EPA Issues Testing Rules and a Significant New Use Rule for HPV Chemicals

TSCA/HPV Chemical Testing:

On October 21, 2011, utilizing its authority under the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601 et seq., EPA published two Federal Register notices announcing testing rules for certain high production volume (HPV) chemicals as well as significant new use rules (SNURs) for other HPV chemicals.  HPV chemicals are those with a production/import volume equal to or greater than 1 million pounds (lbs) per year.  The first notice promulgates a final testing rule for 15 HPV chemicals.  The second notice adopts an innovative approach to regulating HPV chemicals, proposing a testing rule for 23 HPV chemicals and a SNUR for 22 others, along with an alternative proposal to regulate any of the 23 chemicals via a SNUR should public comments indicate a testing rule is unecessary.  Additional details about the rules and the affected chemicals are provided below.

Final Test Rule

The first notice promulgates a final rule under section 4(a)(1)(B) that requires manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemicals.  (As a general matter, only certain manufacturers/importers actually perform testing required under section 4.)  The chemicals are part of the so-called “Third Group of Unsponsored HPV Chemicals (HPV3),” a group of 29 chemicals for which no manufacturer or importer accepted the “challenge” to make publicly available health and environmental effects data under the voluntary High Production Volume Challenge Program launched in 1998.  The rule will be effective on November 21, 2011.

According to EPA, there are insufficient data to reasonably determine or predict the effects on human health or the environment from the manufacture, distribution in commerce, processing, use, or disposal of these chemicals, or from any combination of these activities.  Thus, the Agency concluded that testing is needed.  Data developed under this final rule supposedly will provide EPA with critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate action.

EPA’s action affects more persons than those who are required to perform testing.  Persons who export or intend to export any of the chemicals in any form (e.g., as byproducts, impurities, components of Class 2 chemical substances, etc.) included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D.  Export notification is generally not required for articles, as provided by 40 CFR 707.60(b).  Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical for which the submission of data is required under TSCA section 4 must notify EPA of such export or intent to export.  EPA in turn will notify the government of the importing country of the Agency’s regulatory action with respect to the chemical.

The following chemicals are the subject of this final rule:

CAS

Number

Name

98-09-9

Benzenesulfonyl chloride

98-56-6

Benzene, 1-chloro-4-(trifluoromethyl)-

111-44-4

Ethane, 1,1′-oxybis[2-chloro-.

127-68-4

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)

515-40-2

Benzene, (2-chloro-1,1-dimethylethyl)-

2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)

5026-74-4

2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester

25321-41-9

Benzenesulfonic acid, dimethyl-

52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)

68082-78-0

Lard, oil, Me esters

68442-60-4

Acetaldehyde, reaction products with formaldehyde, by-products from

68610-90-2

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-

72162-15-3

1-Decene, sulfurized

Proposed Test Rule and SNUR

The proposed test rule, adopted pursuant to section 4(a)(1)(B) of TSCA, would require manufacturers, importers, and processors of 23 HPV chemicals to develop screening-level health, environmental, and fate data, based on the potential for substantial exposures of workers and consumers to these chemicals. The proposed significant new use rule (SNUR), adopted pursuant to section 5(a)(2), would require persons to file a “significant new use” notice (SNUN) with EPA prior to manufacturing, importing, or processing any of a separate group of 22 chemicals for (1) use in a consumer product or (2) for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity.  The chemicals are part of the so-called “Fourth Group of Unsponsored HPV Chemicals (HPV4).”  Public comments are due by January 19, 2012.

EPA’s use of two rules is an innovative approach to regulating this group of 45 HPV chemicals.  If successful, the Agency may use the same approach to regulating future HPV chemicals (i.e., those designated HPV in in 2012 and beyond).  According to EPA, it is proposing the two actions together because the Agency believes they are complementary and will best ensure these HPV chemicals are adequately evaluated.  For example, if EPA receives comments on this proposal sufficient to establish that one of the 23 chemicals proposed for testing is not used in a way that meets the substantial exposure criteria in section 4(a)(1)(B), but information received indicates that the chemical meets the criteria for the SNUR, EPA intends to include the chemical in the final SNUR rather than the test rule, without further public notice and comment.  According to the Agency, simply removing such a chemical from the test rule, without including it in the SNUR, would not provide a regulatory mechanism for timely notification to EPA in the event of changed circumstances that would likely justify the issuance of a test rule for the chemical.  EPA also states that, if public comment on these proposed actions is sufficient to establish that any of the uses to be covered for the 22 chemical substances proposed in the SNUR are, in fact, on-going, yet such comments also establish that there is already substantial exposure to the chemical substance, EPA intends to review the status of the chemical and, as warranted, take appropriate steps to promulgate a test rule rather than a SNUR for the chemical.

