Source: https://www.federalregister.gov/documents/2013/06/10/2013-13254/formaldehyde-third-party-certification-framework-for-the-formaldehyde-standards-for-composite-wood
Timestamp: 2018-03-22 03:30:55
Document Index: 514770221

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Federal Register :: Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products
A Proposed Rule by the Environmental Protection Agency on 06/10/2013
78 FR 34795
34795-34820 (26 pages)
FRL-9342-4
D. Formaldehyde Sources and Health Effects
E. History of This Action
F. Objectives of the Framework for the Third-Party Certification Program
G. What background information was used to develop the framework for a third-party certification program?
A. Requirements for Accreditation Bodies
B. Requirements for Third-Party Certifiers of Composite Wood Products
C. Enforcement, Suspension, Revocation, and Modification
D. Status of CARB Approved TPCs
G. Executive Order 13045: Protection of Protection of Children From Environmental Health Risks and Safety Risks
Subpart B—TSCA Title VI Third-Party Certification Program
https://www.federalregister.gov/d/2013-13254 https://www.federalregister.gov/d/2013-13254
Start Preamble Start Printed Page 34796
The Formaldehyde Standards for Composite Wood Products Act (Title VI of the Toxic Substances Control Act (TSCA)) establishes formaldehyde emission standards for hardwood plywood, particleboard, and medium-density fiberboard (composite wood products) and directs EPA to promulgate implementing regulations by January 1, 2013. Pursuant to the requirements of TSCA Title VI, EPA is proposing a framework for a TSCA Title VI Third-Party Certification Program for composite wood products. Under the framework, third-party certifiers (TPCs) would be accredited by EPA-recognized accreditation bodies (ABs) so that TPCs may certify composite wood product panel producers under TSCA Title VI. This proposed rule identifies the roles and responsibilities of the TPCs and ABs involved, as well as the criteria for participation in the TSCA Title VI Third-Party Certification Program. The Agency is proposing the TSCA Title VI Third-Party Certification Program framework prior to the rest of the TSCA Title VI implementing regulations in order to allow interested parties an opportunity to comment and to begin identifying the business practices and infrastructure that may need to be modified or developed in order to effectively participate in the program.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0380, by one of the following methods:
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2011-0380. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
You may be affected by this action if you certify domestic or international composite wood products. Potentially affected entities may include, but are not limited to:
Reconstituted wood product manufacturing (NAICS code 321219).
This list is not intended to be exhaustive, but rather provides a guide for readers likely to be affected by this action. To determine whether you, your business, or your agency is affected, you should carefully examine this proposed rule and the TSCA Title VI (Ref. 1). If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.Start Printed Page 34797
1. Purpose of the regulatory action. EPA is proposing a framework for a TSCA Title VI Third-Party Certification Program for composite wood products. Under the framework, TPCs would be accredited by EPA-recognized ABs so that TPCs may certify composite wood product panel producers under TSCA Title VI, 15 U.S.C. 2697. TSCA Title VI gives EPA the authority to promulgate regulations relating to “third-party testing and certification” and “auditing and reporting of third-party certifiers” with regards to composite wood products. EPA believes that third-party certification is an essential component in ensuring compliance with the TSCA Title VI emission standards for composite wood products.
Costs The annualized costs of this proposed rule are estimated at approximately $34,000 per year using either a 3% discount rate or a 7% discount rate.
Small Entity Impacts This rule would impact an estimated 9 small entities, of which 8 are expected to have impacts of less than 1% of revenues or expenses, and 1 is expected to have impacts between 1% and 3%.
Effects on State, Local, and Tribal Governments Government entities are not expected to be subject to the rule's requirements, which apply to third-party certifiers and accreditation bodies. The rule does not have a significant intergovernmental mandate, significant or unique effect on small governments, or have Federalism implications.
Title VI of TSCA directs EPA to promulgate implementing regulations by January 1, 2013 (Ref. 1). EPA is issuing this proposed rule under TSCA Title VI to establish a framework for a TSCA Title VI Third-Party Certification Program whereby TPCs are accredited by ABs so that they may certify composite wood product panel producers under TSCA Title VI. This proposed rule identifies the roles and responsibilities of the groups involved in the TPC process (EPA, ABs, and TPCs), as well as the criteria for participation in the program. This proposal contains general requirements for TPCs, such as conducting and verifying formaldehyde emission tests, inspecting and auditing panel producers, and ensuring that panel producers' quality assurance and quality control procedures comply with the regulations set forth in this proposed rule. In a subsequent document, EPA will propose additional requirements including the frequency of testing, means for showing test method equivalence, and other implementing provisions as required under TSCA Title VI, such as labeling, chain of custody requirements, sell-through provisions, recordkeeping, and enforcement.
EPA is issuing this proposed rule pursuant to the Formaldehyde Standards for Composite Wood Products Act (Ref. 1), which provides authority for the Administrator to “promulgate regulations to implement the standards required under subsection (b) in a manner that ensures compliance with the emission standards described in subsection (b)(2).” This provision includes authority to promulgate regulations relating to “third-party testing and certification” and “auditing and reporting of third-party certifiers.”
Formaldehyde is a colorless, flammable gas at room temperature and has a strong odor. It is found in resins used in the manufacture of composite wood products (e.g., hardwood plywood, particleboard, and medium-density fiberboard). It is also found in household products such as glues, permanent press fabrics, carpets, antiseptics, medicines, cosmetics, dishwashing liquids, fabric softeners, shoe care agents, lacquers, plastics, and Start Printed Page 34798paper product coatings. It is a by-product of combustion and certain other natural processes. Examples of sources of formaldehyde gas inside homes include cigarette smoke, unvented, fuel-burning appliances (gas stoves, kerosene space heaters), and composite wood products made using formaldehyde-based resins (Ref. 2).
The Integrated Risk Information System (IRIS) Program of EPA's Office of Research and Development (ORD) recently completed a draft assessment of the potential cancer and non-cancer health effects that may result from chronic inhalation exposure to formaldehyde (Ref. 4). This draft IRIS assessment was peer reviewed by the National Academy of Sciences (NAS) (Ref. 5). EPA is currently considering the peer review comments. Both the National Toxicology Program (Ref. 3) and the International Agency for Research on Cancer (Ref. 6) have concluded that formaldehyde is a known human carcinogen. However, in revising the draft IRIS assessment, EPA is following the 2011 recommendation of the National Research Council to evaluate the weight of evidence for specific cancer types in multiple organs, including specific respiratory tract sites and specific lymphohematopoietic cancer subtypes. This analysis will be used to derive a unit risk estimate in the revised draft that reflects more recent data and an updated review of the cancer hazard in humans and animals.
