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  1. Enforcement Story

Field Outreach and Leveraging Activities 2002

Field Outreach and Leveraging Activities 2002

Bioterrorism Training and Workshops

Bioterrorism Workshop

State of New Jersey, Rutgers University (RU) and the University of Medicine and Dentistry of New Jersey – In February 2002, FDA’s New Jersey District Office held a Counter Terrorism Conference. The New Jersey District, a representative from FDA’s Center for Food Safety and Applied Nutrition (CFSAN), State of New Jersey Officials, other public health officials, and industry participated in a workshop sponsored by Rutgers University (RU) and the University of Medicine and Dentistry of New Jersey (UMDNJ) concerning the food system and terrorism. The workshop was intended to identify possible terrorist events that would be most disruptive to the food system and to suggest immediate and long-term collaborative responses from the education and research communities at RU and UMDNJ and their partners from the business and government sectors.

Food Safety and Bioterrorism

New Hampshire Safe Food Alliance - On May 9, 2002, the New Hampshire Safe Food Alliance, along with the New Hampshire Grocers Association, New Hampshire Department of Health and Human Services, Bureau of Food Protection and FDA held a day long conference on food safety and security. The purpose of the conference was to provide the food service industry, regulators, legislators and anyone concerned about food safety with timely information and tools necessary to assist with the prevention of acts of bioterrorism. It was a sold out occasion with over 90 people in attendance. The morning session consisted of presentations by FDA and New Hampshire's Office of Emergency Management. The afternoon session was a town hall type meeting where the audience asked questions from the morning presenters and from FDA, Food Marketing Institute, National Restaurant Association and New Hampshire's Office of Community and Public Health. The audience had numerous questions about how security could be increased in their particular situations.

Bioterrorism and Food Safety

FDA’s Minneapolis District Office – FDA’s Minneapolis District Office participated in a Food Bioterrorism Conference on December 17, 2001. The Minneapolis District Compliance Branch attended the Bio-terrorism and Food Safety-II Conference at the University of Minnesota. The conference was hosted by the University of FDA’s Minneapolis District Office, Minnesota's Center for Infectious Disease Research and Policy (CIDRAP), the Center for Animal Health and Food Safety and the School of Public Health. Other FDA attendees were from ORA-Emergency Operations, FDA’s Center for Food Safety and Applied Nutrition and FDA’s Office of Criminal Investigations. Officials also attended the meeting from Department of Defense, Federal Bureau of Investigations, Centers for Disease Control and Prevention, and the State of Minnesota Epidemiologist Office, Department of Agriculture, Department of Health officials, and industry. The program included presentations and workgroup sessions, which addressed issues and made recommendations.

Bioterrorism Orientation

FDA’s San Juan District Office – On December 12, 2001, FDA’s San Juan District Office attended a 3-hour Bioterrorism Orientation meeting for Federal Agency Heads at the U.S. Department of Agriculture at the Luiz Munoz Marin International Airport, San Juan, Puerto Rico. The meeting was sponsored by the Puerto Rico Safety and Health Council and featured presentations by Jose Carpena (Director, Puerto Rico Area Office, OSHA, Luis Sanchez (GSA/Federal Protective Service Division), John Malave (U.S. Postal Service), a representative of the Junta de Calidad Ambiental (Puerto Rico Environmental Quality Board) and Sandra Gracia, M.D., (Chief, Nuclear Medicine Service, Veterans Administration Medical Center). The presentations focused on procedures to be used for dealing with suspicious packages and letters, including response capabilities of the agencies involved and the development of emergency plans. Approximately 50 representatives of federal agencies attended (including Center for Disease Control and Prevention, Federal Bureau of Investigation, U.S. Department of Agriculture, Occupational Safety and Health Administration, Internal Revenue Service, Environmental Protection Agency, Social Security Administration, Department of Defense, and FDA).

Bioterrorism Preparedness

FDA’s Chicago District Office - FDA’s Chicago District met with Administrators from the Federal Emergency Management Agency (FEMA) on December 4-5, 2001. FDA’s Central Region's Emergency Preparedness Coordinator attended the quarterly FEMA Region V Regional Interagency Steering Committee (RISC) meeting in Chicago, Illinois. Updates were given on FEMA's Urban Search and Rescue, and Center for Disease Control and Prevention’s participation in the World Trade Center incident. The Public Health Service gave a presentation on the National Pharmaceutical Stockpile logistics requirements. The U.S. Coast Guard, Civil Air Patrol, National Weather Service, and Nuclear Regulatory Commission also gave presentations. Continuity of Operations (COOP) and the results of the Joint Federal/State Assessment on Terrorism Preparedness were also discussed.

