Field Outreach and Leveraging Activities 2003

Field Outreach and Leveraging Activities

Academia

University of Georgia

On November 6, 2002, an investigator from the FDA's Atlanta District Office participated in a seminar sponsored by the University of Georgia's Food Science Department regarding "Starting a New Food Business." The seminar was held in Tifton, Georgia. The FDA investigator presented an overview of FDA's role as a regulatory agency, FDA's current good manufacturing practice regulations, among other topics. This seminar was the second of a series planned to assist entrepreneurs starting new food businesses.

Middle Tennessee State University

On November 5, 2002, the FDA's New Orleans District Office Public Affairs Specialist was the guest lecturer for a Food Science and Technology class at Middle Tennessee State University in Murfreesboro, Tennessee. The class provided a basic overview of the FDA with an emphasis on the role of the FDA in food safety in these times of concern related to bioterrorism. Many students were interested in advice on career opportunities. The students came to the presentation with many pertinent questions and a strong understanding of Hazard Analysis and Critical Control Point principles that could be used in their future employment.

University of Minnesota

On February 6, 2003, the FDA's Minneapolis District Office gave presentations at the University of Minnesota's Annual Food Science and Nutrition Advisory Council meeting. The program emphasized Diet, Health and Disease. The presentations and topics included trans fatty acids, whole grains and health, Chronic Wasting Disease, and a moderated discussion on bioterrorism. The presentation on trans fatty acids highlighted industry's support of the inclusion of trans fatty acid amounts in the product, but underscored the dislike of the asterisk below the food facts panel that advises consumers to minimize intake of trans fatty acids. In a presentation on bioterrorism, the role of FDA and U.S. Department of Agriculture's bioterrorism preparedness for food security were both highlighted.

American College of Obstetricians and Gynecologists

The FDA's New Orleans District Office Public Affairs Specialist staffed a food safety exhibit sponsored by the Center for Food Safety and Applied Nutrition. The exhibit was presented at the American College of Obstetricians and Gynecologists 51st Annual Clinical Meeting and Exhibition on April 28 30, 2003, in New Orleans, Louisiana. The Public Affairs Specialist distributed publications on Listeriosis and Pregnancy, Diagnosis and Management of Foodborne Illnesses (A Primer for Physicians), and Food Safety for Seniors. Approximately 4,000 physicians, nurses and other health professionals attended the meeting and exhibition.

Temple University and the Pharmaceutical Industry

The Fourth Annual Pharmaceutical Conference, co sponsored by FDA's Philadelphia District Office and Temple University, was held on April 15, 2003, in Philadelphia. The conference series, entitled, "Creating New Knowledge, FDA and Industry in Dialogue" has become an anticipated event for the Philadelphia area pharmaceutical industry. This year's conference had a keynote address from Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, as well as participation from senior staff from Center for Drug Evaluation and Research, and FDA's New Jersey and Philadelphia Districts. The theme for this year's conference involved risk management in the regulation of the pharmaceutical industry. This year's conference attracted approximately 350 attendees from industry, academia and government.

University of Puerto Rico

On April 24, - 25, 2003, the FDA's San Juan District Office Public Affairs Specialist participated in the Third Environmental and Health Fair sponsored by the University of Puerto Rico, Cayey Campus. The Public Affairs Specialist gave a presentation on food safety to students from the university and consumers from the community. Approximately 4,000 people participated in the fair including attendees from institutions, schools, universities, and government agencies. The Public Affairs Specialist provided attendees with information about FDA's mission, food safety, health fraud, among other topics. FDA provided this information in English and Spanish.

Puerto Rico East University - Excellence Center for Advanced Technology

On August 20, 2003, the FDA's San Juan District attended a press conference held by the Excellence Center for Advanced Technology to announce a collaborative alliance between industry, government and academia. The mission of this joint effort is to educate and prepare highly skilled workers for pharmaceutical and biotechnological plants for Puerto Rico's northern region. A $12 million training center is scheduled to open in September 2003, at the Puerto Rico East University, in Manati, Puerto Rico. Professionals from the pharmaceutical industry and academia engineering and biotechnology professions jointly created the center's curriculum, which will include continued courses in biotechnology, industrial mechanics and environment analysis. The FDA's San Juan District Office will be partnering to provide technical support.

