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.

Senators Lautenberg and Inhofe Staffs Hold Stakeholder Meetings on Safe Chemicals Act of 2011

Way back in April Senator Frank Lautenberg introduced his newest iteration of TSCA reform called the Safe Chemicals Act of 2011.  Last year the Democratic-controlled House took the lead in holding stakeholder meetings to fine tune the 2010 versions of the bill.  With the House controlled by Republicans this year it is left to the 87 year old Lautenberg to initiate stakeholder meetings in the Senate in an attempt to give TSCA reform at least some semblance of movement during the current Congressional term.  Since Republican Senator Inhofe had previously volunteered to work in a bipartisan manner with the Democratic Lautenberg, their staffs have begun meeting with various stakeholders to discuss key issues in the debate.

In June there were separate meetings between staffers and industry and environmental/health advocacy groups (NGOs).  Those meetings primarily dealt with the differing opinions on what should be the "safety standard."  It's unclear at this stage whose viewpoint would win out, but in the past industry has made it clear that the previously proposed standard was unworkable.  At least one more stakeholder meeting with industry representatives was held last week, this time to discuss a prioritization scheme.  A separate meeting with NGOs was due to occur, but it is unclear if it has yet happened.  NGOs had previously pushed to have minimum data sets required for all chemicals, in line with the production volume based tiered requirements currently being compiled by REACH registrants.  This is a fundamental point of difference between the two main groups of stakeholders.


Additional meetings on other key elements of Lautenberg's bill are expected to occur in coming weeks.

Whether a TSCA reform bill can even be taken up for floor discussion in this current Congress is a question mark, though it is safe to say that the likelihood is exceedingly small.  The current contentious environment and uncompromising attitudes of many in the House make passage of any TSCA reform law nearly impossible.  Which means that the EPA must work under the current 35-year old law, the same law that all stakeholders have said is in dire need of modernization.

China Lists Hazardous Chemicals

China has now posted its first list of "hazardous chemicals for priority management" as party of their efforts to update their chemical health and safety management program.  This first list contains 60 chemicals and was released by SAWS, China's State Administration of Work Safety, in late June 2011.

The list can be viewed here in Chinese only.

Chemicals listed for priority management include common substances like benzene, methanol, chlorine, and ammonium hydroxide, as well as methyl hydrazine, acrylic acid, hexachloropentadiene, and methyl tert butyl ether (MTBE).  There are also some substances and mixtures that are listed based on their classification as flammable gases or liquids, pyrophoric liquids or solids, or substances that emit flammable gases when in contact with water.

For chemicals on the list, SAWS will engage in prioritized inspections of facilities that manufacture, store or use the chemicals.  Companies will also be required to prepare emergency response plans to deal with spills and accidents involving chemicals on the list.

Additional lists are expected in the future.

GAO Tells Congressional Panel It Will Review Changes to IRIS Chemical Assessment Process

At a House Science Committee hearing this week, GAO environmental department director David Trimble testified that the GAO was currently undertaking a review of EPA's revised 2009 IRIS assessment process and how EPA was proceeding in implementing changes recommended by the National Academy of Sciences.  Trimble indicated that the 2009 revisions "appeared to represent significant improvement, but the viability of the IRIS program will depend on effective and sustained management and oversight."  The process revisions were initiated by EPA Administrator Lisa Jackson following extensive complaints about the quality of assessments performed during the Bush Administration.

IRIS refers to the Integrated Risk Information System, a human health assessment program that "evaluates quantitative and qualitative risk information on effects that may result from exposure to environmental contaminants...The information in IRIS is intended for those without extensive training in toxicology, but with some knowledge of health sciences."

In their continuing efforts to improve the oft-maligned program, EPA on July 12, 2011 announced plans "to further strengthen and streamline" IRIS and implement the April 2011 recommendations by the National Academy of Sciences.  According to EPA:

The most recent improvements include: reducing volume and redundancy of assessments; fuller discussion of methods and concise statements of criteria used in studies for hazard evaluation; clearer articulation of the rationale and criteria for screening studies; implementing uniform approaches for choosing studies and evaluating their findings; and describing the determinants of weight that were used in synthesizing the evidence. In addition, EPA is working to set up a dedicated advisory committee that will exclusively focus on the quality, transparency and scientific rigor of IRIS assessments. EPA will also create a peer consultation step early in the development of major IRIS assessments. Continually improving the IRIS program is an ongoing priority for the Agency, and these efforts work towards this goal.