Bioterrorism Preparedness

FDA’s Atlanta District Office – On April 17, 2002, FDA’s Atlanta District Office, Southeast Regional Office, and Southeast Regional Laboratory management attended the quarterly Georgia Food Safety Task Force meeting in Atlanta. The principal speaker spoke about Bioterrorism Preparedness in Georgia. The issue of large quantities of cheese being brought into Georgia in personal baggage was also discussed.

Bioterrorism Awareness

FDA’s Pacific Regional Office – FDA’s Pacific Regional Office hosted a two-day meeting focused on bioterrorism awareness levels, plans with the nine states, and Pacific Trust Territories that encompass the Pacific Region. States were represented by directors from their Departments of Agriculture, Health and in some cases Livestock. Also represented was Canada, Centers for Disease Control and Prevention, Federal Bureau of Investigation, FDA’s Office of Criminal Investigation, and he Department of Health and Human Services’ Regions IX and X Emergency Operations personnel. The first day focused on each state reporting their current perspective on bioterrorism and their efforts at planning for prevention and response. The second day was a brainstorming session concerning current needs of the states and territories to continue their prevention and response planning and how better to work with their neighboring states and federal agencies including FDA.

Academia

University of Puerto Rico

FDA’s San Juan District Office – On April 22 - 23, 2002, FDA’s San Juan Public Affairs Specialist participated in the University of Puerto Rico Environmental Health Fair held in Cayey, Puerto Rico. Exhibitors that participated in the fair were the Commonwealth of Puerto Rico Energy Administration, Natural Resources Department, Division of Children and Parents, and the Office of Safety and Health. Also attending were the U.S. Environmental Protection Agency, and the University of Puerto Rico Cayey Campus Sea Grant Program and Zoology and Biology Department, among others. Approximately 400 people visited FDA's booth and requested our printed material.

FDA’s San Juan District Office – The San Juan District and FDA’s Center for Food Safety and Applied Nutrition (CFSAN) provided a workshop for the University of Puerto Rico. On August 23, 2002, CFSAN and the San Juan District in conjunction with the District’s Senior Public Affairs Specialist and the Director of the School of Family Ecology and Nutrition, Education Faculty of the University of Puerto Rico, offered the workshop entitled, "Science and Our Food Supply: Investigating Food Safety from Farm to Table" to a group of 45 educators. Participants included professors of the Family Ecology and Nutrition Department, members of the Coordinating Board of Family and Consumer Sciences of Puerto Rico (which included Directors of Nutrition programs of different universities, state agencies and professional associations), and students in their graduation year. The topics covered included an overview of the science and our food supply program, a presentation on the global food supply, the presentation of a five module video (understanding bacteria, outbreak and future technology, food borne illness investigation, processing and transportation).

A key element was the presentation by a high school teacher who attended the full week workshop in Washington, D.C. two years ago. She brought with her several of her students who gave a demonstration of an experiment they conducted while implementing the program. During the afternoon, participants had an opportunity to break out into groups and work on several related activities. They all provided a brief accomplishment report. Speakers included the Senior Public Affairs Specialist from the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the Director of Emergency Coordination and Response, a CFSAN microbiologist and a food technology specialist from the University of Puerto Rico, Agricultural Extension Service. The Acting District Director provided welcoming remarks and FDA’s senior Public Affairs Specialist moderated the activity.

Georgia Institute of Technology

FDA’s Atlanta District Office – In April 2002, FDA’s Atlanta District Office gave a presentation to the Georgia Institute of Technology chemical engineering students. The class was assigned a biomedical engineering case study and had weekly meetings with outside visitors such as a corporate CEO, a science journalist, a patent lawyer, and a FDA representative. The presentation included a brief overview of the new drug approval process, the need for effective communication between engineers and FDA regulators, thinking like a regulator, how engineers can influence regulations, and the consequences of disobeying regulations. This was the fifth year that FDA was invited to speak to this class. Approximately 25 students were in attendance. Several students expressed an interest in working for FDA and information was provided regarding applying for current FDA openings.

