Final OSHA Rule Published on Globally Harmonized System of Classification and Labeling of Chemicals

GHS/HazCom:

March 26, 2012, the Federal Register published OSHA’s final Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  With this rule OSHA has modified its Hazard Communication Standard (HCS) to be consistent with to the United Nations’ System.

GHS Requirements

OSHA estimates that 880,000 hazardous chemicals are currently used in the U.S., and over 40 million employees are now potentially exposed to hazardous chemicals in over 5 million workplaces.  Approximately 75,000 firms create hazardous chemicals (i.e., products, substances, or mixtures) for which new labels and ‘safety data sheets’ (formerly material safety data sheets) will be required.

OSHA explains that implementation of the GHS will improve HCS by changing the performance requirements for labels to the GHS-specific requirements that labels include four standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s).  The appropriate label elements for a chemical are to be determined by the hazard classification.  Standardized label elements will better convey critically important hazard warnings, and provide useful information regarding precautionary measures that will serve to better protect employees than the performance-oriented approach of the current rule.

Chemical manufacturers and importers will be required to re-evaluate chemicals according to the GHS criteria.  Chemicals must be classified based on the type and degree of hazards posed.  For health hazards, this will involve assigning the chemical both to the appropriate hazard category and subcategory (called hazard class).  For physical hazards new criteria are generally consistent with current DOT transportation requirements.  Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers will also be required.

Jurisdiction

The rule adopts only sections of the GHS within the scope of OSHA jurisdiction.  DOT, CPSC and EPA will implement GHS at a later date.  EPA and OSHA have worked together to develop a common position on coverage of pesticides and chemicals.  The GHS will not require additional labels on pesticides labeled under EPA requirements; that is, the final products that enter into commerce.  However, OSHA GHS requirements will apply to the other chemical ingredients of pesticides; the ‘inactive’ ingredients or cleaning products that are hazardous.  This is a continuation of current OSHA HCS worker protection requirements.  OSHA anticipates that EPA will provide guidance to their regulated community on how to develop an OSHA GHS-compliant SDS to avoid conflict with pesticide labeling requirements.

Key GHS Elements

Hazard communication.  A key goal of the final GHS is to better communicate hazard information to those most at risk—the workers exposed to hazardous chemicals Hazard communication requirements are provided in 29 CFR § 1910.1200.  Appendix C, Allocation of Label Elements, details how specified label elements apply to each hazard class and hazard category.  Appendix D, Safety Data Sheets, specifies requirements for the 16 SDS elements.

Concentration limits.  OSHA announced it will require the most protective GHS concentration limits for hazard classifications.  For example, for sensitizers and reproductive toxins, the final rule requires information to be provided on labels and safety data sheets at concentrations above 0.1%.  (See e.g., Appendix C, Allocation of Label Elements.)

Precautionary statements.  In addition to hazard statements, the GHS requires precautionary statements that describe recommended measures that should be taken to protect against hazardous exposures, or improper storage or handling of a chemical.  (See Appendix D, Safety Data Sheets).  Precautionary statements must also address hazard information necessary to protect workers from “hazards not otherwise classified that have been identified during the classification process.” (See Table D.1.)

Mixtures.  Health hazards posed by mixtures should be addressed based on the risks posed by the mixture itself, rather than by the hazards posed by the component chemicals individually.  The GHS does allow alternative classification methodologies where primary data are unavailable, including extrapolation and bridging.  The rule specifies procedures for determining whether mixtures are covered by the Standard.

Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information.  New information about hazards and ways to protect against hazards must be added to the SDS within three months.

OSHA has modified General Industry Standards containing hazard classification and communication provisions so that they will be internally consistent and aligned with the GHS modifications to the HCS.

Implementation

Timeline.  Compliance with all of the provisions for preparation of new labels and safety data sheets is required by June 1, 2015.  Distributors will be allowed an additional six months to distribute containers received from chemical manufacturers and importers with the old labels and MSDSs in order to accommodate those they receive very close to the compliance date.  Workplace labels and training programs must be updated by June 1, 2016.

