January 3, 2008

 

 

Richard Barnes

Director, DFSR

FDA – U.S. Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

 

Dear Richard,

 

Pursuant to you request on December 10th, we are providing bulleted comments, concerns, needs and issues from the AFDO Board members on the Food Protection Plan:

 

1.         There is not much mention of state and local government agencies, the number of services they provide for the cause, nor how they can and will e first responders of sorts for prevention, assurance and response.

 

2.         There needs to be more details presented on the working relationship with the states and locals.  The document addresses the issue, but in very broad and vague terms.

 

3.             The Plan includes three core elements of protection: Prevent, Intervene, and Respond. It could have included a fourth: Educate.  In order to promote increased corporate responsibility, industry must be educated on what we as science based experts believe they can do better to avert the threat of new or existing pathogens...especially those facilities in foreign countries.

 

4.         The Office of Management and Budget (OMB) recently approved the Manufactured Food Regulatory Program Standards that were recently developed by FDA and state food safety officials. These standards represent recognized best practices of a high-quality risk-based regulatory program, and if complied with can demonstrate a states equivalency to FDA. FDA needs to speed up the implementation process for these standards so more states can participate in the assessment of their food safety program. FDA can then share inspection work plans with state agencies to avoid duplication of efforts.

 

5.         FDA must begin to accept state food laboratory analysis of foods so they can better work with the states on sampling assignments and the sharing of surveillance data. Work performed here should include both imported and domestic products. 

 

6.         FDA must improve their presence in foreign countries. By gaining confidence with state and local governments handling most of the domestic burden, FDA should be able to achieve this goal. A number of states are performing inspection verification for foreign dairy manufacturers of Grade A products. FDA should be performing these inspections. 

 

7.         A number of states are leading the way in mandatory requirements for vegetable growers and packers. California, Florida, and Virginia have all introduced mandatory programs for specific commodities in their states. FDA should model these programs so they become nationally accepted. 

 

8.         There is a huge need to improve our response efforts with food recalls. Recent national recalls for peanut butter, spinach, and chili sauce were too confusing and ineffective. Distribution lists for recalled food products are not readily shared by FDA with state officials and, in many cases, shared very late. As a result, state and local officials will send their field staff out into warehouses and stores searching for these products wherever possible. This is wasteful and very ineffective, but seems to be the only option available to us at this time. North Carolina recently employed an Incident Command System (ICS) utilizing state and local government officials from a multitude of agencies within that state to address the recent chili sauce recall. They performed more recall audit checks in North Carolina than the rest of the country combined. They also found a large number of these botulism-tainted products in children's camps and other non-traditional food venues ready for sale or service. I believe my counterparts in North Carolina may have also saved lives as well. FDA needs to review their response efforts with recalls and establish a formalized strategy with state and local government to better deal with recalls.

 

9.         Suggest that FDA sit down with AFDO and consider a cooperative agreement with us to assist in developing and promoting integrated projects around the country based on successful programs which exist in recalls and imported foods.

 

10.       It does not include amendments to the Federal Food, Drug, and Cosmetic Act that would give FDA more power/authority over PREVENTION.  Current law is mainly for enforcement, including REACTING to problems rather than preventing problems.

 

11.       It does not provide for, nor advocate strongly enough, for adequate funding for the FDA to be an agency engaged in prevention.  Inspections are considered to be preventive if they are done on schedule and within a reasonable period of time.  In Texas, inspectors review the previous inspection report and report back on the numbers of "voluntary corrections" a company has made since the previous inspection.  We total more than 24,000 "voluntary corrections" at food processors and wholesale distributors each year, which we believe prevents a significant number of illnesses.

 

12.       The document needs to call for a budget line item for state contracts/ partnerships/cooperative agreements.  Without this, as we all know, initial funding will disappear in a few years without this authority.

 

13.       With the exception of Seafood and Juice HACCP, FDA's current regulations are all "command and control" regulations.  FDA needs to address ALL food regulation to permit industry innovation....if nothing else, but using HACCP principles for inspection of all food processors.