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TSCA认证:eCFR 770.7 (a) EPA TSCA VI的产品认证机构 临安科达认证技术咨询服务有限公司   时间:2019-04-17   点击:2264 次
EPA TSCA VI的产品ABs(认证机构)。作为EPA TSCA标题VI产品AB参加EPA TSCA标题VI第三方认证计划,产品AB必须具备本节所述的资格,按照本节的规定提交申请并与EPA签署认可协议 ,并经EPA认可后,公平履行本节所述的责任。

 

 

§770.7   Third-party certification. 第三方认证

(a)       EPA TSCA Title VI Product ABs. To participate in the EPA TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI Product AB, a Product AB must have the qualifications described in this section, submit an application and enter into a recognition agreement with EPA as described in this section, and, upon recognition from EPA, impartially perform the responsibilities described in this section.

EPA TSCA VI产品ABs(认证机构)。作为EPA TSCA标题VI产品AB参加EPA TSCA标题VI第三方认证计划,产品AB必须具备本节所述的资格,按照本节的规定提交申请并与EPA签署认可协议 ,并经EPA认可后,公平履行本节所述的责任。

(1)      Qualifications. To qualify for recognition by EPA in the EPA TSCA Title VI Third-Party Certification Program as an EPA TSCA Title VI Product AB, an applicant Product AB must:

1)资格。要获得EPAEPA TSCA Title VI第三方认证计划中作为EPA TSCA Title VI产品AB的认可,申请人产品AB必须:

(i) Be a signatory to the International Accreditation Forum, Inc.'s (IAF) Multilateral Recognition Arrangement (MLA) through level three, or have membership in one of the IAF recognized regional accreditation cooperations, or an equivalent organization as determined by EPA;

i)是三级国际认证论坛,(IAF)多边承认协议(MLA)的签字人,或IAF认可的区域认可合作伙伴之一,或由EPA确定的同等组织

(ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference, see §770.99); and

ii)符合ISO / IEC 170112004E)(通过引用并入,见§770.99

(iii) Be competent to perform accreditation activities for product certification according to ISO/IEC 17065:2012(E) (incorporated by reference, see §770.99).

iii)有权根据ISO / IEC 170652012E)进行产品认证的认证活动(通过引用并入,参见§770.99)。

(2) Application. To be recognized by EPA under the EPA TSCA Title VI Third-Party Certification Program, a Product AB must submit an application to EPA in accordance with §770.8 that contains the following:

2申请。根据EPA TSCA Title VI第三方认证计划获得EPA的认可,产品AB必须按照§770.8EPA提交申请,其中包含以下内容:

(i) Name, address, telephone number, and email address of the organization or primary contact;

i)组织或主要联系人的姓名,地址,电话号码和电子邮件地址

(ii) Documentation of IAF MLA signatory status, membership in one of the IAF recognized regional accreditation cooperations, or an equivalent organization as determined by EPA;

iiIAF MLA签字识别的文件,成为IAF认可的区域认证合作伙伴之一,或由EPA确定的同等组织

(iii) Description of any other qualifications related to the Product AB's experience in performing product accreditation of TPCs for manufactured products including an affirmation that assessors will be technically competent to assess a TPC's ability to perform their activities under paragraph (c)(4) of this section; and

iii)与产品AB在制造产品的TPC产品认证方面的经验相关的任何其他资格的说明包括确认评估员在技术上有权评估TPC根据本节(c)(4)进行其活动的能力

(iv) If not a domestic entity, name and address of an agent for service located in the United States. Service on this agent constitutes service on the AB or any of its officers or employees for any action by EPA or otherwise by the United States related to the requirements of this part. ABs may share an agent for service.

iv)如果不是国内实体,则位于美国的服务代理商的名称和地址。该代理的服务AB等同,或其任何官员或雇员,以其他方式以便符合本部分相关的EPA或美国的要求。 AB可以共享代理服务。

(3) Recognition agreement. To be recognized by EPA under the EPA TSCA Title VI Third-Party Certification Program, a Product AB must enter into a recognition agreement with EPA that describes the EPA TSCA Title VI Product AB's responsibilities under this subpart.

