FDA Produce Safety Activities

 

On this page:

• Introduction
• Next Steps
• Comment Samples

---

 

Introduction

FDA announced in 2010 that work had begun on a proposed rule for the safe production, harvesting and packing of fresh produce. To ensure that we develop the most effective and appropriate rule, now mandated by the recently enacted Food Safety Modernization Act (FSMA), we continue to work more closely than ever with the U.S. Department of Agriculture and its agencies, the Environmental Protection Agency, state departments of agriculture, consumer groups, and the industry.

Over the past year, FDA and USDA technical experts, scientists, and other staff participated in listening sessions and meetings in 13 states. In some of those states, we were able to tour farms large and small and talk to people who have the “on-the-ground” knowledge that FDA realizes must be reflected in the proposed rule.

The comment period under the open docket is now closed. FDA wishes to thank all the stakeholders responding for taking the time to submit comments, examples of their food safety plans, and many other materials.

More than 800 comments were received in all from all parts of the country – an unprecedented number in an FDA produce-related rulemaking action -- from growers large and small; environmental groups; state and local government agencies; retail food chains; academia; consumers, and others who wanted their voices heard and their best practices considered in the development of a fresh produce safety rule.

back to top

Next Steps

There are several key workgroups at FDA concentrating on development of the proposed rule for produce safety, now mandated by FSMA. The comments received under the open docket have been routed to specific areas that these groups have been focusing on, carefully considered and evaluated for inclusion. In addition, FDA will consider testimony and comments received by the U.S. Department of Agriculture (USDA) in response to the proposed National Leafy Greens Marketing Agreement, as well as comments FDA received in response to its draft guidance on leafy greens, tomatoes and melons, issued in 2009.

FDA expects to publish a proposed rule by the end of 2011. That proposed rule will also have a comment period, before any final rule is issued, anticipated sometime in 2012.

back to top

Sample Comments

Here is a sampling of some of the comments we received:

"The FDA GAP guidance is a starting point from which the FDA can work with the produce industry based on demonstrated risk. Indeed, the original 1998 GAPs guide has been the basis for industry and FDA activities that led to the development of commodity-specific guidance for melons, tomatoes, leafy greens and green onions over the last several years. In some instances, the industry has developed food safety programs that are intended to be used in conjunction with the original 1998 FDA GAPs guidance. The Leafy Greens Marketing Agreement’s (LGMA) “metrics” program is an example where its metrics can be seen as an extension of the FDA GAP guidance, with measurements specific to leafy greens production.

Further, as various other commodity groups (e.g., green onions, watermelons, mushrooms and citrus) have sought to develop their own versions of commodity-specific food safety programs, the 1998 FDA GAPs guide has directly or indirectly served the framework for initial discussions and provided a roadmap to guide their risk assessment process. Going forward, as we gain knowledge from ongoing food safety research, improved epidemiological investigations of foodborne illnesses and enhanced risk profiling, the FDA GAP guide and subsequent commodity-specific guidances can serve as starting points for the agency and the industry to overlay this increased knowledge to develop improved general food safety regulation and/or additional commodity or production practice-specific guidance for industry implementation."  -Produce Marketing Association

 

"We think the best approach is for FDA to give commercial produce growers and packers helpful general food safety guidance, based on the most current science, while reserving specific regulatory requirements to the narrowest range of actions compatible with achieving reasonable levels of ultimate consumer safety. This targeted approach, based on a risk analysis of individual produce items or crop groupings, will lessen red tape for producers while ensuring that real and significant food safety risks are attended to by industry and government. It will also serve to avoid any artificial distinction between small and large producers in terms of food safety protection. There is no zero risk. Economics do have to be considered even in food safety." -Northwest Horticultural Council

 

"Small farms (those earning less than $750,000) should not be required to become GAP certified, because the high cost and time commitment could put them out of business.

Small farms are not high-risk operations, and as such they should be required to have food safety education and minimal reporting requirements.

We need to protect and nurture those small farms that we can personally visit to see how they are handling their produce. Their trip from field to plate is short and direct and easy to trace. Their connections with their customers are personal and they care about the quality of what they produce. Keep them accountable to the people they serve through training and education but not through expensive certification.

Small farms are also careful stewards of the land, and that is an important part of our future. They respect and protect diversity, which are crucial to sustainable agriculture practices." - Westford Farmers Market and Sustainable Westford, MA

  

"AFBF has a vital interest in how food safety is practiced, perceived and regulated. We believe that although the U.S. food production system is among the best in the world, improvement is always an important goal. However, it is critical that any new standards not unnecessarily complicate the marketplace without increasing overall food safety. While we understand the need for continuous food safety improvement, the farm-level impact on producers must be considered in any new food safety regulations. A cost-benefit analysis of any new produce safety standard is necessary to ensure that the cost of enhanced measures does not outweigh the benefits.

Any food safety regulation must be scale-appropriate, recognizing the needs of farmers based on the size and scope of their operations. One size does not fit all, and experience in the diversity of farming operations highlights the importance of scalability, regional differences in production and cultural methods. Climatic conditions, production practices, and marketing and distribution systems vary across the country. FDA rules or guidance should take particular care to recognize these differences. A single rigid, prescriptive regulation would place producers in jeopardy of inadvertently being out of compliance and create unjustified economic hardship.

Appropriate standards should reflect risk, and therefore should account for inherent differences in such factors as growing methods (i.e., less stringent for those grown off the ground) and marketing purposes (i.e., cooked before consumption or not consumed at all). Some issues – including air pollution, wildlife, insects, and birds – are realistically beyond the control of growers.

Because food safety is size-neutral, all growers should meet necessary standards. However, the financial interest of a large grower to implement practices and systems to reduce or limit liability should not overburden smaller growers with unnecessary practices that would drive them out of business." -American Farm Bureau Federation (representing more than 6 million member families and growers)

back to top