Small Entity Compliance Guide For Accreditation Bodies and Third-Party Certifiers Formaldehyde Emissions Standards for Composite Wood Products Title VI of the Toxic Substances Control Act &EPA United States Environmental Protection Agency January 2017 EPA -740-B-17-002 ------- &EPA United States Environmental Protection Agency This guide was prepared pursuant to section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996, Pub. L. 104-121 as amended by Pub. L. Number 110-28. THIS DOCUMENT IS NOT INTENDED, NOR CAN IT BE RELIED UPON, TO CREATE ANY RIGHTS ENFORCEABLE BY ANY PARTY IN LITIGATION WITH THE UNITED STATES. The statements in this document are intended solely as guidance to aid you in complying with the formaldehyde emissions standards for composite wood products in Title VI of the Toxic Substances Control Act (TSCA) and the implementing regulations in 40CFR part770. EPA is continually improving and upgrading its rules, policies, compliance programs, and outreach efforts. EPA may decide to revise this guide without public notice to reflect changes in EPA's approach to implementing TSCA Title VI or to clarify information and update text. To determine whether EPA has revised this guide and/or to obtain copies, contact EPA's Small Business Ombudsman Hotline at (800) 368-5888 or (202) 566-1970 in DC, or consult the EPA's formaldehyde website at http://www.epa.gov/formaldehyde. The full texts of TSCA Title VI and the implementing regulations are also available at this website. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 2 ------- Introduction This document is published by EPA as the official compliance guide for small entities, as required by the Small Business Regulatory Enforcement Fairness Act of 1996. Before you begin using the guide you should know that the information in this guide was compiled based on the Formaldehyde Emission Standards for Composite Wood Products regulation published on December 12,2016. EPA is continually improving and upgrading its rules, policies, compliance programs, and outreach efforts. You can determine whether EPA has revised or supplemented the information in this guide by consulting EPA's formaldehyde website at http://www.epa.gov/formaldehyde. Contents This guide is organized as follows: Introduction Regulation Summary and Compliance Timetable Who Must Comply How to Comply For More Information Appendix and Acronym List Terminology Throughout this guide, when the term "composite wood product" is used, it refers to the three composite wood products generally regulated by TSCA Title VI— hardwood plywood, medium-density fiberboard (MDF) and particleboard. Other key terminology is defined in the Appendix: Glossary of Environmental Terms. Who Should Use this Guide? This guide is intended for accreditation bodies (ABs) and third-party certifiers (TPCs) who wish to participate in the EPA Toxic Substances Control Act (TSCA) Title VI Third-Party Certification Program. What Does This Guide Cover? This guide covers the requirements under the final rule for ABs and TPCs who wish to participate in the EPA TSCA Title VI Third-Party Certification Program. For ABs who wish to participate in the EPA program, responsibilities include: Determining the accreditation eligibility and accrediting as appropriate TPCs who wish to participate in the EPA program; Ensuring that accredited TPCs meet certain international voluntary consensus standards (discussed later in this guide); and Helping to ensure the TPCs' ability to oversee and monitor composite wood panel producers. For TPCs who wish to participate in this EPA program, responsibilities include: Regularly inspecting composite wood panel producers to verify their compliance with the formaldehyde emission standards; Conducting and verifying formaldehyde emissions tests; and Ensuring that panel producers' quality assurance/quality control procedures and testing comply with the TSCA Title VI implementing regulations, or 40 CFR part 770. OTHER GUIDES TO CONSIDER: There are other separate small entity compliance guides available for different entities along the value chain, including: 1. Importers, Distributors and Retailers; 2. Fabricators and Laminated Product Producers; and 3. Mills (Panel Producers). Each of these guides can be found at https://www.epa.gov/ formaldehyde/small-entity-compliance-guides-formaldehyde- emission-standards-composite-wood-products. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 3 ------- FIGURE 1 - TSCA TITLE VI PROGRAM Figure 1 outlines the structure of the TSCA Title VI program and shows the relationships between EPA and the various groups involved in implementation of the regulation. ABs and TPCs are identified in blue with their relationship to the remainder of the TSCA Title VI program. Reciprocity Importers Retailers C ARB-approved Third Party Certifiers (TPCs) Distributors Fabricators EPA-recognized Third Party Certifiers (TPCs) EPA-recognized Product & Laboratory Accreditation Bodies (ABs) Panel Producers California Air Resources Board (CARB) I LAC International Laboratory Accreditation Cooperation IAF International Accreditation Forum This compliance guide explains your federal compliance obligations with respect to the formaldehyde regulations under TSCA Title VI as EPA-recognized ABs and TPCs. There may be other state or local requirements which apply to you that are different from, or more stringent than, the federal requirements. How Do I Obtain a Complete Copy of This Rule? A complete copy of the final rule and supporting documents can be found in Federal Register (Vol. 81, No. 81, p. 89674) at https://www.regulations.gov/document?D=EPA- HQ-OPPT-2016-0461 -0001. A copy of the final rule can also be found at https:// www.epa.gov/formaldehyde/resources-guidance- materials-formaldehyde-emission-standards-composite- wood-products. See section entitled "For More Information" of this compliance guide for additional information resources. NOTE: If you wish to serve as a TPC orAB in the state of California you must also comply with the California Air Resource Board's Airborne Toxic Control Measure (CARB ATCM) to control formaldehyde emissions from composite wood products. More information on the CARB ATCM can be found online at http://www.arb.ca.gov/toxics/compwood/compwood.htm. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers ------- Regulation Summary and Compliance Timetable Regulation Summary TSCA Title VI establishes formaldehyde emission standards for three types of composite wood products: hardwood plywood, MDF and particleboard. The purpose of TSCA Title VI and the implementing regulations is to reduce formaldehyde emissions from these composite wood products, which will reduce exposures to formaldehyde, resulting in benefits for human health. The regulations require the covered composite wood products to be tested to ensure compliance with the TSCA Title VI formaldehyde emission standards and certified by an EPA-recognized TPC. Limited testing and certification exemptions are available for products made with no- added formaldehyde (NAF) resins or ultra low-emitting formaldehyde (ULEF) resins. To ensure that only compliant products enter and move through the product supply chain, the regulations contain recordkeeping, reporting, and labeling requirements. The formaldehyde emission standards are identical to the emission standards currently in place in California, and the regulations are as consistent as practical with the requirements currently in effect under the CARB ATCM. CARB-approved TPCs are eligible for recognition under the EPA program through reciprocity with the CARB program. Table 1 provides a summary of the regulatory requirements and compliance dates. The "How to Comply" section of this guide provides more detail on the rule requirements