by Dennis J. Deily
On January 19, 2017, the U.S. Environmental Protection Agency (EPA) published a proposed rule under TSCA Section 6 to prohibit the manufacture (and import), processing and distribution in commerce of Trichloroethylene (TCE) for the specific use of vapor degreasing. The rule proposes further prohibitions on any commercial use of TCE in vapor degreasing. Manufacturers, processors and distributors must keep records of TCE transactions and provide downstream user notifications of the prohibitions. Note: retailers of TCE for ANY use are exempted.
1. This action proposing a TSCA Section 6(a) Rule would make TCE subject to TSCA Section 12(b) Export Notification requirements and could affect TSCA Section 13 Import Certifications for some entities.
2. The proposed Sct. 6 rule is significant in that EPA’s use of its Sct. 6 authority has rarely been exercised since the promulgation of TSCA.
Comments on this proposed rule must be received by the EPA on or before April 19, 2017 (On February 9, 2017, EPA extended the original March 20, 2017 deadline).
Environmental Protection Agency: Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a), Federal Register 82 (January 19, 2017) 7432-7461: https://www.federalregister.gov/documents/2017/01/19/2017-01229/trichloroethylene-tce-regulation-of-use-in-vapor-degreasing-under-tsca-section-6a
by John J. Kowalski, CHMM
"Section 6 of the Toxic Substances Control Act (TSCA) provides the U.S. Environmental Protection Agency (EPA or the Agency) with several authorities for addressing risks from chemical substances". It also includes procedures that EPA must follow in so doing. The Agency 'promulgated regulations shortly after TSCA was originally enacted to implement the procedural requirements for rulemaking under Section 6, as they existed at that time.' But, TSCA was recently amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA).
On December 21, 2016, EPA published a final rule to remove "the regulations specifying certain procedural requirements for rulemaking under TSCA Section 6," because TSCA, as amended by the LCSA, no longer mandates those procedures. The final rule took effect immediately upon publication in the Federal Register. Note, however, that it 'does not affect the substance of any determinations' that the Agency will make under TSCA Section 6, as amended.
Environmental Protection Agency. “Procedures for Rulemaking Under Section 6 of the Toxic Substances Control Act; Amendment.” Federal Register 81 (21 December 2016): 93633-93636. https://www.gpo.gov/fdsys/pkg/FR-2016-12-21/pdf/2016-30055.pdf
by Cara Bolinski
For many years, the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs (OPP) has been interested in the development of animal free alternatives to the traditional, acute toxicity testing of pesticide formulations. In January 2017, in furtherance of this initiative, the EPA introduced a pilot program to evaluate the validity of a mathematical tool to serve as the alternative to animal testing. The mathematical tool under consideration is the Mixtures Equation found in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
Under this pilot program, there is an option for registrants to submit mathematical calculations (the GHS Mixtures Equation data) along with mandatory oral and inhalation acute toxicity data, which together will support the evaluation of a pesticide’s toxicity. For guidelines on the GHS Mixtures Equation, see pages 250-257 of ECHA’s Guidance on the Application of the CLP Criteria (PDF).
To see specific instructions for Submitting Data Regarding Actions Related to EPA Product Registrations click here. Separate instructions for Submitting Data Not Related to a Current Registration Action can be found on the announcement page of the EPA OPP website for this pilot program.
General Guidelines for GHS Mixtures Equation Pilot Submissions
GHS Mixtures Equation data submissions should be paired with oral and/or inhalation acute toxicity data from in vivo animal studies and should specifically include a table or spreadsheet that includes the following content:
* Formulation identity (including chemical name, CAS numbers, % by weight for all active and inert ingredients)
* In vivo LD50 and LC50 values for the formulation and associated Master Record Identifier (MRID) numbers
* Data source(s)/citations for each LD50 and LC50 value for the individual ingredients and whether the data has previously been reviewed by the EPA
* Calculated value(s) for each formulation
* EPA category for the in vivo study(ies)
* GHS category for the in vivo study(ies)
* EPA category for the calculated values based on the Mixtures Equation
* GHS category for the calculated values based on the Mixtures Equation
* A comparison between the calculated endpoints (LD50 and LC50 values) obtained using the GHS Mixtures Equation and the endpoints obtained from animal testing studies.
A submission template (XLSX) has been provided by OPP as a guide to formatting data.
If GHS Mixtures Equation data has been submitted to other regulatory authorities, the original submission format may be used. Upon submission, each study will be associated with an MRID number for tracking purposes. Good Laboratory Practices (GLP) statements are not required along with the GHS Mixtures Equation data.
Any questions about the GHS Mixtures Equation pilot program can be sent to: GHSEquations@epa.gov, with “Question” in the subject line.
The original EPA article announcing this pilot program can be accessed here.
U.S. Environmental Protection Agency: Pesticide Registration Data Requirements: https://www.epa.gov/pesticide-registration/data-requirements-pesticide-registration Pesticide Registration Policy and Guidelines: https://www.epa.gov/pesticide-registration/pesticide-registration-policy-and-guidance
Goals for Adopting 21st Century Science Methodologies: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/strategic-vision-adopting-21st-century-science
by John J. Kowalski, CHMM
On January 12, 2017, the U.S. Environmental Protection Agency (EPA or the Agency) published a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) to establish reporting and recordkeeping requirements for certain chemical substances manufactured or processed at the nanoscale. This rule requires 'one-time reporting for existing forms of certain nanoscale materials and a standing one-time reporting requirement for new forms of certain nanoscale materials before those new forms are manufactured or processed.' However, "persons that manufacture or process, or intend to manufacture or process, these chemical substances as part of articles, as impurities, or in small quantities solely for research and development will not be subject" to this rule.
On April 6, 2015, EPA proposed reporting and recordkeeping requirements for persons that manufacture or process certain chemical substances described in the proposed rule. See our previous blog article entitled “EPA Proposes New Requirements for Nanoscale Materials,” dated 13 April 2015, regarding the proposed rule. The Agency received numerous comments and conducted a public meeting on June 11, 2015 to obtain additional public input. According to EPA, “This final rule is based on that proposal and the consideration of the public comments received.”
The final rule requires "one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information; as well as keeping records of this information for three years." This final rule, which will be codified at 40 CFR § 704.20, is effective May 12, 2017.
Environmental Protection Agency. “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” Federal Register 82 (12 January 2017): 3641-3655. https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2017-00052.pdf