Return to Home

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.

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.

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.

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.

Chemical Facility Security Legislation Introduced in the Senate: Bipartisan chemical facility security legislation was introduced on February 4, 2010 by Senators Susan Collins (R-ME), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, Mark Pryor (D-AR), George Voinovich (R-OH) and Mary Landrieu (D-LA). Titled the “Continuing Chemical Facilities Antiterrorism Security Act,” S. 2996 would reauthorize the current law that is set to sunset on October 4, 2010 for an additional five years through October 4, 2015. In so doing, the legislation would provide the Department of Homeland Security (DHS) with sufficient time to fully implement the Chemical Facilities Anti-Terrorism Standards program. CPDA continues its active engagement in the debate surrounding chemical facility security legislation and remains steadfastly opposed to anylegislative initiative that wouldcreate a mandate to substitute products and processes with a government-selected technology.

CPDA Submits Comments to EPA on Proposed Inert Disclosure Initiative: On April 23, 2010, CPDA submitted comments to EPA voicing its opposition to the Agency's proposal to require the disclosure of inert ingredients on the pesticide label as detailed in an Advance Notice of Proposed Rulemaking (ANPR) published in the Federal Register on December 23, 2009. The ANPR alleges that the lack of information on inert ingredients available to consumers has led to a "market failure" that has resulted in the use of inerts possessing greater hazard potential than would otherwise occur if disclosure was mandatory. EPA has proposed two approaches to disclosure. The first option would limit disclosure to those inert ingredients deemed "hazardous" while the second approach would broaden the scope of disclosure to include most or all inert ingredients, regardless of hazard. In its response to the ANPR, CPDA emphasized that any initiative to mandate the disclosure of inert ingredients is premature at this time. CPDA noted that EPA's premise that the market has failed and regulatory action is needed to correct the market and provide net social benefit is unsupported. In addition, CPDA pointed out that EPA's interpretation that inerts disclosure can be required under FIFRA on the basis of "hazard" rather than risk is incorrect. Finally, CPDA asserted that the ANPR lacks the needed clarification on the appropriate hazard and risk criteria for requiring disclosure of inert ingredients on the pesticide label. Click hereto read CPDA's comments.

CPDA Comments on EPA's Draft PR Notice on Drift Labeling: On March 5, 2010, CPDA submitted comments to the docket in response to EPA's draft PR Notice on pesticide drift labeling. In its comments, CPDA expressed its opposition to the approach used by EPA in the draft document whereby the Agency seemingly attempts to substitute administratively a vague, unsupportable standard of "could cause adverse effects" [or harm] in lieu of the FIFRA risk-based "without unreasonable adverse effects" safety standard. CPDA maintained that EPA's proposed policy constitutes a de facto "no-drift" policy that presumes all offsite drift "could cause" adverse effects or "harm." CPDA recommended that EPA delay issuing the final PR Notice for a period of 6 to 12 months until after the Agency's new drift reduction technology (DRT) program is in place. Such a delay would give EPA an opportunity to ensure that its proposed policy is consistent with the goals and benefits of the DRT program. Moreover, the additional time would eliminate the potential for confusion among registrants, formulators, and distributors with regard to any final label changes that would be required pursuant to the PR Notice. Click hereto read CPDA's comments.