On July 18, 2022 the U.S. Food and Drug Administration (FDA) issued a supplemental notice of proposed rulemaking to extend the compliance dates for the pre-harvest agricultural water provisions as outlined in the recent 2021 agricultural water proposed rule.

The 2021 agricultural water proposed rule, if finalized, will require farms to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The FDA is now proposing extended compliance dates for those proposed pre-harvest requirements and is also providing clarifying information about the enforcement discretion policy for the harvest and post-harvest agricultural water requirements.

The supplemental rulemaking proposes to establish the following compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts:

• 2 years and 9 months after the effective date of a final rule for very small businesses;
• 1 year and 9 months after the effective date of a final rule for small businesses; and
• 9 months after the effective date of a final rule for all other businesses.

Note:  These compliance dates only go into effect when the rule is finalized which we have no information when that will occur!

Compliance Dates for Harvest and Post-Harvest Agricultural Water Requirements

The 2021 pre-harvest agricultural water proposed rule did not propose substantive changes to the harvest and post-harvest agricultural water requirements in the Produce Safety Rule; however, the FDA recognizes that prior to the proposal, stakeholders did not have clarity on whether FDA might propose to change the harvest and post-harvest agricultural water requirements. In addition, the FDA recognizes that adequate training and technical assistance are needed to fully recognize the benefits of the harvest and post-harvest requirements. Therefore, we intend to continue enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety regulation until the following dates:

• January 26, 2025, for very small businesses;
• January 26, 2024, for small businesses; and
• January 26, 2023, for all other businesses.

We are reopening the comment period only with respect to the proposed compliance dates for the pre-harvest agricultural water provisions until September 19, 2022. Comments should be submitted to docket FDA-2021-N-0471 on Regulations.gov.

As has been done with other FSMA rules, the FDA plans to take an “educate before and while we regulate” posture as we begin implementing the harvest and post-harvest requirements. For the first year of compliance, the FDA intends to work closely with state, other regulatory, and industry partners to advance training, technical assistance, educational visits and on-farm readiness reviews to prepare both growers and state regulators for implementing these provisions prior to initiating routine inspections verifying compliance. The FDA will provide further communications as additional resources become available.

Additional Information

• FSMA Proposed Rule on Agricultural Water
• La FDA propone ampliar la fecha de cumplimiento de los requisitos de agua de uso agrícola utilizada antes de la cosecha

Program Details

The Food Safety Certification for Specialty Crops Program (FSCSC) will assist specialty crop operations that incurred eligible on-farm food safety certification and related expenses related to obtaining or renewing a food safety certification in calendar years 2022 and 2023. For each year, FSCSC covers a percentage of the specialty crop operation’s cost of obtaining or renewing their certification, as well as a portion of their related expenses.

To be eligible for FSCSC, the applicant must be a specialty crop operation; meet the definition of a small business or very small business; and have paid eligible expenses related to the 2022 (issued on or after June 21, 2022) or 2023 certification.

Specialty crop operations may receive assistance for the following costs:

• 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

FSCSC payments are calculated separately for each category of eligible costs. A higher payment rate has been set for socially disadvantaged, limited resource, beginning and veteran farmers and ranchers. Details about the payment rates and limitations can be found at farmers.gov/food-safety.

Very small ($250,000) and small farms (less than 500,000) average monetary value of specialty crops sold during the 3-year period preceding the program are eligible.

Applying for Assistance

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. 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.

Producers can visit farmers.gov/food-safety for additional program details, eligibility information and forms needed to apply.

The FDA recently released the long-anticipated proposed changes to the agricultural water requirements (Subpart E) of the Produce Safety Rule. On Thursday, December 16 at 3:00 pm ET, join United Fresh, PMA, Georgia Fruit and Vegetable Growers Association, Northwest Horticultural Council and Western Growers for a timely webinar covering what FDA has proposed and where FDA is seeking public comment (due April 5).

To learn more about the proposed changes and the process of public comment sign up for the webinar: Webinar Registration – Zoom

Subpart E of the Food Safety Modernization Act Produce Safety Rule has been under review for some time.  On December 6, 2021, FDA published in the Federal Register the proposed final rule.  There is a 120-day comment period which ends April 5, 2022.  Once the FDA reviews comments and publishes the final rule it will go into effect 60 days later.  The proposed rule applies to anyone who produces fresh fruits or vegetables and sales over $25,000 annually.

