EPA Proposes Significant New Use Rules for 37 Chemicals and Nanomaterials

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TSCA/SNUR/Nanotechnology:

Background

Continuing its robust exercise of its expansive TSCA authority, EPA last week released proposed Significant New Use Rules (“SNURs”) under TSCA for 37 chemicals, including 14 nanoengineered carbon compounds. The SNURs cover a wide range of uses, including the manufacture, processing, and import of adhesives, coatings, colorants, lubricants, chemical intermediates, etc., and result from premanufacture notice (“PMN”) submissions from as long ago as 2000. For almost half of the affected chemicals, the SNURs essentially codify protective measures already required under existing consent orders; the rest are largely based on PMN use scenarios.

EPA has already determined that 17 of the substances addressed by the proposed rule “may present an unreasonable risk of injury to human health or environment” and thus are subject to risk-based consent orders under TSCA § 5(e). The proposed SNURs for these substances adopt certain safety precautions already required by the consent orders. For example, for certain chemicals, workers would be required to wear specified respirators unless air monitoring shows that the substance is actually present in concentrations lower than the New Chemical Exposure Limit (“NCEL”). The NCEL provisions, already incorporated in the § 5(e) consent orders, were established by EPA “to provide adequate protection to human health” and modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs). Users who wish to pursue the NCEL alternative to the respirator requirement would have to request permission to do so under 40 CFR § 721.30 (“EPA approval of alternative control measures.”) EPA anticipates approving such requests under the same conditions already present in the consent orders.

The other 20 substances covered by the new SNURs are not subject to § 5(e) consent orders. These “non-5(e) SNURs” cover certain changes from the use scenarios described in the PMNs which could result in increased exposure, per 40 CFR § 721.170(c)(2).

In addition to personal protective equipment, the SNURs impose various standard use restrictions on the chemicals, such as prohibiting manufacture in the U.S., limiting use to conditions specified in existing consent orders, and banning release to water. EPA also recommends various types of toxicity testing to better characterize the new chemicals’ environmental effects.

Regulatory actions flowing from SNURs

Upon promulgation of the SNURs, any users of the affected substances will be required to determine whether they must submit a Significant New Use Notification (“SNUN”) to EPA 90 days prior to engaging in one of the designated “new uses.” On receipt of the SNUN, EPA may take further regulatory action under TSCA § 5(e), 5(f), 6 or 7, or otherwise publish a notice in the Federal Register explaining its reasons for not taking action.

In addition, EPA’s proposal of the SNURs triggers export notification requirements under TSCA § 12(b). Any exporter or intended exporter of the affected chemicals must notify EPA of the first export or intended export to a particular country, unless the substance is present at certain low concentrations that qualify for the de minimus exemption. If and when the SNURs are finalized, importers of the affected substances must also certify their compliance the SNURs.

EPA is accepting comments on the proposed SNURs through April 26, 2013.

Naming nanoscale materials and other CBI concerns

In the proposed SNURs, EPA identifies nanoengineered carbon compounds based on generic structural terms in order to protect the confidential chemical identities of the substances. EPA uses terms like, for example, “single-walled carbon nanotube” (or “SWCNT”), along with PMN numbers to identify the substances for inclusion in the TSCA Inventory.

The nomenclature developed by EPA is further described in a document, “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature,” which should be available soon under the docket number EPA–HQ–OPPT–2012–0727. It is likely to be similar to or the same as the identically-named document published with the SNUR finalized in 2011 for a substance named as “multi-walled carbon nanotubes.”

If an intended user is uncertain whether its chemicals are subject to the new SNURs, EPA advises contacting the agency or obtaining a written determination under the bona fide procedures in 40 CFR § 721.11. Since production volume limits and certain other uses detailed in the proposed SNURs may also be claimed as CBI, users may not know whether their intended production volumes constitute a significant new use. The bona fide procedures also apply to such cases. If, after evaluating detailed submissions on the intended use, EPA finds that the user has a bona fide intent to manufacture, produce, or import the substance, the agency will advise whether the intended use would qualify as a significant new use.

EPA Announces FIFRA/TSCA Settlements with Finland-Based Kemira Group

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TSCA/FIFRA Enforcement:

EPA continues to steadily increase its enforcement of U.S. chemical control laws.  Last Thursday, the EPA announced settlements with two subsidiaries of the Finland-based Kemira Group to resolve alleged violations of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substance Control Act (TSCA). Kemira Chemicals agreed to pay a civil penalty of over $300,000 to settle claims that the company sold and distributed unregistered and misbranded pesticides, and violated pesticide production reporting requirements. Kemira Chemicals also agreed to correct the alleged violations.

