OSHA releases Hazard Communication Standard inspection procedures.

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The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has released a new Directive outlining the changes in enforcement caused by the modification of the Hazard Communication Standard (HCS 2012) to harmonize with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new Directive, titled Inspection Procedures for the Hazard Communication Standard (HCS 2012), describes how to determine if a violation has occurred under the revised standard as well as how it will be enforced both during its transition period and after full implementation.

The Inspection Procedures note that HCS 2012 is based on GHS Revision 3 (2009), not the more recent Revisions 4 or 5 issued by the UN in 2011 and 2013, respectively. The Directive notes that using a more recent version of GHS may result in noncompliance with HCS 2012 “if it contradicts or casts doubt on OSHA required information.” Notably, OSHA requires that precautionary and hazard statements incorporated from GHS be changed to mandatory, e.g., “should” must be replaced with “shall.”

The Directive provides significant discussion on hazard classification under the revised standard. Classification must be based on criteria specific to each hazard class, and evaluations must “consider all available data on the hazards.” Other considerations include quality and quantity of data and positive and negative results in a single weight-of-evidence determination. Detailed evaluation procedures are included in the Directive’s appendices. In terms of inspection guidelines, the Directive notes that “[t]he adequacy of a company’s hazard classification should be assessed primarily by examining the outcome of that classification.”

The HCS 2012 labeling and SDS requirements went into effect on June 1, 2015 (except for distributors, for whom labeling requirements do not apply until December 1, 2015). However, where a company has “exercised ‘reasonable diligence’ and ‘good faith’ to obtain HCS 2012-compliant SDSs from upstream suppliers but have not received them, they will be allowed limited continued use of HCS 1994-compliant MSDSs and labels.”

Canada imposes new reporting requirements for nanoscale substances.

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Canada’s Minister of the Environment is requiring manufacturers and importers of certain nanoscale substances to report information for “the development of a list of nanomaterials in commerce in Canada and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities.”

A notice published in the Canada Gazette on July 25 lists 206 substances by CAS number. A listed substance is reportable if it “has a size of between 1 and 100 nanometres in at least one external dimension, or internal or surface structure.” The Minister of Environment intends to use the reported data to assess whether the listed substances “are toxic or are capable of becoming toxic,” or to assess whether and how to control the substances.

The reporting requirements apply to any person who manufactured or imported more than 100 kg of a listed nanoscale substance in calendar year 2014, including imports of substances in mixtures and products, at any concentration. However, the notice does not apply to listed nanoscale substances that are in transit through Canada, are naturally occurring, were incidentally produced, or are covered by various other laws, such as the Fertilizers Act or Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations.

Reportable information includes total quantities manufactured or imported, end uses (commercial, consumer, or use by children under 14 years of age) and studies or data on physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, and release or disposal from the final mixture or product. The reporting deadline is February 23, 2016.

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.

TSCA Modernization Act approved by House Energy and Commerce Committee, floor vote expected by end of June.

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Today, the House Energy and Commerce Committee approved the TSCA Modernization Act (H.R. 2576), setting up the bill for a floor vote currently scheduled for June 23. The vote was 47-0 with one abstention, by Rep. Anna Eshoo (D-CA), who warned of the legislation’s insufficient protections for state chemical laws. Rep. John Shimkus (R-IL), the initial author of the proposal, also won adoption of a technical amendment [PDF] making minor changes to the bill’s language.

The preemption of state laws has been a major sticking point in this year’s proposals to reform the Toxic Substances Control Act (TSCA) in both the House and Senate. Notwithstanding changes to the TSCA Modernization Act designed to address those concerns, environmental and public health advocacy groups have not dropped their opposition to the bill. In addition, a dozen state Attorneys General representing California, Massachusetts, New York, and Maryland, among other states, sent a letter [PDF] last week to Energy and Commerce Committee leaders Fred Upton (R-MI) and Frank Pallone (D-NJ). In the letter, the Attorneys General expressed concern that the bill “scales back the states’ police powers and inhibits the traditional state-federal partnership that protects the public from toxic chemicals.” Following promises from Rep. Upton to negotiate new state preemption language before the floor vote, Rep. Eshoo agreed to withdraw her own proposed amendment [PDF] meant to clarify ambiguities on state authority. Rep. Pallone suggested that the state authority issues might be addressed later, although Rep. Shimkus suggested that the scope of the proposed changes may be too disruptive to win sufficient support for passage.

