EPA Settles with Slack Chemical Company Following Alleged EPCRA Violations

/in , , , /by

On October 11, 2023, EPA announced a settlement with Slack Chemical Company, Inc. (“Slack”) following alleged violations of the Emergency Planning and Community Right-to-Know Act (EPCRA) at two of the New York corporation’s facilities. The settlement includes a civil penalty of $231,300.

Under Section 313 of EPCRA, owners or operators of certain facilities are required to annually submit a Toxic Chemical Release Inventory Reporting Form R (“TRI Form R”) report for each chemical listed under 40 CFR 372.65 that was manufactured, processed or otherwise used in quantities exceeding a certain threshold. TRI Form R reports require information about on-site releases of the chemical into the environment, transfers of the chemical in waste to off-site locations, on-site waste treatment methods, and source reduction and recycling activities. Alternatively, owners or operators can opt to submit a simpler Toxic Chemical Release Inventory Reporting Form A (“TRI Form A”)  report when the quantity of the chemical manufactured, processed, or otherwise used is one million pounds or less, the total quantity released, disposed, and treated at the facility is 500 pounds or less, and the chemical is not considered to be of special concern. TRI Form R/Form A reports are due no later than July 1 for the preceding calendar year.

EPA alleges that Slack, which describes itself as a “chemical warehousing, repackaging and distribution company,” failed to submit timely TRI Form R/Form A reports at its Carthage and Saratoga Springs facilities for calendar years 2019 and 2021. More specifically, EPA alleges that Slack:

  • Submitted TRI Forms R or A for the chemical’s ammonia, methanol, nitric acid, and toluene at its Carthage facility and a TRI Form R for methanol at its Saratoga Springs facility on May 10, 2021, for calendar year 2019, approximately 10 months late; and
  • Submitted TRI Forms R or A for the same chemicals at the facilities on November 21, 2022, for the calendar year 2021, approximately 4.5 months late.

In a news release, EPA stated that Slack has “voluntarily instituted a corporate compliance plan to prevent recurrence of EPCRA reporting violations,” which includes a written procedure listing the steps needed to identify TRI chemicals and their quantities.

EPA Settles with Kyocera After Self-Disclosure of TSCA Violations

/in , /by

On September 5, 2023, EPA signed a consent agreement with Kyocera International, Inc. (“Kyocera”) over three alleged violations of the Toxic Substances Control Act (TSCA). Kyocera’s civil penalty was reduced to $105,937 because of EPA’s audit policy, which rewards companies that “voluntarily discover, promptly disclose and expeditiously correct” violations with reduced fines.

The alleged violations, which pertain to six unnamed chemicals (Chemicals A, B, C, D, E, and F), are as follows:

  1. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without first filing a premanufacture notice (PMN) or an exemption to PMN requirements, in violation of TSCA section 5(a)(1);
  2. Failure to comply with recordkeeping requirements for Chemical D and E’s polymer exemptions to PMN requirements, in violation of TSCA section 5(a)(1); and
  3. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without submission of proper certifications prior to the importation, and importation of Chemical F three times without providing a positive TSCA certification statement for each import, in violation of TSCA section 13(a)(1)(B).

The electronics manufacturer corrected the alleged violations by ceasing importation of Chemicals A, B, C, and D, submitting low-volume exemptions to PMN requirements for Chemicals B and C (which were granted by the Agency), and complying with the polymer exemption requirements for Chemical D. Under the terms of the settlement, EPA gave Kyocera permission to release its self-imposed quarantined stocks of Chemicals B, C, and D.

Kyocera self-disclosed the violations on June 23, 2021, with supplemental information provided in March 2023. The company disclosure and subsequent corrective action satisfied all of EPA’s audit policy conditions except the requirement that the violations be uncovered by “systematic discovery” and was therefore eligible for a 75% reduction in the gravity-based portion of the civil penalty.

