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.
By Lynn L. Bergeson and Margaret R. Graham
On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act. This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called “high priority” chemicals. This is the second rule of three Framework Action rules that amended TSCA has directed EPA to issue in final within one year of enactment, or by mid-June 2017. The Inventory rule, which will require industry reporting of chemicals manufactured/processed in the previous ten years, is expected to be sent to OMB soon. Whether election transition issues will complicate and perhaps slow the review process is unclear but certainly not unlikely.
More information on the implementation of amended TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.
The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription):
- Trump’s EPA transition team will likely receive "massive briefing books" on each of the agency’s programs, including air pollution, water, waste and pesticides, according to Jim Aidala, a senior government affairs consultant with Bergeson & Campbell P.C. in Washington D.C. Aidala, who worked at the EPA from 1993 through 2001, including a stint as Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (now Office of Chemical Safety and Pollution Prevention), told Bloomberg BNA in an interview conducted before the election that those briefing books will need to include updates on pending litigation and decisions that need to be made early in the administration. Aidala highlighted a number of pending decisions that need to be made under the amended Toxic Substances Control Act (Pub. L. No. 114-182) that was signed into law in 2016. For the new chemicals law, the incoming EPA team will need to be briefed on necessary implementation activities, including prioritization of chemicals for review and new hiring to expand the agency’s chemicals program, Aidala said.
Career Staff Cooperation Expected
- Aidala, in a follow-up interview conducted Nov. 9, said that there may be some ‘‘initial skepticism’’ between some at the EPA and the Trump transition team. During the primaries, Trump said he’d like to eliminate the agency, but later backed off on that promise and said he planned to refocus the EPA on its ‘‘core mission’’ of focusing on clean air and safe drinking water. However, Aidala noted many of the mid-level and senior career staff at the EPA have been at the agency long enough that they’ve seen Administrations of both political parties come and go. ‘‘Career staff across the government are professionals,’’ he said. ‘‘There is a general duty to tell the leadership what is important and what is not.’’
By Lynn L. Bergeson
On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency. Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals. As stated in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan, this rule is the first of three “Framework Action” rules that the Frank L. Lautenberg Chemical Safety for the 21st Century Act (new TSCA) has directed EPA to issue in final within one year of enactment, or by mid-June 2017. For all three of these rules, the interim milestone for the proposed rules is mid-December 2016; therefore, it is anticipated that the three other rules will soon be sent to OMB for review as well. The two others are:
- Risk Evaluation Process Rule: A Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals; and
- Inventory Rule: Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.
There is a fourth Framework Action rule that new TSCA has directed EPA to issue as well, but it does not have a deadline for issuance in final; new TSCA only species the mid-June 2017 date as a goal:
- Fees Rule: EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.
More information on the implementation of new TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.
By Zameer Qureshi
Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), presented at Chemical Watch Enforcement Summit Europe in Brussels on November 4, 2016. Topics covered by Ms. Bergeson included “A New [Toxic Substances Control Act (TSCA)] and Expanded Enforcement and Product Liability Opportunities,” “Next Generation Compliance and Implications for Businesses,” and “eDisclosure -- The New Normal?”
Ms. Bergeson informed attendees of the significant amendments made to chemical regulation in the U.S. by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). She indicated that new TSCA amends TSCA in a number of ways and provided delegates with useful detail on the significant amendments made by new TSCA, stating that new TSCA:
- Resets the Chemical Inventory based on industry-supplied data;
- Requires screening assessments for all “active substances”;
- Mandates risk evaluation for all “high-priority” substances and risk management for some substances;
- Compels substantiation of confidential business information (CBI) claims; and
- Authorizes testing order authority (i.e., the U.S. Environmental Protection Agency (EPA) can compel chemical testing in addition to the more traditional test rule and consent order testing procedures).
Ms. Bergeson utilized a slide entitled “New Compliance Mandates = New Enforcement Opportunities” to address EPA’s expanded authority under new TSCA (e.g., Section 4 test orders, Section 5 new chemical safety “determinations,” and Section 6 prioritization). She expressed that EPA’s expanded authority under new TSCA gives rise to significant opportunities for enforcement of allegations of non-compliance when Section 4 test orders are issued.
