June 11, 2007

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

Docket No. 2007N-0051
Safety of Fresh Produce; Public Hearings; Request for Comments
Official Comments from the Association of Food and Drug Officials (AFDO)

The Association of Food & Drug Officials (AFDO) is a national organization that represents state, local, and federal food and drug safety regulatory officials. AFDO is well known for promoting uniformity and cooperation among the regulatory community and has helped to foster numerous collaborative projects to advance these objectives. Among the national projects we were very active in developing and promoting are the Seafood HACCP Alliance, National Food Safety System (NFSS) project, States Helping States program, and the FoodSHIELD community of regulatory programs. Additionally, AFDO has developed a host of model codes that states can utilize in promulgating their own specific regulations. AFDO model codes such as our “Cured Salted and Smoked Fish GMP’s”, “Guidelines for Juice Manufacturers”, “Meat & Poultry Processing at Retail Guidelines” and “Reduced Oxygen Packaging at Retail” were authored following specific food safety concerns associated with these practices. A number of federal and state standards or regulations were developed in part from the information contained within these model codes. Because of AFDO’s strong allegiance to state food safety programs, we possess a unique strength and impact for advancing food safety projects we feel are best addressed through integrated efforts of government at all levels along with industry.

Recent outbreaks associated with fresh fruits and vegetables were investigated by a number of our members and following each of these outbreaks questions were raised as to the current effectiveness of government activities in the fresh produce arena. Our comments to FDA are provided with the understanding that government needs to address food safety concerns with fresh fruits and vegetables in a similar progressive fashion as was conducted for fishery products, meat & poultry, shell eggs, and fruit & vegetable juices. AFDO believes it is time for government to act.

In response to Issue #1 relating to the supply chain for fresh produce, AFDO has the following comments:

1) It is our opinion that current Good Agricultural Practices (GAPs) are primarily market driven and that FDA and the states must begin to look at mandatory controls rather than voluntary compliance. There are no sanctions for non-compliance with guidelines, and the increase in outbreaks associated with fresh cut produce seems to warrant a more structured mandatory system. AFDO further believes that any mandatory controls must be uniformly applied throughout the country.

2) Fruit and vegetable packinghouses as well as grower operations are traditionally not inspected or licensed by state or federal agencies. Prior experience with apple cider operations demonstrate that a lack of regulatory oversight, coupled with poor adherence to food safety “guidance” principles is unwise and can have serious consequences such as food borne illnesses. Fruit and vegetable growers and packers must subscribe to GAPs or Good manufacturing practices (GMP’s) as a first step in producing safe products for ready consumption.

3) In addition to inspection, growers and packers must adhere to control point monitoring and implementing controls where applicable. This may include testing of irrigation water by growers and testing of chlorine disinfection levels at a packinghouse operation. FDA and the states should collaborate on the standards for these operations to follow. AFDO recognizes that there are many voids in the knowledge needed to adopt time-tested regulations directly supported by science; however, we do not believe it is in the best national interest to await research results before adopting regulatory approaches. Rather, we must exercise our best professional judgment, adopting interim standards, and pursue enforcement tools which will allow for timely adaptation as scientific consensus of more appropriate measures are determined. After all, much is already known about water quality, misuse of animal manure or biosolids, hygienic worker practices, and other grower level concerns.

4) As indicated above, AFDO believes FDA should consider regulatory approaches that will provide for timely flexibility as new science emerges. Options may include the establishment of a “Fresh Fruit & Vegetable Alliance” similar in nature to the Seafood HACCP Alliance to address training and intervention strategies for dealing with the food safety hazards associated with fresh fruits and vegetables; development of model codes similar to the Model Food Code; the interim use of a “clearinghouse” to assure uniformity of regulatory and enforcement approaches; or other strategies.

In response to Issue #2 relating to intervention strategies, AFDO has the following comments:

1) AFDO believes that food safety must be addressed from “farm to fork” and that FDA must assign intervention strategies at each point throughout the entire continuum. A failure at any point could impact the safety of the product.

