Commerce Trusted Trader Program, 2412-2421 [2018-00653]
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claim filing deadline will be reviewed
individually and considered on its own
merit. VA may grant exceptions to the
requirements in paragraph (a) of this
section if it determines that there was
good cause for missing the filing
deadline. For example, when dual
coverage exists, CHAMPVA payment, if
any, cannot be determined until after
the primary insurance carrier has
adjudicated the claim. In such
circumstances an exception may be
granted provided that the delay on the
part of the primary insurance carrier is
not attributable to the beneficiary.
Delays due to provider billing
procedures do not constitute a valid
basis for an exception.
(c) Claims for CHAMPVA-covered
services and supplies provided before
the date of the event that qualifies an
individual under § 17.271 are not
reimbursable.
(d) CHAMPVA is the last payer to
OHI, as that term is defined in
§ 17.270(b). CHAMPVA benefits will
generally not be paid until the claim has
been filed with the OHI and the OHI has
issued a final payment determination or
explanation of benefits. CHAMPVA is
secondary payer to Medicare per the
terms of § 17.271(b).
*
*
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*
*
■ 10. Revise newly redesignated
§ 17.277 to read as follows:
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§ 17.277
Appeals.
Notice of the initial determination
regarding payment of CHAMPVA
benefits will be provided to the
CHAMPVA beneficiary on a CHAMPVA
Explanation of Benefits (EOB) form. The
EOB form is generated by the
CHAMPVA automated payment
processing system. If a CHAMPVA
beneficiary or provider disagrees with
the determination concerning
CHAMPVA-covered services and
supplies or calculation of benefits, he or
she may request reconsideration. Such
requests must be submitted to VA in
writing within one year of the date of
the initial determination. The request
must state why the CHAMPVA claimant
believes the decision is in error and
must include any new and relevant
information not previously considered.
Any request for reconsideration that
does not identify the reason for dispute
will be returned to the claimant without
further consideration. After reviewing
the claim and any relevant supporting
documentation, VA will issue a written
determination to the claimant that
affirms, reverses, or modifies the
previous decision. If the claimant is still
dissatisfied, within 90 days of the date
of the decision he or she may make a
written request for review by VA. After
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reviewing the claim and any relevant
supporting documentation, VA will
issue a written determination to the
claimant that affirms, reverses, or
modifies the previous decision. The
decision of VA with respect to benefit
coverage and computation of benefits is
final. When a CHAMPVA beneficiary
has other health insurance (OHI), an
appeal must first be filed with the OHI,
and a determination made, before
submitting the appeal to CHAMPVA
with limited exceptions such as if the
OHI deems the issue non-appealable.
Denial of CHAMPVA benefits based on
legal eligibility requirements may be
appealed to the Board of Veterans’
Appeals in accordance with 38 CFR part
20. Medical determinations are not
appealable to the Board. 38 CFR 20.101.
(Authority: 38 U.S.C. 501, 1781)
11. Revise newly redesignated
§ 17.278 to read as follows:
■
§ 17.278
Medical care cost recovery.
VA will actively pursue medical care
cost recovery in accordance with
applicable law.
(Authority: 42 U.S.C. 2651; 38 U.S.C. 501,
1781)
[FR Doc. 2018–00332 Filed 1–16–18; 8:45 am]
are due on or before March 5, 2018. If
you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this document, you
should advise the contact listed below
as soon as possible.
Federal Communications Commission.
Katura Jackson,
Federal Register Liaison Officer.
[FR Doc. 2018–00451 Filed 1–16–18; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 161228999–7867–01]
RIN 0648–BG51
Commerce Trusted Trader Program
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
BILLING CODE 8320–01–P
The National Marine
Fisheries Service is proposing this
Commerce Trusted Trader Program
(CTTP) as part of an effective seafood
traceability process to combat Illegal,
Unreported, and Unregulated (IUU)
fishing and seafood fraud. The
voluntary CTTP supplements the
Seafood Import Monitoring Program
(SIMP), recently implemented under the
Magnuson-Stevens Fishery
Conservation and Management Act.
Qualified importers who choose to
participate in the CTTP would benefit
from reduced reporting and
recordkeeping requirements, and
streamlined entry into U.S. commerce
for seafood imports subject to the SIMP.
DATES: Written comments must be
received by March 19, 2018.
ADDRESSES: Written comments on this
action, identified by NOAA–NMFS–
2016–0165, may be submitted by either
of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/#!
docketDetail;D=NOAA-NMFS-20160165, click the ‘‘Comment Now!’’ icon,
complete the required fields, and enter
or attach your comments.
• Mail: Melissa Beaudry, Office of
International Affairs and Seafood
Inspection, NOAA Fisheries, 1315 EastWest Highway, Silver Spring, MD
20910.
SUMMARY:
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket No. 17–310; FCC 17–164]
Promoting Telehealth in Rural
America; Correction
Federal Communications
Commission.
ACTION: Notice; correction.
AGENCY:
The Federal Communications
Commission (Commission) published a
document in the Federal Register of
January 3, 2018 seeking comment on
how to strengthen the Rural Health Care
Program and improve access to
telehealth in rural America. The
document contained an incorrect reply
comment date.
FOR FURTHER INFORMATION CONTACT:
Radhika Karmarkar, Wireline
Competition Bureau, (202) 418–7400 or
TTY: (202) 418–0484.
SUMMARY:
Correction
In the Federal Register of January 3,
2018, in FR Doc. 2017–28298, on page
303, in the first column, correct the
DATES caption to read:
DATES: Comments are due on or before
February 2, 2018, and reply comments
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Instructions: All comments received
are a part of the public record and will
generally be posted to https://
www.regulations.gov without change.
All personal identifying information (for
example, name and address) voluntarily
submitted by the commenter may be
publicly accessible. Do not submit
confidential business information or
otherwise sensitive or protected
information. NMFS will accept
anonymous comments. Enter N/A in the
required fields if you wish to remain
anonymous. Attachments to electronic
comments will be accepted in Microsoft
Word, Excel, WordPerfect, or Adobe
portable document file (PDF) formats
only.
Written comments regarding the
burden-hour estimates or other aspects
of the collection-of-information
requirements contained in this proposed
rule may be submitted to the NOAA
Fisheries Office of International Affairs
and Seafood Inspection (IASI) and by
email to: OIRA_Submission@
omb.eop.gov or fax to (202) 395–7285.
FOR FURTHER INFORMATION CONTACT:
Melissa Beaudry, Office of International
Affairs and Seafood Inspection, NOAA
Fisheries (phone (301) 427–8308, or
email Melissa.Beaudry@noaa.gov).
SUPPLEMENTARY INFORMATION:
Background
On March 15, 2015, a multi-agency
Presidential task force published an
Action Plan for combatting IUU fishing
and seafood fraud. This Action Plan
called for the identification of the
seafood species most ‘‘at-risk’’ for IUU
fishing or subject to significant seafood
fraud, and the development of a
traceability program to track these
‘‘priority’’ species from point of harvest
to entry into U.S. commerce, with
eventual expansion of the program to all
seafood species imported into the
United States. A final rule containing
measures to address imported fish and
fish products as part of this traceability
program—called the SIMP)—became
effective on January 9, 2017, with a
compliance date of January 1, 2018 for
most priority species (81 FR 88975;
December 9, 2016).
The Action Plan also called for the
development of a voluntary Commerce
Trusted Trader Program (CTTP) for
importers of species that are subject to
the SIMP. The CTTP is intended to
provide the benefits of reduced
reporting and recordkeeping
requirements and streamlined entry of
applicable species into the United States
for importers who are approved as
Commerce Trusted Traders (CTTs).
U.S. Customs and Border Protection
(CBP) and the U.S. Food and Drug
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Administration (FDA) are both
developing their own voluntary Trusted
Trader programs designed to reduce
costs to both the government and
industry, and streamline processing of
imports. While the CTTP shares many
features with these programs, it is
designed and intended to apply only to
the SIMP.
A critical element of the CTTP is the
assurance that the entire supply chain
for species covered by SIMP, from point
of harvest to entry into U.S. commerce,
is legal and documented, and that the
entry of illegally harvested and
misrepresented fishery products into the
U.S. market is prevented. The program
is intended to increase the security of
the supply chain while reducing the
burden of compliance for those
importers who qualify for CTT status.
This proposed rule, if adopted, would
establish the qualifying criteria and
application procedures for approval as a
CTT. It would also establish
requirements for a Trusted Trader
Compliance Plan, recordkeeping, and
third-party audits for CTTP participants.
Under the proposed rule, a CTT would
be required to establish a secure supply
chain (free of IUU fish or fish product
and falsely labeled seafood product) and
maintain, either directly or through a
third party, the records necessary to
verify the legality of all seafood
products subject to SIMP that he or she
enters into U.S. commerce. Compliance
with these requirements would replace
the SIMP requirement to enter harvest
event data into the International Trade
Data System (ITDS) at the time of filing
an entry, and would provide increased
flexibility for complying with SIMP
recordkeeping requirements.
The CTT would be expected to
produce all traceability documentation
associated with an entry filing subject to
the SIMP within 14 days upon request
by NMFS to support an audit and to
make such documentation available for
inspection, but would have significantly
reduced reporting requirements for
imports of SIMP species. With the
exception of any records or documents
required by other state or Federal
programs, such as the Tuna Tracking
and Verification Program (TTVP) or
FDA’s Prior Notice of Imported Food the
CTT would only be required to enter
their International Fisheries Trade
Permit (IFTP) number and species codes
into the ITDS at the time of entry filing.
I. Qualifying Criteria and Application
for the Commerce Trusted Trader
Program
The CTTP, as proposed, is a voluntary
program for U.S. importers of record
who import, or intend to import, species
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subject to the SIMP (50 CFR
300.324(a)(2)). This proposed rule
provides that certain criteria must be
met in order for an importer to be
approved as a CTT. In addition to other
requirements specified below, an
applicant must be a holder of a valid
IFTP, which can be obtained via online
registration through the NMFS National
Permitting System at https://
fisheriespermits.noaa.gov/npspub/pub_
cmn_login/index_live.jsp. IFTP
regulations are at 50 CFR 300.322. A
single IFTP issued to an importer of
record is valid for imports of all seafood
species that require an IFTP. Separate
permits are not required, for example, if
the imported species are covered under
more than one NMFS import monitoring
program or the importer trades in more
than one covered species. Note,
however, that for some commodities,
permits issued by other agencies may
also be required (e.g., U.S. Fish &
Wildlife Service permits for products of
species listed under the Convention for
International Trade in Endangered
Species (CITES)).
In addition to being an IFTP holder,
the applicant must submit an online
application for the CTTP at a website
designated by NMFS. Incomplete
applications will not be reviewed by
NMFS. A complete application must
contain the following:
(1) The applicant’s IFTP number;
(2) An affirmation that the applicant
has no history, during the previous five
years, of noncompliance (i.e., violations
that resulted in a finding of liability and
assessment of a civil monetary penalty
or criminal fine) with Federal
regulations related to the importation of
fish or fish products and is currently in
compliance with all licensing,
permitting, and reporting requirements
applicable to the importation of fish or
fish products;
(3) An affirmation that the applicant
is in compliance with other state and
federal programs, such as the Highly
Migratory Species (HMS) International
Trade Program, Antarctic Marine Living
Resources (AMLR) Import Export
Certification, and the TTVP, as
applicable, including license and/or
registration number(s) applicable to the
importation of fish or fish products;
(4) Electronic submission of the
applicant’s Trusted Trader Compliance
Plan (see details below); and
(5) Application fee.
The amount of the fee is calculated,
on at least an annual basis, in
accordance with the procedures of the
NOAA Finance Handbook, available
from NMFS, for determining the
administrative costs of each special
product or service. The fee may not
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exceed such costs and is specified on
each application form. At present, the
fee is expected to be approximately $30.
The NMFS Office of International
Affairs and Seafood Inspection (IASI)
will review a CTTP application, as well
as the applicant’s history of compliance
with state and federal regulations
related to the importation of fish or fish
products, in determining whether to
approve the application. If the
application is complete and the
applicant does not have a history of
non-compliance with applicable
regulations, NMFS will approve the
application and will issue a letter to the
applicant that will serve as official
documentation of CTT status. If the
application is incomplete or complete
but not approved, NMFS will issue a
letter to the applicant explaining the
reasons why. If NMFS issues such a
letter, the applicant may respond in
writing with additional information to
address the issues NMFS identified in
its letter. After reviewing such
information, NMFS will issue a letter to
the applicant indicating if CTT status is
approved or explaining the reasons why
such status continues to not be
approved. NMFS’ decision is final upon
issuance of this letter and is not
appealable. NMFS looks forward to
receiving comments on the nature and
extent of the application and
Compliance Plan review.
While the IFTP must be renewed
annually (see 50 CFR 300.322(d)),
approval under the CTTP remains in
effect unless it is revoked (see Section
IV below).
For each entry containing species or
species groups subject to the SIMP, the
CTT or designated entry filer must file
electronically, at the time of entry, the
CTT’s IFTP number and species to be
entered, as required under 50 CFR
300.323(a). No further SIMP data needs
to be provided. NMFS IASI will notify
CBP of the decision to grant CTT status
so that CBP will know that the complete
SIMP data set is not required. See
proposed 50 CFR 300.324(f) for CTT
exemptions from SIMP requirements.
