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TSCA认证:有关有毒物质控制法的FAQs 临安科达认证技术咨询服务有限公司   时间:2019-05-17   点击:719 次
“有毒物质控制法”(TSCA)将术语“化学物质”定义为“具有特定分子特性的任何有机或无机物质,包括 - (i)由于以下原因而全部或部分出现的此类物质的任何组合化学反应或在自然界中发生的和(ii)任何元素或未结合的自由基。“美国环境保护署(EPA)表示:“TSCA广义地定义了'化学物质',涵盖了微生物和传统化学
 

 

 

What is a chemical substance for purposes of regulation under TSCA?

TSCA规定的化学物质是什么

The Toxic Substances Control Act (TSCA) defines the term "chemical substance" as "any organic or inorganic substance of a particular molecular identity, including -- (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical." The Environmental Protection Agency (EPA) states: "TSCA defines ‘chemical substance’ broadly and in terms which cover microorganisms as well as traditional chemicals."

有毒物质控制法TSCA)将术语化学物质定义为具有特定分子特性的任何有机或无机物质,包括 - i)由于以下原因而全部或部分出现的此类物质的任何组合化学反应或在自然界中发生的和(ii)任何元素或未结合的自由基。美国环境保护署(EPA)表示:“TSCA广义地定义了'化学物质',涵盖了微生物和传统化学品。

 

Are there any exemptions from the definition of a "chemical substance"?

化学物质的定义是否有任何豁免?

TSCA specifically exempts from the definition of "chemical substance" (1) mixtures; (2) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticides; (3) tobacco and tobacco products; (4) certain materials regulated under the Atomic Energy Act; (5) firearms and ammunition; and (6) foods, food additives, drugs, cosmetics, and devices regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition to those substances specifically excluded from TSCA, EPA has exempted other categories of substances from certain TSCA requirements. For example, certain chemical substances -- including impurities and byproducts -- are excluded from TSCA Section 5 requirements because "[a]lthough they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part." EPA also exempts "articles" from various TSCA requirements.

TSCA特别豁免化学物质的定义(1)混合物;2)联邦杀虫剂,杀真菌剂和灭鼠剂法(FIFRA)杀虫剂3)烟草和烟草制品;4)根据原子能法规定的某些材料;(五)枪支弹药;6)根据联邦食品,药品和化妆品法案(FFDCA)管制的食品,食品添加剂,药品,化妆品和设备。 除了特别排除在TSCA之外的那些物质,EPA还豁免了其他类别的物质来满足TSCA的某些要求。例如,某些化学物质 - 包括杂质和副产品 - 被排除在TSCA5节的要求之外,因为虽然它们是根据该法案为商业目的而制造的,但它们不是作为化学物质本身在商业上制造的。与他们所属的物质,混合物或物品没有任何商业目的。“ EPA还免除了物品的各种TSCA要求。

 

What are "articles" under TSCA?

TSCA下的物质是什么?

TSCA defines "article" as "a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) depending in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition that have no commercial purpose separate from that of an article, and that results from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles." Fluids and particles are not considered articles, however, regardless of shape or design. Articles that contain chemical substances which are not intended to be removed and have no separate commercial purpose are generally exempt from TSCA. Articles that contain chemical substances designed to be used or released (i.e., ink in pens) are subject to TSCA requirements.

TSCA“物品”定义为“制造物品(1),其在制造期间形成为特定的形状或设计2)具有最终用途功能,其全部或部分取决于其在结束时的形状或设计使用,(3)在最终用途中化学成分没有变化,或者只有那些没有商业目的的成分变化与物品的成分不同,这是由最终使用其他化学物质,混合物或物品时发生的化学反应造成的。然而,无论形状或设计如何,流体和颗粒都不被视为物品。含有不打算除去且没有单独商业用途的化学物质的物品通常免于TSCA。含有设计用于或释放的化学物质的物品(即钢笔中的墨水)符合TSCA要求。

 

Who is subject to TSCA requirements?

谁受TSCA要求的约束?

TSCA may apply to any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance. A person is defined broadly as "any natural or juridicial person including any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality, any interstate body and any department, agency, or instrumentality of the Federal Government."

TSCA可适用于制造,加工,分销商业,使用或处置化学物质的任何人。一个人被广义地定义为“任何自然人或法人,包括任何个人,公司,合伙或协会,其任何国家或政治分支,或任何市政当局,任何州际机构以及联邦政府的任何部门,机构或工具。”

 

How does EPA keep track of the chemical substances subject to TSCA?