Medical Community

Southeast Area Blood Banks Association

FDA’s Atlanta District Office – On March 14, 2002, an official from FDA’s Atlanta District Office delivered a speech on Biological Product Deviation Reporting during the Southeast Area Blood Banks Association (SEABB)/Georgia Clinical Laboratory Scientists Joint Annual Meeting, held in Atlanta, March 13 - 14, 2002. Highlights of the speech included a summation of the requirements as outlined in the final rule, as well as 21 Code of Federal Regulations, Section 606.171, a comparison of FY-00 and FY-01 reportable events received on various types of facilities, and general comments related to the draft guidance document. There were over 100 hospital and community blood banks, transfusion and immuno-hematologic service professionals in attendance.

Association of Clinical Research Professionals

FDA’s Dallas District Office – FDA’s Dallas District Official spoke to a group of members of the Tulsa, Oklahoma, Chapter of the Association of Clinical Research Professionals (ACRP) on March 12, 2002. More than 40 chapter members including Clinical Study Coordinators, Institutional Review Board Coordination Staff, Contract Research Organization Monitors, and Industry Study Monitors attended the presentation entitled, "Common Deviations Observed During FDA Inspections."

Annual Biomedical Focus Conference

FDA’s Minneapolis District Office – FDA’s Minneapolis District representatives were featured speakers and panelists at the 16th Annual Biomedical Focus Conference in Minneapolis, Minnesota, on July 22 - 24, 2002. A presentation entitled, "FDA: What Have We Done for You Lately?" was provided as an overview of FDA, the district, and resources for medical device users and consumers.

Emory University, and Morehouse School of Medicine

FDA’s Atlanta District Office - On April 17, 2002, FDA’s Atlanta District Office Public Affairs Specialist, the Regional Food and Drug Director, Southeast Region and Center for Food Safety and Applied Nutrition representatives participated in a planning meeting with the Department Health and Human Services (DHHS) Region IV Secretary and staff and representatives from Emory University. The purpose of the meeting was to discuss the DHHS/FDA Townhall Meeting that were be held April 21, 2002, at Emory University in Atlanta, Georgia. The program format, list of program participants, target audiences, and anticipated outcome were discussed.

The meeting was sponsored by DHHS Region IV, Emory University, and Morehouse School of Medicine. The theme of the meeting was “Reaching and Serving Communities through Public Health Integration.” The goal of the meeting was to promote health and disease prevention by partnering between government, industry, health care professionals, and community leaders, and to support the President’s priority to make government operations more citizen-centered and result-oriented. The anticipated outcome is education and dissemination of important public health information and positioning for continuing public health integration to improve health outcome.

University of California Berkeley Extension

FDA’s San Francisco District Office – FDA’s San Francisco District Office Public Affairs Specialist (PAS) taught a segment entitled FDA Perspective in a four-day course on "The Drug Development Process" sponsored by the University of California Berkeley Extension. The PAS covered bioresearch monitoring, postmarketing surveillance/MedWatch, PDUFA, guidance documents, recent Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research initiatives, and the Agency's consumer education role, e.g., the "Buying Medical Products Online" campaign. There were 60 participants from Pharmaceutical/biotech firms throughout the United States with such wide-ranging job titles as Director of Drug Safety, CEO/CFO, Scientist/Project Manager, Marketing Director, New Products Director, and Director of Corporate Communications. The long question and answer session covered the gamut from FDA Commissioner to the regulation of dietary supplements.

Temple University School of Pharmacy

FDA’s Philadelphia District Office – FDA’s Philadelphia District Office, Center for Drug Evaluation and Research and the Temple University School of Pharmacy partnered for the third consecutive year in presenting a seminar for the pharmaceutical industry entitled “Creating New Knowledge, FDA and Industry in Dialogue.” The seminar covered a broad range of issues; however, a theme in this year’s event was preparation and response to possible terrorist threats.

Among the presentations that addressed this topic were the keynote presentation by Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, “Counter Terrorism: Strategies for a joint FDA/Industry Response” and a presentation by Ben England, Regulatory Counsel to the ACRA, “Importing Pharmaceuticals, Product Security for Drugs and Biologics.” The seminar was attended by over 200 industry representatives plus another 100 people from Temple University and FDA.

Other Federal Agencies

Indian Health Service

FDA’s Dallas District - The Dallas District’s Public Affairs Specialist participated in a Health and Human Service Region VI-Indian Health Service Communication and Coordination Session on May 22, 2002. The Secretary's Regional Representative and the Indian Health Service Director hosted the event. A senior representative of Intergovernmental Affairs/Indian Health Service provided an historical overview of Native Americans in the U.S. as well as information about their health and social service needs. Several Indian Health Service Directors and Representatives presented information on their respective districts. Likewise, several Health and Human Service agencies presented overviews of their agencies.

