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Leveraging and Outreach Activities 2001

Chapter 8

Last Update: August 07, 2003

Bovine Spongiform Encephalopathy (BSE) Training

Atlanta District

Georgia Department of Agriculture, Plant Food, Feed, and Grain Division – The FDA's Atlanta District met with representatives of the Georgia Department of Agriculture, Plant Food, Feed, and Grain Division on February 2, 2001, regarding BSE inspections and to provide assistance with contractual modifications. The State of Georgia agreed to assist with the coverage of firms that require inspections. They are attempting to get their medicated feed contract modified to include additional BSE inspections.

North Carolina Department of Agriculture, Animal Feed Division – On July 16, 2001, the FDA's Atlanta District Office provided a training workshop to the North Carolina Department of Agriculture, Animal Feed Division (NCDA/AFD) field inspectors, management, and administrative support staff on the performance of BSE inspections, evidence collection, and the documentation of violations on FDA–483. In addition, the training workshop provided an informational overview of the BSE CD–ROM, the report writing process, and a brief discussion of feed mill inspections and tissue residue investigations. NCDA/AFD officials were receptive and voiced their commitment on the prevention of BSE in the U.S.

State of South Carolina – On February 6, 2001, the FDA's Atlanta District Office met with members from other Federal and South Carolina agencies to discuss issues related to BSE and to clarify each agency's regulatory responsibility. This was the first in a series of meetings on preventing BSE in South Carolina. Attending the meeting were Directors, Managers, and Inspectors from the South Carolina Meat and Poultry Inspection Division, the South Carolina Department of Agriculture, the South Carolina State Veterinarian, and the Area Veterinarian in Charge from U.S. Department of Agriculture/APHIS. Issues discussed were the history of compliance to BSE regulations by South Carolina firms, the regulatory responsibilities of the various agencies, available resources, and what actions are needed. Immediate actions are to establish cooperation and communications among the various agencies, to investigate options on educating the South Carolina agriculture community on BSE, and to determine what resources and regulatory authority are available.

Chicago District

Chicago Broker's Association – The FDA's Chicago District Office participated in a joint meeting with U.S. Department of Agriculture/PPQ, US Customs, and the Chicago Broker's Association on June 5, 2001. The meeting involved approximately 150 brokers and included coverage of the BSE guidelines. U.S. Department of Agriculture/PPQ explained how all three agencies are working to prevent BSE products from entering the market place. Each agency gave a report on what requirements must be met to have BSE entries released.

Los Angeles District

State of Arizona Department of Agriculture – The FDA's Los Angeles District Office representatives participated in the initial task force meeting called by the State of Arizona Department of Agriculture to address the issue of BSE. Representatives from FDA, U.S. Department of Agriculture, cattle growers, large and small feed mills, academia, and Arizona Dept. of Agriculture attended. Primary issues discussed included how to prevent BSE from entering Arizona and what to do if it does. Items discussed included research, surveillance, education (of regulators, industry and consumers), CWD, rendering plant inspections, and labeling. The items discussed will be evaluated and further meetings will be held. A meeting was arranged to meet with the Arizona Dept. of Agriculture to discuss the possibility of either a contract or partnership with the state to cover BSE activities.

Cincinnati District Office

Ohio Department of Agriculture – On May 29, 2001, the FDA's Cincinnati District conducted a seminar entitled "BSE Regulatory Enforcement Training" at the Ohio Department of Agriculture (ODA). ODA's Division of Animal Industry coordinated the seminar. Nearly 70 ODA employees were in attendance. Dr. Linda Detwiler, U.S. Department of Agriculture, APHIS, VS was the keynote speaker. The district's BSE coordinator participated by giving a presentation entitled, "FDA BSE Inspection Update". The presentation covered FDA's BSE regulation, gave a summary of FDA's inspectional assignments, and highlighted the success of ODA/The FDA's Cincinnati District Office inspection contract and partnership achievements in the BSE area.

New York District

U.S. Department of Agriculture/APHIS – On July 9, 2001, the FDA's New York District Office Import Operations Branch Upstate attended a U.S. Department of Agriculture/APHIS (Animal and Plant Health Inspection Service) Public Education Event at the Rainbow Bridge Plaza, Niagara Falls, New York. APHIS has opened up a new passenger clearance inspection office/macro laboratory at the Rainbow Bridge. APHIS examines incoming cargo to prevent the inadvertent importation of foreign agricultural pests and diseases, often accompanying prohibited agricultural materials carried by international travelers. IOB Upstate is currently working closely with the local APHIS office on the BSE project involving suspect entries under the jurisdiction of both agencies. Managers from the local APHIS office, and the FDA's New York District office agreed continue to work closely on areas of mutual concern.

