Rule2022-10885
Removal of 9 CFR 355-Certified Products for Dogs, Cats, and Other Carnivora; Inspection, Certification, and Identification as to Class, Quality, Quantity, and Condition
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 20, 2022
Effective
July 19, 2022
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
The Food Safety and Inspection Service (FSIS) is amending its regulations to end the program under which FSIS inspectors provide fee- for-service certification that certain foods for dogs, cats and other carnivora (pet food) are produced under sanitary conditions and meet compositional and labeling requirements. The certified pet food regulations are outdated, and no firms are paying for FSIS certification services for pet food. Further, the fact that both the United States Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) maintain regulations concerning pet food has led to industry and consumer confusion. Both agencies agreed that stakeholders will benefit from the simplification of Federal jurisdiction over pet food.
Full Text
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[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Rules and Regulations]
[Pages 30773-30775]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10885]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 355
[Docket No. FSIS-2020-0013]
RIN 0583-AD83
Removal of 9 CFR 355--Certified Products for Dogs, Cats, and
Other Carnivora; Inspection, Certification, and Identification as to
Class, Quality, Quantity, and Condition
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its
regulations to end the program under which FSIS inspectors provide fee-
for-service certification that certain foods for dogs, cats and other
carnivora (pet food) are produced under sanitary conditions and meet
compositional and labeling requirements. The certified pet food
regulations are outdated, and no firms are paying for FSIS
certification services for pet food. Further, the fact that both the
United States Department of Agriculture (USDA) and the U.S. Food and
Drug Administration (FDA) maintain regulations concerning pet food has
led to industry and consumer confusion. Both agencies agreed that
stakeholders will benefit from the simplification of Federal
jurisdiction over pet food.
DATES: Effective July 19, 2022.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On July 28, 2021, FSIS proposed to remove the certified pet food
provisions (9 CFR part 355) from the regulations because they are
outdated and no companies use the voluntary service. In addition,
because FDA also maintains regulations concerning pet food, the FSIS
regulations have led to industry and consumer confusion (86 FR 40369).
As FSIS explained in the proposed rule, under the Federal Food,
Drug, and Cosmetic Act (FFDCA), FDA is responsible for ensuring that
pet food is safe for animals, produced under sanitary conditions,
contains no harmful substances, and is truthfully labeled. FDA has had
authority to regulate pet food since the FFDCA was passed in 1938. FDA
does not charge pet food producers a fee for any FDA activities related
to pet food. Individual States also regulate and inspect pet food,
which also minimizes the need for FSIS's program.
Since 1958, under the Agricultural Marketing Act (7 U.S.C.
1622(h)), USDA also provided for the voluntary certification of pet
food as having been produced under sanitary conditions and meeting
compositional and labeling requirements. Under the regulations at 9 CFR
part 355, participating facilities pay for this certification. The
regulations governing FSIS certification services for pet food have not
been substantively amended since the 1960s; therefore, the requirements
are outdated (e.g., requirements regarding pet food ingredients and the
submission of firm blueprints). Additionally, the regulations allow for
certification of
[[Page 30774]]
only certain categories of pet food (i.e., canned or semi-moist
maintenance food, canned or fresh frozen certified supplemental animal
foods, and canned certified variety meats). Many types of pet foods
that were developed in the last few decades are thus not eligible for
FSIS certification (e.g., pet jerky, pet treats, pet rawhides, raw pet
food, freeze-dried pet food, and prescription pet food). Likely for
these reasons, no firms are participating in the FSIS certified pet
food program.
After considering the comments received on the proposed rule,
discussed below, FSIS is finalizing the proposed rule without changes.
Summary of Comments and Responses
FSIS received 149 comments on the proposed rule from individuals
and pet food industry groups. Below is a summary of the comments
received and FSIS' responses.
Comments: FSIS received comments from several individuals and two
industry groups that supported the removal of 9 CFR part 355. These
commenters agreed that FSIS' voluntary pet food certification program
is outdated and that having pet food under the jurisdiction of a single
Federal agency will eliminate confusion by pet food consumers and
manufacturers.
FSIS also received comments from pet food buyers and an industry
group stating that FSIS should update its certified pet food program
instead of removing it. The commenters suggested rewriting the
regulation to remove obsolete references and updating the language to
reflect more modern types of pet food.
Response: FSIS is not updating its certified pet food program
because it would not be the best use of Agency resources. As noted
above, no companies are currently participating in the FSIS certified
pet food program, and FDA is responsible for ensuring that pet food is
safe for animals, produced under sanitary conditions, contains no
harmful substances, and is truthfully labeled.
Comments: Several individuals argued that FSIS should not remove
its certified pet food program because they disagree with FDA's pet
food inspection regulations. These individuals stated that FSIS'
requirements are stricter than FDA's requirements.
Response: This final rule will not impact the safety of pet food
products. As explained above and in the proposed rule (86 FR 40369), no
firms are participating in FSIS' certified pet food program. Comments
on FDA's regulation of pet food are outside the scope of this
rulemaking.
Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This final rule has been designated as a ``non-significant'' regulatory
action under section 3(f) of E.O. 12866. Accordingly, the rule has not
been reviewed by the Office of Management and Budget (OMB) under E.O.
12866.
Expected Costs and Benefits of the Final Rule
This final rule clarifies that FDA has sole jurisdiction over pet
food inspection, which benefits industry and consumers by reducing
confusion. No firms are participating in the FSIS certified pet food
program. Therefore, the final rule will not increase industry or Agency
costs or have a negative impact on public health.
