You are here：Home > news2019
Formaldehyde Release Standard Implementation Background for Composite Wood Products
Posted Date:2019/4/24
A. Formaldehyde Sources and Health Effects
Formaldehyde is a colorless, flammable gas at room temperature and has a strong odor. It is found in certain resins used in the manufacture of composite wood products (i.e., hardwood plywood, particleboard and MDF). It is also found in certain household products such as glues, permanent press fabrics, carpets, antiseptics, medicines, cosmetics, dishwashing liquids, fabric softeners, shoe care agents, lacquers, plastics and paper product coatings. It is a by-product of combustion and certain other natural processes. Examples of sources of formaldehyde gas inside homes include cigarette smoke, unvented, fuel-burning appliances (e.g., gas stoves, kerosene space heaters), and composite wood products made using formaldehyde-based resins (Ref. 5). In addition, formaldehyde is a by-product of human metabolism, and thus endogenous levels are present in the body.
Formaldehyde is an irritant and the National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC) have classified it as a known human carcinogen based on sufficient evidence in humans that formaldehyde causes nasopharyngeal cancer and leukemia (Refs. 11-12), a classification supported by the National Research Council of the National Academy of Sciences (NRC) in their 2014 review of the NTP assessment (Ref. 13). Depending on concentration, formaldehyde can cause eye, nose, and throat irritation, even when exposure is of relatively short duration. In the indoor environment, sensory reactions and various symptoms as a result of mucous membrane irritation are potential effects, including respiratory symptoms as previously discussed. Formaldehyde is also listed under section 112(b)(1) of the Clean Air Act as a hazardous air pollutant (Ref. 14).
In 1991, EPA classified formaldehyde as a probable human carcinogen, “based on limited evidence in humans, and sufficient evidence in animals,” and derived an inhalation unit risk factor for assessing formaldehyde cancer risk. The risk factor and supporting documentation is included in EPA's Integrated Risk Information System (IRIS) database (http://www.epa.gov/iris/) (Ref. 15). The IRIS program in EPA's Office of Research and Development (ORD) completed a draft assessment of the potential cancer and non-cancer health effects that may result from chronic exposure to formaldehyde by inhalation (Ref. 16). This draft IRIS assessment was peer reviewed by the NRC in 2011. The draft formaldehyde IRIS assessment is being revised in response to the NRC peer review and public comments, and the final assessment will be posted on the IRIS database. In the interim, this final rule estimates benefits using the 1991 IRIS inhalation unit risk value of 1.3 × 10 − 5 per µg/m 3 (Ref. 15).
In addition, EPA used concentration-response functions to estimate the impact of exposure to formaldehyde on eye irritation for use in the non-cancer benefits assessment to support this rule, as discussed in the proposal. The derivation of these concentration-response functions, uncertainties, and EPA's proposed approach for using the concentration-response functions in the benefits assessment were externally peer reviewed (Ref. 17). While the economic analysis of cancer benefits is based on the unit risk, which is a reasonable upper bound on the central estimate of risk, the non-cancer benefits were evaluated using the estimated concentration-response functions which reflect the central effect estimates rather than upper bounds.
B. History of This Rulemaking
1. The CARB ATCM. In 2007, CARB issued an ATCM to reduce formaldehyde emissions from hardwood plywood with a composite or veneer core, MDF, and particleboard, products referred to collectively as composite wood products. The CARB ATCM was approved on April 18, 2008, by the California Office of Administrative Law and the first emission standards took effect on January 1, 2009 (Ref. 1). Additional emission standards followed through 2012. The CARB ATCM requires manufacturers to meet formaldehyde emission standards for the regulated composite wood products that are sold, offered for sale, supplied, imported or manufactured for use in California. The CARB ATCM also requires that compliant composite wood products be used in finished goods sold, offered for sale, supplied, imported or manufactured for sale in California. The CARB ATCM does not apply to hardwood plywood and particleboard materials when installed in manufactured homes subject to regulations promulgated by the United States Department of Housing and Urban Development (HUD).
On March 24, 2008, 25 organizations and approximately 5,000 individuals petitioned EPA under section 21 of TSCA to use its authority under section 6 of TSCA to adopt the CARB ATCM nationally. On June 27, 2008, EPA denied the petitioners' request to immediately pursue a TSCA section 6 rulemaking, stating that the available information at the time was insufficient to support an evaluation of whether formaldehyde emitted from hardwood plywood, particleboard, and medium-density fiberboard presents or will present an unreasonable risk to human health (including cancer and non-cancer endpoints) under TSCA section 6 (Ref. 18). On December 3, 2008, EPA issued an Advance Notice of Proposed Rulemaking (ANPR) that announced EPA's intention to investigate whether and what regulatory or other action might be appropriate to protect against risks posed by formaldehyde emitted from the products covered by the CARB ATCM as well as other pressed wood products. (Ref. 19)
2. The Formaldehyde Standards for Composite Wood Products Act. The Formaldehyde Standards for Composite Wood Products Act, or Title VI of TSCA, 15 U.S.C. 2697, was enacted on July 7, 2010 (Ref. 20). The statute establishes formaldehyde emission standards that are identical to the CARB ATCM Phase 2 standards for hardwood plywood with a composite or veneer core, MDF, and particleboard sold, supplied, offered for sale, or manufactured in the United States. Pursuant to TSCA section 3(7), the definition of the term “manufacture” includes import. The statute directs EPA to issue final implementing regulations by January 1, 2013. The Act specifically covers composite wood products used in manufactured housing and directs HUD to update its regulation to ensure that it reflects the emission standards in the Act. TSCA Title VI does not give EPA the authority to raise or lower the established emission standards, and EPA must generally promulgate the implementing regulations in a manner that ensures compliance with the standards. Congress directed EPA to consider a number of elements for inclusion in the implementing regulations, many of which are aspects of the CARB program.
3. EPA's proposed rules. On June 10, 2013, EPA issued two Notices of Proposed Rulemaking (NPRMs) containing proposed requirements to implement TSCA Title VI. The first NPRM (the TPC proposal) included a proposed framework for a TSCA Title VI TPC Program (Ref. 21), while the second NPRM included the remainder of the proposed implementing regulations for TSCA Title VI (Ref. 22).
The initial comment period on the TPC proposal was scheduled to end on August 9, 2013, but was extended twice, ultimately closing on September 25, 2013. Information pertaining specifically to the TPC proposal, including the comments received, can be found at http://www.regulations.gov under docket number EPA-HQ-OPPT-2011-0380.
The initial comment period on the implementation proposal was scheduled to end on August 9, 2013, but was also extended twice, ultimately closing on October 9, 2013. The comment period was specifically reopened for additional comments on the laminated products issue from April 8, 2014 to May 26, 2014, including one extension. EPA also held a public meeting on laminated products on April 28, 2014. Information pertaining specifically to the implementation proposal, including the comments received during both comment periods, can be found at http://www.regulations.gov under docket number EPA-HQ-OPPT-2012-0018.
EPA is finalizing both proposed rules in a single final rule under RIN 2070-AJ44. Although this final rule document and supporting information will appear in docket EPA-HQ-OPPT-2016-0461, both dockets for the proposed rules (EPA-HQ-OPPT-2011-0380 and EPA-HQ-OPPT-2012-0018) contain supporting information with respect to this rule and should be considered merged for the purpose of this final rule.