***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 1 of 101 [RIN 2070-AJ44] EO12866_RIN2070-AJ44_Formaldehyde-TPCs-NPRM _Redline_Revisions_2012-09-21.docx 1 Revised to address Interagency Co mments received under EO 12866 Review. 2

________________________________________________________________________ 3 BILLING CODE 6560-50-P 4 ENVIRONMENTAL PRO TECTION AGENCY 5 40 CFR Part 770 6 [EPA-HQ-OPPT-2011-0380; FRL-9342-4] 7 RIN 2070-AJ44 8 Formaldehyde; Third-Party Certification Framework for the Formaldehyde 9 Standards for Composite Wood Products 10 11 AGENCY: Environmental Protection Agency (EPA). 12 ACTION: Proposed rule. 13 SUMMARY : The Formaldehyde Standards for Com posite Wood Products Act (Title VI 14 of the Toxic Substances Control Act (T SCA)) establishes formaldehyde emission 15 standards for hardwood plywood, particleboard, and medium-density fiberboard 16 (composite wood products) and directs EPA to promulgate implementing regulations by 17 January 1, 2013. Pursuant to the requirements of TSCA Title VI, EPA is proposing a 18 framework for a TSCA Title VI Third-Part y Certification Program for composite wood 19 products. Under the framework, third-party ce rtifiers (TPCs) woul d be accredited by 20 EPA-recognized accreditation bodies (ABs) so that TPCs may certify composite wood 21 product panel producers under TSCA Title VI. This proposed rule identifies the roles 22 and responsibilities of the TPCs and ABs involve d, as well as the crite ria for participation 23 in the TSCA Title VI Third-Party Certif ication Program. The Agency is proposing the the 24 TSCA Title VI Third-Party Certification Pr ogram framework prior to the rest of the 25 TSCA Title VI implementing regulations in order to allow interested parties an 26***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 2 of 101 [RIN 2070-AJ44] opportunity to comment and to begin identifyi ng the business practices and infrastructure 27 that may need to be modified or developed in order to effectively participate in the 28
program. 29 DATES: Comments must be recei ved on or before [ insert date 60 days after date of 30 publication in the Federal Register ]. 31 ADDRESSES: Submit your comments, identified by docket identification (ID) number 32 EPA-HQ-OPPT-2011-0380, by one of the following methods: 33

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the online 34 instructions for submitting comments. 35

• Mail : Document Control Office (7407M), Office of Pollution Prevention and 36 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 37 Washington, DC 20460-0001. ATTN: Docket ID Number EPA-HQ-OPPT-2011-0380. 38

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 39 6428, 1201 Constitution Ave., NW., Washington, DC. ATTN: Docket ID Number EPA40 HQ-OPPT-2011-0380. The DCO is open from 8 a. m. to 4 p.m., Monday through Friday, 41 excluding legal holidays. Th e telephone number for the DCO is (202) 564-8930. Such 42 deliveries are only accepted during the DCO’s normal hours of operation, and special 43 arrangements should be made for deliveries of boxed information. 44

• Instructions : Direct your comments to doc ket ID number EPA-HQ-OPPT-2011- 45 0380. EPA’s policy is that all comments receive d will be included in the docket without 46 change and may be made available online at http://www.regulations.gov , including any 47 personal information provided, unless the comme nt includes information claimed to be 48 Confidential Business Information (CBI) or other information whose disclosure is 49***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 3 of 101 [RIN 2070-AJ44] restricted by statute. Do not submit informa tion that you consider to be CBI or otherwise 50 protected through regulations.gov or email. The regulations.gov website is an 51 “anonymous access” system, which means EPA will not know your identity or contact 52 information unless you provide it in the body of your comment. If you send an email 53 comment directly to EPA without going th rough regulations.gov, your email address will 54 be automatically captured and included as part of the comment that is placed in the 55 docket and made available on the Internet. If you submit an electronic comment, EPA 56 recommends that you include your name and other contact information in the body of 57 your comment and with any disk or CD-R OM you submit. If EPA cannot read your 58 comment due to technical difficulties and cannot contact you for clarification, EPA may 59 not be able to consider your comment. El ectronic files should avoid the use of special 60 characters, any form of encryption, and be free of any defects or viruses. 61 Docket : All documents in the docket are list ed in the docket index available at 62 http://www.regulations.gov . Although listed in the index, some information is not 63 publicly available, e.g., CBI or other informati on whose disclosure is restricted by statute. 64 Certain other material, such as copyrighted material, will be publicly available only in 65 hard copy. Publicly available docket mate rials are available electronically at 66 http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket. The 67 OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 68 Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading 69 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 70 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566- 71 1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 72***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 4 of 101 [RIN 2070-AJ44] are required to show photographi c identification, pass through a metal detector, and sign 73 the EPA visitor log. All visito r bags are processed through an X-ray machine and subject 74 to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 75 the building and retu rned upon departure. 76 FOR FURTHER INFORMATION CONTACT: For general information contact : 77 The TSCA-Hotline, ABVI-Goodwill, 422 S outh Clinton Ave., Rochester, NY 14620 ; 78 telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov

. 79 For technical information contact : Erik Winchester, National Program Chemicals 80 Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 81 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 82 564-6450; email address: winchester.erik@epa.gov

. 83 SUPPLEMENTARY INFORMATION: 84 I. General Information 85 A. Does this Action Apply to Me? 86 You may be affected by this action if you certify domestic or international 87 composite wood products. Potentially affected entities may include, but are not limited 88

to: 89 • Reconstituted wood product manufacturing (NAICS code 321219). 90 • Engineering services (NAICS code 541330). 91 • Testing laboratories (NAICS code 541380). 92 • Administrative management and gene ral management consulting services 93 (NAICS code 541611). 94 • All other professional, scientific, an d technical services (NAICS code 541990). 95***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 5 of 101 [RIN 2070-AJ44] • All other support services (NAICS code 561990). 96 • Business associations (NAICS code 813910). 97 • Professional organizations (NAICS code 813920). 98 This list is not intended to be exhausti ve, but rather provide s a guide for readers 99 likely to be affected by this action. To de termine whether you, your business, or your 100 agency is affected, you should carefully exam ine this proposed rule and the TSCA Title 101 VI (Ref. 1). If you have any questions regard ing the applicability of this action to a 102 particular entity, consult the technical person listed under FOR FURTHER 103 INFORMATION CONTACT