EPA如何跟踪受TSCA影响的化学物质?

TSCA Section 8(b) directs EPA to "compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States." This list is known as the TSCA Chemical Substance Inventory (TSCA Inventory). EPA compiled the initial TSCA Inventory in 1977. The TSCA Inventory is continually updated by the addition of chemical substances for which a premanufacture notice (PMN) and subsequent notice of commencement (NOC) have been submitted. For those chemical substances whose identities are confidential, EPA maintains a confidential portion of the TSCA Inventory that only EPA can review.

TSCA8节(b)指示EPA“汇编,保持最新并公布在美国制造或加工的每种化学物质的清单。该清单称为TSCA化学物质清单(TSCA清单)。EPA1977年编制了最初的TSCA清单。TSCA清单通过添加预先制造通知(PMN)和随后的启动通知(NOC)的化学物质不断更新。对于保密的化学物质,EPA保留了TSCA清单的保密部分,只有EPA才能审查。

 

How can a person search the confidential portion of the TSCA Inventory?

个人如何搜索TSCA清单的机密部分?

A manufacturer or importer can request that EPA search the TSCA Confidential Inventory by filing a bona fide intent request (BFI Request). A BFI Request is a letter submitted to EPA by a manufacturer or importer asking EPA to search the TSCA Confidential Inventory. A manufacturer or importer may submit a BFI Request only if it meets the requirements established by EPA at 40 C.F.R. Section 720.25.

制造商或进口商可以通过提交真实意图请求(BFI请求)来请求EPA搜索TSCA机密清单。BFI请求是制造商或进口商向EPA提交的一封信,要求EPA搜索TSCA机密清单。制造商或进口商只有在符合美国环保署于40 C.F.R. 720.25节制定的要求时才可提交BFI请求。

 

What chemical substances are subject to PMN requirements?

哪些化学物质符合PMN要求?

Chemical substances manufactured in or imported into the United States that are not listed on the TSCA Inventory and that are not otherwise exempt from TSCA Inventory listing are considered "new" chemical substances subject to TSCA Section 5 PMN requirements.

在美国生产或进口的化学物质未列入TSCA清单,且未获得TSCA库存清单,则被视为符合TSCA5PMN要求的化学物质。

 

What are the exemptions from PMN requirements?

PMN要求有哪些豁免?

Some chemical substances that are not listed on the TSCA Inventory may be exempt from PMN and related TSCA Section 5 requirements. Several exemptions from PMN requirements are considered "self-executing" because they do not require EPA approval. Instead, once a manufacturer or importer determines that one of the self-executing exemptions applies, the new chemical substance may be manufactured or imported without first submitting a PMN, so long as the company complies with any recordkeeping or other requirements for the particular exemption. The self-executing exemptions are exemptions for chemical substances having no "separate commercial purpose"; polymers meeting specified requirements; and research and development (R&D) substances meeting specified requirements. Other exemptions from PMN requirements require EPA approval. In these instances, a manufacturer or importer must submit, and EPA must approve, an exemption application before a company may authorize the manufacture or import of the new chemical substance. In addition, each manufacturer or importer must comply with any recordkeeping or other requirements for the particular exemption approved by EPA. These exemptions are: low volume exemptions (LVE); low release and exposure exemptions (LoREX); and test marketing exemptions (TME).

未列入TSCA清单的某些化学物质可免除PMNTSCA5节相关的要求。PMN要求的若干豁免被视为自动执行,因为它们不需要EPA批准。相反,一旦制造商或进口商确定其中一项自行执行豁免适用,只要公司符合特定豁免的任何记录保存或其他要求,新化学物质可以在不首先提交PMN的情况下制造或进口。自行豁免是对没有单独商业目的的化学物质的豁免聚合物符合规定要求;以及满足特定要求的研发(RD)物质。PMN要求的其他豁免要求获得EPA批准。在这些情况下,制造商或进口商必须在公司授权生产或进口新化学物质之前提交豁免申请,并且EPA必须批准豁免申请。此外,每个制造商或进口商必须遵守EPA批准的特定豁免的任何记录保存或其他要求。这些豁免是:低量豁免(LVE低释放和暴露豁免(LoREX和测试营销豁免(TME)。

 

What information does EPA initially seek in a PMN?

EPA最初在PMN中寻求哪些信息?