State implementation.  OSHA intends to closely scrutinize amendments to previously approved State hazard communication standards to ensure equal or greater effectiveness, including assurance that any additional requirements do not conflict with, or adversely affect, the effectiveness of the national application of OSHA’s standard.

Guidance.  OSHA will be offering guidance materials such as quick cards and fact sheets to aid firms in developing and implementing the training requirements of this rule.  OSHA will also be releasing a small business compliance guide to provide additional guidance to small businesses, which will ease the economic impact and compliance burden.

Next Steps

OSHA notes that the GHS is a living document, and the UN actively reviews it and considers possible changes based on implementation experiences and other information.  These changes are made on a two-year cycle, referred to as a biennium.  The OSHA proposal and the final rule are based on Revision 3 of the GHS.  OSHA will undertake future rulemaking as necessary to reflect new technological and scientific developments and UN revisions to GHS requirements.

Although not addressed in the rule, OSHA discusses interest in the development of a common classification database.  The European Union plan to deploy one.  Japan, Taiwan, South Korea, and New Zealand have already done so.  However, classifications in these databases are not necessarily the same for the same chemical.  OSHA would like an international database of classifications developed and maintained.  A UN Sub-committee has been established to explore the issue further.

DTSC Delay of Official Draft SCPA Regulation Is Too Coincidental

Green Chemistry Regulations:

As of Friday, stakeholders have reason to doubt the assertions of good faith by the Department of Toxic Substances Control (DTSC).  As readers will undoubtedly know, DTSC has made a concerted effort to reassure stakeholders that it’s operating in good faith – protecting the interests of all stakeholders – when drafting the Safer Consumer Product Alternatives (SCPA) Regulation.  There are YouTube videos and Facebook feeds, and many public meetings have been held.  That facade crumbled Friday.

Last week, DTSC made known that it was deferring until April publication of the official draft of the SCPA Regulation.  The regulation had been scheduled for publication this month, launching the formal rulemaking process.  The delay in itself wasn’t necessarily bad; DTSC could have needed time to refine the regulation in response to the hundreds of pages of public comments it received on the last informal draft. 

On Friday, however, Director Raphael’s confirmation hearing was scheduled for — you guessed it — this month, March 28 to be exact.  Surprise!  So, gone is the opportunity for questioning on the official draft.  No one at the hearing will know – except DTSC staff and other insiders – what the formal draft looks like.  One has to ask:  Why the secrecy?  Why the avoidance?

Delaying publication until after the DTSC Director’s confirmation hearing arguably signals a lack of good faith.  The timing in no way appears coincidental.  One would be justified in expecting the impending draft to be quite controversial.  Whose ox is getting gored is anyone’s guess, although suspicions abound given the deaf ear DTSC has recently turned to a number of industry’s legitimate concerns (e.g., hazard identification, de  minimis thresholds).

Stay tuned for more posts on this impending and important regulatory development. 

OSHA Requests Public Comment on Extending the Information Collection Requirements in the Cadmium in General Industry Standard

OSHA:

On March 6, 2010, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice (77 FR 13359), requesting public comments concerning its proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements set out in the Cadmium in General Industry Standard (29 CFR 1910.1027).  The proposal would extend current requirements into 2015.  According to OSHA, the industries likely to be effected include chemical mixers, utilities, and electroplaters.  OSHA estimates that nearly 50,000 facilities are covered by the rule.  The agency is requesting public comments to ensure that information collection occurs in a way that minimizes paperwork and related burdens on employers.  The docket includes both the FR notice and OSHA’s Information Collection Supporting Statement.  

