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.

States Pick Up the Slack - Pass Chemical Laws While Federal TSCA Reform Goes Nowhere

According to an article in the online publication, Sustainable Business News, nine states "passed legislation to protect the public from toxic chemicals this year."  Overall, "18 states have passed over 80 chemical safety laws in the last nine years by an overwhelming margin with broad bipartisan support."  And this state-level dominance of chemical safety laws is expected to continue for the foreseeable future, primarily because the federal government has failed to take action to modernize the 35-year old Toxic Substances Control Act.

It's not from wont of trying.  Senator Lautenberg again introduced a version of his Safe Chemicals Act in 2011, and is holding a series of stakeholder meetings to try to fine-tune the proposal with stakeholder support from industry, NGOs, and academia.  This follows on several other attempts by Democrats in both the House and Senate to update TSCA, so far to no avail despite the public claims by industry to want modernization of the law.

The biggest reason why industry says they would like TSCA reformed is because they don't want to have to deal with the patchwork of state and local laws that are sometimes conflicting and always more susceptible to more local concerns.  But despite the attempts by legislators to address stakeholder input, industry has to date found the bills "unworkable" and "non-starters."  So while nothing happens at the federal level, the states jump in to protect their citizens.

According to the article:

On the state level, there's been bipartisan support for  protecting children's health and the environment from dangerous chemicals. 99% of Democrats and 86% of Republicans supported the policies listed below. 

Actions in various states have included banning BPA in thermal receipt paper, baby bottles, sippy cups, plastic storage and beverage containers, and other products, as well as restrictions and bans on heavy metals like cadmium in children's jewelry and brominated flame retardants in children's products.  Other states have initiated broader programs to identify "priority chemicals of high concern," reduce the use of toxic chemicals, or pass laws to ensure "Kids Safe Products."  A list of actions can be found in the Sustainable Business news article.


More information on state-level action to protect human health and the environment can be found here.

Whether all this state activity will stimulate federal action or not remains to be seen.  As Congress focuses on cutting programs, many of which are health and safety related actions such as those at EPA (which expects to get substantial funding cuts), the states are forced to spend even more money doing what many of them feel is a federal role.  On the other hand, as more and more states put pressures on industry, perhaps there will be more impetus for industry to recommend TSCA reform bills that they can support.

EPA's Design for the Environment (DfE) Issues Final Alternatives Assessment Criteria

The USEPA Office of Pollution Prevention and Toxics has released its final alternatives assessment criteria for evaluating human and environmental effects in accordance with its Design for the Environment (DfE) program.  DfE helps companies, states and other organizations to "identify safer alternatives to chemicals that may pose a concern to human health and the environment."  More information on the DfE program can be found on EPAs web site.

DfE Alternatives Assessments are "multi-stakeholder partnerships convened to evaluate priority chemicals and functional alternatives."  The goal is to "inform substitution to safer alternatives and reduce the likelihood of unintended consequences that might result if poorly understood alternatives are chosen."  In other words, they don't want to replace one bad chemical with another bad chemical just because they don't know enough about it.  According to DfE, its "expertise and focus is on chemical hazard," and encourages stakeholders to "assist with the selection of the scope of the alternatives assessment, help EPA consider economic realities, and identify likely functional alternatives for evaluation."

So whereas REACH in the EU specifies substances of very high concern and requires authorization for continued use (along with a substitution plan), the DfE program works directly with companies and other stakeholders to fix the problem together.

EPA is currently preparing DfE alternatives assessments for Bisphenol A (BPA), Decabromodiphenyl ether (decaBDE), and Nonylphenol ethoxylate (NPE) surfactants.  The draft reports for public comment are expected to be released by EPA later this year.  In addition, EPA has underway an alternatives assessment for Hexabromocyclodecane (HBCD) in polystyrene insulating foam.  And EPA also plans to conduct an alternatives assessment for phthalates with a kickoff meeting scheduled for August 24, 2011.

