agency received one comment on treated sports drinks, using an analytical Management Branch (address above) the environmental assessment in method with an LOD of 0.5 ppb. Using and may be seen by interested persons response to the filing notice published the residual level of 3.7 ppb and the between 9 a.m. and 4 p.m., Monday in the Federal Register of June 28, 1994 LOD of 0.5 ppb for MC in fruit sparklers through Friday. and sports drinks, respectively, the (59 FR 33299). The comment states that 1. Memorandum from the Chemistry agency estimates the exposure to MC for approval of the subject additive could Review Branch to the Direct Additives all ages from the petitioned use of have two environmental benefits due to Branch, ‘‘FAP 4A4420–Dimethyl Dicarbonate DMDC to be 1.5 microgram/person/day switching from hot-fill bottling of sports as a Yeast Inhibitor in Sports Drinks and in at the 90th percentile (Ref. 1). Using drinks and sparklers to cold-fill. The Fruit or Juice Sparkling Beverages,’’ dated established procedures for quantitative comment claims that this switch could July 8, 1994. risk assessment, the agency estimates greatly reduce water usage in the 2. Memorandum from the Chemistry that the 90th percentile upper-bound bottling process and could reduce Review Branch to the Direct Additives Branch, ‘‘FAP 4A4420–DMDC as a Yeast lifetime risk from potential exposure to cooling water flow into municipal wastewater treatment plants. However, Inhibitor in Sports Drinks and Sparkling MC from the petitioned use of DMDC is Fruit or Juice Beverages. Background 1.5 x 10-8, or less than 1 in 67 million, the comment did not provide Methanol Exposure,’’ dated May 8, 1996. and the 90th percentile upper-bound quantitative data on the magnitude of 3. Memorandum from the Direct Additives lifetime risk from exposure to MC from the claimed environmental benefits of Branch to the Quantitative Risk Assessment all approved and petitioned uses of the approval of this petition. FDA has Committee, ‘‘Estimation of the Upper-Bound DMDC is 1.8 x 10-8, or less than 1 in 56 concluded that the comment does not Lifetime Risk from Methyl Carbamate (MC) million (Refs. 1 and 3). affect the agency’s determination that Formed by the Reaction of Ammonium Ions Therefore, the agency concludes that the approval of this petition will have with Dimethyl Dicarbonate (DMDC) During there is a reasonable certainty of no no significant impact on the the Use of DMDC as Requested in FAP 4A4420 (Miles Inc.),’’ dated May 23, 1995. harm from the exposure to MC that may environment. This comment can be seen result from the use of up to 250 ppm of at the Dockets Management Branch, List of Subjects in 21 CFR Part 172 along with the petitioner’s DMDC in sports drinks and fruit or juice Food additives, Reporting and sparklers. environmental assessment and the agency’s finding of no significant recordkeeping requirements. V. Conclusion on Safety impact. Therefore, under the Federal Food, FDA has evaluated all of the data in Drug, and Cosmetic Act and under VII. Objections the petition pertaining to the use of authority delegated to the Commissioner DMDC in sports drinks and fruit or juice Any person who will be adversely of Food and Drugs, 21 CFR part 172 is sparklers, as well as other data in its affected by this regulation may at any amended as follows: files, and concludes that the additive is time on or before June 28, 1996, file PART 172ÐFOOD ADDITIVES safe for its proposed use. with the Dockets Management Branch To ensure the safe use of the additive (address above) written objections PERMITTED FOR DIRECT ADDITION in sports drinks and fruit or juice thereto. Each objection shall be TO FOOD FOR HUMAN sparklers, FDA, under 21 U.S.C. separately numbered, and each CONSUMPTION 348(c)(1)(A), finds that it is necessary to numbered objection shall specify with require directions on the food additive particularity the provisions of the 1. The authority citation for 21 CFR label limiting the level of use of the regulation to which objection is made part 172 continues to read as follows: additive in these beverages to 250 ppm. and the grounds for the objection. Each Authority: Secs. 201, 401, 402, 409, 701, In accordance with § 171.1(h), the numbered objection on which a hearing 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 379e). petition and the documents that FDA is requested shall specifically so state. considered and relied upon in reaching Failure to request a hearing for any 2. Section 172.133 is amended by its decision to approve the petition are particular objection shall constitute a adding new paragraphs (b)(3) and (b)(4) 26788 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Rules and Regulations and by revising paragraph (c)(2) to read DATES: These regulations are effective Explanation of Provisions and as follows: May 29, 1996. Revisions For dates of applicability of these A. Principal Changes § 172.133 Dimethyl dicarbonate. regulations, see § 301.6109–1(h). * * * * * FOR FURTHER INFORMATION CONTACT: Lilo Section 6109 of the Code generally (b) * * * A. Hester, (202) 874–1490 (not a toll-free provides that, when required by (3) Inhibitor of yeast in carbonated or number). regulations, a person must furnish a noncarbonated, nonjuice-containing taxpayer identifying number (TIN) for SUPPLEMENTARY INFORMATION: (less than or equal to 1 percent juice), securing proper identification of that flavored or unflavored beverages Paperwork Reduction Act person on any return, statement, or other document made under the Code. containing added electrolytes (5–20 The