[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Proposed Rules]
[Pages 34796-34820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13254]



[[Page 34795]]

Vol. 78

Monday,

No. 111

June 10, 2013

Part IV





Environmental Protection Agency





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40 CFR Part 770





Formaldehyde; Third-Party Certification Framework for the Formaldehyde 
Standards for Composite Wood Products; Formaldehyde Emissions Standards 
for Composite Wood Products; Proposed Rules

  Federal Register / Vol. 78 , No. 111 / Monday, June 10, 2013 / 
Proposed Rules  

[[Page 34796]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 770

[EPA-HQ-OPPT-2011-0380; FRL-9342-4]
RIN 2070-AJ44


Formaldehyde; Third-Party Certification Framework for the 
Formaldehyde Standards for Composite Wood Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: 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.

DATES: Comments must be received on or before August 9, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0380, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001. ATTN: Docket ID 
Number EPA-HQ-OPPT-2011-0380.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: 
Docket ID Number EPA-HQ-OPPT-2011-0380. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
     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.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located 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. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: The 
TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 
14620; telephone number: (202) 554-1404; email address: [email protected].
    For technical information contact: Erik Winchester, National 
Program Chemicals Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-6450; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    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).
     Engineering services (NAICS code 541330).
     Testing laboratories (NAICS code 541380).
     Administrative management and general management 
consulting services (NAICS code 541611).
     All other professional, scientific, and technical services 
(NAICS code 541990).
     All other support services (NAICS code 561990).
     Business associations (NAICS code 813910).
     Professional organizations (NAICS code 813920).
    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.

[[Page 34797]]

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. Executive Summary

    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.
    2. Summary of the major provisions. This proposal provides a 
framework for the TSCA Title VI Third-Party Certification Program. It 
lists the qualifications for ABs that wish to participate in the 
program, the process for applying to participate in the program, and 
the responsibilities of participating ABs. It also lists the 
qualifications for TPCs that wish to become TSCA Title VI accredited, 
the process for applying to become TSCA Title VI accredited, and the 
responsibilities of TSCA Title VI accredited TPCs.
    3. Costs and impacts. EPA has prepared an analysis of the potential 
costs and impacts associated with this rulemaking. This analysis is 
summarized in greater detail in Unit VI.A. The following chart provides 
a brief outline of the costs and impacts of this proposal:

------------------------------------------------------------------------
           Category                           Description
------------------------------------------------------------------------
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   Government entities are not expected to
 Tribal Governments.            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.
------------------------------------------------------------------------

B. What action is the agency taking?

    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.

C. What is the agency's authority for taking this action?

    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.''

D. Formaldehyde Sources and Health Effects

    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

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paper 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).
    Formaldehyde is both an irritant and a known human carcinogen (Ref. 
3). Depending on concentration, formaldehyde can cause eye, nose, and 
throat irritation, even when exposure is of relatively short duration. 
In the indoor environment, sensory reactions and various symptoms 
resulting from mucous membrane irritation are potential effects. There 
is also evidence that formaldehyde may be associated with changes in 
pulmonary function and increased risk of asthma in children (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.

E. History of This Action

    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.
    This proposed rule establishes a framework for a TSCA Title VI 
Third-Party Certification Program to help ensure that regulated 
composite wood products consistently meet the TSCA Title VI 
formaldehyde emission standards. EPA will issue a separate proposed 
rule at a later date that includes the rest of the TSCA Title VI 
implementing regulations. That separate proposed rule will include 
specific testing responsibilities of TPCs.
    2. The CARB ATCM. The CARB ATCM establishes emission standards for 
composite wood products sold, offered for sale, supplied, used, or 
manufactured for sale in California (Ref. 7). It includes requirements 
for manufacturers of composite wood products, distributors, importers, 
fabricators, retailers, and TPCs with provisions on sell-through dates, 
labeling, recordkeeping, testing, and certification. It also includes 
special provisions for manufacturers of composite wood products with 
ULEF and NAF resins.
    Under the CARB ATCM, manufacturers of composite wood products must 
have their compliance with the emission standards certified by a TPC 
approved by CARB (Ref. 8). The CARB ATCM defines a third-party 
certifier as ``an organization or entity approved by the Executive 
Officer that: (A) Verifies the accuracy of the emission test procedures 
and facilities used by manufacturers to conduct formaldehyde emission 
tests, (B) monitors manufacturer quality assurance and quality control 
programs, and (C) provides independent audits and inspections.'' In 
order to become a CARB approved TPC, prospective certifiers must submit 
an application to the CARB Executive Officer containing:
    a. Evidence of actual field experience in the verification of 
laboratories and wood products, to demonstrate how the applicant will 
be able to competently perform the TPC requirements under the CARB 
ATCM.
    b. Evidence of the ability to properly train and supervise 
inspectors.
    c. Evidence of a current ``product accreditation body'' 
accreditation issued by a signatory to the International Laboratory 
Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
    d. A list of the composite wood products that the applicant is 
applying to verify and evidence that the applicant is qualified to 
verify these products (Ref. 9).
    If the TPC's application is approved, the CARB Executive Officer 
issues a CARB Executive Order with a duration of 2 years. Upon the 
expiration date of the CARB Executive Order, a TPC may apply for re-
accreditation by submitting an updated application. The CARB Executive 
Officer may, ``for good cause,'' modify or revoke a CARB Executive 
Order approving a TPC after giving the TPC the opportunity for a 
hearing.
    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.
     A list of any non-complying events by manufacturers.
     Certified laboratories and primary or secondary test 
methods utilized by the TPC.
     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

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manufactured 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.

F. Objectives of the Framework for the Third-Party Certification 
Program

    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.
    Qualified and experienced TPCs are essential to ensuring that 
domestic and foreign panel producers supplying products to the United 
States have quality assurance and quality control procedures, are 
having their products tested to determine that they are compliant with 
formaldehyde emissions standards, and are otherwise acting in manner 
that is consistent with the requirements of TSCA Title VI. The TSCA 
Title VI formaldehyde emissions standards apply to hardwood plywood, 
particleboard, and medium-density fiberboard sold, supplied, offered 
for sale, or manufactured (including imported) in the United States. 
Because TSCA defines ``manufacture'' to include ``import into the 
customs territory of the United States'' the standards are applicable 
regardless of whether the composite wood product is manufactured 
domestically or imported from abroad.
    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.

G. What background information was used to develop the framework for a 
third-party certification program?

    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-

[[Page 34800]]

producing 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.
    1. Voluntary consensus standards. In order for EPA to ensure that 
the Third-Party Certification Program under TSCA Title VI is effective 
in ensuring compliance with the emission standards, impartial in its 
operations, and applicable both domestically and internationally, the 
Agency proposes requiring the use of voluntary consensus standards as 
the basis for operating the TSCA Title VI Third-Party Certification 
Program. EPA specifically proposes using International Organization for 
Standardization (ISO) and International Electrotechnical Commission 
(IEC) voluntary consensus standards and guides as general requirements 
for third-party certifications. In addition to industry experts, 
international organizations--both governmental and non-governmental--
work in cooperation with ISO and IEC to develop their consensus 
standards. In the field of conformity assessment, the ISO Committee on 
Conformity Assessment (CASCO) is responsible for the development of 
international standards and guides.
    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 17011:2004(E), Conformity Assessments--General 
Requirements for Accreditation Bodies Accrediting Conformity Assessment 
Bodies. This international voluntary consensus standard offers the 
general requirements for ABs assessing and accrediting conformity 
assessment bodies (CABs). It is also appropriate as a requirement 
document for the peer evaluation process for mutual recognition 
arrangements between ABs (Ref. 14). These general requirements would 
help ensure that the ABs are competent and reliable in accrediting 
TPCs.
     ISO/IEC 17025:2005(E), General Requirements for the 
Competence of Testing and Calibration Laboratories. This international 
voluntary consensus standard specifies the general requirements for 
competence in carrying out tests and/or calibrations, including 
sampling (Ref. 15). EPA believes that requiring TPCs to use 
laboratories that follow these requirements would help ensure that 
reliable and accurate test results are obtained.
     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.
    2. International accreditation and inspection oversight 
organizations. In the profession of conformity assessment (i.e., the 
process of ensuring an organization responsible for implementing a 
consensus standard does so in conformance with the standard) oversight 
of conformity assessment bodies, such as TPCs, is done by organizations 
known as ABs. An AB provides an impartial verification of the 
competency of conformity assessment bodies such as TPCs. The ABs 
themselves also have oversight typically performed by an association or 
cooperative of conformity experts and other ABs through a peer 
evaluation process. Because the proposed TPC framework is international 
in scope and will employ the use of internationally accepted consensus 
standards, EPA reviewed the structure and functions of well known 
international organizations that were established decades ago to 
specifically provide oversight of ABs.
    The two international AB oversight bodies that EPA examined for 
this proposed rule are the International Accreditation Forum, Inc. 
(IAF) and ILAC. EPA believes that using a system where an AB's 
qualifications are verified by international oversight bodies such as 
these and in which the ABs in turn assess the conformity of TPCs to 
international voluntary consensus standards would ensure that the 
requirements of TSCA Title VI are met. The specific details of how EPA 
proposes to leverage this system to ensure compliance with the TSCA 
Title VI are detailed in Unit III.
    The IAF is an association of conformity assessment bodies and other 
bodies. IAF requires its member ABs to comply with appropriate 
international conformity assessment standards. The IAF Multilateral 
Recognition Arrangement (MLA) is an agreement between AB members of the 
IAF whereby the ABs conduct regular evaluations of each other to assure 
the equivalence of their accreditation programs. This MLA agreement 
allows companies with an accredited conformity assessment certification 
in one part of the world to have that certification recognized 
everywhere else in the world, thereby facilitating international trade 
(Ref. 17). The MLA certification provides documentation that a person 
or an organization has been accredited to a specific standard or scheme 
by an IAF MLA signatory AB. In addition, IAF through its MLA ensures 
that all ABs who are capable of accrediting product certification 
bodies, such as TPCs, are in conformance with ISO/IEC Guide 65:1996(E). 
By requiring a TPC to be accredited to ISO/IEC Guide 65:1996(E) by a 
qualified AB that has an IAF endorsement through level 3 of the IAF 
Scope, or is a member of an equivalent oversight body, EPA believes 
that the TPC will be in conformance with ISO/IEC Guide 65:1996(E), the 
voluntary consensus standard used to ensure proper product 
certification. Level 3 of the IAF Scope is the level of accreditation 
which needs to be accomplished by a Product AB under that program to 
ensure that the Product AB is qualified to accredit the TPC.
    The ILAC is an international cooperation of laboratory and 
inspection ABs formed to help remove technical

