California DTSC Requests Comment on Proposed Green Chemistry Regulations for Safer Consumer Product Alternatives

Green Chemistry Regulations:

After nearly two years of public meetings, informal comment periods and other multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) released on September 15, 2010 its proposed Safer Consumer Product Alternatives regulations, a key component of California’s Green Chemistry Initiative.  The proposed regulations would require DTSC to create a list of chemicals identified as posing the greatest threats to human health or the environment, the so-called “Priority Chemicals.”  Using a number of factors such as volume in commerce and extent of public exposure, DTSC would then prioritize products containing those chemicals.  Entities responsible for commercial introduction of the highest priority products, the so-called “Priority Products,” would be required to perform an alternatives assessment to determine whether a viable safer alternative is available.  The alternative ultimately selected would inform DTSC’s regulatory response, which could range from no action to sales prohibitions.

The proposed regulations represent a paradigm shift in the regulation of chemicals and products, having significant implications for all members of a product’s value chain.  The process for identifying Priority Chemicals and Priority Products is complicated and information-intensive.  Products undergoing an alternatives assessment will require a substantial resource commitment.  To help ensure compliance, reduce the risk of reputational harm, maintain market presence, and potentially identify new opportunities, companies will need to understand the process, closely monitor future DTSC pronouncements and be prepared to respond appropriately.

Companies placing products into the stream of commerce in California that have not yet reviewed the proposed regulations are probably doing so now.  Although many industry representatives actively participated in the collaborative drafting process, many more did not, mistakenly believing that their products were not “consumer products” and therefore would not be affected.  The reality is that only a limited universe of products is excluded from the definition of consumer product or otherwise eligible for some type of exemption.

Public comments on the proposed regulations are due on November 1, 2010, the same date as the public hearing on them.  DTSC intends to complete the formal rulemaking process by the end of 2010, as required by statute.  A copy of the proposed regulations, a set of Frequently Asked Questions, a conceptual flowchart, and other information is available here.

Readers that are familiar with the previous draft of the regulations may be interested in the type of changes that DTSC incorporated into the current proposal.  DTSC claims that the changes:

  • Address criticism that the initial scope of chemicals list was too narrow.  DTSC has significantly broadened the proposed scope by expanding the lists of authoritative bodies that could be consulted for establishing the Priority Chemicals list.
  • Respond to concerns that the previous draft regulation’s lack of deadlines could cause unintended delays.  Proposed deadlines are now included for both chemicals and products lists along with specific timelines for various regulatory steps.  (These are set out in more detail below.)
  • Additionally, DTSC has added a tiered process for alternative assessments intended to reduce the time for identifying safer alternatives and provide more specific performance targets to move manufacturers through the regulatory process.
  • Address comments regarding the complexity of the process.  DTSC has simplified the process somewhat and clarified what information would be required and how it would be submitted.
  • Respond to requests to have public comments on regulatory actions.  DTSC now proposes to allow public comment on any regulatory responses that are triggered by a DTSC ruling or determination.

The proposed regulations include the following deadlines:

  • The proposed initial list of Chemicals under Consideration must be issued for public review and comment no later than June 1, 2011;
  • The final initial list of Chemicals under Consideration must be issued no later than March 1, 2012;
  • The proposed initial list of Priority Chemicals must be issued for public review and comment no later than July 1, 2012;
  • The proposed initial list of Products under Consideration must be issued for public review and comment no later than March 1, 2013;
  • The proposed initial list of Priority Products must be issued for public review and comment no later than September 1, 2013;
  • The final initial list of Priority Products must be issued no later than December 1, 2013.

Future postings may delve further into various aspects of the proposed regulations, as well as review public comments that are submitted to DTSC.

EPA Issues Proposed TSCA IUR Modifications Rule

TSCA:

On August 13, 2010, the Environmental Protection Agency (EPA) published a notice in the Federal Register, proposing to modify the Inventory Update Reporting (IUR) rule.  For readers less familiar with the IUR, this is a rule established under section 8(a) of the Toxic Substances Control Act (TSCA).  It enables EPA to collect, and then make public, critical information on the manufacture (including import), processing, and use of certain chemicals listed on the TSCA Chemical Substances Inventory.  This includes current information on volumes of chemical production, manufacturing facility data, and how the chemicals are used.  EPA uses this information to help identify and, when necessary, manage potential risks that some chemicals may pose to human health or the environment.

