EPA Releases Draft Toxicology Assessment of Formaldehyde

The Environmental Protection Agency has released a draft toxicological review of formaldehyde, entitled "Toxicological Review of Formaldehyde Inhalation Assessment: In Support of Summary Information on the Integrated Risk Information System (IRIS).''  (EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. )

EPA announced a 90-day public comment period and a public listening session for the external review draft human health assessment.  The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA said it was releasing this draft assessment for the purpose of pre-dissemination peer review.  Also, a committee of the National Research Council, acting under the auspices of National Academy of Sciences (NAS), will conduct an independent scientific peer review of the EPA draft human health assessment of formaldehyde. The peer review committee will hold meetings, some of which may involve public sessions. Public sessions will be announced before each meeting on the National Academies Web site.  The public comment period and NAS scientific peer review are separate processes that are supposed to provide opportunities for all interested parties to comment on the assessment.

Formaldehyde is present in a wide variety of products including some plywood adhesives, abrasive materials, insulation, insecticides and embalming fluids. The major sources of anthropogenic emissions of formaldehyde are motor vehicle exhaust, power plants, manufacturing plants that produce or use formaldehyde or substances that contain it (i.e. glues), petroleum refineries, coking operations, incinerating, wood burning, and tobacco smoke, says the EPA.  It is used in industry to manufacture building materials and numerous household products and consumer products, including some soaps, shampoos, and shaving cream. 

Of course, alleged exposure to formaldehyde has been involved in numerous toxic tort suits as well as consumer fraud actions.

The draft assessment found that formaldehyde could be more likely to cause cancer than in previous EPA calculations. In the draft, EPA now estimates there could be up to one case of cancer for every 1,000 people breathing formaldehyde at concentrations of 20 parts per billion over their lifetime.  The draft assessment also provides for the first time an agency estimate of a reference concentration (RfC). Lifelong inhalation of formaldehyde at concentrations up to that RfC would not be expected to cause breathing, immune, reproductive, and other non-cancer health effects.

At Section 4.5.4, the report concludes that human epidemiological evidence is sufficient to conclude there is a causal association between formaldehyde exposure and nasopharyngeal cancer, nasal and paranasal cancer, all leukemias, myeloid leukemia and lymphohematopoietic cancers as a group. But, for example, it is questionable whether there really is a demonstrable link between formaldehyde and leukemia.  And the evidence does not appear to support a causal link between formaldehyde and  upper-respiratory tract cancers. See the critical comments of other federal agencies.

Any regulatory decision on this important chemical based on incomplete information could cause significant harm to the economy, as many products critical to the home and commercial building, automotive and aerospace industries, as well as defense-related applications and vaccines used worldwide to prevent polio, cholera, diphtheria, and other major diseases, all use it.  All living things — including people — produce and process formaldehyde. It occurs naturally in the air we breathe and does not accumulate in the environment or in plants, animals or people.

Rep. Henry A. Waxman (D-Calif.) has stated that the draft report is another reason to reform the Toxic Substances Control Act.  He plans to introduce such a bill this Summer. Also, legislation that would amend TSCA to set formaldehyde emissions limits for plywood and other composite wood products was reported out last month by the House Energy and Commerce Committee.  See H.R. 4805, The Formaldehyde Standards for Composite Wood Products Act.

Update: and an alert reader points out that the Senate just this week passed its own version, S.1660, the Formaldehyde Standards for Composite Wood Products Act.  The Senate bill would make the formaldehyde emission standard contained in the California Code of Regulations (relating to an airborne toxic control measure to reduce formaldehyde emissions from composite wood products, as in effect on July 28, 2009) applicable to certain hardwood plywood, medium-density fiberboard, and particleboard sold, supplied, offered for sale, or manufactured in the United States, with certain exemptions, including for composite wood products used inside new vehicles, rail cars, boats, aerospace craft, or aircraft.

NRDC Attacks Changes by EPA to Chemical Risk Assessment Process

MassTortDefense has blogged before about changes to the IRIS system. See here
A reminder: IRIS is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on substances for use in risk assessments, decision-making and regulatory activities. For each chemical contained in IRIS, the database contains summary information on the studies evaluated, any uncertainties or assumptions made in the studies, a statement of the level of confidence that EPA has in the study, the names of EPA scientists to contact for more information, and complete bibliographic citations. Proffered experts in the toxic tort branch of products litigation may refer to and seek to rely on IRIS. E.g., Avance v. Kerr-McGee Chemical, 2006 WL 39124272 (E.D. Texas 1/1//07).


As noted, EPA has proposed various changes to the process for developing chemical assessments, including an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments. The agency said the changes would make the process of assessing the risks of potential environmental contaminants faster, more predictable and more
transparent.

MassTortDefense predicted that environmental groups and Democratic legislators would complain. And they have.