1. Legislative history. On July 7, 2010, President Obama signed into law the Formaldehyde Standards for Composite Wood Products Act (Ref. 1). This legislation adds Title VI to TSCA and establishes formaldehyde emission standards for hardwood plywood, particleboard, and medium-density fiberboard. These emission standards are identical to the California Air Resources Board's (CARB) Airborne Toxic Control Measure (ATCM) Phase II standards (Ref. 7). Title VI of TSCA directs EPA to promulgate implementing regulations by January 1, 2013, that address: Labeling, chain of custody requirements, sell-through provisions, ultra low-emitting formaldehyde (ULEF) resins, no-added formaldehyde-based (NAF) resins, finished goods, third-party testing and certification, auditing and reporting of third-party certifiers, recordkeeping, enforcement, laminated products, and products containing de minimis amounts of composite wood.
Under the CARB ATCM, CARB approved TPCs are required to verify that composite wood product manufacturers are complying with the quality assurance and quality control requirements, verify formaldehyde emission test results, work with manufacturers to establish quality control limits for each product type and production line, provide independent inspections and audits of manufacturers and records, use laboratories that are certified by an AB that is a signatory to the ILAC MRA, maintain records for 2 years; and provide an annual report to CARB. CARB maintains a list of approved TPCs on its Web site (Ref. 8). The annual report must include:
A list of manufacturers certified by the TPC during the previous calendar year, including the resins used by the manufacturers and the average and range of formaldehyde emissions.
Results of inter-laboratory testing comparisons for laboratories used by the TPC.
3. Recent activities related to this proposed rule. On March 24, 2008, 25 organizations and approximately 5,000 individuals petitioned EPA under section 21 of TSCA to use its authority under section 6 of TSCA to adopt the CARB ATCM nationally (Ref. 10). The petitioners asked EPA to assess and reduce the risks posed by formaldehyde emitted from hardwood plywood, particleboard, and medium-density fiberboard by exercising its authority under TSCA section 6 to adopt and apply nationwide the CARB formaldehyde emissions regulation for these composite wood products. In addition, petitioners requested EPA to extend this regulation to include composite wood products used in Start Printed Page 34799manufactured homes. The petitioners expressed particular concern over the levels of formaldehyde found in emergency housing provided for persons displaced from their homes by Hurricane Katrina and noted that there are no Federal regulations on formaldehyde emissions from composite wood products other than the Department of Housing and Urban Development's (HUD) regulations for manufactured housing at 24 CFR 3280.308.
On June 27, 2008, EPA issued a notice explaining the Agency's decision to grant in part and deny in part the petitioners' request (Ref. 11). EPA denied the petitioners' request to immediately pursue a TSCA section 6 rulemaking, stating that the available information at the time was insufficient to support an evaluation of whether formaldehyde emitted from hardwood plywood, particleboard, and medium-density fiberboard presents or will present an unreasonable risk to human health (including cancer and non-cancer endpoints) under TSCA section 6. As discussed in detail in the Federal Register notice announcing EPA's response to the petition, EPA's evaluation of the data provided by the petitioners revealed significant information gaps that would have needed to be filled to support an evaluation of whether use of formaldehyde in these products presents or will present an unreasonable risk under TSCA section 6. However, EPA did agree to initiate a proceeding to investigate whether and what type of regulatory or other action might be appropriate to protect against risks posed by formaldehyde emitted from pressed wood products.
Accordingly, on December 3, 2008, EPA issued an Advance Notice of Proposed Rulemaking (ANPR) that announced EPA's intention to investigate whether and what regulatory or other action might be appropriate to protect against risks posed by formaldehyde emitted from the products covered by the CARB ATCM as well as other pressed wood products (Ref 12). To help inform EPA's decision on the best ways to address risks posed by formaldehyde emissions from pressed wood products, the Agency requested public comments and held six half-day public meetings in Research Triangle Park, NC; Portland, OR; Chicago, IL; Dallas, TX; Washington, DC; and New Orleans, LA. EPA received and reviewed comments submitted during the ANPR comment period which can be found at regulations.gov under docket number EPA-HQ-OPPT-2008-0627.
EPA believes that the TSCA Title VI Third-Party Certification Program must be impartial and applicable uniformly to composite wood products “sold, supplied, offered for sale, or manufactured in the United States” regardless of origin, whether domestic or international. TSCA section 601(b)(1). This proposed rule aims to ensure that these objectives are met, along with ensuring the consistent application of the TPC requirements of TSCA Title VI, by requiring the use of voluntary consensus standards for the TSCA Title VI Third-Party Certification Program, and by leveraging the expertise of international ABs. Additionally, this proposed rule is intended to be as consistent as practicable with the TPC requirements under the CARB ATCM. By aligning itself with the existing CARB ATCM requirements, EPA seeks to avoid differing or duplicative regulatory requirements that would result in an increased burden on the regulated community.
There are a substantial number of panel producers and TPCs that operate solely outside of the United States. Currently, 27 of the 36 CARB-approved TPCs are based outside the United States (Ref. 8). To ensure that oversight of TPCs is as strong abroad as it is domestically, EPA believes a TSCA Title VI Third-Party Certification Program framework should include internationally operating ABs to overcome potential logistical limitations that may hinder regular and rigorous inspection of TPCs operating outside the United States. Many ABs have a global reach, preexisting infrastructure, and experience working in foreign countries, which EPA believes makes them ideal for evaluating the qualifications of TPC candidates. Under EPA's proposed TSCA Title VI Third-Party Certification Program framework, ABs would review, accredit, oversee, audit, and inspect both domestic and foreign TPCs—activities that would enable EPA to ensure the legitimacy of both TPCs and panel producers in the United States and abroad. The ABs' oversight and auditing functions verify that TPCs are fulfilling their regulatory obligations uniformly across the global marketplace. EPA would retain its statutorily delegated roles in program design, establishing the standards, enforcement, and oversight; and utilize ABs to strengthen performance of TPCs.
Effective and successful implementation of EPA's TSCA Title VI Third-Party Certification Program requires that panel producers have in place formaldehyde emissions testing programs and quality assurance and quality control programs for product manufacturing. To achieve these outcomes, EPA is proposing to require the use of voluntary consensus standards for those participating as a TPC in the TSCA Title VI Third-Party Certification Program. In developing this proposed rule, EPA reviewed established voluntary consensus standards that are relied on by industries around the world as a means of ensuring the competency of third-parties in particular fields of technical activity such as testing, instrument calibration, and product performance certification. In addition to reviewing existing voluntary consensus standards, EPA reviewed other successful third-party certification programs that use voluntary consensus standards to determine if such programs could be used as models for the TSCA Title VI Third-Party Certification Program.
