0760 Animal Feed Program SSA 2020 EXT

UNITED STATES FOOD & DRUG ADMINISTRATION
Animal Feed Regulatory Program Standards
OMB Control No. 0910-0760
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or
we) implementation of its Animal Feed Regulatory Program Standards. The FDA Food Safety
Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to
better protect public health by strengthening the human and animal food safety system. In the
United States, Federal and State Government Agencies ensure the safety of animal feed. FDA
is responsible for ensuring that all food and feed moving in interstate commerce, except those
under the U.S. Department of Agriculture jurisdiction, are safe, wholesome, and labeled
properly. States are responsible for conducting inspections and regulatory activities that help
ensure food and feed produced, processed, and distributed within their jurisdictions are safe and
in compliance with State laws and regulations. States primarily perform inspections under their
own regulatory authority. Some States conduct inspections of feed facilities under contract
with FDA. Because jurisdictions may overlap, FDA and States collaborate and share resources
to protect animal feed.
The FDA Food Safety Modernization Act passed on January 4, 2011, calls for enhanced
partnerships and provides a legal mandate for developing an Integrated Food Safety System
(IFSS). FDA is committed to implementing an IFSS thereby optimizing coordination of food
and feed safety efforts with Federal, State, local, tribal, and territorial regulatory and public
health agencies. Model standards provide a consistent, underlying foundation that is critical for
uniformity across State and Federal Agencies to ensure credibility of food and feed programs
within the IFSS.
The program standards provide a uniform and consistent approach to feed regulation in the
United States. Implementation of the draft feed program standards is voluntary. States
implementing the standards will identify and maintain program improvements that will
strengthen the safety and integrity of the U.S. animal feed supply. The feed standards are the
framework that each State should use to design, manage, and improve its feed program. The
standards provide for the following: (1) regulatory foundation; (2) training; (3) inspection
program; (4) auditing; (5) feed-related illness or death and emergency response; (6)
enforcement program; (7) outreach activities; (8) budget and planning; (9) assessment and
improvement; (10) laboratory services; and (11) sampling program.
Each standard has a purpose statement, requirement summary, description of program
elements, projected outcomes, and a list of required documentation. When a State program
voluntarily agrees to implement the feed standards, it must fully implement and maintain the
individual program elements and documentation requirements in each standard in order to fully
implement the standard.

