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 Richard E. Engler, Ph.D. and Margaret R. Graham

On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018.  83 Fed. Reg. 22978.  EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  EPA posted these determinations on its website when they were made.  The statements of findings, all related to premanufacture notices (PMN), and their website links are:

  • EPA Case Number:  P-16-0415; chemical name:  generic:  polyurethane; polymer exemption flag (generic name); intended uses:  coating for oil and gas industry; known and reasonably foreseen use(s):  paint additive and coating additive. 
  • EPA Case Number:  P-18-0002; chemical name:  generic:  phosphinic acid, P,P-alkyl-, salt (generic name); intended use(s) (specific):  chemical intermediate for a non-halogenated flame retardant; known and reasonably foreseen use(s):  chemical intermediate; flame retardant. 
  • EPA Case Number:  P-18-0021; chemical name:  generic: dicarboxylic acids, polymers with substituted poly (substituted alkendiyl), 3-hydroxy-2-(hydroxyalkyl)-2-alkylalkenoic acid, 5-substituted-1-(substituted alkyl)-1,3,3-trialkyl carbomonocyle, alkanediol, alkane-triol, alcohol blocked compounds with aminoalcohol; polymer exemption flag (generic name); intended use(s) (generic):  paint; known and reasonably foreseen use(s):  adhesive and sealant chemical.
  • EPA Case Numbers:  P-18-0044 - 0045:
    • P-18-0044:  chemical name:  generic:  fatty acids (generic name); intended use(s) (generic):  intermediate species known and reasonably foreseen use(s):  chemical intermediate; lubricant and lubricant additive; viscosity adjustor; coating.
    • P-18-0045:  chemical name:  generic:  fatty acids, alkyl esters; intended use(s) (generic):  application coating; known and reasonably foreseen use(s):  lubricant intermediate; mold release agent; plasticizer; processing aid.
  • EPA Case Number:  P-18-0083; chemical name:  specific:  2-propenoic acid, telomers with bualc.-2-[(2-propen-1-yloxy)methyl]oxirane reaction products, sodium bisulfite and sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate(1:1), sodium salts, peroxydisulfuric acid([(HO)S(O)2]2O2) sodium salt (1:2)-initiated. (CASRN: 2118944-42-4); intended use(s) (generic):  dispersant additive; known and reasonably foreseen use(s):  chelating agent.

Commentary

P-18-0044, P-18-0045, and P-18-0083 are notable in that EPA identified a hazard other than “low hazard” for health or the environment and nevertheless concluded that exposures were low enough that the substances are not likely to present an unreasonable risk under the reasonably foreseeable conditions of use.  In the cases of P-18-0044 and P-18-0045, EPA identified health hazards, but EPA expects that exposures to the general population will be low and that there will not be consumer uses.  Furthermore, EPA expects that workers will “use adequate personal protective equipment.”  In the case of P-18-0083, EPA identified acute and chronic aquatic toxicity concentrations of concern of >20,000 and >1,000 parts per billion, respectively.  Even though these do not meet EPA’s thresholds for “low hazard,” EPA does not expect releases to exceed those thresholds.

More information on TSCA’s implementation is available on our TSCA Reform News & Information web page. 


 

By Lynn L. Bergeson and Margaret R. Graham

On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory

The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements “for applicable persons to provide information to assist in the preparation of an ‘inventory of mercury supply, use, and trade in the United States,’ where ‘mercury’ is defined as ‘elemental mercury’ and ‘a mercury compound.’  The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process.”

More information on the proposed rule issued in October 2017 is available in our blog item “EPA Issues Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA.”


 

By Susan M. Kirsch and Margaret R. Graham

On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition.  The bill received unanimous approval in the Senate and only four of 51 House members voted against it, but Governor David Y. Ige (D) has not signed the bill as yet.  The bill states that scientific studies have shown that both chemicals can induce “feminization in adult male fish and increase reproductive diseases in marine invertebrate species (e.g., sea urchins), vertebrate species (e.g., fish such as wrasses, eels, and parrotfish), and mammals (in species similar to the Hawaiian monk seal)” and induce “deformities in the embryonic development of fish, sea urchins, coral, and shrimp and induce neurological behavioral changes in fish that threaten the continuity of fish populations.” 