The full testimony of David Trimble can be read here.

US Senators Propose Banning Chemicals of High Concern Due to Endocrine Disruption

Senators John Kerry and Jim Moran, both Democrats, have introduced legislation that would effectively ban certain uses of chemicals found to pose a high concern for endocrine disruption.  The bill, called the Endocrine-Disrupting Chemicals Exposure Elimination Act, would establish a research program to determine if candidate chemicals are endocrine disruptors, then ask an expert panel to rank them as either "high," "substantial," "minimal," or "no" concern.  The bill would require this panel to assess up to ten chemicals per year.  It would also require an exposure reduction strategy for those deemed to be of high concern.

The bill comes as Congress has seemingly reached a stalemate on how to proceed with reform of the 35-year old Toxic Substances Control Act (TSCA).  Senator Frank Lautenberg introduced the latest version of his Safe Chemicals Act earlier this year, and while at least one in a series of non-public stakeholder meetings have been held to fine-tune the bill, no obvious path forward on passage appears to be in the works.  Likewise, it is unclear what chances the Kerry/Moran bill will have in passage given the clear lack of any action being taken by the Republican-controlled House.


According to Kerry's press release:

Today, there are approximately 80,000 known chemicals in our environment that are potentially harmful, yet many of these chemicals are not tested to determine their effects on human health. This includes common products Americans use every day such as household cleaners, cosmetics or personal care products.  There is an increased rate of disorders affecting the human endocrine system, which children developing in the womb are particularly vulnerable to.

In introducing the bill, Senator Kerry noted that:

“We have a responsibility not just to inform Americans of the dangers, but to protect them from chemicals with the potential to cause serious illnesses from birth defects to cancer. It’s just common sense.”

EU Commission to Ban Biocide Uses for Eight Chemicals

Last week the European Commission issued a decision "concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC," i.e., to ban specific uses for eight biocidal chemicals.  The decision gives manufacturers and formulators until July 1, 2012 to phase out use of the substances for the biocidal product types indicated.  After that date they will be banned from being placed on the market.

The substances and product types for which they will be phased out are:

Formaldehyde: Human hygiene products, drinking water disinfectants, fibre/leather/rubber materials, vermin

2-Chloroacetamide: Veterinary hygiene products, in-can preservatives, metalworking fluids preservatives

Thiabendazole: Private and public health area disinfectants, metalworking fluids preservatives

2,2'-dithiobis[N-methylbenzamide]: metalworking fluids preservatives

Sulphur dioxide: Human hygiene products, private and public health area disinfectants, in-can preservatives, film preservatives, metalworking fluids preservatives

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane: Food and feed area disinfectants

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives


Poly(hexamethylendiamine guanidinium chloride): Human hygiene products, drinking water disinfectants, in-can preservatives, metalworking fluids preservatives

Any other uses not listed are still authorized to continue beyond the phase out date.  In all cases, the uses above were not supported by the manufacturers.

EU Science Committees Call for Comments on How REACH Can Handle "Chemical Mixtures"

Three scientific committees of the European Commission have issued a "preliminary opinion" on how REACH and other chemical regulations can address the risks of chemical mixtures.  The three committees -  the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) - are now opening a public consultation and asking for feedback on the document, "Toxicity and Assessment of Chemical Mixtures."

REACH, the European chemical regulation, is a substance-based law, though some substances as defined can include mixtures of either discrete or variable composition chemicals.  Still, there is concern that mixtures of chemicals, sometimes called "chemical cocktails," could have greater toxicity than the sum of the toxicities for the individual chemicals.  This paper by the three committees attempts to address this concern, though no new amendments to the REACH law were proposed at this time. 