Requirements Proposed for Extension

According to OSHA, the information collection requirements in the Cadmium General Industry Standard  protect workers from the adverse health effects that result from their exposure to cadmium.  The major information collection requirements of the Standard include:  

  • conducting worker exposure monoring,
  • notifying workers of their cadmium exposures,
  • implementing a written compliance program,
  • implementing medical surveillance of workers,
  • providing examining physicians with specific information,
  • ensuring that workers receive a copy of their medical surveillance results,
  • maintaining workers’ exposure monitoring and medical surveillance records for specific periods, and
  • providing access to these records by OSHA, the National Institute for Occupational Safety and Health, the worker who is the subject of the records, the worker’s representative, and other designated parties.

Topics for Public Comment

OSHA is particularly interested in public comments on the following topics:

  • whether the proposed information collection requirements are necessary for the proper performance of the agency’s functions, including whether the information is useful;
  • the accuracy of OSHA’s estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
  • the quality, utility, and clarity of the information collected; and
  • ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

* * * * *

Additional information on OSHA general industry requirements and guidance materials may be found on OSHA’s website.

Environmental Advocates Want Disclosure of Chemicals in Consumer Products

Chemicals in Consumer Products:

Researchers at the Silent Spring Institute argue that the findings of their consumer product evaluation illustrate the need for full disclosure of ingredient information. The Institute tested consumer products — ranging from toothpaste to laundry detergent — for compounds identified as either endocrine disruptors or asthma-related. Most products evaluated by the Institute included one or more “chemicals of concern.”  In their report, the researchers emphasize that current chemical testing and product labeling requirements do not prevent the use of hormone disruptors or asthma-associated chemicals in products or provide enough information for consumers to avoid them. Silent Springs published its findings in the March 8, 2012 issue of the National Institute of Environmental Health Sciences’ Environmental Health Perspectives.  The report has proven highly controversial and been severely criticized by industry for a flawed methodology and equating the mere presence of a chemical in a product with a lack of product safety.

The Institute, and other environmental and public health advocates, clearly plan to use the report to support their arguments for robust reforming of TSCA, the primary federal statute for regulating chemicals in the United States.  Such advocates argue that many consumer products contain chemicals known to adversely affect human health. They note that for numerous common commercial chemicals, information about their presence in consumer products is limited. In particular, little information is available about hazardous chemical exposures from personal care and cleaning products.

The Institute found 55 chemicals of concern in conventional and “green” consumer products. The evaluation assessed consumer products for the presence of 66 known endocrine disruptors and asthma causing chemicals. Tested consumer products ranged from toothpaste to laundry detergent. The researchers found bis-2-ethylhexyl phthalate, diethanolamine, and glycol ethers in high concentrations. They found phthalates, monoethanolamine, alkylphenols, parabens, and cyclosiloxanes in many of the products.  Sunscreens and scented products such as air fresheners and dryer sheets contained both the largest number of target chemicals and some of the highest chemical concentrations. However, the Institute did not report whether these chemicals were present above limits setting safe levels of exposure.  For example, the National Institute for Occupational Safety and Health recommends diethanolamine exposure be limited to 3 parts per million.

The researchers allege that regulations require only limited product labeling, thereby limiting the information available to consumers.  Personal products such as sunscreens, deodorants, and anti-bacterial hand soaps are largely regulated as over-the-counter drugs by the FDA. FDA regulations mandate only that “active” ingredients be identified on product labels.  The Institute asserts that EPA has primary regulatory oversight of cleaning products, and only when these products are pesticide products (e.g., products that will kill bacteria and viruses) is active ingredient labeling required. Many consumer products call themselves “natural,” “non-toxic,” and “green;” however, the Institute contends that these terms are unregulated and the chemical contents of such products do not necessarily differ from comparable products.

The Institute also argues that gaps in ingredient information are also problematic for regulators.  It argues that EPA, for example, relies on ingredient concentrations in products for exposure modeling. 

And lastly, the researchers conclude that further study of the risks posed by the types of chemical mixtures that are found in personal care products, cleaning products, etc. are needed to understand their effects on human health.

US News, Forbes, Consumer Reports, and many other news outlets have published stories on this report.