[[Page 34801]]

barriers 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.
    3. Other third-party certification programs that were evaluated. As 
mentioned in Unit II.F., EPA aims to develop a TSCA Title VI Third-
Party Certification Program that incorporates lessons learned from 
other third-party certification programs. In addition, EPA is 
particularly interested in harmonizing, to the extent practicable, with 
the CARB's third-party certification program to avoid differing or 
duplicative regulatory requirements.
    In developing the TSCA Title VI Third-Party Certification Program 
framework as presented in this proposed rule, EPA started with a review 
of CARB's program, as described in Unit II.E. This included meeting 
with CARB, the composite wood industry, and CARB-approved TPCs.
    EPA also reviewed other EPA and Federal programs that have elements 
relevant to EPA's goals for this proposed program, such as the use of 
voluntary consensus standards and/or a third-party product 
certification process. The following EPA and Federal programs were 
reviewed during development of the proposed TSCA Title VI Third-Party 
Certification Program framework:
    a. National Lead Laboratory Accreditation Program. EPA established 
the National Lead Laboratory Accreditation Program (NLLAP) in 1992, to 
provide protocols, criteria, and minimum performance standards for 
analysis of lead in paint, dust, and soil, as required under TSCA 
section 405 (Ref. 19). Section 405 of TSCA further directs EPA, in 
consultation with the Department of Health and Human Services (HHS), to 
develop a program to certify qualified lead testing laboratories. The 
NLLAP provides the public with a list of qualified laboratories that 
have met EPA criteria and demonstrated the capability to accurately 
analyze paint chip, dust, and soil samples for lead. EPA ensures that 
laboratories comply with these EPA criteria by having them evaluated 
and accredited by third-party laboratory ABs according to ISO/IEC 
performance consensus standards. In order to assure the public that a 
Laboratory AB is capable of performing an adequate assessment of 
participating laboratories, EPA enters into a recognition agreement 
with the AB in recognition of its capability to perform adequate 
laboratory assessments.
    For a laboratory to qualify for recognition under the NLLAP, it 
must pass on-site audits conducted by one of the four laboratory ABs 
with which EPA has a recognition agreement. The Laboratory ABs 
recognize NLLAP laboratories in conformance with ISO/IEC 17025:2005(E). 
Laboratories recognized under the NLLAP must also successfully perform, 
on a continuing basis, in the Environmental Lead Proficiency Analytical 
Testing (ELPAT) Program. The ELPAT is a proficiency testing program 
that is designed to evaluate the analytical performance of laboratories 
by providing the laboratory with standardized test samples on a 
quarterly basis and evaluating their results against consensus results 
from a set of reference laboratories.
    The NLLAP has successfully demonstrated over the years that EPA 
recognized laboratories are capable of accurately analyzing for lead in 
paint chips, dust wipes, and soil samples. Therefore, EPA believes that 
the third-party processes employed by the NLLAP, which include the use 
of third-party laboratory ABs that accredit laboratories by using 
voluntary consensus standards, along with additional specified 
laboratory testing protocols, demonstrate that a similar third-party 
certification program can be used successfully under TSCA Title VI.
    b. National Voluntary Conformity Assessment System Evaluation 
Program. Another program that EPA reviewed is the National Voluntary 
Conformity Assessment System Evaluation (NVCASE) Program at the 
Department of Commerce's National Institute of Standards and Technology 
(NIST). NIST, through its Standards Services Division, offers this 
voluntary program to evaluate and recognize organizations which support 
third-party conformity assessment activities. The NVCASE Program 
includes activities related to third-party laboratory testing, third-
party product certification, and quality system registration. After an 
NVCASE Program evaluation, NIST provides recognition to qualified U.S. 
organizations that effectively demonstrate conformance with established 
criteria. The ultimate goal is to help U.S. manufacturers satisfy 
applicable product requirements mandated by foreign or U.S. regulatory 
authorities through conformity assessment procedures. Under the NVCASE 
Program, NIST accepts requests from only domestic TPCs for domestic and 
international accreditation. The use of NIST's NVCASE Program in the 
United States would significantly hamper the ability of foreign TPC 
candidates to receive and maintain accreditation and would not allow 
EPA to meet its goal of providing testing and certification and 
auditing and reporting of all TPCs, domestic as well as international.
    c. Other EPA programs. EPA also considered the product 
certification components of EPA's WaterSense and Energy Star programs. 
WaterSense is an EPA-sponsored partnership program launched in 2006 
that seeks to protect the future of our nation's water supply by 
promoting water efficiency and enhancing the market for water-efficient 
products, programs, and practices. WaterSense helps consumers identify 
products and programs that meet WaterSense water efficiency and 
performance criteria. Energy Star is a joint program of the EPA and the 
Department of Energy (DOE) designed to help the consumers save money 
and protect the environment through the use of energy efficient 
products and practices. In 1992, EPA introduced Energy Star as a 
voluntary labeling program designed to identify and promote energy-
efficient products to reduce greenhouse gas emissions.
    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

[[Page 34802]]

third-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.

III. What does this proposed rule do?

BILLING CODE 6560-50-P
[GRAPHIC] [TIFF OMITTED] TP10JN13.000


[[Page 34803]]


    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.
     Experience in the composite wood product industry.
     Ability to monitor panel producer quality assurance 
programs for 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).

A. Requirements for Accreditation Bodies

    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.
    1. Necessary qualifications of ABs to be candidates for 
participation in the EPA's Title VI Third-Party Certification Program--
a. Necessary qualifications of Product ABs. To ensure that Product ABs 
are qualified to accredit TPC's for conformance with ISO/IEC Guide 
65:1996(E) and ISO/IEC 17020:1998(E), the Product AB would have to be a 
signatory to the IAF MLA, or a member of an equivalent oversight body. 
AB members of IAF are admitted to the IAF MLA only after a highly 
stringent evaluation of their operations by an IAF peer evaluation team 
which is charged with ensuring that the applicant member complies fully 
with both the international standards and IAF requirements. 
Additionally, once an AB is a signatory to the IAF MLA, it is required 
to recognize the certificates issued by conformity assessment bodies 
accredited by all other signatories of the IAF MLA, with the 
appropriate scope (i.e., levels 1 through 3). The IAF MLA structure has 
5 levels, and EPA would require the Product AB to be endorsed by IAF 
through level 3. Level 1 endorsement ensures that an AB is in 
conformity with ISO/IEC 17011:2004(E) and maintains that conformity; 
level 2 endorsement ensures that the AB has demonstrated basic 
competence to perform accreditation activities for product 
certification according to ISO/IEC Guide 65:1996(E) and ISO/IEC 
17020:1998(E); and level 3 ensures that the AB has policies and 
procedures in place in their operations and management plans to 
accredit a TPC for product certification in conformance with ISO/IEC 
Guide 65:1996(E). In order to participate in the TSCA Title VI Third-
Party Certification Program, a Product AB would have to provide EPA 
with documentation verifying its IAF endorsement that states the level 
of accreditation the AB received from IAF, or with confirmation that 
the AB is a member of an equivalent organization with an equivalent 
scope.
    b. Necessary qualifications of Laboratory ABs. To ensure that the 
Laboratory ABs are qualified to accredit TPC laboratories, the proposed 
TPC framework would require that the Laboratory AB is a signatory to 
the ILAC MRA, or a member of an equivalent organization. To be a 
signatory to the ILAC MRA, an AB must pass an intensive evaluation 
carried out by peers and in accordance with the relevant rules and 
procedures contained in several ILAC publications. Once a signatory to 
the ILAC MRA, each Laboratory AB agrees to abide by its terms and 
conditions, and according to the ILAC evaluation procedures shall:
    i. Maintain conformance with the ISO/IEC 17011:2004(E), related 
ILAC

