James Giese

FDA acts on pharmaceutical-producing corn
On November 19, the Food and Drug Administration announced that the biotechnology firm ProdiGene has agreed to strengthen the controls on any bioengineered plant it grows that will be used in current and future clinical studies. FDA obtained this commitment after learning that a small amount of corn ProdiGene engineered to produce pharmaceutical material for a clinical study had been harvested in a field of soybeans. In mid-October, a small number of volunteer corn stalks were harvested in a field of soybeans in Nebraska and then commingled with about 500,000 bushels of soybeans. According to FDA, the entire lot of soybeans has been secured in a warehouse. ProdiGene has agreed to buy back this lot of soybeans, and the federal government will oversee their disposal. The pharmaceutical material being produced in the corn plants was being studied under an Investigational New Drug application.

FSIS issues E. coli O157:H7 reassessment notice
FSIS issued a notice to provide inspection program personnel with instructions for performing verification of Escherichia coli O157:H7 reassessment on November 4. This follows the October 7, 2002, Federal Register notice, “E. coli O157:H7 Contamination of Beef Products” (FR 67 62325-62334). The notice is at www.fsis.usda.gov/OPPDE/rdad/FSISNotices/44-02.htm.

USDA issues directive to reduce Listeria monocytogenes
The U.S. Dept. of Agriculture released an administrative directive on November 18 outlining additional steps to be taken by its inspectors to ensure that plants producing ready-to-eat meat and poultry products prevent contamination of products with Listeria monocytogenes. The directive is a result of last month’s announcements calling for a strengthening of current Listeria protocols and testing programs. Under this directive, plants producing high- and medium-risk ready-to-eat products (deli-meats and hot dogs) that do not have an evaluated environmental testing regime designed to find and eliminate L. monocytogenes, will be placed under an intensified testing program by USDA’s Food Safety and Inspection Service. FSIS is also in the process of completing a scientific risk assessment on L. monocytogenes to determine how the pathogen may contaminate meat products during production and packaging processes. The risk assessment, in conjunction with a risk ranking of retail products, will provide important additional data for USDA to finalize in the coming months its rulemaking process on an effective regulatory approach to reducing L. monocytogenes in processing plants producing ready-to-eat products. More information is available at www.fsis.usda.gov/OA/topics/lm.htm.

HACCP-based inspection compared to traditional
A technical review of data on the effectiveness of the HACCP-based Inspection Models Project (HIMP) was presented November 7 at a meeting of the National Advisory Committee on Meat and Poultry Inspection. FSIS contracted with the National Alliance for Food Safety, a consortium of 20 universities, to determine the soundness of the design and methodology for the HIMP pilot project and the utility of data collected to determine its validity. The NAFS review team concluded that “Overall, the HIMP system compared favorably to the traditional system of inspection with regard to meaningful parameters to consumers of poultry and poultry products.” The HIMP program was designed to reallocate in-plant responsibilities to provide FSIS inspectors the flexibility to best focus on public health concerns from the farm to table. Under the program, industry carries out certain process control activities, under FSIS oversight, while FSIS inspectors focus their attention on inspection and verification activities.

U.S. signs UN genetic plant treaty
On November 6, the United States added its signature to an International Treaty on Plant Genetic Resources which aims to ensure better use of genetic diversity to meet the challenge of eradicating world hunger, the UN Food and Agriculture Organization announced. The U.S. joins the 76 other countries and the European Union who have signed the Treaty. The Treaty is a comprehensive international agreement, the fruit of almost a quarter of a century of negotiations, which aims to guarantee the future availability of the diversity of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits. For more information, see the FAO news release at www.fao.org/english/newsroom/news/2002/10660-en.html.

Oregon voters reject GM food labeling
On November 5, voters in Oregon rejected a ballot initiative which would have made Oregon the first state to require mandatory labeling of genetically modified foods. More than 73% of the voters rejected the measure.

by JAMES GIESE
Internet Editor