The Produce Safety Project on June 9 posted an 83-page document on its stakeholder discussion series to the FDA docket on Preventive Controls for Fresh Produce. From the executive summary, some selected excerpts:

June 9, 2010
Request for Comments; Extension of the Comment Period
Docket ID:

Produce Safety Project Stakeholders’ Discussion Series  From the Executive Summary


The Produce Safety Project (PSP) – based at Georgetown University and funded by The Pew Charitable Trusts - is a research and advocacy organization that supports the development by the Food and Drug Administration (FDA) of a mandatory and enforceable produce safety standard for the growing, harvesting and packing of fresh fruits and vegetables. Among other activities, PSP sponsored six stakeholder discussions around the country with the goal of providing a platform for stakeholders, with particular emphasis on growers, to discuss their expertise in promoting produce safety through their current practices and offer input for consideration by FDA as it prepares to propose a produce safety rule.

In addition, the Stakeholders’ Discussion Series provided an opportunity for fruit and vegetable growers and other interested stakeholders (extension educators, food retailers, consultants, produce trade association personnel and others) to hear the science associated with four areas identified as important to produce safety:

1) Irrigation and Foliar Contact Water Quality1,
2) Wildlife and Environmental Concerns2;
3)  Composting Issues3; and
4) Worker Health and Hygiene

These four areas are noted as potential vectors for pathogens and causing food-borne illness outbreaks. Four papers were commissioned by PSP to present current information on these issues. These papers, and ideas contained in them, were briefly reviewed and presented during each of the sessions, and served as jumping off points for more detailed discussions organized in smaller group break out sessions.

General Themes
Several themes arose consistently during each of PSP Stakeholders’ Discussion Series sessions. While there may be some regional variations among these themes as reflected in the suggestions, they are themes that clearly are on stakeholders’ minds across the country as they think about a proposed produce safety rule.

Risk-Based Requirements
Many participants strongly recommended the new produce safety rule be risk-based and that the science drive the requirements and standards. T

Commodity-Specific Regulations

Many stakeholders suggested commodity-specific regulations as a means of allowing for a more riskbased
approach. However, small, multi-commodity farmers (including growers in many Amish and Mennonite communities) expressed concern about being over-burdened by commodity-specific regulations. Other growers, many of whom grow tree crops or crops often processed (such as pecans and peaches in Georgia, apples in New York, Brussel sprouts in Ohio, and almonds in California), thought some commodities should have less rigorous requirements, or be exempt.

Multiple/Competing Standards

Growers in all regions, particularly in regions such as Ohio and California – where they have had more experience with changing requirements from buyers – are particularly concerned about the proliferation, and sometimes contradiction, of different regulatory and proprietary standards. 

Draw from Currently Existing Standards

Stakeholders, particularly those in regions with established produce safety requirements or programs (such as the Leafy Green Marketing Agreement in California) think the new rule should be developed from existing standards.


Scalability was discussed at each session and from several different aspects. Many participants voiced a concern that the proposed produce safety rule not be a “one size fits all” approach, and that the small acreage farmer not have the same burden as a large acreage farmer. 

Consistent Interpretation and Enforcement of Standards

Some stakeholders voiced concern that an outcomes approach might increase auditor misinterpretation or inconsistent interpretation of regulations. 

Reasonable Record-Keeping Requirements
Another theme discussed extensively was documentation or record keeping. Sub-themes in this area included confidentiality, liability and proprietary standards. Documentation was often suggested as critical to the implementation, enforcement and credibility of an enhanced produce safety system – “If you do it, then you must document it. Otherwise, it doesn’t count.”

Economic Impacts

Stakeholders identified economic impacts of new regulations as a concern. Many growers view any additional demands on their time as less time dedicated to growing and harvesting food and therefore
a cost. Economic impacts also are felt in some of the new, proprietary standards buyers have used as
a basis to reject crops.

Supportive Infrastructure

Many growers identified an area of concern as the “mechanics” of, and support for, complying with any requirements – whether regulatory or from private contracting. Included in this theme are issues such as the following:

Education and Training
Many stakeholders supported the idea of a strong education and training component for the proposed rule, preferably provided at no cost.

Worker Health and Hygiene

Almost all of the participants in each session recognized the importance of worker health and hygiene.


Many growers practice composting or use compost or raw manure in a variety of ways. Many small farmers (such as the Amish and Mennonite populations of Ohio and Pennsylvania) use raw manure from their farm work animals.

Irrigation and Foliar Contact Water Quality

There are many regulatory themes that stakeholders suggested be included in produce safety regulations governing water quality. One particularly prominent theme was testing protocol. 

Other Areas of Interest

Throughout the Stakeholders’ Discussion Series, participants contributed ideas and suggestions related to produce safety but not directly related to the development of a produce safety rule or on  farm requirements.

Continued research

Growers, scientists and other stakeholders identified research and knowledge gaps in each of the focus areas.