Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients, 101501-101514 [2024-29129]

Agencies

• DEPARTMENT OF COMMERCE
• National Oceanic and Atmospheric Administration

[Federal Register Volume 89, Number 241 (Monday, December 16, 2024)]
[Rules and Regulations]
[Pages 101501-101514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29129]


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DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

50 CFR Part 260

[241206-0315]
RIN 0648-BH37


Inspection and Certification of Establishments, Fishery Products, 
and Other Marine Ingredients

AGENCY: National Marine Fisheries Service (NMFS or Agency), National 
Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION: Final rule.

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SUMMARY: The NMFS Office of International Affairs, Trade, and Commerce 
is revising its current implementing regulations to improve the 
uniformity and reliability of seafood inspection services by adopting 
recognized best practices for inspection. NMFS has not significantly 
revised or updated the existing regulations since first issuing them in 
1971, though it has modified many operating procedures since 
implementation of the current regulations. NMFS anticipates that these 
revisions will benefit the seafood industry by streamlining seafood 
inspection services and providing improved, more accurate inspection 
results.

DATES: This final rule is effective January 15, 2025.

ADDRESSES: Public comments and materials received and used in the 
preparation of this final rule are available online at https://www.regulations.gov in docket number NOAA-NMFS-2024-0061. In case of 
problems accessing these documents, please use the contact listed here 
(see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Melissa Beaudry, Senior Consumer 
Safety Officer, Seafood Inspection Program, National Marine Fisheries 
Service Office of International Affairs, Trade, and Commerce by email 
at [email protected] or by phone at 301-427-8308.

SUPPLEMENTARY INFORMATION:

[[Page 101502]]

Background

    Under the authority of the Agricultural Marketing Act (AMA) of 1946 
(7 U.S.C. 1621 et seq.), and in accordance with the Reorganization Plan 
Number 4 of 1970 (84 Stat. 2090), NOAA administers a voluntary Seafood 
Inspection Program (SIP or Program) which offers inspection and grading 
services for seafood and other marine products, as well as audit and 
consultative services to domestic and international processors, 
importers, and international competent food safety authorities. SIP 
also authorizes the use of certain marks and shields to processors 
meeting specific safety, quality, and other program requirements. The 
existing regulations codified at 50 CFR part 260 have not been 
significantly revised or updated since NMFS first issued them in 1971, 
36 FR 21037 (November 3, 1971), and currently do not reflect the 
changes in industry practices or the expanding role of SIP since that 
time. NMFS published a notice of proposed rulemaking (89 FR 31690, 
April 25, 2024) and requested comments for 30 days. SIP received six 
public comments during the 30-day comment period. We reviewed and 
considered all comments received in development of this final rule. All 
substantive comments received on the proposed rule are addressed in 
this final rule in the Comments and Responses section.

Comments and Responses

    We published the proposed rule in the Federal Register on April 25, 
2024 (89 FR 31690), with a 30-day comment period. During the 30-day 
comment period, we received six comment submissions. The comments 
received were from stakeholders and interested parties on focused areas 
of the Seafood Inspection Program. NMFS appreciates the thoughtful 
comments representing a diverse set of views and has considered them 
thoroughly. The comments generally expressed support of the action by 
the NMFS Office of International Affairs, Trade, and Commerce to revise 
its current implementing regulations to improve the uniformity and 
reliability of seafood inspection services by adopting recognized best 
practices for inspection. There was general support by commenters for 
the intent to modernize and move language from regulation to the online 
SIP Manual. There was also general support for simplifying the 
administrative, inspection, and certification procedures, updating and 
consolidating grade standards wherever possible, and SIP's effort to 
improve the uniformity and reliability of seafood inspections services. 
Our responses to all comments that are pertinent to this action are 
described below.
    Comment 1: Some commentators recommended that periods of public 
comment be longer than 30 days, and that NMFS should give all 
operational alterations, including ones such as this proposed rule, at 
least nine weeks of industry consideration. There was also a request 
for industry-facing seminars/informational sessions, as well as 
consideration for seasonal timing impacts and that all change actions 
allow for industry dialogue and participation going forward.
    Response: A 30-day comment period is generally considered by courts 
to be sufficient to allow for meaningful public participation pursuant 
to the Administrative Procedure Act. Longer comment periods may be 
necessary where a rule is technically complex or lengthy. However, as 
the proposed rule codified NMFS's current practices and did not make 
any changes to NMFS's operation, a longer comment period was not 
necessary. NMFS does agree that before implementing any changes to 
policy that will affect how industry operates or responds, they will 
notify industry and engage in dialogue to ensure all parties understand 
the changes and have sufficient time to implement any changes required.
    Comment 2: One commenter asked NMFS to focus on Gulf shrimp and 
raise tariffs against Thai shrimp.
    Response: The authority to raise tariffs against any country or 
product is outside the scope and regulatory authority of the NMFS SIP.
    Comment 3: One commenter asked whether NMFS conferred with FDA 
(U.S. Food and Drug Administration) regarding definitions of ``fish'', 
``fishery product'', ``inspection service'', ``product'', 
``wholesome.'' Similarly, another commenter recommended examination of 
the final definitions for clarity, as well as the inclusion of sourcing 
for each new definition implemented in the event industry needs 
additional guidance.
    Response: NMFS confirms that the FDA reviewed and provided feedback 
on the proposed rule prior to publication. The definitions used in the 
proposed rule are also in alignment with the definitions in current 
regulations, both under 50 CFR part 260 and 21 CFR parts 123 and 117. 
In the proposed rule, the definition for ``fish'' was revised from ``. 
. . other than birds or mammals, and all mollusks, . . .'' to ``. . . 
other than birds or mammals, and including all mollusks, . . .'' to 
help clarify that all mollusks are defined as fish, which has been a 
source of confusion since the HACCP regulations in 21 CFR part 123 were 
implemented. The definition of fish was also expanded to include 
``other non-food uses.'' These definitions remain unchanged in the 
final rule. NMFS disagrees with the need to source definitions, as the 
terms defined here pertain specifically to use within this regulation 
and source definitions to the use of these terms in other contexts 
would not provide accurate guidance to industry.
    Comment 4: One commenter noted that some definitions refer to 
``animal'' consumption (fish, inspection services) and others do not 
include ``animal consumption'' (fishery product, product, wholesome).
    Response: The inclusion of ``animal'' or ``animal consumption'' in 
definitions varies based on the end use of the product. The definitions 
for ``fish'' and ``inspection services'' identify that the end use of 
the product could be for consumption other than as human food. NMFS 
inspects and certifies a variety of non-human food fishery products, 
whether they be for animal feed, use in making animal food, or other 
industrial uses. The terms ``fishery product'' and ``wholesome'' refer 
specifically to the end use being for human consumption. The definition 
for ``product'' does not include the word ``animal'', but conveys that 
end use with the phrase ``whether or not destined for human 
consumption''.
    Comment 5: Several commenters asked how NMFS will notify industry 
of changes to the online manual. For example, one commenter suggested 
highlighting or striking out changes, or listing date(s) of revisions 
on each title page for transparency. Another commenter suggested that 
SIP establish a method of providing a summary of any modifications to 
the NMFS Fishery Products Inspection Manual (SIP Manual or Manual) so 
stakeholders are aware of and can locate the changes. A third commenter 
recommended a regular update period for the Manual, wherein industry 
may expect to review potential new Manual language annually or 
biannually, rather than needing to react to NMFS actions on short 
timelines when they are communicated. Another commenter recommended 
that amendments to the Manual or other policy changes be marked and 
displayed in ways that make it easy for users to see what is changing 
and how.
    Response: NMFS agrees that changes to the online SIP Manual should 
be communicated to the public in a timely manner and in a transparent 
way.

