Leveraging and Outreach Activities continued 2001
Last Update: August 7, 2003
Partnering With Other Federal Government Agencies
U.S. Department of Agriculture – On January 31, 2001, the FDA's Baltimore District Office held a meeting with the U.S. Department of Agriculture officials (Director Processing Operations and the Branch Chief - Technical Service Center/Field Operations based out of Omaha, NE) to discuss a possible partnership between agencies. The partnership would involve shared responsibilities in the form of HACCP plan implementation within joint jurisdiction firms. The purpose of the meeting was to gain an understanding of both agencies' approach to food (Seafood/Meat & Poultry) HACCP plan inspections. Organizational norms and practices were discussed, revealing commonalties and differences in the scope of a HACCP inspection.
On February 1, 2001, U.S. Department of Agriculture management officials participated in an FDA Seafood HACCP inspection of Cuisine Solutions located in Alexandria, Virginia. This interagency collaborative effort identified possible training needs within U.S. Department of Agriculture in order to incorporate elements of a Seafood HACCP Program with U.S. Department of Agriculture's requisite HACCP Programs. The U.S. Department of Agriculture officials apparently realized that significant differences exist between FDA and U.S. Department of Agriculture approaches to HACCP. Further discussion will take place during a scheduled teleconference between agencies.
U.S. Customs – The FDA's Baltimore District Office personnel met with U.S. Customs representatives in Norfolk, Virginia, on February 8, 2001, regarding implementation of a joint FDA Refusal/U.S. Customs Service Redelivery Notice, currently being developed for use at the Port of Baltimore and Dulles Airport facility. The Assistant Port Director was agreeable and will contact the U.S. Customs Service Regional Office in Atlanta, Georgia. Specifics have yet to be finalized between the two agencies.
San Juan District
Federal Bureau of Investigation – On September 5, 2001, the FDA's San Juan District Office participated in a Domestic Terrorism Working Group meeting held at the office of the FBI in the Federal building in Hato Rey, PR. This was the third in a series of ongoing meetings of representatives of various Federal and Commonwealth of Puerto Rico agencies to discuss the interaction and coordination of their response activities to terrorist events. In addition to a roundtable discussion, there was a FBI presentation of the Aum Shinrikyo terrorist attack on the Japanese subway system (1995) and attempts by animal rights activist groups to use hydrogen cyanide to disrupt a convention in Minnesota.
U.S. Department of Agriculture Food & Nutrition – The FDA's Dallas District Office and the U.S. Department of Agriculture Food & Nutrition Service joined the SW Chili Peppers Nutrition Education Task Force and Langston University in the planning of a food safety & nutrition train-the-trainer course for Nutrition Education Assistants & Specialists who serve Native American families in Oklahoma and New Mexico through U.S. Department of Agriculture's Food Distribution Program. "Honor The Gift Of Food By Keeping It Safe" was conducted on August 28 - 30, 2001, in Shawnee, Oklahoma. Presentations, demonstrations and exercises were conducted on diverse food handling scenarios, proper hand washing, chilling, thermometer use, cross contamination, and the food label. Materials were designed to be culturally competent. Nutrition and diabetes education was an integral part of this training. Several thousand consumer publications were sent to each of the 18 food commodity sites servicing the Native American populated counties.
U.S. Department of Agriculture – The FDA's Kansas City District Office met with FSIS/U.S. Department of Agriculture in Omaha, Nebraska, concerning the MOU and the status of dual jurisdiction firms and inspections. As part of the meeting, the U.S. Department of Agriculture provided an informative tour of the U.S. Department of Agriculture's Omaha Tech Center. This Center serves not only the U.S. Department of Agriculture, but also the general public and other government agencies that have questions about the U.S. Department of Agriculture's regulated products. FDA was advised that the Center had broad Congressional support and that it was an amalgamation of staff from other U.S. Department of Agriculture offices from around the US. Members of the Compliance Staff of the U.S. Department of Agriculture's Des Moines District Office and the District's Director, DIB and Tissue Residue Coordinator discussed broad topics of mutual interest including the compliance status of cases, state contract inspections/notification, work with counsel on filed cases, assessment of the notification process, and assurance of mutual benefit for both agencies. The meeting was part of the annual assessment of the MOU and its functionality.
New York District
U.S. Department of Agriculture – During the week of July 9, 2001, members of the FDA's New York District Office Import Operations Branch (Upstate) attended and provided input into 3 presentations made by the U.S. Department of Agriculture/Agricultural Marketing Service (AgMS) regarding their involvement in the importation requirements for agricultural products into the U.S. Two of these presentations were made to U.S. Customs Inspectors, and 1 was made to Customhouse Brokers.
