Food Safety Expert Testimony: Sandra Eskin

Sandra Eskin

Sandra Eskin is the project director of the food safety campaign at The Pew Charitablre Trusts. The campaign seeks to reduce health risks from foodborne pathogens by strengthening federal government authority and the enforcement of food safety laws.

Before joining Pew, she spent nearly 20 years as a  legal and public-policy consultant to numerous consumer and public-interest Organizations during which she provided strategic and policy advice on a broad range of consumer protection issues, in particular, food and drug safety, labeling, and advertising.

Keeping Produce Safe: Sandra Eskin’s Testimony at the FDA Public Hearing on the Draft FSMA Rule for Produce, February 28, 2013

Good Morning, my name is Sandra Eskin, and I direct The Pew Charitable Trusts’ food safety campaign.  Pew applies a rigorous, analytical approach to improve public policy, inform the public, and stimulate civic life.

In the area of food safety, Pew partnered with many people in this auditorium to get the FDA Food Safety Modernization Act passed, and we are committed to working with FDA, the food industry, consumer advocates, and foodborne illness victims and their families, including those who spoke so movingly before me, to ensure that FSMA is faithfully implemented and enforced. All of the implementing regulations should be finalized as soon as possible – those for produce and processed food as well as for food imports and pet food.  All of these rules are interrelated and they need to be considered together. We hope that the Administration will release the delayed import and pet food proposals shortly.

The draft produce rule is a game changer – for the first time there will be mandatory, enforceable requirements aimed at minimizing the sources of produce contamination that make far too many Americans sick each year.  If steps are taken to prevent pathogens from tainting fresh fruits and vegetables, then illnesses will also be prevented.  

I will focus my testimony today on five issues. 

First, on the issue of agricultural water, we believe that EPA’s recreational water standard, while not perfect, is a reasonable place to start. 

Second, on the issue of testing, we will be working over the next few months to make the case for product and environmental testing in appropriate circumstances – not only for processed foods but also for produce.  We are glad that FDA is proposing testing requirements for sprouts, but we believe they might be appropriate in other situations as well in order to verify that the measures being taken to limit contamination are actually working.

Third, we believe that FDA should develop a flexible mechanism for updating its list of “covered” and “exempt” produce items.  By codifying this list in regulations, it will be next-to-impossible for the agency to respond rapidly to evolving contamination problems. FDA should consider identifying “covered” and “exempt” fruits and vegetables in a guidance document, rather than in a regulation; this approach would enable the agency to more easily and quickly revise this list.

Fourth, we will be closely analyzing the proposed exemptions to the produce safety standards to ensure that the right balance has been struck between minimizing the economic burdens on growers and maximizing the public health benefits. In particular, we are concerned that the potential for cross-contamination has not been factored into the decision to exempt agricultural commodities that are rarely consumed raw.

Finally, we hope that FDA will develop a plan for partnering with the states to ensure compliance with the produce standards along the lines of the Manufactured Food Regulatory Program it has developed for processing facilities.

Finally, I want to resurrect a suggestion that we and our coalition members made in our pre-proposal meetings and written comments. Since development of an effective food safety plan is the fundamental foundation for a preventive-control system, we ask FDA to reconsider its decision not to require any food facilities to submit their initial food safety plans. 

Keeping Processed Food Safe: Sandra Eskin’s Testimony at the FDA Public Hearing on the Draft FSMA Rule for Processed Foods, March 1, 2013 

Good Morning, my name is Sandra Eskin, and I direct The Pew Charitable Trusts’ food safety campaign. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and stimulate civic life. Through our food safety project, we seek to reduce health risks from foodborne pathogens by strengthening federal government authority and the enforcement of food safety laws.

We congratulate FDA for issuing this proposal on prevention-based requirements for processed foods. While the concept of preventing illnesses is common sense, FDA’s thoughtful and thorough draft rule demonstrates that prevention can also be science and risk-based. Once finalized and enforced, this draft proposal – along with the one on produce and the import and pet food proposals we are all anxious to see – will make the food supply safer and result in a reduction in foodborne illnesses, which, as we heard this morning, have had such a profound effect on so many American families.

This morning, I will highlight three aspects of this proposal.

First and foremost is the issue of testing. It is troubling that, while FSMA specifically mentions testing as a method for verifying the effectiveness of measures aimed at minimizing contamination, the draft regulations are silent on it – and fail to even include the word “testing.”

Testing plays a very important role in ensuring the safety of food:

• Testing raw materials and ingredients can verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients;
• Testing the plant environment can verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate ready-to-eat food; and
• Testing finished product can verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the food.

Second, we will be closely analyzing the proposed exemptions to the preventive controls requirements, including the exemption required under the Tester Amendment in FSMA to ensure that the exemptions as well as the modified requirements adequately protect public health.

Finally, I want to resurrect a suggestion that we and our coalition members made in our pre-proposal meetings and written comments. Since development of an effective food safety plan is the fundamental foundation for a preventive-control system, we ask FDA to reconsider its decision not to require any food facilities to submit their initial food safety plans. If the concern is that FDA will be overwhelmed by the sheer volume of documents, then it should consider requesting submission of a subset of plans (from, for example,  facilities producing high-risk products) or a representative sample of all plans, to provide, at the very least, a snapshot of how companies are interpreting FDA’s preventive control regulations. This process might identify some systemic problems related to food safety plans that FDA could correct relatively early in the implementation period.  Without some sort of plan review, it will take years – and many inspections, contamination incidents, illnesses, and recalls – before FDA is able to review and assess the effectiveness of a significant number of food safety plans.