President Obama to sign Lautenberg Act tomorrow.

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The White House has announced that on Wednesday, June 22, President Obama will sign into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” the long-awaited update to the 40-year-old Toxic Substances Control Act (TSCA). The Senate passed the Lautenberg Act by voice vote on June 6, two weeks after the House approved the negotiated legislation. Both houses of Congress approved different versions of the bill in 2015, but were unable to reach a deal to reconcile the legislation until last month.

The bipartisan bill gives EPA new authority to regulate chemicals based on impacts to health and the environment, not cost, and order testing via order rather than rulemaking. Existing chemicals in commerce will be screened and prioritized for risk assessment, and industry will be allowed to apply for fee-funded expedited assessments. Fees for new and existing chemicals will be collected into a “TSCA Implementation Fund” to defray about 25% (initially $25 million annually) of the program cost. For new chemicals, EPA will be required to make an affirmative safety finding that the substance is not likely to present an unreasonable risk. The Lautenberg Act also provides for an “Inventory reset” under Section 8 of TSCA, requiring industry to report to EPA which Inventory chemicals they have manufactured or imported in the previous ten years. Most claims of Confidential Business Information (CBI), which allow companies to avoid disclosing certain information to EPA, will now have to be substantiated when made and will expire after ten years unless re-substantiated. EPA will be required to review and approve or deny past CBI claims for chemical identities on the Inventory.

The preemption of state and local laws was a major sticking point throughout TSCA reform negotiations, resulting in a complicated system of limited preemption. Generally, restrictions by states will not be preempted until EPA takes action on a particular substance, while reporting, monitoring, and disclosure requirements will not be affected. State actions in effect by April 22, 2016, or actions taken under a law in effect on August 31, 2003, will not be preempted. The Act also provides for a process under which states can seek waivers from preemption.

After the Lautenberg Act is signed into law, EPA will soon face a variety of tough implementation challenges. Within the first six months, EPA must designate ten chemicals from the Work Plan for risk assessment. Within the first year, EPA must develop guidance for industry-initiated risk evaluations and rules for Inventory reset reporting, prioritization of chemicals, and risk evaluation process.

Whether EPA will receive adequate funding from Congress to achieve all these goals remains to be seen; the Lautenberg Act does not permit EPA to assess fees unless Congress has appropriated at least the amount appropriated for the “Chemical Risk Review and Reduction” program project in FY 2014. Last week, the Senate Appropriations Committee reported out its appropriations bill for FY 2017, which included language to meet that requirement.

EPA grants partial exemption from Chemical Data Reporting rule for six biodiesel chemicals.

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Today, EPA announced that six biodiesel chemicals will be partially exempt from certain reporting requirements of the Chemical Data Reporting (CDR) rule, under section 8(a) of the Toxic Substances Control Act (TSCA). The Final Rule amends the list of chemical substances exempt from submitting processing and use information by adding the six chemicals, all of which are involved in the production of biodiesel. These chemicals will still be subject to other CDR reporting requirements, on facility and manufacturing and import volume information.

The affected chemicals and their Chemical Abstract Services Registry Numbers (CASRNs) are:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (CASRN 67762-26-9);
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3);
  • Fatty acids, canola oil, methyl esters (CASRN 129828-16-6);
  • Fatty acids, corn oil, methyl esters (CASRN 515152-40-6);
  • Fatty acids, tallow, methyl esters (CASRN 61788-61-2); and
  • Soybean oil, methyl esters (CASRN 67784-80-9).

This partial exemption was granted as part of the petition process for “Low Current Interest” chemicals developed in 2003. Under this process, EPA considers the “totality of information” available for a particular substance and certain considerations, defined in the regulations, including the availability of other risk screening information and whether potential risks of the substance are adequately managed, in determining the agency’s “current assessment of the need for collecting CDR processing and use information.” The agency stresses that this process is not necessarily based on potential risks, and interest may increase in the future, in which case the agency would reconsider the applicability of the partial exemption.

In this case, EPA determined that it had low current interest in processing and use information for the six substances. The analyses (“Review Reports”) for the individual chemicals are available at docket number EPA-HQ-OPPT-2014-0809.

