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.

More Walrus Haulouts in Alaska Due to Lack of Arctic Sea Ice

I have previously noted reports of large walrus haulouts onto land due to the lack of Arctic sea ice, and now there are additional reports.  You can read more about it in this summary here.  The original report came from this source here.

More information on radio-tracking of walrus populations can be found on the US Geological Survey Alaska Science Center page.

A short 2-page FAQ on the science behind the walrus haulouts can be seen here.

ECHA Publishes New "Example Exposure Scenarios" for REACH Chemical Registration

The European Chemicals Agency (ECHA) has now developed some "practical examples of how to generate exposure scenarios (ESs) for risk characterization under the REACH chemical substance regulation.  The ESs were developed in collaboration with industry groups in the cleaning products and construction chemicals industries. 

According to ECHA:

The new example exposure scenarios are featured in two publications that are now available on the ECHA website. These are useful for both registrants and downstream users receiving extended safety data sheets (SDSs) for registered REACH substances.  The publications provide descriptions of both professional and consumer use of the substances. One document presents an example ES that refers to the widespread use of a substance in floor coatings applied by workers. The other document contains an example ES on the use of cleaning products by consumers. In both example ESs, the substances are classified as hazardous to human health but with a relatively low hazard level.

ECHA also notes that each publication includes:

• exposure scenarios, exposure estimations and risk characterisations for the CSR and for communication via the SDS;
• a description of the methodologies applied;
• learning points and conclusions from the exemplification process;
• open questions where further work is needed.

More information and links to the example ESs can be found here.

EU Proposes to Ban 20 Chemical Substances

ECHA, the European Chemicals Agency based in Helsinki, has proposed a list of 20 chemical substances for eventual banning under the EU REACH program.  The August 29, 2011 proposal would label these chemicals as "substances of very high concern" (SVHC), which would make them eligible for placement on the "candidate list."  Once on the candidate list the substances may then be placed on Annex XIV of REACH, which requires manufacturers to apply for authorization for continued use.  Any authorization would be limited to specific uses that can control for the hazardous properties of each substance, and authorization is for a limited time period - just long enough for companies to find substitutes.

Nineteen of the 20 substances are proposed because of their "potentially serious effects on human health." These are classified as carcinogenic and/or toxic for reproduction.  One substance is proposed to be identified as a "substance of equivalent concern...because of its endocrine disrupting properties and potential for serious effects to the environment."

The substances are listed in the table of the ECHA press release here.

Interested parties have until October 13, 2011 to comment on any of the proposed SVHCs. ECHA notes that comments "should focus primarily on the hazardous properties that qualify the chemicals as SVHCs and on the substance identity."  They also ask for "further information on the uses, exposures and availability of safer alternative substances or techniques."

Unless dropped from the list based on comments received, these 20 will join the 53 substances already on the Candidate List. Some of these have already been added to Annex XIV.

More information on the REACH authorization process can be found on ECHA's web site.

EU Adds Five Pesticides to PIC, Japan Considers Three More Chemicals for Prior Informed Consent

The European Union (EU) voted last week to add five new pesticides to the Prior Informed Consent (PIC) list under the Rotterdam Convention.  Meanwhile, Japan is considering the addition of three other pesticides to the PIC list.  The Rotterdam Convention stipulates that "severely hazardous pesticide formulations that present a hazard under conditions of use in developing countries or countries with economies in transition may also be nominated for inclusion in Annex III." Once listed a "decision guidance document" must be prepared that defines how the chemical will be banned or severely restricted.

The five pesticides added to the PIC list by the EU are guazatine, indolylactic acid, 1,3-dichloropropene, ethalfluralin, and thiobencarb.  Beginning on October 1st of this year these pesticides will be restricted for export to developing countries, i.e., the countries must be informed of the hazards prior to the sale and use in that country.  Meanwhile, last week also saw Japan propose to add alachlor (a herbicide) and aldicarb and endosulfan (both insecticides) to the PIC list.  Japan currently has restrictions on use and export of 36 chemicals under the Rotterdam Convention treaty.

The EU action followed on a decision not to include the five pesticides on the EU list of approved pesticides, which means they will be effectively banned from use in the EU.  This action was taken because no manufacturer successfully applied for continued authorization of these chemicals.

More information on the additions to the PIC list can be found in the Official Journal of the European Union or on the Rotterdam Convention home page.

