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FSMA Produce Safety Rule FAQ's

Mike Basedow, Tree Fruit Specialist
Eastern New York Commercial Horticulture

April 6, 2018

FSMA Produce Safety Rule FAQ's

Aaron Finley, NYSDAM

Mike Basedow, CCE-ENYCHP

On behalf of the New York State Department of Agriculture and Markets (Department), this article presents information on the Food Safety Modernization Act (FSMA) Produce Safety Rule and answers frequently-asked questions from producers.

The Produce Safety Rule is the first mandatory federal food safety standard for the production of fruits and vegetables in the United States. In July 2017, New York State adopted the Produce Safety Rule under a grant-funded cooperative agreement with the U.S. Food and Drug Administration (FDA). The Produce Safety Rule will affect many of New York's growers, harvesters, packers and holders of produce. The rule addresses the areas of: personnel health, hygiene and training; agricultural water, including for irrigation and washing; biological soil amendments of animal origin and human waste; domesticated and wild animals; equipment, tools, buildings and sanitation; and sprouts.

The following are frequently-asked questions from producers on the Produce Safety Rule.

1. Which portions of FSMA will impact my farm? 

The Produce Safety Rule affects growers, harvesters, packers and holders of produce whose average produce sales over three years exceed $25,000. The Produce Safety Rule is one of seven rules outlined in FSMA.

2. Where can I determine if I might qualify for any exemptions to the Produce Safety Rule? 

There are certain exemptions from the Produce Safety Rule that would subject farms to recordkeeping requirements, but not to on-farm inspections. There are three potential exemptions for farmers: qualified exemption, rarely consumed raw exemption and processing exemption. 

  • Farms may be eligible for a qualified exemption if they generate less than $500,000 in average annual food sales. A majority of these food sales must also be to a qualified end user. A qualified end user is defined as a consumer, a retail store or a restaurant within the same state or within 275 miles of where the food was produced. The FDA defines food as all human and animal food, including items such as chewing gum, bottled water and dietary supplements.
  • Farms may be eligible for an exemption if they only sell produce that is defined by the FDA as rarely consumed raw.  Rarely consumed raw produce includes: 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; water chestnuts; and milk. This is considered an exhaustive list. Produce not included in the above list is considered covered produce and subject to the Produce Safety Rule. If a farm sells both rarely consumed raw produce and covered produce, the part of the operation that grows and handles covered produce will be subject to inspection.
  • Lastly, farms may be eligible for an exemption if they only sell produce destined for further processing that includes a validated kill step to reduce pathogens. For example, a farm that sells grapes to a facility that makes wine would be eligible for the processing exemption. If a farm sells both produce destined for further processing and other covered produce, the covered produce and the associated farm operation will be subject to on-farm inspections.

Producers can complete an information survey, which will help determine coverage rates and compliance dates: https://www.surveymonkey.com/r/9HM3NTP.

3. Where can I find out how soon my farm will be subject to the Produce Safety Rule?

Farms that average $25,000 in produce sales over three years must meet staggered compliance dates. However, farms will not have to meet agricultural water guidelines at these designated dates. FDA has recently announced its intention to delay the requirements of Subpart E- Agricultural Water until four years after the above compliance dates for each of the farm size categories. Farms with over $500,000 in total produce sales, or "other farms," must comply with the Produce Safety Rule first. These farms have a compliance date of January 26, 2018. 

Farms with over $250,000, but less than $500,000 in total produce sales are considered "small farms" and have a compliance date of January 26, 2019. Lastly, farms with over $25,000, but less than $250,000 in total produce sales are considered "very small farms" and have a compliance date of January 26, 2020. 

4. When will Produce Safety Rule inspections begin? 

The Department will not begin inspections before Spring 2019. Current efforts will be concentrated on outreach and education to the industry.

