[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