Requirements for Additional Traceability Records for Certain Foods Under the Food Safety Modernization Act Produce Safety Rule

The FDA has finalized traceability requirements under FSMA.  The rule takes effect January 20, 2023, but enforcement will be delayed until January 20, 2026.  All operations will need to start complying on that date.  Operations with sales of less than $25,000 on average over the last 3 years adjusted for inflation based on 2020 are exempt. If a grower is exempt from the FSMA: PSR based on sales under $25,000 it is also exempt from the traceability rule. Growers who sell directly to consumers, sell food to institution programs, produce certain foods that are packaged on a farm, grow food that is rarely consumed raw or grow food that receives certain types of processing are exempt. If a grower sells wholesale and direct to consumer, the wholesale product may fall under the traceability rule.

FDA has developed a “Food Traceability List (FTL)”  which is a list of foods for which additional traceability records are required to be maintained.  In New Jersey it covers most of what is grown such as fresh cucumbers, herbs, leafy greens, melons, peppers, etc. unless it is considered rarely consumed raw.

For growers who fall under the rule a traceability plan is required which includes:

  • How the records are maintained including the format and location of the records
  • Description of the procedures used to identify foods on the FTL list
  • Description how traceability lot codes are assigned
  • Contact person who manages the records
  • Farm map showing the areas where commodities are grown and name of each field including coordinates
  • Plans must be retained for 2 years.

Records must be maintained for every “Critical Tracking Event (CTE)” which is an event in the supply chain of a food involving the harvesting, cooling or initial packing of a raw agricultural commodity.  Along with the CTE are “Key Data Elements (KDE)” which is the information which must be maintained.  So what records are required?

  • The commodity at harvest
  • Quantity and unit of measure of the food harvested (boxes, pounds, etc.)
  • Name of the field or growing area including GPS map coordinates
  • The date of harvest
  • Farm name, address and phone number of the operation

Lot codes will need to be assigned when the commodity is packed.  The same lot code will be used throughout the marketing system.  These lot code numbers do not need to be attached to each box or container.  They do need to be on a bill of lading, invoice, etc.

The next three years will be a learning experience for growers, extension educators and regulators.  There are many details in the rule which are not clear even after reading it more than once.  At the New Jersey Agricultural Convention & Trade Show Wednesday February 8 in the Food Safety session (2:45-4:45) we will review the latest interpretation of the rule and discuss which records will be required.  For anyone who wants more details go to:  https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

 

Harvest and Post-Harvest Agricultural Water Requirements Start in 2023 Under The Food Safety Modernization Act Produce Safety Rule

The water rule under the Food Safety Modernization Rule (FSMA) Produce Safety Rule (PSR) has been under review for some time.  The Food and Drug Administration (FDA) has finalized the harvest and post-harvest water portion which includes water used during harvest, for hand washing, cleaning equipment, cooling, and cleaning produce.

As with other FSMA rules, the FDA plans to take an “educate before and while we regulate” posture as they begin implementing the harvest and post-harvest requirements.  The harvest and post-harvest rule go into effect on the following dates:

  • January 26, 2023, for all farms with sales over $500,000.
  • January 26, 2024, for small businesses (total sales more than $250,00 but less than $500,000); and
  • January 26, 2025, for very small businesses (total sales more than $25,000 but less than $250,000).

Growers are required to test ground water sources (wells) four times in the first year and once each year thereafter.  If the water does not meet acceptable levels (non-detectable generic E. coli) the farm would need to stop using the source and determine the cause, make corrections then return to testing four times.  If a municipal water source is used the report from the municipality testing program is sufficient.  Remember untreated surface water can not be used for harvest or post-harvest activities.

Growers will also need to do a water distribution inspection each year that evaluates the water source, connections going into harvest or post-harvest systems and any water delivery systems in a packing house.  Records will need to be maintained for two years showing the inspection results.  There will be more details presented at the New Jersey Agricultural Convention & Trade Show at Harrah’s Resort in Atlantic City February 8, 2023, during the afternoon food safety session.

Pre-Harvest (Irrigation) Agricultural Water Requirements

It is not yet known when the pre-harvest rule will be finalized.  However, when the proposed rule is finalized, it will require farms to conduct an annual systems based agricultural water assessment to determine and guide measures to minimize potential risks associated with pre-harvest agricultural water.  When the rule is finalized, FDA proposes the following compliance dates:

  • Nine months after the effective date for all other businesses (farms over $500,000);
  • One year, nine months after the effective date for small businesses (farms more than $250,00 to $500,000); and
  • Two years, nine months after the effective date for very small businesses (farms more than $25,000 to $250,000).

 

FDA to Hold Webinar on the Food Traceability Final Rule December 7th

The Food and Drug Administration will be holding a webinar on the final food traceability rule under the Food Safety Modernization Act. The final rule goes into effect January 20, 2023, but enforcement does not start until January 20, 2026. This webinar will give growers a chance to help determine whether the rule will affect their operation and whether they may be exempt. Most vegetables, herbs and fruit grown in New Jersey fall under the rule, but some operations will be exempt. This is your opportunity to start understanding the rule.

The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm – 5:00 pm (ET) on the recently released https://www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods issued under the FDA Food Safety Modernization Act (FSMA). The final rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

During the webinar, the FDA will provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and discuss the recordkeeping requirements of the rule. The FDA will answer pre-submitted questions and take questions during the webinar. Foods subject to the final rule requirements appear on the https://www.fda.gov/food/food-safetymodernization-act-fsma/food-traceability-list (FTL), and include fresh-cut fruits and vegetables, shell eggs, nut butters, as well as certain fresh fruits, certain fresh vegetables, ready-to-eat deli salads, soft cheeses, and certain seafood products.

