[Federal Register Volume 61, Number 228 (Monday, November 25, 1996)]
[Proposed Rules]
[Page 59845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30052]



[[Page 59845]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 564

[Docket No. 95N-0313]


Standards for Animal Food and Food Additives in Standardized 
Animal Food

AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to remove 
its animal food standards regulations. This action is in response to 
the administration's ``Reinventing Government'' initiative, which seeks 
to streamline government to ease the burden on regulated industry and 
consumers, and it is intended to remove an unnecessary regulation.

DATES: Comments by February 24, 1997. The agency is proposing that any 
final rule that may be issued based upon this proposal become effective 
30 days after date of publication of the final rule.

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: George Graber, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1724.
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. As part of this initiative, 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outdated or otherwise in need of reform.'' The first results of FDA's 
efforts in implementing the President's plan were published in the 
Federal Register of October 13, 1995 (60 FR 53480).
    In this document, FDA is proposing to remove the regulations in 
part 564 (21 CFR part 564) Definitions and Standards for Animal Food, 
of subchapter E, Animal Drugs, Feeds, and Related Products. Part 564 
contains procedural regulations for establishing standards for animal 
food in subpart A, and regulations applicable to food additives in 
standardized animal food in subpart B. Because the procedures set out 
in part 564 have never been used and because the agency does not 
believe that there is any interest in developing a regulatory standard, 
part 564 is unnecessary. If in the future there were ever to be a 
request from the industry or elsewhere to develop an animal food 
standard regulation, the agency could determine whether procedural 
regulations are necessary and issue such procedures through the notice 
and comment rulemaking process as the standard was being developed.

II. Analysis of Impacts

    FDA has examined the impact of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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 this proposed rule would remove a regulation 
that is not being applied, the agency certifies that the proposed 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.

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.

IV. Request for Comments

    Interested persons may, on or before February 24, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 564

    Animal foods, Food additives.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that Title 21 chapter I be amended as follows:

 PART 564--DEFINITIONS AND STANDARDS FOR ANIMAL FOOD


 Part 564  [Removed]

     Part 564 is removed.

    Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-30052 Filed 11-22-96; 8:45 am]
BILLING CODE 4160-01-F