The New York State Department of Agriculture and Markets Division of Food Safety recently modified their medicated feed contract with the FDA to conduct 32 BSE inspections at feed mills. On March 8, 2001, the FDA's Syracuse Resident Post Supervisory Investigator participated in a training session for the New York State Department of Agriculture and Markets field staff that will be conducting the inspections. The training covered completion of the BSE inspection form, a historical perspective of FDA's involvement in general and the FDA's New York District Office's activities specifically in the BSE Program, as well as responding to numerous questions. A senior inspector from New York State Department of Agriculture and Markets also gave a very informative slide show/presentation of feed mill operations geared toward potential BSE problem areas.

Brokerage Community – The FDAÂ’s New York District Office Import Operations Branch, in conjunction with the Buffalo U.S. Department of Agriculture/APHIS/PPQ Office and the U.S. Customs Service, participated in a presentation on BSE and Foot and Mouth Disease at the Federal Building in Buffalo, New York, on March 21, 2001. The meeting was set up by U.S. Department of Agriculture to discuss entries of BSE and/or Foot and Mouth Disease susceptible items and how they should be handled. U.S. Department of Agriculture discussed both BSE, and Foot and Mouth Disease, including precautions the agency is taking to prevent the spread of both.  FDA discussed BSE issuses, including products of concern regarding BSE and Import Alert 99–25. The meeting was well attended by managers of the brokerage community, U.S. Customs Service, APHIS, FDA , U.S. Fish and Wildlife, and a representative of a Canadian animal feed firm.

Broker Meeting – The FDA's New York District Office – Import Operations (Syracuse Resident Post) participated in a U.S. Custom's sponsored Broker Meeting in Alexandria Bay, New York, on February 27, 2001, FDA and U.S. Department of Agriculture/APHIS/PPQ provided the latest available information to the brokerage community on Bovine Spongiform Encephalopathy (BSE), and the effect on review of entries of BSE susceptible commodities. The meeting was attended by approximately 16 representatives of the brokerage community and was well received. Topics other than BSE included timely submission of entries, prefiling entries and release of entries.

Philadelphia District

U.S. Customs – The FDA's Philadelphia District Office: The district met with representatives of the U.S. Customs Service and U.S. Department of Agriculture/APHIS/PPQ on February 12, 2001, to discuss the recent prohibition of animal–derived products, due to the possibility of cross contamination with the BSE agent, and the guidance set forth in FDA's Import Alert #99–25. The meeting confirmed that all agencies are "on–board" with respect to appropriate coverage of BSE–related importations. Communication channels were established to ensure the exchange of information and, where necessary, U.S. Department of Agriculture concurrence for the release of products into the U.S. Customs, U.S. Department of Agriculture, and FDA agreed that the criteria set in Customs' electronic ACS system to capture entries is adequate, including the availability of manifest and non–ABI entries made through the air cargo facilities.

U.S. Customs – The FDA's Philadelphia District Office met with U.S. Customs Service on February 7, 2001, in follow–up to our May 26, 1999, implementation of "Local Procedures and Guidance" for the local ports serviced by both agencies. We evaluated the effectiveness of our established procedures for the monitoring of refusals, including the disposition of adulterated goods, bond actions, and targeting FDA–regulated products and problem importers. We also discussed the recent issuance of the RPM guidance on Secured Storage, and the assessment of Civil Monetary Penalties by Customs. Overall, U.S. Customs Service is amenable to working with FDA to meet the enforcement goals delineated in both documents. U.S. Customs Service expressed some concerns relative to the limited availability of facilities to accommodate secured storage. However, both agencies agreed to work together in such endeavors. The meeting also provided us with an opportunity to discuss appropriate review and examination of BSE–related importations.

FDA Training for Health Professionals

New Jersey District

New Jersey State Department of Health – On August 23, 2001, the FDA's New Jersey District Office conducted training on new biological product deviation regulations. The New Jersey District Office presented training at a meeting of the Blood Bank Supervisors of New Jersey. Transfusion service, hospital blood bank, and licensed blood center personnel as well as New Jersey State Department of Health Inspectors attended the workshop.