The Public Affairs Specialist gave a brief presentation on two recent collaborations targeting Native Americans as follows: FDA’s Center for Food Safety and Applied Nutrition, Food Safety Initiative entitled "Honor The Gift of Food By Keeping It Safe," a collaboration with the U.S. Department of Agriculture-Food & Nutrition Service/Food Distribution on Indian Reservations program and the Southwest Chili Peppers Nutrition Education Task Force; FDA/Office of Women’s Health initiative entitled, "Take Time To Care About Diabetes For Yourself, Your Family, Your Community" a collaboration with Carl Albert Indian Hospital/Chickasaw Nation Healthcare System. This is a pilot program consisting of extensive community outreach to conduct risk assessments, screening and referral of undiagnosed women with diabetes as well as to promote prevention and adequate management of diabetes.

U.S. Department of Agriculture

FDA’s Atlanta District Office – On August 15, 2002, officials from FDA’s Atlantic District Office met with representatives of the U.S. Department of Agriculture to discuss strategies for developing an aggressive food safety education program for September 2002. The meeting focused on plans for community outreach involving the Global Food Safety Education Campaign and the campaign's presentation at the "Thinking Globally-Working Locally" food safety conference that was held in Orlando, Florida, on September 18-20, 2002. Food safety education and communication leaders from across the country presented projects, assessed current trends, and planned for the future to prevent food borne illness. FDA created GFSEC in 1998. The campaign is supported by Center for Food Safety and Applied Nutrition.

U.S. Department of Agriculture, U.S. Customs Service

FDA’s San Juan District Office – On April 15, 2002, FDA’s San Juan District Office conducted an outreach meeting with veterinarians from Colegio de Veterinarios de Puerto Rico and to representatives from Federal and Commonwealth agencies to discuss veterinary issues and to coordinate strategies to deal with common problems in this area. Eighteen persons from different organizations participated: U.S. Department of Agriculture, U.S. Customs Service, OCI, and the Commonwealth of Puerto Rico, Department of Agriculture. A Compliance Officer from the Center for Veterinary Medicine (CVM) visiting the San Juan District Office and discussed some issues of interest at CVM such as BSE, imports, counter-terrorism, the misuse and compounding of drugs, anti-microbial resistance, and the CVM web page. The group discussed the illegal importation and mis-use of Berenyl, the tissue residue problems such as use of Gentamycin on meat producing animals, and the selling of illegal veterinary drugs in farm stores and pet shops. The group developed 13 action items.

FDA’s New York District Office – In July 2002, FDA’s New York District Office attended the monthly Port of New Jersey Users meeting. Representatives attended from FDA, U.S. Customs Service, U.S. Department of Agriculture (USDA), Fish and Wildlife Service, Port Authority, carriers, warehouses, and railroads. U.S. Fish and Wildlife Service reported the largest ever seizure of caviar for violation of the convention of endangered species. USDA reported a significant increase in their deveining activities.

U.S. Department of Agricultural Research Service -- Eastern Regional Research Center

FDA’s Philadelphia District Office – On July 17, 2002, district representatives met with representatives from the U.S. Department of Agricultural Research Service Eastern Regional Research Center (ERRC). The purpose of the meeting was to update and expand the current partnership between the district and ERRC. The scope of the agreement was expanded to include more opportunities for cross training and sharing of technical expertise, collaborative research, exchange of information between the two agencies, networking with state public health counterparts, and access for FDA to “state of the art” food manufacturing process simulation labs and genomics/proteomics capabilities available at ERRC.

U.S. Customs Service

FDA’s Florida District Office – On July 19, 2002, FDA’s Florida District Office participated jointly with U.S. Customs Service (USCS) and other local Government agencies in a meeting sponsored by the Marketing and Trade Development from the Miami-Dade Aviation Department, Miami, Florida. Representatives from the Bolivian food industry and local food trade entities are also in attendance. The meeting approach was to educate importers of food products in the laws and regulations of importing. FDA and USCS representatives interacted with the participants and responded to their concerns which were mainly those of canned foodstuffs. Attendees of the meeting welcomed the opportunity to discuss and receive feedback from the joint efforts of FDA and USCS and expressed their willingness in complying with import procedures.

FDA’s Baltimore District Office - FDA and the U.S. Customs Service (USCS) in the Port of Baltimore are working on several joint initiatives in an effort to improve procedures and communications. The first completed project under this initiative was the combination of FDA's Notice of Refusal of Admission form and Customs' Redelivery Notice into one single notification letter. The second project is the procedure for joint destruction/exportation of refused merchandise under FDA and Customs' supervision. A meeting was held with USCS, Port of Baltimore, on May 7, 2002, to discuss implementation of the joint destruction/exportation procedure. These initiatives have strengthened the district's relationship with USCS and improved customer service.