The PMN form seeks information on the submitter’s identity, the chemical substance’s identity, production volume, uses, exposures, and environmental fate. TSCA does not require a submitter to test new chemical substances before submitting a PMN. Health and safety data relating to a new chemical substance’s health or environmental effects that are in a submitter’s possession or control, however, must be submitted with the PMN. The submitter must provide this information to "the extent it is known to or reasonably ascertainable by the submitter." EPA has developed a PMN review process to estimate the risk attributable to a new chemical substance and to determine whether an unreasonable risk of injury to health or the environment may occur if the chemical substance is distributed in commerce. EPA may request additional information from a submitter during its review of a PMN application.

PMN表格寻求有关提交者身份,化学物质的身份,产量,用途,暴露和环境归宿的信息。在提交PMN之前,TSCA不要求提交者测试新的化学物质。但是,与提交者拥有或控制的新化学物质的健康或环境影响有关的健康和安全数据必须与PMN一起提交。提交者必须在提交者已知或可合理确定的范围内提供此信息。EPA制定了PMN审查程序,以估算可归因于新化学物质的风险,并确定如果化学物质在商业中分发,是否可能发生不合理的健康或环境伤害风险。在审查PMN申请期间,EPA可能会要求提交者提供其他信息。

 

When must a NOC be submitted?

什么时候必须提交NOC

Within 30 days of the first commercial manufacture (date of completion of production lot) or import (date new chemical substance clears U.S. Customs) of a chemical substance for which EPA has approved a PMN, the manufacturer or importer must prepare a draft NOC using EPA’s Form 7710-56. The NOC seeks information on the submitter’s identity, the chemical substance’s identity, and the date of commencement of manufacture or import. Upon receipt of the NOC, EPA places the PMN chemical substance on the TSCA Inventory.

在第一次商业化生产(生产批次完成日期)或进口(新化学物质清除美国海关的日期)的30天内,EPA批准PMN的化学物质,制造商或进口商必须使用EPA制备NOC草案表格7710-56NOC寻求有关提交者身份,化学物质的身份以及生产或进口的开始日期的信息。在收到NOC后,EPAPMN化学物质放在TSCA清单上。

 

Can EPA require persons to test chemical substances subject to TSCA?

EPA是否可以要求人员测试受TSCA影响的化学物质?

Yes. Under TSCA Section 4, EPA has authority to promulgate rules requiring manufacturers, importers, and processors to test chemical substances or mixtures for their effects on human health and the environment. To require testing, EPA must first find that "there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted," and "testing of such substance or mixture with respect to such effects is necessary to develop such data." EPA must also find that the chemical substance or mixture presents "an unreasonable risk" to human health or the environment, or is produced in substantial quantities that could result in substantial or significant human exposure or environmental release.

是。根据TSCA4部分EPA有权颁布规则,要求制造商,进口商和加工商测试化学物质或混合物对人类健康和环境的影响。为了要求进行测试,EPA必须首先发现没有足够的数据和经验来制造,分销商业,加工,使用或处置此类物质或混合物或这些活动的任何组合对健康或环境可以合理地确定或预测,并且“为了开发这样的数据,必须对这种物质或混合物进行这些影响的测试。”EPA还必须发现化学物质或混合物对人类健康或环境造成“不合理的风险”,或者大量生产可能导致人类暴露或环境释放。

 

Who is subject to testing requirements under TSCA Section 4?

谁符合TSCA4部分的测试要求?

TSCA Section 4 imposes testing requirements on manufacturers (including importers), as well as processors of chemical substances subject to a test rule. Manufacturers, however, are primarily responsible for testing. Under EPA’s regulations, manufacturers will be responsible for testing where testing is necessary to assess risks that arise primarily from manufacturing, from both processing and manufacturing, or from distribution, use, and/or disposal activities. Testing obligations will be imposed on processors where the testing is being conducted to evaluate the risks associated with processing of the chemical, or where no manufacturer submits a notice of intent to conduct testing.

TSCA4节对制造商(包括进口商)以及受测试规则约束的化学物质处理者规定了测试要求。但是,制造商主要负责测试。根据EPA的规定,制造商将负责测试哪些测试是必要的,以评估主要来自制造,加工和制造,或分销,使用和/或处置活动的风险。对正在进行测试的处理器施加测试义务,以评估与化学品处理相关的风险,或者没有制造商提交进行测试的意向通知。

 

What is the High Production Volume (HPV) Challenge Program?

什么是高产量(HPV)挑战计划?