II. Trusted Trader Compliance Plan
Under this proposed rule, CTTP
applicants must have a written Trusted
Trader Compliance Plan (Compliance
Plan) showing that they have a secure
and controlled supply chain, including,
but not limited to, harvest, purchase,
landing, shipping, processing, storage,
and import entry. Importers, regardless
of IFTP status, that do not meet these
requirements will not be approved as
CTTs.
The Compliance Plan must be
designed to meet the objective of the
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SIMP in preventing the importation of
illegally harvested or misrepresented
fish and fish products into United States
commerce. The Compliance Plan may
delegate entry filing, recordkeeping and
other responsibilities to other persons,
but such roles must be clearly defined
in the Compliance Plan, as detailed
below. Ultimately, the CTT is
responsible for adherence to the
Compliance Plan and compliance with
all NOAA import requirements,
including all applicable requirements of
the SIMP and the CTTP, if finalized, and
for ensuring the prevention of illegally
harvested or misrepresented seafood
entering U.S. commerce through the
CTT’s import activities.
The Compliance Plan must, at a
minimum, include the following
components:
(1) An Internal Control System (see
below for requirements);
(2) Procedures for ensuring that the
Compliance Plan and the CTT’s
adherence to it is audited by a certified
third party at least annually (see below
for audit requirements);
(3) The applicant’s written policy and
related supporting materials on
preventing the import of illegally
harvested and misrepresented seafood,
including a description of how the
policy is communicated to any affected
employees, entry filers, representatives,
and suppliers or other parties in the
supply chain, and corrective actions to
be taken as needed;
(4) An organizational chart that
identifies the persons with
responsibility for: entry filing;
custodianship of recordkeeping
documents; developing, administering,
and implementing the Compliance Plan
and its component measures; and
conducting training to ensure effective
implementation of the Compliance Plan;
(5) A signature page completed by the
applicant and the individual at the
highest level of authority in the
applicant’s organization assuming
responsibility for implementing the
Compliance Plan; and
(6) Any changes to the Compliance
Plan, along with an updated signature
page and organizational chart must be
included in the mandatory annual audit
report required (see below).
Internal Control System Requirements
The Internal Control System, which
must be documented in the Compliance
Plan described above, must include
traceability monitoring procedures for
seafood products subject to the SIMP
(50 CFR 300.324(a)(2)). The CTT is
responsible for ensuring
implementation of the Internal Control
System, which must include:
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(1) Procedures to verify the legal
harvest and landing of fish or fish
products subject to the SIMP that the
CTT enters into U.S. commerce.
Verification may rely on flag-state or
port-state harvest and landing records.
Certification of legal harvest by the flagstate may also be used. In any case, the
procedures must be capable of verifying
the legal harvest and landing of any fish
or fish products imported by the CTT of
species that fall under the SIMP by
providing the harvest and landing
information required by the SIMP
regulations at 50 CFR 300.324(b)(1)–(3).
A CTT may establish separate
procedures for verifying legal harvest
and landing from known and trusted
fishery sources and for verifying legal
harvest and landing from new fishery
sources, and may establish separate
measures for each fishery source, as
appropriate;
(2) Procedures to enable verification
of the full chain of custody from point
of first landing (or point of aggregation
for small-scale fisheries) to entry into
U.S. commerce (See 50 CFR 300.324(e)).
These procedures should describe the
process(es) that will be followed, and
documentation that will be used, to
verify chain of custody, and measures in
place to periodically verify the accuracy
of that documentation;
(3) Procedures to ensure that chain of
custody documentation will be
provided to NMFS, upon request,
within 14 days to support an agency
audit. Under 50 CFR 300.325(f) of the
proposed rule, the Compliance Plan
must identify who is responsible for
maintaining chain of custody
documentation, the point along the
supply chain at which the chain of
custody documents are stored and how
the CTT will ensure access to them
when necessary. The documentation
must be maintained and made available
for inspection as required under
§ 300.325(i) of the proposed rule. The
CTT must be able to access records for
no less than two years from the date of
entry of the product into U.S.
commerce, and records must be made
available for inspection, upon request
by NOAA to support an agency audit
and as necessary for purposes of the
annual audit required under
§ 300.325(j);
(4) Procedures for the CTT (or
designee) to perform at least one traceback annually for each species covered
by the SIMP imported by the CTT. A
trace-back is a document review of all
industry records that follow the product
from the point of entry into U.S.
commerce backwards through all steps
of processing, shipping, and storage to
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the point of harvest (or point of first
aggregation for small scale fisheries);
(5) Procedures to be taken in response
to information that illegally harvested or
misrepresented fish or fish products
have entered the supply chain (e.g.,
notice from NOAA’s Office of Law
Enforcement (OLE) or inclusion of the
harvesting vessel in a regional fishery
management organization’s list of
vessels that have engaged in illegal,
unreported and unregulated fishing),
measures to ensure that such fish or fish
products are removed from commerce
and further shipments are prevented
from entering commerce, and
procedures for promptly informing OLE
whether such products are inbound to
the United States or have entered U.S.
commerce;
(6) Procedures to be taken in response
to any supplier in the CTT’s supply
chain for SIMP species being placed on
an FDA Import Alert.. Import Alerts
inform FDA field staff and the public
that the Agency has enough evidence to
allow for Detention Without Physical
Examination (DWPE) of firms and
products that appear to be in violation
of FDA laws and regulations. These
violations could be related to the
product, manufacturer, shipper and/or
other information. More information is
available online at https://www.fda.gov/
ForIndustry/ImportProgram/
ActionsEnforcement/ImportAlerts/
ucm516428.htmand
(7) Procedures to regularly review
internal controls and update procedures
in response to changes in the fish or fish
products that the CTT wants to enter
into U.S. commerce, suppliers, or
operating conditions or nonconformities identified in an audit.
The CTT must ensure that all
information and documentation used for
internal controls related to the
Compliance Plan and Internal Control
System must remain available for U.S.
government audit for no less than two
years from the date of import entry.
NMFS seeks comment generally on
the required elements of the Trusted
Trader Compliance Plan, including the
Internal Control System. NMFS also
invites comment on establishing a
species-specific CTTP. As currently
drafted, this proposed rule would allow
a CTT to import all species subject to
SIMP and benefit from reduced
reporting requirements at the time of
import. As an alternative, an applicant
for CTT status could specify in the
CTTP Application and Compliance Plan
that it has a secure and controlled
supply chain for some, but not all, SIMP
species and request that CTT status be
limited to that subset of SMP species.
Under this species-specific alternative, a
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CTT would be required to comply with
all SIMP reporting and recordkeeping
requirements for imports of SIMP
species not specifically included in its
Compliance Plan. NMFS’ analysis of the
species-specific CTTP, set out in Section
1.3.5 of the regulatory impact review
(available from NMFS; see ADDRESSES),
indicates higher compliance costs for
CTTs under the species-specific CTTP.
Since the per entry reporting and
recordkeeping costs are projected to be
greater under SIMP than under CTTP, a
CTT who chooses to comply with CTTP
requirements for only a subset of the
priority species would be assuming the
higher fixed costs of CTTP compliance
while reducing the economic benefit of
that investment that accrues to every
import entry of a priority species by a
CTT through the reduction of per entry,
incremental costs.
Additionally, NMFS estimates that its
costs for both ITDS/ACE programming
and effective long-term compliance
auditing would be higher with a
species-specific CTTP. NMFS seeks
comment on its assumptions and
conclusions related to a species-specific
CTTP.
III. Procedures for Annual Third-Party
Audit
As noted in Section II, this proposed
rule provides that the CTT’s Compliance
Plan must include procedures for a
third-party audit. The CTT is
responsible for ensuring that this thirdparty audit is conducted annually.
Paragraphs 300.325(j) and (k) of the
proposed rule set forth requirements for
the audit and auditor certification.
Third-Party Audit Requirements
At least once annually, the CTT must
ensure that an audit is conducted by a
certified third-party auditor, consistent
with the requirements of the rule. The
purpose of the audit is to evaluate the
adequacy of the CTT’s Compliance Plan
in meeting the requirements of 50 CFR
300.325(f) and the CTT’s adherence to
that plan. A third-party audit should
include an opening meeting, during
which the auditor will discuss audit
objectives with the CTT and any
personnel supporting the audit.
During each audit, the third party
auditor must review the Compliance
Plan and relevant documents. The CTT
must make all records, written and
electronic, that are pertinent to the
Compliance Plan and Internal Control
System described therein available to
the auditor at the time of the audit. The
auditor will select a minimum of three
import entries containing SIMP species
to serve as the subject of the audit. He
or she must verify that all processes in
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the CTT’s Compliance Plan are being
followed and that the Internal Control
Plan effectively meets the requirements
of the CTTP. The auditor must also
verify that the audited entries can be
traced back to legal harvest (or
production) and landing and that the
species contained in the shipment are
truthfully represented. The auditor must
conduct interviews as necessary with
CTT staff, suppliers, and individuals
delegated responsibilities under the
Compliance Plan and may conduct
other activities as necessary.
A CTT must notify NMFS at least 30
days in advance of each third-party
audit. NMFS, at its discretion, may
attend a third-party audit as an observer
or conduct a side-by-side audit. In a
side-by-side audit, NMFS will review
the same documentation as the third
party auditor at the same time as the
third party auditor to evaluate both the
shipment(s) and performance of the
third party auditor. NMFS may also
conduct an independent audit of a CTT
at any time.
The auditor must have a closing
meeting with the CTT or designee to
review observed weaknesses and any
non-conformities with the Compliance
Plan, and issue a written audit report
within 30 calendar days of the audit. In
the audit report, the auditor must assess
the reliability of the CTT’s Compliance
Plan and the CTT’s adherence to it,
provide results of the audit, and identify
any non-conformities with the
Compliance Plan or its implementation.
The audit report must include the
auditor’s certifying credentials (see
below) and attestations that the auditor
(i.e., individual auditor(s) and auditing
firm): (1) Was not involved in
developing the CTT’s Compliance Plan,
and (2) has no financial relationship
with, or substantial interest in, the CTT
retaining their services beyond
performing the audit and any related
follow up.
The CTT is responsible for ensuring
that the auditor provides a signed and
locked electronic copy of the audit
report (in .pdf format) to the CTT and
NMFS IASI no later than 30 days
following completion of the audit. If the
auditor determines that no corrective
action is needed, the report is
considered the final audit report. If the
auditor determines that corrective
action is required to address nonconformities with the written
Compliance Plan or its implementation,
the report is considered an initial audit
report. In that case, within 60 days
following the audit, the CTT must
ensure that a signed and locked
electronic copy of the final audit report
(in .pdf format) is provided to NMFS
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IASI. The final report must include an
explanation, along with relevant
documentation, of corrective action
taken by the CTT and approved by the
auditor.
If the CTT fails to provide the audit
report to NMFS as required above or
take acceptable corrective actions as
identified in the report, NMFS may
conduct additional audits at its
discretion. NMFS may also take
additional measures up to and including
revocation of CTT status, as deemed
appropriate by NMFS. CTT third-party
audits may be combined with other
Global Food Safety Initiative (GFSI) or
chain of custody audits, provided the
combined audit is in full compliance
with the requirements of the CTTP.
Third-Party Auditor Certification and
Other Requirements
Beyond conducting the audit and any
related follow up for a CTT, a thirdparty auditor (i.e., individual auditor(s)
and auditing firm) must not have any
other financial relationship with, or
substantial interest in, the CTT. In
addition, an auditor must not have been
involved in developing the CTT’s
Compliance Plan. A third-party auditor
should have some familiarity or
experience with the seafood trade to
ensure accurate and critical review of a
CTT’s written Compliance Plan and the
CTT’s adherence to it. The third party
auditor must be certified with respect
to, and affirm his or her knowledge of
current auditing practices and
proficiency in conducting process
audits, identification of nonconformities and review of corrective
actions taken by the CTT. A third-party
must be certified by a competent
certifying body, as evidenced by one or
more of the following:
(1) Current accreditation or
certification by the American Institute
of Certified Public Accountants
(AICPA);
(2) Current accreditation or
certification by the Institute of Internal
Auditors;
(3) Current accreditation or
certification by the American Evaluation
Association;
(4) Current accreditation or
certification by a chain of custody
certifying body;
(5) Current accreditation or
certification by Accreditation Services
International; or other nationally
recognized certifying organizations;
(6) Evidence of current peer-review
certification such as Certified Quality
Auditor (CQA), Certified Internal
Auditor (CIA), Certified Public
Accountant (CPA), and Certified HACCP
Auditor (CHA);
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(7) Successful completion of auditor
training recognized by the International
Register of Certified Auditors (IRCA) or
Registrar Accreditation Board and
Quality Society of Australasia
(RABQSA), in environmental
management standards (EMS); quality
management standards (QMS); or Global
Food Safety Initiative (GFSI), and
registration with IRCA or RABQSA as
an EMS or QMS auditor; or
(8) Other training or certification
approved in writing by NMFS.
IV. Revocation of CTT Status
While the IFTP must be renewed
annually (see 50 CFR 300.322(d)),
approval under the CTTP remains in
effect unless revoked under this section.
If a CTT fails to comply with
requirements of the Program as detailed
above, NMFS may issue a Notification
Letter to the CTT that:
(1) Identifies the alleged failure to
comply with Commerce Trusted Trader
Program regulations and requirements;
(2) Describes the indications and
evidence of the alleged failure;
(3) Sets a Response Date by which the
CTT must submit to NMFS a written
response to the Notification Letter,
including, if applicable, a proposed
solution; and
(4) Explains the CTT’s options if the
CTT believes the Notification Letter is
in error.
