TSCA/EPCRA:
On August 18, EPA posted action plans for benzidine dyes, nonylphenol and nonylphenol ethoxylates, and hexabromocyclododecane. The chemicals at issue are “existing,” meaning that they are currently included on the inventory established under the Toxic Substances Control Act (TSCA) and therefore may be lawfully manufactured, processed, and used in the United States, subject to whatever restrictions or other requirements the Agency imposes. According to EPA, these chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively. Restrictions or further conditions on their use could therefore have significant economic implications for certain stakeholders.
The action plans summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify the specific steps EPA is contemplating to address those concerns. According to the plans, the Agency is contemplating a range of actions under TSCA as well as listings under the Toxic Release Inventory (TRI) established pursuant to Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). As it undertakes the proposed actions, EPA will provide opportunities for public and stakeholder comment and involvement.
The action plans are a further demonstration of EPA’s commitment to using its existing legal authorities to regulate chemicals that may pose a risk to human health and the environment. Until new legislation amending TSCA is enacted, readers should anticipate EPA’s creative and robust use of its existing authorities to implement the Administration’s chemicals management policies.
More information, including copies of the action plans, is available here. A summary of the plans is provided below.
Benzidine Dyes
This action plan addresses 48 dyes derived from benzidine and its congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine.
According to EPA, Benzidine and its congeners are important precursors in the synthesis of dyes. Some of these dyes have the potential to metabolize to aromatic amines that are considered to be carcinogenic. Benzidine and dyes metabolized to benzidine are classified as known human carcinogens, and Benzidine’s congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine and dyes metabolized to the latter two congeners have all been classified as “reasonably anticipated to be human carcinogens.”
The dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. According to the Agency, they have the potential to be leached from textiles, such as clothing, that are in prolonged contact with human skin. They are also used as reagents and biological stains in laboratories, are used in the food industries, and have more recent uses in laser, liquid crystal displays, ink-jet printers, and electro-optical devices. Because the dyes have the potential to metabolize to carcinogenic amines both in and on the human body, EPA is concerned about the potential risk from exposure, including exposure of children, from using products containing benzidine and congener-based dyes.
On the basis of existing information, EPA has concluded that the following actions would be warranted:
1. Initiate rulemaking to add four benzidine-based dyes to an existing TSCA section 5(a)(2)significant new use rule (SNUR) for benzidine-based substances at 40 CFR 721.1660. (A SNUR requires manufacturers who intend to use a chemical for the identified significant new use to submit an application, known as a Significant New Use Notice (SNUN), to the Agency for review at least 90 days prior to beginning that activity. The Agency’s review of the SNUN provides an opportunity to take other regulatory action if appropriate.)
2. Initiate rulemaking to establish a new TSCA section 5(a)(2)SNUR for benzidine congener-based dyes, including 44 specific such dyes.
3. Consider proposing to eliminate the article exemption applied to SNURs to address potential concerns for exposure to these dyes on imported finished textiles.
4. Consider initiating action under TSCA section 6, if EPA learns that these dyes are present in imported finished textiles.
5. Consider additional regulatory action, if EPA determines that there are other ongoing uses for these dyes and needs to obtain information necessary to determine whether those uses present concerns which need to be addressed.
Nonylphenol and Nonylphenol Ethoxylates
This action plan addresses Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs). NP and NPEs are produced in large volumes, with uses that lead to widespread release to the aquatic environment.
NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms. NP has also been shown to exhibit estrogenic properties in in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs.
NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products. Many of these, such as laundry detergents, are “down-the-drain” applications. Some others, such as dust-control agents and deicers, lead to direct release to the environment. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP.
According to the Agency, NP and NPEs have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents.