EPA, in cooperation with the Environmental Defense Fund and the American Chemistry Council (formerly the Chemical Manufacturers Association), established the HPV Challenge Program to encourage chemical manufacturers and importers to conduct testing of chemicals on EPA’s list of HPV chemicals, which was compiled based on the 1990 Inventory Update Rule (IUR). HPV chemicals are defined as those manufactured or imported in quantities exceeding one million pounds. HPV testing is designed to generate basic toxicity information as defined by the Screening Information Data Set (SIDS) program, developed by the Organization for Economic Cooperation and Development (OECD). The SIDS program requires information on basic physical/chemical properties and approximately 13 studies in the areas of ecotoxicity, environmental fate, and mammalian toxicity. All data produced under the HPV program will be made available to the public. EPA will establish and maintain an electronic database designed to present the data and information in a meaningful and accurate way. For chemicals that are not sponsored under the HPV Challenge Program, EPA will use its Section 4 rulemaking authority to compel testing.

EPA与环境保护基金会和美国化学理事会(原化学品制造商协会)合作,制定了HPV挑战计划,鼓励化学品制造商和进口商在EPAHPV化学品清单上进行化学品测试,该清单是根据1990年库存更新规则(IUR)。HPV化学品定义为生产或进口数量超过一百万磅的化学品。HPV测试旨在生成由经济合作与发展组织(OECD)制定的筛查信息数据集(SIDS)计划定义的基本毒性信息。小岛屿发展中国家方案需要有关基本物理/化学特性的信息,以及生态毒性,环境归宿和哺乳动物毒性等领域的大约13项研究。根据HPV计划生成的所有数据将向公众开放。EPA将建立并维护一个电子数据库,旨在以有意义和准确的方式呈现数据和信息。对于未根据HPV挑战计划赞助的化学品,EPA将使用其第4节规则制定机构来强制进行测试。

 

When can EPA issue an administrative order controlling new chemical substances?

EPA何时可以发布控制新化学物质的行政命令?

TSCA Section 5(e) grants to EPA the authority to issue administrative orders controlling new chemical substances where it finds (1) there is insufficient information to evaluate the risk reasonably, and (2) either the chemical may present an unreasonable risk to health or the environment, or it will be produced in substantial quantities that will enter the environment or to which there will be substantial or significant human exposure. In its order, EPA can ban or limit the manufacture, distribution, use, or disposal of the chemical.

TSCA5e)条授予EPA发布控制新化学物质的行政命令的权力,如果发现(1)没有足够的信息来合理评估风险,(2)该化学品可能对健康造成不合理的风险或环境,或大量生产进入环境或将人类暴露环境的风险。在其订单中,EPA可以禁止或限制化学品的制造,分配,使用或处置。

 

What is a significant new use for a chemical substance?

什么是化学物质的重要新用途

Section 5(a) requires manufacturers, importers, and processors of existing chemicals to provide notice to EPA of any use of a substance that EPA has determined is "a significant new use." A determination that a use is significant and new must be made by rule, known as a Significant New Use Rule (SNUR). TSCA does not establish standards or criteria for establishing when a new use is deemed "significant," but requires EPA to consider "all relevant factors" before promulgating a SNUR, including (a) the projected volume of manufacturing and processing of a chemical substance, (b) the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance, (c) the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance, and (d) the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

5a)条要求现有化学品的制造商,进口商和加工商向EPA发出EPA已确定的重要新用途物质使用的通知。必须通过规则确定使用是重要的和新的,称为重要新使用规则(SNUR)。TSCA没有建立确定何时新用途被认为重要规范或标准,但要求EPA在颁布SNUR之前考虑所有相关因素,包括(a)预计的化学物质的制造和加工量, b)使用在何种程度上改变人类或环境对化学物质的暴露类型或形式c)使用增加人类或环境暴露的程度或持续时间的程度化学物质,(d)合理预期的制造,加工,分销商业和处置化学物质的方式和方法。

 

Can EPA seize a chemical substance if EPA determines it presents an unreasonable risk to human health or the environment?

如果EPA认为它对人类健康或环境造成不合理的风险,EPA是否可以扣押此化学物质?

Yes. EPA may commence a civil action in an appropriate United States district court to seize chemical substances or mixtures that EPA determines are imminently hazardous chemical substances or mixtures that will present an unreasonable risk of serious and widespread injury to health and the environment. EPA may commence such action notwithstanding the existence of a final rule under TSCA Section 4, 5, or 6.

是。EPA可以在适当的美国地方法院起诉民事诉讼,以扣押认定的化学物质或混合物,这些化学物质或混合物是即将发生的危险化学物质或混合物,会对健康和环境造成严重和广泛的伤害。尽管根据TSCA4,56条规定存在最终规则,EPA仍可以采取此类行动。

 

What information does EPA seek when it issues a Preliminary Assessment Information Rule (PAIR)?