[[Page 34804]]

guidance documents, and any ILAC supplementary requirements.
    ii. Ensure that all laboratories that they accredit comply with 
ISO/IEC 17025:2005(E) and related ILAC policy and guidance documents. 
Under the proposed TPC framework, a TPC would be required to work with 
its Laboratory AB to provide the Product AB with documentation 
verifying the Laboratory AB's endorsement and scope of accreditation 
from ILAC, or documentation of membership in an equivalent 
organization.
    EPA understands that not all ABs are signatories to either IAF or 
ILAC. EPA requests comment on what other oversight bodies or other 
organizations are equivalent to IAF and ILAC. An equivalent 
organization would provide a process of review and evaluation with a 
level of scrutiny and assessment of an AB's capabilities to ensure that 
an AB is qualified to accredited organizations based on the relevant 
ISO/IEC standards and guide.
    2. Recognition agreement process and relationship between EPA and 
ABs. Under this proposed rule, the Product ABs and Laboratory ABs that 
are interested in participating in the TSCA Title VI Third-Party 
Certification Program would be required to submit an application to EPA 
to be formally recognized by EPA. Once EPA has reviewed the AB's 
credentials and deemed that the AB is qualified, EPA proposes to enter 
into a recognition agreement with Product and Laboratory ABs that want 
to offer services to accredit TPCs according to EPA's requirements. The 
recognition agreement would serve as a mechanism for EPA to formally 
recognize either a Product AB or a Laboratory AB (or both) as qualified 
to implement their respective roles under the TSCA Title VI program. 
The recognition agreement with the Product AB would designate it as the 
recipient of applications from candidate TPCs that want to participate 
in the TSCA Title VI Third-Party Certification Program. As discussed in 
Unit II.G.3., similar recognition agreement approaches have been 
successfully used in a number of EPA programs. The recognition 
agreement is a signed agreement between EPA and each Product AB or 
Laboratory AB that would state:
    a. The regulatory requirements that have been and must continue to 
be met to be an EPA recognized AB.
    b. The roles and responsibilities of the AB under the TSCA Title VI 
Third-Party Certification Program.
    c. EPA's role and interactions with the AB during implementation of 
the TSCA Title VI Third-Party Certification Program.
    d. Criteria and processes for revoking the recognition agreement if 
either the Product AB or Laboratory AB fails to adhere to the 
conditions of the regulations.
    All of the requirements and actions stated in the recognition 
agreement between EPA and each type of AB would be derived from the 
final rule requirements. If the AB applying to EPA for recognition is 
qualified to perform as both a Product AB and a Laboratory AB, then 
that AB would include both sets of credentials in its application 
package and would be recognized by EPA in the recognition agreement as 
performing both accreditation roles. The recognition agreement would be 
effective for 3 years, provided the AB continues to meet all of the 
regulatory requirements. After 3 years, the recognition agreement would 
be eligible for renewal.
    In order to facilitate communication between EPA and ABs, EPA is 
proposing to require ABs to designate an agent in United States in 
their applications. Any information provided by an AB or EPA to the 
designated agent would be equivalent to providing that information 
directly to the AB. The designated agent could not be a mailbox, 
answering machine, or other service where the agent is not physically 
present. The agent would need to be capable of accepting service of 
notices and processes made in administrative and judicial proceedings. 
EPA believes requiring a designated agent in the United States would 
help ensure compliance with the formaldehyde emission standards by 
facilitating the ability to enforce TSCA Title VI and its implementing 
regulations, which in turn encourages the regulated entities to fulfill 
their obligations under the statute and regulations. EPA requests 
comment on this proposed requirement.
    EPA would designate an EPA Recognition Agreement Implementation 
Officer as a point of contact for ABs to consult with on implementation 
of the recognition agreement. EPA would be responsible for directly 
notifying participating ABs of changes in the TSCA Title VI Third-Party 
Certification Program. EPA would maintain a public list of all ABs with 
which EPA has a recognition agreement. The list would be posted on 
EPA's Web site and regularly updated.
    3. Proposed requirements once an AB is recognized. Once EPA has 
entered into a recognition agreement with an AB, that AB becomes 
``recognized'' by EPA as a Product AB, Laboratory AB, or both.
    a. Responsibilities of Product ABs in the TPC application process. 
The Product AB's key TSCA Title VI TPC application review 
responsibilities would include:
    i. Receiving and acting on TPC applications for their participation 
in the TSCA Title VI Third-Party Certification Program and thereby 
ensuring that the TPC is accredited to ISO/IEC Guide 65:1996(E) and 
ISO/IEC 17020:1998(E).
    ii. Transmitting copies of TPC applications and supporting 
documentation requested in the application based on the TSCA Title VI 
implementing regulations to EPA.
    iii. Assigning the TPC a unique number.
    b. General responsibilities of ABs after TPC accreditation into the 
TSCA Title VI Third-Party Certification Program. The EPA recognized 
Product AB would be responsible for:
    i. Ensuring the TPC has a process in place to verify the accuracy 
of the formaldehyde emission tests conducted by the TPC laboratory 
(including any contract laboratory that the TPC would use for 
formaldehyde testing under TSCA Title VI) and the formaldehyde quality 
control tests conducted by the producers of regulated composite wood 
products.
    ii. Ensuring the TPC has a process in place to monitor panel 
producer quality assurance programs.
    iii. Ensuring the TPC has a process in place to conduct independent 
audits and inspections of panel producers and their quality control 
testing facilities.
    iv. Conducting audits of TPCs and their laboratories.
    v. Recordkeeping.
    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).
     Verifying the accuracy of the formaldehyde emissions tests 
conducted by the TPC laboratory through an inter-laboratory comparison 
or proficiency testing program.
     Conducting audits of the laboratory.
     Recordkeeping.
    EPA proposes to require TPCs to participate in an EPA recognized 
inter-laboratory comparison program. If standard reference material is 
developed, EPA would consider

[[Page 34805]]

requiring 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.

B. Requirements for Third-Party Certifiers of Composite Wood Products

    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:
    a. Experience in performing or verifying formaldehyde emissions 
testing on composite wood products.
    b. That its laboratory or contract laboratory has been accredited 
by an EPA recognized Laboratory AB in conformance with ISO/IEC 
17025:2005(E).
    c. The TPC laboratory's or contract laboratory's experience with 
test method ASTM E 1333-96 (Reapproved 2002) (Ref. 20) or successor 
standards and experience evaluating correlation between test methods.
    d. Experience or ability in product certification and complying 
with ISO/IEC Guide 65:1996(E).
    e. Experience in the composite wood product industry.
    f. The ability to inspect and properly train and supervise 
inspectors according to ISO/IEC 17020:1998(E).
    The application would also specify which composite wood products 
the applicant is applying to certify and evidence that the applicant is 
qualified to certify these products. EPA is proposing that TPCs would 
be required to renew their applications every 3 years. EPA requests 
comment on the costs and benefits of a 3-year renewal period as 
compared to a 2-year renewal period (as under the CARB ATCM). The EPA 
also requests comment on whether the proposed requirement for EPA-
recognized ABs to audit TPCs and laboratories used by TPCs every 2 
years should be extended to every 3 years to align with the proposed 3-
year TPC accreditation period.
    In order to facilitate communication between EPA and TPCs, EPA is 
proposing to require TPCs to designate an agent in United States in 
their applications. Any information provided by an AB or EPA to the 
designated agent would be equivalent to providing that information 
directly to the TPC. The designated agent could not be a mailbox, 
answering machine, or other service where the agent is not physically 
present. The agent would need to be capable of accepting service of 
notices and processes made in administrative and judicial proceedings. 
EPA believes requiring a designated agent in the United States would 
help ensure compliance with the emission standards by facilitating the 
ability to enforce TSCA Title VI and its implementing regulations, 
which in turn encourages the regulated entities to fulfill their 
obligations under the statute and regulations. EPA requests comment on 
this proposed requirement.
    Title VI of TSCA requires that compliance with the formaldehyde 
emission standards be measured by quarterly testing using ASTM E1333-96 
(Reapproved 2002) (Ref. 20) or under certain circumstances, ASTM D6007-
02 (Reapproved 2008) (Ref. 21). For quality control testing, the 
statute requires use of ASTM D6007-02 (Reapproved 2008), ASTM D5582-00 
(Reapproved 2006) (Ref. 22), or other test methods established by EPA 
through rulemaking. If a test method other than ASTM E1333-96 
(Reapproved 2002) is used for either quarterly testing or quality 
control testing, TSCA Title VI requires a demonstration of equivalence 
by means established by EPA. Therefore, EPA is proposing that a TPC 
laboratory or contract laboratory must have experience with 
formaldehyde testing using ASTM E1333-96 (Reapproved 2002) or its 
successor standards as well as experience evaluating correlations 
between different test methods. EPA intends to propose the means of 
showing test method equivalence in a subsequent proposal with other 
implementation provisions as required under TSCA Title VI.
    EPA is proposing to require that accredited TPCs conduct the 
quarterly tests required by TSCA Title VI. The

[[Page 34806]]

statute 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).
    EPA intends to propose the means of showing test method equivalence 
for other test methods as well as the number and frequency of tests 
required to demonstrate compliance with the formaldehyde emission 
standards in a subsequent proposal along with the rest of the TSCA 
Title VI implementing regulations. EPA is proposing here that TPC 
laboratories be responsible for conducting quarterly tests, verifying 
quality control tests, and evaluating test method equivalence.
    EPA is proposing that TPCs must have experience operating or using 
laboratories that follow ISO/IEC 17025:2005(E). This international 
voluntary consensus standard specifies the general requirements for the 
competence to carry out tests and/or calibrations, including sampling. 
EPA believes that requiring TPCs to use laboratories that follow these 
requirements would help ensure that reliable and accurate test results 
are obtained.
    EPA is proposing that TPCs must have experience or ability in 
product certification and in complying with ISO/IEC Guide 65:1996(E) 
because certifying compliant composite wood products would be one of 
the main functions of a TSCA Title VI accredited TPC. ISO/IEC Guide 
65:1996(E) is an international voluntary consensus standard that 
specifies general requirements for a third-party operating a product 
certification system. These general requirements would help ensure that 
the TPC is competent and reliable in certifying compliant composite 
wood products.
    EPA is proposing that the TPC must have experience in conducting 
inspections of the manufacturers in conformity with ISO/IEC 
17020:1998(E). This international voluntary consensus standard 
specifies general criteria for the operation of various types of bodies 
performing inspections. EPA is also proposing that TPCs must have the 
ability to properly train and supervise inspectors pursuant to 
conformity with ISO/IEC 17020:1998(E). Inspections by TPCs would be an 
important function of a TPC in helping ensure compliance with the 
regulations under TSCA Title VI.
    EPA is proposing that TPCs must have experience in the composite 
wood products industry because EPA believes that understanding the 
processes used by panel producers to produce composite wood products is 
crucial for the TPC to adequately inspect and audit panel producers. 
Experience in the composite wood products industry would help ensure 
that the TPC would know what to inspect and areas on which to focus 
during inspections and audits of the panel producers. In addition, EPA 
is proposing to require TPCs to have experience with the specific type 
of composite wood product(s) that it would certify. EPA believes that 
certain steps in the manufacture of composite wood products are likely 
important in maintaining low formaldehyde emissions and that because 
manufacturing processes are different for the different types of 
regulated composite wood products, it is important for a TPC to have 
knowledge and experience in the manufacture of the specific type of 
composite wood product(s) that it would certify. EPA requests comment 
on whether EPA should require that the TPC have experience with the 
specific type of composite wood product that it would certify or if 
experience with one type of product is sufficient to certify all types 
of composite wood product.
    2. Denied TPC Applicants. If an AB denies a TPC's application for 
accreditation for failure to submit a complete application, the AB 
would be required to notify the TPC or TPC laboratory in writing of the 
legal and factual basis for the denial, actions, if any, which the 
affected TPC or TPC laboratory may take to receive accreditation in the 
future, and the opportunity and method for requesting a hearing with 
EPA. ``Failure to submit a complete application'' would not include 
failure to pay any accreditation fee or reach a fee agreement.
    3. Proposed requirements once a TPC is accredited. EPA is proposing 
that once an applicant is accredited as a TPC under TSCA Title VI, the 
TPC must:
    a. Verify that panel producers have adequate quality assurance 
controls and are complying with any quality assurance and quality 
control requirements that EPA promulgates pursuant to TSCA Title VI.
    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

