There has been considerable discussion of FDA operations during the 1980s and early 1990s as a result of diminishing resources. At a time when resources are decreasing, CFSAN faces a whole new set of complex issues and regulatory dilemmas that are likely to continue into the 21st century. New convenience foods that are microwaveable and new packaging materials (including recycled products) have entered the marketplace. Changes such as these have created a whole series of products and conditions of use that must be addressed. The biotechnology explosion has opened new frontiers in product development, providing us with the potential to genetically alter the characteristics of foods and requiring us to answer such basic questions as:
What is a tomato? When you genetically alter a tomato to give it a tougher skin, is it still a tomato?
The volume and diversity of imported food have risen dramatically over the decades, and foods once considered exotic are now found throughout the U.S. marketplace. These products present entirely new sets of safety issues and offer new processing situations and techniques that we must address. Finally, CFSAN has the task of continually implementing new legislation, such as the recent Nutrition Labeling and Education Act of 1990, while at the same time continuing, expanding, and improving its current consumer protection programs.
In 1989, the Secretary of Health and Human Services created an external committee called the Edwards Committee, whose task was to review FDA operations and the issues facing the agency. Based on this examination, the committee concluded that the agency was not prepared to cope with the pressures placed upon it, including increasing responsibilities, a stagnant budget, decreasing resources, heightened scrutiny from the media and public interest groups, and the rapidly expanding scientific base of industry.
In 1992, in response to the Edwards Committee's recommendations, the structure of CFSAN was examined, and it became apparent that the organization established in the early 1970s was no longer adequate to meet the needs of the next century. CFSAN was facing new challenges, new legislative mandates, and budgetary constraints. Additionally, closer integration was needed between scientific and regulatory policy in the foods program. It was determined that a product-oriented organization would better serve the U.S. consumer.
Under a Deputy Director for Programs, seven offices were established to focus on specific products and issues:
Each of these offices has a focal point for policy guidance, programs, and enforcement actions, as well as the necessary scientific capabilities to support policy and compliance activities, as an integral part of the office structure. The offices are organized to be more responsive to outside constituent organizations and more effective in accomplishing program objectives. For example, the Office of Premarket Approval provides a centralized, coordinated focal point for food additive petition review. It includes much of the needed scientific support for food additive evaluations team approach to petition review. This new structure will enable better management of petitions submitted by industry, improving the quality of the review.
Four offices were established under a Deputy Director for Systems and Support:
In addition, a small Office for Policy, Planning and Strategic Initiatives under a Senior Associate Director serves as a focal point for foods policy, regulation coordination, strategic planning, timely resolution of critical foods issues, and policy review. Within this office are ten senior staff members who are Strategic Managers responsible for resolving high priority, cross-cutting issues throughout CFSAN. Strategic Managers have the capacity to create temporary working groups to resolve regulatory and scientific issues involving several offices, to coordinate the activities of the groups, and then to disband them. This concept allows the organization to remain responsive to short-term, external stimuli, without requiring organizational restructuring each time a situation arises.
The new CFSAN organizational structure gives scientists increased opportunity for input into the policy-making process. There is greater interaction and communication between scientific disciplines because most offices contain chemists, nutritionists, microbiologists, and toxicologists. Considering the complexity of the food safety and labeling issues to be addressed, it is essential that consistent policies be implemented. When a problem arises, both a research plan of action and a regulatory plan of action are prepared in the same office. This approach ensures more effective coordination and identifies a single spokesperson for each issue. The strategic managers provide a disciplined focus and coordination between program offices. With regulation writers in each office, more focused attention on a smaller set of issues results in quality regulations. Regulation coordination is provided through the Office of Policy Planning and Strategic Initiatives.
The compliance function is dispersed throughout the various offices under the Deputy Director for Programs with central coordination provided by the Office of Field Programs. Compliance personnel, in cooperation with scientists, can readily identify problems for research attention. Because compliance personnel are able to direct their attention to limited areas, they are able to concentrate closely on specific issues and provide focused expertise in compliance and enforcement policy development.
Greater accountability is fostered at all levels. Office Directors are accountable for all products (research. policy, and regulations) of their respective offices. Strategic Managers are accountable for products involving the efforts of more than one office. The different program orientations of the offices enable CFSAN to set program priorities and facilitate program monitoring and review. Specific commodity problems and issues are targeted to a specific office. If there is a cross-cutting issue, for example, if the required talent is located in more than one office, the Strategic Manager brings together an appropriate team to resolve the issue.
The new organizational structure positions FDA for future challenges in the foods area and ensures that program priorities appropriately reflect public health priorities and are commensurate with available resources. CFSAN research scientists are an integral part of the regulatory mission of the organization They ensure the high level of scientific expertise needed to develop sound policies, to review applications. and to respond to public health crises.
The agency requires many different skills to carry out its responsibilities for foods and cosmetics. To meet this need, CFSAN employs individuals with specialized training in many diverse areas and disciplines of science, economics, environmental health, mathematics, risk assessment and management, compliance, law, planning and budgeting, education and training, and data processing. CFSAN's highly specialized scientific staff include chemists, microbiologists, biologists, toxicologists, food technologists, pathologists, pharmacologists, nutritionists, dietitians, physiologists, environmental health specialists, geneticists, epidemiologists, mathematicians, and sanitarians. This diversity in the skills and specialized training of its employees is an indicator of the complex issues handled by CFSAN. CFSAN, with a staff of about 920 employees, is headquartered two blocks from the U.S. Capitol in Washington, DC, at 200 C St., SW. The headquarters building contains most of CFSAN's administrative and compliance offices and many of its scientific laboratories. CFSAN occupies additional office space at the nearby Switzer Building and at 1110 Vermont Ave., NW. CFSAN also has five auxiliary sites. Two of these are adjacent animal research facilities in Laurel, Maryland. The first is the large animal Beltsville Research Facility and the second is the small animal MOD I Laboratory Facility. The three remaining facilities are laboratories in Dauphin Island, Alabama, and in Davisville, Rhode Island, which conduct fisheries safety research and shellfish sanitation studies, and a food technology research facility in Chicago, where CFSAN is a partner with industry and academia in a research consortium at the Illinois Institute of Technology's National Center for Food Safety and Technology. This last facility offers a unique opportunity for FDA scientists to play an important role in pioneering U.S. food science research in food safety, in such areas as food processing and packaging technologies, biotechnology, and quality assurance.
CFSAN relies heavily on FDA district office/resident post staff; most are investigators who perform inspections, conduct wharf examinations, and collect samples; laboratory scientists and technicians who analyze foods and cosmetic products in FDA field laboratories; and compliance officers who follow through with appropriate enforcement action and recommend legal action. The field operations are organized into six regional offices, each under the direction of a Regional Food and Drug Director. Each region is organized into several districts. There are 21 FDA district offices across the country. Investigators are located in these district offices and in nearly 130 local resident posts in 49 states and Puerto Rico.
CFSAN is faced with carrying out an ambitious mission. The challenge for CFSAN is to position itself to succeed at meeting its goals, so vital to the American public. As stated in the Edwards Committee Report.1991: "In rapidly expanding fields...the Agency must be at the leading edge in order to fulfill its responsibilities."
We must evaluate new and innovative technologies, educate the public, and improve our overall operational efficiency, in order to continue to effectively protect consumers as we enter the 21st Century.
This document was excerpted from a 1993 Fact Sheet entitled:
US FDA and CFSAN.
For more recent information on the Overview and History of FDA
and the Center for Food Safety and Applied Nutrition
see http://www.cfsan.fda.gov/~lrd/fdahist.html
Hypertext updated by dav/dms 2001-MAR-23