EPA Seeks Public Comment on Industry Petition for Guidance on Endocrine Disruptor Chemicals

The USEPA on August 10, 2011 published a notice in the Federal Register "seeking public comment on a June 21, 2011 petition" from three major trade associations requesting the Agency "develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program" (EDSP).

Almost two years ago EPA initiated the EDSP Tier 1 screening for a list of 67 chemicals for the potential of being endocrine disruptors.  Orders for testing were issued in the months following, with manufacturers of the initial list of chemicals being required to conduct eleven Tier I screening assays.  The goal of the suite of assays is to "determine the potential for a chemical to interact with estrogen, androgen and thyroid hormone systems."  Chemicals that were identified as possible disruptors could be subject to a second tier of assays designed to further evaluate and quantify endocrine effects. Last month the Inspector General faulted EPA for not moving fast enough to identify endocrine disruptor chemicals, and this response is unlikely to speed up the process.

Herein lies the reason for the industry petition.  Despite efforts to develop higher level assays, the exact assays to be required and the criteria for selecting them remains uncertain.  Crop Life America (CropLife), the Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) filed the petition in an effort to better understand how EPA will use the Tier 1 screening data.  Particularly, the trade associations want EPA to "fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis in order to ensure scientifically sound determinations and to protect the public health and the environment."  In other words, what exactly are you going to do with the data received, and can you at least figure out what it all means before jumping into requiring the suite of tests for hundreds of other chemicals.  And definitely don't even think about requiring Tier 2 tests before you know whether the Tier 1 tests provided any reliable information.

The Federal Register notice can be downloaded as a PDF here.

More information on EPA's Endocrine Disruptor Screening Program can be found on their web site.

Industry Reaction to Lautenberg's Latest Iteration of Safe Chemicals Act

Last week I noted that Senator Frank Lautenberg introduced his Safe Chemicals Act of 2011, which is an updated version of the bill he introduced in the last Congress.  It incorporates much of the feedback received from a wide variety of stakeholders last year.  On Tuesday I provided some of the initial reactions from NGOs, most notably from Richard Denison of EDF.  Denison hoped that this bill would be a starting point for serious discussions that would lead to modernization of the 35-year old TSCA law.  Today I note some of the industry reactions to Lautenberg's bill.

The American Chemistry Council (ACC), which represents most of the largest chemical manufacturers in the country, offered a mixed early reaction.  According to ACC President Cal Dooley:

ACC supported many of the goals and objectives of the senator's legislation in the last Congress, but his earlier proposal was inconsistent with the principles that we have set out for a successful TSCA modernization in several important respects. Further, the bill contained provisions that would not have produced the benefits intended by its authors. Unfortunately, it appears many of our concerns have not been addressed in this new version, and the bill introduced today could put American innovation and jobs at risk.

The Consumer Specialty Products Association (CSPA) also felt that the bill was an improvement but that it still left many concerns unanswered.  According to CSPA President Chris Cathcart:

The new bill introduced today moves in the right direction as it seeks to adopt important concepts of prioritization and tiered minimum data set requirements.  These two elements, along with the preservation of a risk based system, are essential components of any workable regulatory framework under TSCA.  However, we remain concerned about other sections of the bill, including its approach on Reporting and Declarations, the protection of confidential business information (CBI) and the safety standard. A bi-partisan dialogue can resolve these issues.

The industry/free market advocacy group American Council on Science and Health (ACSH) made no pretense of liking parts of the bill, with its President Elizabeth Whelan asserting:

This law is based on the premise that trace level exposure to chemicals is hazardous to health. Sen. Lautenberg is trying to ‘protect’ us from these chemicals, but there’s absolutely no evidence they have harmed humans or the environment.

The National Petrochemical & Refiners Association (NPRA) seemed more concerned over the bills impact on the economy than health and safety.  According to NPRA President Charles Drevna:

NPRA acknowledges Senator Lautenberg's efforts to exclude chemical mixtures from certain requirements and to incorporate some risk-based parameters into the proposed regulatory process. The draft bill, however, would give EPA unprecedented authority over the American economy, allowing the agency to make decisions on what materials can and cannot be used in manufacturing without requiring scientific justification for those decisions. The bill would also give EPA greater authority to force companies to spend enormous sums of money on animal testing, regardless of the likelihood or extent of potential human exposure to particular materials. 

So what next? It seems that both NGOs and industry see improvement over last year's version of Lautenberg's bill, but will there be a willingness to move forward on the common ground established in an effort to actually put a TSCA reform bill into law?

The ball is in the middle of the court.  Now we have to wait to see if any team wants to show up and play.

Washington State Moves Forward on Children's Safe Chemical Rules in Lieu of TSCA Action

I have mentioned previously here that with TSCA chemical reform trudging through Congress on the federal level, the States have continued to move forward with attempts to protect human health and the environment on a more local scale.  One of these efforts is the Children's Safe Product Act (CSPA) passed by Washington State in 2008.  While Governor Gregoire has suspended rulemaking in general because of the state of the economy, she has exempted this particular rule to continue through the development process.  The goal of the proposed law is to focus on protecting children from toxic chemicals.

According to the Department of Ecology, which manages health and safety issues in Washington, the CSPA consists of two parts:

The first part "limited the amount of lead, cadmium and phthalates allowed in children's products sold in Washington after July 1, 2009. These standards were substantially preempted when the U.S. Congress passed the Consumer Product Safety Improvement Act (CPSIA) in July, 2008. The federal Consumer Product Safety Commission will enforce this act."  So this part is essentially dormant.

"The second part of the CSPA requires Ecology, in consultation with the Department of Health, to develop a list of chemicals that manufacturers must report on. As required by the law, chemicals on the list are toxic and have either been found in children’s products or have been documented to be present in human tissue (blood, breast milk, etc.). However, the mere presence of these chemicals in children’s products does not necessarily indicate that there is a risk of exposure." 

Rules to implement this second part of the CSPA are currently open for public comment until December 31st.  These draft rule list 59 chemicals considered to be of high concern to children.  Most are familiar to people in the chemical control business as they have been targeted by other states as well as federal and international laws.  The law stipulates that the chemicals selected must be known to be toxic, commonly found in products used by children, are used in home environments, and found in biomonitoring of human blood and tissue samples. 

Once the final rules are issued, "manufacturers of children's products must report to Ecology if their products contain these chemicals."  These notifications will be required by law on a particular schedule, but the CSPA does not stipulate what happens once they are notified.  Presumably the state is interested in collecting data on what chemicals, and in what volumes, are used in the state so they can take any needed action.