EPA在发布初步评估信息规则(PAIR)时会寻求哪些信息?

Each PAIR requires certain manufacturers and importers of certain chemical substances listed on the TSCA Inventory to submit a one-time report by the date established in the Federal Register announcing the PAIR. The report addresses: (1) the quantities of chemical substances manufactured, imported, used as a reactant, used in industry and consumer products, or lost to the environment; and (2) worker exposure. Manufacturers and importers must submit such information to the extent it is "readily obtainable by management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing." "Extensive" file searches are "not required."

每个PAIR要求TSCA清单中列出的某些化学物质的某些制造商和进口商在联邦登记册中公布PAIR的日期之前提交一次性报告。该报告涉及:(1)制造,进口,用作反应物,工业和消费品中使用或环境损失的化学物质的数量2)工人暴露。制造商和进口商必须在易于由负责制造,加工,分销,技术服务和营销的管理和监督员工获得的范围内提交此类信息。广泛的文件搜索不是必需的

 

How often must manufacturers submit reports under the IUR?

制造商必须多久提交一次IUR报告?

After 2006, the IUR requires certain manufacturers and importers of certain chemical substances listed on the TSCA Inventory and produced above threshold volumes to report, every five years, data on production volume, plant site, and site-limited status of those chemical substances. At the higher threshold of 300,000 pounds, additional downstream processing and use information is required.

2006年之后,IUR要求TSCA清单中列出的某些化学物质的某些制造商和进口商生产高于阈值的数量,每五年报告一次化学物质的生产量,工厂现场和现场限制状态的数据。在300,000磅的较高阈值处,需要额外的下游处理和使用信息。

 

What is a "significant adverse reaction"?

什么是重大不良反应

TSCA regulations define "significant adverse reactions" as "reactions that may indicate a substantial impairment of normal activities, or long-lasting or irreversible damage to health or the environment." Examples of "significant adverse reactions" that must be reported are provided at 40 C.F.R. Section 717.12. They include, but are not limited to, long-lasting or irreversible health effects such as cancer and neurological effects; impairment of normal activities experienced by a number of people exposed to the same event or by one person each time he or she is exposed; long-lasting or irreversible damage to biological species, such as fish-kills or reduction in the ability of a species to survive; and long-lasting or irreversible effects on environmental media, such as groundwater contamination.

TSCA法规将重大不良反应定义为可能表明正常活动严重受损或对健康或环境造成长期或不可逆损害的反应。必须报告的显着不良反应的实例在40 C.F.R.717.12提供。它们包括但不限于长期或不可逆转的健康影响,如癌症和神经系统影响暴露于同一事件的一些人或每次暴露于一个人时所经历的正常活动的损害对生物种造成长期或不可逆转的破坏,例如鱼类死亡或物种生存能力下降对环境介质产生长期或不可逆转的影响,如地下水污染。

 

How must companies record significant adverse reactions?

公司如何记录重大不良反应?

EPA has not created a specific form to use to record TSCA Section 8(c) allegations. TSCA Section 8(c) allegation records must contain, however, the following information concerning each recordable allegation: (1) the name and address of the site that received the allegation; (2) the date the allegation was received; (3) the identity of the chemical substance or mixture; (4) a description of the person making the allegation (i.e., employee, customer, plant neighbor); (5) a description of the alleged reaction(s); and (6) the gender and birth year of any person alleged to have experienced a health effect. The original allegation must be attached to the TSCA Section 8(c) allegation form.

EPA尚未创建用于记录TSCA8c)条指控的特定表格。但是,TSCA8c)条指控记录必须包含有关每个可记录指控的以下信息:(1)收到指控的网站的名称和地址2)收到指控的日期3)化学物质或混合物的特性4)对提出指控的人的描述(即雇员,客户,工厂邻居)5)所谓反应的描述6)任何据称经历健康影响的人的性别和出生年份。最初的指控必须附在TSCA8c)条指控表中。

 

Can EPA require companies to submit to EPA their records of significant adverse reactions?

EPA是否可以要求公司向EPA提交他们的重大不良反应记录?

Yes. EPA may issue a letter or Federal Register notice requiring the submission of TSCA Section 8(c) allegation records to EPA. The Federal Register notice will specify which records or portion of records must be submitted, and whether allegations relating to mixtures must be reported.