[[Page 101503]]

However, NMFS declines to adopt the suggestion to strike out or 
highlight changes in the Manual as this could create confusion and make 
the Manual more difficult to navigate. Additionally, restricting 
updates to only once or twice a year would make the online format less 
flexible, undermining NMFS' goal for the Manual to remain current and 
up to date. Therefore, NMFS will continue to make updates when needed, 
but will make sure to notify all stakeholders and/or staff members when 
changes are made that affect the way in which they interact with NMFS 
SIP. Currently, NMFS adds revision dates to chapter and section 
headings when changes occur to highlight such updates for stakeholders 
and will continue to assess practices which support transparency.
    Comment 6: Several commenters noted that moving procedural changes 
into the Manual will make future changes easier, but is less 
transparent than the formal rulemaking process and can limit the 
opportunity for stakeholder engagement afforded through the open 
comment periods of FR notices. Similarly, some commentators noted that 
the move to the online Manual has led to confusion as to how and when 
updates take place.
    Response: Proposed changes to NMFS SIP policy or operational 
procedures that run counter to current regulations will continue to 
follow the formal rulemaking process, including public notice and 
opportunity for comment. Changes to NMFS SIP's day-to-day operational 
procedures or policies that do not run counter to current regulations 
may be updated in the Manual as needed, with ample notice of these 
changes given to the public. Changes such as updates to the SIP fees 
schedule or new Grade Standards, will also continue to be published in 
the Federal Register.
    Comment 7: One commenter requested that NMFS allow users time to 
make changes to their programs before implementing compliance actions 
whenever the Manual is updated.
    Response: NMFS agrees that whenever the Manual is updated with 
changes required to operational procedures, time will be given to 
stakeholders to fully understand and implement the changes. NMFS also 
will continue to provide outreach and training when changes necessitate 
a more involved response from stakeholders.
    Comment 8: One commenter wrote that NMFS should hold informational 
sessions for users when making revisions so the users can better 
understand the new or revised criteria.
    Response: NMFS agrees that outreach is beneficial to both 
stakeholders and SIP when substantial changes to a system or procedure 
are enacted, and will continue to engage in such activities with 
stakeholders when warranted.
    Comment 9: One commenter wrote that NMFS must ensure that latest 
standards and Sensory Quality indicators are readily available to users 
so they can meet the criteria.
    Response: NMFS agrees that all standards and criteria must be 
available and informed to users prior to their implementation, and will 
continue to ensure that happens. The SIP Manual is updated in real-time 
as new methodologies and standards are developed and employed, and 
whenever clarification is required. Emailed notices go out broadly to 
industry members and program participants when these changes occur, and 
all relevant standards and criteria are housed in the online Manual, 
which is available to the public on the NMFS website at https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual.
    Comment 10: One commenter wrote that moving to the proposed ``one 
size fits all'' sampling plan of six and zero is a significant 
departure from the current sampling plans. The proposed changes to the 
sampling plan will not have the positive impact for firms who currently 
use a sampling plan with a sample size of three or four. A sampling 
plan allowing for more samples and specific number of non-conformances 
should still be allowed. Further, National Fisheries Institute 
disagrees with the assessment that the proposed rule will not have a 
significant economic impact on small entities. The proposed sampling 
plan of six and zero will influence inspection and destructive sampling 
costs for many SIP participants in a negative way.
    Response: NMFS previously experimented with the model sampling plan 
of six and zero (sample size of six with zero non-conforming units) and 
found that it did not have the overall positive impact expected. 
Therefore, NMFS has decided not to go forward with the proposed six and 
zero sampling plan, and will continue to use the single and multiple 
sampling plans formerly found in 50 CFR 260.61, which are also found in 
the Manual. NMFS also allows the use of other validated and 
internationally recognized sampling plans, and participants are 
encouraged to use the sampling plan that works best for their 
situation.
    Comment 11: One commenter suggested that NMFS consider changing the 
way we test for Paralytic Shellfish Poisoning (PSP).
    Response: The mouse bioassay is the current regulatory method for 
determining the presence of PSP and other toxins in shellfish in the 
United States, and is recognized internationally. Changing the approved 
methodology falls outside the scope of NMFS' regulatory authority.
    Comment 12: Several commenters asked how NMFS would cover other 
marine ingredients, such as algae and kelp, which are not covered by 
FDA under 21 CFR part 123.
    Response: NMFS, as the U.S. Competent Authority for export health 
certification for fishery products for human consumption, has for years 
been providing export certification for products such as edible algae 
and kelp when requested by stakeholders, in an effort to keep trade 
flowing. This expansion of NMFS to non-consumer and other marine 
products is an opportunity to facilitate trade for U.S. businesses. The 
inclusion of non-human-consumption fish and fishery products and other 
marine ingredients to the program allows U.S. businesses to compete 
better with industry members from other countries in providing these 
valuable resources to the worldwide marketplace. Adding inspection and 
certification services for non-food, by-products, and other marine 
ingredients in this regulation codifies the ability of NMFS to provide 
services to businesses trading in marine products that traditionally 
the FDA and the U.S. Department of Agriculture (USDA) Food Safety and 
Inspection Service (FSIS) do not provide.
    Comment 13: One commenter wrote that NMFS should be more 
transparent with costs and billing invoices and be more aware of their 
impact to industry users. Another commenter requested further 
consideration into how the payment structure can be adjusted to allow 
industry to better anticipate and absorb these costs, as well as 
implementing controls to minimize overtime and holiday work by 
auditors.
    Response: NMFS strives to maintain fairness and equity in all 
billing processes. When an inspector travels to conduct multiple audits 
at multiple facilities in one geographic location, the total travel 
expenses are divided equally among all facilities involved in that 
trip, while the actual audit time per facility is charged directly. The 
regional inspection offices manage their personnel and duty 
assignments, and to the extent practical, manage working hours to avoid 
overtime and holiday work. However, given the nature of the industry, 
inspections often have to take

[[Page 101504]]

place on evenings, weekends, and holidays due to the constraints of 
specific requests. For example, live product that requires inspection 
and/or certification and is harvested and shipped on a weekend also 
requires weekend work from an inspector. SIP rates are analyzed 
annually and updated as needed to ensure that NMFS recovers as nearly 
as possible the operating expenses of the Program, without generating a 
profit.
    Comment 14: Several commenters wrote that SIP inspectors and 
industry will need time to adjust to the changes in the final rule. 
Companies will need time to make internal changes to their 
documentation and procedures, as well as train employees. Commenters 
further noted that NOAA should recognize the seasonal contracts for 
inspection services to allow for sufficient timing and outreach to 
these participants.
    Response: Since the proposed rule did not make any changes to the 
way in which NMFS SIP currently operates, the agency does not believe 
that an adjustment period is necessary. NMFS does agree that before 
implementing any changes to policy that will affect how industry 
operates or responds, stakeholders will be notified and engaged in 
dialogue to ensure all parties understand the changes and have 
sufficient time to implement any changes required.
    Comment 15: One commenter wrote that NMFS being the only 
organization to provide export health certification and grading for 
other agency purchases does not make it a true voluntary program if 
industry wants to distribute and market their seafood products in a 
global community.
    Response: NMFS offers services to industry that are required as 
part of doing business in the international arena, or with the U.S. 
Government Purchasing Programs. Since SIP operates as a fee-for-service 
agency, and does not have appropriated funding, it is necessary to 
charge for these services. NMFS calculates the rates to recover as 
nearly as possible the operating costs of the Program without 
generating a profit, and analyzes and adjusts them annually. NMFS does 
not mandate the inspections and certification required from importing 
countries and other U.S. Government agencies, but is the Competent 
Authority within the U.S. Government to provide inspection and export 
certification for fish and fishery products. SIP's provision of those 
services allows customers to participate in international trade and 
government purchase programs only if they choose to do so, and at the 
level they choose to participate. NMFS represents the U.S. in 
negotiations with other countries regarding their import requirements, 
and works to reduce the inspection and certification burdens imposed on 
U.S. exporters.

Changes From the Proposed Rule

    NMFS made no changes to the regulatory text from the proposed rule 
to the final rule. NMFS made one change regarding a sampling approach 
that was described in the proposed rule preamble. SIP has decided not 
to go forward with the proposed six and zero sampling plan, and will 
continue to use the single and multiple sampling plans formerly found 
in 50 CFR 260.61, which are also found in the Manual.

Classification

    This final rule is published under the authority of the 
Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621 et seq.). 
The NMFS Assistant Administrator has determined that this final rule is 
consistent with the provisions of this and other applicable laws.

Executive Order 12866

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866.

Executive Order 13175

    A Tribal summary impact statement under section (5)(b)(2)(B) and 
section (5)(c)(2)(B) of E.O. 13175 was not required for this final rule 
because this action does not impose substantial direct compliance costs 
on Indian Tribal Governments and this action does not preempt Tribal 
law. A Tribal summary impact statement is not required and none has 
been prepared.

Final Regulatory Flexibility Act

    The Chief Counsel for Regulation of the Department of Commerce 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration (SBA) that this final rule would not have a significant 
economic impact on a substantial number of small entities. The factual 
basis for the certification was published in the proposed rule and is 
not repeated here. No comments were received regarding this 
certification, and the initial certification remains unchanged. As a 
result, a final regulatory flexibility analysis is not required and 
none has been prepared.