NMFS will establish a Response Date
between 14 and 30 calendar days from
the date of the Notification Letter. The
CTT’s response must be received in
writing by NMFS on or before the
Response Date. If the CTT fails to
respond by the Response Date, CTT
status will be revoked. A CTT who has
submitted a timely response may meet
with NMFS within 21 calendar days of
the date of that response to discuss a
detailed and agreed-upon procedure for
resolving the alleged failure to comply
with the Commerce Trusted Trader
Program regulations and requirements.
If the CTT disagrees with the
Notification Letter and believes that
there is no failure to comply with CTTP
regulations and requirements, NMFS
has incorrectly defined or described the
failure, or NMFS is otherwise in error,
the CTT may submit a written Objection
Letter to NMFS on or before the
Response Date. Within 21 calendar days
of the date of the Objection Letter, the
CTT may meet with NMFS to discuss a
resolution or redefinition of the issue. If
modifications to any part of the
Notification Letter are required, then
NMFS will issue a revised Notification
Letter to the CTT; however, the
Response Date or any other timeline in
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this process would not restart or be
modified unless NMFS decides to do so.
The total process from the date of the
Notification Letter to the date of final
resolution should not exceed 90
calendar days, and may require a shorter
time frame, to be determined by NMFS,
depending on the seriousness of the
alleged failure. In rare circumstances,
NMFS, at its discretion, may extend the
time for resolution of the alleged failure.
In such a case, NMFS will provide a
written notice to the CTT informing him
or her of the extension and the basis for
the extension. If the failure to comply
with CTTP requirements cannot be
resolved through this process, NMFS
will issue a Revocation Letter to the
CTT that:
(1) States that CTT status has been
revoked;
(2) Summarizes the failure to comply
with CTTP requirements;
(3) Summarizes any proposed
procedures, or attempts to produce such
procedures pursuant to sub-paragraph
(3) of this section, to resolve the failure;
(4) Explains why resolution was not
achieved; and
(5) Advises the importer that (1) the
importer is no longer exempt from the
requirements of the SIMP, and (2) the
importer may not reapply for CTT status
for a period of one year. NMFS’ decision
is final upon issuance of the Revocation
Letter and is not appealable.
V. Prohibitions
The proposed rule would amend the
existing prohibitions section in subpart
Q to add five new prohibitions.
Specifically, the proposed rule would
prohibit: (1) Making a false statement on
an application for the CTTP; (2) the
falsification of records required to be
maintained under 50 CFR 300.324(d) or
(e) or 300.325; (3) failure to make
records available for inspection, as
required under 50 CFR 300.324(d) or (e)
or 300.325(i); (4) a CTT from failing to
maintain records containing information
on the chain of custody and custodian
of fish or fish products, provide access
to such records to support an agency
audit, and make such records available
for inspection as required (see 50 CFR
300.325(g)(3) and (i)); and (5) a CTT
from failing to implement or follow the
Trusted Trade Compliance Plan they are
required to have in place as a condition
of being granted, and retaining, that
status (see 50 CFR 300.325 (f) and (g)).
More information and any updates on
the proposed CTTP can be found on our
website at https://
www.iuufishing.noaa.gov/.
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Classification
This proposed rule is published under
the authority of the Magnuson-Stevens
Fishery Conservation and Management
Act, 16 U.S.C. 1801 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 significant for the
purposes of Executive Order 12866.
NMFS has prepared a regulatory impact
review of this action, which is available
from NMFS (see ADDRESSES). This
analysis describes the economic impact
this proposed action, if adopted, would
have on businesses and consumers.
NMFS invites the public to comment on
this proposal and the supporting
analysis.
The regulatory action being
considered is described in the preamble
of this proposed rule. For importers
subject to the SIMP, this proposed rule
would create a voluntary program that
includes exemptions from SIMP
reporting and recordkeeping
requirements. NMFS anticipates that
U.S. persons would not have any
significant adverse economic effects as a
result of this action, because it does not
pose any new burdens with regard to
existing reporting and recordkeeping
requirements. On the contrary, this rule,
if adopted, would reduce reporting and
recordkeeping requirements under the
SIMP for importers who are approved as
CTTs, and result in positive economic
benefits for them. NMFS seeks comment
on whether there could be economic
impacts that have not been addressed in
this proposed rule, or that could be
difficult to anticipate.
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Executive Order 13771
This proposed rule is expected to be
an E.O. 13771 deregulatory action. As
discussed below, this proposed rule
would create cost savings of
approximately $806,810 industry-wide
on an annual basis. Further details on
the estimated cost savings of this
proposed rule can be found in the
regulatory impact review analysis.
Regulatory Flexibility Act
An Initial Regulatory Flexibility
Analysis (IRFA) was prepared, as
required by section 603 of the
Regulatory Flexibility Act (RFA) and is
available from NMFS (see ADDRESSES).
The IRFA describes the economic
impact this proposed rule, if adopted,
would have on small entities. A
description of the action, why it is being
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considered, and the legal basis for this
action are contained at the beginning of
this section in the preamble and in the
SUMMARY section of the preamble. A
summary of the analysis follows.
For this proposed rule, NMFS looked
at two alternatives: No action and a
CTTP, as called for in the March 15,
2015, Presidential task force Action Plan
(see Background). By not joining the
CTTP, importers will need to fully
comply with the SIMP rule and report
information pertaining to the harvest of
species covered under SIMP via the
ITDS prior to entry, and maintain those
records as well as records documenting
the supply chain from point of harvest
to entry into U.S. commerce for a period
of no less than two years. For importers
who do not apply to become a CTT,
there would be no change from current
SIMP requirements and thus no
economic impacts. In the SIMP final
rule, NMFS estimated annual
compliance costs of $6,075,000
including permit fees, reporting,
recordkeeping, and data storage for
2,000 importers who, combined, filed
215,000 entries through the
International Trade Data System (ITDS).
There were 216 importers who filed
more than 250 entries in 2014
(comprising roughly 72% of all entries).
NMFS expects these high volume
importers would benefit financially
from the CTTP. NMFS seeks public
comment on the accuracy of these
baseline conditions used in the
development of this proposed rule.
In the Final Regulatory Flexibility
Analysis for the SIMP rule, NMFS
concluded that all persons subject to the
program requirements could be
classified as small businesses. Likewise,
all importers who choose to apply and
be approved as CTTs would also be
classified as small businesses. CTTs
would realize the benefits of reduced
reporting and recordkeeping and
streamlined entry into U.S. commerce of
their fish and fishery products. The
increased cost of annual third-party
auditing required under the CTTP
would be offset by the reduction in
reporting costs at time of entry.
Consequently, importers with a higher
annual volume of entries would accrue
greater benefits. In comparing entry
reporting cost savings to estimates of the
costs to contract with a third-party
auditor, NMFS estimates that importers
making more than 250 entries per year
would benefit from becoming a CTT.
Considering the same baseline as that
used for the SIMP analysis (entries of
priority species seafood products made
in 2014), approximately 2000 importers
would be required to report harvest
event data upon entry. NMFS estimates
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2417
that 216 of these importers, who each
filed more than 250 entries in 2014,
would benefit from the reduced
reporting burden of becoming a CTT.
Assuming all of these importers would
elect to become CTTs, cost savings of
approximately $806,810 would be
realized industry-wide on an annual
basis.
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 implement a
Commerce Trusted Trader Program are
procedural and administrative in nature
in that they would modify
recordkeeping and auditing
requirements for ongoing authorized
catch and trade activities. Fishing
activity and trade in seafood products
are not 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 contains a
collection-of-information requirement
subject to review and approval by OMB
under the Paperwork Reduction Act
(PRA). This requirement has been
submitted to OMB for approval. The
information collection burden for the
requirements proposed under this rule
(CTTP application; Compliance Plan
development or modification; thirdparty audit; and traceability documents
recordkeeping) are estimated to result in
a significant reduction in both time and
costs for CTTs relative to the burden
associated with compliance with the
reporting and recordkeeping
requirements of the SIMP.
NMFS estimates that approximately
216 International Fisheries Trade Permit
holders would apply for the CTTP, and
that they would need approximately 10
minutes to fill out the online
application, at an hourly rate of $25, for
a total of 36 hours and labor costs of
$900. NMFS considers that most of the
216 entities estimated to apply for CTT
status will already have some form of
internal control plan in place, so the
development of a Compliance Plan
specific to the CTTP will take no more
than 8 hours. If a Compliance Plan
needs to be developed from square one,
NMFS estimates no more than 24 hours
will be required, at an hourly rate of
$50. Assuming that this rule would
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affect 216 importers, the total one-time
burden for application and Compliance
Plan development and submission
amounts to between 1,764 hours and
5,220 hours, and labor costs of between
$87,300 and $260,100.
Because the CTTP removes the
requirement of reporting harvest data
prior to entry into U.S. commerce, a
CTT is expected to realize the cost
savings of not entering such data. NMFS
has calculated the time and cost of a
CTTP entry filing (header record only)
to be 12 minutes at $25 per hour, for a
cost per entry of $5, versus 36 minutes
per SIMP filing (header and all harvest
vessel and landing records) and a cost
of $15 per filing. Using available data
from 2014, the average number of
entries for the 216 importers filing 250
or more entries, which is the point at
which NMFS believes an entity would
likely choose to become a CTT, is 750.
This equates to 162,000 entries. The
annual burden of contracting with a
third-party auditor is estimated to be
one hour at the hourly rate of $50, for
a total of 216 hours and $10,800
annually. The cost of the actual audit is
estimated to be between $1,120 and
$3,600, with an average cost of $2,190,
for a total of $473,040. These burdens
would be offset by the reduced cost
benefit of the program, which cuts out
64,800 hours of data entry filing at a
cost savings of $1,620,000.
Public comment is sought regarding:
whether this proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
the accuracy of the assumptions used in
calculating the burden estimate; ways to
enhance the quality, utility, and clarity
of the information to be collected; and
ways to minimize the burden of the
collection of information, including
through the use of automated collection
techniques or other forms of information
technology. Send comments on these or
any other aspects of the collection of
information to the NOAA Fisheries
Office of International Affairs and
Seafood Inspection at the ADDRESSES
above, and by email to OIRA_
Submission@omb.eop.gov or fax to (202)
395–7285.
Notwithstanding any other provision
of the law, no person is required to
respond to, and no person shall be
subject to penalty for failure to comply
with, a collection of information subject
to the requirements of the PRA, unless
that collection of information displays a
currently valid OMB control number.
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List of Subjects in 50 CFR Part 300
Exports, Fisheries, Fishing, Fishing
vessels, Illegal, unreported or
unregulated fishing, Foreign relations,
Imports, International trade permits,
Treaties.
Dated: January 11, 2018.
Samuel D. Rauch, III,
Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service.
For the reasons set out in the
preamble, 50 CFR part 300, subpart Q,
is proposed to be amended as follows:
PART 300—INTERNATIONAL
FISHERIES REGULATIONS
1. The authority citation for 50 CFR
part 300 continues to read as follows:
■
Authority: 16 U.S.C. 951 et seq., 16 U.S.C.
1801 et seq., 16 U.S.C. 5501 et seq., 16 U.S.C.
2431 et seq., 31 U.S.C. 9701 et seq.
2. In § 300.321, add, in alphabetical
order, a definition for ‘‘Commerce
Trusted Trader’’, ‘‘Commerce Trusted
Trader Program’’, ‘‘Internal Control
System’’, and ‘‘Trusted Trader
Compliance Plan’’ to read as follows:
■
§ 300.321
Definitions.
*
*
*
*
*
Commerce Trusted Trader (CTT)
means an importer of record who holds
a valid International Fisheries Trade
Permit (see § 300.322) and who has been
approved by NMFS under § 300.325.
Commerce Trusted Trader Program
(CTTP) means the voluntary program
established under § 300.325.
*
*
*
*
*
Internal Control System means the
written procedures required under
§ 300.325(g).
*
*
*
*
*
Trusted Trader Compliance Plan or
Compliance Plan means the written
plan required under § 300.325(f).
*
*
*
*
*
■ 3. In § 300.324, add paragraph (f) to
read as follows:
§ 300.324
Seafood Traceability Program.
*
*
*
*
*
(f) An importer of record who is
approved as a Commerce Trusted Trader
(CTT) under § 300.325 shall be exempt
from the reporting requirements of
§ 300.324(b)(1)–(3) and (c) and may
delegate the recordkeeping
responsibilities under § 300.324(e) to
one or more third parties as provided in
§ 300.325(i). However, a CTT is not
exempt from IFTP requirements under
§ 300.322 or any other applicable
requirements and is responsible for
compliance with the obligations of
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§ 300.324(e). CTTP application
procedures and requirements are set
forth at § 300.325.
■ 4. Redesignate § 300.325 as § 300.326
and add a new § 300.325 to read as
follows:
§ 300.325 Commerce Trusted Trader
Program.
(a) Establishment. This section
establishes a voluntary Commerce
Trusted Trader Program (CTTP) which
provides an exemption from the
reporting requirements of the Seafood
Import Monitoring Program (SIMP) (see
§ 300.324(f)) and alternative
recordkeeping options (see paragraph (i)
of this section). Qualifying criteria,
application procedures, requirements
for Trusted Trader Compliance Plans
and recordkeeping, and third-party
audit requirements for CTTP
participants are set forth in the
following sections.
(b) Qualifying Criteria. To be
approved as a Commerce Trusted Trader
(CTT), an applicant must be a U.S.
importer of record who has imported, or
who intends to import, products subject
to the SIMP and must be a holder of a
valid International Fisheries Trade
Permit (IFTP) (see § 300.322).