是。EPA可能会发出一封信或联邦登记公告,要求向EPA提交TSCA8c)条指控记录。联邦公报通知将指明必须提交哪些记录或部分记录,以及是否必须报告与混合物有关的指控。

 

What is a "health and safety study" under TSCA Section 8(d)?

什么是TSCA8d)条下的健康与安全研究

TSCA defines a "health and safety study" as "any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA." Under TSCA Section 8(d), manufacturers, importers, and processors who fall within the North American Industrial Classification System (NAICS) Subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries) must submit, for certain chemical substances and mixtures, unpublished health and safety studies that are in their possession, lists of all unpublished health and safety studies on those chemical substances and mixtures known to them but not in their possession, and lists of all unpublished health and safety studies being conducted or initiated on those chemical substances and mixtures.

TSCA健康与安全研究定义为化学物质或混合物对健康或环境或两者的任何影响的研究,包括基础数据和流行病学研究,化学物质或混合物的职业接触研究,毒理学化学物质或混合物的临床,生态学或其他研究,以及根据TSCA进行的任何测试。根据TSCA8d)条,属于北美工业分类系统(NAICS)分部门325(化学制造和相关产品)或工业集团32411(炼油厂)的制造商,进口商和加工商必须提交某些化学物质和混合物,未发表的健康和安全研究,所有未发表的关于这些化学物质的健康和安全研究清单以及他们所知但尚未掌握的混合物清单,以及正在进行或启动的所有未发表的健康和安全研究清单对这些化学物质和混合物。

 

Are there any requirements to report to EPA adverse information concerning a chemical substance?

是否有任何要求规定EPA报告有关化学物质的不良信息?

Yes. Pursuant to TSCA Section 8(e), any person who manufactures, imports, processes, or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that the chemical substance or mixture poses a "substantial risk of injury" to human beings or the environment must provide the information to EPA immediately. EPA provides that "immediately" means "not later than the 30th calendar day after the date the person obtained such information." Exceptions include information about emergency incidents of environmental contamination, which must be reported immediately, and non-emergency incidents of environmental contamination, which must be reported to EPA within 90 days of obtaining the information unless reported within 90 days to another EPA office, federal or state regulatory agency.

是。根据TSCA8e)条,任何人制造,进口,加工或分销化学物质或混合物,并获得合理支持该化学物质或混合物对人类造成实质性伤害的结论的信息。 众生或环境必须立即向EPA提供信息。EPA规定立即意味着不迟于获得此类信息之日后的第30个日历日。例外情况包括必须立即报告的环境污染紧急事件的信息,以及环境污染的非紧急事件,必须在获取信息后90天内向EPA报告,除非在90天内向另一个EPA办公室,联邦或国家监管机构。

 

Does EPA provide guidance on what is a "substantial risk of injury"?

EPA是否就实质性受伤风险提供指导?

EPA has emphasized that "substantial risk" information "need not and most typically does not establish conclusively that a substantial risk exists." EPA has also said that in deciding whether information is "substantial risk" information, one must consider "(a) the seriousness of the effect . . . and (b) the fact or probability of [the effect’s] occurrence." According to EPA, the two criteria should be weighed differently depending on the seriousness of the effect or the extent of the exposure (the more serious the effect, the less heavily one should weigh exposure, and vice versa).

EPA强调,实质性风险信息不需要,而且大多数情况下通常不会确定存在重大风险EPA还表示,在决定信息是否为重大风险信息时,必须考虑a)效果的严重性......以及(b[效应]发生的事实或概率。根据EPA的说法,这两个标准应根据影响的严重程度或暴露程度进行不同的权衡(影响越严重,曝光量越小,反之亦然)。

 

Are there exemptions from reporting a substantial risk of injury under TSCA Section 8(e)?

根据TSCA8节(e),是否有免于报告实质性伤害风险的情况?

Yes. Information otherwise subject to the reporting requirements of TSCA Section 8(e) need not be submitted if the information: (1) is contained in an EPA study or report; (2) is published in the open scientific literature or major U.S. news publication; (3) has been reported to EPA under mandatory reporting requirements of TSCA or other authority administered by EPA; (4) is contained in a formal publication, report, or statement made available to the public by another federal agency; (5) is corroborative of a well-established adverse effect (and does not newly identify any serious adverse effects or confirm a previously suspected serious adverse effect); or (6) is information for which EPA has waived compliance in accordance with TSCA Section 22.

