Contents

SUBCHAPTER 260 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

260 - OFFICE OF THE CENTER DIRECTOR

The majority of CFSAN's offices moved to a new building in College Park, MD. This address is 5100 Paint Branch Parkway, College Park, MD 20740-3835. Agency and Center on-line directories have been updated.

The CFSAN director is Robert E. Brackett, Ph.D. The Center Director's Office consists of the Deputy Director, Janice F. Oliver; Director Food Safety Initiatives, vacant; Director Office of Regulations and Policy, L. Robert Lake; Director, Office of Constituent Operations, Catherine W. Carnevale, DVM; Director Office of Management Systems, Juanita Wills; and Director Office of Science, Robert L. Buchanan, Ph.D.

This Center develops FDA policy with respect to the safety, composition, quality (including nutrition), and labeling of foods, food additives, colors, and cosmetics.

CFSAN researches and develops standards on the safety and composition of foods, food additives, colors and cosmetics. CFSAN also conducts research to improve methodology and methods of detection of various contaminants for regulated products.

It develops and promulgates good manufacturing practice regulations (GMP's), model ordinances, compliance programs, reviews food and color additive applications and has other food related programs.

CFSAN has about 900 employees.

260.01 - Food Safety Staff (HFS-32) Vacant, Director

This office provides guidance, oversight, and coordination to a variety of substantive activities in response to the President's Food Safety Initiative mandates. Serves as liaison to appropriate Federal, State, local and foreign governments, industry, consumer groups, and academia with regard to the Food Safety Initiative activities.

260.02 - Office of Regulation and Policy (HFS-4), L. Robert Lake, Director

The Office of Regulations and Policy (ORP) coordinates the development and review of food regulations and policies and resolves food policy issues in collaboration with the Center Director and other members of the senior management team. ORP serves as the Center focal point and provides a centralized monitoring, coordinating, and advisory function for the Center on policies involving sensitive, controversial and complex food issues, including proposed regulations. ORP also advises Center officials on regulatory approaches and manages the planning of the Center's regulation development activities. There is one office staff, a Food Biotechnology Coordinator and one office under the Director of Regulation and Policy:

1. Regulations Coordination Staff
2. Food Biotechnology Coordinator

260.021 - Office of Constituent Operations

The Office of Constituent Operations (OCO, HFS-550),

Catherine W. Carnevale, V.M.D., Director

The Office of Constituent Operations (OCO) is responsible for managing and coordinating the Center's international activities, consumer outreach and education functions, day-to-day communication and outreach to the food and cosmetic industries, and coordinating the content of the CFSAN website.

OCO's international functions are managed by the OCO Director's Office and the International Activities Staff. The objectives of these activities are: (1) to provide a CFSAN interface with and support to the FDA Office of International Programs (OIP) in line with the OIP Action Plan on International Activities; (2) to provide programmatic expertise and policy guidance to CFSAN Offices on Center and Agency regulatory decisions as they bear on, or are affected by, international considerations; and (3) to provide counsel and guidance to FDA staff and other U.S. government agencies to assure that CFSAN and FDA food and cosmetic regulatory activities and policies that are carried out under the Food, Drug and Cosmetic Act and other relevant statutes are also consistent with legally binding provisions of international trade agreements to which the United States is a party.

Consumer outreach is coordinated by the Consumer Education Staff. This staff maintains the CFSAN Outreach and Information Center (O&IC). The O&IC operates a 24-hour, multi-line telephone Food and Cosmetic Information Line where consumers can obtain up-to-date information on food and cosmentic safety and labeling issues. CES also handles the majority of FDA's consumer inquiries and correspondence about FDA-regulated foods and cosmetics.

OCO's Industry Activities Staff is a focal point for domestic and foreign food and cosmetic industries, principally production and distribution facilities, to obtain current information on FDA regulations, procedures and practices. This staff responds to day-to-day telephone, e-mail and letter inquiries to assist industry with understanding means of compliance with FDA regulations.

Finally, OCO, through the Website Content Coordinator, provides oversight and coordination of the content of CFSAN's internet website.

260.03 - Office of Management Systems (HFS-650), Juanita Wills, Director

Advise the Center Director on administrative policies and guidelines and scientific and technical information systems. Plans and directs all operations related to budget, financial, personnel management, training, employee development, etc. Provides guidance for Center ADP systems and there purchase.

The Office has the following:

Special Assistant: Michele Chatfied

Safety Management Staff: Director, Dorie Waddick

Division of Administrative Services: Director:Carolyn Redmond (Acting)

Division of Planning and Financial Resources Management: Director: Grover G. Heiman, III. The Division of Planning and Financial Resources Management has the following teams.