(c) Application. The applicant must
submit an online application for the
CTTP at a website designated by NMFS.
Incomplete applications will not be
reviewed by NMFS. A complete
application must contain the following:
(1) The applicant’s IFTP number;
(2) Affirmation that the applicant has
no history, during the previous five
years, of noncompliance (i.e., violations
that resulted in a finding of liability and
assessment of a civil monetary fine or
criminal penalty) with federal
regulations related to the importation of
fish and fish products and is currently
in compliance with all licensing,
permitting, and reporting requirements
applicable to the importation of fish and
fish products;
(3) Affirmation that the applicant is in
compliance with other state and federal
programs, as applicable, including
license and/or registration number(s)
applicable to the importation of fish and
fish products;
(4) Electronic submission of the
applicant’s Trusted Trader Compliance
Plan (see paragraph (f) of this section);
and
(5) Application fee.
(d) Fees. Applicants for the CTTP
must electronically pay an application
fee assessed by NMFS to recover
application review costs. If an
application fee is paid with a
commercial instrument that is
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insufficiently funded, the CTTP
application will not be processed.
(e) Review and Approval of
Application.
(1) The NMFS Office of International
Affairs and Seafood Inspection (IASI)
will review a CTTP application, as well
as the applicant’s history of compliance
with federal regulations related to the
importation of fish and fish products, in
determining whether to approve the
application.
(2) If NMFS IASI approves the
application, it will issue a letter to the
applicant that will serve as official
documentation of CTT status.
(3) If the application is incomplete or
complete but not approved, NMFS will
issue a letter to the applicant explaining
the reasons why.
(4) If NMFS issues a letter under
paragraph (e)(3), the applicant may
respond in writing with additional
information to address the issues NMFS
identified in its letter. After reviewing
such information, NMFS will issue a
letter to the applicant indicating if CTT
status is approved or explaining the
reasons why such status continues to
not be approved. NMFS’ decision is
final upon issuance of this letter and is
not appealable. The applicant may
reapply no earlier than one year from
the date of NMFS’ final decision.
(5) While the IFTP must be renewed
annually (see § 300.322(d)), approval
under the CTTP remains in effect unless
it is revoked under paragraph (l).
(f) Trusted Trader Compliance Plan.
In order to be approved as a CTT, the
applicant must have a Trusted Trader
Compliance Plan (Compliance Plan) that
is designed to meet the objective of the
SIMP in preventing the importation of
illegally harvested or misrepresented
fish and fish products into United States
commerce. The Compliance Plan may
delegate entry filing, recordkeeping and
other responsibilities to other persons,
but the CTT remains responsible for
ensuring adherence to the Compliance
Plan and compliance with all NOAA
import requirements, including all
applicable requirements of the SIMP
and the CTTP. The Compliance Plan
must, at a minimum, include the
following components:
(1) An Internal Control System (see
paragraph (g) of this section for
requirements);
(2) Procedures for ensuring that the
Compliance Plan and the CTT’s
adherence to it is audited by a certified
third party at least annually (see
paragraph (j) of this section for audit
requirements);
(3) The applicant’s written policy and
related supporting materials on
preventing the import of illegally
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harvested and misrepresented seafood,
including a description of how the
policy is communicated to any affected
employees, entry filers, representatives,
and suppliers or other parties in the
supply chain, and corrective actions to
be taken as needed;
(4) An organizational chart that
identifies the persons with
responsibility for: Entry filing;
custodianship of recordkeeping
documents; developing, administering,
and implementing the Compliance Plan
and its component measures; and
conducting training to ensure effective
implementation of the Compliance Plan;
(5) A signature page completed by the
applicant and the individual at the
highest level of authority in the
applicant’s organization assuming
responsibility for implementing the
Compliance Plan. This signature page
and the organizational chart must be
updated each year at the time of the
annual audit in order for a CTT’s status
to remain current; and
(6) Any changes to the Compliance
Plan, along with an updated signature
page and organizational chart must be
included in the annual audit report
required under paragraph (j) of this
section.
(g) Internal Control System
Requirements. The Internal Control
System, which must be documented in
the Compliance Plan under paragraph
(f) of this section, must include
traceability monitoring procedures for
seafood products subject to the SIMP
(§ 300.324). The CTT is responsible for
ensuring implementation of the internal
control system, which must include:
(1) Procedures to verify the legal
harvest and landing of fish or fish
products subject to the SIMP that the
CTT enters into U.S. commerce. Such
procedures may rely on flag-state and/
or port-state harvest and landing records
or flag-state certification of legal harvest.
A CTT may establish separate
verification procedures for each fishery
source, as appropriate (e.g., known and
trusted vs. new sources);
(2) Procedures to enable verification
of the full chain of custody from point
of first landing (or point of aggregation
for small-scale fisheries) to entry into
U.S. commerce (See paragraph (i) of this
section). These procedures should
describe the process(es) that will be
followed, and documentation that will
be used, to verify chain of custody, and
measures in place to periodically verify
the accuracy of that documentation;
(3) Procedures to ensure that chain of
custody documentation will be
provided to NMFS, upon request,
within 14 days to support an agency
audit. The Compliance Plan under
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2419
paragraph (f) of this section must
identify who is responsible for
maintaining chain of custody
documentation, the point along the
supply chain at which the chain of
custody documents are stored and how
the CTT will ensure access to them
when necessary. The documentation
must be maintained and made available
for inspection as required under
paragraph (i) of this section;
(4) Procedures for the CTT (or
designee) to perform at least one traceback annually for each species covered
by the SIMP that is imported by the
CTT. A trace-back is a document review
of all records that follow the product
from the point of entry into U.S.
commerce backwards through the
supply chain (e.g., through all steps of
processing, shipping, purchase, and
storage) to the point of harvest (or point
of first aggregation for small scale
fisheries);
(5) Procedures to be taken in response
to information that illegally harvested or
misrepresented fish or fish products
have entered the supply chain (e.g.,
notice from NOAA’s Office of Law
Enforcement (OLE) or inclusion of the
harvesting vessel in a regional fishery
management organization’s list of
vessels that have engaged in illegal,
unreported and unregulated fishing),
measures to ensure that such fish and
fish products are removed from
commerce and further shipments are
prevented from entering commerce, and
procedures for promptly informing OLE
whether such products are inbound to
the United States or have entered U.S.
commerce;
(6) Procedures to be taken in response
to a supplier being placed on an FDA
Import Alert List. FDA Import Alerts
inform FDA field staff and the public
that the Agency has enough evidence to
allow for Detention Without Physical
Examination (DWPE) of products that
appear to be in violation of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) or FDA regulations. These
violations could be related to the
product, manufacturer, shipper and/or
other information. More information is
available online at https://www.fda.gov/
ForIndustry/ImportProgram/
ActionsEnforcement/ImportAlerts/
ucm516428.htm; and
(7) Procedures to regularly review and
update internal control procedures in
response to changes in the fish or fish
products that the CTT wants to enter
into U.S. commerce, suppliers, or
operating conditions, or nonconformities identified in an audit.
(h) Entry filing requirements. NMFS
will alert U. S. Customs and Border
Protection when it approves a CTT
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under paragraph (e) of this section. For
each entry containing species or species
groups subject to the SIMP, at the time
of entry, the CTT or designated entry
filer must file electronically, as required
under § 300.323(a), the CTT’s IFTP
number and species to be entered. No
further information needs to be
provided. See § 300.324(f) for
exemptions from SIMP requirements.
(i) Recordkeeping requirements. As
specified in § 300.324(e), records
containing information on the chain of
custody and custodian of fish or fish
products (e.g., trans-shipper, processor,
storage facility or distributor) must be
maintained. However, CTTs have the
option of delegating the recordkeeping
requirements to one or more third
parties. The records must be maintained
either by the CTT, or at designated
points within the supply chain to which
the CTT has unrestricted access, or with
any third-party that the CTT designates
in its Compliance Plan. Regardless of
which option it chooses, the CTT is
responsible for ensuring that the
required chain of custody
documentation for all species and
species groups subject to SIMP is
maintained for a period of two years
from the date of entry of product into
U.S. commerce, providing such
documentation to NMFS in accordance
with paragraph (g)(3) of this section, and
making it available for inspection as
required under § 300.324(e).
(j) Third-party Audit Requirements.
At least once annually, the CTT must
ensure that an audit is conducted by a
certified third-party auditor, consistent
with the requirements of this paragraph
and paragraph (k) of this section. The
purpose of the audit is to evaluate the
adequacy of the CTT’s Compliance Plan
in meeting the requirements of
paragraphs (f) and (g) of this section and
the CTT’s adherence to that plan. The
audit must include:
(1) Review of the Compliance Plan
and relevant documents; full trace back
to point(s) of harvest of at least three
shipments of products falling under the
SIMP, selected by the third-party
auditor; interviews as necessary with
CTT staff, suppliers, and individuals
delegated responsibilities under the
Compliance Plan; and other activities as
necessary;
(2) A closing meeting between the
auditor and the CTT or designee to
review observed weaknesses and any
non-conformities with the Compliance
Plan; and
(3) Issuance of audit reports.
(i) Notification and NMFS Audit. The
CTT shall notify NMFS at least 30 days
in advance of each third-party audit.
NMFS, at its discretion, may attend a
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third-party audit as an observer or
conduct a side-by-side audit. NMFS
may conduct an independent audit of a
CTT at any time.
(ii) Audit Reports. In an audit report,
a third-party auditor must assess the
reliability of the CTT’s Compliance Plan
and the CTT’s adherence to it, provide
results of the audit, and identify any
non-conformities with the Compliance
Plan or its implementation. The audit
report must include the auditor’s
certifying credentials (see paragraph (k)
of this section) and attestations that the
auditor (i.e., individual auditor(s) and
auditing firm): (1) Was not involved in
developing the CTT’s Compliance Plan,
and (2) has no financial relationship
with, or substantial interest in, the CTT
retaining their services beyond
performing the audit and any related
follow up.
(iii) Follow Up on Audit Reports. The
CTT is responsible for ensuring that the
auditor provides a signed and locked
electronic copy (in .pdf format) of the
audit report to the CTT and IASI no
later than 30 days following completion
of the audit. If the auditor determines
that no corrective action is needed, the
report is considered the final audit
report. If the auditor determines that
corrective action is required to address
non-conformities with the Compliance
Plan or its implementation, the report is
considered an initial audit report. In
that case, within 60 days following the
audit, the CTT must ensure that a signed
and locked electronic copy of the final
audit report (in .pdf format) is provided
to NMFS IASI. The final report must
include an explanation, along with
relevant documentation, of corrective
action taken by the CTT and approved
by the auditor.
(iv) If the CTT fails to provide the
audit report as required above or take
acceptable corrective actions, NMFS
may conduct additional audits at its
discretion. NMFS may also take
additional measures up to and including
revocation of CTT status as deemed
appropriate by NMFS.
(k) Third-Party Auditor Certification
and Other Requirements.
(1) Beyond conducting the audit and
any related follow up for a CTT, a thirdparty auditor (i.e., individual auditor(s)
and auditing firm) must not have any
other financial relationship with, or
substantial interest in, the CTT. In
addition, an auditor must not have been
involved in developing the CTT’s
Compliance Plan. A third-party auditor
should have some familiarity or
experience with the seafood trade to
ensure an accurate and critical review of
a CTT’s Compliance Plan and the CTT’s
adherence to it. The third party auditor
PO 00000
Frm 00048
Fmt 4702
Sfmt 4702
must be certified in and affirm his or her
knowledge of current auditing practices
and proficiency in conducting process
audits, identification of nonconformities and review of corrective
actions taken by the CTT.
(2) A third-party auditor must be
certified by a competent certifying body,
as evidenced by one or more of the
following:
(i) Current accreditation or
certification by the American Institute
of Certified Public Accountants
(AICPA);
(ii) Current accreditation or
certification by the Institute of Internal
Auditors;
(iii) Current accreditation or
certification by the American Evaluation
Association;
(iv) Current accreditation or
certification by a chain of custody
certifying body;
(v) Current accreditation or
certification by Accreditation Services
International, or other nationally
recognized certifying organizations;
(vi) Evidence of current peer-review
certification such as Certified Quality
Auditor (CQA), Certified Internal
Auditor (CIA), Certified Public
Accountant (CPA), and Certified HACCP
Auditor (CHA);
(vii) Successful completion of auditor
training recognized by the International
Register of Certified Auditors (IRCA) or
Registrar Accreditation Board and
Quality Society of Australasia
(RABQSA), in environmental
management standards (EMS); quality
management standards (QMS); or Global
Food Safety Initiative (GFSI), and
registration with IRCA or RABQSA as
an EMS or QMS auditor; and
(viii) Other training or certification as
approved in writing by NMFS.
(l) Revocation of CTT status.
(1) If a CTT fails to comply with
requirements under this section, NMFS
may issue a Notification Letter to the
CTT that:
(i) Identifies the alleged failure to
comply with CTTP regulations and
requirements;
(ii) Describes the indications and
evidence of the alleged failure;
(iii) Sets a Response Date by which
the CTT must submit to NMFS a written
response to the Notification Letter,
including, if applicable, a proposed
solution; and
(iv) Explains the CTT’s options if the
CTT believes the Notification Letter is
in error.
(2) NMFS will establish a Response
Date between 14 and 30 calendar days
from the date of the Notification Letter.