for ABs and TPCs and what they must do to document compliance with the regulation. Table 1. Summary Provsions and Compliance Timetable Entity Provision Compliance Date ABs ABs may begin to seek recognition to accredit TPCs under the EPA program. Beginning February 10, 2017 CARB-approved TPCs In order to be recognized by EPA to certify composite wood products under the EPA TSCA Title VI Third-Party Certification program, a CARB- approved TPC may apply to EPA with all the information requested in 40 CFR §770.7(c)(2) other than the accreditation documentation under (c)(2) (iii) and (iv). Beginning February 10, 2017 CARB-approved TPCs In order to continue certifying products under the EPA TSCA Title VI Third-Party Certification program after December 12, 2018, obtain the proper accreditations from an EPA-recognized AB to international voluntary consensus standards (discussed later in this guide) with the proper scopes of accreditation and provide documentation of that accreditation to EPA in addition to performing the responsibilities of certifying products under the EPA program. December 12, 2018* CARB-approved TPCs that apply to CARB and EPA after the transitional period concludes Must apply to EPA pursuant to 40 CFR §770.7(c)(2) to be recognized by EPA to certify composite wood products under the EPA TSCA Title VI Third- Party Certification Program. December 12, 2018* TPCs (other than CARB-approved TPCs) May apply to EPA pursuant to 40 CFR §770.7(c)(2) to be recognized by EPA to certify composite wood products. EPA-recognized TPCs must begin certifying composite wood products one year after publication of the final rule under the EPA TSCA Title VI Third-Party Certification Program. Beginning February 10, 2017 'Note: CARB-approved TPCs may seek to meet the EPA accreditation requirements at any time prior to the conclusion of the two-year transitional period and submit this documentation to EPA. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 5 ------- Emission Standards Product Emission Standard Hardwood Plywood - Veneer Core 0.05 ppm of formaldehyde Hardwood Plywood - Composite Core 0.05 ppm of formaldehyde MDF 0.11 ppm of formaldehyde Thin MDF 0.13 ppm of formaldehyde Particleboard 0.09 ppm of formaldehyde *Note: ppm refers to parts per million. Who Must Comply How Can I Tell If I Am Subject to This Rule? ABs that accredit TPCs that wish to participate in the EPA TSCA Title VI Third-Party Certification Program are also subject to the final rule requirements. TPCs that seek to certify compliance of composite wood panel producers' product with the final rule's formaldehyde emission standards and other rule requirements are subject to the final rule. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 6 ------- How to Comply What Must I Do to Comply? ABs Overview ABs interested in participating in the EPA program must apply to EPA and, if deemed qualified, be approved by and enter into a recognition agreement with EPA. After being recognized by EPA, ABs would then accredit TPCs to international consensus standards incorporated into the final rule (discussed later in this guide) and assess the ability of TPCs to fulfill the requirements established in 40 CFR §770.7. There are two types of ABs that can be involved in the implementation of the EPA program: Product ABs and Laboratory ABs. EPA recognizes it is also possible that an AB may be qualified to perform the roles of both types of ABs, and accredit a TPC for both its product certification capabilities (Product AB function) and formaldehyde emissions laboratory testing capabilities (Laboratory AB function). In such a case, the AB would fulfill the two AB roles under the EPA program. Product ABs Compliance Requirements for Product ABs Under the EPA program, Product ABs will ensure that TPCs are qualified to certify composite wood products by accrediting them to recognized international voluntary consensus standards and the TSCA Title VI regulatory requirements discussed below. Required Qualifications for Participation in the EPA Program To qualify for recognition by EPA as a Product AB, an applicant Product AB must be: A signatory to the International Accreditation Forum, Inc. (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; In conformance with the International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) 17011:2004(E): General requirements for accreditation bodies accrediting conformity assessment bodies; and Competent to perform accreditation activities for product certification according to ISO/IEC17065:2012(E): Requirements for bodies certifying products, processes and services. Application for Recognition under the EPA Program To be recognized by EPA, Product ABs must apply for recognition via the EPA Central Data Exchange (CDX) found at http://cdx.epa.gov. The EPA CDX is an AB's point of entry into the Environmental Information Exchange Network (Exchange Network) used for electronic data submissions. The CDX registration process includes completing an electronic signature agreement, preparing a data file for submission, agreeing to the terms and conditions of CDX, providing information about the submitter and organization, selecting a user name and password, and following the procedures outlined in the guidance document for CDX available at http://cdx.epa.gov/Content/Documents/CDX_Quick_User_ Guide.pdf. The required Product AB application information includes: Name, address, telephone number, and email address of the organization or primary contact; Documentation of IAF MLAsignatory status, membership in one of the IAF recognized regional accreditation cooperations (if applicable), or an equivalent organization as determined by EPA; Description of any other qualifications related to the Product AB's experience in performing product accreditation of TPCs; and If not a domestic entity, name and address of an Agent for Service located in the United States. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 7 ------- NOTE: An Agent for Service is an entity designated by a TPC or AB to receive legal documents on their behalf. ABs have the option to share an Agent for Service, meaning one Agent for Service can provide service for multiple ABs recognized under TSCA Title VI. Recognition Agreement with EPA To be recognized under the EPA program, a Product AB must enter into a recognition agreement with EPA via CDX. The recognition agreement establishes a relationship between the Product AB and EPA to help ensure the proper oversight of TPCs participating in the EPA program. Each recognition agreement will be valid for three years. Product ABs must submit a renewal application via the EPA CDX before the three-year period of the recognition agreement lapses. The renewal application must indicate any changes from the Product AB's initial application or most recent renewal application. If the Product AB fails to submit an application for renewal prior to the expiration of the previous recognition agreement, its recognition will lapse and the Product AB may not provide accreditation services under the EPA program. Note that if a 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. Additionally, information in the recognition agreement is not eligible for treatment as Confidential Business Information (CBI). Commitment to Impartiality Product ABs must commit to act impartially when performing activities under the EPA program. This commitment is consistent with the impartiality provisions of the ISO/IEC standards incorporated in the final rule. To demonstrate impartiality, Product ABs must ensure that an accreditation decision regarding a TPC is made by persons different from those who conducted the assessment of the TPC, and 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. Responsibilities 0 Accreditation. The Product ABs must determine the accreditation eligibility, and accredit, if appropriate, each TPC seeking recognition under the EPA program by performing an assessment of each TPC. The assessment must include all of the following components: 1. An on-site assessment to determine whether the TPC meets the requirements of ISO/IEC 17065:2012(E). TPCs will also be assessed to determine whether they are in conformance with ISO/IEC 17020:2012(E) as required under ISO/IEC 17065:2012(E) Section 6.2.1 and TPC requirements under 40 CFR §770.7. In performing the on-site assessment, the Product AB must develop a checklist of the TPC requirements under 40 CFR §770.7(c)(4) and the key accreditation elements of ISO/IEC 17065:2012(E), and use the checklist for each on-site assessment. 