• Program Planning and Analysis Team
• Extramural and Operating Contracts Team
• Budget Execution Team

Division of Management Operations: Director: Denise K. Riley. The Division of Management Operations has the following teams

• Human Resources Development Team
• General Services Team
• Metro Lab and Offices Service Team

Division of Information Resources Management:Director: Charles Exley

The Division of Information Resources Management has the following:

Computer Systems Branch

• Personal Computer Management Team
• Database Applications Team
• Library Services Staff

Telecommunication and Scientific Computer Support Branch

• Data Communications and Network Team
• Intranet Services Team
• System Programming Team

260.04 - Office of Science (HFS-6) Robert L. Buchanan

Advises Center Director and CFSAN management team on scientific issues related to food safety and applied nutrition. Provides coordination and review on matters related to cross-cutting scientific issues involving multiple offices or disciplines. Develops centerwide management systems for effective planning, use and mobilization of CFSAN scientific resources. Serves as focal point for activities related to scientific collaborations, particularly scientific consortia in which CFSAN is a member (i.e. National Center for Food Safety and Technology, Joint Institute for Food Safety and Applied Nutrition, National Center for Natural Products Research.

Associate Senior Science Advisor: Patricia Hansen

Associate Senior Science Advisor for Research and Planning: V. Kelly Bunning

Advisory Committee Staff: Catherine DeRoever

Joint Institute for Food Safety and Applied Nutrition: Arthur J. Miller, Ph.D.

Staff College: George J. Jackson, Ph.D.

National Center for Food Safety and Technology: David Armstrong

Lead Scientist for Nutrition: Elizabeth Yetley

Lead Scientist for Epidemiology: Morris E. Potter, DVM

261 - OFFICE OF THE DEPUTY DIRECTOR, JANICE F. OLIVER

This office advises and assists the Center Director and other key officials on Center programmatic matters. It provides direction, coordination and oversight for the programmatic activities of the center.

261.01 - Associate Director of Operations, Arnold P. Borsetti, Ph.D.

Assists the Deputy Center Director in providing direction and oversight to CFSAN program functions.

261.02 - EEO Office, Joan J. Jappa, Ph.D.

This office plans, develops and implements the Center's Affirmative Action and Equal Employment Opportunity Programs.

261.03 - Executive Operations Staff, Catherine J. Bailey, Director

This office provides correspondence control for the Center; processes Agency public correspondence referred to the Center Director; develops and operates tracking systems designed to provide early warning and to resolve delays in controlled correspondence. It provides direct support to the Center Director and to the Deputy Center Director including briefing materials, background information for meetings and preparation and coordination of speeches. The staff manages the Center's Freedom of Information Act activities, coordinating responses with other Center technical, regulatory and policy units as well as developing direct responses and performs special Center wide assignments involving complex problems and issues related to Center programs, strategies and activities.

261.04 - Office of Cosmetics and Colors (HFS-100), Linda Katz, Ph.D., Director

Serves as focal point for actions involving colors and cosmetics including, but not limited to scientific studies, toxicological studies, microbiological studies, etc. It also serves as reviewer of cosmetic and color petitions, legal actions involving these products and develops regulations, compliance policy, position papers, regulatory guidelines and advisory opinions.

261.05 - Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Christine J. Taylor, Ph.D., Director

Has the primary responsibility for all matters pertaining to food labeling, food standards, dietary supplements and special nutritionals, including infant formula and medical foods. The office develops regulations, compliance policy, position papers, regulatory guidelines, and advisory opinions for matters within the scope of the responsibility of the Office and establishes labeling requirements appropriate for such foods, in coordination with other Center components. Reviews proposed regulatory actions for policy consideration, and provides technical evaluation and necessary scientific support. Develops appropriate methods for food and dietary supplement analyses and, in cooperation with the Field, maintains the Center's analytical capability for labeling compliance. Provides expert advice and assistance to the Center Director, other key officials, and the field on policy issues, field programs, and responses to petitions, initiatives, and related activities within the scope of the responsibility of the Office. The Office of Nutritional Products, Labeling and Dietary Supplements has four divisions which are:

1. Division of Compliance and Enforcement
   (HFS-810), John B. Foret
2. Division of Standards and Labeling Regulations
   (HFS-820), Felicia B. Satchell
3. Division of Nutrition Science and Policy (HFS-830),
   Lynn A. Larsen
4. Division of Research and Applied Technology
   (HFS-840), Jeanne I. Rader
5. Infant Formula and Medical Foods Staff (HFS-850), Dr. Charles Mize, Acting Director 

261.06 - Office of Food Additive Safety (HFS-200), Alan M. Rulis, Ph.D., Director

Develops regulations, advisory opinions, guidelines, position papers, etc. related to safe uses of food additives, color additives, GRAS substances, prior sanctioned substances and bioengineered foods. Manages petition review process for food and color additives and notification processes for food contact substances, GRAS substances, and bioengineered foods. Reviews proposed regulatory actions.