National Environmental Policy Act

    Under NOAA Administrative Order (NAO 216-6A), the promulgation of 
regulations that are administrative, financial, legal, technical or 
procedural in nature are categorically excluded from the requirement to 
prepare an Environmental Assessment. This final rule to update 50 CFR 
part 260 is procedural and administrative in nature, in that it merely 
reflects the actual operations of the SIP today. Neither fishing 
activity nor trade in seafood products are further restricted relative 
to any existing laws or regulations, either foreign or domestic. Given 
the procedural and administrative nature of this rulemaking, an 
Environmental Assessment was not required and none has been prepared.

Paperwork Reduction Act

    This final rule does not contain a change to a collection of 
information requirement for purposes of the Paperwork Reduction Act of 
1995. The existing collection of information requirements would 
continue to apply under the following OMB Control Number: 0648-0266, 
Seafood Inspection and Certification Requirements. Notwithstanding any 
other provision of the law, no person is required to respond to, nor 
shall any person be subject to a penalty for failure to comply with, a 
collection of information subject to the requirements of the PRA, 
unless that collection of information displays a currently valid OMB 
Control Number.

List of Subjects in 50 CFR Part 260

    Inspection, Inspection Services, Certification, Approved 
Establishment, Sampling, Imports, Exports, Fish and Fisheries Products, 
Marine Ingredients, Grade Standards, Marks.

    Dated: December 6, 2024.
Samuel D. Rauch III,
Deputy Assistant Administrator for Regulatory Programs, National Marine 
Fisheries Service.


0
For the reasons set out in the preamble, NMFS revises 50 CFR part 260 
as follows:

PART 260--INSPECTION AND CERTIFICATION

Subpart A--Inspection and Certification of Establishments, Fishery 
Products, and Other Marine Ingredients
Sec.
260.1 Administration of regulations.

Definitions

260.2 Terms defined.
260.3 Designation and use of official certificates, memoranda, 
marks, other identifications, and devices for purposes of the 
Agricultural Marketing Act.

Inspection Service

260.4 Where inspection service is offered.
260.5 Who may obtain inspection service.
260.6 Application for inspection service.

[[Page 101505]]

260.7 Rejection of application for inspection service.
260.8 Withdrawal of an application for inspection service.
260.9 Disposition of inspected samples.
260.10 Basis of inspection, grade and compliance assessment.
260.11 Order of inspection service.
260.12 Financial interest of inspector.
260.13 Official forms for inspection services.
260.14 Issuance of certificates.
260.15 Issuance of corrected certificates.
260.16 Issuance of an inspection report in lieu of an inspection 
certificate.
260.17 Retention and provision of inspection certificates.
260.18 Report of inspection results prior to issuance of formal 
report.

Appeal Service

260.19 Requesting an appeal.
260.20 Withdrawing an appeal application.
260.21 Declining an appeal application.
260.22 Appeal inspector selection protocol.
260.23 Appeal documentation.

Licensing of Inspectors and Samplers

260.24 Inspectors.
260.25 Licensed sampler.
260.26 Suspension or revocation of licensed inspector or licensed 
sampler.
260.27 Surrender of license.

Sampling

260.28 Sampling plans and procedures.
260.29 Shipment of samples.

Fees and Charges

260.30 Inspection fees, payment guarantees, charges and payments.

Requirements for Approved Establishments

260.31 Application for SIP Approved Establishment.
260.32 Requirements for the provision of Inspection Services for 
Approved Establishments.
260.33 Compliance with statutory and regulatory requirements.

Miscellaneous

260.34 Policies and procedures.
260.35 Approved marks, shields, stamps and official statements.
260.36 Revocation of approval to use inspection marks and 
statements.
260.37 Compliance with other laws.
260.38 Identification.
260.39 Debarment and suspension.

    Authority:  Sec. 6, 70 Stat. 1122, 16 U.S.C. 742e; secs. 203, 
205, 60 Stat. 1087, 1090 as amended; 7 U.S.C. 1622, 1624; 
Reorganization Plan No. 4 of 1970 (84 Stat. 2090).

Subpart A--Inspection and Certification of Establishments, Fishery 
Products, and Other Marine Ingredients


Sec.  260.1  Administration of regulations.

    The Secretary of the Department of Commerce is charged by the 
Agricultural Marketing Act of 1946 with the administration of the 
regulations in this part, except that they may delegate any or all of 
such functions to any officer or employee of the National Marine 
Fisheries Service (the Agency) of the Department at their discretion.

Definitions


Sec.  260.2  Terms defined.

    Words in the regulations in this part in the singular form shall be 
deemed to import the plural and vice versa, as the case may demand. For 
the purposes of the regulations in this part, unless the context 
otherwise requires, the following terms shall have the following 
meanings:
    Acceptance number means the number in a sampling plan that 
indicates the maximum number of nonconformities permitted in a sample 
of a lot that meets a specific requirement.
    Act means the applicable provisions of the Agricultural Marketing 
Act of 1946 (60 Stat. 1087 et seq., as amended; 7 U.S.C. 1621 et seq.) 
or any other act of Congress conferring like authority.
    Administrator means the Administrator of NOAA (Under Secretary of 
Commerce for Oceans and Atmosphere) or a designee.
    Agency means the National Marine Fisheries Service, National 
Oceanic and Atmospheric Administration, Department of Commerce.
    Applicant means any interested party who requests inspection 
service under the regulations in this part.
    Approved Establishment means an establishment which has been 
approved by the Agency pursuant to this Part and the NMFS Fishery 
Products Inspection Manual (SIP Manual) and utilizes inspection service 
on a contract basis.
    Certificate of loading means an official certificate or document 
that makes a statement relative to check-loading of a fish or fishery 
product or other marine ingredient subsequent to inspection thereof 
issued pursuant to the regulations in this part.
    Certificate of sampling means an official certificate or document 
that makes a statement pursuant to the regulations in this part 
identifying officially drawn samples and may include a description of 
the condition of containers and the condition under which the fish or 
fishery product or other marine ingredient is stored.
    Class means a grade or rank of quality.
    Condition means the degree of soundness of the product that may 
affect its merchantability and includes but is not limited to those 
factors that are subject to change due to age, improper preparation and 
processing, improper packaging, improper storage, or improper handling.
    Cross-Licensed Inspector means a qualified person employed and 
licensed by the agency to perform specified inspection services under a 
joint Federal-State inspection service arrangement.
    Department means the U.S. Department of Commerce.
    Director means the Assistant Administrator for Fisheries, NOAA, or 
a designee.
    Establishment means the premises, buildings, structures, 
facilities, and equipment (including machines, utensils, fixtures and 
transit vehicles) used with respect to the receipt, processing and 
transport of fish and fishery products and other marine ingredients.
    Fish means a fresh or saltwater finfish, crustaceans, other forms 
of aquatic animal life (including, but not limited to, alligator, frog, 
aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of 
such animals) other than birds or mammals, and including all mollusks, 
where such animal life is intended for human or animal consumption or 
for other non-food uses.
    Fishery product means any human food product in which fish is a 
characterizing ingredient.
     Inspection certificate means a statement, either written or 
printed, issued pursuant to the regulations in this part, setting forth 
the quality and condition of the product, or any part thereof, in 
addition to appropriate descriptive information relative to a fish, 
fishery product, or other marine ingredient, and the container thereof. 
It may also include a description of the conditions under which the 
product is stored.
    Inspection service means:
    (1) The performance of sampling pursuant to the regulations in this 
part;
    (2) The determination pursuant to the regulations and requirements 
in this part:
    (i) Assessing compliance with statutory and regulatory requirements 
pertaining to the interstate commerce of fish and fishery products or 
other marine ingredients for human or animal food;
    (ii) Identifying the essential characteristics such as style, type, 
size, or identity of any fish or fishery product or other marine 
ingredient; or
    (iii) Assessing the class, quality, and condition of any fish or 
fishery product or other marine ingredient, including the condition of 
the container thereof by the examination of appropriate samples;
    (3) The issuance of any certificates of sampling, inspection 
certificates, or