While the Environmental Working Group criticized the bill’s approval, saying the legislation “falls short,” industry groups responded favorably and continue to push for action in the Senate. Over 140 trade groups ranging from the Alliance of Automobile Manufacturers to the U.S. Chamber of Commerce, organized as the American Alliance for Innovation sent a letter [PDF] to Senate Majority Leader Mitch McConnell (R-KY) urging the swift passage of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” which they described as a “balanced compromise.” Yesterday, Bloomberg BNA reported that Sen. McConnell had not scheduled floor time for the bill yet, so it would not reach the floor until July or August.

TSCA reform: NYT calls for more high-priority chemical assessments, House bill formally introduced.

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Even while Congress is in recess this week, the cause of reforming the Toxic Substances Control Act (TSCA) continues to progress. Notably, the New York Times Editorial Board is calling for stronger regulation of chemicals by requiring and empowering EPA to evaluate “at least 20 high-priority chemicals a year of its own choosing.” The editorial describes the current TSCA reform proposals in Congress as “a substantial improvement” while simultaneously decrying the bills’ failure to provide “speedy evaluations of the most worrisome chemicals among tens of thousands that have never been tested for safety.” The Times notes the “remarkable feat” of attracting 20 Republican and 20 Democratic co-sponsors to the Senate bill, but criticizes the legislation’s “slow pace of designating high-priority chemicals that require safety assessments.” The editorial also claims that under the House proposal, EPA would be tied up with conducting industry-initiated assessments instead of “chemicals the agency might regard as posing the highest risk.”

Meanwhile, Rep. John Shimkus (R-IL) formally introduced his bill, the TSCA Modernization Act of 2015 (H.R. 2576), on Tuesday. The legislation’s initial co-sponsors are Representatives Fred Upton (R-MI), Frank Pallone (D-NJ), and Paul Tonko (D-NY). The bill was unanimously approved by the House Subcommittee on Environment and the Economy earlier this month.

Rep. Shimkus’ TSCA reform bill receives unanimous, bipartisan approval in House Subcommittee.

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The House Subcommittee on Environment and the Economy unanimously approved the Toxic Substances Control Act Modernization Act of 2015, a revised version of the bill first introduced by Subcommittee Chair Rep. John Shimkus (R-IL) last month to fix key flaws in the Toxic Substances Control Act (TSCA). At today’s markup, Rep. Shimkus said he was “more encouraged than ever” that the outdated law would finally be modernized to meet the public’s expectations and protect human health and the environment.

Yesterday, Rep. Shimkus was joined by new co-sponsors Rep. Paul Tonko (D-NY), Ranking Member of the Subcommittee; Rep. Fred Upton (R-MI), Chair of the Energy and Commerce Committee; and Rep. Frank Pallone (D-NJ), Ranking Member of the full Committee, in unveiling changes to the draft bill and calling for the legislation’s passage. The changes addressed some of the most criticized and controversial aspects of the original draft and TSCA reform, including timelines for chemical assessments and federal preemption of state laws.

Rep. Shimkus emphasized that the revised legislation’s basic approach remained the same as in his original draft: empowering EPA to review existing chemicals on the market and “make science-based decisions about whether they pose an unreasonable risk of injury to human health or the environment.” Under the bill, EPA would first assess the safety of a chemical based on hazard and exposure. Cost and other economic factors, including benefits, would not be considered until the second step, when EPA chooses how to regulate the assessed chemical, and a “reasonable transition period” would be required.