Third-party certification involves a process by which a product, process, or service is reviewed by a reputable and qualified independent third-party to verify that a set of norms, criteria, claims, practices, or standards are being met. Third-party certification has been widely and successfully used for decades by a number of industries such as engineering, electronics, energy, software, automotive, and food and consumer products. The standards used in third-party certification are typically voluntary consensus standards developed by nationally or internationally recognized standards-Start Printed Page 34800producing organizations or industry groups. Voluntary consensus standards establish uniform engineering or technical criteria, methods, processes, and practices for an industry practice or product, and are developed by experts in the relevant field through a process that allows input by all persons interested and affected by the scope or provisions of the standard. Parties in that industry then choose to accept and voluntarily abide by the consensus standards. Otherwise, the existence of multiple and non-harmonized standards for similar products, processes, and services in different countries or regions can create barriers to trade.
The appropriate ISO/IEC standards and guide that EPA proposes requiring are:
ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating Product Certification Systems. This is the international voluntary consensus standard that specifies general requirements for a third-party operating a product certification program (Ref. 13). These general requirements would help ensure that the TPC is competent and reliable in certifying compliant composite wood products.
ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types of Bodies Performing Inspections. This international voluntary consensus standard specifies general criteria for the competence of impartial bodies performing inspection. It is intended for use by inspection bodies and their accreditation bodies (Ref. 16).
EPA believes that requiring TPCs to follow these requirements would help ensure greater homogeneity of the inspection process among the TPCs recognized by EPA.
The appropriate use of each guide and standard and a description of the party responsible under the proposed TPC framework for ensuring compliance with the standard are detailed in Unit III. The use of the guide and standards furthers the goal of the National Technology Transfer and Advancement Act (NTTAA), as discussed in Unit VI. These ISO standards and guide will be made available for viewing in the EPA/DC Public Reading Room and, during the public comment period. Online access to the ISO standards will also be available to the public free of charge during the comment period through the ANSI Web site at http://webstore.ansi.org/​EPA/​Download.aspx. A user account, which may be created through the ANSI Web site, is required to access the standards.
The ILAC is an international cooperation of laboratory and inspection ABs formed to help remove technical Start Printed Page 34801barriers to trade. ABs around the world, which have been evaluated by peers as competent, have signed an MRA that enhances the acceptance of products and services across national borders (Ref. 18). By requiring a TPC's emissions testing laboratory, or its contract laboratory, to be accredited by an AB that is a signatory to the ILAC MRA or equivalent oversight body, EPA believes that there will be a greater assurance of compliance with ISO/IEC 17025:2005(E), the voluntary consensus standard that is critical to ensuring adequate verification of performance for TSCA Title VI required laboratory formaldehyde emissions testing.
Both the WaterSense and Energy Star certification programs specify the minimum criteria that EPA licensed product ABs must observe when certifying product conformance to specifications and when authorizing the use of the program's labels. These programs provide specific criteria for the application of ISO/IEC Guide 65:1996(E) in order to satisfy the criteria for certification of Energy Star and WaterSense products. They also provide the basis for consistent application of voluntary consensus standards by licensed ABs. The ISO/IEC Guide 65:1996(E) has been successfully used in these two programs for auditing, certifying, and reporting of the status of certification. The Energy Star and WaterSense programs' use of ABs who certify under voluntary consensus standards for product certification also demonstrates the utility and workability of this approach.
Each of the aforementioned programs informed EPA's decision on how to develop an appropriate and credible third-party certification program for TSCA Title VI. EPA is proposing a framework under TSCA Title VI that incorporates elements of the CARB Start Printed Page 34802third-party certification program, the use of recognition agreements with ABs (e.g., as in NLAAP), and a product certification system element such as those used in the WaterSense and Energy Star programs.
EPA is proposing a framework which it believes would enable implementation of a credible third-party certification program that ensures that TPCs are impartial and operate at the highest standards of competence. Although EPA's proposed TSCA Title VI Third-Party Certification Program framework, including the underlying requirements and implementation process, are based on, or are the same as, CARB's third-party certification program, EPA is proposing to also use qualified, internationally recognized ABs in implementing the program to establish a globally uniform process. Under EPA's proposed TSCA Title VI Third-Party Certification Program framework, ABs, recognized by EPA through recognition agreements, would accredit TPCs based on the requirements for TPCs established by EPA through this proposed rule. Like CARB, EPA would require that TPCs provide evidence of competency in four key areas:
Experience and ability to verify the accuracy of formaldehyde emission testing of composite wood products.
Ability to conduct auditing and inspection of panel producer activities and products.
However, unlike the CARB system, under which CARB evaluates and accredits TPCs without the input of ABs, ABs would conduct the evaluation and determine if the TPCs are competent in these four areas. Based on the results of ABs' evaluations that would be conducted according to EPA's requirements, including the standards for ABs in ISO/IEC Guide 65:1996(E) (which includes inspection accreditation based on compliance with ISO/IEC 17020:1998(E)) and laboratory accreditation based on compliance with ISO/IEC 17025:2005(E), the ABs would accredit TPCs that meet the requirements. The ABs would also be required to participate in oversight activities, including recordkeeping, reporting to EPA, and auditing of TSCA Title VI accredited TPCs and their formaldehyde emissions testing laboratories. EPA would exercise authority to conduct independent oversight and actions, including the authority to review the determinations of ABs, and approve or revoke a TPC's TSCA Title VI accreditations based on the criteria laid out in this proposed rule.
While the AB component of EPA's proposed TSCA Title VI Third-Party Certification Program framework differs from the CARB program, EPA believes it will enhance the implementation of TSCA Title VI. The proposed TSCA Title VI Third-Party Certification Program framework is otherwise generally consistent with CARB's current third-party certification program requirements. Furthermore, EPA will work with CARB to help promote compatibility and consistency within the programs and to harmonize the third-party certification programs wherever practicable. EPA believes that compliance with the proposed the TSCA Title VI Third-Party Certification Program would not require substantial changes to procedures TPCs, laboratories, and panel producers currently use to conduct their TPC activities under the CARB ATCM (Ref. 7).
Based on EPA's understanding of how the international consensus standards oversight industry is structured, EPA envisions that two types of ABs could be involved in implementation of the proposed TPC framework. The first type of AB is the “Product AB.” The Product AB would be responsible for accrediting the TPCs, recordkeeping and ensuring that a TPC is in conformance with ISO/IEC Guide 65:1996(E) (involving product certification systems) and ISO/IEC 17020:1998(E) (involving general criteria for inspections). The second type of AB is the “Laboratory AB.” The Laboratory AB would be responsible for ensuring that the TPC's formaldehyde emissions testing laboratory (or its contracted laboratory) is of the highest quality and is in conformance with ISO/IEC 17025:2005(E) (involving the general requirements for laboratories conducting testing and/or calibrations, including sampling and calibration). EPA recognizes it is also possible that a single AB may have the ability to accredit both product certification and emissions testing, and therefore can accredit conformance to ISO/IEC Guide 65:1996(E), ISO/IEC 17020:1998(E), and ISO/IEC 17025:2005(E). In such cases, a single AB would be considered qualified to accredit TPCs for their product certification capabilities and also accredit the TPC laboratories for conducting formaldehyde emissions testing, and only that AB would need to be involved in accepting and reviewing TPC applications and implementing the ABs' roles under the proposed TSCA Title VI Third-Party Certification Program framework.
i. Maintain conformance with the ISO/IEC 17011:2004(E), related ILAC Start Printed Page 34804guidance documents, and any ILAC supplementary requirements.