2. A review of how: The TPC will 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. The TPC will evaluate: i. A panel producer's quality assurance and quality control processes; ii. The proficiency of the panel producer's quality assurance and quality control personnel; iii. The required elements of a panel producer's quality assurance and quality control manual; iv. Sufficiency of on-site testing facilities as applicable; and v. The process for sample selection, handling, and shipping procedures that the panel producer will use for quality control testing as applicable. The TPC laboratory will establish correlation or equivalence between ASTM El 333-10: Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber and ASTM Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 8 ------- D6007-02: Standard Test Method for Determining Formaldehyde Concentrations in Air from Wood Products Using a Small-Scale Chamber, if used, or allowable formaldehyde test methods listed under 40 CFR section 770.20. 3. A review of the accreditation credentials of the TPC laboratory, including a verification that the laboratory has been accredited by an EPA-recognized Laboratory AB to ISO/IEC 17025:2005(E): General requirements for the competence of testing and calibration laboratories, with a scope of accreditation to include 40 CFR part 770— Formaldehyde Standards for Composite Wood Products and the formaldehyde test methods ASTM El 333-10 and ASTM D6007-02, if used, by a Laboratory AB. 0 Reassessment. Each Product AB must, in accordance with ISO/IEC 17011:2004(E) Section 7.11, conduct an on-site reassessment or surveillance on-site assessment at least every two years of each EPA-recognized TPC that the AB has accredited. 0 Suspension, reduction, withdrawal. Each Product AB must suspend, reduce, or withdraw (as defined in ISO/IEC 17011:2004(E)) the accreditation of an EPA-recognized TPC that the AB has accredited when circumstances, based on the professional judgment of the AB, warrant such action. 0 Notifications. Each Product AB must provide the following notifications to the EPA CDX for the following events: 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. When a TPC has failed to comply with any provision of 40 CFR part 770, notification 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. Where there is a suspension, reduction or withdrawal of an EPA-recognized TPC's accreditation, the notification must be provided within 72 hours of the time that the suspension, reduction or withdrawal takes effect. Where there is a change in a non-domestic Product AB's Agent for Service, notification must be provided within five calendar days. 0 Records. Each Product ABs 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-recognized TPCs for three years. 0 Annual report. Product ABs must provide EPA an annual report electronically via the EPA CDX 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-recognized TPC. 0 EPA meetings. Product ABs 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 program. EPA believes that this requirement will further ensure the proper oversight of the EPA program. 0 Inspections. Product ABs must allow inspections of their 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. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 9 ------- Laboratory ABs Compliance Requirements for Laboratory ABs Under the EPA program, Laboratory ABs will ensure that laboratories are qualified to conduct formaldehyde emissions laboratory testing services, by accrediting them to recognized international voluntary consensus standards and the TSCA Title VI regulatory requirements discussed below. Required Qualifications for Participation in the EPA Program To qualify for recognition by EPA as a Laboratory AB, an applicant Laboratory AB must be: A signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), or have membership in one of the ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA; In conformance with ISO/IEC 17011:2004(E); Competent to perform accreditation activities for laboratory accreditation according to ISO/IEC 17025:2005(E); and Competent to ensure EPA-recognized TPC inspection activities are in conformance with ISO/IEC 17020:2012(E): Requirements for the operation of various types of bodies performing inspection. Application for Recognition under the EPA Program To be recognized under the EPA program, a Laboratory AB must submit an application to EPA, which may be submitted in conjunction with a Product AB application, via the EPA CDX. Similar to Product ABs, the registration process includes completing an electronic signature agreement, preparing a data file for submission, agreeing to the terms and conditions of CDX, providing information about the submitter and organization, selecting a user name and password, and following the procedures outlined in the guidance document for CDX available at http://cdx.epa.gov/ Content/Documents/CDX_Quick_User_Guide.pdf. The required Laboratory AB application information includes: Name, address, telephone number, and email address of the organization or primary contact; Documentation of ILAC MRA signatory status, membership in one of the ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA; Description of any other qualifications related to the Laboratory AB's experience in performing laboratory accreditation and inspection certification of TPCs including an affirmation that assessors will be technically competent to assess TPCs ability to perform their activities under the final rule; and If not a domestic entity, name and address of an Agent for Service located in the United States. Recognition Agreement with EPA To be recognized by EPA under the EPA program, like Product ABs, a Laboratory AB must enter into a recognition agreement with EPA that describes the Laboratory AB's responsibilities under the final rule. As with the recognition agreement requirement for Product ABs, the recognition agreement establishes a relationship between the Laboratory AB and EPA to help ensure the proper oversight of TPCs participating in the EPA program. Each recognition agreement will be valid for three years. Laboratory ABs must submit a renewal application via the EPA CDX before the three-year period of the recognition agreement lapses. The renewal application must indicate any changes from the Laboratory AB's initial application or most recent renewal application. If the Laboratory fails to submit an application for renewal prior to the expiration of the previous recognition agreement, its recognition will lapse and the Laboratory AB may not provide accreditation services under the EPA program. Note that if a Laboratory 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 Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 10 ------- previous recognition agreement until EPA has taken action on its application for renewal of the recognition agreement. Note that information in this recognition agreement is not eligible for treatment as CBI under TSCA Title VI. Commitment to Impartiality Laboratory ABs must commit to act impartially when performing activities under the EPA program by ensuring that: An accreditation decision regarding a TPC is made by persons different from those who conducted the assessment of the TPC; and The AB's personnel who assess TPCs or make decisions regarding accreditation do not receive financial benefit from the outcome of an accreditation decision. Responsibilities 0 Accreditation. Each Laboratory AB must determine the accreditation eligibility and accredit, if appropriate, each TPC seeking recognition under the EPA program by performing an assessment of each TPC. The assessment must include the following components: An on-site assessment by the Laboratory AB to determine whether the laboratory meets the requirements of ISO/IEC 17025:2005(E) and the EPA-recognized TPC requirements under 40 CFR §770.7(c)(4) including the formaldehyde test methods ASTM El 333-10 and ASTM D6007-02, if used. In performing the on-site assessment, the Laboratory AB must develop a checklist of the TPC requirements under paragraph 40 CFR §770.7(c)(4) of this and the key conformity elements of ISO/IEC 17025:2005(E). 