The CTT’s response must be received in
writing by NMFS on or before the
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Response Date. If the CTT fails to
respond by the Response Date, CTT
status will be revoked. At its discretion
and for good cause, NMFS may extend
the Response Date to a maximum of 60
calendar days from the date of the
Notification Letter.
(3) A CTT who has submitted a timely
response may meet with NMFS within
21 calendar days of the date of that
response to discuss a detailed and
agreed-upon procedure for resolving the
alleged failure to comply with the CTTP
regulations and requirements. The
meeting may be in person or via
conference call or webcast.
(4) If the CTT disagrees with the
Notification Letter and believes that
there is no failure to comply with CTTP
regulations and requirements, NMFS
has incorrectly defined or described the
failure, or NMFS is otherwise in error,
the CTT may submit a written Objection
Letter to NMFS on or before the
Response Date. Within 21 calendar days
of the date of the Objection Letter, the
CTT may meet with NMFS to discuss a
resolution or redefinition of the issue.
The meeting may be in person, or via
conference call or webcast. If
modifications to any part of the
Notification Letter are required, then
NMFS will issue a revised Notification
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Letter to the CTT; however, the
Response Date or any other timeline in
this process would not restart or be
modified unless NMFS decides to do so,
at its discretion.
(5) The total process from the date of
the Notification Letter to the date of
final resolution should not exceed 90
calendar days, and may require a shorter
time frame, to be determined by NMFS,
depending on the seriousness of the
alleged failure. In rare circumstances,
NMFS, at its discretion, may extend the
time for resolution of the alleged failure.
In such a case, NMFS will provide a
written notice to the CTT informing him
or her of the extension and the basis for
the extension.
(6) If the failure to comply with CTTP
requirements cannot be resolved
through this process, NMFS will issue a
Revocation Letter to the CTT that:
(i) States that CTT status has been
revoked;
(ii) Summarizes the failure to comply
with CTTP requirements;
(iii) Summarizes any proposed
procedures, or attempts to produce such
procedures pursuant to sub-paragraph
(3) of this paragraph to resolve the
failure;
(iv) Explains why resolution was not
achieved; and
PO 00000
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2421
(v) Advises the importer that:
(A) The importer is no longer exempt
from the requirements of the SIMP; and
(B) The importer may not reapply for
CTT status for a period of one year.
(7) NMFS’ decision is final upon
issuance of the Revocation Letter and is
not appealable.
■ 5. In newly redesignated § 300.326,
add paragraphs (d), (e), (f), (g), and (h)
to read as follows:
§ 300.326
Prohibitions.
*
*
*
*
*
(d) Make a false statement on an
application for the CTTP.
(e) Falsify records required to be
maintained under § 300.324(d) or (e) or
§ 300.325(i).
(f) Fail to make records available for
inspection as required under
§ 300.324(d) or (e) or § 300.325(i).
(g) As a CTT, fail to maintain and
provide access to records as required
under § 300.325(i) or to produce records
as required under § 300.325(g)(3).
(h) As a CTT, fail to implement or
follow the procedures in the Trusted
Trader Compliance Plan submitted to
NMFS in a CTT application or as part
of an annual audit report.
[FR Doc. 2018–00653 Filed 1–16–18; 8:45 am]
BILLING CODE 3510–22–P
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Agencies
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Proposed Rules]
[Pages 2412-2421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00653]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 300
[Docket No. 161228999-7867-01]
RIN 0648-BG51
Commerce Trusted Trader Program
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Proposed rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: The National Marine Fisheries Service is proposing this
Commerce Trusted Trader Program (CTTP) as part of an effective seafood
traceability process to combat Illegal, Unreported, and Unregulated
(IUU) fishing and seafood fraud. The voluntary CTTP supplements the
Seafood Import Monitoring Program (SIMP), recently implemented under
the Magnuson-Stevens Fishery Conservation and Management Act. Qualified
importers who choose to participate in the CTTP would benefit from
reduced reporting and recordkeeping requirements, and streamlined entry
into U.S. commerce for seafood imports subject to the SIMP.
DATES: Written comments must be received by March 19, 2018.
ADDRESSES: Written comments on this action, identified by NOAA-NMFS-
2016-0165, may be submitted by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0165, click the
``Comment Now!'' icon, complete the required fields, and enter or
attach your comments.
Mail: Melissa Beaudry, Office of International Affairs and
Seafood Inspection, NOAA Fisheries, 1315 East-West Highway, Silver
Spring, MD 20910.
[[Page 2413]]
Instructions: All comments received are a part of the public record
and will generally be posted to https://www.regulations.gov without
change. All personal identifying information (for example, name and
address) voluntarily submitted by the commenter may be publicly
accessible. Do not submit confidential business information or
otherwise sensitive or protected information. NMFS will accept
anonymous comments. Enter N/A in the required fields if you wish to
remain anonymous. Attachments to electronic comments will be accepted
in Microsoft Word, Excel, WordPerfect, or Adobe portable document file
(PDF) formats only.
Written comments regarding the burden-hour estimates or other
aspects of the collection-of-information requirements contained in this
proposed rule may be submitted to the NOAA Fisheries Office of
International Affairs and Seafood Inspection (IASI) and by email to:
[email protected] or fax to (202) 395-7285.
FOR FURTHER INFORMATION CONTACT: Melissa Beaudry, Office of
International Affairs and Seafood Inspection, NOAA Fisheries (phone
(301) 427-8308, or email [email protected]).
SUPPLEMENTARY INFORMATION:
Background
On March 15, 2015, a multi-agency Presidential task force published
an Action Plan for combatting IUU fishing and seafood fraud. This
Action Plan called for the identification of the seafood species most
``at-risk'' for IUU fishing or subject to significant seafood fraud,
and the development of a traceability program to track these
``priority'' species from point of harvest to entry into U.S. commerce,
with eventual expansion of the program to all seafood species imported
into the United States. A final rule containing measures to address
imported fish and fish products as part of this traceability program--
called the SIMP)--became effective on January 9, 2017, with a
compliance date of January 1, 2018 for most priority species (81 FR
88975; December 9, 2016).
The Action Plan also called for the development of a voluntary
Commerce Trusted Trader Program (CTTP) for importers of species that
are subject to the SIMP. The CTTP is intended to provide the benefits
of reduced reporting and recordkeeping requirements and streamlined
entry of applicable species into the United States for importers who
are approved as Commerce Trusted Traders (CTTs).
U.S. Customs and Border Protection (CBP) and the U.S. Food and Drug
Administration (FDA) are both developing their own voluntary Trusted
Trader programs designed to reduce costs to both the government and
industry, and streamline processing of imports. While the CTTP shares
many features with these programs, it is designed and intended to apply
only to the SIMP.
A critical element of the CTTP is the assurance that the entire
supply chain for species covered by SIMP, from point of harvest to
entry into U.S. commerce, is legal and documented, and that the entry
of illegally harvested and misrepresented fishery products into the
U.S. market is prevented. The program is intended to increase the
security of the supply chain while reducing the burden of compliance
for those importers who qualify for CTT status. This proposed rule, if
adopted, would establish the qualifying criteria and application
procedures for approval as a CTT. It would also establish requirements
for a Trusted Trader Compliance Plan, recordkeeping, and third-party
audits for CTTP participants. Under the proposed rule, a CTT would be
required to establish a secure supply chain (free of IUU fish or fish
product and falsely labeled seafood product) and maintain, either
directly or through a third party, the records necessary to verify the
legality of all seafood products subject to SIMP that he or she enters
into U.S. commerce. Compliance with these requirements would replace
the SIMP requirement to enter harvest event data into the International
Trade Data System (ITDS) at the time of filing an entry, and would
provide increased flexibility for complying with SIMP recordkeeping
requirements.
The CTT would be expected to produce all traceability documentation
associated with an entry filing subject to the SIMP within 14 days upon
request by NMFS to support an audit and to make such documentation
available for inspection, but would have significantly reduced
reporting requirements for imports of SIMP species. With the exception
of any records or documents required by other state or Federal
programs, such as the Tuna Tracking and Verification Program (TTVP) or
FDA's Prior Notice of Imported Food the CTT would only be required to
enter their International Fisheries Trade Permit (IFTP) number and
species codes into the ITDS at the time of entry filing.
I. Qualifying Criteria and Application for the Commerce Trusted Trader
Program
The CTTP, as proposed, is a voluntary program for U.S. importers of
record who import, or intend to import, species subject to the SIMP (50
CFR 300.324(a)(2)). This proposed rule provides that certain criteria
must be met in order for an importer to be approved as a CTT. In
addition to other requirements specified below, an applicant must be a
holder of a valid IFTP, which can be obtained via online registration
through the NMFS National Permitting System at https://fisheriespermits.noaa.gov/npspub/pub_cmn_login/index_live.jsp. IFTP
regulations are at 50 CFR 300.322. A single IFTP issued to an importer
of record is valid for imports of all seafood species that require an
IFTP. Separate permits are not required, for example, if the imported
species are covered under more than one NMFS import monitoring program
or the importer trades in more than one covered species. Note, however,
that for some commodities, permits issued by other agencies may also be
required (e.g., U.S. Fish & Wildlife Service permits for products of
species listed under the Convention for International Trade in
Endangered Species (CITES)).
In addition to being an IFTP holder, the applicant must submit an
online application for the CTTP at a website designated by NMFS.
Incomplete applications will not be reviewed by NMFS. A complete
application must contain the following:
(1) The applicant's IFTP number;
(2) An affirmation that the applicant has no history, during the
previous five years, of noncompliance (i.e., violations that resulted
in a finding of liability and assessment of a civil monetary penalty or
criminal fine) with Federal regulations related to the importation of
fish or fish products and is currently in compliance with all
licensing, permitting, and reporting requirements applicable to the
importation of fish or fish products;
(3) An affirmation that the applicant is in compliance with other
state and federal programs, such as the Highly Migratory Species (HMS)
International Trade Program, Antarctic Marine Living Resources (AMLR)
Import Export Certification, and the TTVP, as applicable, including
license and/or registration number(s) applicable to the importation of
fish or fish products;
(4) Electronic submission of the applicant's Trusted Trader
Compliance Plan (see details below); and
(5) Application fee.
The amount of the fee is calculated, on at least an annual basis,
in accordance with the procedures of the NOAA Finance Handbook,
available from NMFS, for determining the administrative costs of each
special product or service. The fee may not
[[Page 2414]]
exceed such costs and is specified on each application form. At
present, the fee is expected to be approximately $30.
The NMFS Office of International Affairs and Seafood Inspection
(IASI) will review a CTTP application, as well as the applicant's
history of compliance with state and federal regulations related to the
importation of fish or fish products, in determining whether to approve
the application. If the application is complete and the applicant does
not have a history of non-compliance with applicable regulations, NMFS
will approve the application and will issue a letter to the applicant
that will serve as official documentation of CTT status. If the
application is incomplete or complete but not approved, NMFS will issue
a letter to the applicant explaining the reasons why. If NMFS issues
such a letter, the applicant may respond in writing with additional
information to address the issues NMFS identified in its letter. After
reviewing such information, NMFS will issue a letter to the applicant
indicating if CTT status is approved or explaining the reasons why such
status continues to not be approved. NMFS' decision is final upon
issuance of this letter and is not appealable. NMFS looks forward to
receiving comments on the nature and extent of the application and
Compliance Plan review.
While the IFTP must be renewed annually (see 50 CFR 300.322(d)),
approval under the CTTP remains in effect unless it is revoked (see
Section IV below).
For each entry containing species or species groups subject to the
SIMP, the CTT or designated entry filer must file electronically, at
the time of entry, the CTT's IFTP number and species to be entered, as
required under 50 CFR 300.323(a). No further SIMP data needs to be
provided. NMFS IASI will notify CBP of the decision to grant CTT status
so that CBP will know that the complete SIMP data set is not required.
See proposed 50 CFR 300.324(f) for CTT exemptions from SIMP
requirements.
II. Trusted Trader Compliance Plan
Under this proposed rule, CTTP applicants must have a written
Trusted Trader Compliance Plan (Compliance Plan) showing that they have
a secure and controlled supply chain, including, but not limited to,
harvest, purchase, landing, shipping, processing, storage, and import
entry. Importers, regardless of IFTP status, that do not meet these
requirements will not be approved as CTTs.
The Compliance Plan must be designed to meet the objective of the
SIMP in preventing the importation of illegally harvested or
misrepresented fish and fish products into United States commerce. The
Compliance Plan may delegate entry filing, recordkeeping and other
responsibilities to other persons, but such roles must be clearly
defined in the Compliance Plan, as detailed below. Ultimately, the CTT
is responsible for adherence to the Compliance Plan and compliance with
all NOAA import requirements, including all applicable requirements of
the SIMP and the CTTP, if finalized, and for ensuring the prevention of
illegally harvested or misrepresented seafood entering U.S. commerce
through the CTT's import activities.
The Compliance Plan must, at a minimum, include the following
components:
(1) An Internal Control System (see below for requirements);
(2) Procedures for ensuring that the Compliance Plan and the CTT's
adherence to it is audited by a certified third party at least annually
(see below for audit requirements);
(3) The applicant's written policy and related supporting materials
on preventing the import of illegally harvested and misrepresented
seafood, including a description of how the policy is communicated to
any affected employees, entry filers, representatives, and suppliers or
other parties in the supply chain, and corrective actions to be taken
as needed;
(4) An organizational chart that identifies the persons with
responsibility for: entry filing; custodianship of recordkeeping
documents; developing, administering, and implementing the Compliance
Plan and its component measures; and conducting training to ensure
effective implementation of the Compliance Plan;
(5) A signature page completed by the applicant and the individual
at the highest level of authority in the applicant's organization
assuming responsibility for implementing the Compliance Plan; and
(6) Any changes to the Compliance Plan, along with an updated
signature page and organizational chart must be included in the
mandatory annual audit report required (see below).
