Chemical Heritage Foundation Posts the Video from its TSCA Reform Event

TSCA/TSCA Reform:

The Chemical Heritage Foundation (CHF) posted the video from its recent event on the federal Toxic Substances Control Act (TSCA), the primary federal statute governing the safety of chemicals in U.S. commerce.  Readers less familiar with CHF should know that it is a Philadelphia-based non-profit that aims to foster an understanding of chemistry’s impact on society.  CHF is currently completing an oral history project on the statute’s evolution from legislative proposal through implementation and now reform.  The project has required CHF to interview various persons, including former EPA officials, responsible for key aspects of that evolution.  The March 3 event, entitled “TSCA: From Inception to Reform, a Public Dialogue,” was an outgrowth of the oral history project.

The event featured a panel of five former administrators in the EPA office responsible for implementing the statute at various times since its enactment in 1976. They included James V. Aidala, Charles M. Auer, Charles L. Elkins, Mark A. Greenwood, and Glenn E. Schweitzer.  Each panelist discussed the statute’s perceived strengths and weaknesses, major accomplishments achieved under it, and some of the ways in which Congress could address the perceived weaknesses in future legislative amendments.  Afterward, they answered questions from the audience.

The event was a terrific success.  For readers unable to attend, more information about CHF, its oral history project, and the video recording are available here.

EPA Denies Protection for Chemical Identities in TSCA 8(e) Reports

TSCA:

As part of EPA’s initiative to increase transparency under the Toxic Substances Control Act (TSCA), on February 10, 2011, the Agency sent a letter to five companies informing them that the identities of 14 chemicals contained in certain health and safety studies were ineligible for protection from public disclosure.  The studies are “substantial risk” reports that the companies submitted to EPA to fulfill their obligations under section 8(e) of TSCA (15 U.S.C. § 2607(e)).  Readers will recall that substantial risk reports disclose information that reasonably supports the conclusion that a chemical substance or mixture (collectively “chemicals”) presents a substantial risk of injury to health or the environment.  EPA reasons that the public has a right to know the identities of chemicals posing such risks.  In contrast, industry frequently contends that disclosure of identities could reveal commercially valuable information about formulations or manufacturing processes.  To stop the disclosure of the identities of its chemicals, a company would need to initiate a legal challenge within 30 days of receiving the Agency’s February letter.

The letters comprise the Agency’s first serious attempt to implement a new transparency policy announced on January 21, 2010.  (The scope of the policy was subsequently expanded in May 2010.)  As announced in January, EPA will deny Confidential Business Information (CBI) protection for the identities of chemicals included in section 8(e) reports when those chemicals are listed on the public version of the TSCA Inventory.  EPA contends that substantial risk reports are a type of health and safety study, as defined under section 3(6) of TSCA (15 U.S.C. § 2602(6)) and the regulations at 40 C.F.R. § 2.306(a)(3).  The Agency also asserts that a chemical’s identity is either part of a health and safety study or the data included within such study, as explained in various TSCA regulations such as those at 40 C.F.R. § 716.3; § 720.3(k).  And because section 14(b)(1) of TSCA (15 U.S.C. § 2613(b)(1)) “does not prohibit disclosure of” health and safety studies (and their data) concerning chemicals offered for commercial distribution, EPA concludes that a chemical’s identity would be eligible for disclosure when it is listed on the public version of the TSCA Inventory and it is the subject of a substantial risk report.

According to EPA’s letter, the chemicals fit squarely within the Agency’s policy.  Each of the chemicals is currently listed on the public version of the TSCA Inventory of “existing” substances.  (The Inventory is EPA’s official list of chemicals that can be lawfully imported or manufactured for commercial distribution without first submitting a premanufacture notice under section 5 of TSCA – the public version lists those chemicals whose identities are not confidential.)  And each of them supposedly was the subject of a substantial risk report.

However, section 14(b)(1) prohibits disclosure of data from health and safety studies when such disclosure would reveal “processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release [would disclose] the portion of the mixture comprised by any of the chemical substances in the mixture.”  These exceptions are designed to prevent the disclosure of trade secrets and other sensitive business information.  EPA’s letter seems to anticipate this objection from the companies, noting “that the [chemical] identity itself, as well as any information that might be derived from it about processes or portions, has already been disclosed” and therefore neither exception applies.

Whether the companies will seek judicial review remains to be seen.  Many challenged CBI claims are withdrawn, and judicial review is expensive.  If the companies seek judicial review, they may challenge EPA’s statutory interpretion or its conclusion that neither disclosure exception applies.  (If a challenge(s) is brought, look for a future blog post discussing the various arguments.)

Regardless of whether there’s a challenge, the Agency’s decision is somewhat controversial – applauded by some and criticized by others.  Unless there’s a successful legal challenge or some other restraint imposed, look for EPA’s continued release of unredacted substantial risk reports and possibly other health and safety studies.  The Agency has clearly signalled its intention to increase the amount of publicly-available information concerning chemical risks.  When balancing commercial interests against environmental and health interests, EPA’s current administration plans to favor the latter at the expense of the former, raising the question:  “Could a better balance be achieved?”  Perhaps – EPA could release the reports with a descriptive generic name in lieu of the chemical’s specific name, a practice the Agency’s used elsewhere under TSCA. 