Veterans Administration

FDA’s Minneapolis District Office – The University of Minnesota, the HHS/Office of Human Research Protections, the Veterans Administration, and FDA co-sponsored a conference which was held at the University of Minnesota on May 13 -14, 2002, titled “Innovation, Inclusiveness, and Informed Consent: Current Challenges for IRBs.” There were 225 attendees. The district co-presented a workshop on “Medical Devices and Regulatory Compliance Challenges for IRBs” with a Medtronic, Inc., representative. Following the conference, Dr. David Lepay and Stan Woollen of FDA’s Office for Good Clinical Practice visited the district to meet with the Biomedical Research Monitoring group and management. An excellent exchange of information took place at the district and at the conference.

State Governments

Michigan Department of Agriculture

FDA’s Detroit District Office – On January 20, 2002, the district personnel gave a presentation to approximately 150 Michigan Department of Agriculture, Michigan County Health Department personnel, and Food Industry Representatives. The presentation covered practical aspects of trace backs, recalls and related activities, and some of the real life problems that can arise during these activities. Handouts were given out. The hand out packet included a copy of the overhead presentation, a summarized trace back (tracing back to the origin of a product) example, an example of a recall envelope, and a copy of the Federal Anti-Tampering Act. Also included was a Small Business Program Brochure that was supplied by the CER Small Business Representative. The presentation generated many excellent questions from the audience concerning recalls and trace backs.

Illinois Health Fraud Task Force

FDA’s Chicago District Office - FDA’s Chicago District hosted the Illinois Health Fraud Task Force meeting on August 21, 2002. Donna Weathersby Davis, Vice Chair of the Illinois Health Fraud Task Force, attended the National AIDS Health Fraud Task Force Partnership meeting in New Orleans. She shared information on how to prepare for a budget request, discussed the selection of officers, the mission of the National AIDS Task Force, conference call participation, membership drive, and brainstorming issues regarding the structure of the task forces. In addition, the Illinois Health Fraud Task Force provided information on their current budget, plans for FY 03 activities, and the contents of their membership handbook.

New York State Department of Agriculture and Markets

FDA’s New York District Office – FDA’s New York District Office held a second workshop in upstate New York regarding common labeling violations that lead to imported foods being recalled in Batavia, New York. A prior workshop had been held in downstate New York in the Jamaica complex. The workshop, sponsored by the Niagara Frontier Conference of CASA, was well attended, with 52 of the 80 attendees Traveling from Canada to attend the workshop. Representatives from the New York State Department of Agriculture and Markets were present, and the local area supervisor gave an overview of labeling violations found in New York State recalled Food products. The District Director, downstate recall coordinator, an import compliance officer, the director, upstate import branch, and the special assistant to the district director gave very informative presentations. The workshop was well received and a request for a third workshop was requested to address the northern border of New York State and Canadian exporters from Quebec.

FDA’s New York District Office- - A training conference was held at the New York State Department of Agriculture and Markets (NYSDAM) office in Albany, New York, on March 4, and May 2, 2002. The training conference was part of FDA/NYSDAM Medicated Feed State Contract. The conference agenda was well organized and represented most all aspects of the Bovine Spongiform Encephalopathy (BSE) program with speakers from FDA’s New York District Office, NYSDAM, FDA’s Center for Veterinary Medicine (CVM) and Industry. Nineteen state farm product inspectors were trained to perform the BSE state contract inspections. The State is contracted to do 372 inspections for prohibited protein (BSE) compliance, mainly at animal feed stores and feed mills. The animal industry consultant described a trade organization (AFIA) BSE certification program which is spreading throughout the industry and which we have recently encountered in the course of our prohibited protein inspections. NYSDAM Commissioner made an unexpected presentation to the attendees thanking them for the work they have done in this program area and stressing the importance which exists in the BSE arena.

California Food and Drug Branch

FDA’s Los Angeles District Office and FDA’s San Francisco District Office management met with representatives of the California Food and Drug Branch to discuss the Food Safety Partnership in May 2002. The goal of the meeting was to enhance communications, procedures and processes relating to the partnership. Steps were taken to plan food work and share inspectional findings to allow better leveraging of agency resources while increasing consumer protection.