The consent decree comes after a June 30, 2022, EPA Inspector General report which found that eDisclosure, EPA’s violation self-disclosure system, “does not have adequate internal controls in place to ensure that the EPA’s screening process is effective and that significant concerns . . . are identified and addressed.” EPA agreed with all four of the report’s recommendations and proposed corrective actions, including the development of national guidance and eDisclosure-specific training for EPA staff who monitor eDisclosure submissions.

Better Business Bureau Challenge Results in Clarifying Disclosure in Antimicrobial Toilet Seat Advertising

/in /by

In response to a challenge initiated by Bemis Manufacturing Company, the National Advertising Division (NAD) of BBB National Programs has ruled that Ginsey Industries, Inc. needs to include additional clarifying language to validate the assertions made about the antimicrobial safeguards offered by its Clorox Antimicrobial range of toilet seats. (NAD did not find any issues with the underlying efficacy of the antimicrobial properties, solely how the antimicrobial benefits were conveyed to consumers.)

During the course of this challenge, Ginsey voluntarily committed to undertake the following measures:

  1. Incorporate a disclosure (a statement for clarification) onto its product packaging, advertising materials, and all descriptions of products featuring the term “antimicrobial.” This statement would read as follows: “This product does not provide protection against bacteria, viruses, or other disease organisms. It is important to thoroughly clean and wash this product before and after each use.”
  2. Revise all online listings of its products to eliminate the depiction of a shield containing an antimicrobial checkmark emblem positioned within the Clorox chevron logo.

NAD also recommended that Ginsey adjust its advertising to guarantee the prominent visibility of the clarifying statement. This recommendation included the following steps:

  1. Modify the advertising on its official website by relocating the clarifying statement in close proximity to any “antimicrobial” claims that trigger its usage.
  2. Collaborate with retailers to apply similar alterations to the advertising materials for its products on retail websites.

Additionally, NAD proposed that the clarifying statement should be prominently displayed and positioned in close proximity to any assertions that promote Ginsey’s products as having antimicrobial properties or containing such attributes. This recommendation extended to situations where such claims were associated with the well-known Clorox chevron logo on third-party websites.

Walmart and Reynolds Sued Over Recyclable Plastic Bag Marketing Claim

/in , , /by

The State Attorney General of Minnesota has filed a lawsuit against Walmart Inc. and Reynolds Consumer Products Inc. (the owner of the trash bag trademark “Hefty”) for falsely marketing their plastic bags as recyclable. The Complaint alleges violations of Minnesota’s Prevention of Consumer Fraud Protection Act, Deceptive Trade Practices Act, False Statement in Advertising Act, and deceptive environmental marketing claim regulations.

These statutes utilize language explicitly prohibiting the use and dissemination of false, deceptive, or misleading statements. For example, Minnesota’s False Statement in Advertising Act strictly prohibits advertising that contains any material assertion, representation, or statement of fact that is untrue, deceptive, or misleading. Minnesota’s Deceptive Trade Practices Act further states:

“A person engages in a deceptive trade practice when …the person … represents that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits, or quantities that they do not have….” (emphasis added).

Defendants, through their product labeling, advertised their products as recyclable, which was false.  In addition, their actions disqualified the recyclable contents of the plastic bags from being recycled. In Minnesota, when recyclable materials or products are placed in non-recyclable bags on the curb, waste management will render the contents of the entire bag unrecyclable, leading both the bag and its contents to end up in landfills.

Additionally, the Complaint alleges deceptive environmental marketing claims by Walmart, citing the Federal Trade Commission’s (“FTCs”) Guides for the Use of Environmental Marketing Claims (also referred to as the “Green Guides”). The Green Guides state, “it is deceptive to misrepresent, directly or by implication, that a product or package is recyclable. A product or package should not be marketed as recyclable unless it can be collected, separated, or otherwise recovered from the waste stream through an established recycling program for reuse or use in manufacturing or assembling another item.” Minnesota recycling facilities cannot process the Hefty brand plastic trash bags labeled as recyclable); in fact, they can cause machine malfunctions and even serious damage.

