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S.A.I.L.

State Action Information Letter

Published by the Division of Federal-State Relations
Office of Regulatory Affairs
Food and Drug Administration

Report from the Director

Recent events involving food safety issues and recalls affecting a number of school systems resulted in the General Accounting Office making inquiries to the FDA regarding the Agency’s role in providing food safety information to the nation’s school systems. As a result of those inquiries, the FDA, through the Division of Federal-State Relations, has added FAX numbers of all 50 State Departments of Education to our Broadcast database.

On September 26, 2002, DFSR issued the first FAX Broadcast to the listing of the State Departments of Education. The message was to introduce these officials to FDA’s FAX/Email Broadcast system and to offer them the opportunity to receive Food/Food Service/Food Safety messages either by FAX or Email.

Since this initial message, a number of food messages have been relayed to these officials. For more information on this new procedure, contact Carl I. Vassar at cvassar@ora.fda.gov.

News from the States

 Texas:

The Texas State Food Safety Task Force sponsored a Food Safety and Security Symposium in Arlington, TX on September 11-12. The Task Force used funds obtained by grants from the USDA/FSIS and the FDA to fund travel and registration for over 30 local health department representatives from all across this large state. Total attendance topped 150, including many industry representatives. Speakers included Dr. Rhona Applebaum, Vice President of the National Food Processors Association; Tim Weigner, Director of Food Safety for the Food Marketing Institute (FMI); George Hughes, FDA's Office of Criminal Investigations, Washington, D.C.; Lou Carson, FDA's Center for Food Safety and Applied Nutrition (CFSAN) in Silver Springs, MD.

The Keynote Address was given by Ralph Stafko in the absence of Dr. Elsa Murano, Under Secretary for Food Safety, who was advised by the President not to fly on September 11th. Other speakers included Dr. Suzanne Barth, Section Chief, TDH Bureau of Laboratories who spoke on Pulsed Field Gel Electrophoresis (PFGE); Dr. Doug Johnson, Texas A&M University who spoke on Food Irradiation; and Mark Fleck of Avure Industries who spoke on High Pressure Treatment/Pasteurization of foods. Dan Sowards spoke on Specialty Foods Processing at Retail, updating the audience on the progress of the federal grant received by the Association of Food and Drug Officials (AFDO) to develop 7 model guidelines for various types of food processing at retail. A nationally renowned speaker, Dr. Richard Cheatham, gave a very stirring and entertaining lecture on "Coping with Personal and Professional Change." To demonstrate the extent of the success of the Symposium, over 100 evaluations were returned with not a single negative comment.

For more information, contact Dan Sowards at Dan.Sowards@tdh.state.tx.us.

Nebraska:

In the fall of 2001, the Nebraska Department of Agriculture received a grant from the USDA Food Safety and Inspection Service (FSIS) to establish a food safety task force and develop food safety training for retail grocery managers and employees, especially those involved in meat and poultry processing. With input from the Nebraska Grocery Industry Association (NGIA), NDA decided to utilize the Food Marketing Certification Program as their training tool. A University of Nebraska Extension Educator was certified as an instructor and training sessions were held throughout the state. In addition to retail employees, State Department of Agriculture sanitarians also participated in the training. The NGIA promotes the training through their ‘Fast Fax’ system where notices are faxed to all the stores in the state with FAX capability.

- A bill to update the current Food Code, Graded Egg Act, and the Nebraska Pure Food Act, will be presented to the 2003 Nebraska Legislature in January, 2003. The proposal is to adopt the 2001 Food Code Recommended by FDA, with minor modifications. Currently the state code is patterned after the 1997 Food Code, with updates following the recommendations of the Conference for Food Protection. A major modification to the 2001 Code will be to lower the hot holding temperature of potentially hazardous foods to 135°, based on discussions at CFP.

For more information contact: George H. Hanssen at (402) 471-2536 or at georgehh@agr.state.ne.us.

