Nov 13, 2015

Three more food safety rules finalized by FDA

FDA has published three final rules that are key components of the revised Food Safety Modernization Act. The rules are accessible through the online Federal Register links below.

The Produce Safety rule establishes science-based standards for growing, harvesting, packing, and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms.

The Foreign Supplier Verification Program rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards. In 2013, the U.S. Department of Agriculture estimated that imported food accounted for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans.

The Accredited Third Party Certification rule establishes a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.

The final rules build on the preventive controls rules the FDA finalized in September 2015, which mandate modern preventive practices in food processing and storage facilities. These rules work together to systematically strengthen the food safety system and better protect public health, FDA said.

FDA has now finalized five of the seven major rules that implement the core of FSMA. The remaining two rules on Sanitary Transportation and Intentional Adulteration are scheduled for release in spring 2016.

FDA also has released the Final Environmental Impact Statement (EIS) for the produce safety rule. The EIS places the produce safety rule in the context of its likely impact on the environment, including human health and socioeconomic effects.

The EIS evaluates the impact of the rule as originally proposed in January 2013 and as amended in a September 2014 supplemental proposal, in addition to alternative provisions. It focuses on four areas in the rule that could significantly affect the environment: the scope of the rule, water quality standards, the use of raw manure and compost, and provisions affecting domesticated and wild animals and considers the combined impacts of all the provisions that comprise the rule.

A significant beneficial impact on public health is expected due to the anticipated decrease in the number of illnesses tied to produce contamination, according to FDA. Only the water quality standards were found to potentially have a significant adverse environmental impact. As in the draft EIS, the final EIS notes that any produce regulation that causes a farmer to use ground water instead of surface water could exacerbate existing groundwater shortages, although added flexibility in the water provisions make such a management decision unlikely.

The FDA considered public comments submitted in response to the Draft EIS, published in January 2015, in drafting the final version. The agency then considered the findings of the Final EIS in finalizing the produce rule.

The agency is also required to prepare a public document, called the Record of Decision (ROD), to state FDA’s decision with respect to the provisions of the final rule. In the ROD, the agency explains how the provisions in the final rule best meet FDA’s public health goals while minimizing environmental impacts as much as possible.