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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

Richard H. Barnes

Happy New Year to you all! The events of September 11 have changed the way we all look at our world. Certainly they have changed FDA's priorities. We are placing greater emphasis on Counterterrorism, particularly in the areas of foods, drugs, vaccines and medicated feeds. Our Division of Emergency and Investigational Operations has been reorganized into two new Divisions - the Division of Emergencies and the Division of Field Investigations. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, is now assigned to the coordination of the Agency's Counterterrorism activities. Training in how to deal with terrorism, in all its forms, is being given to our investigators and our managers. Finally, FDA, for the first time in over 30 years, is in a major hiring mode, recruiting new investigators, analysts and support staff to help with the increase in border patrol, inspections and analysis that is needed.

All of this will have a direct impact on state and local agencies and will certainly expand our ways of interacting and sharing the responsibility of protecting consumer health. It's good to know that FDA can depend on you!

Reports from the States

NORTH CAROLINA - Adopts New Arsenic Standard:

On December 11, 2001, the N.C. Commission for Health Services approved a proposal from public health officials to lower the State’s standard for arsenic in public drinking water from 50 parts per billion (ppb) to 10 ppb. The new rule closely follows the U.S. Environmental Protection Agency’s (EPA) October 31, 2001, announcement of a national arsenic standard of 10 ppb.

The EPA’s rule requires public water suppliers to comply with its new standard by 2006. The State’s new arsenic rule does not require public water suppliers to reduce their arsenic levels any sooner than the EPA’s schedule, but it does require them to have notified their customers by January 1, 2002, if their arsenic levels exceeded the 10 ppb standard.

Arsenic in drinking water poses significant health risks to consumers. It has been linked to cancer, heart disease, and diabetes. According to the EPA, reducing arsenic levels nationally from 50 ppb to 10 ppb is expected to prevent 19-31 cases of bladder cancer per year, preventing 5-8 deaths from this cancer; 19-25 cases of lung cancer per year, preventing 16-22 deaths from this cancer; and numerous cases of other non-cancerous diseases, including diabetes and heart disease. 

North Carolina is fortunate in that it does not have the high levels of naturally occurring arsenic that is found in the western states. Only a small number of systems – approximately twelve – currently have arsenic levels that exceed 10 ppb. With thoughtful planning and some expense, these systems should be able to conform to the new state and national standards no later than 2006. For more information, contact Kimberly Hattaway, Public Information Officer, NC Division of Environmental Health at (919) 715-3204. 

TEXAS:

The Texas Department of Health, Bureau of Food and Drug Safety, is moving forward on the issue of Food and Drug Bio-Security (bioterrorism). Dan Sowards, Director, Manufactured Foods Division, is on special assignment for the next three months to develop a plan for addressing both preventive steps for the agency and the industry; as well as to develop a plan of action to address issues that would involve an actual bioterrorist event. A work group has been chosen, including one person from each of the Bureau’s six Divisions to develop plans of action.

A process known as Operational Risk Management will be used in conjunction with certain HACCP elements, to address both "violations" of current laws and regulations that may involve prevention of a bioterrorist threat or event, and "advice" to industry on issues that are not violative, but would involve "good practices" in the area of prevention. Advice would be industry specific (meat, food processing, food wholesale, milk and dairy, seafood, transportation, and retail). This process will require additional training for the field staff and changes in the Bureau’s inspectional procedures. For more information, contact Dan Sowards at (512) 719-0243 or FAX (512) 719-0263.

On the reactive side, the Bureau has developed and will continue to modify a new Appendix to the Health Department’s Annex H of the State Emergency Management Plan to address an actual bioterrorist threat or event.

The State Food Safety Task Force is planning a two-day symposium for September 2002. The thrust of this Symposium will also be food bio-security and how it relates to traditional food safety issues, from farm to table.

Finally, a one-day intensive Symposium has been developed on Food Bio-Security for the Association of Food and Drug Officials (AFDO), which will be presented in New Orleans on March 27^th. AFDO is going to FULLY FUND ONE PERSON FROM EACH STATE to attend this Symposium. For more information and an application, please contact the AFDO office at 717-757-2888. See AFDO News below!

CALIFORNIA:

The Food and Drug Branch of the California Department of Health Services ordered a drug and cosmetic manufacturing firm in Southern California, White Pearl  Manufacturing, DBA Fanie International, to recall two  products - "Action Warm-Up Creme" and "Sateen Velvet Moisturizing Lotion"   due to contamination with Pseudomonas at levels of 100,000 and 300,000   CFU. The Sateen Velvet Moisturizing Lotion had Pseudomonas aeroginosa in two samples. The firm had been inspected two years ago and ordered to  cease manufacturing drugs because they did not have a drug manufacturing  license and had few Good Manufacturing Practices controls. Cosmetic and  drug products were found to be contaminated with Pseudomonas at that time.   They agreed to cease manufacturing drugs and institute controls. However,  the new inspection revealed continuing violations as well as new internet advertising violations where a cleanser is touted to treat early stages of  tuberculosis and a Digit Liquid Solution is sold as an anti-fungal.  Products were embargoed.

