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Info on the upcoming SRA Workshop on EDSP: http://www.neutralsource.org/content/calendar/detail/1243/ WK9: Workshop on Scientific Methods
for Evaluating EDSP Screening Data and Estimating Dose-Response for Endocrine
Disruption, Organizer: Richard
Belzer, Preregistration:
$495, Onsite: $555. Law enacted
in 1996 (codified at 21 U.S.C. 346a(p)) directs EPA to develop a screening
program, using appropriate validated test systems and “other scientifically
relevant information,” to determine whether certain substances may have adverse
endocrine effects in humans. EPA’s Endocrine Disruptor Screening Program has
proven challenging to implement for several reasons, including the difficulty of
defining “adverse” endocrine effects in humans, and devising and validating
appropriate toxicological test systems that are sufficiently sensitive and
specific to achieve the statutory goal. EPA is implementing a two-tiered
testing strategy. Tier 1 will screen for potential adverse effects, and Tier 2
will characterize human dose-response. EPA does not yet have a scientific
weight-of-evidence framework for evaluating Tier 1 data and “other
scientifically relevant information,” This workshop has two objectives. The
morning session will evaluate the Tier 1 test battery to ascertain (1) whether
Tier 1 data can satisfy statutory criteria; and (2) if so, how outputs from Tier
1 can be used to develop a (minimally) ordinal or (desirably) cardinal ranking
that is scientific, transparent, reproducible, and objective. The afternoon
session will focus on selecting and designing “appropriate validated test
systems” for Tier 2, taking into account these statutory requirements. In part
because no established methods now exist for estimating human endocrine
dose-response, Tier 2 provides a novel opportunity for innovative scientific
work in toxicology, modeling and biostatistics. Registrants will participate
with invited experts in toxicology, endocrinology, and biostatistics. The
workshop will produce a report suitable for peer review publication. Lunch is
included in this course. ISAA 2010: The
9th International Symposium on Adjuvants for Agrochemicals (ISAA 2010)
will be held at the Campus of the Technical University of Munich in
Freising, Bavaria, Germany during August 16-20, 2010. ISAA 2010
focuses on the education and advancement of the use of adjuvants in
agricultural chemical formulations. The symposium also includes a
trade show exhibit. Organizers of the symposium have provided the
following sponsorship and exhibition information for ISAA 2010: Basic Sponsorship, Diamond Sponsorship and Additional Event Details, and Trade Exhibition. Registration and additional details are available at http://events.isaa-online.org/page/62/welcome-to-isaa-2010-.html. EPA Takes Significant Step Forward in EDSP Implementation: In the October 21, 2009 Federal Register,
EPA published a notice that announces the Agency’s schedule for issuing
Tier 1 test orders under the first phase of the Endocrine Disruptor
Screening Program (EDSP). The orders will be issued in batches between
the dates of October 29, 2009 and February 26, 2010 and are applicable
to the final list of 67 chemicals (consisting of 58 pesticide active
ingredients and 9 inerts) that are subject to the initial testing under
the EDSP. The EDSP Tier 1 screening data required to satisfy an order
are due within two years of the date of issuance of the order. EPA
states that details on the status of the orders will be made available
on its web site at http://www.epa.gov/endo including
information on the order issuance date, the identity of the
recipient(s) of the order, the response from each test order recipient,
and the order due date. The Agency states that it intends to update its
web site with subsequent publications and postings as appropriate. The October 21, 2009 Federal Register
also includes an EPA notice that announces the availability of the EDSP
Tier 1 battery of assays and the availability of test guidelines
(protocols) for conducting the assays included in the battery. The Federal Register
notice provides a summary of the peer review results for the battery
and explains EPA’s rationale for the selection and integration of the
screening assays contained in the battery. The Federal Register notice announcing the schedule for the issuance of the EDSP Tier 1 test orders may be accessed at http://edocket.access.gpo.gov/2009/pdf/E9-25352.pdf. The Federal Register notice announcing the availability of the EDSP Tier 1 battery of assays is posted at http://edocket.access.gpo.gov/2009/pdf/E9-25348.pdf. OMB Approves ICR for EDSP:
In related developments, on October 2, 2009 the Office of Management
and Budget (OMB) approved the Information Collection Request (ICR)
for the EDSP, a requirement for the issuance of the test orders
subsequently announced by EPA. The trade associations representing
manufacturers and registrants of these pesticide ingredients worked
diligently during the ICR review, collectively and individually, to
provide OMB with science-based and economic evidence in support of our
continuing concerns over the program. CPDA and others believe that the
Agency: 1) has not demonstrated the “practical utility” or benefit of
collecting the data in the Tier I battery; 2) did not adequately
develop a weight-of-evidence approach for determining how the Agency
will determine whether a chemical needs to continue on to Tier II
testing based on results of the Tier I battery; 3) did not adequately
estimate the “burden” or costs to industry to generate the data; and 4)
has not identified how it will consider existing data that may preclude
the need for some or all of the Tier I assays for some chemicals. CPDA
believes that the OMB notice on the EDSP ICR challenges the Agency to
address each of these concerns before it will consider approval of a
revised/new ICR for the testing of additional chemicals. It requires
EPA to conduct a thorough analysis of this information collection to
demonstrate “practical utility” or benefit, to re-estimate the “burden”
of the program, and to explain the reasoning for concluding that
existing data are insufficient to satisfy the test orders. It also
requires public comment and peer review of the Agency’s interpretation
and use of the collected data. In order for this full analysis to
occur before a subsequent round of EDSP screening, the screening of
these initial chemicals must be all but concluded. If EPA is held to
these requirements, future test orders will not be forthcoming for
several years. The OMB notice may be viewed at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=200904-2070-001. EPA Announces Plans to Move Forward with Inert Disclosure Regulatory Action:
EPA has announced its plans to move forward with an Advance Notice of
Proposed Rulemaking (ANPR) requiring the full disclosure of inert
ingredients, including those not deemed hazardous, on pesticide labels.