The EPA recognized Laboratory ABs would be responsible for verifying that the TPC laboratory is experienced and capable of conducting formaldehyde emissions tests according to the requirements of TSCA Title VI and its implementing regulations. The Laboratory ABs' key responsibilities would include:
Ensuring the laboratory's conformance to the regulatory requirements, including ISO/IEC 17025:2005(E).
EPA proposes to require TPCs to participate in an EPA recognized inter-laboratory comparison program. If standard reference material is developed, EPA would consider Start Printed Page 34805requiring TPCs to participate in an EPA recognized proficiency testing program. In order to reduce duplicative requirements, EPA proposes that it would utilize the preexisting CARB-administered inter-laboratory comparison program to the extent feasible. EPA requests comment on ways it might integrate with CARB's inter-laboratory comparison program and on what criteria should be used to determine the adequacy of performance. EPA also requests comment on how participating Laboratory ABs could administer an inter-laboratory comparison program or proficiency testing program for the TPCs that it accredits. EPA would like information on the costs of such a program and whether such an activity presents conflict of interest issues for Laboratory ABs.
4. Revocation of EPA's recognition of an AB. EPA is proposing that it may suspend, revoke, or modify the recognition of an AB, if the AB is not complying with the requirements promulgated for ABs under TSCA Title VI. If an AB is removed or withdraws from the TSCA Title VI Third-Party Certification Program, that AB would be responsible for promptly notifying EPA and all TPCs that receive its accreditation services. If an AB is removed or withdraws from the TSCA Title VI Third-Party Certification Program for reasons other than fraud or providing false or misleading statements related to a particular TPC or TPCs, or other than a reason that implicates a particular TPC or TPCs in a violation of TSCA Title VI or its implementing regulations, EPA proposes to allow the TPCs that were accredited by that AB to have 365 days, or 180 days if less than 365 days were left on their 3-year accreditation period, to be accredited again by another EPA recognized AB. While it is seeking accreditation from an alternate AB, a TPC would need to continue to comply with all other aspects of TSCA Title VI and its implementing regulations, and the TPC would remain subject to inspection by EPA. If an AB is removed from the TSCA Title VI Third-Party Certification Program 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 or its implementing regulations, that TPC would not be allowed to provide any TSCA Title VI certification services until it has been accredited by an alternate AB. Should this situation occur, EPA would provide notifications to the affected TPCs at the time it commences formal action against the AB. Any action EPA would take against an AB would not preclude an enforcement action against a TPC. EPA believes it is appropriate to be more stringent in these situations because the AB's nonperformance or altered status under the recognition agreement may call into question the legitimacy of the TPC's underlying accreditation. EPA requests comment on whether it has provided adequate time for a TPC to seek an alternate AB's accreditation under this proposed rule. Issues related to the de-accreditation of a TPC and the amount of time a panel producer has to seek a new TPC are discussed in Unit III.B.4.
1. Requirements to apply for participation in the TSCA Title VI Third-Party Certification Program. EPA is proposing that the TPC must apply to an EPA recognized Product AB to certify composite wood products pursuant to TSCA Title VI. In its application to an EPA recognized Product AB, the TPC would be required to demonstrate experience and competency in certain areas that EPA believes are important in ensuring the TPC's ability to conduct audits, testing, and certification of composite wood products. The application would be reviewed by the Product AB, who would provide EPA with a copy of each application. TPC applications would provide information to document:
EPA is proposing to require that accredited TPCs conduct the quarterly tests required by TSCA Title VI. The Start Printed Page 34806statute requires these tests to be performed using ASTM E1333-96 (Reapproved 2002) or, under some circumstances ASTM D6007-02 (Reapproved 2008). Section 601(d)(5) of TSCA allows EPA to substitute, after public notice and an opportunity for comment, a test method referenced in TSCA Title VI with its successor version. The version of ASTM E1333-96 (Reapproved 2002) referenced in TSCA Title VI is not the most current version. In this proposed rule, EPA is proposing to incorporate the current version, ASTM E1333-10 (Ref. 23), into the testing requirements in this proposed rule in place of ASTM E1333-96 (Reapproved 2002) referenced in the statute. EPA notes that there are only relatively minor differences between ASTM E1333-96 (Reapproved 2002) and ASTM E1333-10. For example, referenced standards have been updated to cite the most recent version of the standards. In addition, under Apparatus, Make-up Air, 6.1.2.2, a new requirement has been added, specifying that the dry gas test meter or other airflow rate measuring device be “permanently placed in the chamber air intake duct.” A new loading ratio was added for “low density particleboard door core” and a note specifying that “Panel grades are defined in the ANSI standards referenced in 2.3.” Under 9.2 Conditioning, a note was added stating “Test specimens with low levels of formaldehyde may absorb formaldehyde from the air when the air formaldehyde content exceeds that of the text [sic] specimen. Consideration should be taken to avoid such air conditions during storage and conditioning.” In addition, the following requirement was added: “Circulation of the conditioning air shall be achieved by fans that direct air flow horizontally in the direction parallel to the primary surface of the test specimens.” Under Test Procedure for Materials, 10.1.3, the following phrase was deleted: “as measured by a totalizing dry gas meter permanently placed in the chamber air intake duct.” Under note 9, the following clarifying phrase was added: “unless testing is extended and chamber concentrations in air and emission rates are obtained for the tested product at multiple chamber air exchange rates or multiple product loading ratios, or both.” Under Report the Following Information, 12.1.7, the following was added: “and the air circulation conditions (for example, air velocity or air exchange rate.” Under (Nonmandatory Information) X1. Reagents, Materials, and Equipment Found Suitable for Use, footnotes specifying where apparatuses are available have been deleted. In addition, X1.3.2 Sulfuric Acid, has been changed from “concentrated reagent grade. Nitrate concentration shall be less than 10 ppm.” to “ACS grade. Nitrate concentration shall be no greater than 0.2 ppm.” EPA requests comment on whether ASTM E1333-10 should be incorporated into the testing requirements under TSCA Title VI in place of ASTM E1333-96 (Reapproved 2002).
b. Verify quality control test results compared with ASTM E1333-10 test results by having laboratories conduct quarterly tests and evaluate test method equivalence pursuant to testing Start Printed Page 34807requirements promulgated under TSCA Title VI.
