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 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.

California DTSC Releases Public Comments on Informal Draft Green Chemistry Regulations

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.

US EPA and California DTSC Form Green Chemistry Partnership

Sustainable Products/Green Chemistry:

On January 12, 2012, the US Environmental Protection Agency (EPA) and the California Department of Toxic Substances Control (DTSC) announced their Green Chemistry Partnership.  The agencies’ agreement is memorialized in a Memorandum of Understanding (MOU) that outlines principles by which the agencies will cooperate to reduce toxic chemicals in consumer products, create new business opportunities in the emerging safer consumer products economy, and reduce the burden on consumers and businesses struggling to identify what’s in the products they buy for their families and customers.

The agrement supposedly will allow DTSC and EPA to minimize duplication of effort and promote consistency in their assessment methodologies, potentially providing increased environmental protection. The agreement sets up a framework for the agencies to collaborate on Green Chemistry issues so that California’s innovative “Green Chemistry” program can grow.

Jim Jones, EPA’s acting assistant administrator for the Office of Chemical Safety and Pollution Prevention said:  “This partnership will build and harmonize common tools and practices used to conduct alternative assessments to promote safer products ….  These alternative assessments inform and speed the adoption of safer chemicals for use in products, homes, schools, and workplaces, which produce significant environmental and economic benefits.”

In its press release, EPA said:  “The agreement represents a major advance for Californians looking to buy safer children’s toys, personal care products, household cleaners and other products. By shifting the question of an ingredient’s toxicity to the product development stage, concerns raised by … consumers can be addressed early on. The approach results in safer ingredients, and provides an opportunity for California industry to once again demonstrate its innovative spirit by making products that meet consumer demand throughout the world.”

EPA and DTSC signed the agreement in a ceremony at California’s Kaiser Permanente Sidney R. Garfield Health Care Innovation Center in San Leandro. Kaiser Permanente is nationally recognized as an industry leader in safer products, using its purchasing power and a sustainability scorecard to press suppliers for safer chemicals in medical products. 

FDA Regulation of Nanotechnology

Nanotechnology:

Readers interested in learning about FDA’s regulation of nanotechnology might want to download the free book available here:  FDA REGULATION OF NANOTECHNOLOGY .  Verdant attorney, Philip Moffat, and many others authored the book over the course of the past several years.  This book is a valuable resource to those wanting to learn about regulation in the United States of foods, cosmetics, drugs, medical devices and many other products that have been enhanced with nanotechnology.  Further information about FDA’s role in the regulation of nanotechnology may be found on the agency’s website, here.  Enjoy!

Reminder: Upcoming Workshop on California's Green Chemistry Regulations

Green Chemistry Regulations:

For readers interested in learning more about California’s latest revision of the so-called Green Chemistry Regulations, the Department of Toxic Substances Control (DTSC) is convening a public workshop on December 5, 2011, to discuss the latest proposal.  Details of the workshop are set out below.

________________________________________________________

DTSC: Green Chemistry Initiative

Please join us for the Workshop on Safer Consumer Product Regulations:

December 5, 2011

9:30 a.m. to 3:30 p.m.

Cal/EPA Headquarters Building

Byron Sher Auditorium

1001 “I” Street, 2nd Floor

Sacramento, CA 95814

As a reminder, if you have questions about the informal draft Safer Consumer Product regulations that you would like to have addressed at the workshop, please submit them via e-mail to gcregs@dtsc.ca.gov by November 28, 2011.  You may submit comments or questions in real time during the workshop and, as time allows, DTSC staff will read and respond to them aloud.  Submitting your questions in advance will ensure your questions will be addressed at the workshop.

Additionally, if you plan to speak at the workshop, please let us know by December 1, 2011, via e-mail at gcregs@dtsc.ca.gov.  Include in the e-mail: (1) affiliation, (2) subject of your comments/questions, and (3) the amount of time you are requesting.  This information will assist DTSC staff in planning the workshop and will place you in the speaker?s queue.  Please note, however, that DTSC cannot guarantee that each speaker will get the full amount of time requested. 

The December 5, 2011, Workshop Notice may be found at:

http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/SCP-Workshop-Notice-10312011.pdf

The regulations and other related documents may be found at:

http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/SCPA.cfm  and http://www.dtsc.ca.gov/SCPRegulations.cfm

Phil Moffat Will Participate on ABA Panel Concerning California's Green Chemistry Regulations

Green Chemistry Regulations:

Verdant is pleased to announce that Philip Moffat will participate on a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources, titled California Dreaming, Reality, or Nightmare?  California’s New Paradigm in Chemicals and Products Regulation Is Coming to a Store Near You.”  The December 13, 2011, teleconference will discuss the substantially revised regulations recently proposed by the California Department of Toxic Substances Control (DTSC) to implement AB 1879, a new California Green Chemistry Initiative law designed to “accelerate the quest for safer products” in the state.  In addition to discussing the law’s requirements and its implementation, the teleconference will provide both industry and public health perspectives. 

Other speakers include:

  • Philip Crowley, Assistant General Counsel, Johnson & Johnson, New Brunswick, NJ
  • Dr. Joseph Guth, UC Berkeley Center for Green Chemistry; and the Science and Environmental Health Network, Berkeley, CA
  • Dr. Jeff Wong, Chief Scientist, DTSC, Sacramento, CA
  • Ann Grimaldi, McKenna Long & Aldridge LLP, San Francisco, CA

There are two ways to participate in this program, either attending a host site location or individual dial-in.  Participation at a host site location is free of charge for ABA members, and $110 for non-members.  Registration with the host site contact is required, however.  The host sites are:

  • San Francisco, CA
    McKenna Long & Aldridge LLP, 101 California St., # 41
    RSVP: Cynthia Kelly, (415) 267-4051 or ckelly@mckennalong.com
  • Washington, DC
    McKenna Long & Aldridge LLP, 1900 K Street, NW
    RSVP: Debbie Leitner, (202) 496-7372, dleitner@mckennalong.com

The teleconference will begin promptly at 1:00 pm EasternTime, Tuesday, December 13, 2011, and last for 105 minutes.

  • 1:00 p.m. – 2:45 p.m. Eastern Time / 12:00 p.m. – 1:45 p.m. Central Time
  • 11:00 a.m. – 12:45 p.m. Mountain Time / 10:00 a.m. – 11:45 a.m. Pacific Time

Additional information about the teleconference is available here.

Reminder: Upcoming Meeting of California's Green Ribbon Science Panel

Green Chemistry Regulations:

California’s Green Ribbon Science Panel (GRSP), the expert body established to advise the Department of Toxic Substances Control (DTSC) on green chemistry and the regulation of consumer products, will convene in Sacramento on November 14 (all day) and 15 (morning only) to discuss the latest informal draft of the so-called Safer Consumer Product Alternatives (SCPA) Regulations.  No agenda or other meeting materials have been publicly released at this time, but a copy of the informal draft regulations and related information is available here.