The proposed rule includes a number of important changes that will impact industry.  Among these include: requiring electronic reporting; increasing the reporting frequency; requiring process and use information for substances over 25,000 pounds; changing the method for determining whether the reporting threshold has been exceeded; replacing the “readily obtainable” reporting threshold with “reasonably ascertainable” for processing and use information; and requiring submission of production volume information for all years in between reporting periods. 

EPA intends to issue the final rule in advance of, and have it apply to, the 2011 submissions.  That submission period runs from June 1, 2011 through September 30, 2011.  Reporting companies are closely monitoring this development to ensure compliance with the requirements EPA ultimately adopts.  Comments must be received on or before October 12, 2010.

EPA states that it is modifying the rule to meet four primary goals:

  • To tailor the information collected to better meet the Agency’s overall information needs;
  • To increase its ability to effectively provide public access to the information;
  • To obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and
  • To improve the usefulness of the information reported.

The changes the Agency is proposing to meet these goals are discussed in further detail below.

I.      General Reporting Changes

  • The reporting frequency would be increased.  Reporting would return to its previous four-year cycle, making the first post-2011 submission due in 2015.  EPA also requested comment on whether to require a different reporting frequency. 
  • The method would change for determining whether a report was required. 
    • In general, an IUR report would be required for any post-2011 submission whenever a non-exempt chemical is manufactured or imported in volumes of 25,000 lbs. or more at any single site owned or controlled by the manufacturer in any calendar year since the last principal reporting year.
    • EPA also requested comment on whether alternative methods would provide an equally accurate picture of chemical production, and whether more frequent reporting on a limited set of chemicals would be more appropriate.
    • However, the 25,000 lb. threshold would eliminated for reporting on chemicals subject to a rule promulgated pursuant to TSCA sections 5(a)(2), 5(b)(4) or (6), subject to a TSCA section 5(e) or section 5(f) order, or that is the subject of relief granted in a civil action under TSCA sections 5 or 7.  EPA also requested comment on whether chemicals included in a proposedrule under sections 5(a)(2), 5(b)(4), or 6 should be part of this group as well, and whether a de minimus reporting threshold should set for the group.
    • EPA also requested comment on changing the applicability threshold from 25,000 lbs. to 10,000 lbs.
  • Electronic reporting, using reporting software and the internet, would be required for preparation and submission of all IUR information.  Paper reporting and submitting reports as files on electronic media (e.g., CD-ROM) would no longer be allowed.
  • The requirements concerning assertion of claims of confidential business information (CBI) and EPA’s response to such claims would be changed.
    • EPA would release publicly chemical identity information without notice to the reporting company for those chemicals already on the public portion of the TSCA Inventory.
    • Substantiation would need to be provided up front for processing and use information; otherwise, the Agency would not consider the information confidential and would make it publicly available without notice to the reporting company.
    • EPA would disallow confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable.”
    • EPA would consider the name and site identity to be separate items, requiring separate claims and substantiation for each.

II.      Reporting of Manufacturing Information

  • More manufacturing (and importing) data elements would reported, such as:
    • The name of the ultimate domestic parent company, making the IUR report consistent with the Toxic Release Inventory (TRI) reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA);
    • The current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, would be required as part of the chemical identity;
    • Production volume for each year since the previous principal reporting year (i.e., 2005), rather than just the principal reporting year;
    • The production volume of a manufactured (including imported) chemical used at the reporting site;
    • Whether an imported chemical is physically at the reporting site;
    • The production volume of the chemical directly exported and not domestically processed or used; and
    • Whether a manufactured chemical, such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked.