In addition, Kemira Water Solutions agreed to pay a civil penalty of over $500,000 regarding violations of TSCA’s Inventory Update Reporting (IUR) rule during the 2006 reporting period. Under the IUR rule, manufacturers and importers of substances included on the TSCA Chemical Substances Inventory must report the production volume and location of each facility processing such chemicals; this information is used to develop risk-screening and assessment. EPA discovered Kemira Water Solutions’ reporting violations following a January 2012 inspection and the company has since submitted the required information.

EPA Removes 16 Chemicals from HPV 'Orphan' List

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TSCA:

On December 19, 2012, the Interagency Testing Committee (ITC) recommended to EPA that 16 High Production Volume (HPV) Challenge Program orphan chemicals be removed from the TSCA Section 4(e) Priority Testing List.  (Federal Register notice available here.)   The chemicals are listed below. The ITC determined that appropriate actions have been taken to evaluate the hazardous potential of these chemicals.  Public comments are due January 18, 2013.

CAS No.

Chemical Name

ITC Report

Removal Rationale

62-56-6

Thiourea

55

EPA NPRM

81-16-3

1-Naphthalenesulfonic acid, 2-amino-

55

55 OECD SIDS

84-69-5

1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester

55

EPA NPRM

91-68-9

Phenol, 3-(diethylamino)-

55

Sponsored chemical

110-18-9

1,2-Ethanediamine, N1,N1,N2,N2-tetramethyl-

55

Sponsored chemical

119-33-5

Phenol, 4-methyl-2-nitro-

55

OECD SIDS program

121-69-7

Benzenamine, N,N-dimethyl-

55

Sponsored chemical

131-57-7

Methanone, (2-hydroxy-4-methoxyphenyl)phenyl-

55

EPA NPRM

870-72-4

Methanesulfonic acid, 1-hydroxy-, sodium salt (1:1)

55

EPA NPRM

6473-13-8

2-Naphthalenesulfonicacid, 6-[2-(2,4-diaminophenyl)diazenyl]-3- [2-[4-[[4-[2-[7-[2-(2,4-diaminophenyl)diazenyl]-1-hydroxy-3-sulfo-2-naphthalenyl]diazenyl]phe nyl]amino]-3-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:3)

55

EPA NPRM

28188-24-1

Octadecanoic acid, 1,1′-2- (hydroxymethyl)-2-[[(1- oxooctadecyl)oxy]methyl]- 1,3-propanediyl ester

55

EPA NPRM

61788-44-1

Phenol, styrenated

56

Sponsored chemical

68334-01-0

Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products

55

Sponsored chemical

68457-74-9

Phenol, isobutylenated methylstyrenated

56

Sponsored chemical

68915-39-9

Cyclohexane, oxidized, aq. ext., sodium salt

55

Analog to CAS No. 68915-38-8

90640-80-5

Anthracene oil

55

OECD SIDS program

CRS Report Published on Chemical Regulation Issues for 113th Congress

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TSCA Reform:

Last week, the Congressional Research Service (“CRS”) released a new report previewing chemical regulation issues for the 113th Congress. According to CRS, lawmakers are likely to prioritize legislative priorities that languished in the last Congress, like bills that would require increased public disclosure of chemicals used in hydraulic fracturing as well as a proposal to broadly reform the Toxic Substances Control Act (“TSCA”).

Legislative TSCA reform efforts are already under way; in a January 4, 2013 statement on EPA’s release of its TSCA Work Plan draft risk assessments, Sen. Frank Lautenberg emphasized the continuing need to pass TSCA reform. A long-time advocate of TSCA reform, Sen. Lautenberg promised that he would re-introduce his Safe Chemicals Act. Last summer, the Safe Chemicals Act was successfully reported out of the Senate Committee on Environment and Public Works but failed to win Republican support and never reached a floor vote. Sen. David Vitter is reportedly preparing a competing TSCA reform bill for the new Congress as well.

CRS also highlighted scientific integrity issues that have been raised in recent years, such as the compositional balance of EPA’s Scientific Advisory Board and the need for reforming the agency’s Integrated Risk Information System (“IRIS”) for conducting chemical risk assessments. Legislators may also pick up where the 112th Congress left off on exempting the regulation of certain pesticide applications under the Clean Water Act. In addition, Congress may amend existing statutes to implement three U.S.-signed treaties on the reduction of persistent organic pollutants (“POPs”). In appropriations activity, CRS reported that Congress is expected to revise parameters for grants that address lead paint hazards in older homes, a program which is generally funded at over $100 million.