EPA is proposing to require that TPCs participate in an EPA-recognized inter-laboratory comparison studies or proficiency testing, if developed. The inter-laboratory comparisons would involve the participation of laboratories that are provided composite wood product samples to test for formaldehyde; each laboratory would test the sample using the same test method (e.g., ASTM E1333-10), and the results from all of the laboratories would be compared. If a standard reference material for formaldehyde emissions is developed, EPA proposes to require annual proficiency testing. The CARB ATCM requires laboratories to participate in an inter-laboratory comparison during the first year that the laboratory is used by a TPC, followed by participation in inter-laboratory comparisons every 2 years. EPA believes that evaluating the performance of laboratories used by the TPC by inter-laboratory comparisons or proficiency testing is vital to ensuring that laboratories are performing the formaldehyde testing properly, and EPA is therefore proposing that this be an annual requirement. EPA requests Start Printed Page 34808comment on whether inter-laboratory comparisons should take place more or less frequently. EPA is also seeking comment on criteria to use in evaluating performance in inter-laboratory comparisons.
EPA is proposing to require TPCs to maintain records in electronic form for 3 years. TSCA Title VI directs EPA to address recordkeeping requirements in its implementing regulations and EPA believes that certain records will greatly assist the EPA in monitoring compliance with the emissions standards and other provisions. These records would be:
A list of panel producers and their respective product types, including resins used, that the TPC has certified.
Methods and results for establishing test method correlations and equivalence.
EPA is proposing to require TPCs to submit an annual report to EPA and the AB that accredits the TPC. The annual report would include:
A list of panel producers and their products that the TPC has certified during the previous year, including resins used and the average and range of formaldehyde emissions by panel producer, resin, and product type.
Results of inter-laboratory comparison or proficiency testing for the laboratories used by the TPC.
EPA is proposing to require that the TPC inform the AB(s) that accredit the TPC of any changes in key personnel qualifications, procedures, or laboratories used that could affect the TPC's ability to fulfill its obligations under this unit. EPA believes such changes could impact the TPC's ability to properly verify formaldehyde emissions, inspect and audit, and certify compliant composite wood products. EPA is proposing that the AB review the changes to determine whether the changes would impact the TPC's ability to perform its duties.
If a TPC loses its accreditation or discontinues participation in the TSCA Title VI Third-Party Certification Program for any reason, it would be responsible for promptly notifying EPA and all panel producers that it provides TSCA Title VI certification services to. If a TPC loses its accreditation or discontinues participation in the program for reasons other than fraud or providing false or misleading statements, or other than a reason that implicates a particular panel producer in a violation of TSCA Title VI or its implementing regulations, the panel producers that used the TPC to certify their products would need to enlist another TPC to certify their products within 3 months (90 days). In these cases, the panel producers would not be required to recall or recertify their products merely because the certifying TPC lost its accreditation. During the time a panel producer is seeking a new TPC, it would need to continue to comply with all other requirements of TSCA Title VI and its implementing regulations, including quality control testing. During this period the panel producer would remain subject to inspection by EPA. If the panel producer is unable to comply with all other aspects of TSCA Title VI and its implementing regulations, the panel producer would not be permitted to sell, offer for sale, or supply its products in the United States until its products are recertified as compliant. If a TPC loses its accreditation 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 or the regulations promulgated thereunder, that panel producer would not be permitted to offer regulated composite wood products for sale in the United States until its composite wood products have been recertified by another TPC. If such a situation does occur, EPA would notify affected panel producer at the time it commences action against the TPC. EPA believes it is appropriate to be more stringent in these situations because the TPC's behavior may call into question the legitimacy of the manufacture's product certification. Any action EPA would take against a TPC would not preclude an enforcement action against a panel producer. EPA requests comment on whether it has provided adequate time for a panel producer to seek an alternate certification.
1. Enforcement under TSCA sections 15-17. EPA may conduct inspections of participating TPCs and ABs and issue subpoenas according to the requirements for accreditation and recognition and/or pursuant to the provisions of TSCA section 11 (15 U.S.C. 2610) to ensure compliance with TSCA Title VI and the regulations promulgated thereunder. Enforcement issues related to manufacturers, importers, distributors, and retailers will be covered in a subsequent proposal.
EPA would exercise the authority to withdraw from a recognition agreement with an AB and pursue penalties under TSCA section 15 (15 U.S.C. 2614) for any violation of TSCA Title VI or the regulations promulgated thereunder. In addition to an administrative or judicial finding of violation, grounds for withdrawing from a recognition agreement and/or pursuing an enforcement action against an AB include if the AB:
Submits false or misleading information to EPA;Start Printed Page 34809
Or otherwise fails to comply with TSCA Title VI or the regulations promulgated thereunder.
2. Suspension, revocation and modification. EPA would exercise the authority to suspend, revoke, or modify a TPC's TSCA Title VI accreditation, with or without the participation of the AB that provided the accreditation, if the TPC fails to comply with TSCA Title VI or the regulations promulgated thereunder. Any violation of TSCA Title VI or the regulations promulgated thereunder would also be a prohibited act under TSCA section 15. Grounds for suspending, modifying, or revoking a TPC's accreditation include if the TPC:
Prior to withdrawal from a recognition agreement with an AB, or the suspension, revocation, or modification of a TPC's accreditation, EPA would provide notification to the affected AB or TPC of:
The legal and factual basis for the proposed action.
The opportunity and method for requesting a hearing prior to the final action.
If an individual or organization requests a hearing, EPA would:
Provide the affected entity an opportunity to offer written statements in response to EPA's assertions of the legal and factual basis for its proposed action.
Appoint an impartial official of EPA as Presiding Officer to conduct the hearing.
The Presiding Officer would conduct a fair, orderly, and impartial hearing within 90 days of the request for a hearing. The Presiding Officer would consider all relevant evidence, explanations, comments, and arguments submitted and notify the affected entity in writing within 90 days of completion of the hearing of his or her decision and order. Such an order is a final agency action which may be subject to judicial review. The order must contain the commencement date and duration of the suspension, revocation, or modification.
Any notice, decision, or order issued by EPA in response to a hearing, any transcript or other verbatim record of oral testimony, and any documents filed in response to a hearing would be available to the public, except as otherwise provided by TSCA section 14. Any such hearing at which oral testimony is presented would 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 section14.
