[Federal Register Volume 69, Number 86 (Tuesday, May 4, 2004)]
[Rules and Regulations]
[Pages 24511-24512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10026]



[[Page 24511]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73, 172, 175, 176, 177, 178, 184, and 186

[Docket No. 2004N-0076]


Food and Color Additives and Generally Recognized As Safe 
Substances; 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 that address food and color additives and generally 
recognized as safe (GRAS) substances. The purpose of the amendments is 
to correct minor errors and inadvertent omissions in the Code of 
Federal Regulations (CFR). The technical amendments made by this final 
rule are editorial in nature and are intended to provide accuracy and 
clarity to the agency's regulations.

DATES: Effective May 4, 2004.

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, 202-418-3089.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations for parts 
73, 172, 175, 176, 177, 178, 184, and 186 (21 CFR parts 73, 172, 175, 
176, 177, 178, 184, and 186). FDA discovered that minor errors and 
omissions were inadvertently published in the CFR affecting its 
regulations that address food and color additives (parts 73, 172, 175, 
176, 177, and 178) and GRAS substances (parts 184 and 186). This 
document 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. The changes addressed in this 
document are as follows:
    1. In Sec.  73.1(b)(2), the regulatory section citation for the 
identification of rosin and rosin derivatives is currently erroneously 
written as Sec.  172.820 and is corrected to read Sec.  172.615.
    2. The listing for ``oak moss'' in the table in Sec.  172.510(b) is 
being corrected. The entry under ``Limitations'' for this listing was 
amended to ``Finished food thujone free\1\'' in the Federal Register of 
September 6, 1967 (32 FR 12751). Subsequently in the 1972 edition of 
the Code of Federal Regulations (CFR) the word ``free\1\'' was 
inadvertently dropped from the limitation. This document adds this 
phrase.
    3. The agency is also correcting several Chemical Abstract Service 
registry numbers (CAS Reg. No.) that are incorrectly listed. The agency 
is correcting registry numbers found in Sec.  73.3125 Iron oxides; 
Sec.  175.105 Adhesives; Sec.  176.300 Slimicides; Sec.  177.1632 Poly 
(phenyleneterephthalamide) resins; Sec.  178.1010 Sanitizing solutions; 
Sec.  178.2010 Antioxidants and/or stabilizers for polymers; Sec.  
178.3400 Emulsifiers and/or surface-active agents; Sec.  178.3770 
Polyhydric alcohol esters of oxidatively refined (Gersthofen process) 
montan wax acids; Sec.  178.3910 Surface lubricants used in the 
manufacture of metallic articles; Sec.  184.1034 Catalase (bovine 
liver); Sec.  184.1307a Ferrous ascorbate; Sec.  184.1434 Magnesium 
phosphate; and, Sec.  186.1374 Iron oxides.
    4. Finally, the agency is also correcting several typographical 
errors. Two misspelled terms are being corrected: ``Hydroxycitronellol; 
3,7-dimethyl-1,7-octanediol'' in Sec.  172.515 Synthetic flavoring 
substances and adjuvants and ``Methyl ethers of mono-, di- and 
tripropylene glycol'' in Sec.  176.180 Components of paper and 
paperboard in contact with dry food. In Sec.  177.1500 Nylon resins an 
incorrect reference to a paragraph is being corrected as well as a 
typographical error in the described melting point of ``Nylon 46 
resins.'' Finally, in Sec.  184.1090 Stearic acid the incorrect 
chemical notation for stearic acid is being corrected.
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because these 
amendments are merely correcting nonsubstantive errors.

List of Subjects

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

21 CFR Part 175

    Adhesives, Food additives, Food packaging.

21 CFR Parts 176, 177, and 178

    Food additives, Food packaging.

21 CFR 184

    Food additives.

21 CFR 186

    Food additives, Food packaging.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
73, 172, 175, 176, 177, 178, 184, and 186 are amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


Sec.  73.1  [Amended]

0
2. Section 73.1 Diluents in color additive mixtures for food use exempt 
from certification is amended in paragraph (b)(2) by removing ``Rosin 
and rosin derivatives (as identified in Sec.  172.820 of this 
chapter).'' and by adding in its place ``Rosin and rosin derivatives 
(as identified in Sec.  172.615 of this chapter).''.


Sec.  73.3125   [Amended]

0
3. Section 73.3125 Iron oxides is amended in paragraph (a) by removing 
``(CAS Reg. No. 977053-38-5)'' and by adding in its place ``(CAS Reg. 
No. 1332-37-2)''.

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

0
4. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.


Sec.  172.510   [Amended]

0
5. Section 172.510 Natural flavoring substances and natural substances 
used in conjunction with flavors is amended in the table in paragraph 
(b) in the entry for ``Oak moss'' under the heading ``Limitations'' by 
adding ``free\1\'' after ``thujone''.


Sec.  172.515  [Amended]

0
6. Section 172.515 Synthetic flavoring substances and adjuvants is 
amended in paragraph (b) by removing ``Hydroxycitronellal; 3,7-
dimethyl-1,7-octanediol'' and adding in its place ``Hydroxycitronellol; 
3,7-dimethyl-1,7-octanediol''.

