Food Safety Modernization Act
The Food Safety Modernization Act (FSMA, often pronounced "fizz-ma") was signed into law on January 4, 2011. FSMA authorizes the Food and Drug Administration (FDA) to take a preventative approach to food safety.
There are seven rules included within FSMA. The Produce Safety Rule is one of these Rules and was finalized in 2015. The Produce Safety Rule sets food safety standards for farms in an effort to minimize the risks of microbiological contamination that may occur during the growing, harvesting, packing and holding of fresh produce. The key elements to the Produce Safety Rule and additional resources are listed below. For more information, attend one of the PSA Grower Training courses.
- Employee qualifications and training. Farm workers who handle produce and/or food contact surfaces must have certain training, including the importance of health and hygiene.
- Worker health and hygiene. Workers can carry, introduce and spread contamination to fresh produce so it's critical to have training in place for employees and visitors. Farms must also implement worker practices such as, washing hands after using the restroom and notifying their supervisor when they are ill.
- Agricultural water used during growing, harvesting, packing and holding. Water is a potential source of contamination if it's not monitored or used appropriately. The Produce Safety Rule addresses production water (e.g. irrigation) and post-harvest water (e.g. rinsing) standards. Note- the FDA is expanding the compliance dates for the agricultural water portion of the PSR. We expect more guidance to be released soon.
- Biological soil amendments. Appropriate use of raw manure and compost minimizes the risk of contamination.
- Domesticated and wild animals. Produce growing areas must be visually monitored for signs of animal intrusion and workers must not harvest produce that is likely contaminated (e.g. don't harvest melons with bird poop on them). Farms are not required to exclude animals from their fields or destroy animal habitat.
- Equipment, Tools and Buildings. The Produce Safety Rule establishes standards related to the use and sanitation of equipment, tools and buildings to prevent contaminating produce.
- Record Keeping. Certain records are required by the Produce Safety Rule. In general, records should be accurate, legible, and indelible; dated and signed by the person who performed the activity; and should be created at the time of the activity. Records should be keep for at least two years.
- Sprouts. Sprouts have specific requirements because of their susceptibility to contamination. Contact the Sprout Safety Alliance if you are a sprout grower.
- FSMA does not take the place of Good Agricultural Practices (GAPs) although farms utilizing these programs will be in a great position to comply with the Produce Safety Rule. It is expected that the FDA and USDA will continue to work together to release guidance. For more information about coverage and exemptions, review the following links:
NEW links and resources:
Content and information on this web page were supported in part by the Food and Drug Administration through grant PAR-16-137. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the FDA.
Exemptions to the Produce Safety Rule
Use the tool linked in the blue button below to help determine if the Produce Safety Rule applies to your farm or commodity. Not all farms or commodities are subject to the new rules- there are exemptions and exclusions (this is just a summary, for a full explanation review the Final Rule).
Produce Safety Rule
Exemption Decision Tool
Produce Safety Rule Exemptions Webinar from the Produce Safety Alliance
- The rule does not apply to food grown only for personal consumption.
- If your farm has average annual produce sales less than $25,000, the rule does not apply. Click here to see inflation adjusted values.
- The rule does not apply to produce commodities that are "rarely consumed raw." The list of these commodities are below.
- 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); eggplant; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; water chestnuts.
- There is an exemption for produce that receives commercial processing that adequately reduces harmful pathogens (e.g. a kill step). Specific written assurances and disclosures must be documented.
- A farm is eligible for a "qualified exemption" when it meets both of the following requirements: (1) the farm must have total food sales averaging less than $500,000 annually during the previous 3 years; and (2) the majority of the farm's sales is to qualified end-users*. Qualified exempt farms must keep documentation to show eligibility for the exemption. They must also display their name and address on the label of the produce or at the point of purchase (e.g. sign at the farmers market). Click here to see inflation adjusted values.
- *A qualified end-user is either: (1) the direct consumer of the food or (2) a restaurant or retail food establishment that is located in the same state or reservation as the farm OR within 275 miles.