The California Food and Drug Branch has embargoed large lots of Konjac candies worth   in excess of $500,000 at distributors in Southern California. The candies have been associated with a number of choking deaths in children in the  U.S., Canada, Taiwan, Japan, and Hong Kong and are considered a choking  hazard by the U.S. Food and Drug Administration (FDA). Two years ago a  Northern California child died from eating one of these candies. The candies are contained in small packages roughly the size of a child’s  mouth, so when they are eaten, they are capable of blocking the breathing  passage. The konjac ingredient is a very viscous substance that does not   lend itself to dissolving. FDA has initiated the process for civil  seizure on the products embargoed. 

For more information, contact  James M. Waddell, Acting Chief,  Food and Drug Branch,  (916) 324-3990 FAX (916) 440-5171 or  email: jwaddell@dhs.ca.gov .

PENNSYLVANIA:

Effective January 14, 2002, Bobby L. McLean has been named Director of the Bureau of Food Safety and Laboratory Services, Pennsylvania State Department of Agriculture. Most recently, Mr. McLean served as a Food Sanitarian Supervisor in Region II. You can contact him in Harrisburg at Telephone 717-787- 4315, FAX 717-787-1873 or e-mail bmclean@state.pa.us .

NEW YORK:

Recently, the New York State Legislature passed a law requiring out-of-state registration of drug establishments. This law takes effect in March 2003. The NYS Board of Pharmacy is currently developing forms to implement this law and will have information available by the end of 2002. For more information, contact Lawrence H. Mokhiber at (518) 474-3817, ext. 130, or at pharmbd@mail.nysed.gov.

KANSAS:

Kansas hosted an FDA Training November 26-29, 2001. The FDA training team conducted their "Food Processing and Distribution" program to inspectors from around the area. The training was a huge success with inspectors from Kansas and Oklahoma in attendance.

The Kansas Food Protection Consumer Safety Program held its’ "Secretary’s Food Safety Advisory Committee Meeting" on December 11^th and 12^th 2001. These committee meetings are funded by a grant from the FDA that supports Food Safety Task Forces’ in various locations. Participants in attendance included members of the food industry, academia, regulatory and other state and federal government agencies. This committee works together to continuously improve food safety in the state of Kansas by sharing of information, action planning and creating and improving relationships among all parties in order to protect Kansas Consumers. This year's discussion groups focused on Bio-terrorism and the updating of the Kansas "Focus on Food Safety" materials, a user friendly condensed version of the Kansas Food Code book.

After the events of September 11^th and the Anthrax events, many things have changed. We have noticed a greater concern about food safety and the importance of Handwashing. This was indicated by a huge increase in "HITS" to our website and our "Did You Wash ‘Em" Handwashing Campaign. Our number of hits increased from an average of 2,000 hits per month to a record high of just over 12,000 hits in the month of October. If you would like to visit our site go to http://www.kdhe.state.ks.us/wash_em/index.html

Kansas received a grant this fall from the FDA to update and create an interactive web site and CD-ROM that contains "Focus on Food Safety" educational materials. Mary Glassburner, Director of the Kansas Food Protection Consumer Safety Program, created the materials. It condenses our Kansas Food Code down into a bare-boned, user-friendly booklet for folks in the food industry to use as a training tool. Our goal is to have the website and materials up and available by late spring/early summer. We are working on a format that would allow all other states the ability to download, edit and replicate the materials for use in your area. Feel free to contact us at 785-368-7261 or by email at mparsons@kdhe.state.ks.us.

FDA News 

FDA's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) in it's Center for Food Safety and Applied Nutrition has just added a consumer information piece called "Tips for the Savvy Supplement User: Making Informed Decisions and Evaluating Information" to its Dietary Supplement Web site: http://www.cfsan.fda.gov/~dms/ds-savvy.html . This was developed to help consumers sort out the abundant information on dietary supplements, by providing tips related to basic points to consider, questions to ask health professionals, suggestions for searching the Web or evaluating research, and ways to check common assumptions. Selected references on these and other topics are also provided. In addition, this Web piece will be printed in FDA Consumer in the spring.

If you're interested in Food Labeling, look for the new Food Label Quiz that will be coming out very soon on FDA's Food Labeling and Nutrition Web site at: http://www.cfsan.fda.gov/label.html. The quiz will cover how to use the food label in terms of serving size, nutrient levels, using the % Daily Value to make dietary trade offs and more. For more information, contact Jeanne Latham at (301) 436-1756 or Naomi Kulakow at (301) 436-2373.