The 23 chemicals subject to the test rule, and for which the SNUR is an option, are the following:

CAS Number

Name

56-40-6

Glycine

67-72-1

Ethane, 1,1,1,2,2,2-hexachloro-

78-00-2

Plumbane, tetraethyl-

95-14-7

1H-Benzotriazole

118-48-9

2H-3,1-Benzoxazine-2,4(1H)-dione

128-44-9

1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1)

928-72-3

Glycine, N-(carboxymethyl)-, sodium salt (1:2)

1809-19-4

Phosphonic acid, dibutyl ester

25377-73-5

2,5-Furandione, 3-(dodecen-1-yl)dihydro-

26544-38-7

2,5-Furandione, dihydro-3-(tetrapropenyl)-

27859-58-1

Butanedioic acid,2-(tetrapropenyl)-

28777-98-2

2,5-Furandione, dihydro-3-(octadecen-1-yl)-

29385-43-1

1H-Benzotriazole, 6(or75)-methyl-.

32072-96-1

2,5-Furandione, 3-(hexadecen-1-yl)dihydro-

61789-73-9

Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

64665-57-2

1H-Benzotriazole, 6(or7)-methyl-, sodium salt

68131-13-5

Naphthenic acids, reaction products with diethylenetriamine

68153-60-6

Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates

68424-85-1

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

68442-77-3

2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.

68607-28-3

Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides

68909-18-2

Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides

69834-17-9

Benzene, decylphenoxy-

The 22 chemicals subject to the SNUR, and for which a future test rule is an option, are the following:

CAS Number

Name

98-16-8

Benzenamine, 3-(trifluoromethyl)-

100-53-8

Benzenemethanethiol

104-91-6

Phenol, 4-nitroso-

110-03-2

2,5-Hexanediol, 2,5-dimethyl-

124-63-0

Methanesulfonyl chloride

142-30-3

3-Hexyne-2,5-diol, 2,5-dimethyl-

460-00-4

Benzene, 1-bromo-4-fluoro-

542-92-7

1,3-Cyclopentadiene

553-26-4

4,4′-Bipyridine

8007-45-2

Tar, coal

28106-30-1

Benzene, ethenylethyl-

35203-06-6

Benzenamine, 2-ethyl-6-methyl-N-methylene-

35203-08-8

Benzenamine, 2,6-diethyl-N-methylene-

37734-45-5

Carbonochloridothioic acid, S-(phenylmethyl) ester

37764-25-3

Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl-

61789-72-8

Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides

61790-13-4

Naphthenic acids, sodium salts

65996-91-0

Distillates (coal tar), upper

68308-01-0

Tail gas (petroleum), cracked distillate hydrotreater stripper

68478-20-6

Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free.

68526-82-9

Alkenes, C6-10, hydroformylation products, highboiling

68909-77-3

Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. Residues

Similar to the final rule discussed above, EPA’s action affects more persons than those who are required to perform testing or submit SNUNs.  Once the rule became final, exporters of the chemicals subject to the final test rule would be subject to the export notification requirements in section 12(b).  However, exporters of chemicals subject to the proposed SNUR became subject to those requirements upon publication of this proposed rule.

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Readers interested in following EPA’s innovative approach to regulating HPV should look for future posts on this topic, here at the Green Chemistry Law Report.

EPA to Identify Priority Chemicals for Review

Readers interested in EPA chemical risk management efforts may be interested in the Agency’s new initiative to identify priority chemicals for review and possible risk management action under TSCA. This initiative is part Agency efforts to enhance its chemical management program.  The Office of Pollution Prevention and Toxics notes that strengthening EPA’s chemicals management and risk assessment program is an Agency priority. Goals for the chemical prioritization initiative include identification of highest priority chemicals, determination of whether risk is significant, and whether risk management or other action under TSCA is warranted. The Agency plans to release an initial list of priority chemicals by late fall.

To identify candidate chemicals for review, EPA will consider risk-based prioritization factors similar to those used for selecting chemicals on which EPA has recently prepared Chemical Action Plans. Children’s health issues, PBT chemicals, and carcinogens are among the Agency’s highest hazard-based priorities.

The Agency has specifically solicited public input on which prioritization factors should receive greatest consideration. Following this data collection, EPA will refine the list of priority chemicals for review using a broader range of data sources. It has also requested comments on which data sources the Agency should consider to help identify priority chemicals. Potential data sources for both exposure and use-related information and hazard data sources are listed in the Discussion Guide for Identifying Priority Chemicals for Review and Assessment (available here). A web-based discussion forum is available for submitting suggestions. Submissions will be accepted only until 5:00 PM Eastern Daylight Time on September 14, 2011. At a later date this information will also be available in docket, EPA-HQ-OPPT-2011-0516, at http://www.regulations.gov.

EPA stresses that decisions about whether or not a chemical presents a risk to human health or the environment will be made only after review and assessment efforts are completed. That is, identification of a chemical as a priority chemical for review is not an Agency “finding” under TSCA.