Associations

San Diego Brokers Association

In March 2003, the FDA's Southwest Import District's Otay Mesa Resident Post delivered a presentation to the San Diego Brokers Association on the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Specifically, the presentation covered the registration and prior notice sections for food products imported into the country. Many of the attendees of Customshouse brokers and their clients had missed the earlier satellite downlink and used this opportunity to gather information and answer questions before the final date for submitting comments to FDA. The group was spirited in their questions following the presentations, and seemed to be able to accept the registration more easily than the prior notice aspects of the Bioterrorism Act. They plan to be prepared to comply with the regulations once implemented.

Independent Bakers Association

On February 4, 2003, the FDA's Miami Resident Post Public Affairs Specialist was guest speaker at the Independent Bakers Association (IBA) Winter Membership Meeting in Palm Beach, Florida. IBA is a national trade association comprised of small to medium sized wholesale bakers and allied trades of the baking industry. The Public Affairs Specialist discussed FDA's Food Security Efforts. The majority of questions from the audience were about the Registration of Food Establishments proposed rule.

Blood Bank Supervisor's Association

In April 2003, Public Affairs Specialist from the FDA's New York District Office and the Center for Biologics Evaluation and Research participated at the 14th Symposium Transfusion Medicine Update. The Spring Symposium presented a broad range of subjects to medical professionals, blood bank supervisors and pertinent technologists. Public Affairs Specialists provided current guidance for industry, recommendations for deferral of donors, and quarantine and retrieval of blood and blood products in recent recipients of smallpox vaccine (vaccinia virus and certain contacts of smallpox vaccine recipients). Over 200 participants visited the FDA exhibit and inquired about blood related issues.

American Association of Bovine Practitioners

The FDA's Cincinnati District Office assisted representatives from the FDA's Center for Veterinary Medicine at an exhibit for the national conference of the American Association of Bovine Practitioners. The exhibit and conference were held in Columbus, Ohio, September 18 - 20, 2003, with approximately 2000 professionals (and students) from the United States, Canada, Mexico and several other foreign countries attending. Reporting adverse drug experiences (ADE) was emphasized. Several people reported that they appreciated having access to ADE summary information on the FDA web site. FDA materials were well received.

International Dairy Foods Association

On April 8, 2003, the FDA's Chicago District Office Supervisor spoke to the Plant Operations Conference of the International Dairy Foods Association in Chicago, Illinois. The audience consisted of about 100 dairy plant managers from across the United States. The presentation covered an overview of the Bioterrorism Act. The presentation also included more detailed coverage of the provisions of the Act pertaining to facility registration and prior notification of import product. The presentation also included an update on the FDA participation in Operation Liberty Shield.

Pharmaceutical Industry Association of Puerto Rico

• On April 2, 2003, AThe 2nd Caribbean Regulatory Conference, Current Good Manufacturing Practices for the 21st Century, A Collaborative Approach@ was held at the Wyndham El San Juan Hotel in Isla Verde, Puerto Rico. The Conference was sponsored by the Food and Drug Administration (FDA), the Pharmaceutical Industry Association of Puerto Rico, and the Association of Food and Drug Officials. The FDA presentation provided the audience with insight into the FDA's new approach to pharmaceutical drug product regulation. Officials from FDA included the Associate Commissioner for Regulatory Affairs and his staff, the Southeast Regional Food and Drug Director, the Director of Compliance, Center for Drug Evaluation and Research's, the Division of Field Investigation, and district personnel. Over 300 pharmaceutical industry officials benefited from a wealth of information centered around the new Current Good Manufacturing Practices Initiative project. The first Caribbean Conference was held in San Juan in May 2001.
• On March 31, 2003, the FDA's Southeast Regional Food and Drug Director, the FDA's San Juan District Office Director, and other district managers attended a meeting with approximately 10 industry executives organized by the Executive Committee of the Pharmaceutical Industry Association of Puerto Rico. The intent of the meeting was to exchange ideas and share information on the FDA's new security initiatives in order to identify areas for collaboration in the pharmaceutical industry area. During the meeting, discussions centered around the need to establish working groups in the areas of pharmaceutical product security and laboratory networks. The meeting emphasized the commitment to continue collaborating to strengthen FDA pharmaceutical industry relations.

Indiana Society of Radiologic Technologists

On March 22, 2003, the Regional Radiological Health Specialist, an investigator from the FDA's Detroit District Office and the Indianapolis Public Affairs Specialist presented a program on Mammography Standards at the 2003 Indiana Society of Radiologic Technologists (ISRT) meeting. Approximately 200 radiologic technologists registered for the two day conference. An FDA Detroit investigator described the Mammography Quality Standards Act's re-authorization and updated regulations. The Regional Radiological Health Specialist provided important information on the regulations and an overview of activities on the national level. FDA made slides, FDA handout information and a videotape of the program available to conference attendees. Two hours of continuing education credit was awarded for this program.