The Complaint asked the court to order a stop on the sale of these products as marketed. Further, the Complaint requests that the court order the defendants to fund a program to educate Minnesota residents about recyclable materials.

This is not the only lawsuit related to Hefty’s recycling bags. Last year Connecticut’s Attorney General filed a lawsuit against the manufacturer, Reynolds, alleging the company has falsely and deceptively marketed the same Hefty recycling at issue in the Minnesota case. The Complaint states that Reynolds has marketed and sold these bags “despite full knowledge that their bags were incompatible with recycling facilities in Connecticut.” This case is still being litigated.

New Jersey Reaches Historic Settlement with Solvay Polymers over PFAS Contamination

/in , /by

On June 28, 2023, New Jersey’s Department of Environmental Protection (NJDEP) announced a proposed settlement with Solvay Specialty Polymers USA, LLC (“Solvay”) over the company’s discharge of PFAS and other hazardous substances from its West Deptford facility.  According to a press release from New Jersey’s Office of Attorney General (NJOAG), the $392.7 million proposed settlement is the “largest single-site natural resource damages and remediation case in New Jersey history.”

In the 2020 complaint that led to the proposed settlement, NJDEP alleged that PFAS discharges and emissions from Solvay’s West Deptford facility had caused “widespread soil, sediment, groundwater, and surface water contamination.”  In particular, NJDEP asserted that levels of PFNA­—a type of PFAS—detected in surface water and public drinking water near the facility were higher than levels reported “anywhere else in the world.”  According to NJDEP, Solvay and the facility’s previous owner knew or should have known about the dangers posed by PFAS but “failed to disclose the impact of their use and releases of PFAS into the environment to the Department and the surrounding community.”

Under the terms of the proposed settlement, Solvay would be required to reimburse NJDEP for previous remediation efforts, pay claims for natural resource damages, and fund additional remedial activities to be undertaken by NJDEP and the company.  Solvay would be responsible for identifying and remediating contaminated natural resources and wells and providing regular reports of its remedial activities to NJDEP.  Funds allocated to NJDEP would primarily be used to address PFAS in drinking water systems.

The settlement comes after a 2019 NJDEP directive for Solvay and four other chemical manufacturers responsible for “significant contamination of New Jersey’s natural resources” to provide financial compensation for PFAS-related contamination and information on their PFAS use and emissions.  NJDEP’s 2020 complaint argued that Solvay did not fully comply with the directive.  According to NJOAG, Solvay is the first company identified by the directive to reach a proposed settlement with NJDEP.

A formal notice of the proposed settlement was published in the New Jersey Register on August 7, 2023.  Public comments on the proposal will be accepted through October 6, 2023.

TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR

/in , , , /by

In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.

The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”).  The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.

Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.

According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”)  Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements.  The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.

Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.

In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.

In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.

EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:

  • Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
  • Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
  • Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
  • Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.

Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.

Case Update

In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”

On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.

EPA Takes Action Against Denka for Air Pollution

/in , , /by

On March 20, 2023, the Department of Justice (“DOJ”), on behalf of EPA, filed a motion for a preliminary injunction under the Clean Air Act (“CAA”), asking the federal district court for the eastern district of Louisiana to order Denka Performance Elastomer LLC (“Denka”) to immediately reduce chloroprene emissions from its neoprene manufacturing facility in LaPlace, Louisiana. The motion follows DOJ’s February complaint arguing that plant operations present an imminent and substantial endangerment to public health and welfare due to cancer risks posed by Denka’s chloroprene emissions.

The Denka facility is currently the only facility in the country producing neoprene, a flexible, synthetic rubber used to manufacture a variety of products, including wetsuits, automotive belts and hoses, and orthopedic braces. Chloroprene is a liquid raw material used to produce neoprene.  It is emitted into the air from various production processes at the facility.

In 2010, EPA Integrated Risk Information System (IRIS) found that chloroprene is “likely to be carcinogenic to humans.” In a separate civil proceeding, Denka has challenged the process by which the Environmental Protection Agency considered the scientific information supporting its understanding of the human health risks posed by chloroprene.