[[Page 101506]]

certificates of loading of a fish or fishery product or other marine 
ingredient, or any report relative to any of the foregoing; or
    (4) The performance by an inspector of any related services, such 
as:
    (i) Observing the preparation of the product from its raw state 
through each step in the entire process;
    (ii) Observing the conditions under which the product is being 
harvested, prepared, handled, stored, processed, packed, preserved, 
transported, or held;
    (iii) Observing the sanitation conditions as a prerequisite to the 
inspection of the processed product, either on a contract basis or 
periodic basis;
    (iv) Check-loading the inspected processed product in connection 
with the marketing of the product; or
    (v) Conducting any other type of service of a consultative or 
advisory nature related herewith as outlined in the NMFS Fishery 
Products Inspection Manual. Inspector means any employee of the 
Department authorized by the Secretary or any other person licensed by 
the Secretary to investigate, sample, inspect, and certify in 
accordance with the regulations in this part to any interested party 
the class, quality and condition of processed products covered in this 
part and to perform related duties in connection with the inspection 
service.
    Interested party means any person who has a financial interest in 
the fish or fishery product or other marine ingredient involved.
    Licensed sampler means any person who is authorized by the 
Secretary to draw samples of fish and fishery products or other marine 
ingredients for inspection service, to confirm the identification and 
condition of containers in a lot, and may, when authorized by the 
Secretary, perform other related services under the act and the 
regulations in this part.
    Lot means a defined quantity of product accumulated under 
conditions considered uniform for sampling purposes.
    (1) For processors who manufacture fish and fishery products or 
other marine ingredients, a lot is a production unit as defined by 
mutual agreement between the processor and SIP, consisting of fish or 
fishery products or other marine ingredients of the same type, style, 
form and size, which have been marked or labeled as such and produced 
under conditions as nearly uniform as possible, during a single 8 hour 
shift (or as defined and approved) on an individual processing line.
    (2) For establishments that receive fish or fishery products or 
other marine ingredients and perform no additional processing, such as 
distribution warehouses and foodservice distributors, a lot is defined 
by mutual agreement between the establishment and SIP and must consist 
of fish or fishery products or other marine ingredients located in a 
discrete grouping that consists of fish or fishery products or other 
marine ingredients of the same type, style and size and are marked or 
labeled as such. Except that: Fish or fishery products or other marine 
ingredients located in separate groups that differ from each other as 
to grade or other factors may be deemed as separate lots in some cases, 
for example:
    (i) Fish or fishery products or other marine ingredients located in 
the same group bearing an identification mark different from other 
containers in that group may be deemed as separate lots;
    (ii) Containers of fish or fishery products or other marine 
ingredients in a group bearing an identification mark different from 
other containers in that group, if determined to be of lower grade or 
deficient in other factors, may be deemed as separate lots; or
    (iii) If the applicant requests more than one inspection 
certificate covering different portions of a lot, the quantity of the 
product covered by each certificate shall be deemed a separate lot.
    Marine ingredient means any product of marine origin, whether or 
not intended for human consumption, including, but not limited to, 
fishmeal, fish oil, fish-based fertilizer, seaweed, kelp, and algae.
    NMFS Fishery Products Inspection Manual (SIP Manual) means the 
online handbook, housed at https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual, that provides 
procedures of how services shall be scheduled, planned, conducted, and 
documented and describes services that conform to global activities 
that harmonize inspection protocols.
    Officially drawn sample means any sample that has been selected 
from a particular lot by an inspector, licensed sampler, or by any 
other person authorized by the Secretary pursuant to the regulations in 
this part.
    Person means any individual, partnership, association, business 
trust, corporation, any organized group of persons (whether 
incorporated or not); the United States (including, but not limited to, 
any corporate agencies thereof) any State, county, or municipal 
government; any common carrier; and any authorized agent of any of the 
foregoing.
    Processing means, with respect to fish and fishery products and 
other marine ingredients, activities that an establishment engages in 
including handling, storing, preparing, heading, eviscerating, 
shucking, freezing, changing into different market forms, 
manufacturing, preserving, packing, labeling, dockside unloading, or 
holding.
    Product means any fish or fishery product or other marine 
ingredient, whether or not destined for human consumption, presented to 
NMFS for inspection and/or certification service.
    Quality means the inherent properties of any processed product that 
determine the relative degree of excellence of such product, includes 
the effects of preparation and processing, and may or may not include 
the effects of packing media or added ingredients.
    Rejection number means the smallest number of nonconformities, 
defectives (or defects) in the sample or samples under consideration 
that will require rejection of the lot.
    Sample means the number of sample units drawn from a lot for 
purposes of inspection to reach a decision regarding acceptance of the 
lot and for purposes of quality to reach a conclusion regarding 
conformity of the lot.
    Sample unit means a ``unit of product'', a primary container and 
its contents that makes up the sample that is inspected to determine 
whether it complies with regulatory criteria and that is quality 
assessed to determine whether it conforms to quality criteria.
    Sampling means the process of selecting sample units that comprise 
the sample for the purpose of inspection and quality assessment under 
the regulations of this part.
    Seafood Inspection Program (SIP) means the program within the U.S. 
Department of Commerce, National Oceanic and Atmospheric 
Administration, which offers inspection and grading services for 
seafood and other marine products as well as audit and consultative 
services to domestic and international processors, importers, and 
international competent food safety authorities.
    Secretary means the Secretary of the Department of Commerce or any 
other officer or employee of the Department authorized to exercise the 
powers and to perform the duties of the Secretary with respect to the 
matters covered by the regulations in this part.
    Shipping container means an individual container designed for 
shipping a number of packages or cans ordinarily packed in a container 
for shipping or designed for packing

[[Page 101507]]

unpackaged fish or fishery products or other marine ingredients for 
shipping.
    Unofficially drawn sample means any sample that has been selected 
by any person other than an inspector or licensed sampler.
    Wholesome means the minimum basis of acceptability for human food 
purposes of any fish or fishery product or other marine ingredient as 
defined in section 402 of the Federal Food, Drug, and Cosmetic Act, as 
amended.


Sec.  260.3  Designation and use of official certificates, memoranda, 
marks, other identifications, and devices for purposes of the 
Agricultural Marketing Act.

    Section 203(h) of the Agricultural Marketing Act of 1946 provides 
criminal penalties for various specified offenses relating to the 
misuse of official certificates, memoranda, marks or other 
identifications and devices for making such marks or identifications, 
issued or authorized under section 203 of said Act, and certain 
misrepresentations concerning the inspection or grading of agricultural 
products under said section. For the purposes of said section and the 
provisions in this part, the terms listed below shall have the 
respective meanings specified:
    Official certificate means any form of written, printed or 
electronic certification, including those defined in Sec.  260.2, used 
under this part to document and/or certify the compliance of fish or 
fishery products and other marine ingredients to applicable 
specifications with respect to inspection compliance and conformity to 
class, grade, quality, size, quantity, or condition requirements.
    Official device means a mechanically or manually operated tool, 
appliance or other means approved by the Agency to apply an official 
mark or other identification to any product or the packaging material 
thereof that is approved by the Director, including, but not limited 
to, a stamping appliance, branding device, stencil, or printed label.
    Official identification means any designation of class, grade, 
quality, size, quantity, condition, or attribute specified by this part 
or any symbol, stamp, label, seal, or official statement indicating 
that the product has been inspected or graded using specifications 
deemed appropriate by SIP or otherwise evaluated for any buyer 
specified attribute.
    Official insignia means a grade mark, inspection mark, combined 
inspection and grade mark, shield, stamp, other emblem, and/or official 
statement approved by the Secretary, authorized by the Agency, and used 
in accordance with the NMFS Fishery Products Inspection Manual (SIP 
Manual).
    Official document means a record of findings made by an authorized 
person having performed any inspection, certification, grading, audit 
or any other service pursuant to this part.

Inspection Service


Sec.  260.4  Where inspection service is offered.

    Inspection services may be furnished where an inspector, cross-
licensed inspector, or licensed sampler is available and when the 
establishment's facilities and conditions are appropriate for the 
conduct of such service. This location can include, but is not limited 
to, SIP regional and field offices, warehouses, processing facilities, 
docks, and vessels, as detailed in the SIP Manual.


Sec.  260.5   Who may obtain inspection service.

    Any person engaged in the processing, shipping or receiving of fish 
and fishery products or other marine ingredients in interstate commerce 
may apply for inspection service.


Sec.  260.6  Application for inspection service.

    Prospective service participants must submit an application for 
inspection service per the Application for Inspection Services 
procedures in the SIP Manual. To be considered for approval, 
applications for inspection service must be complete and conform to all 
SIP inspection service requirements as specified in the SIP Manual.


Sec.  260.7  Rejection of application for inspection service.