III.      Reporting of Processing and Use Information

  • The threshold would change for reporting processing and use information.  The current 300,000 lb. threshold would be eliminated.  Companies submitting Parts I and II of Form U would also complete Part III.  EPA also requested comments on whether stakeholders disagree and believe that there should be a threshold for this information. 
  • The standard for reporting would be changed from reporting of all information “readily obtainable” to the “known to or reasonably ascertainable to the submitter” standard that applies to the other information reported on Form U.
  • The list of industrial function categories for the reporting of processing and use information would be revised and the five-digit North American Industrial Classification System (NAICS) codes would be replaced with 48 Industrial Sectors (IS), and entries of “other” would be required to include a written description of the use.
  • Reporting on consumer and commercial product categories would be changed.
    • Companies would have to distinguish between consumer and commercial product categories, or indicate if both are relevant.
    • The consumer and commercial product categories would be revised and expanded for consumer and commercial use information, and an explanation would be necessary with the “other” product category is selected.
    • Reporting on the number of commercial workers potentially exposed to the chemical would be required.
  • EPA requested comments on potentially changing the IUR reporting requirements in the future to parallel exposure reporting required on new chemicals via the pre-manufacture notification (PMN), thereby allowing more quantitative exposure assessment, and whether such detailed information might be collected through the IUR, a new reporting mechanism under TSCA Section 8(a), or through the use of TSCA Section 11(c) subpoena authority.
  • EPA also requested comments on whether processors should be subject to future exposure-related reporting.

IV.    Other Proposed Changes

  • Definitions would be adopted or revised to address toll manufacturing, portable manufacturing, and other past reporting challenges.  Among these include: 
    • “Manufacture” would be revised to include production under a toll arrangement and the manufacturing entity and the entity contracting for such service would both be defined as the “manufacturer” and thus, responsible for filing an IUR, although only one report need be filed.
    • “Site” would be revised to address toll manufacturing, portable manufacturing, and importation.  Specifically, the new definition would make the place of production under a toll agreement the “site” for purposes of IUR reporting.  The distribution center would be designated as the “site” for manufacture in portable manufacturing units.  Lastly, the location of an importer’s headquarters in the United States, the location of an operating unit in the United States, or, if neither of those locations exists, the address of the agent in the United States authorized to accept service of process would be designated as the “site.”
  • Several chemicals would receive expanded exemptions and others would be deemed ineligible for exemptions:
    • Manufactured water, water from petroleum streams, and the three polymers that are currently partially exempt from the IUR requirements would be completely exempted; and
    • Chemicals for which an enforceable consent agreement (ECA) to conduct testing has been made would be ineligible.
  • Responding to questions and issues that have arisen concerning byproduct reporting; EPA developed and requests comments on draft guidance for such reporting.

V.      Concluding Thoughts

EPA’s proposed changes move the Agency closer to meeting its stated goals.  They should help resolve many of the difficulties it encountered using the information received in the last IUR reporting cycle.  The limitations and requirements on the protection of CBI are not surprising given the Agency’s stated interest in expanding public access to information on chemicals.  Nonetheless, it is clear that the proposed changes will increase industry’s reporting burden and place more confidential business information at greater risk of public disclosure. 

Reminder: Upcoming California DTSC Symposium on Life Cycle Analysis

Green Chemistry:

This evening the California Department of Toxic Substances Control (DTSC) circulated the following announcement, reminding interested persons about the upcoming symposium on life cycle analysis.

“DTSC invites you to the Life Cycle Analysis: 101 Brown-Bag Symposium, taking place on Thursday, Sept. 23, 2010. This session looks at real-world examples of life cycle analysis (LCA) and how it affects product formulation, decision analysis and business practices. Presenters from HP, P&G, PE Americas and UCLA will share their front-line experiences of developing protocol and collaboration to successfully complete LCAs.

The symposium takes place in the Elihu M. Harris Building in Oakland, from 10:30 a.m. to 3 p.m. Bring a lunch and plenty of questions for our presenters. Register (http://www.dtsc.ca.gov/LCA_symposium.cfm) to attend in person or participate via webcast.”

