[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Rules and Regulations]
[Pages 41501-41503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18591]



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 Rules and Regulations
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  Federal Register / Vol. 82 , No. 169 / Friday, September 1, 2017 / 
Rules and Regulations  

[[Page 41501]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 300, 441, 530, 531, 532, 533, 534, 537, 539, 540, 541, 
544, 548, 550, 552, 555, 557, 559, 560, and 561

[Docket No. FSIS-2017-0003]


Changes to the Inspection Coverage in Official Establishments 
That Slaughter Fish of the Order Siluriformes

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Response to comments; confirmation of implementation date.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is confirming 
that on September 1, 2017, it will adjust inspection coverage at 
official establishments that slaughter fish of the order Siluriformes 
from all hours of operation to once per production shift. FSIS also is 
responding to comments received on the May 17, 2017 Federal Register 
document that announced these changes.

DATES: FSIS will adjust inspection coverage at official establishments 
that slaughter Siluriformes fish from all hours of operation to once 
per production shift, beginning September 1, 2017.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Deputy Assistant 
Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495, or by Fax: (202) 720-2025.

Background

    On December 2, 2015, FSIS amended its regulations by publishing the 
final rule, ``Mandatory Inspection of Fish of the Order Siluriformes 
and Products Derived from Such Fish'' (80 FR 75590). Fish of the order 
Siluriformes include, but are not limited to, ``catfish'' (fish of the 
family Ictaluridae) and ``basa'' and ``swai'' (fish of the family 
Pangasiidae). For convenience, this notice will use ``fish'' to mean 
all fish of the order Siluriformes.
    Specifically, the final rule established regulations to implement 
the provisions of the 2008 and 2014 Farm Bills, which amended the 
Federal Meat Inspection Act (FMIA) to include fish as amenable and to 
provide for their inspection by FSIS. In the preamble to the final 
rule, FSIS stated that during an 18-month transitional period, it would 
assign inspection program personnel to be present during all hours of 
operation at domestic establishments that slaughter fish and, at the 
start of the period, assign inspection program personnel to conduct 
inspection at processing-only facilities at least quarterly. FSIS also 
stated that it might adjust inspection frequency in fish slaughter 
establishments in the future and, that at the end of the 18-month 
transitional period, inspection program personnel would be assigned at 
least once per day per shift at processing-only establishments (80 FR 
75606).
    On May 17, 2017, FSIS announced and requested comment on its 
decision to adjust inspection coverage at fish slaughter 
establishments, starting September 1, 2017, from all hours of operation 
to once per production shift (82 FR 22609). This decision was based on 
the Agency's experience inspecting official fish slaughter 
establishments since implementing the mandatory inspection program on 
March 1, 2016. FSIS found that the typical fish slaughter operation is 
a streamlined, automated process that combines slaughter with 
processing in the same continuous operation, more like meat processing-
only operations than like slaughter operations for other species 
amenable to the FMIA.
    A consumer advocacy organization requested that FSIS extend the 
comment period by 30 days, so as to make informed comments. FSIS agreed 
and on June 16, 2017, extended the comment period until July 17, 2017 
(82 FR 27680). At the conclusion of the comment period, FSIS had 
received eight comments. After reviewing these comments, FSIS is 
affirming its plan to adjust inspection coverage at official fish 
slaughter establishments from all hours of operation to once per 
production shift, beginning September 1, 2017. Issues raised by the 
comments received and FSIS's responses follow.

Comments and FSIS Responses

    FSIS received eight comments in response to its announced plans to 
adjust inspection coverage at official fish slaughter establishments. 
The comments were from two trade associations, one fish establishment, 
two FSIS inspectors, two consumer advocacy organizations and a foreign 
government. Four of the comments supported the change, agreeing that 
establishments that slaughter fish are most similar in operation and 
design to meat processing-only establishments and, therefore, should be 
inspected like a meat processing-only establishment, as opposed to meat 
slaughter establishments, i.e., once per production shift.
    The comment from the foreign government agreed with the rationale 
for the proposed change, but advocated for even less frequent 
inspection of fish, owing to its position that fish products pose 
little risk to the public health. As stated above, amendments to the 
FMIA in 2008 and 2014 directed FSIS to inspect the preparation of fish 
and fish products. USDA has historically interpreted the requirements 
in the FMIA for inspection of meat processing to mandate inspection at 
least once per production shift. Because FSIS has determined that 
operations in fish slaughter establishments are more like those in meat 
processing-only establishments, it is requiring inspection at a 
frequency of once per production shift there, as well.
    Several of the supportive comments expressed concern that the 
adjustment in inspection frequency would affect an establishment's 
approved hours of operation (typically 8-hour shifts) and charges for 
inspection services outside these hours. It will not. The regulations 
at 9 CFR 307.4 through 307.6, and associated FSIS policies, regarding 
the provision of inspection services, would continue to apply to fish 
establishments. Official fish establishments should coordinate with 
their District Office to determine hours of operation and for 
clarification on what activities require inspection.
    Comments from the two consumer advocacy organizations and from an 
FSIS inspector opposed the change. One of the consumer advocacy 
organizations questioned the Agency's implementation of inspection 
under 21 U.S.C. 606, for both fish and other meat