Georgia Department of Agriculture

FDA’s Atlanta District – On May 24, 2002, FDA’s Atlanta District Office and the Georgia Department of Agriculture, Chemical Laboratories Division, presented a joint talk at the Southwest and Southeast AOAC Laboratory Conference in Atlanta, Georgia, regarding recent activities involving imported cheese. The State laboratory presented the most recent illness outbreaks, which included fetal deaths and the analytical results of the outbreaks which included pathogenic organisms, such as Listeria. Recent cases mentioned included the states of California, North Carolina, and Georgia. FDA’s Atlanta District Office presented recent activities at the Atlanta Airport, Atlanta, Georgia, regarding passenger baggage importation of El Salvadorian cheese under Import Alert 12-11.

Illinois Department of Public Health

FDA’s Chicago District Office – Representatives from the FDA’s Chicago District Office and the Illinois Department of Public Health, Division of Food, Drugs and Dairies met in Springfield met on March 30, 2002, to develop the annual workplan. Topics covered in the meeting included State Food Contract assignments, Seafood Hazard Analysis and Critical Control Points, and Low-Acid Canned Food Partnerships.

Minnesota Department of Health

FDA’s Minneapolis District Office – On May 15, 2002, district representatives from FDA’s Minneapolis District Office attended the Minnesota Department of Health's planning meeting to develop a statewide food safety plan. Planning for this activity started two years ago and includes state and local governments, grassroots organizations, academia, and industry representatives. The district announced the grant funds for summer food safety education, and solicited partnership and activity ideas from the attendees.

Michigan Department of Agriculture

FDA’s Detroit District Office – On April 24, 2002, a district representative served as a member of the Food Safety Advisory Committee to the Michigan Department of Agriculture in Lansing, Michigan. This committee is charged with the responsibility of approving over $300,000 of funding for consumer and industry food safety education programming throughout Michigan.

Minnesota Governor's Food Safety Task Force

FDA’s Minneapolis District Office – FDA’s Minneapolis District received approval for a $1,500 food safety education grant from FDA Center for Food Safety and Applied Nutrition entitled "Summer Food Illness -- It's No Picnic!" The district formed a partnership with the Food Safety and Inspection Service of the U.S. Department of Agriculture and the Minnesota Governor's Food Safety Task Force for this summer initiative to educate food service workers and consumers about outdoor food safety.

Illinois Foundation for Quality Health Care

FDA’s Chicago District Office – The Chicago District officials participated in the 2002 Mammography Conference at the Hyatt Hotel in Oak Lawn, Illinois, sponsored by the Illinois Foundation for Quality Health Care. This organization is responsible for informing health care professionals and other health care partners about recent trends in the detection and treatment of breast cancer and providing methods for educating minority communities about the importance of early detection.

State of Maryland

FDA’s Philadelphia District Office – On April 30, 2002, FDA’s Regional Shellfish Specialist hosted and chaired a meeting of representatives of the agencies responsible for enforcement of the National Shellfish Sanitation Program (NSSP) within the State of Maryland. The purpose of the meeting was to update the 1977 Memorandum of Understanding (MOU) delineating NSSP responsibilities among the agencies. The meeting was very useful and the participants agreed to their responsibilities. Upon completion of the new MOU, it will be presented for signature to the Secretaries of the Maryland Department of Health and Mental Hygiene, Department of the Environment and the Department of Natural Resources.

State of New Jersey

FDA’s New Jersey District Office – On April 18, 2002, FDA’s New Jersey District officials met with the County and Municipal Consumer Agencies of New Jersey. This group consists of local government officials involved in investigating, among other things, consumer fraud. The Consumer Product Safety Commission, the Postal Inspection Service, and the Veterans Administration also participated in the meeting. A major topic of discussion involved plans for Consumer Bowls -- high school competitions that test and educate high school students about consumer fraud thereby making them less likely to be future victims of such fraud.

Industry

Nogales Broker Association in Nogales, Arizona

FDA’s Southwest Import Division - FDA’s Southwest Import Division (SWID) held private laboratory seminars in Arizona. SWID’s Laboratory Assessment Officer, Nogales Compliance Officer and Arizona Laboratory Microbiologist presented a half-day seminar on April 25, 2002, to the Nogales Broker Association in Nogales, Arizona. The seminar educated the membership on importing and exporting regulations, what private laboratories need to know, microbiological determinations and other compliance regulations. There were 20 attendees in the Nogales, Arizona seminar including Mexican representatives from a sampling service. On April 26, 2002, a similar but all day seminar was given to the Southwest Arizona Port Users Association in San Luis, Arizona. The San Luis membership requested more in-depth education through their requested topics. There were 40 attendees including several Mexican exporters and growers of raw agricultural products.

