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

     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.

                          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,
information about the
Chemical Right-to-
Know Initiative,
please visit our web
site at
chemrtk or call
(202) 260-3951.
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.