Rule2024-29129
Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 16, 2024
Effective
January 15, 2025
Issuing agencies
Commerce DepartmentNational Oceanic and Atmospheric Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 241 (Monday, December 16, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="/cdn-cgi/l/email-protection#afe2cac3c6dcdcce81edcacedacbddd6efc1c0cece81c8c0d9"><span class="__cf_email__" data-cfemail="8bc6eee7e2f8f8eaa5c9eeeafeeff9f2cbe5e4eaeaa5ece4fd">[email protected]</span></a> 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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual">https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual</a>.
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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual">https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual</a>, 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
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</html>Indexed from Federal Register on December 16, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.