Constituent Update - June 19, 2020
FSIS Extends Comment Period on STEC Testing Expansion
In June, FSIS announced it was seeking comments on the proposed expansion of its routine verification testing for six Shiga toxin-producing Escherichia coli (non-O157 STEC; O26, O45, O103, O111, O121, or O145) that are adulterants, in addition to the adulterant Escherichia coli (E. coli) O157:H7, to samples of ground beef, bench trim, and raw ground beef components other than raw beef manufacturing, collected at official establishments, 85 FR 34397, June 4, 2020).
FSIS received a request from an industry association for a 60-day extension of the comment period, citing the need to evaluate the proposal’s impact on the industry and the associated cost analysis, as well as the extra time needed for analyses owing to the COVID-19 pandemic. In response, the agency has decided to extend the comment period by an additional 30 days. This extension should provide interested members of the public with sufficient time to review the agency’s proposal and cost benefit analysis. The comment period will now end on September 3, 2020.
Comments may be submitted by one of the following methods: Federal eRulemaking portal, available at http://www.regulations.gov; by mail sent to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 6065, Washington, D.C., 20250-3700. All items submitted by mail or electronic mail must include the agency name and docket number FSIS-2010-0023.
Tips for Faster Label Approval Process
Labels are currently taking about 5-7 business days to evaluate.
TIP: As a reminder, if a label bears a claim about hormone use in swine relating to pork products, the label application (for new approvals) and label record (for existing approvals) must include adequate documentation to support the claim.
Previous animal raising labeling claim guidance issued by FSIS stated that hormones were not approved for use in swine. Therefore, FSIS only approved “no hormone” claims on pork with a disclaimer statement such as, “Federal Regulations prohibit the use of hormones in pork. There are no hormones approved for use in swine by Federal Regulations.” However, because there are hormones approved by the Food and Drug Administration for use in swine in the United States (e.g., during gestation), this disclaimer statement is no longer accurate. Thus, the updated 2019 Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims for Label Submissions explains that if establishments submit a pork label with a “no hormones” claim to FSIS, the agency will look for documentation to support the claim before approving the label.
Additionally, disclaimer statements should no longer be included on labels with these claims. If establishments submit such labels with a disclaimer statement, FSIS will remove the disclaimer from the claim to approve the claim, provided the application contains adequate documentation to justify the claim. Examples of this type of claim include: Raised Without Added Hormones, No Added Hormones Administered, Raised Without Steroids, No Growth Promotants.
Establishments with a prior approval from FSIS for this type of claim need to update their labeling records or make plans for removing the claim at next printing. Also, establishments do not need to resubmit their labels for approval to remove the disclaimer statement from pork and pork product labels. The change can be made generically under 9 CFR 412.1. Establishments should make the change at the next printing of the label or take steps to remove the disclaimer immediately.
FSIS will continue to provide updates regarding label turnaround time, as well as suggestions to assist industry to streamline label submissions in its Constituent Update.
FSIS to Post Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella
On June 22, 2020, FSIS will update the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts and comminuted poultry products.
Additionally, FSIS will post the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young chicken or turkey carcasses, raw chicken parts or not ready-to-eat (NRTE) comminuted poultry products.
FSIS Creates Food Safety Fellowship Program
FSIS is establishing a Food Safety Fellowship program for graduate students at the agency. This fellowship is a scientific research opportunity that will assist FSIS in its goal of building strong relationships with academia. The agency is committed to data-driven and science-based approaches to all aspects of its public health mission. This opportunity will provide the student with an understanding of the type of research that supports FSIS decision making to ensure the safety of the food supply.
FSIS has identified several food safety research priorities that support its mission. Applicants are encouraged to identify a specific research priority when applying and propose how they will address it. If selected, the participant will create a project that is supportive of FSIS research priorities with the guidance of a university mentor.
This is a one-year, part-time, paid fellowship position. The appointment will be served at the selected participant's location. Candidates must be a student working towards a graduate degree in food science, veterinary medicine, animal science, or similar program, enrolled in an accredited U.S. college, university, or technical institute. This fellowship program is administered through the Oak Ridge Institute for Science and Education.
Information on applying for the fellowship is available at https://www.zintellect.com/Opportunity/Details/USDA-FSIS-2020-0134.
FSIS Releases Strategic Assessment of Sampling Resources Evaluation
FSIS recently completed a Strategic Assessment of Sampling Resources (SASR) to maximize the efficiency, effectiveness, and value of the agency’s sampling projects. Analysts developed a five-phased framework with tools to assess each of the sampling projects and resulting data, guided by a fundamental premise that sampling only fulfills its purpose when the data it generates are used by the agency. The assessment resulted in nine major findings with associated recommendations. These findings can be broadly characterized as either process-related, or statistics-related. Examples of recommendations include an annual review of the inventory of sampling projects, adopting the weighted criteria from this report to evaluate the potential benefits of sampling projects, and the use of a tool to optimize the number of samples that should be collected and analyzed for sampling projects.
FSIS is currently implementing the SASR recommendations, which will yield stronger, more efficient, and more effective sampling programs and a process to ensure the programs remain strong long into the future. For example, FSIS’ Sampling Coordination Committee has updated the process to initiate or change sampling projects to address the relevant SASR recommendations, and an internal workgroup is conducting an in-depth review of the value of sampling projects which ranked below a 0.3 benefit score. These actions illustrate the agency’s commitment to good governance and to ensuring that we are deploying our resources in as effective a manner as possible.
Read a a briefing memo and the report.
FSIS notices and directives on public health and regulatory issues are available at their respective libraries. The following policy updates were recently issued:
FSIS Notice 33-20 - Corrected Item Numbers For Face Shields
FSIS Directive 5000.8 Rev. 1 - Verifying Compliance With Requirements For Written Recall Plan Procedures
Export Requirements Updates
The Library of Export Requirements has been updated for the following countries:
- China, People's Republic of
- French Polynesia
- New Caledonia
- Republic of Kiribati