EPA Will Identify Priority Chemicals by Thanksgiving (or so)

EPA will identify chemicals to be prioritized sometime this fall as it tries to move forward under the old TSCA as Congress makes no progress on developing a new TSCA.  To do so EPA will take into consideration feedback they received from a variety of stakeholders in two recent outreach attempts related to their proposed prioritization process. 

EPA introduced its proposed prioritization scheme and "discussion guide" back in August.  They then had a webinar on September 7th to give an overview of the proposed scheme and to invite feedback.  Finally, EPA also invited the public to share their thoughts in an online discussion forum.  That discussion forum closed on September 14th.


All comments received from stakeholders are now being assimilated and reviewed by EPA staff, who are working to identify chemicals to be prioritized for review.  In general the feedback was very constructive and included both concerns for the data sources being proposed as well as suggestions for other data sources to include in the evaluation. Other stakeholders cautioned that the use of production volume as a surrogate for exposure could lead to chemicals with very low risk being prioritized while chemicals of low production volume by high exposure potential, and thus risk, might be left out.  Some stakeholders suggested the addition of additional health effects such as endocrine disruption, neurotoxicity and skin or respiratory sensitization be used early in the prioritization process, while others cautioned that the process could get bogged down in the minutia if too many factors were included in the first step.

More information on the EPA chemical prioritization can be found on the discussion forum web site and EPA's existing chemicals "Identifying priority chemicals for review" page.

ECHA Goes to Commission on REACH Testing Proposal

How many Member State Competent Authorities does it take to make a decision on REACH testing proposals?  Apparently more than they have.  The Member State Committee (MSC) at the European Chemicals Agency (ECHA) "could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal."

Let's go to the Commission!  For the first time ECHA will employ Article 51(7) of the REACH Regulation and refer a case to the European Commission for decision making.

This non-decision by the MSC took place last week.  Not that they were stymied on all decisions.  They did agree on the draft decisions "for all five compliance checks" they were charged with reviewing.  And they did come to unanimous agreement on two of the four draft decisions on "testing proposal examinations." But two testing proposals were particularly tricky.  For one, the MSC refined the proposal during the meeting and expect to agree in writing shortly. 

The final testing proposal reached stalemate, hence the referral to the Commission.  The proposal:

"concerns a testing proposal examination where the registrant has proposed to perform a two-generation reproductive toxicity test in accordance with the EU test method B.35. This information would be necessary to fill the data gap regarding reproductive toxicity for the substance that is produced in quantities of over 1000 tonnes per annum.  Some MSC members preferred to ask the registrant to use the recently adopted OECD test guideline 443, the extended one-generation reproductive toxicity study (EOGRTS). Others wanted to maintain the present requirement of performing a two-generation study."

No information on when (or if) the Commission will make its decision.

More on what the Member States Committee does can be found on their web page here.

REACH Chemical Regulation Group Offers Advice and Recommendations

The Director's Contact Group (DCG) has issued a report on the "Achievements, Lessons Learned and Recommendations" garnered from its supporting role for last year's first REACH registration deadline.  The DCB was formed to deal with a wide range of issues related to REACH chemical regulation - 28 different issues in all.  And now the DCG has been renewed until the end of September 2013 so that it can address any issues that might arise with the next registration deadline, which is May 30, 2013.

The DCG report gives a summary of its achievements, and presents many of the lessons learned from the experience.  All of this sets the stage for recommendations that hopefully will ease the burden for companies preparing for the 2013 (and 2018) registration deadlines.  An annex of the report gives short summaries of the 28 issues addressed by the group to date.

