[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Rules and Regulations]
[Pages 14244-14247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7883]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I


Food and Drugs; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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-SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to correct those portions that pertain to foods. This 
action is being taken to improve the accuracy of the regulations.

EFFECTIVE DATE: April 1, 1996.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR 
Chapter I of Title 21 of the Code of Federal Regulations to correct 
certain portions that pertain to foods. These amendments include two 
minor redesignations. The first change is in Sec. 173.69 Chlorine 
dioxide (21 CFR 173.69). When the regulation was issued on March 1, 
1995 (60 FR 11899 at 11900), it was incorrectly placed in part 173, 
subpart A--Polymer Substances and Polymer Adjuvants for Food Treatment. 
The agency now recognizes that this regulation belongs more 
appropriately under part 173, subpart D--Specific Usage Additives. This 
regulation will be redesignated as Sec. 173.300.
    The second correction is in Sec. 182.8458 Manganese hypophosphite 
(21 CFR 182.8458). When the list of nutrients was separated into part 
182, subpart F--Dietary Supplements and subpart I--

[[Page 14245]]
Nutrients, this compound was incorrectly listed and numbered in subpart 
I--Nutrients. It should have been included with the other dietary 
supplements in subpart F. Both of these corrections are merely 
renumbering sections to more closely categorize them into the correct 
subpart.
    In addition to these redesignations, FDA is making a number of 
other minor corrections including spelling errors, typographical 
errors, and inadvertent omissions.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.

List of Subjects

21 CFR Part 25

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

21 CFR Part 114

    Food packaging, Foods, Reporting and recordkeeping requirements.

21 CFR Part 136

    Bakery products, Food grades and standards.

221 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

21 CFR Parts 173 and 180

    Food additives.

 21 CFR Part 175

    Adhesives, Food additives, Food packaging.

21 CFR Parts 176, 177, and 178

    Food additives, Food packaging.

21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

21 CFR Part 182

    Food ingredients, Food packaging, Spices and flavorings.

21 CFR Part 184

    Food ingredients.

21 CFR Part 186

    Food ingredients, Food packaging.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
Chapter 1 is amended as follows:

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

    1. The authority citation for 21 CFR part 25 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-393); secs. 351, 354-361 of the Public Health 
Service Act (42 U.S.C. 262, 263b-264); 42 U.S.C. 4321, 4322; 40 CFR 
parts 1500-1508; E.O. 11514 as amended by E.O. 11991; E.O. 12114.

Sec. 25.22  [Amended]

    2. Section 25.22 Actions requiring preparation of an environmental 
assessment is amended in paragraph (a) by removing the word 
``oridinarily'' and adding in its place ``ordinarily''.


Sec. 25.24  [Amended]

    3. Section 25.24 Categorical exclusions is amended in paragraph (b) 
(2) by removing the phrase ``studies for research'' and adding in its 
place ``studies or research''.


Sec. 25.30  [Amended]

    4. Section 25.30 Content and format is amended in paragraph (a) by 
removing the words ``bureau, national'' and adding the word ``of'' 
after the word ``interpretation'' in the last line of this paragraph.

PART 114--ACIDIFIED FOODS

    5. The authority citation for 21 CFR part 114 continues to read as 
follows:

    Authority: Secs. 402, 701, 704 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public 
Health Service Act (42 U.S.C. 264).

Sec. 114.3  [Amended]

    6. Section 114.3 Definitions is amended in paragraph (b) by 
removing ``fo'' from the last line of the paragraph and adding in its 
place ``of''.

PART 136--BAKERY PRODUCTS

    7. The authority citation for 21 CFR part 136 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).

Sec. 136.115  [Amended]

    8. Section 136.115 Enriched bread, rolls, and buns is amended in 
paragraph (a)(3) by removing the ``NOTE: * * *'' that follows the 
table.

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    11. The authority citation for 21 CFR part 172 continues to reads 
as follows:

    Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

Sec. 172.133  [Amended]

    12. Section 172.133 Dimethyl dicarbonate is amended in paragraph 
(a)(2) by removing the phrase ``Division of Food and Color Additives,'' 
and by removing the mail code ``(HFF-334)'' and adding in its place 
``(HFS-200)''.


Sec. 172.210  [Amended]

    13. Section 172.210 Coatings on fresh citrus fruit is amended in 
the table in paragraph (b)(3) by removing the limitation listed for 
potassium persulfate and by adding ``Do'' in its place.


Sec. 172.515  [Amended]

    14. Section 172.515 Synthetic flavoring substances and adjuvants is 
amended in paragraph (b) by removing ``Methyl 2-methylthiopropionate'' 
and adding in its place ``Methyl-3-methylthiopropionate''.

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

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

    Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

Sec. 173.300  [Redesignated from Sec. 173.69]

    16. Section 173.69 Chlorine dioxide is removed from subpart A and 
added to subpart D as newly redesignated Sec. 173.300.


Sec. 173.310  [Amended]

    17. Section 173.310 Boiler water additives is amended in the table 
in paragraph (c) under ``Substances'' by removing ``Sodium carboxy-
methylcellulose'' and adding in its place ``Sodium 
carboxymethylcellulose''.


Sec. 173.357  [Amended]

    18. Section 173.357 Materials used as fixing agents in the 
immobilization of enzyme preparations is amended in the table in 
paragraph (a)(2) in the entry for ``Polyethylenimine reaction product 
with 1,2-dichloroethane'' by removing the phrase ``Division of Food and 
Color Additives,'' and by removing the mail code ``(HFF-334)'' and 
adding in its place ``(HFS-200)''.