    Applicants will be notified if an Application for Inspection 
Service is rejected. Inspection Service applications may be rejected 
when: (a) the application is incomplete or in contravention of 
regulations and/or policy; (b) there is a noncompliance with NOAA 
financial policy, such as nonpayment for previous inspection services 
rendered; (c) the fish or fishery product or other marine ingredient is 
not properly identified; or (d) it appears that the performance of the 
inspection service would not be in the best interests of the 
Government.


Sec.  260.8  Withdrawal of an application for inspection service.

    The applicant may withdraw an Application for Inspection Service at 
any time before the inspection is performed, provided that the 
applicant shall pay for all costs and expenses which have been incurred 
by the inspection service in connection with such application.


Sec.  260.9  Disposition of inspected samples.

    Any product sample that has been used for inspection may be 
returned to the applicant, at its request and expense; otherwise it 
shall be destroyed or, when appropriate, diverted to a charitable 
institution.


Sec.  260.10   Basis of inspection, grade and compliance assessment.

    (a) Finished product inspection and certification services shall be 
performed on the basis of the specifications deemed appropriate by SIP.
    (b) Unless otherwise approved by SIP, compliance with the 
appropriate specifications shall be determined by evaluating the 
product, or sample, in accordance with the product inspection and 
quality assessment procedures outlined in the SIP Manual. Provided, 
that:
    (1) Such sample complies with the applicable standards of quality 
promulgated under the Federal Food, Drug, and Cosmetic Act;
    (2) Such sample complies with the product description;
    (3) Such sample meets the indicated grade with respect to factors 
of quality which are not rated by score points; and
    (4) The number of sample units classed as deviants does not exceed 
the applicable acceptance number indicated in the sampling plans 
approved and used. A ``deviant,'' as used in this paragraph, means a 
sample unit that falls below the indicated grade or specification 
parameter.


Sec.  260.11  Order of inspection service.

    Inspection services shall be performed, insofar as practicable, in 
the order in which Application for Inspection Service is made, except 
that precedence is given first to the United States (including, but not 
limited to, any instrumentality or agency thereof); second, to an 
inspection contract holder; and third, to an interested party without 
an inspection contract.


Sec.  260.12  Financial interest of inspector.

    No inspector shall inspect any product in which s/he has a direct 
or indirect financial interest.


Sec.  260.13  Official forms for inspection services.

    Inspection certificates, memoranda, reports and other documents 
associated with inspection services shall only be issued on forms 
approved by the Agency.


Sec.  260.14   Issuance of certificates.

    Inspection Certificates and Certificates of Loading may be issued 
by an inspector authorized by the Agency

[[Page 101508]]

to affix their signature to a certificate that has been prepared in 
accordance with the documented evidence in connection with the 
inspection service provided.


Sec.  260.15  Issuance of corrected certificates.

    When an issued inspection certificate contains errors or otherwise 
requires revision, the inspector who issued the original document or 
another employee of the Agency may issue a corrected inspection 
certificate. The corrected certificate will supersede the original 
document, which will become null and void after the issuance of the 
corrected certificate.


Sec.  260.16  Issuance of an inspection report in lieu of an inspection 
certificate.

    A written report in lieu of an inspection certificate may be issued 
by an inspector when such action appears to be more suitable than an 
inspection certificate.


Sec.  260.17  Retention and provision of inspection certificates.

    Inspection certificate copies or other documents issued under the 
regulations in this part shall be retained by the Agency in accordance 
with Agency record retention policies. The original certificate 
(electronic or other) or copy is provided to the inspection service 
requester, and copies may be provided to other interested parties as 
identified by the Agency.


Sec.  260.18   Report of inspection results prior to issuance of formal 
report.

    Upon request by any interested party and approval by the Agency, 
the interim inspection findings may be provided.

Appeal Service


Sec.  260.19  Requesting an appeal.

    (a) An application for an appeal may be made by any interested 
party who has cause to disagree with the results of a product 
inspection or audit finding. An official appeal inspection of a product 
inspection may only be performed when the lot of fish or fishery 
products or other marine ingredients can be positively identified by 
the inspection service as the lot from which officially drawn samples 
were previously inspected.
    (b) Such application shall be made in adherence with the SIP Manual 
and shall be made within 30 days following the day on which the 
previous result was communicated, except that upon approval by SIP the 
time may be extended.


Sec.  260.20  Withdrawing an appeal application.

    An application for appeal may be withdrawn by the applicant at any 
time before the appeal service is performed, provided that the 
applicant shall pay for all costs and expenses which have been incurred 
by the inspection service in connection with such application.


Sec.  260.21  Declining an appeal application.

    A request for an appeal may be declined when:
    (a) The reasons for the appeal are frivolous or not substantial;
    (b) The quality or condition of the product has undergone a 
material change since the inspection covering the product on which an 
appeal inspection is requested;
    (c) The lot relative to which an appeal inspection is requested is 
not, or cannot be made, accessible for the selection of officially 
drawn samples;
    (d) The lot relative to which an appeal inspection is requested 
cannot be positively identified by the inspector as the lot from which 
officially drawn samples were previously inspected; or
    (e) There is noncompliance with the regulations in this part. The 
applicant shall be notified promptly if a request for appeal is 
declined, as outlined in the SIP Manual.


Sec.  260.22   Appeal inspector selection protocol.

    (a) An inspector who did not perform the original product 
inspection shall be assigned to perform the appeal service; provided 
that the inspector who made the original product inspection on which an 
appeal is requested may be authorized to draw the samples when another 
inspector or licensed sampler is not available in the area where the 
product is located.
    (b) Whenever practical, the appeal service shall be conducted 
jointly by two inspectors.


Sec.  260.23  Appeal documentation.

    (a) After an appeal service has been completed, the results will be 
recorded on an appropriate document, as outlined in the SIP Manual. Any 
appeal document shall supersede the certificate or report previously 
issued for the product or establishment involved.
    (b) The superseded document shall become null and void upon the 
issuance of the appeal document and shall no longer represent the 
quality or condition of the product, system, or establishment described 
therein.
    (c) If the original document and all copies have not been returned 
to the inspector(s) performing the appeal service, the appeal document 
shall be issued to the person(s) the inspector(s) considers necessary 
to prevent misuse of the superseded document.
    (d) All provisions in this regulation concerning the use, issuance 
and disposition of inspection certificates shall apply to appeal 
inspection certificates, except that electronic copies of the appeal 
inspection certificates shall be furnished to all interested parties 
who received the superseded certificate.

Licensing of Inspectors and Samplers


Sec.  260.24  Inspectors.

    (a) Federal Government employees licensed or authorized as 
inspectors will perform inspections.
    (b) In addition, qualified persons may be employed and licensed 
(Cross-Licensee) by the Agency to perform specified inspection services 
under a joint Federal-State inspection service arrangement.
    (c) An Inspector or Cross-Licensee shall perform their duties 
pursuant to the regulations in this part as directed by the Director.


Sec.  260.25   Licensed samplers.

    (a) Any person deemed to have the necessary qualifications may be 
approved as a licensed sampler.
    (b) Licensed samplers are authorized to draw samples, to confirm 
the identity of the lot, and assess the condition of containers in the 
lot.
    (c) Licensed samplers are not authorized to inspect fish or fishery 
products or other marine ingredients.


Sec.  260.26  Suspension or revocation of licensed inspector or 
licensed sampler.

    In adherence to Federal and Agency requirements, the Agency may 
suspend or revoke the license of a licensed inspector or licensed 
sampler when deemed necessary, as outlined in the SIP Manual.


Sec.  260.27  Surrender of license.

    Upon suspension, revocation and/or termination of the services of a 
licensed inspector and/or licensed sampler, or in the case of an 
expired license, the licensee shall surrender their license to the 
Agency.

Sampling


Sec.  260.28  Sampling plans and procedures.

    (a) When finished product inspections of fish and fishery products 
and other marine ingredients are performed, the Sampling Plans and 
Sampling Procedures set forth in the SIP Manual will be followed.
    (b) Defined lots of product must be accessible, allowing thorough 
and proper sampling in accordance with the

[[Page 101509]]

regulations of this part. Failure to make lots accessible for proper 
sampling shall be sufficient cause for postponing or canceling 
inspection service.
    (c) Lots must be readily identifiable; if lots to be sampled are 
not suitably identified, the inspector or licensed sampler will mark 
the lot in a manner prescribed by the agency in the regulations and in 
the SIP Manual.
    (d) Samples shall be furnished for inspection at no cost to the 
Agency.
    (e) A certificate of sampling shall be prepared and signed by the 
inspector or licensed sampler.
    (f) Officially drawn samples shall be marked by the Agency 
representative so such samples can be properly identified for 
inspection.