EPA is initiating both voluntary and regulatory actions to manage potential risks from NP and NPEs. EPA intends to:
1. Support and encourage the ongoing voluntary phase-out of NPEs in industrial laundry detergents, as agreed to by the Textile Rental Services Association of America (TRSA). The phase out, which has already begun, is being coordinated with EPA’s DfE Safer Detergents Stewardship Initiative (SDSI)program and would end the use of NPEs in industrial laundry detergents by 2013 for liquid detergents and 2014 for powder detergents. In addition, EPA intends to encourage the manufacturers of all NPE-containing direct-release products (e.g., firefighting gels and foams, dust-control agents and deicers) to move to NPE-free formulations. EPA will develop an alternatives analysis and encourage the elimination of NPE in other industries that discharge NPEs to water, such as the pulp and paper processing and textile processing sectors, where safer alternatives may be available.
2. Initiate rulemaking to simultaneously propose a SNUR under TSCA section 5(a)and a test rule for NP and NPEs under TSCA section 4. The SNUR would designate use of NPEs in detergents and cleaning products as a significant new use, which would require submission of a SNUN at least 90 days before beginning that use. The proposed test rule would require development of the information necessary to determine the effects that NPEs and NP may have on human health or the environment.
3. Consider initiating rulemaking under TSCA section 5(b)(4)to add NP and NPEs to the Concern List of chemicals that present or may present an unreasonable risk of injury to health or the environment.
4. Initiate rulemaking to add NP and NPEs to the Toxics Release Inventory (TRI) established under EPCRA, which would require facilities to report releases of these chemicals to the environment.
Hexabromocyclododecane
This action plan addresses EPA’s review of hexabromocyclododecane (HBCD), a category of brominated flame retardants. HBCD is used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products.
According to EPA, people may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment. HBCD is supposedly found world-wide in the environment and wildlife. EPA claims that HBCD is found in human breast milk, adipose tissue, and blood. It supposedly bioaccumulates in living organisms and biomagnifies in the food chain, and it is persistent in the environment and is transported long distances.
The action plan finds that HBCD is highly toxic to aquatic organisms. It also presents human health concerns based on animal test results indicating potential reproductive, developmental and neurological effects.
EPA intends to initiate the following actions to manage the risk that may be presented by HBCD.
1. Consider initiating rulemaking under TSCA section 5(b)(4)to add HBCD to the Concern List of chemicals which present or may present an unreasonable risk of injury to health or the environment. EPA intends to publish this notice of proposed rulemaking by the end of 2011.
2. Initiate rulemaking under TSCA section 5(a)(2) to designate manufacture or processing of HBCD for use as a flame retardant in consumer textiles as a significant new use. This would require manufacturers and processors to file a SNUN 90 days before manufacturing or processing HBCD for this use. The SNUR also would be proposed to apply to imports of consumer textiles articles containing HBCD.
3. Consider initiating rulemaking under TSCA section 6(a)to regulate HBCD. A section 6(a) action could take the form of a comprehensive ban on the manufacturing, processing, distribution in commerce and use of a chemical substance, or a more targeted regulation to address specific activities. The extent of the rule for HBCD would be determined during the rulemaking process.
4. Initiate rulemaking in 2011 to add HBCD to the Toxics Release Inventory (TRI). Listing on TRI will require manufacturers or importers to provide environmental release information.
5. Conduct a Design for the Environment (DfE)alternatives assessment of HBCD. The information developed may be used to encourage industry to move away from HBCD instead of, in addition to, or as part of any regulatory action taken under TSCA. The alternatives assessment would build upon existing knowledge and would consider various exposed populations, including sensitive human subpopulations, as well as environmental exposure. The work will begin in 2011, with completion expected in 2013.
* * * *
Follow the Green Chemistry Law Report for future updates on EPA’s contemplated actions for these chemicals.
EPA Requests Comments on Its Role in Advancing Sustainable Products
/in Pollution Prevention Act, Sustainable ProductsPollution Prevention Act/Sustainable Products:
In today’s Federal Register, EPA solicited comments from stakeholders on potential roles for the Agency in advancing sustainable products. According to the notice, EPA will consider the comments it receives and as well as information it gathers from other sources to help define its role and develop a strategy that identifies how the Agency can make a meaningful contribution to the development, manufacture, designation, and use of sustainable products. Comments are due by October 19, 2010.
