甲醛来源和健康影响
Formaldehyde is a colorless, flammable gas at roomtemperature and has a strong odor. It is found in certain resins used in themanufacture of composite wood products (i.e., hardwoodplywood, particleboard and MDF). It is also found in certain household productssuch 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 andcertain other natural processes. Examples of sources of formaldehyde gas insidehomes include cigarette smoke, unvented, fuel-burning appliances (e.g., gas stoves, kerosene spaceheaters), and composite wood products made using formaldehyde-based resins(Ref. 5). In addition, formaldehyde is a by-product of human metabolism, andthus endogenous levels are present in the body.
甲醛在室温下是无色易燃气体，具有强烈的气味。在用于制造复合木制品的某些树脂（即硬木胶合板，刨花板和MDF）中存在。它还存在于某些家用产品中，例如胶水，永久压榨织物，地毯，防腐剂，药品，化妆品，餐具洗涤液，织物柔软剂，鞋护理剂，清漆，塑料和纸制品涂料。它是燃烧和某些其他自然过程的副产品。家庭内甲醛气体来源的实例包括香烟烟雾，不通风，燃料燃烧器具（例如燃气灶，煤油空间加热器）和使用甲醛基树脂制成的复合木制品（参考文献5）。
此外，甲醛是人体新陈代谢的副产物，因此体内存在内源性水平。
Formaldehyde is an irritant and the National ToxicologyProgram (NTP) and the International Agency for Research on Cancer (IARC) haveclassified it as a known human carcinogen based on sufficient evidence inhumans that formaldehyde causes nasopharyngeal cancer and leukemia (Refs.11-12), a classification supported by the National Research Council of theNational Academy of Sciences (NRC) in their 2014 review of the NTP assessment(Ref. 13). Depending on concentration, formaldehyde can cause eye, nose, andthroat irritation, even when exposure is of relatively short duration. In theindoor environment, sensory reactions and various symptoms as a result ofmucous membrane irritation are potential effects, including respiratorysymptoms as previously discussed. Formaldehyde is also listed under section112(b)(1) of the Clean Air Act as a hazardous air pollutant (Ref. 14).
甲醛是一种刺激物，国家毒理学计划（NTP）和国际癌症研究机构（IARC）根据人类充分证据表明甲醛会导致鼻咽癌和白血病，将其归类为已知的人类致癌物（参考文献11-12）），由美国国家科学院国家研究委员会（NRC）在其2014年NTP评估审查中支持的分类（参考文献13）。根据浓度，即使暴露时间相对较短，甲醛也会引起眼睛，鼻子和喉咙的刺激。在室内环境中，由于粘膜刺激引起的感觉反应和各种症状是潜在的影响，包括如前所述的呼吸症状。根据“清洁空气法”第112（b）（1）节，甲醛也列为有害空气污染物（参考文献14）。
In 1991, EPA classified formaldehyde as a probable humancarcinogen, “based on limited evidence in humans, and sufficient evidence inanimals,” and derived an inhalation unit risk factor for assessing formaldehydecancer risk. The risk factor and supporting documentation is included in EPA'sIntegrated Risk Information System (IRIS) database (http://www.epa.gov/iris/) (Ref. 15). The IRIS program in EPA'sOffice of Research and Development (ORD) completed a draft assessment of thepotential cancer and non-cancer health effects that may result from chronicexposure to formaldehyde by inhalation (Ref. 16). This draft IRIS assessmentwas peer reviewed by the NRC in 2011. The draft formaldehyde IRIS assessment isbeing revised in response to the NRC peer review and public comments, and thefinal assessment will be posted on the IRIS database. In the interim, thisfinal rule estimates benefits using the 1991 IRIS inhalation unit risk value of1.3 × 10 − 5 per µg/m 3 (Ref.15).
1991年，EPA将甲醛列为可能的人类致癌物，“基于人类的有限证据，以及动物的充分证据”，并得出吸入单位风险因子来评估甲醛癌症风险。风险因素和支持文件包含在EPA的综合风险信息系统（IRIS）数据库（http://www.epa.gov/iris/）中（参考文献15）。EPA研究与发展办公室（ORD）的IRIS计划完成了一项评估草案，该草案可能因吸入长期接触甲醛而导致潜在的癌症和非癌症健康影响（参考文献16）。IRIS评估草案于2011年由NRC进行了同行评审。甲醛IRIS评估草案正在根据NRC同行评审和公众意见进行修订，最终评估将发布在IRIS数据库中。在此期间，该最终规则使用1991年IRIS吸入单位风险值1.3×10 - 5 /μg/ m 3来估算效益（参考文献15）。
In addition, EPA used concentration-response functions toestimate the impact of exposure to formaldehyde on eye irritation for use inthe non-cancer benefits assessment to support this rule, as discussed in theproposal. The derivation of these concentration-response functions,uncertainties, and EPA's proposed approach for using the concentration-responsefunctions in the benefits assessment were externally peer reviewed (Ref. 17).While the economic analysis of cancer benefits is based on the unit risk, whichis a reasonable upper bound on the central estimate of risk, the non-cancerbenefits were evaluated using the estimated concentration-response functionswhich reflect the central effect estimates rather than upper bounds.