Puerto Rico Industrial Security Association

On February 28, 2003, the FDA's San Juan District Office District Director and the Acting Director of the Investigations Branch attended a meeting on pharmaceutical product security sponsored by the Puerto Rico Industrial Security Association (PRISA). The Resident in Charge from the FDA's Office of Criminal Investigations gave a presentation on drug counterfeiting and product diversion. The presentation addressed new concerns regarding product security. The audience consisted of 30 Security Managers encompassing the major pharmaceutical drug manufacturers on the island of Puerto Rico. This meeting opened a new door for communication with this group of security professionals thus expanding FDA's network for information gathering and leveraging. This leveraging will enhance the safety of pharmaceutical products.

Michigan Medical Device Association

The FDA's Detroit District Office hosted the annual meeting of the Michigan Medical Device Association on June 25, 2003. The meeting provided an opportunity to introduce the Detroit District Director. The Supervisory Consumer Safety Officer in the Detroit District gave a presentation on the Medical Device User Fee and Modernization Act of 2002, and a Medical Device Update featuring the turbo Establishment Inspection Report and "Top Ten" common Quality System Regulation violations.

National Association of Retired Federal Employees

In April 2003, the FDA's Los Angeles District Office Public Affairs Specialist spoke to the Orange County chapter of the National Association of Retired Federal Employees in Fountain Valley. The presentation focused on food safety, health fraud, and dietary supplements. Questions focused on FDA's curtailing of Canadian prescription drug access, dietary supplements and health fraud, and the concern with food safety issues. FDA also supplied materials to all on a variety of additional topics such as prostate and breast cancer, weight loss, healthy eating, tetanus shots, and medication safety.

National Fisheries Institute

The FDA's New York District Office reported in March 2003, the FDA's New York Downstate Imports Branch Director addressed the National Fisheries Institute at their regional meeting in Teaneck, New Jersey. U.S. Customs and Border Protection also gave presentations, covering their Customs Trade Partnership Against Terrorism (CTPAT) procedures and the move of the Service to the Department of Homeland Security. The FDA presentation covered problems encountered with sampling of seafood imports and implementation of the Bioterrorism Act of 2002. Both presentations were well received.

Industry

Johnson and Johnson

The FDA's San Juan District Office and Johnson and Johnson (J&J ) Joint Quality Conference was held on February 25, 2003. The San Juan District provided 11 speakers for the "FDA/J&J Joint Quality Conference," which is an annual event held at the Marriott Hotel in Condado, Puerto Rico. The topics presented included regulatory, compliance and inspection issues related to drugs, devices, biologics, counterterrorism, and product security. Over 250 individuals from the J&J 's companies attended. These included representatives from the J&J facilities in Miami, Florida, New Jersey (Titusville, Bridgewater, New Brunswick, Raritan, Bridgewater, and Franklin), California (Palo Alto, Menlo Park, Vacaville, Redwood City). In addition, J&J facilities from other nations included Janssen Cilag in Mexico, Janssen Cilag in Brazil, and other J&J firms in Argentina, Belgium, Italy, Canada and the Netherlands.

The J&J coordinator of the event sent the FDA's San Juan District Office a message thanking us for a "great job" on our presentations and saying that the conference had met its objectives: providing a deeper understanding of the level of Current Good Manufacturing Practices compliance; training the organization in new regulatory tendencies and requirements by promoting the spirit of partnership between the local FDA and J&J companies; and providing the organization with information about current company/industry tendencies, challenges, and opportunities.

Importers

In August 2003, New York District Office of Import Operations, held a one day training seminar for filers and importers attended by 82 participants. The training given covered product codes, the entry review process, expectation of changes upcoming for the Bioterrorism Act of 2002, BSE procedures update, and compliance issues. The audience participation showed the import communities eagerness to remain well informed.

American Society for Quality

On April 14, 2003, the FDA's Minneapolis District Office Compliance Officer gave a presentation at the Biomedical Focus conference in Minneapolis, Minnesota. The conference, sponsored by the American Society for Quality, provided a forum for exchange of information between the FDA and the biomedical industry. The presentation covered "Recalls and Field Corrective Actions in the CAPA System."