EPA Releases Draft Chemical Regulation Priorities for Fiscal Year 2013

Chemical Regulation:

Readers interested in EPA FY 2013 plans may wish to review the Agency’s draft National Program Manager (NPM) Guidance plans. The draft plan from the Office of Chemical Safety and Pollution Prevention (OCSPP) discusses priorities for the Office of Pesticide Programs (OPP), the Office of Pollution Prevention and Toxics (OPPT), and regional priorities. Also addressed are OCSPP efforts with respect to environmental justice and plans for collaboration among EPA programs and offices.

The NPM stresses EPA plans for Sustainable Materials Management (SMM) and Pollution Prevention (P2). SMM efforts will work to reduce negative environmental and societal impacts across material life. P2 programs will facilitate the development of safer, “greener” materials and products. A key element of P2 efforts is the Agency’s green chemistry program. (See e.g., Design for the Environment–EPA’s Safer Product Labeling Program for further information on EPA’s Green Chemistry efforts.)

Hazard assessment and risk management will comprise OCSPP efforts to address disproportionate risks to children and other vulnerable populations. In addition, OCSPP plans to build on existing activities to meet environmental justice goals.

The NPM also reports that OCSPP and the Office of Enforcement and Compliance Assurance (OECA) will continue efforts to enhance collaboration between the two offices to enhance Agency efforts to protect the public and environment from chemical risks.

NRDC Recommends Improvements to Chemical Risk Assessment Methods

Chemical Risk Assessment: 

Readers following efforts to improve chemical management and control in the United States may be interested in a recent National Resources Defense Council (NRDC) White Paper, Strengthening Toxic Chemical Risk Assessments to Protect Human Health.  In the White Paper, NRDC reaches several conclusions in reliance on National Academy of Sciences (NAS) findings that significant improvements in both chemical testing and risk assessment are needed to protect people from toxic chemicals.  NRDC emphasizes the need to address the following:

  • the range of human exposures and vulnerabilities,
  • data gaps and uncertainties, and
  • impacts of exposure to multiple chemicals.

NRDC also argues that risk assessment should not presume that a zero effect exposure level exists, unless there are sufficient data to support this assumption.

Each of NRDC’s points is discussed further below.

Citing the NAS findings, NRDC concludes that differences among human exposures and individual vulnerabilities are important determinants of risk.  NRDC therefore recommends that risk assessment consider vulnerable individuals and those who are more highly exposed.  NAS had noted that a broad variety of factors, including nutrition, health status, and psychosocial stress, can increase and individual’s vulnerability to toxic chemicals, and these factors—and their variability—need to be incorporated into risk assessments so that adequate measures can be employed to protect public health.  NRDC also cites an NAS recommendation that risk assessments incorporate analyses that address the uncertainty and variability inherent in a risk assessment—including uncertainty and variability in the measurement of chemical releases into the environment, environmental fate and transport, exposure assessment, dose-response assessment, and risk characterization.  

To address data gaps and uncertainties, NRDC stresses the need for agencies to develop robust risk assessments by updating default factors and assumptions.  It cites the NAS recommendation that agencies update risk assessment protocols based on the best current science.  NAS had identified significant missing default assumptions.  For example, most chemicals are not tested for their potential interference with the hormone systems that govern growth and development, learning, and behavior; the assumption being that chemicals have no effect on hormones—an implicit default assumption that may or may not be true.  And, NRDC noted, allowing such assumptions does not protect health.

NRDC emphasizes the need to address the impacts of multiple chemical exposures.  It faults risk assessment methodologies that focus on only single chemical exposure, rather than endeavoring to model the actual complexity of the world.  NRDC relies on a NAS finding that stressed the need for cumulative risk assessments that address the combined risks posed by aggregate exposure to multiple agents or stressors.  

And finally, the NRDC challenges the standard assumption that there is a safe level of exposure to most chemicals.   NRDC notes that NAS recommends risk assessments assume that all exposures, even low level, are associated with some level of risk, unless there are sufficient data to the contrary.  NRDC explains that science has found many examples of chemicals that increase the risk of various non-cancer health effects—such as reproductive harm and neurological effects—at low doses, without any scientifically-identifiable threshold.