According to the complaint, air monitoring conducted by both the EPA and Denka over the past several years consistently shows chloroprene concentrations in the air near Denka’s LaPlace facility that are as high as 14 times the recommended levels.  In the complaint, DOJ expressed particular concern for students attending the 5th Ward Elementary School, located approximately 450 feet from Denka’s facility.

Associate Attorney General Vanita Gupta commented on the complaint stating, “We allege that Denka’s emissions have led to unsafe concentrations of carcinogenic chloroprene near homes and schools in St. John the Baptist Parish, Louisiana. The Justice Department’s environmental justice efforts require ensuring that every community, no matter its demographics, can breathe clean air and drink clean water. Our suit aims to stop Denka’s dangerous pollution.”

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

/in , , /by

On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims stating that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their own company websites as well as on Amazon. The product’s labeling contained public health claims that EPA stated differ substantially from statements submitted to the Agency in connection with its pesticide registration; in other words, the companies were committing misbranding under FIFRA, The product’s registration allows only for labeling claims related to effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae. The product is not registered for use as a disinfectant or sanitizer, nor is it registered for any public health purpose. Therefore, it was a violation of the statute to make such claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.

Environmental Appeals Board interprets TSCA § 8(e).

/in , , /by

Last month, the U.S. Environmental Appeals Board (EAB) issued a rare and much-anticipated opinion interpreting the continuing violations doctrine and section 8(e) of the Toxic Substances Control Act (TSCA) in In re Elementis Chromium, TSCA Appeal No. 13-03 (March 13, 2015). The EAB overturned the November 2013 ruling [PDF] by the Administrative Law Judge (ALJ), which found that Elementis Chromium, Inc., a manufacturer of chromium chemicals, had violated TSCA § 8(e) by failing to report to EPA an epidemiological study on hexavalent chromium. In its March 13 decision, the EAB affirmed the ALJ in finding that the “continuing violations” doctrine applies to § 8(e) violations, thus rejecting Elementis’ statute of limitations argument. However, the EAB also held that Elementis had not violated TSCA § 8(e) because the corroborative information reporting exemption applied, and vacated the $2.5 million penalty imposed by the ALJ.

TSCA § 8(e) requires the immediate reporting to EPA of “information which reasonably supports the conclusion” that a substance “presents a substantial risk of injury to health or the environment.” In this case, a trade group of which Elementis was a member commissioned an epidemiological study on exposure to hexavalent chromium and lung cancer. EPA conducted a similar study in 2000, based on data from one facility, while the Elementis study, which finished in 2002, involved multiple “modernized” manufacturing plants. Both studies concluded that there was a positive association between hexavalent chromium exposure and lung cancer. EPA learned of the Elementis study in a 2006 Washington Post article, subpoenaed the study in 2008, and filed an administrative complaint against Elementis in 2010.

The EAB rejected Elementis’ claim that the general five-year federal statute of limitations barred EPA’s enforcement action. Elementis argued that the alleged violation accrued in 2002, when the company obtained the study, so the statute of limitations expired in 2007. However, the EAB found that the continuing violations doctrine, a special rule of accrual meaning that the period of limitations runs anew each day, applies to TSCA § 8(e), meaning that the limitations period only begins to run once the contested information is finally reported. The EAB concluded that the plain language and substance of § 8(e) imposes a continuing obligation, and violations of such are also continuing in nature. In Elementis, the company’s “last act of non-compliance” occurred on November 17, 2008, when the study was submitted to EPA, so the agency’s 2010 administrative complaint was within the five-year period.

Next, the EAB affirmed that the entire study was presumptively reportable as information which reasonably supports the conclusion that a substance presents a substantial risk of injury, rejecting Elementis’ argument that the only reportable information was “the single sentence conclusion regarding an elevated risk of cancer.” Instead, the EAB adopted a broad interpretation of the terms “information” and “reasonably supports,” concluding that Congress intended to address “the underlying data, assumptions, methodology, and analyses that actually provide the verification, corroboration, and substantiation” of the conclusion that a chemical poses a substantial risk of injury.

