Today, EPA announced the promulgation of a final Significant New Use Rule (SNUR) [PDF] under Toxic Substances Control Act (TSCA) targeting three different chemical types: certain benzidine-based dyes, di-n-pentyl phthalate (DnPP), and alkanes, C12-13, chloro, a short-chain chlorinated paraffin (SCCP). Benzidine-based dyes can be used in textiles, paints, and inks; DnPP in PVC plastics; and alkanes in industrial lubricants. EPA found that all of the affected chemicals can cause health effects including aquatic toxicity, cancer, persistence and bioaccumulation, and reproductive and developmental effects.
Like other SNURs, the rule requires manufacturers (including importers) or processors of the identified substances to notify EPA at least 90 days before beginning any significant new use. Under this SNUR, any new use is considered a significant new use for the benzidine-based dyes and alkanes. For DnPP, EPA has designated “any use other than as a chemical standard for analytical experiments” as a significant new use. For the benzidine-based dyes, EPA is adding nine chemicals to an existing rule regulating benzidine-based chemicals.
Notably, the SNUR makes inapplicable the usual TSCA exemption for importing or processing chemicals as part of an article, calling it a “loophole.” Thus, 90-day notification will be required of importers or processors of any articles containing benzidine-based chemicals, encompassing both the nine newly-added dyes as well as those first regulated in 1996. The elimination of this articles exemption has been questioned by the chemical industry, and marks a shift in EPA’s policy. In today’s SNUR, the agency notes that it is “concerned that commencement of the manufacture (including import) or processing for any new uses, including resumption of past uses… could significantly increase the magnitude and duration of exposure to humans.”
Today’s rule is not the agency’s only effort at regulating these chemicals; benzidine dyes and SCCPs are both already subject to Action Plans, while other phthalates (not including DnPP), as well as medium-chain and long-chain chlorinated paraffins have been added for assessment under the TSCA Work Plan. SCCPs have been nominated for addition to the Stockholm Convention for Persistent Organic Pollutants, and manufacturing and importing in the U.S. has ceased following EPA enforcement actions in 2012. EPA also notes that its Design for the Environment program has identified safer dye and colorant alternatives on its Safer Chemical Ingredients List.
The SNUR will go into effect 60 days after its publication in the Federal Register, which will likely occur in the next week.
In today’s Federal Register, the EPA has published a final Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for seven ethylene glycol ethers, also known as glymes. Glymes are used as industrial solvents or processing aids, and in some consumer products, such as inks, paints, coatings, adhesives, graffiti removers, and soldering compounds. The seven chemicals affected are:
monoethylene glycol dimethyl ether (monoglyme);
diethylene glycol dimethyl ether (diglyme);
diethylene glycol diethyl ether (ethyldiglyme);
triethylene glycol dimethyl ether (triglyme);
diethylene glycol dibutyl ether (butyl diglyme);
ethylene glycol diethyl ether (ethylglyme); and
triethylene glycol dibutyl ether (butyl triglyme).
The SNUR will require manufacturers (including importers) to notify EPA at least 90 days before starting any activity identified as a significant new use. For six of the glymes, the agency is designating all new consumer uses as significant new uses, while any new use constitutes a significant new use for the seventh glyme, triethylene glycol dibutyl ether (butyltriglyme). Three of the glymes subject to the SNUR contain carve-outs for certain uses, such as when diethylene glycol diethyl ether (ethyldiglyme) is used as a component of inks, coatings and adhesives, and as a component of paint/graffiti removers. In addition, in response to comments, EPA clarified that ethylene glycol ethers in brake fluid contained in a motor vehicle at point of sale would not be considered to have been “’sold or made available to consumers for their use,’ merely because it has been made available to motor vehicle manufacturers (as part of a brake fluid mixture for their use in manufacturing customers’ motor vehicles) or used car dealers.” Likewise, monoethylene glycol dimethyl ether (monoglyme) contained in sealed lithium batteries does not constitute use in a consumer product.
The agency is issuing this SNUR because glymes ”have been shown to cause damage to reproductive organs and DNA, as well as toxicity to blood and blood forming organs.” EPA first proposed a SNUR for 14 glymes on July 12, 2011, but is not currently finalizing the rule for the other seven glymes ”because the Agency believes that these chemicals are not sufficiently similar to the seven chemicals subject to this SNUR and therefore do not raise the same concern for potential exposure to these chemicals.”
