What is the Food Safety Modernization Act Produce Safety Rule?
The Produce Safety Rule is part of the FDA Food Safety Modernization Act (FSMA) that was passed by President Obama on January 4, 2011. This regulation focuses on setting the first-ever federal regulatory standards for the production, harvest, and handling of fruits and vegetables, in an effort to prevent microbial contamination and reduce foodborne illnesses associated with fresh produce. The Produce Safety Rule was made available publicly on November 13, 2015 and was published in the Federal Register on November 27, 2015.
What does the FSMA Produce Safety Rule cover?
The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs). The rule is divided into several parts, including standards for:
- Worker health, hygiene, and training
- Agricultural water, both for production and post-harvest uses
- Biological soil amendments (e.g., compost, manure)
- Domesticated and wild animals
- Equipment, tools, buildings, and sanitation
- Production of sprouts*
* The Sprout Safety Alliance, based at the Illinois Institute of Technology, is developing a core curriculum, training and outreach programs for stakeholders in the sprout production community to enhance the industry's understanding and implementation of best practices for improving sprout safety, and requirements for sprout producers included in the FSMA Produce Safety Rule.
The FDA has a brief summary of the key requirements for the final Produce Safety Rule available on their website.
Will my farm be subject to the regulation?
If you grow, pack, process, or sell fresh produce, this regulation may apply to you. Review § 112.1—112.7 of the regulation to determine if your farm and the commodities you grow are subject to the regulation. You can also refer to the FDA’s factsheet on coverage, exclusions, and exemptions to help you determine whether you are subject to the regulation.
Here are a few key exemptions and exclusions:
- The rule does not apply to certain specified produce commodities that are rarely consumed raw. You can find the list of produce covered by the regulation in § 112.2.
- The rule does not apply to produce that is used for personal or on-farm consumption, or that is not a Raw Agricultural Commodity (RAC).
- The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance (e.g., via a “kill step”) as long as certain disclosures are made and written assurances are received, with appropriate documentation.
- The rule does not cover produce farms that have an average annual value of produce sold during the previous 3-year period of $25,000 or less.
- The rule provides a qualified exemption and modified requirements for farms that meet two requirements: (1) the farm must have averaging less than $500,000 per year during the previous 3 years; and (2) the farm’s sales to qualified end-users must exceed sales to others.
A qualified end-user is either: (1) the consumer of the food or (2) a restaurant or retail food establishment that is located in the same State or the same Indian reservation as the farm or not more than 275 miles away. Instead, these farms are required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or to display the same information at the point-of-purchase. These farms are also required to establish and keep certain documentation (See § 112.7).
FSMA Produce Safety Rule Timeline
The FDA has been developing and drafting the Produce Safety Rule since FSMA was passed in 2011. There were two open comment periods during which the FDA solicited feedback from produce growers, industry members, academics, and the general public. A timeline of the process is outlined below including future dates of when to expect compliance dates will become effective.
- January 4, 2011: FSMA was passed by President Obama.
- January 16, 2013: The proposed Produce Safety Rule was published.
- First open comment period ended on November 22, 2013. The FDA received over 15,000 comments during the first open comment period!
- September 29, 2014: The FDA released a supplemental document to the proposed Produce Safety Rule to revise the standards and make them more flexible and less burdensome in key areas.
- The comment period on the proposed Produce Safety Rule Supplement closed on December 15, 2014.
- A redline version of the changes from the original and supplemental document is available.
- November 2, 2015: The final Produce Safety Rule is sent to the Federal Register.
- November 13, 2015: The final Produce Safety Rule is available for public viewing online.
- November 27, 2015: The official publication date of the Produce Safety Rule.
- The rules will go into effect 60 days after the publication date in the Federal Register, but will affect businesses and farms at different times, depending on their operation size and the specific provision.
- The largest businesses, defined as greater than $500,000 in annual (three year average) gross produce sales, have 2 years from the effective date of the rule to comply with the regulation. They will have an additional two years to comply with certain specified agricultural water requirements.
- Small businesses, defined as greater than $250,000 but less than $500,000 in annual (three year average) produce sales, will have 3 years from the effective date of the rule to comply with the regulation. They will have an additional two years to comply with certain specified agricultural water requirements.
- Very small businesses, defined as greater than $25,000 but less than $250,000 in annual (three year average) produce sales, will have 4 years from the effective date of the rule to comply with the regulation. They will have an additional two years to comply with certain specified agricultural water requirements.
How do I get more information about the FSMA Produce Safety Rule?
There are a number of ways you can stay up-to-date with regulation.
- Sign up for the PSA general listserv. We send updates as we receive new information on the regulation, as well as educational opportunities and other produce safety information.
- Attend a training. Sign up for the PSA’s listserv for the latest information on when training is available.
- Sign up for the FDA’s e-mail updates
- Ask your local or state collaborator
- Contact us!
What educational opportunities are available to me?
The Produce Safety Alliance is dedicated to providing fundamental, science-based, on-farm food safety knowledge to fresh fruit and vegetable farmers, packers, regulatory personnel and others interested in the safety of fresh produce. This includes helping prepare fresh produce growers to meet the regulatory requirements included in the United States Food and Drug Administration’s proposed Food Safety Modernization Act (FSMA) Produce Safety Rule.
Since 2010, the PSA has been developing a standardized curriculum to satisfy the training requirements outlined within the Produce Safety Rule. The Produce Safety Rule outlines in § 112.22(c), that “at least one supervisor or responsible party from the farm to successfully complete food safety training at least equivalent to that received under the standardized curriculum recognized as adequate by the Food and Drug Administration”. The Produce Safety Alliance curriculum is recognized as one way to satisfy this training requirement.
The PSA will be launching training programs for produce growers (one-day training) and trainers (two-day training) in September 2016. The PSA will also be hosting webinars to increase awareness and understanding of the FSMA Produce Safety Rule. See our news page for archived presentations and audio recordings.
For more information about training opportunities for other FSMA regulations and alternate training opportunities, visit the FDA’s training strategy page.
- FDA Public Meetings and Transcripts
- Key Requirements: Final Produce Safety Rule
- Produce Safety Rule: Questions & Answers
- What Is FDA Doing to Promote the Safe Use of Manure and Compost on Crops? Questions and Answers with Michael Mahovic
- How Did FDA Establish Requirements for Water Quality and Testing of Irrigation Water? Questions and Answers with Samir Assar
- What the Produce Rule Means for Consumers
- Environmental Impact Statement (EIS) for the FSMA Final Rule for Produce Safety
- Final Qualitative Assessment of Risk to Public Health From On Farm Contamination of Produc
Have questions related to the FSMA regulations?
You can submit questions to the FDA Food Safety Modernization Act (FSMA) Technical Assistance Network or send a mail inquiry to the FDA at:
Food and Drug Administration
5100 Paint Branch Pkwy
Wiley Building, HFS-009
Attn: FSMA Outreach
College Park, MD 20740