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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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: 

  1. Resets the Chemical Inventory based on industry-supplied data;
  2. Requires screening assessments for all “active substances”;
  3. Mandates risk evaluation for all “high-priority” substances and risk management for some substances;
  4. Compels substantiation of confidential business information (CBI) claims; and
  5. 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:  

  1. Read and understand the law and engage in “trade associations’ implementation activities”;
  2. Assess chemical product inventories;
  3. Manage the “business and optics” of chemical assessment, management, and substitution;
  4. Assess CBI options; and
  5. 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.


 
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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. 

Commentary

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:

  1. 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.
  2. 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.
  3. 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.


 
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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.


 
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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, 2019More information on these PBTs and EPA’s implementation of the amended TSCA can be found on our blog under keyword:  PBTs.


 
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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.


 
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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.


 
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The September 2016 issue of the Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter is now available.  This newsletter is prepared by the American Bar Association’s (ABA) Section of Environment, Energy, and Resources, and edited by Lynn L. Bergeson.  Several professionals from Bergeson & Campbell, P.C. (B&C®) contributed articles to this issue of the newsletter. 

Articles in this special edition of the September 2016 issue are exclusively focused on Toxic Substances Control Act (TSCA) reform.  The articles include:

  • From the Chair;
  • From the Editor;
  • New TSCA and EPA's Enhanced Testing Authority;
  • New Chemicals under New TSCA;
  • Is the Section 5 Review Period Fixed or Flexible in New TSCA?;
  • New TSCA -- Existing Substances;
  • Implementing the 2016 TSCA Amendments;
  • 2017 “Reset” of New TSCA Inventory Will Affect All Chemical Users, Not Just Manufacturers;
  • Changes Regarding Confidential Information in New TSCA;
  • Preemption under New TSCA;
  • New Fees Provisions in New TSCA;
  • Weight of Evidence in New TSCA;
  • PBT Actions under New TSCA; and
  • New TSCA and “Articles.”

 
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On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016.  According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain aspects of the electronic reporting system that impact a business’s ability to submit within the required timeframe, and agreed that additional time should be afforded.  EPA clearly states, however, that the extension is a one-time extension for the 2016 reporting period only.  The action does not impact the reporting timeframe for the 2020 CDR.

Because the original reporting deadline of September 30, 2016, was imminent, EPA will utilize discretion under the Administrative Procedure Act that allows it to issue a final rule if standard public review and comments are impracticable (Section 553(b)(3)(B)) and for “good cause” (Section 553(d)).

The rulemaking will be effective upon publication in the Federal Register.


 
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By Sheryl L. Dolan and Kathleen M. Roberts

On September 13, 2016, the U.S. Environmental Protection Agency (EPA) convened its second industry stakeholder meeting to discuss the development of a fees rule under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182, “new TSCA”); a copy of the presentation is available here.  Under new Toxic Substances Control Act (TSCA) Section 26(b)(4)(E), EPA is required to solicit input in support of fees rulemaking.  EPA convened its first stakeholder meeting on August 11, 2016.  Comments submitted by the August 24, 2016, deadline are available in the docket.  During its second meeting, EPA stated it would continue to consider input received by Friday, September 23, 2016; any additional comments should be sent to .(JavaScript must be enabled to view this email address).  EPA states it intends to send its proposal to the Office of Management and Budget (OMB) by mid-October 2016, and expects a proposed rule will be published by the second half of December 2016.

