Proposed Rule2024-08676
Inspection and Certification of Establishments, Fishery Products, and Other Marine Ingredients
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 25, 2024
Issuing agencies
Commerce DepartmentNational Oceanic and Atmospheric Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 81 (Thursday, April 25, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08676]
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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
AGENCY: National Marine Fisheries Service (NMFS or Agency), National
Oceanic and Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule; request for comments.
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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:
<bullet> Electronic Submissions: Submit all electronic public
comments via the Federal eRulemaking Portal. Go to <a href="http://www.regulations.gov/document/NOAA-NMFS-240412-0106">http://www.regulations.gov/document/NOAA-NMFS-240412-0106</a>, click the
``Comment'' icon, complete the required fields, and enter or attach
your comments.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<a href="/cdn-cgi/l/email-protection#236c6a71627c7056414e4a50504a4c4d634c4e410d464c530d444c55"><span class="__cf_email__" data-cfemail="f3bcbaa1b2aca086919e9a80809a9c9db39c9e91dd969c83dd949c85">[email protected]</span></a> or fax to (202) 395-7285.
FOR FURTHER INFORMATION CONTACT: Steven Wilson, Chief, Seafood
Inspection Program, by email at <a href="/cdn-cgi/l/email-protection#98cbecfdeefdf6b6cff1f4ebf7f6d8f6f7f9f9b6fff7ee"><span class="__cf_email__" data-cfemail="81d2f5e4f7e4efafd6e8edf2eeefc1efeee0e0afe6eef7">[email protected]</span></a> 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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual">https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual</a>. 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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-trade/inspection-and-analytical-services-fees">https://www.fisheries.noaa.gov/national/seafood-commerce-trade/inspection-and-analytical-services-fees</a>. 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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual">https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual</a>. 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: <a href="https://www.sba.gov/document/support--table-size-standards">https://www.sba.gov/document/support--table-size-standards</a>.
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 <a href="https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual">https://www.fisheries.noaa.gov/national/seafood-commerce-certification/seafood-inspection-manual</a>, that provides
procedures of how services shall be scheduled, planned, conducted, and
documented and describes services that conform to global activities
that harmonize inspection protocols.
[[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
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</html>Indexed from Federal Register on April 25, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.