Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients, 31690-31708 [2024-08676]
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
statute until final disposition by an
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provided by law.
*
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(i) Duration of right to challenge.
(1) The Government may review the
validity of any restriction on technical
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[FR Doc. 2024–08438 Filed 4–24–24; 8:45 am]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 260
[Docket No. 240412–0106]
RIN 0648–BH37
Inspection and Certification of
Establishments, Fishery Products, and
Other Marine Ingredients
National Marine Fisheries
Service (NMFS or Agency), National
Oceanic and Atmospheric
Administration (NOAA), Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
The NMFS Office of
International Affairs, Trade, and
Commerce proposes to revise 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, as described below.
DATES: Written comments must be
received by May 28, 2024.
ADDRESSES: Written comments on this
action, identified by NOAA–NMFS–
2024–0022, may be submitted by either
of the following methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal eRulemaking Portal. Go to
https://www.regulations.gov/document/
NOAA-NMFS-240412-0106, click the
‘‘Comment’’ icon, complete the required
fields, and enter or attach your
comments.
• Mail: Steven Wilson, Chief, Seafood
Inspection Program, Office of
International Affairs, Trade, and
Commerce, 1315 East-West Highway,
Silver Spring, MD 20910. All comments
received are a part of the public record
and will generally be posted to https://
www.regulations.gov without change.
All personal identifying information (for
example, name and address) voluntarily
submitted by the commenter may be
publicly accessible. Do not submit
confidential business information or
otherwise sensitive or protected
information.
SUMMARY:
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NMFS will accept anonymous
comments. Enter N/A in the required
fields if you wish to remain anonymous.
Attachments to electronic comments
will be accepted in Microsoft Word,
Excel, WordPerfect, or Adobe portable
document file (PDF) formats only.
Written comments regarding the
burden-hour estimates or other aspects
of the collection-of-information
requirements contained in this proposed
rule may be submitted to the NMFS
Office of International Affairs, Trade,
and Commerce and by email to: OIRA_
Submission@omb.eop.gov or fax to (202)
395–7285.
FOR FURTHER INFORMATION CONTACT:
Steven Wilson, Chief, Seafood
Inspection Program, by email at
Steven.Wilson@noaa.gov or by phone at
301–427–8312.
SUPPLEMENTARY INFORMATION:
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. On October 15,
2019, NMFS issued an advance notice of
proposed rulemaking (ANPR) requesting
input from stakeholders and interested
parties on focused areas of the Seafood
Inspection Program regulations. Based
on the eight public comments received
and NMFS’ overall assessment of the
current program, NMFS proposes these
comprehensive updates to the existing
regulations. NMFS looks forward to
receiving comments on the updates and
modernizations proposed here.
The revisions proposed herein
incorporate the significant changes and
updates that SIP has already made and
those that it still needs to implement to
simplify its administrative, inspection,
and certification procedures. These
changes and updates will lead to
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increased uniformity of and efficiencies
associated with inspections, while
retaining the reliability and validity of
inspection results. In an effort to
minimize costs, streamline operations,
and enable updates in a cost-effective
and timely fashion, SIP is proposing to
remove certain provisions from 50 CFR
part 260 and place them in the NMFS
Fishery Products Inspection Manual
(SIP Manual), which can be found
online at https://
www.fisheries.noaa.gov/national/
seafood-commerce-certification/
seafood-inspection-manual. The
proposed rule does not change the way
SIP currently operates but removes
outdated regulatory text, adds relevant
text to incorporate current practices,
and moves certain provisions to the SIP
Manual so that the regulations would
both more accurately reflect current
industry practices and allow for
adaptation to potential changes in
technologies and product requirements.
NMFS anticipates that these revisions
will benefit the seafood industry by
clarifying and simplifying the
procedures for obtaining seafood
inspection services and providing
improved, more accurate and consistent
inspection results, as compared with the
current published regulations. Table 1
below summarizes the proposed rule’s
impacts on section number and title
changes, as well as identifying
provisions that would be deleted from
the regulations.
1. Modernize Definitions and
Administrative Procedures
With respect to administrative
procedures, NMFS proposes to remove
specific provisions that are no longer in
use, such as the option to request
inspection service via telegraph, from
the regulatory text. The requirement to
request inspection services would be
retained, while the specific, detailed
procedures for requesting such service
would be moved from the regulatory
text to the online SIP Manual, where
they can more readily be updated and
modified as new technologies and
procedures are implemented. Putting
these strictly procedural matters in the
online manual would make
implementing cost-neutral and costsaving procedural changes more timely
and efficient for both government and
industry.
Definitions
The proposed rule would update
definitions in § 260.6 (proposed § 260.2)
to reflect the current use and meaning
of certain terms used throughout part
260 and in general use in industry.
Terms such as ‘‘Approved
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Establishment,’’ ‘‘Fish,’’ ‘‘Fishery
Product,’’ ‘‘Marine Ingredient,’’ ‘‘NMFS
Fishery Products Inspection Manual
(SIP Manual),’’ ‘‘Processing,’’ and
‘‘Product’’ would be added to align with
current SIP policies and procedures, as
well as current U.S. Standards for
Grades (50 CFR part 261), Food and
Drug Administration (FDA) Hazard
Analysis and Critical Control Point
(HACCP) regulations (21 CFR part 123),
and Good Manufacturing Practices
(GMPs) (21 CFR part 117). Other terms,
such as ‘‘Deviant,’’ ‘‘Deviation,’’ and
‘‘Plant’’ would be removed because they
are either no longer commonly used in
the context of seafood inspection or are
more accurately defined in other terms.
In general, only terms that pertain
specifically to the regulations in this
part are defined therein.
Inspection Service and Appeal
Inspection
The existing regulations at §§ 260.12–
260.41 are out of date and inconsistent
with current procedures for requesting
inspection services, performance of
inspections and product grading
activities, issuance of certificates, and
appeal of inspection results. The
proposed regulations reflect the nowcommon use of the internet and the
online Seafood Inspection Services
Portal (online portal) system for
requesting SIP inspection services, as
well as the use of electronic documents
(e.g., inspection certificates), which the
current regulations do not address. The
online portal, first deployed in 2008 for
inspection services requests and
issuance of certificates and reports,
enables SIP staff to address the needs of
industry in a more timely and consistent
manner. Tracking service requests
through the online portal system also
enables SIP management to better
allocate resources to meet the needs of
its customers. Public comment on the
ANPR supported the increased use of
the online portal for requesting all
inspection services and continued
electronic transfer of records. In
addition to the increases in efficiency,
the use of the online portal for the
generation of official inspection
certificates, whether printed on watermarked paper or delivered
electronically, has reduced government
costs by eliminating the need to print
and secure the old carbon-copy
controlled certificate books, whereby
each inspector or office had to secure a
log and retain a copy of each certificate
type issued.
While the proposed regulations would
still allow for inspection services to be
requested by fax, the move to the online
portal system reduces the cost to
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seafood businesses by allowing
computer access to all services in one
account, storing information, reducing
the amount of time required to make a
request, and eliminating the need to
have a separate fax machine, which
many smaller businesses do not
otherwise use or need. The proposed
rule would consolidate the current
sections associated with applying for
service (§§ 260.14–260.17) into a new
§ 260.6, with language updated to reflect
the current practice of applying for
inspection services through the online
portal system per the instructions in the
SIP Manual, found in part 1, chapter 12.
The regulatory language in
§ 260.21(b)(1–5) (proposed
§ 260.10(b)(1–4)) would be updated to
reflect the current product inspection
grade and compliance assessment
practices. SIP’s intent is to consolidate
and harmonize the current U.S. Grade
Standards outside of this rulemaking
action, and to keep current product
inspection and quality assessment
procedures detailed in the SIP Manual.
This shift will allow SIP to keep current
with changes and improvements in
inspection techniques, as well as any
changes to finished product
specifications and the approval process
of buyer and customer specifications.
NMFS proposes removing § 260.23,
Postponement of Inspection Service,
from regulatory text, and placing this
procedure in the SIP Manual, part 1,
chapter 12. This specific activity is
strictly procedural in nature and does
not need to be regulated in part 260.
The proposed rule would modify the
existing provisions for requesting and
performing appeal inspections found in
§§ 260.36–260.41 by removing the
procedures to file the request for appeal
(§ 260.36; proposed § 260.19) and the
mechanics of numbering and dating the
appeal inspection certificates (§ 260.41;
proposed § 260.23) from part 260 and
placing them in the SIP Manual, part 1,
chapter 14. NMFS proposes to leave the
remainder of the appeal process in
regulatory text and add provisions for
appeals of audits and other services (the
current regulations only address appeal
of fishery product inspections) to ensure
that all customers get equitable and
consistent treatment, regardless of their
level of participation in SIP. For
example, a person requesting one lot
inspection would have the same right to
appeal as a company with multiple
facilities and vessels participating in SIP
as an Approved Establishment.
Fees and Charges
NMFS proposes to consolidate the
current subgroup Fees and Charges
(§§ 260.69—260.81) into a new § 260.30,
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Inspection Fees, Payment Guarantees,
Charges and Payments, and remove the
details of individual fees and charges
from regulatory text. The current fees for
all SIP services are available in the SIP
Manual, part 1, chapter 13 and on the
SIP website at https://www.fisheries.
noaa.gov/national/seafood-commercetrade/inspection-and-analyticalservices-fees. Putting the specific fees
and charges in the SIP Manual, rather
than in the regulatory text, would allow
for annual updates and any
modifications to the fee structure to be
accurately reflected in a timely manner
without additional rulemaking. SIP
would continue to provide notice of fee
updates and modifications to the fee
structure in the Federal Register
consistent with existing §§ 260.70 and
260.81.
In response to the ANPR, one
commenter suggested that travel costs
be the same for all participants in SIP
and not based on their contract/noncontract type or level of participation.
The commenter also suggested that
HACCP contract rates have become too
high for many small businesses and that
when a participant regularly
demonstrates compliance and minimal
deficiencies in an audit, the frequency
of HACCP audits should be reduced to
twice yearly. Another comment
suggested that with the online portal
system, where most certificate
information is filled out online by the
requestor instead of SIP staff, the cost of
certificates should be reduced, while
another commenter suggested that the
fees charged for scoresheets and
duplicate certificates should be reevaluated. NMFS also received one
comment suggesting that SIP clarify its
billing processes and activity time
charges and make them consistent
across the regions and offices. The same
commenter expressed concern that any
changes made to sampling plans not
increase the cost of inspection.
While there may be an incremental
cost increase for small entities choosing
to participate in the activities of SIP, all
of the fees assessed by SIP are analyzed
and updated regularly and are set in
such a way as to offset the costs of the
program while not generating a profit
per the Financial Policy outlined in the
SIP Manual in part 1, chapter 13. This
includes certificate fees, whether or not
issued through the online portal. All
travel costs incurred with inspection
services, including mileage,
transportation, travel time, and lodging
and per diem when required, are billed
to the requestor. Lodging, per diem, and
the personal vehicle mileage rate are set
annually by the U.S. General Services
Administration (GSA) and are applied
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equally to all users, so any disparity in
these charges between regions can be
attributed to cost variations in different
parts of the country. Billing for travelrelated costs is detailed in the SIP
Manual, part 4, chapter 18, and in part
1, chapter 14. Any changes proposed to
sampling plans resulting from this
proposed rule are expected to have a
positive impact on associated costs and
will be detailed in the SIP Manual, part
4, chapter 19. These positive impacts
could include using smaller sample
sizes and less destructive sampling,
which would decrease both the cost of
the samples themselves as well as the
time required for sampling and
inspecting said samples. The frequency
of HACCP and surveillance audits is
established and detailed in the SIP
Manual in part 3, chapters 11 and 12
and appendix 1. Audit frequency may
be increased or tightened based on the
results of an audit as determined by the
Regional Inspection Branch. NMFS has
set the minimum audit frequency at
levels appropriate to ensure that federal
regulations and Program requirements
are being met.
Policies and Procedures
The proposed rule would update the
current § 260.84, Policies and
procedures (see proposed § 260.34), to
reflect that NOAA no longer publishes
a hard-copy inspection manual,
formerly known as NOAA Handbook 25.
All SIP policies and procedures are now
contained in the SIP Manual, which is
publicly available online at https://
www.fisheries.noaa.gov/national/
seafood-commerce-certification/
seafood-inspection-manual. The SIP
Manual moved to the online format over
a decade ago to allow for updates and
corrections in real time. The online
version is always current and available
to inspection staff, program participants,
and the general public at all times and
in any location with internet access.
Any update to a policy or procedure can
be uploaded to the SIP Manual and
broadcast to all users within hours. The
move to the online format also saves the
government money by eliminating the
costs of printing and postage, as well as
eliminating the need for inspectors to
spend time each quarter manually
removing old pages and adding new
pages to the hard-copy handbook.
NMFS is proposing to remove the
section on Political Activity (currently
§ 260.88), since it is now specifically
governed through the Hatch Act, as
amended (see 5 U.S.C. 7321–7326), and
its inclusion in the updated SIP
regulations is redundant.
A few minor updates are proposed to
§ 260.93, Debarment and suspension
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(proposed § 260.39), to reflect the use of
more modern terms (i.e., ‘‘Grade A
Equivalent’’ and ‘‘processing
establishment’’ instead of ‘‘plant’’). In
addition, the requirement to file five
copies of all documents would be
removed from § 260.93(h)(1), as that
practice is no longer necessary. Any
documents filed today are likely to be
converted to electronic format, if not
submitted electronically.
Approved Establishments
Under the proposed rule, the
provisions regarding Approved
Establishments would be moved and
updated. Requirements for Plants
Operating Under Continuous Inspection
on a Contract Basis, currently
§§ 260.96–260.104, would be
renumbered §§ 260.31–260.33 and
retitled Requirements for Approved
Establishments for purposes of clarity
and to reflect current practices. In this
proposed format, the requirements for
becoming an Approved Establishment
are set out prior to specifying the
benefits of being an Approved
Establishment, such as the ability to use
marks and official statements on seafood
products, providing a more logical flow
for these provisions. Section 260.96,
Application for fishery products
inspection service on a contract basis at
official establishments, would be retitled Application for SIP Approved
Establishment and re-numbered as
§ 260.31. The requirement to submit an
application to SIP for inspection
services would remain in the part 260
regulations, but the specific details of
the application procedures would be
placed into the SIP Manual, part 3,
chapter 5. This movement aligns
directly with the Agency’s goal of
keeping the operational requirements
and procedures of SIP up to date as
technologies and methods of
communication change, as well as
staying current with industry practices.