Version 2.0 of the Alternatives Assessment Criteria document can be downloaded as a PDF here.

More information and links to the phthalates kickoff meeting signup materials can be found in the right sidebar of the DfE page.

Women in STEM: A Gender Gap to Innovation - New Report Suggests Women in Science Still Make Less Money than Men

A new report concludes that women in science still make less money than their male counterparts, though that "gender wage gap" was smaller than that gap "compared to others in non-STEM occupations."  The report, "Women in STEM: A Gender Gap to Innovation," examined women working in Science, Technology, Engineering, and Mathematics (STEM) jobs.  It was released by the Department of Commerce and is based on an American Community Survey conducted in 2009 by the Census Bureau.

The report concludes that:

• Women are underrepresented both in STEM jobs and STEM undergraduate degrees, and have been consistently over the last decade.
• The relatively few women who receive STEM degrees are concentrated in physical and life sciences,
  in contrast to men, who are concentrated primarily in engineering.
• Women who do receive STEM degrees are less likely to work in STEM jobs than their male counterparts, though they experience a smaller gender wage gap compared to others in non-STEM occupations.

The report suggests that the under-representation of women in the sciences may be a combination of a variety of factors. One factor is that these fields "may be less accommodating to people cycling in and out of the workforce to raise a family.  Other factors may be the lack of female role models, the different choices men and women typically make in response to incentives in STEM education and employment, and "perhaps
strong gender stereotypes discourage women from pursuing STEM education and STEM jobs."  The report cautions that it "does not - and cannot – explain why gender differences in STEM exist, it does aim to provide data and insight that will enable more informed policymaking."

The findings provide definitive evidence of a need to encourage and support women in STEM with a goal of gender parity. Given the high-quality, well-paying jobs in the fields of science, technology, engineering and math, there is great opportunity for growth in STEM in support of American competitiveness, innovation and jobs of the future.

The full report can be downloaded as a PDF and read here.

EPA Issues Draft Scientific Integrity Policy

The USEPA has issued a draft scientific integrity policy, following similar documents by NOAA and the Department of the Interior, and in response to President Obama's Executive Order calling for all agencies to develop such a policy.  The draft policy comes as no surprise, as EPA in June named long-time EPA staffer William Sanders as the "Scientific Integrity Officer."

The 12-page document, which can be downloaded as a PDF here, essentially formalizes integrity policies that have already been in force at EPA for years.  It covers all scientific staff and is designed to:

• Ensure that their work is of the highest integrity, free from political influence.
• Represent their own work fairly and accurately
• Represent and acknowledge the intellectual contributions of others.
• Avoid conflicts of interest and ensure impartiality.
• Be cognizant of and understand the specific programmatic statutes that guide the employee’s work.
• Welcome differing views and opinions on scientific and technical matters as a
  legitimate and necessary part of the scientific process.
• Accept the affirmative responsibility to report any breach of this Scientific
  Integrity Policy.

The policy specifies four areas in which these goals are to be achieved, "a) the culture of scientific integrity at EPA, b) public communications, c) the use of Federal advisory committees and peer review, and d) professional development of government scientists and engineers."

The draft policy also "establishes a Scientific Integrity Committee," which is charged with implementing the policy across EPA.  The makeup of the committee is still under development, but will be responsible for "implementing, reviewing, and revising as needed" the policy.

The draft policy is open for public comment through September 6, 2011 and should be emailed to osa.staff@epa.gov.

More information, contact info, and links to the policy can be found in EPA's news release.

Cadmium to be Added to Priority Testing List Under Toxic Substances Control Act

The TSCA InterAgency Testing Committee (ITC) has added cadmium and 103 other cadmium compounds to the Priority Testing List.  The action came in the 68th semiannual report to the EPA Administrator by the ITC.  According to the ITC, the action is necessary because EPA and the Consumer Product Safety Commission believe there is reason for concern about cadmium in children's toys, jewelry, and a variety of other consumer products.