Internal Control System Requirements
The Internal Control System, which must be documented in the
Compliance Plan described above, must include traceability monitoring
procedures for seafood products subject to the SIMP (50 CFR
300.324(a)(2)). The CTT is responsible for ensuring implementation of
the Internal Control System, which must include:
(1) Procedures to verify the legal harvest and landing of fish or
fish products subject to the SIMP that the CTT enters into U.S.
commerce. Verification may rely on flag-state or port-state harvest and
landing records. Certification of legal harvest by the flag-state may
also be used. In any case, the procedures must be capable of verifying
the legal harvest and landing of any fish or fish products imported by
the CTT of species that fall under the SIMP by providing the harvest
and landing information required by the SIMP regulations at 50 CFR
300.324(b)(1)-(3). A CTT may establish separate procedures for
verifying legal harvest and landing from known and trusted fishery
sources and for verifying legal harvest and landing from new fishery
sources, and may establish separate measures for each fishery source,
as appropriate;
(2) Procedures to enable verification of the full chain of custody
from point of first landing (or point of aggregation for small-scale
fisheries) to entry into U.S. commerce (See 50 CFR 300.324(e)). These
procedures should describe the process(es) that will be followed, and
documentation that will be used, to verify chain of custody, and
measures in place to periodically verify the accuracy of that
documentation;
(3) Procedures to ensure that chain of custody documentation will
be provided to NMFS, upon request, within 14 days to support an agency
audit. Under 50 CFR 300.325(f) of the proposed rule, the Compliance
Plan must identify who is responsible for maintaining chain of custody
documentation, the point along the supply chain at which the chain of
custody documents are stored and how the CTT will ensure access to them
when necessary. The documentation must be maintained and made available
for inspection as required under Sec. 300.325(i) of the proposed rule.
The CTT must be able to access records for no less than two years from
the date of entry of the product into U.S. commerce, and records must
be made available for inspection, upon request by NOAA to support an
agency audit and as necessary for purposes of the annual audit required
under Sec. 300.325(j);
(4) Procedures for the CTT (or designee) to perform at least one
trace-back annually for each species covered by the SIMP imported by
the CTT. A trace-back is a document review of all industry records that
follow the product from the point of entry into U.S. commerce backwards
through all steps of processing, shipping, and storage to
[[Page 2415]]
the point of harvest (or point of first aggregation for small scale
fisheries);
(5) Procedures to be taken in response to information that
illegally harvested or misrepresented fish or fish products have
entered the supply chain (e.g., notice from NOAA's Office of Law
Enforcement (OLE) or inclusion of the harvesting vessel in a regional
fishery management organization's list of vessels that have engaged in
illegal, unreported and unregulated fishing), measures to ensure that
such fish or fish products are removed from commerce and further
shipments are prevented from entering commerce, and procedures for
promptly informing OLE whether such products are inbound to the United
States or have entered U.S. commerce;
(6) Procedures to be taken in response to any supplier in the CTT's
supply chain for SIMP species being placed on an FDA Import Alert..
Import Alerts inform FDA field staff and the public that the Agency has
enough evidence to allow for Detention Without Physical Examination
(DWPE) of firms and products that appear to be in violation of FDA laws
and regulations. These violations could be related to the product,
manufacturer, shipper and/or other information. More information is
available online at https://www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/ImportAlerts/ucm516428.htmand
(7) Procedures to regularly review internal controls and update
procedures in response to changes in the fish or fish products that the
CTT wants to enter into U.S. commerce, suppliers, or operating
conditions or non-conformities identified in an audit.
The CTT must ensure that all information and documentation used for
internal controls related to the Compliance Plan and Internal Control
System must remain available for U.S. government audit for no less than
two years from the date of import entry.
NMFS seeks comment generally on the required elements of the
Trusted Trader Compliance Plan, including the Internal Control System.
NMFS also invites comment on establishing a species-specific CTTP. As
currently drafted, this proposed rule would allow a CTT to import all
species subject to SIMP and benefit from reduced reporting requirements
at the time of import. As an alternative, an applicant for CTT status
could specify in the CTTP Application and Compliance Plan that it has a
secure and controlled supply chain for some, but not all, SIMP species
and request that CTT status be limited to that subset of SMP species.
Under this species-specific alternative, a CTT would be required to
comply with all SIMP reporting and recordkeeping requirements for
imports of SIMP species not specifically included in its Compliance
Plan. NMFS' analysis of the species-specific CTTP, set out in Section
1.3.5 of the regulatory impact review (available from NMFS; see
ADDRESSES), indicates higher compliance costs for CTTs under the
species-specific CTTP. Since the per entry reporting and recordkeeping
costs are projected to be greater under SIMP than under CTTP, a CTT who
chooses to comply with CTTP requirements for only a subset of the
priority species would be assuming the higher fixed costs of CTTP
compliance while reducing the economic benefit of that investment that
accrues to every import entry of a priority species by a CTT through
the reduction of per entry, incremental costs.
Additionally, NMFS estimates that its costs for both ITDS/ACE
programming and effective long-term compliance auditing would be higher
with a species-specific CTTP. NMFS seeks comment on its assumptions and
conclusions related to a species-specific CTTP.
III. Procedures for Annual Third-Party Audit
As noted in Section II, this proposed rule provides that the CTT's
Compliance Plan must include procedures for a third-party audit. The
CTT is responsible for ensuring that this third-party audit is
conducted annually. Paragraphs 300.325(j) and (k) of the proposed rule
set forth requirements for the audit and auditor certification.
Third-Party Audit Requirements
At least once annually, the CTT must ensure that an audit is
conducted by a certified third-party auditor, consistent with the
requirements of the rule. The purpose of the audit is to evaluate the
adequacy of the CTT's Compliance Plan in meeting the requirements of 50
CFR 300.325(f) and the CTT's adherence to that plan. A third-party
audit should include an opening meeting, during which the auditor will
discuss audit objectives with the CTT and any personnel supporting the
audit.
During each audit, the third party auditor must review the
Compliance Plan and relevant documents. The CTT must make all records,
written and electronic, that are pertinent to the Compliance Plan and
Internal Control System described therein available to the auditor at
the time of the audit. The auditor will select a minimum of three
import entries containing SIMP species to serve as the subject of the
audit. He or she must verify that all processes in the CTT's Compliance
Plan are being followed and that the Internal Control Plan effectively
meets the requirements of the CTTP. The auditor must also verify that
the audited entries can be traced back to legal harvest (or production)
and landing and that the species contained in the shipment are
truthfully represented. The auditor must conduct interviews as
necessary with CTT staff, suppliers, and individuals delegated
responsibilities under the Compliance Plan and may conduct other
activities as necessary.
A CTT must notify NMFS at least 30 days in advance of each third-
party audit. NMFS, at its discretion, may attend a third-party audit as
an observer or conduct a side-by-side audit. In a side-by-side audit,
NMFS will review the same documentation as the third party auditor at
the same time as the third party auditor to evaluate both the
shipment(s) and performance of the third party auditor. NMFS may also
conduct an independent audit of a CTT at any time.
The auditor must have a closing meeting with the CTT or designee to
review observed weaknesses and any non-conformities with the Compliance
Plan, and issue a written audit report within 30 calendar days of the
audit. In the audit report, the auditor must assess the reliability of
the CTT's Compliance Plan and the CTT's adherence to it, provide
results of the audit, and identify any non-conformities with the
Compliance Plan or its implementation. The audit report must include
the auditor's certifying credentials (see below) and attestations that
the auditor (i.e., individual auditor(s) and auditing firm): (1) Was
not involved in developing the CTT's Compliance Plan, and (2) has no
financial relationship with, or substantial interest in, the CTT
retaining their services beyond performing the audit and any related
follow up.
The CTT is responsible for ensuring that the auditor provides a
signed and locked electronic copy of the audit report (in .pdf format)
to the CTT and NMFS IASI no later than 30 days following completion of
the audit. If the auditor determines that no corrective action is
needed, the report is considered the final audit report. If the auditor
determines that corrective action is required to address non-
conformities with the written Compliance Plan or its implementation,
the report is considered an initial audit report. In that case, within
60 days following the audit, the CTT must ensure that a signed and
locked electronic copy of the final audit report (in .pdf format) is
provided to NMFS
[[Page 2416]]
IASI. The final report must include an explanation, along with relevant
documentation, of corrective action taken by the CTT and approved by
the auditor.
If the CTT fails to provide the audit report to NMFS as required
above or take acceptable corrective actions as identified in the
report, NMFS may conduct additional audits at its discretion. NMFS may
also take additional measures up to and including revocation of CTT
status, as deemed appropriate by NMFS. CTT third-party audits may be
combined with other Global Food Safety Initiative (GFSI) or chain of
custody audits, provided the combined audit is in full compliance with
the requirements of the CTTP.
Third-Party Auditor Certification and Other Requirements
Beyond conducting the audit and any related follow up for a CTT, a
third-party auditor (i.e., individual auditor(s) and auditing firm)
must not have any other financial relationship with, or substantial
interest in, the CTT. In addition, an auditor must not have been
involved in developing the CTT's Compliance Plan. A third-party auditor
should have some familiarity or experience with the seafood trade to
ensure accurate and critical review of a CTT's written Compliance Plan
and the CTT's adherence to it. The third party auditor must be
certified with respect to, and affirm his or her knowledge of current
auditing practices and proficiency in conducting process audits,
identification of non-conformities and review of corrective actions
taken by the CTT. A third-party must be certified by a competent
certifying body, as evidenced by one or more of the following:
(1) Current accreditation or certification by the American
Institute of Certified Public Accountants (AICPA);
(2) Current accreditation or certification by the Institute of
Internal Auditors;
(3) Current accreditation or certification by the American
Evaluation Association;
(4) Current accreditation or certification by a chain of custody
certifying body;
(5) Current accreditation or certification by Accreditation
Services International; or other nationally recognized certifying
organizations;
(6) Evidence of current peer-review certification such as Certified
Quality Auditor (CQA), Certified Internal Auditor (CIA), Certified
Public Accountant (CPA), and Certified HACCP Auditor (CHA);
(7) Successful completion of auditor training recognized by the
International Register of Certified Auditors (IRCA) or Registrar
Accreditation Board and Quality Society of Australasia (RABQSA), in
environmental management standards (EMS); quality management standards
(QMS); or Global Food Safety Initiative (GFSI), and registration with
IRCA or RABQSA as an EMS or QMS auditor; or
(8) Other training or certification approved in writing by NMFS.
IV. Revocation of CTT Status
While the IFTP must be renewed annually (see 50 CFR 300.322(d)),
approval under the CTTP remains in effect unless revoked under this
section. If a CTT fails to comply with requirements of the Program as
detailed above, NMFS may issue a Notification Letter to the CTT that:
(1) Identifies the alleged failure to comply with Commerce Trusted
Trader Program regulations and requirements;
(2) Describes the indications and evidence of the alleged failure;
(3) Sets a Response Date by which the CTT must submit to NMFS a
written response to the Notification Letter, including, if applicable,
a proposed solution; and
(4) Explains the CTT's options if the CTT believes the Notification
Letter is in error.
NMFS will establish a Response Date between 14 and 30 calendar days
from the date of the Notification Letter. The CTT's response must be
received in writing by NMFS on or before the Response Date. If the CTT
fails to respond by the Response Date, CTT status will be revoked. A
CTT who has submitted a timely response may meet with NMFS within 21
calendar days of the date of that response to discuss a detailed and
agreed-upon procedure for resolving the alleged failure to comply with
the Commerce Trusted Trader Program regulations and requirements.
If the CTT disagrees with the Notification Letter and believes that
there is no failure to comply with CTTP regulations and requirements,
NMFS has incorrectly defined or described the failure, or NMFS is
otherwise in error, the CTT may submit a written Objection Letter to
NMFS on or before the Response Date. Within 21 calendar days of the
date of the Objection Letter, the CTT may meet with NMFS to discuss a
resolution or redefinition of the issue. If modifications to any part
of the Notification Letter are required, then NMFS will issue a revised
Notification Letter to the CTT; however, the Response Date or any other
timeline in this process would not restart or be modified unless NMFS
decides to do so.
The total process from the date of the Notification Letter to the
date of final resolution should not exceed 90 calendar days, and may
require a shorter time frame, to be determined by NMFS, depending on
the seriousness of the alleged failure. In rare circumstances, NMFS, at
its discretion, may extend the time for resolution of the alleged
failure. In such a case, NMFS will provide a written notice to the CTT
informing him or her of the extension and the basis for the extension.
If the failure to comply with CTTP requirements cannot be resolved
through this process, NMFS will issue a Revocation Letter to the CTT
that:
(1) States that CTT status has been revoked;
(2) Summarizes the failure to comply with CTTP requirements;
(3) Summarizes any proposed procedures, or attempts to produce such
procedures pursuant to sub-paragraph (3) of this section, to resolve
the failure;
(4) Explains why resolution was not achieved; and
(5) Advises the importer that (1) the importer is no longer exempt
from the requirements of the SIMP, and (2) the importer may not reapply
for CTT status for a period of one year. NMFS' decision is final upon
issuance of the Revocation Letter and is not appealable.