EPA requested input on the following questions:
1. What do you see as the major policy and research challenges, opportunities, and trends impacting the development, manufacture, designation, and use of sustainable products?
2. What do you see as EPA’s overall role in addressing these challenges and opportunities?
3. In particular, how do you see EPA’s role in:
EPA cites Section 13103(b) of the Pollution Prevention Act of 1990 (PPA) as its authority for this action. That section requires the Administrator of EPA to facilitate the adoption of source reduction techniques by businesses and to identify opportunities to use Federal procurement to encourage source reduction. For those who are less familiar with the PPA, 2010 is the Act’s 20th anniversary.
It’s nice to see EPA allowing its use of the PPA authority to evolve in response to today’s market demands and societal needs. However, the potential impact on market competition from Agency involvement in this area means that EPA’s notice is likely to receive a mixed reception. Some will welcome it as an opportunity to help organize a market that seems crowded, disorganized, confusing, and misleading in some cases. Others will prefer to let this rapidly evolving market mature without excessive government involvement. And still others will worry about the regulatory consequences for products that are not deemed sustainable should the Agency promote a defined set of criteria or support a particular eco-label. Undoubtedly, many stakeholders will submit comments to sensitize the Agency to these concerns, as well as the potential trade-offs and other considerations.
So, what do readers think? Should EPA attempt to set criteria identifying which products are “sustainable” or should the market be left to do that? Again, comments are due by October 19, 2010.
Update – Impending Release of California's Draft Green Chemistry Regulations
/in Green Chemistry RegulationGreen Chemistry Regulations:
Here’s a quick update for those who are tracking the development of California’s Green Chemistry Regulations for Safer Consumer Products. I was told by a reliable source this afternoon that the Department of Toxic Substances Control (DTSC) will release tomorrow, September 14, a revised draft of the regulations. This will commence the formal rulemaking process, which requires public hearings and a 45-day public comment period. It should be an interesting four months as DTSC sprints to complete the rulemaking process by the January 2011 statutory deadline.
According to an email that DTSC circulated late on September 13, the Department will post the Initial Statement of Reasons, the 45-day notice of public comment, a list of frequently asked questions, and a news release announcing the proposed regulation at 10:00 am (Pacific) at: http://dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/Proposed-Regulation.cfm.
ATSDR Announces Development of the Set 24 Toxicological Profiles
/in ATSDRATSDR:
On September 9, the Agency for Toxic Substances and Disease Registry (ATSDR) of the Department of Health and Human Services announced the development of the Set 24 Toxicological Profiles. According to the Federal Register notice, the profiles will be available to the public for review and comment on or about October 17, 2010.
ATSDR develops these profiles to fulfill its obligations under the Superfund Amendments and Reauthorization Act of 1986 (42 U.S.C. 9601 et seq.), which amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) (42 U.S.C. 9601 et seq.) Among the statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances. This list names 275 hazardous substances found at National Priorities List (NPL) sites that pose the most significant potential threat to human health as determined by ATSDR and EPA. The list is not a list of “most toxic” substances, but rather a prioritization of substances based on a combination of their frequency, toxicity, and potential for human exposure at NPL sites.
The profiles are used to set cleanup priorities at waste sites, but the EPA also uses them to support regulatory actions under the Toxic Substances Control Act (TSCA) and other statutes. Thus, companies manufacturing, processing, and using chemicals, as well as environmental and public health groups, are frequently interested in the development of ATSDR Toxicological Profiles.