The ITC report was published in the Federal Register on August 1, 2011.

The main concerns identified for cadmium include developmental effects in animals such as fetal teratogenicity.  Conclusive evidence of harm in humans has not been seen, but the animal effects led to the ITC's decision to include cadmium on their list for further assessment.  This action in the US mirrors to some extent a similar action in the EU in the spring.

The ITC list is a rolling list, and several chemicals were removed for various reasons.  Currently the priority list "includes 2 alkylphenols, 16 chemicals with insufficient dermal absorption rate data, 178 HPV Challenge Program orphan chemicals, and cadmium and 103 cadmium compounds."

The full ITC report can be viewed on the Regulations.gov web site.

Washington State Adopts Children's Safe Product Rule to Control Chemicals of Concern to Children

Washington State has adopted a new rule implementing the state's 3-year old Children's Safe Product Act law.  Amongst other things, the rule requires companies to report all children's products manufactured or imported for sale in Washington that contain any of 66 "Chemicals of High Concern to Children" (CHCC) that exceed the "Practical Quantification Limit" (PQL).  The PQL is defined as "the lowest concentration that can be reliably measured within specified limits of precision, accuracy, representativeness, completeness, and comparability during routine laboratory operating conditions."

The rule provides for a phase-in period for reporting different categories of products and the size of the manufacturer and size of the products.  Within 12 months, the largest companies who are making products that are likely to come in contact with the skin of children or be placed in a child's mouth, must make their first report.  First reporting extends out to as long as 84 months (7 years) for "tiny" companies making products with limited potential for contact with children's skin. After the first notice date, reporting must occur annually on the anniversary of the first notice date.

The list of 66 Chemicals of High Concern to Children includes many of the same chemicals usually seen on such lists, including formaldehyde, benzene, Bisphenol A, many phthalates, brominated flame retardants, PFOS, and heavy metals such as mercury, cadmium and molybdenum.

Information on the new rule can be found on the Washington State Department of Ecology web site.

A PDF of the full rule can be downloaded and read here, including the list of 66 CHCCs.

EPA Issues its IUR Rule - Sets New Submission Period!

Several weeks ago I noted that OMB had finally finished its review of the Inventory Update Rule (IUR), and today EPA announced that published the rule.  This new rule, now called the "Chemical Data Reporting" rule (CDR), increases "the type and amount of information" EPA collects from manufacturers on commercial chemicals.  The "improved" rule also "requires that companies submit the information electronically to EPA" in an attempt to streamline the reporting process.  It also limits the confidentiality claims that can be made by reporting companies.

According to EPA's press release:

The CDR rule, which falls under the Toxic Substances Control Act inventory update rule (IUR), requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relating to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. The improved information will allow EPA to better identify and manage risks associated with chemicals. 

Companies will have to start reporting under the new requirements during the next data submission period, which has been set for February 1, 2012 to June 30, 2012.  EPA had suspended the previous reporting period last May when it became clear that the OMB review would not be complete in time for manufacturers to comply.

Companies will be required to start following the new reporting requirements in the next data submission period, which will occur February 1, 2012 to June 30, 2012. 

The full Chemical Data Reporting rule can be reviewed on EPA's IUR web page.

Canada to Ban Four Categories of Chemicals

Canada issued a proposed regulation in the Canada Gazette on July 23, 2011 designed to essentially ban four groups of chemicals.  According to the proposal, the four chemicals are Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST), short-chain chlorinated alkanes, polychlorinated naphthalenes (PCNs) and tributyltins (TBTs) for non-pesticidal uses.  All four were assessed in accordance with the Canadian Environmental Protection Act of 1999 (CEPA), which concluded that all four may be harmful to the environment.  Health Canada determined that short-chain chlorinated alkanes also constitute a danger in Canada to human life or health. 