EPA Requires Testing of 19 High Production Volume (HPV) Chemicals

TSCA/HPV Chemicals:

On January 7, 2011, EPA published a final rule under section 4(a)(1)(B) of theToxic Substances Control Act (TSCA), (15U.S.C. 2603(a)(1)(B)), requiring manufacturers, importers, and processors to test 19 high production volume (HPV) chemicals.  The rule, which takes effect on February 7, 2011, requires these persons to obtain screening level data for health and environmental effects and chemical fate, and then provide that data to the Agency.  The rule is one of a series of actions that EPA is taking to ensure that it has the data necessary to adequately review priority chemicals.  In addition, now that the Agency has issued a final test rule, any person (including those required to test) who exports, or intends to export, any of the 19 chemicals will be subject to the export notification requirements in 40 CFR part 707, subpart D.  The chemicals are listed below:

CAS No.

Chemical Name

75-07-0

Acetaldehyde

78-11-5

1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

84-65-1

9,10-Anthracenedione

89-32-7

1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone

110-44-1

2,4-Hexadienoic acid, (E,E)-

118-82-1

Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)-

119-61-9

diphenylmethanone

144-62-7

Ethanedioic acid

149-44-0

Methanesulfinic acid, hydroxy-, monosodium salt

2524-04-1

Phosphorochloridothioic acid, O,O-diethyl ester

4719-04-4

1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

6381-77-7

D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt

31138-65-5

D-gluco-Heptonic acid, monosodium salt, (2.xi.)-

66241-11-0

C.I. Leuco Sulphur Black 1

68187-76-8

Castor oil, sulfated, sodium salt

68187-84-8

Castor oil, oxidized

68479-98-1

Benzenediamine, ar,ar-diethyl-ar-methyl-

68527-02-6

Alkenes, C12–24, chloro

68647-60-9

Hydrocarbons, C > 4

The 19 chemicals were originally included in the voluntary High Production Volume (HPV) Challenge Program, which “challenged” companies to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities.  HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year.  EPA has determined that HPV chemicals account for approximately 95% of total chemical production in the United States.  As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.  However, no data were provided for the 19 chemicals, making a mandatory test rule necessary.

More information on EPA’s HPV Challenge Program is available here.

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. 

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.

* * * *

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

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.

* * * *

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

EPA Promulgates Direct Final SNURs under TSCA for Seventeen Chemicals

TSCA:

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.

TSCA CBI – New Practices Adopted at EPA While Further Changes Are Debated in Congress

TSCA, TSCA Reform: 

Confidential Business Information (CBI) continues to be a focal point of the debates over improving implementation of the current version of TSCA, as well as amending the statute.  Here’s a short update on where those debates currently stand.

EPA Adopts New Practices under TSCA

On May 27, 2009, EPA announced in a Federal Register notice that the Agency will begin a “general practice” of reviewing CBI claims for chemical identities in health and safety studies and related data, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B.  According to the notice, “Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” If the chemical identity does not clearly reveal mixture portions or process information, EPA is unlikely to find the information eligible for confidential treatment.  EPA will apply its new practice to both newly submitted and existing claims, beginning August 25, 2010. 

Stakeholders supporting or opposing this new practice are likely to submit comments to the Agency in advance of the August implementation.

Congressional Debate over the Bills to Modernize TSCA

Both the Senate and House bills would revise and narrow the protections for CBI.  The bills would require all CBI claims to be justified up front.  EPA would have to review the claims within a prescribed time period.  Only those that withstood the review – applying standards that EPA would adopt within one year of enactment of the legislation – would be eligible for protection.  Approved claims would receive protection for up to five years. 

Similar to the current version of Section 14, the bills would not allow “the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Nonetheless, the chemical industry remains concerned about the negative impact the new CBI provisions would have on innovation, jobs, and the U.S. industry’s general competitiveness.   ICIS reports that the CEOs from 30 different chemical companies planned to meet this past Wednesday with 50 different members of Congress or their staff to discuss the bills, and the CBI provisions concerning chemical identities were on the top of their list of concerns. 

* * * *

Watch for future postings as the debates over CBI evolve.

 

EPA Expands Public Access to Information on Chemicals

TSCA:

On May 17, EPA issued a press release, announcing that it had added more than 6,300 chemicals and 3,800 facilities, regulated under the Toxic Substances Control Act (TSCA), to the public database known as Envirofacts.   The Agency said its action further demonstrated Administrator Lisa Jackson’s commitment to increasing public access to information on chemicals.   

The Envirofacts database is available on EPA’s website.  The database is designed to provide information on facility activities that may affect air, water, and land in the United States.   Included in the database is information such as facility name and address, aerial imagery, maps, and links to other records such as those available on the Agency’s Enforcement Compliance History Online (ECHO) database, which provides inspection and compliance reports.

In the press release, EPA stated that it has conducted a series of efforts to increase public access to chemical information including reducing confidentiality claims by industry and making the public portion of the TSCA inventory available for free on its website.  EPA supposedly intends to take additional actions in the months ahead to further increase the amount of information available to the public.  Additional details regarding EPA’s plans are available here.

I plan to continue following and reporting on EPA’s public-access initiative, as well as the confidential business information (CBI) provisions in the Congressional bills proposing to modify TSCA.  Stay tuned for future postings here at The Green Chemistry Law Report!