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U.S. GOVERNMENT AGENCIES AND RELATED ORGANIZATIONS

FDA:- Center for Veterinary Medicine (CVM)

Overview

Governed by	Food and Drug Administration (FDA)
Mission Statement	The Center for Veterinary Medicine is a consumer protection organization. We foster public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities.
Director	Dr. Stephen Sundlof
Web Page	http://www.fda.gov/cvm/
Overview	The following statement is taken from CVM's website: The Food and Drug Administration's Center for Veterinary Medicine (CVM) is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. This authority is derived from the Federal Food, Drug, and Cosmetic Act (the Act). The Act was amended in 1968 to include sections which specifically address animal drugs. These amendments were designed to ensure that animal drugs are safe and effective for their intended uses and that they do not result in unsafe residues in foods. One of CVM's highest priorities is assuring the safety of the food supply. And, because of the Center's work and the cooperative efforts of all FDA employees, the American food supply is among the safest in the world.  The responsibilities of CVM have a direct effect on the safety of the human food supply and on the safety to animals of veterinary products. CVM works to educate consumers as well as the regulated industry; evaluates data on proposed veterinary products carefully before permitting them to be marketed; discovers volatile marketed products through surveillance programs, and initiates legal action, if necessary, to bring violators into compliance with the law; and conducts research to support Center activities. Whether developing and disseminating information, approving animal drug products for marketing, monitoring marketed animal drug products, or conducting research, CVM is committed to the important goal of protecting animal and human health throughout the United States.
Paper Trail	See PARA's Paper Trail for communications between PARA and various agencies of the U.S. Government.

Before proceeding further, we would encourage you to read the Important Developments Page prior to reading the rest of this webpage. This will give you some background which may be helpful in evaluating the action or inaction taken by CVM, and to assess PARA's Concerns in light of significant developments that have taken place around the world.

Introduction

It is clear that the Center for Veterinary Medicine holds responsibility for being the gatekeeper of foodborne pathogens from entering the food chain, as evidenced in this FDA CVM Notice issued in April of 1998, putting researchers on notice that $1,000,000 of research monies would be awarded. CVM certainly holds some responsibility for detecting and dealing with emergency of human pathogens in the animal environment and in foods derived from animals. An excerpt from this notice states:

"FDA is mandated to assure the microbiological safety of foods, including those derived from animals. The President's Food Safety Initiative (FSI) of 1997 calls for increased allocation of resources for research by FDA to identify and investigate microbiological hazards associated with food produced by animal agriculture. Even though the American food supply is among the safest in the world, millions of Americans are stricken by illness each year caused by the food they consume and some 9,000 a year, primarily the very young and elderly, die as a result. The goal of the FSI is to further reduce the incidence of foodborne disease to the greatest extent possible. Specifically, FSI mandates research be conducted to develop the means to: (1) Identify and characterize more rapidly and accurately foodborne hazards, (2) provide the tools for regulatory enforcement, and (3) to develop interventions that can be used as appropriate to prevent hazards at each step from production to consumption of food.

"The role of FDA's CVM in this research relates to microbial hazards associated with pre-harvest phases of food animal production, including aquaculture. The FSI specifically identifies a need for research addressing the microbial ecology of the food animal production environment which includes animal feeds. This research will include: (1) Development and/or evaluation of methods for the detection of human foodborne pathogens in the animal environment and feeds; (2) investigations of factors associated with the emergence, transmission, and carriage of human foodborne pathogens in or on food-producing animals and edible products derived from them; and (3) investigations of the microbiological consequences of the use of antibiotics in the animal production environment, including selection and elaboration of antibiotic resistant pathogens and possible interactions which would create conditions for increased pathogen carriage rates."

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It should be noted that MAP was not included in this call for research grants, and as of August, 1999, CVM has not seen fit to fund any research into MAP as a foodborne pathogen.

PARA's concerns

PARA's concern is that the role of the Center for Veterinary Medicine in food safety is unclear. In a telephone conversation in the summer of 1998 with Dr. Sundlof, Director of CVM, PARA was assured that CVM had no involvement with policy in relation to microbial pathogens in dairy foods. But that position is questionable in view of the following:

When the National Johne's Working Group in 1997 passed a resolution requesting FDA to review milk pasteurization standards in relation to MAP (Resolution 16), the FDA Center that received the request was the Center for Veterinary Medicine, as can be seen from this letter to USDA-APHIS dated February 9^th 1998.

If CVM has no interest in dairy food safety, then why did they receive this request from the NJWG?

What is certain is that responsibility for food safety is very ill-defined within the FDA, inevitably leading to situations where nobody seems willing to take responsibility for important matters. The Center for Food Safety and Applied Nutrition and the Center Veterinary Medicine do seem very eager to pass responsibility to each other.
 

Action you can take

Please visit PARA's "How to Help" section to learn how you can get involved in creating awareness about this vital issue.