The feed standards package includes forms, worksheets, and templates to help the State
program assess and meet the program elements in the standard. State programs are not
obligated to use the forms, worksheets, and templates provided with the feed standards. Other
manual or automated forms, worksheets, and templates may be used as long as the pertinent
data elements are present. Records and other documents specified in the feed standards must
be maintained in good order by the State program and must be available to verify the
implementation of each standard. The feed standards are not intended to address the
performance appraisal processes that a State agency may use to evaluate individual employee
performance.
As set forth in the feed standards, available from our website at: https://www.fda.gov/federalstate-local-tribal-and-territorial-officials/regulatory-program-standards/animal-feed-regulatoryprogram-standards-afrps, the State program is expected to review and update its improvement
plan on an annual basis. The State program completes an evaluation of its implementation
status at least every 3 years following the baseline evaluation by reviewing and updating the
self-assessment worksheets and required documentation for each standard. The evaluation is
needed to determine if each standard's requirements are, or remain, fully met, partially met, or
not met. The State program revises the improvement plan based upon this evaluation.
Accordingly, we are requesting extension of OMB approval for the information collection
provisions associated with our Animal Feed Regulatory Standards program as discussed in this
supporting statement.
2. Purpose and Use of the Information Collection
This information collection will be used by both FDA and the States to maximize the use of
resources and better direct their regulatory activities to help ensure food and feed produced,
processed, and distributed within their jurisdiction are safe and in compliance with State laws
and regulations.
3. Use of Improved Information Technology and Burden Reduction
FDA estimates that 98 percent of the respondents will use electronic means to fulfill the
agency’s requirement or request. Current practices allow the reporting and recordkeeping
requirements to be met through electronic means. The fill-in forms and worksheets will be in
Portable Document Format (PDF), Excel or Word Format and available on the internet; they
are fillable and fileable, but not signable.
4. Efforts to Identify Duplication and Similar Information
We are unaware of duplicative information collection.
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5. Impact on Small Business or Other Small Entities
FDA does not anticipate responses from small businesses and does not believe it will adversely
affect small businesses or other small entities. The Animal Feed Standards do not impact
business or small entities.
6. Consequences of Collecting the Information Less Frequently
Respondents will respond to the information collection on occasion, at least every three years.
Collecting the information less frequently than that would degrade FDA’s ability to measure
progress and adjust resource allocations accordingly.
7. Consistency with the Guidelines in 5 CFR 1320.5
There are no special circumstances for this collection of this 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 September 20, 2019 (84 FR 49524) to which the agency received one
comment. However, this comment did not address the information collection as specified
under the Animal Feed Regulatory Program Standards and was therefore not addressed.
9. Explanation of any Payment of Gift to Respondents
No gift or payment is offered to respondents for completing the information collection. The
standards do correspond to a grant program that conforms to federal regulations. States can
apply for a cooperative agreement allowing them to receive up to $300,000 each year for a
period of five years to work toward significant conformance with the eleven standards. The
States will conduct a baseline self-assessment and develop a strategic plan to fully implement
the program standard in five years.
10. Assurance of Confidentiality Provided to Respondents
This ICR is not collecting personally identifiable information (PII) or other data of a personal
nature. Information collected is about state animal food safety programs through the Animal
Feed Food Regulatory Program Standards which ranges from information about state laws and
regulations to procedures for dealing with foodborne illness outbreaks. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), the public has broad access to government documents.
However, FOIA provides certain exemptions from mandatory public disclosure of government
records (5 U.S.C. 552(b)(1-9). FDA makes the fullest possible disclosure of records to the
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public, consistent with the rights of individuals to privacy, the property rights of persons in
trade and confidential commercial or financial information.
11. Justification of Sensitive Questions
This information collection does not include questions pertaining to sexual behavior, attitude,
religious beliefs, or any other matters that are commonly considered private or sensitive in
nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Respondents to the information collection are State agencies seeking to avail
themselves of the options described in the document. States agencies that conduct feed
inspections under contract are interested in implementing the standards. The total estimated
annual recordkeeping burden for implementation is 569 hours per respondent. The burden was
determined by capturing the average amount of time for each respondent to assess the current
state of the program and work toward implementation of each of the eleven standards contained
in the animal food regulatory program standards (AFRPS). The hours per state feed regulatory
program will average the same to account for continual improvement and self-sufficiency in the
program. Our burden estimate reflects a decrease of 100,654 hours as a result of fewer
respondents to the collection and a reevaluation of the time we ascribe for recordkeeping
activities. This current burden is based on FDA’s understanding that State agencies-maintained
records of the usual and customary activities required by their inspection programs. The
requested burden to the States for their implementation of the standards has been addressed and
funding opportunities have been given to the States as an option for significant conformance of
the eleven standards.
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1
Type of Respondent

No. of
Recordkeepers

No. of Records
per
Recordkeeper
1

Total
Annual
Records
34

Average Burden
per
Recordkeeping
569

Total
Hours

State Animal Feed
34
19,346
Regulatory Program in
the United States
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Estimated Annual Cost Burden
FDA assumes an average hourly wage rate of $15 per hour. Doubling this wage to
account for overhead costs, we calculate respondent costs to $580,380 (19,346 x $30.00).
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13. Estimate of the 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 of
information.
14. Annualized Cost to the Federal Government
The information collection itself will not incur any annualized cost to the federal government.
States who opt into the standards may be awarded grants of up to $300,000 per year.
15. Explanation for Program Changes or Adjustments
This information collection reflects adjustment. Twenty-two (22) state animal feed regulatory
programs are currently enrolled in the feed standards and there is a potential for total
enrollment of thirty-four (34) states based on eligibility requirements for enrollment. The total
estimated burden of this collection has decreased by 6 annual responses based on a reduction in
recordkeepers from 40 to 34, as well as a decrease by 100,654 annual hours based on a
reduction in the estimate for annual recordkeeping activities.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA does not intend to publish the results of this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of information
collection would be inappropriate.
18. Exception to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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