The Set 24 Toxicological Profiles
The following toxicological profiles are now being developed:
————————————————————————
Toxicological profile CAS number
————————————————————————
Toxaphene……………………………………….. 8001-35-2
Trichlorobenzene*
1,2,3-Trichlorobenzene………………………… 87-61-6
1,2,4-Trichlorobenzene………………………… 120-82-1
1,3,5-Trichlorobenzene………………………… 108-70-3
Trichlorobenzene………………………….. 12002-48-1
————————————————————————
* Denotes new profile.
EPA Announces Action Plans for Chemicals Used in Dyes, Detergents, and Flame Retardants
/in EPCRA, TSCATSCA/EPCRA:
On August 18, EPA posted action plans for benzidine dyes, nonylphenol and nonylphenol ethoxylates, and hexabromocyclododecane. The chemicals at issue are “existing,” meaning that they are currently included on the inventory established under the Toxic Substances Control Act (TSCA) and therefore may be lawfully manufactured, processed, and used in the United States, subject to whatever restrictions or other requirements the Agency imposes. According to EPA, these chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively. Restrictions or further conditions on their use could therefore have significant economic implications for certain stakeholders.
The action plans summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify the specific steps EPA is contemplating to address those concerns. According to the plans, the Agency is contemplating a range of actions under TSCA as well as listings under the Toxic Release Inventory (TRI) established pursuant to Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). As it undertakes the proposed actions, EPA will provide opportunities for public and stakeholder comment and involvement.
The action plans are a further demonstration of EPA’s commitment to using its existing legal authorities to regulate chemicals that may pose a risk to human health and the environment. Until new legislation amending TSCA is enacted, readers should anticipate EPA’s creative and robust use of its existing authorities to implement the Administration’s chemicals management policies.
More information, including copies of the action plans, is available here. A summary of the plans is provided below.
Benzidine Dyes
This action plan addresses 48 dyes derived from benzidine and its congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine.
According to EPA, Benzidine and its congeners are important precursors in the synthesis of dyes. Some of these dyes have the potential to metabolize to aromatic amines that are considered to be carcinogenic. Benzidine and dyes metabolized to benzidine are classified as known human carcinogens, and Benzidine’s congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine and dyes metabolized to the latter two congeners have all been classified as “reasonably anticipated to be human carcinogens.”
The dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals. According to the Agency, they have the potential to be leached from textiles, such as clothing, that are in prolonged contact with human skin. They are also used as reagents and biological stains in laboratories, are used in the food industries, and have more recent uses in laser, liquid crystal displays, ink-jet printers, and electro-optical devices. Because the dyes have the potential to metabolize to carcinogenic amines both in and on the human body, EPA is concerned about the potential risk from exposure, including exposure of children, from using products containing benzidine and congener-based dyes.
On the basis of existing information, EPA has concluded that the following actions would be warranted:
1. Initiate rulemaking to add four benzidine-based dyes to an existing TSCA section 5(a)(2)significant new use rule (SNUR) for benzidine-based substances at 40 CFR 721.1660. (A SNUR requires manufacturers who intend to use a chemical for the identified significant new use to submit an application, known as a Significant New Use Notice (SNUN), to the Agency for review at least 90 days prior to beginning that activity. The Agency’s review of the SNUN provides an opportunity to take other regulatory action if appropriate.)
2. Initiate rulemaking to establish a new TSCA section 5(a)(2)SNUR for benzidine congener-based dyes, including 44 specific such dyes.
3. Consider proposing to eliminate the article exemption applied to SNURs to address potential concerns for exposure to these dyes on imported finished textiles.
4. Consider initiating action under TSCA section 6, if EPA learns that these dyes are present in imported finished textiles.
5. Consider additional regulatory action, if EPA determines that there are other ongoing uses for these dyes and needs to obtain information necessary to determine whether those uses present concerns which need to be addressed.
Nonylphenol and Nonylphenol Ethoxylates
This action plan addresses Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs). NP and NPEs are produced in large volumes, with uses that lead to widespread release to the aquatic environment.
NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms. NP has also been shown to exhibit estrogenic properties in in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs.
NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products. Many of these, such as laundry detergents, are “down-the-drain” applications. Some others, such as dust-control agents and deicers, lead to direct release to the environment. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP.
According to the Agency, NP and NPEs have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents.
EPA is initiating both voluntary and regulatory actions to manage potential risks from NP and NPEs. EPA intends to:
1. Support and encourage the ongoing voluntary phase-out of NPEs in industrial laundry detergents, as agreed to by the Textile Rental Services Association of America (TRSA). The phase out, which has already begun, is being coordinated with EPA’s DfE Safer Detergents Stewardship Initiative (SDSI)program and would end the use of NPEs in industrial laundry detergents by 2013 for liquid detergents and 2014 for powder detergents. In addition, EPA intends to encourage the manufacturers of all NPE-containing direct-release products (e.g., firefighting gels and foams, dust-control agents and deicers) to move to NPE-free formulations. EPA will develop an alternatives analysis and encourage the elimination of NPE in other industries that discharge NPEs to water, such as the pulp and paper processing and textile processing sectors, where safer alternatives may be available.
2. Initiate rulemaking to simultaneously propose a SNUR under TSCA section 5(a)and a test rule for NP and NPEs under TSCA section 4. The SNUR would designate use of NPEs in detergents and cleaning products as a significant new use, which would require submission of a SNUN at least 90 days before beginning that use. The proposed test rule would require development of the information necessary to determine the effects that NPEs and NP may have on human health or the environment.
3. Consider initiating rulemaking under TSCA section 5(b)(4)to add NP and NPEs to the Concern List of chemicals that present or may present an unreasonable risk of injury to health or the environment.
4. Initiate rulemaking to add NP and NPEs to the Toxics Release Inventory (TRI) established under EPCRA, which would require facilities to report releases of these chemicals to the environment.
Hexabromocyclododecane
This action plan addresses EPA’s review of hexabromocyclododecane (HBCD), a category of brominated flame retardants. HBCD is used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products.
According to EPA, people may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment. HBCD is supposedly found world-wide in the environment and wildlife. EPA claims that HBCD is found in human breast milk, adipose tissue, and blood. It supposedly bioaccumulates in living organisms and biomagnifies in the food chain, and it is persistent in the environment and is transported long distances.
The action plan finds that HBCD is highly toxic to aquatic organisms. It also presents human health concerns based on animal test results indicating potential reproductive, developmental and neurological effects.
EPA intends to initiate the following actions to manage the risk that may be presented by HBCD.
1. Consider initiating rulemaking under TSCA section 5(b)(4)to add HBCD to the Concern List of chemicals which present or may present an unreasonable risk of injury to health or the environment. EPA intends to publish this notice of proposed rulemaking by the end of 2011.
2. Initiate rulemaking under TSCA section 5(a)(2) to designate manufacture or processing of HBCD for use as a flame retardant in consumer textiles as a significant new use. This would require manufacturers and processors to file a SNUN 90 days before manufacturing or processing HBCD for this use. The SNUR also would be proposed to apply to imports of consumer textiles articles containing HBCD.
3. Consider initiating rulemaking under TSCA section 6(a)to regulate HBCD. A section 6(a) action could take the form of a comprehensive ban on the manufacturing, processing, distribution in commerce and use of a chemical substance, or a more targeted regulation to address specific activities. The extent of the rule for HBCD would be determined during the rulemaking process.
4. Initiate rulemaking in 2011 to add HBCD to the Toxics Release Inventory (TRI). Listing on TRI will require manufacturers or importers to provide environmental release information.
5. Conduct a Design for the Environment (DfE)alternatives assessment of HBCD. The information developed may be used to encourage industry to move away from HBCD instead of, in addition to, or as part of any regulatory action taken under TSCA. The alternatives assessment would build upon existing knowledge and would consider various exposed populations, including sensitive human subpopulations, as well as environmental exposure. The work will begin in 2011, with completion expected in 2013.