Sec.  260.29  Shipment of samples.

    Samples that require shipment to an Inspection Office shall be 
shipped in a manner to avoid, if possible, any material change in the 
quality or condition of the product. Costs associated with shipments 
shall be at the expense of the applicant.

Fees and Charges


Sec.  260.30  Inspection fees, payment guarantees, charges and 
payments.

    (a) A schedule of fees, charges, payment guarantees and payments 
for inspection services shall be made in accordance with the applicable 
provisions of the regulations in this part and the Financial Policy 
provided in the SIP Manual.
    (b) The Schedule of Fees to be charged and collected for any 
inspection service performed under the regulations of this part will be 
determined annually, or as required, and published as a Notice in the 
Federal Register.
    (c) Fees for inspection under a cooperative agreement with any 
State or person shall be transferred and collected in accordance with 
the terms of such agreement. Such portion of the fees collected under a 
cooperative agreement as may be due the United States shall be remitted 
in accordance with this section and the Financial Policy as provided in 
the SIP Manual.
    (d) Charges may be made to cover the cost of travel and other 
expenses incurred in connection with the performance of any inspection 
service, including appeal inspections, as provided in the SIP Manual.
    (e) Inspection services may be made on a contract basis or via a 
memorandum of understanding with other Federal and State entities 
pursuant to the Agricultural Marketing Act of 1946, provided the Agency 
is reimbursed for the full cost of such service.
    (f) For each calendar year, SIP will calculate the rate for 
services, per hour per program employee, using the following formulas:
    (1) Regular rate. The total SIP inspection program personnel direct 
pay divided by direct hours, which is then multiplied by the next 
year's percentage of cost of living increase, plus the benefits rate, 
plus the operating rate, plus the allowance for bad debt rate. If 
applicable, travel expenses may also be added to the cost of providing 
the service. The regular rate shall be the contract rate.
    (2) Overtime rate. The total SIP inspection program personnel 
direct pay divided by direct hours, which is then multiplied by the 
next year's percentage of cost of living increase and then multiplied 
by 1.5 plus the benefits rate, plus the operating rate, plus an 
allowance for bad debt. If applicable, travel expenses may also be 
added to the cost of providing the service.
    (3) Holiday rate. The total SIP inspection program personnel direct 
pay divided by direct hours which is then multiplied by the next year's 
percentage of cost of living increase and then multiplied by 2, plus 
benefits rate, plus the operating rate, plus an allowance for bad debt. 
If applicable, travel expenses may also be added to the cost of 
providing the service.
    (g) For each calendar year, based on previous fiscal year/
historical actual costs, SIP will calculate the benefits, operating, 
and allowance for bad debt components of the regular, overtime and 
holiday rates as follows:
    (1) Benefits rate. The total SIP inspection program direct benefits 
costs divided by the total hours (regular, overtime, and holiday) 
worked, which is then multiplied by the next calendar year's percentage 
cost of living increase. Some examples of direct benefits are health 
insurance, retirement, life insurance, and Thrift Savings Plan (TSP) 
retirement basic and matching contributions.
    (2) Operating rate. The total SIP inspection program operating 
costs divided by total hours (regular, overtime, and holiday) worked, 
which is then multiplied by the percentage of inflation.
    (3) Allowance for bad debt rate. Total allowance for bad debt 
divided by total hours (regular, overtime, and holiday) worked.
    (h) The calendar year cost of living expenses and percentage of 
inflation factors used in the formulas in this section are based on the 
most recent Office of Management and Budget's Presidential Economic 
Assumptions.
    (1) When an inspection is delayed because product is not available 
or readily accessible, a charge for waiting time shall be determined 
using the formulas in this section.

Requirements for Approved Establishments


Sec.  260.31  Application for SIP Approved Establishment.

    Any person desiring to process and pack fish and fishery products 
and other marine ingredients as an SIP Approved Establishment must 
receive approval of their written and implemented food management 
system per the application procedures which are detailed in the SIP 
Manual.


Sec.  260.32   Requirements for the provision of Inspection Services 
for Approved Establishments.

    All establishments must remain in good standing in order to receive 
services per this Part.
    (a) The determination as to the inspection effort required to 
adequately provide inspection service at any establishment will be made 
by NMFS. The person-hours required may vary at different establishments 
due to factors such as, but not limited to, size and complexity of 
operations, volume and variety of products produced, and adequacy of 
control systems and cooperation. The inspection effort requirement may 
be reevaluated when the contracting party or NMFS deems there is 
sufficient change in production, equipment and change of quality 
control input to warrant reevaluation. Inspectors will not be available 
to perform any of the employee or management duties; however, they will 
be available for consultation purposes. NMFS reserves the right to 
reassign inspectors as it deems necessary.
    (b) Assessment of an establishment's good standing will be made by 
the Agency through systems, process, and product auditing and 
inspection activities, which are further specified in the SIP Manual.
    (c) The Agency shall not be held responsible:
    (1) For damages occurring through any act of commission or omission 
on the part of its inspectors when engaged in performing services; or
    (2) For production errors, such as processing temperatures, length 
of process, or misbranding of products; or
    (3) For failure to supply enough inspection effort during any 
period of service.
    (d) Approved Establishments shall:
    (1) Use, handle, process, store and distribute only raw materials 
and finished products that meet processing

[[Page 101510]]

and sanitation statutory and regulatory requirements for food safety, 
wholesomeness and labeling;
    (2) Adequately code each primary container and master case of 
products sold or otherwise distributed from a manufacturing, 
processing, packing, or repackaging activity to enable lot 
identification to facilitate, where necessary, the segregation of 
specific food lots that may have become contaminated or otherwise unfit 
for their intended use;
    (3) Provide adequate office space in the designated establishment, 
if required by the Agency, and furnish suitable desks, office 
equipment, internet services access, laboratory facilities and 
equipment required to perform product verification and inspection, as 
prescribed by the Agency;
    (4) Furnish and provide laundry service for coats, trousers, 
smocks, and towels used by inspectors during performance of duty in 
establishments if required by the Agency; and
    (5) During all reasonable times, provide representatives of the 
Agency free and immediate access to the establishment under the 
applicant's control for the purpose of performing any and all 
inspection services.
    (e) Retention tags:
    (1) Any equipment such as, but not limited to, conveyors, tillers, 
sorters, choppers, and containers which fail to meet appropriate and 
adequate sanitation requirements will be identified by the inspector in 
an appropriate and conspicuous manner with the word ``RETAINED.'' 
Following such identification, the equipment shall not be used until 
the discrepancy has been resolved, the equipment re-inspected and 
approved by the inspector and the ``RETAINED'' identification removed 
by the inspector.
    (2) Lot(s) of processed products that may be considered to be 
mislabeled and/or unwholesome by reason of contaminants, or which may 
otherwise be in such condition as to require further evaluation or 
testing to determine that the product is properly labeled and/or 
wholesome, will be identified by the inspector in an appropriate and 
conspicuous manner with the word ``RETAINED.'' Such lot(s) of product 
shall be held for re-inspection or testing. Final disposition of the 
lot(s) shall be determined by NMFS and the removal of the ``RETAINED'' 
identification shall be performed by the inspector.
    (f) Termination of inspection services:
    (1) The fishery products inspection service, including the issuance 
of inspection reports, shall be rendered from the date of the 
commencement specified in the contract and continue until suspended or 
terminated:
    (i) by mutual consent;
    (ii) by either party giving the other party 60 days' written notice 
specifying the date of suspension or termination;
    (iii) by written notice by the Agency in the event the applicant 
does not meet financial obligations;
    (iv) by written notice by the Agency, terminating service in the 
event the applicant fails to meet statutory and/or regulatory 
requirements, or in the event the applicant fails to comply with any 
provisions of the regulations contained in this part;
    (v) by automatic termination in case of bankruptcy, closing out of 
business, or change in controlling ownership.
    (2) In case the contracting party wishes to terminate the fishery 
products inspection service under the terms of paragraph (f)(1)(i) or 
(ii) of this section:
    (i) the service must be continued until all unused containers, 
labels, and advertising material on hand or in possession of his 
supplier bearing official identification marks or reference to the 
fishery products inspection service have been used;
    (ii) all unused containers, labels, and advertising material 
bearing official identification marks or reference to the fishery 
products inspection service must be destroyed;
    (iii) official identification marks and all other reference to the 
fishery products inspection service on all unused containers, labels, 
advertising material must be obliterated; or
    (iv) assurance satisfactory to NMFS must be furnished that all 
unused containers, labels, and advertising material bearing official 
identification marks or reference to the fishery products inspection 
service will not be used in violation of any of the provisions of the 
regulations in the part.
    (3) In case the fishery products inspection service is terminated 
for cause by NMFS under the terms of paragraph (f)(1)(iii) or (iv) of 
this section, or in case of automatic termination under terms of 
paragraph (f)(1)(v) of this section, the contracting party must destroy 
all unused containers, labels, and advertising material on hand bearing 
official identification marks or reference to the fishery products 
inspection service or must obliterate official identification marks and 
all reference to the fishery products inspection service on said 
containers, labels and advertising material. After termination of the 
fishery products inspection service, NMFS may, at such time or times as 
it may determine to be necessary, during regular business hours, enter 
the establishment(s) or other facilities in order to ascertain that the 
containers, labels, and advertising material have been altered or 
disposed of in the manner provided herein, to the satisfaction of NMFS.