0 Reassessment. Laboratory ABs must, in accordance with ISO/IEC 17011:2004(E) Section 7.11, conduct a follow-up reassessment or surveillance on-site assessment of each TPC laboratory that the AB has accredited. 0 Proficiency. Each Laboratory ABs must verify the accuracy of the formaldehyde emissions tests conducted by the TPC laboratory by ensuring the TPC laboratory participates in the CARB interlaboratory comparison for formaldehyde emissions when offered. In lieu of participation in the CARB interlaboratory comparison, ensure that the TPC laboratory participates in an EPA-recognized proficiency testing program, if available. 0 Suspension, reduction, withdrawal. Each Laboratory AB must suspend, reduce, or withdraw (as defined in ISO/IEC 17011:2004(E)) the accreditation of a TPC laboratory that the AB has accredited when circumstances warrant, based on the professional opinion of the Laboratory AB. 0 Notifications. Each Laboratory AB must provide the following notifications to the EPA CDX for the following events: Loss of its status as a signatory to the ILAC MRA, or loss of membership in one of the ILAC 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 notice of the loss of its signatory or membership status; When a TPC laboratory has failed to comply with any provision of 40 CFR §770.7, notification must be provided within 72 hours of the time the Laboratory AB identifies the deficiency. The notice must include a description of the steps taken to address the deficiency; Notification of suspension, reduction or withdrawal of a TPC laboratory's accreditation must be provided within 72 hours of the time that the suspension, reduction or withdrawal takes effect; and Where there is a change in a non-domestic Laboratory AB's Agent for Service, notification must be provided within five calendar days. 0 Records. Each Laboratory 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 TPC Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 11 ------- laboratories for three years. 0 Annual Report. Each Laboratory AB must provide an annual report via the EPA CDX on or before March 1st of each year for AB services performed during the previous calendar year including the number and locations of assessment, reassessment, and surveillance on-site assessments performed for each TPC laboratory. 0 EPA meetings. Each Laboratory 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 program. EPA believes that this requirement will further ensure the proper oversight of the EPA program. 0 Inspections. Each Laboratory 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. TPCs Compliance Requirements for TPCs that Certify Composite Wood Products TPCs that certify hardwood plywood, MDF, particleboard and finished goods containing these products that are sold, supplied, offered for sale, or manufactured (including imported) in the United States must be recognized under the EPA program. To be recognized under the EPA program, a TPC must be accredited by an EPA-recognized Product AB, use a laboratory that is accredited by an EPA-recognized Laboratory AB, have the other qualifications described in 40 CFR §770.7, submit an application and be recognized by EPA, and, upon recognition from EPA, impartially perform their responsibilities under 40 CFR §770.7. Alternatively, CARB-approved TPCs must meet the criteria for reciprocity in 40 CFR §770.7 (d) in order to be recognized by EPA as an EPA TSCATitle VI TPC. See the section of this guide titled Reciprocity TPCs Approved by CARB. Required Qualifications for Participation in the EPA Program To qualify for recognition by EPA as a TPC, an applicant TPC must: Be accredited by an EPA TSCA Title VI Product AB to ISO/IEC 17065:2012(E) with a scope of accreditation that includes include composite wood products and 40 CFR part 770—Formaldehyde Standards for Composite Wood Products; NOTE: The scope of accreditation requirement "40 CFR part 770—Formaldehyde Standards for Composite Wood Products" means that the AB has verified the TPCs ability to perform their duties under the regulation including their responsibilities under40 CFR §770.7 (c)(4). Be accredited, or have a contract with a laboratory that is accredited, by an EPA-recognized Laboratory AB to ISO/IEC 17025:2005(E) with a scope of accreditation to include 40 CFR part 770—Formaldehyde Standards for Composite Wood Products and the formaldehyde test methods ASTM El 333-10 and ASTM D6007-02, if used; NOTE: The scope of accreditation requirement "40 CFR part 770—Formaldehyde Standards for Composite Wood Products" means that the AB has verified the TPCs ability to perform their duties under the regulation including their responsibilities under 40 CFR §770.7 (c)(4). The scope of accreditation requirement for the test methods "ASTM El 333-10 and ASTM D6007-02, if used" means that the TPC has been accredited to be proficient in ASTM El333-10 and, if the TPC uses the test method, ASTM D6007-02. Have the ability to conduct inspections of composite wood products and properly train and supervise inspectors to inspect composite wood products in conformance with ISO/IEC 17020:2012(E) as required under ISO/IEC 17065:2012(E) Section 6.2.1.; Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 12 ------- NOTE: TPCs are not required to be accredited to ISO/IEC 17020:2012(E), but rather be in conformance with the standard. Have demonstrated experience in the composite wood product industry with at least one type of composite wood product and indicated the specific product(s) the applicant intends to certify; and Have demonstrated experience in performing or verifying formaldehyde emissions testing on composite wood products, including experience with test method ASTM El333-10 and ASTM D6007-02, if used, and experience evaluating correlation between test methods. Application for Recognition under the EPA Program To be recognized by EPA under the EPA program, a TPC must submit an application and renew that application every two years via the EPA CDX. The registration process includes completing an electronic signature agreement, preparing a data file for submission, agreeing to the Terms and Conditions of CDX, providing information about the submitter and organization, selecting a user name and password, and following the procedures outlined in the guidance document for CDX available at http://cdx.epa.gov/ Content/Documents/CDX_Quick_User_Guide.pdf. The required TPC application information includes: Name, address, telephone number, and email address of the organization or primary contact; Type of composite wood products that the applicant intends to certify; A copy of the TPC's certificate