EPA Issues Final Plan to Review Regulations in an Effort to Remove Regulatory Burdens on Industry

The USEPA this week issued its final regulatory review plan in accordance with an Executive Order signed by President Obama earlier this year.  The goal of the review is to modify or eliminate regulations that are overly burdensome or costly.  EPA wants to develop a "21st century approach to environmental protection."

Under the plan, EPA will review a total of 35 separate regulations. About half (16) fit into the category of "early actions" and will be reviewed during 2011, with the rest scheduled for longer term actions in subsequent years.  For the early action list EPA "intends to propose or finalize an action to modify, streamline, expand, or repeal a regulation or related program."  The 16 regulatory topics to be reviewed in 2011 include:

• Gasoline and diesel regulations
• Equipment leak detection and repair
• Regulatory certainty for farmers
• Modern science and technology methods in chemical regulation
• Electronic online reporting of health and safety data under TSCA, FIFRA, FFDCA
• National Priorities List rules
• Quick changes to some TSCA reporting requirements
• National Pollutant Discharge Elimination System (NPDES)
• National primary drinking water regulations
• Combined Sewer Overflows (CSOs) and integrated planning for wet weather infrastructure
• Vehicle regulations, e.g., GHG and fuel economy standards and emissions standards
• Multiple air pollutants, e.g., coordinating emission reduction regulations
• NSPS reviews and revisions under the Clean Air Act
• Clean Air Act Title V Permit program simplification
• Innovative technology, i.e., seeking to encourage innovation
• Costs of regulations, i.e., seeking to improve cost estimates

EPA notes that the actions it has taken just in the last few months have resulted in streamlined regulations and savings of up to $360 million per year.  Overall the EPA expects this regulatory review to result in $1.5 billion in savings over the next five years.  EPA further noted that it expects to conduct regulatory reviews on a "predictable, transparent, five-year cycle," including public requests for nominations of additional regulations for review.


The full EPA final regulatory review plan can be downloaded from the White House web site.

Melting Arctic Sea Ice Forces Walruses Onto Land

A US Geological Survey study suggests that the fast melting of Arctic sea ice is the reason why walruses are coming up onto land in exceptional numbers.  Normally walruses spend much of their time on sea ice, where they rest from their feeding dives, avoid predators, and even give birth.  But when the sea ice is scarce they hop up onto land.  Radio transmitters on tracking collars show researchers that walruses appear to be spreading out and spending substantial time looking for sea ice.

Last September saw 10,000 to 20,000 walruses haul up onto land, coinciding with the lowest ice extent of the year.  But this year the Arctic sea ice has been melting at near record pace, with July setting a new record for the lowest extent in that month.  Weather conditions in the Arctic suggest that August ice melt could be accelerated, which could mean the September minimum will be much lower than last year, and with less ice there could be more walruses up on land.  That puts them at greater risk, both from land predators, density-based aggression, and inability to find food. 

More information on this study, as well as other walrus research, can be found on the USGS site.

EPA to Discuss TSCA Chemical Prioritization Process in Upcoming Webinar - Invites Comments

The USEPA is reevaluating and seeks to enhance their current chemicals management program as authorized under the Toxic Substances Control Act (TSCA).  As part of this reevaluation EPA has scheduled a webinar on the prioritization factors and data sources the Agency plans to use to identify priority substances.  EPA is also inviting the public to share their thoughts in an online discussion forum.


The discussion forum seeks comments on two steps in the process.  The first step is prioritization and is split into two substeps - the priority factors to be used to identify substances of high priority, and the sources of data for those factors.  The second step is to look at additional factors and sources for further analysis beyond the prioritization step.

More information and links to the discussion forum for each of the steps can be found on the
EPA discussion forum site.  All comments will be reviewed by the EPA, though since this is not a formal rule-making EPA will not respond directly to each comment.  The online forum is now open and will remain open through 5:00 pm EDT on September 14, 2011.

In conjunction, EPA is inviting participation in a webinar that will discuss the prioritization factors and data sources.  The webinar will be held on Wednesday, September 7, 2011 from 1:30 to 4:30 pm EDT.  Interested parties may register for the webinar here.

Prior to the webinar or submitting comments in the online discussion forum, all are encouraged to read EPA's background paper and discussion guide, which lays out the current thought process.  This can be downloaded as a PDF file here.