Cincinnati District Office

Toledo Hospital Institutional Review Board – The FDA's Cincinnati District Office gave a presentation to the Toledo Hospital Institutional Review Board (IRB). The presentation entitled "How to Prepare for an Audit" was given by a district BIMO Specialist on June 6, 2001, at the Toledo Hospital, Toledo, Ohio, as part of the ProMedica Health System Continuing Medical Education series. The presentation focused on FDA inspections of Institutional Review Boards and how to prepare for such inspections. In attendance at this presentation were IRB members and staff, clinical investigators, and other health care professionals involved in clinical research from institutions throughout the Toledo metropolitan area as well as institutions from surrounding areas.

Pacific Regional Laboratory

The FDA's Pacific Regional Laboratory sponsored a seminar by Dr. Michael Brodsky, president of AOAC International. This organization sets standards for chemical, microbiological and entomological analyses done by FDA and other regulatory labs. Accompanying Dr. Brodsky were three scientists from the Washington State Department of Health who are interested in establishing more technical contacts with FDA on matters of public health concern. The seminar was a prelude to the regional AOAC International meeting held at the University of Puget Sound, June 21–22, 2001. A number of FDA scientists attended, presented technical papers or chaired sessions.

New England District

On March 19, 2001, the FDA's New England District officials met with three physicians from the Commonwealth Fund Harvard University Fellowship in Minority Health Policy. FDA gave presentations on FDA and its role in consumer protection, the organization of ORA and how the field fits into to it, the role of WEAC and how the District goes about its work. The three physicians were interested in clinical trials and how they effect minorities, genetically engineered foods, and BSE.

FDA Training for Industry

Minnesota District

Medical Device Manufacturers – On April 30, 2001, the FDA's Minnesota District Compliance Office gave a presentation to a group of medical device manufacturers at a workshop and trade show in Calgary, Alberta, Canada. The presentation, entitled "Manufacturing Compliance–What the FDA Requires," covered Establishment Registration, Device Listing, Pre–Market Approval & Pre–Market Clearance, Good Manufacturing Practices, Medical Device Reporting, and other regulations. Information was also provided about FDA inspections and import operations. About 80 people attended the presentation.

New York District

The FDA's New York District Office – The Special Assistant to the District Director (SADD) gave a presentation titled, "Understanding the Legal Requirements for Foods Exported to the U.S.", to small and medium–size business owners at the Grocery Showcase West Food Show in Vancouver, Canada. Following the presentation, the SADD answered questions about exporting and labeling for clients who were working with the Government of Canada, market and industry officials who were interested in exporting to the U.S.

Southeast Region

American Society of Heating, Refrigerating, and Air–conditioning Engineers – The Southeast Regional Retail Food Specialist spoke to over 100 national and international professionals at the American Society of Heating, Refrigerating, and Air–conditioning Engineers (ASHRAE) National Conference at the Atlanta World Congress Center, Atlanta, Georgia, on January 31, 2001. The topic of the presentation was, The Role of the FDA Model Retail Food Code, Retail HACCP, and the CDC Risk Factors Regarding Cooling and Refrigeration Temperatures for potentially Hazardous Foods at the Retail Level.

Atlanta District

Southeast American Society for Quality Conference – The FDA's Atlanta District Office staff gave presentations on investigative strategies and compliance update on January 26, 2001, at the Southeast American Society for Quality Conference, Raleigh, North Carolina. There were approximately 100 participants from the drug and device industry. FDA National Drug and Device Experts were also speakers.

New Jersey District

Pharmaceutical Trade Associations – On August 27, 2001, the FDA's New Jersey District participated in a Pharmaceutical Outsourcing Conference. The New Jersey district director made presentations and participated in an interactive workshop concerning pharmaceutical contracting and outsourcing. This workshop was sponsored by all the pharmaceutical trade associations –– the Consumer Healthcare Products Association, the Pharmaceutical Research Manufacturers Association, the Generic Pharmaceutical Association, and the International Pharmaceutical Excipients Council of the Americas. Over 600 people attended the workshop. A major discussion point involved CGMP roles and responsibilities in the client–contractor relationship. This workshop also reaffirmed the strong trend for pharmaceutical companies to outsource many manufacturing and testing operations.

