Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety
The following is dedicated to FDA’s Environmental Impact Statement (EIS) for the FSMA Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumptionin (“Proposed Produce Safety Rule”) released January 2013. 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; the FDA’s Environmental Impact Considerations procedures under 21 CFR Part 25; and all other applicable laws.
- Project Overview
- NEPA Process
- FDA Notices
- Public Involvement
- Additional Information & Downloads
- 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 during the period 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 January 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 to react to problems after they occur. FDA proposed several rules for stakeholders to follow along the entire food supply chain, which are designed to protect public health by promoting safe, sanitary standards that upon implementation will minimize or prevent food safety hazards.
FDA prepared a categorical exclusion that was published with the Proposed Produce Safety Rule 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 evaluate the potential significant environmental impacts that may result from certain provisions, if finalized, of the Proposed Produce Safety Rule.
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. When FDA publishes the Draft EIS (expected December 2014) the public will be asked to submit comments to FDA’s Division of Dockets Management at http://www.regulations.gov.
On January 4, 2013, FDA released for public comment its Proposed Produce Safety Rule to establish science-based Standards for Growing, Harvesting, Packing, and Holding Produce for Human Consumption (Proposed Produce Safety Rule). The Proposed Produce Safety Rule is one of five proposed rulemakings that would lay the cornerstone of the prevention-based, modern food safety system we need to help preserve human health from foodborne illness associated with the consumption of contaminated produce. FDA published the Proposed Produce Safety Rule in the Federal Register on January 16, 2013, and then published an updated version on March 20, 2013. The published Proposed Produce Safety Rule 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 Proposed Produce Safety Rule, and reconsidering the potential significant environmental impacts that may result from the implementation of the Proposed Produce Safety Rule, FDA announced its intent to prepare an Environmental Impact Statement (EIS) and the beginning of the EIS scoping period on August 16, 2013. The notice was published in the Federal Register on August 19, 2013.
FDA extended the EIS scoping period in both November 2013 and March 2014 to allow the public additional time to review the Proposed Produce Safety Rule and comment on the scope of the EIS, including topics for FDA to consider for evaluation in more detail in the EIS. FDA held a scoping meeting on April 4, 2014. Participants were provided an opportunity to participate in person at the meeting location in College Park, Maryland, or connect online through a Webinar to listen to the proceedings live. All meeting materials presented at the meeting will be made available to the public on this Web site’s Project Library, and on the FSMA Proposed Produce Safety Rule Website.
Following the EIS scoping period, which ended on April 18, 2013, the FDA will prepare a Draft EIS (expected December 2014). The Draft EIS will be made available on this Web site. FDA will publish a Notice of Availability (NOA) in the Federal Register that announces the availability of the Draft EIS and the duration of the public comment period. The Draft EIS and public comment period will be followed by publication of a Final EIS and Record of Decision. Both documents will be made available on this Web site.
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
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
- Purpose and Need: Why the Produce Safety Rule is Not Limited to Specific Commodities Associated with Past Outbreaks (PDF: 129KB)
- What is Not Covered by the Produce Safety Rule (PDF: 752KB)
- Entities Potentially Affected by the Produce Safety Rule (PDF: 136KB)
- NEPA Alternatives for Evaluation (PDF: 888KB)
- History of the Proposed Produce Safety Rule / Rulemaking Process (PDF: 150KB)
- Produce Safety Rule Public Outreach Poster (PDF: 2MB)
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) 402-1200
This is a process diagram. The diagram starts 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 NOI was published on August 19 2014. Moving forward, there is a large circle that reads, public and agency scoping period, which lasted for two hundred forty-two days. This scoping period ended on April eighteenth of two thousand fourteen. During this time period FDA asked the public to comment on the scope of the EIS. The box below the large circle shows that FDA is presently reviewing public and agency scoping comments. This box is followed by a box that reads Publish Notice of Availability or NOA and Draft EIS. The Draft EIS is expected to be published for public comment in December 2014. The following small circle displays the words Comment Period. This is another opportunity for the public to comment on the Draft EIS. The box below the small circle reads Review and Incorporate Draft EIS comments, which will occur after the comment period closes. The following box reads the words Publish Final EIS. This 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.