Testimony of Pew Expert Sandra Eskin on the Supplemental FSMA Proposal for Processed Foods

On Nov. 13, Pew’s food safety director, Sandra Eskin, delivered testimony before the U.S. Food and Drug Administration on the FDA Food Safety Modernization Act’s supplemental proposal for processed foods.

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

My comments this morning and later this afternoon on the supplemental FSMA proposals are focused on addressing a fundamental question:  Do these proposals adequately protect public health; do they maximize public health and minimize undue burdens on food producers, in particular smaller operations?  

While we have not yet completed our analysis and research for our written comments, we want to take this opportunity to address three issues.  First, we support the proposed codified language that addresses testing, and we view this change from FDA’s original proposal as providing significantly more public health protection. We understand that there are some concerns that the proposed language is very general, but given that the factors to be considered in determining whether, when, and how to test product are facility specific, the language of the regulations must, by necessity, be generic.  This is an issue where very specific companion guidance documents are absolutely essential: These documents will provide companies with detailed examples to help them put in place appropriate testing regimes.

By contrast, we are concerned about two changes that FDA has proposed in the supplemental notice that relate to the modified exemption for qualified facilities   First, FSMA provides fortwo options for facilities to use in order to qualify for modified safety requirements: (1) “very small businesses” and (2) businesses that meet specific geographic and sales limitations and sell only to limited “end-users” (retailers and restaurants).  FDA’s tentative decision in the supplemental proposal to define a “very small business” as one with less than $1,000,000 in annual sales conflicts with, and essentially nullifies, the other type of facility (option 2), which must have an annual sales limit of $500,000.  We are concerned that this proposed definition of very small business upsets the delicate balance struck by legislators when they created this exemption provision: they wanted to minimize the regulatory burden on small operations and, at the same time, minimize any resulting harm to public health. If FDA sets the sales volume for a very small business at more than $500,000, then no processors would try to qualify under option #2.   We question whether this could have been Congress’s intent.

If FDA’s proposed definition of a very small business is codified and, as a result, fewer food processers are subject to FSMA’s prevention-based requirements, then we are worried that significantly more contaminated food products would be sold to consumers, and more people will get sick.  This is an unacceptable increase in the risk to the public’s health. 

Second, we are concerns the agency’s proposal to allow for reinstatement of the qualified exemption when it has been revoked.  We support FDA’s tentative decision to provide some basic due process protections before withdrawing an exemption, but we believe that the agency should not provide for reinstatement, when this option has not been provided by the underlying law.  We fear that, by creating a right to reinstatement, FDA will encourage food processors that initially qualify for the exemption to sell contaminated products, knowing that they will be able to quickly fix a problem and regain an exemption. If reinstatement is allowed, then it is likely that more contaminated food products would be sold and the risk that consumers will contract a foodborne illness will increase. This result would undercut the central goal of the FDA Food Safety Modernization Act.