[Federal Register Volume 72, Number 45 (Thursday, March 8, 2007)]
[Rules and Regulations]
[Pages 10356-10357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 71, 73, 74, 170, 171, 172, 180, and 184

[Docket No. 2006N-0391]


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 update the name of an FDA office, to correct minor errors in the 
Code of Federal Regulations (CFR), and to delete obsolete information. 
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: This rule is effective March 8, 2007.

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, 301-436-1256.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations for parts 
71, 73, 74, 170, 171, 172, 180 and 184 (21 CFR parts 71, 73, 74, 170, 
171, 172, 180 and 184). Specifically, as a result of an FDA 
reorganization, the Office of Premarket Approval was renamed the Office 
of Food Additive Safety. Therefore, this rule updates the name and 
contact information for this office in Sec. Sec.  71.1 and 171.1. In 
addition, FDA discovered that minor errors were inadvertently published 
in the CFR affecting its regulations that address food and color 
additives (parts 71, 73, 74, 170, 171, 172, and 180) and GRAS 
substances (part 184). 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. Sec.  71.1 Petitions and 171.1 Petitions the agency is 
updating contact information. In Sec.  71.1 Petitions, the regulations 
currently identify the Office of Premarket Approval as the FDA office 
responsible for receiving petitions. The new name for the Office of 
Premarket Approval is the Office of Food Additive Safety. In Sec.  
171.1 Petitions, the regulations currently identify the Petitions 
Control Branch, Food and Drug Administration, Department of Health and 
Human Services, Washington, DC 20204 as the FDA office responsible for 
receiving petitions. The correct name and contact information is the 
Office of Food Additive Safety (HFS-200), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740.
    2. Section 73.1128 Mica-based pearlescent pigments is redesignated 
as Sec.  73.1350.
    3. In Sec.  73.2396 Lead acetate, the regulatory section citation 
for the labeling requirements for color additives (other than hair dye) 
is currently erroneously written as Sec.  170.25 and is corrected to 
read Sec.  70.25.
    4. In Sec.  74.2052 D&C Black No. 2, the agency is correcting a 
typographical error in the spelling of the chemical nomenclature. 
``Benzo[e]pyrene'' is being corrected to read ``Benzo[a]pyrene.''
    5. In Sec. Sec.  170.45 Fluorine-containing compounds and 184.1769a 
Sodium metasilicate, the agency is updating references to a regulatory 
section citation which has been recodified. Section 103.35 has been 
recodified as Sec.  165.110. Accordingly, in Sec.  170.45, reference to 
``Sec.  103.35(d)'' is corrected to read ``Sec.  165.110(d)'' and in 
Sec.  184.1769a, reference to ``Sec.  103.35'' is corrected to read 
``Sec.  165.110''.
    6. The agency is also updating Sec.  170.45 Fluorine-containing 
compounds to correct a reference to a section of the agency's 
regulations which has been removed from the CFR. In Sec.  170.45 the 
reference to ``Sec.  250.203'' is removed.
    7. In Sec.  172.510 Natural flavoring substances and natural 
substances used in conjunction with flavors, the agency is correcting a 
typographical error. The incorrect nomenclature ``concretes'' is being 
corrected to read ``concentrates''.
    8. In Sec.  180.37 Saccharin, ammonium saccharin, calcium saccharin 
and sodium saccharin, the agency is correcting references to a 
regulatory section citation which has been removed from the CFR. In 
Sec.  180.37, reference to ``Sec.  100.130'' is removed.
    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. 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.

List of Subjects

21 CFR Part 71

    Administrative practice and procedure, Color additives, 
Confidential business information, Cosmetics, Drugs, Reporting and 
recordkeeping requirements.

21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

21 CFR Part 74

    Color additives, Cosmetics, Drugs.

[[Page 10357]]

21 CFR Part 170

    Administrative practice and procedure, Food additives, Reporting 
and recordkeeping requirements.

21 CFR Part 171

    Administrative practice and procedure, Food additives.

21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

21 CFR Part 180

    Food additives.

21 CFR Part 184

    Food additives.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
71, 73, 74, 170, 171, 172, 180, and 184 are amended as follows:

PART 71--COLOR ADDITIVE PETITIONS

0
1. The authority citation for 21 CFR part 71 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 
360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.


Sec.  71.1  [Amended]

0
2. Section 71.1 is amended in paragraph (c) by removing ``Office of 
Premarket Approval (HFS-200),'' and by adding in its place ``Office of 
Food Additive Safety (HFS-200),''.

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
3. 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.  73.1128  [Redesignated]

0
4. Section 73.1128 is redesignated as Sec.  73.1350.


Sec.  73.2396  [Amended]

0
5. Section 73.2396 is amended in paragraph (d)(1) by removing 
``170.25'' and by adding in its place ``Sec.  70.25''.

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

0
6. The authority citation for 21 CFR part 74 continues to read as 
follows:

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


Sec.  74.2052  [Amended]

0
7. Section 74.2052 is amended in paragraph (b)(9) by removing 
``Benzo[e]pyrene'' and by adding in its place ``Benzo[a]pyrene''.

PART 170--FOOD ADDITIVES

0
8. The authority citation for 21 CFR part 170 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.


Sec.  170.45  [Amended]

0
9. Section 170.45 is amended by removing the phrase ``as stated in 
Sec.  250.203 of this chapter'' and by removing ``Sec.  103.35(d)'' and 
adding in its place ``Sec.  165.110(d)''.

PART 171--FOOD ADDITIVE PETITIONS

0
10. The authority citation for 21 CFR part 171 continues to read as 
follows:

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


Sec.  171.1  [Amended]

0
11. Section 171.1 is amended in paragraph (c) by removing
    ``Petitions Control Branch
    Food and Drug Administration
    Department of Health and Human Services, Washington, DC 20204.''
    and by adding in its place
    ``Office of Food Additive Safety (HFS-200), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740.''

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

0
12. 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
13. Section 172.510 is amended in paragraph (b) by removing 
``concretes'' and adding in its place ``concentrates''.

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

0
14. The authority citation for 21 CFR part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241.


Sec.  180.37  [Amended]

0
15. Section 180.37 is amended in paragraph (f)(2)(iii) by removing ``or 
Sec.  100.130''.

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

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

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


Sec.  184.1769a  [Amended]

0
17. Section 184.1769a is amended in paragraph (c)(2) by removing 
``Sec.  103.35'' and adding in its place ``Sec.  165.110''.

    Dated: February 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4104 Filed 3-7-07; 8:45 am]
BILLING CODE 4160-01-S