Issues that are expected to be priority for the next deadline include:

• Organizational issues within SIEFs, the Substance Information Exchange Forums, that had mixed reviews during the first round of registrations,
• Guidance on how to deal with situations in which the companies have merged or spun off units during the registration period (which is especially important for the many small and medium size entities that are expected to be part of the second round),
• Guidance on communication within the supply chain, again a difficult issue for small and medium sized companies with less resources
• Updating of information technology tools like IUCLID, REACH-IT, and guidance documents

One thing that the DCG and ECHA agree on is that companies planning to register chemicals by May 2013 should "Act Now!"  Members say that industry cannot prepare early enough, and many (but not all) companies are heeding that advise. 

The DCG report can be downloaded as a PDF here.

More information on REACH can be found on the ECHA web site.

NSF Announces Steps to Improve Participation of Women in STEM Science Careers

The National Science Foundation (NSF) is announcing steps that will "make it easier for women to pursue careers in engineering and the sciences," according to an Op-Ed by Valerie Jarrett and Tina Tchen in yesterday's Washington Post.  They note that "women working in science, technology, engineering and math [STEM] careers earn 33 percent more than those in other occupations, and these 'STEM' skills will become even more important in high-growth, high-tech fields such as health-care technology and advanced manufacturing."

Jarrett and Tchen note that circumstances often work against women:

As with women throughout the workforce, however, women in STEM jobs are often expected to establish themselves professionally at the same time they are starting families. This forces women to choose between their careers and their responsibilities at home. Understandably, many of our most promising young scientists and engineers drop out of the pipeline. 

Ways that NSF is looking to make it easier for women in STEM careers include:

• Working with women researchers who need to delay the start of a funded project for a family-related reason,
• Options to add the lost time if female researchers interrupt research to have a baby,
• Support for research into the effectiveness of flexible workplace policies.

 For a more in-depth discussion, see the Washington Post article by Jarrett and Tchen. 

More information is on the National Science Foundation web site.

ECHA Starts REACH 2013 Campaign to Urge Chemical Companies to Act Now!

The European Chemicals Agency (ECHA) has launched a campaign to encourage chemical companies to "Act Now!" to meet their planned registration obligations for the second round of REACH.  The next registration deadline - for substances manufactured or imported at tonnages at or above 100 tonnes per year - is May 31 2013. 

ECHA's goal is to get companies thinking now about how they will fulfill the data requirements and interact with other members of SIEFs, including any data gathering and compensation to existing data holders.  Preparing for and submitting registrations earlier rather than all at the last minute is good for both ECHA and the registering companies.

To do this, ECHA has started a program called REACH 2013 - Act Now!

The web page provides "key information to support you in your preparations for the 2013 registration."  It includes "links to all the steps of the registration process: from the formation of the Substance Information Exchange Fora (SIEFs) to data sharing, dossier preparation and online submission."


According to the site, potential registrants need to be getting organized to do:

1. Substance identification, hazard information, data-sharing
1. Substance identification and sameness of substance: Confirm with the other pre-registrants that you have the same substance;
2. Hazard information: Collect all data available on the intrinsic properties of the substance to be registered;
3. Data sharing: As part of a joint registration, gather and share existing information, consider alternatives to testing and answer any information request from within your SIEF;
2. Chemical safety assessment: Carry out a chemical safety assessment in order to produce a chemical safety report based on the hazard information collected and knowledge on the uses.

 More information can be found on the ECHA web site.

ACC's Chemical Prioritization Tool - EDFs Analysis is One Thumb Up, One Thumb Down

Last week I reported on an analysis of the EPA's proposed chemical prioritization tool done by Richard Denison of the Environmental Defense Fund (EDF).  Today I report on Denison's follow up analysis on the counter-proposal prioritization scheme released by the American Chemistry Council the day prior to EPA's webinar.  I'll start with Denison's conclusion:

"While ACC’s tool has some serious flaws and is not something that EPA has the authority or resources to utilize under current TSCA, ACC has put forth a serious proposal for prioritization that should help to raise the level of debate over this critical issue in TSCA reform."