The Natural Resources Defense Council testified before Congress last week that the proposed
changes would allow the White House to delay scientific assessments of chemicals’ health risks and hinder opportunities for public comment and scientific debate. An NRDC director told the House Science & Technology Committee’s Investigations and Oversight Subcommittee that the changes would damage EPA's ability to identify chemicals that pose the greatest risk to public health. The NRDC argues that instead of providing greater transparency, objectivity, balance, rigor and predictability to the IRIS assessments, as EPA claims, the process will somehow give industry more access and more influence to what has historically been an objective scientific evaluation process. The new IRIS process, NRDC claims, introduces steps that are time consuming and undermine the objectivity and transparency for credible and valid risk assessments. 

NRDC thus asked committee members to overturn or withdraw the new IRIS process and require IRIS health assessments to be reviewed in a more “open process.”

It seems like the thrust of the criticism relates to an obviously good thing, the proposal to have various interested federal agencies communicate and coordinate. The new steps in the process include greater opportunities for other federal agencies to conduct research to fill data gaps.

EPA Revises Chemical Risk Information System

Readers of MassTortDefense who have an interest in toxic torts may wish to take note that the Environmental Protection Agency’s (EPA) Office of Research and Development recently announced revisions to the Integrated Risk Information System (IRIS).

What Is IRIS?

IRIS is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on substances for use in risk assessments, decision-making and regulatory activities. For each chemical contained in IRIS,  the database contains summary information on the studies evaluated, any uncertainties or assumptions made in the studies, a statement of the level of confidence that EPA has in the study, the names of EPA scientists to contact for more information, and complete bibliographic citations. See Report of the IRIS Quality Action Team on External Peer Review and Public Involvement at 5 (July 1994).

IRIS provides human health risk information describing the potential adverse health effects that may result from exposure to over 540 environmental contaminants. IRIS includes descriptions of hazard identification and dose-response information, quantitative risk estimates for chronic non-cancer and cancer effects, and access to searchable scientific documentation.

Not Just Regulatory

While EPA often will base regulatory rules on IRIS evaluations, this is not just a regulatory issue. IRIS is generally accepted as a reliable source of information on the potential hazardous effects of those chemicals that are included in IRIS. See National Oilseed Processors Ass'n v. Browner, 924 F.Supp. 1193 (D.D.C.,1996). Thus, proffered experts in the toxic tort branch of products litigation may refer to and seek to rely on IRIS. E.g., Avance v. Kerr-McGee Chemical, 2006 WL 39124272 (E.D. Texas 1/1//07); Allgood v. General Motors, 2006 WL 2669337 (S.D. Ind. 9/18/06). And this is true of class actions, e.g., Pohl v. NGK Metals Corp., 2003 WL 24207633 (Pa. Com. Pl. 7/9/03)(rejecting medical monitoring class action), and mass toxic torts. E.g., In re Welding Fume Products Liab. Litig., 2006 WL 4507859 (N.D. Ohio 8/8/06).

The upcoming changes are to the process for developing chemical assessments, and will include an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments.

How It Works And How It Will Change

On an annual basis, the IRIS Program requests nominations for new or updated IRIS assessments from EPA Program Offices and Regions and from the public. The IRIS process has started with the development of a draft Toxicological Review for the chemical.  A health scientist, referred to as a Chemical Manager, is assigned to each substance. The Chemical Manager is responsible for developing the draft assessment and shepherding draft documents though the review process. Development of a draft assessment consists of a literature search and preparation of a draft Toxicological Review and an IRIS Summary. The Chemical Manager may work with a team of toxicologists, epidemiologists, and statisticians in reviewing and analyzing the available literature. EPA’s risk assessment guidelines form the basis for the analysis. This work is often supported by an EPA outside contractor.

The next stage includes internal and external scientific reviews of the draft document, conducted in accordance with Agency guidance on peer review. These may include internal (EPA) peer review, a review by a standing group of senior health scientists representing EPA’s Offices and Regions and by selected senior health scientists with scientific expertise relevant to the substance, review by other federal agencies, and external peer review, typically via a panel meeting. Final steps are the EPA response to review comments, and development and posting on the IRIS web site of an IRIS Summary and final Toxicological Review. www.epa.gov/iris

The new steps in the process include increased participation by other federal agencies and the public in the development of the Toxicological Review and greater opportunities for other federal agencies to conduct research to fill data gaps. Together, these changes to the IRIS process are supposed to help create a more predictable, streamlined, and transparent process for conducting IRIS assessments. A major stated goal of the Agency is to define the important role that public and inter-agency comments and interactions play in the process, and to foster greater communication and sharing of relevant scientific information between experts, interested parties, and EPA.

Effects on Readers?

The revised procedure is not without controversy, as environmental groups and Democratic legislators – ironically those often calling for more public input and participation – have argued that chemical risk assessments will become a “special-interest scrum.”  But for clients of readers of MassTortDefense, it may offer increased opportunities to ensure their voice is at least heard.