Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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Bergeson & Campbell, P.C. (B&C®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation.  We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees.  The dates and topics will be confirmed when EPA makes announcements in the Federal Register.


 
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By Lynn L. Bergeson and Margaret R. Graham

On July 14, 2016, the Environmental Law Institute (ELI) hosted an event in which the individuals and organizations critical to Toxic Substances Control Act (TSCA) reform, discussed the intricacies and challenges faced in drafting the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), the amended law, and its ultimate enactment. 

The panelists included John Pendergrass, VP of Programs & Publications, ELI (moderator), Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, PC (B&C®), Sarah Brozena, Senior Director, Regulatory & Technical Affairs, American Chemistry Council, Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund, David Goldston, Director of Government Affairs, Natural Resources Defense Council, James J. Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, U.S. Environmental Protection Agency (EPA), David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce, and  Senator Tom Udall, U.S. Senate (D-NM).

The overall consensus from the panelists was that the process undertaken in getting Lautenberg passed was challenging, but also inspiring and a true group effort on both sides of the aisle.  Some of the key points from the discussion included:

  • On June 23, 2015, when H.R. 2576 was passed by an overwhelming 398-1, there was a great spirit of bipartisanship in the House.  McCarthy observed that this spirit of bipartisanship was especially acute on June 23, a rare event in Congress these days.
  • Making a strong law that could be implemented by Jones and EPA was a high priority, and Jones’ role was “absolutely indispensable,” according to Udall who also stated, “[t]he one thing we wanted to make sure we did is not to produce a law that wasn’t going to work for [Jones] and his folks over at EPA.”  In answer, Jones stated that EPA Staff were “excited about implementation,” and have “hit the ground running.”  The law is strong, has great potential for serious reform and applicability, and is “an elegantly written, balanced and entirely implementable law that will make the world a better place,” according to Bergeson.
  • In terms of cooperation and momentum, finding champions with endurance, and rewarding that support with some compromise on bill provisions created the recipe for success.  As Udall stated “[y]ou need to find champions on your environmental bills that also have political will,” who are “will to do more than just introduce a bill.  They need to deal with every stakeholder.”  Denison followed with “to move the bill through the legislative process – to get people to engage, to make changes in exchange for their support, and broaden that” was the only way to get the bill passed, and these actions were “not only to build support, but to sustain momentum over more than one Congress to ultimately get it done.”

More information on the event can be found in the Environment & Energy Daily article “Architects of TSCA Compromise See Hope for Polarized Congress” available online, through paid subscription.  A video recording of the event and other materials from the event are available to ELI Associates on ELI’s website.  ELI Associates must login to see the materials.  A full analysis of Lautenberg is available in the B&C memorandum An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.


 
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The House’s Office of the Law Revision Counsel has posted the U.S. Code version of the Toxic Substances Control Act, as revised by the Frank R. Lautenberg Chemical Safety for the 21st  Century Act, Public Law No. 114-182.  The U.S. Government Publishing Office (GPO) has not yet posted the official version of the public law, but is expected to soon.  The GPO version of the public law will be available at https://www.gpo.gov/fdsys/.


 
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On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell P.C. (B&C®), in the article, “Give EPA Detailed New Chemical Notices, Attorneys Advise.”

Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed,” Lynn Bergeson, managing partner of Bergeson & Campbell PC said during a July 14 webinar the firm organized.

[…]

Both the old and newly amended TSCA say the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson said, referring to Section 2601(b)(3).

The new law makes “very consequential changes” to the new chemicals provisions of TSCA as the EPA will have to carefully balance the requirements imposed by different sections of the law, she said.


 
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On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), in the article “Give EPA Detailed New Chemical Notices, Attorneys Advise.”

Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed,” Lynn Bergeson, managing partner of Bergeson & Campbell PC said during a July 14 webinar the firm organized.

Bergeson, Marrapese and Rosenberg discussed the implications of these new decisions and criteria and the impact they may have on the chemical industry's ability to innovate new products.

Both the old and newly amended TSCA say the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson said, referring to Section 2601(b)(3).

The new law makes “very consequential changes” to the new chemicals provisions of TSCA as the EPA will have to carefully balance the requirements imposed by different sections of the law, she said.


 
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On July 14, 2016, Bloomberg BNA Daily Environment Report included quotes from the B&C® and Chemical Watch webinar “The New TSCA Series Webinar 2: Impacts on New Chemical Programs.”