Cincinnati District

International Trade and Customs Broker Association – On May 19, 2001, the FDA's Cincinnati District Office met with the International Trade and Customs Broker Association. At the invitation of the office of U.S. Rep. Stephanie Tubbs Jones (D–Ohio) and the U.S. Customs Port Director in Cleveland, Ohio, the district participated in the initial meeting of a new importer and customs broker association in Cleveland, Ohio. U.S. Customs, FDA, U.S. Department of Agriculture, INS, and the Coast Guard gave short presentations and then answered questions from the audience. Approximately 100 people attended, including representatives from industry, government agencies, a caseworker from Rep. Jones' office, and a trade official from New Zealand.

Seattle District

Surimi Industry Conference – The FDA's Seattle District Office's seafood coordinator attended the Surimi Industry Conference, Astoria, Oregon on April 9, 2001. Oregon State University (OSU) sponsored the conference. OSU has held a surimi training class each year since 1992 and this was the first year having an industry conference preceding the surimi course. Approximately 140 representatives from industry, academia and Sea Grant were in attendance. The conference covered various issues: surimi resources – supply, demand and future; comparative studies of surimi from various species; new surimi production methods (panel discussion); how Tyson Foods develops new product; surimi seafood in Europe; and surimi seafood pasteurization (panel discussion).

The district representative participated in the last panel session, and discussed the two barrier requirements in a HACCP system for refrigerated, vacuum packed surimi analog products. This is a very sensitive issue in this segment of the seafood industry and the discussion generated a significant number of questions that were addressed. The panel included representatives from academia, Sea Grant, National Food Processors Association, and surimi analog manufacturers from Washington State and Motley, Minnesota.

Chicago District

American Association of Medical Instrumentation – On July 25 – 26, 2001, the FDA's Chicago District participated in an American Association of Medical Instrumentation (AAMI) working group meeting in Rosemont, Illinois. The group is drafting a Technical Guidance Document detailing how to group similar medical device products by family for EtO sterilization validation. The group is composed of approximately twenty representatives of major medical device manufacturers from throughout the country. The group includes a large number of convenience kit manufacturers. The district's representative provided information on FDA's pending guidance document regarding convenience kits.

Southwest Import Division

U.S. Customhouse Brokers Association, Fresh Produce Association of the Americas, Arizona Department of Agriculture, U.S. Customs Service, and Pepsico Food Imports – The FDA's Southwest Import Division, Nogales Resident Post Personnel along with the Southwest Regional Director and District Director attended a trade meeting that consisted of representatives from the U.S. Customhouse Brokers Association, Fresh Produce Association of the Americas, Arizona Department of Agriculture, U.S. Customs Service, and Pepsico Food Imports. The meeting was held at the Deconcini Port of Entry and dealt specifically with FDA Import issues, such as the Southwest Import District Pilot, secured storage policy, and the additional fresh produce micro assignment. At the conclusion of the meeting, attendees were pleased with FDA's presentation and hope to have additional meetings in the future.

SWID, Nogales Resident Post Supervisor, provided a brief tour of the Port Operations to a total of 12 Food Reporter's. The tour consisted of a brief explanation of FDA's rules and regulations on imported goods from Mexico followed by a brief question and answer session with U.S. Customs Service and FDA. At the conclusion of the tour, the attendees were very pleased with the operational support within the Federal agencies and local representatives at the Nogales Commercial Port of Entry.

Philadelphia District

International Society for Pharmaceutical Engineering – On February 13, 2001, the FDA's Philadelphia District Office/Montgomeryville Resident Post gave a presentation to the Delaware Valley Chapter of the International Society for Pharmaceutical Engineering (ISPE), entitled "Failure Investigations: The Impact on Qualification and Validation." Over 120 industry representatives attended the presentation, which included a discussion of agency expectations for product validation and qualification, as well as effective systems for identifying and handling process and product deviations.

Atlanta District

National Association of Processors Industry – The FDA's Atlanta District Office gave a presentation to a select committee group of the National Association of Processors Industry (APPI) on March 6, 2001, in Atlanta, Georgia. The informative speech provided a general scenario of the inspection process, as well as covering the key points outlined on FDA's Attachment B, Report of Inspection For Compliance with 21 C.F.R. 589.2000.

Minneapolis District

Viking Vending Food and Equipment – On April 26, 2001, the FDA's Minneapolis District Office ITS Specialist gave a presentation to the Viking Vending Food and Equipment show, St. Paul, Minnesota. Information presented included Listeria and Ready–to–Eat foods, Food Allergens, and a Consumer Notice on the BSE issues. FDA's ITS Specialist was also on the question and answer panel following the presentation. The presentation was well–received by the approximately 30 people in attendance.