Changes from the original bill include:

  • Requires EPA to complete at least 10 chemical assessments per year and to issue risk management rules within 90 days completing an assessment;
  • Creates an accelerated path for assessing persistent, bioaccumulative, and toxic (PBT) substances;
  • Sets different timelines for completing assessments depending on whether they are initiated by EPA or requested by industry;
  • Explicitly preserves private causes of action and existing state laws not in conflict with TSCA, including California’s Proposition 65 and other chemical laws passed before August 1, 2015;
  • Limits the effectiveness of federal preemption of state chemical laws until after EPA makes a final assessment decision;
  • Ensures that user fees are spent only for specific purposes, rather than deposited in the Treasury’s General Fund;
  • Allows EPA to issue five-year “critical use” exemptions for chemicals if the agency’s regulatory requirements would not be cost-effective for a specific use and EPA determines that application of the requirement “would significantly disrupt the national economy, national security, or critical infrastructure.”

While subpanel members were all supportive of the new draft, some remaining issues were highlighted. Rep. Shimkus encouraged a bipartisan effort to amend TSCA section 8, which the current draft does not address.

Both industry and environmental groups have voiced support for the new version of the bill. The American Chemistry Council called it “balanced” and “pragmatic,” while the Safer Chemicals Healthy Families coalition said the changes brought the legislation “within striking distance of meaningful, if limited, reform.”

The bill now proceeds to the full Energy and Commerce Committee, which may schedule a markup as soon as next week.

Udall-Vitter TSCA reform bill gains momentum on the way to Senate floor; House markup expected soon.

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The bipartisan Senate bill to modernize the Toxic Substances Control Act (TSCA) conforms to the Obama Administration’s principles for TSCA reform, said EPA Administrator Gina McCarthy, thus adding momentum to Congress’ protracted effort to overhaul the nation’s outdated chemical safety laws. While appearing last week before the Senate Subcommittee on Appropriations for Interior, Environment and Related Agencies, McCarthy lauded recent changes to S. 697, which was approved by the Senate Environment and Public Works Committee last week. Responding to questions from Senator Tom Udall (D-NM), who introduced the legislation along with Senator David Vitter (R-LA), McCarthy noted that EPA Assistant Administrator for Chemical Safety and Pollution Prevention Jim Jones had previously identified the proposal’s shortcomings, but “the most recent amendments really addressed those issues.” McCarthy also confirmed that the Udall-Vitter bill would provide EPA with the “tools it needs” to effectively regulate asbestos, saying the agency could designate asbestos as a high priority chemical subject to assessment and regulatory determinations.

After meeting with Senate Majority Leader Mitch McConnell (R-KY) to schedule floor time for the bill, Sen. Udall expects S. 697 to reach the Senate floor in June, where it might take three to six weeks to pass as other legislators, including Senator Barbara Boxer (D-CA), are likely to offer several amendments. Senators Vitter and Jim Inhofe (R-LA) are also expected to discuss the matter with the Majority Leader soon, although Sen. McConnell’s office says no decision on scheduling has been made yet.

On the House side, Sen. Udall said that the Subcommittee on Environment and the Economy would hold a markup on May 18, calling it “a very good sign” that both bodies were “moving in tandem.” The legislation in the House, introduced by Rep. John Shimkus (R-IL), provides for a more limited overhaul of TSCA and does not currently contain the controversial state preemption provisions found in the Senate bill. Rep. Shimkus told E&E Daily that he is a “big fan” of the compromise amendments made to S. 697 which won over support from Democrats.

Critics of S. 697, including the Environmental Working Group and Safer Chemicals Healthy Families coalition, are more sanguine about Rep. Shimkus’ bill because it does not present the “regulatory void” problem found in S. 697, where states would be prevented from banning chemicals while EPA is in the process of reviewing the substances for potential regulatory action. Other stakeholders are skeptical of the House legislation’s limited scope; E&E Daily reports that Environmental Defense Fund senior scientist Richard Denison said the bill fails to fix “even the core problems of TSCA.” American Chemistry Council spokesperson Ann Kolton told E&E Daily that the industry group “will be ready to support efforts in any way we can be helpful to find the right balance between the two bills.”