EPA intends to propose that the formaldehyde emissions standards in TSCA Title VI become effective 365 days after the promulgation of the TSCA Title VI implementing regulations (which are required by TSCA Title VI to be promulgated no later than January 1, 2013). EPA proposes that CARB approved TPCs would have 365 days after the promulgation of the TSCA Title VI implementing regulations to become accredited by an AB with which EPA has entered into a recognition agreement. In order to determine which TPCs are CARB approved, EPA will consult the listing of TPC's that CARB maintains on its Internet site. EPA believes that 365 days is a sufficient period of time for EPA to enter into recognition agreements with ABs and for TPCs to seek accreditation from EPA recognized ABs, ensuring no interruption in a TPC's services. During the transition period between when the final TSCA Title VI implementing regulations are promulgated and the date 365 days after promulgation, the CARB approved TPCs may carry out certification activities under TSCA Title VI provided that they are compliant with all other aspects of TSCA Title VI and the regulations promulgated thereunder. TPCs that are certifying products as compliant with TSCA Title VI are subject to inspection by EPA and enforcement actions for any violations of TSCA Title VI or the regulations promulgated thereunder. To reduce burden on existing CARB approved TPCs, the EPA requests comment on ways to better synchronize the timing for the TSCA Title VI accreditation period for existing CARB approved TPCs. For example, one option might be to extend the allowable time period for acquiring accreditation from 1 to 2 years. Another option might be to align the TSCA Title VI accreditation requirement for CARB approved TPCs with their existing CARB accreditation renewal, such that they could use the same information to be accredited by EPA and CARB at the same time. Alternatively, the TPCs could be required to obtain accreditation from an EPA-recognized AB no later than 1 year after the first EPA-recognized AB enters into a recognition agreement with the EPA under the TSCA Title VI. EPA expects to communicate with CARB regarding its third-party certification program and to collaborate, where possible, in order to promote the mutual acceptance of TPCs.
EPA has a commitment to uphold the values of transparency and openness in conducting EPA operations (Ref. 24). Transparency promotes accountability and provides information for citizens about what their government is doing (Ref. 25). EPA would support its commitment by making documentation of recognized ABs, TPCs, and panel producers available to the public. EPA is proposing to make the following information publically available on the Internet:
4. A list of panel producers approved for reduced testing and reduced third-party certification requirements.Start Printed Page 34810
EPA requests comment on what, if any, additional information should be made publically available (e.g., annual reports from TPCs and other required notifications) and on whether there are other ways EPA might improve program transparency. EPA requests comment on whether making the following information available publically on the Internet would be useful to the public or present challenges for regulated entities:
A list of panel producers and their products that each TPC has certified, including resins used and the average and range of formaldehyde emissions by panel producer, resin, and product type.
The results of inter-laboratory comparison or proficiency testing for the laboratories used by TPCs.
EPA requests comment on whether such information might contain CBI. EPA is considering requiring some information to be reported into a publicly viewable database, should such a database be developed. Generally, EPA is considering requiring electronic reporting of the information proposed to be reported. In particular, EPA requests comment on whether the data elements in the ABs' and TPCs' annual reports, and the required notifications should be reported into a publicly viewable database.
EPA also requests comment on the amount of time ABs and TPCs, during their ordinary course of business, typically retain records of their accreditation or certification activities and whether this is due to any external factors such as, industry standards, customer demand, customary business practices, or other.
The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), published in the Federal Register on October 13, 2005 (70 FR 59848) (FRL-7977-1), provides that any requirement in title 40 of the Code of Federal Regulations (CFR) to submit a report directly to EPA can be satisfied with an electronic submission that meets certain conditions once the Agency publishes a regulation that an electronic document submission process is available for that requirement.
EPA is considering requiring information reported to EPA from TPCs and ABs be reported electronically through EPA's Central Data Exchange (CDX). CDX provides the capability for submitters to access their data through the use of web services. For more information about CDX, go to http://epa.gov/​cdx.
Should EPA adopt a mandatory electronic reporting requirement, submitters would be required to register with EPA's CDX, complete an electronic signature agreement, and to prepare a data file for submission. To submit electronically to EPA via CDX, individuals must first register with that system at, http://cdx.epa.gov/​epa_​home.asp. To register in CDX, the CDX registrant agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at https://cdx.epa.gov/​TSCA/​eTSCA-RegistrationGuide.pdf. The registrant would also select a role and complete an electronic signature agreement either through electronic validation using the LexisNexis services or through wet ink signature. Once registration and the electronic signature agreement are complete, the user would prepare a submission.
EPA is considering requiring mandatory electronic reporting requirement because such a requirement would streamline the reporting process and reduce the administrative costs associated with information submission and recordkeeping. The effort to eliminate paper-based submissions in favor of CDX reporting is part of broader government efforts to move to modern, electronic methods of information gathering. Electronic reporting allows for more efficient data transmittal and a reduction in errors with the built-in validation procedures. EPA believes the adoption of electronic reporting reduces the reporting burden for submitters by Start Printed Page 34811reducing the cost and time required to review. EPA requests comment on whether it should require mandatory electronic reporting. For more information on how a TSCA Title VI electronic reporting application would function and the burdens and benefits associated with electronic reporting please see Ref. 27.
In addition to the areas on which EPA has specifically requested comment, EPA requests comment on all other aspects of this proposed rule.
As indicated under ADDRESSES, a docket has been established for this rulemaking under docket ID number EPA-HQ-OPPT-2011-0380. The following is a listing of the documents that are specifically referenced in this action. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.
4. EPA, ORD. Integrated Risk Information System (IRIS) Program. IRIS Toxicological Review of Formaldehyde-Inhalation Assessment (2010 External Review Draft). Available online at: http://cfpub.epa.gov/​ncea/​iris_​drafts/​recordisplay.cfm?​deid=​223614.
5. National Academy of Sciences (NAS). Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde. 2011. Available online at: http://www.nap.edu/​catalog.php?​record_​id=​13142.
6. International Agency for Research on Cancer (June 2006). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 88 (2006): Formaldehyde, 2-Butoxyethanol and 1-tert-Butoxypropan-2-ol.
7. California Environmental Protection Agency Air Resource Board. CARB Airborne Toxic Control Measure. April 26, 2007. Available online at: http://www.arb.ca.gov/​toxics/​compwood/​compwood.htm.
8. California Environmental Protection Agency Air Resources Board, Composite Wood Products ATCM, List of CARB Approved Third-party Certifiers (Accessed August, 2011). Available online at: http://www.arb.ca.gov/​toxics/​compwood/​listoftpcs.htm.
9. California Environmental Protection Agency Air Resources Board, Application to be a Third-party Certifier (TPC) of Composite Wood Products. Available online at: http://www.arb.ca.gov/​toxics/​compwood/​tpc/​tpcapplication.pdf.
10. Sierra Club. Citizen Petition to EPA Regarding Formaldehyde in Wood Products. March 20, 2008. Available online at: http://www.epa.gov/​opptintr/​chemtest/​formaldehyde/​index.html.
