EPA
Draws Suite Of Challenges Over Endocrine Chemical Testing
Proposal
Industry
and activist groups are attacking EPA?s endocrine screening program on several
fronts, with two industry groups filing administrative petitions challenging the
validity of a key test the program uses for evaluating whether pesticides and
other chemicals are endocrine disrupting compounds. At the same time, activists
met with White House officials to press EPA to use non-animal testing methods in
the program.
The
Center for Regulatory Effectiveness (CRE) July 10 filed a Data Quality Act (DQA) petition with EPA over
a frog assay that is a key component of EPA?s upcoming endocrine disruptor
screening program (EDSP). The EDSP is intended to narrow a list of chemicals
that require additional testing to determine whether they disrupt the endocrine
system. An informed source says the agency is making ?inaccurate and misleading?
comments on the accuracy of the frog study, and says scientific uncertainty
renders the entire first tier of the EDSP ?useless.?
Additionally,
the informed source says that representatives from the Physicians Committee for
Responsible Medicine (PCRM) and People for the Ethical Treatment of Animals
(PETA), who are supportive of the CRE petition, met July 16 with White House
Office of Management & Budget (OMB) officials to advocate for the use of
non-animal tests that are currently in the process of being validated.
Meanwhile,
the trade organization CropLife America filed a petition under the Administrative
Procedure Act and the Federal Food, Drug & Cosmetic Act urging EPA to avoid
burdens of additional testing by reviewing data already submitted by pesticide
registrants, fully validate the 12 assays in the first tier of the EDSP, and
prepare a regulatory flexibility analysis and develop alternative procedures to
reduce the program?s impact on small businesses -- though CropLife America notes
it is not trying to delay the August launch of the program.
Endocrine
disruptors are chemicals that mimic or block normal functioning of hormones,
inducing a variety of developmental and other health effects. The chemicals have
been shown to cause developmental problems in many animals, including mixed-sex
organs in aquatic species. The findings raise the question of whether the
chemicals cause similar effects in humans, though little evidence is available
for many suspected endocrine-disrupting compounds.
In
a bid to improve understanding of the compounds, Congress ordered EPA in the
1996 Food Quality Protection Act to assess the endocrine-disrupting potential of
all pesticides. But EPA has struggled to create the program. In EPA?s fiscal
year 2008 appropriations bill, Congress ordered the agency to issue in August
orders for industry to begin the screenings. EPA also must finalize in August
the list of pesticides that will go through the screening program first.
Industrial and other chemicals will be tested later.
Earlier
this year, EPA won lukewarm approval from its Scientific Advisory Panel (SAP),
enabling the screening program to move forward as the agency?s Office of
Pesticides, Prevention & Toxics pushes to meet the August deadline. The
advisors declared some of EPA?s tests outdated, but also rejected industry
arguments for replacing some of the proposed tests with industry?s preferred
alternatives.
In
its proposal, the frog assay is one of the assays that EPA proposes to require
companies to use during the first tier of the EDSP. The assay is key to EPA?s
effort because it is the only one of the first-tier testing assays to focus on
the chemical?s harmful effects on the thyroid gland, which regulates hormones in
the body.
The
agency has said that, ?Overall, it is concluded that the amphibian metamorphosis
assay is valid for its intended purpose? and that is ?validated and ready for
use.?
But
the informed source says if CRE can successfully challenge EPA?s statements
about the validity of the amphibian metamorphosis assay, then the entire first
round of the screening program would be invalidated, because the frog study is
the only one of the 12 assays to look at the thyroid. If the DQA challenge
succeeds, then EPA ?will not be able to issue an order requiring companies to
test their products. If they proceed with the remainder of the tests, the test
data will be incomplete,? the source says, adding, ?If this one assay being
challenged falls, then the whole [EDSP] falls.?
The
DQA allows parties to challenge the quality and accuracy of information released
by the government, including statements and other findings issued by EPA. The
law was passed as part of the fiscal year 2001 Treasury Department
appropriations law. CRE?s move is one of just a handful of DQA petitions filed
by outside groups since the law took effect in 2001, though federal courts have
so far declined to review agencies? denials of petitions.
In
the petition, obtained by Inside EPA, CRE ask the agency to correct its
public statements that the frog assay is reproducible and properly validated.
CRE says the agency cannot use the frog assay in the program unless EPA first
demonstrates it is valid for its intended endpoints. In order to do this, the
agency must demonstrate the assay is reproducible both in a single laboratory
and among different laboratories, according to the petition.
The
PETA and PCRM officials met with the White House July 16 to advocate for the
creation of an ?effective Tier 1 battery? that would include several non-animal
methods that are currently in the process of being validated, according to PETA.
The informed source says that OMB and EPA officials present at the meeting were
?non-committal? on whether they would adopt the groups' suggestions.
Meanwhile,
CropLife America in its petition to the agency says it does not want to delay
implementation of the EDSP but is requesting further explanation and examination
of the program and its processes.
In
a July 14 press release, the organization said it filed its petition ?to help
keep the EDSP on schedule and ensure that EPA takes into consideration the
unique aspects of conventional pesticide regulatory requirements as they
intersect with the endocrine screening regulatory process.?
CropLife
says EPA must demonstrate why existing and substantial data on the toxicity of
pesticides, including data on reproductive and developmental toxicity, are not
sufficient to meet the program?s requirements and allow EPA to avoid the ?time
consuming effort of examining more rudimentary tier one test data? on
pesticides, according to the press release. The petition in part requests that
EPA perform a regulatory flexibility analysis that would highlight the program?s
costs to industry.
In
particular, the petition asks EPA to: minimize ?unnecessary and redundant?
testing; fully validate the program assays; develop protocols for interpreting,
evaluating and prioritizing screening data to determine whether additional
testing would be required; and finalize how any additional testing would be
conducted.
?We
believe that EPA already has the data they need to successfully implement this
program for pesticides and that the current proposal could place unnecessary
financial, time, and resource burdens on our industry, EPA and society,?
CropLife said in a statement.
An
EPA spokesman did not return calls for comment. -- Anthony Lacey
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