0021 Supporting Statement 2016

Interstate Shellfish Dealer’s Certificate
OMB Control No. 0910-0021
SUPPORTING STATEMENT

Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Under 42 U.S.C. 243, FDA is required to cooperate with and aid State and local authorities in the
enforcement of their health regulations and is authorized to assist States in the prevention and
suppression of communicable diseases. Under this authority, FDA participates with State
regulatory agencies, some foreign nations, and the molluscan shellfish industry in the National
Shellfish Sanitation Program (NSSP).
Molluscan shellfish consumed fresh (raw) and fresh frozen poses unique public health concerns.
The safety of molluscan shellfish directly reflects the cleanliness of the waters where they are
grown. Molluscan shellfish are nonmotile, filter feeding organisms that pump large quantities of
water through their bodies during their normal feeding process. The relationship between shellfish
harvesting waters that are contaminated with sewage and other forms of pollution and food safety
concerns has been demonstrated often. Additionally, molluscan shellfish must be held, packed, and
shipped under sanitary conditions to prevent contamination subsequent to harvest and prior to
delivery to the consumer.
The NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by
providing for the classification and patrol of shellfish growing waters and for the inspection and
certification of shellfish processors. Each participating State and foreign nation monitors its
molluscan shellfish processors and issues certificates for those that meet the State or foreign
shellfish control authority’s criteria. Each participating State and nation provides a certificate of its
certified shellfish processors to FDA on Form FDA 3038, “Interstate Shellfish Dealer’s Certificate.”
FDA uses this information to publish the “Interstate Certified Shellfish Shippers List,” a monthly
comprehensive listing of all molluscan shellfish processors certified under the cooperative program.
If FDA did not collect the information necessary to compile this list, participating States would not
be able to identify and keep out shellfish processed by uncertified processors in other States and
foreign nations. Consequently, the NSSP would not be able to control the distribution of uncertified
and possibly unsafe shellfish in interstate commerce, and its effectiveness would be nullified.
FDA requests the extension of OMB approval of the information collection provisions of the
Interstate Shellfish Dealer’s Certificate program, and approval of the revised Form FDA 3038,
titled, “Interstate Shellfish Dealer's Certificate.”

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2. Purpose and Use of the Information Collection
FDA uses this information to publish the “Interstate Certified Shellfish Shippers List,” a monthly comprehensive listing
of all molluscan shellfish processors certified under the cooperative program. State and local food control officials and
the food industry use the list to determine certified sources of shellfish. Shellfish offered for sale that originate from
non-listed dealers will be removed by State and local food control officials. This procedure assists FDA and the states
to assure that shellfish are produced, packed and shipped under proper sanitary controls to protect the health of
consumers of molluscan shellfish.

3. Use of Improved Information Technology and Burden Reduction
The Interstate Shellfish Dealers Certificate Form FDA 3038 may be submitted on paper or
submitted electronically by state or international officials. These officials securely log into a
shellfish shippers account to fill out the Form FDA 3038 electronically. The information obtained
from the form has been entirely automated. The forms transmitted by the states, after approval by
an FDA official, are entered into a FDA computer database program that allows the addition,
deletion, down loading and generating of the Interstate Certified Shellfish Shippers List, published
monthly in PDF format, and may be updated daily when new data is available.
FDA estimates that ninety percent (90%) of the respondents will use electronic means to submit the
Form FDA 3038.
4. Efforts to Identify Duplication and Use of Similar Information
There is no other information available that can be used for these purposes. FDA is the only
Federal agency that collects this information. There are no similar data that can be used or modified
for this use. This information is only provided to FDA when a State or foreign nation issues
certificates for those processors that meet the State or foreign shellfish control authority's criteria.
Therefore, the information being submitted to the agency will be original for each submission.
5. Impact on Small Businesses or Other Small Entities
Respondents are State and local regulatory agencies and foreign nations, not businesses. No small
businesses will be involved in this information collection.
6. Consequences of Collecting the Information Less Frequently
Respondents submit the required information on a yearly basis, as determined by applicable State or
foreign law. Each State has a different expiration date for its certifications; therefore, there is a
need for year-round collection of data. However, most States certify for a one year period or the
applicable shellfish season within that State's jurisdiction.
If the information was not collected, the consequences to the program would be to nullify its
effectiveness to control shellfish in interstate commerce. Without the collection and periodic
dissemination of this list of certified shellfish dealers, the existing public health controls pertaining
to molluscan shellfish in interstate commerce would be less effective. States that are in the program
are not willing to receive shellfish from noncertified shippers.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of August 20, 2015 (80 FR 50640). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
All information collected is part of State government agencies’ administrative files and is available
to the public. The information collected is not confidential.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: Respondents to this information collection are participating State and
local regulatory agencies and foreign nations. Respondents are “State, Local or Tribal
Governments.”
12 a. Annualized Hour Burden Estimate
We estimate the burden for this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
Activity

FDA
Form
No.

No. of
Respondents

Submission of Interstate
Shellfish Dealer’s
Certificate

3038

40

No. of
Responses per
Respondent

57

3

Total
Annual
Responses

Avg.
Burden per
Response

Total
Hours

2,280

0.10

228

There are a total of 40 respondents. In the past year the program received approximately 2,280
responses, or an average of 57 responses per respondent. The respondents complete a three-part
Form FDA 3038, Interstate Shellfish Dealer’s Certificate, using the information they have collected
previously during state and international inspections. The original copy of this form is sent to FDA,
the other parts are retained for their files. The information is readily available from State and
international records which must be kept to satisfy their own laws and regulations. FDA estimates
that it takes a respondent an average of 6 minutes, or 0.1 hours, to complete each form. Therefore,
2,280 responses x 0.10 hours = 228 hours total response time. FDA bases its estimate on its
experience and the number of certificates received in the past 3 years.
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to
be approximately $7,816.48. FDA estimates that this certification will be prepared by an employee
making an average wage similar to that of a Federal government employee at the GS-5/Step-1 rate,
in the Washington-Baltimore Locality Pay Area for the year 2015, which is $16.66 per hour. To
account for overhead, this cost is increased by 100 percent, which is $33.32 per hour. Thus, the
annual wage cost for completion and submission of these certifications is approximately $7,596.96
(228 hours x $33.32 per hour). Administrative cost, i.e. printing and mailing are estimated at
$370.00. Therefore, total costs are $7,966.96 ($7,596.96 + $370.00).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
FDA receives approximately 2,280 responses from 40 respondents annually which include the
States and some international countries. FDA estimates that it expends $18,623 in processing the
data received in these forms. Administrative expenses account for approximately $800 of this sum,
and the remainder is personnel cost. FDA bases its estimate on the salary of one full-time employee
at the GS-8, Step 1 rate, in the Washington-Baltimore Locality Pay Area for the year 2015 who
spends an estimated 780 hours on this program (780 hours x $22.85/hour = $17,823). Thus, the
total estimated cost to the Federal government is approximately $18,623 ($17,823 + $800.00).
15. Explanation for Program Changes or Adjustments
The burden for the collection of information is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA publishes the “Interstate Certified Shellfish Shippers List” on the Internet on a monthly basis.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to not display the expiration date for OMB approval of the information
collection.
18.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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