The U.S. Food and Drug Administration (FDA) announced Monday that it will hold a public meeting on April 4 in College Park, MD, to discuss the scope of the Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption (“Produce Safety Proposed Rule”). FDA also said it is extending the public scoping period for the EIS to April 18.

On August 19, 2013, FDA announced its intent to prepare an EIS to evaluate the potential environmental effects of the Produce Safety Proposed Rule and also announced the beginning of the scoping process. During the scoping process, FDA solicits public comments to identify issues to be analyzed in the EIS, a draft of which the agency expects to release later this year for public input prior to preparing a final EIS. The public scoping period for the EIS was first scheduled to end November 15, 2013, was later extended to March 15, 2014, and is being extended again to incorporate input from the April 4 public meeting.

FDA announced on December 19, 2013, that it intends to revise certain provisions of the Produce Safety Proposed Rule and publish the revisions for public comment by early summer 2014. FDA officials said the EIS process is required under the National Environmental Policy Act (NEPA) and is distinct from, and in addition to, the process that FDA has announced to revise parts of the proposed rule and seek comment on the revisions.

The scope of the EIS includes consideration of alternatives to a range of actions. To facilitate public input during the scoping process, FDA is identifying a number of issues and a range of potential alternatives to be considered in the EIS. Alternatives have been identified in areas where potential environmental impacts are likely. Agency officials said they anticipate that these alternatives would likely incorporate any significant issues resulting from revisions to the Produce Safety Proposed Rule or any Produce Safety final rule.

Alternatives have been identified for the following key provisions: (1) microbial standard for agricultural water used during growing activities for covered produce (other than sprouts) using a direct water application method, (2) minimum application intervals for biological soil amendments of animal origin, (3) measures related to animal grazing and animal intrusion, and (4) scope of proposed rule and implications to land use and land management. FDA is inviting comment on whether there are other issues it should consider for in-depth analysis in the EIS and any alternatives related to these issues.

Comments may be submitted electronically via Regulations.gov using docket number FDA-2011-N-0921, or by mail (using that same docket number and including the name of the submitting organization) to the following address:

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

For more information, see:

• FSMA Public Meeting: Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• Federal Register Notice: Environmental Impact Statement for the Proposed Rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Public Meeting on Scoping of Environmental Impact Statement and Extension of Comment Period