Minnesota:

The Minnesota Kids Kick Off Food Safety Event in Marshall on September 26th was a rip-roaring success. Four hundred students from two schools had an educational and fun time with the Crazy Cooks: Becky Bacteria, Debbie Diarrhea and Eddie Ecoli (the principal). Using black light and glowing "germs" the kids and teachers learned how to thoroughly wash their hands. Several students and teachers touched the agar medium in Petri dishes to grow bacteria from their hands. All students will be trying both experiments in their classrooms throughout the year. A video from NASA was used to demonstrate the importance and safety of food irradiation. A plaque was presented to the school for their participation in what is hoped to be the first of many such school presentations around the state.

All students received donated goodie bags valued at $30 each. Goodie bag sponsors included: General Mills, Minnesota Farm Bureau, Minnesota Beef Council, Deli Express, Burger King, US Food and Drug Administration, Lunds/Byerly’s, Schwan’s, Subway, Taco Johns,

Taher Food Service, University of Minnesota Extension Service, USDA Food Safety and Inspection Service, Lincoln-Lyon-Murray-Pipestone Public Health Agency, University of MN College of Agriculture/Food and Environmental Sciences, and the State Departments of Agriculture and Health.

The press was there in full force with front-page coverage in the Marshall Independent and a lengthy television spot. Articles appeared in newsletters and interviews were conducted on several radio stations. This kick-off event was a huge success because of the many partners who worked together to make it happen. Photos from the event can be seen at: www.health.state.mn.us/divs/eh/food/sos and press “Go to photos” in the first paragraph.

The next phase of the campaign will be to train teachers and place donated Safe or Sorry (SOS) food safety tool kits in each of the 339 state public school districts. Safe or Sorry is a newly developed food safety program for consumers of all ages developed by the Minnesota Department of Health. Funds for 176 SOS food safety tool kits have been donated by Cargill, Schwan’s, General Mills, the Minnesota Grocer’s Association, the Minnesota Beef Council, Hormel, Malt-O-Meal, Deli Express, Lunds/Byerly’s, and the State Departments of Health and Agriculture. Corporate partner Cargill has also announced that it will be taking an SOS food safety tool kit and curriculum to its Asian markets.

For questions or suggestions for additional kit sponsors, please contact Carol Schreiber at Carol.Schreiber@state.mn.us.

Wisconsin:

Cow-share agreements, used to sell raw milk to consumers, are illegal and must stop, under terms of an order signed Oct. 30 by Jim Harsdorf, Secretary of Agriculture, Trade and Consumer Protection. The order is the result of a dispute between the department and two dairy farms using cow-share agreements: Clearview Acres, Hayward, owned by Gleta Martin and managed by Tim Wightman; and Midvalleyvu Farm, Arkansaw, owned by Wayne and Janet Brunner. It applies to all dairy producers in Wisconsin, however. An administrative law judge in the department, whose role is to help settle disputes over the department’s rules, sent a proposed order to Harsdorf and the producers on Sept. 20. It was not final until Harsdorf signed it. Raw milk is milk that has not been pasteurized to destroy organisms that may cause human illness. Under Wisconsin law, dairy producers may consume raw milk from their own farms, but it is illegal to sell raw milk except as an “incidental sale.” The issue in the dispute was the definition of “incidental sale.” The order says that cow-share agreements, in which consumers have part ownership in a cow and receive milk, do not fall within the intent of the law regarding incidental sales. It upholds the department’s long-standing interpretation that limits raw milk sales to farm employees, and directs the department’s Food Safety Division to reinstate language in its rules that clearly defines this interpretation. However, the order acknowledges that bona fide owners of a milk producer license may consume raw milk. If there are several co-owners of the milk producer license, each of those owners could legally use raw milk from the farm. Ownership arrangements would have to comply with security laws. “If the potential purchaser understands the benefits and risks through full disclosure…then all are in a position to make the informed choice to obtain their milk in its ungraded raw form,” the order states.