Regulatory Flexibility Act Assessment
The FSIS Administrator certifies that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule is not
expected to increase costs to industry.
Paperwork Reduction Act
There are no new paperwork or recordkeeping requirements associated
with this final rule under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
Executive Order 13175
This proposed rule will have no implications for Indian Tribal
governments. More specifically, it does not have substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal government and Indian tribes, or on the distribution of power
and responsibilities between the Federal government and Indian tribes.
Therefore, the consultation requirements of Executive Order 13175 do
not apply.
Environmental Impact
Pursuant to the National Environmental Policy Act (42 U.S.C. 4321,
et seq.) (NEPA), Federal agencies must prepare an environmental impact
statement (EIS) for any ``major Federal actions significantly affecting
the quality of the human environment'' (42 U.S.C. 4332(2)(C)). NEPA
established the Council on Environmental Quality (CEQ), which
promulgated regulations (40 CFR parts 1501-1508) to govern NEPA
compliance. When a major Federal action is unlikely to have significant
environmental effects or the significance of the effects is unknown,
the Agency may prepare an environmental assessment (EA) (40 CFR
1501.3(a)(2), 1501.5) (2020). Federal agencies also may identify
classes of actions that normally do not have significant environmental
effects and therefore do require the preparation of either an EA or EIS
(40 CFR 1501.4(a)). Such classes of actions are ``categorically
excluded'' from NEPA review unless extraordinary circumstances exist in
which a normally excluded action may have a significant environmental
effect (40 CFR 1501.3(a)(1), 1501.4)).
USDA's NEPA implementing regulations establish a categorical
exclusion for specified categories of actions and the actions of
certain USDA agencies and agency units (7 CFR 1b.3, 1b.4). USDA has
determined that the listed agencies, including FSIS (7 CFR 1b.4(b)(6)),
``conduct programs and activities that have been found to have no
individual or cumulative effect on the human environment'' (7 CFR
1b.4(a)). Accordingly, all FSIS actions are categorically excluded from
preparation of an EA or EIS unless the Agency head determines that a
particular action may have a significant environmental effect (Id.).
The action thus is categorically excluded unless FSIS anticipates that
extraordinary circumstances from ending the certification program may
have a significant environmental effect (7 CFR 1501.4(b)). This final
rule, which removes 9 CFR 355 from the Code of Federal Regulations,
will not create any extraordinary circumstances that will result in
this normally excluded action having a significant effect on the human
environment. Therefore, this action is appropriately subject to the
categorical exclusion from the preparation of an environmental
assessment or environmental impact statement provided under 7 CFR 1b.4
of the USDA regulations.
Executive Order 12988, Civil Justice Reform
This final rule has been reviewed under E.O. 12988, Civil Justice
Reform. Under this rule: (1) All State and local laws and regulations
that are inconsistent with this rule will be preempted; (2) no
retroactive effect will
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be given to this rule; and (3) no administrative proceedings will be
required before parties may file suit in court challenging this rule.
E-Government Act
FSIS and USDA are committed to achieving the purpose of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the internet and other information technologies
and providing increased opportunities for citizens access to Government
information and services, and for other purposes.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS website located at:
<a href="https://www.fsis.usda.gov/policy/federal-register-rulemaking">https://www.fsis.usda.gov/policy/federal-register-rulemaking</a>.
FSIS also will make copies of this publication available through
the FSIS Constituent Update, which is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, and other types of information that
could affect or would be of interest to our constituents and
stakeholders. The Constituent Update is available on the FSIS website.
Through the website, FSIS is able to provide information to a much
broader, more diverse audience. In addition, FSIS offers an email
subscription service which provides automatic and customized access to
selected food safety news and information. This service is available
at: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. Options range from recalls to
export information, regulations, directives, and notices. Customers can
add or delete subscriptions themselves and have the option to password
protect their accounts.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801, et seq.),
the Office of Information and Regulatory Affairs has determined that
this rule is not a ``major rule,'' as defined by 5 U.S.C. 804(2).
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and USDA civil rights
regulations and policies, the USDA, its Agencies, offices, and
employees, and institutions participating in or administering USDA
programs are prohibited from discriminating based on race, color,
national origin, religion, sex, gender identity (including gender
expression), sexual orientation, disability, age, marital status,
family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the responsible
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> and
at any USDA office or write a letter addressed to USDA and provide in
the letter all of the information requested in the form. To request a
copy of the complaint form, call (866) 632-9992. Submit your completed
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture,
Office of the Assistant Secretary for Civil Rights, 1400 Independence
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3)
email: <a href="/cdn-cgi/l/email-protection#4e3e3c21293c2f236027203a2f252b0e3b3d2a2f60292138"><span class="__cf_email__" data-cfemail="88f8fae7effae9e5a6e1e6fce9e3edc8fdfbece9a6efe7fe">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
List of Subjects in 9 CFR Part 355
Animal foods, Certified pet food, Labeling, Meat inspection,
Packaging and containers, Reporting and recordkeeping.
PART 355--[REMOVED AND RESERVED]
0
For the reasons set out in the preamble, and under the authority of 7
U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), and 2.55, FSIS removes 9 CFR
part 355.
Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2022-10885 Filed 5-19-22; 8:45 am]
BILLING CODE 3410-DM-P
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