Sec.  260.33  Compliance with statutory and regulatory requirements.

    Approved Establishments shall comply with all statutory and 
regulatory requirements and provisions pertaining to the production of 
fish and fishery products and other marine ingredients for human or 
animal consumption.

Miscellaneous


Sec.  260.34  Policies and procedures.

    The policies and procedures pertaining to the Agency's inspection 
services are contained within the SIP Manual.


Sec.  260.35  Approved marks, shields, stamps and official statements.

    As prescribed by the SIP Manual, Inspection Service participants 
meeting the requirements may request approval to utilize specified SIP 
Grade Marks, Shields, Stamps and Official Statements (collectively SIP 
Insignia).
    (a) Participants as approved establishments. (1) Fish and Fishery 
products and other marine ingredients that are processed under Federal 
inspection to assure compliance with all applicable regulatory 
requirements through the SIP Approved Establishments Program may be 
eligible to bear an:
    (i) Approved Establishment inspection mark; and/or,
    (ii) Approved Establishment Official Statement.

Figure 1 to Paragraph (a)(1)(ii)--USDC Approved Establishment 
Inspection Mark

[[Page 101511]]

[GRAPHIC] [TIFF OMITTED] TR16DE24.009

    (2) Fish and Fishery products and other marine ingredients that are 
processed under Federal inspection to ensure compliance with all 
applicable regulatory requirements through the SIP Approved 
Establishments Program and certified by an inspector as meeting the 
requirements of the applicable Approved Specification additionally may 
be eligible to bear (as applicable):
    (i) Grade A shield;
    (ii) Processed Under Federal Inspection (PUFI) mark; and/or
    (iii) Other official statements and/or marks, as approved by SIP, 
e.g.

Figure 2 to Paragraph (a)(2)(i)--U.S. Grade A Shield
[GRAPHIC] [TIFF OMITTED] TR16DE24.010

Figure 3 to Paragraph (a)(2)(ii)--Processed Under Federal Inspection 
(PUFI) Mark
[GRAPHIC] [TIFF OMITTED] TR16DE24.011

    (3) Approved Establishments will not make deceptive, fraudulent, or 
unauthorized use in advertising, or otherwise, of the fishery products 
inspection service marks, the inspection certificates or reports 
issued, or the containers on which official identification marks are 
embossed or otherwise identified, in connection with the sale of any 
processed products;
    (b) Lot inspection marks. (1) Fish and fishery products and other 
marine ingredients that have not been processed under Federal 
inspection may not be approved for the use of Grade or Inspection 
Marks. Such products may, however, be inspected on a Lot Inspection 
basis.
    (2) Master cases and inspection certificates for products that are 
submitted for inspection through the lot inspection process identified 
in the SIP Manual and are certified by an inspector as meeting the 
requirements of the applicable USDC Approved Specification 
corresponding with the shield, may bear one or more of the following:
    (i) USDC Accepted per Specifications shield;

Figure 4 to Paragraph (b)(2)(i)--USDC Accepted per Specifications 
Shield
[GRAPHIC] [TIFF OMITTED] TR16DE24.012

    (ii) Officially Sampled shield, e.g.

Figure 5 to Paragraph (b)(2)(ii)--Officially Sampled Shield
[GRAPHIC] [TIFF OMITTED] TR16DE24.013


[[Page 101512]]




Sec.  260.36  Revocation of approval to use inspection marks and 
statements.

    (a) Approval for use of SIP inspection marks, statements, and 
insignia will be rescinded when evidence indicates that processing 
conditions and/or product lots do not meet applicable regulatory, 
inspection and/or quality requirements per the SIP Manual.
    (b) Any affected lot(s) shall be retained and may not enter 
commerce unless the lot meets minimum regulatory requirements to enter 
commerce and the SIP insignia is removed.
    (c) The establishment or processor shall obtain written clearance 
from the Agency for the release of product lots that have been put on 
hold under this part.


Sec.  260.37  Compliance with other laws.

    None of the requirements in the regulations in this part shall 
excuse failure to comply with any Federal, State, county, or municipal 
laws applicable to the operation of food processing establishments and 
to processed food products.


Sec.  260.38  Identification.

    Each inspector and licensed sampler shall have a means of 
identification furnished by the Agency in his/her possession and, while 
on duty, present such identification upon request.


Sec.  260.39  Debarment and suspension.

    (a) Debarment. Any person may be debarred from using or benefiting 
from the inspection service provided under the regulations of this 
subchapter or under the terms of any inspection contract, and such 
debarment may apply to one or more processing establishments under 
their control, if such person engages in one or more of the following 
acts or activities:
    (1) Misrepresenting, misstating, or withholding any material or 
relevant facts or information in conjunction with any application or 
request for an inspection contract, inspection service, inspection 
appeal, lot inspection, or other service provided for under the 
regulations of this subchapter.
    (2) Using on a fish or fishery or other marine ingredient product 
any label that displays any official identification, official device, 
or official mark, when the label is not currently approved for use by 
the Director or his/her delegate.
    (3) Using on a fish or fishery product or other marine ingredient 
any label that displays the words ``USDC Approved Establishment'' or 
``Processed Under Federal Inspection, U.S. Department of Commerce''; 
any official mark, official device, or official identification; or a 
facsimile of the foregoing, when such product has not been inspected 
under the regulations of this subchapter.
    (4) Making any statement or reference to the U.S. Grade of any 
product or any inspection service provided under the regulations of 
this subchapter on the label or in the advertising of any product when 
such product has not been inspected under the regulations of this 
subchapter.
    (5) Making, using, issuing or attempting to issue or use in 
conjunction with the sale, shipment, transfer or advertisement of a 
product any certificate of loading, certificate of sampling, inspection 
certificate, official device, official identification, official mark, 
official document, or score sheet which has not been issued, approved, 
or authorized for use with such product by an inspector.
    (6) Using any of the terms ``United States,'' ``Officially 
graded,'' ``Officially inspected,'' ``Government inspected,'' 
``Federally inspected,'' ``Officially sampled,'' ``Grade A Equivalent'' 
or words of similar import or meanings, or using any official device, 
official identification, or official mark on the label, on the shipping 
container, or in the advertising of any fish or fishery product or 
other marine ingredient, when such product has not been inspected under 
the regulations of this subchapter.
    (7) Using, attempting to use, altering or reproducing any 
certificate, certificate form, design, insignia, mark, shield, device, 
or figure which simulates in whole or in part any official mark, 
official device, official identification, certificate of loading, 
certificate of sampling, inspection certificate or other official 
certificate issued pursuant to the regulations of this subchapter.
    (8) Assaulting, harassing, interfering, obstructing or attempting 
to interfere with or obstruct any inspector or licensed sampler in the 
performance of their duties under the regulations of this subchapter.
    (9) Violating any one or more of the terms of any inspection 
contract or the provisions of the regulations of this subchapter.
    (10) Engaging in acts or activities which destroy or interfere with 
the purposes of the inspection program or which have the effect of 
undermining the integrity of the inspection program.
    (b) Temporary suspension. (1) Whenever the Director has reasonable 
cause to believe that any person has engaged in any act or activity 
described in paragraph (a) of this section and such act or activity, in 
the judgment of the Director, would cause serious and irreparable 
injury to the inspection program and services provided under the 
regulations of this subchapter, the Director may, without a hearing, 
temporarily suspend, either before or after the institution of a 
debarment hearing, the inspection service provided under the 
regulations of this subchapter or under any inspection contract for one 
or more processing establishments under the control of such person. 
Notice of suspension shall be served by registered or certified mail, 
return receipt requested, and the notice shall specifically state those 
acts or activities of such person that are the basis for the 
suspension. The suspension shall become effective 5 days after receipt 
of the notice.
    (2) Once a person has received a notice of a temporary suspension, 
a debarment hearing will be set for 30 days after the effective date of 
the suspension. Within 60 days after the completion of the debarment 
hearing, the Hearing Examiner shall determine, based upon evidence of 
record, whether the temporary suspension shall be continued or 
terminated. A temporary suspension shall be terminated by the Hearing 
Examiner if they determine that the acts or activities that were the 
bases for the suspension did not occur or will not cause serious and 
irreparable injury to the inspection program and services provided 
under the regulations of this subchapter. This determination of the 
Hearing Examiner on the continuation or termination of the temporary 
suspension shall be final, and there shall be no appeal of this 
determination. The initial decision by the Hearing Examiner on the 
debarment shall be made in accordance with paragraph (b)(l), Decisions, 
of this section.
    (3) After a debarment hearing has been instituted against any 
person by a suspension, such suspension will remain in effect until a 
final decision is rendered on the debarment in accordance with the 
regulations of this section or the temporary suspension is terminated 
by the Hearing Examiner.
    (4) When a debarment hearing has been instituted against any person 
not under suspension, the Director may, in accordance with the 
regulations of this paragraph (b), of this section, temporarily suspend 
such person, and the suspension will remain in effect until a final 
decision on the debarment is rendered in accordance with the 
regulations of this section or the temporary suspension is terminated 
by the Hearing Examiner.
    (c) Hearing Examiner. All hearings shall be held before a Hearing 
Examiner appointed by the Secretary or the Director.