In anticipation of the second meeting, EPA shared its general observations as to a way forward for fee assessment under TSCA Sections 4, 5, 6, and 14 and some of EPA’s key take aways from the comments submitted to the docket.  In its meeting presentation, EPA outlined its estimated annual costs by 2019 (i.e., once the Section 6 risk evaluation schedule is ramped up).  While no specific fee proposals emerged from the meeting discussions, the following information was discussed, which provides some insight into EPA’s ongoing process:

  • EPA’s projected annual cost for implementing TSCA Sections 4, 5, 6 and 14 includes both direct and indirect/overhead costs, with a 22.75 percent adjustment to cover overhead, consistent with EPA’s overall budget practice.
  • In estimating the anticipated number of Section 5 submissions, EPA stated that based on industry comments regarding the effect of fees, it assumed a 30 percent reduction from recent years.  EPA essentially stated that 30 percent is an educated guess, noting that Notices of Commencement (NOC) are only filed on approximately 50 percent of premanufacture notices (PMN).
  • EPA stated that, consistent with industry’s comments, it most likely will not propose to charge separately for individual confidential business information (CBI) claims, but instead will incorporate that into overhead costs.
  • EPA stated that it is implementing a time accounting system, which may support future refinements of its cost estimates; EPA is required to review its fee program every three years under TSCA Section 26(b)(4)(F).
  • EPA stated that it is pursuing consultation with the Small Business Administration regarding revisiting the applicable definition of a small business concern.  While clarifying that this is not a proposal, EPA noted that if the producer price index is applied to the small business concern definition in 40 C.F.R. § 700.43, the $40 million revenue cap in the definition would increase to $91 million.  As reflected in the circulated spreadsheet, EPA plans to propose reduced fees for small businesses as required by TSCA Section 26(b)(4)(A).  EPA also stated that approximately 14 percent of TSCA submissions are made by small businesses.
  • Section 6 risk evaluation fees remain one of the greater uncertainties.  During the September 13, 2016, meeting, suggestions were made that these fees should be assessed incrementally, perhaps tied to milestones, with a schedule that perhaps could allow tying the fees to actual costs.  In response, EPA noted that OMB requirements preclude federal agencies from seeking fees in reimbursement for completed activities.

Based on its projected costs, EPA will seek to raise the $25 million annual maximum allowed by new TSCA.  Regardless of how these costs are distributed among Sections 4, 5, and 6 (assuming EPA’s proposal does not separately charge for Section 14 activities), it is clear that the proposed rule will be a significant change from the $2,500 PMN fee in place since the 1980’s.


 
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ChemCon The Americas is a global chemical control conference offering authoritative speakers, in-depth sessions, and a global perspective on existing and emerging chemical regulatory schemes.  ChemCon The Americas 2016 will be held October 17 - 21, 2016, in Toronto, Canada. 

Highlights from the diverse and substantive program planned for Toronto include:

  • Workshop on the modernized Toxic Substances Control Act, with speakers including Jeff Morris, Deputy Director, U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT), and Lynn L. Bergeson, Managing Partner, B&C®, and President, Acta®, Monday, October 17, 2016
  • Chemical control legislation in Middle and South America, with speakers including Alberto da Rocha Neto, Ministry of Environment of Brazil, and Michael S. Wenk, M.S., Senior Regulatory Consultant, B&C and Acta, Tuesday, October 18, 2016
  • Update on regulatory issues in Asia with speakers including J. Brian Xu, M.D., Ph.D., DABT®, Toxicologist, B&C and Acta,  Friday, October 21, 2016

The full ChemCon agenda is available online. A video overview of the ChemCon experience -- the sessions, exhibition, and networking and socializing opportunities -- is available on ChemCon’s YouTube channel.  For more information and to register, visit the ChemCon The Americas 2016 website.


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

On September 12, 2016, Chemical Watch and Bergeson & Campbell, P.C. (B&C®) presented the third webinar in “The New TSCA:  What You Need To Know” webinar series:  “Webinar 3:  Inventory, CDR, and CBI (Sections 8 & 14).”  This webinar provided insight and information regarding Toxic Substances Control Act (TSCA) reform as it is being enacted and implemented, specifically related to Sections 8 and 14 of the reformed TSCA, which included the TSCA Inventory, chemical data reporting (CDR), and confidential business information (CBI).  Companies and trade groups who could not participate in the webinar can contact .(JavaScript must be enabled to view this email address) to request a recording and copy of the presentation slides.

