[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Rules and Regulations]
[Pages 4293-4294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2057]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to remove its animal food standards regulations. The 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 
unnecessary regulations.

DATES: This final rule becomes effective on March 1, 1999.

FOR FURTHER INFORMATION CONTACT: George Graber, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6651, E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 25, l996 (61 FR 59845), FDA 
published a proposed rule that would remove part 564 (21 CFR part 564), 
Definitions and Standards for Animal Food, of subchapter E, Animal 
Drugs, Feeds, and Related Products. Subpart A of part 564 contains 
procedural regulations for establishing standards for animal food, and 
subpart B contains regulations applicable to food additives included in 
standardized animal foods.
    FDA continues to believe, as stated in the preamble to the proposed 
rule, that because neither FDA nor the private sector has ever used the 
procedures in part 564 to develop a regulatory standard, part 564 is 
unnecessary. Further, should FDA ever receive a request 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. Response to Comments

    Forty-two comments were received on the proposed rule. Four 
comments were from organizations and the remainder from individuals. 
The majority of comments appear to have been prompted by an ``Action 
Alert'' (Alert) issued by one organization that states that there is no 
Federal regulation of animal food. The Alert states that enforcement is 
inconsistent and that standards for animal nutrition are inadequate.
    1. Thirteen comments were identical form letters that repeat 
virtually the same language contained in the Alert, but concluding with 
the statement ``Apparently, there is no interest by your department, 
the FDA, in developing a regulatory standard for animal and food

[[Page 4294]]

additives, although there is a need for such standards. Therefore, the 
current regulation should be eliminated as a part of President 
Clinton's `Reinventing Government' initiative.''
    2. Twelve comments digress from the issue at hand, to discuss 
topics such as bovine spongiform encephalopathy or other animal food 
safety matters that do not relate to part 564.
    3. The remaining comments paraphrased the form letter mentioned 
previously. Many included the erroneous statement that ``At the present 
there is NO federal regulation of animal food,'' adding that regulation 
is only at the State level. The comments inaccurately concluded that 
part 564 provides our only authority to regulate animal foods, implying 
that in this regulation's absence we have no authority to regulate.
     FDA disagrees with comments that suggest removal of part 564 
adversely affects the agency's authority to regulate animal food. A 
misconception of FDA's regulatory authority apparently exists, because 
the agency has never relied on part 564 for regulation of animal food. 
FDA's authority under the Federal Food, Drug, and Cosmetic Act (the 
act), and the regulations under 21 CFR part 501 (labeling), 21 CFR part 
502 (common or usual names), 21 CFR part 509 (contaminants), 21 CFR 
parts 570, 571, and 573 (food additives), 21 CFR part 579 
(irradiation), 21 CFR part 582 (generally recognized as safe (GRAS) 
substances), and 21 CFR part 589 (prohibited substances), provide 
adequate authority for the needed regulation of animal food formulation 
and labeling.
    The act prohibits the sale of adulterated and misbranded food in 
interstate commerce. The definition of food relates to food for man or 
animal, i.e., feed. The act also allows the agency to establish 
standards of identity or standards of fill as needed. However, there 
has been no interest or perceived need by the agency or other parties 
in developing standards under part 564.
    In addition to the existing regulations and statute cited 
previously, FDA and State regulatory authorities recognize the common 
feed ingredient definitions established by the Association of American 
Feed Control Officials (AAFCO) with input from FDA. Feed ingredient 
definitions consist of specifications established to standardize feed 
ingredients to ensure that the production, sale and use of ingredients 
will result in safe and effective feeds. AAFCO has also developed 
standards, such as the AAFCO Dog and Cat Nutrient Profiles and Feeding 
Protocols, to help ensure that pet foods contain ingredients needed to 
meet the animals' nutritional requirements. FDA considers these 
protocols to be acceptable and appropriate for the evaluation of 
performance characteristics of commercial foods for dogs and cats.
    The definitions and standards that AAFCO issues have served as 
models for State laws and regulations covering feed ingredients and 
their proper labeling. Because most pet food manufacturers market 
products in more than one State, those companies are obligated to 
manufacture and label pet food products to be in compliance with both 
FDA and State laws. Thus, the agency finds no basis to conclude that 
removal of part 564 would adversely affect the authority to regulate 
animal food.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), 
and under the Unfunded Mandates Reform Act (Pub. L. 104-4). 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, and distributive impacts and equity). The Regulatory 
Flexibility Act requires agencies to examine the economic impact of a 
rule on small entities. The Unfunded Mandates Reform Act requires 
agencies to prepare an assessment of anticipated costs and benefits 
before enacting any rule that may result in an expenditure in any 1 
year by State, local and tribal governments, in the aggregate, or by 
the private sector, of $100 million (adjusted annually for inflation). 
The agency has reviewed this final rule and has determined that the 
rule is consistent with the principles set forth in the Executive Order 
and in these two statutes. FDA finds that the rule will not be a major 
rule under the Executive Order.
    The rule would remove the regulations establishing standards for 
animal foods, since neither FDA nor the private sector have ever used 
the procedures for developing a regulatory standard. FDA is taking this 
action in response to the administration's ``Reinventing Government'' 
initiative which seeks to remove unnecessary regulations.
    FDA, in accordance with the Regulatory Flexibility Act, has 
considered the effect that this rule will have on small entities, 
including small businesses, and certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
FDA has also analyzed this rule in accordance with the Unfunded 
Mandates Reform Act and determined that the rule will not result in the 
expenditure by State, local, and tribal Governments, in the aggregate, 
or by the private sector of $100 million. Therefore, no further 
analysis is required.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

V. The Paperwork Reduction Act of 1995

    FDA tentatively concludes that this final rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

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, 21 CFR part 
564 is removed and reserved.

PART 564--DEFINITIONS AND STANDARDS FOR ANIMAL FOOD

    1. Part 564 is removed and reserved.

    Dated: January 22, 1999.
William K. Hubbard,
Associate Deputy Commissioner for Policy.
[FR Doc. 99-2057 Filed 1-27-99; 8:45 am]
BILLING CODE 4160-01-F