Diagnostic X-ray Equipment Assemblers

FDA’s Detroit District Office: On August 20, 2002, FDA’s Detroit District, in partnership with the State of Michigan, presented a workshop for diagnostic x-ray equipment assemblers. The workshop was held in the Lansing, Michigan area and included presentations by the FDA’s District Radiological Health Specialist and physicists from the State of Michigan, Radiation Safety Section. The agenda also included a presentation from FDA’s Center for Devices and Radiologic Health (CDRH) covering new proposed revisions to the Federal Performance Standard for fluoroscopic x-ray equipment. Approximately fifty attendees representing more than thirty companies attended the workshop. X-ray assembler reporting and testing requirements for both Federal and State regulations were discussed at the workshop.

2002 Chemists Convention

FDA’s San Juan District Office - On August 9, 2002, the district provided a one-day course entitled “New Drug Development” to an audience of about 125 chemists participating in the 2002 Chemists Convention held in the Caribe Hilton Hotel in San Juan, Puerto Rico. One Senior Chemist, a Compliance Officer and the district's Pre-Approval Manager shared information on the new drug approval process from research and development to marketing of the new drug, describing the stages any new drug product must go through before getting to the consumer and the steps taken by the Agency to ensure the product's safety and efficacy.

International Society of Pharmaceutical Engineers

FDA’s Atlanta District Office – FDA’s Atlanta District Resident Post investigator made a presentation at the International Society of Pharmaceutical Engineers (ISPE) held in Durham, North Carolina. A speech on the Agency's revised Drug Process Inspections compliance program was addressed to an audience of over 300 individuals from various pharmaceutical related industries. The speech was well received, and the committee expressed their appreciation to FDA for the presentation.

Importers and Brokers

FDA’s Chicago District Office - FDA’s Chicago District, in cooperation with the Illinois Department of Public Health, made a presentation to area importers and brokers on April 10, 2002. The program included a morning session covering the seafood Hazard Analysis and Critical Control Point (HACCP) regulation for importers. The afternoon session included coverage of general importation concerns, including changes to FDA’s import program since September 11, 2001, and coverage of FDA food security guidance for importers and filers. Over 100 area filers and importers attended the presentations on Seafood HACCP regulations and importation concerns.

Association of Food Industries

New York District Office – FDA’s New York District Office Import Operations held a meeting with the Association of Food Industries (AFI), Neptune, New Jersey, in the Atrium Conference Room of the FDA Jamaica complex. Forty AFI members attended. Bob Bauer, AFI President, submitted a list of questions on importing food products in advance. FDA gave a two-hour presentation during the meeting, which covered the answers to AFI questions. The AFI membership was very interested and asked viable questions. The format of this meeting provided information that will facilitate FDA review through a higher level of data integrity entered electronically by the AFI members' Customs House Brokers.

AFI also distributed their annual magazine which contained an article resulting from FDA’s New York District Office seminar on "Food Labeling Problems." FDA's top labeling violations were covered in the article. Another article in the magazine was "Bioterrorism in Food Imports."

Pharmaceutical Industry

FDA’s New York District Office - The New York District and the Northeast Regional Laboratory employees, including managers, analysts, and investigators gave presentations at the 3rd FDA/PQI Laboratory Current Good Manufacturing Practices Conference conducted December 3 - 5 2002, in Woodcliff Lake, New Jersey. Officials from FDA’s Northeast Regional Laboratory and FDA’s New York District Office speakers covered all aspects of laboratory current good manufacturing practices regulations.

Topics discussed at the Conference included the following: conducting FDA inspections of pharmaceutical laboratories, FDA's priority pharmaceutical analytical programs, the NDA/ANDA method validation program, active pharmaceutical ingredient (API) impurity research conducted at the Northeast Regional Laboratory and the USP impurity requirements. In addition, an “FDA Question and Answer” panel was held to discuss API laboratory issues, and microbiological laboratory issues. In addition to the many FDA speakers, there were a number of speakers representing the pharmaceutical industry or pharmaceutical consultants. The conference was attended by approximately 120 pharmaceutical industry representatives.

