Environmental Impact Considerations, Food Additives, and Generally Recognized as Safe Substances:

Federal Register Volume 76, Number 186 (Monday, September 26, 2011)

Rules and Regulations

Pages 59247-59250

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-24455

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Parts 25, 173, 175, 177, 178, 182, and 184

Docket No. FDA-2011-N-0011

Environmental Impact Considerations, Food Additives, and

Generally Recognized As Safe Substances; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

SUMMARY: The Food and Drug Administration (FDA) is amending certain regulations regarding environmental impact considerations, food additives, and generally recognized as safe (GRAS) substances to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

DATES: This rule is effective October 3, 2011.

FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1256.

SUPPLEMENTARY INFORMATION: FDA is amending certain regulations in parts 25, 173, 175, 177, 178, 182, and 184 (21 CFR parts 25, 173, 175, 177, 178, 182, and 184). Minor errors were inadvertently published in the

CFR affecting certain regulations regarding environmental impact considerations (part 25), food additives (parts 173, 175, 177, and 178), and GRAS substances (parts 182 and 184). This action makes the needed corrections.

The final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork

Reduction Act of 1995 is not required.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). These amendments are merely correcting nonsubstantive errors. FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. The changes addressed in this document are as follows: 1. The Agency is correcting typographical errors. Two chemical names are corrected: Polytetrafluoroethylene in Sec. 175.105 and dialkyl (C8-C18) dimethylammonium chloride in

Sec. 177.2600. Two chemical formulas are corrected: N,N-B-is(2- hydroxyethyl) alkylamine, where the alkyl groups (C14-

C18) are derived from tallow in Sec. 178.3130, and

MnCl2in Sec. 184.1446. 2. The Agency is also correcting five Chemical Abstract Service registry numbers (CAS Reg. Nos.) that are incorrectly listed: 123-93-5 in Sec. 173.375, 1302-78-9 in Sec. 184.1155, 7758-99-8 in Sec. 184.1261, 10024-66-5 in Sec. 184.1449, and 10025-69-1 in Sec. 184.1845. 3. The Agency is updating citations. The two citations in 21 CFR 182.99 are updated to 40 CFR 180.910 and 40 CFR 180.920 due to a recent

U.S. Environmental Protection Agency regulation. A citation in Sec. 25.32 is updated. Section 25.32(p) refers to a petition pertaining to the label declaration of ingredients as described in Sec. 101.103 (21

CFR 101.103). However, FDA revoked Sec. 101.103 on June 3, 1996 (61 FR 27771 at 27779) because it duplicated the procedures in 21 CFR 10.30 for citizen petitions. 4. The Agency is amending tables in Sec. Sec. 175.300 and 177.1210. 5. Finally, the Agency is updating Sec. 184.1165. Under Sec. 184.1165(a), both n-butane and iso-butane are described as odorless.

However, the Food Chemicals Codex, 7th Edition (2010) \1\ does not use the word ``odorless'' to describe the gases. Therefore, the Agency is amending its description by removing the word ``odorless.''

\1\ Food Chemicals Codex, 7th Edition, pp. 115 and 529,

Rockville, MD: United States Pharmacopeial Convention, 2010.

List of Subjects 21 CFR Part 25

Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements. 21 CFR Part 173

Food additives. 21 CFR Part 175

Adhesives, Food additives, Food packaging.

Page 59248

21 CFR Part 177

Food additives, Food packaging. 21 CFR Part 178

Food additives, Food packaging. 21 CFR Part 182

Food ingredients, Food packaging, Spices and flavorings. 21 CFR Part 184

Food additives.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 25, 173, 175, 177, 178, 182, and 184 are amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS 0 1. The authority citation for 21 CFR part 25 continues to read as follows:

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980

Comp., p. 356-360. 0 2. Section 25.32 is amended by revising paragraph (p) to read as follows:

Sec. 25.32 Foods, food additives, and color additives.

* * * * *

(p) Issuance, amendment, or revocation of a regulation in response to a reference amount petition as described in Sec. 101.12(h) of this chapter, a nutrient content claim petition as described in Sec. 101.69 of this chapter, a health claim petition as described in Sec. 101.70 of this chapter, or a petition pertaining to the label declaration of ingredients as described in Sec. 10.30 of this chapter.

* * * * *

PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR

HUMAN CONSUMPTION 0 3. The authority citation for 21 CFR part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348. 0 4. Section 173.375 is amended by revising the introductory text to read as follows:

Sec. 173.375 Cetylpyridinium chloride.

Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions:

* * * * *

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF

COATINGS 0 5. The authority citation for 21 CFR part 175 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

Sec. 175.105 [Amended] 0 6. Section 175.105 is amended in the table in paragraph (c)(5), in the

``Substances'' column, by removing the entry for

``Polytretrafluoroethylene'' and by adding in its place the entry for

``Polytetrafluoroethylene.'' 0 7. Section 175.300 is amended by revising Table 2 in paragraph (d) to read as follows:

Sec. 175.300 Resinous and polymeric coatings.

* * * * *

(d) * * *

Table 2--Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and

Beverages

Extractant

Types of food (see ----------------------------------------------------------------------------------------------

Condition of use

Table 1)

Heptane\1,2\ (time and

8% alcohol (time and

Water (time and temperature)

temperature)

temperature)

1. High temperature heat-

   I, IV-B.............. 250 [deg]F, 2 hr.............. .............................. ............................. sterilized (e.g., over 212

   deg

   F).

   III, IV-A, VII....... do............................ 150 [deg]F, 2 hr.............. .............................

2. Boiling water-sterilized....... II................... 212 [deg]F, 30 min............ .............................. .............................

   III, VII............. do............................ 120 [deg]F, 30 min............

3. Hot filled or pasteurized above II, IV-B............. Fill boiling, cool to 100

   .............................. ............................. 150 [deg]F.

   degF.

   III, IV-A............ do............................ 120 [deg]F, 15 min............ .............................

   V.................... .............................. do............................ .............................

4. Hot filled or pasteurized below II, IV-B, VI-B....... 150 [deg]F, 2 hr.............. .............................. ............................. 150 [deg]F.

   III, IV-A............ do............................ 100 [deg]F, 30 min............ .............................

   V.................... .............................. do............................ .............................

   VI-A................. .............................. .............................. 150 [deg]F, 2 hr.

5. Room temperature filled and

   II, IV-B, VI-B....... 120 [deg]F, 24 hr............. .............................. ............................. stored (no thermal treatment in the container).

   III, IV-A............ do............................ 70 [deg]F, 30 min............. .............................

   V, VII............... .............................. do............................ .............................

   VI-A................. .............................. .............................. 120 [deg]F, 24 hr.

6. Refrigerated storage (no

   I, II, III, IV-A, IV- 70 [deg]F, 48 hr.............. .............................. ............................. thermal treatment in the

   B, VI-B,VII. container).

   VI-A................. .............................. .............................. 70 [deg]F, 48 hr.

7. Frozen storage (no thermal

   I, II, III, IV-B, VII 70 [deg]F, 24 hr.............. .............................. ............................. treatment in the container).

8. Frozen storage: Ready-prepared foods intended to be reheated in container at time of use: 1. Aqueous or oil in water

   I, II, IV-B.......... 212 [deg]F, 30 min............ .............................. ............................. emulsion of high or low fat. 2. Aqueous, high or low free

   III, IV-A, VII....... do............................ 120 [deg]F, 30 min............ ............................. oil or fat.

   \1\ Heptane extractant not to be used on wax-lined containers.

   \2\ Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.

   Page 59249

   * * * * *

   PART 177--INDIRECT FOOD ADDITIVES: POLYMERS 0 8. The authority citation for 21 CFR part 177 continues to read as follows:

   Authority: 21 U.S.C. 321, 342, 348, 379e. 0 9. Section 177.1210 is amended by revising Table 4 of paragraph (c) to read as follows:

   Sec. 177.1210 Closures with sealing gaskets for food containers.

   * * * * *

   (c) * * *

   Table 4--Test Procedures With Time-Temperature Conditions for Determining Amount of Extractives From Closure-Sealing Gaskets, Using Solvents Simulating

   Types of Foods and Beverages

   Extractant

   Types of food (see ----------------------------------------------------------------------------------------------

   Conditions of use

   Table 3)

   Heptane\1\ (time and

   8% alcohol (time and

   Water (time and temperature)

   temperature)

   temperature)

1. High temperature heat-

   I, IV-B.............. 250 [deg]F, 2 hr.............. .............................. ............................. sterilized (e.g., over 212

   deg

   F).

   III, IV-A, VII....... do............................ 150 [deg]F, 2 hr.............. .............................

2. Boiling water-sterilized....... II................... 212 [deg]F, 30 min............ .............................. .............................

   III, VII............. do............................ 120 [deg]F, 30 min............ .............................

3. Hot filled or pasteurized above II, IV-B............. Fill boiling, cool to 100

   .............................. ............................. 150 [deg]F.

   degF.

   III, IV-A............ do............................ 120 [deg]F, 15 min............ .............................

   V.................... .............................. do............................ .............................

4. Hot filled or pasteurized below II, IV-B, VI-B....... 150 [deg]F, 2 hr.............. .............................. ............................. 150 [deg]F.

   III, IV-A............ do............................ 100 [deg]F, 30 min............ .............................

   V.................... .............................. do............................ .............................