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

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


[[Page 14246]]

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

Sec. 175.320  [Amended]

    20. Section 175.320 Resinous and polymeric coatings for polyolefin 
films is amended in the table in paragraph (b)(3)(i) under ``List of 
substances'' in both entries for ``Siloxanes and silicones'' by 
removing ``CAS Reg. Nos. 67762-94-1'' and adding in its place ``CAS 
Reg. Nos. 68083-19-2''.

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    21. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).

Sec. 176.170  [Amended]

    22. Section 176.170 Components of paper and paperboard in contact 
with aqueous and fatty foods is amended in paragraph (b)(2) under 
``List of substances'' in both entries for ``Siloxanes and silicones'' 
by removing the ``CAS Reg. Nos. 67762-94-1'' and adding in its place 
``CAS Reg. Nos. 68083-19-2''.


Sec. 176.210  [Amended]

    23. Section 176.210 Defoaming agents used in the manufacture of 
paper and paperboard is amended in paragraph (d)(3) by removing 
``Isopropylamine salt of dodecylbenzene suffonic'' and adding in its 
place ``Isopropylamine salt of dodecylbenzene sulfonic''.

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

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

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

Sec. 177.1520  [Amended]

    25. Section 177.1520 Olefin polymers is amended in the table in 
paragraph (b) under ``Substances'' in the entry for ``Petroleum 
hydrocarbon resins'' by removing the phrase ``3,000 cubic centimeters 
per second'' and adding in its place ``3,000 centipoise''.


Sec. 177.2600  [Amended]

    26. Section 177.2600 Rubber articles intended for repeated use is 
amended in paragraph (c)(4)(i) under the entry for ``Hydrogenated 
butadiene/acrylonitrile copolymers'' by removing the phrase ``Division 
of Petition Control,'' and by removing the mail code ``(HFS-215)'' and 
adding in its place ``(HFS-200)''.

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

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

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

Sec. 178.2010  [Amended]

    28. Section 178.2010 Antioxidants and/or stabilizers for polymers 
is amended in the table in paragraph (b) under ``Substances'' in the 
entry for ``1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-
hydroxybenzyl) benzene'' by adding ``(CAS Reg. No. 1709-70-2)'' after 
the word ``benzene''.


Sec. 178.3297  [Amended]

    29. Section 178.3297 Colorants for polymers is amended in the table 
in paragraph (e) under ``Limitations'' in the entry for ``2,2'-(2,5-
Thiophenediyl)-bis'' by removing ``4 [Reserved]'' and adding in its 
place ``4. At levels not to exceed 0.01 percent by weight of 
polyoxymethylene complying with Sec. 177.2480 of this chapter.''

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

    30. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: Secs. 201, 402, 403, 409, 703, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373, 
374).

Sec. 179.21  [Amended]

    31. Section 179.21 Sources of radiation used for inspection of 
food, for inspection of packaged food, and for controlling food 
processing is amended in paragraph (b)(2)(ii) by removing the phrase 
``1,000 rads'' and adding in its place ``10 grays'' and in paragraph 
(b)(2)(iii) by removing the phrase ``200 millirads'' and adding in its 
place ``2 milligrays''.


Sec. 179.45  [Amended]

    32. Section 179.45 Packaging materials for use during the 
irradiation of prepackaged foods is amended in paragraph (b) by 
removing ``1 megarad'' and adding in its place ``10 kilograys'', in 
paragraph (b)(5) by removing ``50,000 rads'' and adding in its place 
``500 grays'', and in paragraph (d) by removing ``6 megarads'' and 
adding in its place ``60 kilograys''.

PART 180--FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD 
ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

    33. The authority citation for 21 CFR part 180 continues to read as 
follows:

    Authority: Secs. 201, 402, 403, 409, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 371); sec. 301 
of the Public Health Service Act (42 U.S.C. 241).
    34. The heading for part 180 is revised to read as set forth above.
    35. Section 180.22 Acrylonitrile copolymers is amended in paragraph 
(b) by removing the phrase ``Bureau of Foods,'' and adding the phrase 
``Center for Food Safety and Applied Nutrition (HFS-200),'' before the 
phrase ``Food and Drug Administration'' the first time it appears, and 
in paragraphs (e) and (f)(1) by removing the phrase ``Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, Division 
of Food and Color Additives (HFF-330)'' and adding in its place 
``Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration''.

PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE

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

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

Sec. 182.10  [Amended]

    37. Section 182.10 Spices and other natural seasonings and 
flavorings is amended in the table under ``Common name'' by removing 
the entry for ``All spice'' and adding in its place ``Allspice''.


Sec. 182.5484  [Redesignated from Sec. 182.8458]

     38. Section 182.8458 Manganese hypophosphite is removed from 
subpart I and added to subpart F as newly redesignated Sec. 182.5484.


Sec. 182.5697  [Amended]

    39. Section 182.5697 is amended in the section heading and in 
paragraph (a) by removing the term ``Riboflavin-5-phosphate'' and 
adding in its place ``Riboflavin-5' phosphate.''

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

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

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


[[Page 14247]]



Sec. 184.1193  [Amended]

    41. Section 184.1193 Calcium chloride is amended in paragraph (c) 
by removing ``Sec. 170.3(o)(2)'' the second time it appears and adding 
in its place ``Sec. 170.3(o)(20)''.


Sec. 184.1634  [Amended]

    42. Section 184.1634 Potassium iodide is amended in paragraph (a) 
by removing ``and is salt'' and adding in its place ``and in salt''.

    Dated: March 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-7883 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-F