* * * *
Follow the Green Chemistry Law Report for future updates on EPA’s contemplated actions for these chemicals.
Consultation Periods Open on Proposals to Harmonize Classification and Labeling of Four Substances under the EU's CLP Regulation
/in CLP Regulation, GHSEU CLP Regulation:
Public consultation periods have opened on propoosals to harmonize the classification and labeling of four substances under the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures (the so-called “CLP Regulation,” (EC) No 1272/2008). The CLP Regulation implements the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (“GHS“). The substances are: 2-Ethoxyethanol (CAS No. 203-804-4); Reaction mass of 2,4,4-Trimethylpent-1-ene and 2,4,4-Trimethylpent-2-ene (CAS No. 246-690-9); Vinyl acetate (CAS No. 203.545-4); and Indoxacarb and Indoxacarb (enantiomeric reaction mass S:R 75:25 (Indoxocarb CAS No. 173584-44-6). Copies of the proposals, and other details such as the deadlines for submitting comments, are available on the website of the European Chemicals Agency (“ECHA”).
If a proposal is accepted, the substance would be added to the list of harmonised classifications in Annex VI, part 3 of the CLP Regulation. Thereafter, all manufacturers, importers and users of the substance in the EU would need to abide by the new harmonised classification and labelling. Persons potentially affected may be interested in submitting comments.
Background on CLP Regulation and Harmonization
The so-called CLP Regulation entered into force on January 20, 2009. The regulation will gradually replace the Dangerous Substances Directive (67/548/EEC) and Dangerous Preparations Directive (1999/45/EC). Both directives will be repealed by June 1, 2015.
Under the Regulation, individual EU Member States (“Competent Authorities” or “CAs”) and industry may propose harmonization of the classification and labelling of substances. The decision on a particular classification for a substance or mixture is usually made by the supplier (“self-classification”). However, in certain cases the decision on the classification of a substance is made at the Community level, which is then called “harmonized classification.” A harmonized classification must be applied by default by the suppliers of the respective substance.
Hamonized classification and labeling may be approved:
carcinogenic;
mutagenic;
toxic for reproduction; and/or
a respiratory sensitiser;
when the substance is an active substance in a biocidal or plant protection products; or
when there is a need to harmonize a classification at EU level, as supported by a justification demonstrating the need for such action.
* * * *
Check back periodically for future postings on CLP developments.
DTSC Announces New Date for the Public Workshop on Nanomaterials
/in Nanotechnology, News & EventsNanotechnology:
The California Department of Toxic Substances Control (DTSC) announced a new date for its public workshop on nanomaterials. State budget constraints forced the agency to reschedule the meeting from its original date of August 13. The new date is Wednesday, September 22, 2010. The workshop will be held at the U.S. EPA Region 9 office in San Francisco, California.
Persons who previously registered are not required to re-register. However, DTSC has circulated an email to registrants requesting confirmation of their plans to attend on the new date.
At the workshop, DTSC and EPA will discuss the results of the carbon nanotube (CNT) information call-in that DTSC recently completed, future activities by DTSC on other nanomaterial call-ins, and U.S. EPA efforts related to CNTs and future regulatory plans for other nanomaterials.
Reminder: DTSC Reschedules Meeting on Results of Information Call-In for Carbon Nanotubes
/in California, Nanotechnology, News & EventsNanotechnology:
Due to state budget constraints, the California Department of Toxic Substances Control (DTSC) has had to reschedule its August 13 meeting on carbon nanotubes (CNTs) and other nanoscale chemicals substances and materials. No new date has been provided.
DTSC was co-sponsoring the meeting with the US Environmental Protection Agency (EPA) and the University of California, Los Angeles. The sponsors had planned to discuss the results of the CNT information call-in that DTSC recently completed, future activities by DTSC on nanomaterial call-ins, and U.S. EPA efforts related to carbon nanotubes and future regulatory plans for nanomaterials.
