Tag Archive for: TSCA

EPA Proposes Significant New Use Rules for 37 Chemicals and Nanomaterials

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

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

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

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

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

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

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.

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

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

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.

EPA Proposes TSCA SNUR for Certain Perfluorinated Chemicals

TSCA:

On August 8, 2012, EPA signed a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) to:

  • Require companies to report 90 days in advance of all new uses of long-chain perfluoroalkyl carboxylic (LCPFAC) chemicals as part of carpets or to treat carpets, including the import of new carpet containing LCPFACs;
  • Add seven perfluoroalkyl sulfonate (PFAS) chemicals to the existing PFAS SNUR (40 CFR 721.9582), and amend that SNUR to include “processing” in the definition of significant new use for PFAS chemicals.

The following is a link to the pre-publication copy of the proposed SNUR:

http://www.epa.gov/oppt/pfoa/pubs/PrePublication_LCPFC-SNUR_NPRM_2012-08-07.pdf

Comments on the proposed SNUR are due 60 days after the SNUR is published in the Federal Register. For more information, see EPA’s website

TSCA Fines Announced

EPA issued a News Release Monday July 23 announcing fines for violations of TSCA’s recordkeeping and reporting requirements.

The announcement details the following settlements:

  • Haldor Topsoe, Inc., paid $202,779 to settle a complaint that it had violated the 2006 IUR rule for 13 chemical substances.
  • Chemtura Corporation paid $55,901 to settle a complaint that its El Dorado, Arizona facility failed to report two chemicals pursuant to the 2006 IUR rule.
  • Bethlehem Apparatus Company paid a $103,433 to settle a complaint that it had failed to comply with import certification and export notification requirements, and that if also failed to meet 2006 IUR requirements for one chemical substance.

See below for the full News Release.

WASHINGTON – The U.S. Environmental Protection Agency (EPA) has issued complaints seeking civil penalties against three companies for alleged violations of the reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA). The alleged violations involved the companies’ failure to comply with EPA’s TSCA section 8 Inventory Update Reporting (IUR) regulations, which require companies to submit accurate data about the production and use of chemical substances manufactured or imported during a calendar year. Under TSCA, penalties can be assessed up to $37,500 per day, per violation.

Formerly known as the IUR, the TSCA Chemical Data Reporting Rule requires the collection of information about existing chemicals on the market by requiring periodic reports about the production and use of chemicals to help understand the risks they may pose to human health and the environment. The data collected by EPA is the most comprehensive source of information for chemicals currently in commerce in the U.S.

The reporting deadline for the 2006 IUR rule ended in March of 2007. EPA’s enforcement efforts have led to 43 civil enforcement actions and approximately $2.3 million dollars in civil penalties against companies that failed to report required chemical data information. The reporting deadline for the 2012 submission period of the Chemical Data Reporting Rule is August 13, 2012.

The three most recent cases are against Chemtura Corporation, Bethlehem Apparatus Company, and Haldor Topsoe, Inc., and resulted in penalties totaling $362,113.

The Chemtura Corporation is headquartered in Philadelphia, Pa. and has a facility located in El Dorado, Arizona. In a May 31, 2012 complaint, EPA alleged that the facility failed to report two chemicals pursuant to the 2006 IUR rule and assessed a penalty of $55,901. The company corrected the violations, paid the penalty and a final order was issued by the Environmental Appeals Board (EAB) on June 25, 2012.

During an inspection of the Bethlehem Apparatus Company, located in Hellertown, Pa., EPA found that the facility was in violation of the 2006 IUR Rule for one chemical substance. EPA also determined during the inspection that the company had failed to comply with the export notification requirements as required under TSCA section 12(b) and the import certification requirements as required under TSCA section 13 on a number of occasions for the same chemical substance. The company corrected the violations and paid a $103,433 penalty proposed in a May 31, 2012 complaint.

Haldor Topsoe, Inc., headquartered in Houston, Texas, is subject to a TSCA complaint that was filed on June 20, 2012. The complaint alleged that that the company had violated the 2006 IUR rule for 13 chemical substances. The complaint assessed a proposed penalty of $202,779, which the company paid on July 2, 2012.

More information about the settlements and EPA’s TSCA enforcement program: http://www.epa.gov/compliance/resources/civil/tsca/tscaiur.html

More information about TSCA reporting requirements: http://www.epa.gov/iur/