An Eau Claire area meat processor faces charges of slaughtering a diseased animal, selling sausage containing venison, and theft of venison from a customer. The Chippewa County District Attorney’s office filed the charges Tuesday, Aug. 13, in Circuit Court against Jeffrey E. Zais, owner of Boyd Locker Service in Boyd. The charges stemmed from an investigation by the Wisconsin Department of Agriculture, Trade and Consumer Protection, in which the Department of Natural Resources assisted. Zais is charged with seven criminal counts and one civil count that carry a possible total of more than 10 years in prison and $15,000 in penalties. The most serious charge is a felony count of slaughtering, transporting and storing meat from a diseased animal, which carries a sentence of up to 7½ years and a fine of $500 to $1,000. Six of the remaining charges are misdemeanors, related to the alleged sale of sausages containing venison. Zais is charged with two counts of selling adulterated meat, two counts of selling uninspected meat, two counts of unlawful sale of deer. The final charge -- game larceny - is a civil offense alleging that Zais withheld venison from a deer he processed for a customer and used it in sausage that he sold. A court appearance is set for Sept. 10. No trial date was set. Zais is free on a $500 signature bond. The investigation ran from February to July. Investigators inspected the processing and storage facilities, questioned employees and customers, and bought products undercover for analysis. The Wisconsin Department of Agriculture, Trade and Consumer Protection licenses and inspects meat processing and storage facilities and regulates slaughter of animals. Boyd Locker Service operated a mobile slaughter unit for on-farm slaughter, a meat processing and storage locker facility, and a retail shop, along with selling wholesale to bars and restaurants in the area. The Chippewa County District’s Attorney’s office reminded members of the public that everyone is innocent until proven guilty.

For more information, contact Donna Gilson at Donna.Gilson@datcp.state.wi.us.

Colorado:

The Colorado Department of Public Health and Environment has participated in encephalitis surveillance since 1969, when the Department and CDC set up sentinel chicken flocks in Sterling, San Luis Valley, Lamar, Grand Junction, and Durango. Cooperative surveillance activities with CDC continued until 1972. Following the 1977 Big Thompson flood, sentinel chicken flocks were again set-up as a precaution to monitor for encephalitis activity.

Following the 1987 encephalitis outbreak that resulted in thirty (30) human cases and 1 death in Colorado, local health departments and CDPHE established a surveillance system to monitor for Western equine and St. Louis encephalitis. Over the past 14 years, the program has expanded to include sixteen (16) local health departments, private firms, mosquito abatement districts, CDC and members of the public.

In anticipation of the arrival of the West Nile Virus (WNV) into Colorado, the surveillance program was expanded beyond its traditional sentinel chicken flocks to include dead birds and mosquitoes. Since St. Louis (SLE) and Western equine encephalitis (WEE) are bird viruses that occasionally infect humans and horses, chickens are used to provide an early warning system to public health officials that the virus is circulating in the local bird population. Although WNV is also essentially a bird virus, the disease has created new problems and challenges for the surveillance program. It is hoped that sentinel chicken flocks supplemented with dead bird surveillance and increased mosquito trapping and testing will provide the program with a detection system that will enable CDPHE to provide timely public announcements as well as guidance to local health authorities relative to response and control strategies.

Next year, it is anticipated that mosquito trapping and testing will increase as a component of encephalitis surveillance since they are the insect vector in the transmission cycle of the disease. All three viruses can be tested because the portability of the traps allows trapping to be done nearly anywhere mosquito activity is suspected. In regard to mosquito control issues, monitoring mosquito breeding areas and trapping adult mosquitoes are key to determining whether control efforts are necessary. To maximize the use of limited resources, monitoring the presence of mosquitoes is paramount before instituting control measures. Dipping for mosquito larvae provides information on breeding habitat, species, and relative numbers. Adult mosquito trapping provides information on the species of mosquito present, historical comparison of population density, and specimens to test for the presence of virus.

This year, the lab began testing mosquitoes for the presence of WNV, SLE, and WEE. The Colorado Department of Public Health and Environment Laboratory and Radiation Services (CDPHE/LARS) performed a molecular test (i.e., RT-PCR) to determine the presence of virus. In addition, the department also purchased portable field test kits that could detect the presence of virus in mosquitoes in a 30 minute test. Although these portable test kits are only half as sensitive as the molecular test being used by the lab, the field test kits can provide real time results for local health departments.

