[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37680-37682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 500, 505, 507, 508, 510, and 570
[Docket No. 95N-310V]
Revocation of Certain Animal Food and Drug Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revoking certain
regulations regarding animal food and animal drugs that are obsolete or
no longer necessary to achieve public health goals. These regulations
have been identified for revocation as the result of a page-by-page
review of the agency's regulations. This regulatory review is in
response to the administration's ``Reinventing Government'' initiative
which seeks to streamline Government to ease the burden on regulated
industry and consumers. These regulations are being consolidated in
order to respond to ``Reinventing Government.''
EFFECTIVE DATE: August 19, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Kristi O. Smedley, Center for
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the administration's
``Reinventing Government'' initiative. In his March 4 directive, the
President ordered all Federal agencies to conduct a page-by-page review
of all of their regulations and to ``eliminate or revise those that are
outdated or otherwise in need of reform.'' In the Federal Register of
October 13, 1995 (60 FR 53480), FDA provided its initial efforts in
implementing the President's plan. The proposed rule announced
regulations that FDA intended to eliminate based on the page-by-page
review.
The agency received no comments regarding their intention to
eliminate any of the regulations that cover animal food or animal drug
regulations. Therefore the agency is removing the following
regulations:
1. Section 500.49 Chlorofluorocarbon propellants (21 CFR 500.49).
This section prohibits the use of chlorofluorocarbons as propellants in
self-pressurized containers in animal drugs. Chlorofluorocarbons are
prohibited by the Clean Air Act Amendments of 1990 (42 U.S.C. 7671) and
can no longer be marketed for this use. This section is unnecessary
because coverage in Sec. 2.125 (21 CFR 2.125) of this prohibition is
sufficient.
2. Section 505.3 Warnings on animal drugs intended for
administration to diseased animals (21 CFR 505.3). This section states
that no warning or caution statements recommended for use in the
labeling of animal drugs intended for administration to diseased
animals shall be construed to suggest or imply that a product of
diseased animals is suitable for food use. This provision cautions
against misuse of language in Sec. 505.20 (21 CFR 505.20) which is now
being withdrawn and is, therefore, unnecessary.
3. Section 505.20 Recommended animal drug warning and caution
statements. This section provides recommended animal drug warning and
caution statements for specific drugs. The statements provided are
voluntary label statements that do not contain requirements and need
not appear in the CFR.
4. Part 507--Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers (21 CFR part 507). This part contains
the criteria that apply in determining whether the facilities, methods,
practices, and
[[Page 37681]]
controls used by the commercial processor in the manufacture,
processing, and packing of low-acid foods for animals in hermetically
sealed containers are operated or administered in a manner adequate to
protect the public health. Part 507 is identical to part 113 (21 CFR
part 113), which applies to human foods. Therefore, the agency is
removing part 507, and adding a new Sec. 500.23 to state that the
provisions in part 113 apply to animal foods.
5. Part 508--Emergency Permit Control (21 CFR part 508) covers the
requirements and issuance of emergency control permits for the
manufacturer or packer of thermally processed low-acid foods packaged
in hermetically sealed containers. Part 508 is identical to part 108
(21 CFR part 108), which applies to human foods. Therefore, the agency
is removing part 508, and adding a new Sec. 500.24 to state that the
provisions in part 108 apply to food intended for animals.
6. Section 510.120 Suspension of approval of new-drug applications
for certain diethylstilbestrol and diethylstilbestrol-containing drugs
(21 CFR 510.120). This section provides the suspension of approval of
the seven listed diethylstilbestrol (DES)-containing animal drug
products. There are no approved new animal drug applications for DES-
containing products. This regulation is obsolete and should be deleted.
7. Section 510.200 Export of new animal drug (21 CFR 510.200). This
section states that to export a new animal drug the product must comply
with regulations issued under section 512 of the act (21 U.S.C. 360b).
This provision has been superseded by changes in the act (see 21 U.S.C.
381).