National Shellfish Sanitation Program

FDA’s Philadelphia District Office – On April 30, 2002, FDA’s Regional Shellfish Specialist hosted and chaired a meeting of representatives of the agencies responsible for enforcement of the National Shellfish Sanitation Program (NSSP) within the State of Maryland. The purpose of the meeting was to update the 1977 Memorandum of Understanding (MOU) delineating NSSP responsibilities among the agencies. The meeting was very useful and the participants agreed to their responsibilities. Upon completion of the new MOU, it was presented for signature to the Secretaries of the Maryland Department of Health and Mental Hygiene, Department of the Environment and the Department of Natural Resources.

The Diabetes Coalition

FDA’s Chicago District Office – FDA’s Chicago District participated in the Chicago Southeast Diabetes Community Action Coalition on May 23, 2002. FDA investigators attended several workshops on Disparities in Diabetes Health and Media outreach and gave a presentation to the forum on the Office of Women’s Health “Take Time to Care about Diabetes.” Other workshops included: “How Does Diabetes Affect African Americans and Latinos/Hispanics,” and “Risk Factors for Diabetics.” Approximately 250 people were in attendance representing the Midwest Latino Health Research Training and Policy Center, Illinois Diabetes Control Program, Food and Drug Administration, Illinois Department of Human Services, Region V, Office of Women’s Health, Center for Disease Control and Prevention from Atlanta, Georgia, as well as the National Black Nurses Association, Centro Juan Diego and the Racial and Ethnic Approaches to Community Health 2010 Initiative (REACH). Diabetes Coalition mission and goals are to reduce diabetes mortality, hospitalizations, complications and related disabilities among African American and Latinos in Chicago’s southeast side communities.

Foreign Countries

Canada

FDA’s New York District Office – On December 12, 2001, FDA’s New York District Office hosted a meeting with six representatives of the Canadian Food Inspection Agency (CFIA) at the Buffalo office. The meeting was held to discuss topics of mutual interest including notifications of refused/rejected goods, botulism found in Lake Erie fish this Public Affairs Specialist summer, and emerging problems. The CFIA representatives were from the Mississauga, Ontario, and Napanee, Ontario Offices, and deal primarily with seafood products. The CFIA representatives also attended the satellite downlink broadcast on Fish and Fisheries Products Hazards and Controls Guidance.

Mexico

FDA’s Southwest Import Division – personnel from FDA’s Otay Mesa Resident Post gave a presentation on FDA's role in Food Safety along the California/Baja California Border held at the Universidad Autonoma de Baja California, Mexicali, B.C., Mexico. The forum was set up so that governmental officials from both sides of the border could discuss similar topics from each perspective. Other discussion topics included pesticides, lead poisoning and water quality along the border. The forum was sponsored by the California Center for Border and Regional Economic Studies (CCBRES) located at Imperial Valley Campus of San Diego State University. The audience was composed of federal and state governmental officials, educators, and industry personnel with the goal of facilitating communication between the different environmental health sectors of the California/Baja California Border region.

Argentina

FDA’s San Juan District Office - On July 17, 2002, a district Drug Specialist Consumer Safety Officer gave a three-hour presentation on FDA's Systems Approach for Drug CGMP Inspections. The presentation was given at a CGMP training course sponsored by the World Health Organization (WHO) in Buenos Aires, Argentina. This one-week course is currently being offered in several Latin American countries, and is one of the initiatives of the Pan American Network for Drug Regulatory Harmonization. This Network includes representatives from Regulatory Agencies, Industry, Academia, Consumer Groups and Trade Associations from Latin American Countries and the USA. The objectives of the Network are: identify global harmonization issues and the relevance to the region; identify stage of development in current sub-regional groups; identify common obstacles and problems; and recommend subjects, strategies and actions to facilitate hemispheric Drug Regulatory Harmonization. Approximately 40 representatives from Industry, Regulatory Agencies and Academia from Argentina attended FDA's session. The audience showed great interest and asked numerous questions related to the topic and other FDA-related issues.

International Association of Trade Commissioners

FDA’s Florida District Office – The Florida District participated jointly with U.S. Customs Service (USCS) on November 27, 2001, in a seminar sponsored by the International Association of Trade Commissioners formed by the Trade Commissioners of Argentina, Brazil, Guatemala, Peru, and Mexico, among other countries represented in the conference. The conference approach was to educate importers of food products relating to import laws and general requirements on importing food and beverages into the U.S. in order to improve compliance of the imported product coming in through our ports. FDA and USCS representatives interacted with conference participants and responded to their concerns in the areas of foods in general, particularly, imports. Attendees of the conference were very pleased with the presentation given by both Agencies and expressed their willingness in complying with the import procedures.