State and Local Government Agencies

City of Baltimore

Ten Consumer Safety Officers from the FDA's Baltimore District Office (both import and domestic Consumer Safety Officers) assisted Baltimore City sanitarians in inspecting approximately 500 restaurants and retail establishments. FDA assisted sanitarians from September 21 - 24, 2003. Baltimore City placed an official request for Federal assistance through Federal Emergency Management Agency. In addition, District Consumer Safety Officers performed approximately 300 limited, directed, inspections of Maryland and Virginia food manufacturers, repackers and warehouses in those areas hit hardest by Hurricane Isabel. Following this assistance to the City of Baltimore, the District focused on continuing inspections of food firms in the Norfolk and surrounding areas.

State of Arizona

In April 2003, the FDA's Los Angeles District Office Director hosted Congressional, county and state officials from the State of Arizona for an update on agency initiatives including counter terrorism concerns. Field Congressional staff attended presentations by the Los Angeles District Director, the Phoenix Resident Post Public Affairs Specialist and Supervisory Consumer Safety Officer from the Southwest Import District. An FDA exhibit and publications were displayed and a packet given to each attendee. The District Director also met with the directors of Homeland Security and the Department of Health Services for Arizona. The discussion focused on FDA's supportive role during this period of heighten alert. Additionally, the District Director met with health officials from the State of Arizona and Maricopa County, the fastest growing big county nationwide. The District Director agreed to chair a committee of local health officials who are developing a coordinated counterterrorism plan for Phoenix and Arizona.

State of California

The FDA's Los Angeles District Office Public Affairs Specialists attended the REACH 2010 Conference held in Long Beach, California, on February 27 28, 2003, where all the REACH grant recipients of Centers for Disease Control and Prevention were gathered. Many local networks and community based organizations joined the Centers for Disease Control and Prevention staff and the California Endowment to provide training and updates as to the progress of the initiative. The REACH 2010 initiative strives to meet the Healthy People 2010 goals by involving local community networks in developing strategies and programs that will decrease the racial and ethnic disparities in health outcomes in the U.S.

State of California - Santa Clara County

On May 3, 2003, the Santa Clara County Office of the California Childhood Lead Poisoning Prevention Program (CLPPP) with assistance from the FDA's San Francisco District Office distributed a flyer written in Spanish about the potential hazards of Mexican folk terra cotta (due to leachable lead) at the Cinco de Mayo festival at the Mexican Heritage Plaza in San Jose, California. The flyer featured a color photo of a variety of Mexican folk terra cotta wares typically found to leach lead by the FDA's San Francisco District Office's laboratory.

In addition, a CLPPP community worker had a bean pot on display and demonstrated how to use a LeadCheck Swab. Swabs with Spanish instructions were given to parents of young children who have Mexican folk terra cotta at home. This outreach effort is in keeping with FDA's commitment to work with partners to improve health information to Hispanic communities.

State of Colorado

• On July 8 - 10, 2003, three FDA Southwest Region Food Specialists, with support from the Colorado Department of Public Heath and Environment, conducted a two and one-half day Hazard Analysis and Critical Control Point (HACCP) Workshop. The workshop was held at the Denver District Office and field work was conducted in local area restaurants. The goal of the workshop was to promote the use of HACCP principles and the concepts of "Active Managerial Control" during routine inspections. The workshop was also applicable to the Voluntary National Retail Food Regulatory Program Standards. Attendees included Colorado FDA Standardized Training Officers and representatives from local jurisdictions, City of Vail and El Paso County Health Department (Colorado Springs). The agenda was divided among classroom and actual field training exercises to apply HACCP from the scientific to the applied realm in retail food establishments.
• On February 26, 2003, the FDA's Denver District Office Public Affairs Specialist represented FDA on a panel of speakers at two rural informational meetings sponsored by the Colorado State Department of Agriculture. Other speakers represented U.S. Department of Agriculture, Colorado State University, industry and an opponent of biotech products. The Public Affairs Specialist introduced the new Draft Guidance to Industry for plant made pharmaceuticals. The February 2003 meeting in Montrose, Colorado, attracted 140 attendees, many of whom represented environmental groups in opposition to biotech products.
• On February 5, 2003, the Special Assistant to the FDA's Denver District Director participated in a Colorado Department of Public Health and Environment (CDPHE) Food borne Illness Taskforce System (FITS) Conference in Denver, Colorado. Over 80 Environmental Health Specialists and Public Health Nurses from each of the state's local health departments as well as representatives from the CDPHE Divisions of Consumer Protection and Epidemiology participated. The agenda included instruction on the Colorado Electronic Disease Reporting System (CEDRS), FDA's Food Security Guidelines, and an afternoon long table top exercise involving a statewide food borne illness outbreak.