V. Prohibitions
The proposed rule would amend the existing prohibitions section in
subpart Q to add five new prohibitions. Specifically, the proposed rule
would prohibit: (1) Making a false statement on an application for the
CTTP; (2) the falsification of records required to be maintained under
50 CFR 300.324(d) or (e) or 300.325; (3) failure to make records
available for inspection, as required under 50 CFR 300.324(d) or (e) or
300.325(i); (4) a CTT from failing to maintain records containing
information on the chain of custody and custodian of fish or fish
products, provide access to such records to support an agency audit,
and make such records available for inspection as required (see 50 CFR
300.325(g)(3) and (i)); and (5) a CTT from failing to implement or
follow the Trusted Trade Compliance Plan they are required to have in
place as a condition of being granted, and retaining, that status (see
50 CFR 300.325 (f) and (g)).
More information and any updates on the proposed CTTP can be found
on our website at https://www.iuufishing.noaa.gov/.
[[Page 2417]]
Classification
This proposed rule is published under the authority of the
Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C.
1801 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 significant for the
purposes of Executive Order 12866. NMFS has prepared a regulatory
impact review of this action, which is available from NMFS (see
ADDRESSES). This analysis describes the economic impact this proposed
action, if adopted, would have on businesses and consumers. NMFS
invites the public to comment on this proposal and the supporting
analysis.
The regulatory action being considered is described in the preamble
of this proposed rule. For importers subject to the SIMP, this proposed
rule would create a voluntary program that includes exemptions from
SIMP reporting and recordkeeping requirements. NMFS anticipates that
U.S. persons would not have any significant adverse economic effects as
a result of this action, because it does not pose any new burdens with
regard to existing reporting and recordkeeping requirements. On the
contrary, this rule, if adopted, would reduce reporting and
recordkeeping requirements under the SIMP for importers who are
approved as CTTs, and result in positive economic benefits for them.
NMFS seeks comment on whether there could be economic impacts that have
not been addressed in this proposed rule, or that could be difficult to
anticipate.
Executive Order 13771
This proposed rule is expected to be an E.O. 13771 deregulatory
action. As discussed below, this proposed rule would create cost
savings of approximately $806,810 industry-wide on an annual basis.
Further details on the estimated cost savings of this proposed rule can
be found in the regulatory impact review analysis.
Regulatory Flexibility Act
An Initial Regulatory Flexibility Analysis (IRFA) was prepared, as
required by section 603 of the Regulatory Flexibility Act (RFA) and is
available from NMFS (see ADDRESSES). The IRFA describes the economic
impact this proposed rule, if adopted, would have on small entities. A
description of the action, why it is being considered, and the legal
basis for this action are contained at the beginning of this section in
the preamble and in the SUMMARY section of the preamble. A summary of
the analysis follows.
For this proposed rule, NMFS looked at two alternatives: No action
and a CTTP, as called for in the March 15, 2015, Presidential task
force Action Plan (see Background). By not joining the CTTP, importers
will need to fully comply with the SIMP rule and report information
pertaining to the harvest of species covered under SIMP via the ITDS
prior to entry, and maintain those records as well as records
documenting the supply chain from point of harvest to entry into U.S.
commerce for a period of no less than two years. For importers who do
not apply to become a CTT, there would be no change from current SIMP
requirements and thus no economic impacts. In the SIMP final rule, NMFS
estimated annual compliance costs of $6,075,000 including permit fees,
reporting, recordkeeping, and data storage for 2,000 importers who,
combined, filed 215,000 entries through the International Trade Data
System (ITDS). There were 216 importers who filed more than 250 entries
in 2014 (comprising roughly 72% of all entries). NMFS expects these
high volume importers would benefit financially from the CTTP. NMFS
seeks public comment on the accuracy of these baseline conditions used
in the development of this proposed rule.
In the Final Regulatory Flexibility Analysis for the SIMP rule,
NMFS concluded that all persons subject to the program requirements
could be classified as small businesses. Likewise, all importers who
choose to apply and be approved as CTTs would also be classified as
small businesses. CTTs would realize the benefits of reduced reporting
and recordkeeping and streamlined entry into U.S. commerce of their
fish and fishery products. The increased cost of annual third-party
auditing required under the CTTP would be offset by the reduction in
reporting costs at time of entry. Consequently, importers with a higher
annual volume of entries would accrue greater benefits. In comparing
entry reporting cost savings to estimates of the costs to contract with
a third-party auditor, NMFS estimates that importers making more than
250 entries per year would benefit from becoming a CTT. Considering the
same baseline as that used for the SIMP analysis (entries of priority
species seafood products made in 2014), approximately 2000 importers
would be required to report harvest event data upon entry. NMFS
estimates that 216 of these importers, who each filed more than 250
entries in 2014, would benefit from the reduced reporting burden of
becoming a CTT. Assuming all of these importers would elect to become
CTTs, cost savings of approximately $806,810 would be realized
industry-wide on an annual basis.
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
implement a Commerce Trusted Trader Program are procedural and
administrative in nature in that they would modify recordkeeping and
auditing requirements for ongoing authorized catch and trade
activities. Fishing activity and trade in seafood products are not
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 contains a collection-of-information requirement
subject to review and approval by OMB under the Paperwork Reduction Act
(PRA). This requirement has been submitted to OMB for approval. The
information collection burden for the requirements proposed under this
rule (CTTP application; Compliance Plan development or modification;
third-party audit; and traceability documents recordkeeping) are
estimated to result in a significant reduction in both time and costs
for CTTs relative to the burden associated with compliance with the
reporting and recordkeeping requirements of the SIMP.
NMFS estimates that approximately 216 International Fisheries Trade
Permit holders would apply for the CTTP, and that they would need
approximately 10 minutes to fill out the online application, at an
hourly rate of $25, for a total of 36 hours and labor costs of $900.
NMFS considers that most of the 216 entities estimated to apply for CTT
status will already have some form of internal control plan in place,
so the development of a Compliance Plan specific to the CTTP will take
no more than 8 hours. If a Compliance Plan needs to be developed from
square one, NMFS estimates no more than 24 hours will be required, at
an hourly rate of $50. Assuming that this rule would
[[Page 2418]]
affect 216 importers, the total one-time burden for application and
Compliance Plan development and submission amounts to between 1,764
hours and 5,220 hours, and labor costs of between $87,300 and $260,100.
Because the CTTP removes the requirement of reporting harvest data
prior to entry into U.S. commerce, a CTT is expected to realize the
cost savings of not entering such data. NMFS has calculated the time
and cost of a CTTP entry filing (header record only) to be 12 minutes
at $25 per hour, for a cost per entry of $5, versus 36 minutes per SIMP
filing (header and all harvest vessel and landing records) and a cost
of $15 per filing. Using available data from 2014, the average number
of entries for the 216 importers filing 250 or more entries, which is
the point at which NMFS believes an entity would likely choose to
become a CTT, is 750. This equates to 162,000 entries. The annual
burden of contracting with a third-party auditor is estimated to be one
hour at the hourly rate of $50, for a total of 216 hours and $10,800
annually. The cost of the actual audit is estimated to be between
$1,120 and $3,600, with an average cost of $2,190, for a total of
$473,040. These burdens would be offset by the reduced cost benefit of
the program, which cuts out 64,800 hours of data entry filing at a cost
savings of $1,620,000.
Public comment is sought regarding: whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; the accuracy of the assumptions used in
calculating the burden estimate; ways to enhance the quality, utility,
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information, including through the use
of automated collection techniques or other forms of information
technology. Send comments on these or any other aspects of the
collection of information to the NOAA Fisheries Office of International
Affairs and Seafood Inspection at the ADDRESSES above, and by email to
[email protected] or fax to (202) 395-7285.
Notwithstanding any other provision of the law, no person is
required to respond to, and no person shall be subject to penalty for
failure to comply with, a collection of information subject to the
requirements of the PRA, unless that collection of information displays
a currently valid OMB control number.
List of Subjects in 50 CFR Part 300
Exports, Fisheries, Fishing, Fishing vessels, Illegal, unreported
or unregulated fishing, Foreign relations, Imports, International trade
permits, Treaties.
Dated: January 11, 2018.
Samuel D. Rauch, III,
Deputy Assistant Administrator for Regulatory Programs, National Marine
Fisheries Service.
For the reasons set out in the preamble, 50 CFR part 300, subpart
Q, is proposed to be amended as follows:
PART 300--INTERNATIONAL FISHERIES REGULATIONS
0
1. The authority citation for 50 CFR part 300 continues to read as
follows:
Authority: 16 U.S.C. 951 et seq., 16 U.S.C. 1801 et seq., 16
U.S.C. 5501 et seq., 16 U.S.C. 2431 et seq., 31 U.S.C. 9701 et seq.
0
2. In Sec. 300.321, add, in alphabetical order, a definition for
``Commerce Trusted Trader'', ``Commerce Trusted Trader Program'',
``Internal Control System'', and ``Trusted Trader Compliance Plan'' to
read as follows:
Sec. 300.321 Definitions.
* * * * *
Commerce Trusted Trader (CTT) means an importer of record who holds
a valid International Fisheries Trade Permit (see Sec. 300.322) and
who has been approved by NMFS under Sec. 300.325.
Commerce Trusted Trader Program (CTTP) means the voluntary program
established under Sec. 300.325.
* * * * *
Internal Control System means the written procedures required under
Sec. 300.325(g).
* * * * *
Trusted Trader Compliance Plan or Compliance Plan means the written
plan required under Sec. 300.325(f).
* * * * *
0
3. In Sec. 300.324, add paragraph (f) to read as follows:
Sec. 300.324 Seafood Traceability Program.
* * * * *
(f) An importer of record who is approved as a Commerce Trusted
Trader (CTT) under Sec. 300.325 shall be exempt from the reporting
requirements of Sec. 300.324(b)(1)-(3) and (c) and may delegate the
recordkeeping responsibilities under Sec. 300.324(e) to one or more
third parties as provided in Sec. 300.325(i). However, a CTT is not
exempt from IFTP requirements under Sec. 300.322 or any other
applicable requirements and is responsible for compliance with the
obligations of Sec. 300.324(e). CTTP application procedures and
requirements are set forth at Sec. 300.325.
0
4. Redesignate Sec. 300.325 as Sec. 300.326 and add a new Sec.
300.325 to read as follows:
Sec. 300.325 Commerce Trusted Trader Program.
(a) Establishment. This section establishes a voluntary Commerce
Trusted Trader Program (CTTP) which provides an exemption from the
reporting requirements of the Seafood Import Monitoring Program (SIMP)
(see Sec. 300.324(f)) and alternative recordkeeping options (see
paragraph (i) of this section). Qualifying criteria, application
procedures, requirements for Trusted Trader Compliance Plans and
recordkeeping, and third-party audit requirements for CTTP participants
are set forth in the following sections.
(b) Qualifying Criteria. To be approved as a Commerce Trusted
Trader (CTT), an applicant must be a U.S. importer of record who has
imported, or who intends to import, products subject to the SIMP and
must be a holder of a valid International Fisheries Trade Permit (IFTP)
(see Sec. 300.322).
(c) Application. The applicant must submit an online application
for the CTTP at a website designated by NMFS. Incomplete applications
will not be reviewed by NMFS. A complete application must contain the
following:
(1) The applicant's IFTP number;
(2) Affirmation that the applicant has no history, during the
previous five years, of noncompliance (i.e., violations that resulted
in a finding of liability and assessment of a civil monetary fine or
criminal penalty) with federal regulations related to the importation
of fish and fish products and is currently in compliance with all
licensing, permitting, and reporting requirements applicable to the
importation of fish and fish products;
(3) Affirmation that the applicant is in compliance with other
state and federal programs, as applicable, including license and/or
registration number(s) applicable to the importation of fish and fish
products;
(4) Electronic submission of the applicant's Trusted Trader
Compliance Plan (see paragraph (f) of this section); and
(5) Application fee.
(d) Fees. Applicants for the CTTP must electronically pay an
application fee assessed by NMFS to recover application review costs.
If an application fee is paid with a commercial instrument that is
[[Page 2419]]
insufficiently funded, the CTTP application will not be processed.
(e) Review and Approval of Application.
(1) The NMFS Office of International Affairs and Seafood Inspection
(IASI) will review a CTTP application, as well as the applicant's
history of compliance with federal regulations related to the
importation of fish and fish products, in determining whether to
approve the application.
(2) If NMFS IASI approves the application, it will issue a letter
to the applicant that will serve as official documentation of CTT
status.
(3) If the application is incomplete or complete but not approved,
NMFS will issue a letter to the applicant explaining the reasons why.
(4) If NMFS issues a letter under paragraph (e)(3), the applicant
may respond in writing with additional information to address the
issues NMFS identified in its letter. After reviewing such information,
NMFS will issue a letter to the applicant indicating if CTT status is
approved or explaining the reasons why such status continues to not be
approved. NMFS' decision is final upon issuance of this letter and is
not appealable. The applicant may reapply no earlier than one year from
the date of NMFS' final decision.
(5) While the IFTP must be renewed annually (see Sec. 300.322(d)),
approval under the CTTP remains in effect unless it is revoked under
paragraph (l).