261.07 - Office of Plant and Dairy Food and Beverages (HFS-300) Terry C. Troxell, Ph.D., Director

Develops regulations, compliance policy, position papers, regulatory guidelines, etc. on food production and packaging techniques including chemical and microbial issues of food safety. Assesses chemical and biological contaminants including pesticides and industrial chemicals in foods for safety. Reviews proposed regulatory actions.

261.08 - Office of Seafoods (HFS-400), Philip Spiller, Director

Develops regulations, compliance policy, regulatory guidelines, labeling requirements, etc. for seafood and related products. Manages voluntary and mandatory seafood safety programs and researches various seafood industries such as aquaculture, harvesting and processing. Administers the National Shellfish Sanitation Program. Reviews proposed regulatory actions.

The Office of Seafood has two Divisions which are:

1. Division of Programs and Enforcement Policy
   (HFS-415) - Mary I. Snyder, Director
2. Division of Applied Science and Technology
   (HFS-425) - George Hoskin, Director

261.09 - Office of Applied Research and Safety Assessment (HFS-025), Thomas A. Cebula, Director

The Office of Applied Research and Safety Assessment (OARSA) recommends, develops, coordinates and conducts research in the areas of molecular biology, microbiology (virulence assessment), toxicology and nutrition to help meet the research needs of the Center's Program Offices. The Office also coordinates development of long-term research planning, in responsible program areas, with other Center and Agency components, and serves as the Center's principal research liaison with other agency centers and organizations outside the Agency. Within the molecular biology and microbial areas, OARSA scientists provide materials and training in gene probe methodology and conduct research on: the effects of microbes, their toxins and metabolic products using a variety of animal and in vitro models; identification of unknown microbial illness factors; and the mechanisms of gene activation. The toxicology divisions conduct research to determine the safety and health hazards of foods, nutritional supplements, food and color additives, chemical contaminants, cosmetic ingredients and natural toxicants, and the metabolites of these substances. The elucidation of toxicological effects is undertaken using a variety of short-term indicators, including tissue and cell culture methods, as well as through the conduct of standard regulatory toxicology studies.

261.10 - Office of Compliance (HFS-600), Joseph Baca, Director

Serves as CFSAN's liaison and focal point with the field. Serves as Center's lead office for all communications between ORA/ORO/Emergency Operations Center, HFC-160 and CFSAN relating to emergency response. Coordinates Center's program office activities with the Office of Regional Operations in development of field programs and evaluates field accomplishments by providing feedback to Center management. Manages and provides guidance to the various cooperative programs such as shellfish, milk safety, food service, interstate travel sanitation and HACCP.

This Office has the following three divisions:

1. Division of Enforcement (HFS-605)
   Judith Gushee, Director
2. Division of Field Programs (HFS-615)
   Leslie Bluhm, Director
3. Division of Cooperative Programs (HFS-625)
   Faye Feldstein, Acting Director

261.11 - Office of Scientific Analysis and Support (HFS-700) Kenneth J. Falci, Ph.D., Director

Provides scientific analysis and support to all CFSAN offices in carrying out their mission. This includes developing economic impact analyses for food and cosmetic regulations, conducting consumer attitude and behavior studies related to diet and disease, biotechnology, food labeling and claims, and infant feeding and food safety practices. Provides epidemiological reviews for microorganism risk assessment, acute health hazard evaluations, and estimates the burden of foodborne illness. Supports CFSAN research through assistance with experimental design, mathematical input and statistical analysis of experimental data. Conducts post-market surveillance and assesses adverse reactions to food products. Develops compliance and survey sampling plans. Assists international organizations such as the AOAC International and CODEX in the development of policy and criteria for review of analytical methods performance and in developing sampling plans to ensure fair and valid procedures are used when food is being tested for compliance with commodity standards. Provides pathology support to the in-house experimental studies for animal necropsies and processing and evaluation of animal tissues, in evaluating pathology data and reviewing microslides provides to the Agency as part of industry submissions, and in assisting other FDA Centers with pathology issues when requested. Provides analytical support. Additionally, the Office contributes to the activities of the Health Hazard Evaluation Board, the Institutional Animal Care and Use Committee (IACUC), and Cancer Assessment and Quantitative Risk Assessment Committees.

This office has the following divisions:

1. Division of Mathematics - Foster D. McClure,
   Director Petition Review and Experimental Design
   Team Biometrics and Risk Assessment Team
2. Division of General Scientific Support - Prem N.
   Dua, DVM, Ph.D., Director
3. Division of Market Studies - Richard A. Williams,
   Jr., Ph.D., Director
4. CFSAN Adverse Events Reporting (CAERS) Staff
   The Division of Market Studies has the following Teams:
   1. Economics Team
   2. Consumer Studies Team
   3. Epidemiology Team