. 104 B. What Should I Consider as I Prepare My Comments for EPA? 105
1. Submitting CBI . Do not submit this information to EPA through 106 regulations.gov or email. Clearly mark the part or all of the information that you claim to 107 be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 108 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 109 CD-ROM the specific information that is cl aimed as CBI. In addition to one complete 110 version of the comment that includes inform ation claimed as CBI, a copy of the comment 111 that does not contain the information claimed as CBI must be submitted for inclusion in 112 the public docket. Information so marked will not be disclosed except in accordance with 113 procedures set forth in 40 CFR part 2. 114
2. Tips for preparing your comments . When submitting comments, remember to: 115 i. Identify the document by docket ID nu mber and other identifying information 116 (subject heading, Federal Register date and page number). 117 ii. Follow directions. The Agency may ask you to respond to specific questions or 118***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 6 of 101 [RIN 2070-AJ44] organize comments by referencing a Code of Federal Regulations (C FR) part or section 119 number. 120 iii. Explain why you agree or disagree; suggest alternatives and substitute 121 language for your requested changes. 122 iv. Describe any assumptions and provid e any technical information and/or data 123 that you used. 124 v. If you estimate potential costs or bu rdens, explain how you arrived at your 125 estimate in sufficient detail to allow for it to be reproduced. 126 vi. Provide specific examples to illustra te your concerns and suggest alternatives. 127 vii. Explain your views as clearly as possible, avoidi ng the use of profanity or 128 personal threats. 129 viii. Make sure to submit your comments by the comment period deadline 130 identified. 131 II. Background 132
A. Executive Summary 133
1 . Purpose of the regulatory action. EPA is proposing a framework for a Toxic 134 Substances Control Act (TSCA) Title VI Third-Party Certification Program for 135 composite wood products. Under the framework, third-party certifiers (TPCs) would be 136 accredited by EPA-recognized accreditation bodies (ABs) so that TPCs may certify 137 composite wood product panel producers under TSCA Title VI, 15 U.S.C. 2697. TSCA 138 Title VI gives EPA the authority to promulgate regulations relating to “third-party testing 139 and certification” and “auditing and reporting of third-party ce rtifiers” with regards to 140 composite wood products. EPA believes that th ird-party certification is an essential 141***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 7 of 101 [RIN 2070-AJ44] component in ensuring compliance with th e TSCA Title VI emission standards for 142 composite wood products. 143
2. Summary of the major provisions . This proposal provides a framework for the 144 TSCA Title VI Third-Party Certification Program. It lists the qualifications for ABs that 145 wish to participate in the program, the proce ss for applying to partic ipate in the program, 146 and the responsibilities of participating ABs. It also lists the qualifications for TPCs that 147 wish to become TSCA Title VI accredited, the process fo r applying to become TSCA 148 Title VI accredited, and the responsibilitie s of TSCA Title VI accredited TPCs. 149
3. Costs and impacts . Under section 3(f)(1) of Executive Order 12866 (58 FR 150 51735, October 4, 1993), this is a “significant re gulatory action” because it may raise 151 novel legal or policy issues related to the es tablishment of a new regulatory program as 152 mandated by a new statutory amendment. Accordingly, EPA submitted this action to the 153 Office of Management and Budget (OMB) for review under Executive Orders 12866 and 154 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB 155 recommendations are documented in the docket for this action. 156 EPA has prepared an analysis of the potenti al costs and impacts associated with this 157 rulemaking. This analysis is summarized in gr eater detail in Unit VI.A . of this proposal. 158 The following chart provides a brief outline of the costs and impacts of this proposal: 159
160 Category Description Costs The annualized costs of th is 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 imp act 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%.***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 8 of 101 [RIN 2070-AJ44] Category Description Effects on State, Local, and Tribal Governments Government entities are not expe cted to be subject to the rule’s requirements, which appl y 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. 161 162 B. What Action is the Agency Taking? 163 Title VI of TSCA directs EPA to pr omulgate implementing regulations by 164 January 1, 2013 (Ref. 1). EPA is issuing this proposed rule under TSCA Title VI to 165 establish a framework for a TSCA Title VI Third-Party Certification Program whereby 166 TPCs are accredited by ABs so that they may certify composite wood product panel 167 producers under TSCA Title VI. This proposed rule id entifies the roles and 168 responsibilities of the groups involved in the TPC process (EPA, ABs, and TPCs), as well 169 as the criteria for participation in th e program. This proposal contains general 170 requirements for TPCs, such as conducting and verifying formaldehyde emission tests, 171 inspecting and auditing panel producers, a nd ensuring that pane l producers’ quality 172 assurance and quality control pr ocedures comply with the regulations set forth in this 173 proposed rule. In a subsequent document, EPA will propose addi tional requirements 174 including the frequency of testing, means for showing test method equivalence, and other 175 implementing provisions as required under TSCA Title VI, such as labeling, chain of 176 custody requirements, sell-through provision s, recordkeeping, and enforcement. 177
B C

. What is the Agency’s Author ity for Taking this Action? 178 EPA is issuing this proposed rule pu rsuant to the Formaldehyde Standards for 179 Composite Wood Products Act (Ref. 1), which provides authority fo r the Administrator 180 to “promulgate regulations to implement the standards required unde r subsection (b) in a 181***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 9 of 101 [RIN 2070-AJ44] manner that ensures compliance with the em ission standards desc ribed in subsection 182 (b)(2).” This provision includes authority to promulgate regul ations relating to “third183 party testing and certification” and “auditing and reporting of third-party certifiers.” 184
C D

. Formaldehyde Sources and Health Effects 185 Formaldehyde is a colorless, flammable gas at room temperature and has a strong 186 odor. It is found in resins used in the manufacture of composite wood products (e.g., 187 hardwood plywood, particleboard, and medium-density fiberboa rd). It is also found in 188 household products such as glues, permanen t press fabrics, carpets, antiseptics, 189 medicines, cosmetics, dishwashing liquids, fa bric softeners, shoe care agents, lacquers, 190 plastics, and paper product coatings. It is a by-product of combustion and certain other 191 natural processes. Examples of sources of formaldehyde gas inside homes include 192 cigarette smoke, unvented, fuel-burning applianc es (gas stoves, kerosene space heaters), 193 and composite wood products made usi ng formaldehyde-based resins (Ref. 2). 194 Formaldehyde is both an irritant and a known human carcinogen (Ref. 3). 195 Depending on concentration, formaldehyde can cau se eye, nose, and throat irritation, 196 even when exposure is of relatively short duration. In the indoor environment, sensory 197 reactions and various symptoms resulting from mucous membrane irritation are potential 198 effects. There is also evidence that formal dehyde may be associated with changes in 199 pulmonary function and increased risk of asthma in children (Ref. 2). 200 The Integrated Risk Information System (IRIS) Program of EPA’s Office of 201 Research and Development (ORD) recently comp leted a draft assessment of the potential 202 cancer and non-cancer health e ffects that may result from chronic inhalation exposure to 203 formaldehyde (Ref. 4). This draft IRIS a ssessment was peer reviewed by the National 204***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 10 of 101 [RIN 2070-AJ44] Academy of Sciences (NAS) (Ref. 5). EPA is currently considering the peer review 205

comments EPA is currently considering the peer review comments. Both the National 206 Toxicology Program (Ref. 3) a nd the International Agency fo r Research on Cancer (Ref. 207 6) have concluded that formaldehyde is a known human carcinogen. However, in 208 revising the draft IRIS assessment, EPA is following the 2011 recommendation of the 209 National Research Council to evaluate the weig ht of evidence for specific cancer types in 210 multiple organs, including specific respiratory tract sites and specific 211 lymphohematopoietic cancer subtypes. This anal ysis will be used to derive a unit risk 212 estimate in the revised draft that reflects mo re recent data and an updated review of the 213 cancer hazard in humans and animals