EPA Releases First Set of Draft Risk Assessments Under Existing Chemicals Work Plan Effort

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On January 4, EPA  released for public comment draft risk assessments, for particular uses, on five chemicals found in common household products. The draft risk assessments were developed as part of the agency’s Toxic Substances Control Act (TSCA) Work Plan, which identified common chemicals for review over the coming years to assess any impacts on people’s health and the environment. Following public comment, the agency will seek an independent, scientific peer review of the assessments before beginning to finalize them in the fall of 2013.

“The draft risk assessments released today for public review and comment highlight the agency’s ongoing commitment to ensure the safety of chemicals we encounter in our daily lives,” said James J. Jones, acting assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention. “The public and scientific peer review will ensure use of the best science to evaluate any impacts of these substances on people’s health and the environment.”

The five assessments address the following chemical uses: methylene chloride or dichloromethane (DCM) and n-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a synergist in halogenated flame retardants; and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products. The draft assessments focus either on human health or ecological hazards for specific uses which are subject to regulation under TSCA. Three of the draft risk assessments— DCM, NMP, and TCE— indicate a potential concern for human health under specific exposure scenarios for particular uses. The preliminary assessments for ATO and HHCB indicate a low concern for ecological health.

EPA recommends the public follow product label directions and take precautions that can reduce exposures, such as using the product outside or in an extremely well ventilated area and wearing protective equipment to reduce exposure. If EPA concludes in finalizing the risk assessments that there is a potential for concern, the agency will take action as appropriate to address possible risks.

The draft assessments were undertaken as part of EPA’s efforts to identify chemicals for review under the TSCA Work Plan, which EPA released in March 2012. At that time, EPA identified 83 chemicals as candidates for review over the coming years and outlined the data sources and other information the agency would use in the reviews. This initiative is part of EPA’s comprehensive approach to enhance the current chemicals management program within the limits of existing TSCA authorities. EPA continues to support updating TSCA to strengthen and modernize the law.

Additional information on the TSCA Work Plan effort and the specific draft risk assessments can be found at: http://www.epa.gov/oppt/existingchemicals/pubs/workplans.html

 

EPA finalizes withdrawal of TSCA § 8(d) reporting rule for cadmium

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TSCA:

As we previously reported, EPA announced that it would withdraw its TSCA § 8(d) final rule requiring manufacturers of cadmium or cadmium compounds to report certain unpublished health and safety studies. Today, EPA released the pre-publication version of the final rule withdrawing the December 3, 2012 reporting rule. The reporting rule for cadmium was withdrawn due to “significant confusion…in certain industrial sectors subject to the final rule,” including uncertainty about which industries were subject to the rule.

EPA’s action today is based on the agency’s conclusion that the commenters’ concerns constitute good cause to withdraw the reporting rule without prior notice and comment per the Administrative Procedures Act. Likewise, because the withdrawal does not impose any new requirements, EPA found that the action is not subject to any Executive Orders (such as E.O. 12866, “Regulatory Planning and Review”), nor is it subject to the requirements of the Regulatory Flexibility Act or Title II of the Unfunded Mandates Reform Act. Per the Congressional Review Act (“CRA”), EPA will submit the withdrawal document along with other required information to Congress and the Comptroller General. Following section 808 of the CRA, the withdrawal rule will take effect early, on January 2, 2013.   A draft copy of the Federal Register notice is available here:  Prepublication_Cadmium-FRM-Withdrawal_2012-12-20[1].

EPA Withdraws Immediate Final TSCA 8(d) Rule for Cadmium

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TSCA:

On Friday, December 14, Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention and Toxics (OPPT), announced the U.S. Environmental Protection Agency’s (EPA) decision to withdraw the Toxic Substances Control Act (TSCA) section 8(d) immediate final rule published on December 3, 2012.  In its announcment the agency said: “Based on several letters asking questions and raising concerns about the scope and extent of the immediate final rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule, EPA has decided to withdraw the immediate final rule.” EPA will announce the withdrawal in the Federal Register, no later than January 2, 2013, the original effective date of the final rule. 

EPA  also said that it “will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children’s metal jewelry.”

More information about this development is available at the agency’s website here.  Information about section 8(d) is available here.