3)认可协议。根据EPA TSCA Title VI第三方认证计划获得EPA的认可,产品AB必须与EPA签订认可协议,该协议描述了EPA TSCA Title VI产品AB在本子部分下的责任。

(i) Each recognition agreement will be valid for three years.

i)每份认可协议有效期为三年。

(ii) Each recognition agreement will identify an EPA Recognition Agreement Implementation Officer and an EPA TSCA Title VI Product AB Implementation Officer that will serve as the point of contact for the EPA TSCA Title VI Third-Party Certification Program.

ii)每份认可协议将确定EPA认可协议执行官和EPA TSCA Title VI产品AB执行官,这将作为EPA TSCA Title VI第三方认证计划的联系人。

(iii) To renew a recognition agreement for an additional three-year period, the EPA TSCA Title VI Product AB must submit an application for renewal in accordance with §770.8 before the three-year period of the recognition agreement lapses. The application must indicate any changes from the EPA TSCA Title VI Product AB's initial application or most recent renewal application.

iii)续签三年期的认可协议,EPA TSCA Title VI产品AB必须在认可协议的三年期限届满之前按照§770.8提交续签申请。申请必须表明EPA TSCA Title VI Product AB的初始申请或最新续签申请的任何变更。

(iv) If an EPA TSCA Title VI Product AB fails to submit an application for renewal prior to the expiration of the previous recognition agreement, its recognition will lapse and the EPA TSCA Title VI Product AB may not provide accreditation services under TSCA Title VI.

iv)如果EPA TSCA Title VI Product AB在之前的认可协议到期之前未能提交续展申请,则其认可将失效,EPA TSCA Title VI Product AB可能不会根据TSCA Title VI提供认证服务。

(v) If an EPA TSCA Title VI Product AB does submit an application for renewal prior to the expiration of the previous recognition agreement, it may continue to provide TSCA Title VI accreditation services under the terms of its previous recognition agreement until EPA has taken action on its application for renewal of the recognition agreement.

v)如果EPA TSCA Title VI Product AB在之前的认可协议到期之前确实提交了续展申请,它可以继续根据其先前的认可协议条款提供TSCA Title VI认证服务,直到EPA采取行动为止关于续签认可协议的申请。

(4) Impartiality. EPA TSCA Title VI Product ABs must act impartially when performing activities under the EPA TSCA Title VI Third-Party Certification Program. To demonstrate impartiality, Product ABs must:

4)公正。EPA TSCA Title VI产品AB在根据EPA TSCA Title VI第三方认证计划开展活动时必须公正行事。为了证明公正性,产品AB必须:

(i) Ensure that an accreditation decision regarding a TPC is made by persons different from those who conducted the assessment of the TPC; and

i)确保有关TPC的认证决定由不同于对TPC进行评估的人员制作

(ii) Ensure that the AB's personnel who assess TPCs or make decisions regarding accreditation do not receive financial benefit from the outcome of an accreditation decision.

ii)确保评估TPC或做出有关认证决策的AB人员不会从认可决定的结果中获得经济利益。

(5) Responsibilities. Each EPA TSCA Title VI Product AB has the following responsibilities under the EPA TSCA Title VI Third-Party Certification Program:

5)职责。每个EPA TSCA Title VI Product ABEPA TSCA Title VI第三方认证计划下承担以下责任:

(i) Accreditation. EPA TSCA Title VI Product ABs must determine the accreditation eligibility, and accredit if appropriate, each TPC seeking recognition under the EPA TSCA Title VI Third-Party Certification Program by performing an assessment of each TPC as described in this section. The assessment must include all of the following components:

i)认可。EPA TSCA Title VI产品AB必须确定认证资格,如果合适,每个TPC都要通过对EPA TSCA Title VI第三方认证计划的认可,通过对本节所述的每个TPC进行评估来进行认证。评估必须包括以下所有组件:

