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European Chemical Industry Debuts Chemical Combination Screening Tool – Concludes Regulating Individual Chemicals is Usually Adequate

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Chemical Mixture Risk Assessment:

May 31, the European Chemical Industry Council (Cefic) unveiled a tool for assessing the risks posed by chemical combinations: the Maximum Cumulative Ratio (MCR) (see e.g., news release, combination effects tools).  MCR compares the toxicity of individual chemicals to the cumulative toxicity of all chemicals in an exposure scenario.  Cefic argues that in most exposure scenarios the risk of one or two chemicals contribute nearly all risk of harm.  The organization notes that prioritization of chemical combinations is necessary to identify combinations of concern that warrant full risk assessment. 

Cefic references Maximum Cumulative Ratio (MCR) as a Tool for Assessing the Value of Performing a Cumulative Risk Assessment (in International Journal of Environmental Research and Public Health) for full discussion of the application of MCR.  The article comprises an investigation of the magnitude of toxicity from multiple chemical exposure that is missed in scenarios where no cumulative risk assessment is conducted.  U.S. Geological Survey water quality data were used for the evaluation. From 5 to 81 chemicals were present in the 3,000 samples analyzed.  The authors estimate that approximately 20 percent of cumulative toxicity –compared to component chemical toxicity– is missed where cumulative risk assessments are not conducted.  However, mixture toxicities were dominated by only a fraction of chemical compounds present.

Because risk is usually driven by one or two chemicals in a combination, Cefic believes that controlling individual substances through the current regulatory schemes will often control the risk from combination exposures.

Cefic notes that MCR is based on the WHO risk assessment framework (see e.g., Combined Exposure Risk Assessment Workshop Report) and relies on cumulative risk assessment theories from the European Scientific Committees (see e.g., Environmental Risk Assessment of Mixtures Symposium).

EPA Draft (IRIS) Ammonia Assessment Available for Public Comment

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Integrated Risk Information System (IRIS):

Today, EPA released for a 60-day public comment period the draft IRIS assessment for ammonia.   Excerpts from the agency’s press release are provided below, and a copy of the draft assessment is avaialble here. 

IRIS is a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants. Through the IRIS Program, EPA attempts to provide the highest quality science-based human health assessments to support the Agency’s regulatory activities.  The IRIS database is web-accessible and contains information on more than 550 chemical substances.  Readers familiar with IRIS will recall the various criticisms of the agency’s evaluation process, which EPA has been attempting to address, as described in further detail here.  General background information on IRIS is available here.

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FOR IMMEDIATE RELEASE

June 1, 2012 

EPA Draft Ammonia Assessment Available for Public Comment

Draft assessment continues agency’s responsiveness to NAS recommendations 

WASHINGTON – The U.S Environmental Protection Agency today announced the release of its draft Integrated Risk Information System (IRIS) health assessment for ammonia. The draft assessment will be available for public comment for 60 days and will be sent for independent expert peer review.

Ammonia is used in agricultural fertilizers, the manufacture of pharmaceuticals and explosives, water purification, household cleaners, as a refrigerant, and in many industries. Scientific studies show that ammonia can affect the respiratory system. The draft assessment includes an estimate of the amount of ammonia a person can inhale daily throughout a lifetime that is not likely to cause harmful health effects, which is less stringent than the current value for ammonia on IRIS.

 The draft IRIS assessment for ammonia represents major progress for EPA in implementing the April 2011 National Academy of Sciences (NAS) recommendations for improving IRIS assessments. The draft assessment uses a new streamlined document structure that is more transparent and clear; includes a template for describing the literature search approach; identifies the strengths and weaknesses of analyzed studies; and describes how EPA applied their guidance, methods, and criteria in developing the assessment.

 When the assessment is final it will be posted to the IRIS database. IRIS is a publicly available online database that provides high quality science-based human health assessments used to inform the agency’s decisions on protecting public health and the environment.

  The IRIS database contains crucial information on more than 550 chemical substances and their impacts on human health. Governments and private entities use data from IRIS in conjunction with exposure information to help characterize the public health risks of chemical substances. These characterizations are then considered in risk management decisions to protect public health. 