[[Page 34807]]

requirements promulgated under TSCA Title VI.
    c. Review applications from panel producers for reduced testing or 
third-party certification requirements.
    d. Establish quality control limits in consultation with panel 
producers, and, if applicable, shipping quality control or other limits 
for each product type and production line.
    e. Inform panel producers of the process that will be used to 
determine if product lots are exceeding the applicable quality control 
limit.
    f. Inspect and audit panel producers and their records at least 
quarterly.
    g. Use a testing laboratory or laboratories that comply with ISO/
IEC 17025:2005(E).
    h. Certify composite wood product types that comply with 
requirements under TSCA Title VI following ISO/IEC Guide 65:1996(E).
    i. Follow ISO/IEC 17020:1998(E) in the carrying out of their 
inspections of the panel producers.
    j. Provide approved TPC number (supplied by the accrediting AB) to 
the panel producer for labeling and recordkeeping.
    k. Use laboratories that participate in an inter-laboratory 
comparison or proficiency testing program.
    l. Maintain records in electronic form for 3 years.
    m. Provide an annual report to EPA and the AB(s) that provided it 
with its accreditation.
    n. Inform the AB(s) that provided it with its accreditation of any 
changes in key personnel qualifications, procedures, or laboratories 
used by the TPC that could affect the TPC's ability to fulfill its 
obligations under this unit.
    One of the main functions of TPCs under this proposed rule would be 
to help ensure that panel producers have adequate quality control of 
their manufacturing process, are following appropriate quality 
assurance procedures, and are complying with any quality assurance 
requirements that EPA may implement under TSCA Title VI. Under the CARB 
ATCM, manufacturers are required to implement specific quality 
assurance procedures as described in Appendix 2 of the ATCM. EPA 
anticipates promulgating quality assurance requirements for panel 
producers under TSCA Title VI in a subsequent proposal with other 
implementation provisions as required under TSCA Title VI. EPA is 
proposing to use TPCs to help ensure compliance with quality control 
and quality assurance procedures.
    EPA is proposing to require TPCs to verify quality control tests 
that measure formaldehyde emissions by having laboratories conduct 
quarterly testing.
    Under TSCA Title VI, EPA intends to promulgate specific 
formaldehyde testing requirements. The subsequent proposal may also 
provide for reduced testing for specified products such as those made 
with NAF or ULEF resins. In this proposed rule, EPA is proposing to 
require TPCs to review and approve, when appropriate, applications from 
panel producers for reduced testing and third-party certification 
requirements according to EPA's implementing regulations. The CARB ATCM 
allows for reduced testing for products manufactured with NAF and ULEF 
resins, and CARB reviews and approves NAF and ULEF applications. EPA is 
proposing to instead require TPCs to review these applications because 
EPA believes they are best suited to determine whether the panel 
producers will be able to consistently comply with the emission 
standards even with reduced testing requirements. EPA intends to 
further specify requirements for reduced testing in a subsequent 
proposal with other implementation provisions as required under TSCA 
Title VI.
    EPA is proposing to require TPC laboratories (including contract 
laboratories) to establish quality control limits in consultation with 
panel producers and, if applicable, shipping quality control or other 
limits for each product type and production line to ensure compliance 
with the emission standards. A quality control limit would be 
established if test methods other than ASTM E1333-10 are being used to 
make it easier for the panel producer to determine whether any products 
are likely to exceed the emission standards. A quality control limit 
would be the value from a test other than ASTM E1333-10 that is the 
correlative equivalent to the applicable standard. A TPC may also 
establish a limit to account for process and testing variation to help 
ensure that the emission for a product would not exceed the applicable 
standard. EPA is proposing to require TPCs to inform panel producers of 
the process that the TPC would use to determine if product lots are 
exceeding the applicable quality control limit. In the broader TSCA 
Title VI implementing regulations, EPA intends to describe these limits 
in more detail as well as implications and procedures for cases where 
tests exceed the limits in a subsequent proposal with other 
implementation provisions as required under TSCA Title VI.
    EPA is proposing to require that TPCs inspect and on-site audit 
panel producers and their records at least quarterly and comply with 
ISO/IEC 17020:1998(E) when conducting their inspections. Quarterly 
inspections and on-site audits are consistent with requirements under 
the CARB ATCM, and EPA believes that requiring inspections quarterly 
should be sufficiently frequent to allow TPCs to observe and mitigate 
any potential violations. However, under certain circumstances, a TPC 
could determine that more frequent inspections and on-site audits are 
necessary to ensure compliance. EPA requests comment on whether 
enhanced testing or inspection requirements should be required where a 
TPC finds that a panel producer has failed quality control or quarterly 
tests at a certain frequency, or upon other circumstances. In addition 
to failed test results, circumstances that EPA envisions possibly 
warranting increased TPC inspections and audits include a panel 
producer failing to comply with its quality control manual or 
inconsistencies in records.
    EPA is proposing to require that TPCs use laboratories for 
formaldehyde testing that comply with ISO/IEC 17025:2005(E). As 
discussed in Unit II.G.1., this international voluntary consensus 
standard specifies the general requirements for the competence to carry 
out tests and/or calibrations, including sampling. EPA believes that 
requiring TPCs to use laboratories that follow these requirements would 
help ensure that TPCs obtain reliable and accurate test results.
    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

[[Page 34808]]

comment 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 follow ISO/IEC Guide 65:1996(E) 
to certify composite wood product types that comply with requirements 
under TSCA Title VI. As discussed in Unit II.G.1., ISO/IEC Guide 
65:1996(E) is an international voluntary consensus standard that 
specifies general requirements for a third-party operating a product 
certification system. EPA believes that requiring TPCs to follow these 
general requirements for certifying products would help ensure that the 
TPC is properly certifying only compliant composite wood products.
    A TPC would be supplied with a TPC identification number by the 
Product AB once it has been accredited for TSCA Title VI purposes. EPA 
is proposing to require that the TPC provide this number to panel 
producers so that they can include the TPC number on the label of their 
certified products and include it in their records.
    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.
     Results of inspections, audits, and emission tests 
conducted for and linked to each panel producer and product type.
     A list of laboratories used by the TPC, test methods, 
including test conditions and conditioning time, and test results.
     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.
     List of any non-complying products or events by panel 
producers.
     A list of laboratories and test methods used by the TPC.
     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.
    4. Removal and reaccreditation of third-party certifiers. EPA is 
proposing to exercise the authority to revoke the TSCA Title VI 
accreditation of a TPC or its laboratory, after notice and an 
opportunity for a hearing, if the TPC or its laboratory: Fails to meet 
any of the applicable requirements promulgated under TSCA Title VI 
(such as by failing to comply with ISO/IEC Guide 65:1996(E), ISO/IEC 
17020:1998(E), or ISO/IEC 17025:2005(E)); makes false or misleading 
statements on its application, records, or reports; or makes changes to 
key personnel qualifications, procedures, or laboratories that would 
make it unable to perform its duties. ABs would also be able to revoke 
an accreditation of a TPC, subject to an opportunity for a hearing with 
EPA. A TPC whose accreditation has been revoked may reapply to an AB to 
be reaccredited as a TPC.
    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.

C. Enforcement, Suspension, Revocation, and Modification

    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;

[[Page 34809]]

     Fails to maintain or falsifies required records; or
     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:
    a. Submits false or misleading information to EPA or its AB;
    b. Fails to maintain or falsifies required records; or
    c. Fails to comply with TSCA Title VI or regulations promulgated 
thereunder.
    The ISO/IEC standards and guide that are referenced in this 
proposed rule require that policies and procedures be in place to 
identify and remedy nonconformities with the implementation of those 
standards (ISO/IEC 17025:2005(E), section 4.9; ISO/IEC 17011:2004(E), 
section 5.5; ISO/IEC 17020:1998(E), section 7.8; ISO/IEC Guide 
65:1996(E), section 47). Should a TPC or AB identify a nonconformity or 
discrepancy with its implementation of one of the ISO standards via an 
internal audit or other means, that entity must take remedial action 
within the timeframe specified by the AB or the time specified in the 
TPC's quality management plan in order to avoid the possibility of an 
enforcement action.
    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 anticipated commencement date and duration of any 
suspension, revocation, modification, or other action.
     What actions, if any, the affected entity may take to 
avoid suspension, revocation, modification, or otherwise continue 
participation in the program.
     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.
    If EPA determines that the public health, interest, or welfare 
warrants immediate action to suspend the recognition of an AB or the 
accreditation of a TPC prior to the opportunity for a hearing, it would 
notify the affected AB or TPC of its right to request a hearing on the 
immediate suspension within 15 days of the suspension taking place and 
the procedures for the conduct of such a hearing.
    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.