Sections 260.97(a) and § 260.97(b)
would be modified to reflect that the
requirements for receiving inspection
services at establishments are based on
an establishment’s good standing, which
is assessed by the Agency through the
combination of systems, process and
product auditing and inspection
activities. Approved Establishments are
included in a list published on the
Program’s website and periodically in
hard copy. Inclusion on this list is
contingent upon the firm’s continued
adherence to the Program requirements,
which are addressed in detail in the SIP
Manual at part 3. They also include
FDA and U.S. Department of Commerce
(USDC) regulations governing the
construction and maintenance of
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facilities and equipment, processing
techniques, and employee practices, all
of which are verified by on-site facility
and product audits. The provisions in
§ 260.97(b) would be retained in
proposed § 260.32(c). Sub-sections
260.97(c)(3–6) and (14) regarding the
use of labels and other NOAA marks
would be addressed in the proposed
§§ 260.35 and 260.36. Sub-sections
260.97(c)(1–2), regarding raw materials
and lot identification, and 260.97(c)(8–
10), regarding office and lab space and
laundry service, would be moved to
§ 260.32(d)(1–4). The procedures
currently at § 260.97(c)(7), (12–13), and
(15–16) detailing furnishing NOAA with
reports, product specifications, label
proofs, and other insignia, would also
be removed entirely from the
regulations in this part and placed in
the SIP Manual, parts 3 and 4. Again,
this move from regulatory text to the SIP
Manual is an effort to align with the
Agency’s goal of being able to adapt to
changes in policies and industry
practices in real time. Section
260.97(c)(11) would be removed
completely from the rule since the
practice of having contracting parties
provide clerical and stenographic
assistance to the Agency is obsolete.
For purposes of clarity, § 260.97(c)(17)
(proposed § 260.32(d)(5)) would be reworded to cover all inspection services,
and § 260.97(d), Termination of
Inspection Services, would be moved to
§ 260.32(f). Current section
260.97(d)(1)(iii) would be separated into
two sub-items: § 260.32(f)(1)(iii) would
detail how service may be terminated
due to failure of the contracting party to
meet financial obligations and
§ 260.32(f)(1)(iv) would detail how
service may be terminated due to failure
of the contracting party to meet
statutory or regulatory requirements,
including the provisions of the
regulations in this part.
With one exception, §§ 260.98–
260.104 would be condensed into one
new § 260.33, Compliance with
Statutory and Regulatory Requirements,
which would read: ‘‘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.’’ This provision
would underscore that participation as
an Approved Establishment does not
exempt an establishment from any
statutory or regulatory requirements.
The audit criteria for Approved
Establishments detailed in the SIP
Manual, part 3, encompasses all of the
requirements previously covered in
regulatory text in these sections
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regarding premises, buildings and
structures, facilities, lavatory
accommodations, equipment, effective
sanitation programs, and personnel. The
Agency is not adopting by reference
other agencies’ regulations as part of
this rulemaking, specifically FDA
HACCP regulations (21 CFR part 123)
and GMPs (21 CFR part 117), which
already cover the requirements for
premises, sanitation programs, and
personnel.
The current § 260.103(f) detailing the
authority of NMFS to reject product and
retain equipment would be relocated to
§ 260.32(e). This move aligns with
NMFS’ goal of streamlining the
regulatory text and consolidating the
requirements for Approved
Establishments but in no way
diminishes the authority of NMFS to
identify, isolate, and hold any product
that has been deemed mislabeled or
unwholesome or any equipment that
has been deemed unsanitary or likely to
contaminate processed product in any
way. Any product or equipment that has
been placed on such hold and identified
with the word ‘‘RETAINED’’ may not be
used or disposed of until inspection or
testing has been completed and the
NMFS inspector has removed the
‘‘RETAINED’’ identification.
2. Modernize Sampling Plan and Lot
Compliance Determination Procedures
NMFS proposes several adjustments
to the current section ‘‘Licensing of
Samplers and Inspectors’’ (§§ 260.47–
260.51). The text currently at § 260.48
regarding the application to become a
licensed sampler would be removed.
The Agency no longer requires formal
application for a person to become a
licensed sampler, though the person’s
qualifications must still meet the
standards outlined in the SIP Manual,
part 1, chapter 6, and be approved by an
authorized employee of the Agency. The
current sections on Licensed Sampler
(§ 260.47) and Inspectors (§ 260.49)
would be reversed in order and
renumbered as § 260.24–25. The intent
of this renumbering is to emphasize the
role of inspectors, NOAA employees
who are qualified to perform the full
catalog of inspection services, over the
role of licensed samplers, who are only
authorized to pull samples.
Sampling
The changes proposed to the section
Sampling, currently under §§ 260.57–
260.63 (proposed §§ 260.28–29), are
intended to make sampling less
restrictive and more flexible for both
industry and government. The
opportunity and flexibility to use
different sampling plans for lot
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inspections is detailed in the SIP
Manual in part 4, chapter 19, and for
grading standards in part 5, chapter 5.
The use of more flexible sampling plans
is expected to reduce the amount of
destructive sampling and the time and
costs associated with the act of sampling
itself and increase the reliability of the
results based on the samples used. Since
1966, when the current sampling plan
(§ 260.61) was established, many
improvements have been made by both
industry and government in terms of
sampling and lot compliance
determination. NMFS has determined
that using a static sample size of six and
acceptance number of zero, regardless of
the lot size, will both simplify the
sampling procedures and maintain the
statistical validity of the inspection
results. With the current sampling
plans, the sample size can range from 3
to over 72 sample units and often
involves destruction of the product and
packaging. Having a uniform sample
size of six would reduce the time
needed to select samples in most cases
and minimize the destruction and loss
of product due to sampling.
Determining lot compliance would also
be easier, since the assessment of the
lowest performing sample unit would
apply to the entire lot with an
acceptance number of zero. This would
mean the lot must have zero nonconforming sample units to be accepted.
In other words, if one sample unit does
not meet the inspection requirements,
the entire lot is rendered nonconforming. Removing the specific
sampling procedures and sampling
plans from the regulatory text in this
part and placing them in the SIP Manual
aligns with the Agency’s goal of being
more adaptable to changes in industry
practice and applying new techniques
as they become available. It would also
allow SIP to keep up to date with the
Codex Alimentarius (CODEX) and other
internationally agreed upon standards
as they are improved and updated
without requiring new regulatory action.
When finished product inspection is
required, a SIP inspector would follow
the Sampling Procedures and Sampling
Plans set forth in the SIP Manual, part
4, chapters 12 and 19.
The following requirements related to
lot identification and sampling are
unchanged in the rulemaking updates
proposed here (§ 260.60–61; proposed
§ 260.28–29): all product must be
readily identifiable and accessible for
sufficient sampling; officially drawn
samples shall be marked by the Agency
representative so they can be properly
identified for inspection; a certificate of
sampling shall be prepared and signed
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by the inspector or licensed sampler;
any lot not readily identifiable shall be
marked by the Agency representative in
a manner prescribed by the Agency; and
any 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 fish or fishery product
or other marine ingredient. All costs
associated with furnishing samples for
inspection and shipments shall be at the
expense of the applicant.
NMFS proposes to remove from
regulatory text the single and multiple
sampling plans and procedures for
determining lot compliance, currently
found in § 260.61, and adopt
internationally recognized standards
and specifications for sampling
practices, sample sizes, and lot
compliance determinations. These
standards and specifications would
continue to be housed and detailed in
the SIP Manual, part 4, chapter 12 and
19 for lot inspections and in part 5,
chapter 5 for grading standards rather
than in regulatory text. One comment
received on the ANPR suggested that
NMFS consult with the National
Institute for Standards and Technology
(NIST) to ensure that any modified
sampling plans align with their
procedures and provide uniformity
between states’ and SIP’s inspection
results regarding net weight compliance.
The commenter also suggested that
NMFS use information from the
research of the CODEX Committee on
Methods of Analysis and Sampling
(CCMAS) as a benchmark to align SIP’s
sample size and lot compliance
procedures with other globally accepted
methods. NMFS works closely with
NIST, agrees with the goal of alignment
with other globally accepted
procedures, and seeks additional
comment specifically on modifications
to sampling plans, sample sizes, and lot
compliance determination, as found in
the SIP Manual, part 4, chapter 19.
3. Modernize Use of Inspection and
Certification Marks
The section on marks and official
statements (§ 260.86; proposed § 260.35)
would be updated to reflect the changes
associated with the development of
Approved Establishments and their
associated marks and statements.
Products may bear a mark showing they
were processed in an approved facility
and/or a mark showing that they meet
applicable SIP-approved specifications
or inspections as prescribed in part 3,
chapter 16, and part 4, chapter 10, of the
SIP Manual. The ‘‘USDC Lot Inspected
Shield’’ would be removed, as it is
antiquated and no longer in use.
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16:45 Apr 24, 2024
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Proposed § 260.36 would be added to
clearly identify the terms for revocation
of approval to use inspection marks and
statements. The outdated mention of
any marks referencing the U.S.
Department of the Interior would be
removed.
One public comment suggested using
a special mark to identify product
sourced sustainably, such as
aquaculture grown in a safe and
sustainable manner, stating that
certification standards reflecting more
sustainable practices would be
recognized by consumers and help
influence industry guidelines to reflect
more sustainable practices. NMFS fully
supports sustainability in all aspects of
fisheries, but the Agricultural Marketing
Act of 1946 only authorizes NMFS to
certify the quality, quantity, and
condition of products. Sustainability
claims are out of the scope and
authority of SIP at this time. One
commenter suggested that NMFS survey
current program users to see what value
SIP marks still have, if any, given the
numerous third-party program available
today, and then develop and implement
a new communication effort to improve
the understanding among consumers of
what the marks actually signify. SIP
marks continue to be sought-after by
industry participants, and the agency
publicizes the value of SIP-inspected
products as resources permit.
Another commenter added that the
value of existing labeling would be
increased if it was simplified and made
clearer to consumers and included an
assessment of the facility(ies) involved.
While NMFS appreciates the
suggestions for making SIP marks more
effective and recognizable to the
consumer, we believe the Approved
Establishment marks and statements
already convey such an assessment. In
order to qualify to bear these marks, a
facility must comply with all the
requirements spelled out in the SIP
Manual, part 3, regarding approved
establishments and maintain a level of
compliance assessed through regular
auditing.
4. Extension of Services to Product
Forms Beyond Those for Human
Consumption
The proposed rule expands the scope
of service to include certain foods for
animal consumption such as fishmeal,
fish bone meal, fish for bait and some
types of pet food for cats and dogs, but
it does not include products such as
food for aquarium fish. This proposed
expansion also covers other products of
marine origin, such as seaweed, kelp,
algae, fish-based fertilizers, and other
fishery by-products whether or not
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intended for human consumption. The
expansion of SIP to non-consumer and
other marine products is an expansion
of opportunity and markets and helps to
facilitate trade for U.S. businesses. By
including non-human-consumption fish
and fishery products and other marine
ingredients to the program, U.S.
businesses are better able to compete
with industry members from other
countries in providing these valuable
resources to the worldwide marketplace.
Some countries, such as China and the
Republic of Korea, already require both
physical product inspection and
participation in SIP in order to export
fish and fishery products to those
countries, including items such as fish
meal and fishery by-products. At the
request of industry, SIP has been
providing these services for several
years, so there is little to no cost
increase to the Agency or industry to
include these products through this
proposed rule. Specifically, adding
inspection and certification services for
non-food, by-products, and other marine
ingredients in the revised SIP
regulations would enable SIP 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. While
NMFS does propose to expand
inspection and certification services to
include fish food for aquaculture
operations, the Agency does not propose
to expand services to pet foods, such as
fish food for aquarium fish, or to
ornamental/brood stock/research
animals, as these products fall under the
regulatory authority of the USDA
Animal and Plant Health Inspection
Service (APHIS).
The fish oil market is growing at 5.8
percent annually and is expected to
reach $3.34 billion by 2030 (Reports and
Data, February 2023). To facilitate trade
with foreign nations, U.S. suppliers
must effectively identify the sourcing
history of their products, which could
be satisfied if NMFS continued and
expanded its support for the trade and
certification of fishery by-products,
including fish oils. Multiple
commenters supported and encouraged
the efforts of SIP to provide certification
services for inedible fishery products,
including aquatic fish food, the latter of
which the Agency lacks the authority to
inspect.
5. Modernize U.S. Grade Standards
In the ANPR (84 FR 55130, October
15, 2019), NMFS also requested
comment on the modernization of the
U.S. Grade Standards found in 50 CFR
part 261. Comments from industry
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
members generally support the
maintenance of U.S. Grade Standards in
the SIP Manual, currently in part 5, and
encourage the development of
simplified grading documentation and
harmonizing of the grading standards
across regions, stakeholders, and
products. Based on comments received
and NMFS’ internal review, the Agency
has decided not to update the U.S.
Grade Standards as part of this proposed
rulemaking but may address changes to
50 CFR part 261 in future rulemaking.
Currently, NMFS intends to reduce the
existing grade standards down to seven
or eight consolidated U.S. Standards for
fishery products and to adopt a uniform
sample size of six with zero nonconformities for lot acceptance. This
means that for all lot sizes, six sample
units would be selected for inspection,
and each sample unit must meet the
regulatory or quality criteria for the lot
to be accepted.
The changes proposed to ‘‘Basis of
inspection, grade, and compliance
assessment’’ currently at § 260.21
(proposed § 260.10) would enable SIP to
perform finished product inspections
based on specifications and procedures
found in the SIP Manual, parts 4 and 5,
and compliance would be determined
according to the inspection and
assessment procedures outlined in the
SIP Manual in parts 4 and 5.