Regarding testing, Ms. Bergeson stated “the [U.S.] testing program has relevance for people anywhere in the world” as chemical manufacturers can be expected to be ordered to test, and manufacturers include importers. Ms. Bergeson expressed that more testing will trigger an enhanced need to consider reporting under new TSCA Section 8(e). She described the possible outcomes of new chemical safety “determinations” by EPA under Section 5 and indicated that as a consequence of new TSCA “we’re going to see lots and lots of new [Significant New Use Rules (SNUR)].” Additionally, Ms. Bergeson stated “[Chemical Data Reporting (CDR)] requirements and Section 8 requirements are much more robust now.”
Drawing on her experience and current information from EPA, Ms. Bergeson analyzed “Next Generation Compliance” and provided insights to attendees on what it means for industry. She relied on a diagram from EPA that indicates Next Generation Compliance encompasses an intersection of “Regulation and Permit Design,” “Advanced Monitoring,” “Electronic Reporting,” “Transparency,” and “Innovative Enforcement.” Ms. Bergeson stated “Next Gen Compliance is an Obama Administration initiative” and emphasized the relevance of the U.S. presidential election for the future of Next Generation Compliance by stating “Next Generation Compliance will likely grow under the Clinton Administration or may die on the vine under a Trump Administration.” She then discussed each of the individual components of Next Generation Compliance.
Regarding Regulation and Permit Design, Ms. Bergeson stated that EPA’s goals were to “make permits clearer,” promote self-monitoring and third-party reporting, make compliance easier than non-compliance, and leverage market forces and incentives.
Ms. Bergeson stated that the expansion of “Advanced Monitoring Technologies” means there are new tools that can assist industry. She described the usefulness of real-time monitoring (i.e., knowing about releases into the environment on a real-time basis), facility feedback loops, fenceline and community monitoring, and remote sensing. Ms. Bergeson noted, as a potential drawback of Advanced Monitoring, that “technologies that have not necessarily been vetted” are finding their way into enforcement consent agreements. She then indicated that while this may be fine, the reliability of such technologies for regulatory purposes is untested and reliance on such technologies in regulatory contexts should not replace more traditional notice and comment rulemaking.
Ms. Bergeson stated “Electronic Reporting is a huge part of Next Generation Compliance; the era of submitting paper [is over],” and informed delegates that “information technologies enable new solutions, but invite concerns regarding accuracy and regulatory reliability.” She stated “Electronic Reporting does not always go as intended and greatly facilitates finding non-compliance.” Ms. Bergeson referenced the relevant EPA memorandum and informed attendees that Electronic Reporting is the default mechanism for providing information under new TSCA, and stated that Ohio Discharge Monitoring Report Electronic Reporting “checks submissions overnight and sends notices” if there are problems, thereby allowing the permittee to make corrections and resubmit.
Regarding Innovative Enforcement, Ms. Bergeson expressed that EPA is using Next Generation tools in enforcement settlements, and that Innovative Enforcement enhances targeting and data analysis to identify and address the most serious violations. She stated “we really like new technologies, but if a technology is new it may not be standardized, making reliance on it necessarily more focused to enforcement and not rulemaking purposes.” Additionally, Ms. Bergeson informed delegates that there is “a little concern in the regulated community in the U.S.” that some of the new technologies evolving from Innovative Enforcement efforts could undermine the notice and comment rulemaking process if these technologies are used for purposes beyond consent orders.
Ms. Bergeson stated that EPA’s “eDisclosure” portal provides companies with a new way to self-report violations of environmental law and is intended to “streamline confessions” by the “legal and corporate community,” and described the two-tier system within EPA’s eDisclosure portal and stated that for some violations “you can get on with your life.”
Ms. Bergeson stated “we always urge [B&C] clients to fix the problem immediately … The issue arises in some contexts of ‘do we tell EPA?’” She then informed delegates of the underpinning principles of eDisclosure by stating “it is believed that self-confessing should be rewarded.” Ms. Bergeson advised that companies can seek to reduce penalties by self-confessing, but the decision to self-confess is always fact dependent, and then indicated that the future of eDisclosure could be significantly impacted by the outcome of the U.S. presidential election.