EPA also notes that ethylene glycol dimethyl ether (monoglyme) is on the Work Plan for Chemical Assessments, because it met the criteria for priority assessment due to toxicity and use in commercial and consumer products. Under the Work Plan, EPA will conduct a risk assessment and determine if further risk reduction is necessary.
The SNUR goes into effect on February 17, 2015.
This week, Bloomberg BNA reported that American Chemistry Council attorneys recently met with representatives of the Office of Management and Budget (OMB) to ask that the Environmental Protection Agency (EPA) be required to conduct further information-gathering on a proposed rule under the Toxic Substances Control Act (TSCA) that would regulate benzidine-based dyes, among other chemicals. The proposed Significant New Use Rule (SNUR), published in March 2012, would add nine chemicals to the SNUR already listed at 40 C.F.R. § 721.1660 and make unavailable the customary “articles exemption,” which exempts persons processing or importing the regulated chemicals as part of an article. Under this SNUR, importers or processors of articles containing benzidine-based dyes would have to provide 90-day advance notice to EPA. According to Bloomberg BNA, the ACC told OMB of its concern that the proposed SNUR “lacked a rationale explaining how or why the EPA decided it was necessary to regulate articles rather than focus solely on chemicals as it typically does in new use rules.”
In its June 2012 comments on the proposed rule, the ACC noted that the proposed revocation of the articles exemption “herald[s] a shift by the Agency towards greater regulation of chemicals in articles.” The ACC argued that removing the articles exemption “should be limited to exceptional circumstances” and be “based on sound criteria,” and recommended that EPA “define a clear policy framework including criteria for determining when TSCA regulation of articles is appropriate. In any proposed SNUR, the Agency should present a compelling basis for a decision to apply a SNUR to articles.”
The OMB’s Office of Information and Regulatory Affairs (OIRA) reviews all significant rulemaking before publication, and may return an agency rule for further consideration and review if, for example, OIRA finds that the proposed rule is not justified by the analysis.
The articles restriction in the benzidine-based dyes SNUR is in line with other recent SNURs regulating articles; Bloomberg BNA reports that since 2012, EPA has proposed at least four SNURs that would eliminate the articles exemption for certain chemicals, including the 2013 rule on carpets containing long-chain perfluoralkyl carboxylates.
In today’s Federal Register, the EPA published Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) applying to 52 chemical substances, ranging from “functionalized carbon nanotubes” to amine adducts. The affected chemicals were all subject to Premanufacture Notices (PMNs), and nine are also subject to consent orders under TSCA § 5(e). Today’s SNURs extend the provisions of the § 5(e) consent orders and require manufacturers and processors of the chemicals to notify EPA prior to engaging in any activity designated in the rules as a significant new use. The SNURs were issued by Direct Final Rule, meaning that the SNURs will go into effect in 60 days unless EPA receives written adverse or critical comments, or notice of intent to submit such comments, by November 26.
Today, EPA released its first update [PDF] to the Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. Drawing on new data collected through Chemical Data Reporting (CDR) and the Toxic Release Inventory program, EPA adjusted the exposure rankings for the chemicals initially screened for the Work Plan and added 23 chemicals to the Work Plan list for further assessment. The agency also removed 15 chemicals which are mostly no longer in commerce; of the 15, mercury (and mercury compounds) and quartz were removed because risks associated with those substances are already sufficiently managed. In addition, benzo[a]pyrene was designated to be evaluated as part of the assessment of creosote. Today’s changes had no effect on 67 chemicals and bring the Work Plan total to 90 chemicals.
Included in the 23 new Work Plan chemicals, EPA added the following five Action Plan chemicals or chemical groups to the Work Plan for further assessment:
- Bisphenol A (BPA)
- Decabromodiphenyl ether (decaBDE)
- Hexabromocyclododecane (HBCD)
- Nonylphenols and nonylphenol ethoxylates (NP/NPE)
- Group of phthalates (dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP), and di-isobutyl phthalate (DIBP)
These Action Plan chemicals were all identified as highly-ranked for hazard and exposure; decaBDE and HBCD also had high rankings for persistence/bioaccumulation. The other five Action Plan chemicals not added to the Work Plan were not selected for reasons including lower toxicity and potential exposure or because they are no longer produced or imported into the United States. Of these non-Work Plan chemicals, the agency plans to propose Significant New Use Rules (SNURs) for benzidene dyes and toluene diisocyanate (TDI). In the case of long-chain perfluorinated chemicals (PFCs), EPA noted that while it has already begun risk management actions, including a voluntary stewardship program, it intends to gather “additional data regarding use of PFCs in imported articles before determining if these chemicals should be candidates for the assessment process.”