As suggested, Denison notes that the ACC proposal offers some "refreshing elements and acknowledgements."  He describes it as "substantive and specific" and is "welcome in several ways."  He goes on to summarize some of the areas he feels are constructive (see his full blog entry).  Notwithstanding these kudos, however, Denison does suggest that ACC's proposal seems better suited for a full TSCA Reform element and that implementation of the ACC plan is not likely to be possible under the current (and likely future) resource and funding constraints limiting EPA's activities.


Denison finds that there are "a number of quite problematic aspects of ACC's proposal," including:

• Overly rigid rules applied in lockstep: Denison finds ACC's proposed "equal basis" rule to be "sleight of hand" that will "rule out any types of information that may indicate a hazard or exposure of high concern unless it has been measured across basically all chemicals subject to prioritization."  The "high hazard and high exposure" rule would allow prioritization of only those chemicals "for which high hazard and high exposure can be demonstrated;" a proposal that Denison finds to be "simply shortsighted." He also critiques ACC's "persistent and bioaccumulative" rule, which he finds includes "extremely narrow definitions of P and B" that would avoid prioritizing chemicals that would in fact be either P or B (or both).
• Consistent use of the least conservative classification values: Denison points out that the ACC proposal relies on the classification criteria developed under GHS, which he generally supports.  However, he does quibble with what he feels are two limitations - GHS doesn't include every endpoint of concern and ACC chooses the least conservative values instead of adhering to GHS' cutoff values faithfully.  A choice where Denison feels "ACC fails badly."
• Over-relying on limited exposure information and discounting evidence of hazard: Denison notes that ACC's tool lumps together its health and environmental hazard rankings into a single score while combining scores for its three exposure elements, which "means that a chemical that harms both people and other organisms only gets counted once, while a chemical that is low-volume and used only as an intermediate and is not P or B gets credit for being of low concern for all three attributes."  The way the tool handles hazard vs exposure rankings also is likely to skew the results such as to avoid prioritization for chemicals that could indeed be problematic.

Despite these significant critiques, Denison feels that the ACC prioritization tool is a good effort and a basis for informed debate as the process moves forward.  Combined with his previous critique of the EPA prioritization proposal, there clearly is a path forward for enhancing chemical regulation and improving protection of the environment and human health.  But will it happen?

ECHA Risk Assessment Committee Adopts Seven Scientific Opinions

The following information comes from the ECHA web site:



The Committee for Risk Assessment (RAC) has adopted opinions on seven proposals for harmonised classification and labelling across Europe during its 17th meeting, held from 13-16 September 2011 in Helsinki.


Polyhexamethylene biguanide hydrochloride (PHMB)

RAC agreed with the proposal from France to classify PHMB as acutely toxic by the oral and inhalation route, damaging to the eye, as a skin sensitiser, as toxic to the respiratory tract after repeated exposure, suspected carcinogen and hazardous to the aquatic environment. The classification of this substance is not currently harmonised at EU level. PHMB is used as biocidal product (disinfectant).

Di-n-hexyl phthalate (DnHP)

RAC agreed with the proposal from France to classify DnHP for reproductive toxicity due to the potential for effects on unborn babies as well as on male fertility. The classification of this substance is not currently harmonised at EU level. DnHP is used in the manufacture of plastics.

Fenamiphos

RAC agreed with the proposal from the Netherlands to classify Fenamiphos as acutely toxic by the inhalation route and as an eye irritant. Fenamiphos already has a harmonised classification as acutely toxic by the oral and dermal route and as hazardous to the aquatic environment. RAC agreed with the proposal to replace the minimum classification for acute toxicity (indicate by an asterix) with the definite classification based on data. Further, RAC proposed an M-factor of 100 for chronic aquatic toxicity. Fenamiphos is used as a plant protection product.

Trichloromethylstannane (MMTC)

RAC agreed with the proposal from France to classify MMTC as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMTC as mutagenic. The classification of this substance is not currently harmonised at EU level. MMTC is used as an industrial intermediate in the production of other organotin chemicals.