(A) An on-site assessment by the EPA TSCA Title VI Product AB to determine whether the TPC meets the requirements of ISO/IEC 17065:2012(E), is in conformance with ISO/IEC 17020:2012(E) as required under ISO/IEC 17065:2012(E) section 6.2.1 (incorporated by reference, see §770.99) and the EPA TSCA Title VI TPC requirements under this part. In performing the on-site assessment, the EPA TSCA Title VI Product AB must:

AEPA TSCA Title VI产品AB的现场评估,以确定TPC是否符合ISO / IEC 170652012E)的要求,符合ISO / IEC 170202012EISO / IEC 170652012E)第6.2.1节的要求(通过引用并入,见§770.99)和本部分下的EPA TSCA Title VI TPC要求。在进行现场评估时,EPA TSCA Title VI Product AB必须:

(1) Develop a checklist of the EPA TSCA Title VI TPC requirements under paragraph (c)(4) of this section and the key accreditation elements of ISO/IEC 17065:2012(E) (incorporated by reference, see §770.99); and

1)根据本节(c)(4)制定EPA TSCA Title VI TPC要求清单和ISO / IEC 170652012E)的关键认证要素(通过引用纳入,见§770.99

(2) Use the checklist for each on-site assessment.

2)使用每个现场评估的清单。

(B) A review of the approach that the TPC will use to verify the accuracy of the formaldehyde emissions tests conducted by the TPC laboratory and the formaldehyde quality control tests conducted by or for the panel producers producing composite wood products that are subject to the requirements of TSCA Title VI.

B)审查TPC将用于验证TPC实验室进行的甲醛排放测试准确性的方法以及由生产复合木制品的面板生产商进行的甲醛质量控制测试,这些测试符合TSCA Title VI的要求。

(C) A review of the approach that the TPC will use for evaluating a panel producer's quality assurance and quality control processes, the proficiency of the panel producer's quality assurance and quality control personnel, the required elements of a panel producer's quality assurance and quality control manual, and sufficiency of on-site testing facilities as applicable.

C)审查TPC将用于评估面板生产商的质量保证和质量控制过程的方法,面板生产商的质量保证和质量控制人员的熟练程度,面板生产商质量保证和质量控制手册的必要元素,以及适用的现场测试设施的充分性。

(D) A review of the approach that the TPC laboratory will use for establishing correlation or equivalence between ASTM E1333-14 and ASTM D6007-14, if used, (incorporated by reference, see §770.99) or allowable formaldehyde test methods listed under §770.20.

D审查TPC实验室将用于建立ASTM E1333-14ASTM D6007-14之间的相关性或等效性的方法,如果使用,(通过引用并入,参见§770.99)或§770.20中列出的允许甲醛测试方法。

(E) A review of the approach that the TPC will use for evaluating the process for sample selection, handling, and shipping procedures that the panel producer will use for quality control testing as applicable.

E)审查TPC将用于评估样品选择,处理和运输程序的方法,面板生产商将用于质量控制测试(如适用)。

(F) A review of the accreditation credentials of the TPC laboratory, including a verification that the laboratory has been accredited to ISO/IEC 17025:2005(E) (incorporated by reference, see §770.99) with a scope of accreditation to include this part—Formaldehyde Standards for Composite Wood Products and the formaldehyde test methods ASTM E1333-14 and ASTM D6007-14, if used, by an EPA TSCA Title VI Laboratory AB (incorporated by reference, see §770.99).

F)对TPC实验室认可证书的审查,包括验证实验室已通过ISO / IEC 170252005E)认证(通过引用并入,见§770.99)具有认可范围包括该部分 - 复合木制品的甲醛标准和甲醛测试方法ASTM E1333-14ASTM D6007-14,如果使用,由EPA TSCA Title VI 实验室 AB进行(通过引用并入,参见§770.99)。

(ii) Reassessment. Each EPA TSCA Title VI Product AB must, in accordance with ISO/IEC 17011:2004(E) section 7.11 (incorporated by reference, see §770.99), conduct an on-site reassessment or surveillance on-site assessment at least every two years of each EPA TSCA Title VI TPC that the AB has accredited.

ii)再评估。每个EPA TSCA Title VI 产品 AB必须符合ISO / IEC 170112004E)第7.11节(通过引用并入,见§770.99),对于AB认可的每个EPA TSCA Title VI TPC,至少每两年进行一次现场重新评估或监督现场评估。

