f _(# U.S. FOOD & DRUG ,,,.-... 11 

~,-:if ADMINISTRATION 

February 7, 2019 

Dear State Agriculture Commissioners, Secretaries, and Directors: 

As I have done periodically, I want to provide you, our regulatory partners, with an update on 

work to implement the Produce Safety Rule mandated by the FDA Food Safety Modernization 

Act (FSMA). 

When I attended the National Association of State Departments of Agriculture (NASDA) 

conference in 2017, I announced that routine inspections associated with the Produce Safety Rule 

would begin in spring of 2019 for the largest produce farms (other than sprouts operations, which 

have requirements specific to them). Routine inspections of small farms (other than sprouts 

operations), for which the compliance date arrived January 28, 2019, will begin in spring 2020. 

This timeline was intended to ensure that produce farmers had the tools needed to help them 

comply with the new rule requirements. Routine Produce Safety Rule inspections will also begin 

this year for large farms in countries that export produce to the United States, and FDA intends 

to begin routine inspections of produce importers under FSMA’s Foreign Supplier Verification 

Programs rule in fall 2019. 

I am grateful for my dedicated colleagues at FDA who have continued to work to ensure that we 

are able to maintain our plans to initiate inspections this spring, and I’m grateful to NASDA and 

individual states for your work to prepare for this critical new phase in our regulation of produce 

farms. 

Below, please find an update on some of the remaining deliverables we have been working on to 

support a successful initiation of inspections. 

IMPLEMENTATION PREPAREDNESS 

• Training 

There has been significant progress in training farmers around the world who must comply 

with the Produce Safety Rule. Training currently is provided by the Produce Safety Alliance 

(PSA) domestically and the Produce International Partnership for Education and Outreach 

(PIP) internationally. PIP is a collaboration between the Joint Institute for Food Safety and 

Applied Nutrition (JIFSAN) and PSA. PIP is charged with implementing the international 

outreach strategy for the Produce Safety Rule with materials that consider cultural, 

technological, and language differences and needs. 

Through PSA and PIP, 1,359 grower training courses have been conducted domestically and 

internationally; more than 31,000 farmers have been trained as of mid-December. Seventyseven domestic and international train-the-trainer courses have been held, with almost 2,500 

U.S. Food & Drug Administration 

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trainers trained. Internationally, 688 trainers and lead trainers have been trained in 32 

countries. In 2018, training was provided to countries in Latin America designated as 

priorities for produce training. International grower and train-the-trainer courses are being 

planned for 2019. 

For our regulators, we continue to provide training to our staff and our state partners who 

will be performing farm inspections. We have conducted eight regulator training courses 

since August 2017, training 177 state personnel on produce inspections since then. 

Additional courses are planned this year, including one that was held January 29 to February 

1 in California. 

FDA has worked with NASDA and other stakeholders to enhance the regulator training, and 

we are updating the course continually in response to participants’ comments and to 

incorporate new materials developed through the FDA/NASDA cooperative agreement. For 

the regulators who have already attended the course, we are planning a webinar to provide 

them with the updated materials; this webinar is being planned for February. We have also 

provided training for the state extension partners so that they have a basic understanding of 

produce farm inspections. 

• On-Farm Readiness Review (OFRR) Visits 

FDA has been working closely with NASDA in its development of the OFRR program. 

Through these efforts, more than 350 farms have already had a voluntary OFRR evaluation. 

I had the opportunity to visit a farm in Oregon some months ago to get a firsthand 

understanding of how OFRRs can be a powerful tool in preparing for future inspections. 

NASDA continues to train our state partners to make more personnel available to do the 

OFRRs in the future, and we will continue to provide our support to make OFRRs an 

available tool for farmers even as routine inspections begin for the largest farms (other than 

sprouts operations). 

• Produce Guidance 

We published the Draft Compliance and Implementation Guidance1 for the Produce Safety 

Rule in October 2018, along with fact sheets highlighting key information in each chapter. 

This draft guidance has been a long time in the making, and we appreciate the assistance 

NASDA has provided during the guidance development. We have conducted four public 

meetings to discuss the draft guidance with stakeholders. 

When finalized, the draft guidance will contain non-binding recommendations that provide a 

means for us to explain our current thinking on implementation. It provides examples, 

clarification, and information to help farms develop their own practices because the Produce 

Safety Rule generally includes enough flexibility for farmers to implement the requirements 

in a way that best fits their operation. We don’t try to describe every possible scenario or 

solution; there may be several different approaches that all result in compliance. 

1 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm606284.htm 
 

 

 

 

 

 

 

 

 

 

 

 

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Our target audience includes those engaged with implementation on a farm, including the 

owner, operator agent, and farm management personnel. It also includes organizations that 

assist farms with implementation, such as extension service, trade associations, and 

academia. The draft guidance, when finalized, will also be useful to the federal and state 

inspection staff as they help farmers achieve compliance. 

• Creating Specialized Documents 

FDA and NASDA have worked to explore new ways of ensuring objectivity and consistency 

for produce inspections as well as ways to handle disagreements between regulatory agencies 

conducting produce inspections. As I indicated in my last letter, FDA and NASDA have 

made major progress on two new documents that will support produce inspections, and these 

documents are now finalized and publicly available. 

