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:

• Data limitations: There are many instances throughout the DEIS where the agency acknowledges a lack of data necessary to fully assess any impacts. We recognize that data limitations are a significant problem — a problem that has plagued numerous aspects of the FSMA rulemaking. However, the agency must take a hard look at the impacts, and perform the best analysis it can, with the best available data. Thus, the agency must do a careful, thorough search for all available data. If the data are not there, the agency must make its best, most reasoned estimates of impacts. The agency cannot simply choose not to consider important impacts just because the data is hard to locate or incomplete.
• Cumulative impacts: In the EIS, FDA must consider the cumulative impacts of the rule together with other reasonably foreseeable impacts beyond the rule itself. This should include not only a consideration of the impacts of the Produce Rule in tandem with the rest of the FSMA rules, but also a consideration of the impacts associated with farms – particularly small farms – that choose to stop growing covered produce, and the associated impacts on the economy and access to fresh fruits and vegetables. We have consistently urged the agency to clearly identify and articulate the extent to which farms may be subject to multiple rules, without result, and the agency’s failure to meaningfully discuss this scenario in the DEIS continues this troubling trend.
• Reliance on other laws, regulations, or voluntary compliance programs to mitigate the environmental impacts of the rule. It is well settled that agencies cannot rely on compliance with another agency’s requirements in an EIS. This issue is particularly concerning where the agency defers to compliance with voluntary programs like NRCS conservation programs or USDA GAPs to address potential environmental impacts.

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.