State of Florida

On June 17 - 18, 2003, the FDA's Florida District Office provided training to 15 Florida Department of Agriculture and Consumer Services (FDACS) employees received training in Bartow, Florida. The training focused on how to conduct effective BSE inspections. The training was provided by the FDA's Center for Veterinary Medicine with support from Division of Federal-State Relations and the FDA's Florida District Office. FDACS currently has 4 Inspectors conducting BSE inspections for the FDA's Florida District Office under contract. The training of 11 additional employees reduced the distance for FDACS to travel to the inspection sites. The training also provided a better understanding of inspection techniques and current policies regarding BSE.

State of Georgia

The FDA's Atlanta District Office attended the Georgia Task Force Quarterly Meeting. On May 2, 2003, six Atlanta District and Southeast Regional FDA personnel attended The Georgia Task Force quarterly meeting which was held at The Georgia Department of Human Resources building in Atlanta, Georgia. Epidemiology and specific food borne outbreaks were discussed primarily. The SARS outbreak also was discussed by Georgia State Epidemiologist.

State of Illinois

On March 19, 2003, the FDA's Chicago District Director and the Director of Investigations attended a meeting of the Illinois Bioterrorism and Response Task Committee, Food and Water Security Work Group, that was held in Bloomington, Illinois. The group is part of the Illinois Governor's Task Force on Bioterrorism and consists of members from various Illinois state agencies, FDA, U.S. Department of Agriculture, and several industry representatives. The group has been charged to study current health issues with potential biological and chemical agent release scenarios, identify public health response and prevention strategies, coordinate public messages, and review results of exercises, threats and incidents. The group's objectives are to develop risk assessments, provide guidance to food producers and related firms, and to promote information sharing.

State of Minnesota

• The FDA's Minneapolis District Office participated in the Minnesota Governor's Food Safety Task Force's food safety event for junior high students in Crookston, Minnesota. The second annual "Minnesota Kids Kick Off Food Safety" event was organized to recognize National Food Safety Education Month and Minnesota's Food Safety Month. About 400 students in grades 5th, 6th and 7th at Highland School in Crookston were treated to a cookout of irradiated hamburgers sponsored by the Minnesota Beef Council, Crookston Food Service, and University of Minnesota Extension. Staff from Congressman Peterson's office, the mayor of Crookston, school board members, and local farm bureau representatives attended the event.
• On March 28, 2003, the FDA's Minneapolis District Office Public Affairs Specialist spoke about FDA consumer issues to 50 seniors at the Bismarck Senior Center. The presentation focused on food safety, buying medical products online, and dietary supplements. Seniors asked questions on buying prescription medicines from overseas, dietary supplements for arthritis, and medical devices. Additionally, the District met with North Dakota Aging Services to discuss FDA's resources for Seniors. North Dakota Aging Services and FDA will partner to share information on food safety and consumer issues.

State of Mississippi

On July 23, 2003, the FDA's New Orleans District Office attended the Mississippi Food Safety Task Force (MFSTF) Meeting in Jackson, Mississippi. The agenda for the meeting included task force objectives, agency updates, and the annual MFSTF project. Discussions during this meeting focused on fostering communications between all stakeholders in the state/local food safety system, reviewing information sharing/data collection abilities and formats among and between the food safety agencies, and coordinating efforts to produce a food safety resource flyer.

State of New York

On April 30, 2003, the FDA's New York District Office Public Affairs Specialists held a meeting with the Native American Indian Special Emphasis Program at the Bronx Veterans Affairs Medical Center and the New York State Native American Indian Health Council. Public Affairs Specialist provided an overview of the FDA and said she was committed to outreach the tribal groups. She explained about Food Safety, Diabetes, Seniors, and other educational projects that could be beneficial to the Native American Indian community.

State of North Carolina

On June 20, 2003, the FDA's Raleigh Resident Post Public Affairs Specialist attended and participated in the North Carolina Food Security and Safety Coalition's Dark Pantry Tabletop Exercise. The day long "by invitation only" exercise, was the first of four. The purpose was to engage the North Carolina Department of Agriculture, the North Carolina Public Health, state law enforcement, their supporting federal and county agencies, and industry in a Aresponse@ to a deliberately staged terrorist attack by means of a lethal contamination of the state's food supply. The State Health Director and the North Carolina Commissioner of Agriculture opened the session, welcomed the attendees and emphasized the importance of the exercise. Sixteen representatives of federal, state, county agencies and industry formed the main panel. An additional 20 observers offered comments, suggestions, and observations. Thirty-four follow-up items were identified. Media observations and interviews were filmed during the working lunch.