Nevertheless, the EAB found that the contested study was ultimately exempt from the reporting obligation because EPA established via guidance an exemption for information that is “corroborative of well-established adverse effects.” The EAB diverged from the ALJ’s analysis in finding that the Elementis study addressed a well-established adverse effect, i.e., increased incidence in lung cancer is a well-established adverse effect of exposure to hexavalent chromium. In contrast, the ALJ focused on the dose-response relationship between chromium and cancer, which the EAB characterized as an inapposite description of the potency of the chemical or conclusion about risk.

The EAB further found that the study was “corroborative” of well-established adverse effects, based not on the ordinary meaning of “corroborative,” but on agency guidance documents. This guidance describes that information is non-corroborative when it shows “the effects of a chemical are of ‘a more serious degree or different kind’ than previously perceived.” Therefore, information would be corroborative “if it shows that effects are less severe, they occur only at higher doses, or they occur in a species or strain of test animal, or by a route of exposure, that has been previously documented.” In this case, the study “only revealed statistically significant lung cancer effects at a substantially higher level” than in EPA’s own study. Thus, the Elementis study qualified for the exemption, although the EAB noted that it would have affirmed the ALJ’s decision but for EPA’s self-imposed limitation on “the broad reach of the statute with its interpretation of what information EPA is ‘adequately informed of’ in its guidance documents.”

The Elementis decision raises several interesting issues under TSCA, especially concerning the breadth of information companies must report under § 8(e) and which other TSCA sections might be interpreted as imposing continuing obligations. How EPA reacts to the decision will be instructive, especially if it chooses to refine or redefine its guidance on the corroborative information reporting exemption. Alternatively, Elementis may be of interest to legislators and stakeholders currently involved in negotiating a new framework for TSCA.

EPA’s new Strategic Plan: continuity in chemicals while enforcement focuses on Next Generation Compliance.

/in , /by

In April, EPA published its final Strategic Plan for FY 2014-2018, which includes ensuring chemical safety as a top-level goal and emphasizes the agency’s new paradigm of “Next Generation Compliance.” As proposed in the draft plan released in November, EPA plans to reduce the number of inspections and enforcement actions in order to focus instead on large, complex cases with the “highest impact on protecting public health and the environment.” In the final Plan, the agency clarifies that the advanced monitoring and electronic reporting entailed in its Next Generation Compliance approach will be used to supplement traditional enforcement techniques, rather than replace them.

The Strategic Plan is organized around the following five goals:

  • Goal 1: Addressing climate change and improving air quality
  • Goal 2: Protecting America’s waters
  • Goal 3: Cleaning up communities and advancing sustainable development
  • Goal 4: Ensuring the safety of chemicals and preventing pollution
  • Goal 5: Protecting human health and the environment by enforcing laws and assuring compliance

We will discuss goals 4 and 5 in this blog post.

Goal 4: Safe chemicals and pollution prevention

In pursuit of Goal 4, the Agency’s announced “Priority Goal” for the next year is to “[a]ssess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce.” EPA plans to complete more than 250 assessments of pesticides and other commercially available chemicals by September 30, 2015. These assessments will include the evaluation of potential risks to endocrine system disruption. By 2018, EPA plans to make Endocrine Disruptor Screening Program (EDSP) decisions for all “chemicals for which complete EDSP data are expected to be available by the end of 2017,” as well as complete assessments of all currently identified TSCA Work Plan chemicals. In addition, one of EPA’s strategic measures for pollution prevention is to increase the number of safer chemicals and safer chemical products by 1,900 by 2018 – currently, EPA’s Design for the Environment program recognizes 600 safer chemicals and 2,500 safer chemical products.

The Plan also emphasizes the agency’s support for strengthening and modernizing the Toxic Substances Control Act (TSCA), arguing that EPA needs the “mechanisms and authorities to expeditiously target and promptly assess and regulate new and existing chemicals.” In particular, EPA points to “large, troubling gaps” in the data available and current knowledge on many widely used chemicals.

