Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety
The following information is dedicated to FDA’s Environmental Impact Statement (EIS) for the FSMA proposed rule entitled Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (here called the “Produce Safety Proposed Rule” or PS PR). FDA published this proposed rule in the Federal Register on Jan. 16, 2013 (“the 2013 proposed rule”), for codification in 21 CFR Part 112 (78 Fed. Reg. 3504). On March 20, 2013, FDA issued a notice to correct technical errors and errors in reference numbers cited in the 2013 proposed rule (78 Fed. Reg. 17155). Subsequent to the publication of the 2013 proposed rule, extensive information received in public comments led to significant changes in FDA’s thinking, As a result, on Sept. 29, 2014 FDA issued a supplemental notice of proposed rulemaking (“the supplemental proposed rule”), amending certain specific provisions of the 2013 proposed rule (79 Fed. Reg. 58434). Taken together, these publications constitute the PS PR.
This EIS is being developed in accordance with the National Environmental Policy Act (NEPA) of 1969, as amended; the regulations issued by the Council for Environmental Quality (CEQ), 40 CFR Parts 1500 - 1508; FDA’s Environmental Impact Considerations procedures under 21 CFR Part 25; and all other applicable laws. For more information on the development of this EIS, please visit the NEPA Process page of this website.
- Project Overview
- NEPA Process
- FDA Notices
- Public Involvement
- Draft Environmental Impact Statement (EIS)
- Contact Information
Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to estimates from the Centers for Disease Control and Prevention (CDC). Fruits and vegetables are a part of a healthy diet, but fresh produce may have microbial contamination that can cause foodborne illness. FDA’s analysis of available foodborne illness outbreak data from 1996 to 2010 documented 131 outbreaks associated with contaminated produce, causing more than 14,000 serious illnesses.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, gives FDA the ability to better protect public health by strengthening the food safety system. The law provides FDA the enforcement authority to prevent food safety problems rather than primarily reacting to problems after they occur. FDA has proposed seven foundational rules for stakeholders along the entire food supply chain to follow, designed to protect public health by promoting safe, sanitary standards to minimize or prevent food safety hazards.
FDA prepared a categorical exclusion that was published with the PS PR in January 2013. However, based on currently available information, including comments received from the public, and upon further analysis, FDA determined that an EIS is necessary to assess the environmental (including human) and related socioeconomic impacts of those provisions of the PS PR that may significantly affect the quality of the human environment (here referred to as “potentially significant provisions”), the determination of which was based on public and agency comments prior to and during the EIS scoping period, and alternatives to those provisions.
FDA held a scoping meeting that was open to the public on April 4, 2014. This meeting provided the public the opportunity to ask questions about and discuss issues relating to the scope of the EIS. The EIS scoping period ended on April 18, 2014.
On January 12, 2015, FDA made public its Draft EIS for the proposed Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. On January 12, 2015 FDA published the Notice of Availability (NOA) for the Draft EIS to be published in the Federal Register, which begins a 60-day public comment period that will end on approximately March 10, 2015. Please see FR notice for official closing date.
FDA is hosting a public meeting on the Draft EIS on February 10, 2015 from 1 p.m. to 4 p.m. at the Wiley Auditorium, Harvey W. Wiley Federal Bldg., 5100 Paint Branch Pkwy., College Park, MD 20740. The public is asked to submit comments to FDA’s Division of Dockets Management at http://www.regulations.gov.
On Jan. 4, 2013, FDA released for public comment its proposed Standards for Growing, Harvesting, Packing, and Holding Produce for Human Consumption. This is one of five proposed rules that would lay the cornerstone of a prevention-based, modern food safety system. FDA published the Produce Safety Proposed Rule (PS PR) in the Federal Register on Jan. 16, 2013, and then published an updated version on March 20, 2013. The published PS PR was accompanied by a categorical exclusion in accordance with FDA’s NEPA procedures at 21 CFR Part 25.30(j).