Chemical manufacturers and processors will need to give exposure and toxicity data to the EPA for it to evaluate the risks of new and existing chemicals as required by the recently amended Toxic Substances Control Act, said Charles Auer, who directed the EPA Office of Pollution Prevention and Toxics under multiple administrations. Auer spoke July 14 during a webinar organized by Bergeson & Campbell PC.

The webinar focused on changes the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. Law No. 114-182) made to provisions of TSCA that govern chemicals in commerce, called “existing chemicals,” and new chemicals, which manufacturers would like to make or import but have never been in U.S. commerce.

Health and environmental toxicity tests have been codified into law by the EPA, said Lynn Bergeson, managing partner of Bergeson & Campbell in Washington, D.C.

It can direct companies to use such tests to develop data using the order and other authorities provided under the Lautenberg Act, she said.

The agency does not have standard exposure tests, said Auer, a consultant with Charles Auer & Associates LLC.

“The need to develop those will slow things at least initially, but I'm confident EPA is up to the challenge,” he said.

Richard Denison, lead senior scientist with the Environmental Defense Fund, said there are established methodologies for certain types of exposure tests that could provide EPA data.

These include environmental and biological monitoring equipment, Denison said. Monitors measure the presence of chemicals, for example, in the workplace, air, water or soil.

He agreed with Auer, however, that the agency will need to develop agreement on and issue guidance for other sources of exposure data. These include computer models that could generate exposure predictions, Denison said.


 
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On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee, further complicating the fragile House and Senate negotiations. Inside EPA's source stated: "Nobody wanted to step on anybody's toes. [...] Pretty much everything else [was] in [Energy and Commerce's] jurisdiction or was sufficiently small enough [to not raise concerns.] There were a lot of concessions on all sides." The green chemistry provision was originally added to the Senate version of the TSCA Reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), by Senator Chris Coons (D-DE), and was primarily focused on funding the research and development of green chemistry.

The green chemistry provision of S. 697 called for a study of how to best incentivize sustainable chemistry research and development, as well as support "economic, legal and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry." The bill also created a working group to coordinate federal sustainable chemistry activities that would be lead by EPA's research chief and the National Science Foundation (NSF) director, as well as an advisory council to coordinate with the working group. Although green chemistry language in S. 697 did not remain in the final version of the bill, there are still supporters in Congress who are prepared to work to get the programs outlined in S. 697 into law.


 
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An Environmental Law Institute Seminar and Webinar, Complimentary for members, $50 for non-members.

On June 22, 2016 President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act for the first time since its passage in 1976. While environmental organizations, public health advocates, the regulated community, and EPA have all supported updating the law since at least 2009, political challenges seemed destined to prevent comprehensive reform. Nonetheless, dedicated advocates from various stakeholder groups and committed members of Congress and their staffs overcame the hurdles and passed the most significant federal environmental law in a quarter century.


How did stakeholders and elected officials negotiate the political gridlock surrounding most recent attempts at environmental legislation? How were major issues such as the preemption of state law and financing addressed? What other roadblocks were overcome, and what can environmental, public health, and industry advocates learn from the experience?


Join us to examine the unique history of TSCA reform, and hear from people and organizations critical to its ultimate success. Speakers will share insight from the road to reform and field questions from the audience.


Panelists:
John Pendergrass, VP of Programs & Publications, Environmental Law Institute (moderator)
Lynn Bergeson, Managing Partner, Bergeson & Campbell PC
Sarah Brozena, Senior Director of Regulatory & Technical Affairs, American Chemistry Council
Richard Denison, Lead Senior Scientist, Environmental Defense Fund
David Goldston, Director of Government Affairs, Natural Resources Defense Council (invited)
Jim Jones, Assistant Administrator, Office of Chemical Safety & Pollution Prevention, US EPA
David J. McCarthy, Chief Counsel, Subcommittee on Environment and the Economy, House Committee on Energy and Commerce
Senator Tom Udall, US Senate (D-NM)

When:
July 14, 2016
2:30 PM to 4:00 PM ET


Where:
Environmental Law Institute
1730 M Street NW, Suite 700
Washington, DC 20036

And via webinar

Register: http://www.eli.org/events/story-tsca-reform

Environmental Law Institute | 1730 M Street NW, Suite 700, Washington, DC 20036 | 1.202.939.3800 | http://www.eli.org


 
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Lynn L. Bergeson Comments On TSCA Implementation Featured In Bloomberg BNA Daily Environment Report Article “More Than 300 New Chemicals Snagged as EPA Implements Law”

On July 12, 2016, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), was quoted in the Bloomberg BNA Daily Environment Report article “More Than 300 New Chemicals Snagged as EPA Implements Law.”

Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA July 11 the number of new chemicals affected by the EPA's implementation of the newly amended Toxic Substances Control Act isn't large.

For an individual company, however, every day that delays its ability to bring a new chemical or a new use of a chemical to market is huge, Bergeson said. “Every day counts.”

Jim Jones, EPA assistant administrator for chemical safety and pollution prevention, said June 28 he expects the EPA to use the Lautenberg Act's criteria to reach one of the new chemical decisions the law provides within a week to 10 days. Jones spoke at an American Bar Association forum about the TSCA amendments.

During that same forum, Bergeson said some of the clients her law firm represents had nearly reached the end of the agency's original 90-day review period just prior to the Lautenberg Act becoming law.

As of July 12, none of those clients had been told whether it can make or import those new chemicals, she told Bloomberg BNA.


 
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On June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182.  A link to the presentation is available online. The topics from the webinar included:

  • Major Improvements over Current Law;
  • Specific Requirements for Existing Chemicals;
  • Testing Authority;
  • Confidential Business Information;
  • Source of Funding; and
  • State-Federal Partnership, among others.

More information concerning EPA’s implementation of the Act is available on EPA’s website.

 

Tags: EPA, TSCA, webinar

 
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On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage.  This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans.  EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30, 2016, in which EPA provided an overview of the new TSCA, and an unofficial version of TSCA as recently amended.


 
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If you are having trouble understanding basic process flows under the new Toxic Substances Control Act (TSCA), please reference Dr. Richard A. Denison’s flow charts that depict the basic processes applicable to existing chemicals already in commerce, and applicable to new chemicals prior to market entry.  Comparisons are shown between the processes under the old and new TSCA.  Dr. Denison is a Lead Senior Scientist at the Environmental Defense Fund (EDF).  There are three flowcharts available:

  • How the Lautenberg Act Works (Existing Chemicals);
  • How the Original TSCA Worked (Existing Chemicals); and
  • TSCA vs. Lautenberg Act (New Chemicals).

You can access the flow charts in Dr. Denison’s blog post on EDF’s Health webpage:  Understanding basic process flows under the new TSCA.


 
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By Lynn L. Bergeson and Margaret R. Graham

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA).  The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182.  EPA notes that the new law imposes new responsibilities on EPA, while providing “comparatively short” deadlines to implement them.  EPA “takes these responsibilities and deadlines seriously,” and intends for the Implementation Plan to be a roadmap of the major activities on which EPA will focus during the initial year of implementation.  EPA organizes the Implementation Plan by the statutory timeframes during which the activities must be completed, rather than by what is of importance to EPA.  EPA states that the Implementation Plan is a living document, and EPA will further develop it over time.  EPA cautions that the Implementation Plan “is NOT intended to be a comprehensive listing of all requirements in the new law.” 

Bergeson & Campbell, P.C. (B&C®) is pleased that EPA is making strong early efforts to communicate and engage with stakeholders about its early implementation of the new TSCA and its thinking regarding specific provisions.  Completing the items listed in the Implementation Plan represents a prodigious amount of work for EPA over the coming months and years.  Stakeholders will need to be prepared to respond thoughtfully to rules, lists, and process descriptions as they appear in the Federal Register, or as they are posted.

More information on EPA’s Implementation Plan is available in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan.


 
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For a deeper dive into how and when Toxic Substances Control Act (TSCA) programs will change and adapt to “New TSCA,” Chemical Watch and Bergeson & Campbell, P.C. (B&C®) are offering a series of complimentary webinars on “‘The New TSCA’ -- What You Need to Know,” featuring an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. Federal and State regulatory authorities.  The second one in the series, Impacts on New and Existing Chemicals Programs (Sections 4, 5 and 6), is scheduled for July 14, 2016.  The archived webcast for the first webinar, Major Changes: What to Expect and When to Expect It, is available online.  The third and fourth webinars in the series, on Information and Reporting (Sections 8 and 14), and other provisions -- PBTs, Preemption, Green/Sustainable Chemistry, will be scheduled soon.  The webinars are moderated by B&C Managing Partner Lynn L. Bergeson.


 
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An in-depth memorandum of the reformed Toxic Substances Control Act (TSCA), TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, includes an initial overview, a summary of information on the timing of various activities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) as related to enactment and other important milestones, and a more detailed discussion of the changes in Lautenberg relative to TSCA as they relate to these and other provisions.  This and other Bergeson & Campbell, P.C. (B&C®) memoranda regarding TSCA reform are available on the B&C website.


 
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