Culex pipiens is suspected of being the primary mosquito species that circulates WNV, SLE, and WEE among birds. Culex tarsalis is thought to be a very good mosquito species for transmitting the viruses to humans and other mammals. Controlling mosquito populations by eliminating breeding sites is the key to breaking the transmission cycle of WNV, WEE, SLE, and other mosquito borne diseases. The process is not simple nor is it cheap; however, domestic actions as simple as eliminating/draining or frequently changing water filled containers (e.g., bird baths, fountains, unused tires, cans, leaking sprinkler heads, wading pools, livestock tanks, etc.) collectively can dramatically reduce the number of mosquitoes and subsequently reduce the risk of exposure to these diseases. For more information, contact Therese Pilonetti at therese.pilonetti@state.co.us.

Enceph Photographs

During July and August of this year, Disease Control and Environmental Epidemiology (DCEED), Consumer Protection (CPD) and Laboratory and Radiation Services (LARS) Divisions participated in the investigation of a foodborne illness outbreak associated with the consumption of ground beef contaminated with E. coli 0157:H7. E. coli 0157:H7 is a bacterial illness causing non-bloody diarrhea that progresses to diarrhea with visible blood. Other symptoms include abdominal cramps, fever, fatigue, and vomiting. Hemolytic uremic syndrome (HUS) is a severe complication of E. coli O157:H7. Transmission is most often through ingestion of contaminated foods and incubation ranges from 1-8 days, with an average of 3-5 days.

In response to two national ground beef recalls and evidence of an increase in cases of E. coli 0157:H7, a news release entitled “Thoroughly Cooked Hamburgers Important to Safe Holiday,” was distributed by CDPHE to remind Coloradoans of the importance of thoroughly cooking hamburger to prevent illnesses caused by the E. coli bacteria. At the same time, epidemiologic investigations of E. coli O157:H7 cases began to show an association of illness to ground beef purchased at Safeway stores. Additionally, it was discovered by CPD that the ground beef purchased at the Safeway stores originated from the ConAgra Beef Company which had recalled 354,200 pounds of ground beef on June 30, 2002. ConAgra supplied a list of distributors who were then contacted by CPD to ensure that the contaminated meat was being removed from distribution.

By July 8th, LARS had identified 12 matching cases of E. coli 0157:H7 by using pulse field gel electrophoresis (PFGE) a method of DNA fingerprinting. Based on information DCEED, CPD and LARS, a press release was issued noting that ground beef sold in Colorado was the focus of an E. coli 0157:H7 outbreak. This press release resulted in front page coverage by the Denver Post indicating that 12 cases of E. coli 017:H7 from nine counties had been identified. Consumers were warned to check their freezers, dispose of any suspect product, to wash their hands when preparing ground beef, sanitize all surfaces that come in contact with raw ground beef, and to thoroughly cook all ground beef to a minimum temperature of 160 0F.

The following week, as case counts continued to increase, the Centers for Disease Control and Prevention, (CDC) confirmed that the PFGE pattern from a hamburger sample obtained by the USDA from the ConAgra Beef Company in Greeley, matched the PFGE pattern of the cases in Colorado. Additionally, ground beef from the freezer of one of the initial cases also matched the outbreak PFGE pattern. At the same time, more cases of E. coli 0157:H7 linked to ConAgra ground beef were being identified in other states which prompted ConAgra to expand their ground beef recall to 18.6 million pounds on July 19, 2002. This was the second largest recall of ground beef in US history.

