January 27, 2014

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852

Re: Proposed Rule for Foreign Supplier Verification Program of FSMA  

Federal Docket: FDA-2011-N-0143

Pennsylvania Farm Bureau (PFB) is pleased to offer its perspectives on imported produce safety through the following comments on the Food Safety Modernization Act (FSMA) Proposed Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

PFB is a general farm organization, made up of more than 58,000 members, providing legislative support, information, and services to Pennsylvania's farmers and rural families since 1950. Our organization includes 54 local organizations (county Farm Bureaus) that actively operate in 64 of Pennsylvania’s 67 counties. PFB is the state affiliate of the American Farm Bureau Federation (AFBF), an organization representing more than six million member families throughout the United States. In addition to the comments we are offering today, we want to affirm our support of comments to be filed by AFBF on this topic, and would request that AFBF’s comments be treated as part of the comments contained herein.

General Comments  

PFB’s members are keenly aware and involved in voluntary promotion of sound food safety practices, and appreciate the opportunity to provide input on how food safety is regulated. We believe that although the U.S. food production system is among the best in the world, efforts to feasibly improve the quality and safety or food production are important and worthwhile.

PFB recognizes that food systems, due to their biological nature, will never be risk free. But even as the food safety environment has encountered increasing levels of change, in large part due to changes in Americans’ dietary habits and choices, foodborne illness statistics have improved. The U.S. now imports food from more than 150 different countries through more than 300 ports of entry. About half of the fresh fruits eaten in America are grown outside of the country, and these imports allow consumers to enjoy their favorite produce year-round. Exports and imports of food products allows for a more varied and customized diet suited to today’s consumer preferences. International trade of food products gives our farmers and other food producers the opportunity to sell their goods abroad—but it also creates challenges for the Food & Drug Administration (FDA) to ensure that the safety of food products moving interstate and internationally meets reasonable health and safety standards that US consumers have grown to expect.

It is critical when promulgating FSVP requirements to ensure that the importers’ foreign suppliers are producing in compliance with processes and procedures that provide at least the same level of public health protection as those processes and procedures required of domestic suppliers. The rules on domestically produced items must be applied in the same manner as rules on imported items covered under the FSVP rules. If this is not achieved, the FSMA rules could be considered as constituting a trade barrier that may then be open to a World Trade Organization (WTO) challenge.

We also point out the necessity for FDA to have adequate resources to implement this rule. FDA must have sufficient personnel and systems in place to inspect importers and ensure that those importers have and implement strong supplier verification programs. Without robust enforcement, the content of both the produce safety rule and the FSVP which extends those standards to imported produce are meaningless from a food safety perspective.

1. FDA should allow for a second comment period on the proposed rule following its review of the initial round of comments, in order to allow stakeholders the opportunity to comment on the inevitable changes that will be made to the rule to reflect the initial comments received.  

The scope and complexity of issues that FDA is attempting to address through its proposed food safety regulations are, by their very nature, extremely challenging for this agency to understand and appreciate the effects and unintended consequences to farmers and others engaged in food production in merely one round of public review. The likelihood that the comments received will be sufficiently substantive as to require significant changes to the rule leads PFB to believe that another comment period will be needed to further evaluate those changes. Without an additional comment period to respond to any changes, farmers may find the solutions so difficult to understand as to render them completely unworkable.

Given the complexity of the proposed rules, the current process of responding to comments on this draft rule with a final rule as the next step does not allow FDA to craft a sound and operable food safety program. An interim step, such as a second draft rule or interim final rule, is needed to work through the regulatory process with adequate stakeholder input.

FDA is creating regulations governing the future of the domestic and imported food supply, and even with all due deliberation, mistakes and unintended consequences are likely. It is in the best interest of everyone – regulators, growers, and consumers alike – to keep those mistakes at a minimum. Given the complexity of the proposed rules, the current process of responding to comments on the initial draft produce safety rule with a final rule as the next step does not allow FDA to craft a sound and operable food safety regulatory framework for domestic producers or imported produce. An interim step, such as a second draft rule or interim final rule, is needed to work through the regulatory process with adequate stakeholder input.