The FDA's Public Affairs Specialist provided participants and observers with copies of the Guidance for Industry: Food Producers, Processors, and Transporters Food Security Preventive Measures Guidance.

State of North Dakota

On April 28, 2003, the FDA's Minneapolis District Office Public Affairs Specialist met with the North Dakota Department of Agriculture and Health Staff. The purpose of the meeting was to provide an update on FDA's activities in the district. Both Departments are interested in participating in the upcoming Bioterrorism public meeting via satellite downlink. Additionally, they are interested in information from Division of Federal State Relations to reactivate their informal food safety task force.

State of South Carolina

• On March 4, 2003, the FDA's Atlanta District Office attended a meeting with the South Carolina Interagency Food Safety Council and South Carolina Agriculture. The quarterly meeting of the South Carolina Interagency Food Safety Council met at the South Carolina Agriculture Laboratory building. The agenda included discussions about Mad Cow Disease, the formation of a South Carolina Bioterriorism Advisory Committee, and other public health issues. There were 45 industry, and state and local people in attendance.
• On September 27, 2003, the FDA's Atlanta District Office attended the South Carolina Statewide Cancer Outreach Initiative. This Outreach Initiative focused on cancer awareness, education and support campaign in Charleston, South Carolina. Representatives from the FDA, including FDA Commissioner McClellan, South Carolina Senator Hollings, and Chair of President Bush's Cancer Panel, Dr. LaSalle D. Leffall, Jr., participated. Dr. McClellan spoke about FDA's role in Mammgraphy Quality Standards Act and the Agency's efforts to improve the utilization of mammography screening for people with cancer and to quickly get new products to the market. Dr. McClellan further discussed his priorities for better informed consumers, and the Take Time to Care Campaign. The local News Media, Channel 2, ABC affiliate, interviewed Dr. McClellan about FDA's support of the Campaign. More than 600 churches were represented at the meeting. In a follow up to the program, the campaign was advertised to 15,000 participants at the Moja Cultural Festival. The campaign seeks to increase utilization of mammography screening, particularly among minority and underserved populations.

State of South Dakota

On June 26, 2003, the FDA's Minneapolis District Office Consumer Safety Officer made a presentation on food allergens at the South Dakota Public Health Conference: Cultivating Stronger & Healthier South Dakota Communities, in Pierre, South Dakota. The presentation covered the difference between food allergies and food intolerances, as well as current FDA food allergen initiatives. Approximately 50 public health nurses, environmental health workers and sanitarians were in attendance.

State of Tennessee

• The FDA's New Orleans District Office reported that the Tennessee Food Safety Task Force met in FDA's Nashville Branch on April 16, 2003. The full agenda covered reports from sub committees on food security, education, and interagency sharing. The task force had the opportunity to view the U.S. Department of Agriculture/FSIS Food Safety Mobile, heard speakers from various Tennessee agencies discuss their roles with Weapons of Mass Destruction, and began plans for a conference on the topic of Food Security to be held this year.
• On July 23, 2003, the FDA's New Orleans District Office attended the Tennessee Food Safety Task Force meeting. Sixteen persons representing Tennessee Departments of Agriculture, Education, Extension and Health, the Metro Nashville Health Department, industry, and FDA participated in a quarterly meeting in the FDA Nashville office. Plans were finalized for an upcoming conference entitled, "Food Security: Understanding and Minimizing the Risks" to be held September 4, 2003, in Nashville, Tennessee.
• On April 3, 2003, the FDA's New Orleans District Office reported that representatives of the Tennessee Food Safety Task Force met with the staff of the Tennessee Department of Education in the FDA's Nashville Branch office to discuss the topic of food safety. Members of the task force expressed concerns and opinions about the topic and, in turn, met individuals responsible for development and oversight of specific elements of the curriculum, which includes food safety information. All attending felt they learned much more about the information than is included in the state curriculum, and each promised to use the other as a resource.