Ms. Bergeson addressed “Design and Use of Safer Chemicals” and told attendees that EPA has “tried very hard” to promote Safer Chemicals through Green Chemistry, Safer Choice Labels, and the Safer Chemical Ingredient List, and that “creative technologies that are better, cheaper, and less toxic” are actively encouraged by EPA and welcomed by the U.S. chemical regulatory community.
Ms. Bergeson expressed that the implications of new TSCA are significant for the chemical manufacturing, importing, and downstream user sectors and provided beneficial “Closing Thoughts” to attendees. She stated that chemical manufacturers, importers, and downstream users need to:
- Read and understand the law and engage in “trade associations’ implementation activities”;
- Assess chemical product inventories;
- Manage the “business and optics” of chemical assessment, management, and substitution;
- Assess CBI options; and
- Manage chemical data information carefully.
Ms. Bergeson stated that the “implications of new TSCA are paradigm shifting … In the next two to five years we’re going to see opportunities for non-compliance.” Regarding CBI, Ms. Bergeson stated “we need to be very cognizant … Some of the changes are very subtle and it is an area ripe for enforcement … Assertion of CBI is at a higher standard -- EPA will be very vigilant.” Ms. Bergeson emphasized EPA’s “much richer implementation authority” under new TSCA and informed delegates that Next Generation enforcement and eDisclosure tools “add to the pressure” on the U.S. chemical industry to monitor carefully chemical portfolios.
Ms. Bergeson answered a number of questions on new TSCA and EPA’s likely enforcement of it. In response to a delegate’s question relating to the capacity of EPA to manage enforcement of new TSCA, she stated that EPA requires greater resources and is currently recruiting. Ms. Bergeson answered questions from attendees on timelines for pending rules from EPA and highlighted EPA’s interest in expediting its rulemaking on fees. She indicated that fees will be higher under new TSCA. Ms. Bergeson responded to a question regarding the scope of new TSCA by clarifying that new TSCA relates to industrial chemicals and that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) will continue to maintain their previous regulatory scope. Ms. Bergeson indicated that the only exception is found under TSCA Section 8(b)(10), which requires any or all mercury or mercury compounds, or any intentional use of mercury in a manufacturing process to be reported to EPA under the mercury inventory and reporting provisions, regardless of whether the use of the mercury or mercury compound is regulated under FIFRA or FFDCA.
By Lynn L. Bergeson, Charlie M. Auer, and Margaret R. Graham
On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter. EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.” The proposed rule would amend the TSCA SNU regulations to align them with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. The proposed rule would also amend regulations for SNU rules (SNUR) previously proposed and issued and make a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices.
The brief notice reopening the comment period does little to reinforce the magnitude and consequences of these proposed changes. Our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards provides a detailed account of the significant and complex issues that these changes raise, briefly reiterated here:
- The challenges in aligning labeling, as well as legal and regulatory ambiguities. EPA has devoted considerable effort to clarifying the application of HCS/GHS requirements to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) but unresolved issues still remain. The implementation of these revisions will most likely present similar challenges.
- EPA’s use of the hierarchy of controls (HOC) approach in the significant new use provisions, even though Congress did not include this approach in new TSCA. The wisdom of the inclusion of the HOC approach, even though we recognize and appreciate the importance of HOC as an element in a system to manage or eliminate occupational risks, is questionable and inconsistent.
- Whether or not EPA's review considered the possibility that new TSCA may materially impact the content of the proposal. There are signs, such as EPA’s inclusion of old TSCA citations, that point to them not having done this review, and there are no reassurances from EPA that new TSCA’s potential impacts were considered.
Our memorandum TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors also brings to light another important legal issue, concerning interesting anomalies that appear in the proposal's discussion of bona fide requests and the disclosure of information potentially considered confidential. EPA proposes to modify the procedures for determining if a specific substance or chemical use is subject to a SNUR when the substance, production volume, or use is claimed as confidential business information (CBI). The source of EPA’s authority to disclose CBI in the ways described in the proposed rule is unclear, as neither old nor new TSCA specifies them, such as the statutory basis and rationale for informing a bona fide intent notice (BFN) submitter of confidential use or production volume conditions. Also, EPA does not justify why disclosure to the BFN submitter is necessary. The current proposed SNUR provides for neither equal disclosure nor equal confidentiality as a result of BFN submission.