of accreditation from an EPA-recognized Product AB to ISO/IEC 17065:2012(E) with a scope of accreditation that includes composite wood products and 40 CFR part 770—Formaldehyde Standards for Composite Wood Products; A copy of the TPC laboratory's certificate of accreditation from an EPA-recognized Laboratory AB to ISO/IEC 17025:2005(E) with a scope of accreditation to include 40 CFR part 770-Formaldehyde Standards for Composite Wood Products and the formaldehyde test methods ASTM El 333-10 and ASTM D6007-02, if used; An affirmation of the TPC's ability to conduct inspections of composite wood products and properly train and supervise inspectors to inspect composite wood products in conformance with ISO/IEC 17020:2012(E) as required under ISO/IEC 17065:2012(E) Section 6.2.1.; A description of the TPC's experience in the composite wood product industry with at least one type of composite wood product and indicate the specific product(s) the applicant intends to certify; A description of the TPC's experience in performing or verifying formaldehyde emissions testing on composite wood products; A description of the TPC's experience with test method ASTM El 333-10 and/or ASTM D6007-02, if used, and experience evaluating correlation between test methods; and If not a domestic entity, the name and address of an Agent for Service located in the United States. Commitment to Impartiality TPCs must act impartially in accordance with their accreditation when performing activities under the EPA program. To ensure the integrity of the EPA program, TPCs must take the steps necessary to address any conflicts of interest. To demonstrate impartiality, TPCs must: Not also be, or have a financial interest in, a panel producer, fabricator, laminated product producer, importer, designer, distributor or retailer of composite wood products; Ensure that TPC management personnel and TPC Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 13 NOTE: Applicant TPCs that have demonstrated experience with test method ASTM D6007-02 only must be contracting testing with a laboratory that has a large chamber and demonstrate its experience with ASTM El333-10. NOTE: An Agent for Service is an entity designated by a TPC or AB to receive legal documents on their behalf. TPCs have the option to share an Agent for Service, meaning one Agent for Service can provide service for multiple TPCs recognized under TSCA Title VI. ------- personnel involved in the review and certification decision-making process for composite wood products are not involved in activities within the same or separate legal entity that may compromise the impartiality of its certification decision-making process, such as advocacy or consulting activities; Ensure that TPC management personnel and TPC personnel of the same or separate legal entity involved in activities such as advocacy or consulting are not involved in the management of the certification body, the review, or the certification decisions; and Ensure that TPC management personnel and TPC personnel certifying composite wood products sign a conflict of interest statement attesting that they will receive no financial benefit from the outcome of certification. Responsibilities 0 Certification. TPCs recognized under the EPA program must certify composite wood products that are produced in accordance with 40 CFR part 770 and that comply with the emission standards of TSCA Title VI and 40 CFR §770.7, in accordance with ISO/IEC 17065:2012(E). For each panel producer making composite wood products certified by the TPC, the TPC must: Verify that each panel producer has adequate quality assurance and quality control procedures and is complying with the applicable quality assurance and quality control requirements; Verify each panel producer's quality control test results compared with test results from ASTM El 333-10 and ASTM D6007-02, if used, by having the TPC laboratory conduct quarterly tests and evaluate test method equivalence and correlation as required under 40 CFR §770.20; In consultation with the panel producer, establish quality control limits (QCLs) for formaldehyde emissions, and, if applicable, shipping quality control limits or other formaldehyde emission limits, for each panel producer and product type; Establish, for each panel producer, the process that will be used to determine if products are exceeding the applicable QCL; Provide its CARB or EPA TPC number to each panel producer for labeling and recordkeeping; and Inspect each panel producer, its products, and its records at least quarterly in conformance with ISO/IEC 17020:2012(E) as required under ISO/IEC 17065:2012(E) Section 6.2.1. 0 Laboratories. For quarterly testing, each TPC must use only laboratories that have been accredited by an EPA- recognized Laboratory AB and that either participate in the CARB interlaboratory comparison for formaldehyde emissions when offered or in an EPA-recognized proficiency or interlaboratory program, if available. 0 NAF and ULEF. For panel producers that do not receive approval for NAF or ULEF third-party certification exemptions or ULEF reduced testing from CARB, TPCs must review applications for NAF or ULEF third-party certification exemptions or ULEF reduced testing. Each TPC must approve these applications within 90 calendar days of receipt if the panel producer demonstrates that the requirements for third-party certification exemption under 40 CFR §770.17 or 770.18 or reduced testing under 40 CFR §770.18 are met. 0 Reduced testing for MDF orparticleboard. TPCs must review applications from panel producers to reduce the number of quality control tests for particleboard and MDF, and approve these applications within 90 calendar days of receipt if the panel producer demonstrates that the requirements for reduced testing under 40 CFR section 770.20 (b)(2)(ii) are met. 0 Notifications to EPA. Each TPC must provide notifications to EPA via the EPA CDX for the following events: An approved or rejected application, including a renewal application, for a NAF or ULEF third-party certification exemption or ULEF reduced testing. The notification must be provided within five calendar days of the approval or Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 14 ------- rejection and copies of all approved applications must be forwarded to EPA within 30 calendar days of approval. An approved or rejected application, including a renewal application, for reduced testing for MDF or particleboard. Notification must be provided within five calendar days of the approval or rejection and copies of all approved applications must be forwarded to EPA within 30 calendar days of approval. When a panel producer exceeds its established QCL for more than two consecutive quality control tests, notification must be provided within 72 hours of the time that the TPC becomes aware of the second exceedance. The notice must include the product type, dates of the quality control tests that exceeded the QCL, quality control test results, ASTM El 333-10 correlative equivalent values, the established QCL value(s) and the quality control method used. For each failed quarterly tests, (i.e., any sample that exceeds the applicable formaldehyde emission standard in 40 CFR §770.10), notification must be provided to EPA within 72 hours. Information in this notification is not eligible for treatment as confidential business information. Where there is a change in a non-domestic TPC's Agent for Service, notification must be provided within five calendar days. Loss of accreditation or notification that the TPC has discontinued its participation in the EPA program must be provided within 72 hours. 