Puerto Rico Department of Health

On February 28, 2003, the FDA's San Juan District Office participated in a seafood conference entitled "Critical Aspects in the Consumption and Handling of Fish and Fishery Products." The conference was held at the Tropimar Beach Club in San Juan, Puerto Rico. The conference was sponsored by the Sea Grant College Program of the University of Puerto Rico and the Puerto Rico Department of Health, the Agricultural Extension Service, and the Mayaguez Campus of the University of Puerto Rico among others. The FDA's San Juan District Office Food Programs supervisor gave a presentation about the seafood requirements for importers and domestic processors as codified in 21 CFR Part 123, and other regulations enforced by the FDA. About 170 people representing the University of Puerto Rico, the Puerto Rico Department of Health, the Puerto Rico Department of Agriculture, the Agricultural Extension Service, local seafood processors, and university students attended the conference.

State of Utah

On April 9 - 11, 2003, the FDA's Denver District Director and others from the Denver District Office met officials from the Utah Department of Health and the Utah Department of Health in Salt Lake City, Utah. A separate meeting was held with the Secretary of the Utah Department of Agriculture and Food, including other representatives from the Utah Department of Agriculture and Food in Salt Lake City, Utah. Both meetings discussed areas of mutual jurisdiction, interest and aid. The meetings afforded all of the participants an opportunity to meet and become acquainted with newly appointed officials to their respective positions.

All parties pledged continued support and cooperation. In addition, a regularly scheduled meeting of the Medical Device Grassroots Taskforce was held in Salt Lake City, Utah. Present during the Grassroots meeting were the Director of the Center for Devices and Radiological Health (CDRH), the Director of the Office of Compliance in CDRH, the Director of the Office of New Device Evaluation, the CDRH Ombudsman and the Deputy Director of the Office of Enforcement. FDA officials also participated in a breakfast meeting at the Utah Life Science and Industry Association (ULISA) at the Salt Lake City Hilton Hotel. The Director of CDRH gave a presentation concerning new issues and initiatives for CDRH and the Medical Device Manufacturing Industry. During the Utah visit the FDA officials toured a medical device manufacturing facility in South Jordan, Utah; and met with the employees of Denver District's Salt Lake City Resident Post.

Health Professionals

Society of Clinical Research Associates

The FDA's Phildadelphia District Office, in cooperation with the Society of Clinical Research Associates (SOCRA), presented a seminar entitled "FDA Clinical Trial Requirements: Regulations, Compliance and GCP," in Pittsburgh, Pennsylvania on June 25-26, 2003. The event is designed to aid the clinical research professional's understanding of the mission, responsibility and authority of the FDA and to facilitate an understanding of applicable...regulations and guidelines. The planned session appears to be meeting a need of the clinical research community because, as of June 17, 2003, there were 139 registrants more than anticipated. Among them were directors of clinical research, clinical research coordinators and associates, regulatory affairs managers, clinical investigators, GCP auditors, corporate officers, QA directors, physicians and attorneys. They represent large and small firms, universities, research institutions and government facilities in twenty four states and two Canadian provinces.

The FDA's Minneapolis District Office presented the Regional Environmental Heath Workshop on April 9, 2003. The district gave an update on FDA's activities to fifteen IHS sanitarians and environmental health specialists at their annual Environmental Health Workshop in Minneapolis. The presentation covered Operation Liberty Shield, the Bioterrorism Act, Food Security Regulations, the FDA Commissioner and the Minneapolis District Director, blood bank safety, antibiotic resistance, infant formula, and bare hand contact. Participants asked questions about any new agency actions on chronic wasting disease, and whether FDA will conduct workshops or give training on bioterrorism and food security for industry. Each participant received Center for Food Safety and Applied Nutrition's CD ROM on the Bioterrorism Act and the information packet on the new proposed regulations.

Pro Health for Seniors Task Force

On July 31, 2003, the FDA's Atlanta District Office Public Affairs Specialist participated in the semi annual meeting of the Pro Health for Seniors Task Force, held at Brighton Gardens Assisted Living, a Sunrise Senior Living Community in Atlanta. The meeting theme "Depression in Older Adults: Recognizing the Symptoms, Understanding Treatment Options and Advocating for Adequate Treatment" was presented by Emory School of Nursing. The Public Affairs Specialist interacted with over 60 professionals in the fields of aging, health and shared materials and information about FDA's senior programs and activities. Pro Health for Seniors was a major supporter of FDA's National Diabetes Campaign in 2002. New initiatives with FDA and Pro Health for Seniors are under construction for seniors.

Orange County Nutrition Alert Coalition

The FDA's Los Angeles District Office hosts and co sponsors 2nd Annual Symposium Consumer Health Reality Check: Making Informed Health Decisions with the Orange County Nutrition Alert Coalition and the San Bernardino Nutrition Quackery Task Force. The symposium focused on dietary supplements, and consumers' ability to differentiate promotions from reality. A full house of 205 registrants, mostly dietitians, nurses, and some pharmacists, attended the program held at the Irvine conference room.