31695
General public comments on the
ANPR also included a request for NMFS
to continue its outreach to program
participants, including hosting webinars
and public meetings where industry
could provide more input on the efforts
to modernize the SIP. NMFS encourages
and actively seeks public comment on
all of the modernization efforts
proposed here. Any public meetings
and/or webinars will be posted on our
website and announced through the
current communication channels to all
program participants and interested
industry members. See table 1 below for
details of all the proposed section
number and title changes.
TABLE 1—PROPOSED RE-ORDERING OF PART 260
PART 260—INSPECTION AND CERTIFICATION
Current Subpart A—Inspection and Certification of Establishments and Fishery Products for Human Consumption
Proposed Subpart A—Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients
Current section
Proposed
section
Current section title
260.1 .....................
Administration of regulations.
260.1 ....................
Definitions 260.6–260.7
260.6 .....................
260.7 .....................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
...................
260.29 ...................
260.30 ...................
Terms defined.
Designation of official certificates, memoranda, marks, other
identifications, and devices for purposes of the Agricultural Marketing Act.
260.2 ....................
260.3 ....................
260.38 ...................
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260.39 ...................
260.40 ...................
260.41 ...................
Where inspection service is offered.
Who may obtain inspection service.
How to make application.
Information required in connection with application.
Filing of application
Record of filing time.
When application may be rejected.
When application may be withdrawn.
Disposition of inspected sample.
Basis of inspection and grade or compliance determination.
Order of inspection service.
Postponing inspection service
Financial interest of inspector.
Forms of certificates.
Issuance of certificates.
Issuance of corrected certificates.
Issuance of an inspection report in lieu of an inspection certificate.
Disposition of inspection certificates.
Report of inspection results prior to issuance of formal report.
260.4 ....................
260.5 ....................
260.6 ....................
...............................
...............................
...............................
260.7 ....................
260.8 ....................
260.9 ....................
260.10 ..................
260.11 ..................
...............................
260.12 ..................
260.13 ..................
260.14 ..................
260.15 ..................
260.16 ..................
260.17 ..................
260.18 ..................
...................
...................
...................
...................
260.51 ...................
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When appeal inspection may be requested.
Where to file for an appeal inspection and information required.
When an application for an appeal inspection may be withdrawn.
When appeal inspection may be refused.
Who shall perform appeal inspection.
Appeal inspection certificate.
260.19 ..................
...............................
Requesting an appeal.
Deleted.
260.20 ..................
Withdrawing an appeal application.
260.21 ..................
260.22 ..................
260.23 ..................
Declining an appeal application.
Appeal inspector selection protocol.
Appeal documentation.
Licensing of Inspectors and Samplers 260.24–260.27
Who may become licensed sampler.
Application to become a licensed sampler.
Inspectors.
Suspension or revocation of license of licensed sampler or
licensed inspector.
Surrender of license.
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Where inspection service is offered.
Who may obtain inspection service.
Application for inspection service.
Deleted.
Deleted.
Deleted.
Rejection of application for inspection service.
Withdrawal of an application for inspection service.
Disposition of inspected samples.
Basis of inspection grade and compliance assessment.
Order of inspection service.
Deleted.
Financial interest of inspector.
Official forms for inspection services.
Issuance of certificates.
Issuance of corrected certificates.
Issuance of an inspection report in lieu of an inspection certificate.
Retention and provision of inspection certificates.
Report of inspection results prior to issuance of formal report.
Appeal Service 260.19–260.23
Licensing of Samplers and Inspectors 260.47–260.51
260.47
260.48
260.49
260.50
Terms defined.
Designation and use of official certificates, memoranda,
marks, other identifications, and devices for purposes of
the Agricultural Marketing Act.
Inspection Service 260.4–260.18
Appeal Inspection 260.36–260.41
260.36 ...................
260.37 ...................
Administration of regulations.
Definitions 260.2–260.3
Inspection Service 260.12–260.30
260.12
260.13
260.14
260.15
260.16
260.17
260.18
260.19
260.20
260.21
260.22
260.23
260.24
260.25
260.26
260.27
260.28
Proposed section title
Frm 00037
Fmt 4702
260.25 ..................
...............................
260.24 ..................
260.26 ..................
260.27 ..................
Sfmt 4702
Licensed sampler.
Deleted.
Inspectors.
Suspension or revocation of licensed inspector or licensed
sampler.
Surrender of license.
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TABLE 1—PROPOSED RE-ORDERING OF PART 260—Continued
PART 260—INSPECTION AND CERTIFICATION
Current Subpart A—Inspection and Certification of Establishments and Fishery Products for Human Consumption
Proposed Subpart A—Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients
Current section
Proposed
section
Current section title
Proposed section title
Sampling 260.57–260.63
260.57 ...................
Sampling 260.28–260.29
260.62 ...................
260.63 ...................
How samples are drawn by inspectors or licensed samplers.
Accessibility for sampling.
How officially drawn samples are to be identified.
How samples are to be shipped.
Sampling plans and procedures for determining lot compliance.
Issuance of certificate of sampling.
Identification of lots sampled.
260.69 ...................
Payment fees and charges.
260.30 ..................
260.70 ...................
260.71 ...................
260.72 ...................
Schedule of fees.
[Reserved]
Fees for inspection service performed under cooperative
agreement.
Disposition of fees for inspections made under cooperative
agreement.
Fee for appeal inspection.
[Reserved]
Fees for score sheets.
Fees for additional copies of inspection certificates.
Travel and other expenses.
Charges for inspection service on a contract basis.
Readjustment and increase in hourly rates of fees.
...............................
...............................
...............................
Inspection fees, payment guarantees, charges and payments.
Deleted.
Deleted.
Deleted.
...............................
Deleted.
...............................
...............................
...............................
...............................
...............................
...............................
...............................
Deleted.
Deleted.
Deleted.
Deleted.
Deleted.
Deleted.
Deleted.
260.58
260.59
260.60
260.61
...................
...................
...................
...................
...............................
Deleted.
...............................
...............................
260.29 ..................
260.28 ..................
Deleted.
Deleted.
Shipment of samples.
Sampling plans and procedures.
...............................
...............................
Deleted.
Deleted.
Fees and Charges 260.69–260.81
260.73 ...................
260.74
260.76
260.77
260.78
260.79
260.80
260.81
...................
...................
...................
...................
...................
...................
...................
Fees and Charges 260.30
Miscellaneous 260.84–260.93
Miscellaneous 260.34–260.39
260.84 ...................
260.86 ...................
Policies and procedures.
Approved identification.
260.34 ..................
260.35 ..................
260.36 ..................
260.88
260.90
260.91
260.93
Political activity.
Compliance with other laws.
Identification.
Debarment and suspension.
...............................
260.37 ..................
260.38 ..................
260.39 ..................
...................
...................
...................
...................
Policies and procedures.
Approved marks, shields, stamps and official statements.
Revocation of approval to use inspection marks and statements.
Deleted.
Compliance with other laws.
Identification.
Debarment and suspension.
Requirements for Plants Operating Under Continuous
Inspection on a Contract Basis 260.96–260.104
260.96 ...................
Requirements for Approved
Establishments 260.31–260.33
260.104 .................
Application for fishery products inspection service on a contract basis at official establishments.
Conditions for providing fishery products inspection service
at official establishments.
Premises.
Buildings and structures.
Facilities.
Lavatory accommodations.
Equipment.
Operations and operating procedures shall be in accordance with an effective sanitation program.
Personnel
260.200–260.201 ..
[Reserved]
260.97 ...................
260.98 ...................
260.99 ...................
260.100 .................
260.101 .................
260.102 .................
260.103 .................
260.31 ..................
Application for SIP Approved Establishment.
260.32 ..................
...............................
...............................
...............................
...............................
...............................
260.33 ..................
Requirements for the provision of inspection services for
Approved Establishments.
Deleted.
Deleted.
Deleted.
Deleted.
Deleted.
Compliance with statutory and regulatory requirements.
...............................
Deleted.
...............................
Deleted.
Labeling Requirements 260.200
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Classification
This proposed 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 proposed action is consistent
with the provisions of this and other
applicable laws, subject to further
consideration after public comment.
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Deleted
Executive Order 12866
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866.
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 proposed rule, if adopted,
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would not have a significant economic
impact on a substantial number of small
entities. A description of the factual
basis for this determination follows.
The regulatory action being
considered is described in the preamble
of this proposed rule and includes
updates, deletions, and additions to the
regulations currently found at 50 CFR
part 260. The proposed action reflects
the significant changes and updates SIP
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
has already made to simplify its
administrative, inspection, and
certification procedures, which will
result in increased uniformity of
inspection results and efficiencies
associated with inspection effort, while
retaining the reliability and validity of
inspection results, detailed in the above
sections. Many of the changes proposed
here are not actual changes to the way
SIP currently operates, but merely a
removal of outdated regulatory text, so
the regulations both more accurately
reflect current Program and industry
practices and remain adaptable to
potential future changes in technologies
and product requirements.
Even though SIP operates as a fee-forservice program, it must adhere to the
regulatory authority of the FDA under
which all seafood processors in the
United States operate, regardless of their
status or participation in SIP. The
proposed rule clarifies the authority SIP
has to provide services for fishery
products, regardless of intended enduse, and allows SIP the flexibility to
keep its policies and operational
procedures current with both industry
practices and international standards by
housing the day-to-day operational
details in the online SIP Manual versus
in regulatory text.
The entities affected by this
rulemaking include all seafood
harvesters, processors, brokers,
importers, exporters, storage facilities,
and other entities who utilize the feebased services provided by the SIP. This
group includes both businesses that
choose to contract with the Agency for
certain services and those who wish to
export seafood products that require
certification that only SIP can provide.
SIP services both domestic and foreign
businesses. Per the RFA’s definition of
small business and regulations issued
by the SBA, impacts on ‘‘a business
entity organized for profit, with a place
of business located in the United States,
and which operates primarily with the
United States or which makes a
significant contribution to the U.S.
economy though payment of taxes or
use of American products, material or
labor’’ will be analyzed below.
Small entities include ‘‘small
businesses,’’ ‘‘small organizations,’’ and
‘‘small governmental jurisdictions.’’ The
SBA has established size standards for
all major industry sectors using the
North American Industry Classification
System (NAICS). Size thresholds can be
based on either a company’s number of
employees or its sales, depending on
SBA’s criteria for that industry. On
December 29, 2015, NMFS issued a final
rule establishing a small business size
standard of $11 million in annual gross
receipts for all businesses primarily
engaged in the commercial fishing
industry (NAICS 11411) for RFA
compliance purposes only (80 FR
81194). The $11 million standard
became effective on July 1, 2016, and is
to be used in place of the U.S. NAICS
114111, 114112, and 114119 sectors of
the U.S. commercial fishing industry in
all NMFS rules subject to the RFA after
July 1, 2016. Id. at 81194.
Based on the list of SIP businesses
requesting services in 2021, 64 NAICS
industries were identified. This analysis
applies those SBA/NMFS small
business definitions to the 64 6-digit
NAICS industries. For the purposes of
this analysis, it is assumed that the
choice to participate in SIP is not
correlated with business size, and thus
the estimated number of small entities
is the fraction of that NAICS industry
that is considered small multiplied by
the number of entities in that industry
participating in SIP. The total number of
entities that are small for NAICS with
employment-based small entity
definitions is calculated using the 2021
Statistics of U.S. Businesses (SUSB) by
detailed employment size (U.S. Census
Bureau 2023). In some cases, the small
business threshold is somewhere in the
middle of a SUSB bracket, in which case
an adjustment is necessary. Assuming
that firms are uniformly distributed
within an employment size bracket, the
number of small firms from the subdivided bracket is estimated based on
the proportion of the bracket below the
threshold. For example, if the small
business threshold is 125 employees
and SUSB reports 40 businesses in the
100–149 employee bracket, it is
assumed that 20 of the businesses are
small because half of the bracket is
below the 125-employee threshold.
However, if the small business
threshold is in the top bracket (e.g. a
threshold of 750 employees with a top
bracket of 500+ employees), then a
conservative estimate is made that all
the affected entities are small. The
percentage of businesses that are small
for NAICS with revenue-based small
business definitions is calculated using
the 2017 SUSB by revenue,1 with
revenues inflated to 2022 dollars using
the Consumer Price Index Inflator. The
same proportional rules are applied here
when the threshold lies somewhere in
the data bracket.
A complete list of the NAICS codes,
NAICS descriptions, the corresponding
SBA size standard thresholds, total
entities and the number of entities
determined to be small entities affected
by this rule is provided in table 2.
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TABLE 2—NAICS CODES, SMALL BUSINESS THRESHOLDS AND ENTITY TOTALS
NAICS Code
NAICS description
Small business threshold
11411 .................
112511 ...............
112519 ...............
311119 ...............
311412 ...............
311423 ...............
311615 ...............
311710 ...............
311942 ...............
311999 ...............
325311 ...............
325411 ...............
325412 ...............
325414 ...............
325612 ...............
Commercial Fishing Industry ......................................
Finfish Farming and Fish Hatcheries .........................
Other Aquaculture ......................................................
Other Animal Food Manufacturing .............................
Frozen Specialty Food Manufacturing .......................
Dry and Dehydrated Food Manufacturing ..................
Poultry Processing .....................................................
Seafood Product and Preparation and Packaging ....
Spice and Extract Manufacturing ...............................
All Other Miscellaneous Food Manufacturing ............
Nitrogenous Fertilizer Manufacturing .........................
Medicinal and Botanical Manufacturing .....................
Pharmaceutical Preparation Manufacturing ...............
Biological Product (except Diagnostic) Manufacturing
Polish and Other Sanitation Good Manufacturing .....
11 million ........................................
3.75 million .....................................
3.75 million .....................................
650 employees ...............................
1250 employees .............................
750 employees ...............................
1250 employees .............................
750 employees ...............................
650 employees ...............................