[[Page 101513]]

    (d) Hearing. If one or more of the acts or activities described in 
paragraph (a) of this section have occurred, the Director may institute 
a hearing to determine the length of time during which the person shall 
be debarred and those processing establishments to which the debarment 
shall apply. No person may be debarred unless there is a hearing, as 
prescribed in this section, and it has been determined by the Hearing 
Examiner, based on evidence of record, that one or more of the 
activities described in paragraph (a) of this section have occurred. 
Any debarment or suspension must be instituted within 2 years of the 
time when such acts or activities described in paragraph (a) of this 
section have occurred.
    (e) Notice of hearing. The Director shall notify such person of the 
debarment hearing by registered or certified mail, return receipt 
requested. The notice shall set forth the time and place of the 
hearing, the specific acts or activities which are the basis for the 
debarment hearing, the time period of debarment being sought, and those 
processing establishments to which the debarment shall apply. Except 
for the debarment hearing provided for in paragraph (b) of this section 
the hearing will be set for a time not longer than 120 days after 
receipt of the notice of hearing.
    (f) Time and place of hearing. The hearing shall be held at a time 
and place fixed by the Director: Provided, however, the Hearing 
Examiner may, upon a proper showing of inconvenience, change the time 
and place of the hearing. Motions for change of time or place of the 
hearing must be mailed to or served upon the Hearing Examiner no later 
than 10 days before the hearing.
    (g) Right to counsel. In all proceedings under this section, all 
persons and the Department of Commerce shall have the right to be 
represented by counsel, in accordance with the rules and regulations 
set forth in title 15, Code of Federal Regulations, Part 906.
    (h) Form, execution, and service of documents. (1) All papers to be 
filed under the regulations in this section shall be clear and legible; 
and shall be dated, signed in ink, contain the docket description and 
title of the proceeding, if any, and the address of the signatory. 
Documents filed shall be executed by:
    (i) The person or persons filing same;
    (ii) An authorized officer thereof if it be a corporation; or
    (iii) An attorney or other person having authority with respect 
thereto.
    (2) All documents, when filed, shall show that service has been 
made upon all parties to the proceeding. Such service shall be made by 
delivering one copy to each party in person or by mailing by first-
class mail, properly addressed with postage prepaid. When a party has 
appeared by attorney or other representative, service on such attorney 
or other representative will be deemed service upon the party. The date 
of service of document shall be the day when the matter served is 
deposited in the U.S. mail, shown by the postmark thereon, or is 
delivered in person, as the case may be.
    (3) A person is deemed to have appeared in a hearing by filing with 
the Director a written notice of their appearance or their authority to 
appear on behalf of one of the parties to the hearing.
    (4) The original of every document filed under this section and 
required to be served upon all parties to a proceeding shall be 
accompanied by a certificate of service signed by the party making 
service, stating that such service has been made upon each party to the 
proceeding. Certificates of service may be in substantially the 
following form: ``I hereby certify that I have this day served the 
foregoing document upon all parties of record in this proceeding by: 
(1) Mailing postage prepaid, (2) delivering in person, or (3) 
electronically delivering a copy to each party.

Dated at____this____day of____, 20__


Signature______''

    (i) Procedures and evidence. (1) All parties to a hearing shall be 
entitled to introduce all relevant evidence on the issues as stated in 
the notice for hearing or as determined by the Hearing Examiner at the 
outset of or during the hearing.
    (2) Technical rules of evidence shall not apply to hearings 
conducted pursuant to this section, but rules or principles designed to 
assure production of the most credible evidence available and to 
subject testimony to test by cross-examination shall be applied where 
reasonably necessary.
    (j) Duties of Hearing Examiner. The Hearing Examiner shall have the 
authority to:
    (1) Take depositions or cause depositions to be taken;
    (2) Regulate the course of the hearings;
    (3) Prescribe the order in which evidence shall be presented;
    (4) Dispose of procedural requests or similar matters;
    (5) Hear and initially rule upon all motions and petitions before 
them;
    (6) Administer oaths and affirmations;
    (7) Rule upon offers of proof and receive competent, relevant, 
material, reliable, and probative evidence;
    (8) Prevent the admission of irrelevant, immaterial, incompetent, 
unreliable, repetitious, or cumulative evidence;
    (9) Hear oral arguments if the Hearing Examiner determined such 
requirement is necessary;
    (10) Fix the time for filing briefs, motions, and other documents 
to be filed in connection with hearings;
    (11) Issue the initial decision and dispose of any other pertinent 
matters that normally and properly arise in the course of proceedings; 
and
    (12) Do all other things necessary for an orderly and impartial 
hearing.
    (k) The record. (1) The Director will designate an official 
reporter for all hearings. The official transcript of testimony taken, 
together with any exhibits and briefs filed therewith, shall be filed 
with the Director. Transcripts of testimony will be available in any 
proceeding under the regulations of this section at rates fixed by the 
contract between the United States of America and the reporter. If the 
reporter is an employee of the Department of Commerce, the Director 
will fix the rate.
    (2) The transcript of testimony and exhibits, together with all 
briefs, papers, and all rulings by the Hearing Examiner shall 
constitute the record. The initial decision will be predicated on the 
same record, as will the final decision.
    (l) Decisions. (1) The Hearing Examiner shall render the initial 
decision in all debarment proceedings before them. The same Hearing 
Examiner who presides at the hearing shall render the initial decision 
except when such Examiner becomes unavailable to the Department of 
Commerce. In such case, another Hearing Examiner will be designated by 
the Secretary or Director to render the initial decision. Briefs or 
other documents to be submitted after the hearing must be received not 
later than 20 days after the hearing unless otherwise extended by the 
Hearing Examiner upon motion by a party. The initial decision shall be 
made within 60 days after the receipt of all briefs. If no appeal from 
the initial decision is served upon the Director within 10 days of the 
date of the initial decision, it will become the final decision on the 
20th day following the date of the initial decision. If an appeal is 
received, the appeal will be transmitted to the Secretary who will 
render the final decision after considering the record and the appeal.
    (2) All initial and final decisions shall include a statement of 
findings and

[[Page 101514]]

conclusions, as well as the reasons or bases therefore, upon the 
material issues presented. A copy of each decision shall be served on 
the parties to the proceeding and furnished to interested persons upon 
request.
    (3) It shall be the duty of the Hearing Examiner, and the Secretary 
where there is an appeal, to determine whether the person has engaged 
in one or more of the acts or activities described in paragraph (a) of 
this section, and, if there is a finding that the person has engaged in 
such acts or activities, the length of time the person shall be 
debarred and the processing establishments to which the debarment shall 
apply.

[FR Doc. 2024-29129 Filed 12-13-24; 8:45 am]
BILLING CODE 3510-22-P