Regulations: December 1999
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.
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.
issued this action in response to a petition filed by an Oklahoma based
manufacturer of antimicrobial and biocidal products.
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.
Week: December 1999