The topics from Section 8 of TSCA, regarding reporting and retention of information, included:  Small Manufacturer Definition; Reporting by Processors; Inorganic Byproduct Rulemaking and Reporting; TSCA Inventory; and Nomenclature.  The key points from this portion included:

  • The sales thresholds for small manufacturers are likely to rise from the current level that was set in 1986;
  • TSCA Inventory “reset” will require companies to report for substances manufactured or imported in the last 10 years and there will be no exemptions for polymers or low volume substances;
  • EPA may impose different requirements for CDR reporting by manufacturers and processors;
  • EPA must enter into negotiated rulemaking to reduce CDR reporting for recycling and reprocessing inorganic byproducts; and
  • Interested parties should be aware of rulemaking on these issues as well as rules that EPA will be promulgating to implement other sections of TSCA. 

The topics from Section 14 of TSCA, regarding CBI, included:  Information Not Protected; Asserting CBI; Presumptive CBI; Requirements for CBI Claims; Exemptions to Protection from Disclosure; Review and Resubstantiation; Duties of Administrator; and Criminal Penalties.  The key points from this portion included:

  • Most CBI claims made prior to enactment of TSCA reform will not require substantiation, but claims going forward, including chemical identity for substances notified as “active” on the TSCA Inventory will require substantiation;
  • EPA must review all CBI claims for chemical identity;
  • CBI protection that requires substantiation will sunset after ten years; claimants may reassert and resubstantiate claims to continue protection for another ten year period;
  • EPA must disclose CBI upon request from state, municipal, and tribal officials who demonstrate the need for the information and agree to protect CBI;
  • EPA must also disclose CBI upon request from medical professionals if it is reasonable to believe the information is necessary to treat a patient; and
  • In most cases, EPA will notify CBI claimants prior to disclosing CBI to persons that are not federal employees or federal contractors.

The panel speakers were, from B&C: Charles M. Auer, Senior Regulatory and Policy Advisor, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA); Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Senior Chemist, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program; and Kathleen M. Roberts, Vice President, B&C Consortia Management, L.L.C.; and from Chemical Watch:  Kelly Franklin, North America Reporter & Editor.

The fourth and final webinar in the series, “Other Provisions -- PBTs, Preemption, and Green/Sustainable Chemistry” will be presented on September 27, 2016.  


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

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&A).  EPA added a series of Q&As of particular relevance given the fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry to request a risk evaluation for persistent, bioaccumulative, and toxic (PBT) chemicals listed in the 2014 TSCA Work Plan.  Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.”  As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as with other high-priority chemicals.  Instead, EPA will proceed immediately to assess and identify appropriate risk management actions for these chemicals that EPA believes achieves the goal of reduced exposure to the “extent practicable.”  EPA is required under new TSCA to issue the proposed risk management rules by June 2019, three years from enactment of new TSCA, and issue the final rules six months thereafter.

As we noted in an earlier blog, this deadline poses ups and downs.  On the one hand, absent a risk evaluation, fast tracking the process necessarily invites worst-case assumptions and a high degree of probability that regulatory actions will be extensive.  On the other hand, in the absence of a defined risk evaluation process and a yet-to-be-defined fee assessment process or schedule, volunteers may be few and far between.  Understandably, a potential requester can be expected to want to know what the risk evaluation cost will be before making a commitment to pay that amount.  Even with these uncertainties, under some circumstances the election may be worth considering and stakeholders are urged to consider the risks and benefits quickly, as September 19 is only days away.

EPA’s new Q&As pertinent to PBTs relate to:

Interestingly, EPA’s Q&As address some, but not all, questions. Careful review of the questions and EPA’s answers is advised.  In short:

  • There are seven substances on the Work Plan list that are PBTs;
  • There is no formal request form; all that is required is the substance and company identity, along with the contact information of the requesting official; 
  • Entities requesting the assessment are disallowed from defining the scope and EPA intends to “evaluate the chemical substance in accordance with TSCA section 6(b)” regardless of a more narrowly defined set of uses of interest to the submitter;
  • The submitter will be expected to pay for the full assessment; and
  • The request is irrevocable and cannot be withdrawn.