U.S. Department of Agriculture is involved with assuring that pests are not inadvertently imported into the US along with the imported commodity and for performing grading services. FDA also is involved with the importation of the same commodities, primarily from a pesticide/microbiological perspective. The MOU between the agencies regarding each agency's responsibilities was discussed. Both agencies emphasized the need for Brokers to inform their customers that, although the commodities may be conditionally released to allow movement to the consignee location, the goods were not released for distribution/consumption until each involved agency issued its final release.
Federal Emergency Management Agency – The FDA's Denver District Office Special Assistant to the District on May 1-2, 2001 in Salt Lake City, Utah, participated in the quarterly meeting of the Regional Interagency Steering Committee (RISC) for the Federal Emergency Response Plan. This is a quarterly meeting organized and conducted by representatives from Region VIII of the Federal Emergency Management Agency (FEMA). All such meetings during calendar year 2001 are focused on planning for the Federal Agency Family for the 2002 Winter Olympic Games in Salt Lake City. Former President Clinton had designated this event as a National Special Security Event (NSSE).
The NSSE designation by the President under the Federal Emergency Response Plan allows for positioning federal response assets in and around Salt Lake City to respond in the event of a Natural Disaster, a Terrorism, a Bioterrorism or a Weapons of Mass Destruction incident during the 2002 Winter Olympic Games. In addition, extensive discussions were completed for after action report to the Watsach Rings Field Training Exercise, which occurred on April 3-5, 2001. That exercise involved a scenario of an explosion and a release of radioactive material at the Utah Winter Olympic Sports Park.
FDA Training For State Government Officials
New York District
State of New York – On December 31, 2000, The FDA's New York District Office Downstate PAS conducted a presentation on the National Education Initiative "Buying Prescription Medicines Online" to over 25 Directors of Consumer Affairs office throughout New York State. As part of the objective of the new Initiative, PAS partnered with the following consumer affairs representatives: New York State Attorney's General, Nassau and Suffolk Counties, New York State Public Service Commission, Nassau and Suffolk District Attorney's office, New York State Department of Health, New York State Consumer Protection Board, Cornell Cooperative Extension, Nassau and Suffolk Consumers Affairs, U.S. CAPS, U.S. Department of Labor, U.S. Postal Service, Cornell Consumer Education Coalition, Keyspan, Water Company, Verizon, LIPA, and the Greater New York Auto Dealers Association. The array of federal, state and local governments were very attentive to the message of prescription drugs online. PAS distributed over 500 brochures to the group. The meeting was held at Cornell Cooperative extension office, Plainview, New York.
Otay Mesa Resident Post
State of California – The week of September 18, 2001, the FDA's Otay Mesa Resident Post hosted visitors from several California state and local agencies. The agencies included the new Southern Border representative from the State of California Department of Pesticide Regulation (DPR), the Senior Agricultural Inspector for the County of San Diego Department of Agriculture, Weights and Measures, and the U.S. EPA, San Diego Border Office. The purpose of the visit was to see first hand the border operations at Otay Mesa, and to discuss the partnering agreement between FDA and California Department of Pesticide Regulation. This agreement allows information on firms that have been found by DPR to have violative produce in the California marketplace, be used to place these firms on increased review for FDA import sampling.
Ohio Department of Agriculture – On May 30, 2001, the FDA's Cincinnati District participated in Tissue Residue Training. The district participated in training that the Ohio Department of Agriculture was giving to their veterinary medical offices and Livestock inspectors on tissue residue investigations. The morning training session covered the FDA's Tissue Residue Compliance Program, how to conduct tissue residue inspections at the slaughter house, the auction markets, the livestock dealers, the livestock haulers, and at the veterinarian. Information was also provided on the format to use when writing an inspectional report that is to be submitted to the FDA and how to use the FDA 483.
Kentucky Food Safety Taskforce – The FDA's Cincinnati District Office Director, Investigations Branch and Kentucky contract supervisor attended the initial meeting of the Kentucky Food Safety Taskforce in Frankfort, Kentucky. The task force, comprised of local, state, federal, university, and industry representatives and formed using an FDA grant, is charged with identifying and addressing Kentucky's priority food safety issues. Issues identified during the meeting included developing food safety education materials targeted to seniors and children; developing mechanisms to train food service workers and managers; distributing information regarding the nutritional aspects of the diets of Kentucky citizens, and working on updating Kentucky's Food Safety Regulations.
