Producer FSMA FAQs
Click the question to go to the answer on this page.
- What is the Food Safety Modernization Act?
- What is the Produce Safety Rule (PSR)?
- How do I know if I am covered or exempt?
- What produce is covered by this rule, and what produce is not covered?
- Are there special rules for Qualified Exempt farms?
- Is the Produce Safety Rule the same as GAP certification?
- If I am already GAP certified, do I also need to comply with FSMA PSR?
- When will compliance dates become effective?
- Who will be regulating the PSR in Virginia?
What is the Food Safety Modernization Act?
The Food Safety Modernization Act (FSMA) was passed in 2011 by President Obama and is the most sweeping reform of our food safety laws in more than 70+ years (since the Food Drug and Cosmetic Act of 1938). The act aims to ensure the US food supply is safe by shifting the focus from responding to contamination to preventing it. The Food and Drug Administration has developed seven different regulations that encompass FSMA including (1) Produce Safety Rule, (2) Preventive Controls for Food for Human Rule, (3) Preventive Controls for Food for Animals Rule, (4) Mitigation Strategies to Protect Food Against Intentional Adulteration Rule, (5) Sanitary Transportation of Human and Animal Food Rule, (6) Foreign Supplier Verification Programs Rule, and (7) Accredited Third-Party Certification Rule. Additionally, many of the FSMA rules require food safety training to fulfill compliance.
What is the Produce Safety Rule?
The Produce Safety Rule (PSR) is one of the seven food safety regulations that are part of the Food Safety Modernization Act (FSMA). The PSR sets a series of standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption: 21 Code of Federal Regulations Part 112 . Similar to the other FSMA rules, the PSR aims to be proactive rather than reactive by focusing on high risk practices and identification of hazards within individual operations. For example, there are no requirements for uncontrollable factors, such as number of wildlife allowed in fields. Instead, the PSR mandates covered produce not be harvested when contaminated by feces (e.g., bird dropping on a tomato intended for fresh market). Standards are set for: agricultural water; biological soil amendments; sprouts; wildlife and domesticated animals; worker health, hygiene, and training; equipment, tools, and buildings; among others. Here, we describe the PSR standards wildlife and domesticated animals.
How do I know if I am covered or exempt?
This question is tricky and not easily answered in a simple FAQ. There are some nice resources in the Producer Resources section that you can explore that will help to answer your questions:
- FDA Standards for Produce Safety: Coverage and Exemptions/Exclusions for 21 PART 112
- Is my farm operation covered or exempt from the Produce Safety Rule?
- ¿Mi huerta está cubierta o exenta de la Norma de Inocuidad de los Productos Agrícolas Frescos (PSA por sus siglas en Ingles)?
- FSMA’s Produce Safety Rule... Are you Covered or Exempt?
What produce is covered by this rule, and what produce is not covered?
All types of produce are covered by the rule except as provided by specific exemptions from the rule. Exemptions include produce that:
- is grown for personal or on-farm consumption
- is not a “raw agricultural commodity.” (A raw agricultural commodity is any food in its raw or natural state)
- will receive commercial processing that adequately reduces microorganisms of public health concern (e.g., through use of a “kill step”) is eligible for exemption under certain conditions (including keeping certain documentation).
- is on the “rarely consumed raw” list. The “rarely consumed raw” list is exhaustive and contains the following fruits and vegetables: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts. [The content of this list in the final rule is somewhat different from the proposed version. These changes were made in response to public comments and based on FDA’s analysis of available data. For example, Brussels sprouts and kale were removed from the proposed list, and pecans were added to the final list.]
What are special rules for Qualified Exempt farms?
Carolina Farm Stewardship Association: FSMA Frequently Asked Questions: What are the Special Rules for Qualified Exempt Farms?
Is the Produce Safety Rule the same as GAP certification?
The Produce Safety Rule (PSR) is regulation that 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). However, while the PSR is based on a solid framework of understanding on-farm risks and GAPs, it is not the same as GAP certification. Whereas the FSMA PSR is regulatory and mandatory for growers who are covered under the PSR, GAP certification is a voluntary program that verify that fruits and vegetables are produced, packed, handled, and stored as safely as possible to minimize risks of microbial food safety hazards.
If I am already GAP certified, do I also need to comply with FSMA PSR?
Although a farm may already be GAP certified, If that farm is covered under the PSR, then it must still adhere to and comply with the requirements of the regulation. For a quick glance ar key components of the rule see FDA Key Requirements: Final Rule on Produce Safety.
When will compliance dates become effective?
The Produce Safety Alliance has provided information related to compliance dates on their website. For a PDF of the revised compliance dates click here.
Who will be regulating the PSR in Virginia?
The Virginia Department of Agriculture and Consumer Services received federal grant funding in 2016 to establish a Produce Safety Program within the Office of Dairy and Foods. This new regulatory program will work to address the growing, packing, holding and dissemination of produce grown on farms and will encourage the safe production of fruits and vegetables and promote understanding and compliance with the FDA Produce Safety Rule and state legislation. Website.