The Agency has provided a draft of the ANPR to the Office of Management
and Budget (OMB) for review and anticipates its publication before the
end of this year. EPA’s decision to pursue rulemaking is articulated in
its September 30, 2009 response to two petitions, one filed by the
Northwest Coalition for Alternatives to Pesticides and one filed by a
group of State Attorney Generals, which identified a set of more than
350 pesticide inert ingredients as hazardous and requested that the
Agency require the disclosure of these substances on the labels of
formulations in which they are found. Both petitions were received by
EPA on August 1, 2006. In its response, EPA states that it will
consider ideas to increase the disclosure of inert ingredient
identities “to an even greater degree” than that requested by the
petitioners by requiring the disclosure of all inerts rather than
limiting disclosure only to those substances considered to be
hazardous. In addition, EPA states that it is considering the
feasibility of voluntary initiatives to achieve full disclosure. The
Agency cites a number of issues that must be considered in pursuing
regulatory action that seeks to achieve full public disclosure of
inerts. Specifically, EPA must establish the criteria for determining
what inert ingredient identities should be made public, the extent to
which disclosure independent of hazard can be supported under existing
statute, whether a concentration threshold should trigger a disclosure
requirement, whether public disclosure should be made on pesticide
labels or though some other vehicle such as the Internet, and what form
the disclosed ingredients should take (e.g., Chemical Abstract Service
names, common chemical names, trade names, etc.). EPA states that the
initiation of this regulatory initiative will affect a "sea change" in
how inert ingredient information is made publicly available. For more
detailed information regarding this issue, please click on the
following: Petition of the Northwest Coalition for Alternatives to Pesticides, Petition of Attorney Generals, EPA's Response to the Inert Disclosure Petitions. EPA Announces New Review of Atrazine:
EPA has announced that it is launching a new comprehensive evaluation
of atrazine. The Agency states that based on this evaluation, it will
decide whether to revise current atrazine risk assessments and whether
new restrictions on use are necessary. During the first year of this
evaluation, EPA intends to consider the potential for atrazine cancer
and non-cancer effects, including data generated since 2003 from
laboratory animal and human epidemiology studies. In conducting its
re-evaluation of the human health effects of atrazine, EPA will
seek the input of the independent FIFRA Scientific Advisory Panel
(SAP). On its web site, the Agency has posted the following timetable
and description of its planned atrazine review activities: November 3, 2009 – EPA will present its plan for the new atrazine evaluation. February
2010 – EPA will present and seek scientific peer review of its proposed
plan for incorporating epidemiology studies into the atrazine risk
assessment. April 2010
– EPA will present and seek peer review of its evaluation of atrazine
non-cancer effects based on animal laboratory toxicology studies,
selection of safety factors in the risk assessment, and the sampling
design currently used to monitor drinking water in community water
systems. September
2010 – EPA will present and seek peer review of its evaluation of
atrazine cancer and non-cancer effects based on animal toxicology
studies and epidemiology studies. According to EPA, this review is
intended to include the most recent results from the National Cancer
Institute’s Agricultural Health Study, expected to be published in 2010. EPA
states that at the conclusion of the evaluation of atrazine’s human
health effects, it will ask the SAP to review atrazine’s potential
effects on amphibians and aquatic ecosystems. The Agency adds that it
intends to meet with interested groups to explore better ways to inform
the public more quickly about results of atrazine drinking water
monitoring. OSHA Publishes Proposed Rule on GHS:
The Occupational Safety and Health Administration (OSHA) of the U.S.
Department of Labor has published a proposed rule to modify its
existing Hazard Communication Standard (HCS) to conform with the
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS). The proposal was published in the September 30, 2009 Federal Register
with a deadline of December 29, 2009 for public comment. CPDA is in
the process of reviewing the proposed rule to evaluate its potential
impact on the association membership. To access the rule, visit http://edocket.access.gpo.gov/2009/pdf/E9-22483.pdf. 2007-2009 Report of the Association Now Available: CPDA's most current Report of the Association is available on the website. To view it please click here. CPDA would like to thank Makhteshim Agan of North America, Inc. for sponsoring publication of the report. |