5. Who will be conducting these inspections? 

The Department's Division of Food Safety and Inspection will be conducting inspections. The Department adopted the Produce Safety Rule into its own laws so that New York State inspectors would be conducting outreach, education, and inspections on New York State farms rather than the FDA. We expect cooperation with the FDA and do not expect them to be conducting inspections.

6. How do these inspections differ from Good Agricultural Practices (GAP) audits?

Produce Safety Rule inspections are mandatory and required under FSMA. These inspections are free and encompass all covered commodities and covered activities on the farm. In comparison, GAP audits are voluntary and driven by the market. Producers must pay for the audit and choose what commodities and what scopes are included.

7. Can GAP audits and Produce Safety Rule inspections be combined into one inspection? 

The Produce Safety Rule aims to refine these voluntary GAP audits and provide a standardized food safety inspection for produce. However, producers that are exempt from the Produce Safety Rule may still be required by their buyer to undergo a third-party food safety audit, such as USDA's GAP, Harmonized GAP or Safe Quality Food (SQF) Institute. The third-party, GAP audit will always be driven by the buyer. There have been discussions with states, USDA and FDA to address this issue. The USDA Harmonized GAP audit is currently being aligned with the Produce Safety Rule so that all aspects of the Produce Safety Rule will be contained in the Harmonized standard. 

8. Will the Department be providing mock inspections? 

The Department will be performing On-Farm Readiness Reviews (OFRR) in conjunction with Cornell Cooperative Extension (CCE) to producers willing to participate. This will not be a mock inspection, but rather an educational visit. The OFRR will consist of a walk-through of farm operations to observe what areas may or may not be compliant with the Produce Safety Rule.

9. How can I sign up for this educational visit?

An OFRR may be scheduled by contacting Aaron Finley at (518) 457-3846 or Aaron.Finley@agriculture.ny.gov. Aaron is the Department's Produce Safety Program Office Administrator based in Albany. Steve Schirmer is also an administrator of the program and serves as the Department's Produce Safety Program Field Administrator based in Syracuse. Steve can be contacted at Steve.Schirmer@agriculture.ny.gov. Producers can also indicate on their Farm Information Form that they want to participate in an OFRR. Farm Information Forms have been distributed at grower trainings and by produce associations.

10. How often will I have to perform water quality testing for my agricultural water? 

Guidelines and compliance dates for the use of agricultural water are currently under review by FDA. Agricultural water includes both production and postharvest water used in contact with covered produce. Producers should consider the source, quality, application method and timing of the application of their water.

There is no requirement to test water from a public water supply. However, documentation must be provided of test results or current certificates of compliance. Ground and surface water must be tested. Samples must be representative of use and must be collected as close in time as practicable to, but before, harvest. Ground water will need to be tested four or more times during the growing season or over the period of a year. Additionally, one or more samples must be rolled into a profile every year after the initial year. Surface water must be tested twenty or more times over a period of two to four years. Additionally, five or more samples must be rolled into a profile every year after the initial survey.

Updated information on agricultural water requirements will be distributed by the Department as received by the FDA.

For more information on FSMA, the Produce Safety Rule in New York State and to determine your farm's coverage or exemption under the rule, please visit the Department website at: https://www.agriculture.ny.gov/FS/general/fsma.html. Questions can also be sent to Aaron.Finley@agriculture.ny.gov and Steve.Schirmer@agriculture.ny.gov



FSMA Produce Safety Rule FAQ's (pdf; 121KB)

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Upcoming Events

Farm Financial Management Tuesdays - Planning for a Change or Exiting Your Farm Business

November 30, 2021 : Assessing the Financial Ramifications of and Options for Significant Change to Your Farm Business

The inflationary economy is upon us! The huge influx of money into the US economy following the COVID-19 pandemic has manufactured high prices and in turn increased operating costs for farm business thus forcing many businesses into net operating loss situations. Other farms are facing high labor costs or chronic labor shortages.  Some farms have taken on debt loads that make these increased costs unaffordable.  Depending on the stage in the business lifecycle, it may make sense to change enterprises or exit the farming business entirely. 