Interestingly, three of the chemical classes are already no longer manufactured or used in Canada.  So the main impact will be on the ban of BNST, which is an antioxidant additive in vehicle engine oils and industrial lubricants.  Under the regulations, there would be a two-year transition period in which BNST could still be used for specific uses so that industry has time to conduct research to find alternatives.  The transition period would also allow manufacturers to gain product performance certification for any product modifications using BNST subsitutes.

For all four chemical classes Environment Canada and Health Canada believe risk management measures are necessary to prevent harm to the environment and human health.  Also, they determined that all four "meet the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations."

The regulations as proposed would also modify existing restrictions on hexachlorobenezene (HCB), which is commonly found as an impurity in chlorinated solvents and other manufactured products.  HCB would be moved from Part 2 to Part 1 of the schedule of toxic substances, which would put it on a track for full banning.

The public may provide comment on the draft regulations until October 6, 2011.  More information is available in the Canada Gazette online.

NOAA Issues Draft Scientific Integrity Policy for Public Comment

The National Oceanic and Atmospheric Administration (NOAA) has issued a draft scientific integrity policy for public comment.  It joins a similar release by the Department of the Interior in February as a response to President Obama's executive order requiring federal agencies to provide guidance on how they will ensure scientific integrity. NOAA would like interested parties to provide feedback by August 20, 2011.

The policy, which can be read in full here, establishes Codes of Conduct and Ethics and identifies eight "Principles of Scientific Integrity."  They include such things as how NOAA employees conduct, publish, and communicate research and results, and the benefits and limitations of NOAA scientists' participation in professional organizations, as well as rules for receiving awards. The primary goals are to ensure transparency, maintain the highest of levels of scientific integrity, and assist in the accurate communication of scientific findings to the public and policy-makers. 

To support this policy, among other things, NOAA will facilitate the free flow of scientific information online and in other formats, document the scientific findings considered in decision-making, and ensure selection of scientific staff "based on a candidate's integrity, knowledge, credentials, and experience relevant to the responsibility of the position." 

The new draft policy was welcomed by at least one scientific organization, the American Geophysical Union, which issued a press release.


The link for the NOAA scientific integrity policy, and instructions for providing feedback to the Agency, can be found here.

Environmental and Health Organizations Say "Fully Fund the National Children's Study"

A group of national and state environmental and health organizations have written a letter to the Senate and House Committees on Appropriations calling for full funding of the National Children’s Study.  The study was "authorized by the Children’s Health Act of 2000," and is "one of the most comprehensive national efforts to study environmental, social and genetic influences on children’s health, including air, water, diet, noise, family dynamics and community and cultural influences."  Unfortunately, it has never been properly funded.

According to a press release by the Environmental Working Group, one of the 24 organizations that signed the letter, it includes:

“There are great and growing concerns about the increased rate of chronic and acute disease in the United States, and the National Children’s Study is designed to help all Americans have a better understanding of the links between those diseases and our environment. However, to ensure the study’s success, it is critical that it continue to receive the necessary funding throughout each and every stage. No study has ever followed children from before birth to age 21, but to do so the National Children’s Study must receive sufficient and consistent funding.”

Further, the letter says that "the study will examine how the events and exposures of early life can lead to specific outcomes including birth defects, asthma, obesity, diabetes, and mental health disorders among other possible outcomes." It suggests that "science continues to emerge and show that early exposures, especially those during vulnerable times of development, are linked to future adverse health effects."

EPA Gives Advance Notice - Wants Input on Whether to Require Toxicity Testing on Bisphenol A

The USEPA is considering a rulemaking in which they would require additional toxicity testing on bisphenol-A, known commonly as BPA.  Yesterday EPA published an "Advanced Notice of Proposed Rulemaking" asking for public comment on whether and/or how they should require testing "to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations."  The notice is subject to a 60-day comment period.