[[Page 24512]]

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

0
7. 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
8. Section 175.105 Adhesives is amended in the table in paragraph 
(c)(5) in the entry for ``Isodecyl benzoate'' under the heading 
``Substances'' by removing ``(CAS Reg. No. 131298-44-77)'' and adding 
in its place ``(CAS Reg. No. 131298-44-7)''.

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

0
9. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.


Sec.  176.180   [Amended]

0
10. Section 176.180 Components of paper and paperboard in contact with 
dry food is amended in the table in paragraph (b)(2) by removing the 
entry for ``Methyl esters of mono-, di- and tripropylene glycol'' and 
adding in its place ``Methyl ethers of mono-, di- and tripropylene 
glycol''.


Sec.  176.300  [Amended]

0
11. Section 176.300 Slimicides is amended in the table in paragraph (c) 
in the entry for ``4-(Diiodomethylsulfonyl) toluene'' under the heading 
``List of substances'' by removing ``(CAS Reg. No. 20018-09-01)'' and 
adding in its place ``(CAS Reg. No. 20018-09-1)''.

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

0
12. The authority citation for 21 CFR part 177 continues to read as 
follows:

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


Sec.  177.1500   [Amended]

0
13. Section 177.1500 Nylon resins is amended in paragraph (a) by 
removing ``methods described in paragraph (c)'' and adding in its place 
``methods described in paragraph (d)'', and in the table in paragraph 
(b) in entry 15 for ``Nylon 46 resins'' under the heading ``Melting 
point (degrees Fahrenheit)'' by removing ``551-09592'' and adding in 
its place ``551-592''.


Sec.  177.1632  [Amended]

0
14. Section 177.1632 Poly (phenyleneterephthalamide) resins is amended 
in the table in paragraph (b)(2) in the entry for ``Poly(oxyethylene) 
mono(nonylphenyl)ether'' under the heading ``List of substances'' by 
removing ``(CAS Reg. No. 9019-45-9)'' and adding in its place ``(CAS 
Reg. No. 9016-45-9)''.

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

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

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


Sec.  178.1010  [Amended]

0
16. Section 178.1010 Sanitizing solutions is amended in paragraph 
(b)(36) by removing ``1,2-octanedisulfonic acid (CAS Reg. No. 
1934210)'' and adding in its place ``1,2-octanedisulfonic acid (CAS 
Reg. No. 113669-58-2)''.


Sec.  178.2010  [Amended]

0
17. Section 178.2010 Antioxidants and/or stabilizers for polymers is 
amended in the table in paragraph (b) in the entry for ``2-Hydroxy-4-
isooctoxy- benzophenone'' under the heading ``Substances'' by removing 
``CA Registry No. 330:59-05-1'' and adding in its place ``CAS Registry 
No. 33059-05-1''.


Sec.  178.3400   [Amended]

0
18. Section 178.3400 Emulsifiers and/or surface-active agents is 
amended in the table in paragraph (c) in the entry for ``Alpha-sulfo-
omega-(dodecyloxy)poly(oxyethylene) ammonium salt'' under the heading 
``List of substances'' by removing ``(CAS Reg. No. 30174-67-5)'' and 
adding in its place ``(CAS Reg. No. 32612-48-9)''.


Sec.  178.3770  [Amended]

0
19. Section 178.3770 Polyhydric alcohol esters of oxidatively refined 
(Gersthofen process) montan wax acids is amended in paragraph (c)(1) by 
removing ``(CAS Reg. No. 9005-98-2)'' and adding in its place ``(CAS 
Reg. No. 9004-98-2)''.


Sec.  178.3910   [Amended]

0
20. Section 178.3910 Surface lubricants used in the manufacture of 
metallic articles is amended in the table in paragraph (a)(2) in the 
entry for ``Sodium petroleum sulfonate'' under the heading ``Listing of 
substances'' by removing ``(CAS Reg. No. 68608-24-4)'' and adding in 
its place ``(CAS Reg. No. 68608-26-4)''.

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

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

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


Sec.  184.1034   [Amended]

0
22. Section 184.1034 Catalase (bovine liver) is amended in paragraph 
(a) by removing ``(CAS Reg. No. 9001-05-2)'' and adding in its place 
``(CAS Reg. No. 81457-95-6)''.


Sec.  184.1090   [Amended]

0
23. Section 184.1090 Stearic acid is amended in paragraph (a) by 
removing ``C16H36O2'' and adding in 
its place ``C18H36O2''.


Sec.  184.1307a   [Amended]

0
24. Section 184.1307a Ferrous ascorbate is amended in paragraph (a) by 
removing ``(CAS Reg. No. 14536-17-5)'' and adding in its place ``(CAS 
Reg. No. 24808-52-4)''.


Sec.  184.1434   [Amended]

0
25. Section 184.1434 Magnesium phosphate is amended in paragraph (a) by 
removing ``CAS Reg. No. 7727-0987-091'' and adding in its place ``CAS 
Reg. No. 7757-87-1''.

PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

0
26. The authority citation for 21 CFR part 186 continues to read as 
follows:

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


Sec.  186.1374   [Amended]

0
27. Section 186.1374 Iron oxides is amended in paragraph (a) by 
removing ``CAS Reg. No. 97705-33-85'' and adding in its place``CAS Reg. 
No. 1332-37-2''.

    Dated: March 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10026 Filed 5-3-04; 8:45 am]
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