此外，如提案中所讨论的，EPA使用浓度 - 响应函数来估计暴露于甲醛对眼睛刺激的影响，以用于非癌症效益评估以支持该规则。这些浓度 - 响应函数，不确定性和EPA提出的在效益评估中使用浓度 - 响应函数的方法的推导在外部进行了同行评审（参考文献17）。虽然癌症效益的经济分析是基于单位风险，
这是中央风险估计的合理上限，使用估计的浓度 - 反应函数评估非癌症益处，这些函数反映了中心效应估计而不是上限。
这个规则制定的历史
1. The CARB ATCM. In 2007, CARB issued an ATCM to reduceformaldehyde emissions from hardwood plywood with a composite or veneer core,MDF, and particleboard, products referred to collectively as composite woodproducts. The CARB ATCM was approved on April 18, 2008, by the CaliforniaOffice of Administrative Law and the first emission standards took effect onJanuary 1, 2009 (Ref. 1). Additional emission standards followed through 2012.The CARB ATCM requires manufacturers to meet formaldehyde emission standardsfor the regulated composite wood products that are sold, offered for sale,supplied, imported or manufactured for use in California. The CARB ATCM alsorequires 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 materialswhen installed in manufactured homes subject to regulations promulgated by theUnited States Department of Housing and Urban Development (HUD).
1. CARB ATCM。 2007年，CARB发布了ATCM，以减少硬木胶合板的甲醛释放量，复合材料或单板芯，MDF和刨花板，产品统称为复合木制品。CARB ATCM于2008年4月18日由加州行政法办公室批准，第一批排放标准于2009年1月1日生效（参考文献1）。其他排放标准贯穿2012年。CARB ATCM要求制造商满足在加利福尼亚州销售，销售，供应，进口或制造的受管制复合木制品的甲醛释放标准。CARB ATCM还要求符合标准的复合木制品用于在加利福尼亚州销售，销售，供应，进口或制造的成品。根据美国住房和城市发展部（HUD）颁布的规定，CARB ATCM在安装在制造房屋中时不适用于硬木胶合板和刨花板材料。
On March 24, 2008, 25 organizations and approximately 5,000individuals petitioned EPA under section 21 of TSCA to use its authority undersection 6 of TSCA to adopt the CARB ATCM nationally. On June 27, 2008, EPAdenied the petitioners' request to immediately pursue a TSCA section 6rulemaking, stating that the available information at the time was insufficientto support an evaluation of whether formaldehyde emitted from hardwood plywood,particleboard, and medium-density fiberboard presents or will present an unreasonablerisk to human health (including cancer and non-cancer endpoints) under TSCAsection 6 (Ref. 18). On December 3, 2008, EPA issued an Advance Notice ofProposed Rulemaking (ANPR) that announced EPA's intention to investigatewhether and what regulatory or other action might be appropriate to protectagainst risks posed by formaldehyde emitted from the products covered by theCARB ATCM as well as other pressed wood products. (Ref. 19)
2008年3月24日，25个组织和约5,000名个人根据TSCA第21条向EPA提出申请，要求其根据TSCA第6节的规定在全国范围内采用CARB ATCM。2008年6月27日，EPA否决了请愿人要求立即进行TSCA第6条规则制定的请求，
说当时的可用信息不足以支持评估硬木胶合板是否释放甲醛，刨花板和中密度纤维板在TSCA第6节（参考文献18）下对人类健康（包括癌症和非癌症终点）提出或将会产生不合理的风险。2008年12月3日，EPA发布了建议规则制定预告（ANPR），该通知宣布EPA有意调查是否以及采取何种监管措施或其他措施来防范CARB ATCM所涵盖产品排放的甲醛所带来的风险以及其他压制木制品。（参考文献19）
2. The Formaldehyde Standards for Composite Wood Products Act. TheFormaldehyde Standards for Composite Wood Products Act, or Title VI of TSCA, 15U.S.C. 2697, was enacted on July 7, 2010 (Ref. 20). The statute establishesformaldehyde emission standards that are identical to the CARB ATCM Phase 2standards for hardwood plywood with a composite or veneer core, MDF, andparticleboard sold, supplied, offered for sale, or manufactured in the UnitedStates. Pursuant to TSCA section 3(7), the definition of the term “manufacture”includes import. The statute directs EPA to issue final implementingregulations by January 1, 2013. The Act specifically covers composite woodproducts used in manufactured housing and directs HUD to update its regulationto ensure that it reflects the emission standards in the Act. TSCA Title VIdoes not give EPA the authority to raise or lower the established emissionstandards, and EPA must generally promulgate the implementing regulations in amanner that ensures compliance with the standards. Congress directed EPA toconsider a number of elements for inclusion in the implementing regulations,many of which are aspects of the CARB program.