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 Lynn L. Bergeson
On October 11, 2016, the U.S. Environmental Protection Agency (EPA) announced that it would be taking expedited action on reducing exposures to the following persistent, bioaccumulative, and toxic chemicals (PBT). As stated in our blog item Deadline for Requesting Risk Evaluation for PBT Chemicals Fast Approaching, Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.” Instead of conducting a standard risk evaluation, EPA immediately will proceed to assess and identify appropriate risk management actions for these chemicals:
- Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
- Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
- Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
- Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
- 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.
Manufacturers were given until September 19, 2016, to request that EPA conduct a risk evaluation prior to risk management decisions on any of the PBT chemicals listed on EPA’s 2014 Work Plan; EPA states that requests for risk evaluations were made for two chemicals that can be used in fragrance mixtures, but for the remaining PBT chemicals, “it must move ahead to take expedited action to reduce exposure those chemicals.” The two requests were made for:
- Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl); and
- Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl.
As a result of the requests, EPA has excluded these two chemicals from the expedited action requirements under Section 6(h). The statutory deadline for EPA to propose action is June 22, 2019. More information on these PBTs and EPA’s implementation of the amended TSCA can be found on our blog under keyword: PBTs.
By Zameer Qureshi
On October 4, 2016, Bergeson & Campbell, P.C. (B&C®) hosted its fourth and final webinar in its series of webinars on the new Toxic Substances Control Act (TSCA) in collaboration with Chemical Watch. The webinar addressed numerous important issues for a wide array of stakeholders. The webinar was moderated by Lynn L. Bergeson, Managing Partner at B&C, and the expert panel included Charles M. Auer, Richard E. Engler, Ph.D., Lisa R. Burchi, and Sheryl L. Dolan.
Mr. Auer, Senior Regulatory and Policy Advisor at B&C, addressed “Administration of the Act” and described important changes between old and new TSCA. Mr. Auer’s presentation consisted of three segments: (1) “Section 26 Science Requirements”; (2) “Section 26 Information and Guidance”; and (3) “Section 26 ‘Savings’ Provision.”
Mr. Auer addressed the “Scientific Standards” requirements of new TSCA Section 26(h), the “Weight of Scientific Evidence” requirements of Section 26(i), and the Section 26(o) provisions of new TSCA relating to Consultation with the Science Advisory Committee on Chemicals (SACC). Mr. Auer addressed a number of additional rules and requirements in Section 26, including the U.S. Environmental Protection Agency’s (EPA) obligation to submit a report to Congress and issue an Annual Plan under Sections 26(m)-(n).
Ms. Burchi, Of Counsel at B&C, discussed “Preemption” under Section 18 of new TSCA. Ms. Burchi described preemption as “one of the most debated subjects in [the TSCA reform] debate” and stated that she had heard it referred to as a “linchpin” in terms of reaching agreement on provisions for TSCA reform to occur. Ms. Burchi stated “Everything in the new Section 18 is new or very significantly changed from what we were used to with regard to preemption … The final provisions are fairly complicated … It will remain to be seen whether states continue to act with regard to chemical substances in the way that they have been.”
Ms. Burchi addressed the three “main” provisions related to preemption under new TSCA Sections 18(a)(1)(A)-(C), and analyzed more specific issues (e.g., pause preemption) and the related exceptions. Ms. Burchi described the TSCA Section 18(d)-(e) provisions relating to “Exceptions” and “Preservation of Certain Laws.” Ms. Burchi also addressed new TSCA’s Section 18(f) “Waivers” provisions and concluded her segment of the presentation with the following statement: “It remains to be seen whether states are going to be jumping in to [take action] when EPA has already identified a chemical for prioritization and review … [There will be some interesting provisions and interplay] to be seen as we move forward under new TSCA.”
