[Pharmwaste] US, EU To Seek 'Harmonized' Endocrine Approach In New Pilot Program

DeBiasi, Deborah (DEQ) Deborah.DeBiasi at deq.virginia.gov
Fri Oct 10 14:18:09 EDT 2014


Subject: US, EU To Seek 'Harmonized' Endocrine Approach In New Pilot Program

US, EU To Seek 'Harmonized' Endocrine Approach In New Pilot Program
Posted: October 10, 2014

Regulators from EPA and other U.S. agencies will work with the European Union (E.U.) to initiate a new pilot program last this month with the goal of reaching a "harmonized approach" toward testing chemicals to determine whether they might be endocrine disruptors that affect human hormones, an EPA spokeswoman says.

The kick-off meeting for the pilot program is scheduled for Oct. 15, the spokeswoman says. "Our goal is to have a harmonized approach to prioritization and screening of chemicals based on endocrine bioactivity and environmental exposure," she says.
The initiative on endocrine disruptors is one of three pilot programs on chemicals launched by the U.S. and E.U. in parallel with the ongoing American-European trade negotiations known as the Transatlantic Trade and Investment Partnership (TTIP). The E.U. announced the other two pilot programs, which are focused on chemicals screening and labeling, last summer after the sixth round of TTIP talks.

The screening pilot program is expected to entail regulators at EPA and the European Chemicals Agency (ECHA) figuring out how they might share the burden in testing substances that either has prioritized for further assessment. Although it is unclear how they might proceed in this area, two possible options for cooperation would be for each agency to divide up different phases of individual risk assessments, or split up the list of chemicals that are slated to be evaluated by both agencies and share the data from the separate risk assessments at the end.

The U.S. and E.U. industries hope that this pilot program could pave the way for the establishment of a joint scientific committee under TTIP that would cooperate more regularly on risk assessments.

In the labeling pilot program, the sides are planning to cooperate on how to reduce divergences in their regimes for classification and labeling of chemicals, the commission indicated. The agreement to launch these two pilot programs appears to be the first concrete action taken by the U.S. and E.U. to test some of the proposals for sectoral regulatory cooperation that have been explored by the TTIP talks.

It is unclear which E.U. agencies will be involved in the endocrine disruptors pilot program. The European Commission's directorate-generals for Health & Consumers (DG SANCO) and the Environment (DG ENV) both play a role in regulating endocrine disruptors in the EU, as does ECHA. A DG ENV spokeswoman declined to comment on the pilot program on endocrine disruptors, and the EPA spokeswoman did not respond to subsequent requests for additional details.

Disruptors Criteria

The planned launch of the endocrine pilot program comes even as the E.U. seeks to define criteria for what endocrine disruptors are, a requirement of its regulations on biocidal and plant protection products. The European Commission Sept. 29 opened a new public comment period on the issue, seeking "help [to] define criteria for endocrine disruptors . . ." with a closing date of Jan. 16.

However, the EPA spokeswoman's Aug. 12 statement makes clear that prioritization, or deciding which chemicals should be tested first among the thousands on the market, will be one element of the endocrine disruptor pilot program. The U.S. and E.U. do not share a common approach to identifying which chemicals should be screened for endocrine activity.

But beyond that, the scope of the program is not clear. One possibility is that the program will focus on finding a common approach toward the risk assessment of endocrine disruptors, one source said. The idea would likely be to minimize the chance that the criteria and methods used in one jurisdiction could give a different result than in the other, the source added.
This could be challenging -- and controversial -- for several reasons. The first is that the European Commission is in the midst of reviewing its legislation and policies surrounding endocrine disruptors, and still has yet to agree internally on what criteria should be used to define such substances.

One of the critical issues in that debate is whether an endocrine disruptor should necessarily be defined as having a demonstrable adverse effect. Some environmental and health advocates argue that would set the bar too high and allow chemicals onto the market that may have latent adverse effects, or that have a disproportionate impact on humans during critical stages of development, which may not be discernible in a risk assessment.

Another challenge is that the E.U. law governing pesticides bars endocrine disruptors entirely and does not allow them to be used in chemicals sprayed on crops in any quantity. This is different from the approach of the EPA, which typically aims to identify a threshold level below which usage can be considered safe in certain conditions.

Endocrine Program

By contrast, Congress in the 1996 Food Quality Protection Act mandated that EPA create a program to test chemicals for their potential to interact with human estrogen hormones. As a result, EPA created a two-tiered screening and testing process, known as the Endocrine Disruptor Screening Program. The first tier, is designed to identify chemicals that have the potential to interact with human estrogen, androgen or thyroid hormones.

The second, still incomplete tier is aimed at gathering additional information determining the endocrine-related effects caused by each chemical and obtaining information about effects at various doses for use in risk assessment. The program's slow pace and cost has frustrated many stakeholders, and the agency is seeking to transition the program to more computational screening approaches to make it cheaper and more efficient.

The first group of 67 chemicals identified for tier one screening in 2009 -- pesticide active ingredients and chemicals produced in high quantities used as pesticide inert ingredients -- are still undergoing EPA review to determine which should undergo tier two testing.



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