September 22, 2020

Volume X, Number 266

September 22, 2020

Subscribe to Latest Legal News and Analysis

September 21, 2020

Subscribe to Latest Legal News and Analysis

EPA Issues First TSCA Section 6 Final Rule in Thirty Years

Until today, EPA had not adopted a final risk management rule under section 6 of the Toxic Substances Control Act in 30 years. That drought has ended, now that EPA has published a final rule restricting consumer use of methylene chloride for stripping paint and coatings. 84 Fed. Reg. 11420 (Mar. 27, 2019). The final rule will prohibit the manufacture (including import), processing, distribution of methylene chloride for consumer paint and coating removal. The rule will also require manufacturers, processors, and distributors of methylene chloride for any use to provide downstream notifications of the restriction, and will impose certain recordkeeping requirements.

The final rule will go into effect on May 28, 2019, as Subpart B of a new 40 C.F.R. Part 751. Companies that import and export methylene chloride, or mixtures containing methylene chloride, for any use should be aware of the effects of this action on imports and exports.

EPA decided not to extend the ban on use of methylene chloride in paint strippers to commercial use. Instead, it has opted to publish an advance notice of proposed rulemaking (ANPRM) soliciting public comment on potential training, certification, and limited access requirements that would apply to use of methylene chloride in commercial paint and coating removal. 84 Fed. Reg. 11466 (May 27, 2019). Public comments on the ANPRM are due by May 28, 2019.

This decision not to apply the consumer use ban to commercial use as well was anticipated and criticized during a hearing on March 13 of the Environment & Climate Change Subcommittee of the House Energy & Commerce Committee. As the ANPRM notes, however, the approach taken in the ANPRM is somewhat similar to that taken under REACH with respect to commercial use of methylene chloride in paint stripping. Annex XVII allows Member States to authorize professional use under specified restrictions, but only in such Member States; otherwise, professional use is prohibited. The California Department of Toxic Substances Control has designated paint or varnish strippers containing methylene chloride as a priority product under its Safer Consumer Products program. The listing applies to both consumer and commercial use. 22 C.C.R. § 69511.3.

Prohibition on Methylene Chloride in Paint and Coating Removers for Consumer Use

Background and Regulatory History

Per EPA data, methylene chloride was imported or domestically manufactured in amounts exceeding 250 million pounds in 2015. Less than 10% of that amount was for paint and coating removal. Other uses included adhesives, pharmaceuticals, metal cleaning, chemical processing, and chemical feedstock. (EPA is reviewing some of those uses in an ongoing risk evaluation for methylene chloride under section 6(b)(2)(A).) EPA determined that there have been at least 53 fatalities since 1976 resulting from acute consumer or commercial worker exposure to methylene chloride during paint or coating removal. 

Under section 6(a) of TSCA, if EPA makes a determination that a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, EPA must promulgate a rule imposing restrictions so that the substance no longer presents an unreasonable risk. In the 2012 TSCA Work Plan, EPA ranked methylene chloride high for health hazards and exposure potential. Methylene chloride also appeared on the 2014 update to the TSCA Work Plan. EPA published a risk assessment for methylene chloride in 2014. 

On the last day of the Obama Administration, EPA proposed to prohibit both consumer and commercial use of methylene chloride for paint and coating removal. 82 Fed. Reg. 7464 (Jan. 19, 2017). The final rule prohibits only consumer use, with commercial use addressed by further rulemaking. 

Prohibitions and Obligations

Once effective, the final rule will prohibit the manufacture, processing, and distribution, as well as retail sale, of methylene chloride for paint and coating removal for all consumer uses. Commercial use of methylene chloride will not be restricted. 

The final rule will require manufacturers, processors, and distributors (excluding retailers) of methylene chloride for any use to notify downstream recipients of the prohibitions by adding the following language to sections 1(c) and 15 of SDSs: “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.” 

Finally, manufacturers, processors, and distributors of methylene chloride for any use must maintain the following documentation for three years from the date of shipment: the entities to whom the methylene chloride was shipped; a copy of the downstream notification provided; and the amount of methylene chloride shipped.

Effect on Imports and Exports of Methylene Chloride

Importers and exporters of methylene chloride for any purpose should be aware of how this final rule may affect them. 

Importers of methylene chloride are subject to section 13 import certification requirements and regulations issued thereunder. 19 C.F.R. §§ 12.118-12.127. Such importers are required to certify that shipments of methylene chloride comply with all applicable TSCA restrictions, which will include the new final rule once it takes effect. 

