February 11, 2015
On February 10, 2015, the Food and Drug Administration (FDA) held a public listening session on the recently released Draft Environmental Impact Statement (DEIS) for the proposed Food Safety Modernization Act rule for produce safety (Produce Rule). NSAC presented comments at the session.
Background on the Environmental Review Process
When FDA originally issued the proposed Produce Rule in January 2013, the agency had determined that it did not need to do an environmental impact analysis. FDA later announced that it would conduct an EIS for the Produce Rule after all, having determined that the rule was likely to have a significant impact on the environment. NSAC, along with several other organizations, advocated for a full environmental analysis from the outset, given the very real and significant impacts the proposed rule will have on our natural resources and public health, and we were encouraged by FDA’s decision to reconsider the earlier no-impact determination.
The DEIS is a 500-page document that sets out to analyze the various environmental impacts – individually and cumulatively – that the Produce Rule could have on water, air, soil, public health, and other socioeconomic impacts. The DEIS focuses on the potential impacts of four specific provisions in the proposed rule: (1) the microbial standard for agricultural water; (2) the minimum application intervals for biological soil amendments of animal origin; (3) measures related to wild and domesticated animals; and (4) the scope of proposed rule and implications to land use and land management.
Findings and Implications for the Final Produce Rule
The DEIS found that the Produce Rule could have a significant adverse impact on groundwater quantity, but that all other potential impacts from the proposed rule were not significant. The public has until March 13 to comment on the DEIS. Then, FDA must consider all comments received as it finalizes the EIS and ultimately the produce safety rule.
The purpose of this environmental review process is to provide FDA with the necessary information to consider regarding any potential environmental impacts of the Produce Rule and provide the public with an opportunity to weigh in on the decision-making process, all before the rules are finalized.
Given that the DEIS wasn’t released until after the comment periods had closed on the Produce Rule, there is legitimate concern that FDA will not properly integrate the findings of the EIS with the final rule, or do the necessary, thorough analysis of national, state, and local impacts given the short timeline the agency is facing. FDA is under a court-imposed deadline to finalize the Produce Rule by October 31, 2015. The final EIS is likely to be completed at the same time the Produce Rule is finalized, though FDA hopes to issue the final EIS in September.
NSAC’s Key Concerns
At this initial stage of analysis, our key concerns include:
NSAC previously submitted comments on the scope of the EIS and will be submitting comprehensive written comments to the docket upon a full analysis of the DEIS.
You can find more information on the DEIS, and download full document, on FDA’s website.
To learn more about issues in the FSMA rules, visit NSAC’s FSMA page.
Categories: Food Safety