1999-12

FDA denies petition on antimicrobial soaps.

HAPPI: December 1999

A citizen petition filed in the US by the Soap and Detergent Association, the Cosmetic, Toiletry &Fragrance Association and the Consumer Healthcare Product Association has been denied by the Food and Drug Administration (FDA).  The petition asked that any enforcement action against antimicrobial lotion products be deferred by the FDA until after the completion of rulemaking proceedings under the OTC Drug Review.

EPA TO ISSUE GUIDANCE REGARDING EXEMPT PESTICIDES

International Regulations: December 1999

EPA is preparing a guidance document that is designed to help manufacturers of pesticide products and state regulators determine what products are exempt from federal regulation under the Federal Insecticide, Fungicide and Rodenticide Act. This guidance document is expected to be released in the form of a pesticide registration notice in the near future. It will help define exactly what products are exempt from FIFRA regulation and which do not have to be registered with EPA prior to their lawful sale. It is expected that this pesticide registration notice will pull together lists of pesticides and ingredients that are exempt from regulation by EPA as a pesticide. Currently, these materials are scattered in three or four different places including Federal Register notices. Pesticides exempt from FIFRA regulation include those containing any of the thirty "minimum risk" active ingredients and List 4A inert ingredients. Under EPA regulations, such exempt pesticides cannot make "false or misleading" statements. The anticipated PR Notice also will clarify what type of statements fall into this category.

The Notice will also provide assistance to state regulators in identifying those products that are exempt from EPA registration requirements as a pesticide. This action will help clarify exactly what products need to be registered with each respective state in which it is sold. States are obligated through cooperative agreements with EPA to ensure that all pesticide products offered for sale in a state are properly registered in the state and with EPA. Approximately half of the states still require state registration of minimal risk pesticides that EPA excludes from regulation under FIFRA.

FDA APPROVES ANTIMICROBIAL FOR SEAFOOD PROCESSING

ISSA: December 1999

FDA amended the food additive regulations to allow for the safe use of acidified solutions of sodium chlorite as an antimicrobial agent to be used in processing water and ice that come into contact with seafood. As such, FDA stated that such solutions should reduce the population of microbes as long as a residual level of the solution is maintained.

FDA issued this action in response to a petition filed by an Oklahoma based manufacturer of antimicrobial and biocidal products.

After evaluating data contained in the company's petition as well as other material, FDA concluded that the proposed use of the acidified solution of sodium chlorite is to reduce microbial contamination of water and ice used to rinse, wash, thaw, transport, or store seafood is safe, and "will achieve its intended technical effect." Under the Antimicrobial Regulation Technical Corrections Act of 1998, the use of such an acidified solution as an antimicrobial agent in water and ice that come into contact with seafood is subject to regulation by FDA as a food additive. Such solutions are to be used in water that comes in contact with the food in preparing, packing, or holding of the food for commercial purposes.

FDA ISSUES GUIDANCE OVER ANTIMICROBIAL PRODUCTS

ISSA: December 1999

The U.S. Food and Drug Administration recently announced the availability of a guidance document that clarifies federal jurisdiction over antimicrobials used in food related uses. The FDA guidance document follows changes made in jurisdiction between the FDA and the Environmental Protection Agency under the Food Quality Protection Act of 1996 and the Antimicrobial Regulation Technical Corrections Act of 1998. In effect, the guidance document is designed to instruct companies that manufacture antimicrobial products as to which federal agency to go to for regulatory approval. The FDA guidance document, in general, defines jurisdiction over antimicrobial products consistent with FDA and EPA practices over the past few years. Under the Federal Food, Drug and Cosmetic Act, EPA regulates pesticide chemicals while FDA regulates substances as food additives. According to the FDA guidance document, the U.S. Food and Drug Administration regulates antimicrobials used in or on processed foods. However, with the passage of the 1998 law, raw agricultural commodities fall within the authority of the FDA when antimicrobials are used to kill microbes on such commodities within food processing plants. Previously, such chemicals used to kill bacteria on raw agricultural chemicals would be considered pesticides and would have been regulated by EPA. Excluded from FDA authority are antimicrobials applied in the field, treatments such as washing, waxing, fumigating, and packing, or chemicals applied in transportation, according to the guidance document. These products are under the jurisdiction of EPA. In addition, EPA authority extends to those antimicrobials used in processing plants that are used to kill pests in the water, not on the food. This distinction was drawn in the Antimicrobial Regulation Technical Corrections Act of 1998.

The FDA guidance document also clarifies that sanitizers used on food contact surfaces are regulated by EPA. In fact, these products have legally been within EPA's jurisdiction since 1996. As such sanitizers used on food contact surfaces will be subject to EPA tolerance provisions including the recently proposed tolerance fees. Furthermore, another clarification made in the guidance document is that packaging materials for foods are within FDA's authority. Treated articles such as cutting boards that make claims of killing microbes are under EPA's jurisdiction, but preservatives incidental to the manufacturing of the articles are under FDA jurisdiction.

News on formaldehyde risks

Chemical Week: December 1999

The Chemnical Industry’s Institute of Toxicology (CIIT) predicts significantly lower risks of cancer from formaldehyde exposure compared to previous assessments.  The researchers used a fluid dynamics model incorporating at risk respiratory cells and integrated EPA cancer data.