While EPA’s interpretation comes as no surprise, reasonable people are likely to disagree as to whether the law must be read as EPA reads it.  EPA may find more willing sponsors if, for example, the fee is limited to cover the scope of nominated uses.  EPA could evaluate a broader scope, but the additional expense would not be entirely borne by the nominating company.


 
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The American Chemical Society (ACS), together with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and Honorary Co-Hosts Representatives Ken Calvert (R-CA) and Earl Blumenauer (D-OR), through ACS’ Science & the Congress Project have announced that they will be hosting a panel on “Alternatives to Animal Testing:  Emerging Uses and Policy Implications” on Tuesday, September 13, 2016, from Noon - 1:30 p.m. on Capitol Hill at the Cannon House Office Building in Room 340.  The panel will cover new and evolving non-animal based technologies and science that are being used to advance toxicology and safety testing and improve prospects in biomedical research, and will discuss how to robustly develop and incentivize adoption of these new methods, followed by an audience Q&A.  Lunch will be provided.  The moderator and panelists include:

  • Pamela Frasch, J.D., Lewis & Clark Law School (Moderator);
  • Warren Casey, Ph.D., National Institute of Environmental Health Sciences  and the U.S. Department of Health and Human Services National Toxicology Program;
  • Amy Clippinger, Ph.D., PETA International Science Consortium Ltd.;
  • Paul A. Locke, J.D., Dr. P.H.,  JHSPH;
  • Pamela J. Spencer, Ph.D., D.A.B.T., Scientific Director of Toxicology and Environmental Research & Consulting, The Dow Chemical Company.

Registration for the panel is available online


 
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By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are:

New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several statements.  The certification language is incorporated into electronic reporting tools for TSCA submissions requiring or permitting electronic reporting. Entities who make TSCA submissions on paper must now also include the following statements in the submission:

  • I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
  • I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that:
    • (i) My company has taken reasonable measures to protect the confidentiality of the information;
    • (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
    • (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
    • (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
  • Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Substantiation Requirements.  Existing substantiation requirements for certain types of CBI claims continue to remain in effect.  EPA notes that it may develop further guidance and require additional requirements in the future.

Generic Names.  A structurally descriptive generic name is now required where specific chemical identity is claimed as CBI.  EPA will be relying on existing generic name guidance for the creation and approval of generic names until updated guidance is developed.

EPA’s Review of Claims.  EPA will be reviewing and approving or denying a CBI claim for specific chemical identity and a proportion of CBI claims for other types of information in accordance with TSCA § 14.  EPA states that it may contact submitters of CBI to corroborate their CBI claims to the extent that substantiation has not already been provided.

While the guidance is welcomed and useful, it sheds no light on how best to corroborate a claim of CBI and how best to respond to an EPA allegation that the CBI claim is lacking.  These questions will continue to be debated; when in doubt, consult legal counsel.

More information is available on EPA’s website.  Please also join Bergeson & Campbell, P.C. (B&C®) and Chemical Watch on September 12, 2016, for the third complementary webinar in the series on “‘The New TSCA -- What You Need to Know,” featuring information on the TSCA Inventory, Chemical Data Reporting (CDR), and CBI.   

Tags: CBI, EPA, guidance, TSCA

 
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Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.

All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.

Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."

Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)

Speakers:

  • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
     
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
     
  • Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
     
  • Kelly Franklin, Chemical Watch
     
  • Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.

 

Topics Covered:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition
       
    • Reporting by Processors
       
    • Byproduct Rulemaking and Reporting
       
    • Toxic Substances Control Act (TSCA) Inventory
       
    • Nomenclature
       
  • Section 14 Confidential Business Information (CBI)
     
    • Information Not Protected
       
    • Asserting CBI
       
    • Presumptive CBI
       
    • Requirements for CBI Claims
       
    • Exemptions to Protection from Disclosure
       
    • Review and Resubstantiation
       
    • Duties of Administrator
       
    • Criminal Penalties

Register Online

 

Additional Webinars in "The New TSCA" Series:

 

Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.

 
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