. 214
D E

. History of this Action 215
1. Legislative history . On July 7, 2010, President Obama signed into law the 216 Formaldehyde Standards for Composite Wood Products Act (Ref. 1). This legislation 217 adds Title VI to TSCA and establishes formaldehyde emission standards for hardwood 218 plywood, particleboard, and medium-density fiberboard. These emission standards are 219 identical to the California Air Resources Board’s (CARB) Airborne Toxic Control 220 Measure (ATCM) Phase II standards (Ref. 6 7 ). Title VI of TSCA directs EPA to 221 promulgate implementing regulations by Janua ry 1, 2013, that address: Labeling, chain of 222 custody requirements, sell-through provision s, ultra low-emitting formaldehyde (ULEF) 223 resins, no-added formaldehyde-based (NAF) re sins, finished goods, third-party testing 224 and certification, auditing a nd reporting of third-party certifiers, recordkeeping, 225 enforcement, laminated products, and products containing de minimis amounts of 226 composite wood. 227***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 11 of 101 [RIN 2070-AJ44] This proposed rule establishes a framew ork for a TSCA Title VI Third-Party 228 Certification Program to help ensure that regulated composite wood products consistently 229 meet the TSCA Title VI formaldehyde emi ssion standards. EPA will issue a separate 230 proposed rule at a later date that includes the rest of the TSCA Title VI implementing 231 regulations. That separate propos ed rule will include specific testing responsibilities of 232
TPCs. 233
2. The CARB ATCM . The CARB ATCM establishes emission standards for 234 composite wood products sold, offered for sale , supplied, used, or manufactured for sale 235 in California (Ref. 6 7 ). It includes requirements for manufacturers of composite wood 236 products, distributors, importers, fabricators, retailers, and TP Cs with provisions on sell237 through dates, labeling, recordk eeping, testing, and cer tification. It also includes special 238 provisions for manufacturers of composite wood products with ULEF and NAF resins. 239 Under the CARB ATCM, manufacturers of co mposite wood products must have their 240 compliance with the emission standards certified by a TPC approved by CARB (Ref. 7 8 ). 241 The CARB ATCM defines a third-party certif ier as “an organization or entity approved 242 by the Executive Officer that: (A) verifies th e accuracy of the emission test procedures 243 and facilities used by manufacturers to conduct formaldehyde emission tests, (B) 244 monitors manufacturer quality assurance and quality control programs, and (C) provides 245 independent audits and inspections.” In order to become a CARB approved TPC, 246 prospective certifiers must submit an a pplication to the CARB Executive Officer 247 containing: 248 a. Evidence of actual field experience in the verificati on of laboratories and wood 249 products, to demonstrate how th e applicant will be able to competently perform the TPC 250***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 12 of 101 [RIN 2070-AJ44] requirements under the CARB ATCM. 251 b. Evidence of the ability to properl y train and supervise inspectors. 252 c. Evidence of a current “product accre ditation body” accreditation issued by a 253 signatory to the Internati onal Laboratory Accreditati on Cooperation (ILAC) Mutual 254 Recognition Arrangement (MRA). 255 d. A list of the composite wood products th at the applicant is applying to verify 256 and evidence that the applicant is qualified to verify these products (Ref. 8 9 ). 257 If the TPC’s application is approved, the CARB Executive Officer issues a CARB 258 Executive Order with a duration of 2 years. Upon the expiration date of the CARB 259 Executive Order, a TPC may apply for re-accreditation by submitting an updated 260 application. The CARB Executive Officer ma y, “for good cause,” modify or revoke a 261 CARB Executive Order approvi ng a TPC after giving the TPC the opportunity for a 262 hearing. 263 Under the CARB ATCM, CARB approved TP Cs are required to verify that 264 composite wood product manufacturers are co mplying with the quality assurance and 265 quality control requirements, verify formal dehyde emission test results, work with 266 manufacturers to establish quality contro l limits for each product type and production 267 line, provide independent inspections and a udits of manufacturers and records, use 268 laboratories that are certified by an AB that is a signatory to the ILAC MRA, maintain 269 records for 2 years; and provi de an annual report to CARB . CARB maintains a list of 270 approved TPCs on its website (Ref. 7 8 ). The annual report must include: 271***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 13 of 101 [RIN 2070-AJ44] • A list of manufacturers certified by th e TPC during the previous calendar year, 272 including the resins used by the manuf acturers and the average and range of 273 formaldehyde emissions. 274 • A list of any non-complying events by manufacturers. 275 • Certified laboratories and primary or secondary test methods utilized by the 276
TPC. 277 • Results of inter-laborator y testing comparisons for la boratories used by the TPC. 278
3. Recent activities related to this proposed rule

. In On March 24, 2008, the Sierra 279 Club and numerous other 25 organizations and approximately 5,000 individuals petitioned 280 EPA under TSCA section 21 . The petitioners requested that EPA of TSCA to use TSCA 281 its authority under section 6 of TSCA to adopt nationally the CARB ATCM nationally 282 (Ref. 10). The petitioners asked EPA to assess and reduce the risks posed by 283 formaldehyde emission standards for composite wood products (i.e., emitted from 284 hardwood plywood, particleboard, an d medium-density fiberboard ) (Ref. 9). by 285 exercising its authority unde r TSCA section 6 to adopt and apply nationwide the CARB 286 formaldehyde emissions regulation for thes e composite wood products. In addition, 287 petitioners requested EPA to extend this re gulation to include composite wood products 288 used in manufactured homes. The petitioners expressed part icular concern over the levels 289 of formaldehyde found in emergency housing pr ovided for persons displaced from their 290 homes by Hurricane Katrina and noted th at there are no Federal regulations on 291 formaldehyde emissions from composite wood products other than the Department of 292 Housing and Urban Development’s (HUD) re gulations for manufactured housing at 24 293
CFR 3280.308. In response to the petition, EPA announced in the Federal Register on 294***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 14 of 101 [RIN 2070-AJ44] June 27, 2008 , that EPA would 295 On June 27, 2008, EPA issued a Federal Register notice explaining the Agency’s 296 decision to grant in part and deny in part the petitioners’ re quest (Ref. 11). EPA denied 297 the petitioners’ request to im mediately pursue a TSCA section 6 rulemaking, stating that 298 the available information at the time was insufficient to support an evaluation of whether 299 formaldehyde emitted from hardwood plywood, particleboard, and medium-density 300 fiberboard presents or will present an unr easonable risk to human health (including 301 cancer and non-cancer endpoints) under TSCA section 6. As di scussed in detail in the 302 Federal Register notice announcing EPA’s response to the petition, EPA’s evaluation of 303 the data provided by the petitioners revealed significant information gaps that would have 304 needed to be filled to support an evaluati on of whether use of formaldehyde in these 305 products presents or will present an unreas onable risk under TSCA section 6. However, 306 EPA did agree to initiate a proceeding to investigate whether and what type of regulatory 307 or other action might be appropr iate to protect against risks that may be posed by 308 formaldehyde emitted from pressed wood products (Ref. 10 ). In the Federal Register o f 309 December 3, 2008, EPA published an Advance Notice of Proposed Rulemaking (ANPR) 310 to publicly initiate the in vestigation and obtain stak eholder input (Ref. 11).