EPA Grants TSCA Section 21 Petition on Cadmium

TSCA/CPSIA/FHSA:

On August 30, 2010, EPA granted a citizen’s petition filed under section 21 of the Toxic Substances Control Act (TSCA) requesting Agency action on cadmium and cadmium compounds.  Empire State Consumer Project, the Sierra Club, the Center for Environmental Health, and Rochesterians Against the Misuse of Pesticides filed the petition on May 28, 2010.  The petitioners wanted the Consumer Product Safety Commission (CPSC) to act to protect children against cadmium present in toy jewelry, but if the CPSC did not act, they wanted EPA to take action under TSCA.  The petitioners argued that analysis of Chinese imports strongly suggested that cadmium was being used in toy jewelry as a cheap substitute for lead, which is now strictly regulated by the CPSC.  The petition followed several recalls ordered by the CPSC and numerous warnings to Chinese exporters and others.

The Petition

The petition demanded that CPSC take several actions, including: (1) classifying as a banned hazardous substance under sections 2 and 3 of the Federal Hazardous Substance Act (FHSA) toy metal jewelry containing cadmium above trace amounts, thereby requiring manufacturers, importers, and processors to test and certify their products under the Consumer Product Safety Safety Improvement Act of 2008 (CPSIA); (2) revising the test method, if the cadmium limit is to be based on the amount that can be extracted, to better reflect usage scenarios; and (3) using its participation on the Interagency Testing Committee (ITC) established under TSCA to request EPA’s immediate adoption of testing and reporting methods, if CPSC believes that it lacks sufficient information on the extent of cadmium in children’s products or needs additional information to determine the appropriate limit for cadmium in those products.

The petition also sought specific EPA actions, including: (1) requiring health and safety data reporting for cadmium and cadmium compounds under section 8(d) of TSCA; and (2) issuing under section 6 a rule setting limits on cadmium and cadmium compounds in toy jewelry.   The section 8(d) rule was to apply to producers, importers, and processors of cadmium and cadmium compounds reasonably likely to be incorporated into consumer products.  Petitioners demanded that EPA seek lists and/or copies of the following types of ongoing and completed health and safety studies:

a.   epidemiological or clinical studies;
b.   studies of occupational exposure;
c.   health effects studies;
d.   ecological effects studies; and
e.   environmental fate studies (including relevant physicochemical properties).

The Agencies Respond

On August 19, 2010, the CPSC published a Federal Register notice, requesting public comments on the petition.  The public comment period closes October 18, 2010.  Many observers anticipate CPSC’s eventual adoption of restrictions on cadmium in certain consumer products, including metal toy jewelry.

EPA is further along in responding to the petition.  In a letter, dated August 30, 2010, EPA Assistant Administrator Steve Owens agreed to have EPA issue a TSCA Section 8(d) rule regarding cadmium and cadmium compounds used in consumer products, especially metal toy jewelry.  The rule will require reporting by producers, importers, and processors of cadmium and cadmium compounds that are reasonably likely to be incorporated into consumer products.   He also indicated that the Agency is willing to consider banning or restricting the metal if the CPSC does not address consumer uses of cadmium; however, the Agency has not used its section 6 authority in many years and it is unlikely to need to do so in light of anticipated CPSC action.

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Check back occasionally for additional posts concerning the evolving debate over the appropriate regulation of cadmium and cadmium compounds.

EPA Requests Comments on Its Role in Advancing Sustainable Products

Pollution 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:

  • Assembling information and databases.
  • Identifying sustainability ‘‘hotspots’’and setting product sustainability priorities.
  • Evaluating the multiple impacts of products across their entire life cycle.
  • Defining criteria for more sustainable products.
  • Generating eco-labels and/or standards.
  • Establishing the scientific foundation for these eco-labels and/or standards.
  • Verifying that products meet standards.
  • Stimulating the market.
  • Developing end-of-life management systems (reuse, recycling, etc.).
  • Measuring results, evaluating programs.

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

Green 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

ATSDR:

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

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.

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Follow the Green Chemistry Law Report for future updates on EPA’s contemplated actions for these chemicals.