D. Status of CARB Approved TPCs

    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.

E. Transparency

    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:
    1. The names and addresses of all ABs that EPA has a recognition 
agreement with and the status of that recognition agreement.
    2. A list of all accredited TPCs with their TPC number and 
accreditation status.
    3. Annual reports from ABs.
    4. A list of panel producers approved for reduced testing and 
reduced third-party certification requirements.

[[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.
     A list of any non-complying products or events by panel 
producer.
     A list of laboratories and test methods used by each TPC.
     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 is proposing a 3 year record retention period for all TSCA 
Title VI AB and TPC record keeping requirements. While EPA is proposing 
a 3 year record retention period as is common under the Paperwork 
Reduction Act, EPA requests comments on ways to reduce the burden and 
costs of hard-copy record keeping over multiple years on the regulated 
community, such as by requiring that the entities regulated under this 
rule be allowed to keep required records electronically and make them 
available to the Agency and others via their business Web site, or 
other electronic media.
    Under the proposed rulemaking, composite wood products would be 
regulated starting with the manufacture (including import) of panels, 
through their incorporation into component parts and finished goods, 
the distribution of those products, and the retail sale of those 
products. This can be a lengthy process and the amount of time 
composite wood panels are held in inventory and the amount of time 
before they are incorporated into finished goods is variable. This 
variability can result from prevailing economic conditions, the 
complexity of the individual products, the origin of the products, and 
other factors. This point was illustrated by the fact that CARB had to 
extend its ``sell-through dates'' multiple times. CARB found that these 
extensions were necessary because the recession increased the amount of 
time manufacturers needed to clear preexisting inventory. As CARB found 
that items remained in inventory for extended periods, it is possible 
that an issue could arise with a particular composite wood item several 
years after it was manufactured. Learning the source of the item may be 
important in order to identify and correct a problem. Because retail 
companies receive composite wood items from many sources and the third 
party certifier could vary with each item, retaining records for 3 
years would help assure that problems can be identified and corrected.
    Third party certifiers of compliance with formaldehyde emissions 
from composite wood products would need to maintain certain records 
long enough to assure that their oversight role in the system is 
operating properly to protect human health. An adequate record 
retention period is essential to fair and efficient enforcement of the 
regulatory requirements and allows EPA and interested downstream 
consumers to be assured that finished goods are made from compliant 
composite wood panels. EPA seeks to avoid the situation where records 
surrounding the certification of regulated products that remain 
available for retail sale in the United States have already been 
disposed of because of the passage of time. To that end, EPA requests 
comment on the length of time composite wood panels may take to reach 
their end user, whether incorporated into a finished good or not.
    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.

F. Electronic Reporting

    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.
    Most of the information requested in the reporting requirements of 
these collections is not of a confidential nature. Nonetheless, the 
application would be designed to support TSCA CBI needs by providing a 
secure environment that meets Federal standards.
    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

[[Page 34811]]

reducing 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.

IV. Request for Comment

    In addition to the areas on which EPA has specifically requested 
comment, EPA requests comment on all other aspects of this proposed 
rule.

V. References

    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.

    1. Public Law 111-199, Title VI--Formaldehyde Standards for 
Composite Wood Products Act, enacted July 7, 2010. (TSCA section 
601(d), 15 U.S.C. 2601 et seq.)
    2. Agency for Toxic Substances and Disease Registry (ATSDR). 
1999. Toxicological Profile for Formaldehyde and 2010 Addendum to 
the Profile. Atlanta, GA: U.S. Department of Health and Human 
Services, Public Health Service.
    3. National Toxicology Program, U.S. Department of Health and 
Human Services (HHS), 12th Report on Carcinogens, June 10, 2011.
    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).
    13. ISO/IEC Guide 65:1996(E), General Requirements for Bodies 
Operating Product Certification Systems (First Edition) 1996.
    14. ISO/IEC 17011:2004(E), Conformity Assessments--General 
Requirements for Accreditation Bodies Accrediting Conformity 
Assessment Bodies (Corrected Version), February 15, 2005.
    15. ISO/IEC 17025:2005(E), General Requirements for the 
Competence of Testing and Calibration Laboratories (Second Edition), 
May 15, 2005.
    16. ISO/IEC 17020:1998(E), General Criteria for the Operation of 
Various Types of Bodies Performing Inspections (First Edition) 
November 15, 1998.
    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.
    21. 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.
    22. ASTM D5582-00 (Reapproved 2006), October 1, 2006. Standard 
Test Method for Determining Formaldehyde Levels from Wood Products 
Using a Desiccator.
    23. ASTM E1333-10 (May 1, 2010). 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.
    27. EPA. Information Collection Request (ICR) for the 
Formaldehyde Emissions From Composite Wood Products, Third-Party 
Certification Framework, Recordkeeping and Reporting; Proposed Rule, 
(RIN 2070-AJ44). EPA ICR No. 2441.01 and OMB No. 2070-[NEW]. 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.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    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.
    EPA prepared an analysis of the potential costs and benefits 
associated with this action. A copy of this Economic Analysis (Ref. 26) 
is available in the docket for this proposed and the analysis is 
briefly summarized here.
    This proposed rule would require ABs to submit an application and 
enter into a recognition agreement with EPA, provide notifications and 
annual reports, and maintain records. A typical AB is estimated to 
incur an annualized cost of nearly $800 per year. For the purposes of 
cost estimation EPA assumes that eight organizations in the United 
States will become ABs in the TSCA Title VI Third-Party Certification 
Program, so total costs to U.S. ABs are estimated to be approximately 
$6,300 per year.
    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

[[Page 34812]]

accredited 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.

B. Paperwork Reduction Act (PRA)

    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.
    This proposed rule would require TPCs to provide EPA and ABs with 
pertinent information necessary for accreditation. Also, this proposed 
rule would require ABs to provide EPA with necessary information 
through a recognition agreement in order to qualify them to function as 
an AB pursuant to the regulations. EPA has therefore prepared and 
submitted to OMB an ICR document entitled ``Formaldehyde Emissions From 
Composite Wood Products, Third-Party Certification Framework, 
Recordkeeping and Reporting; Proposed Rule (RIN 2070-AJ44),'' 
identified under EPA ICR No. 2441.01 and OMB Control No. 2070-[NEW], 
which is also available for review in the docket for this proposed rule 
(Ref. 27). The ICR describes the information collection activities and 
the estimated burden hours and costs, which are briefly summarized 
here.
    Because the approval requirements for information collection 
requests under PRA is not limited to U.S. entities, the reporting and 
recordkeeping burden of the proposed rule is calculated for both 
foreign and domestic entities.
    The average reporting and recordkeeping burden for ABs is estimated 
at approximately 21 hours per year. EPA assumes that 8 U.S. ABs and 17 
foreign ABs will participate in the TSCA Title VI program, so the 
annual burden for ABs is estimated to be 500 hours. The average 
reporting and recordkeeping burden for TPCs is estimated at 
approximately 25 hours per year. EPA assumes there will be nine 
domestic TPCs and 27 foreign TPCs that participate in the TCA Title VI 
program, so the annual burden for ABs is estimated at approximately 900 
hours. Total respondent burden for ABs and TPCs combined is estimated 
at approximately 1,400 hours per year. The total cost to United States 
and foreign TPCs that need to obtain additional accreditation is 
estimated to average $140,000 per year. Burden is defined at 5 CFR 
1320.3(b).
    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.

C. Regulatory Flexibility Act (RFA)

    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.
    Small entities include small businesses, small organizations, and 
small governmental jurisdictions. For purposes of assessing the impacts 
of this proposed rule on small entities, a small entity is defined as:
    1. A small business, as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201. The SBA's 
definitions typically are based upon either a sales or an employment 
level, depending on the nature of the industry.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district, or special district with a 
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field.
    Since the regulated community does not include small governmental 
jurisdictions, the Agency's analysis focuses on small businesses and 
small non-profits organizations.
    After considering the economic impacts of this proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The Agency's 
basis is briefly summarized here and is detailed in the Economic 
Analysis (Ref. 26).
    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.

[[Page 34813]]

    EPA assumed that 5 small non-profit organizations and 4 small 
businesses in the United States will participate as ABs or TPCs in the 
TSCA Title VI program. All of the small non-profit organizations are 
expected to have cost impacts below the 1% level. Three of the small 
businesses are expected to have cost impacts below the 1% level, and 
one is expected to have cost impacts between 1% and 3%. So of the 9 
total small entities assumed to be affected by the final rule, 8 are 
expected to have impacts under 1%, and 1 is expected to have impacts 
between 1% and 3%.
    In general, EPA strives to minimize potential adverse impacts on 
small entities when developing regulations to achieve the environmental 
and human health protection goals of the statute and the Agency. EPA 
solicits comments specifically about the potential economic impacts 
that this proposed rule may impose on small entities.
    Although not required by RFA to convene a Small Business Advocacy 
Review (SBAR) Panel for this particular proposed rule because EPA has 
determined that this proposal would not have a significant economic 
impacts on a substantial number of small entities, EPA convened a SBAR 
Panel to obtain advice and recommendations from small entities 
representatives potentially subject to the proposed rule's 
requirements. The SBAR Panel covered the proposed regulations and the 
broader TSCA Title VI implementing regulations proposal which will 
follow. The SBAR Panel was convened by EPA's Small Business Advocacy 
Chairperson on February 3, 2011. In addition to the chairperson, the 
Panel consisted of the Assistant Administrator of the Office of 
Chemical Safety and Pollution Prevention, the Administrator of the 
Office of Information and Regulatory Affairs within OMB, and the Chief 
Counsel for Advocacy of the SBA.
    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.

D. Unfunded Mandates Reform Act (UMRA)

    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.

E. Executive Order 13132: Federalism

    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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    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.

G. Executive Order 13045: Protection of Protection of Children From 
Environmental Health Risks and Safety Risks

    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.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    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.

