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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 is due to be 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:

* 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:

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.

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.

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 January 2016, once the final regulatory language has been incorporated into the training modules. The PSA will also be hosting webinars to increase awareness and understanding of the FSMA Produce Safety Rule. The first webinar is tentatively scheduled to be held on December 17 at 2:00 PM EST. Information about how to join this webinar will be sent through the PSA listserve, so be sure to enroll at:

For more information about training opportunities for other FSMA regulations and alternate training opportunities, visit the FDA’s training strategy page.

Supplemental Information

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

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