collection of information milliequivalents (meq)/liter sodium ion The notice of proposed rulemaking contained in these final regulations has contains two principal changes to the (Na+) and 3–7 meq/liter potassium ion been reviewed and approved by the (K+)). The additive may be added to the existing regulations. The first change is Office of Management and Budget in the introduction of a new IRS-issued beverage in an amount not to exceed accordance with the Paperwork 250 ppm. TIN, called an IRS individual taxpayer Reduction Act (44 U.S.C. 3507) under identification number (ITIN), for use by (4) Inhibitor of yeast in carbonated, control number 1545–1461. dilute beverages containing juice, fruit alien individuals, whether resident or An agency may not conduct or nonresident, who currently do not have, flavor, or both, with juice content not to sponsor, and a person is not required to exceed 50 percent. The additive may be and are not eligible to obtain, social respond to, a collection of information security numbers. The Social Security added to the beverage in an amount not unless the collection of information to exceed 250 ppm. Administration generally limits its displays a valid control number. assignment of social security numbers to (c) * * * The estimated annual burden for the (2) Directions to provide that not more individuals who are U.S. citizens and collection of information contained in than 200 ppm of dimethyl dicarbonate alien individuals legally admitted to the § 301.6109–1(d) is reflected in the will be added to the wine, United States for permanent residence burden of Form W–7. dealcoholized wine, or low alcohol or under other immigration categories Comments concerning the accuracy of wine and not more than 250 ppm of which authorize U.S. employment. this burden estimate and suggestions for dimethyl dicarbonate will be added to Therefore, this change is designed to reducing this burden should be sent to the ready-to-drink tea or to the help taxpayers (who need a TIN but the Internal Revenue Service, Attn: IRS beverages described in parts (b)(3) and cannot qualify for a social security Reports Clearance Officer, PC:FP, (b)(4) of this section. number) maintain compliance with TIN Washington, DC 20224, and to the requirements under the Code and Dated: May 17, 1996. Office of Management and Budget, Attn: regulations. William K. Hubbard, Desk Officer for the Department of the The second change is to modify the Associate Commissioner for Policy Treasury, Office of Information and existing rule set forth in § 301.6109–1(g) Coordination. Regulatory Affairs, Washington, DC that currently excludes from the general [FR Doc. 96–13303 Filed 5–28–96; 8:45 am] 20503. requirement of providing a TIN, foreign BILLING CODE 4160±01±F Books or records relating to this persons that do not have either (1) collection of information must be income effectively connected with the retained as long as their contents may conduct of a U.S. trade or business or DEPARTMENT OF THE TREASURY become material in the administration (2) a U.S. office or place of business or of any internal revenue law. Generally, a U.S. fiscal or paying agent. Under Internal Revenue Service tax returns and tax return information these regulations, the exclusion is are confidential, as required by 26 modified to require that any foreign 26 CFR Parts 301 and 602 U.S.C. 6103. person who makes a return of tax (i.e., [TD 8671] Background income, gift, and estate tax returns, amended returns, or refund claims, but RIN 1545±AS83 On June 8, 1995, the IRS published in excluding information returns) furnish the Federal Register (60 FR 30211) the Taxpayer Identifying Numbers (TINs) its TIN on that return. This change is withdrawal of the notice of proposed intended to address the IRS’ and AGENCY: Internal Revenue Service (IRS), rulemaking published in the Federal Treasury’s concern that, without TINs, Treasury. Register on September 27, 1990 at 55 FR taxpayers cannot be identified ACTION: Final regulations. 39427, a notice of proposed rulemaking, efficiently and tax returns cannot be and a notice of public hearing relating processed effectively. SUMMARY: This document contains final to taxpayer identifying numbers as regulations relating to requirements for contained in the Income Tax B. Comments furnishing a taxpayer identifying Regulations (26 CFR part 301) under Regarding the assignment of ITINs number on returns, statements, or other section 6109 of the Internal Revenue under § 301.6109–1(d)(3)(iii) of the documents. These regulations set forth Code (Code). proposed regulations, commentators procedures for requesting a taxpayer Written comments responding to the suggested that the IRS develop a process identifying number for certain alien notice of proposed rulemaking were whereby either (1) the Social Security individuals for whom a social security received, and a public hearing was held Administration (SSA) issues the ITIN number is not available. These numbers on September 28, 1995. After when the individual is not eligible for are called ‘‘IRS individual taxpayer consideration of all the comments, the a social security number, or (2) the identification numbers.’’ These proposed regulations under 6109 of the Immigration and Naturalization Service regulations also require foreign persons Code are adopted as revised by this (INS) (within the Department of Justice) to furnish a taxpayer identifying number Treasury decision. The comments and and the U.S. consulate offices (within on their tax returns. revisions are discussed below. the Department of State) issue the ITIN