CBO Estimates Senator Lautenberg's TSCA Reform Bill Would Cost $128 Million over the Next Five Years

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TSCA Reform:

On Tuesday, October 2, the Congressional Budget Office published its evaluation of the costs of implementing the amended version of S.847, The Safe Chemicals Act of 2011, which is Senator Lautenberg’s latest attempt to amend the federal Toxic Substances Control Act (TSCA).  Readers will recall that the Senate Committee on Environment & Public Works passed the amended bill on July 25, sending it to the full Senate for a vote.  Our blog post on that version of the bill is available here.

The CBO press release says the following:

“S. 847 would modify the Toxic Substances Control Act (TSCA), the law that regulates the manufacture, importation, and processing of chemicals, with the aim of shifting the burden from the Environmental Protection Agency (EPA) to chemical manufacturers to prove that substances are safe before they enter the marketplace. This new responsibility for chemical manufacturers would be accomplished primarily by increasing the amount of information about chemical toxicity and usage that they would be required to submit to EPA. Enacting this legislation also would require EPA to undertake other activities that would encourage and support the development of safer alternatives to existing hazardous chemical substances.

CBO estimates that implementing this legislation would cost $128 million over the next five years, assuming appropriation of the necessary amounts, as EPA would incur additional administrative costs to meet the new requirements imposed by S. 847.

Enacting S. 847 could affect direct spending and revenues because the bill would increase some existing civil and criminal penalties for violations of TSCA, establish some new civil and criminal penalties for violations related to that act, and authorize EPA to charge fees to chemical manufacturers. Therefore, pay-as-you-go procedures apply to S. 847. CBO estimates that any changes in revenues and direct spending would not be significant.

A copy of the CBO report is available here.

EPA Publishes the Peer Review Plans for the Risk Assessments on the Seven 2012 Work Plan Chemicals

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TSCA:

Today, August 17, 2012, EPA published the Peer Review Plans for the risk assessments on the seven 2012 work plan chemicals. The plans, which form part of the Agency’s Peer Review Agenda, describe the focus of the risk assessment being conducted on each chemical, indicate how peer reviewers will be selected and how the peer review will be conducted, and provide the time line for the reviews. As indicated in the plans, EPA will publish a notice in the Federal Register when the External Review Drafts of the assessments become available, and will provide a 60-day period for public comment on the drafts before the peer review begins. The public will also be able to present comments at the teleconference panel review meetings. You can access and submit comments on the individual peer review plans for each chemical by using the following links:

EPA to Post List of Chemicals Acceptable for DfE-labeled Products

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Design for the Environment (DfE) / Green Chemistry:

EPA’s Design for the Environment (DfE) team announced today that, in September, it will post on the agency’s website a list of chemicals that are acceptable for use in DfE-labeled products.   Questions or comments about the proposal should be submitted to EPA by August 24, 2012.  The contact at DfE is Bridget Williams (williams.bridget@epa.gov).

As readers know, over the years many DfE stakeholders have requested that EPA issue a list of safer chemicals.  According to the agency’s press release, EPA’s intent is for the list to serve as a resource for product formulators and consumers, to increase understanding of the DfE Safer Product Labeling Program and the types of chemicals in DfE-labeled products.  The list is also intended to enhance the dialogue on safer chemicals and products.  

EPA is compiling its list from the ingredients in DfE-labeled products, as well as from chemicals eligible for use in labeled products – i.e., chemicals that meet the DfE criteria. The chemicals will be identified by their specific chemical name and Chemical Abstract Service (CAS) number and grouped by functional class—surfactants, solvents, etc. (chemicals with more than one common functionality may be listed in multiple classes).

A color code will appear next to each chemical to indicate its safer chemical status.  A green circle will appear next to chemicals that have met the DfE component-class criteria; a green/yellow square next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but are missing some experimental data on potential hazards; and a yellow triangle next to chemicals that have met the DfE criteria as adapted for their necessary functional characteristics, but have unresolved hazard profile issues.

No other information about the chemical—not its source, manufacturer, or use; association with a trade name product, percentages in formulation, etc.—will appear in the listing. EPA intends to include on this list the ingredients in third-party formulations sold by manufacturers to DfE participants, and will likewise not associate those ingredients with specific products. Also, no chemicals on the confidential portion of the Toxic Substances Control Act Inventory will be included in the listing.

According to the agency’s press release, the DfE list will complement the Green-Blue Institute’s CleanGredients database (www.cleangredients.org), which will continue to serve as a marketplace for chemicals that are acceptable for use in DfE-labeled products and provide trade name chemicals, physical-chemical and functional properties, hazard information, vendor contacts, and other information.