After ConAgra expanded their initial recall, CPD made continuous efforts to obtain lists of distributors and wholesalers from ConAgra. Once received, every distributor and wholesaler in Colorado that had any meat implicated in this recall was contacted. Contacts made resulted in determining that very little of the product was returned to ConAgra. The majority of the contaminated ground beef was cooked and served in several restaurants throughout Colorado and sold directly to customers in seven different grocery stores, one of which was a national grocery chain. All reported illnesses in Colorado were the result of ground beef prepared at home. None of the reported illnesses were implicated as a result of consuming contaminated ground beef from a restaurant. DCEED reported that a total of 22 cases of E.coli 0157:H7 from 10 counties were associated with this outbreak. The average age was 22 years with a range from 1 - 72 years. Onset dates of illness were from June 12th to July 22nd, 2002. Colorado had 12 hospitalizations, 4 cases of HUS, and no deaths associated with this outbreak. Nationally, the CDC reported 38 cases from 11 states, 17 hospitalizations, 6 cases of HUS, and one death associated with this outbreak.

Lessons learned include: (1) that communication between local, state, and national entities is essential in identifying and investigating a multi-state outbreak associated with ground beef contamination; (2) that PFGE is an important laboratory method in identifying outbreak cases and potential vehicles of contamination; (3) that collaboration between health agencies, the public, and private industry is vital in protecting the health of the public and in preventing additional illnesses in such an outbreak; and (4) that teamwork between DCEED, CPD and LARS is fundamental in the identification, investigation and prevention of this public health threat. For more information, contact Therese Pilonetti at therese.pilonetti@state.co.us.

Orlen J. Wiemann died on September 12, 2002. Mr. Wiemann was head of the Milk, Food, and Drug Section of the Colorado Department of Health until he retired in May of 1979. This section is currently the Consumer Protection Division of the Colorado Department of Public Health and Environment. Orlen Wiemann provided a key leadership role for the drafting, adoption, and implementation of the Colorado Pure Food and Drug Law, Colorado Restaurant Law, and the Colorado Hazardous Substances Act. Mr. Wiemann served twice as president of the Western Association of Food and Drug Officials (WAFDO) and the highest award given by WAFDO is named after the first recipient of the award, Orlen J. Wiemann.He was president of the Association of Food and Drug Officials (AFDO) in 1967 and was the recipient of AFDO’s Harvey W. Wiley Award in 1987. Mr. Wiemann served as Editor of the AFDO Journal from 1970 until 1987 and was active on numerous AFDO committees. Orlen Wiemann’s contributions to public health protection continue to provide a structure for core regulatory responsibilities and are greatly valued.

News from AFDO:

The Association of Food and Drug Officials (AFDO) has begun the third year of a cooperative agreement with the Centers for Disease Control and Prevention (CDC) entitled “States Helping States”. The goal of this agreement is to strengthen State and local food safety programs and to improve the environmental health component of foodborne outbreak investigations. AFDO serves as the liaison, coordinator and facilitator between Federal, State, and local food protection programs to accomplish these goals. One aspect of this project is the unveiling this Fall of the U.S. Food and Drug Administration’s “ORA-U.” ORA-U was initially developed to train FDA food and drug investigators, but for the first time in history, this web-based training will be provided at no cost to state and local regulatory officials responsible for food and drug inspections. The cost savings will be significant since regulators will be able to take the courses from their own offices. Forty-nine courses are currently available with more than double that number of courses in developmental stages.

By November 1, 2002, each state, regulatory agency should have received information explaining how to take advantage of this program. As the next step in implementing ORA-U, local and tribal regulatory agencies will be contacted over the winter. If you do not receive information from FDA by the end of the year, or have a question about the program, visit http://www.fda.gov/ora/training/course_ora.html or email ORAU@ora.fda.gov. To take a sample “Tour of the FDA” visit: http://www.fda.gov/ora/training/ORAU/Whats_New.htm. Additional “States Helping States” resources developed by AFDO to augment the training include the following:

• Development of a classroom applications course that will provide follow up hands-on training on the topics presented by ORA-U. This course is currently under development by AFDO and will be pilot tested during the upcoming year. Following the pilot test, the course will be offered in locations throughout the US.
• The implementation of a searchable database of state subject area specialists available for consultation (currently under development).
• A roster of emergency response personnel for all U.S. states and territories. Available on-line now!
• The Crumbine Award winning submittals for the past four years, and
• Links to state environmental health association web pages, state emergency management offices, and to the web pages and food regulations of state and territorial food safety agencies.