. 311
E Accordingly, on December 3, 2008, EPA issu ed an Advance Notice of Proposed 312 Rulemaking (ANPR) that announced EPA’s in tention to investigate whether and what 313 regulatory or other action mi ght be appropriate to prot ect against risks posed by 314 formaldehyde emitted from the products cove red by the CARB ATCM as well as other 315 pressed wood products (Ref 12). To help inform EPA’s decision on the best ways to 316 address risks posed by formaldehyde emissions from pressed wood products, the Agency 317***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 15 of 101 [RIN 2070-AJ44] requested public comments and held six half -day public meetings in Research Triangle 318 Park, NC; Portland, OR; Chicago, IL; Dallas, TX; Washington, DC; and New Orleans, 319 LA. EPA received and reviewed co mments submitted during the ANPR comment 320 period which can be found at regulati ons.gov under docket number EPA-HQ-OPPT321
2008-0627. 322
F . Objectives of the Framework for th e Third-Party Certification Program 323 EPA believes that the TSCA Title VI Thir d-Party Certification Program must be 324 impartial and applicable uniformly to both domestically manufactured and imported 325 composite wood products. composite wood products “sold, supplied, offered for sale, or 326 manufactured in the United States” regardless of origin, whether domestic or 327 international. TSCA section 601(b)(1). This proposed rule aims to ensure that these 328 objectives are met, along with ensuring th e consistent application of the TPC 329 requirements of TSCA Title VI, by requiring the use of voluntary consensus standards for 330 the TSCA Title VI Third-Party Certification Program, and by leveraging the expertise of 331 international ABs. Additionally, this proposed rule is intended to be as consistent as 332 practicable with the TPC re quirements under the CARB ATCM