These chemicals were requested to be added to the partial exemption list in a petition submitted by a biofuels industry group in October 2014. EPA initially granted the petition in a Direct Final Rule published in January 2015, but withdrew the rule in March 2015 after receiving an adverse comment to the Direct Final Rule. The agency proposed to make the same additions to the partial exemption list in a Proposed Rule published July 22, 2015; the Final Rule announced today makes no changes from that Proposed Rule. However, the Final Rule does discuss comments submitted by the petitioner arguing that these biodiesel chemicals should be treated similarly to comparable “petroleum process” chemicals, which the EPA has designated partially exempt because the agency “believes worker exposure is diminished.” The agency made “no determination” on the petitioner’s argument that the biodiesel chemicals should be partially exempt because they share similar manufacturing conditions, properties, and uses as petroleum process chemicals, since the issue is “moot” as the agency is now granting equivalent partial exemption under the “Low Current Interest” process.

The EPA signed the Final Rule on March 22, 2016. The partial exemption goes into effect when the rule is published in the Federal Register, which should be well before the June 1 start of the 2016 CDR reporting cycle.

Congressional leaders at work on reconciling TSCA reform bills.

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Quickly reconciling the recently passed House and Senate bills overhauling the Toxic Substances Control Act (TSCA) is reportedly a top priority for congressional leaders this year. Earlier this month, Bloomberg BNA reported that House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. John Shimkus (R-IL), chairman of the energy committee’s Environment and the Economy Subcommittee, would be meeting privately to set the subcommittee’s agenda, including how to reconcile the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) and the TSCA Modernization Act (H.R. 2576). Senator James Inhofe (R-OK), chairman of the Senate Environment and Public Works Committee, also told reporters that he was meeting with Rep. Upton to discuss the same topic.

Asked when final legislation might come before Congress, Sen. Inhofe suggested as early as this month or next month. He also noted that priorities for reconciliation include “making sure the EPA does what they’re supposed to be doing in pre-classifying chemicals.” Rep. Upton told Bloomberg BNA that reconciling the two bills is “high on both of our agendas,” and Rep. Shimkus said he was “pretty optimistic.”

It remains unclear, however, if both chambers will hold a formal conference committee or find a compromise in private that would then be approved by the House and Senate.

The bills are supported by a broad range of industry stakeholders, including the 3M, American Apparel & Footwear Association, American Chemistry Council, BASF, Dow Chemical, DuPont, and the National Retail Federation.

However, state and territorial environmental regulators have taken a more critical position. Last week, the Environmental Council of States released an analysis of the two bills highlighting provisions and sections that should be added or retained during reconciliation. Although not an official position of the organization, ECOS said the analysis is meant to be “a guide to selected issues of interest” to state environmental agencies. The analysis focuses mainly on preemption issues, including timing, grandfathering, and waivers, as well as the requirement that EPA share Confidential Business Information (CBI) data with states, and largely favors the Senate bill. However, the analysis also strongly advocates eliminating several provisions from the Senate version, including those authorizing a “regulatory pause” on state action and industry requests for safety determinations.

Yesterday, Chemical Watch reported that the Society of Chemical Manufacturers and Affiliates (SOCMA) sent a letter to key members of Congress expressing its preference for certain features of the House bill. SOCMA, the trade group for specialty chemical manufacturers, cited the House version’s stronger protections for the confidentiality of chemical identity. The trade group argued that the Senate version would have the perverse effect of discouraging submitters of Premanufacture Notices (PMNs) from conducting health and safety studies, which would trigger the disclosure of chemical identity information. SOCMA also wrote in support of the House bill’s provisions on fees, which are linked to recovering costs for the TSCA Section 5 program and do not apply to businesses that are exempt from submitting data, whereas the Senate bill authorizes fees for exemption requests. In addition, the letter urged Congress “to resist calls to adopt an approach that would prevent a [PMN] submitter from commencing manufacture until EPA issued its determination, even if EPA missed its 90/180-day deadline.”

U.S. Senate passes TSCA reform bill.