(f) Trusted Trader Compliance Plan. In order to be approved as a
CTT, the applicant must have a Trusted Trader Compliance Plan
(Compliance Plan) that is designed to meet the objective of the SIMP in
preventing the importation of illegally harvested or misrepresented
fish and fish products into United States commerce. The Compliance Plan
may delegate entry filing, recordkeeping and other responsibilities to
other persons, but the CTT remains responsible for ensuring adherence
to the Compliance Plan and compliance with all NOAA import
requirements, including all applicable requirements of the SIMP and the
CTTP. The Compliance Plan must, at a minimum, include the following
components:
(1) An Internal Control System (see paragraph (g) of this section
for requirements);
(2) Procedures for ensuring that the Compliance Plan and the CTT's
adherence to it is audited by a certified third party at least annually
(see paragraph (j) of this section for audit requirements);
(3) The applicant's written policy and related supporting materials
on preventing the import of illegally harvested and misrepresented
seafood, including a description of how the policy is communicated to
any affected employees, entry filers, representatives, and suppliers or
other parties in the supply chain, and corrective actions to be taken
as needed;
(4) An organizational chart that identifies the persons with
responsibility for: Entry filing; custodianship of recordkeeping
documents; developing, administering, and implementing the Compliance
Plan and its component measures; and conducting training to ensure
effective implementation of the Compliance Plan;
(5) A signature page completed by the applicant and the individual
at the highest level of authority in the applicant's organization
assuming responsibility for implementing the Compliance Plan. This
signature page and the organizational chart must be updated each year
at the time of the annual audit in order for a CTT's status to remain
current; and
(6) Any changes to the Compliance Plan, along with an updated
signature page and organizational chart must be included in the annual
audit report required under paragraph (j) of this section.
(g) Internal Control System Requirements. The Internal Control
System, which must be documented in the Compliance Plan under paragraph
(f) of this section, must include traceability monitoring procedures
for seafood products subject to the SIMP (Sec. 300.324). The CTT is
responsible for ensuring implementation of the internal control system,
which must include:
(1) Procedures to verify the legal harvest and landing of fish or
fish products subject to the SIMP that the CTT enters into U.S.
commerce. Such procedures may rely on flag-state and/or port-state
harvest and landing records or flag-state certification of legal
harvest. A CTT may establish separate verification procedures for each
fishery source, as appropriate (e.g., known and trusted vs. new
sources);
(2) Procedures to enable verification of the full chain of custody
from point of first landing (or point of aggregation for small-scale
fisheries) to entry into U.S. commerce (See paragraph (i) of this
section). These procedures should describe the process(es) that will be
followed, and documentation that will be used, to verify chain of
custody, and measures in place to periodically verify the accuracy of
that documentation;
(3) Procedures to ensure that chain of custody documentation will
be provided to NMFS, upon request, within 14 days to support an agency
audit. The Compliance Plan under paragraph (f) of this section must
identify who is responsible for maintaining chain of custody
documentation, the point along the supply chain at which the chain of
custody documents are stored and how the CTT will ensure access to them
when necessary. The documentation must be maintained and made available
for inspection as required under paragraph (i) of this section;
(4) Procedures for the CTT (or designee) to perform at least one
trace-back annually for each species covered by the SIMP that is
imported by the CTT. A trace-back is a document review of all records
that follow the product from the point of entry into U.S. commerce
backwards through the supply chain (e.g., through all steps of
processing, shipping, purchase, and storage) to the point of harvest
(or point of first aggregation for small scale fisheries);
(5) Procedures to be taken in response to information that
illegally harvested or misrepresented fish or fish products have
entered the supply chain (e.g., notice from NOAA's Office of Law
Enforcement (OLE) or inclusion of the harvesting vessel in a regional
fishery management organization's list of vessels that have engaged in
illegal, unreported and unregulated fishing), measures to ensure that
such fish and fish products are removed from commerce and further
shipments are prevented from entering commerce, and procedures for
promptly informing OLE whether such products are inbound to the United
States or have entered U.S. commerce;
(6) Procedures to be taken in response to a supplier being placed
on an FDA Import Alert List. FDA Import Alerts inform FDA field staff
and the public that the Agency has enough evidence to allow for
Detention Without Physical Examination (DWPE) of products that appear
to be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) or FDA regulations. These violations could be related to the
product, manufacturer, shipper and/or other information. More
information is available online at https://www.fda.gov/ForIndustry/ImportProgram/ActionsEnforcement/ImportAlerts/ucm516428.htm; and
(7) Procedures to regularly review and update internal control
procedures in response to changes in the fish or fish products that the
CTT wants to enter into U.S. commerce, suppliers, or operating
conditions, or non-conformities identified in an audit.
(h) Entry filing requirements. NMFS will alert U. S. Customs and
Border Protection when it approves a CTT
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under paragraph (e) of this section. For each entry containing species
or species groups subject to the SIMP, at the time of entry, the CTT or
designated entry filer must file electronically, as required under
Sec. 300.323(a), the CTT's IFTP number and species to be entered. No
further information needs to be provided. See Sec. 300.324(f) for
exemptions from SIMP requirements.
(i) Recordkeeping requirements. As specified in Sec. 300.324(e),
records containing information on the chain of custody and custodian of
fish or fish products (e.g., trans-shipper, processor, storage facility
or distributor) must be maintained. However, CTTs have the option of
delegating the recordkeeping requirements to one or more third parties.
The records must be maintained either by the CTT, or at designated
points within the supply chain to which the CTT has unrestricted
access, or with any third-party that the CTT designates in its
Compliance Plan. Regardless of which option it chooses, the CTT is
responsible for ensuring that the required chain of custody
documentation for all species and species groups subject to SIMP is
maintained for a period of two years from the date of entry of product
into U.S. commerce, providing such documentation to NMFS in accordance
with paragraph (g)(3) of this section, and making it available for
inspection as required under Sec. 300.324(e).
(j) Third-party Audit Requirements. At least once annually, the CTT
must ensure that an audit is conducted by a certified third-party
auditor, consistent with the requirements of this paragraph and
paragraph (k) of this section. The purpose of the audit is to evaluate
the adequacy of the CTT's Compliance Plan in meeting the requirements
of paragraphs (f) and (g) of this section and the CTT's adherence to
that plan. The audit must include:
(1) Review of the Compliance Plan and relevant documents; full
trace back to point(s) of harvest of at least three shipments of
products falling under the SIMP, selected by the third-party auditor;
interviews as necessary with CTT staff, suppliers, and individuals
delegated responsibilities under the Compliance Plan; and other
activities as necessary;
(2) A closing meeting between the auditor and the CTT or designee
to review observed weaknesses and any non-conformities with the
Compliance Plan; and
(3) Issuance of audit reports.
(i) Notification and NMFS Audit. The CTT shall notify NMFS at least
30 days in advance of each third-party audit. NMFS, at its discretion,
may attend a third-party audit as an observer or conduct a side-by-side
audit. NMFS may conduct an independent audit of a CTT at any time.
(ii) Audit Reports. In an audit report, a third-party auditor must
assess the reliability of the CTT's Compliance Plan and the CTT's
adherence to it, provide results of the audit, and identify any non-
conformities with the Compliance Plan or its implementation. The audit
report must include the auditor's certifying credentials (see paragraph
(k) of this section) and attestations that the auditor (i.e.,
individual auditor(s) and auditing firm): (1) Was not involved in
developing the CTT's Compliance Plan, and (2) has no financial
relationship with, or substantial interest in, the CTT retaining their
services beyond performing the audit and any related follow up.
(iii) Follow Up on Audit Reports. The CTT is responsible for
ensuring that the auditor provides a signed and locked electronic copy
(in .pdf format) of the audit report to the CTT and IASI no later than
30 days following completion of the audit. If the auditor determines
that no corrective action is needed, the report is considered the final
audit report. If the auditor determines that corrective action is
required to address non-conformities with the Compliance Plan or its
implementation, the report is considered an initial audit report. In
that case, within 60 days following the audit, the CTT must ensure that
a signed and locked electronic copy of the final audit report (in .pdf
format) is provided to NMFS IASI. The final report must include an
explanation, along with relevant documentation, of corrective action
taken by the CTT and approved by the auditor.
(iv) If the CTT fails to provide the audit report as required above
or take acceptable corrective actions, NMFS may conduct additional
audits at its discretion. NMFS may also take additional measures up to
and including revocation of CTT status as deemed appropriate by NMFS.
(k) Third-Party Auditor Certification and Other Requirements.
(1) Beyond conducting the audit and any related follow up for a
CTT, a third-party auditor (i.e., individual auditor(s) and auditing
firm) must not have any other financial relationship with, or
substantial interest in, the CTT. In addition, an auditor must not have
been involved in developing the CTT's Compliance Plan. A third-party
auditor should have some familiarity or experience with the seafood
trade to ensure an accurate and critical review of a CTT's Compliance
Plan and the CTT's adherence to it. The third party auditor must be
certified in and affirm his or her knowledge of current auditing
practices and proficiency in conducting process audits, identification
of non-conformities and review of corrective actions taken by the CTT.
(2) A third-party auditor must be certified by a competent
certifying body, as evidenced by one or more of the following:
(i) Current accreditation or certification by the American
Institute of Certified Public Accountants (AICPA);
(ii) Current accreditation or certification by the Institute of
Internal Auditors;
(iii) Current accreditation or certification by the American
Evaluation Association;
(iv) Current accreditation or certification by a chain of custody
certifying body;
(v) Current accreditation or certification by Accreditation
Services International, or other nationally recognized certifying
organizations;
(vi) Evidence of current peer-review certification such as
Certified Quality Auditor (CQA), Certified Internal Auditor (CIA),
Certified Public Accountant (CPA), and Certified HACCP Auditor (CHA);
(vii) Successful completion of auditor training recognized by the
International Register of Certified Auditors (IRCA) or Registrar
Accreditation Board and Quality Society of Australasia (RABQSA), in
environmental management standards (EMS); quality management standards
(QMS); or Global Food Safety Initiative (GFSI), and registration with
IRCA or RABQSA as an EMS or QMS auditor; and
(viii) Other training or certification as approved in writing by
NMFS.
(l) Revocation of CTT status.
(1) If a CTT fails to comply with requirements under this section,
NMFS may issue a Notification Letter to the CTT that:
(i) Identifies the alleged failure to comply with CTTP regulations
and requirements;
(ii) Describes the indications and evidence of the alleged failure;
(iii) Sets a Response Date by which the CTT must submit to NMFS a
written response to the Notification Letter, including, if applicable,
a proposed solution; and
(iv) Explains the CTT's options if the CTT believes the
Notification Letter is in error.
(2) NMFS will establish a Response Date between 14 and 30 calendar
days from the date of the Notification Letter. The CTT's response must
be received in writing by NMFS on or before the
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Response Date. If the CTT fails to respond by the Response Date, CTT
status will be revoked. At its discretion and for good cause, NMFS may
extend the Response Date to a maximum of 60 calendar days from the date
of the Notification Letter.
(3) A CTT who has submitted a timely response may meet with NMFS
within 21 calendar days of the date of that response to discuss a
detailed and agreed-upon procedure for resolving the alleged failure to
comply with the CTTP regulations and requirements. The meeting may be
in person or via conference call or webcast.
(4) If the CTT disagrees with the Notification Letter and believes
that there is no failure to comply with CTTP regulations and
requirements, NMFS has incorrectly defined or described the failure, or
NMFS is otherwise in error, the CTT may submit a written Objection
Letter to NMFS on or before the Response Date. Within 21 calendar days
of the date of the Objection Letter, the CTT may meet with NMFS to
discuss a resolution or redefinition of the issue. The meeting may be
in person, or via conference call or webcast. If modifications to any
part of the Notification Letter are required, then NMFS will issue a
revised Notification Letter to the CTT; however, the Response Date or
any other timeline in this process would not restart or be modified
unless NMFS decides to do so, at its discretion.
(5) The total process from the date of the Notification Letter to
the date of final resolution should not exceed 90 calendar days, and
may require a shorter time frame, to be determined by NMFS, depending
on the seriousness of the alleged failure. In rare circumstances, NMFS,
at its discretion, may extend the time for resolution of the alleged
failure. In such a case, NMFS will provide a written notice to the CTT
informing him or her of the extension and the basis for the extension.
(6) If the failure to comply with CTTP requirements cannot be
resolved through this process, NMFS will issue a Revocation Letter to
the CTT that:
(i) States that CTT status has been revoked;
(ii) Summarizes the failure to comply with CTTP requirements;
(iii) Summarizes any proposed procedures, or attempts to produce
such procedures pursuant to sub-paragraph (3) of this paragraph to
resolve the failure;
(iv) Explains why resolution was not achieved; and
(v) Advises the importer that:
(A) The importer is no longer exempt from the requirements of the
SIMP; and
(B) The importer may not reapply for CTT status for a period of one
year.
(7) NMFS' decision is final upon issuance of the Revocation Letter
and is not appealable.
0
5. In newly redesignated Sec. 300.326, add paragraphs (d), (e), (f),
(g), and (h) to read as follows:
Sec. 300.326 Prohibitions.
* * * * *
(d) Make a false statement on an application for the CTTP.
(e) Falsify records required to be maintained under Sec.
300.324(d) or (e) or Sec. 300.325(i).
(f) Fail to make records available for inspection as required under
Sec. 300.324(d) or (e) or Sec. 300.325(i).
(g) As a CTT, fail to maintain and provide access to records as
required under Sec. 300.325(i) or to produce records as required under
Sec. 300.325(g)(3).
(h) As a CTT, fail to implement or follow the procedures in the
Trusted Trader Compliance Plan submitted to NMFS in a CTT application
or as part of an annual audit report.
[FR Doc. 2018-00653 Filed 1-16-18; 8:45 am]
BILLING CODE 3510-22-P