EPA Finalizes Third TSCA Test Rule for HPV Chemicals

The USEPA is finally promulgating a final rule under Section 4 of TSCA "to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule."  The 15 chemicals represent only half of the 29 HPV chemicals that were listed in the the draft rule, which was originally proposed nearly two years ago on February 25, 2010.  According to EPA, based on comments received on the proposed rule, the remaining chemicals were dropped because they did not" meet the criteria for testing at this time."

For the 15 chemicals listed in this final rule, manufacturers will need to conduct the specified tests and provide the data to EPA prior to the deadline, which is set for the end of 2012.  EPA notes that "this test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety."  Required tests vary by chemical but can include physical-chemical properties, environmental fate and degradation, aquatic toxicity, mammalian acute and reproductive/developmental toxicity, and genotoxicity.

Companies that are effected by the rule must submit test plans for each chemical within 90 days of the effective date (i.e., 90 days from November 21, 2011).

The list of chemicals can be accessed here.

A full hyperlinked version of the Federal Register notice can be accessed here.

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.

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.

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 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.

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.

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.