700 employees ...............................
1050 employees .............................
1000 employees .............................
1300 employees .............................
1250 employees .............................
900 employees ...............................
1 The 2019 and 2021 SUSB updates do not
include data by revenue, so this is the most recent
available.
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25APP1
Total entities
by NAICS
18
4
2
4
5
2
3
80
1
5
1
3
4
1
1
Estimated
small entities
18
4
2
4
5
2
3
78
1
5
1
3
4
1
1
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
TABLE 2—NAICS CODES, SMALL BUSINESS THRESHOLDS AND ENTITY TOTALS—Continued
Estimated
small entities
NAICS description
Small business threshold
325998 ...............
All Other Miscellaneous Chemical Product and Preparation Manufacturing.
Food Product Machinery Manufacturing ....................
All Other Miscellaneous General Purpose Machinery
Manufacturing.
Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers.
Refrigeration Equipment and Supplies Merchant
Wholesalers.
Drugs and Druggists’ Sundries Merchant Wholesalers.
General Line Grocery Merchant Wholesalers ............
Packaged Frozen Food Merchant Wholesalers .........
Poultry and Poultry Product Merchant Wholesalers ..
Fish and Seafood Merchant Wholesalers ..................
Meat and Meat Product Merchant Wholesalers ........
Fresh Fruit and Vegetable Merchant Wholesalers ....
Other Grocery and Related Products Merchant
Wholesalers.
Farm Supplies Merchant Wholesalers .......................
Other miscellaneous nondurable goods merchant
wholesalers.
Supermarkets and Other Grocery (except Convenience) Stores Retailers.
Meat Markets Retailers ..............................................
Fish and Seafood Markets Retailers ..........................
All Other Specialty Food Retailers .............................
Pharmacies and Drug Stores Retailers .....................
Food Health Supplement Stores Retailers ................
Sporting Goods Stores Retailers ...............................
Pet and Pet Supplies Stores Retailers ......................
All Other General Merchandise Stores Retailers .......
Deep Sea Freight Transportation ...............................
Coastal and Great Lakes Freight Transportation ......
General Freight Trucking, Local .................................
Support Activities for Rail Transportation ..................
Marine Cargo Handling ..............................................
Freight Transportation Arrangement ..........................
All Other Support Activities for Transportation ..........
General Warehousing and Storage ...........................
Refrigerated Warehousing and Storage ....................
Commodity Contracts Dealing Intermediation ...........
Miscellaneous Intermediation .....................................
Trust, Fiduciary, and Custody Activities .....................
Administrative Management and General Management Consulting Services.
Other Services Related to Advertising .......................
All Other Professional, Scientific, and Technical
Services.
Office Administrative Services ...................................
All Other Business Support Services .........................
Travel Agencies ..........................................................
Packaging and Labeling Service ................................
All Other Support Services .........................................
All Other Traveler Accommodation ............................
Recreational and Vacation Camps (except Campgrounds).
Full-Service Restaurants ............................................
Other Social Advocacy Organizations .......................
Non-classifiable Establishments .................................
TOTAL ........................................................................
650 employees ...............................
2
2
500 employees ...............................
700 employees ...............................
1
3
1
3
200 employees ...............................
1
1
125 employees ...............................
1
1
250 employees ...............................
3
3
...............................
...............................
...............................
...............................
...............................
...............................
...............................
18
15
4
233
10
2
16
17
14
4
228
10
2
16
200 employees ...............................
100 employees ...............................
1
15
1
15
40 million ........................................
3
3
500 employees ...............................
9 million ..........................................
10 million ........................................
37.5 million .....................................
22.5 million .....................................
26.5 million .....................................
32 million ........................................
40 million ........................................
1050 employees .............................
800 employees ...............................
34 million ........................................
34 million ........................................
47 million ........................................
20 million ........................................
25 million ........................................
34 million ........................................
36.5 million .....................................
47 million ........................................
47 million ........................................
47 million ........................................
24.5 million .....................................
2
11
4
1
5
1
2
2
1
1
1
1
1
29
2
7
5
1
1
1
3
2
11
4
1
5
1
2
2
1
1
1
1
1
27
2
5
5
1
1
1
3
19 million ........................................
19.5 million .....................................
1
1
1
1
12.5 million .....................................
21.5 million .....................................
25 million ........................................
19.5 million .....................................
16.5 million .....................................
9 million ..........................................
9 million ..........................................
3
5
2
1
1
1
1
3
5
2
1
1
1
1
11.5 million .....................................
18 million ........................................
n/a ..................................................
........................................................
15
1
1
577
15
1
1
553
333241 ...............
333998 ...............
423450 ...............
423740 ...............
424210 ...............
424410
424420
424440
424460
424470
424480
424490
...............
...............
...............
...............
...............
...............
...............
424910 ...............
424990 ...............
445110 ...............
445210
445250
445298
456110
456191
459110
459910
455219
483111
483113
484110
488210
488320
488510
488999
493110
493120
523160
523910
523991
541611
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
541890 ...............
541990 ...............
561110
561499
561510
561910
561990
721199
721214
...............
...............
...............
...............
...............
...............
...............
722511 ...............
813319 ...............
........................
........................
lotter on DSK11XQN23PROD with PROPOSALS1
Total entities
by NAICS
NAICS Code
250
200
150
100
150
100
250
employees
employees
employees
employees
employees
employees
employees
Source: U.S. Small Business Administration Table of Small Business Size Standards (Effective date January 1, 2022). Available at: https://
www.sba.gov/document/support--table-size-standards.
Based on the information above,
NMFS expects approximately 553 small
entities ranging across 64 NAICS sectors
would be directly affected by this rule
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upon implementation. As more entities
participate in the services, including
those expanded services proposed in the
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rule, the number of entities is likely to
increase marginally over time.
This proposed action would not
establish any new reporting,
E:\FR\FM\25APP1.SGM
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
recordkeeping, or other compliance
requirements for small entities. The
proposed rule would add or amend
definitions, clarify the authority SIP has
to provide services for fishery products
(regardless of intended end-use), and
allow SIP the flexibility to keep its
policies and operational procedures
current with both industry practices and
international standards by housing the
day-to-day operational details in the
online SIP Manual versus in regulatory
text. The actions proposed would not
change the way SIP currently operates
but merely remove outdated regulatory
text so the regulations both more
accurately reflect current industry
practices and remain adaptable to
potential changes in technologies and
product requirements. Thus, no small
business or local government would be
required to undertake any additional
reporting, recordkeeping, or other
affirmative actions in order to comply
with the proposed rule. No duplicative,
overlapping, or conflicting federal rules
have been identified.
Using the 2021 SUSB by detailed
employment size (U.S. Census Bureau
2023) and 2017 SUSB by revenue, most
of the entities affected represent less
than one percent of the total number of
firms in their NAICS sector. Those
industries in NAICS code sectors that
had five or fewer entities participating
in the SIP programs were assumed to be
well below one percent of the total
number of firms in the sector since
sectors generally contain many
hundreds of entities.
Only two NAICS sectors exceeded one
percent, Seafood Product Preparation
and Packaging (311710) with 13.6
percent and Fish and Seafood Merchant
Wholesalers (424460) with 11.2 percent.
The affected small entities do not
represent a large portion of their sectors,
but the total number of affected small
entities (78 and 228, respectively) could
be considered a substantial number.
NMFS anticipates some small entities
affected by the rule would likely incur
some compliance cost associated with
familiarizing themselves with the
relocated text in the online manual. The
SIP Manual was moved online over a
31699
decade ago, allowing for updates and
corrections to be made in real time. The
online version is routinely updated and
available to inspection staff, program
participants, and the general public at
all times, and in any location with
internet access. Based on existing
participants’ knowledge and current use
of the online manual, NMFS anticipates
small entities will likely incur 2 burden
hours associated with rule, definition,
and online manual familiarization
associated with changes proposed in the
rule. Table 3 provides the most common
services and the occupation title most
associated with those requesting
services. Wage rates for Office Clerks
(General) and Food Service Managers
are from the U.S. Bureau of Labor
Statistics’ (BLS) Employer Costs for
Employee Compensation (ECEC)
historical data for May 2022 (BLS
2022a). The estimate and cost per firm
is provided in table 4. The affected
small businesses subject to the rule are
likely to incur 2 burden hours at an
average cost of $59.54 per firm, for a
total of $32,925.62.
TABLE 3—SUMMARY OF ESTIMATED BURDEN HOURS AND COST FOR USERS REQUESTING COMMON SERVICES
Average
burden
(hour)
Mean hourly
wage rate 1
(for type
of user)
Total annual
wage burden
costs
Common services
Type of user
(e.g., occupational title)
§ 260.15 (prop. § 260.6) Application for Inspection
Services.
§ 260.36 (prop. § 260.19) Application for appeal ......
§ 260.96 (prop. § 260.31) Contract Completion ........
§ 260.97(c)(12), (13), and (15) (prop. § 260.32)
Label and Specification Submission.
HACCP Participants ..................................................
Office Clerks, General (43–9061) ........
2.00
$19.78
$39.56
Food Service Managers (11–9051) .....
Food Service Managers (11–9051) .....
Food Service Managers (11–9051) .....
2.00
2.00
2.00
32.27
32.27
32.27
64.54
64.54
64.54
Food Service Managers (11–9051) .....
2.00
32.27
64.54
........................
29.77
59.54
Average per Firm ...............................................
1 Source:
BLS 2022.
TABLE 4—SUMMARY OF COMPLIANCE COST BY ACTIVITY
lotter on DSK11XQN23PROD with PROPOSALS1
Average
burden per
firm
(hours)
Number of
affected
firms
Activity
Total burden
(hours)
Average cost
per firm
(2022$)
Total cost
(2022$)
Rule Familiarization .............................................................
Definition Familiarization ......................................................
SIP Online Manual Familiarization ......................................
553
553
553
0.5
0.5
1
276.5
276.5
553
$14.89
14.89
29.77
$8,231.41
8,231.41
16,462.81
Total Cost for all activities ............................................
........................
........................
........................
59.55
32,925.62
While NMFS does not have firm level
information on profit, an annual cost of
$59.55 can reasonably be assumed to be
well below 1 percent of total profit for
the affected entities. For the 553 small
entities subject to the rule, 100 percent
are expected to have cost impacts of less
than 1 percent of their annual revenues.
Therefore, NMFS does not expect the
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cost associated with the proposed rule
to represent a significant impact to
small entities.
NMFS believes the actions contained
in this rule would not create a
competitive disadvantage for small
entities vis-a-vis large entities. The
proposed rule, if finalized, would help
ensure that all entities regardless of size
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get equitable and consistent treatment,
regardless of their level of participation
in the SIP. A person requesting one lot
inspection has the same access to
information and available services, as
well as the equal right to an appeal
inspection, as a company with multiple
facilities and vessels.
E:\FR\FM\25APP1.SGM
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
While unable to quantify cost savings,
NMFS assumes the overall impact of the
rule to be neutral to marginally positive
on profitability for all entities, is not
expected to significantly reduce profits
for a substantial number of small
entities, and does not create a
significant competitive disadvantage to
small entities. While it is debatable if
the number of affected small entities
may qualify as ‘‘substantial,’’ the
economic impact of this rule is very
small. Therefore, NMFS does not expect
the proposed rule, if finalized, to have
a significant economic impact on a
substantial number of small entities. An
initial 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. These
proposed regulations to update 50 CFR
part 260 are procedural and
administrative in nature, in that they
merely reflect 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
prepared.
Paperwork Reduction Act
This proposed 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.
List of Subjects in 50 CFR Part 260
lotter on DSK11XQN23PROD with PROPOSALS1
Inspection, Inspection Services,
Certification, Approved Establishment,
Sampling, Imports, Exports, Fish and
Fisheries Products, Marine Ingredients,
Grade Standards, Marks.
Dated: April 18, 2024.
Samuel D. Rauch III,
Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service.
For the reasons set out in the
preamble, NOAA proposes to revise part
260 of title 50 of the Code of Federal
Regulations to read as follows:
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Jkt 262001
PART 260—INSPECTION AND
CERTIFICATION
260.37
260.38
260.39
Subpart A—Inspection and Certification of
Establishments, Fishery Products, and
Other Marine Ingredients
Sec.
260.1 Administration of regulations.
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).
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.
Subpart A—Inspection and
Certification of Establishments,
Fishery Products, and Other Marine
Ingredients
Inspection Service
260.4 Where inspection service is offered.
260.5 Who may obtain inspection service.
260.6 Application for inspection service.
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.
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.
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.
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Compliance with other laws.
Identification.
Debarment and suspension.
§ 260.1
Administration of regulations.
Definitions
§ 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 checkloading of a fish or fishery product or
other marine ingredient subsequent to
inspection thereof issued pursuant to
the regulations in this part.
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
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:
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Jkt 262001
(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
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
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Fmt 4702
Sfmt 4702
31701
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.
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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
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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
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.
§ 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
§ 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.
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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
§ 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.
§ 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.
§ 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.
§ 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
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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.
§ 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.
§ 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.
§ 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.
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§ 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.
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§ 260.12
Financial interest of inspector.
No inspector shall inspect any
product in which s/he has a direct or
indirect financial interest.
§ 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.
§ 260.14
Issuance of certificates.
Inspection Certificates and
Certificates of Loading may be issued by
an inspector authorized by the Agency
to affix their signature to a certificate
that has been prepared in accordance
with the documented evidence in
connection with the inspection service
provided.
§ 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.
§ 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.
§ 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.
§ 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
§ 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
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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.
§ 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.
§ 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.
§ 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.
§ 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
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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
§ 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 (CrossLicensee) 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.
§ 260.25
Licensed sampler.
(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.
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§ 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.
§ 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.
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Sampling
§ 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
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.
§ 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
§ 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
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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
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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
§ 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.
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§ 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
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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
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 reinspected 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
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31705
with the word ‘‘RETAINED.’’ Such lot(s)
of product shall be held for reinspection 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
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processed under Federal inspection to
ensure compliance with all applicable
regulatory requirements through the SIP
Approved Establishments Program and
(2) 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.