State of Georgia – On July 31, 2001, the FDA's Atlanta District Office participated in the Georgia Mammography Society's continuing education program entitled, A Day of MQSA. The program was held in Atlanta, Georgia, and was attended by approximately 200 FDA inspectors, State inspectors, physicists, radiologic technologists, and consultants from the Southeast. The program provided radiology professionals and regulatory personnel an opportunity to discuss mammography related concerns. The speakers for this program were the Executive Director of the American College of Radiology, who gave a speech on Top Ten Reasons for Mammography Accreditation Failure; The FDA's Atlanta District Office Radiological Health Specialist, who presented a speech on Processor Quality Control-Be Your Own Consultant; and a representative from the Division of Mammography Quality and Radiation Programs, who updated the group on the latest MQSA issues.
San Juan District
Commonwealth of Puerto Rico – On June 27 - 2 8, 2001, the FDA's San Juan District Office conducted training on "Inspection Techniques and Evidence Development" for health officers of various Commonwealth of Puerto Rico agencies (Department of Health, Department of Agriculture, and DACO) at the Cardio-Vascular Center, San Juan. This was part of a new partnership to enhance the skills of our counterparts at the Commonwealth of Puerto Rico level. Fifteen staff members presented 2 plenary sessions and 4 workshops on drugs, foods, radiological health, medical devices, and blood banks, and agricultural and veterinary issues. Over 70 health officers and program directors attended.
Florida Department of Agriculture and Consumer Services – On November 16, 2000, the FDA's Florida District Investigations Branch Director, the Tampa Resident Post Consumer Safety Officer and the Tallahassee Resident Post Consumer Safety Office met in Tallahassee, Florida, with several top ranking officials from the Florida Department of Agriculture and Consumer Services (FDACS). Subjects discussed included revisions of the ongoing Seafood HACCP Partnership and Pesticide Partnership Agreements. On January 31, and February 2, 2001, three Supervisory Consumer Safety Officers (2 from domestics and 1 from imports) and an official from FDACS met in Miami, Florida, to prepare draft revisions for both partnership agreements.
AIDS Therapy Information Network – The FDA's Atlanta District Office exhibited and 3 representatives attended the National AIDS Health Fraud Task Force Network Shirt Sleeve Summit in San Antonio, Texas, on July 9 - 12, 2001. Members from the various AIDS Task forces received training confronting AIDS fraud, use of alternative medicines, effective budgeting, identifying alternative funding sources, and recruitment and retention.
State of Maryland – The FDA's Baltimore District Office director and public affairs staff gave a presentation on February 20, 2001, to 50 State of Maryland food laboratory employees. Topics included Food CGMPS, the Food Safety Initiative, and a brief overview of NLEA. The presentation was well received and included an extensive Q & A session.
Kansas City District
Iowa Department of Agriculture and Land Stewardship – The FDA's Kansas City District Office Supervisory Investigator, the Tissue Residue Monitor, and a Livestock Compliance Investigator for the Iowa Dept. of Agriculture and Land Stewardship conducted tissue residue investigation training for 11 individuals (primarily veterinarians) from the Missouri Dept. of Agriculture on March 31, 2001. The Missouri Department of Agriculture has had a partnership with the FDA's Kansas City District Office to conduct these investigations since 1996 but there has been a shift in the employees conducting the work that necessitated the training. The FDA's Kansas City District Office is hopeful we will be able to eventually commission some or all the trainees and later enter into a contract.
Ohio Department of Agriculture – On July 11, 2001, the FDA's Cincinnati District Office met with local and State Officials at the Ohio Department of Agriculture, Reynoldsburg, Ohio. Representatives from local health departments, Ohio Department of Agriculture (ODA), Ohio Department of Health, U.S. Department of Agriculture and FDA attended the meeting. This group meets quarterly. Discussion topics during this meeting included foot and mouth disease, Salmonella in turtles, food borne outbreaks, and press and media issues. Ohio Department of Health discussed guidance that will be sent to local health departments on addressing the commercial distribution of small turtles and preventing reptile associated Salmonellosis.