For more information see the NAS reports:

France to require mandatory reporting of nanoscale materials in 2013

Nanotechnology:

France will implement a compulsory declaration scheme for the quantities and uses of nanoparticle substances or nanomaterials produced in, distributed in, or imported to France January 1, 2013. Information about material identity, quantity, uses, and users will be required from all companies producing, distributing and importing nanomaterials, and public and private research laboratories. The declaration scheme will be implemented by the Ministries of Ecology, Sustainable Development, Transport and Housing; Economic, Financial and Industrial Affairs; Labor, Employment and Health; and Agriculture, Food, Fisheries, Rural Affairs and Planning. Detailed information on reporting requirements will be published in the Official Journal of the French Republic.

The reporting mandate was published February 19, 2012 in Decree 2012-232 (available in French only) (the December 2011 draft decree is available in English). The decree explains that the purpose of the scheme is to improve knowledge of nanomaterials and their uses, to monitor the channels of use, to improve knowledge of the market and the volumes sold and to collect available information on toxicological and eco-toxicological properties.  Data on 2012 nanomaterial use must be submitted by May 1, 2013.

Reporting requirements affect materials that are at least 50 percent comprised of particles with one or more external dimension between 1 nm and 100 nm. When any such material is produced, imported or distributed in quantities of 100 grams, the user must declare identity of the producer, importer, or distributor; identity of the nanomaterial; quantity of nanomaterial produced, distributed or imported; intended uses, and identifying information about the professional users to whom the material has been distributed. Specifics of the reporting requirements include:

  • Identity of the producer, importer, or distributor:
    • business name, official address, VAT number; and
    •  apacity (manufacturer, importer or distributor) and field of activity.
  • Identity of the nanomaterial:
    • chemical identification of the substance,
    • potential presence of impurities,
    • average particle diameter and particle size distribution,
    • specific surface,
    • surface coating, and
    • surface charge.

 

EPA Denies TSCA Petition for Banning Lead Fishing Tackle

TSCA:

On February 14, 2012, EPA formally announced that it was denying the Center for Biological Diversity’s petition to ban or restrict lead (Pb) in fishing tackle  – fishing weights, sinkers, lures,jigs, etc. – pursuant to section 6 of the Toxic Substances Control Act (TSCA).  The agency stated succinctly:  “After careful review, EPA has determined that, while the petition does provide evidence ofexposure and a risk to waterfowl in some areas ofthe United States, it does not provide a basis for finding that the risk presented is an unreasonable risk for which federal action under section 6(a) of TSCA is necessary to adequately protect against such risks.”  In other words, CBD failed to show that (a) an unreasonable risk of injury was present, and (b) that risk required federal action to correct.   A copy of EPA’s letter is available here, and the Federal Register notice, setting out the complete supporting analysis, is available here.  CBD’s petition is avaialble here.

EPA reasoned that existing federal and state regulatory and educational efforts were sufficiently protective.   “Your petition does not demonstrate why federal action is necessary given the mix of regulatory and education actions state agencies and the Federal Government already are taking to address the impact of lead fishing tackle on local environments. The risk described in the petition does appear to be more prevalent in some geographic areas than others, and the trend over the past decade has been for increasing state and localized federal activity regarding lead in fishing tackle. The petition does not demonstrate that these state and local efforts are ineffective or have failed to reduce the exposure and risks presented to waterfowl in particular.”  In other words, the data simply weren’t there to support the petitioners’ request.

EPA Budget Would Increase Spending on Chemical Assessment and Control

EPA Budget/Chemical Control

According to an EPA press release, today the Obama Administration proposed a FY 2013 budget of $8.344 billion for the agency. The budget is $105 million below the EPA’s enacted level for FY 2012, but it increases spending by $11 million, or approximately 16%, to “protect … Americans from harmful chemicals.”  This increase for chemical assessment and control signals a clear intention to promote regulatory TSCA reform and related efforts in the absence of legislative reform. 

