Environmental Impact Considerations, Food Additives, and Generally Recognized As Safe Substances; 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.

Table of Figures

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 § 175.105 and dialkyl (C 8-C 18) dimethylammonium chloride in § 177.2600. Two chemical formulas are corrected:N,N-B-is(2-hydroxyethyl) alkylamine, where the alkyl groups (C 14-C 18) are derived from tallow in § 178.3130, and MnCl 2 in § 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 § 173.375, 1302-78-9 in § 184.1155, 7758-99-8 in § 184.1261, 10024-66-5 in § 184.1449, and 10025-69-1 in § 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 § 25.32 is updated. Section 25.32(p) refers to a petition pertaining to the label declaration of ingredients as described in § 101.103 (21 CFR 101.103). However, FDA revoked § 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 §§ 175.300 and 177.1210.

5. Finally, the Agency is updating § 184.1165. Under § 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.”

List of subjects

Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements.

Food additives.

Adhesives, Food additives, Food packaging.

Food additives, Food packaging.

Food additives, Food packaging.

Food ingredients, Food packaging, Spices and flavorings.

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

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.

2. Section 25.32 is amended by revising paragraph (p) to read as follows: § 25.32 * * * * *

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

* * * * *

Part 173—secondary direct food additives permitted in food for human consumption

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

Authority:

21 U.S.C. 321, 342, 348.

4. Section 173.375 is amended by revising the introductory text to read as follows: § 173.375

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

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

Authority:

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

§ 175.105 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.” 7. Section 175.300 is amended by revising Table 2 in paragraph (d) to read as follows: § 175.300 * * * * *

(d) * * *

Table 2—Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and Beverages
Condition of useTypes of food(see Table 1) Extractant
Water(time and temperature) Heptane1,2 (time and temperature) 8% alcohol(time and temperature)
1Heptane extractant not to be used on wax-lined containers.
2Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
A. High temperature heat-sterilized (e.g., over 212 °F) I, IV-B 250 °F, 2 hr
III, IV-A, VII do 150 °F, 2 hr
B. Boiling water-sterilized II 212 °F, 30 min
III, VII do 120 °F, 30 min
C. Hot filled or pasteurized above 150 °F II, IV-B Fill boiling, cool to 100 °F
III, IV-A do 120 °F, 15 min
V do
D. Hot filled or pasteurized below 150 °F II, IV-B, VI-B 150 °F, 2 hr
III, IV-A do 100 °F, 30 min
V do
VI-A 150 °F, 2 hr.
E. Room temperature filled and stored (no thermal treatment in the container) II, IV-B, VI-B 120 °F, 24 hr
III, IV-A do 70 °F, 30 min
V, VII do
VI-A 120 °F, 24 hr.
F. Refrigerated storage (no thermal treatment in the container) I, II, III, IV-A, IV-B, VI-B,VII 70 °F, 48 hr
VI-A 70 °F, 48 hr.
G. Frozen storage (no thermal treatment in the container) I, II, III, IV-B, VII 70 °F, 24 hr
H. Frozen storage: Ready-prepared foods intended to be reheated in container at time of use:
1. Aqueous or oil in water emulsion of high or low fat I, II, IV-B 212 °F, 30 min
2. Aqueous, high or low free oil or fat III, IV-A, VII do 120 °F, 30 min
* * * * *

Part 177—indirect food additives: polymers

8. The authority citation for 21 CFR part 177 continues to read as follows:

Authority:

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

9. Section 177.1210 is amended by revising Table 4 of paragraph (c) to read as follows: § 177.1210 * * * * *

(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
Conditions of useTypes of food(see Table 3) Extractant
Water (time and temperature)Heptane1(time and temperature)8% alcohol(time and temperature)
1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
A. High temperature heat-sterilized (e.g., over 212 °F) I, IV-B 250 °F, 2 hr
III, IV-A, VII do 150 °F, 2 hr
B. Boiling water-sterilized II 212 °F, 30 min
III, VII do 120 °F, 30 min
C. Hot filled or pasteurized above 150 °F II, IV-B Fill boiling, cool to 100 °F
III, IV-A do 120 °F, 15 min
V do
D. Hot filled or pasteurized below 150 °F II, IV-B, VI-B 150 °F, 2 hr
III, IV-A do 100 °F, 30 min
V do
VI-A 150 °F, 2 hr.
E. Room temperature filled and stored (no thermal treatment in the container) II, IV-B, VI-B 120 °F, 24 hr
III, IV-A do 70 °F, 30 min
V do
VI-A 120 °F, 24 hr.
F. Refrigerated storage (no thermal treatment) I, II, III, IV-A, IV-B, VI-B,VII 70 °F, 48 hr 70 °F, 30 min
VI-A 70 °F, 48 hr.
G. Frozen storage (no thermal treatment in the container) I, II, III, IV-B, VII 70 °F, 24 hr
§ 177.2600 10. Section 177.2600 is amended in paragraph (c)(4)(ix) by removing the entry for “Dialkyl (C 8-C 18” and by adding in its place the entry for “Dialkyl (C 8-C 18) dimethylammonium chloride for use only as a flocculating agent in the manufacture of silica.”

Part 178—indirect food additives: adjuvants, production aids, and sanitizers

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

Authority:

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

§ 178.3130 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 (C 1-C 18) are derived from tallow.” and by adding in its place the entry for “N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups (C 14-C 18) are derived from tallow.”

Part 182—substances generally recognized as safe

13. The authority citation for 21 CFR part 182 continues to read as follows:

Authority:

21 U.S.C. 321, 342, 348, 371.

14. Section 182.99 is revised to read as follows: § 182.99

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

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

Authority:

21 U.S.C. 321, 342, 348, 371.

16. Section 184.1155 is amended by revising the first sentence of paragraph (a) to read as follows: § 184.1155

(a) Bentonite (Al 2 O 34SiO 2 nH 2 O, CAS Reg. No. 1302-78-9) is principally a colloidal hydrated aluminum silicate. * * *

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

(a) n-Butane and iso-butane (empirical formula C 4 H 10, CAS Reg. Nos. 106-97-8 and 75-28-5, respectively) are colorless, flammable gases at normal temperatures and pressures. * * *

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

(a) Copper sulfate (cupric sulfate, CuSO 4·5 H 2 O, CAS Reg. No. 7758-99-8)usually is used in the pentahydrate form. * * *

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

(a) Manganese chloride (MnCl 2, CAS Reg. No. 7773-01-5) is a pink, translucent, crystalline product. * * *

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

(a) Manganese citrate (Mn 3(C 6 H 5 O 7)2, CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. * * *

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

(a) * * * Dihydrated stannous chloride (SnCl 2·2H 2 O, 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.

Footnotes

1. Food Chemicals Codex,7th Edition, pp. 115 and 529, Rockville, MD: United States Pharmacopeial Convention, 2010.

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