San Francisco and Los Angeles District

Food Industry Workers – The San Francisco and Los Angeles District offices in conjunction with the State of California, Food and Drug Branch (FDB) hosted Basic Sanitation and CGMP courses in Spanish. The courses were held in San Jose, California on May 17, 2001. The course was designed for local food industry workers, QA/QC personnel, and line managers/supervisors. The course and translated materials were developed by a San Francisco Consumer Safety Officer. Over 35 attendees attended the course. Speakers were from the San Francisco District office and two FDB. The audience also took with them a sanitation and CGMP manual in Spanish. The manual was comprised of the presentations delivered, additional translated sanitation material, and FDA publications available in Spanish (printing supplied from FDB). Attendees included Solano County inspectors; attendees from U.S. Department of Agriculture regulated firms, and attendees from a diverse assemblage of food firms. The course was enthusiastically received by the attendees for holding this type of rare workshop in Spanish and demonstrated both a critical need for this type of outreach and interest in attending and holding others.

New Jersey District

American Society of Quality – On May 16, 2001, the FDA's New Jersey District Office participated in the Spring Quality Conference of the American Society of Quality (ASQ) held in Whippany, New Jersey. District personnel made presentations on the new systems–based Pharmaceutical Inspection Pilot Program and compared QSIT with the Pharmaceutical Pilot Program. Approximately 300 people attended the conference.

San Juan District

The Forum for Innovation in Pharmaceutical and Packaging Technologies – On May 8 – 11, 2001, the FDA's San Juan District Office participated in the Forum for Innovation in Pharmaceutical and Packaging Technologies, held in Dorado, Puerto Rico. The FDA's San Juan District Office DD, DCB, Acting Lab Dir., the Pre–Approval Manager, and a drug specialist made presentations. The forum, a non–profit organization, had representatives from industry and academia, and focused on packaging technology, information technology, and modern pharmaceutical processes.

Two FDA presentations were: 1) San Juan Presentation on Quality Systems Inspections– The FDA's San Juan District Office Drug Specialist gave a presentation to a group of about 40 industry officials on Quality Systems Inspections. 2) FDA Panel Presentation to Pharmaceutical Industry– an FDA panel presented updates and trends on regulatory issues affecting the pharmaceutical industry in Puerto Rico from a strategic, compliance, pre–approval, and laboratory point of view to a group of about 60 industry officials representing some of the major establishments in our inventory of firms. After the presentations, the panel was open to questions from the audience, which prompted an open and frank discussion of current issues and policies regarding the pharmaceutical industry.

Los Angeles District

LSG/SKY CHEFS – The FDA's Los Angeles District Office ITP Specialist participated as a speaker, on March 13 – 14, 2001, in training of 53 managers for LSG/SKY CHEFS, Los Angeles kitchens. This participation offered an opportunity to increase manager's awareness of food safety and how it affects their business, and increase FDA's visibility within the firm, which ranks as the second largest airline caterer in the world.

Grower–Shipper Vegetable Association of Santa Barbara and San Luis Obispo Counties – The FDA's Los Angeles District Office Imports Compliance Officer participated in a Grower/Shipper seminar that was held by the Grower–Shipper Vegetable Association of Santa Barbara and San Luis Obispo Counties in Santa Maria, California on April 10, 2001. This seminar was entitled "What the Grower Needs to Know about Produce Food Safety". Besides FDA, other guest speakers included representatives from California Department of Food and Agriculture and University of California Davis. This meeting targeted local small operating growers and shippers that were interested in obtaining a better understanding of what "Good Agricultural Practices" entails so that it could be applied to their small operations.

Minneapolis District Office

Society of Cosmetic Chemists – The FDA's Minneapolis District Office investigators presented information about cosmetic manufacturing guidelines, as well as drug CGMPS, at a monthly meeting of the Society of Cosmetic Chemists, Twin Cities Chapter, Minneapolis, Minnesota, in March 2001. FDA also presented information concerning the use of bovine tissue in consumer products. Questions included the quality of water used in the production of cosmetics and drugs, FDA's jurisdiction over cosmetic ingredients sold on the Internet, and the benefits of voluntarily registering cosmetic ingredients and raw materials with the FDA.

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