是。如果信息如下,则无需提交符合TSCA8节(e)报告要求的信息:(1)包含在EPA研究或报告中2)发表于公开科学文献或美国主要新闻出版物3)已根据美国环保署管理的TSCA或其他权限的强制性报告要求向EPA报告4)包含在另一个联邦机构向公众提供的正式出版物,报告或声明中5)证实有明确的不良反应(并且不会新发现任何严重不良反应或确认先前可疑的严重不良反应)或(6)是EPA根据TSCA22节放弃遵守的信息。

 

Can a company claim information submitted to EPA as confidential?

公司可以将提交给EPA的信息声称为机密信息吗?

Yes. TSCA Section 14(a) prohibits EPA, except in certain limited circumstances, from disclosing to the public "trade secrets and commercial or financial information obtained from a person and privileged or confidential." Confidential information can be disclosed (1) to any officer or employee of the United States "(A) in connection with the official duties of such officer or employee under any law for the protection of health or the environment, or (B) for specific law enforcement purposes"; (2) to contractors with the United States if "disclosure is necessary for the satisfactory performance by the contractor"; (3) if the Administrator "determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment"; or (4) when "relevant in any proceeding under [TSCA]."

是。TSCA14a)条禁止EPA(在某些有限的情况下)向公众披露“从一个人获得的商业秘密和商业或财务信息,特权或机密信息”。机密信息可以披露1)任何美国高级人员或雇员A)有关该人员或雇员根据任何法律保护健康或环境的公职,或(B)为特定执法目的而言2)如果“承包商履行令人满意的业绩需要披露”,则向美国的承包商提供3)如果管理员“认定有必要保护健康或环境免受不健康的健康或环境伤害风险”或(4“在[TSCA]的任何程序中有关”

 

When must exporters notify a country that it intends to export a chemical substance?

出口商什么时候必须通知某国打算出口化学物质?

Chemical substances and mixtures subject to TSCA Section 12(b) export notification requirements are those for which EPA has taken one or more of the following actions: (1) data have been required under TSCA Section 4 or 5(b); (2) an order has been issued under TSCA Section 5; (3) a rule has been proposed or promulgated under TSCA Section 5 or 6; or (4) an action is pending or relief has been granted under TSCA Section 5 or 7.

符合TSCA12b)条出口通知要求的化学物质和混合物是EPA采取以下一项或多项措施的要求:(1TSCA4节或第5b)条要求提供数据2)已根据TSCA5条发出命令3)根据TSCA56条提出或颁布的规则或(4)正在根据TSCA57条批准的诉讼或救济。

 

What information must be provided in a TSCA Section 12(b) export notification?

TSCA12b)条出口通知中必须提供哪些信息?

If a TSCA Section 12(b) export notification is required for any chemical substance or mixture, the exporter must prepare a notice to EPA. Each notice must include the: (1) name of the chemical substance or mixture (if a confidential product is exported a generic name or product name must be used); (2) Chemical Abstracts Service (CAS) Number (if readily available); (3) name and address of the exporter; (4) country or countries of import, which is defined as the "country where the goods are to be consumed, further processed, or manufactured, as known to the exporter at the time or exportation." If the exporter does not know the country of ultimate destination, the shipment is credited to the last country to which the exporter knows that the merchandise will be shipped"; (5) date(s) of export or intended export; and (6) TSCA section under which EPA has taken action (i.e., TSCA Section 4, 5, 6, or 7).

如果任何化学物质或混合物需要TSCA12b)条出口通知,出口商必须向EPA准备通知。每份通知必须包括:(1)化学物质或混合物的名称(如果出口机密产品,必须使用通用名称或产品名称)2)化学文摘社(CAS)编号(如果随时可用)3)出口商的名称和地址4)进口国或进口国,其定义为出口商在当时或出口时已知的货物将被消费,进一步加工或制造的国家。如果出口商不知道最终目的地的国家,则该货物将记入出口商知道该商品将被运送到的最后一个国家5)出口或者拟出口的日期6EPA采取行动的TSCA部分(即TSCA4,5,67条)。

 

Does TSCA regulate the importation of chemical substance?

TSCA是否规范化学物质的进口?

Yes. Under TSCA Section 13, the Secretary of the Treasury (United States Customs Service or Customs) must refuse entry into the United States of any shipment containing any chemical substance -- including a chemical substance that is a component of a mixture and a chemical substance or mixture contained in an article that is designed to be used or released -- if that shipment fails to comply with TSCA. Under rules adopted by the United States Customs Service, importers must certify at the point of entry, for each shipment containing chemical substances, mixtures, or articles, that: (1) all chemical substances, mixtures, and articles being imported comply with all applicable rules and orders under TSCA Sections 5, 6, and 7, and are not offered for entry in violation of TSCA (positive certification); or (2) all chemical substances, mixtures, and articles being imported are not subject to TSCA (negative certification).

