Today NSAC submitted supplemental comments on the scope of the Environmental Impact Statement (EIS) that the Food and Drug Administration (FDA) will undertake in conjunction with the Food Safety Modernization Act (FSMA) proposed rule for produce safety.  FDA requested comments on the range of impacts and alternatives that it should consider in the EIS.

When FDA originally issued the proposed rule for produce safety in January 2013, the agency decided it did not need to do an environmental impact analysis.  FDA later announced that it would conduct an EIS for the produce safety rule afterall, having determined that the rule was likely to have a significant impact on the environment.  NSAC has 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 are encouraged by FDA’s decision to reconsider the earlier no-impact determination.

Extensions and Re-proposals

NSAC submitted comments at the close of the initial scoping notice comment period in November 2013, which coincided with the comment deadlines for the proposed produce safety and the proposed preventive controls regulations.  The scoping notice comment period was later extended until today.

In the midst of this, FDA also announced that it would be re-proposing several important components of the produce safety standards.  This cast some confusion on the ability to constructively comment on the scope of the EIS, given that certain key standards within the proposed rule would be revised and the environmental impacts would also change accordingly.

FDA has provided some clarity on this point in the extension notice and at a public meeting, indicating that the range of alternatives it is seeking comment on for the draft EIS will likely encompass any revisions to the produce safety standards that FDA will re-propose this summer.  These include the microbial standard for agricultural water, the application intervals for biological soil amendments such as manure and compost, practices around animal grazing and intrusion, and the scope of the proposed rule.

NSAC’s supplemental comments to the scoping notice not only provide recommendations for additional direct, indirect, and cumulative impacts that FDA should address in the EIS, but also provide specific comments relating to the alternatives FDA proposes for the four standards above.

Next Steps

FDA will consider all public comments received through the scoping process in crafting the draft EIS.  FDA has said that the start of the public comment period for the draft EIS will occur after the revised sections of the rules are released for additional public comment this summer.  It is unclear at this time whether the public comment periods on the draft EIS and the re-proposal will coincide.  FDA expects to finalize the EIS at the same time as it releases the finalized produce safety regulations.