Cefic Reports on EU Chemical Industry Sustainability Initiatives

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Sustainability:

The European Chemical Industry Council (Cefic) published The Chemical Industry in Europe: Towards Sustainability on May 8. In the report, Cefic stresses the importance of applying sustainable chemistry to the entire product life cycle, beginning with consideration of raw material sourcing impacts, and including manufacturing, packaging, transport and distribution, sales and use, and post-use recovery or disposal. Towards Sustainability asserts that chemistry innovation is a catalyst for sustainable innovation in up- and downstream industries including consumer product sectors. In addition, the authors argue that “Industry’s ongoing focus on using renewable raw materials is helping identify new ways of protecting the environment.”

Towards Sustainability details chemical industry initiatives to reduce waste, drive down emissions, conserve resources, and improve energy efficiency. Major reductions in emissions purportedly have been achieved through optimizing production processes and implementing improved emission control technologies. Industry initiatives promote energy efficiency through the value chain. Many companies have applied new technologies and processes to use fewer raw materials and to reuse or recycle products in a closed loop system. In addition, reducing the amount of material in products without performance loss, down-gauging, has helped industry optimize resources. Also, partnerships throughout industry have turned waste into resources. According to the report, successes include:

  • an International Association for Soaps sustainability project which reduced water use during manufacture, emissions, packaging;
  • detergent manufacturers reduced the impact of shipping by reducing chemicals, packaging and energy used in product manufacturing;
  • excess heat and CO2 from fertilizer manufactures pumped to local greenhouses;
  • glucose-containing effluent generated by a one producer is used by a nearby chemical complex to maintain bacteria levels in its biotreatment plant; and
  • a new abatement system at an ink manufacturer reduced emissions from the stream by 98 percent.

The industry has also published technical information on abatement and recovery options for solvent emissions.

Featured in the report is a case study on the relationship between new chemical industry products and development of a sustainable construction sector. For example, Cefic explains, plastic insulating materials save many times the amount of energy used in production. The materials are stable and durable, and unaffected by moisture, rotting, or mold. And plastic materials are easily and completely recyclable or recoverable.

Towards Sustainability stresses the importance of sustainability to corporate viability. The authors quote securities analyst statements, such as

“Investors are beginning to acknowledge the impact of sustainability topics on a company’s financial valuation. By adopting effective product life cycle assessment strategies chemical companies can realign their portfolios towards sustainable innovation and at the same time provide financial investors with increased transparency about their commitment to sustainability.” Andrea Ricci , Equity Analyst -Sustainable Asset Management

The report also highlights Cefic members’ efforts to enhance chemicals management throughout the supply chain. Activities include:

  • an effort in the polyvinyl chloride industry to improve behavioral safety;
  • outreach by the solvents sector on safe working practices;
  • safe handling cyanides through the entire value chain; and
  • best practices outreach by the formaldehyde industry.

Towards Sustainability also reports that industry is working with academia, regulators and NGOs to identify alternatives to the use of animal testing. Cefic is a founding member of the European Platform for Alternatives to Animal Testing which focuses on meeting safety requirements while also reducing the use of and replacing animal testing.

Towards Sustainability can be downloaded from Cefic’s website.

Phil Moffat Will Speak at Informa Conference about REACH-like Programs Outside the EU and US

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Global Chemical Regulation:

Verdant Law is pleased to announce that Phil Moffat will be speaking at the upcoming Informa conference, “REACH and CLP:  Practical and Technical Strategies for American Exporters to Europe on REACH and CLP Requirements and the Impact of Future Regulatory Strategy.”  Mr. Moffat will talk about other chemical regulatory programs outside the EU and the US in his presentation, “Beyond REACH: Comparing and Approaching Upcoming REACH-like Regulations Across the World.”  The conference is being held August 1 – 2, at the Hilton North Raleigh/Mid Town Hotel in Raleigh, North Carolina, USA.  Additional details are available here. 