The press release states – “EPA is proposing $68 million, an increase of $11 million from FY 2012, to reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to toxic chemical information. Funding will sustain the agency’s successes in managing the potential risks of new chemicals coming into the market and accelerating the progress to help ensure the safety of chemicals on the market that have not been tested for adverse human health and environmental impacts.”

A complete copy of the agency’s budget proposal is available here.

EPA Fines Dover Chemical $1.4 Million for TSCA Violations – But Was EPA Really Looking for an Easy Way to Ban SCCPs?

TSCA Enforcement:

On February 7, 2012, the federal Environmental Protection Agency (EPA) and the Department of Justice (DOJ) announced a settlement with the Dover Chemical Company to resolve alleged violations of the premanufacture notice (PMN) requirements in section 5 of the federal Toxic Substances Control Act (TSCA).  Section 5 requires companies to file a PMN and receive EPA approval before manufacturing a “new” chemical – i.e., one not listed on the TSCA Inventory of existing chemical substances.  EPA accused Dover of failing to file PMNs before manufacturing various chlorinated paraffins at the company’s facilities in Ohio and Indiana.  Although the settlement is noteworthy in demonstrating EPA’s willingness to reinterpret the TSCA Inventory and enforce that reinterpretation, it is perhaps more noteworthy because it suggests EPA is willing to use enforcement as a shortcut to banning substances, as described in the last paragraph of this posting.  A copy of the settlement agreement is available here, and the EPA press release is available here

As part of the settlement, Dover will pay $1.4 million in civil penalties, and the company will stop manufacturing short-chain chlorinated paraffins (SCCPs).  Dover is the only domestic producer of those substances.  In addition, Dover will file PMNs for certain medium-chain and long-chain chlorinated paraffins (MCCPs and LCCPs) in hopes of receiving EPA approval.  Whether the company will receive approval – and if so, under what terms – remains to be seen.

Dover appears to have fun afoul of EPA’s nomenclature guidance and ever-evolving interpretation of the TSCA Inventory.  When EPA first established the TSCA Inventory, the agency arguably required less precision with substance identification.  Over time, however, that has changed.  The agency would certainly disagree, arguing it has been consistent over time, but experience suggests otherwise.  In 1995, EPA published nomenclature guidance – available here – – for complex reaction products, UVCB substances, mixtures, and substances containing varying carbon chain lengths (such as some SCCPs have).  In certain cases, that guidance conflicted with earlier agency statements, requiring some companies to seek Inventory corrections, pursue exemptions or file PMNs for substances they had been manufacturing for years.  Since 1995, EPA has reinterpreted the Inventory status of statutory mixtures and activated phosphors, among others.  It’s almost certain that more changes are on the horizon with the current Administration’s aggressive and expansive use of the TSCA statute.

Perhaps of greatest interest to cynics is the agency’s apparent use of the enforcement mechanism to essentially achieve a ban on SCCPs.  In December 2009, EPA published a Chemical Action Plan for SCCPs , proposing to ban or restrict SCCPs under section 6(a) because the chemicals are thought to be persistent, bioaccumulative, and toxic (PBT), a set of hazard traits that regulatory agencies are particularly concerned about.  The Plan also identified Dover as the only known domestic producer.  According to the settlement agreement, December 2009 was the same month that Dover received a NOV for alleged violations of the PMN requirements for SCCPs and other chemicals.  It is doubtful that this timing was coincidental.  While Dover’s agreement to cease production of SCCPs doesn’t apply to other manufacturers/importers, by shutting down the only domestic production and publicly questioning the Inventory status of many SCCPs, EPA effectively achieved a ban.   This is a cynical conclusion perhaps, but the publicly available facts suggest it’s a reasonable one to draw.  Did EPA initiate enforcement to achieve a result that would have been more difficult to achieve under section 6(a)?  You decide.