Although readers can register here to attend in-person or via teleconference, no new date for the event has been provided.
DTSC Posts Public Comments on Draft Green Chemistry Regulation for Safer Consumer Products
/in Green Chemistry, Green Chemistry Regulation, News & EventsGreen Chemistry Regulations:
The California Department of Toxic Substances Control (DTSC) circulated the following announcement, informing stakeholders that the agency published all public comments received to date on the draft Green Chemistry Regulation for Safer Consumer Products. The comments should make interesting reading. Those of potential importance may be featured in future postings on the Green Chemistry Law Report, so stay tuned!
“DTSC: Green Chemistry Initiative
As part of DTSC’s commitment to transparency and public participation, we have posted, in the order received, all public comments on the Green Chemistry Initiative draft Regulation for Safer Consumer Products http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/gc_draft_regs.cfm.
The regulation reflects nearly 16 months of collaboration with stakeholders, including numerous formal and informal meetings and workshops; input from the Green Ribbon Science Panel; and comments on the conceptual process flowchart, earlier drafts and the draft regulation outline released in the spring of 2010.
DTSC requested public comments during this informal comment period be received by July 15. This posting includes the comments received to date. Additional comments are expected and will be posted when received.
DTSC will now evaluate all comments and consider changes to the regulation. DTSC expects to move into the formal Administrative Procedure Act (APA) rulemaking process in late summer.”
House of Representatives Introduces Bill to Modernize TSCA
/in TSCA ReformTSCA Reform:
On July 22, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (“TCSA,” confusingly similar to the acronym of the current statute). The bill is intended to modernize the current Toxic Substances Control Act (“TSCA”). The introduced bill is different in many respects from the discussion draft the Representatives circulated back in April. In some instances the introduced bill is better and in others it is worse. A short summary of the bill, provided by the House Committee on Energy and Commerce, is set out below. A more detailed analysis will be available in a future posting on the Green Chemistry Law Report.
According to the House Committee, the bill would:
Key documents, including a copy of the bill, are available here.
EPA Promulgates Direct Final SNURs under TSCA for Seventeen Chemicals
/in TSCATSCA:
On June 24, 2010, EPA promulgated significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 17 chemical substances that were the subject of premanufacture notices (PMNs), the type of notice submitted prior to manufacturing or importing a “new chemical” for commercial purposes. The Federal Register notice announcing the SNURs can be found at 75 Fed. Reg. 35977.
Two of the substances are subject to ‘‘risk-based’’ consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the substances may present unreasonable risks to human health or the environment. The SNURs for these two substances are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders.
The other 15 substances are not subject to consent orders under section 5(e). EPA did not find that the use scenarios described in their PMNs triggered the determinations set forth under TSCA section 5(e). Nonetheless, the Agency concluded that certain changes from the use scenarios could result in increased exposures potentially causing adverse human health or environmental effects, or both, and thereby would constitute ‘‘significant new uses.’’
The Agency used its direct final rulemaking procedure to promulgate the SNURs, which means the rules will become effective on August 23, 2010, if EPA does not receive by July 26, 2010, written adverse or critical comments, or notice of intent to submit such comments. In that instance, EPA would withdraw the SNUR for the substance(s) for which it received comments or notices, and instead it would issue a proposed SNUR and provide a 30-day public comment period.
A short overview of each substance, and the next steps some companies will likely consider, are set out below.
Overview of the Chemicals Affected
Persons who intend to manufacture, import, or process any of these 17 substances for an activity that is designated as a significant new use are required to notify EPA at least 90 days before commencing that activity. The required notification will give EPA the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Each substance is listed below – typically with a generic name to protect Confidential Business Information (CBI) – along with the Code of Federal Regulations (CFR) citation to its respective SNUR, the PMN number, and the use(s) identified in its PMN.