Foreign Countries

Argentina

On March 17, 2003, the FDA's Florida District Office, U.S. Customs and Border Protection (Customs) and Alcohol, Tobacco and Firearms (ATF), participated in an import law seminar sponsored by the Consulate General of Argentina in Miami, Florida. The purpose of the seminar was to educate importers and manufacturers of food products on import laws (including the Bioterrorism Act) and general requirements governing the importation of food and beverages in order to improve compliance of the products coming into the U.S. through our ports. FDA, Customs and ATF representatives interacted with conference participants and responded to their concerns. All Government presentations were conducted in Spanish. Attendees of the conference, mostly foreign food manufacturers, were pleased with the presentations given by the Agencies and expressed their willingness to comply with the import procedures.

Mexico

• On July 25, 2003, the FDA's Southwest Regional Small Business Representative (SBR) delivered, in Spanish, a presentation on FDA's proposed Bioterrorism regulations to Mexico's National Custom Brokers Confederation (Confederación de Asociaciones de Agentes Aduanales de la Republica Mexicana, CAAAREM) during their LXIV National Conference in Mexico City. The SBR's presentation was complemented with a presentation by the Director for Special Enforcement, Office of Field Operations and Trade Programs of the U.S. Customs and Border Protection, who focused on the U.S. Customs aspects of these proposed regulations. The main focus of both presentations were on the proposed registration and prior notification regulations. The audience, about 400 participants, expressed great interest on the subject. The majority of those attending had no previous knowledge or awareness of these proposed regulations and were very appreciative of the information. A reporter with "El Independiente," a national newspaper, interviewed the SBR to help disseminate this information throughout the country.
• On August 18, 2003, the FDA's San Juan District Office participated in an International Convention Sponsored by Mexico's Center for Development (Canifarma). The FDA's San Juan District Compliance Branch Director and the Acting Investigation's Branch Director provided a 2 hour presentation on FDA Current Initiatives to an audience of about 60 pharmaceutical plant directors and managers from Mexico and Central America during the First International Convention of Pharmaceutical Plant Directors held in Rio Grande, Puerto Rico. The audience also included regulators from the "Secretaria de Salud", Mexico's Health Department. The presentations given covered the FDA's San Juan District Office's activities and priorities as well as expanded on topics related to agency wide priorities. Topics discussed included the accomplishments under the Pharmaceutical Current Good Manufacturing Practices for the 21st Century Initiative, Bioterrorism Act and Counterterrorism related activities, and Risk Management, among others. Puerto Rico served as a pharmaceutical industry showcase to our international visitors, who in addition to the conferences attended, were also able to tour various major pharmaceutical and bio technology plant sites as well as visit a major filter manufacturer on the island as part of the week long program.

Canada

On June 23, 2003, the FDA's New York District Office Import Operations Branch gave a presentation at the Sixth Annual Conference, Customs Compliance, sponsored by the Canadian Institute. The 1/2 hour Power Point presentation provided an overview of FDA's Bioterrorism Act and addressed the Registration, Prior Notice, Establishment/Maintenance of Records, and Administrative Detention provisions of the Act. The presentation was followed by a question and answer period and was well received. Over thirty attendees were present. Other presenters included Canada Customs and Revenue Agency and various trade representatives.

Guam

The FDA's Pacific Region reported in March 2003, that an FDA Regional Milk Specialist and a Regional Food Specialist completed a one week trip to Guam which included a day trip to Saipan. The purpose of the visit was to provide Good Manufacturing/Good Retail Practices Training to the environmental health field staff from Guam and Saipan. This training consisted of both classroom and field activities. Significant time was spent at the dairy facility on Guam to assess their typhoon damages and review the firm's construction plans and facility improvements. The local environmental health inspectors and their management participated with the Regional Milk Specialist in this review and assessment. Overall, the course critiques were extremely favorable and indicated a strong desire for future training and assistance from FDA.

Additionally, the Specialists discussed organizational structure and program operations with management of both Guam and Saipan. An initial self assessment of the Guam Retail Food Program utilizing the National Retail Food Voluntary Program Standards was completed by Guam. The completed self assessment was submitted to the Regional Food Specialist for inclusion in the FDA website of enrolled jurisdictions. Saipan was also introduced to the National Retail Food Voluntary Program Standards. They indicated their intention to officially enroll in this program.