On January 4, 2011, President Obama signed the Food Safety Modernization Act (FSMA) into law. The FSMA amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) to regulate certain food products. The FFDCA does not regulate most meat, poultry, and processed egg products, and those products are not directly impacted by the FSMA.
The FSMA includes many updates and expansions, but most notably, the FSMA calls for increased inspections, gives FDA the authority to demand a mandatory recall, requires certain “facilities” to analyze and produce a written plan regarding its own food safety law compliance, and directs the FDA to assess and collect fees related to food facility reinspection, food recalls, and importer reinspections. In addition, the FSMA requires that the FDA promulgate new regulations to implement the FSMA.
Below is a summary of the Food Safety Modernization Act:
Mandatory Recalls. The FDA will be entitled to recall any covered food products. A civil penalty will be charged to “any person who does not comply with a recall order...”
Required Food Safety Plans. All “facilities” under the FSMA will be required to have food safety plans.
- Each food facility is required to evaluate hazards and implement preventative controls.
- Food suppliers will have to put together a plan identifying possible sources of contamination and ways to prevent them.
- Plans will be accessible by the government in case of an emergency. These would include hazard analysis and a plan for implementing corrective measures.
- Facilities will be required to register as a food facility under Sec. 415(a) of 21 U.S.C.
- Under the FFDCA, a facility includes “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. A facility does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).”
- Exempted Facilities: (a/k/a the “Tester Amendment”)
- Qualified small facilities are exempt from some of the FSMA’s requirements. This includes small businesses that either:
- Meet the FDA’s definition of “very small business” (which will be defined in rules to be promulgated by the FDA in the future), or
- Have an average annual monetary value of food that is less than $500,000 (in annual sales/revenues, not profits), and such food is sold within the same state or within 275 miles from where it was processed or harvested.
- If a small business fits within one of the exemptions, the business is still required to disclose the location from which the food originated from directly on the product or at the point of sale. In addition, exempt facilities must demonstrate they are in compliance with state and local food safety laws or demonstrate that they have identified potential hazards in their facilities and are implementing preventive controls to address those hazards.
Documentation/Access to Records. Upon the FDA’s belief of a reasonable probability of serious adverse health consequences, each “person” (which excludes farms and restaurants but makes no mention of excluding grocery stores) must allow access to and copy of all records relating to the product in question and to any other product the FDA believes could be affected in a similar manner.
Increased Investigations. The FSMA allows for increased investigations of retail food establishments.
Authority for FDA to Promulgate Regulations. The FDA is directed to promulgate regulations to:
- Identify preventative programs and practices to promote safety and security of food;
- Ensure sanitary food transportation practices;
- Develop a policy to manage risk of food allergy and anaphylaxis in schools and early childhood education programs;
- Allocate inspection resources based on the risk profile of food facilities or food;
- Recognize bodies that accredit food testing laboratories; and
- Improve capacity of the FDA to track and trace raw agricultural commodities.
Concerns for Grocery Stores:
- The FSMA requires grocery stores to maintain records as to certain foods (produced on a farm and sold to a grocery store by the owner, operator, or agent in charge of the farm), documenting the farm that was the source of such food.
- The FDA will be required to prepare a report of critical information with respect to articles (except fruits and vegetables that are raw agricultural commodities) in a one-page standardized summary. This summary will be posted on the Web site of the FDA, in a format to be easily printed by a grocery store for purposes of consumer notification.
- If a grocery store sold a “reportable food” that is the subject of the posting, and such store is part of a chain of establishments with 15 or more physical locations, then the store, not later than 24 hours after the summary was published, must prominently display each summary or the information from such summary for 14 days. The FDA will publish a list of acceptable locations and manners for the stores to choose from.
- It is important to note that knowing and willful failure to comply with the notification requirement set forth above will be a “prohibited act” added to 21 U.S.C. 331.
Concerns for Importers:
- A major part of the FSMA is to heighten the requirements for imported food to the U.S.
- Many sections of the law reference special requirements for importers, including the collection of fees.
- Increased inspection of imports
- Enforcement actions as to imports
- Foreign Supplier Verification Program
- Voluntary Qualified Importer Program
- Authority to require import certifications for food
- Prior notice of imported food shipments
Concerns Related to Seafood:
- Exemption for certain seafood facilities. A facility that handles seafood and otherwise complies with the Seafood Hazard Analysis Critical Control Points Program of the FDA is exempted from the plan requirements of the FSMA.
- “Interagency Agreements with Respect to Seafood.” Agencies may enter into agreements as necessary or appropriate to improve seafood safety.
- Processing of Raw Oysters. The FDA is required to file a report regarding post harvest processing of raw oysters.
- Foreign Supplier Verification Program. This is required of any importer. This is an exemption for seafood if facility complies with the Seafood Hazard Analysis Critical Control Points Program of the FDA.
Other notable provisions of the FSMA include the following: (1) Reports and actions on such things as information technology, data sharing, research, and government capacity are required; (2) New regulations on transportation of food; (3) Regulations to enhance foodborne illness surveillance systems to improve collection, analysis, reporting, and usefulness of data on food-borne illnesses; (4) Whistleblower protections are established for employees of facilities, providing information relating to a FFDCA violation.
If you have questions or want more information on the FSMA, please contact Jeff Peterson (firstname.lastname@example.org, 320.202.5339) or Hailey Harren (email@example.com, 320.202.5349).