According to the press release, the main conclusions of this preliminary opinion are:

• Chemicals with common modes of action may act jointly to produce combined effects that are larger than the effects of each mixture component alone.
• For chemicals with different modes of action (i.e. acting independently), no robust evidence is available that exposure to a mixture of such substances is of health concern if each individual chemical is present at or below their no effect levels.
• For chemicals that interact, interactions (including antagonism, potentiation, synergies) usually occur at medium or high-dose levels (relative to the lowest effect levels). At low exposure levels they are either not occurring or toxicologically insignificant.

The deadline for comments is September 9, 2011.  Commenters are asked to use a special web site to assist the EU in compiling what they expect to be a significant number of comments.

OMB Review of Inventory Update Rule Complete - Expects to Publish Soon

After a long and anxious wait, the Office of Management and Budget (OMB) has finally completed its review of EPA's inventory update reporting rule (IUR) changes.  The delay in OMB review had caused EPA to suspend the reporting period, which was supposed to have run from June 1 to September 30, 2011.  The proposed rule revised the amounts and types of information that chemical manufacturers and others had to report to EPA under the IUR.  While OMB hasn't released its findings yet, it appears they will approve the rule but recommend some changes.

Basically the IUR is designed to provide EPA with key information on chemical production and processing in the United States.  The data companies are required to submit includes information that can help EPA - and the public - assess exposure to the chemicals that are on the reporting list.  These data, along with hazard data such as toxicity and environmental fate information, are used to identify potential risks to the public.

Since OMB does not expect to publish their findings for several days or even weeks, EPA must wait before they can set a new reporting deadline.  In the past EPA representatives have tried to ease industry anxiety by insisting there would be adequate lead time for companies to collect the information needed prior to a new reporting period.  Obviously, most of the data that need to be submitted are the same as has been done by industry for several previous IUR reporting periods, and with the EPA changes already identified in the proposed rule, industry should already be in a position to start collecting data.  Because of the OMB delay, EPA will likely be under pressure to set the new reporting period sooner rather than later to avoid disrupting the next cycle of IUR reporting, so it would behoove companies to start the process internally while waiting for publication.

India Meets Criteria to Join OECD "Mutual Acceptance of Data" Program

India has now met all of the requirements to be accepted into the OECD Mutual Acceptance of Data (MAD) program.  It did so by demonstrating that it could successfully conduct health and safety testing under Good Laboratory Practices (GLPs), which is the standard for such testing in all thirty-four of the OECD countries (which includes EU countries, the US and Canada, among others).  The achievement allows Indian chemical manufacturers to conduct and provide single tests in support of their products in all OECD countries.  This makes it easier and less costly to enter the marketplace.

The achievement is important because OECD consists of mostly economically developed countries, and India joins Brazil, Singapore and South Africa as the only developing countries to meet the tough OECD standards.  Being able to enjoy the benefits of the MAD program will greatly enhance marketability.  MAD is the system in which the results of a set of health and safety studies can be submitted in support of a product, and acceptance by a rapporteur member state is deemed acceptance by all member states.

ECHA Reports that REACH and CLP Chemical Regulations are "Working Well"

The European Chemicals Agency (ECHA) recently published two reports, both required by law, in which they conclude that despite many industry misgivings prior to enactment, the REACH and CLP regulations are "working well and that the various actors responsible for the work are responding as required." REACH is the chemical control law in Europe and the CLP is the Classification, Labeling and Packaging Regulation.  ECHA attributes the success largely to "the commitment and collaborative work between industry, stakeholders, the Member States, the European Comission and ECHA."

According to their press release, ECHA offers "three key lessons" from the experience:

•    The uncertainty over the number of registrations for the first deadline was a challenge to manage and more accurate estimates would be helpful in future.
•   Close working relationships with industry and stakeholders are vital to ensure success and the Agency can help by providing stable tools and guidance.
•    The interrelationship between the various elements of the two regulations is important and has become increasingly apparent.  For example, ambiguities in substance identification can lead to problems in forming Substance Information Exchange Fora (SIEF), evaluation and risk management activities. 

The report, which can be downloaded here as a PDF, offered recommendations for improving implementation of the laws in the future.

A second report on the implementation of efforts to reduce unnecessary animal testing can also be downloaded as a PDF here.