The Agency anticipates that the chemicals identified as priority chemicals for review will likely be well-characterized for hazard and have information indicating exposure potential. The discussion guide notes that EPA will continue to use its TSCA information collection, testing, and subpoena authorities, including sections 4, 8, and 11(c) of TSCA, to develop needed information on additional chemicals that currently have less robust hazard or exposure databases.

A webinar describing this effort was conducted September 7, 2001. The slides presented during that program are available here.

More Information on EPA’s efforts to Identify Priority Chemicals for Review available here.

General information on EPA’s Enhancing EPA’s Chemical Management Program available here.

Information on EPA Development of Chemical Action Plans available here.

EPA Publicly Discloses More Chemical Identities Claimed Confidential under TSCA

TSCA/CBI:

On June 8, 2011, EPA announced the public disclosure of the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential under the Toxic Substances Control Act (TSCA).  For those 104 studies, the chemical identity will no longer be redacted, or kept from public view.  According to EPA, the chemicals at issue are used in dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead.  This latest development is another demonstration of EPA’s commitment to increasing transparency under the Toxic Substances Control Act (TSCA) by making publicly available more information about chemical hazards.

Readers will recall that, in 2010, EPA challenged industry to declassify voluntarily unwarranted claims of confidential business information (CBI).  EPA also issued new guidance outlining plans to deny CBI claims for chemical identity in health and safety studies under TSCA.  Based on this guidance, EPA notified a number of companies in February 2011 that it had determined that their CBI claims were not eligible for confidential treatment under TSCA and that EPA intended to make the information public.  (See related posts here and here.)   The health and safety studies included in the lastest disclosure  include some declassified by EPA and other voluntary declassifications by companies in response to EPA’s challenge.

In addition to these actions, EPA over the past several months has taken a number of other steps to make chemical information more readily available.  EPA provided the public, for the first time ever, with free access to the consolidated TSCA Inventory on the EPA and Data.Gov websites.  EPA also launched a new chemical data access tool that gives the public the ability electronically to search EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals that they may come in contact with every day. (See related post here.)  More information about EPA’s transparency initiative under TSCA is avaialble here.

New EPA Rule for Carbon-Nanotubes

Readers engaged in nanomaterial applications may be interested in EPA’s new Significant New Use Rule (SNUR) for multi-walled carbon nanotubes (MWCNTs). Enterprises wishing to manufacture, import, or process MWCNTS are now potentially subject to Significant New Use Notice (SNUN) regulatory procedures which include the submission of ‘appropriate’ health and safety data. This rule is incorporated into the Code of Federal Regulations at 40 CFR § 721.10183.

EPA evaluation of MWCNTs, and carbon nanotubes generally, has established that exposure may cause lung effects (pulmonary toxicity, fibrosis, carcinogenicity), immunotoxicity, and mutagenicity. More information on toxicological effects is reported in the Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes (available in the MWCNT SNUR Docket).

EPA recommends SNUNs provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substance.
  • Potential benefits of the chemical substance.
  • Information on risks posed by the chemical substance compared to risks posed by potential substitutes.

EPA notes that upon review of a SNUN, the Agency has the authority to require additional testing. Any manufacturers, importers, or processors who intend to conduct testing or submit a SNUN are encouraged to contact EPA to determine ‘appropriate’ testing methods. Substantial detail about this and other governing TSCA provisions is provided in the FR notice (76 FR 26186 (available in the MWCNT SNUR Docket)). More information on SNUN requirements generally is available here and information on requirements for test data is available from EPA and the ACC.

This SNUR is specific to MWCNTs of a specific structure. However, confidentiality claims preclude a more detailed description of the identity of this MWCNT. To determine whether a specific CNT, MWCNT, or single-wall carbon nanotube is on the TSCA Inventory, manufacturers should submit a bona fide intent to manufacture or import to EPA.

Exempt from the rule are MWCNTs that are completely reacted (cured), incorporated or embedded into a polymer matrix that itself has been reacted (cured), or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

EPA Publishes Chemical Action Plans For Diisocyanate Compounds

TSCA:

On April 13, 2011, EPA published chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI) and related compounds.  According to EPA, diisocyanates are well known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. Worker exposures are already subject to protective controls in occupational settings, but EPA is concerned about potential health effects that may result from exposures to the consumer or self-employed worker while using products containing uncured (unreacted) MDI, TDI, and their related polyisocyanates (e.g., spray-applied foam sealants, adhesives, and coatings) or incidental exposures to the general population while such products are used in or around buildings including homes or schools. 

The Agency is proposing a number of regulatory actions under the Toxic Substances Control Act.  These include promulgation of significant new use rules (SNURs) under Section 5(a)(2) for TDI and its related polyisocyanates in consumer products; Section 4 test rules requesting certain exposure monitoring; reporting and data call-ins under Section 8(c) and 8(d); and certain restrictions adopted pursuant to Section 6.  The chemical action plan for MDI and related compounds is available here.  The plan for TDI and related compounds is available here

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.

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