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (MMT (EHMA))

RAC agreed with the proposal from France to classify MMT(EHMA) as toxic to reproduction. RAC did not agree with the proposal from France, to classify MMT(EHMA) as mutagenic. The classification of this substance is not currently harmonised at EU level. MMT(EHMA) is used as a heat stabiliser in PVC.

Benzenamine, 2-chloro-6-nitro-3-phenoxy- (Aclonifen)

RAC agreed with the proposal from Germany to classify Aclonifen as a suspected carcinogen, as a skin sensitiser and as hazardous to the aquatic environment. Aclonifen already has a harmonised classification as hazardous to the aquatic environment. Aclonifen is used as a plant protection product (herbicide).

Perestane

RAC agreed with the proposal from the UK to classify Perestane as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and as toxic to the eye after single exposure and to remove the classification for mutagenicity. Perestane already has a harmonised classification as acutely toxic by the oral, dermal and inhalation routes, skin corrosive and mutagenic. Perestane is used as a biocide (surface disinfectant).

More information can be found on the ECHA web site.

Denmark Proposes Restriction of Four Phthalates under REACH Chemical Regulation

Denmark has proposed to restrict "the placing on the market and use of certain articles containing four classified phthalates (DEHP, BBP, DBP and DIBP)."  These common phthalates are found in a variety of professional and consumer products, including PVC and in dispersions, paints and varnishes.  The primary rationale for these restrictions is that these "phthalates are all reported to affect reproductivity."

The Danish proposal is part of the REACH chemical regulation process, in which substances of very high concern can be proposed by Member States to be restricted from further use.  All interested parties (e.g., manufacturers and formulators, as well as other Competent Authorities) can comment on the proposal.  All comments will be "reviewed and taken into account by ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC)."  By September 2012 these Committees would provide their opinions, which will be the basis for final decisions on whether to restrict the substances from use in commerce

Comments are requested by December 16, 2011, though officially the 6-month public consultation being announced today ends in March 2012.

According to the ECHA news release:

The widespread use of phthalates is raising concern, regarding human exposure from consumer articles. The dossier addresses the combined exposure based on common effects seen with exposure to these phthalates.
In the report, Denmark suggests a ban for the placing on the market of articles intended for indoor use and articles that may come into direct contact with the skin or mucous membranes, containing one or more of these four phthalates in a concentration greater than 0.1 % by weight of any plasticised material.

More information can be found on the ECHA site.

Avoiding Paralysis by Analysis - EDF's Analysis of the EPA TSCA Chemical Prioritization Proposal

Last week the USEPA held a webinar to introduce their proposal for how they will attempt to prioritize TSCA chemicals for closer assessment.  One day prior to the webinar the ACC announced its own competing prioritization scheme. Earlier this week, Environmental Defense Fund Senior Scientist Richard Denison offered his views on the EPA scheme, which he called "a sensible approach to identifying chemicals of concern." [Note: Denison will be addressing the ACC proposal in a following post on the EDF web site.]

The "paralysis by analysis" noted to in the title refers to the futility of asking EPA to evaluate the entire TSCA Inventory akin to the Canadian approach.  The Canadian approach was actually "mandated by statute" (via the 1999 amendments to the CEPA) and both Environment Canada and Health Canada were given "seven years and a major infusion of new resources" just to complete the first phase of the process.  According to Denison, with nearly four times as many chemicals on the Inventory, and "without the authority and the resources, well, that's just a recipe for paralysis by analysis" to ask EPA to do the same. 

Which is why the EPA proposal is so reasonable, according to Denison.  He indicates that EDF and the Safer Chemicals Healthy Families coalition "generally support EPA's approach and believe it strikes the right balance between clarity and transparency and avoiding paralysis by analysis."  Denison does, however, offer a series of 10 additional suggestions for improving the EPA proposal.  The full list can be seen on the EDF blog page, but include broadening the sources of data specified in Step 1 (perhaps by including some of the source from Step 2), consideration of the published literature, adding specific criteria for children's health and exposure, expanding the range of "vulnerable subpopulations" beyond just children's health, and providing additional clarity on how EPA plans to move from Step 1 to Step 2.