§ 260.36 Revocation of approval to use
inspection marks and statements.
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Figure 1 to Paragraph (a)(1)(ii)—USDC
Approved Establishment Inspection
Mark
(2) Fish and Fishery products and
other marine ingredients that are (1)
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§ 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.
§ 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.
§ 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
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EP25AP24.127</GPH>
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.
(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 (1)
submitted for inspection through the lot
inspection process identified in the SIP
Manual and are (2) 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;
(ii) Officially Sampled shield, e.g.
EP25AP24.126</GPH>
§ 260.35 Approved marks, shields, stamps
and official statements.
EP25AP24.125</GPH>
Policies and procedures.
The policies and procedures
pertaining to the Agency’s inspection
services are contained within the SIP
Manual.
(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.
EP25AP24.124</GPH>
Figure 3 to Paragraph (a)(2)(ii)—
Processed Under Federal Inspection
(PUFI) Mark
Miscellaneous
§ 260.34
Figure 5 to Paragraph (b)(2)(ii)—
Officially Sampled Shield
Figure 2 to Paragraph (a)(2)(i)—U.S.
Grade A Shield
§ 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.
Figure 4 to Paragraph (b)(2)(i)—USDC
Accepted Per Specifications Shield
EP25AP24.123</GPH>
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.
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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.
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16:45 Apr 24, 2024
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(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
PO 00000
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Fmt 4702
Sfmt 4702
31707
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.
(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
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Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Proposed Rules
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
Dated at llll this llll day of
shall constitute the record. The initial
llll, 20ll
decision will be predicated on the same
Signature llllllllllllll record, as will the final decision.
(l) Decisions.
(i) Procedures and evidence.
(1) The Hearing Examiner shall render
(1) All parties to a hearing shall be
the initial decision in all debarment
entitled to introduce all relevant
proceedings before them. The same
evidence on the issues as stated in the
Hearing Examiner who presides at the
notice for hearing or as determined by
the Hearing Examiner at the outset of or hearing shall render the initial decision
except when such Examiner becomes
during the hearing.
(2) Technical rules of evidence shall
unavailable to the Department of
not apply to hearings conducted
Commerce. In such case, another
pursuant to this section, but rules or
Hearing Examiner will be designated by
lotter on DSK11XQN23PROD with PROPOSALS1
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.
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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
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. 2024–08676 Filed 4–24–24; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 240417–0110]
RIN 0648–BM67
International Fisheries; Pacific Tuna
Fisheries; Safe Handling and Release
Practices for Sharks on Longline
Vessels and Revision to Vessel
Monitoring System Requirements in
the Eastern Pacific Ocean
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
NMFS is proposing
regulations under the Tuna Conventions
SUMMARY:
E:\FR\FM\25APP1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Proposed Rules]
[Pages 31690-31708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08676]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 260
[Docket No. 240412-0106]
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: Proposed rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: The NMFS Office of International Affairs, Trade, and Commerce
proposes to revise 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, as described below.
DATES: Written comments must be received by May 28, 2024.
ADDRESSES: Written comments on this action, identified by NOAA-NMFS-
2024-0022, may be submitted by either of the following methods:
Electronic Submissions: Submit all electronic public
comments via the Federal eRulemaking Portal. Go to https://www.regulations.gov/document/NOAA-NMFS-240412-0106, click the
``Comment'' icon, complete the required fields, and enter or attach
your comments.
Mail: Steven Wilson, Chief, Seafood Inspection Program,
Office of International Affairs, Trade, and Commerce, 1315 East-West
Highway, Silver Spring, MD 20910. All comments received are a part of
the public record and will generally be posted to https://www.regulations.gov without change. All personal identifying
information (for example, name and address) voluntarily submitted by
the commenter may be publicly accessible. Do not submit confidential
business information or otherwise sensitive or protected information.
NMFS will accept anonymous comments. Enter N/A in the required
fields if you wish to remain anonymous. Attachments to electronic
comments will be accepted in Microsoft Word, Excel, WordPerfect, or
Adobe portable document file (PDF) formats only.
Written comments regarding the burden-hour estimates or other
aspects of the collection-of-information requirements contained in this
proposed rule may be submitted to the NMFS Office of International
Affairs, Trade, and Commerce and by email to:
[email protected] or fax to (202) 395-7285.
FOR FURTHER INFORMATION CONTACT: Steven Wilson, Chief, Seafood
Inspection Program, by email at [email protected] or by phone at
301-427-8312.
SUPPLEMENTARY INFORMATION:
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. On October 15, 2019, NMFS issued an advance notice of proposed
rulemaking (ANPR) requesting input from stakeholders and interested
parties on focused areas of the Seafood Inspection Program regulations.
Based on the eight public comments received and NMFS' overall
assessment of the current program, NMFS proposes these comprehensive
updates to the existing regulations. NMFS looks forward to receiving
comments on the updates and modernizations proposed here.
The revisions proposed herein incorporate the significant changes
and updates that SIP has already made and those that it still needs to
implement to simplify its administrative, inspection, and certification
procedures. These changes and updates will lead to
[[Page 31691]]
increased uniformity of and efficiencies associated with inspections,
while retaining the reliability and validity of inspection results. In
an effort to minimize costs, streamline operations, and enable updates
in a cost-effective and timely fashion, SIP is proposing to remove
certain provisions from 50 CFR part 260 and place them in the NMFS
Fishery Products Inspection Manual (SIP Manual), which can be found
online at https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual. The proposed rule does not
change the way SIP currently operates but removes outdated regulatory
text, adds relevant text to incorporate current practices, and moves
certain provisions to the SIP Manual so that the regulations would both
more accurately reflect current industry practices and allow for
adaptation to potential changes in technologies and product
requirements. NMFS anticipates that these revisions will benefit the
seafood industry by clarifying and simplifying the procedures for
obtaining seafood inspection services and providing improved, more
accurate and consistent inspection results, as compared with the
current published regulations. Table 1 below summarizes the proposed
rule's impacts on section number and title changes, as well as
identifying provisions that would be deleted from the regulations.
1. Modernize Definitions and Administrative Procedures
With respect to administrative procedures, NMFS proposes to remove
specific provisions that are no longer in use, such as the option to
request inspection service via telegraph, from the regulatory text. The
requirement to request inspection services would be retained, while the
specific, detailed procedures for requesting such service would be
moved from the regulatory text to the online SIP Manual, where they can
more readily be updated and modified as new technologies and procedures
are implemented. Putting these strictly procedural matters in the
online manual would make implementing cost-neutral and cost-saving
procedural changes more timely and efficient for both government and
industry.
Definitions
The proposed rule would update definitions in Sec. 260.6 (proposed
Sec. 260.2) to reflect the current use and meaning of certain terms
used throughout part 260 and in general use in industry. Terms such as
``Approved Establishment,'' ``Fish,'' ``Fishery Product,'' ``Marine
Ingredient,'' ``NMFS Fishery Products Inspection Manual (SIP Manual),''
``Processing,'' and ``Product'' would be added to align with current
SIP policies and procedures, as well as current U.S. Standards for
Grades (50 CFR part 261), Food and Drug Administration (FDA) Hazard
Analysis and Critical Control Point (HACCP) regulations (21 CFR part
123), and Good Manufacturing Practices (GMPs) (21 CFR part 117). Other
terms, such as ``Deviant,'' ``Deviation,'' and ``Plant'' would be
removed because they are either no longer commonly used in the context
of seafood inspection or are more accurately defined in other terms. In
general, only terms that pertain specifically to the regulations in
this part are defined therein.
Inspection Service and Appeal Inspection
The existing regulations at Sec. Sec. 260.12-260.41 are out of
date and inconsistent with current procedures for requesting inspection
services, performance of inspections and product grading activities,
issuance of certificates, and appeal of inspection results. The
proposed regulations reflect the now-common use of the internet and the
online Seafood Inspection Services Portal (online portal) system for
requesting SIP inspection services, as well as the use of electronic
documents (e.g., inspection certificates), which the current
regulations do not address. The online portal, first deployed in 2008
for inspection services requests and issuance of certificates and
reports, enables SIP staff to address the needs of industry in a more
timely and consistent manner. Tracking service requests through the
online portal system also enables SIP management to better allocate
resources to meet the needs of its customers. Public comment on the
ANPR supported the increased use of the online portal for requesting
all inspection services and continued electronic transfer of records.
In addition to the increases in efficiency, the use of the online
portal for the generation of official inspection certificates, whether
printed on water-marked paper or delivered electronically, has reduced
government costs by eliminating the need to print and secure the old
carbon-copy controlled certificate books, whereby each inspector or
office had to secure a log and retain a copy of each certificate type
issued.
While the proposed regulations would still allow for inspection
services to be requested by fax, the move to the online portal system
reduces the cost to seafood businesses by allowing computer access to
all services in one account, storing information, reducing the amount
of time required to make a request, and eliminating the need to have a
separate fax machine, which many smaller businesses do not otherwise
use or need. The proposed rule would consolidate the current sections
associated with applying for service (Sec. Sec. 260.14-260.17) into a
new Sec. 260.6, with language updated to reflect the current practice
of applying for inspection services through the online portal system
per the instructions in the SIP Manual, found in part 1, chapter 12.
The regulatory language in Sec. 260.21(b)(1-5) (proposed Sec.
260.10(b)(1-4)) would be updated to reflect the current product
inspection grade and compliance assessment practices. SIP's intent is
to consolidate and harmonize the current U.S. Grade Standards outside
of this rulemaking action, and to keep current product inspection and
quality assessment procedures detailed in the SIP Manual. This shift
will allow SIP to keep current with changes and improvements in
inspection techniques, as well as any changes to finished product
specifications and the approval process of buyer and customer
specifications.
NMFS proposes removing Sec. 260.23, Postponement of Inspection
Service, from regulatory text, and placing this procedure in the SIP
Manual, part 1, chapter 12. This specific activity is strictly
procedural in nature and does not need to be regulated in part 260.
The proposed rule would modify the existing provisions for
requesting and performing appeal inspections found in Sec. Sec.
260.36-260.41 by removing the procedures to file the request for appeal
(Sec. 260.36; proposed Sec. 260.19) and the mechanics of numbering
and dating the appeal inspection certificates (Sec. 260.41; proposed
Sec. 260.23) from part 260 and placing them in the SIP Manual, part 1,
chapter 14. NMFS proposes to leave the remainder of the appeal process
in regulatory text and add provisions for appeals of audits and other
services (the current regulations only address appeal of fishery
product inspections) to ensure that all customers get equitable and
consistent treatment, regardless of their level of participation in
SIP. For example, a person requesting one lot inspection would have the
same right to appeal as a company with multiple facilities and vessels
participating in SIP as an Approved Establishment.
Fees and Charges
NMFS proposes to consolidate the current subgroup Fees and Charges
(Sec. Sec. 260.69--260.81) into a new Sec. 260.30,
[[Page 31692]]
Inspection Fees, Payment Guarantees, Charges and Payments, and remove
the details of individual fees and charges from regulatory text. The
current fees for all SIP services are available in the SIP Manual, part
1, chapter 13 and on the SIP website at https://www.fisheries.noaa.gov/national/seafood-commerce-trade/inspection-and-analytical-services-fees. Putting the specific fees and charges in the SIP Manual, rather
than in the regulatory text, would allow for annual updates and any
modifications to the fee structure to be accurately reflected in a
timely manner without additional rulemaking. SIP would continue to
provide notice of fee updates and modifications to the fee structure in
the Federal Register consistent with existing Sec. Sec. 260.70 and
260.81.
In response to the ANPR, one commenter suggested that travel costs
be the same for all participants in SIP and not based on their
contract/non-contract type or level of participation. The commenter
also suggested that HACCP contract rates have become too high for many
small businesses and that when a participant regularly demonstrates
compliance and minimal deficiencies in an audit, the frequency of HACCP
audits should be reduced to twice yearly. Another comment suggested
that with the online portal system, where most certificate information
is filled out online by the requestor instead of SIP staff, the cost of
certificates should be reduced, while another commenter suggested that
the fees charged for scoresheets and duplicate certificates should be
re-evaluated. NMFS also received one comment suggesting that SIP
clarify its billing processes and activity time charges and make them
consistent across the regions and offices. The same commenter expressed
concern that any changes made to sampling plans not increase the cost
of inspection.
While there may be an incremental cost increase for small entities
choosing to participate in the activities of SIP, all of the fees
assessed by SIP are analyzed and updated regularly and are set in such
a way as to offset the costs of the program while not generating a
profit per the Financial Policy outlined in the SIP Manual in part 1,
chapter 13. This includes certificate fees, whether or not issued
through the online portal. All travel costs incurred with inspection
services, including mileage, transportation, travel time, and lodging
and per diem when required, are billed to the requestor. Lodging, per
diem, and the personal vehicle mileage rate are set annually by the
U.S. General Services Administration (GSA) and are applied equally to
all users, so any disparity in these charges between regions can be
attributed to cost variations in different parts of the country.
Billing for travel-related costs is detailed in the SIP Manual, part 4,
chapter 18, and in part 1, chapter 14. Any changes proposed to sampling
plans resulting from this proposed rule are expected to have a positive
impact on associated costs and will be detailed in the SIP Manual, part
4, chapter 19. These positive impacts could include using smaller
sample sizes and less destructive sampling, which would decrease both
the cost of the samples themselves as well as the time required for
sampling and inspecting said samples. The frequency of HACCP and
surveillance audits is established and detailed in the SIP Manual in
part 3, chapters 11 and 12 and appendix 1. Audit frequency may be
increased or tightened based on the results of an audit as determined
by the Regional Inspection Branch. NMFS has set the minimum audit
frequency at levels appropriate to ensure that federal regulations and
Program requirements are being met.