11. EPA. Formaldehyde Emissions from Composite Wood Products; Disposition of TSCA Section 21 Petition. Federal Register. (73 FR 36504, June 27, 2008) (FRL-8371-5).
12. EPA. Formaldehyde Emissions from Composite Wood Products; Advanced notice of proposed rulemaking and notice of public meetings. Federal Register. (73 FR 73620, December 3, 2008) (FRL-8386-3).
17. International Accreditation Forum. Available online at: http://www.iaf.nu/​.
18. International Laboratory Accreditation Cooperation. Available online at: http://www.ilac.org.
19. EPA. National Lead Laboratory Accreditation (NLLAP). Available at: http://www.epa.gov/​lead/​pubs/​nllap.htm.
20. ASTM E1333-96 (Reapproved 2002). Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber.
24. EPA. Memorandum from Lisa Jackson to EPA Employees (April 23, 2009). Available online at: http://www.epa.gov/​Administrator/​operationsmemo.html.
25. Memorandum from President Barack Obama to the Heads of Executive Departments and Agencies. January 21, 2009. Available online at: http://www.whitehouse.gov/​the_​press_​office/​TransparencyandOpenGovernment.
26. EPA. Economic Analysis of the Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products Act Proposed Rule (Economic Analysis). May 2013.
28. EPA. Report of the Small Business Advocacy Review Panel on EPA's Planned Proposed Rule Implementing the Formaldehyde Standards for Composite Wood Products Act (TSCA Title VI). April 4, 2011.
Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), this is a “significant regulatory action” because it may raise novel legal or policy issues related to the establishment of a new regulatory program as mandated by a new statutory amendment. Accordingly, EPA submitted this proposed rule to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations are documented in the docket for this proposed rule.
This proposed rule would require TPCs to submit an application, submit notifications and annual reports, and maintain records. These requirements are estimated to cost an average TPC about $1,100 per year. The proposed rule also would require TPCs to be Start Printed Page 34812accredited for certain ISO/IEC guide and standards. Most potential TPCs that are likely to participate in the TSCA Title VI Third-Party Certification Program are expected to already have all the necessary accreditations, but some TPCs are assumed to need an additional accreditation at a cost of $25,000 in the first year and $5,000 per year in subsequent years. For the purposes of cost estimation EPA assumes that there will be nine U.S. TPCs under this proposed rule. Total costs to U.S. TPCs due to the proposed rule are estimated to be approximately $94,000 in the first year and $24,000 to $28,000 per year in subsequent years. Annualized costs to U.S. TPCs are $27,000 and $28,000 per year, using a 3% and 7% discount rate, respectively.
The combined total cost for accreditation bodies and TPCs is estimated to be $107,000 in the first year. Annualized costs are estimated at approximately $34,000 per year using either a 3% or7% discount rate.
The information collection requirements in this proposed rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The ICR document prepared by EPA has been assigned EPA ICR No. 2441.01.
An agency may not conduct or sponsor, and a person is not required to respond to an information collection request unless it displays a currently valid OMB control number, or is otherwise required to submit the specific information by a statute. The OMB control numbers for EPA's regulations codified in title 40 of the Code of Federal Regulations, after appearing in the preamble of the final rule, are further displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in a list at 40 CFR 9.1.
To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, EPA has established a public docket for this proposed rule, which includes this ICR, under docket ID number EPA-HQ-OPPT-2011-0380. Submit any comments related to the ICR to EPA and OMB. See ADDRESSES at the beginning of this proposed rule for where to submit comments to EPA. Send comments to OMB at the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th St. NW., Washington, DC 20503, ATTN: Desk Office for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after June 10, 2013, a comment to OMB is best assured of having its full effect if OMB receives it by July 10, 2013. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposed rule.
The RFA, 5 U.S.C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act, 5 U.S.C. 553, or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.
EPA evaluated two factors in its analysis of the proposed rule's requirements on small entities, the number and type of small entities potentially affected, and the extent of the rule's potential economic impact on those entities as measured by the cost-to-revenue ratio for businesses and the cost-to-expenses ratio for non-profit organizations. This ratio is a good measure of entities' ability to afford the costs attributable to a regulatory requirement, because comparing compliance costs to revenues or expenses provides a reasonable indication of the magnitude of the regulatory burden relative to a commonly available measure of economic activity. Where regulatory costs represent a small fraction of a typical entity's revenues or expenses, the financial impacts of the regulation on such entities may be considered as not significant. The impact ratios were calculated using annualized costs, because these costs are more representative of the continuing costs entities would face to comply with this proposed rule.Start Printed Page 34813
Seventeen potentially impacted small entities served as Small Entity Representatives (SERs), representing a broad range of small entities from diverse geographic locations and five association representatives. EPA hosted two meetings with the SERs to obtain feedback. During the Pre-Panel Outreach Meeting on January 6, 2011, and the Panel Outreach Meeting on February 17, 2011, EPA reviewed the major areas of regulation, including options for the proposed framework of the TSCA Title VI Third-Party Certification Program, with the SBAR Panel and the SERs. The SBAR Panel solicited comments from the SERs on the options presented by EPA, their experiences with the CARB ATCM, any additional concerns they might have, and the costs of regulatory options. Several SERs submitted written comments to EPA following the meetings. The Panel evaluated the assembled materials and small entity comments on issues related to the elements of an IRFA. A copy of the SBAR Panel report is included in the docket for this proposed rule (Ref. 28). As a result of its deliberations, the Panel made a number of recommendations. With regards to the proposed TSCA Title VI Third-Party Certification Program, the Panel recommended that EPA continue to explore how it can capitalize on the expertise of international ABs, while at the same time maintaining control over the design and implementation of its certification system.
Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, or tribal governments, in the aggregate, or the private sector in any 1 year. No State, local, or tribal governments currently acts as accreditation bodies or TPCs, and none are anticipated to do so in the future, so the proposed rule would not result in expenditures by these government bodies. The costs of the proposed rule to the private sector are expected to be approximately $100,000 in the first year, and significantly less costly in subsequent years. Thus, this proposed rule is not subject to the requirements of UMRA sections 202 or 205. This proposed rule is also not subject to the requirements of UMRA section 203 because it contains no regulatory requirements that might significantly or uniquely affect small governments. Since no State, local, or tribal governments are expected to act as accreditation bodies or TPCs.
This action does not have federalism implications because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). No States are expected to act as accreditation bodies or TPCs, and EPA would administer these requirements not the States. The proposed rule would not impose substantial direct compliance costs on States. Furthermore, the proposed rule would not preempt State or local law. Thus, Executive Order 13132 does not apply to this action. Nonetheless, since California also has a program to regulate formaldehyde emissions from composite wood products, EPA held numerous consultations with representatives of the California Air Resources Board while developing this proposed rule.