Florida Department of Agriculture and Consumer Services – The FDA's Florida District Office met with Division Directors, Computer Specialists, and field personnel from the Florida Department of Agriculture and Consumer Services (FDACS) on June 28, 2001, at the request FDACS in response to a recent change for their Agency to upgrade their electronic inspection reporting system. The purpose of this meeting was to demonstrate the use of the Turbo EIR for conducting establishment inspections. The demonstration included downloading inspection assignments from FACTS into Turbo EIR; creating, amending, and printing Inspectional Observations (FDA-483s); creating, editing, and printing EIRs; transferring EIRs between their notebook computer and a network server; and synchronizing Turbo EIR data on their notebook computer with a network server.
New Orleans District
Tennessee Department of Agriculture – The FDA's New Orleans District Office Nashville Branch conducted a training course on June 28, 2001, attended by inspectors and managers of the Tennessee Department of Agriculture (TDA) involved in the conduct of work under the Tennessee State contract for food inspections. The training course was designed to cover FDA's work-planning process as it relates to contracts, new audit procedures, the need for certain information and data for application in FACTS, FDA's commissioning process, and food safety issues. The course was attended by 25 TDA employees.
utah Congressional Delegation – The FDA's Denver District Office Special Assistant to the District, on May 3, 2001, participated along with representatives from Region VIII and Headquarters elements of Department of Health and Human Services and the Utah Department of Health in a briefing for the Utah Congressional Delegation. The briefing took place in the Salt Lake City Offices of Senator Orrin Hatch in the Bennett Federal Office Building in Salt Lake City, Utah. Congressional representatives included State Directors, Legislative Assistants, Press Secretaries and Congressional Field Coordinators from the offices of Senator Orrin Hatch, Senator Robert Bennett, Congressman James Hanson, Congressman James Matheson, and Congressman Chris Cannon. The briefing covered plans and commitments made to date by the various Operating Divisions and Agencies of Department of Health and Human Services to support the 2002 Winter Olympics both operationally and in the event of a Natural Disaster, Terrorist, Bioterrorist or Weapons of Mass Destruction incident.
New England District
State of Connecticut, Drug Division – The FDA's New England District gave a 4-hour Drug/Medical Gas CGMP training course to the State of Connecticut, Drug Division. The FDA's New England District Office Public Affairs Specialist was also present for training purposes. The Drug Control Division had 16 agents attend the training, including the Director and the Director of the Analytical Laboratory. The training went very well with a lot of questions regarding drug manufacturing. The Connecticut Drug Division Director is very interested in a partnership. The FDA's New England District Office will be in contact with Connecticut Officials to begin working on a Medical Gas CGMP partnership to include CGMP inspections and OEI work.
States of North and South Dakota – The FDA's Minneapolis District Office Milk Specialist presented a Pasteurization Controls and Tests Short Course at South Dakota State University (SDSU) in Brookings, South Dakota, on March 6 - 7, 2001. The course, which was requested by and coordinated with the South Dakota Department of Agriculture Dairy Department, had 42 attendees from both South and North Dakota representing State Regulatory Officials, Industry Quality Control and Production personnel and SDSU faculty and students. The course consisted of approximately 8 hours of classroom presentation with slides and videotapes, followed by several hours of hands-on equipment testing in the college's dairy plant.
San Juan District
Commonwealth of Puerto Rico – On May 2, 2001, the FDA's San Juan District Office was host to a group of Federal and Commonwealth of Puerto Rico agencies that met to discuss the possibility of forming a consortium of law enforcement and regulatory agencies that regulate foods and drugs. Consortium members would work together to develop common strategies to address issues and problems.
Texas Department of Health – Drug and Device Division – In April 2001, the FDA's Dallas District, the Dallas District Medical Device Coalition and AFDO partnered to present a 3-day workshop on Industrial Sterilization for Drugs and Devices. The workshop was attended by approximately 100 attendees, many of which were from FDA and the Texas Department of Health - Drug and Device Division. The ORA National Experts provided excellent presentations for the group and were invaluable to the success of the program.
Los Angeles Distirict
Southern California Organization of Consumer Protection Partners – The FDA's Los Angeles District Office Director of Import Operations and two Public Affairs Officers participated in a membership meeting of the Southern California Organization of Consumer Protection Partners (SCOCPP) held April 12, 2001 and hosted by San Diego County Health Department-Food and Housing Division. The meeting, chaired by the DIOB, was attended by 25 representatives from various health regulatory agencies including the California State Department of Health/ Food & Drug Branch, the Counties of San Diego, San Bernardino, Orange and Los Angeles and SWID. Topics discussed were Pediatric Lead Poisoning, Regulation of Maquiladoras, Sale of Prescription Medications at SWAP Meets. The next meeting of the organization will be to plan to Food Safety Conference to be funded by FDA Partnership monies.