Small Plant News: Volume 6, Number 7
- How To Submit a Petition to FSIS
- Pre-shipment Review Pending Test Results
- Commonly Asked Questions & Answers
How To Submit a Petition to FSIS
By Beth A. McKew, DVM
In Volume 4, Number 12 of Small Plant News, the feature article titled “What Does it Take to Create a Regulation?” described the evolution of a regulation from start to finish. We all know that the finish line for a new regulation is a published Final Rule.
But where do the ideas for new regulations begin? A new rule or regulation may begin with new legislation passed by Congress, an emergency situation or a petition submitted by citizens. The petition is unique in that it is a means by which any interested person or group can request a rulemaking change, including you! This article describes the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service’s (FSIS) petition submission process.
FSIS’ regulatory definition of a petition is a “written request to issue, amend, or repeal a regulation administered by FSIS.” Any individual, partnership, cooperation, association, or public or private organization may file a petition for rulemaking.
The process for submitting a petition to FSIS is outlined in the regulations under Title 9 of the Code of Federal Regulations (CFR) 392. In order for the agency to consider the requested rulemaking, it’s important for the petition to be well supported. The regulations provide guidelines for how to support a petition. It’s important to remember that 9 CFR 392 addresses petitions for new rulemaking, as well as for amending existing rules.
The regulations clearly describe what specific information the petition for rulemaking must include:
- Name, address, telephone number, and email address of the person submitting the petition.
- A full statement of the action requested by the petitioner including the citation and exact wording of any existing regulation affected by the requested action.
- A statement of the factual and legal basis for the requested action, including all relevant information known to the petitioner, both favorable and unfavorable to the petitioner’s position. The statement of the factual and legal basis should identify the problem that the requested action is intended to address and explain why the requested action is needed to address the problem.
While support for the change requested by the petition is not required, FSIS considers adequate support necessary to evaluate a petition in an efficient and effective manner. Providing support will also facilitate regulatory development in the event that the petition is granted. Appropriate sources for support include, but are not limited to:
- professional journal articles,
- official government statistics,
- official government reports,
- scientific textbooks,
- research reports, and
- industry or consumer data.
Any information provided as support should be provided in full and should include a copy of any source cited in the petition. If original research reports are used to support a petition, the information should be presented in a form that would be acceptable for publication in a peer-reviewed scientific or technical journal. If quantitative data are used to support a petition, the presentation of data should include a complete statistical analysis using conventional statistical methods.
What to Expect After Submitting a Petition
After FSIS receives the petition, it will be stamped with the date of filing and assigned a number. FSIS will inform the petitioner in writing when a petition has been filed, along with providing the petition number and an agency contact for the petition. A petition may be withdrawn at any time by informing FSIS in writing.
The information contained within the petition for rulemaking will be put on public display, along with any supporting documentation that was submitted with the petition. All rulemaking petitions and supporting documentation will be available for public inspection in the FSIS docket room and posted on FSIS’ Website at www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions/petitions.
Once a petition has been filed with FSIS, any interested person may submit written comments. Comments should be submitted within 60 days of the posting date of the petition and should identify the number assigned to the petition to which the comments refer. FSIS will consider all comments that are submitted in a timely manner as part of its review of the rulemaking petition. Comments become part of the petition file and, like the petition, will be on display in the FSIS Docket room and posted on the agency’s Website referenced above. FSIS will take no further action on a comment that is actually a request for rulemaking for a different rule, as that request must be submitted as a separate petition.
Petitions that request actions, which are intended to enhance public health by removing or reducing foodborne pathogens or other potential food safety hazards that might be present in or on meat, poultry, or egg products, qualify for expedited review. To be considered for expedited review, the petitioner must submit scientific information that demonstrates the requested action will reduce or remove foodborne pathogens or other potential food safety hazards and how it will do so.
FSIS believes that providing clear guidance on how to prepare and submit a petition will best ensure prompt and appropriate consideration by the agency. Consistency in the content of rulemaking petitions and the submission of adequate supporting documentation will reduce the administrative costs associated with FSIS’ review process as well as decrease the time it takes to evaluate rulemaking petitions.
Persons interested in submitting a petition for rulemaking to FSIS should follow the guidance in this article, review 9 CFR 392, and submit the petition along with supporting documents to the Docket Clerk at:
U.S. Department of Agriculture (USDA), FSIS
Patriots Plaza III
1400 Independence Avenue SW
Room 8-163A, Mailstop 3782
Washington, DC 20250-3700
Pre-shipment Review Pending Receipt of FSIS Test Results for Adulterants
By Jane Johnson, DVM
On February 8, 2013, FSIS began withholding its determination as to whether meat and poultry products are not adulterated, and thus eligible to enter commerce, until all test results that bear on the determination have been received.
One of the most frequently asked questions regarding this change in policy, sometimes referred to as “test-and-hold,” involves the pre-shipment review. Specifically, can your plant complete pre-shipment review pending receipt of FSIS test results for adulterants?
The answer, of course, is no. To complete the pre-shipment review, you must have FSIS test results for adulterants. The purpose of pre-shipment review is to ensure that your plant is not introducing adulterated product in commerce.
However, your establishment may accomplish this pre-shipment review process in various ways, provided that you have documentation that the product was under your control until you received acceptable test results. For example, you may sign the pre-shipment review in stages (e.g., after completion of final CCP step and again after FSIS results become available). An electronic recordkeeping system may also be used to document control of your product until receipt of acceptable results. Your plant needs to have records from this electronic recordkeeping system readily available to inspection program personnel. Only after receiving notification that the test results are acceptable and having all stages of the pre-shipment review complete can you release the product into commerce.
FSIS has consistently indicated that it will be flexible in considering the specific mechanisms that establishments use to meet this requirement of pre-shipment review set out in 9 CFR 417.5(c). This means that pre-shipment review may be accomplished if your product is at a location other than your producing establishment, such as a storage location, as long as the review of all relevant documents and compliance with 9 CFR 417.5(c) occurs before the product leaves the control of your plant. Any product associated with the FSIS sample must, however, have been the subject of a pre-shipment review and be under your plant’s direct control until the FSIS result is received and found negative.
For guidance on complying with the FSIS “test-and-hold” policy, visit FSIS’ Web site at www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index and click on the link titled “FSIS Compliance Guideline for Controlling Meat and Poultry Products Pending FSIS Test Results.”
Commonly Asked Questions & Answers
Q. Can changes be made to the name and address of the manufacturer, packer, or distributor (i.e., the signature line) generically, or would this require resubmitting the label for sketch approval?
A. Yes. A company can change the name and address of the manufacturer, packer, or distributor in the signature line generically per 9 CFR 317.5(b)(9)(vii) and 381.133 (b)(9)(vii).
Small Plant News
Editor in Chief: Daniel P. Puzo
Editor: Keith Payne
Managing Editor: Jane Johnson, DVM
Manager: Sally Fernandez
Layout/Design: Gordon E. Wilson, Duane Robinson
Contributing Writer: Jeff Tarrant, Commander, U.S. Public Health Service
Office of Outreach, Employee Education and Training: Michael G. Watts, Assistant Administrator
Small Plant News, USDA/FSIS, Patriots Plaza III, Rm. 9-267A, Mailstop 3778,
1400 Independence Ave., SW, Washington, DC 20250. (800) 336-3747; E-mail: SmallPlantNews@fsis.usda.gov
FSIS Small Plant Help Desk