March 14, 2003
and Records Integrity Branch (PIRIB)
Office of Pesticides
Protection Agency (7502C)
Dear Sir or Madam,
The Center for Regulatory
Effectiveness (“CRE”) submits the following comments on the Advance Notice of
Public Rulemaking published in the Federal Register on January 24,
2003. This ANPR focuses on regulations
and policies affecting the process for consultation under the Endangered
Species Act (“ESA”) between EPA , the Fish and Wildlife Service (“FWS”), and
the National Marine Fisheries Service (“NMFS”) regarding EPA actions in its
pesticide regulatory program under the Federal Insecticide, Fungicide, and
Rodenticide Act (“FIFRA”). CRE’s
comments primarily concern the definition of “Best Scientific and Commercial
Data Available.” This is one of the ESA Consultation issues for which comment
is expressly requested in the ANPR.
For purposes of ESA consultation,
EPA cannot make an effects determination for a
particular pesticide without reliable test data. Similarly, FWS and NMFS cannot issue a biological
opinion without reliable test data. Tests that have not been demonstrated to be
reliable should not be used in effects determinations or biological
opinions. This conclusion is based on
principles of sound science, and it is mandated given the requirements of the
Data Quality Act, 44 U.S.C. § 3516 Statutory and Historical Notes.
The Data Quality Act imposes
standards on the quality of information disseminated by most federal agencies,
including EPA, FWS and NMFS. EPA, FWS
and the Department of the Interior, which includes NMFS, have published their
own agency-specific Data Quality Guidelines pursuant to the Act and OMB’s
government-wide guidelines implementing the Act. Effects determinations and biological opinions are publicly
disseminated, and are therefore subject to the Data Quality Act standards.
The Act, OMB’s government-wide
guidelines, and the relevant agency-specific guidelines require that publicly
disseminated information meet objectivity and utility standards. The Objectivity standard requires that disseminated
information be accurate, reliable and unbiased. The Utility standard requires
that disseminated information be useful.
Influential scientific information is subject to especially stringent
reproducibility and risk assessment
standards.1 ESA effects determinations and biological
opinions must comply with these Data Quality standards.
CRE believes a specific example
would be helpful to the agencies in understanding the new Data Quality Act
requirements and their impact on the ESA consultation process. CRE and agricultural groups filed a request for
correction under the Data Quality Act of EPA’s FIFRA Environmental Risk
Assessment for the herbicide atrazine.
This Request for Correction contended that the Environmental Risk
Assessment violated the Act’s objectivity and utility standards because it
concluded, on the basis on non-validated tests, that atrazine caused endocrine effects in various wildlife
including frogs and endangered
salmon. Tests that have not been
validated have not been demonstrated to be accurate, reliable and useful.
EPA responded to this Request for
Correction by stating in its Interim Registration Decision for atrazine:
• endocrine disruption, or
potential effects on endocrine mediated pathways, cannot be regarded as an
atrazine regulatory endpoint at this time; and appropriate testing protocols
must be established before EPA can reach a conclusion regarding atrazine's
EPA also revised its atrazine
Environmental Risk Assessment in response to this Request for Correction to
state that atrazine should be subject to testing to determine its endocrine
in wildlife once
appropriate screening and testing protocols have been developed under EPA’s
Endocrine Disruptor Screening Program, which is in the process of trying to
validate appropriate tests.3
CRE is encouraged by EPA’s
acknowledgment in the atrazine FIFRA review that the Data Quality Act requires
information disseminated by federal agencies to be based on tests that have
been demonstrated to be accurate and reliable.
This same principle applies to effects determinations and biological
opinions under the ESA.
Thank you for the opportunity to
submit these comments.
pp. 68, 72.