0 Other Notifications. Each TPC must provide the following notifications, if applicable: Notification of each failed quarterly tests, that is any sample that exceeds the applicable formaldehyde emission standard in 40 CFR §770.10, must be provided to the panel producer in writing within 72 hours. Notification of a loss of accreditation or notification that the TPC has discontinued its participation in the EPA program must be provided within 72 hours to all panel producers for which it provides EPA TSCA Title VI certification services. Notification of any changes in personnel qualifications, procedures, or laboratories used must be provided to the TPC's EPA-recognized ABs within 30 calendar days. 0 Records. Each TPC must maintain, in electronic form, the following records for three years from the date the record is created, and provide them to EPA within 30 calendar days of a request from EPA: A list of panel producers and their respective products and product types, including type of resin systems used, that the TPC has certified; Results of inspections and formaldehyde emissions tests conducted for and linked to each panel producer and product type; A list of laboratories used by the TPC, as well as all test methods used, including test conditions and conditioning time, and quarterly test results; Methods and results for establishing test method correlations and equivalence; Documentation for NAF or ULEF third-party certification exemptions or ULEF reduced testing approvals, including the name of the panel producer, facility, products approved, type of resin systems used and dates of approval; Documentation of reduced testing approval for panel producers of MDF or particleboard, including the name of the panel producer, products approved and dates of approval; and A copy of the most recent assessment, reassessment, and/or surveillance on-site assessment report provided by its EPA-recognized ABs. 0 Annual Report. Each TPC must provide an annual report via the EPA CDX on or before March 1st of each year for the TPC services performed during the previous calendar year. The report must contain all of the following elements, as applicable: For each panel producer making composite wood products certified by the TPC, the TPC must provide the following information: i. Composite wood products that the TPC has certified Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 15 ------- during the previous calendar year; ii. Types of resin systems used for the composite wood products certified; iii. Dates of quarterly inspections; iv. For each quarterly test, the date, result, test method, and whether a contract laboratory was used; v. For each failed quarterly test, the product type, the volume of product affected, the results of recertification testing, and a description of the final disposition of the affected product, including how the non-complying lot was addressed; vi. For each non-complying lot resulting from a failed quality control test, the test date, method, product type, volume of product affected, lot numbers, the results of retesting, and a description of the final disposition of the affected product, including how the non-complying lot was addressed; and vii. Any corrective actions that resulted from quarterly tests and inspections. The TPC must provide a list of laboratories and test methods used by the TPC, number and volume (cubic meters) of large and small chambers, date of equivalence determination and equivalence data. The TPC must describe any non-conformities identified by its EPA-recognized AB(s) and how they were addressed. The TPC must provide the results, compared with the mean of the interlaboratory comparison, for all formaldehyde emissions interlaboratory comparisons outside of the CARB interlaboratory comparison or, if available, the results of an EPA-recognized proficiency testing program. 0 Assessments and Inspections. Upon request, each EPA TPC must allow EPA representatives to: Accompany the TPC's staff during an assessment, reassessment or surveillance on-site assessment of the TPC by its AB(s); and Inspect the TPC's facilities, at reasonable times, within reasonable limits, and in a reasonable manner, upon the presentation of appropriate credentials and a written notification to the TPC. Reciprocity for TPCs Approved by CARB During the Transitional Period Existing TPCs approved by the California Air Resources Board and TPCs approved by CARB during the transitional period (beginning on December 12, 2016 and ending on December 12, 2018) may certify composite wood products under TSCA Title VI until December 12,2018, as long as they: Remain approved by CARB; Apply to EPA via the EPA CDX at https://cdx.epa.gov and become recognized by EPA; Comply with all aspects of the rule requirements at 40 CFR §770.7 other than the requirements of 40 CFR §770.7(c)(1)(i)-(ii) and (c)(2)(iii) and (iv); Provide panel producers with the TPC number issued by CARB; Provide the annual report required by 40 CFR Section 770.7(c)(4)(viii), and mentioned earlier in this guide, to CARB and EPA during the two-year transitional period; Provide notifications required by paragraph (c)(4)(v) to EPA; and Receive recognition from EPA as an EPA TSCA Title VI TPC. After the Transitional Period After December 12, 2018, TPCs approved by CARB and recognized by EPA as EPA TSCA Title VI TPCs may continue to certify composite wood products under TSCA Title VI after the two-year transitional period, if the TPC: Maintains its CARB approval; Complies with the requirements of 40 CFR §770.7 (including the accreditation requirements at 40 CFR §§ 770.7(c)(1)(i)-(ii)); and Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 16 NOTE: The annual reporting and notification requirements must be submitted to EPA via the EPA CDX. ------- Submits to EPA via the EPA CDXthefollowing information: i. Documentation from CARB that specifies their eligibility for reciprocity; and ii. A copy of the application submitted to CARB to be recognized as a TPC under the CARB ATCM. Receives recognition from EPA as an EPA TSCA Title VI TPC. Suspension, Revocation or Modification of EPA Recognition TPCs EPA may suspend, revoke or modify the recognition of a TPC, if the TPC: Fails to comply with any requirement of TSCA Title VI or 40 CFR part 770; Makes any false or misleading statements on its application, records, or reports; or Makes substantial changes to personnel qualifications, procedures, or laboratories that make the TPC or TPC laboratory unable to comply with any applicable requirements of 40 CFR part 770. ABs EPA may suspend, revoke or modify the recognition of an AB if the AB: No longer maintains signatory status to the IAF MLA or ILAC MRA, membership in one of the IAF/ILAC recognized regional accreditation cooperations, or an equivalent organization as determined by EPA; Fails to comply with any requirement of TSCA Title VI or 40 CFR part 770; Makes any false or misleading statements on its application, records, or reports; or Makes substantial changes to personnel qualifications or procedures that make the AB, TPC and/or TPC laboratory unable to comply with any applicable requirements of 40 CFR part 770. Process for Suspending, Revoking or Modifying Recognition Prior to taking action to suspend, revoke or modify recognition, EPA will notify the participant AB or the participant TPC in writing of the following: The legal and factual basis for the proposed suspension, revocation or modification; The anticipated commencement date and duration of the suspension, revocation or modification; Actions, if any, which the affected AB or TPC may take to avoid suspension, revocation or modification, or to receive recognition in the future; The opportunity and method for requesting a hearing with EPA prior to final suspension, revocation or modification; and If the affected AB or TPC requests a hearing in writing to EPA within 30 calendar days of receipt of the notification, EPA will: i. Provide the affected AB or TPC an opportunity to offer written statements in response to EPA's or the AB's assertions of the legal and factual basis for the proposed action; and ii. Appoint an impartial EPA official as Presiding Officer to conduct the hearing. The Presiding Officer will: Conduct a fair, orderly, and impartial hearing within 90 calendar days of the request; Consider all relevant evidence, explanations, comments and arguments submitted; and Notify the affected AB or TPC in writing within 90 calendar days of completion of the hearing of his or her decision and order. Such an order is a final EPA action which may be subject to judicial review. The order must contain the basis, commencement date, and duration of the suspension, revocation or modification. If EPA determines that the public health, interest, or NOTE: EPA retains the authority to deny recognition ofCARB- approved TPCs who seek recognition through reciprocity in the EPA program if EPA has information indicating that the TPC is not qualified. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 17 ------- welfare warrants immediate action to revoke the recognition of an AB or TPC prior to the opportunity for a hearing, it will notify the affected AB or TPC of its right to request a hearing on the immediate revocation within 15 calendar days of the revocation taking place and the procedures for the conduct of such a hearing. Any notification, decision, or order issued by EPA under this section, any transcript or other verbatim record of oral testimony, and any documents filed by a certified individual or firm in a hearing under this section will be available to the public, except as otherwise provided by TSCA §14. Any such hearing at which oral testimony is presented will be open to the public, except that the Presiding Officer may exclude the public to the extent necessary to allow presentation of information which may be entitled to confidential treatment under TSCA §14. EPA will maintain a publicly available list of ABs on its website whose recognition has been suspended, revoked or modified, or reinstated and a publicly available list of TPCs whose recognition has been suspended, revoked, modified, or reinstated. Unless specified otherwise, an AB or a TPC whose recognition has been revoked must reapply for recognition in order to become recognized again. Also, unless specified otherwise, an AB whose recognition has been revoked or a TPC whose recognition has been revoked, must immediately notify all TPCs or panel producers to which it provides TSCA Title VI accreditation or certification services of the revocation. Effect of the Loss of Recognition or Accreditation ABs If an AB is removed or withdraws from the EPA program: For reasons other than fraud or providing false or misleading statements, and other than a reason that implicates a particular TPC in a violation of TSCA Title VI, TPCs accredited by that AB can continue to certify products under TSCA Title VI for 180 calendar days. Following 180 calendar days, the TPC may not certify products under TSCA Title VI until they are accredited by another EPA-recognized AB and re-recognized by EPA; and Due to fraud or providing false or misleading statements with respect to a particular TPC, or for any other reason that implicates a particular TPC in a violation of TSCA Title VI, that TPC may not provide any TSCA Title VI certification services until it has been accredited again by another EPA-recognized AB and re-recognized by EPA. TPCs If a TPC loses its accreditation, or if a TPC is removed or withdraws from the EPA program: For reasons other than fraud or providing false or misleading statements, and other than a reason that implicates a particular panel producer in a violation of TSCA Title VI, the panel producers that used the TPC to certify their products must enlist another EPA-recognized TPC to certify their products within 90 calendar days. If the panel producer is not able to obtain the services of another EPA TSCA Title VI TPC within 90 days, the panel producer may request from EPA a 90 calendar day extension. During the time a panel producer is seeking a new TPC, it must continue to comply with all other requirements of TSCA Title VI, including quality control testing; and Due to fraud or providing false or misleading statements with respect to a particular panel producer, or for any other reason that implicates a particular panel producer in a violation of TSCA Title VI, that panel producer may not sell, supply, offer for sale, or manufacture composite wood products for sale in the United States until its composite wood products have been recertified by another EPA-recognized TPC. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 18 ------- Process for Denying EPA TSCA Title VI Recognition Upon EPA denying a request for recognition of an AB or TPC, EPA will notify the AB or TPC in writing of the following: The legal and factual basis for the denial; and Actions, if any, which the affected AB or TPC may take to receive recognition in the future. CBI Substantiation TPCs and ABs will be able to submit CBI claims on behalf of themselves or their clients for the other information reported to EPA. EPA requests that CBI claims for information that is generally already publicly available (status of a TPC or AB's participation in the EPA TSCA Title VI Third- Party Certification Program, and the basic credentials and contact information for those entities) be substantiated when provided via the EPA CDX. This type of information is expected to typically be publicly available (e.g., on an entity's own website or marketing material), but in case there are exceptions EPA is allowing the opportunity to claim this information as CBI. EPA notes that ABs and TPCs may use a business email and phone number, and write the descriptions of their credentials broadly so that it excludes information the entity considers to be confidential. Pursuant to the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182) signed into law on June 22, 2016, TSCA §14(c) now requires a supporting statement and certification for confidentiality claims asserted after June 22, 2016. EPA is requiring a statement and certification consistent with the Section 14(c)(1)(B) statement (and with a related certification requirement in Section 14(c)(5) of the revised statute) to meet the new statutory requirements. TSCA §14(g)(1) also requires EPA to make determinations for at least 25% of most types of CBI claims, which will include claims submitted by TPCs and ABs. How Is My Compliance Determined, and What Happens if the Agency Discovers a Violation? To maximize compliance, EPA implements a balanced program of compliance assistance, compliance incentives, and traditional law enforcement. EPA knows that small businesses that must comply with complicated new statutes or rules want to do the right thing, but may lack the requisite knowledge, resources, or skills. Compliance assistance information and technical advice helps small businesses to understand and meet their environmental obligations. Compliance incentives, such as EPA's Small Business Policy, apply to businesses with 100 or fewer employees and encourage persons to voluntarily discover, disclose, and correct violations before they are identified by the government (more information about EPA's Small Business Policy is available at https://www.epa.gov/enforcement/ small-businesses-and-enforcement). EPA's enforcement program is aimed at protecting the public by targeting persons or entities who neither comply nor cooperate to address their legal obligations. EPA uses a variety of methods to determine whether businesses are complying, including facility inspections, reviewing records and reports, coordinating with