(iii) Suspension, reduction, withdrawal. Each EPA TSCA Title VI Product AB must suspend, reduce, or withdraw the accreditation of an EPA TSCA Title VI TPC that the AB has accredited when circumstances warrant.

iii)暂停,减少,撤回。每个EPA TSCA Title VI 产品 AB必须暂停,减少或撤销在环境允许时AB认可的EPA TSCA Title VI TPC的认证。

(iv) Notifications. Each EPA TSCA Title VI Product AB must provide, in accordance with §770.8, the following notifications to EPA, as applicable:

iv)通知。 根据§770.8,每个EPA TSCA Title VI 产品AB必须向EPA提供以下通知(如适用):

(A) Notification of the loss of its status as a signatory to the IAF MLA, or loss of membership in one of the IAF recognized regional accreditation cooperations, or an equivalent organization as determined by EPA must be provided within five calendar days of the date that the body receives notification of the loss of its signatory or membership status.

A)通知失去其作为IAF工作重点的签字人的身份,或失去IAF认可的区域认证合作的成员资格,或者由EPA确定的同等组织必须在机构收到其签字人或会员资格丧失通知之日起的五个日历日内提供。

(B) Notification that an EPA TSCA Title VI TPC has failed to comply with any provision of this part must be provided within 72 hours of the time the Product AB identifies the deficiency. The notice must include a description of the steps taken to address the deficiency.

B)必须在产品AB确定缺陷的72小时内提供EPA TSCA Title VI TPC未能遵守本部分任何规定的通知。通知必须包括解决缺陷所采取步骤的说明。

(C) Notification of suspension, reduction or withdrawal of an EPA TSCA Title VI TPC's accreditation must be provided within 72 hours of the time that the suspension, reduction or withdrawal takes effect.

C)暂停,减少或撤销EPA的通知TSCA标题VI TPC的认证必须在暂停,减少或撤销生效后72小时内提供。

(D) Notification of a change in a non-domestic Product AB's agent for service must be provided within five calendar days.

D)必须在五个日历日内提供非国内产品AB的服务代理变更通知。

(v) Records. Each EPA TSCA Title VI Product AB must maintain, in electronic form, the checklists and other records documenting compliance with the requirements for assessment, reassessment, and surveillance on-site assessments of EPA TSCA Title VI TPCs for three years.

v)记录。每个EPA TSCA Title VI产品AB必须以电子形式保存三年,核对清单和其他记录符合评估,重新评估,和监督现场评估EPA TSCA Title VI TPC

(vi) Annual report. Each EPA TSCA Title VI Product AB must provide, in accordance with §770.8, an annual report on or before March 1st of each year for the AB services performed during the previous calendar year including the number and locations of assessment, reassessment, and surveillance on-site assessments performed for each EPA TSCA Title VI TPC.

vi)年度报告。每个EPA TSCA Title VI产品AB必须按照§770.8提供,每年31日或之前为上一日历年进行的AB服务的年度报告,包括评估的数量和地点,为每个EPA TSCA Title VI TPC进行重新评估和现场监督评估。

(vii) EPA meetings. Each EPA TSCA Title VI Product AB must meet with EPA at least once every two years in person, via teleconference, or through other virtual methods to discuss the implementation of the EPA TSCA Title VI Third-Party Certification Program.

viiEPA会议。每个EPA TSCA Title VI 产品 AB必须至少每两年与EPA会面一次,通过电话会议,或通过其他虚拟方法讨论EPA TSCA Title VI第三方认证计划的实施。

(viii) Inspections. Each EPA TSCA Title VI Product AB must allow inspections of the AB's facilities by EPA, at reasonable times, within reasonable limits, and in a reasonable manner, upon the presentation of appropriate credentials and a written notification to the AB.

viii)检查。每个EPA TSCA Title VI产品AB必须允许EPA在合理的时间内,在合理的限度内,以合理的方式,在向AB提交适当的凭证和书面通知后检查AB的设施。

 

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