Overall, Denison finds that the attempts by EPA to reintroduce "action" into their proposed prioritization and action plan process are much needed.  He welcomes EPA looking at chemicals in commerce to identify those for which it would be prudent to take a closer look at their potential risk.  And with the additional actions suggested, he believes that it is a good step in the right direction.

To read EDF's analysis and the full list of suggestions, see Richard Denison's blog entry for September 13, 2011.

Congressional Briefing Says Animal Testing Should be Replaced with Alternative Methods

Yesterday there was a briefing held on Capitol Hill to update lawmakers on the status of non-animal test methods for assessing the toxicity of chemicals.  Led by Dr. Paul Locke of the Johns Hopkins Center for Alternatives to Animal Testing (CAAT), the briefing discussed the "3Rs" in US chemical law and policy.  Speaking at the briefing was Representative James Moran, who is ranking member of the House Appropriation Committee's subcommittee on Interior, Environment and Related Agencies.

Moran is also co-chair of the Congressional Animal Protection Caucus (CAPC), a group staffed by both parties that seeks to raise awareness of animal welfare issues in Congress.  CAPC replaced the "Friends of Animals Caucus" that had existed in previous Congresses.  The briefing was in conjunction with CAPC.

Dr. Locke outlined the 3Rs, i.e., finding alternative testing methods that refine existing tests by minimizing animal distress, reduce animal usage, or replace whole animal tests.  Ultimately, CAAT and other organizations would like to see a shift to all non-animal testing such as those being developed as part of Tox21, the testing program that came out of the National Academy of Sciences report "Toxicity Testing for the 21st Century: A Vision and a Strategy."

Representative Moran concurred.  During the meeting he said that "virtually all animal tests are outdated in terms of efficiency and effectiveness."  He strongly suggested that the robotic tests being advanced by Tox21 could help rapidly screen the thousands of existing chemicals that so far have received no technical review, and do so more effectively than the standard animal tests.

More information on CAAT and the briefing can be found here.

Inspector General Seeks More Answers as EPA Nears Key Deadline for Endocrine Disruptor Chemicals

The Inspector General (IG) has issued a further response to EPA's continuing attempts to address issues raised by the IG regarding how EPA will assess potential endocrine disrupting chemicals.  The IG also seeks clarification that the EPA will indeed provide additional feedback by September 30, 2011.  The deadline is supposed to be when EPA will complete its prioritization approach for selecting chemicals for testing.

The crux of the concerns raised by the IG relate to an oft-repeated industry question about how EPA will use the Tier 1 screening data already underway for List 1 Test Orders.  Industry filed a petition asking 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."  Last month EPA issued a Federal Register notice seeking public comment on the industry petition.

The IG's memorandum indicates that they are satisfied with EPA's response to recommendations 4 and 5 pending agreed upon Agency action.  The IG also was satisfied with responses to recommendations 3(a) and 6.  However, while the IG indicates that EPA is showing progress in developing a "mutually satisfactory solution" for recommendations 1, 2 and 3(b), the IG was "seeking additional information regarding OCSPP's planned corrective actions for these recommendations." They also wanted to have clarification of what would be completed by September 30, 2011 and what would not be completed until a Management Plan is published on June 30, 2012.

The IG memorandum can be read here and downloaded as a PDF.

European Chemicals Agency Publishes Chemical Safety Data Sheet Guidance

The European Chemicals Agency (ECHA) has added to its already voluminous library of guidance documents that support the REACH chemical control law. The new "Guidance on the Compilation of Safety Sheets" (Version 1.0, September 2011) provides information on:

• what is new in SDSs according to REACH by comparison with the previous legislation
• issues to consider when compiling an SDS;
• details of the requirements for information to be included in each Section of an SDS, in particular detailing the changes arising from the revisions of Annex II of REACH;
• the timetables for implementation of Annex II and its amended Annexes;
• who should compile the SDS and what competences the author should have.