是。根据TSCA13节,财政部长(美国海关总署或海关)必须拒绝任何含有任何化学物质的货物进入美国 - 包括作为混合物和化学物质成分的化学物质或 设计用于或释放的物品中包含的混合物 - 如果该货物不符合TSCA。根据美国海关总署采用的规则,进口商必须在入境时对含有化学物质,混合物或物品的每批货物进行以下认证:(1)所有进口的化学物质,混合物和物品均符合所有适用条件根据TSCA5,67条规定的规则和命令,不允许违反TSCA(正面认证)进入或(2)所有进口的化学物质,混合物和物品不受TSCA(负面认证)的约束。

 

What document(s) must accompany shipments of chemical substances imported into the United States?

进口到美国的化学物质运输必须附带哪些文件?

Import certificates must accompany each shipment containing chemical substances, mixtures, or articles that are not exempt from TSCA importation requirements. There are three types of Import Certificates: positive, negative, and blanket. One of these types of Import Certificates must accompany each applicable shipment. Import Certificates must be preprinted, typed, or stamped on the invoice for each shipment or attached to such invoice. Import Certificates may be signed by means of an authorized facsimile signature.

每批含有化学物质,混合物或物品的货物必须随附进口证书,但不得免除TSCA进口要求。导入证书有三种类型:正面,负面和一揽子。每种适用的货件必须附带其中一种进口证书。进口证书必须预先打印,打印或盖印在每张货件的发票上或附在此发票上。进口证书可以通过授权的传真签名进行签字。

 

Does EPA have inspection authority under TSCA?

EPA是否根据TSCA拥有检验权?

Yes. TSCA Section 11 grants to EPA broad authority to conduct inspections to enforce the Act. Under TSCA Section 11(a), EPA may inspect any establishment, facility, or other premises in which chemical substances or mixtures are manufactured, processed, stored, or held before or after their distribution in commerce, and any conveyance being used to transport chemical substances in connection with their distribution in commerce. Failure or refusal to permit entry or inspection as required under Section 11 constitutes an unlawful act under TSCA Section 15, giving rise to civil penalties.

是。TSCA11节授予EPA广泛授权进行检查以执行该法案。根据TSCA11a)条,EPA可以检查在商业分销之前或之后制造,加工,储存或保存化学物质或混合物的任何企业,设施或其他场所,以及用于运输化学品的任何运输工具。 与其在商业中的分布有关的物质。根据第11节的规定,未能或拒绝允许进入或检查构成TSCA15条规定的非法行为,从而导致民事处罚。

 

What activities are unlawful under TSCA?

根据TSCA,哪些活动是非法的?

Under TSCA Section 15, it is unlawful to (1) fail or refuse to comply with a Section 4 test rule or order, or any rule, order, or requirement issued under Section 5 or 6; (2) use for commercial purpose a chemical substance or mixture which the person knew or had reason to know was manufactured, processed, or distributed in violation of Section 5 or 6, or a rule or order issued under Section 5, 6, or 7; (3) fail or refuse to establish or maintain records, submit reports, notices or other information, or permit access to or copying of records required under TSCA; or (4) fail or refuse to permit entry or inspection as required by Section 11.

根据TSCA15节,以下这些是非法的(1)未能或拒绝遵守第4节测试规则或命令,或根据第56条发布的任何规则,命令或要求2)出于商业目的使用该人知道或有理由知道的化学物质或混合物是违反第56条制造,加工或分发的,或根据第5,67条发出的规则或命令3)未能或拒绝建立或保持记录,提交报告,通知或其他信息,或允许访问或复制TSCA所要求的记录或(4)未能或拒绝按第11条的规定准许进入或检查。

 

Are there criminal liabilities under TSCA?

TSCA是否有刑事责任?

TSCA Section 16(b) authorizes EPA to seek criminal penalties against any person who "knowingly or willfully" violates any provision of TSCA Section 15. EPA can seek criminal fines of up to $32,500 for each day the violation continues and/or imprisonment for up to one year. EPA can seek criminal penalties in lieu of, or in addition to, civil penalties.

TSCA16b)条授权EPA对任何故意或故意违反TSCA15条规定的人进行刑事处罚。EPA可以在违规行为持续和/或监禁长达一年的情况下,每天处以高达32,500美元的刑事罚款。EPA可以代替民事处罚或者除民事处罚外,寻求刑事处罚。

 

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