In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comments on this proposed action from State and local officials.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). No Tribes are expected to act as accreditation bodies or TPCs, and EPA would administer these requirements not Tribes. Thus, Executive Order 13175 does not apply to this action. EPA specifically solicits additional comment on this proposed action from tribal officials.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045, because it would not establish an environmental standard intended to mitigate health or safety risks.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse energy affects because it sets up a framework for a TSCA Title VI Third-Party Certification Program, and does not require any action related to the supply, distribution, or use of energy.Start Printed Page 34814
Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, business practices, etc.) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
EPA welcomes comments on this aspect of the proposed rule, and specifically invites the public to identify potentially applicable voluntary consensus standards and to explain why such standards should be used in the final rule.
Therefore, it is proposed that 40 CFR chapter I, subchapter R, be amended by adding a new part 770 to read as follows:
Subpart C—[Reserved] Subpart D—Incorporation by Reference
Laboratory Accreditation Body or Laboratory AB means an accreditation body that accredits laboratories to ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99).
Product Accreditation Body or Product AB means an accreditation body that accredits conformity assessment bodies to ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 770.99) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99).
TSCA Title VI Accredited Third-Party Certifier or TSCA Title VI Accredited Start Printed Page 34815TPC means an organization or entity that is accredited by an EPA recognized Product AB and an EPA recognized Laboratory AB pursuant to § 770.7(c)(1).
(ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference, see § 770.99) and maintain that conformity.
(iii) Demonstrate basic competence to perform accreditation activities for product certification according to ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 770.99).
(iv) Demonstrate competence to perform accreditation activities for inspection certification according to ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99).
(A) An on-site assessment by the Product AB to determine whether the TPC applicant's program requirements are consistent with ISO/IEC Guide 65:1996(E) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99). The Product AB must develop a checklist that lists all of the key conformity elements of ISO/IEC Guide 65:1996(E) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99) and the Product ABs must use the checklist for each on-site assessment.
(D) A review of the approach that the TPC applicant's laboratory will use for establishing correlation or equivalence between alternative formaldehyde test methods and ASTM E1333-10 (incorporated by reference, see § 770.99).
(F) A review of the accreditation credentials of the laboratory that the TPC applicant will use. The review must ensure that the laboratory has been accredited to ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99) by a Laboratory AB that is a signatory to the ILAC MRA or equivalent.
(vi) Accredit TPCs that submit a complete application as described in § 770.7(c)(1)(i) and that meet the requirements of § 770.7(c).
(viii) Suspend, modify, or revoke the accreditation of a TPC in accordance with § 770.7(e).
(E) Notification of a decision to make changes in its organizational policies or management structure that could adversely affect the TPC accreditation program must be provided to EPA within 30 days of the decision to make the changes.Start Printed Page 34816
(ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference. see § 770.99) and maintain that conformity.
(iii) Demonstrate competence to perform accreditation activities for laboratory accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99).
(A) An on-site assessment by the Laboratory AB to determine whether the TPC applicant's laboratory is consistent with all regulatory requirements and ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99).
(B) Include a checklist that lists all of the key conformity elements of ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99) and the Laboratory AB's assessors must use the checklist for each on-site assessment.
(v) Accredit laboratories that submit a complete application as described in § 770.7(c)(1)(ii) and that continue to meet the requirements of § 770.7(c).
(viii) Suspend, modify, or revoke the accreditation of TPCs' laboratories in accordance with § 770.7(e).
(x) Maintain checklists and other records documenting compliance with the requirements for systems audits and on-site assessments of laboratories must be retained for 3 years. These records Start Printed Page 34817must be in electronic form and provided to EPA within 30 days of request.
(1) Experience or ability in product certification and complying with ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 770.99).
(3) Ability to conduct inspections and properly train and supervise inspectors pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99).
(2) Experience complying with ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99).
(3) Experience with test method ASTM E1333-10 (incorporated by reference, see § 770.99) and experience evaluating correlation between test methods.
(ii) Verify quality control test results compared with ASTM E1333-10 (incorporated by reference, see § 770.99) test results by having TPC laboratories conduct quarterly tests and evaluate test method equivalence.
(vi) Inspect and audit panel producers and products and their records at least quarterly and pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99).
(viii) Certify composite wood product types that comply with the emission standards of TSCA Title VI and this subpart, following ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 770.99).
(A) A list of panel producers and their products that the TPC has certified during the previous year, including resins used and the average and range Start Printed Page 34818of formaldehyde emissions by panel producer, resin, and product type.
(vi) Unless the decision and order issued under this paragraph (d)(3) of this section specify otherwise, an AB whose recognition has been revoked or a TPC or TPC laboratory whose accreditation has been revoked must reapply for recognition or accreditation after the revocation ends in order to Start Printed Page 34819become recognized or accredited under this subpart again.
(c) Violators may be subject to civil and criminal sanctions pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.
The materials listed in this section are incorporated by reference into this part with the approval of the Director of the Office of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, a document must be published in the Federal Register and the material must be available to the public. All approved materials are available for inspection at the OPPT Docket in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. In addition, these materials are available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030 or go to http://www.archives.gov/​federal_​register/​code_​of_​federal_​regulations/​ibr_​locations.html. These materials may also be obtained from the sources listed in this section.
(1) ASTM D6007-02 (Reapproved 2008), October 1, 2008, Standard Test Method for Determining Formaldehyde Concentrations in Air from Wood Products Using a Small-Scale Chamber, IBR approved for § 770.7(a) through (c).
(2) ASTM D5582-00 (Reapproved 2006), October 1, 2006, Standard Test Method for Determining Formaldehyde Levels from Wood Products Using a Desiccator, IBR approved for § 770.7(a) through (c).
(3) ASTM E1333-10 (Approved May 1, 2010), Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber, IBR approved for § 770.7(a) through (c).
(c) ISO material. Copies of these materials may be obtained from the International Organization for Standardization, 1, ch. de la Voie-Start Printed Page 34820Creuse, CP 56, CH-1211 Geneve 20, Switzerland, or by calling +41-22-749-01-11, or at http://www.iso.org.
(1) ISO/IEC 17011:2004(E), Conformity Assessments—General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies (First Edition) February 15, 2005, IBR approved for § 770.7(a) through (c).
(2) ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types of Bodies Performing Inspections (First Edition), November 15, 1998, IBR approved for § 770.7(a) through (c).
(3) ISO/IEC 17025:2005(E), General Requirements for the Competence of Testing and Calibration Laboratories (Second Edition), May 15, 2005, IBR approved for § 770.7(a) through (c).
(4) ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating Product Certification Systems (First Edition), 1996, IBR approved for § 770.7(a) through (c).
[FR Doc. 2013-13254 Filed 6-7-13; 8:45 am]