To view these features and for more information on “States Helping States”, visit the AFDO website at: http://www.afdo.org/.

AFDO has just received information that funds are available to states to assist organic producers or organic handlers certified to the National Organic Program. States interested in obtaining cost-share funds for their organic producers or handlers will have to submit an application for Federal Assistance, and will have to enter into a cooperative agreement with AMS for the allocation of such funds. Completed applications for federal assistance along with signed cooperative agreements must be received by December 31, 2002 in order to participate in the program.

Individual producer/handler payments for certification are limited to 75% of the costs incurred by the producer or handler in obtaining certification under the National Organic Program as certified to and approved by the Secretary, up to a maximum of $500 per year.

For additional information, interested producers and handlers should contact their state agency (Department of Agriculture) contact person. A state contact list can be found at www.ams.usda.gov/nop. The state agencies will be collecting applications and making the decisions on reimbursement.

News from CASA:

The Pittsburgh Conference of the Central Atlantic States Association of Food and Drug Officials, in partnership with the Pennsylvania Environmental Health Association, is sponsoring its annual Christmas meeting and training session. The meeting will take place on Tuesday, December 10, 2002, at Dave & Buster’s @ The Waterfront in Homestead, PA. Registration begins at 8:15 am; cost is $20 per person including breaks and the Grand Buffet luncheon. Agenda items include “FDA Retail Food Standards;” “Why No Bare Hand Contact;” “FDA’s Response to Counter Terrorism;” “Listeria Prevalence in Ready-to-Eat Foods;” “Hot Holding Drops to 130 Degrees F - Scientific Analysis”; and “Interstate Travel Team - Inspection of Conveyances.” To register, contact D. Lauria at Allegheny County Health Dept., 3190 Sassafras Way, Pittsburgh, PA 15201, no later than December 4, 2002, or via dlauria@achd.net.

News from FDA: FDA Bioterrorism Act Website online!

FDA has added a new page to its existing bioterrorism website to provide information on the agency’s efforts to implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). Signed into law by President Bush on June 12, 2002, this semiannual legislation authorizes the Department of Health and Human Services (HHS) to take specific measures to protect the nation’s food and drug supplies against bioterrorist threats. FDA, as the primary regulatory arm of HHS for these products, is responsible for implementing those measures.

The new page on the Bioterrorism Act provides easy access to the Act, the provisions of the law related to FDA, and the Agency’s activities to implement these provisions. Among the website’s features are:

• An overview of the Bioterrorism Act, including those aspects that most involve FDA such as protecting the nation’s food, drug and biologic supplies.
• FDA’s plans for implementing the Act, including four proposed rules for protecting the food supply. These rules include Registration of Food Facilities; Establishment and Maintenance of Records for Food Facilities; Prior Notice of Imported Food Shipments; and Administrative Detention Authority.
• Summaries of the provisions related to FDA as well as links to guidance documents, Federal Register notices, and dockets associated with the respective provisions.
• Links for directly submitting electronic comments to the dockets established for registration of food facilities; establishments and maintenance of records for food facilities; prior notice of imported food shipments; and administrative detention authority.
• Links to other sources of information related to the Bioterrorism Act at websites for the White House, the U.S. Centers for Disease Control and Prevention, and individual FDA centers
• Access to FDA updates on its activities related to the Bioterrorism Act through a free subscription to a directed E-mail list. The new FDA Bioterrorism Act site is at, http://www.fda.gov/oc/bioterrorism/bioact.html. FDA’s main bioterrorism site is http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html.

FDA Satellite Videoconferences on BT Legislation: In addition, FDA is sponsoring two satellite videoconferences to discuss how the agency is implementing the BT legislation and to ask for public comment on the regulations they are drafting. These satellite conferences will be held on or about January 29 (Registration and Prior Notice) and March 19 (Automatic Detention and Recordkeeping). Anyone with satellite downlink capability will be able to participate in these interactive videoconferences. Watch the FDA Bioterrorism Act websites for more information on the downlinks and how you can participate!