In addition to the Action Plan chemicals, EPA added ten chemicals which were previously screened for the Work Plan in 2012. These ten chemicals now have increased exposure scores, according to recent CDR and TRI data, due to “being domestically produced or imported in greater quantities and …used in a larger variety of consumer and children’s products.” Two flame retardants, triphenyl phosphate (TPP) and isopropylated phenol, phosphate (iPTPP), were also added.
Yesterday, EPA released a pre-publication version of its proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) targeting nonylphenols (NPs) and nonylphenol ethoxylates (NPEs). NPEs are a type of nonionic surfactant used in a wide variety of industrial processes and applications, including detergents, dry cleaning, cosmetics, adhesives, and paints and coatings; NPs are primarily used as an intermediate in producing NPEs. Under the SNUR, any person intending to manufacture, import, or process NPs or NPEs for the identified significant new uses must notify EPA before beginning any such activity, so that the agency may have the opportunity to evaluate each intended use and impose any appropriate controls.
The proposed SNUR [PDF] applies to 15 chemical substances; for 13 of these, any use is considered a significant new use, while “any use other than use as an intermediate or use as an epoxy cure catalyst” constitutes a significant new use for 4-nonylphenol, branched and 2-nonylphenol, branched. In discussing the environmental effects of NPs and NPEs, EPA cited the chemicals’ persistence, high toxicity to aquatic life and wide usage that can lead to “widespread releases to the aquatic environment.”
NPs and NPEs were also the subject of an Advanced Notice of Proposed Rulemaking in 2009, following EPA’s settlement of a citizens petition to initiate rulemaking brought by several environmental groups and other NGOs. The release of the proposed SNUR is in line with EPA’s 2010 Action Plan for these chemicals. Other Action Plan efforts to regulate NPs and NPEs and reduce their risks include completing an alternatives assessment under the Design for Environment (DfE) program in 2012 and collaborating with the Textile Rental Services Association of America to phase out NPEs in industrial laundry detergents.
Comments will be accepted on the proposed SNUR for 60 days following the rule’s Federal Register publication, which is anticipated to occur the week of September 29.
EPA finalized Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 36 substances on September 2, including several nanoengineered carbon compounds. The SNURs were first proposed in February 2013, and include several substances subject to § 5(e) consent orders. EPA is not finalizing the proposed SNUR for one substance, premanufacture notice (PMN) number P-11-155, in response to a comment from the PMN submitter urging the SNUR’s withdrawal while the agency’s recommended environmental toxicity testing is ongoing. Other changes in the final SNURs are mostly minor and involve ensuring consistency with existing consent orders and Occupational Safety and Health Administration (OSHA) requirements. In response to comments on the hierarchy of engineering and administrative controls and collaboration with OSHA and the National Institute for Occupational Safety and Health (NIOSH), EPA noted that it is “currently in the process of developing revisions to existing SNUR regulations that will serve as a template for future SNURs and SNURs already issued” and will consult with OSHA and NIOSH.
In July, we reported that EPA released two sets of SNURs by direct final rule. Earlier this month, EPA withdrew six of those SNURs after receiving notices of intent to submit adverse comment. The agency withdrew rules for the substances identified generically and by PMN number as follows:
- 1,1′- methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in alkane polyols;
- aromatic dibenzoate (P-14-60);
- propylene glycol, alpha isocyanate, omega silane (P-13-270);
- aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4- dialkyl aromatic dicarboxylate, alkanedioic acid, alkanediol, .alpha.- hydro-.omega.-hydroxypoly[oxy(alkyl- alkanediyl)], hydroxyalkyl 2-alkyl-2- alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2- alkenoic acid (P-13-563);
- alkanedioic acid, polymer with alkyl 2- alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.- hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2- alkenoate and 2-alkyl-2-alkenoic acid (P-13-617); and
- alkanedioic acid, polymer with alkyl alkyl- alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.- hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkyl- alkeneoate and alkyl-alkenoic acid (P-13-619).