   VI-A................. .............................. .............................. 150 [deg]F, 2 hr.

5. Room temperature filled and

   II, IV-B, VI-B....... 120 [deg]F, 24 hr............. .............................. ............................. stored (no thermal treatment in the container).

   III, IV-A............ do............................ 70 [deg]F, 30 min............. .............................

   V.................... .............................. do............................ .............................

   VI-A................. .............................. .............................. 120 [deg]F, 24 hr.

6. Refrigerated storage (no

   I, II, III, IV-A, IV- 70 [deg]F, 48 hr.............. 70 [deg]F, 30 min............. ............................. thermal treatment).

   B, VI-B,VII.

   VI-A................. .............................. .............................. 70 [deg]F, 48 hr.

7. Frozen storage (no thermal

   I, II, III, IV-B, VII 70 [deg]F, 24 hr.............. .............................. ............................. treatment in the container).

   \1\Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.

   Sec. 177.2600 [Amended] 0 10. Section 177.2600 is amended in paragraph (c)(4)(ix) by removing the entry for ``Dialkyl (C8-C18'' and by adding in its place the entry for ``Dialkyl (C8-C18) dimethylammonium chloride for use only as a flocculating agent in the manufacture of silica.''

   PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND

   SANITIZERS 0 11. The authority citation for 21 CFR part 178 continues to read as follows:

   Authority: 21 U.S.C. 321, 342, 348, 379e.

   Sec. 178.3130 [Amended] 0 12. Section 178.3130 is amended in the table in paragraph (b), in the

   ``List of Substances'' column, by removing the entry for ``N,N-Bis(2- hydroxyethyl) alkylamine, where the alkyl groups (C1-

   C18) are derived from tallow.'' and by adding in its place the entry for ``N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups (C14-C18) are derived from tallow.''

   PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE 0 13. The authority citation for 21 CFR part 182 continues to read as follows:

   Authority: 21 U.S.C. 321, 342, 348, 371. 0 14. Section 182.99 is revised to read as follows:

   Sec. 182.99 Adjuvants for pesticide chemicals.

   Adjuvants, identified and used in accordance with 40 CFR 180.910 and 40 CFR 180.920, which are added to pesticide use dilutions by a grower or applicator prior to application to the raw agricultural commodity, are exempt from the requirement of tolerances under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348).

   PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED

   AS SAFE 0 15. The authority citation for 21 CFR part 184 continues to read as follows:

   Authority: 21 U.S.C. 321, 342, 348, 371. 0 16. Section 184.1155 is amended by revising the first sentence of paragraph (a) to read as follows:

   Sec. 184.1155 Bentonite.

   (a) Bentonite

   (Al2O34SiO2nH2O, CAS Reg.

   No. 1302-78-9) is principally a colloidal hydrated aluminum silicate. *

   * *

   * * * * * 0 17. Section 184.1165 is amended by revising the first sentence of paragraph (a) to read as follows:

   Sec. 184.1165 n-Butane and iso-butane.

   (a) n-Butane and iso-butane (empirical formula

   C4H10,CAS Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, flammable gases at normal temperatures and pressures. * * *

   * * * * * 0 18. Section 184.1261 is amended by revising the first sentence of paragraph (a) to read as follows:

   Sec. 184.1261 Copper sulfate.

   (a) Copper sulfate (cupric sulfate, CuSO4[middot]5

   H2O, CAS Reg. No. 7758-99-8)

   Page 59250

   usually is used in the pentahydrate form. * * *

   * * * * * 0 19. Section 184.1446 is amended by revising the first sentence of paragraph (a) to read as follows:

   Sec. 184.1446 Manganese chloride.

   (a) Manganese chloride (MnCl2,CAS Reg. No. 7773-01-5) is a pink, translucent, crystalline product. * * *

   * * * * * 0 20. Section 184.1449 is amended by revising the first sentence of paragraph (a) to read as follows:

   Sec. 184.1449 Manganese citrate.

   (a) Manganese citrate

   (Mn3(C6H5O7)2,

   CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. * *

   *

   * * * * * 0 21. Section 184.1845 is amended by revising the fourth sentence of paragraph (a) to read as follows:

   Sec. 184.1845 Stannous chloride (anhydrous and dehydrated).

   (a) * * * Dihydrated stannous chloride

   (SnCl2[middot]2H2O, CAS Reg. No. 10025-69-1) is the chloride salt of metallic tin that contains two molecules of water.

   * * *

   * * * * *

   Dated: September 19, 2011.

   Susan Bernard,

   Acting Director, Office of Regulations, Policy and Social Sciences,

   Center for Food Safety and Applied Nutrition.

   FR Doc. 2011-24455 Filed 9-23-11; 8:45 am

   BILLING CODE 4160-01-P