. By aligning itself with 333 the existing CARB ATCM requirements, EP A seeks to avoid differing or duplicative 334 regulatory requirements that would result in an increas ed burden on the regulated 335 community. 336 Qualified and experienced TPCs are e ssential to ensuring that domestic and 337 foreign panel producers supplying products to the United States have quality assurance 338 and quality control procedures, are having their products tested to determine that they are 339 compliant with formaldehyde emissions sta ndards, and are otherwise acting in manner 340***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 16 of 101 [RIN 2070-AJ44] that is consistent with the requirement s of TSCA Title VI. The TSCA Title VI 341 formaldehyde emissions standards apply to hardwood plywood, particleboard, and 342 medium-density fiberboard sold, supplied, o ffered for sale, or manufactured (including 343 imported) in the United States. Because TSCA defines “manufacture” to include “import 344 into the customs territory of the United States ” the standards are applicable regardless of 345 whether the composite wood product is manuf actured domestically or imported from 346 abroad. 347 There are a substantial number of pane l producers and TPCs that operate solely 348 outside of the United States. Currently, 27 of the 36 CARB-approved TPCs are based 349 outside the United States (Ref. 7 8 ). To ensure that oversight of TPCs is as strong abroad 350 as it is domestically, EPA believes a TSCA T itle VI Third-Party Certification Program 351 framework should include internationally opera ting ABs to overcome potential logistical 352 limitations that may hinder regular and rigorous inspection of TPCs operating outside the 353 United States. Many ABs have a global reac h, preexisting infrastructure, and experience 354 working in foreign countries, which EPA be lieves makes them ideal for evaluating the 355 qualifications of TPC candidates. Under EP A’s proposed TSCA Title VI Third-Party 356 Certification Program framework, ABs woul d review, accredit, oversee, audit, and 357 inspect both domestic and foreign TPCs--activi ties that would enable EPA to ensure the 358 legitimacy of both TPCs and panel producers inthe United States and abroad. The ABs’ 359 oversight and auditing functions verify th at TPCs are fulfilling their regulatory 360 obligations uniformly across the global mark etplace. EPA would reta in its statutorily 361 delegated roles in program design, establ ishing the standards, enforcement, and 362 oversight; and utilize ABs to st rengthen performance of TPCs. 363***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 17 of 101 [RIN 2070-AJ44] F G . What Background Information was Used to Develop the Framework for a Third364 Party Certification Program? 365 366 Effective and successful implementation of EPA’s TSCA Title VI Third-Party 367 Certification Program requires that pane l producers have in place formaldehyde 368 emissions testing programs and quality assurance and quality control programs for 369 product manufacturing. To achieve these outcome s, EPA is proposing to require the use 370 of voluntary consensus standards for those part icipating as a TPC in the TSCA Title VI 371 Third-Party Certification Program. In deve loping this proposed rule, EPA reviewed 372 established voluntary consensu s standards that are reliedon by industries around the 373 world as a means of ensuring the competency of third-parties in particular fields of 374 technical activity such as testing, instrument calibration, and product performance 375 certification. In addition to reviewing ex isting voluntary consensus standards, EPA 376 reviewed other successful third-party certifi cation programs that us e voluntary consensus 377 standards to determine if such programs could be used as models for the TSCA Title VI 378 Third-Party Certification Program. 379 Third-party certification involves a process by which a product, process, or 380 service is reviewed by a reputab le and qualified independent th ird-party to verify that a 381 set of norms, criteria, claims, practices, or standards are being met. Third-party 382 certification has been widely and successfully used for decades by a number of industries 383 such as engineering, electronics, energy, so ftware, automotive, and food and consumer 384 products. The standards used in third-party certification are typically voluntary consensus 385 standards developed by nationa lly or internationally r ecognized standards-producing 386 organizations or industry groups. Voluntar y consensus standards establish uniform 387 engineering or technical crit eria, methods, processes, and practices for an industry 388***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 18 of 101 [RIN 2070-AJ44] practice or product, and are developed by expe rts in the relevant field through a process 389 that allows input by all persons interested a nd affected by the scope or provisions of the 390 standard. Parties in that industry then c hoose to accept and voluntarily abide by the 391 consensus standards. Otherwise, the existe nce of multiple and non-harmonized standards 392 for similar products, processes, and services in different countries or regions can create 393 barriers to trade. 394
1. Voluntary consensus standards . In order for EPA to ensu re that the Third-Party 395 Certification Program under TSCA Title VI is effective in ensuring compliance with the 396 emission standards, impartial in its operat ions, and applicable both domestically and 397 internationally, the Agency proposes requiri ng the use of voluntary consensus standards 398 as the basis for operating the TSCA Title VI Third-Party Certification Program. EPA 399 specifically proposes using In ternational Organization for Standardization (ISO) and 400 International Electrotechnical Commission (IEC) voluntary consensus standards and 401 guides as general requirements for third-part y certifications. In addition to industry 402 experts, international orga nizations--both governmental and non-governmental--work in 403 cooperation with ISO and IEC to develop thei r consensus standards. In the field of 404 conformity assessment, the ISO Committ ee on Conformity Assessment (CASCO) is 405 responsible for the development of international standards and guides. 406 The appropriate ISO/IEC standards and guide that EPA proposes requiring are: 407 • ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 408 Product Certification Systems. This is the inte rnational voluntary cons ensus standard that 409 specifies general requirements for a third-pa rty operating a product certification program 410 (Ref. 12 13 ). These general requirements would he lp ensure that the TPC is competent 411***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 19 of 101 [RIN 2070-AJ44] and reliable in certifying co mpliant composite wood products. 412 • ISO/IEC 17011:2004(E), Conformity A ssessments--General Requirements for 413 Accreditation Bodies Accrediting Conform ity Assessment Bodies. This international 414 voluntary consensus standard offers the general requirements for ABs assessing and 415 accrediting conformity assessment bodies (CABs). It is also appropriate as a requirement 416 document for the peer evaluation process fo r mutual recognition arrangements between 417 ABs (Ref. 13 14 ). These general requirements woul d help ensure that the ABs are 418 competent and reliable in accrediting TPCs. 419 • ISO/IEC 17025:2005(E), General Require ments for the Competence of Testing 420 and Calibration Laboratories. This internati onal voluntary consensus standard specifies 421 the general requirements for competence in carrying out tests and/or calibrations, 422 including sampling (Ref. 1 4 15 ). EPA believes that requiring TPCs to use laboratories that 423 follow these requirements would help ensure th at reliable and accura te test results are 424 obtained. 425 • ISO/IEC 17020:1998(E), Gene ral Criteria for the Operat ion of Various Types of 426 Bodies Performing Inspections. This internat ional voluntary consensu s standard specifies 427 general criteria for the comp etence of impartial bodies performing inspection. It is 428 intended for use by inspection bodies a nd their accreditati on bodies (Ref. 15 16 ). 429 EPA believes that requiring TPCs to follo w these requirements would help ensure 430 greater homogeneity of the inspection pr ocess among the TPCs recognized by EPA. 431 The appropriate use of each guide and standard and a description of the party responsible 432 under the proposed TPC framework for ensu ring compliance with the standard are 433 detailed in Unit III. The use of the guide a nd standards furthers th e goal of the National 434***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 20 of 101 [RIN 2070-AJ44] Technology Transfer and Advancement Act (NTTAA), as discussed in Unit VI. These 435 ISO standards and guide will be made available for viewing in EPA’s reading room and, 436 during the public comment pe riod, online at [Placeholder]. 437
2 . International accred itation and inspection ov ersight organizations. In the 438 profession of conformity assessment (i.e., the process of ensu ring an organization 439 responsible for implementing a consensus st andard does so in conformance with the 440 standard) oversight of c onformity assessment bodies, such as TPCs, is done by 441 organizations known as ABs. An AB provi des an impartial verification of the 442 competency of conformity assessment bodies such as TPCs. The ABs themselves also 443 have oversight typically perf ormed by an association or cooperative of conformity 444 experts and other ABs through a peer evalua tion process. Because the proposed TPC 445 framework is international in scope and will employ the use of internationally accepted 446 consensus standards, EPA reviewed th e structure and functions of well known 447 international organizations that were estab lished decades ago to specifically provide 448 oversight of ABs. 449 The two international AB oversight bodies that EPA examined for this proposed 450 rule are the International Accreditation Foru m, Inc. (IAF) and ILAC. EPA believes that 451 using a system where an AB’s qualifications are verified by inte rnational oversight 452 bodies such as these and in which the ABs in turn assess the conf ormity of TPCs to 453 international voluntary consensus standards woul d ensure that the requirements of TSCA 454 Title VI are met. The specific details of how EPA proposes to leverage this system to 455 ensure compliance with the TSCA Title VI are detailed in Unit III. 456***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 21 of 101 [RIN 2070-AJ44] The IAF is an association of conform ity assessment bodies and other bodies. IAF 457 requires its member ABs to comply with appr opriate international conformity assessment 458 standards. The IAF Multilateral Recogniti on Arrangement (MLA) is an agreement 459 between AB members of the IAF whereby th e ABs conduct regular evaluations of each 460 other to assure the equivalence of their accreditation programs. This MLA agreement 461 allows companies with an accredited conform ity assessment certification in one part of 462 the world to have that certif ication recognized everywhere else in the world, thereby 463 facilitating international trade (Ref. 16 17 ). The MLA certification provides 464 documentation that a person or an organization has been accredited to a specific standard 465 or scheme by an IAF MLA signatory AB. In addition, IAF through its MLA ensures that 466 all ABs who are capable of accrediting product certification bodies, such as TPCs, are in 467 conformance with ISO/IEC Guide 65:1996(E). By requiring a TPC to be accredited to 468 ISO/IEC Guide 65:1996(E) by a qualified AB th at has an IAF endorsement through level 469 3 of the IAF Scope, or is a member of an equivalent oversight body, EPA believes that 470 the TPC will be in conformance with ISO/IEC Guide 65:1996(E), the voluntary 471 consensus standard used to ensure proper pr oduct certification. Level 3 of the IAF Scope 472 is the level of accreditation which needs to be accomplished by a Product AB under that 473 program to ensure that the Product AB is qualified to accredit the TPC. 474 The ILAC is an international coopera tion of laboratory and inspection ABs 475 formed to help remove technical barriers to trade. ABs around the world, which have 476 been evaluated by peers as competent, have signed an MRA that enhances the acceptance 477 of products and services acr oss national borders (Ref. 17 18 ). By requiring a TPC’s 478 emissions testing laboratory, or it s contract laboratory, to be a ccredited by an AB that is a 479***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 22 of 101 [RIN 2070-AJ44] signatory to the ILAC MRA or equivalent oversight body , EPA believes that there will be 480 a greater assurance of compliance with ISO/IEC 17025:2005(E), the voluntary consensus 481 standard that is critical to ensuring adequa te verification of performance for TSCA Title 482 VI required laboratory form aldehyde emissions testing. 483
3. Other third-party certificati on programs that were evaluated