Oxybenzone and octinoxate are among a group of chemical filters of ultraviolet (UV) light used in sunscreens.  According to an Environmental Working Group 2017 survey, oxybenzone is found in 65 percent of commercially available chemically based sunscreens.  There is disagreement among the scientific community about the role that oxybenzone and other chemical sunscreens play in the degradation of coral reefs.  This February 2017 article in Nature discusses available science on reefs and sunscreens, including research findings that legislative champions of the Hawaii bill used as support for proposing its ban.  As a possible alternative, mineral-based sunscreens, such as those with titanium dioxide and zinc oxide, have not been shown to cause harm to corals, according to the National Oceanic and Atmospheric Administration (NOAA).

Hawaii’s Department of Land and Natural Resources (DLNR) has been requesting that people who enter the ocean and use beach showers avoid using sunscreens containing oxybenzone since September 2016, stating that “studies have shown that oxybenzone causes deformities in coral larvae (planulae), making them unable to swim, settle out, and form new coral colonies.  It also increases the rate at which coral bleaching occurs.”

Several sunscreen manufacturers and trade associations opposed the bill, citing the U.S. Food and Drug Association’s (FDA) approval of oxybenzone and octinoxate (a/k/a octyl methoxycinnamate) as active ingredients in sunscreen.  FDA’s website lists oxybenzone and octyl methoxycinnamate as “acceptable active ingredients in products that are labeled as sunscreen” that protect “skin from the sun’s harmful UV rays.”

If enacted, Hawaii’s ban will be the first of its kind in the U.S. and in the world.  Among U.S. states and territories, coral reefs can also be found off the coasts of Florida, Texas, Puerto Rico, and the Virgin Islands.  These states and territories, and other countries with direct interests in preserving reef ecosystems, may begin to explore similar bans.  


 

By Charles M. Auer and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization.  The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions.  OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program.  In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.

How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time.  From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense.  The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA).  The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure.  Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA.  Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues.  While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.

More information and commentary on this reorganization is available in our memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham

On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget.  The budget was plainly not the primary topic as the House Committee Members covered a lot of ground.  Pruitt fielded many questions and comments from House Democrats on his alleged ethical lapses regarding spending, security details, retaliation towards EPA employees who reportedly questioned his practices, and concerns about a hostile work environment.  Lawmakers from both sides of the aisle expressed concern over the installation of a secure phone booth in his office.  His opening statement addressed these criticisms only vaguely, stating that they are merely a distraction and an attempt to “attack and derail the President’s agenda and these administration’s priorities.”  There were also questions concerning the delay of the proposed rule banning the use of methylene chloride, and criticism regarding EPA’s recent proposed rule to strengthen transparency in regulatory science (the “secret” Science Rule). 

No attempt is made here to summarize the lengthy hearing.

Pruitt’s testimony statement is available here.  It does not contain information on the Science Rule, but it briefly references the implementation of the Toxic Substances Control Act (TSCA) in a section entitled “Ensuring the Safety of Chemicals in Commerce.”

More information on the many TSCA implementation initiatives is available on our TSCA Reform News & Information webpage, as well as the TSCAblogTM.  A summary of Pruitt’s testimony before the Senate Committee on Environment and Public Works is available in our blog item “Pruitt Addresses Legacy Issues, TSCA Implementation in Oversight Hearing.” 


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it would be presenting a webinar to assist processors with reporting under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule, published in the Federal Register on August 11, 2017.  This webinar, scheduled for May 23, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) will “include an overview of reporting requirements for processors, a demonstration of the electronic reporting application (Central Data Exchange, or CDX), and will provide time for questions and answers.”  Registration for the webinar is not required.  The webinar will be available through the following link on May 23: http://epawebconferencing.acms.com/tsca_inventory/.  A link to access the TSCA Inventory is available here.  The upcoming deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

More information on TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and in our memorandum “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. - Canada Regulatory Cooperation Council (RCC) Stakeholder Group announced that a 2018 RCC Stakeholder Event will be held on June 4-5, 2018, in Washington, D.C. to “bring together senior regulatory officials, industry, and other members of the public on both sides of the border to provide progress reports on existing RCC work plans and to discuss new opportunities for regulatory cooperation.”  The announcement states that details regarding the 2018 RCC Stakeholder Event, including the registration process, will be forthcoming and to please contact .(JavaScript must be enabled to view this email address) with any questions. 

More information on the existing work plans and the RCC in general is available on the Government of Canada’s Regulatory Cooperation webpage and on our blog under key word RCC.


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.”  This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.

 On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.”  The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”

 More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available.  For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:

  • Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
  • Notices of Commencement received by EPA since June 21, 2006; and
  • Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.

EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule.  EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018.  According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date.  Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent.  The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page.  More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.”  Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”


 
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