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.

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.”  82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017).  The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA).  The notices listed in the December 2016 statement of findings are:

The notices listed in the February 2017 statement of findings are:

Commentary

The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website.  It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website.  We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices.  We are pleased to see new chemicals cleared for production.

Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform.  Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues.  To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards.  With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.


 

By  Lynn L. Bergeson and Molly R. Blessing


As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA).  Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m.  Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.

EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.”  Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.

More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.

Commentary

As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders.  Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”

Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.

This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B))  that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).”  The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination.  We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).  

While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  During the meeting, interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMN), microbial commercial activities notices (MCAN), and significant new use notices (SNUN), under TSCA Section 5.  EPA states that information obtained during this meeting and from submitted written comments will be considered as it works to implement the new requirements and increase efficiency in its review process under TSCA. 

There has been considerable concern with the impact of new TSCA on EPA’s New Chemicals Program.  EPA is to be recognized for seeking stakeholder input, and interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can reasonably achieve from the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016.  Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658.  More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.


 

Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA): 

The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed.  The term is defined in TSCA Section 3 and also appears one or more times in the following Sections:  5, 6, 9, 14, 18, 21, and 26.  The term is not used in Sections 4 and 8.  B&C’s BNA article explores the use and application of conditions of use under Sections 5 and 6 and provides insights into the implications of what may be its unusual use in Section 5 in comparison to Section 6.

Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU).  EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions.  Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions.  Charles M. Auer and Lynn L. Bergeson’s September ABA article analyzes that question.

Other B&C articles on amended TSCA and other regulatory issues of interest are available on our website.


 

By Charles M. Auer and Oscar Hernandez, Ph.D.

On September 21, 2016, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its regulatory determinations for a batch of Microbial Commercial Activity Notices (MCAN) and premanufacture notices (PMN).

The announcement by EPA consisted of ten new microorganisms submitted as MCANs and seven new chemicals submitted as PMNs.  All microorganisms and chemical substances were determined “not likely to present an unreasonable risk” (per Toxic Substances Control Act (TSCA) Section 5(a)(3)(C)).  This determination was based in all cases on the low hazard of the microorganism or the chemical substance.  The microorganisms and chemical substances are:

MCANs:

  • J-16-0010:  Generic: Saccharomyces cerevisiae modified;
  • J-16-0011, J-16-0012, J-16-0013, J-16-0014, J-16-0015, and J-16-0016:  Generic:  Biofuel Producing Organism;
  • J-16-0017:  Generic: Saccharomyces cerevisiae modified;
  • J-16-0018:  Generic: Saccharomyces cerevisiae modified; and
  • J-16-0006:  Generic: Trichoderma reesei modified.

PMNs:

  • P-16-0343 and P-16-0344:  Generic:  Modified urethane polymer;
  • P-16-0391:  Generic:  Polyester polyol polymer with aliphatic isocyanate and phenol derivates;
  • P-16-0366: Generic:  Blocked polyisocyanate;
  • P-16-0373:  Generic:  Tris(alkyloxyphenyl)triazine compounds;
  • P-16-0466:  Generic:  2,5-Furandione, telomer with ethenylbenzene and (alkylethyl)benzene, amides with polyethylene-polypropylene glycol aminoalkyl Me ether, alkali salts; and
  • P-16-0348:  Generic: Polypentaerythritol, mixed esters with linear and branched monoacids.

In both types of submissions, the EPA reports are facilitated by the use of templates.  The footnotes in the template describe the approach and methodology followed to identify uses and to determine persistence, bioaccumulation, human health hazard, and environmental hazard. 

The MCAN template includes three footnotes that describe:  (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for human health hazard; and (3) criteria for ecological hazard.

The PMN template includes seven footnotes that describe:  (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for persistence; (3) criteria for bioaccumulation; (4) criteria for human health hazard ranking; (5) criteria for ecological hazard ranking; (6) link to the TSCA New Chemicals Program Chemical Categories; and (7) link to the Organization for Economic Cooperation and Development’s (OECD) 2014 Guidance on Grouping of Chemicals.   The OECD link and a link to the Sustainable Futures Manual within footnote 5 are obsolete.

The ecological hazard ranking criteria are consistent with OPPT’s past practice.  The human health ranking criteria departs from practice by using a single descriptor for all endpoints.  Other approaches that EPA has used for several years utilize criteria that address specific end points.  Examples include the ChAMP (Chemical Assessment and Management Program) Methodology and the section 8(e) program.

Risk Determinations

For the MCANs, the “unlikely to present” determination is based on the human health hazard criteria identified in the template for human health hazard:  “a microorganism is considered to have low human health hazard if it is not known to be a frank human pathogen that causes disease in healthy adults, and/or animal studies have demonstrated a lack of pathogenicity or toxicity”; and “a microorganism is considered to be of low ecological hazard if it is not known to be an animal or plant pathogen, and the genetic modifications do not impart pathogenic or toxigenic traits, and the introduced genetic material does not provide a selective growth advantage in outcompeting indigenous microbial communities in the environment.”

For the chemical substances, estimates indicated that the majority of these chemicals were persistent or very persistent and bioaccumulation potential was low for all chemicals.  Human health hazard was determined by using a combination of physicochemical properties and structural analogs.  Ecological hazard determinations utilized analog information and, as appropriate, estimates made by the Ecological Structure Activity Relationships (ECOSAR) Class Program.  Exposure estimates were not conducted based of the low hazard concern from which followed the “not likely to present an unreasonable risk” determination.


 

On July 18, 2016, Bloomberg BNA’s Daily Environmental Report reported on the U.S. Environmental Protection Agency’s (EPA) new chemical notice process, and included insight from industry leaders at Bergeson & Campbell, P.C.’s (B&C®) July 14, 2016, webinar, The New TSCA: Impacts on New and Existing Chemicals Programs. 

B&C Managing Partner Lynn L. Bergeson was quoted as saying that premanufacture notifications, or PMNs, that chemical manufacturers 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.”

Both the old and newly amended TSCA state 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 stated, referring to Section 2601(b)(3).  The new law makes “very consequential changes” to the new chemicals provisions of TSCA as EPA will have to balance carefully the requirements imposed by different sections of the law.

Richard A. Denison, Ph.D., Senior Scientist with the Environmental Defense Fund, stated that the changes the amended law makes to EPA's new chemicals program “are not trivial.”  Further, the changes will make it easier for the public to understand why EPA concludes that new chemicals may or may not enter commerce, what restrictions it may impose on the uses of those chemicals, and why.

BNA’s article, “Detailed New Chemical Applications Needed to Boost Market Chances: Attorneys,” is available online, through paid subscription.


 

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.


 

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.