Comments by
R. Dan Sowards, President
Betsy Woodward, Director of Public Policy
Comments on behalf of the Association of Food and Drug Officials (AFDO)

Leveraging Collaborating with Stakeholders

The Board of Directors of the Association of Food and Drug Officials (referred to henceforth as AFDO) is pleased to provide the following comments to the U.S. Food and Drug Administration regarding Leveraging--Collaborating with Stakeholders.

AFDO, as the preeminent organization in the U.S. of federal, state, and local regulatory officials, is a key participant in the opportunities for FDA's leveraging of resources. We have promoted science-based food, drug, and medical device safety through the development of model laws and regulations and have provided uniform training in food and drug safety throughout our 103 year history. Regulated industry encompasses almost 50 percent of AFDO's membership. During the past two years AFDO has advocated an integrated food safety system for the U.S. to eliminate duplication and gaps in our current system of regulating foods.

This vision provides FDA one of the largest, most far-reaching and effective leveraging opportunities in the implementation of AFDO's vision for a truly integrated food safety system. This vision was formally presented to the National Academy of Science in 1998 and forms much of the basis for current food safety initiatives. Fundamental to integration is the leveraging of all state, local, and federal resources to meet statutory requirements in consumer protection in foods, drugs, cosmetics, and medical devices. By way of this statement, AFDO is referencing other comments provided on the integration process which have been previously provided to the FDA. This Federal Register announcement failed to identify integration as a means of leveraging. The success of integration is critical to fulfilling the agency's mandate and outreach. Through this effort, other agencies can assist the FDA in meeting its annual work plan goals

That said, AFDO would like to address specific areas for leveraging in response to the requested information in this Federal Register announcement. Leveraging requires a relationship of equality and trust between parties so that results are equivalent and useful to the FDA and the parties involved. Any leveraging will require a federal oversight component. Most state and local governments have a history of working cooperatively with the FDA through partnerships and contract programs. These programs have, particularly over the past five years, resulted in less duplication and increased coverage of areas of mutual responsibility and priority. However, these contracts, partnerships and MOUs fall short of establishing a formal mechanism for FDA recognition of state inspection, even though some do involve limited mutual recognition of inspection and laboratory results and are targeted to meet special agency needs. Basically AFDO concurs with California's comments here and also recommends that the FDA establish a mechanism for formalizing a recognition of state inspections and laboratory results that includes:

1) Recognition criteria
2) A quality assurance program
3) Periodic management evaluation
4) Mutual training to maintain quality and uniformity
5) Routine joint work planning
6) Common or mutually accessible databases for inspection, analytical and compliance information needed for enforcement and follow-up by either agency.

It must be understood by all concerned with using partnerships and contracts for leveraging, that states operate on budgets similar to the federal agency and planning is a critical element. These programs need to move beyond a year-to-year funding that limits states' ability to plan for an appropriately trained workforce to carry out the functions. Time and flexibility provided through longer term funding will improve effectiveness and efficiency of these leveraging activities.

In addition, because of resource shortages, the FDA is using "regulatory discretion" much more frequently when dealing with products in violation of the Food, Drug and Cosmetic Act. States can only work in harmony with the FDA if the FDA will do two things: 1) take a stand on a product or issue when requested by the state; and 2) communicate that stand to the state officials in a timely fashion. By doing these two steps, many problems needing attention can be handled by the state using state resources and done so with uniformity state-to-state.

FDA already partners and contracts with states in many areas of food inspection (seafood, low acid canned foods, wholesale, and food manufacturing for example), food testing, mammography inspections, medical device inspections, and education. The following provides some examples of opportunities for continued and improved resource leveraging:

a) Some states are quite involved in the inspection of dietary supplements. Since this is an agency priority, FDA should consider partnerships with these states to conduct inspections of manufacturers AND collection of product samples to verify product compliance, both with respect to safety and labeling, and as necessary, testing for a confirmation of active ingredient level.

b) Sampling of domestically produced fresh produce is also a priority for the FDA and again is an opportunity for leveraging with State partners. States can either collect, test and supply results on product samples, or they can collect samples for FDA laboratory examination. Leveraging with states' resources will enable FDA to address more of its time to import issues associated with fresh produce. Florida and several other states already have partnership agreements relating to pesticide residues on produce. This can be expanded to other states and to develop data on microbiological quality.

c) Imports. Many violative imported products are being identified by the State programs after the products enter domestic commerce. These ıdomestic imports result in the majority of the violative products that are recalled each year. FDA currently has one or more partnership agreements with various states to either assist with import monitoring, or with respect to recalls. New York accounts for a significant percentage of import recalls through its partnership with the FDA. FDA should propose to specific states a partnership that involves not only monitoring the domestic marketplace, but which also leverages resources at border crossings and at international airports to detect these products prior to entry into domestic commerce.

d) Assessment of the bacteriological quality of fresh juice in the marketplace. Although FDA's proposed Juice HACCP regulation excludes juice processed and sold at retail, we believe that it would be an excellent use of FDA resources to partnership with the states to determine whether these sources of fresh juice pose the same risks of illness that FDA believes other sources of processed juice pose. States could also conduct inspections and sampling of wholesale juice processors as well.

e) Enforcement of various new FDA regulations and policies. If FDA is not already doing so, the states could certainly conduct follow-up inspections of sprout producers, for example, to determine compliance with FDA's new enforcement policy for this industry.

f) Incentives for the adoption of the FDA Food Code. Considering the impact on food safety that the retail segment of the food chain has, combined with the fact that states and local jurisdictions are adopting the Food Code at a very slow rate, FDA should work closely with the states and locals to leverage resources to encourage adoption of the Food Code.

g) Drugs and Medical Device Inspections. There are several states with considerable expertise in the inspection of these facilities. FDA should increase partnerships with those states capable of conducting these inspections and provide training for State personnel to leverage resources in these areas.

h) Monitoring of the Internet for Inappropriate Advertising of Prescription Drugs and Dietary Supplements as well as the unmentioned area of veterinary drugs and animal feed. A number of states have the knowledge and capabilities to assist FDA in these areas. Partnerships should be formed to carry out this activity.

The current level of funding for contracts FDA has with the states to conduct inspections of regulated industry is minimal and has been in a state of serious decline. For instance, six years ago FDA's contract with the Texas Department of Health (TDH) for food inspections stood at 650 inspections per year. Further, FDA had contracts with TDH to conduct drug and medical device inspections. Today the only contracts still in place are the Tissue Residue Contract and the Food Inspection Contract, which calls for only 350 inspections. FDA should therefore identify where high and medium risk establishments exist, then increase funding for contracts with those states for foods, drugs, and medical devices. AFDO is very much aware that State inspections cost much less than FDA inspections, are of high quality, and with adequate FDA oversight of the State programs, considerable leveraging of resources could be achieved.

AFDO is in a position to assist FDA with training in many different areas, including dietary supplements, drugs, medical devices, food Good Manufacturing Practices (GMPs), dietary supplement GMPs, retail processing and other areas of mutual concern. AFDO is also in a position to conduct surveys of the states with respect to any number of issues, including capacity, resources and other leveraging parameters. FDA should consider partnering with AFDO in these areas. Mr. Gary German, FDA's Director of the Division of Human Resource

Development, is quite familiar with AFDO and AFDO's abilities in the area of training, which can complement training already being conducted by DHRD.

AFDO appreciates this opportunity to comment on leveraging opportunities through the AFDO organization as well as the states and locals it represents. We feel that integration and the leveraging of resources it involves is absolutely fundamental to a successful consumer protection program at all government levels.