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New Food Safety Regulations: Food Safety Modernization Act (FSMA)
What's Happening with FSMA?
The final rules are here.
After years of lawmaking, rulemaking, and extensive public feedback, the U.S. Food and Drug Administration (FDA) is now rolling out the final rules under the federal Food Safety Modernization Act.
On Nov. 13, 2015, FDA released the final "Produce Rule" that establishes new food safety rules for farms that grow, harvest, pack, or hold covered produce for human consumption.
The rule, published in the Federal Register on Nov. 27, is effective as of January 26, 2017. Farms covered by the rule (in full or in part) will have 2 to 4 years to come into compliance, based primarily on revenue thresholds.
Farms are eligible for a qualified exemption and modified requirements if they:
- Have food sales averaging less than $500,000 per year during the previous three years; and
- Sell more than 50% of its sales direct-to-consumer or to a restaurant or retail food establishment in the same state or within 275 miles.
Qualified exempt farms must still: label their products with farm name and address and must keep records that document that they qualify for the exemption. They must begin keeping these records as soon as the rule comes into effect (60 days after Nov. 27, 2015) but do not have to submit them to FDA.
Preventive Controls for Human Food
This rule, published September 17 and effective as of January 2016, applies to food "facilities," not farms. The final rule is a major improvement over earlier drafts that categorized many standard farm activities as facility activities. FDA clearly listened to extensive feedback from farmers and the sustainable agriculture community.
However, farms that do certain low-risk manufacturing and processing activities ("mixed-type" farms) AND qualify as small or very small businesses do have to register but are exempt from most of the requirements of the PC rule.
To sort all of this out, we suggest starting with this pair of articles from the National Sustainable Agriculture Coalition:
- Who is and is not subject to the Preventive Controls rule
- Partially exempt and modified requirements - this one includes the list of "low risk" activities and what "small" and "very small" mean for businesses
Roadside farmstands, farmers markets, and community supported agriculture operations are considered "retail food establishments" and are therefore not affected by the rule.
FDA summarizes the Preventive Controls rule here. The agency plans to issue guidance that will clarify the various exemptions and associated requirements.
- FDA fact sheet on the final Produce Rule: Covers key requirements, exemptions, variances, compliance dates, and additional information.
- Produce Rule in the Federal Register
- Preventive Controls for Human Food Rule in the Federal Register
- FDA flow chart to determine if and how you are covered by the Produce Rule
- National Sustainable Agriculture Coalition analysis of the final Produce Rule
- FDA fact sheet on the final Preventive Controls for Human Food rule: key requirements & compliance dates.
The federal Food Safety Modernization Act (FSMA), signed into law in 2011, is the first significant overhaul of food safety regulations since the 1930s and was designed to prevent food borne illness. FSMA will be implemented by the U.S. Food and Drug Administration (FDA) and relevant state agencies.
The OSU Small Farms Program, working with others who support small-scale, organic and sustainable, local farms and food businesses, has focused on two rules: the Produce Rule and the Preventive Controls Rule.
We submitted comments on the two rules during both rounds of the public process during rulemaking. You can request copies of our comments by emailing us at smallfarms[at]oregonstate.edu.
During the first public comment period in 2013, tens of thousands of farmers and others expressed many concerns about the draft rules. FDA agreed to revise specific parts of the rules to offer alternatives for provisions that raised the most concern.
The OSU Small Farms Program will continue to provide information here about FSMA next steps, training opportunities, and more. Check back here and watch our Facebook page.