Policies and Procedures
The proposed rule would update the current Sec. 260.84, Policies
and procedures (see proposed Sec. 260.34), to reflect that NOAA no
longer publishes a hard-copy inspection manual, formerly known as NOAA
Handbook 25. All SIP policies and procedures are now contained in the
SIP Manual, which is publicly available online at https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual. The SIP Manual moved to the online format over a
decade ago to allow for updates and corrections in real time. The
online version is always current and available to inspection staff,
program participants, and the general public at all times and in any
location with internet access. Any update to a policy or procedure can
be uploaded to the SIP Manual and broadcast to all users within hours.
The move to the online format also saves the government money by
eliminating the costs of printing and postage, as well as eliminating
the need for inspectors to spend time each quarter manually removing
old pages and adding new pages to the hard-copy handbook.
NMFS is proposing to remove the section on Political Activity
(currently Sec. 260.88), since it is now specifically governed through
the Hatch Act, as amended (see 5 U.S.C. 7321-7326), and its inclusion
in the updated SIP regulations is redundant.
A few minor updates are proposed to Sec. 260.93, Debarment and
suspension (proposed Sec. 260.39), to reflect the use of more modern
terms (i.e., ``Grade A Equivalent'' and ``processing establishment''
instead of ``plant''). In addition, the requirement to file five copies
of all documents would be removed from Sec. 260.93(h)(1), as that
practice is no longer necessary. Any documents filed today are likely
to be converted to electronic format, if not submitted electronically.
Approved Establishments
Under the proposed rule, the provisions regarding Approved
Establishments would be moved and updated. Requirements for Plants
Operating Under Continuous Inspection on a Contract Basis, currently
Sec. Sec. 260.96-260.104, would be renumbered Sec. Sec. 260.31-260.33
and retitled Requirements for Approved Establishments for purposes of
clarity and to reflect current practices. In this proposed format, the
requirements for becoming an Approved Establishment are set out prior
to specifying the benefits of being an Approved Establishment, such as
the ability to use marks and official statements on seafood products,
providing a more logical flow for these provisions. Section 260.96,
Application for fishery products inspection service on a contract basis
at official establishments, would be re-titled Application for SIP
Approved Establishment and re-numbered as Sec. 260.31. The requirement
to submit an application to SIP for inspection services would remain in
the part 260 regulations, but the specific details of the application
procedures would be placed into the SIP Manual, part 3, chapter 5. This
movement aligns directly with the Agency's goal of keeping the
operational requirements and procedures of SIP up to date as
technologies and methods of communication change, as well as staying
current with industry practices.
Sections 260.97(a) and Sec. 260.97(b) would be modified to reflect
that the requirements for receiving inspection services at
establishments are based on an establishment's good standing, which is
assessed by the Agency through the combination of systems, process and
product auditing and inspection activities. Approved Establishments are
included in a list published on the Program's website and periodically
in hard copy. Inclusion on this list is contingent upon the firm's
continued adherence to the Program requirements, which are addressed in
detail in the SIP Manual at part 3. They also include FDA and U.S.
Department of Commerce (USDC) regulations governing the construction
and maintenance of
[[Page 31693]]
facilities and equipment, processing techniques, and employee
practices, all of which are verified by on-site facility and product
audits. The provisions in Sec. 260.97(b) would be retained in proposed
Sec. 260.32(c). Sub-sections 260.97(c)(3-6) and (14) regarding the use
of labels and other NOAA marks would be addressed in the proposed
Sec. Sec. 260.35 and 260.36. Sub-sections 260.97(c)(1-2), regarding
raw materials and lot identification, and 260.97(c)(8-10), regarding
office and lab space and laundry service, would be moved to Sec.
260.32(d)(1-4). The procedures currently at Sec. 260.97(c)(7), (12-
13), and (15-16) detailing furnishing NOAA with reports, product
specifications, label proofs, and other insignia, would also be removed
entirely from the regulations in this part and placed in the SIP
Manual, parts 3 and 4. Again, this move from regulatory text to the SIP
Manual is an effort to align with the Agency's goal of being able to
adapt to changes in policies and industry practices in real time.
Section 260.97(c)(11) would be removed completely from the rule since
the practice of having contracting parties provide clerical and
stenographic assistance to the Agency is obsolete.
For purposes of clarity, Sec. 260.97(c)(17) (proposed Sec.
260.32(d)(5)) would be re-worded to cover all inspection services, and
Sec. 260.97(d), Termination of Inspection Services, would be moved to
Sec. 260.32(f). Current section 260.97(d)(1)(iii) would be separated
into two sub-items: Sec. 260.32(f)(1)(iii) would detail how service
may be terminated due to failure of the contracting party to meet
financial obligations and Sec. 260.32(f)(1)(iv) would detail how
service may be terminated due to failure of the contracting party to
meet statutory or regulatory requirements, including the provisions of
the regulations in this part.
With one exception, Sec. Sec. 260.98-260.104 would be condensed
into one new Sec. 260.33, Compliance with Statutory and Regulatory
Requirements, which would read: ``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.'' This provision
would underscore that participation as an Approved Establishment does
not exempt an establishment from any statutory or regulatory
requirements. The audit criteria for Approved Establishments detailed
in the SIP Manual, part 3, encompasses all of the requirements
previously covered in regulatory text in these sections regarding
premises, buildings and structures, facilities, lavatory
accommodations, equipment, effective sanitation programs, and
personnel. The Agency is not adopting by reference other agencies'
regulations as part of this rulemaking, specifically FDA HACCP
regulations (21 CFR part 123) and GMPs (21 CFR part 117), which already
cover the requirements for premises, sanitation programs, and
personnel.
The current Sec. 260.103(f) detailing the authority of NMFS to
reject product and retain equipment would be relocated to Sec.
260.32(e). This move aligns with NMFS' goal of streamlining the
regulatory text and consolidating the requirements for Approved
Establishments but in no way diminishes the authority of NMFS to
identify, isolate, and hold any product that has been deemed mislabeled
or unwholesome or any equipment that has been deemed unsanitary or
likely to contaminate processed product in any way. Any product or
equipment that has been placed on such hold and identified with the
word ``RETAINED'' may not be used or disposed of until inspection or
testing has been completed and the NMFS inspector has removed the
``RETAINED'' identification.
2. Modernize Sampling Plan and Lot Compliance Determination Procedures
NMFS proposes several adjustments to the current section
``Licensing of Samplers and Inspectors'' (Sec. Sec. 260.47-260.51).
The text currently at Sec. 260.48 regarding the application to become
a licensed sampler would be removed. The Agency no longer requires
formal application for a person to become a licensed sampler, though
the person's qualifications must still meet the standards outlined in
the SIP Manual, part 1, chapter 6, and be approved by an authorized
employee of the Agency. The current sections on Licensed Sampler (Sec.
260.47) and Inspectors (Sec. 260.49) would be reversed in order and
renumbered as Sec. 260.24-25. The intent of this renumbering is to
emphasize the role of inspectors, NOAA employees who are qualified to
perform the full catalog of inspection services, over the role of
licensed samplers, who are only authorized to pull samples.
Sampling
The changes proposed to the section Sampling, currently under
Sec. Sec. 260.57-260.63 (proposed Sec. Sec. 260.28-29), are intended
to make sampling less restrictive and more flexible for both industry
and government. The opportunity and flexibility to use different
sampling plans for lot inspections is detailed in the SIP Manual in
part 4, chapter 19, and for grading standards in part 5, chapter 5. The
use of more flexible sampling plans is expected to reduce the amount of
destructive sampling and the time and costs associated with the act of
sampling itself and increase the reliability of the results based on
the samples used. Since 1966, when the current sampling plan (Sec.
260.61) was established, many improvements have been made by both
industry and government in terms of sampling and lot compliance
determination. NMFS has determined that using a static sample size of
six and acceptance number of zero, regardless of the lot size, will
both simplify the sampling procedures and maintain the statistical
validity of the inspection results. With the current sampling plans,
the sample size can range from 3 to over 72 sample units and often
involves destruction of the product and packaging. Having a uniform
sample size of six would reduce the time needed to select samples in
most cases and minimize the destruction and loss of product due to
sampling. Determining lot compliance would also be easier, since the
assessment of the lowest performing sample unit would apply to the
entire lot with an acceptance number of zero. This would mean the lot
must have zero non-conforming sample units to be accepted. In other
words, if one sample unit does not meet the inspection requirements,
the entire lot is rendered non-conforming. Removing the specific
sampling procedures and sampling plans from the regulatory text in this
part and placing them in the SIP Manual aligns with the Agency's goal
of being more adaptable to changes in industry practice and applying
new techniques as they become available. It would also allow SIP to
keep up to date with the Codex Alimentarius (CODEX) and other
internationally agreed upon standards as they are improved and updated
without requiring new regulatory action. When finished product
inspection is required, a SIP inspector would follow the Sampling
Procedures and Sampling Plans set forth in the SIP Manual, part 4,
chapters 12 and 19.
The following requirements related to lot identification and
sampling are unchanged in the rulemaking updates proposed here (Sec.
260.60-61; proposed Sec. 260.28-29): all product must be readily
identifiable and accessible for sufficient sampling; officially drawn
samples shall be marked by the Agency representative so they can be
properly identified for inspection; a certificate of sampling shall be
prepared and signed
[[Page 31694]]
by the inspector or licensed sampler; any lot not readily identifiable
shall be marked by the Agency representative in a manner prescribed by
the Agency; and any 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 fish or fishery product or
other marine ingredient. All costs associated with furnishing samples
for inspection and shipments shall be at the expense of the applicant.
NMFS proposes to remove from regulatory text the single and
multiple sampling plans and procedures for determining lot compliance,
currently found in Sec. 260.61, and adopt internationally recognized
standards and specifications for sampling practices, sample sizes, and
lot compliance determinations. These standards and specifications would
continue to be housed and detailed in the SIP Manual, part 4, chapter
12 and 19 for lot inspections and in part 5, chapter 5 for grading
standards rather than in regulatory text. One comment received on the
ANPR suggested that NMFS consult with the National Institute for
Standards and Technology (NIST) to ensure that any modified sampling
plans align with their procedures and provide uniformity between
states' and SIP's inspection results regarding net weight compliance.
The commenter also suggested that NMFS use information from the
research of the CODEX Committee on Methods of Analysis and Sampling
(CCMAS) as a benchmark to align SIP's sample size and lot compliance
procedures with other globally accepted methods. NMFS works closely
with NIST, agrees with the goal of alignment with other globally
accepted procedures, and seeks additional comment specifically on
modifications to sampling plans, sample sizes, and lot compliance
determination, as found in the SIP Manual, part 4, chapter 19.
3. Modernize Use of Inspection and Certification Marks
The section on marks and official statements (Sec. 260.86;
proposed Sec. 260.35) would be updated to reflect the changes
associated with the development of Approved Establishments and their
associated marks and statements. Products may bear a mark showing they
were processed in an approved facility and/or a mark showing that they
meet applicable SIP-approved specifications or inspections as
prescribed in part 3, chapter 16, and part 4, chapter 10, of the SIP
Manual. The ``USDC Lot Inspected Shield'' would be removed, as it is
antiquated and no longer in use. Proposed Sec. 260.36 would be added
to clearly identify the terms for revocation of approval to use
inspection marks and statements. The outdated mention of any marks
referencing the U.S. Department of the Interior would be removed.
One public comment suggested using a special mark to identify
product sourced sustainably, such as aquaculture grown in a safe and
sustainable manner, stating that certification standards reflecting
more sustainable practices would be recognized by consumers and help
influence industry guidelines to reflect more sustainable practices.
NMFS fully supports sustainability in all aspects of fisheries, but the
Agricultural Marketing Act of 1946 only authorizes NMFS to certify the
quality, quantity, and condition of products. Sustainability claims are
out of the scope and authority of SIP at this time. One commenter
suggested that NMFS survey current program users to see what value SIP
marks still have, if any, given the numerous third-party program
available today, and then develop and implement a new communication
effort to improve the understanding among consumers of what the marks
actually signify. SIP marks continue to be sought-after by industry
participants, and the agency publicizes the value of SIP-inspected
products as resources permit.
Another commenter added that the value of existing labeling would
be increased if it was simplified and made clearer to consumers and
included an assessment of the facility(ies) involved. While NMFS
appreciates the suggestions for making SIP marks more effective and
recognizable to the consumer, we believe the Approved Establishment
marks and statements already convey such an assessment. In order to
qualify to bear these marks, a facility must comply with all the
requirements spelled out in the SIP Manual, part 3, regarding approved
establishments and maintain a level of compliance assessed through
regular auditing.
4. Extension of Services to Product Forms Beyond Those for Human
Consumption
The proposed rule expands the scope of service to include certain
foods for animal consumption such as fishmeal, fish bone meal, fish for
bait and some types of pet food for cats and dogs, but it does not
include products such as food for aquarium fish. This proposed
expansion also covers other products of marine origin, such as seaweed,
kelp, algae, fish-based fertilizers, and other fishery by-products
whether or not intended for human consumption. The expansion of SIP to
non-consumer and other marine products is an expansion of opportunity
and markets and helps to facilitate trade for U.S. businesses. By
including non-human-consumption fish and fishery products and other
marine ingredients to the program, U.S. businesses are better able to
compete with industry members from other countries in providing these
valuable resources to the worldwide marketplace. Some countries, such
as China and the Republic of Korea, already require both physical
product inspection and participation in SIP in order to export fish and
fishery products to those countries, including items such as fish meal
and fishery by-products. At the request of industry, SIP has been
providing these services for several years, so there is little to no
cost increase to the Agency or industry to include these products
through this proposed rule. Specifically, adding inspection and
certification services for non-food, by-products, and other marine
ingredients in the revised SIP regulations would enable SIP 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. While NMFS does propose to
expand inspection and certification services to include fish food for
aquaculture operations, the Agency does not propose to expand services
to pet foods, such as fish food for aquarium fish, or to ornamental/
brood stock/research animals, as these products fall under the
regulatory authority of the USDA Animal and Plant Health Inspection
Service (APHIS).
The fish oil market is growing at 5.8 percent annually and is
expected to reach $3.34 billion by 2030 (Reports and Data, February
2023). To facilitate trade with foreign nations, U.S. suppliers must
effectively identify the sourcing history of their products, which
could be satisfied if NMFS continued and expanded its support for the
trade and certification of fishery by-products, including fish oils.
