iAs we have covered in the past (See here), the U.S. Food and Drug Administration (FDA) has been in the throes of rolling out its implementation rules and guidelines for the Food Safety and Modernization Act (FSMA). FSMA, signed into law in 2011, represents the most dramatic overhaul of the U.S. food system since the Food, Drug and Cosmetic Act was passed in 1938 (hint: since the FDA was first granted statutory authority to oversee the safety of food, drugs, and cosmetics).
Naturally, the FDA's enhanced mandate under FSMA comes with substantial budgetary and resource needs. The President's FY 2016 budget includes an increase of $301 million for FSMA implementation. The FDA intends to issue a series of fact sheets which outline how the FDA intends to use additional funds, where a funding gap still exists, and what has been funded in the past (see fact sheet on Key Investments or Plans for Requested Budget Authority).
If FSMA directly impacts you or your business, the FDA's various summary sheets regarding budgetary authority provide insight into what the FDA believes it has accomplished to date regarding FSMA and the timeline for what it plans to accomplish in the future--in other words, the raw justification for why FSMA warrants increased funding. As the FDA sets out the costs for implementing FSMA in light of looming court ordered deadlines, we have a clear view of the timeline for the seven key FSMA rules: (1) Preventive Controls for Human Food; (2) Preventive Controls for Animal Food; (3) Foreign Supplier Verification Programs; (4) Produce Safety; (5) Accreditation of Third Party Auditors; (6) Sanitary Transportation; and (7) Mitigation Strategies for Intentionally Adulterated Food. Please see the following key dates for each rule (in chronological order by rule publication deadline):
(1) Preventive Controls for Human Food
Will set safety requirements for facilities that process, package and store food.
- Final rule deadline: Aug. 30, 2015
- Compliance deadlines:
- Businesses with 500+ employees: 1 year after publication
- Businesses less than 500 employees: 2 years after publication
- Businesses with less than $1 million in annual sales: 3 years after publication
(2) Preventive Controls for Animal Food
Intended to protect animal food from contaminants.
- Final rule deadline: Aug. 30, 2015
- Compliance deadlines:
- Businesses with 500+ employees: 1 year after publication
- Business with less than 500 employees: 2 years after publication
- Businesses with less than $2.5 million in annual sales: 3 years after publication
(3) Foreign Supplier Verification Program (FSVP)
Will make importers responsible (liable) for guaranteeing that foreign food suppliers meet the same standards required of domestic producers.
- Final rule deadline: Oct. 31, 2015
- Compliance deadlines:
- For most businesses: 18 months after publication or 6 months after foreign suppliers’ reach their FSMA compliance deadlines (whichever is later)
(4) Produce Safety Rule
Will establish new standards for growing, harvesting, packing and holding produce on domestic and foreign farms.
- Final rule deadline: Oct. 31, 2015
- Compliance deadlines:
- Farms/businesses with $500,000+ in annual produce sales: 2 years after publication.
- Farms/small businesses with $250,000-500,000 in annual produce sales: 3 years after publication
- Farms/very small businesses with $25,000-250,000 in annual produce sales: 4 years after publication
- Farms with less than $25k in produces sales are exempt.
- Compliance deadline for water quality standards and related testing: 2 additional years past produce rule compliance date
(5) Third Party Certification of Auditors for Foreign Suppliers
Will be responsible for the accreditation of third-party auditors to inspect foreign food producers.
- Final rule deadline: Oct. 31, 2015
- FDA plans to implement this program “as soon as possible after publication of the final rule,” as well as the publication of Model Accreditation Standards.
(6) Sanitary Transportation Rule
Will establish new sanitary standards and practices for transporting food.
- Final rule deadline: March 31, 2016
- Compliance deadline:
- Motor carriers with $25.5+ million in annual receipts or businesses with 500+ employees: 1 year after publication
- Motor carriers with less than $25.5 million in annual receipts or businesses with fewer than 500 employees: 2 years after publication
(7) Intentional Adulteration Rule
Will require facilities to develop a food defense plan to prevent actions intended to cause public harm.
- Final rule deadline: May 31, 2016
- Compliance deadlines:
- Business with 500+ employees: 1 year after publication
- Businesses with less than 500 employees: 2 years after publication
- Businesses with less than $10 million in annual sales: 3 years after publication
This is only a broad overview of relevant compliance deadlines. They are contingent on the publication date of the final rule and there may be nuances for different businesses. More to come as the final rules are published.