. As mentioned in 484 Unit II. E F ., EPA aims to develop a TSCA Title VI Third-Party Certification Program that 485 incorporates lessons learned from other third-party certific ation programs. In addition, 486 EPA is particularly interested in harmonizing, to the extent practicable, with the CARB’s 487 third-party certification program to a void differing or duplicative regulatory 488 requirements. 489 In developing the TSCA Title VI Third- Party Certification Program framework as 490 presented in this proposed rule, EPA starte d with a review of CARB’s program, as 491 described in Unit II. D E . This included meeting with CARB, the composite wood 492 industry, and CARB-approved TPCs. 493 EPA also reviewed other EPA and Federal programs that have elements relevant 494 to EPA’s goals for this proposed program, such as the use of voluntary consensus 495 standards and/or a third-pa rty product certification pro cess. The following EPA and 496 Federal programs were reviewed during de velopment of the proposed TSCA Title VI 497 Third-Party Certificatio n Program framework: 498

a. National Lead Laboratory Accreditation Program . EPA established the 499 National Lead Laboratory Accreditation Program (NLLAP) in 1992, to provide protocols, 500 criteria, and minimum performance standards for analysis of lead in paint, dust, and soil, 501 as required under TSCA section 405 (Ref. 18 19 ). Section 405 of TSCA further directs 502***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 23 of 101 [RIN 2070-AJ44] EPA, in consultation with the Department of Health and Human Services (HHS), to 503 develop a program to certify qualified lead te sting laboratories. The NLLAP provides the 504 public with a list of qualified laboratories th at have met EPA criter ia and demonstrated 505 the capability to accurately analyze paint chip, dust, and soil samples for lead. EPA 506 ensures that laboratories comply with thes e EPA criteria by having them evaluated and 507 accredited by third-party laboratory ABs according to ISO/IEC performance consensus 508 standards. In order to assure the public that a Laboratory AB is capable of performing an 509 adequate assessment of participating labor atories, EPA enters into a recognition 510 agreement with the AB in recognition of its capability to perform adequate laboratory 511

assessments. 512 For a laboratory to qualify for recognition under the NLLAP, it must pass on-site 513 audits conducted by one of the four labor atory ABs with which EPA has a recognition 514 agreement. The Laboratory ABs recognize N LLAP laboratories in conformance with 515 ISO/IEC 17025:2005(E). Laboratories recogn ized under the NLLAP must also 516 successfully perform, on a continuing basi s, in the Environmen tal Lead Proficiency 517 Analytical Testing (ELPAT) Pr ogram. The ELPAT is a profic iency testing program that 518 is designed to evaluate the analytical performance of laboratories by providing the 519 laboratory with standardized test samples on a quarterly basis and ev aluating their results 520 against consensus results from a set of reference laboratories. 521 The NLLAP has successfully demonstratedover the years that EPA recognized 522 laboratories are capable of accura tely analyzing for lead in pa int chips, dust wipes, and 523 soil samples. Therefore, EPA believes thatthe third-party processes employed by the 524 NLLAP, which include the use of third-party laboratory ABs th at accredit laboratories by 525***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 24 of 101 [RIN 2070-AJ44] using voluntary consensus standards, along w ith additional specified laboratory testing 526 protocols, demonstrate that a similar thir d-party certification pr ogram can be used 527 successfully under TSCA Title VI. 528 b. National Voluntary Conformity A ssessment System Evaluation Program

. 529 Another program that EPA reviewed is th e National Voluntary Conformity Assessment 530 System Evaluation (NVCASE) Program at the Department of Commerce’s National 531 Institute of Standards and Technology (NIS T). NIST, through its Standards Services 532 Division, offers this voluntary program to evaluate and recognize organizations which 533 support third-party conformity assessment activities. The NVCASE Program includes 534 activities related to third-party laboratory testing, third-party pr oduct certification, and 535 quality system registration. After an NVCASE Program evaluation, NIST provides 536 recognition to qualified U.S. or ganizations that effectively demonstrate conformance with 537 established criteria. The ultimate goal is to help U.S. manufacturers satisfy applicable 538 product requirements mandated by foreign or U.S. regulatory authorities through 539 conformity assessment procedures. Under the NVCASE Program, NIST accepts requests 540 from only domestic TPCs for domestic and in ternational accreditation. The use of NIST’s 541 NVCASE Program in the United States would si gnificantly hamper the ability of foreign 542 TPC candidates to receive and maintain accr editation and would notallow EPA to meet 543 its goal of providing testing and certification and auditing and reporting of all TPCs, 544 domestic as well as international. 545

c. Other EPA programs. EPA also considered the product ce rtification 546 components of EPA’s WaterSens e and Energy Star programs. WaterSense is an EPA547 sponsored partnership program launched in 2006 that seeks to protect the future of our 548***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 25 of 101 [RIN 2070-AJ44] nation's water supply by promoting water effi ciency and enhancing the market for water549 efficient products, programs, and practic es. WaterSense helps consumers identify 550 products and programs that meet WaterSense water efficiency and performance criteria. 551 Energy Star is a joint program of the EPA and the U.S. Department of Energy (DOE) 552 designed to help the consumers save money and protect the envir onment through the use 553 of energy efficient products and practices . In 1992, EPA introduced Energy Star as a 554 voluntary labeling program designed to identif y and promote energy-efficient products to 555 reduce greenhouse gas emissions. 556 Both the WaterSense and Energy Star certification programs specify the minimum 557 criteria that EPA licensed product ABs must observe when certifying product 558 conformance to specifications and when aut horizing the use of the program’s labels. 559 These programs provide specific criteria for the application of ISO/IEC Guide 560 65:1996(E) in order to satisfy th e criteria for certification of Energy Star and WaterSense 561 products. They also provide the basis for c onsistent application of voluntary consensus 562 standards by licensed ABs. The ISO/IEC Guid e 65:1996(E) has been successfully used in 563 these two programs for auditing, certifying, and reporting of the status of certification. 564 The Energy Star and WaterSense programs ’ use of ABs who certify under voluntary 565 consensus standards for product certification al so demonstrates the u tility and workability 566 of this approach. 567 Each of the aforementioned program s informed EPA’s decision on how to 568 develop an appropriate and credible third-party certification program for TSCA Title VI. 569 EPA is proposing a framework under TSCA Title VI that incorporates elements of the 570 CARB third-party certificati on program, the use of recognition agreements with ABs 571***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 26 of 101 [RIN 2070-AJ44] (e.g., as in NLAAP), and a product certification system element such as those used in the 572 WaterSense and Energy Star programs. 573 III. What Does this Proposed Rule Do? 574 575***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 27 of 101 [RIN 2070-AJ44] Illustration 1: TSCA Tile VI Proposed Third-Party Certification Framework 576 577 International Standards 578 Organizations 579 Develop consensus-ba sed international 580 standards for quality management 581 and conformity assessment 582 583 584 International Standards Bodies 585 Ensure competency of Accrediting Accreditation 586 Bodies and their conformance with 587 international standards 588

 Ensures AB conformance to 589 ISO/IEC 17011 1 590

 Ensure ABs are qualified to oversee 591 TPC conformance to ISO/IEC Guide 65 592 ISO/IEC17020 and/or ISO/IEC 17025 593 594 595 Accrediting Accreditation Bodies 596 Ensure competency of TPCs; verify accuracy 597 of emission test procedures, monitor TPC 598 quality assurance programs, audit and inspect 599 TPCs. 600

 Management systems conform to 601 ISO/IEC 17011 602

 Ensure TPC conformance to 603 applicable ISO/IEC Guide & Standards 604 605 606 Third-Party Certifiers 607 Ensure that panel producers are in 608 compliance with statutory 609 formaldehyde emission standards 610