Persons who manufacture, process, pack, or hold foods on the FTL must maintain records including Key Data Elements (KDEs) related to Critical Tracking Events (CTEs) in the supply chain for the food (link). Covered entities – including farms, manufacturers, distributors, retail food establishments, and restaurants – will be required to provide this traceability information to the FDA within 24 hours of an official request, or within some reasonable time to which the FDA agrees.

Registration is at https://www.surveymonkey.com/r/DYRQFTL

You may submit a question in advance when registering. You may also submit your question to FSMA204Traceability@fda.hhs.gov.

For questions about the Food Traceability final rule, visit Frequently Asked Questions on FSMA at https:// www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-fsma.

Two Food Safety Webinars

On December 8th there will be two webinars related to on-farm food safety.  The first is part of our Lunchtime On-the-Go On-Farm Food Safety Webinar Series.

Using Sanitizers in a Postharvest Setting: Selecting a Sanitizer and Understanding its Label

Presented by: Donna Clements, Produce Safety Alliance Coordinator and NE Regional Extension Associate, Food Science Cornell AgriTech from 12:00-1:00. This series is Free! Connect with computer, the mobile app, or by calling in! You will get the link to sign on or call in a few days before the event.

Growers are taught “the label is the law” but finding the right information and understanding what the language means can be difficult. This webinar will make understanding and following the label instructions more manageable in the postharvest setting and discuss the FSMA Postharvest water compliance requirements and timeframes.

At the end of the webinar participants will understand:

    • EPA labeling, what to look for and what it means
    • Ideal chemistries for use in surface sanitation and postharvest water
    • Best practices for sanitizing surfaces and postharvest water
    • Management of postharvest sanitation systems
    • FSMA Postharvest water compliance dates

To sign up or for more information go to: Rutgers On-Farm Food Safety Programs Deadline to register is December 5, 2022

Agricultural Water “Risky to You?”

The second webinar scheduled from 3:00-5:30 is a continuation of the prior webinar on agricultural water and will feature Dr. Don Schaffner from Rutgers University. He will explain what attributes of a water testing program need to be included if it is to be risk based. The webinar will consist of a one-hour presentation followed by 30 min of interactive Q&A.

Registration link 👉 https://virginiatech.zoom.us/webinar/register/WN_GKkO7INqSUGnhPVCdAZX_Q

 

 

USDA Assistance for On-Farm Food Safety Expenses

We mentioned a new program from United States Department of Agriculture (USDA) to off set some expenses to help an operation prepare for food safety requirements earlier this year.  The “Food Safety Certification For Specialty Crops (FSCSC)” will cost share expenses for:

  • Developing a food safety plan for first-time food safety certification.
  • Maintaining or updating an existing food safety plan.
  • Food safety certification.
  • Certification upload fees.
  • Microbiological testing for products, soil amendments and water.
  • Training.

The FSCSC application period for 2022 is June 27, 2022, through January 31, 2023, and the application period for 2023 will be announced at a later date. FSA will issue payments at the time of application approval for 2022 and after the application period ends for 2023. If calculated payments exceed the amount of available funding, payments will be prorated.

Interested specialty crop producers can apply by completing the FSA-888, Food Safety Certification for Specialty Crops Program (FSCSC) application. All documents and additional information can be downloaded at farmers.gov/food-safety.  The application, along with other required documents, can be submitted to the FSA office at any USDA Service Center nationwide by mail, fax, hand delivery or via electronic means. Producers can visit farmers.gov/service-locator to find their local FSA office. Specialty crop producers can also call 877-508-8364 to speak directly with a USDA employee ready to assist.

Farm Storage Facility Loans

A second program that has been available for several years is the farm storage loan program.  This covers cold storage construction along with equipment in a packing operations such as baggers, brush polishers, bulk bin tippers, cement flooring, circulation fans, dip tanks, conveyors, graders, refrigeration units, sizers, sorting bins and tables, trucks, washers, waxers, etc.  A grower may borrow up to $500,000 for up to 12 years.  If an operation needs to make major changes in a packinghouse or needs a refrigerated truck this program is worth considering.  Contact the FSA office listed above.

 RAM-AMS Harmonized GAP Assistance Program

The USDA Risk Management Agency (RMA) and USDA Agricultural Marketing Service (AMS) have covered the cost of voluntary USDA Harmonized GAP and Harmonized Plus audits over several years.  This program ended with the announcement of the new FSCSC program.  If you have used the RMA program to cover your audit, seriously consider applying for the new program.  The advantage of the new program is it covers many things which RMA did not cover.

Using Sanitizers in a Postharvest Setting: Selecting a Sanitizer and Understanding its Label

December 8, from 12-1PM EST

Growers are taught “the label is the law” but finding the right information and understanding what the language means can be difficult.  This free webinar will make understanding and following the label instructions more manageable in the postharvest setting and discuss the FSMA Postharvest water compliance requirements and timeframes.

Presented by: Donna Clements, Produce Safety Alliance Coordinator and NE Regional Extension Associate, Food Science Cornell AgriTech.

At the end of the webinar participants will understand:

  • EPA labeling, what to look for and what it means
  • Ideal chemistries for use in surface sanitation and postharvest water
  • Best practices for sanitizing surfaces and postharvest water
  • Management of postharvest sanitation systems
  • FSMA Postharvest water compliance dates

For more information on this free webinar or to sign up:  Go to: https://go.rutgers.edu/8bgart4a