0266 ss ren 070908rev

SUPPORTING STATEMENT
SEAFOOD INSPECTION AND CERTIFICATION REQUIREMENTS
OMB CONTROL NO. 0648-0266

A.

JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary.
The National Marine Fisheries Service (NMFS) operates a voluntary fee-for-service seafood
inspection program (Program) under the authorities of the Agricultural Marketing Act of 1946,
as amended, the Fish and Wildlife Act of 1956, and the Reorganization Plan No. 4 of 1970. The
regulations for the Program are contained in 50 CFR Part 260. The Program offers inspection
grading and certification services including the use of official quality grade marks which indicate
that specific products have been federally inspected. In addition, the Program is the only Federal
entity which establishes quality grade standards for seafood marketed in the United States.
Qualified participants are permitted to use the Program’s official quality grade marks on their
products to facilitate trade of fishery products.
2. Explain how, by whom, how frequently, and for what purpose the information will be
used. If the information collected will be disseminated to the public or used to support
information that will be disseminated to the public, then explain how the collection
complies with all applicable Information Quality Guidelines.
Participants in the Program include all segments of the seafood industry from harvesters to
retailers. When inspection services are desired, participants are requested to submit specific
information pertaining to the type of inspection service needed [§260.15]. That is, applicants
provide the Program information regarding the type of products to be inspected, the quantity, the
location of the product, and the date when the inspection is needed. There are also application
requirements (i.e., a letter from the participant) if there is an appeal on previous inspection
results [§260.36]. Participants requesting regular inspection services on a contractual basis
submit a contract using the form provided [§260.96]. Any changes to the contract require a
contract amendment, using the same form. Participants interested in using official grade marks
are required to submit product labels and specifications for review and approval to ensure
compliance with mandatory labeling regulations established by the United States (U.S.) Food
and Drug Administration (FDA) as well as proper use of the Program’s marks [§260.97(c)(12),
(13), (14) and (15)].
Current regulations state requirements for approval of drawings and specifications prior to
approval of facilities [§260.96(b) and (c)]. There are no respondents under this section. The
Program will amend this part of the regulations in a future action.
In July 1992, NMFS announced new inspection services, which were fully based on guidelines
recommended by the National Academy of Sciences, known as Hazard Analysis Critical Control
Point (HACCP). The information collection requirements fall under §260.15 of the regulations.
These guidelines required that a facility’s quality control system have a written plan of the
operation, identification of control points with acceptance criteria and a corrective action plan, as
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well as identified personnel responsible for oversight of the system. A supplementary document
to this request, entitled “Development, Assessment, Approval, and Continuing Compliance
Evaluation of HACCP-based Inspection Systems”, a chapter from the NMFS Fishery Products
Inspection Manual, describes in detail the requirements for participants choosing to receive
NMFS HACCP-based inspection services.
HACCP requires continuing monitoring and record keeping by the facility’s personnel.
Although HACCP involves substantial self-monitoring by the industry, the HACCP-based
program is not a self-certification program. It relies on unannounced system audits by NMFS.
The frequency of audits is determined by the ability of the firm to monitor its operation. By
means of these audits, NMFS reviews the records produced through the program participant’s
self-monitoring. The audits determine whether the participant’s HACCP-based system is in
compliance by checking for overall sanitation, accordance with good manufacturing practices,
labeling, and other requirements. In addition, in-process reviews, end-product sampling, and
laboratory analyses are performed by NMFS at frequencies based on the potential consumer risk
associated with the product and/or the firm’s history of compliance with the program’s criteria.
The information collected is used to determine a participant’s compliance with the program. The
reported information, a HACCP plan, is needed only once. Other information is collected and
kept by the participant as part of its routine monitoring activities. NMFS audits the participant’s
records on unannounced frequencies to further determine compliance.
The FDA implemented mandatory HACCP seafood safety requirements in December 1997. The
FDA regulations [21 CFR Part 123] include some of the same reporting elements as the NMFS
HACCP program. However, one of the significant differences is that the FDA regulation is
mandatory for seafood processors and focuses on seafood safety only. The NMFS HACCP
program is voluntary, is available to all segments of the seafood industry (from harvesters to
retailers), and addresses not only seafood safety, but also wholesomeness (hygiene), economic
integrity and seafood quality. There is a NMFS HACCP mark available to participants to assist
them in marketing their products. FDA’s mandatory program has no mark. Further, the FDA
regulations require a HACCP plan only if a hazard analysis reveals a seafood safety hazard.
NMFS requires a HACCP plan for all participants in the HACCP Program. The NMFS HACCP
program also assures participants compliance with international trade standards.
As explained in the preceding paragraphs, the information gathered has utility. National Oceanic
and Atmospheric Administration, National Marine Fisheries Service (NOAA, NMFS) will retain
control over the information and safeguard it from improper access, modification, and
destruction, consistent with NOAA standards for confidentiality, privacy, and electronic
information. See response #10 of this Supporting Statement for more information on
confidentiality and privacy. The information collection is designed to yield data that meet all
applicable information quality guidelines. Prior to dissemination, the information will be
subjected to quality control measures and a pre-dissemination review pursuant to Section 515 of
Public Law 106-554.