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Today, the U.S. Senate broke its months-long deadlock on chemical safety reform and approved by voice vote the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (S. 697). The bill, sponsored by Senators David Vitter (R-LA) and Tom Udall (D-NM), overhauls the decades-old Toxic Substances Control Act (TSCA) for the first time. We previously discussed aspects of S. 697 upon its March introduction and approval, a month later, by the Senate Environment and Public Works Committee.

After two years of negotiations, the legislation earned the support of 60 Senators of both parties as well as industry and many environmental groups. However, the bill was held up in October by Senators Richard Burr (R-NC) and Kelly Ayotte (R-NH), who were seeking to renew the Land and Water Conservation Fund. After that hold was lifted earlier this week, Sen. Barbara Boxer (D-CA), who has long criticized the proposal as too weak, placed another hold on the bill. Sen. Boxer reportedly lifted her hold after being promised that the legislation would be changed in reconciliation to more closely match the bill passed by the House (H.R. 2567) in June, which Sen. Boxer considers more protective.

The main issue legislators will face in reconciliation will likely be whether states will be allowed to impose tighter restrictions than federal standards.

TSCA reform becomes filibuster proof, but floor vote remains elusive.

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Last week, the U.S. Senate came closer to passing bipartisan legislation to reform the Toxic Substances Control Act (TSCA) than ever before – but still failed to bring S. 697 to the floor. The bill, co-authored by Senators Tom Udall (D-NM) and David Vitter (R-LA), is still not scheduled for a floor vote, which will have to wait until after Congress returns from its Columbus Day recess.

On Friday, October 2, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” reached the filibuster-proof level of 60 cosponsors with the added support of Senators Ed Markey (D-MA) and Dick Durbin (D-IL). The new cosponsors came aboard as part of a deal promising changes to the bill, including increases to the annual funding cap for industry fees from $18 million to $25 million and measures to streamline the state preemption waiver process. At the same time, Senator Barbara Boxer (D-CA), who has been a vocal critic of the bill, reportedly agreed to allow S. 697 to advance. On Thursday, a diverse alliance of advocates – including the American Chemistry Council and Environmental Defense Fund – rallied outside the Capitol to support the legislation.

However, the news and optimism was quickly overshadowed by the announcement on Monday, October 5, from Senators Richard Burr (R-NC) and Kelly Ayotte (R-NH) that they would block consideration of the TSCA reform bill unless reauthorization of the Land and Water Conservation Fund (LWCF) was added as an amendment.

The LWCF proposal was met with resistance by Senators Udall and James Inhofe (R-OK), chair of the Environment and Public Works Committee, who are trying to keep out amendments that are not “germane.” In a letter to Senate Majority Leader Mitch McConnell (R-KY), Senate Democratic leaders pushed for separate floor time to address the reauthorization of LWCF, with the hope of clearing the way for TSCA reform.

Instead, the Senate adjourned today for a week-long recess without voting on the matter, meaning the Udall-Vitter bill could not reach the floor until October 19, at the earliest. Senators Udall and McConnell are said to be working on resolving the LWCF roadblock in order to secure the passage of S. 697, which is expected to pass easily once the procedural hurdles of scheduling a floor vote are surpassed.

EPA issues final Significant New Use Rule for HBCD in textiles.

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EPA has released the prepublication version [PDF] of its final Significant New Use Rule (SNUR) for the brominated flame retardants hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). HBCD is persistent, bioaccumulative, toxic, and poses potential human health concerns, including reproductive and developmental effects. This Final Rule designates the use of HBCD in consumer textiles as a significant new use which must be reported to EPA at least 90 days in advance. Under this SNUR, consumer textiles include “bolts of cloth and draperies, as well as textiles that are part of household furniture and mattresses.” The Rule does not apply to the use of HBCD in motor vehicles or other current uses, such as non-consumer textiles, like firefighters’ suits, and building insulation.

The SNUR partially revokes the usual articles exemption, 40 CFR 721.45(f), meaning that the rule’s notification requirements apply to importers and processors of HBCD as part of a “textile article,” like an upholstered chair. Notably, the SNUR applies to all importers and processors of HBCD as part of a textile article, regardless of whether it is a “consumer textile.” EPA’s rationale is that “if the inapplicability of the exemption was limited to consumer textiles, undifferentiated textiles (e.g., the type of textiles that could be for a consumer use or a non-consumer use), could be imported or processed and distributed in commerce for consumer use without notification to the Agency.”

