The American Feed Industry Association reminds its members that between Oct. 1 and Dec. 31, firms are responsible for the reregistration of their animal food facilities with the Food and Drug Administration, as required in even-numbered years by the Food Safety Modernization Act. This is based on the basic registration requirement in the Bioterrorism Act and the 2003 FDA final rule requiring facility registration for any non-exempt facilities that manufacture, process, pack or hold animal food (e.g., ingredients, pet food or feed).
The FDA has released some new guidance documents, but AFIA staff have not found any new requirements in these documents, as has happened in the past. The link above details the notice, an updated Question and Answer document (seventh edition) and a “Supplemental” Question and Answer document, which will be melded with the other Q&A in the future.
If your facilities were not registered before and are not new, they likely do not need to be registered now. However, to be sure, review the FDA facility registration requirements here.
You will need your facility ID and password to reregister. If those are not available, the main Q&A document provides details on how to obtain them from the FDA.
Facility registration is basically a “license to do business.” If your facility is not registered with the FDA or is new, you must obtain registration before operating. Also, if you do not reregister by Dec. 31, the FDA will assume you are out of business and will cancel your registration, which means you may not lawfully operate that facility.
This registration is not the same as is required for licensed medicated feed mills, for which a notice will be sent separately. All licensed medicated mills must reregister annually between Oct. 1 and Dec. 31.
FDA FSMA Reinspection Fees for FY 2019
In a July 27 Federal Register notice, the FDA published new reinspection fees for those facilities that “failed” a FDA inspection or for which the FDA must revisit an import facility. The FDA can also charge facilities these fees if the agency issues a recall order, and the firm fails to meet the requirements of the order, and the FDA has to physically recall the products.
The fiscal year 2019 (beginning Oct. 1) hourly rate for investigators requiring domestic travel is $253 per hour and for investigators requiring international travel is $282 per hour. These amounts are inclusive of other expenses. The FDA will send an invoice when an amount is due from the facility.
If you are interested in how the FDA arrived at these numbers or the specifics of when the agency can require payment of these fees, please visit the Federal Register notice here.
Visit the FDA’s FSMA webpage for the latest FSMA news and to sign up for email updates. For questions on any aspect of FSMA, please contact the AFIA staff:
- Richard Sellers, senior vice president of public policy and education, (703) 558-3569
- Leah Wilkinson, vice president of public policy and education, (703) 558-3560
- Gina Tumbarello, director of international policy and trade, (703) 558-3561
- Gary Huddleston, director of feed manufacturing and regulatory affairs, (703) 666-8854
- Paul Davis, Ph.D., director of quality, animal food safety and education, (703) 650-0146
- Louise Calderwood, director of regulatory affairs, (703) 558-3568
Signed into law Jan. 4, 2011, FSMA provides the Food and Drug Administration with sweeping new authorities and requirements for the animal food industry. The food and feed industries originally supported the bipartisan law, which, among other provisions, authorized the FDA to: promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, recall adulterated products and hire more than 4,000 new field staff. It is estimated that if fully implemented, the law will cost the U.S. feed and pet food industries more than $1 billion with little improvement to animal health, animal food safety or other real benefit. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.
Although the FDA has announced that the agency would not inspect facilities with more than 500 employees for hazard analysis and preventive controls compliance until late 2018, AFIA believes facilities must be in compliance with FSMA rules applicable to the firms’ sizes. For more information on required compliance dates, visit FDA’s website. Moreover, AFIA has urged the FDA to reopen the comment period to the animal food final rule and extend compliance dates, so that comments can be taken on the inapplicability of certain parts of the final rule to the feed industry.