The Plan also emphasizes EPA’s continuing effort to increase public access to the agency’s chemical information and assessment tools, such as ChemView and the Chemical Information System (CIS). EPA is planning to enhance both of these tools, which are both part of the Next Generation Compliance initiative. CIS will be upgraded to allow electronic reporting for “nearly all required TSCA submissions” and to add tools and models related to chemical risk management. Planned improvements to ChemView will expand public access to TSCA chemical information and enable faster, automated posting of non-confidential data for the public.

EPA plans to complete several evaluations of its work in this area over the next four years, the results of which may direct future agency efforts. In FY 2014, EPA will begin reviewing key factors affecting TSCA Work Plan chemical assessments, followed by an evaluation of the effectiveness of new aspects of the pesticide registration review process, in FY 2015. In addition, biennial reviews are scheduled for 2015 and 2017 of the fee levels charged to submitters of New Chemical Pre-Manufacture Notices.

Goal 5: Enforcement and compliance assurance

The EPA’s main objective under Goal 5 is to target the most serious hazards for enforcement actions, particularly cases “where noncompliance is a significant contributing factor, and where federal enforcement attention can have a significant impact.” EPA’s intent here is not only to address the problems with the biggest impact, but to take on the largest and most complex cases that states might not be equipped to handle. Notably, this includes situations where “the patterns of noncompliance are broad in scope and scale such that EPA is best suited to take action.”

Under the Plan, the Next Generation Compliance approach not only relies on improvements in monitoring and reporting technology, but also entails “embracing new strategies for rule design and case targeting.” Of particular interest to regulated entities is the agency’s focus on expanding transparency and sharing data. The agency plans to build “compliance drivers” into rules and permits to make them more effective, such as improved monitoring, self- and third-party certifications, public disclosure, and “easily monitored product designs or physical structures in facilities.” Another part of Next Generation Compliance is EPA’s use of data analysis and targeting tools to improve identification, public notification, and responses to serious violations. EPA is currently considering new enforcement approaches, such as “electronic responses to electronically reported violations.”

Notably, in the Plan’s table of “Strategic Enforcement and Compliance Measures,” the Next Generation Compliance Measures are described as supplemental “examples” which are still under discussion with states and other parties. These measures include: the number of settlements resulting from or incorporating advanced monitoring technologies; use by regulated entities of advanced self-monitoring technologies; and public use of compliance technology tools (such as ECHO). In addition, the Plan notes that new ways of measuring effectiveness under Next Generation Compliance may emerge in the future, such as credit for avoiding violations.

Effects of the Strategic Plan

EPA’s goals in the realm of chemicals management likely come as no surprise to those in the sector. The agency’s support for TSCA modernization has been clear for years, and the Strategic Plan maintains EPA’s commitment to assessing TSCA Work Plan chemicals – of course, both of these efforts may be affected if Congress manages to successfully pass new TSCA legislation this session. Likewise, the Plan renews the agency’s commitment to increasing the number of safer chemicals and safer chemical products through its Design for the Environment program, and to the evaluation of endocrine disruptors. The Strategic Plan’s incorporation of various programs to improve information access and handling may be of more immediate significance to regulated entities as new electronic reporting processes are rolled out. Firms will also have to continue to manage the balance between protecting Confidential Business Information and EPA’s desired transparency goals.

Ultimately, EPA’s enforcement focus on targeting the largest and most complex cases will likely mean that fewer federal enforcement actions will be pursued in the case of less serious violations and hazards. At the same time, the agency’s commitment to the Next Generation Compliance initiative means that EPA may be able to use more sophisticated data analytics and targeting to recognize broad patterns of noncompliance. More speculatively, the enhanced focus on self-certification, public disclosure, transparency and data sharing, together with improved cooperation with states, may result in increased citizen suits, toxic tort litigation, and state-level enforcement actions along with pressure on companies to reduce or eliminate certain chemicals.