After reviewing public comments on the PS PR, and reconsidering the potential significant environmental impacts that may result from the its implementation, FDA announced its intent to prepare an EIS and the beginning of the EIS scoping period on Aug.16, 2013. The notice was published in the Federal Register on Aug.19, 2013.
FDA extended the EIS scoping period in both November 2013 and March 2014 to allow the public additional time to review the PS PR and comment on the scope of the EIS, including topics for FDA to consider for evaluation in more detail. FDA held a scoping meeting on April 4, 2014. Participants were provided an opportunity to participate in person at the meeting in College Park, MD, or to connect online through a webinar to listen to the proceedings live. All meeting materials were made available to the public on this website’s project library under the heading of Additional Information and Downloads, and on the FSMA Proposed Rule for Produce Safety website.
Following the EIS scoping period, which ended on April 18, 2013, FDA began preparing a Draft EIS. On Sept. 29, 2014 FDA issued the supplemental proposed rule, amending certain specific provisions of the 2013 proposed rule. The Draft EIS, which is published on this website, takes into consideration comments during the EIS scoping period and comments that were submitted during the comment period for the supplemental proposed rule.
On Jan. 12, 2015, FDA made public its Draft EIS for the proposed Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. On Jan. 12, 2015 FDA published the Notice of Availability (NOA) for the Draft EIS to be published in the Federal Register, which begins a 60-day public comment period that will end on March 10, 2015.
The Draft EIS and public comment period will be followed by publication of a Final EIS and Record of Decision (ROD). Both documents will also be made available on this website.
For more information, see the following Constituent Updates:
Diagram of the NEPA Process
August 19, 2013 Federal Register Notice: Notice of Intent (NOI) to Prepare an Environmental Impact Statement for the Proposed (Produce Safety) Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
November 18, 2013 Federal Register Notice: Notice of Intent (NOI) to Prepare an Environmental Impact Statement for the Proposed (Produce Safety) Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Comment Period
March 11, 2014 Federal Register Notice: Notice of Intent (NOI) to Prepare an Environmental Impact Statement for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Public Meeting on Scoping of Environmental Impact Statement and Extension of Comment Period for Environmental Impact Statement
January 12, 2015: Federal Register Notice: Notice of Availability (NOA) for Draft Environmental Impact Statement for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; and notice for Public Meeting on Draft Environmental Impact Statement
FDA has participated in an unprecedented level of outreach to producers throughout the United States in the past year since the publication of the proposed Produce Safety Rule in an effort to hear directly from those who will be most affected by that proposed rule.
Since the January 2013 release of the proposed Produce Safety Rule, FDA has conducted extensive outreach to all stakeholders impacted by the proposed Produce Safety Rule standards including more than 100 presentations to industry and consumer groups, farmers, state and local officials, international officials and the research community. Included in this number are three (3) FDA sponsored public meetings (DC; Chicago; Portland, OR); six (6) sponsored state meetings (NC, GA, CA (2), MI and OH), numerous other listening sessions done via webinar or in-person with stakeholder groups, and meetings in Europe with the EU, WTO and GFSI; and two (2) extensive U.S. regional farm tours in the Pacific Northwest and in New England as well as farm tours in Mexico to discuss the combination of FSMA rules FDA has proposed this year to help ensure the safety of both domestic and imported foods. Outreach efforts by the Office of Foods and Veterinary Medicine and program headquarters staff have been complemented by the outreach of our field and foreign offices who have also been actively conducting outreach in the various regions where we have postings.
Prior to the release of the Proposed Produce Safety Rule, senior FDA staff visited more than 20 farms in 13 states and interfaced with hundreds of stakeholders at various meetings across the country to develop the Proposed Produce Safety Rule. Many of these meetings included senior officials from the U.S. Department of Agriculture, as well as state commissioners of agriculture.