[[Page 41502]]

products, as allowing for inspection once per shift. This commenter 
further opined that Congress, in fact, intended for FSIS to ``apply a 
greater care in inspecting catfish than with other meat food 
products,'' because of the addition of paragraph (b) under this 
section, which directs USDA to consider the conditions under which fish 
is raised and transported.
    FSIS disagrees. A narrow interpretation of the language in 21 
U.S.C. 606, requiring that each unit of meat product be individually 
inspected by FSIS before movement in commerce, would create enormous 
costs without significantly increasing the effectiveness of inspection. 
USDA has never interpreted this language so narrowly in administration 
of the FMIA at meat processing-only establishments. In regard to the 
new section 21 U.S.C. 606(b), FSIS has determined that this section 
grants the Agency authority to conduct verification activities 
regarding the raising or transport of fish, but does not address the 
frequency of inspection or verification activities regarding the 
preparation of fish. Again, FSIS believes that the risks associated 
with fish slaughter are more closely aligned with meat processing, as 
further confirmed by explicit Congressional exemption of fish from the 
ante-mortem and post-mortem inspection provisions of the FMIA.
    When FSIS inspection program personnel visit meat processing-only 
establishments, they systematically verify compliance with the 
regulatory requirements. Inspectors routinely check the cleanliness of 
equipment and facilities, wholesomeness of incoming source materials, 
processing procedures, Hazard Analysis and Critical Control Point 
(HACCP) records, product labels, as well as other things. In addition, 
they submit samples for analysis, as directed in FSIS's Public Health 
Information System. FSIS inspection program personnel assigned to 
official fish establishments will be instructed to follow the same 
procedures. Therefore, we believe this approach will provide a high 
level of assurance that the fish products are safe, wholesome, and 
properly packaged and labeled, and that the public health will continue 
to be effectively protected by the change in inspection coverage.
    Both comments from consumer advocacy organizations raise concerns 
about the effect of the adjustment in inspection frequency on the 
Agency's programs to ensure the safety of imported fish and fish 
products. One comment contends that FSIS has not considered the 
conditions under which imported fish have been raised or transported. 
The other comment cites the number of shipments of foreign fish and 
fish products rejected by FSIS for import or recalled from commerce, 
because of violative residues found through FSIS testing, as evidence 
that foreign fish production, processing and inspection systems are 
inadequate. The commenter suggests that inspection during all hours of 
operation should be required for foreign slaughter and processing of 
fish intended for import to the United States.
    FSIS does consider the conditions under which imported fish are 
raised and transported through both the equivalence process and its 
testing of imported fish and fish products. When applying to export 
fish and fish products to the United States, a foreign country's 
Central Competent Authority (CCA) must demonstrate to FSIS that it 
ensures fish for export are raised and transported under conditions 
that prevent product adulteration. For example, the CCA must provide 
information regarding how it ensures that fish are not grown or farmed 
under conditions that would cause them to be adulterated; details of 
its sampling of feed, fish or the body of water from which the fish are 
harvested; and information on its program for ensuring that fish are 
transported under sanitary conditions from harvest to processing 
establishments. A foreign country's inspection program cannot be deemed 
equivalent unless the CCA demonstrates that it prevents the 
adulteration of fish during raising and transport.
    Additionally, FSIS tests fish and fish products collected during 
reinspection for chemical residues, Salmonella, and speciation. In 
regard to chemical residues, FSIS tests imported fish for veterinary 
drug residues, including nitrofurans and some fluoroquinolones; 
malachite green; gentian violet; metals and pesticides. This testing 
serves to verify that imported fish were raised under conditions to 
prevent product adulteration and keeps adulterated fish and fish 
products out of United States commerce.
    In regard to inspection frequency for imported fish and fish 
products, the FMIA and the regulations specifically require that 
imported products be held to the same standards as domestic products. 
The FMIA at 21 U.S.C. 620 requires that no product may be imported into 
the United States unless it complies with all applicable provisions of 
the FMIA and the regulations issued thereunder. The fish import 
regulations at 9 CFR 557.3 specifically require that no fish or fish 
product offered for importation from any foreign country shall be 
admitted into the United States if it is adulterated or misbranded or 
does not comply with all the requirements that would apply to it if it 
were a domestic product.
    Therefore, because FSIS will require government inspection of fish 
preparation at least once per production shift, to be determined 
equivalent, a foreign country's fish inspection system must also 
provide government inspection at least once per production shift. FSIS 
sees no basis to impose inspection requirements for imported fish that 
are in addition to those applied to domestic fish. Food safety issues 
with imported fish can be addressed through import reinspection, 
enforcement and the equivalence process.
    Finally, one inspector opposed the change in inspection frequency 
at fish slaughter establishments, expressing concern that the change 
would result in increased workloads for inspectors that are currently 
assigned to these establishments. FSIS disagrees. The change in 
inspection frequency will simply place establishments that slaughter 
fish into ``patrol assignments'' including other meat and poultry 
processing establishments. The inspection workload for affected 
inspectors will be no different than the workload associated with 
current patrol assignments of processing establishments.

USDA Nondiscrimination 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.
    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: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.)

[[Page 41503]]

should contact USDA's TARGET Center at (202)720-2600 (voice and TDD).

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at http://www.fsis.usda.gov/federal-register.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update (CU), 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 constituents 
and stakeholders. The CU is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The CU is also available on the FSIS Web 
page. In addition, FSIS offers an electronic mail 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 to regulations, directives, and notices. Customers can add 
or delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done at Washington, DC on: August 29, 2017.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2017-18591 Filed 8-31-17; 8:45 am]
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