 Management systems conform to 611 ISO/IEC Guide 65 612

 Conform to applicable ISO/IEC 613 Guide & Standards for 614 Product & Laboratory Certification 615 and Inspections 616 617 Composite Wood 618 Panel Producers 619 620 1 ISO/IEC 17011:2004(E) – Conformity Asse ssments--General Requirements for Accreditation Bodi es Accrediting 621 Conformity Assessment Bodies. 622 2 MLA – IAF’s Multilateral Recognition Arrangement requires AB signatories to demonstrate they are capable of 623 accrediting product certification bodies in conformance with ISO/IEC Guide 65:1996(E) – General Requirements for 624 Bodies Operating Product Certification Systems and ISO/IEC 17020:1998(E) – Gene ral Criteria for the Operation of 625 Various Types of Bodies Performing Inspections. 626 3 MRA – ILAC’s Mutual Recognition Arrangement requires AB signatories to demonstrate they are capable of 627 accrediting testing laboratories in conformance with ISO/IEC 17025:2005(E) – General Requirements for the 628 Competence of Testing and Calibration Laboratories. 629 630 International Organization for Standardization (ISO) International Electrotechnical Commission (IEC)

International Accreditation Forum, Inc (IAF) or equivalent organization

 Ensures AB conformance to ISO/IEC 17011 1

 Require member ABs to be a signatory to MLA 2 International Laboratory Accreditation Cooperation (ILAC) or equivalent organization

 Ensures AB conformance to ISO/IEC 17011 1

 Require member ABs to be a signatory to MRA 3

TPC #2 Accredited by AB #3 TPC #1 Accredited by AB #1 & AB #2

Mfg #4 Product Certified by TPC #2 Mfg #3 Product Certified by TPC #2 Mfg #2 Product Certified by TPC #1 Mfg #1 Product Certified by TPC #1 AB Type #3 Product & Lab Accreditation Body

 Recognition agreement with EPA

 Signatory to IAF MLA and ILAC MRA or equivalents

 Ensure TPC conformance to ISO/IEC Guide 65, ISO/IEC 17020 & ISO/IEC 17025 AB Type #2 Laboratory Accreditation Body

 Recognition agreement with EPA

 Signatory to ILAC MRA or equivalent

 Ensure TPC conformance to ISO/IEC 17025 AB Type #1

Product Accreditation Body

 Recognition agreement with EPA

 Signatory to IAF MLA or equivalent

 Ensure TPC conformance to ISO/IEC Guide 65 & ISO/IEC 17020***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 28 of 101 [RIN 2070-AJ44] EPA is proposing a framework which it be lieves would enable implementation of 631 a credible third-party certification program that ensures that TPCs are impartial and 632 operate at the highest standards of compet ence. Although EPA’s proposed TSCA Title VI 633 Third-Party Certification Program framework, including the underlying requirements and 634 implementation process, are based on, orare the same as, CARB’s third-party 635 certification program, EPA is proposing to al so use qualified, intern ationally recognized 636 ABs in implementing the program to establis h a globally uniform process. Under EPA’s 637 proposed TSCA Title VI Third-Party Certif ication Program framework, ABs, recognized 638 by EPA through recognition agreements, would accredit TPCs based on the requirements 639 for TPCs established by EPA through this proposed rule. Like CARB, EPA would 640 require that TPCs provide evidence of competency in four key areas: 641 • Experience and ability to verify th e accuracy of formaldehyde emission testing 642 of composite wood products. 643 • Experience in the com posite wood product industry. 644 • Ability to monitor panel producer quali ty assurance programs for composite 645 wood products. 646 • Ability to conduct auditing and inspec tion of panel producer activities and 647 products. 648 However, unlike the CARB system, under whic h CARB evaluates and accredits TPCs 649 without the input of ABs, AB s would conduct the evaluation and determine if the TPCs 650 are competent in these four areas. Based on th e results of ABs’ evaluations that would be 651 conducted according to EPA’s requirements, including the standards for ABs in ISO/IEC 652 Guide 65:1996(E) (which includes inspecti on accreditation based on compliance with 653***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 29 of 101 [RIN 2070-AJ44] ISO/IEC 17020:1998(E)) and laboratory acc reditation based on compliance with 654 ISO/IEC 17025:2005(E), the ABs would accredit TP Cs that meet the requirements. The 655 ABs would also be required to particip ate in oversight ac tivities, including 656 recordkeeping, reporting to EPA, and auditing of TSCA Title VI accredited TPCs and 657 their formaldehyde emissions testing laborat ories. EPA would exercise authority to 658 conduct independent oversight and actions, including the authority to review the 659 determinations of ABs, and approve or re voke a TPC’s TSCA Title VI accreditations 660 based on the criteria laid out in this proposed rule. 661 While the AB component of EPA’s proposed TSCA Title VI Third-Party 662 Certification Program framework differs from the CARB program, EPA believes it will 663 enhance the implementation of TSCA Title VI . The proposed TSCA Title VI Third-Party 664 Certification Program framework is otherwis e generally consistent with CARB’s current 665 third-party certification program requirement s. Furthermore, EPA will work with CARB 666 to help promote compatibility and consistency within the programs

. and to harmonize the 667 third-party certification pr ograms wherever practicable. EPA believes that compliance 668 with the proposed the TSCA Title VI Th ird-Party Certification Program would not 669 require substantial changes to procedures TPCs, laboratories, and panel producers 670 currently use to conduct their TPC ac tivities under the CARB ATCM (Ref. 6 7 ). 671 A. Requirements for Accreditation Bodies 672 Based on EPA’s understanding of how th e international c onsensus standards 673 oversight industry is structured, EPA envisions that two types of ABs could be involved 674 in implementation of the proposed TPC framew ork. The first type of AB is the “Product 675 AB.” The Product AB would be responsible for accrediting the TPCs, recordkeeping and 676***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 30 of 101 [RIN 2070-AJ44] ensuring that a TPC is in conforman ce with ISO/IEC Guide 65:1996(E) (involving 677 product certification systems) and ISO/IE C 17020:1998(E) (involving ge neral criteria for 678 inspections). The second type of AB is the “Laboratory AB.” The Laboratory AB would 679 be responsible for ensuring that the TPC’s formaldehyde emissions testing laboratory (or 680 its contracted laboratory) is of the highest quality and is in conf ormance with ISO/IEC 681 17025:2005(E) (involving the gene ral requirements for labor atories conducting testing 682 and/or calibrations, including sampling and calibration). EPA recognizes it is also 683 possible that a single AB may have the abil ity to accredit both pr oduct certification and 684 emissions testing, and therefore can accredit conformance to ISO/IEC Guide 65:1996(E), 685 ISO/IEC 17020:1998(E), and ISO/IEC 17025:2005(E). In such cases, a single AB would 686 be considered qualified to accredit TPCs for their product certification capabilities and 687 also accredit the TPC laboratories for conducting formaldehyde emissions testing, and 688 only that AB would need to be involved in accepting and reviewing TPC applications and 689 implementing the ABs’ roles under the proposed TSCA Title VI Third-Party Certification 690 Program framework. 691
1. Necessary qualifications of ABs to be candidates fo r participation in the EPA’s 692 Title VI Third-Party Certification Program -- a. Necessary qualifications of Product ABs