[[Page 34814]]

I. National Technology Transfer and Advancement Act (NTTAA)

    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.
    This proposed rule involves technical standards. EPA proposes to 
use voluntary consensus standards. The proposed framework of this TSCA 
Title VI Third-Party Certification Program is based on the ability of 
ABs to review TPCs for their conformity to ISO/IEC Guide 65:1996(E), 
ISO/IEC 17025:2005(E), and ISO/IEC 17020:1998(E). Both Product ABs and 
Laboratory ABs would be required to maintain their conformity to ISO/
IEC 17011:2004(E).
    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.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
Federal executive policy on environmental justice. Its main provision 
directs Federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this proposed rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it does not 
affect the level of protection provided to human health or the 
environment. This proposed rule would establish a system whereby ABs 
accredits TPCs, and TPCs certify composite wood products in order to 
ensure compliance with the emissions standards in TSCA Title VI. This 
proposed rule does not relax a pollution control measure and therefore 
will not cause emissions increases.

List of Subjects in 40 CFR Part 770

    Environmental protection, Composite wood products, Formaldehyde, 
Reporting and recordkeeping, Third-party certification.

    Dated: May 23, 2013.
Bob Perciasepe,
Acting Administrator.
    Therefore, it is proposed that 40 CFR chapter I, subchapter R, be 
amended by adding a new part 770 to read as follows:

PART 770--FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD PRODUCTS

Subpart A--General Provisions
Sec.
770.1 Scope and applicability.
770.2 Effective dates.
770.3 Definitions.
Subpart B--TSCA Title VI Third-Party Certification Program
770.7 Third-party certification.
770.9 Prohibited Acts.
Subpart C--[Reserved]
Subpart D--Incorporation by Reference
770.99 Incorporation by reference.


    Authority: 15 U.S.C. 2697(d).

Subpart A--General Provisions


Sec.  770.1  Scope and applicability.

    (a) This subpart applies to:
    (1) Laboratory Accreditation Bodies (ABs) and Product ABs that are 
accrediting third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 
2697(d)) purposes and those that wish to commence accrediting third-
party certifiers for TSCA Title VI purposes. (2) TPCs that are 
certifying composite wood products for TSCA Title VI compliance and 
those that wish to commence certifying composite wood products for TSCA 
Title VI compliance.
    (b) [Reserved]


Sec.  770.2  Effective dates.

    (a) Laboratory and Product ABs that wish to accredit TPCs for TSCA 
Title VI purposes may apply to EPA to become recognized beginning on 
[date of publication of the final rule in the Federal Register]. 
Laboratory and Product ABs must be recognized by EPA before they begin 
providing TSCA Title VI accreditation services.
    (b) TPCs that wish to provide TSCA Title VI certification services 
must meet all the requirements of this subpart before they commence 
providing TSCA Title VI certification services.
    (c) Notwithstanding any other provision of this subpart, TPCs that 
are approved by the California Air Resources Board to certify composite 
wood products have until [date 1 year after date of publication of the 
final rule in the Federal Register] to become accredited pursuant to 
the requirements of this subpart. During the year following [date of 
publication of the final rule in the Federal Register], the California 
Air Resources Board-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. Third-party certifiers that are certifying products as 
compliant with TSCA Title VI are subject to enforcement actions for any 
violations of TSCA Title VI or the regulations promulgated thereunder.


Sec.  770.3  Definitions.

    For purposes of this part:
    Accreditation Body or AB means an organization that provides an 
impartial verification of the competency of conformity assessment 
bodies such as TPCs.
    Composite wood product means hardwood plywood, medium-density 
fiberboard, and particleboard.
    EPA Recognized Laboratory Accreditation Body or EPA Recognized 
Laboratory AB means a Laboratory AB that has a recognition agreement 
with EPA under the TSCA Title VI Third-Party Certification Program.
    EPA Recognized Product Accreditation Body or EPA Recognized Product 
AB means a Product AB that has a recognition agreement with EPA under 
the TSCA Title VI Third-Party Certification Program.
    Laboratory Accreditation Body or Laboratory AB means an 
accreditation body that accredits laboratories to ISO/IEC 17025:2005(E) 
(incorporated by reference, see Sec.  770.99).
    Panel producer means a manufacturing plant or other facility that 
manufactures (excluding imports) hardwood plywood, particle board, or 
medium density fiberboard.
    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 Sec.  770.99) and ISO/IEC 
17020:1998(E) (incorporated by reference, see Sec.  770.99).
    TSCA Title VI Accredited Third-Party Certifier or TSCA Title VI 
Accredited

[[Page 34815]]

TPC means an organization or entity that is accredited by an EPA 
recognized Product AB and an EPA recognized Laboratory AB pursuant to 
Sec.  770.7(c)(1).

Subpart B--TSCA Title VI Third-Party Certification Program


Sec.  770.7  Third-party certification.

    (a) Product ABs--(1) Qualifications. To apply to be recognized by 
EPA as a Product AB, a candidate Product AB must:
    (i) Be a signatory to the International Accreditation Forum, Inc.'s 
(IAF) Multilateral Recognition Arrangement (MLA) through level 3, or an 
equivalent organization.
    (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by 
reference, see Sec.  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 Sec.  770.99).
    (iv) Demonstrate competence to perform accreditation activities for 
inspection certification according to ISO/IEC 17020:1998(E) 
(incorporated by reference, see Sec.  770.99).
    (2) Recognition. To be recognized by EPA, a Product AB must apply 
to EPA by fulfilling the requirements in the paragraphs (a)(2)(i) 
through (ii) of this section:
    (i) Submitting an application to the EPA with the following 
information:
    (A) Name, address, telephone number, and email address of primary 
contact.
    (B) Documentation of its IAF MLA signatory status, or equivalent.
    (C) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the AB or any of its officers or employees for any action by 
EPA or otherwise by the United States related to the requirements of 
this subpart.
    (D) Description of any other qualifications related to its 
experience in performing product accreditation of conformity assessment 
bodies or TPCs of manufactured products.
    (ii) Entering into a recognition agreement with EPA that describes 
the Product AB's responsibilities under this subpart.
    (A) Each recognition agreement will be valid for 3 years.
    (B) To renew a recognition agreement for additional 3 year periods, 
the Product AB must submit an application for renewal (before the 3 
year period of the recognition agreement lapses) that indicates any 
changes from the Product AB's initial application.
    (C) If a 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 TSCA Title VI 
accreditation services.
    (D) If the 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.
    (3) Responsibilities. EPA recognized Product ABs must fulfill the 
requirements in paragraphs (a)(3)(i) through (xiv) of this section:
    (i) Receive and act on applications for accreditation from TPCs.
    (ii) Assign a unique number to each accredited TPC.
    (iii) Forward a copy of a TPC's application for TSCA Title VI 
accreditation to EPA at the address identified in the recognition 
agreement within 90 days of the date of receipt.
    (iv) Perform an in-depth systems audit, as described in this unit, 
on each TPC applicant who submits a complete application at the time of 
initial application. The systems audit must include the components 
described in paragraphs (a)(3)(iv)(A) through (F) of this section:
    (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 Sec.  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 Sec.  770.99) and the 
Product ABs must use the checklist for each on-site assessment.
    (B) A review of the approach that the TPC applicant will use to 
verify the accuracy of the formaldehyde emissions tests conducted by 
the TPC laboratory or contract laboratory and the formaldehyde quality 
control tests conducted by the panel producers producing composite wood 
products that are subject to the requirements of TSCA Title VI.
    (C) A review of the approach that the TPC applicant will use for 
evaluating a panel producer's quality assurance and quality control 
processes, the qualifications of the panel producer's quality assurance 
and quality control personnel, the required elements of a panel 
producer's quality assurance and quality control manual, and 
sufficiency of on-site testing facilities as applicable.
    (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 Sec.  770.99).
    (E) A review of the approach that the TPC applicant will use for 
evaluating the process for sample selection, handling, and shipping 
procedures, if applicable, that the panel producer will use for quality 
control testing.
    (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 Sec.  770.99) by a Laboratory AB that is a signatory 
to the ILAC MRA or equivalent.
    (v) Upon request, allow EPA representatives to accompany its 
assessors during an on-site assessment to observe the audit of a TPC.
    (vi) Accredit TPCs that submit a complete application as described 
in Sec.  770.7(c)(1)(i) and that meet the requirements of Sec.  
770.7(c).
    (vii) Conduct a follow-up systems audit, including an on-site 
assessment, of each TPC that the AB has accredited at least every 2 
years.
    (viii) Suspend, modify, or revoke the accreditation of a TPC in 
accordance with Sec.  770.7(e).
    (ix) Provide written notifications to EPA at the address identified 
in the recognition agreement, as follows:
    (A) Notification of loss of its status as a signatory to the IAF 
MLA (or membership in an equivalent organization) must be provided to 
EPA within 5 business days of the date that the body receives 
notification of the loss of its signatory status.
    (B) Notification of the TSCA Title VI accreditation of a TPC must 
be provided to EPA within 5 business days of the date that the TPC is 
accredited.
    (C) Notification that an accredited TPC has failed to comply with 
any provision of this section must be provided to EPA within 24 hours 
of the time the Product AB identifies the failure.
    (D) Notification of suspension or revocation of a TPC's 
accreditation must be provided to EPA within 24 hours of the time that 
the suspension or revocation takes effect.
    (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.