In addition, exporters of methylene chloride must comply with section 12(b) export notification provisions. 40 C.F.R. Part 707, Subpart D. This is not a change, however, since the proposed section 6 rule added methylene chloride to EPA’s list of chemicals subject to export notification requirements.

ANPRM on Methylene Chloride for Commercial Paint and Coating Removal

As explained in the ANPRM, EPA is considering a regulation that would limit commercial use of methylene chloride for paint and coating removal to individuals who have certified they are able to engage in safe work practices. EPA acknowledges that a more restrictive approach may not be necessary due to robust worker protection programs that comply with the Occupational Safety and Health Administration’s methylene chloride standard, 29 C.F.R. § 1910.1052, which also has a training requirement. 

EPA is seeking comments by May 28, 2019, on the following questions:

  1. Is a training, certification, and limited access program an appropriate method for addressing risks presented by methylene chloride for commercial paint and coating removal?

  2. Would such a program sufficiently address any existing risks?

  3. What metrics should EPA use to measure the effectiveness of such a program?

  4. Would such a program allow some use of methylene chloride for commercial paint and coating removal to continue?

  5. Do existing commercial users have existing work practices, controls, or training?

  6. Should EPA consider requirements other than a training, certification, and limited access program?

Manufacturers (including importers), processors, distributors, and retailers of methylene chloride – including mixtures that contain methylene chloride – should evaluate how EPA’s actions regarding this chemical may affect their compliance programs and markets.

© 2020 Beveridge & Diamond PC National Law Review, Volume IX, Number 88


About this Author

Ryan J. Carra Environmental Attorney Beveridge & Diamond Washington, DC

A Ph.D. in Organic Chemistry compliments Ryan's law practice.

Ryan uses his extensive technical background to counsel clients in the chemicals, products, and energy sectors regarding environmental regulatory issues. Ryan’s experience includes:

  • Advising clients on Toxic Substances Control Act (TSCA) matters, including implementation of the 2016 reform legislation.
  • Advising product manufacturers, retailers, and other clients on extended producer responsibility, waste classification, chemical hazard classification, chemical notification...
Mark N. Duvall Chemicals Regulation Attorney Beveridge & Diamond Washington, DC

Mark has over two decades of experience working in-house at large chemical companies. 

His focus is product regulation at the federal, state, and international levels across a wide range of programs, and occupational safety and health.

He leads the firm’s Chemicals group. His experience under the Toxic Substances Control Act (TSCA) includes enforcement actions, counseling, rulemaking, advocacy, and legislative actions. Since the enactment of TSCA amendments in 2016, he has been heavily involved in advocacy, compliance activity, and litigation arising from EPA's implementation of these amendments. He also works with foreign counterparts to TSCA, including REACH and CEPA.

He is also a leader of the firm’s Occupational Safety and Health practice. He has extensive experience with OSHA and state OSHA inspections, enforcement litigation, compliance counseling, advocacy, and rulemaking. He has counseled clients on the EPA risk management program requirements under Section 112(r) of the Clean Air Act and state worker protection programs, and on inspections by the Chemical Safety and Health Investigation Board.

He has extensive experience with the Federal Insecticide, Fungicide, and Rodenticide Act, particularly with respect to regulation of antimicrobials, and with the Biocidal Products Directive in Europe.

He heads the firm’s FDA practice, having worked on FDA regulation of food and food additives, dietary supplements, drugs, medical devices, and cosmetics, and European counterparts. He is knowledgeable about human testing requirements, having served as the Chair of an institutional review board for several years.

He has counseled clients on the regulation of consumer products by the Consumer Product Safety Commission and the Federal Trade Commission. He has reviewed hundreds of green marketing claims and counseled on federal, state, and international regulation of such claims.

He has worked on green chemistry issues at the federal and state levels, as well as a variety of voluntary programs that affect products. He has helped clients with the Emergency Planning and Community Right-to-Know Act, the Controlled Substances Act, the Chemical Weapons Convention, and other chemicals-related requirements.

He has advised clients and written and lectured on the regulation of the products of nanotechnology by FDA and by EPA under FIFRA and TSCA, and on related product stewardship issues.

Service Areas & Industries

  • Chemicals Regulation
  • Chemicals
  • Food, Beverage
  • Occupational Safety and Health
  • Pesticides
  • Industrial Hemp & Cannabis