GENTECH archive 8.96-97

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new epa regs on biotech



PR 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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