United States Pollution Prevention EPA 745-F-99-003
Environmental Protection and Toxics April 2001
Agency (7401)
Chemical Right to Know
High Production Volume Challenge Program
Fact Sheet on Animal Welfare
The HPV Challenge Program
The goal of the HPV Challenge Program is to ensure that a baseline set of environmen-
tal and health effects data on approximately 2,800 high production volume (HPV) chemicals
is made available to EPA and the public. EPA believes that the availability of this informa-
tion is vitally important so that the public can better understand chemical hazards in their
communities, homes, and workplaces, and so that EPA can make sound decisions about
priorities for possible future regulation and take appropriate risk management actions if
necessary.
U.S. manufacturers and importers are voluntarily providing basic human health and
environmental effects data for their HPV chemicals; i.e., those produced or imported into
the U.S. in volumes of 1 million pounds or more per year. These data comprise the HPV
Screening Information Data Set (SIDS), developed by the Organization for Economic
Cooperation and Development (OECD). EPA intends to consider specific chemicals which
are not voluntarily sponsored as candidates for test rules under Section 4 of the Toxic
Substances Control Act. Sponsorship entails identifying existing information and assessing
its adequacy, conducting new testing only if adequate information does not exist, and
providing the new and existing data to EPA. EPA is making this information accessible to
the public.
The Role of Existing Data
EPA believes that it is important to achieve the goals of the HPV Challenge Program
in a manner that takes into account animal welfare concerns. As a result, this Program has
been designed from the start to encourage companies to consider approaches that can reduce
the amount of testing needed and avoid duplicative testing. EPA encourages industry and
others to search for relevant and scientifically valid existing data, and to share that informa-
tion with EPA and the public. Companies have the opportunity to submit plans for testing
chemical categories, which involves collecting data on a subset of chemicals considered to
be representative of an entire class or group of chemicals. Chemicals for which adequate
SIDS data exist are not retested under the HPV Challenge Program or any associated test
rule(s) that are limited to SIDS testing. All test plans submitted by sponsors under the HPV
Challenge Program are posted on the Internet for a 120-day review period prior to the start
of testing. This provides an opportunity for identifying scientifically valid existing data
which may not have been cited and for recommending revisions to the test plans which
could reduce the need for additional animal testing.
Efforts to Reduce Animal Testing
EPA is committed to examining alternative test methods that reduce the number of
animals needed for testing, reduce pain and suffering of test animals, and whenever pos-
sible, replace animals in testing with validated in vitro (non-animal) test systems. EPA has
released guidance on this issue to companies participating in the HPV Challenge Program.
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This guidance promotes the maximum use of existing data, and encourages companies to
disclose existing data not previously made publicly available. The guidance also states that
sponsors are encouraged to defer certain animal tests and use certain in vitro tests to address
endpoints for which adequate existing data are not available. EPA recommends delaying
some necessary testing of individual chemicals until November 2001, and testing of closed
system intermediates, which present less risk of exposure, until 2003. Federal funds have
also been committed to the evaluation of alternative test methods.
For more information
on the specific
actions EPA is taking
to reduce the use of
animals in the HPV
Challenge Prog ram,
orgeneral
information about the
Chemical Right-to-
Know Initiative,
please visit our web
site at
http://www.epa.gov/
chemrtk or call
(202) 260-3951.
Interested
stakeholders may
join our automated
updated notification
service on the
"What's New" page to
receive email
updates on the HPV
Program. All
documents posted on
the website may be
obtained in hard copy
by contacting the
TSCA Assistance
Information Service
at (202) 554-1404.
EPA has taken several important steps to address animal welfare issues in the HPV
Challenge Program. EPA recommends the use of an alternative to the standard LD50 test
that reduces the number of rodents needed by 60 percent. EPA has reevaluated its preference
for the rodent genetic toxicity test and encourages the use of non-animal alternatives. EPA
also recommends the use of combined studies and specific actions to reduce pain and distress
in test animals. Taken together, the measures which EPA has recommended would reduce
animal usage by 68 to 80 percent. EPA has communicated these testing recommendations to
sponsors of HPV chemicals.
Types and Validity of Data to be Collected
The OECD HPV SIDS data set represents an internationally agreed upon set of studies
needed to screen HPV chemicals and identify potential hazards. These include studies for
physical chemical properties (e.g., water solubility), environmental fate (e.g., biodegrada-
tion), environmental toxicity to fish and other aquatic species, and mammalian toxicity (acute
toxicity, genetic toxicity, repeat dose toxicity, and reproductive and developmental toxicity).
The SIDS data set does not include the developmental neurotoxicity test (DNT). Conse-
quently, the DNT is not part of the HPV Challenge Program. Any needed testing under the
this Program is to be conducted using test guidelines which are recognized and accepted by
governments and scientists worldwide as providing high quality, screening level data.
Scientific Validation of Alternative Non-Animal Testing
Scientific validation is an essential step in determining the adequacy of new alternative
test methods. Scientific peer review to determine the level of validation of alternative
protocols is performed by various recognized authorities such as the U.S. Interagency Coordi-
nating Committee on the Validation of Alternative Methods (ICCVAM), of which EPA is a
member. Following the recommendations of such organizations, federal agencies then decide
whether to adopt alternative test methods for their regulatory purposes.
Until non-animal test methods are validated and achieve regulatory acceptance, these
methods cannot be relied on as alternatives to established test guideline studies for purposes
of the HPV Challenge Program or any associated test rule(s). EPA is working with other
federal agencies to identify, validate, and peer review potential alternative protocols, and to
ensure the scientific and regulatory acceptability of the tests. ICCVAM recently initiated a
process to investigate the potential for validation of various acute in vitro methods, including
the Multi-center Evaluation of In Vitro Cytotoxicity (MEIC) battery of tests. These in vitro
tests are being evaluated as possible alternatives to or supplements for animal tests for acute
toxicity. EPA and ICCVAM co-sponsored a workshop in October 2000, on in vitro methods
for acute toxicity. The recommendations of that workshop will be used to consider validation
of the most promising methods. As relevant alternative test methods become validated and
achieve regulatory acceptance during the implementation of the HPV Challenge Program,
EPA will consider their immediate implementation in the Program. To enhance the use of
alternative testing methods, EPA will continue to involve animal welfare interest groups and
other interested parties in a constructive dialogue to identify and develop such methods.
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