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.

New Report From National Research Council On Nanotechnology

A new report from the National Research Council questions the government's current plan for research on the possible health and environmental risks posed by nanomaterials, which are increasingly being used in consumer products and other industry. The report emphasizes the need for an effective national plan for identifying and managing potential risks, a step seen as essential to the successful development and public acceptance of nanotechnology-enabled products.

Nanoscale engineering manipulates materials at the molecular and atomic level to create structures with unique and useful properties – materials that are both very strong and very light, for example. More than 600 products involving nanomaterials are already on the market, the majority of them health and fitness products, such as skin care and cosmetics. And over the next decade, nanomaterials will be used increasingly in products ranging from medical therapies to food additives to electronics. MassTortDefense has posted about nano-issues before.

Growing use of nanomaterials means that more workers and consumers may be exposed to them, and uncertainties remain in the minds of some about their health and environmental effects; while nanomaterials can yield tremendous, special utility, they may also have possibly toxic risk properties.

The National Nanotechnology Initiative, which coordinates federal agency investments in nanoscale R&D, developed a research plan to investigate these risks, and the office that oversees NNI asked the National Research Council to review the plan.  (The NRC report was sponsored by the National Nanotechnology Coordination Office. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter.)  The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering.

The committee report did not focus on current uses of nanomaterials and any potential risks to the public. Rather, the report focused on what would constitute an effective national research strategy for ensuring that current and future uses of nanomaterials are without significant impacts on human health or the environment.

The current plan, involving nano-risk research across several federal agencies, lacks an overarching research strategy needed to gain public acceptance and realize the promise of nanotechnology, according to the report.  NNI's plan identifies broad research categories for assessing health and environmental risks, and many of the research needs listed within these categories will aid risk assessment, the report says. But the plan fails to identify some important other areas that should be investigated; for example, "Nanomaterials and Human Health" should include a more comprehensive evaluation of how nanomaterials are absorbed and metabolized by the body and how toxic they are at realistic exposure levels. Furthermore, the current research plan, according to the report, does not provide a clear picture of the current understanding of these risks or where it should be in 10 years. And though the research needs listed in the plan are valuable, the NRC committee thinks they are incomplete, in some cases missing elements crucial for progress in understanding nanomaterials' health and safety impacts.

In its assessment of gaps in existing research, the current NNI plan overstates the degree to which already funded studies are meeting the need for research on health and environmental risks, the report says. For example, more than half of the currently funded projects on nanotechnology and human health are aimed at developing therapies for diseases. While this research is important, it will not shed light on health risks that may be posed by nanomaterials. Moreover, the plan does not note the current lack of studies on how to manage consumer and environmental risks, such as how to manage accidents and spills or mitigate exposure through consumer products.

A truly robust national strategic plan would involve a broader group of stakeholders, and would consider the untapped knowledge of nongovernment researchers and academics, the committee said. The current structure of NNI would make developing a new strategy difficult, says the report. NNI should continue to foster successful interagency coordination, with the aim of ensuring that the federal research strategy on the health and safety impacts of nanotechnology is an integral part of the broader national strategic plan.