Update:  A copy of Mr. Moffat’s presentation is available here. Moffat_REACH_around_world

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

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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.

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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

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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.

NRDC Recommends Improvements to Chemical Risk Assessment Methods

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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:

EPA Budget Would Increase Spending on Chemical Assessment and Control

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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.

California DTSC Releases Public Comments on Informal Draft Green Chemistry Regulations

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Green Chemistry Regulations:

The public comment for the latest informal draft version of California’s “Safer Consumer Product Regulations” closed on December 30, 2011.   On January 20, 2012, the implementing agency, the California Department of Toxic Substances Control (DTSC), posted the comments on its website.  DTSC received ninety submissions from a range of stakeholder interests.  More information about the regulations is available here.

California Releases Informal Draft of the Revised Green Chemistry Regulations

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Green Chemistry Regulations:

On Monday, October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of its revised green chemistry regulations, the so-called “Safer Consumer Product Alternatives (SCPA) Regulations.”  DTSC spent the last year further revising the regulations after some stakeholders decried the proposed final version released for public comment over the Thanksgiving holiday in 2010.  Public comments on the lastest informal draft are due by December 30, 2011.  The formal rulemaking process will begin in 2012.

On Monday DTSC also released a document setting out the most significant changes from the November 2010 version of the regulations. (For purposes of comparison, a summary of the November 2010 version is available here.)  It is clear that DTSC is envisioning a more robust program with shorter timelines and fewer exemptions, ultimately requiring more agency and private resources to implement without a clear benefit from doing so. In light of the poor state of California’s economy, and the relative weakness of the U.S. economy as a whole, one has to wonder why DTSC has chosen its proposed path. According to DTSC, the following are the most significant changes found in the current informal draft. 

Timeframes

(1) Many timeframes have been shortened and/or made more specific.

(2) Timing of initial Chemicals of Concern (COC) list — effective date of the regulations.

(3) Timing of initial Priority Products list — 6 months for the proposed list.

(4) Both the chemicals and products lists will be reviewed at least once every 3 years.

Chemical / Product Prioritization

(1) The regulations will establish an immediate robust (~3,000) list of COCs (which DTSC can add onto later), based on work already done by numerous authoritative bodies.

 (2) The list of hazard traits has been expanded to include all hazard traits and environmental and toxicological endpoints specified by OEHHA. Additionally, the universe of chemicals considered to be carcinogens and reproductive toxins is no longer limited to only those chemicals listed on a short list of lists.

(3) The regulations no longer limit the product categories that DTSC can consider when listing Priority Products during the first 5 years.

(4) Worker exposure has been added as a prioritization factor.

(5) The requirement for responsible entities to provide chemical and product information during the prioritization process has been eliminated. (DTSC will request this information and list anyone who does not provide the information on a Failure to Respond list.)

Alternatives Assessments

(1) The regulations expand the primary responsibility for compliance beyond the product producer to also include: (i) the person who controls the product design; and (ii) the U.S. importer.

(2) The alternatives assessment (AA) process is more specific and structured, but allows for flexibility.

(3) There is no requirement to fill information gaps during the AA — instead DTSC has the option to require this as a regulatory response.

(4) The third-party verification requirement for AAs has been eliminated — instead AAs are required to be conducted by a certified assessor. Also, DTSC will play a greater role in auditing AAs.

Exemptions

(1) The default de minimis level is 0.01% for chemicals with one of 9 specified hazard traits, and 0.1% for all other chemicals — DTSC can set a lower or higher de minimis level.

(2) The exemption for unintentionally-added chemicals has been eliminated. However, these chemicals are a consideration for setting a higher de minimis level.

(3) The “no exposure pathway” exemption has been eliminated. However, exposure potential will still be considered during the chemical/product prioritization process.

Readers wanting more information should check back for future posts on this development, as well as visit the DTSC website. In addition, there will be a public workshop on the draft proposal on December 5, 2011 from 9:30 am to 3:30 pm in Sacramento. The Green Ribbon Science Panel also will dicuss the proposal at the Panel’s meeting on November 14 – 15, also in Sacramento.