Multiple commenters supported and encouraged the efforts of SIP to
provide certification services for inedible fishery products, including
aquatic fish food, the latter of which the Agency lacks the authority
to inspect.
5. Modernize U.S. Grade Standards
In the ANPR (84 FR 55130, October 15, 2019), NMFS also requested
comment on the modernization of the U.S. Grade Standards found in 50
CFR part 261. Comments from industry
[[Page 31695]]
members generally support the maintenance of U.S. Grade Standards in
the SIP Manual, currently in part 5, and encourage the development of
simplified grading documentation and harmonizing of the grading
standards across regions, stakeholders, and products. Based on comments
received and NMFS' internal review, the Agency has decided not to
update the U.S. Grade Standards as part of this proposed rulemaking but
may address changes to 50 CFR part 261 in future rulemaking. Currently,
NMFS intends to reduce the existing grade standards down to seven or
eight consolidated U.S. Standards for fishery products and to adopt a
uniform sample size of six with zero non-conformities for lot
acceptance. This means that for all lot sizes, six sample units would
be selected for inspection, and each sample unit must meet the
regulatory or quality criteria for the lot to be accepted.
The changes proposed to ``Basis of inspection, grade, and
compliance assessment'' currently at Sec. 260.21 (proposed Sec.
260.10) would enable SIP to perform finished product inspections based
on specifications and procedures found in the SIP Manual, parts 4 and
5, and compliance would be determined according to the inspection and
assessment procedures outlined in the SIP Manual in parts 4 and 5.
General public comments on the ANPR also included a request for
NMFS to continue its outreach to program participants, including
hosting webinars and public meetings where industry could provide more
input on the efforts to modernize the SIP. NMFS encourages and actively
seeks public comment on all of the modernization efforts proposed here.
Any public meetings and/or webinars will be posted on our website and
announced through the current communication channels to all program
participants and interested industry members. See table 1 below for
details of all the proposed section number and title changes.
Table 1--Proposed Re-ordering of Part 260
PART 260--INSPECTION AND CERTIFICATION
Current Subpart A--Inspection and Certification of Establishments and Fishery Products for Human Consumption
Proposed Subpart A--Inspection and Certification of Establishments, Fishery Products, and Other Marine
Ingredients
----------------------------------------------------------------------------------------------------------------
Current section Current section title Proposed section Proposed section title
----------------------------------------------------------------------------------------------------------------
260.1................... Administration of regulations. 260.1.................. Administration of
regulations.
----------------------------------------------------------------------------------------------------------------
Definitions 260.6-260.7 Definitions 260.2-260.3
----------------------------------------------------------------------------------------------------------------
260.6................... Terms defined. 260.2.................. Terms defined.
260.7................... Designation of official 260.3.................. Designation and use of
certificates, memoranda, marks, official certificates,
other identifications, and devices memoranda, marks,
for purposes of the Agricultural other identifications,
Marketing Act. and devices for
purposes of the
Agricultural Marketing
Act.
----------------------------------------------------------------------------------------------------------------
Inspection Service 260.12-Inspection Service 260.4-260.18
----------------------------------------------------------------------------------------------------------------
260.12.................. Where inspection service is offered. 260.4.................. Where inspection
service is offered.
260.13.................. Who may obtain inspection service. 260.5.................. Who may obtain
inspection service.
260.14.................. How to make application. 260.6.................. Application for
inspection service.
260.15.................. Information required in connection ....................... Deleted.
with application.
260.16.................. Filing of application ....................... Deleted.
260.17.................. Record of filing time. ....................... Deleted.
260.18.................. When application may be rejected. 260.7.................. Rejection of
application for
inspection service.
260.19.................. When application may be withdrawn. 260.8.................. Withdrawal of an
application for
inspection service.
260.20.................. Disposition of inspected sample. 260.9.................. Disposition of
inspected samples.
260.21.................. Basis of inspection and grade or 260.10................. Basis of inspection
compliance determination. grade and compliance
assessment.
260.22.................. Order of inspection service. 260.11................. Order of inspection
service.
260.23.................. Postponing inspection service ....................... Deleted.
260.24.................. Financial interest of inspector. 260.12................. Financial interest of
inspector.
260.25.................. Forms of certificates. 260.13................. Official forms for
inspection services.
260.26.................. Issuance of certificates. 260.14................. Issuance of
certificates.
260.27.................. Issuance of corrected certificates. 260.15................. Issuance of corrected
certificates.
260.28.................. Issuance of an inspection report in 260.16................. Issuance of an
lieu of an inspection certificate. inspection report in
lieu of an inspection
certificate.
260.29.................. Disposition of inspection 260.17................. Retention and provision
certificates. of inspection
certificates.
260.30.................. Report of inspection results prior 260.18................. Report of inspection
to issuance of formal report. results prior to
issuance of formal
report.
----------------------------------------------------------------------------------------------------------------
Appeal Inspection 260.36-26Appeal Service 260.19-260.23
----------------------------------------------------------------------------------------------------------------
260.36.................. When appeal inspection may be 260.19................. Requesting an appeal.
requested.
260.37.................. Where to file for an appeal ....................... Deleted.
inspection and information
required.
260.38.................. When an application for an appeal 260.20................. Withdrawing an appeal
inspection may be withdrawn. application.
260.39.................. When appeal inspection may be 260.21................. Declining an appeal
refused. application.
260.40.................. Who shall perform appeal inspection. 260.22................. Appeal inspector
selection protocol.
260.41.................. Appeal inspection certificate. 260.23................. Appeal documentation.
----------------------------------------------------------------------------------------------------------------
Licensing of Samplers and Licensing of Inspectors and Samplers 260.24-260.27
----------------------------------------------------------------------------------------------------------------
260.47.................. Who may become licensed sampler. 260.25................. Licensed sampler.
260.48.................. Application to become a licensed ....................... Deleted.
sampler.
260.49.................. Inspectors. 260.24................. Inspectors.
260.50.................. Suspension or revocation of license 260.26................. Suspension or
of licensed sampler or licensed revocation of licensed
inspector. inspector or licensed
sampler.
260.51.................. Surrender of license. 260.27................. Surrender of license.
----------------------------------------------------------------------------------------------------------------
[[Page 31696]]
Sampling 260.57-260.63 Sampling 260.28-260.29
----------------------------------------------------------------------------------------------------------------
260.57.................. How samples are drawn by inspectors ....................... Deleted.
or licensed samplers.
260.58.................. Accessibility for sampling. ....................... Deleted.
260.59.................. How officially drawn samples are to ....................... Deleted.
be identified.
260.60.................. How samples are to be shipped. 260.29................. Shipment of samples.
260.61.................. Sampling plans and procedures for 260.28................. Sampling plans and
determining lot compliance. procedures.
260.62.................. Issuance of certificate of sampling. ....................... Deleted.
260.63.................. Identification of lots sampled. ....................... Deleted.
----------------------------------------------------------------------------------------------------------------
Fees and Charges 260.69-260.8Fees and Charges 260.30
----------------------------------------------------------------------------------------------------------------
260.69.................. Payment fees and charges. 260.30................. Inspection fees,
payment guarantees,
charges and payments.
260.70.................. Schedule of fees. ....................... Deleted.
260.71.................. [Reserved] ....................... Deleted.
260.72.................. Fees for inspection service ....................... Deleted.
performed under cooperative
agreement.
260.73.................. Disposition of fees for inspections ....................... Deleted.
made under cooperative agreement.
260.74.................. Fee for appeal inspection. ....................... Deleted.
260.76.................. [Reserved] ....................... Deleted.
260.77.................. Fees for score sheets. ....................... Deleted.
260.78.................. Fees for additional copies of ....................... Deleted.
inspection certificates.
260.79.................. Travel and other expenses. ....................... Deleted.
260.80.................. Charges for inspection service on a ....................... Deleted.
contract basis.
260.81.................. Readjustment and increase in hourly ....................... Deleted.
rates of fees.
----------------------------------------------------------------------------------------------------------------
Miscellaneous 260.84-260.Miscellaneous 260.34-260.39
----------------------------------------------------------------------------------------------------------------
260.84.................. Policies and procedures. 260.34................. Policies and
procedures.
260.86.................. Approved identification. 260.35................. Approved marks,
shields, stamps and
official statements.
.................................... 260.36................. Revocation of approval
to use inspection
marks and statements.
260.88.................. Political activity. ....................... Deleted.
260.90.................. Compliance with other laws. 260.37................. Compliance with other
laws.
260.91.................. Identification. 260.38................. Identification.
260.93.................. Debarment and suspension. 260.39................. Debarment and
suspension.
----------------------------------------------------------------------------------------------------------------
Requirements for Plants Operating UndeRequirements for Approved
Inspection on a Contract Basis 26 Establishments 260.31-260.33
----------------------------------------------------------------------------------------------------------------
260.96.................. Application for fishery products 260.31................. Application for SIP
inspection service on a contract Approved
basis at official establishments. Establishment.
260.97.................. Conditions for providing fishery 260.32................. Requirements for the
products inspection service at provision of
official establishments. inspection services
for Approved
Establishments.
260.98.................. Premises. ....................... Deleted.
260.99.................. Buildings and structures. ....................... Deleted.
260.100................. Facilities. ....................... Deleted.
260.101................. Lavatory accommodations. ....................... Deleted.
260.102................. Equipment. ....................... Deleted.
260.103................. Operations and operating procedures 260.33................. Compliance with
shall be in accordance with an statutory and
effective sanitation program. regulatory
requirements.
260.104................. Personnel ....................... Deleted.
----------------------------------------------------------------------------------------------------------------
Labeling Requirements 260.200 Deleted
----------------------------------------------------------------------------------------------------------------
260.200-260.201......... [Reserved] ....................... Deleted.
----------------------------------------------------------------------------------------------------------------
Classification
This proposed 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 proposed
action is consistent with the provisions of this and other applicable
laws, subject to further consideration after public comment.
Executive Order 12866
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866.
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 proposed rule, if adopted, would not
have a significant economic impact on a substantial number of small
entities. A description of the factual basis for this determination
follows.
The regulatory action being considered is described in the preamble
of this proposed rule and includes updates, deletions, and additions to
the regulations currently found at 50 CFR part 260. The proposed action
reflects the significant changes and updates SIP
[[Page 31697]]
has already made to simplify its administrative, inspection, and
certification procedures, which will result in increased uniformity of
inspection results and efficiencies associated with inspection effort,
while retaining the reliability and validity of inspection results,
detailed in the above sections. Many of the changes proposed here are
not actual changes to the way SIP currently operates, but merely a
removal of outdated regulatory text, so the regulations both more
accurately reflect current Program and industry practices and remain
adaptable to potential future changes in technologies and product
requirements.
Even though SIP operates as a fee-for-service program, it must
adhere to the regulatory authority of the FDA under which all seafood
processors in the United States operate, regardless of their status or
participation in SIP. The proposed rule clarifies the authority SIP has
to provide services for fishery products, regardless of intended end-
use, and allows SIP the flexibility to keep its policies and
operational procedures current with both industry practices and
international standards by housing the day-to-day operational details
in the online SIP Manual versus in regulatory text.
The entities affected by this rulemaking include all seafood
harvesters, processors, brokers, importers, exporters, storage
facilities, and other entities who utilize the fee-based services
provided by the SIP. This group includes both businesses that choose to
contract with the Agency for certain services and those who wish to
export seafood products that require certification that only SIP can
provide. SIP services both domestic and foreign businesses. Per the
RFA's definition of small business and regulations issued by the SBA,
impacts on ``a business entity organized for profit, with a place of
business located in the United States, and which operates primarily
with the United States or which makes a significant contribution to the
U.S. economy though payment of taxes or use of American products,
material or labor'' will be analyzed below.
Small entities include ``small businesses,'' ``small
organizations,'' and ``small governmental jurisdictions.'' The SBA has
established size standards for all major industry sectors using the
North American Industry Classification System (NAICS). Size thresholds
can be based on either a company's number of employees or its sales,
depending on SBA's criteria for that industry. On December 29, 2015,
NMFS issued a final rule establishing a small business size standard of
$11 million in annual gross receipts for all businesses primarily
engaged in the commercial fishing industry (NAICS 11411) for RFA
compliance purposes only (80 FR 81194). The $11 million standard became
effective on July 1, 2016, and is to be used in place of the U.S. NAICS
114111, 114112, and 114119 sectors of the U.S. commercial fishing
industry in all NMFS rules subject to the RFA after July 1, 2016. Id.
at 81194.
Based on the list of SIP businesses requesting services in 2021, 64
NAICS industries were identified. This analysis applies those SBA/NMFS
small business definitions to the 64 6-digit NAICS industries. For the
purposes of this analysis, it is assumed that the choice to participate
in SIP is not correlated with business size, and thus the estimated
number of small entities is the fraction of that NAICS industry that is
considered small multiplied by the number of entities in that industry
participating in SIP. The total number of entities that are small for
NAICS with employment-based small entity definitions is calculated
using the 2021 Statistics of U.S. Businesses (SUSB) by detailed
employment size (U.S. Census Bureau 2023). In some cases, the small
business threshold is somewhere in the middle of a SUSB bracket, in
which case an adjustment is necessary. Assuming that firms are
uniformly distributed within an employment size bracket, the number of
small firms from the sub-divided bracket is estimated based on the
proportion of the bracket below the threshold. For example, if the
small business threshold is 125 employees and SUSB reports 40
businesses in the 100-149 employee bracket, it is assumed that 20 of
the businesses are small because half of the bracket is below the 125-
employee threshold. However, if the small business threshold is in the
top bracket (e.g. a threshold of 750 employees with a top bracket of
500+ employees), then a conservative estimate is made that all the
affected entities are small. The percentage of businesses that are
small for NAICS with revenue-based small business definitions is
calculated using the 2017 SUSB by revenue,\1\ with revenues inflated to
2022 dollars using the Consumer Price Index Inflator. The same
proportional rules are applied here when the threshold lies somewhere
in the data bracket.