Produce Safety Alliance
The Produce Safety Alliance (PSA) is a collaborative project between the US Department of Agriculture, the Food and Drug Administration and Cornell University. Visit their main page to sign up for their newsletter or find them on Facebook. Below are a few areas of focus for the PSA.
Training: The PSA has taken the lead in creating standardized training curriculum and materials for produce growers. Currently, this training curriculum is the only FDA approved training to meet the FSMA requirements for farms that are subject to the Produce Safety Rule. The FSMA Produce Safety Rule requires at least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA. In the future, there may be alternative trainings offered, but as of September 2018, the PSA Grower Training is the only one "recognized as adequate." If you have questions about whether or not a training will meet the requirements, please contact Andrea Sarchet at the Department of Agriculture (406) 444-0131 or firstname.lastname@example.org . Future training is being planned in Montana, but you are welcome to take the PSA Grower training wherever it is offered. See a list of upcoming courses by clicking here.
Resources: The PSA is continually adding resources and materials to their web page. Below are just a few topics you can find.
- Agricultural water calculation tools
- Exemption and exclusion presentation
- Farm food safety plan writing resources (you are not required to have a safety plan for your farm, but it is recommended)
Frequently Asked Questions
Below are responses to some of the commonly received questions about the Food Safety Modernization Act and the Produce Safety Rule. If you have questions beyond the scope of this list, or would like further explanation, please contact Andrea Sarchet at the Department of Agriculture (406) 444-0131 or Andrea.Sarchet@mt.gov.
How do I know if this rule applies to me?
There are a few exceptions to the Produce Safety Rule. Exemptions include produce that is: grown for personal consumption; will receive commercial processing; or is rarely consumed raw (such as potatoes). Additional exemptions are for farms that have less than $25,000 in average annual produce sales. Complete the questions on the survey/decision tool and/or MDA's online Produce Safety Rule Exemption Decision Tool to help determine if your farm will be exempt from the rule or not.
i have already determined that My farm is going to be subject to the rule, when do I need to comply?
Compliance dates are staggered based on the average annual produce sales. Farms with more than $500,000 of average annual produce sales will be fully covered by the rule and will need to comply by Jan. 26, 2018
Farms with more than $250,000 but less than $500,000 of average annual produce sales will need to comply by Jan. 28, 2019
Farms with more than $25,000 but less than $250,000 of average annual produce sales will need to comply by Jan. 27, 2020
An additional 2 years should be factored in for water testing requirements, unless you are a sprout grower.
A third-party already does GAP audits on my farm, is that enough to comply?
Currently, a GAP audit is not sufficient to comply with the FSMA Produce Safety Rule. However, being GAP certified or having a farm food safety plan will make it easier for you to meet the requirements. Depending on the program you use, you may find that your audit requirements are higher than the FSMA Produce Safety Rule requirements. Contact the Montana Department of Agriculture if you have more questions.
Am I required to have a food safety plan?
No, you are not required to have an on-farm food safety plan under the FSMA Produce Safety Rule. However, having a plan is an excellent way to organize and manage your safety policies and procedures. Additionally, if you are exempt from the rule, have a food safety plan to show your buyers can demonstrate your commitment to safe produce. Multiple online resources exist to help you create a plan. Find templates and guides by clicking here.
I've heard that the water testing requirements are changing. What do I need to know?
The FDA is exploring ways to simplify the microbial quality and testing requirements for agricultural water. It is possible that additional testing methods will become available for farmers to use. Until further guidance is released, it is recommended that farms subject to the rule continue to maintain current water testing practices.
As someone who eats produce, how will this affect me?
As a consumer, you should still take measures to reduce microbial contamination on fruits and vegetables at home. Steps include:
- Refrigerate perishable fruits and veggies at 40 degrees or below.
- Be mindful not to cross contaminate raw meat or seafood products with produce
- Wash your hands with soap and water before preparing fresh produce
- Wash fruits and vegetables with water before eating or cutting
Find more tips at www.foodsafety.gov.