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3. Describe whether, and to what extent, the collection of information involves the use of
automated, electronic, mechanical, or other technological techniques or other forms of
information technology.
The information collected does not involve the use of automated, electronic or other
technological techniques. Much of the information for inspection requests is gathered over the
phone and documented by the Program’s inspection personnel. Examples of labels and
specifications are generally submitted in hard copy to the Program’s review staff for approval.
Electronic submissions, via attachments to email, for example, are also acceptable. The form for
Request for Inspection Services may be printed off the Program’s Website at:
http://seafood.nmfs.noaa.gov/InspectionRequest.pdf.
4. Describe efforts to identify duplication.
As mentioned in Question 2, the FDA HACCP regulations require some of the same reporting
elements as the NMFS HACCP program. This statement includes reporting burden beyond what
is required under the FDA regulations to better ensure seafood safety. In other words, an
applicant’s NMFS HACCP plan is acceptable under the FDA regulations so that no additional
plan is needed for FDA. If, however, the applicant wishes to participant in the NMFS HACCP
program and has an FDA HACCP plan, the FDA HACCP plan would be expanded to include the
NMFS requirements which address not only seafood safety, but also wholesomeness (hygiene),
economic fraud, and seafood quality.
5. If the collection of information involves small businesses or other small entities, describe
the methods used to minimize burden.
Small businesses may voluntarily participate in the Program and respond to the collection.
Specific instructions are provided, where needed, to all businesses to prevent submission of
unnecessary information and to minimize the burden.
6. Describe the consequences to the Federal program or policy activities if the collection is
not conducted or is conducted less frequently.
If the collection were not conducted, efficient operation of the Program would be jeopardized
and would lessen the service to the customers for whom it is intended.
7. Explain any special circumstances that require the collection to be conducted in a
manner inconsistent with OMB guidelines.
For participants to continue to obtain the benefits of advertising the official Program marks and
to ensure the Program’s marks are being used with integrity, some of the collections are done at a
frequency inconsistent with the Office of Management and Budget (OMB) guidelines. For
example, HACCP participants submit their HACCP plan only once, but changes in the plan may
occur whenever their processing operations dictate, which may be outside of the OMB
guidelines. In addition, monitoring of the HACCP plan is an ongoing activity which is then
audited by Program personnel at varying frequencies to determine the participant’s compliance
with the Program requirements.
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The regulations for label approval [§260.97(b) (13) and (15)] require one more copy than
recommended by OMB. The labels, once approved, are distributed to the applicant, the inspector
in the facility, the regional inspection office, and the label approving officer for their records and
future reference, which can be critical particularly if there is a question or dispute.
8. Provide information on the PRA Federal Register Notice that solicited public comments
on the information collection prior to this submission. Summarize the public comments
received in response to that notice and describe the actions taken by the agency in response
to those comments. Describe the efforts to consult with persons outside the agency to
obtain their views on the availability of data, frequency of collection, the clarity of
instructions and recordkeeping, disclosure, or reporting format (if any), and on the data
elements to be recorded, disclosed, or reported.
A Federal Register Notice was published on February 13, 2008 (73 FR 8292) for public
comment. No comments were received.
9. Explain any decisions to provide payments or gifts to respondents, other than
remuneration of contractors or grantees.
No payments or gifts are made.
10. Describe any assurance of confidentiality provided to respondents and the basis for
assurance in statute, regulation, or agency policy.
Participants in the Program are assured of the confidentiality of certain information, such as
records of sanitation and HACCP plans, which may contain privileged trade information. The
Department of Commerce, with the concurrence of the U.S. Department of Justice, determined
that this information is protected from disclosure pursuant to the Freedom of Information Act
Exemption (b)(4), 5 U.S.C. § 552(b)(4), which applies to trade secrets and commercial or
financial information obtained from a person that is privileged or confidential.
11. Provide additional justification for any questions of a sensitive nature, such as sexual
behavior and attitudes, religious beliefs, and other matters that are commonly considered