---------------------------------------------------------------------------
\1\ The 2019 and 2021 SUSB updates do not include data by
revenue, so this is the most recent available.
---------------------------------------------------------------------------
A complete list of the NAICS codes, NAICS descriptions, the
corresponding SBA size standard thresholds, total entities and the
number of entities determined to be small entities affected by this
rule is provided in table 2.
Table 2--NAICS Codes, Small Business Thresholds and Entity Totals
----------------------------------------------------------------------------------------------------------------
Small business Total entities Estimated
NAICS Code NAICS description threshold by NAICS small entities
----------------------------------------------------------------------------------------------------------------
11411............................. Commercial Fishing 11 million........... 18 18
Industry.
112511............................ Finfish Farming and 3.75 million......... 4 4
Fish Hatcheries.
112519............................ Other Aquaculture.... 3.75 million......... 2 2
311119............................ Other Animal Food 650 employees........ 4 4
Manufacturing.
311412............................ Frozen Specialty Food 1250 employees....... 5 5
Manufacturing.
311423............................ Dry and Dehydrated 750 employees........ 2 2
Food Manufacturing.
311615............................ Poultry Processing... 1250 employees....... 3 3
311710............................ Seafood Product and 750 employees........ 80 78
Preparation and
Packaging.
311942............................ Spice and Extract 650 employees........ 1 1
Manufacturing.
311999............................ All Other 700 employees........ 5 5
Miscellaneous Food
Manufacturing.
325311............................ Nitrogenous 1050 employees....... 1 1
Fertilizer
Manufacturing.
325411............................ Medicinal and 1000 employees....... 3 3
Botanical
Manufacturing.
325412............................ Pharmaceutical 1300 employees....... 4 4
Preparation
Manufacturing.
325414............................ Biological Product 1250 employees....... 1 1
(except Diagnostic)
Manufacturing.
325612............................ Polish and Other 900 employees........ 1 1
Sanitation Good
Manufacturing.
[[Page 31698]]
325998............................ All Other 650 employees........ 2 2
Miscellaneous
Chemical Product and
Preparation
Manufacturing.
333241............................ Food Product 500 employees........ 1 1
Machinery
Manufacturing.
333998............................ All Other 700 employees........ 3 3
Miscellaneous
General Purpose
Machinery
Manufacturing.
423450............................ Medical, Dental, and 200 employees........ 1 1
Hospital Equipment
and Supplies
Merchant Wholesalers.
423740............................ Refrigeration 125 employees........ 1 1
Equipment and
Supplies Merchant
Wholesalers.
424210............................ Drugs and Druggists' 250 employees........ 3 3
Sundries Merchant
Wholesalers.
424410............................ General Line Grocery 250 employees........ 18 17
Merchant Wholesalers.
424420............................ Packaged Frozen Food 200 employees........ 15 14
Merchant Wholesalers.
424440............................ Poultry and Poultry 150 employees........ 4 4
Product Merchant
Wholesalers.
424460............................ Fish and Seafood 100 employees........ 233 228
Merchant Wholesalers.
424470............................ Meat and Meat Product 150 employees........ 10 10
Merchant Wholesalers.
424480............................ Fresh Fruit and 100 employees........ 2 2
Vegetable Merchant
Wholesalers.
424490............................ Other Grocery and 250 employees........ 16 16
Related Products
Merchant Wholesalers.
424910............................ Farm Supplies 200 employees........ 1 1
Merchant Wholesalers.
424990............................ Other miscellaneous 100 employees........ 15 15
nondurable goods
merchant wholesalers.
445110............................ Supermarkets and 40 million........... 3 3
Other Grocery
(except Convenience)
Stores Retailers.
445210............................ Meat Markets 500 employees........ 2 2
Retailers.
445250............................ Fish and Seafood 9 million............ 11 11
Markets Retailers.
445298............................ All Other Specialty 10 million........... 4 4
Food Retailers.
456110............................ Pharmacies and Drug 37.5 million......... 1 1
Stores Retailers.
456191............................ Food Health 22.5 million......... 5 5
Supplement Stores
Retailers.
459110............................ Sporting Goods Stores 26.5 million......... 1 1
Retailers.
459910............................ Pet and Pet Supplies 32 million........... 2 2
Stores Retailers.
455219............................ All Other General 40 million........... 2 2
Merchandise Stores
Retailers.
483111............................ Deep Sea Freight 1050 employees....... 1 1
Transportation.
483113............................ Coastal and Great 800 employees........ 1 1
Lakes Freight
Transportation.
484110............................ General Freight 34 million........... 1 1
Trucking, Local.
488210............................ Support Activities 34 million........... 1 1
for Rail
Transportation.
488320............................ Marine Cargo Handling 47 million........... 1 1
488510............................ Freight 20 million........... 29 27
Transportation
Arrangement.
488999............................ All Other Support 25 million........... 2 2
Activities for
Transportation.
493110............................ General Warehousing 34 million........... 7 5
and Storage.
493120............................ Refrigerated 36.5 million......... 5 5
Warehousing and
Storage.
523160............................ Commodity Contracts 47 million........... 1 1
Dealing
Intermediation.
523910............................ Miscellaneous 47 million........... 1 1
Intermediation.
523991............................ Trust, Fiduciary, and 47 million........... 1 1
Custody Activities.
541611............................ Administrative 24.5 million......... 3 3
Management and
General Management
Consulting Services.
541890............................ Other Services 19 million........... 1 1
Related to
Advertising.
541990............................ All Other 19.5 million......... 1 1
Professional,
Scientific, and
Technical Services.
561110............................ Office Administrative 12.5 million......... 3 3
Services.
561499............................ All Other Business 21.5 million......... 5 5
Support Services.
561510............................ Travel Agencies...... 25 million........... 2 2
561910............................ Packaging and 19.5 million......... 1 1
Labeling Service.
561990............................ All Other Support 16.5 million......... 1 1
Services.
721199............................ All Other Traveler 9 million............ 1 1
Accommodation.
721214............................ Recreational and 9 million............ 1 1
Vacation Camps
(except Campgrounds).
722511............................ Full-Service 11.5 million......... 15 15
Restaurants.
813319............................ Other Social Advocacy 18 million........... 1 1
Organizations.
Non-classifiable n/a.................. 1 1
Establishments.
TOTAL................ ..................... 577 553
----------------------------------------------------------------------------------------------------------------
Source: U.S. Small Business Administration Table of Small Business Size Standards (Effective date January 1,
2022). Available at: https://www.sba.gov/document/support--table-size-standards.
Based on the information above, NMFS expects approximately 553
small entities ranging across 64 NAICS sectors would be directly
affected by this rule upon implementation. As more entities participate
in the services, including those expanded services proposed in the
rule, the number of entities is likely to increase marginally over
time.
This proposed action would not establish any new reporting,
[[Page 31699]]
recordkeeping, or other compliance requirements for small entities. The
proposed rule would add or amend definitions, clarify the authority SIP
has to provide services for fishery products (regardless of intended
end-use), and allow SIP the flexibility to keep its policies and
operational procedures current with both industry practices and
international standards by housing the day-to-day operational details
in the online SIP Manual versus in regulatory text. The actions
proposed would not change the way SIP currently operates but merely
remove outdated regulatory text so the regulations both more accurately
reflect current industry practices and remain adaptable to potential
changes in technologies and product requirements. Thus, no small
business or local government would be required to undertake any
additional reporting, recordkeeping, or other affirmative actions in
order to comply with the proposed rule. No duplicative, overlapping, or
conflicting federal rules have been identified.
Using the 2021 SUSB by detailed employment size (U.S. Census Bureau
2023) and 2017 SUSB by revenue, most of the entities affected represent
less than one percent of the total number of firms in their NAICS
sector. Those industries in NAICS code sectors that had five or fewer
entities participating in the SIP programs were assumed to be well
below one percent of the total number of firms in the sector since
sectors generally contain many hundreds of entities.
Only two NAICS sectors exceeded one percent, Seafood Product
Preparation and Packaging (311710) with 13.6 percent and Fish and
Seafood Merchant Wholesalers (424460) with 11.2 percent. The affected
small entities do not represent a large portion of their sectors, but
the total number of affected small entities (78 and 228, respectively)
could be considered a substantial number.
NMFS anticipates some small entities affected by the rule would
likely incur some compliance cost associated with familiarizing
themselves with the relocated text in the online manual. The SIP Manual
was moved online over a decade ago, allowing for updates and
corrections to be made in real time. The online version is routinely
updated and available to inspection staff, program participants, and
the general public at all times, and in any location with internet
access. Based on existing participants' knowledge and current use of
the online manual, NMFS anticipates small entities will likely incur 2
burden hours associated with rule, definition, and online manual
familiarization associated with changes proposed in the rule. Table 3
provides the most common services and the occupation title most
associated with those requesting services. Wage rates for Office Clerks
(General) and Food Service Managers are from the U.S. Bureau of Labor
Statistics' (BLS) Employer Costs for Employee Compensation (ECEC)
historical data for May 2022 (BLS 2022a). The estimate and cost per
firm is provided in table 4. The affected small businesses subject to
the rule are likely to incur 2 burden hours at an average cost of
$59.54 per firm, for a total of $32,925.62.
Table 3--Summary of Estimated Burden Hours and Cost for Users Requesting Common Services
----------------------------------------------------------------------------------------------------------------
Mean hourly
Type of user (e.g., Average burden wage rate \1\ Total annual
Common services occupational title) (hour) (for type of wage burden
user) costs
----------------------------------------------------------------------------------------------------------------
Sec. 260.15 (prop. Sec. 260.6) Office Clerks, General 2.00 $19.78 $39.56
Application for Inspection Services. (43-9061).
Sec. 260.36 (prop. Sec. 260.19) Food Service Managers 2.00 32.27 64.54
Application for appeal. (11-9051).
Sec. 260.96 (prop. Sec. 260.31) Food Service Managers 2.00 32.27 64.54
Contract Completion. (11-9051).
Sec. 260.97(c)(12), (13), and (15) Food Service Managers 2.00 32.27 64.54
(prop. Sec. 260.32) Label and (11-9051).
Specification Submission.
HACCP Participants.................... Food Service Managers 2.00 32.27 64.54
(11-9051).
-------------------------------------------------------------------------
Average per Firm.................. .............. 29.77 59.54
----------------------------------------------------------------------------------------------------------------
\1\ Source: BLS 2022.
Table 4--Summary of Compliance Cost by Activity
----------------------------------------------------------------------------------------------------------------
Average burden Average cost
Activity Number of per firm Total burden per firm Total cost
affected firms (hours) (hours) (2022$) (2022$)
----------------------------------------------------------------------------------------------------------------
Rule Familiarization............ 553 0.5 276.5 $14.89 $8,231.41
Definition Familiarization...... 553 0.5 276.5 14.89 8,231.41
SIP Online Manual 553 1 553 29.77 16,462.81
Familiarization................
-------------------------------------------------------------------------------
Total Cost for all .............. .............. .............. 59.55 32,925.62
activities.................
----------------------------------------------------------------------------------------------------------------
While NMFS does not have firm level information on profit, an
annual cost of $59.55 can reasonably be assumed to be well below 1
percent of total profit for the affected entities. For the 553 small
entities subject to the rule, 100 percent are expected to have cost
impacts of less than 1 percent of their annual revenues. Therefore,
NMFS does not expect the cost associated with the proposed rule to
represent a significant impact to small entities.
NMFS believes the actions contained in this rule would not create a
competitive disadvantage for small entities vis-a-vis large entities.
The proposed rule, if finalized, would help ensure that all entities
regardless of size get equitable and consistent treatment, regardless
of their level of participation in the SIP. A person requesting one lot
inspection has the same access to information and available services,
as well as the equal right to an appeal inspection, as a company with
multiple facilities and vessels.
[[Page 31700]]
While unable to quantify cost savings, NMFS assumes the overall
impact of the rule to be neutral to marginally positive on
profitability for all entities, is not expected to significantly reduce
profits for a substantial number of small entities, and does not create
a significant competitive disadvantage to small entities. While it is
debatable if the number of affected small entities may qualify as
``substantial,'' the economic impact of this rule is very small.
Therefore, NMFS does not expect the proposed rule, if finalized, to
have a significant economic impact on a substantial number of small
entities. An initial 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. These proposed regulations to
update 50 CFR part 260 are procedural and administrative in nature, in
that they merely reflect 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 prepared.
Paperwork Reduction Act
This proposed 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.
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: April 18, 2024.
Samuel D. Rauch III,
Deputy Assistant Administrator for Regulatory Programs, National Marine
Fisheries Service.
For the reasons set out in the preamble, NOAA proposes to revise
part 260 of title 50 of the Code of Federal Regulations to read 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.
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.
[[Page 31701]]
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 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.
[[Page 31702]]
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 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
[[Page 31703]]
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 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
[[Page 31704]]
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 sampler.
(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 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
[[Page 31705]]
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 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
[[Page 31706]]
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
[GRAPHIC] [TIFF OMITTED] TP25AP24.123
(2) Fish and Fishery products and other marine ingredients that are
(1) processed under Federal inspection to ensure compliance with all
applicable regulatory requirements through the SIP Approved
Establishments Program and (2) 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] TP25AP24.124
Figure 3 to Paragraph (a)(2)(ii)--Processed Under Federal Inspection
(PUFI) Mark
[GRAPHIC] [TIFF OMITTED] TP25AP24.125
(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
(1) submitted for inspection through the lot inspection process
identified in the SIP Manual and are (2) 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;
(ii) Officially Sampled shield, e.g.
Figure 4 to Paragraph (b)(2)(i)--USDC Accepted Per Specifications
Shield
[GRAPHIC] [TIFF OMITTED] TP25AP24.126
Figure 5 to Paragraph (b)(2)(ii)--Officially Sampled Shield
[GRAPHIC] [TIFF OMITTED] TP25AP24.127
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
[[Page 31707]]
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.
(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
[[Page 31708]]
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 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. 2024-08676 Filed 4-24-24; 8:45 am]
BILLING CODE 3510-22-P