U.S. Customs and Border Protection on importing, and responding to citizen tips and complaints. Under TSCA, EPA may file an enforcement action against violators seeking penalties of up to $37,500 per violation, per day. The proposed penalty in a given case will depend on many factors, including the number, length, and severity of the violations, the economic benefit obtained by the violator, and its ability to pay. EPA has policies in place to ensure penalties are calculated fairly. These policies are available to the public. In addition, any company charged with a violation has the right to contest EPA's allegations and proposed penalty before an impartial judge or jury. EPA encourages small businesses to work with the Agency to discover, disclose, and correct violations. The Agency has developed self-disclosure, small business, and Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 19 ------- small-community policies to modify penalties for small and large entities that cooperate with EPA to address compliance problems. For more information on compliance assistance and other EPA programs for small businesses, please contact EPA's Small Business Ombudsman at (202) 566-2075. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 20 ------- For More Information Get additional information at http://www.epa.gov/ formaldehyde. The regulations can be found in the Federal Register (Vol. 81, No. 81, p. 89674) at https://www.regulations.gov/ document?D=EPA-HQ-OPPT-2016-0461 -0001. Where Can I Go If I Have Questions or Need Further Assistance? For inquiries specific to AB and TPC compliance, applications, and recognition maintenance, please contact the EPA TSCA Title VI Third-Party Certification Program team with questions by email at NPCD-HCHO@epa.gov. For general inquiries about EPA's TSCA Title VI Program, please contact EPA's TSCA Hotline with questions by telephone at (202) 554-1404, by fax at (585) 232-3111, or by email at tsca-hotline@epa.gov. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 21 ------- Appendix Acronym List AB Accreditation Body CARB California Air Resources Board FR Federal Register IAF MLA International Accreditation Forum Multilateral Agreement ILAC MR A International Laboratory Accreditation Cooperation Mutual Recognition Agreement MDF Medium-Density Fiberboard NAF No-Added Formaldehyde QCL Quality Control Limit TPC Third-Party Certifier TSCA Toxic Substances Control Act ULEF Ultra Low-Emitting Formaldehyde Glossary of Environmental Terms Agent for Service means an entity designated by a TPC or AB to receive legal documents on their behalf. Assessment means a process to include an on-site review undertaken by an AB to assess the competence of all operations of a conformity assessment body and TPC, based on particular standard(s) and/or other normative documents for a defined scope of accreditation, as defined in ISO/ IEC 17011:2004(E) (incorporated by reference, see 40 CFR §770.99). EPA TSCA Title VI Laboratory Accreditation Body or EPA TSCA Title VI Laboratory AB means an AB that has a recognition agreement with EPA under the EPA TSCA Title VI Third-Party Certification Program, accredits a TPC's testing laboratory or contract testing laboratory to ISO/ IEC 17025:2005(E) (incorporated by reference, see 40 CFR §770.99) with a scope of accreditation to include 40 CFR part 770 and the formaldehyde test methods used to comply with 40 CFR part 770, and assesses the testing laboratory's conformance to ISO/IEC 17020:2012(E) (incorporated by reference, see § 770.99) in order to perform laboratory testing services. EPA TSCA Title VI Product Accreditation Body or EPA TSCA Title VI Product AB means an AB that has a recognition agreement with EPA under the EPA TSCA Title VI Third-Party Certification Program, accredits a TPC to ISO/ IEC 17065:2012(E) (incorporated by reference, see 40 CFR §770.99) with a scope of accreditation to include composite wood products and 40 CFR part 770, and assesses the TPC's conformance to ISO/IEC 17020:2012(E) (incorporated by reference, see 40 CFR §770.99) in order to perform product certification. EPA TSCA Title VI Third-Party Certifier or EPA TSCA Title VI TPC means a conformity assessment body that provides both product certification services and laboratory testing services (either directly or through contracted services), is accredited by an EPA TSCA Title VI Product AB and an EPA TSCA Title VI Laboratory AB (unless the laboratory testing services are contracted to a laboratory accredited by an EPA TSCA Title VI Laboratory AB), and is recognized by EPA pursuant to 40 CFR §770.7(c). Laboratory Accreditation Body or Laboratory AB means an AB that accredits conformity assessment body testing laboratories. No-added formaldehyde-based or NAF resin means a resin formulated with no added formaldehyde as part of the resin crosslinking structure in a composite wood product that meets the emission standards in § 770.17(c). Non-complying lot means any lot of composite wood product represented by a quarterly test value or quality control test result that indicates that the lot exceeds the applicable standard for the particular composite wood product in 40 CFR §770.10(b). A quality control test result that exceeds the QCL is considered a test result that indicates that the lot exceeds the applicable standard. Future production of the product type(s) represented by a failed quarterly test are not considered certified and must be treated as a non- complying lot until the product type(s) are re-qualified through a successful quarterly test. Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 22 ------- Product Accreditation Body or Product AB means an AB that accredits conformity assessment bodies who perform product certification. Quality control limit or QCL means the value from the quality control method test that is the correlative equivalent to the applicable emission standard based on the ASTM El 333-10 method (incorporated by reference, see § 770.99). Reassessment means an assessment, as described in Sections 7.5 to 7.11 of ISO/IEC 17011:2004(E) (incorporated by reference, see 40 CFR §770.99), except that experience gained during previous assessments shall be taken into account. Scavenger means a chemical or chemicals that can be applied to resins or composite wood products either during or after manufacture and that react with residual or excess formaldehyde to reduce the amount of formaldehyde that can be emitted from composite wood products. Shipping quality control limit means a quality control limit that is developed in conjunction with an EPA TSCA Title VI TPC that is based on panels prior to shipment rather than immediately after manufacturing. Third-party certifier or TPC means a conformity assessment body that provides both product certification services and laboratory testing services (either directly or through contracted services). TPC laboratory means a laboratory or contract laboratory of an EPA TSCA Title VI TPC that is accredited by an EPA TSCA Title VI Laboratory AB to ISO/IEC 17025:2005(E) (incorporated by reference, see 40 CFR §770.99), and whose inspection activities are in conformance with ISO/IEC 17020:2012(E) (incorporated by reference, see 40 CFR §770.99). Surveillance On-Site Assessment means a set of on-site activities that are less comprehensive than reassessment, to monitor the continued fulfilment by accredited conformance assessment bodies of requirements for accreditation, as described in Sections 7.5 to 7.11 of ISO/IEC 17011:2004(E) (incorporated by reference, see 40 CFR §770.99). Ultra low-emitting formaldehyde or ULEF resin means a resin in a composite wood product that meets the emission standards in 40 CFR §770.18(c). Small Entity Compliance Guide for Accreditation Bodies and Third-Party Certifiers 23 ------- |