Join CCE ENYCH Ag Business Educator, Elizabeth Higgins, and CAAHP Ag Business Educator, Dayton Maxwell, for a one-hour program to learn about the financial aspects of changing or exiting a farm business. 

December 7, 2021 : The Family and Emotional Component; Shifting Business Direction and Life After Farming

As farm business enterprises are changed or disbanded, the emotional stress can be tremendous, especially when individuals and family members maintain diminished assurance relative to future security. 

Join Gabriel Gurley and Brenda O'Brien of New York FarmNet for a one-hour program focused on successfully navigating the emotional turmoil of a family farm business transition.

December 14, 2021 : New Venture Creation; Shifting Business Direction and Life After Farming

Change creates opportunity and new opportunities are certain when farm businesses change or end. 

Join Gabriel Gurley of New York FarmNet for a one-hour overview of identifying ways and means to capitalize on new opportunities resulting from farm business transitions.

 

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Remote Produce Safety Alliance Grower Training Course - Dec 2021

December 8 - December 9, 2021

A grower training course developed by the Produce Safety Alliance (PSA) that meets the regulatory requirements of the Food Safety Modernization Act (FSMA) for farms subject to the Produce Safety Rule. All farms are welcome to attend to learn about recommended food safety practices for growing, handling, and storing fresh produce. Course registration fee includes a course manual and certificate of course completion by the Association of Food and Drug Officials (AFDO).

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Tax Management for Beginning and Small Farm Businesses

January 18, 2022

Tax Management for Beginning and Small Farm Businesses.

A one-night virtual meeting for beginning and part-time farmers that provides useful tax information enabling participants to be make better tax decisions for their business.   Federal and state income taxes will be covered. Tax regulations specific to NYS will be covered as well. 


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Announcements

2021 SWD Insecticide Quick Guide

Prepare your sprayer and make sure you have the insecticides of choice on hand. Click on the following link for the revised 2021 SWD Insecticide Quick Guide: https://rvpadmin.cce.cornell.edu/uploads/doc_981.pdf

Current recommendations are to use the most effective material you can early in the spray program - even though the population seems small. The strategy is to keep the population small for as long as possible as it's very hard to gain control after the numbers have ballooned.  

USDA Offers Disaster Assistance for Producers

USDA Offers Disaster Assistance for Producers Facing Inclement Weather

Severe weather events create significant challenges and often result in catastrophic loss for agricultural producers. Despite every attempt to mitigate risk, your operation may suffer losses. USDA offers several programs to help with recovery.

Risk Management
For producers who have risk protection through Federal Crop Insurance or the Noninsured Crop Disaster Assistance Program (NAP), we want to remind you to report crop damage to your crop insurance agent or the local Farm Service Agency (FSA) office.

If you have crop insurance, contact your agency within 72 hours of discovering damage and be sure to follow up in writing within 15 days. If you have NAP coverage, file a Notice of Loss (also called Form CCC-576) within 15 days of loss becoming apparent, except for hand-harvested crops, which should be reported within 72 hours.

Disaster Assistance
USDA also offers disaster assistance programs, which is especially important to livestock, fruit and vegetable, specialty and perennial crop producers who have fewer risk management options.
First, the Livestock Indemnity Program (LIP) and Emergency Assistance for Livestock, Honeybee and Farm-raised Fish Program (ELAP) reimburses producers for a portion of the value of livestock, poultry and other animals that died as a result of a qualifying natural disaster event or for loss of grazing acres, feed and forage. And, the Livestock Forage Disaster Program (LFP) provides assistance to producers of grazed forage crop acres that have suffered crop loss due to a qualifying drought. Livestock producers suffering the impacts of drought can also request Emergency Haying and Grazing on Conservation Reserve Program (CRP) acres.

For LIP and ELAP, you will need to file a Notice of Loss for livestock and grazing or feed losses within 30 days and honeybee losses within 15 days. For TAP, you will need to file a program application within 90 days.

