[Federal Register Volume 83, Number 147 (Tuesday, July 31, 2018)]
[Proposed Rules]
[Pages 36797-36799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16339]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318 and 381

[Docket No. FSIS 2016-0032]
RIN 0583-AD66


Preparation of Uninspected Products Outside of the Hours of 
Inspectional Supervision

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: FSIS is proposing to amend the Federal meat and poultry 
products inspection regulations to eliminate prescriptive requirements 
governing the manufacture of uninspected products, such as pet food, in 
edible product areas of official establishments and to allow official 
establishments to manufacture such products outside the hours of 
inspection.

DATES: To receive full consideration, comments should be received by 
August 30, 2018.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by one of the following 
methods:
    <bullet> Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
    <bullet> Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
    <bullet> Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2018-0005. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS regulations at 9 CFR 318.12 and 381.152 govern the manufacture 
of pet food and other uninspected, inedible products in official meat 
and poultry establishments. These regulations set forth prescriptive 
requirements intended to prevent the creation of insanitary conditions 
in official establishments, the commingling of inedible and edible meat 
and poultry products, and the movement of inedible meat and poultry 
products into commerce as human food. They also require that pet food 
and other inedible products be manufactured in official establishments 
only when an FSIS inspector is on premises.
    These prescriptive requirements for the production of pet food and 
other inedible products (e.g., inedible rendered fats, lungs, lung 
lobes, and experimental products) are incompatible with the Hazard 
Analysis and Critical Control Point (HACCP) regulations at 9 CFR part 
417 and the related sanitation regulations at 9 CFR part 416. Under the 
HACCP regulations, establishments are responsible for developing and 
implementing HACCP plans incorporating the controls determined by the 
establishment to be necessary and appropriate to produce safe, 
unadulterated products. Specifically under HACCP, official 
establishments must determine the food safety hazards reasonably likely 
to occur in the production process; institute controls necessary to 
prevent those hazards from occurring or keeping them within acceptable 
limits; monitor the performance of controls and verify the HACCP system 
is working as intended; and maintain required HACCP records. HACCP is a 
flexible system that appropriately places the responsibility for food 
safety on establishments and enables them to tailor their control 
systems to the needs of specific processes and operating conditions.
    Similarly, the Sanitation Performance Standards (SPS) and 
requirements for Sanitation Standard Operating Procedures (SOPs) at 9 
CFR part 416 set forth sanitation objectives to be achieved, while 
allowing establishments to develop and employ innovative and effective 
sanitation procedures customized to the nature of their operations. 
Under the Sanitation SOP regulations, FSIS requires that all inspected 
establishments develop and implement written Sanitation SOPs to prevent 
direct contamination or adulteration of product before and during 
operations. An establishment's Sanitation SOP typically covers the 
scheduled, daily pre-operational and operational cleaning and 
sanitation of equipment and surfaces that may contact product directly. 
Under the SPS regulations, establishments must address all of the other 
aspects of establishment sanitation that can affect food safety, e.g., 
pest control, adequate ventilation, lighting, and plumbing systems.
    Under the HACCP and sanitation requirements, an establishment that 
produces both edible and inedible meat and poultry products must 
develop and implement the controls and procedures necessary to prevent 
the adulteration of edible products by insanitary conditions and 
product commingling, as well as the movement of inedible products into 
commerce as human food. FSIS inspectors verify the implementation and 
effectiveness of these controls through inspection, records review and, 
as necessary, product sampling. Thus, FSIS inspectors do not need to be 
present in an official establishment when it manufactures inedible 
products in order to verify that edible products are not adulterated as 
a result.

Proposed Changes

    FSIS is proposing to eliminate the prescriptive regulatory 
requirements at 9 CFR 318.12 and 381.152 governing the manufacture of 
uninspected, inedible products, such as pet food, and restricting the 
hours during which such products may be prepared in an official 
establishment. Specifically, these regulations set forth specific 
requirements regarding the sanitary handling of inedible products and 
their separation from edible products, as well as the placement, 
movement and cleaning of equipment in areas where inedible product is 
manufactured. They also require that the manufacture of uninspected, 
inedible products be conducted only during those hours in which the 
establishment operates under inspectional supervision. These 
regulations were issued before FSIS published its HACCP and Sanitation 
SOP regulations, when prescriptive regulatory requirements were deemed 
necessary to prevent the adulteration of meat and poultry products by 
the

[[Page 36798]]

preparation of inedible products in the same establishment.
    FSIS is proposing to replace the prescriptive requirements in 9 CFR 
318.12 and 381.152 with general standards governing the manufacture of 
uninspected, inedible products in official establishments. The proposed 
standards require that the manufacture of uninspected products in 
official establishments must not result in the adulteration of meat and 
poultry products, create insanitary conditions whereby meat and poultry 
products may be adulterated, or prevent or otherwise interfere with 
inspection or other program tasks performed by FSIS personnel. 
Establishments that manufacture pet food and other inedible products 
should be meeting these proposed standards already, through the 
implementation of their HACCP plans, Sanitation SOPs or other 
prerequisite programs.

Executive Order 12866 and the Regulatory Flexibility Act

    This proposed rule has been designated as a ``non-significant'' 
regulatory action under section 3(f) of Executive Order (E.O.) 12866. 
Accordingly, the proposed rule has not been reviewed by the Office of 
Management and Budget under E.O. 12866.

