[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: ggraber@bangate.fda.gov.
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
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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