[[Page 34816]]

    (x) If the Product AB is removed or withdraws from the TSCA Title 
VI Third-Party Certification Program, notification must be given to all 
of the TPCs that receive its accreditation services within 5 business 
days.
    (xi) Maintain the checklists and other records documenting 
compliance with the requirements for systems audits and on-site 
assessments of TPCs for 3 years. These records must be in electronic 
form, and the Product AB must provide them to EPA within 30 days upon 
request.
    (xii) Provide a report to EPA at least once each year (12 months 
from the anniversary of the date of the recognition agreement), that 
includes the number and locations of systems audits and on-site 
assessments performed.
    (xiii) Meet with EPA at least once every 2 years to discuss the 
implementation of the TPC accreditation program.
    (xiv) Allow inspections by EPA, conducted at reasonable times, 
within reasonable limits, and in a reasonable manner, upon the 
presentation of appropriate credentials and a written notification to 
the Product AB.
    (b) Laboratory ABs--(1) Qualifications. To apply to be recognized 
by EPA as a Laboratory AB, a candidate Laboratory AB must:
    (i) Be a signatory to the ILAC MRA, or an equivalent organization.
    (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by 
reference. see Sec.  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 Sec.  770.99).
    (2) Recognition. To be recognized by EPA, a Laboratory AB must 
apply to EPA by fulfilling the requirements in paragraphs (b)(2)(i) 
through (ii) of this section:
    (i) Submit an application to the EPA with the information listed in 
paragraphs (b)(2)(i)(A) through (D) of this section (if the 
accreditation body is also applying to be recognized as a Product AB, 
this application may be submitted in conjunction with the Product AB 
application):
    (A) Name, address, telephone number, and email address of primary 
contact.
    (B) Documentation of ILAC MRA signatory status, or equivalent.
    (C) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the AB or any of its officers or employees for any action by 
EPA or otherwise by the United States related to the requirements of 
this subpart.
    (D) Description of any other qualifications related to the 
Laboratory AB's experience in performing laboratory accreditation and 
inspection certification of conformity assessment bodies or TPCs.
    (ii) Enter into a recognition agreement with EPA that describes the 
Laboratory AB's responsibilities under this subpart.
    (A) Each recognition agreement will be valid for 3 years.
    (B) To renew a recognition agreement for additional 3 year periods, 
the Laboratory AB must submit an application for renewal (before the 3 
year period of the recognition agreement lapses) that indicates any 
changes from the Laboratory AB's initial application.
    (C) If the 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 previous recognition agreement until EPA has taken action 
on its application for renewal of the recognition agreement.
    (3) Responsibilities. EPA recognized Laboratory ABs must fulfill 
the requirements in paragraphs (b)(3)(i) through (xiii) of this 
section:
    (i) Receive and act on applications for laboratory accreditation 
from TPC laboratories (including contract laboratories).
    (ii) Within 15 days of a request by a TPC or their EPA recognized 
Product AB, forward copies of a TPC's TSCA Title VI laboratory 
application and accreditation documentation to the applicable EPA 
recognized Product AB (if the Laboratory AB is not also recognized as a 
Product AB) at the address identified by the TPC.
    (iii) Perform an in-depth systems audit on the laboratory of each 
TPC applicant who submits a complete application at the time of initial 
application. The systems audit must include:
    (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 
Sec.  770.99).
    (B) Include a checklist that lists all of the key conformity 
elements of ISO/IEC 17025:2005(E) (incorporated by reference, see Sec.  
770.99) and the Laboratory AB's assessors must use the checklist for 
each on-site assessment.
    (iv) Upon request, allow EPA representatives to accompany its 
assessors during an on-site assessment to observe the audit of a TPC.
    (v) Accredit laboratories that submit a complete application as 
described in Sec.  770.7(c)(1)(ii) and that continue to meet the 
requirements of Sec.  770.7(c).
    (vi) Verify the accuracy of the formaldehyde emissions tests 
conducted by the TPC laboratory through an inter-laboratory comparison 
or proficiency testing program if available.
    (vii) Conduct a follow-up systems audit at least every 2 years, 
including an on-site assessment, of each TPC laboratory that the 
accreditation body has accredited. TPCs' laboratories that have not 
adequately performed an inter-laboratory comparison or proficiency 
testing must be audited at least once each year for a period of 2 years 
from the date of the latest poor proficiency test or inter-laboratory 
comparison.
    (viii) Suspend, modify, or revoke the accreditation of TPCs' 
laboratories in accordance with Sec.  770.7(e).
    (ix) Provide the following written notifications to EPA and to the 
applicable EPA recognized Product AB (if the Laboratory AB is not also 
recognized as a Product AB) at the address identified in the 
recognition agreement:
    (A) Notification of loss of its status as a signatory to the ILAC 
MRA, or membership in an equivalent organization, must be provided 
within 5 business days of the date that the body receives notice of the 
loss of its signatory status.
    (B) Notice of accreditation of a TPC's laboratory must be provided 
within 5 business days of the date that the laboratory is accredited.
    (C) Notice that an accredited laboratory has failed to comply with 
any provision of this section must be provided within 24 hours of the 
time the Laboratory AB identifies the failure.
    (D) Notice that an accredited TPC has failed to comply with any 
provision of this section must be provided within 24 hours of the time 
the Laboratory AB identifies the failure.
    (E) Notice of a decision to make changes in its organizational 
policies or management structure that could adversely affect the 
laboratory accreditation program must be provided to EPA within 30 days 
of the decision to make the changes.
    (F) Notice if the Laboratory AB suspends or revokes a laboratory's 
accreditation must be provided within 24 hours of the time that the 
suspension or revocation takes effect.
    (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

[[Page 34817]]

must be in electronic form and provided to EPA within 30 days of 
request.
    (xi) Provide a report to EPA at least once each year (12 months 
from the date of the recognition agreement) that includes the following 
information:
    (A) The names and contact information of all the TSCA Title VI 
accredited TPC laboratories.
    (B) Number and locations of systems audits and on-site assessments 
performed.
    (C) Results of inter-laboratory comparisons or proficiency testing 
for each of the AB's TSCA Title VI accredited TPC laboratories, if such 
an EPA recognized inter-laboratory comparisons or proficiency testing 
program is available.
    (xii) Meet with EPA at least once every 2 years to discuss the 
implementation of the laboratory accreditation program.
    (xiii) Allow inspections by EPA, conducted at reasonable times, 
within reasonable limits, and in a reasonable manner, upon the 
presentation of appropriate credentials and written notice to the 
laboratory accreditation body.
    (c) Third-party certifiers--(1) Qualifications. In order to 
participate as a TPC of composite wood products under TSCA Title VI, a 
TPC must apply to an EPA recognized Product AB. In its application the 
TPC must demonstrate that it has been accredited by an EPA recognized 
Laboratory AB, unless the TPC is applying to an EPA recognized Product 
AB that is also an EPA recognized Laboratory AB and the TPC is seeking 
both accreditations from this single AB. In such a case, the TPC will 
obtain the required product and laboratory accreditations pursuant to 
ISO/IEC Guide 65:1996(E) and ISO/IEC 17025:2005(E), respectively, from 
the EPA recognized Product AB.
    (i) To participate in the TSCA Title VI Third-Party Certification 
Program, a TPC must submit an application to an EPA recognized Product 
AB every 3 years that includes the elements in paragraphs (c)(1)(i)(A) 
through (D) of this section:
    (A) Name, address, telephone number, and email address of primary 
contact.
    (B) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the TPC or any of its officers or employees for any action 
by EPA or otherwise by the United States related to the requirements of 
this subpart.
    (C) Type of composite wood products that the applicant intends to 
certify if accredited.
    (D) Description of the TPC's qualifications, including indications 
that the TPC has:
    (1) Experience or ability in product certification and complying 
with ISO/IEC Guide 65:1996(E) (incorporated by reference, see Sec.  
770.99).
    (2) Experience in the composite wood product industry with the 
specific product(s) the applicant intends to certify.
    (3) Ability to conduct inspections and properly train and supervise 
inspectors pursuant to ISO/IEC 17020:1998(E) (incorporated by 
reference, see Sec.  770.99).
    (ii) To be accredited by a laboratory accreditation body under TSCA 
Title VI, a TPC or its laboratories must submit an application to an 
EPA recognized Laboratory AB every 3 years that includes the elements 
in paragraphs (c)(1)(ii)(A) through (C) of this section:
    (A) Name, address, telephone number, and email address of primary 
contact.
    (B) If not a domestic entity, name and address of an agent for 
service located in the United States. Service on this agent constitutes 
service on the TPC or any of its officers or employees for any action 
by EPA or otherwise by the United States related to the requirements of 
this subpart.
    (C) Description of the TPC's laboratory's qualifications, including 
indications that the TPC's laboratory has:
    (1) Experience in performing or verifying formaldehyde testing on 
composite wood products.
    (2) Experience complying with ISO/IEC 17025:2005(E) (incorporated 
by reference, see Sec.  770.99).
    (3) Experience with test method ASTM E1333-10 (incorporated by 
reference, see Sec.  770.99) and experience evaluating correlation 
between test methods.
    (2) Responsibilities. To maintain participation in the TPC TSCA 
Title VI program, TSCA Title VI accredited TPCs must fulfill the 
requirements in paragraphs (c)(2)(i) through (xvi) of this section:
    (i) Verify that panel producers have adequate quality assurance and 
quality control procedures and are complying with applicable quality 
assurance and quality control requirements pursuant to TSCA Title VI, 
including the requirements of this subpart.
    (ii) Verify quality control test results compared with ASTM E1333-
10 (incorporated by reference, see Sec.  770.99) test results by having 
TPC laboratories conduct quarterly tests and evaluate test method 
equivalence.
    (iii) Review applications from panel producers for reduced testing, 
approve an application within 90 days of receipt if it demonstrates 
that the requirements for reduced testing under TSCA Title VI are met, 
and notify EPA of all approvals for reduced testing within 5 days of 
the approval, and forward copies of all approved applications for 
reduced test to EPA within 30 days of receipt.
    (iv) Establish quality control limits in consultation with panel 
producers and, if applicable, shipping quality control or other limits 
for each panel producer, product type, and production line.
    (v) Establish for each panel producer the process that will be used 
to determine if product lots are exceeding the applicable quality 
control limit.
    (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 Sec.  770.99).
    (vii) Use only laboratories that have been accredited by an EPA 
recognized Laboratory AB and participate in an EPA-approved inter-
laboratory comparison or proficiency testing program and ensure the 
results of the EPA-approved inter-laboratory comparison or proficiency 
testing program are provided to the Laboratory AB.
    (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 Sec.  770.99).
    (ix) Provide its accreditation number to the panel producer for 
labeling and recordkeeping.
    (x) Maintain the following records, in electronic form, for 3 years 
from the date the record is created, and provide them to EPA within 30 
days of the request:
    (A) A list of panel producers and their respective product types, 
including resins used, that the TPC has certified.
    (B) Results of inspections, audits, and emission tests conducted 
for and linked to each panel producer and product type.
    (C) A list of laboratories used by the TPC, as well as test 
methods, including test conditions and conditioning time, and test 
results.
    (D) Methods and results for establishing test method correlations 
and equivalence.
    (xi) Provide an annual report to its accreditation body or bodies 
(Product AB and Laboratory AB) and to EPA that contains the following:
    (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