The SNUR subjects exporters of HBCD in consumer textiles to the export notification requirements of Section 12(b) of the Toxic Substances Control Act (TSCA). However, EPA declined to require § 13 import certification for HBCD as part of articles.

EPA has made two changes to this SNUR since it was first proposed in 2012. First, the agency narrowed the inapplicability of the articles exemption to apply only to importers and processors of HBCD as part of a textile article. Thus, importers and processors of HBCD in non-textile articles are not subject to the SNUR. In addition, EPA made minor clarifying changes to its definition of “consumer textile,” which is now defined as follows:

Consumer textile means any cloth, fabric, or other item produced during a milling process for textiles (including spinning, weaving, knitting, felting, or finishing), that is sold or made available either as a product or as part of a product, to a private individual who uses it in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. Consumer textiles can include, but are not limited to, bolts of cloth and draperies, as well as textiles that are part of upholstered household furniture and mattresses.

EPA also rejected commenters’ requests to establish a “policy framework by rule for the issuance of article SNURs.” The agency responded that a policy framework was not necessary to reach the conclusion that notification should be required for importing or processing HBCD in consumer textiles.

HBCD has recently been subject to significant scrutiny by EPA and others. Last month, EPA issued initial documents for its TSCA Work Plan risk assessment of HBCD in foam and polystyrene products. In 2014, EPA’s Design for Environment (DfE) program released an Alternatives Assessment for HBCD, identifying safer alternatives in foam insulation applications. The Consumer Product Safety Commission (CPSC) has been petitioned by a coalition of environmental, health, and consumer advocates to ban certain products containing HBCD and related flame retardants. Outside the U.S., HBCD was added as a prohibited substance to the Stockholm Convention on Persistent Organic Pollutants and is being withdrawn in Europe under REACH.

 

EPA releases initial TSCA Work Plan assessments of four flame retardants.

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Last week, EPA released preliminary assessment documents for four structurally similar flame retardant chemical clusters. These documents represent the first step in the Toxic Substances Control Act (TSCA) Work Plan Chemical assessment process for these substances, which were all on the Work Plan list. The TSCA Work Plan is the agency’s program to evaluate potential risks of existing chemicals, first introduced in 2012 and updated in 2014. The notice of the availability of these assessments will be published in the Federal Register on August 18.

EPA released Problem Formulations and Initial Assessments for three flame retardant chemical clusters:

  • Tetrabromobisphenol A (TBBPA), also known as Brominated Bisphenol A – used in plastics and printed circuit boards;
  • Chlorinated phosphate esters – used in furniture foams and textiles; and
  • Cyclic aliphatic bromides/hexabromocyclododecane (HBCD) – used in expanded polystyrene foams and polystyrene foam products.

The Problem Formulations and Initial Assessments discuss likely exposure and hazard scenarios to workers and consumers, based on current production, use, and exposure information. These assessments aim to identify scenarios where further risk analysis may be necessary. In the case of these three flame retardants, EPA will conduct assessments of risk to human health (workers and consumers) and the environment. EPA will accept public comment on these Problem Formulations and Initial Assessments for 60 days.

In addition, EPA released a Data Needs Assessment for the Brominated Phthalates (TBB and TBPH) cluster of flame retardants used in polyurethane foam products. After reviewing previous assessments of this cluster, EPA identified critical gaps in existing data on toxicity, exposure, and commercial mixtures. The Data Needs Assessment for brominated phthalates is meant to guide the collection of additional data and information and provide stakeholders and the public with the opportunity to submit data or information that may fill the identified gaps. As information is identified or submitted, the agency will “continue to evaluate the adequacy of the database to conduct a risk assessment that can inform decision making.” Public comment on the Data Needs Assessment will be accepted for 120 days.

EPA to hold training webinars on TSCA section 5 e-PMN electronic reporting system.