Aliphatic triamine (generic). CAS number not available. PMN Number P–02–996. Will be used as a monomer for polymers with amide or imide links; a crosslinker for epoxy type coatings, adhesives and sealants; a crosslinker for epoxy type composites; a monomer for urea and urethane urea polymers used in coatings; a chemical intermediate for functional chemicals: amides, imides; a chemical intermediate for functional chemicals: isocyanates, salts; and a chemical intermediate for functional chemicals: cyclic amines, etc.. SNUR to be codified at 40 CFR § 721.10184.
1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts). CAS number: 328389–90–8. PMN Number P–03–106. Will be used as a surface treatment agent. SNUR to be codified at 40 CFR § 721.10185.
Ethylhexyl oxetane (generic). CAS number not available. PMN P–04–132. Will be used as an additive for industrial applications. SNUR to be codified at 40 CFR § 721.10186.
4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-. CAS No. 1003863–30–6. PMN P–05–186. Will be used as a curing agent for epoxy coating systems. SNUR to be codified at 40 CFR § 721.10187.
Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic). CAS number not available. PMN P–05–186. Will be used as a curing agent for epoxy coating systems. SNUR to be codified at 40 CFR § 721.10188.
Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic). CAS number not available. PMN P–05–186. Will be used as a curing agent for epoxy coating systems. SNUR to be codified at 40 CFR § 721.10189.
Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic). CAS number not available. PMN P–05–186. Will be used as a curing agent for epoxy coating systems. SNUR to be codified at 40 CFR § 721.10190.
Amides, coco, N-[3-(dibutylamino)propyl]. CAS No. 851544–20–2. PMN P–06–262. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10191.
Amides, coco, N-[3-(dibutylamino)propyl], acrylates. CAS No. 851545–09–0. PMN P–06–263. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10192.
1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-,N-coco acyl derivs., inner salts. CAS No. 851545–17–0. PMN P–06–263. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10193.
Dialkylcocoamidoalkylpropionate (generic). CAS number not available. PMN P–06–264. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10194.
Dialkylcornoilamidoalkylamine (generic). CAS number not available. PMN P–06–265. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10195.
Dialkylcornoilamidoacrylate (generic). CAS number not available. PMN P–06–266. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10196.
Dialkycornoilamidoalkylbetaine (generic). CAS number not available. PMN P–06–266. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10197.
Dialkylcornoilamidopropionate (generic). CAS number not available. PMN P–06–267. Will be used as an intermediate for hydrate inhibitor in oil and gas production. SNUR to be codified at 40 CFR § 721.10198.
Substituted aliphatic amine (generic). CAS number not available. PMN P–06–702. Will be used as a polymer curative. SNUR to be codified at 40 CFR § 721.10199.
Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic). CAS number not available. PMN P–09–75. Will be used as a component of odorant compositions for highly dispersive applications.. SNUR to be codified at 40 CFR § 721.10200.
Next Steps
First, many companies are probably determining whether they currently manufacture, import, or process any of these substances, or have plans to do so in the future. If so, they may be assessing whether and how these rules would affect their business and deciding whether to submit comments to EPA by the deadline noted above.
Second, companies that import any of these substances are likely confirming that they are prepared to make the necessary import certifications. TSCA section 13 (15 U.S.C. 2612) requires importers to certify that each shipment of a chemical substance complies with all applicable rules and orders under TSCA. Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements. The import certification requirements are set out in the regulations at 19 CFR 12.118 – 12.127, and 127.28 (the corresponding EPA policy is codified at 40 CFR part 707, subpart B).
Lastly, companies may also be confirming that they are prepared to make the necessary export certifications. In general, any person who exports or intends to export a chemical substance that is the subject of a proposed or final SNUR is subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and the regulations at 40 CFR part 707, subpart D. The export notification requirements apply even when a company does not manufacture, import, or process the substance in a manner restricted by the SNUR. The notification requirement applies regardless of whether the company is required to take any action under the SNUR.