8. Section 510.310 Records and reports for new animal drugs
approved before June 20, 1963 (21 CFR 510.310). This section sets out
separate requirements for recordkeeping and reporting to the agency for
drugs approved prior to June 20, 1963. These requirements are outdated
and inaccurate. The agency believes it is appropriate to apply the
current recordkeeping and reporting requirements to drugs that were
approved before 1963.
9. Section 510.413 Chloroform used as an ingredient (active or
inactive) in animal drug products (21 CFR 510.413). This section
prohibits the use of chloroform as an ingredient in animal drugs and
provides certain requirements for products that contain chloroform that
must be met by October 3, 1977. Chloroform is no longer used as an
ingredient in any animal drug formulations. Drug formulation is
reviewed by the manufacturing chemists in FDA's Center for Veterinary
Medicine (CVM), and this regulation is no longer necessary.
10. Section 570.22 Safety factors to be considered (21 CFR 570.22).
This section sets out a proposed safety factor to be used by CVM
scientists when there is not justification of a different safety
factor. The safety factors provided in the regulations are
scientifically obsolete for food additives intended for animals and are
best handled within the review process.
II. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354), and Pub.
L. 104-121. Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The agency believes that this final rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the final rule is not a significant regulatory action as
defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the deletions have no compliance costs and
do not result in any new requirements, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required.
Pub. L. 104-121 provides for a major rule is to be effective 60
days after date of publication in the Federal Register or 60 days after
submission of the rule to Congress for review, whichever is later. This
rule is not a major rule for purposes of Pub. L. 104-121. Therefore,
this rule is effective 30 days after date of publication.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(9) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated
biphenyls (PCB's).
21 CFR Part 505
Animal drugs, Labeling, Over-the-counter drugs.
21 CFR Part 507
Animal foods, Packaging and containers, Reporting and recordkeeping
requirements.
21 CFR Part 508
Animal foods.
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 570
Animal feeds, Animal foods, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 500, 505, 507, 508, 510, and 570 are
amended as follows:
PART 500--GENERAL
1. The authority citation for 21 CFR part 500 continues to read as
follows:
Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512,
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331,
342, 343, 348, 351, 352, 353, 360b, 371).
2. Section 500.23 is added to subpart B to read as follows:
Sec. 500.23 Thermally processed low-acid foods packaged in
hermetically sealed containers.
The provisions of part 113 of this chapter shall apply to the
manufacture, processing or packing of low-acid foods in hermetically
sealed containers, and intended for use as food for animals.
3. Section 500.24 is added to subpart B to read as follows:
Sec. 500.24 Emergency permit control.
The provisions of part 108 of this chapter shall apply to the
issuance of emergency control permits for the manufacturer or packer of
thermally processed low-acid foods packaged in hermetically sealed
containers, and intended for use as food for animals.
[[Page 37682]]
Sec. 500.49 [Removed]
4. Section 500.49 Chlorofluorocarbon propellants is removed.
PART 505--[REMOVED]
5. Part 505 is removed.
PART 507--[REMOVED]
6. Part 507 is removed.
PART 508--[REMOVED]
7. Part 508 is removed.
PART 510--NEW ANIMAL DRUGS
8. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.120 [Removed]
9. Section 510.120 Suspension of approval of new-drug applications
for certain diethylstilbestrol and diethylstilbestrol-containing drugs
is removed.
Sec. 510.200 [Removed]
10. Subpart C, consisting of Sec. 510.200, is removed and reserved.
Sec. 510.310 [Removed]
11. Section 510.310 Records and reports for new animal drugs
approved before June 20, 1963 is removed.
Sec. 510.413 [Removed]
12. Section 510.413 Chloroform used as an ingredient (active or
inactive) in animal drug products is removed.
PART 570--FOOD ADDITIVES
13. The authority citation for 21 CFR part 570 continues to read as
follows:
Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348,
371).
Sec. 570.22 [Removed]
14. Section 570.22 Safety factors to be considered is removed.
Dated: July 3, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-18234 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F