We remain concerned about the manner in which several proposed rules overlap have been published. We encourage FDA to release a second draft of the combined produce safety, preventive controls for human food and animal feed, foreign supplier verification program and third-party audit certification rules, to allow for sufficient review as to how all the rules are intended to work together. Because all five rules contain overlapping provisions that together affect our members both directly and indirectly, it is critical that they be evaluated in context as a complete package. If the rules are re-issued as a combined rule, all should be published simultaneously with concurrent comment periods and the second comment periods for each of these rules should also be aligned. This strategy would help ensure the success of each individual rule and FSMA as a whole.

2. Foreign and domestic producers should be subject to the same level of regulation under the proposed rule.  

Increased federal standards will place United States producers at a competitive disadvantage with foreign producers if the same standards are not aggressively enforced on imports. The same standards and exemptions for domestic produce must also be extended to imported produce in order to comply with WTO rules.

The proposed regulatory exception based solely on size for growers with farm sales of $25,000 per year or less in the produce safety rule would be particularly relevant when applied to foreign suppliers. While we believe that few, if any, domestic growers would qualify for this exemption, its consequences for imports are dramatic.

The amount of farm production required to reach the equivalent of $25,000 (U.S.) is vastly different in numerous foreign countries, many of which are serious produce exporters to the United States. In its comments, AFBF cited the example of Chinese apple production, which leads the world, but is the product of many small farms, several of which make less than $25,000 (U.S.) per year. Under the small farm exemptions in the proposed rule, the vast majority of apples imported from China would be exempt from the proposed rule, putting United States producers at a significant competitive disadvantage in their own domestic markets, creating a widely divergent and unpredictable level of food safety regulation for United States consumers. In many cases, inclusion of this exemption in its current form will mislead the consuming public on the actual degree to which imported food products have been subjected to the regulations’ food safety protocols.

At the same time, we have concerns about the treatment of very small importers (as defined in § 1.500) and very small foreign suppliers (as defined in § 1.512). As proposed in § 1.512, modified FSVP requirements would only mandate written assurance of compliance rather than hazard-analysis and verification. FDA already estimates that 59 percent of processed food suppliers and 93 percent of raw produce suppliers would fall under this category, which would leave a large amount of imported foods outside the program.

3. The proposed rule must promote compliance with international trade protocols.  

FDA’s supplier verification regulations must conform with international standards and agreements. Section 404 of FSMA states that the provisions of FSMA are not to be construed in a manner inconsistent with U.S. international obligations. As a WTO member, the United States is to act consistently with its WTO obligations, including those contained in the Agreement on the Application of Sanitary and Phytosanitary Measures.

PFB generally agrees with FDA’s position, as explained in the preamble of the proposed FSVP rule, that the agency is obligated to take a parallel approach to domestic supplier verification within its preventive controls regulations to enhance compliance with WTO obligations and ensure trade access. Importantly, the United States is the world’s largest economy and the largest exporter and importer of goods and services. Trade is critical to our country’s prosperity. United States food and agricultural exports reached an all-time high in 2012 at more than $145 billion, and supported an estimated 923 thousand jobs on and off the farm.

Therefore, FDA should take a cautious and balanced approach when implementing the requirements associated with foreign supplier verification, recognizing such requirements have potential trade implications and that obligations placed on foreign suppliers also will be imposed in a parallel manner on domestic suppliers. Such requirements must be flexible in application and commensurate with both the risk associated with the food or feed product and the supplier itself so as to avoid unnecessary and burdensome costs.


Pennsylvania Farm Bureau is committed to improving produce safety in a targeted, scientific, and risk-based manner, and its members look forward to continuing our working partnership with FDA to promote food safety.


Grant Gulibon
Director, Regulatory Affairs