Thompson, et al. v. Western States Medical Center Pharmacy, et al. (U.S. Supreme Court, No. 01-344). On October 29, 2001, the United States Supreme Court agreed to review the Ninth Circuit's decision that two commercial speech-related provisions in section 503A of the Act (21 U.S.C. § 353a) violate the First Amendment. Section 503A, which was enacted in November 1997 as part of the Food and Drug Administration Modernization Act (FDAMA), exempts compounded drugs from the Federal Food, Drug and Cosmetics Act's new drug approval, adequate directions for use, and good manufacturing practice requirements if specified conditions are met. The provisions that the Ninth Circuit found to be unconstitutional provide that, in order to qualify for the exemption, the compounded drug may not be based on a solicited prescription, section 503A(a) and the pharmacy, pharmacist, or physician may not advertise or promote the compounding of a particular drug, class of drug, or drug type. The Ninth Circuit concluded that the provisions in that section may not be severed from the remainder of that section of the Act and held that section 503A is invalid in its entirety. Neither the government nor the plaintiffs-respondents sought review of this aspect of the Ninth Circuit’s decision. Pending a decision by the Supreme Court on the First Amendment question, section 503A remains in effect outside the Ninth Circuit. The government’s brief is due December 13. We expect that oral argument will be scheduled for spring 2002, and that the Court will issue its decision by early summer. 

In conjunction with the CDC, FDA, NFPA and USDA, AFDO is sponsoring a Food Bio-Security Symposium to be held March 27, 2002, in New Orleans, LA. Speakers include representatives from the Chemical & Biological Arms Control Institute, the Domestic Counter Terrorism Program of the FBI, CDC, FDA, USDA and the food industry. Learn what industry is doing, what proactive steps regulatory actions are taking and the roles of the FBI, OCI, local and state law enforcement agencies. AFDO's Endowment Foundation is providing scholarships for one representative from each state to attend this symposium. The applications may be obtained by contacting AFDO at 717-757-2888 or afdo@afdo.org. All applications must to the AFDO office by 2/8/02.

In addition, AFDO is repeating its symposium on Managing Food Allergens on April 25, 2002, in Costa Mesa, CA. This editor attended the last symposia last November in Crystal City, VA and found it to be outstanding. Many of the same speakers will be at the California program, with some slight modifications, so get your applications in! For more information and to register, contact AFDO at their website, afdo@afdo.org or call Tiffany Wimmer at (717) 757-2888.

Conference for Food Protection Meeting:  The biennial meeting of the Conference for Food Protection will be held April 19 - 24, 2002, at the Sheraton Nashville Downtown in Nashville, TN.  Registration packets, conference and hotel registration forms, Issue Submission forms, a tentative agenda and other Conference information were mailed in December 2001.

All who attended the past Conference in Milwaukee and those who have become members since, will receive registration and Issue submission packets. Persons who are not currently members may receive information regarding the Conference by going to the CFP web site at "foodprotect.org" or by contacting Trevor Hayes, CFP Executive Secretary, 1085 Denio Avenue, Gilroy, CA 95020-9206, telephone/fax: (408) 848-2255 or e-mail: TWHgilroy@aol.com.

Food Processors Institute: The January issue of the FPI Newsletter is available on their Website at www.fpi-food.org.

International Food Information Council: The November/December issue of Food Insight is now available at the IFIC website at http://ific.org/foodinsight.

NAACHO: The National Association of County and City Health Officials’ (NACCHO) has released a final report on the 2000 Food Safety Assessment and Focus Groups, evaluating the existing needs and capacities of local public health agencies’ (LPHAs) food safety programs. Based on the survey findings, NACCHO will provide funding to enhance LPHA’s food safety programs in four areas: infrastructure, marketing, training, and program assessment. Copies of the survey and final report are available at http://www.naccho.org/GENERAL459.cfm.   For more information, contact Grace Ibanga at (202) 783-5550 x249 or gibanga@naccho.org.

NEFDOA the Northeast Food and Drug Officials has a new and expanded website at www.nefdoa.org. For more information, contact Frank Greene, Food & Standards Division, Connecticut Department of Consumer Protection, Room 165, 165 Capitol Avenue, Hartford, CT 06106, Fax (860) 713-7237

Mark Your Calendars!

Food safety education and communication leaders from across the country will meet in Orlando, September 18, 2002, assess current trends and plan for the future. Under the banner "Thinking Globally--Working Locally," conference planners are focusing on the food safety education implications of the global nature of the U.S. food supply, while at the same time recognizing that worldwide food safety education is very much a local effort.

Sponsored by the U.S. Department of Agriculture and U.S. Department of Health and Human Services, in cooperation with the Partnership for Food Safety Education, the program will also include guidance from community-based food safety education specialists. The conference will provide an excellent opportunity for educators to present and share projects through presentations, poster sessions, exhibits, and workshops.

Some conference topics:

• Epidemiology of foodborne illness in the U.S.
• Latest findings from consumer behavior research and what they mean in terms of creating consumer education programs that target the most important food safety issues which result in positive behavior change
• Successfully communicating risk to consumers
• Consumer and foodservice education initiatives
• Successful partnerships with tips for building and maintaining partnerships
• Shaping the future direction of food safety education

Abstracts for presentations and poster sessions/educational exhibits are currently being accepted. To find out about submitting abstracts, registration information, and conference updates, check the "Thinking Globally--Working Locally" web site at www.fsis.usda.gov/Orlando2002.

To read a portable document format (PDF), you will need to have Adobe Acrobat Reader installed on your computer. This program can be downloaded free of charge from Adobe at: http://www.adobe.com/products/acrobat/readstep2.html

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