Earlier in June (June 12), I sent the Food and Drug Administration press office a few questions related to coverage I was planning for a food safety/traceability section for The Packer.

The responses to those questions hit my inbox June 26, a little late for the deadline. Still, I will share my questions and their responses.

Here they are:

Q Considering continuing outbreaks, is the FDA considering identifying a list of high-risk foods that may require more record-keeping provisions?

FDA: Yes, FDA is considering identifying a list of high-risk foods.  In 2014, we issued a federal register notice to solicit comments on our draft approach.  With the input we received from the comments, we have been working on finalizing the approach.  We have shared the approach and relevant data with peer reviewers and are in the process of incorporating their feedback.


Q  Any chance for simplified guidance on whether packing houses fall under the preventive controls or produce safety rules?

FDA A threshold question to determine whether an entity falls under the preventive controls or produce safety regulations is whether the entity is a “farm” as defined in the FDA’s registration regulation.  Feedback from regulated entities has raised complex questions about factors, such as farm-related activities and farm ownership, that impact the determination of whether an entity is a “farm.”  In addition, certain activities conducted on produce raw agricultural commodities are similar regardless of where they happen.

Therefore, in guidance we issued in January entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs,” we stated that we intend to initiate rulemaking that could change the applicability of the preventive controls and CGMP requirements to some entities that conduct farm-related activities.  That rule is under development and, when final, we expect it will clearly communicate the status of packing houses under the preventive controls and produce safety rules.  

Q  What has FDA learned about fresh produce industry compliance with the preventive controls rule so far this year? 

FDA: Preventive Controls for Human Food inspections have just begun recently, and therefore specifics regarding compliance are not yet available. The FDA is currently in the process of compiling and analyzing this information and will share this information once it is available.

Q Is there any progress on how the FDA may change the water requirement in the produce safety rule? 

FDA: Last September, we proposed to extend the compliance dates for Subpart E for covered produce other than sprouts. As we continue to work with stakeholders on issues raised regarding the agricultural water requirements, we do not intend to enforce the agricultural water provisions in subpart E of the produce safety regulation for covered produce other than sprouts. The proposed extension will give the agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country, while protecting public health. During this time, we will also be determining which mechanism we will use to address stakeholder concerns – whether that be through guidance, rulemaking, or a combination of the two. We continue to engage with stakeholders to learn more from farmers, state regulatory partners and others about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations.

Q.   (Asked June 12)   Is there a working theory behind the romaine E.coli outbreak that could explain what happened?

FDA: (June 26 reply)  We continue to explore multiple hypotheses, and further assess information collected during a recent investigation to the Yuma, AZ, growing region. In the foodborne illness outbreak context, an environmental assessment is an investigation that is triggered by an outbreak of foodborne illness or a food contamination incident to determine how the “environment” contributed to the introduction and transmission of pathogens or other hazards that caused illness or contamination. FDA considers it important to release environmental assessments it has conducted because they may be instructive to other stakeholders. Once the environmental assessment report is complete, we will post it publicly.


TK: This answer from FDA came before yesterday’s (June 28) announcement that CDC analysis of samples taken from canal water in the region has identified the presence of E. coli 0157:H7 with the same genetic fingerprint as the outbreak strain. The FDA has identified additional strains of Shiga-toxin producing E. coli in water and soil samples, but at this time, the samples from the canal water are the only matches to the outbreak strain, the agency said.

Providing that the suspected link with irrigation water is, in fact, the case, let’s hope the agency can find when, where and how the pathogen entered the water supply and what practical steps can be taken to prevent a repeat episode.

There is a recent question that I asked the USDA press office about what information, if any, is shared by the USDA with the FDA on Good Agricultural Practice audits conducted by USDA.

Does USDA share with FDA on the granular level about every audit they do? Or is there no communication at all?

From the USDA press office:

USDA: Regarding your question about data sharing:

USDA has a long-standing working relationship with FDA. Under memoranda of understanding with FDA, AMS agreed to provide aggregated information on deficiencies found in audits.

TK: That approach makes sense. The FDA may be able to learn from the accumulated results of the audits USDA perform. To give the industry equal footing, and the chance to course-correct, those aggregated results also should be made public to all interested parties.