[[Page 34818]]

of formaldehyde emissions by panel producer, resin, and product type.
    (B) A list of any non-complying products or events by panel 
producers.
    (C) A list of laboratories and test methods used by the TPC.
    (xii) Inform its accreditation body or bodies (Product AB and 
Laboratory AB) within 30 days of any changes in personnel 
qualifications, procedures, or laboratories used by the TPC.
    (xiii) Allow inspections by EPA, conducted at reasonable times, 
within reasonable limits, and in a reasonable manner, upon the 
presentation of appropriate credentials and of a written notice to the 
TPC.
    (xiv) If not a domestic entity, the TPC must maintain an agent for 
service located in the United States and notify EPA of any changes in 
the name or address of that agent within 5 business days.
    (xv) Participate an inter-laboratory comparison or proficiency 
testing program annually, or use only contract laboratories that 
participate in such a program.
    (xvi) If a TPC or its laboratory loses its accreditation or 
discontinues participation in the program for any reason, it must 
notify EPA and all the panel producers it provides TSCA Title VI 
certification services to within 3 business days.
    (d) Third-party certifiers approved by the California Air Resources 
Board. TPCs approved by the California Air Resources Board as of [date 
60 days after date of publication of the final rule in the Federal 
Register] may certify composite wood products under TSCA Title VI until 
[date 1 year after date of publication of the final rule in the Federal 
Register] as long as they remain approved by the California Air 
Resources Board for that period and comply with all aspects of this 
subpart other than the accreditation requirements of paragraph (c)(1) 
of this section. In lieu of the accreditation number required to be 
provided according to paragraph (c)(2)(ix) of this section, a TPC 
approved by CARB according to this section must provide the panel 
producer with the TPC number issued by CARB. For a TPC approved by CARB 
according to this section, the annual report under paragraph (c)(2)(xi) 
of this section must be provided to CARB in lieu of the AB. After [date 
1 year after date of publication of the final rule in the Federal 
Register], no TPC may certify composite wood products under TSCA Title 
VI unless the TPC is accredited in accordance with paragraph (c)(1) of 
this section.
    (e) Suspension, revocation, or modification of recognition or 
accreditation--(1) Third-party certifiers. EPA or an AB may suspend, 
revoke, or modify the accreditation of a TPC or a TPC laboratory, if 
the TPC or TPC laboratory:
    (i) Fails to comply with any requirement of TSCA Title VI or this 
subpart;
    (ii) Makes any false or misleading statements on its application, 
records, or reports; or
    (iii) Makes substantial changes to personnel qualifications, 
procedures, or laboratories that make the TPC or TPC laboratory unable 
to comply with any applicable requirements of this subpart.
    (2) ABs. EPA may suspend, revoke, or modify the recognition of an 
AB if the AB:
    (i) Fails to comply with the requirements of the applicable 
recognition agreement(s) (the International Accreditation Forum 
Multilateral Recognition Arrangement and the International Laboratory 
Accreditation Cooperation Mutual Recognition Agreement or 
equivalent(s));
    (ii) Fails to comply with any requirement of TSCA Title VI or this 
subpart;
    (iii) Makes any false or misleading statements on its application, 
records, or reports; or
    (iv) Makes substantial changes to personnel qualifications or 
procedures that make the TPC unable to comply with any applicable 
requirements of this subpart.
    (3) Process for suspending, revoking, or modifying accreditation or 
recognition. (i) Prior to taking action to suspend, revoke, or modify 
accreditation or recognition, EPA or the accreditation body will notify 
the recognized AB or the accredited TPC or TPC laboratory in writing of 
the following:
    (A) The legal and factual basis for the proposed suspension, 
revocation, or modification.
    (B) The anticipated commencement date and duration of the 
suspension, revocation, or modification.
    (C) Actions, if any, which the affected AB or TPC or TPC laboratory 
may take to avoid suspension, revocation, or modification, or to 
receive accreditation in the future.
    (D) The opportunity and method for requesting a hearing with EPA 
prior to final suspension, revocation, or modification.
    (ii) If the affected AB or TPC or TPC laboratory requests a hearing 
in writing to EPA within 30 days of receipt of the notification, EPA 
will:
    (A) Provide the affected accreditation body or TPC or TPC 
laboratory an opportunity to offer written statements in response to 
EPA's or the accreditation body's assertions of the legal and factual 
basis for the proposed action.
    (B) Appoint an impartial EPA official as Presiding Officer to 
conduct the hearing. The Presiding Officer will:
    (1) Conduct a fair, orderly, and impartial hearing within 90 days 
of the request for a hearing.
    (2) Consider all relevant evidence, explanation, comment, and 
argument submitted.
    (3) Notify the affected AB or TPC or TPC laboratory in writing 
within 90 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.
    (iii) If EPA determines that the public health, interest, or 
welfare warrants immediate action to suspend the recognition of an AB 
or the accreditation of a TPC or TPC laboratory prior to the 
opportunity for a hearing, it will notify the affected AB, TPC, or TPC 
laboratory of its right to request a hearing on the immediate 
suspension within 15 days of the suspension taking place and the 
procedures for the conduct of such a hearing.
    (iv) 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 section 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 section 14.
    (v) EPA will maintain a publicly available list of accreditation 
bodies whose recognition has been suspended, revoked, modified, or 
reinstated and a publicly available list of TPCs and laboratories whose 
accreditation has been suspended, revoked, modified, or reinstated.
    (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

[[Page 34819]]

become recognized or accredited under this subpart again.
    (vii) Unless the decision and order issued under paragraph (d)(3) 
of this section specifies otherwise, an AB whose recognition has been 
revoked or a TPC or TPC laboratory whose accreditation 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.
    (f) Process for denying a TSCA Title VI accreditation--(1) Upon 
denying to accredit a TPC or a TPC laboratory for failure to submit a 
complete application, the accreditation body will notify the TPC or TPC 
laboratory in writing of the following:
    (i) The legal and factual basis for the denial.
    (ii) Actions, if any, which the affected TPC or TPC laboratory may 
take to receive accreditation in the future.
    (iii) The opportunity and method for requesting a hearing with EPA.
    (2) If the affected TPC or TPC laboratory requests a hearing in 
writing to EPA within 30 days of receipt of the notice, EPA will:
    (i) Provide the affected TPC or TPC laboratory an opportunity to 
offer written statements in response to the legal and factual basis for 
the denial.
    (ii) Appoint an impartial EPA official as Presiding Officer to 
conduct the hearing. The Presiding Officer will:
    (A) Conduct a fair, orderly, and impartial hearing within 90 days 
of the request for a hearing.
    (B) Consider all relevant evidence, explanation, comment, and 
argument submitted.
    (C) Notify the affected TPC or TPC laboratory 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 basis for the denial.
    (3) 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 section 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 section 14.
    (g) Process of seeking alternate accreditations or certifications--
(1) If AB is removed or withdraws from the TSCA Title VI Third-Party 
Certification Program:
    (i) For reasons other than fraud or providing false or misleading 
statements, or other than a reason that implicates a particular TPC in 
a violation of TSCA Title VI or its implementing regulations, TPCs 
accredited by that AB have 365 days, or 180 days if less than 365 days 
were left on their 3 year accreditation period, to be accredited again 
by an alternate EPA recognized AB.
    (ii) 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 may not provide any TSCA Title VI certification 
services until it has been accredited by an alternate EPA recognized 
AB.
    (2) If a TPC loses its accreditation or discontinues participation 
in the program:
    (i) 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 must enlist another TPC to certify their products within 3 
months (90 days). During the time a panel producer is seeking a new 
TPC, it must continue to comply with all other requirements of TSCA 
Title VI and its implementing regulations, including quality control 
testing.
    (ii) 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 its implementing regulations, that panel producer may not offer 
regulated composite wood products for sale in the United States until 
its composite wood products have been recertified by another TPC.


Sec.  770.9  Prohibited Acts.

    (a) Failure or refusal to comply with any requirement of TSCA 
section 601 (15 U.S.C. 2697) or this subpart part is a violation of 
TSCA section 15 (15 U.S.C. 2614).
    (b) Failure or refusal to establish and maintain records or to make 
available or permit access to or copying of records, as required by 
this subpart, is a violation of TSCA section 15 (15 U.S.C. 2614).
    (c) Violators may be subject to civil and criminal sanctions 
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.

Subpart C--[Reserved]

Subpart D--Incorporation by Reference


Sec.  770.99  Incorporation by reference.

    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.
    (a) [Reserved]
    (b) ASTM material. Copies of these materials may be obtained from 
ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West 
Conshohocken, PA 19428-2959, or by calling (877) 909-ASTM, or at http://www.astm.org.
    (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 Sec.  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 Sec.  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 Sec.  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-

[[Page 34820]]

Creuse, 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 Sec.  
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 Sec.  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 Sec.  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 Sec.  770.7(a) through (c).
[FR Doc. 2013-13254 Filed 6-7-13; 8:45 am]
BILLING CODE 6560-50-P