NEW NOTIFICATION AND SCREENING REQ. FOR BIOTECH PRODUCTS

FOR RELEASE: THURSDAY, MARCH 27, 1997

EPA Issues New Notification and Screening Requirements for Biotech Products

The U.S. Environmental Protection Agency is issuing new regulations that establish a streamlined process for the screening of certain microbial biotechnology products to ensure that they are safely developed for commercial use in a broad range of industrial and environmental applications. The new regulations are being issued under the Toxic Substances Control Act (TSCA).

"Today's action achieves the Clinton Administration's objective to protect human health and the environment, while providing flexibility for the development of our nation's emerging biotechnology industry," said EPA Administrator Carol M. Browner. "Our goal is to help the nation safely realize the widespread benefits of biotechnology in a number of markets, from pollution prevention to environmental cleanup."

The regulations cover those microbial biotechnology products developed for industrial applications subject to EPA oversight under TSCA. Other federal authorities regulate the development and introduction of biological pesticides, drugs and food additives.

Under these regulations companies that manufacture or researchers who develop microbial biotechnology products are required to notify and obtain EPA review prior to the use of their products in commerce or testing in the environment. Specifically the new regulations:

Tailor pre-existing screening requirements for new chemicals and establish a distinct program for microbial biotechnology products under section 5 of TSCA. EPA has been reviewing microbial biotechnology products for 10 years under the authority of a policy statement issued in 1986 and under TSCA regulations originally written for new chemicals. Today's action supersedes these pre-existing policies and regulations.

Continue to focus the Agency's regulatory attention on microorganisms that are likely to display new traits or to exhibit less predictable behavior in the environment.

Provide full or partial exemptions from the notification and screening requirements for certain categories of new microorganisms introduced for commercial use or testing in the environment and for which EPA has acquired substantial assessment experience. A process for seeking additional exemptions also is provided.

The final rule is expected to be published in the Federal Register April 11. The text of the final rule and certain support documents also will be made available electronically upon the date of publication in the Federal Register. These documents may be accessed

through the Office of Pollution Prevention and Toxic's Biotechnology Program homepage at: http://www.epa.gov/opptintr/biotech/, or at: gopher.epa.gov.

PR EPA ANNOUNCES COMP. PLANS FOR PROTECTING FOOD SAFETY

FOR RELEASE: TUESDAY, MARCH 18, 1997

EPA ANNOUNCES COMPREHENSIVE PLANS FOR PROTECTING FOOD SAFETY, REGULATING PESTICIDES UNDER THE 1996 FOOD QUALITY PROTECTION ACT

The U.S. Environmental Protection Agency today issued a comprehensive, detailed plan for implementing the l996 Food Quality Protection Act (FQPA). The new law includes sweeping new food safety protections and requires major changes in how pesticides are regulated, with the goal of improving environmental and public health protection, especially for children. "The Food Quality Protection Act is one of the most significant pieces of legislation enacted in the past two decades," said EPA Administrator Carol M. Browner. "We are committed to providing greater assurance that infants and children are protected from pesticide risks, expanding the public right-to-know about pesticides, and using the best available science in reaching our regulatory decisions as we carry out this important new law."

The FQPA Implementation Plan is based on five guiding principles that will govern the Agency's actions: sound science; a protective, health-based approach to food safety; promotion of safer, effective pest control methods; an open, fair and consistent process that involves consultation with stakeholders and an informed public; and public accountability of EPA's actions and resources to achieve the goals of the law.

The major provisions of the new law include:

oEstablishing a single, health-based standard for all pesticide residues in food, whether raw or processed;

oProviding for a more thorough assessment of potential risks, with special protections for potentially sensitive populations, such as infants and children;

oRequiring EPA to reassess roughly 9,000 existing tolerances (maximum legally permissible residue levels in food) to ensure they meet the new standard;

oRequiring EPA to develop consumer information, to be displayed in grocery stores, on the risks and benefits of pesticides used in or on food, as well as recommendations to consumers for reducing dietary exposure to pesticides while maintaining a healthy diet; and

oEnsuring that all pesticides will be periodically re-evaluated to make sure they meet current testing and safety standards.

Among the major reforms of FQPA are requirements that EPA routinely address a number of new considerations in establishing tolerances for pesticide residues in food. Many of these new provisions raise complex scientific issues and call for new policies and evaluation methods. EPA has already brought a number of these issues before expert scientific review panels and will continue to consult with these expert bodies as implementation proceeds. Specifically, FQPA requires EPA to:

--use an extra safety factor in conducting risk assessments to assure the protection of infants and children;

--assess total pesticide exposure from all non-occupational sources including through the diet, in drinking water, and as a result of household pesticide use;

--assess effects of exposure to multiple pesticides with a common mechanism of toxicity;

--assess effects of in utero exposure; and

--assess potential effects on the endocrine system.

"The FQPA calls for a comprehensive overhaul of pesticide policies and we are working with leading scientists and other interested groups to update and reinvent our procedures and scientific approaches as called for by this law," said Dr. Lynn Goldman, EPA Assistant Administrator for Prevention, Pesticides and Toxic Substances. "In the meantime, we must continue to make decisions and move ahead. We have adopted interim measures to ensure that decisions meet the new requirements of the law, including decisions on new pesticide registrations and the establishment of new tolerances for residues in food."

Soon after FQPA was enacted, EPA convened a broadly representative, high level Food Safety Advisory Committee to advise the Agency on strategic implementation issues. The Committee met in public sessions four times and concluded its work in December. EPA also established a new Endocrine Disruptors Screening and Testing Advisory Committee which met in December and February. This group is working to develop a chemical screening and testing program to assess potential estrogenic and other hormonal effects as required by FQPA and the Safe Drinking Water Amendments of l996. EPA is also continuing to consult with the ongoing Pesticide Program Dialogue Committee, including the formation of a working group to address such major new efforts on the development of consumer right-to-know information on pesticides for display in retail stores.

Since the FQPA was passed in August l996, relying on the interim strategy released earlier this year, the Agency has registered six new conventional pesticides active ingredients (two of which are reduced risk products), l0 new biological pesticides and one new anti-microbial pesticide. EPA has also granted 52 emergency exemptions requested by the states facing critical pest control needs to deal with pest outbreaks that could not be controlled by currently registered products.

The Implementation Plan and additional information on FQPA and its implementation are available through the Office of Pesticide Programs Public Docket located at l921 Jefferson Davis Highway, Arlington, Va., Rm. 1132; telephone: 703-305-5805. Information is also posted on the Internet: http://www.epa.gov/pesticides/lawsregs.htm..

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