If both the House and Senate bills pass, legislators would face significant challenges in reconciling the two proposals in conference committee, particularly regarding the issue of state preemption.

EPA releases interim guidance on data requirements for antimicrobial pesticides and food contact surfaces.

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Last week, EPA released interim guidance on the agency’s toxicology data requirements for antimicrobial pesticides on food contact surfaces. The interim guidance clarifies that the 200 parts per billion (ppb) threshold that triggers different data requirements is based on “total estimated daily dietary intake” for an individual and not the total amount of residue on a food item, which interpretation is in line with the policy of the U.S. Food and Drug Administration (FDA). Generally, if pesticide residues from food contact services are found in food at 200 ppb or less, EPA requires the submission of certain toxicology data, and additional data may be required if residues are greater than 200 ppb.

The interim guidance was issued as part of a March 2, 2015 settlement reached between the EPA and the American Chemistry Council (ACC) resolving the trade group’s challenge of EPA’s 2013 Final Rule on “Data Requirements for Antimicrobial Pesticides.” The settlement also requires that EPA propose, by July 2, 2015, a guidance document called the “Antimicrobial Pesticide Use Site Index,” which will be subject to public comment. In addition, by September 2, 2017, the agency must propose a “correction” to 40 C.F.R. § 158.2230(d) clarifying that the 200 ppb level relates to total estimated daily dietary intake, consistent with the FDA policy.

Udall-Vitter TSCA reform bill approved by Senate EPW Committee.

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The prospects for passing legislation to modernize the Toxic Substances Control Act (TSCA) have improved considerably with the approval of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” by the Senate Environment and Public Works Committee. In a 15-5 vote, the Senate panel passed a compromise version of the legislation, called a “manager’s amendment,” following weeks of negotiation which won over the support of Senators Sheldon Whitehouse (D-RI), Jeff Merkley (D-CO), and Cory Booker (D-NJ). Lawmakers announced late yesterday that they had reached an agreement on changes to the bill, which was originally introduced in March by Senators Tom Udall (D-NM) and David Vitter (R-LA). According to E&E Daily and the Huffington Post, the compromise changes include:

  • State preemption: States can regulate specific chemicals when EPA is in the process of making a safety determination, but new restrictions are preempted if EPA “defines the scope of the uses of a chemical.” If EPA fails to meet deadlines for safety determinations or state waiver requests, states automatically receive a waiver keeping state law in effect. States will also be allowed to impose chemical disclosure requirements and keep existing chemical bans effective before August 1, 2015 (previously January 1, 2015).
  • State co-enforcement: States will continue to be able to co-enforce federal laws; penalties may not be collected for the same offense.
  • Prioritization standards: Chemicals are to be designated as high priority if they present “significant” hazard and exposure, instead of “high” hazard and “widespread” exposure. The designation of a chemical as low priority will be subject to a 90-day comment period.
  • Persistent, bioaccumulative, and toxic (PBT) chemicals: EPA will be required to prioritize PBT chemicals for review from the current TSCA Work Plan list.
  • Requested assessments: Companies can request the assessment of a particular chemical, but EPA is not required to count such assessments towards the agency’s annual quota of assessments. These requested assessments would have no effect on state laws until a final regulatory action is taken by EPA. A limit on requested assessments relative to agency-initiated assessments will also be imposed.
  • Product imports: The compromise bill removed a section making it more difficult for EPA to regulate articles under the safety evaluation process.

Senator Barbara Boxer (D-CA), who had introduced a competing TSCA reform proposal, offered several amendments in Committee, but none attracted sufficient votes to pass. While vowing to continue lobbying for her amendments – which would give states more power, set tighter deadlines, and require EPA to target asbestos and track and act on local disease clusters, etc. – Sen. Boxer praised the compromises, saying, “We got rid of a horrible bill. We have a bill that makes progress.” Most environmental and health advocacy groups have also applauded the Senate panel’s work, calling it “an important milestone,” but are continuing to call for changes.

The bill is expected to proceed to the full Senate in the coming weeks.