The Food Safety Modernization Act was signed into law just this past January, representing the first major overhaul of food-safety legislation in 70 years and providing the Food and Drug Administration with a number of new tools as it works to improve the safety of food consumed in the United States. In the last six months, there has been a flurry of articles, blog postings and other media mentions discussing the impact of FSMA on the food industry. What is often overlooked though is the fact that FSMA has a significant impact on not just the human-food industry, but the feed and grain sectors as well.
Who is Impacted?
FSMA applies to FDA-regulated facilities and food. It generally excludes products regulated by USDA (meat, poultry and certain egg products). If a facility has to register with the FDA under the Bioterrorism Act of 2002, it most likely must comply with FSMA. This includes grain elevators, animal- and pet-feed ingredient manufacturers, grain millers and processors, among others.
Farms are required to register with FDA if:
(1) The farm packs or holds food or animal feed not grown, raised or consumed on that farm or another farm under the same ownership; or
(2) The farm manufactures or processes food (including animal feed) that is not consumed on that farm or another farm under the same ownership.
FSMA requires FDA to issue regulations that specify what activities fall under each of these categories. Generally, if you process, manufacture, store or sell animal feed, you are regulated under FSMA. FDA may develop a few exemptions, such as an exemption for small or very small businesses, and there may be a potential exemption of certain on-farm activities from the preventive control plan requirements. However, at this time we have few details about these potential exemptions, and it may be some time before FDA releases any details.
Three Broad Areas of Focus
FSMA broadly focuses on three areas: prevention, detection and response, as well as imported foods. Let’s review a few key areas that are likely to have an impact on the feed industry.
1) Preventative Measures: This requires a hazard analysis and preventive controls plan. These are similar to a hazard analysis and critical control point plan, but are broader and more comprehensive.
The voluntary programs give companies a head start on complying with the new requirements, but will not ensure compliance with the yet-to-be-determined details. Even though FDA has the authority under FSMA to exempt or modify these requirements for animal-feed facilities, it is unlikely FDA will fully exempt many, if any, feed companies.
FSMA does provide FDA with substantially increased access to records.
2) Detection and Response Measures: These provide FDA with new authority to issue mandatory recall of a food product. Congress has established a formal process that FDA must follow, including the opportunity to challenge a recall (but only after the fact).
Effective this July, it does lower the standard for FDA to administratively detain food items. We will likely see FDA increase use of this authority.
It allows increased inspection of facilities. High-risk facilities will be inspected once by 2016 and then at least once every three years. Other facilities will be inspected once by 2018 and then at least once every five years.
Any business facing inspections should ensure there’s a plan in place for employees to follow during an inspection. At minimum, it should identify employees responsible for working with FDA during an inspection, where relevant documents are kept and how the company plans to respond to any issues that FDA may identify.
Regarding Reportable Food Registry updates, these apply equally to the human- and animal-food industries. If you are required to register with the FDA, you are subject to the RFR requirements. A report must be made within 24 hours of the time a company becomes aware of a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.
Traceability can be a concern for the grain industry when it comes to the RFR. After filing a report, you may be required to notify other parties in the stream of commerce. Recordkeeping is a key component of this requirement, and companies need to ensure that records are adequate to at least help narrow the focus of this notification. Good recordkeeping practices and at least minimal traceability procedures will help ensure reporting with the RFR or in the event of a recall.
3) Imported Foods: This relates to the Foreign Supplier Verification Program. Importers must conduct risk-based verifications of foreign suppliers to ensure compliance with food-safety requirements. Responsibility falls upon importers to verify foreign supplier compliance and keep records of verification efforts for at least two years. An importer is broadly defined as the owner of a food item or ingredient at the time it enters the United States.
FDA is required to release regulations regarding FSVP by January 2012. Ahead of this, companies should gather information and records, identify foreign suppliers of feed ingredients and begin to educate them about the upcoming regulations.
There is a Voluntary Qualified Importer Program, which will allow importers to seek expedited review and importation of certain foods from qualified foreign facilities — in essence, a fast track. Like most of these new programs, details are sparse at this point.
FDA may require a certificate of compliance before it allows the import of certain high-risk foods. These are foods that have known risks associated with them, risks related to country of origin and/or a finding that the country of origin cannot adequately ensure that U.S. food-safety standards are being met.
What Can We Expect Next?
FDA has a lot of work to do over the next 18 months. While the rulemaking process has begun, many questions remain such as whether FDA will be able to complete all the necessary work within the timeframes and how FDA will be able to implement many of FSMA’s provisions without increased funds. FDA is seeking industry input on implementing FSMA. Whether by attending an FDA-sponsored workshop or by submitting comments on proposed rules, it’s important that the feed and grain sectors participate in the process to ensure their voices are heard. Numerous companies and associations have been participating, with most comments publically available.
More information on the RFR and the complete listing of reporting requirements, as well as information on FSMA, can be found on FDA’s website.
Editor’s note: Kristin Eads, Jennifer Williams Zwagerman and Steve Toeniskoetter are attorneys in Faegre & Benson’s food, agriculture and biofuels industry practice. You may e-mail them at firstname.lastname@example.org, email@example.com and firstname.lastname@example.org. Visit F&B’s blog foodagbiofuels.com for more related news.