复合木制品甲醛标准法。复合木制品甲醛标准法案，或TSCA第15篇，15 U.S.C. 2697年，于2010年7月7日颁布（参考文献20）。该法规规定了与CARB ATCM第2阶段标准相同的甲醛排放标准，该标准适用于在美国销售，供应，销售或生产的复合材料或单板芯，MDF和刨花板。根据TSCA第3（7）条，“制造”一词的定义包括进口。该法令指示EPA在2013年1月1日之前颁布最终实施条例。该法案专门涵盖用于制造住房的复合木制品，并指示HUD更新其监管，以确保其反映该法案中的排放标准。TSCA Title VI没有赋予EPA提高或降低既定排放标准的权力，EPA通常必须以确保符合标准的方式颁布实施条例。大会指示EPA考虑将若干要素纳入实施条例，其中许多要素是CARB计划的各个方面。
3. EPA's proposed rules. On June 10, 2013, EPA issued two Noticesof Proposed Rulemaking (NPRMs) containing proposed requirements to implementTSCA Title VI. The first NPRM (the TPC proposal) included a proposed frameworkfor a TSCA Title VI TPC Program (Ref. 21), while the second NPRM included theremainder of the proposed implementing regulations for TSCA Title VI (Ref. 22).
EPA提出的规则。2013年6月10日，EPA发布了两份拟议规则制定通知（NPRM），其中载有实施TSCA Title VI的拟议要求。第一个NPRM（TPC提案）包括TSCA Title VI TPC计划的建议框架（参考文献21），而第二个NPRM包括TSCA Title VI的提议实施规则的其余部分（参考文献22）。
The initial comment period on the TPC proposal was scheduledto end on August 9, 2013, but was extended twice, ultimately closing onSeptember 25, 2013. Information pertaining specifically to the TPC proposal,including the comments received, can be found at http://www.regulations.gov under docket numberEPA-HQ-OPPT-2011-0380.
TPC提案的初始评议期定于2013年8月9日结束，但延长了两次，最终于2013年9月25日结束。有关TPC提案的具体信息，包括收到的意见，可在http://www.regulations.gov的案卷号EPA-HQ-OPPT-2011-0380下找到。
The initial comment period on the implementation proposal wasscheduled to end on August 9, 2013, but was also extended twice, ultimatelyclosing on October 9, 2013. The comment period was specifically reopened foradditional comments on the laminated products issue from April 8, 2014 to May26, 2014, including one extension. EPA also held a public meeting on laminatedproducts on April 28, 2014. Information pertaining specifically to theimplementation proposal, including the comments received during both commentperiods, can be found at http://www.regulations.gov underdocket number EPA-HQ-OPPT-2012-0018.
实施提案的初始意见征询期定于2013年8月9日结束，但也延长了两次，最终于2013年10月9日结束。评论期特别重新开放，以便对2014年4月8日至2014年5月26日期间的层压产品问题进行补充评论，包括一次延期。EPA还于2014年4月28日举行了关于层压产品的公开会议。有关实施建议的信息，包括在两个评论期内收到的意见，可在http://www.regulations.gov的案卷号EPA-HQ-OPPT-2012-0018下找到。
EPA is finalizing both proposed rules in a single final ruleunder RIN 2070-AJ44. Although this final rule document and supportinginformation will appear in docket EPA-HQ-OPPT-2016-0461, both dockets for theproposed rules (EPA-HQ-OPPT-2011-0380 and EPA-HQ-OPPT-2012-0018) containsupporting information with respect to this rule and should be consideredmerged for the purpose of this final rule.
EPA正在根据RIN 2070-AJ44在单一最终规则中最终确定两项拟议规则。尽管此最终规则文档和支持信息将出现在EPA-HQ-OPPT-2016-0461号文件中，但拟议规则的两个框架（EPA-HQ-OPPT-2011-0380和EPA-HQ-OPPT-2012-0018）包含支持有关此规则的信息，并应考虑合并为本最终规则的目的。