Ms. Dolan, Senior Regulatory Consultant at B&C, analyzed “Fees” under new TSCA and addressed EPA’s obligations to: (1) set lower fees for small business concerns; (2) consider balance between manufacturers and processors; and (3) consult with the regulated community. Ms. Dolan stated “new TSCA directs EPA to review its fee program on a three-year cycle and revise it as needed to raise the target fees … While new TSCA did not set a deadline for developing the fees program, it really didn’t have to -- EPA, of course, has every incentive to knock this rulemaking out quickly.”
Ms. Dolan indicated that a final rule is expected on fees under new TSCA by June 2017, and provided an overview of comments received on the proposed rule. Ms. Dolan stated that “overarching themes” in the comments included that: (1) fees should be tied to the level of required effort; (2) fees should encourage innovation; and (3) fees should not be overly complex or difficult to administer. In relation to (3), Ms. Dolan quoted a commenter that stated “don’t give us the [Internal Revenue Service (IRS)] Code.”
Ms. Dolan stated “everyone seems to want to know how much will a [pre-manufacture notice (PMN)] cost in the future … I think the answer to that [will come with a big red bow] in December. Specifically, EPA states that it will send a proposal to [the Office of Management and Budget (OMB)] in mid-October … EPA may well set a comment period of at least 60 days for this proposed rule.”
Dr. Engler, Senior Chemist at B&C, discussed Sustainable Chemistry (i.e., Green Chemistry) under new TSCA. Dr. Engler stated “new TSCA is largely silent on sustainability” and indicated that the “primary benefit” to Sustainable Chemistry under new TSCA is the abbreviated review period when EPA determines that a new chemical is “not likely to present” an unreasonable risk (i.e., 90-day period waived and manufacturers can commence manufacturing immediately). Dr. Engler addressed chemicals that EPA considers to present low hazard for health and ecotoxicity (“low/low” chemicals) and stated that new TSCA could be “more of a driver for Sustainable Chemistry,” if only low/low chemicals escape regulation.
Dr. Engler addressed “Relative Risk under New TSCA” and EPA’s “Safer Choice Program” (SCP). Dr. Engler discussed the Senate Report on S. 697, which suggested that EPA should consider “private sector voluntary consensus standards as an alternative” to SCP. Dr. Engler indicated that as the relevant section of the Senate report concerns Section 23, the Sustainable Chemistry Section that was not included in the enacted new TSCA, it is unclear how it applies to new TSCA as enacted. Dr. Engler stated that EPA is proceeding with SCP and hosting a summit in November on this topic.
The webinar concluded with a Questions and Discussion (Q&D) session, and B&C’s expert panel provided useful answers and analyses in response to attendees’ questions. Ms. Bergeson moderated the Q&D session, which was organized by topic.
In the Q&D session, Ms. Bergeson stated and asked Ms. Dolan: “Fees are super important … [small businesses and startups] might have a hard time mustering any type of financial liquidity to get their notifications through the gauntlet of EPA -- so how would you expect EPA to be defining lower fees for purposes of small business provision?”
Ms. Dolan responded by stating “[currently, the ratio is $2,500 and $100 for small businesses. I would imagine there will be some kind of comparable proportionality and currently there are other submissions (e.g., Low Volume Exemptions) that don’t require any fees. EPA has got to raise the money somewhere -- the more they put it on something else or the more they try to avoid charging fees for things, the more it’s going to jack up the cost and other things. I would imagine that they are going to charge something for everything. Whether they maintain that proportionality of 100:2500 remains to be seen. Another consideration is what constitutes a small business. There is a lot of conversation about that and the fact that definition hasn’t been updated in quite a while … This might be something that is the focus of a lot of attention in the proposed rule.]”
Ms. Bergeson drew on Mr. Auer’s extensive experience with EPA on several occasions during the Q&D session, starting questions with “If you were back at EPA,” and Mr. Auer’s responses were comprehensive. Dr. Engler responded to questions regarding Green Chemistry and discussed Persistent, Bioaccumulative, and Toxic (PBT) substances under new TSCA, and Ms. Burchi answered questions on California’s Safer Consumer Products Regulation (SCPR) and preemption under new TSCA.
More information on TSCA reform and B&C’s “The New TSCA: What You Need to Know” webinar series is available online.
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:
- 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.
- 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.
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.