The guidance document can be downloaded as a PDF file on the ECHA Guidance web site.

ACC Proposes TSCA Prioritization Tool to Improve Chemical Review Process

The American Chemistry Council (ACC), a trade association representing many large chemical manufacturers, has proposed a new prioritization tool "to increase effectiveness of EPA's chemical review process."  The press release comes in a preemptive strike a day before EPA holds a webinar in which it will describe its own proposal for prioritizing chemicals.

ACC states that "EPA does not have a systematic way to determine which chemical uses need further characterization" and worries that "EPA may be wasting time, energy and resources gathering additional information on already well-understood chemicals."  According to their fact sheet and an accompanying powerpoint presentation, ACC's prioritization tool "would be administered by EPA" to:

• Evaluate chemicals against transparent, consistent, scientifically-based criteria focused on the hazard associated with the chemical, how the chemical is used and how people or the environment are exposed to the chemical;
• Ascribe a score based on the criteria;
• Rank order chemicals based on their scores and the professional judgment of EPA officials; 
• Utilize the rankings to determine which chemicals should be given full risk assessments

Individual criteria for ranking chemicals would include human health hazards (e.g., carcinogenicity or reproductive/developmental toxicity), potential environmental effects, the industrial, commercial and consumer uses, persistence and bioaccumulation potential, production volume, and other factors such as use in children's products or detected in biomonitoring programs.

EPA's prioritization scheme to be discussed tomorrow (September 7, 2011) differs significantly from the ACC plan.  ACC has clear scoring criteria for all chemicals where the EPA plan relies more on prior listings of chemicals by other regulatory bodies.  ACC's plan also gives greater weight to potential exposure (i.e., focus on risk) whereas EPA's plan would rely more on hazard for at least its first steps.

More information on the ACC prioritization proposal can be found on their TSCA prioritization page, including links to criteria documents, presentation and background information.

EPA Kicks Off Initiative to Find Alternatives to Phthalates

The kickoff meeting of a partnership between the USEPA and interested parties was held August 24, 2011 in the Washington DC area.  The goal is for EPA and industry to work within the Design for the Environment (DfE) framework to "evaluate phthalates and potential alternatives based on a range of human health and environmental endpoints, and provide this information to stakeholders for informed decision making."

Participants in the kickoff meeting included a variety of stakeholders ranging from manufacturers, state and local regulatory agencies, trade associations, international regulatory bodies, and NGOs. Individual manufactures and users of phthalates present included ExxonMobil, BASF, IBM, Dow Chemical, and others.  It is expected that future activities will include development of a list of existing potential alternatives and an evaluation of the potential environmental and human health effects of those alternatives that seem most viable.  The next meeting of the partnership initiative is will be in October 2001, with early spring 2013 planned for a final report on the project.

An action plan on which this DfE initiative is based was released in December of 2009.  The phthalates identified in the action plan for assessment are:

• Dibutyl phthalate (DBP)
• Diisobutyl phthalate (DIBP)
• Butyl benzyl phthalate (BBP) 
• Di-n-pentyl phthalate (DnPP) 
• Di(2-ethylhexyl) phthalate (DEHP) 
• Di-n-octyl phthalate (DnOP) 
• Di-isononyl phthalate (DINP) and associated chemical*
• Di-isodecyl phthalate (DIDP) and associated chemical*

 *each are a mixture of two phthalates

The partnership participants will decide on which substances offer the potential as alternatives.  Collaboration with ongoing reviews by the US Consumer Product Safety Commission (due to use of phthalates in children's toys and baby bottles) and the Green Chemistry in Commerce Council will also be part of the review process.

More information the Design for the Environment Program can be found here.