Map of FDA's Public Involvement
The EIS assesses the environmental (including human) and related socioeconomic impacts for those provisions that FDA has determined may significantly affect the quality of the human environment (hereinafter referred to as “potentially significant provisions”), and alternatives to those provisions. It also assesses the No Action Alternative, which is made up of baseline agricultural practices, regulations, and industry programs, as well as background environmental conditions.
Download the Draft Environmental Impact Statement (PDF: 23MB).
Commenting on the Draft EIS opens January 12, 2015 and ends March 13, 2015.
For more information on the draft statement, see:
- Docket No. FDA-2014-N-2244, includes submitted comments
- Federal Register Notice announcing the Draft EIS
For general information about the FDA NEPA process, or about this Environmental Impact Statement (EIS), please contact:
Annette McCarthy, Ph.D.
Center for Food Safety and Applied Nutrition (HFS-205)
Food and Drug Administration
5100 Paint Branch Pkwy.
College Park, MD 20740
Phone: (240) 402-1057
This graphic displays the Food and Drug Administration process for preparing the Environmental Impact Statement or E I S for the Produce Safety Proposed Rule. The E I S is being prepared in accordance with the National Environmental Policy Act of Nineteen sixty-nine, NEPA.
There is a process diagram. Rectangular boxes represent the steps that the F D A has taken and will take as part of the NEPA process. Circles represent periods for public and agency comment as part of the NEPA process. The diagram begins with a rectangular box that reads, Begin Environmental Impact Statement. FDA then published a notice of intent, N O I, which is displayed in the graphic as the second box. The N O I was published on August nineteenth, two thousand thirteen.
Moving forward from the N O I, there is a circle that reads, public and agency scoping period, which lasted for two hundred forty-two days. This scoping period ended on April eighteenth, two thousand fourteen. During that time period FDA asked the public to comment on the scope of the EIS.
An arrow leads to a box below the large circle that shows that FDA reviewed public and agency scoping comments, and incorporated them into the scope of the E I S.
This box is followed by a box that reads Publish Notice of Availability or N O A and Draft E I S, which is the current stage of the NEPA process. The N O A officially begins a 60-day public comment period for the Draft E I S. The 60-day public comment period is represented on this process diagram by the small circle that follows the N O A box.
The rectangular box below the small circle reads Review and Incorporate Draft E I S comments. That step will occur after the comment period closes. The following box reads the words Publish Final E I S.
This Final E I S publication box is followed by the last box in the process diagram that reads Issue Record of Decision or ROD.
This graphic is a map of the United States that shows where the FDA has conducted public and agency outreach meetings and tours since 2009. These meetings were about the Rules being proposed under the FSMA, including the Proposed Produce Safety Rule.
The green shaded states display where the FDA conducted widespread tours to gather information from farmers and agricultural producers throughout those regions where they heard the proposed rules may impact farmers the most. These regions include the states of Washington, Oregon, Idaho, California, Texas, Florida, North Carolina, Delaware, Ohio, Vermont, Massachusetts, New Hampshire, Rhode Island, and Maine.
States shaded in purple or having a purple outline were the locations of state sponsored meetings where FDA discussed the Proposed Rules. These states include California, Georgia, North Carolina, Ohio, and Michigan.
FDA sponsored public meetings are indicated by a purple push pin icon on the map. FDA sponsored public meetings occurred in Portland Oregon; Chicago Illinois; and Washington DC.
The orange push pin icons on the map show locations where FDA conducted public outreach after the Proposed Produce Safety Rule was released in January 2013. These locations include; the states of Washington, Oregon, and Idaho. Meetings were held specifically in Woodland California and Tulare California; Atlanta Georgia; Raleigh North Carolina; Washington DC; Wooster Ohio; Lansing Michigan; Hanover New Hampshire; Waitsfield Vermont; Northampton Massachusetts; and Augusta Maine.
Finally, the silver shaded push pin indicates a recent tour of seven farms in Long Island New York. This tour was conducted by FDA, the Department of Agriculture, and the Department of Health and Human Services.