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.

We continue to get questions about what signage is required for an audit or the Produce Safety Rule and where to get them.  Not all the signs listed below are, but handwashing and visitor signs need to be posted in English and in the language of the workers.  For example, if you have a mixture of Spanish and Creole speakers, you will need signs in three languages.

The signs and posters listed below are available at the following locations – Rutgers Cooperative Extension office in Cumberland County (291 Morton Ave., Millville Tel. 856-451-2800 x 1) or Rutgers Cooperative Extension office in Mercer County (1440 Parkside Ave., Ewing, NJ 08638 Tel. 609-989-6830). If you would like any of the signs, please call the office to schedule a pick-up.

Please Wash Your Hands Often! (8.5x11inches) – English, Spanish, Creole, Chinese, Greek, Polish, Portuguese, Russian and Vietnamese.

Please Put Used Toilet Paper in the Toilet (8.5×11 inches) – English and Spanish

Please Use Toilets Provided in the Field (8.5×11 inches) – English and Spanish

When Must Hands Be Washed (8.5×11 and 21.5×27.5 inches) – English and Spanish

Health and Safety Notice for Visitors (21.5×27.5 inches) – English and Spanish

Cleaning and Sanitizing Food Contact Surfaces (21.5×27.5 inches) – English and Spanish

Service Animals Covered by the ADA are Welcome Here (8.5×11 and 21.5×27.5 inches) – English and Spanish

Many of these signs can also be downloaded from our revised website onfarmfoodsafety.rutgers.edu starting July 1^st.

We have been watching as the state executive orders continue to roll out and how this impacts the agricultural community.  The two key take-aways for farms this season are:

1. Ensure that your customer capacity limits allow for 6′ of social distancing
2. Communicate to customers that masks will be required when indoors and when social distancing isn’t possible out of doors

Guidance documents have been updated on the following topics 
U-Pick Operation Guidelines under COVID-19
RCE Wholesale Grower Questions
Best Practices for Direct Market Sales
Complying with NJ Executive Orders – Pick Your Own

The Rutgers On-Farm Food Safety Team now has a COVID-19 Information For the Agricultural Industry webpage where these updated documents are housed, along with other COVID resources and vaccine information including printable posters in multiple languages.