The first document is the form FDA 40562, “Produce Farm Inspection Observations.” This 

form represents a new way of providing feedback to farms and documenting observations 

that is different from FDA’s traditional process of reporting inspection observations made 

during an inspection, which has traditionally been through the FDA 483 Inspectional 

Observations Form. The new form (FDA 4056) is designed around the specific provisions in 

the Produce Safety Rule and was developed to help farmers better understand what is being 

examined in an inspection. FDA will issue the new 4056 form at the end of every farm 

inspection, whether or not any non-compliance issues were identified. When observations 

are noted during an inspection, the format of the FDA 4056 will help farmers understand 

what is being examined in an inspection and how any observation relates to the regulation. 

We are working with states to promote consistency across the produce program through use 

of the new form. 

As you know, last summer we also reached agreement on the Dispute Mitigation and 

Resolution Procedures. While we hope and anticipate that such instances will be rare, we 

understand the importance of having processes in place to prevent any differences of 

interpretation and to quickly resolve any disagreements between agencies with produce 

safety regulatory authority. FDA has now incorporated the finalized Dispute Mitigation and 

Resolution Procedures into Field Management Directive 1523

, and we are ensuring that our 

investigators are aware of these new procedures. 

FDA will also be rolling out a Regulator Technical Assistance Network (rTAN) to support 

produce safety inspections. This resource, available to FDA investigators and state 

inspectors, will be available to provide timely technical assistance from subject matter 

experts at the Agency before or during inspections. We will be providing more information 

on this to our state partners in the near future. 

• Produce Inspections Web Page 

2 https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM630765.pdf 

3 https://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM630608.pdf 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

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We recognize that keeping track of the many produce-related resources can be a challenge, 

so we’ve created a new Produce Inspections web page4 at fda.gov. We hope it will be a 

useful, central location for our stakeholders and state partners to find resources as they make 

their final preparations for the start of routine inspections this spring. 

RULEMAKING-RELATED UPDATES 

• Agricultural Water 

We are working to ensure that the standards for agricultural water in the Produce Safety Rule 

are feasible and effective for all sizes and types of produce farms. We have proposed to 

extend the compliance dates for these standards (for produce other than sprouts), and we 

continue to exercise enforcement discretion as we consider how to move forward. 

As we work on how best to achieve public health protections related to agricultural water 

used on covered produce, we are also mindful of recent produce-associated outbreaks. FDA 

considers that the most likely way romaine lettuce became contaminated with E. coli 

O157:H7 during an outbreak in the spring of 2018 was from the use of water from an 

irrigation canal. This was the largest multistate outbreak of E. coli O157 infections in the 

United States since 2006, leaving hundreds sick and claiming the lives of five people who 

consumed contaminated romaine lettuce. 

FDA is working with stakeholders, including growers, processors, irrigation districts, and 

state and local regulatory partners, to better understand potential sources and routes of 

contamination, and to prevent outbreaks like this one from happening again. For example, 

the Agency has been collecting romaine lettuce samples at commercial coolers in the Yuma, 

Arizona, growing region, which service growers in both Arizona and the Imperial Valley in 

California, and analyzing them for the presence of Salmonella and pathogenic E. coli. FDA 

chose to collect samples at leafy greens coolers because we can efficiently collect samples 

from multiple farms at one location while maintaining the identity of the farm that 

corresponds to each sample. 

The Agency is also working with stakeholders to develop and implement a multi-year study 

in the Yuma County and Imperial County growing regions to better understand the presence 

of pathogens, especially E. coli O157:H7, in the growing environment. 

Knowing where produce was grown and when it was harvested will play an important role in 

helping retail establishments and consumers avoid contaminated products and facilitating 

market withdrawals and tracebacks. Thus, we have engaged with the leafy greens industry to 

implement voluntary labeling to improve FDA’s ability to provide, and retail and consumers’ 

ability to use, targeted information about product origin in the event of future outbreaks. 

And we are strongly encouraging the entire leafy greens supply chain to adopt traceability 

best practices and state-of-the-art technology to ensure rapid access to key data when leafy 

greens are involved in a potential recall or outbreak. 

4 https://www.fda.gov/ICECI/Inspections/UCM627767.htm 
 

 

 

 

 

 

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Outbreaks related to fresh produce reinforce the importance of the work we are doing 

together to enhance the safety of all fresh fruits and vegetables through science, technology, 

and the Produce Safety Rule. 

NEW LEADERSHIP AT FDA 

Dr. Stephen Ostroff, our Deputy Commissioner for Foods and Veterinary Medicine since May 

2016, has retired after a distinguished and dedicated career in public service, including more than 

5 years of exceptional service at FDA. I am immensely grateful for his dedication to FDA’s 

public health initiatives and our vital consumer mission. 

Frank Yiannas, a renowned food safety and supply chain expert, has joined FDA as Deputy 

Commissioner for Food Policy and Response. Throughout his private sector career, he’s been a 

food safety champion and instrumental in forging public-private collaborations to advance public 

health. I welcome Frank to our Foods Team, and I know that he will be an invaluable partner in 

continuing our work with NASDA to ensure the safety of the American food supply. 

Sincerely, 

Scott Gottlieb, M.D. 

Commissioner of Food and Drugs