According to its Federal Register notice, EPA intends to publish proposed SNURs for these substances under separate notice-and-comment procedures in the near future.
Today, EPA released a pre-publication version of Significant New Use Rules (SNURs) for 43 chemicals under the Toxic Substances Control Act (TSCA). All 43 substances have been subject to Premanufacture Notices (PMNs) and six of them are subject to section 5(e) consent orders, where EPA determined that activities associated with the substances may present unreasonable risk to human health or the environment. The SNURs are being promulgated by direct final rule and will be published in the Federal Register tomorrow, July 9.
The new SNURs cover a wide range of chemicals, including perfluorinated chemicals and lithium salts, in a variety of industrial uses, from herbicide intermediates to surfactants for laboratory use fluid.The SNURs impose various recordkeeping, notification, protective and other requirements on persons engaging in a “significant new use,” i.e., any use outside the use scenarios identified in the applicable PMNs or without specified protective measures, in the case of the 5(e) SNURs.
These 43 SNURs come a day after another set of 13 SNURs which were published in today’s Federal Register, all of which were subject to PMNs and three of which were subject to section 5(e) consent orders. Two of the substances covered in this set of SNURs are identified as carbon nanotubes.
The SNURs applying to the substances subject to section 5(e) consent orders are “based on and consistent with the provisions in the underlying consent orders.” The other substances subject to the new SNURs met the criteria of concern established at 40 CFR § 721.170.
Both sets of SNURs will go into effect 60 days following publication in the Federal Register (September 8 and 9) unless EPA receives written adverse or critical comments, or notice of intent to submit such comments, within 30 days of publication (August 7 and 8).
The EPA will withdraw a 2011 proposed rule requiring testing and other data for 23 High Production Volume (HPV) chemicals and imposing Significant New Use Rules (SNURs) on 22 other HPV chemicals. Last week, Bloomberg BNA reported that the agency had confirmed in an email that the rule will be formally withdrawn, although a timeline has not been established yet. Under the Toxic Substances Control Act (TSCA), HPV chemicals are those produced or imported into the U.S. at the rate of at least 1 million pounds per year. However, significant data gaps exist regarding the hazards associated with these substances.
The rules were part of the EPA’s HPV Challenge Program, which encouraged the voluntary submission of health and hazard data for approximately 1,400 HPV chemicals sponsored by companies. EPA previously issued three other test rules for “unsponsored chemicals.”
EPA justified the withdrawal of the fourth set of rules by alluding to higher priorities, such as the agency’s TSCA Work Plan, an initiative launched in 2012 that identified 83 substances on which to conduct risk assessments. When the regulatory package was proposed, industry groups commented that the proposal was duplicative in requesting data already developed for and collected by the European Chemicals Agency (ECHA), which implements REACH.
Data from over 860 chemicals was made publicly available to the HPV Challenge Program through international efforts. However, of the over 2,200 chemicals sponsored through the voluntary part of the HPV Challenge Program, data was received for only 82 percent of the substances – and not all of that data is complete.
Until the regulatory package is withdrawn, the substances subject to the SNURs remain subject to 12(b) export notification requirements.
Yesterday, U.S. EPA issued Significant New Use Rules (SNURs) for 35 substances which were subject to Premanufacture Notices (PMNs) under the Toxic Substances Control Act (TSCA). The SNURs were promulgated as a Direct Final Rule, and take effect starting April 14, 2014.
Fourteen of the substances, including various polyfluorinated alkyl compounds and multi-walled carbon nanotubes, are subject to “risk-based” TSCA § 5(e) consent orders which require use of protective measures to limit exposure or otherwise mitigate risk; the SNURs for these substances designate as a significant new use the absence of these protective measures. The SNURs for the other 21 substances designate various significant new uses, including releases to water as well as certain industrial, commercial and consumer activities, and establish certain protection in the workplace requirements, such as the use of respirators.
Written adverse or critical comments, or notice of intent to submit such comments, must be received by E.P.A. by March 14, 2014.