private.
No sensitive questions are asked.
12. Provide an estimate in hours of the burden of the collection of information.
The estimates below are based on data from Program personnel.
§260.15 Application for Inspection Services. The estimated time per response is an average
based on the wide range of applicants. Regular applicants, for example, have made extra copies
of the form with the standard information completed so that they simply fill in several additional
blocks, which would likely require much less than 5 minutes, then fax it to the inspection office.
New applicants, on the other hand, may take longer. They may provide the information over the
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phone or we may fax them a blank form which they complete and fax in return. Also, not all of
the blocks on the form are required to be completed before inspection services can be provided.
Missing information may be inserted by the inspector at a later date and kept as an internal
record.
Estimated Number of Respondents: 2,390
Estimated Number of Responses: 7,490
Estimated Time Per Response: 5 minutes
Estimated Total Annual Burden Hours: 624.
§260.36 Application for Appeal. As mentioned in Question 2, this is simply a short letter
notifying the inspection office that an appeal is requested.
Estimated Number of Respondents: 62
Estimated Number of Responses: 62
Estimated Time Per Response: 5 minutes
Estimated Total Annual Burden Hours: 5.
§260.96 Contract Completion. This estimate includes new applicants, estimated at about 35
annually, and current participants who amend their contracts during the year. The burden
estimate is considered equal for both situations.
Estimated Number of Respondents: 205
Estimated Number of Responses: 205
Estimated Time Per Response: 5 minutes
Estimated Total Annual Burden Hours: 17.
§260.97(c)(12), (13), and (15) Label and Specification Submission. This estimate includes not
only completing the form, but also the estimate to develop a new specification or revise an
existing one. The estimate also includes the time to compile, duplicate, and package the
submission.
Estimated Number of Respondents: 542
Estimated Number of Responses: 2,986
Estimated Time Per Response: 30 minutes
Estimated Total Annual Burden Hours: 1,493.
§260.15 HACCP Participant Application
New Respondents. These are applicants that are not currently in the NMFS HACCP Program,
who need to develop a NMFS HACCP Plan, which as explained previously, is required only
once. It is possible that if the applicant has an FDA HACCP plan, expansion of it to include
NMFS requirements may take a little less time. The burden reflected is an average of response
times in both situations.
Estimated Number of Respondents: 20
Estimated Number of Responses: 20
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Estimated Time Per Response: 60 hours
Estimated Total Annual Burden Hours: 1,200.
Current Respondents. These are participants already in the NMFS HACCP Program, with an
operating HACCP Plan. These participants are responsible for certain monitoring and record
keeping functions as described in the manual release.
Estimated Number of Respondents: 120
Estimated Number of Responses: 120
Estimated Time Per Response: 40 hours
Estimated Total Annual Burden Hours: 4,800.
TOTAL RESPONDENTS: 3,339
TOTAL RESPONSES: 10,883
TOTAL BURDEN HOURS: 8,139
13. Provide an estimate of the total annual cost burden to the respondents or recordkeepers resulting from the collection (excluding the value of the burden hours in #12
above).
Some of the information is faxed and some is mailed. The combined annual cost for copying,
faxing or mailing is $6,000.
14. Provide estimates of annualized cost to the Federal government.
As this is a fee-for-service program as explained in Question 1, all of the costs to the Federal
government for the collection are paid by the respondents.
15. Explain the reasons for any program changes or adjustments reported in Items 13 or
14 of the OMB 83-I.
Adjustments in burden: 1) estimated times for HACCP plans and reports have decreased, so that
hours for these two information collections are 5,150 hours less; 2) responses have increased for
the other information collections, resulting in an increase of 224 hours. The net decrease in hours
is 4,926.
The increases in postage rates over the past three years account for the reporting/recordkeeping
costs having been adjusted upward by $2,000 (rounded down to $1,999 in ROCIS).
16. For collections whose results will be published, outline the plans for tabulation and
publication.
Results are not published.

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17. If seeking approval to not display the expiration date for OMB approval of the
information collection, explain the reasons why display would be inappropriate.
Not applicable.
18. Explain each exception to the certification statement identified in Item 19 of the
OMB 83-I.
Not applicable.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
This collection does not employ statistical methods.

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