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Today, U.S. EPA announced a series of webinars to assist submitters with the agency’s new web-based system for Toxic Substances Control Act (TSCA) Section 5 submissions. The new electronic reporting system, finalized by rule last month, applies to premanufacture notices (PMNs) and certain other § 5 notices and support documents. The three webinars will walk submitters through the process of registering with EPA’s Central Data Exchange (CDX) and using the new, cloud-based e-PMN software to complete PMNs and other submissions. The webinars are scheduled for August 26, September 16, and September 30; audio recordings and slides will be posted online for those unable to attend.

EPA issues new electronic reporting rule for TSCA section 5.

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Today, EPA released a pre-publication version of a new rule for electronic reporting under section 5 of the Toxic Substances Control Act (TSCA). The action, which comes in the form of a Direct Final Rule, amends the regulations governing the electronic submission of premanufacture notices (PMNs), other TSCA § 5 notices, and related documents to EPA. The rule provides for various new procedures and requirements for registration, reporting and submission, including new ways to access and complete the electronic-PMNs (e-PMNs), changes to the registration process for the Central Data Exchange (CDX), and requiring all “bona fide intents to manufacture” notices to be submitted electronically. The Agency’s intention in passing this rule is “to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and the EPA.”

The Agency previously issued a Final Rule in January 2010 requiring the use of e-PMN reporting software for the submission of PMNs, other TSCA § 5 notices, and related documents through CDX. The new rule mandates the use of a new version of the e-PMN software, which is cloud-based. Firewall and file submission size limitations from the old version of the software have been eliminated.

Other minor changes to the regulations include:

  • Corrections of regulatory cross- references in 40 CFR parts 720 and 721;
  • Standardizes use of “manufacture” and similar language in parts 720, 721, and 725; and
  • Specifies electronic reporting procedures for the notification of new manufacturing sites pursuant to 40 CFR 723.50(j)(6)(ii).

After this rule, the only submissions related to TSCA § 5 that cannot be handled via e-PMN are:

  • Certain notices, like polymer exemption annual reports;
  • Certain support documents, including § 5(e) consent orders;
  • Certain communications, such as pre-notice communications and TSCA Inventory correspondence.

The Agency “may consider offering electronic reporting of these and other submissions in the future.”

The rule is scheduled to be published on Monday, July 20, and will become effective 180 days thereafter, unless EPA receives adverse comment within 30 days of the rule’s publication date. EPA will begin accepting submissions via the new e-PMN system beginning 45 days after the rule’s publication.

Senate leaders urged to consider competing TSCA reform bills.

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Since our last update, U.S. lawmakers and other stakeholders have kept busy with competing legislation to reform the Toxic Substance Control Act (TSCA), with the hope of bringing the issue to the Senate floor for debate before the August Congressional recess. The TSCA Modernization Act of 2015 (H.R. 2567) passed the House by a vote of 398-1 on June 23, while the Udall-Vitter bill (S. 697), which was approved by the Senate Environment and Public Works Committee in April, continues to await scheduling for a floor vote.

Last week, Democratic supporters of the bipartisan Udall-Vitter bill urged Senate leaders to bring the bill to a floor vote “as soon as possible.” In a letter addressed to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Harry Reid (D-NV), thirteen senators lauded S. 697 as “stronger and more comprehensive” than the House bill. The lawmakers criticized the House bill for creating a “virtually unlimited pathway for chemicals favored for review by industry.” The Democrats also took issue with the House bill for failing to overhaul the new chemical review program, provide for an independent funding mechanism, limit animal testing, or mandate EPA to review Confidential Business Information (CBI) claims.

A vocal critic of S. 697, Sen. Barbara Boxer (D-CA) joined a group of environmental and public health organizations in lobbying for adoption of the more limited House bill, which she called “the best approach for meaningful TSCA reform.” Led by the Safer Chemicals, Healthy Families coalition, 57 advocacy groups sent a letter [PDF] advocating the House bill as “more appropriate to use as the vehicle for changes as the process moves forward.” The coalition stressed that if the Senate proceeds with S. 697, then the bill’s “primarily failings” – including provisions regarding state preemption and the “low-priority loophole” – must be addressed.