2) While we support mandatory control measures, we do recognize that there are many wide variations in commodities, microbiological ecology, and production practices in the farming industry. Thus, many specific control measures may require application in a more singular fashion. What may be necessary for tomatoes may not be practical for leafy vegetables. Strategies developed must be science based and specific to the particular commodity, production methods, and perhaps, specific organisms of concern.

In response to Issue #3 relating to traceback, AFDO has the following comments:

1) AFDO believes that adequate product or lot coding, record keeping, or other traceback methods may have reduced the incidence of cases associated with recent foodborne outbreaks associated with fresh fruits and vegetables. Rapid identification of affected products and their sources are critical to mitigating the outbreak and preventing distribution of newly contaminated product. When we can accurately trace problems to their sources, identify the factors that contribute to or directly cause contamination, and implement appropriate control measures, we will begin to make significant progress in decreasing the size and number of produce related outbreaks. Despite the recognized difficulty it may present to the industry, traceback information must be required. We see no other viable option to employ.

2) Packers and re-packers should utilize a system of manual records or UPC scanning technology in order to document grower receiving information as well as distribution information. Traceback is paramount for food defense purposes as well as establishing food safety controls.

In response to Issue #4 relating to food safety plans, sanitation standard operating procedures (SSOP’s), and monitoring records, AFDO has the following comments:

1) AFDO supports the inclusion of all of these strategies. It is very possible that guidance could easily be provided to these industries in the form of an alliance as previously mentioned, or through other mechanisms to ensure broad outreach and education for whatever guidance or regulatory approach FDA adopts.

2) Many states already require recordkeeping for pesticide application, environmental management, organic certification, and other regulatory programs. So, in our view; SSOP’s are not an unreasonable demand.

3) We further believe an alliance of regulatory, industry, and academic groups, working with consumer input could develop model food safety plans, which specific growers and packers could employ. Verification of adherence to these plans could be accomplished through regulatory, third party or government fee for service functions. Much of this is already in existence although mostly market driven.

4) Food safety training should be mandated for growers and packers as well. Once developed, state agencies, cooperative extension, and grower associations are well-suited to provide accredited training or offer exams leading to operator certification. Distance learning to facilitate business should be an option.

In response to Issue #5 relating to audit verification, AFDO has the following comments:

1) There needs to be a model auditing system which singularly addresses food safety. Standards currently recognized in this country are not always similar as some may include pesticide controls in addition to food safety controls. While we do not object to the pesticide standards, we believe specific and minimum food safety controls must be established.

2) AFDO supports the application of auditor certification as currently utilized by the United States Department of Agriculture; Agriculture Marketing Service (USDA/AMS) and endorsed by state agriculture departments. This system has already produced a multitude of certified federal and state auditors.

3) We further believe that a system for establishing equivalency among audits must be established. At this time multiple audits are required of many businesses, and this system is an unnecessary financial burden for the grower.

To date, AFDO has not yet endorsed a specific mandatory regulatory system; however, we do believe in the need for developing appropriate standards in the form of a model code for adoption by state and local regulatory agencies. Industry, in a renewed emphasis for food safety at the grower and packer levels is now seeking leadership from government officials. In fact, at a recent meeting of the nation’s leading tomato growers, AFDO was asked to assist in developing uniform regulations adopting specific GAPs and Best Management Practices (BMP’s) for their industry. AFDO has established a working group which is comprised of government, industry, academia, and consumer interests to consider this and other control measures specific to other fruit and vegetable industries. This group could serve as the foundation for a larger alliance to assist in the development, widespread acceptance and implementation of additional measures to ensure the safety of fresh fruits and vegetables.

AFDO believes that the concept of an alliance with the support of all stakeholders can influence the direction necessary for establishing controls for fruit and vegetable growers and packers. The working group already formed can serve as the foundation for a broader alliance to accomplish the goal of ensuring a safe supply of fresh produce. There is already a track record of success for such cooperative and collaborative programs, and AFDO believes this is an avenue for FDA to direct its resources to. AFDO greatly appreciates the opportunity to comment on this very important issue.

Respectfully,

Charlene Bruce, President
Association of Food and Drug Officials