Documentation
It's critical to keep accurate records to document all losses following this devastating cold weather event. Livestock producers are advised to document beginning livestock numbers by taking time and date-stamped video or pictures prior to after the loss.

Other common documentation options include:
- Purchase records
- Production records
- Vaccination records
- Bank or other loan documents
- Third-party certification

Additional Resources
On farmers.gov, the Disaster Assistance Discovery Tool, Disaster-at-a-Glance fact sheet, and Farm Loan Discovery Tool can help you determine program or loan options.

While we never want to have to implement disaster programs, we are here to help. To file a Notice of Loss or to ask questions about available programs, contact the Rensselaer County USDA Service Center @ 518 271 1889 ext. 2. The office is open for business, however due to pandemic restrictions all in-person visits require an appointment.


Resources from CCE ENYCHP!

We are developing new ways to connect with the CCE ENYCHP team this year! We have a Youtube page located at this link. Check out videos on Table Grape Production, Pest Updates and the 20 Minute Ag Manager - in 4 Minutes series

We have a Facebook Page here as well as an Instagram page. We keep these places updated with current projects, events, and other interesting articles and deadlines.

There are also text alerts available. Fruit and vegetable farmers in 17 Eastern NY counties can now receive real time alerts on high risk disease and pest outbreaks texted directly to their cell phone. The Eastern NY Commercial Horticulture program, which is supported by local Cornell Cooperative Extension associations, will now offer text alerts to those that enroll in our program in 2019. 

The text alerts will be reserved for important crop alerts that could impact management decisions immediately. For instance, if there were an outbreak of Late Blight in the area, this would be transmitted to vegetable growers.

Farmers can choose the crop for which they wish to receive updates. Additionally they can request that Ag Business Alerts be sent to them. These alerts might include due dates for crop insurance deadlines, market opportunities etc.

If you have questions, please contact enychp@cornell.edu


Podcasts

FSMA Updates with Gretchen Wall

August 10, 2021
In this episode, Elisabeth Hodgdon discusses news and updates related to FSMA’s Produce Safety Rule with food safety specialist Gretchen Wall. They discuss inspection schedules for the 2021 season, On Farm Readiness Reviews, water testing, new resources available for growers, and more.

Resources:
Records Required by the FSMA Produce Safety Rule, by K. Woods, D. Stoeckel, B. Fick, G. Wall, and E.A. Bihn. This fact sheet includes an explanation of required records as well as printable record templates:
https://producesafetyalliance.cornell.edu/sites/producesafetyalliance.cornell.edu/files/shared/documents/Records-Required-by-the-FSMA-PSR.pdf

Upcoming Remote, Online, and In-Person Produce Safety Alliance Grower Training Courses:
https://producesafetyalliance.cornell.edu/training/grower-training-courses/upcoming-grower-trainings/

Interactive Google map of water testing labs, created by the Northeast Center to Advance Food Safety:
https://www.google.com/maps/d/u/0/viewer?amp%3Busp=sharing&mid=1C8KHM6jJszj9auYQttUbVtPKtb4eEBSJ&ll=41.22288057139939%2C-78.58548244999999&z=5\

Interested in joining the Produce Safety Alliance listserv? Sign up here to receive FSMA updates, notifications of educational opportunities and new resources, and more:
https://producesafetyalliance.cornell.edu/

Contact Information:
To schedule an On Farm Readiness Review or discuss your farm’s FSMA PSR coverage status, contact Steve Schirmer (315-487–0852 or steve.schirmer@agriculture.ny.gov), or Aaron Finley (518-474-5235 or aaron.finley@agriculture.ny.gov).

Episode speakers:
Elisabeth Hodgdon, ENYCHP vegetable specialist: 518-650-5323 or eh528@cornell.edu
Gretchen Wall, Produce Safety Alliance coordinator and Northeast Regional Extension Associate: 607-882-3087 or glw53@cornell.edu

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