Federal Register:  https://www.federalregister.gov/documents/2021/12/06/2021-26127/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-relating.  The proposed rule is 35 pages – 69120 to 69155 (small print).  The actual proposed rule starts on page 69130.

The current agricultural water compliance dates are set to begin in January 2022, but

FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts) while proposing to extend the compliance dates for ALL Subpart E provisions.  More information about the proposed compliance dates will be announced in the Federal Register and we will publicize those dates when announced.

FDA is looking for comments that are thoughtful and substantive, containing real life examples and solutions will assist them in creating a document that better suits the needs of fresh produce farmers across the country.

The On-Farm Food Safety Team has started to review the proposed rule.  We will be sending out more information with areas where you may want to comment in the next few weeks.

Following are the instructions for making comments:

Proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: https://public-inspection.federalregister.gov/2021-26127.pdf

Submit electronic comments in the following way:

Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)

Mail/Hand Delivery/Courier (for written/paper submissions):
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2021-N-0471 for “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at Dockets Management Staff between 9 a.m. and 4 p.m. Eastern Time, Monday through Friday, 240-402-7500.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Join us on October 7th from 4-6pm at the Rutgers Agricultural Research and Extension Center, 121 Northville Rd., Bridgeton, NJ 08302) for a hands-on grower meeting that will cover: how to assess washing and packing equipment; differences of sanitization products; and how to monitor pH and sanitizer concentrations.  We will be demonstrating a new packing line obtained through a grant from NJDA and the Food and Drug Administration.

The program is free, but please register by October 4^th at http://rutgersonfarmfoodsafety.eventbrite.com.  Ten people must register to hold this event.  As per Rutgers policy, masks will be required during the entire meeting since it is inside.  If you do not have a mask, one will be provided, and hand sanitizers will be available.

The Produce Safety Rule under the Food Safety Modernization Act is now fully implemented.  This means that one person from an operation who sells over $25,000 in fresh produce needs to attend a training course.  There are some exemptions and modifications to the rule, but the best way to find out is to attend the course.  We will have the next online training September 15 and 16 if 10 people register by September 1.  The preregistration is required since training material must be sent to each participant prior to the training.  Visit our website to register.

Produce Safety Training:

The Produce Safety Alliance Grower Training Course is one way to satisfy the FSMA Produce Safety Rule requirement outlined in § 112.22(c) that 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 the standardized curriculum recognized as adequate by the Food and Drug Administration’.  This is the only training recognized by the FDA at this time!

Fruit and vegetables growers and others interested in learning about produce safety, the Food Safety Modernization Act (FSMA) Produce Safety Rule, Good Agricultural Practices (GAPs) and co-management of natural resources and food safety should also attend this training.

What to Expect at the PSA Grower Training Course?

This is approximately a seven-hour course to cover these seven modules:

• Introduction to Produce Safety
• Worker Health, Hygiene, and Training
• Soil Amendments
• Wildlife, Domesticated Animals, and Land Use
• Agricultural Water (Part I: Production Water; Part II: Postharvest Water)
• Postharvest Handling and Sanitation
• How to Develop a Farm Food Safety Plan

In addition to learning about produce safety best practices, parts of the FSMA Produce Safety Rule requirements are outlined within each module and are included in the grower manual provided.  There is time for questions and discussion, so participants are encouraged to share their experiences and produce safety questions.

Benefits of Attending the Course

The course provides a foundation of Good Agricultural Practices (GAPs) and co-management information, FSMA Produce Safety Rule requirements, and details on how to develop a farm food safety plan.  Individuals who participate in this course are expected to gain a basic understanding of:

• Microorganisms relevant to produce safety and where they may be found on the farm
• How to identify microbial risks, practices that reduce risks, and how to begin implementing produce safety practices on the farm
• Parts of a farm food safety plan and how to begin writing one
• Requirements in the FSMA Produce Safety Rule and how to meet them.

After attending the entire course, participants will be eligible to receive a certificate from the Association of Food and Drug Officials (AFDO) that verifies they have completed the training course.  To receive an AFDO certificate, a participant must be present for the entire training and submit the appropriate paperwork to the trainers at the end of the course.

Inspections:

The New Jersey Department of Agriculture (NJDA) began inspections for the U.S. Food and Drug Administration (FDA) for operations over $500,000.  The other size operations will also be delayed by one year i.e. 2020 for small operations and 2021 for very small operations.  The first inspections will be educational with the NJDA evaluating the farming operation.  This will give the grower an opportunity to see what the NJDA considers area where improvement may be needed.  After the inspection NJDA may do another inspection with possible enforcement in the future.