Economic Impact Analysis

    As stated above, the HACCP and the sanitation regulations provide a 
framework or food safety system for establishments to produce safe, 
unadulterated product. Compliance with these requirements makes the 
prescriptive requirements in 9 CFR 318.12 and 381.151 unnecessary. 
Because these prescriptive requirements are no longer necessary to 
ensure the production of safe, unadulterated food, removing them will 
have no negative public health impact. In addition, this rule will not 
impose costs on the industry or the Agency.
    Further, removing the unnecessary, prescriptive requirements should 
allow establishments additional flexibility to be innovative and to 
operate in the most efficient manner. Similarly, the rule should also 
allow FSIS to use its resources more appropriately by relieving 
inspectors of unnecessary tasks.

Regulatory Flexibility Act (RFA)

    FSIS has examined the economic implications of the proposed rule as 
required by the RFA (5 U.S.C 601-612). If a rule has a significant 
economic impact on a substantial number of small entities, the RFA 
requires that regulatory options that would lessen the economic effect 
of the rule on small entities be analyzed. FSIS has determined that, 
should it become final, the proposed rule would not have a significant 
impact on a substantial number of small entities.

Executive Order 13771

    This proposed rule, if finalized as proposed, is expected to be a 
deregulatory action under E.O. 13771. Assessment of the costs and cost 
savings may be found in the preceding economic analysis.

Paperwork Reduction Act

    There are no paperwork or recordkeeping requirements associated 
with this proposed rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

E-Government Act

    FSIS and USDA are committed to achieving the purposes 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 citizen access to Government 
information and services, and for other purposes.

Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 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 be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult 
and coordinate with tribes on a government-to-government basis on 
policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that 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.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, the Food Safety and Inspection Service 
will work with the Office of Tribal Relations to ensure meaningful 
consultation is provided where changes, additions and modifications 
identified herein are not expressly mandated by Congress.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email: Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410; 
Fax: (202) 690-7442; Email: <a href="/cdn-cgi/l/email-protection#4030322f2732212d6e292e34212b2500353324216e272f36"><span class="__cf_email__" data-cfemail="9dedeff2faeffcf0b3f4f3e9fcf6f8dde8eef9fcb3faf2eb">[email protected]</span></a>.
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

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 web page located at: 
http://www.fsis.usda.gov/federal-register.
    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 Update is available on the FSIS web page. Through the 
web page, FSIS is able to provide information to a much broader, more 
diverse audience. In

[[Page 36799]]

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: http://www.fsis.usda.gov/subscribe. 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.

List of Subjects

9 CFR Part 318

    Food additives, Food packaging, Laboratories, Meat inspection, 
Reporting and recordkeeping requirements, Signs and symbols.

9 CFR Part 381

    Administrative practice and procedure, Animal diseases, Crime, 
Exports, Food grades and standards, Food labeling, Food packaging, 
Government employees, Grant programs-agriculture, Intergovernmental 
relations, Laboratories, Meat inspection, Nutrition, Polychlorinated 
biphenyls, Poultry and poultry products, Reporting and recordkeeping 
requirements, Seizures and forfeitures, Signs and symbols, Technical 
Assistance, Transportation.

    For the reasons set forth in the preamble, FSIS is proposing to 
amend 9 CFR parts 318 and 381 as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

0
1. The authority citation for part 318 continues to read as follows:

    Authority:  7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 
CFR 2.18, 2.53.

0
2. Section 318.12 is revised to read as follows:


Sec.  318.12  Manufacture of uninspected, inedible products at official 
establishments.

    (a) Official establishments may manufacture pet food or similar 
uninspected, inedible products in areas where edible products also are 
produced, provided that the manufacture of uninspected, inedible 
products does not:
    (1) Adulterate edible products;
    (2) Create insanitary conditions in the official establishment 
whereby edible products may be adulterated; or
    (3) Prevent or interfere with inspection or other program tasks 
performed by FSIS personnel in the official establishment.
    (b) Pet food and similar uninspected, inedible products must be 
distinguished from edible products so as to avoid their distribution as 
human food. Pet food or similar uninspected, inedible products must be 
labeled or otherwise identified in accordance with Sec.  325.11(d) of 
this subchapter.

PART 381--POULTRY PRODUCTS INSPECTIONS REGULATIONS

0
3. The authority citation for part 381 continues to read as follows:

    Authority:  7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 
CFR 2.18, 2.53.

0
4. Section 381.152 is revised to read as follows:


Sec.  381.152  Manufacture of uninspected, inedible products at 
official establishments.

    (a) Official establishments may manufacture pet food or similar 
uninspected, inedible products in areas where edible products also are 
produced, provided that the manufacture of uninspected, inedible 
products does not:
    (1) Adulterate edible products;
    (2) Create insanitary conditions in the official establishment 
whereby edible products may be adulterated; or
    (3) Prevent or interfere with inspection or other program tasks 
performed by FSIS personnel in the official establishment.
    (b) The immediate container of uninspected, inedible products 
manufactured in an official establishment shall be conspicuously 
labeled so as to distinguish them from human food.

    Done in Washington, DC.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-16339 Filed 7-30-18; 8:45 am]
 BILLING CODE 3410-DM-P


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