0910-NEW_Produce Regulatory Program Standards_2024

United States Food and Drug Administration

Produce Regulatory Program Standards

OMB Control No. 0910-NEW

SUPPORTING STATEMENT

Part A. Justification

1. Circumstances Making the Collection of Information Necessary

The Food Safety Modernization Act (FSMA) (P.L.111-353) 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 human and animal food. FDA is responsible for ensuring that all human and animal food 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 human and animal food and 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 human or animal food facilities under contract with FDA. Because jurisdictions may overlap, FDA and States collaborate and share resources to protect human and animal food.

Section 205(c) of FSMA (codified in 21 U.S.C. 2224) 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 human and animal food 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 human and animal food programs within the IFSS.

As part of this effort, we have initiated programs that include developing and instituting regulatory standards intended to reduce the risk of foodborne illness through coordinated efforts with our strategic partners. Regulatory program standards establish a uniform foundation for the design and management of State, local, tribal, and territorial programs that have the responsibility for regulating human and animal food. Partnering with other regulatory officials also helps maximize limited resources in administering FDA regulations pertaining to the manufacturing/processing, packing, or holding of produce for consumption in the United States.

We are therefore requesting OMB approval for the information collection provisions associated with the Produce Regulatory Program Standards (PRPS) 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 produce manufactured, processed, packed, or held for consumption in each jurisdiction is safe and in compliance with state laws and regulations.

The regulatory program standards provide a uniform and consistent approach to produce regulation in the United States. States may implement the program standards on a voluntary basis. The PRPS is the framework that each participating state should use to design, manage, and improve its produce regulatory programs. The PRPS provide for the following eleven standards: (1) regulatory foundation; (2) training program; (3) inspection program; (4) audit program; (5) foodborne illness outbreak response; (6) compliance and enforcement program; (7) outreach activities; (8) program resources; (9) assessment and improvement; and (10) laboratory services.

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 standards, it must fully implement and maintain the individual program elements and documentation requirements in each standard to fully implement the standard. We invite you to visit our website (FDA Regulatory Program Standards) for more information and to access the PRAP.

The PRPS 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 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 standards must be maintained in good order by the state program and must be available to verify the implementation of each standard.

As set forth in the standards, the state program is expected to review and update its improvement plan on an annual basis. At least every year, the state program reviews and updates 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.

3. Use of Improved Information Technology and Burden Reduction

FDA estimates that 100 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. We will use our website to communicate information regarding the individual programs at Regulatory Program Standards, where current program standards, associated worksheets, activity booklets, and applicable regulatory authorities may be publicly viewed and downloaded, and questions may be directed to FDA through dedicated e-mail.

4. Efforts to Identify Duplication and Use of Similar Information

The information described is not duplicative and must be obtained from the enrolled programs.

5. Impact on Small Businesses 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 PRPS do not impact business or small entities.

6. Consequences of Collecting the Information Less Frequently

Collecting the information solicited in this collection less frequently would negatively impact FDA’s ability to evaluate annual grantee performance. The twice annual collection is proportionate and appropriate.

There are no technical or legal obstacles to the collection of this information.

7. Special Circumstances Relating to the Guidelines of 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 June 28, 2024 (89 FR 54009). We received one comment that we determined was not relevant to this information collection request.

The FDA also worked closely with stakeholders through the Association of Food and Drug Officials (AFDO) and the National Association of State Departments of Agriculture (NASDA). FDA coordinated with AFDO, NASDA, and state produce safety regulatory programs to draft and develop content for the PRPS. PRPS content was drafted workgroups consisting of representatives from FDA, NASDA, AFDO, and state produce safety programs.

9. Explanation of Any Payment or 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.

10. Assurance of Confidentiality Provided to Respondents

In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate identification and handling of information collected.

This ICR collects personally identifiable information (PII). PII is collected in the context of the subject individuals’ professional capacity and the FDA-related work they perform for their employer (e.g., point of contact at a regulated entity). The PII submitted via FDA ORA Produce Regulatory Program Standards worksheets and inspection reports is name, job title, work email address, and work telephone number. FDA determined that although PII is collected, the collection is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Act do not apply. Specifically, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected. Through appropriate form and webpage design, FDA limited submission fields and minimized the PII collected to protect the privacy of the individuals.

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 will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information.

11. Justification for 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

12 a. Annualized Hour Burden Estimate

Table 2. – Estimated Annual Recordkeeping Burden1
Respondent	No. of Recordkeepers	No. of Records per Recordkeeper	Total Annual Records	Average Burden per Record-keeping	Total Hours
State or Territorial Governments; Maintenance of data records consistent with the PRPS	48	11	528	85.36	45,072

¹There are no capital costs or operating and maintenance costs associated with this collection of information.

To demonstrate conformance with the standards prior to and after enrollment in the grant programs, State and Territorial governments participating in the PRPS (respondents) submit comprehensive program assessments and evaluations to their technical advisors at FDA using a dedicated email. The information required for these submissions is outlined in the provided worksheets. Additionally, the PRPS requires ongoing documentation to verify conformance. We estimate, based on the historical performance of similar standards programs and informal consultation with the affected State and Territorial governments, that the information collection activities will average 938.96 hours per respondent, for a total of 45,072 hours across the entire respondent population.

12b. Annualized Cost Burden Estimate

FDA assumes an average hourly wage rate of $43.55 per hour¹. Doubling that to approximate a “fully loaded” cost estimate produces $87.10/hr. We therefore calculate respondent costs to be $3,925,771.20 (45,072 x $87.10).

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 of information.

14. Annualized Cost to the Federal Government

Staff needs specific to this collection include effort to review report submissions, provide technical guidance to program participants on using the forms, and facilitation of periodic review and updates to the PRPS when needed.

Table 4. – Estimated Government Costs2
Government Personnel	Effort Commitment	Average Annual Salary	Total Costs
GS-12 (1)	5%	$99,200	$4,960.00
GS-13 (2 @ 100% each)	200%	$117,962	$235,924.00
GS-14 (1)	10%	$139,395	$13,939.50
GS-15 (1)	5%	$169,429	$8,471.45
Total			$263,294.95

15. Explanation for Program Changes or Adjustments

This is a new data collection.

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

Not applicable.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 Per U.S. Bureau of Labor Statistics May 2023 National Occupational Employment and Wage Estimates – Mean hourly wage for Business and Financial Operations occupations: https://www.bls.gov/oes/current/oes_nat.htm#13-0000

2 Calculated using U.S. Office of Management and Budget 2024 Washington, D.C. Metro Area GS Pay Table: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2023/DCB.pdf

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