According to the Federal Register notice, BPA is a high production volume (HPV) chemical and "is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic."  The concern is that while there have been quite a few studies conducted, many of these have what some believe are significant flaws, thus calling into question their validity and/or ability to be used for regulatory purposes.  BPA is a common ingredient in plastics and has come under intense scrutiny for its potential to be an endocrine disruptor.  Given the disagreement over the scientific evidence and the significant ramifications of a BPA ban (and the similarly significant ramifications of a lack of BPA should the potential adverse effects be demonstrated), EPA is seeking to conduct definitive testing to settle the science.

In addition to toxicity testing, EPA is also considering environmental monitoring to determine the levels of BPA in "surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases."  At present, the advanced notice is focused "only  toward the environmental presence and environmental effects of BPA."  While EPA continues to work with the Department of Health and Human Services on potential human health issues, it "is not considering any additional testing specifically in regard to human health issues at this time."

The full Federal Register notice can be viewed here.  The deadline for public comment is September 26, 2011.

Inspector General Says Voluntary Children's Chemical Safety Program Failed to Protect Children

As I noted back in December 2010, EPA's Inspector General's office had launched an inquiry into the Voluntary Children’s Chemical Evaluation Program (VCCEP) program because of complaints that it was ineffective.  The IG has now completed their report and the findings are not good.  In it's report released on July 21, 2011, the IG found that the VCCEP pilot program "did not achieve its goals to design a process to assess and report on the safety of chemicals to children."  Further, the IG found that the design of the VCCEP pilot itself was flawed, and "did not allow for desired outcomes to be produced."

Specific problems include "a flawed chemical selection process" and a "lack of an effective communication strategy."  The IG also specifically pointed at the lack of industry effort, "who chose not to voluntarily collect and submit information," as well as EPA's "decision not to exercise its regulatory authorities" under TSCA to "compel data collection."

The IG report recommends that EPA should design and implement a new process that:

• identifies the chemicals with highest potential risk to children
• applies the TSCA regulatory authorities as appropriate for data collection
• interprets results and disseminates information to the public, and 
• includes outcome measures that assure valid and timely results.

In a response from EPA included in the report, EPA concurred with the IG's findings and indicated that work was ongoing in the existing chemicals program in an attempt to address the IG's concerns. The IG wasn't necessarily satisfied with EPA's response, and stressed the importance of having a workable program to protect children from chemical exposure.

The full report from the EPA's Inspector General can be downloaded here.

Updated QSAR Tools Made Available to Assess Chemicals

Quantitative Structure-Activity Relationships (QSAR) are computer based tools that allow the estimation of chemical properties and toxicity based on a chemical's structure rather than from doing animal testing.  QSARS, and their more qualitative cousins, SARs, are commonly used as screening tools to determine whether animal testing is needed.  They are routinely used by the USEPA to assess premanufacture notice (PMN) submissions for new chemicals, which generally have very little actual testing data included.  With the advent of REACH, the EU has also shifted to a greater acceptance of SARs and QSARs in lieu of actual laboratory testing.

To this end the European Chemicals Agency (ECHA) has made various QSAR tools developed by industry and governments available to companies registering chemicals under the REACH chemical registration law that went into force in 2007.  ECHA has now released an updated, Version 2.2, of the "OECD QSAR Toolbox" for "grouping chemicals into categories" and "to fill data gaps by read-across, trend analysis and to assess the (eco)toxicity hazards of chemicals."  The goal is to provide data for decision-making while reducing costs and unnecessary vertebrate animal testing.  According to ECHA, users of the QSAR Toolbox can:

• Identify analogues for a chemical, retrieve experimental results available for those analogues and fill data gaps by read-across or trend analysis;
• Categorise large inventories of chemicals according to mechanisms or modes of action;
• Fill data gaps for any chemical by using the library of (Q)SAR models;
• Evaluate the robustness of a potential analogue for read-across;
• Evaluate the appropriateness of a (Q)SAR model for filling a data gap for a particular target chemical;
• Build (Q)SAR models.

More information on the OECD QSAR Toolbox can be found here.