. 693 To ensure that Product ABs are qualified to accredit TPC’s for conformance with 694 ISO/IEC Guide 65:1996(E) and ISO/IEC 17020: 1998(E), the Product AB would have to 695 be a signatory to the IAF MLA, or a memb er of an equivalent oversight body. AB 696 members of IAF are admitted to the IAF MLA only after a highly st ringent evaluation of 697 their operations by an IAF peer evaluation team which is charged w ith ensuring that the 698 applicant member complies fully with bot h the international standards and IAF 699***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 31 of 101 [RIN 2070-AJ44] requirements

. Additionally, once an AB is a signatory to the IAF MLA, it is required to 700 recognize the certificates issuedby conformity assessment bodi es accredited by all other 701 signatories of the IAF MLA, with the appr opriate scope (i.e., le vels 1 through 3). The 702 IAF MLA structure has 5 levels, and EPA w ould require the Product AB to be endorsed 703 by IAF through level 3. Level 1 endorsement ensu res that an AB is in conformity with 704 ISO/IEC 17011:2004(E) and maintains that confor mity; level 2 endorsement ensures that 705 the AB has demonstrated basic competence to perform accreditation ac tivities for product 706 certification according to ISO/IEC Guid e 65:1996(E) and ISO/IEC 17020:1998(E); and 707 level 3 ensures that the AB has policies and pr ocedures in place in their operations and 708 management plans to accredit a TPC for product certification in conformance with 709 ISO/IEC Guide 65:1996(E). In order to partic ipate in the TSCA Title VI Third-Party 710 Certification Program, a Product AB would have to provide EPA with documentation 711 verifying its IAF endorsement th at states the level of accred itation the AB received from 712 IAF, or with confirmation that the AB is a me mber of an equivalent organization with an 713 equivalent scope. 714 b. Necessary qualifications of Laboratory ABs . To ensure that the Laboratory 715 ABs are qualified to accredit TPC laborato ries, the proposed TPC framework would 716 require that the Laboratory AB is a signatory to the ILAC MRA, or a member of an 717 equivalent organization. To be a signatory to the ILAC MRA, an AB must pass an 718 intensive evaluation carried out by peers and in accordance with the relevant rules and 719 procedures contained in several ILAC public ations. Once a signatory to the ILAC MRA, 720 each Laboratory AB agrees to abide by its terms and conditions, and according to the 721 ILAC evaluation procedures shall: 722***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 32 of 101 [RIN 2070-AJ44] i. Maintain conformance with the ISO/IEC 17011:2004(E), related ILAC 723 guidance documents, and any ILAC supplementary requirements. 724 ii. Ensure that all laboratories th at they accredit comply with ISO/IEC 725 17025:2005(E) and related ILAC po licy and guidance documents. 726 Under the proposed TPC framework, a TPC would be required to work with its 727 Laboratory AB to provide th e Product AB with documentation verifying the Laboratory 728 AB’s endorsement and scope of accredita tion from ILAC, or documentation of 729 membership in an equivalent organization. 730 EPA understands that not all ABs are si gnatories to either IAF or ILAC. EPA 731 requests comment on what other oversight bodies or other orga nizations are equivalent to 732 IAF and ILAC. An equivalent organizati on would provide a pro cess of review and 733 evaluation with a level of scru tiny and assessment of an AB’s capabilities to ensure that 734 an AB is qualified to accredited organizati ons based on the relevant ISO/IEC standards 735 and guide. 736
2. Recognition agreement process and relationship between EPA and ABs. Under 737 this proposed rule, the Product ABs and Laboratory ABs that are interested in 738 participating in the TSCA Title VI Third-Party Certification Program would be required 739 to submit an application to EPA to be formally recognized by EPA. Once EPA has 740 reviewed the AB’s cr edentials and deemed that the AB is qualified, EPA proposes to 741 enter into a recognition agreement with Produc t and Laboratory ABs th at want to offer 742 services to accredit TPCs according to EP A’s requirements. The recognition agreement 743 would serve as a mechanism for EPA to form ally recognize either a Product AB or a 744 Laboratory AB (or both) as qualified to im plement their respective roles under the TSCA 745***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 33 of 101 [RIN 2070-AJ44] Title VI program. The recognition agreement w ith the Product AB would designate it as 746 the recipient of applications from candidate TPCs that want to participate in the TSCA 747 Title VI Third-Party Certification Program. As discussed in Unit II. F G .3., similar 748 recognition agreement approaches have been successfully used in a number of EPA 749 programs. The recognition agreement is a signed agreement between EPA and each 750 Product AB or Laboratory AB that would state: 751 a. The regulatory requirements that have b een and must continue to be met to be 752 an EPA recognized AB. 753 b. The roles and responsibili ties of the AB under the TSCA Title VI Third-Party 754 Certification Program. 755 c. EPA’s role and interactions with the AB during implementation of the TSCA 756 Title VI Third-Party Certification Program. 757 d. Criteria and processes for revoking th e recognition agreemen t if either the 758 Product AB or Laboratory AB fails to adhere to the conditions of the regulations. 759 All of the requirements and act ions stated in the recogniti on agreement between EPA and 760 each type of AB would be derived from the fi nal rule requirements. If the AB applying to 761 EPA for recognition is qualified to perform as both a Product AB and a Laboratory AB, 762 then that AB would include both sets of cred entials in its application package and would 763 be recognized by EPA in the recognition agreement as performing both accreditation 764 roles. The recognition agreement would be effective for 3 years, provided the AB 765 continues to meet all of th e regulatory requirements. Af ter 3 years, the recognition 766 agreement would be eligible for renewal. 767 In order to facilitate communication between EPA and ABs, EPA is proposing to 768***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 34 of 101 [RIN 2070-AJ44] require ABs to designate an agent in United St ates in their applications. Any information 769 provided by an AB or EPA to the designated ag ent would be equivale nt to providing that 770 information directly to the AB. The designa ted agent could not be a mailbox, answering 771 machine, or other service where the agent is not physically present. The agent would need 772 to be capable of accepting service of notices and processes made in administrative and 773 judicial proceedings. EPA be lieves requiring a designated ag ent in the United States 774 would help ensure compliance with the fo rmaldehyde emission standards by facilitating 775 the ability to enforce TSCA Title VI and its implementing regulations, which in turn 776 encourages the regulated entities to fulf ill their obligations under the statute and 777 regulations. EPA requests comment on this proposed requirement. 778 EPA would designate an EPA recognition agreement Implementation Officer as a 779 point of contact for ABs to consult with on implementation of the recognition agreement. 780 EPA would be responsible for directly notif ying participating ABs of changes in the 781 TSCA Title VI Third-Party Certification Pr ogram. EPA would maintain a public list of 782 all ABs with which EPA has a recognition agr eement. The list would be posted on EPA’s 783 website and regularly updated. 784
3. Proposed requirements once an AB is recognized. Once EPA has entered into a 785 recognition agreement with an AB, that AB becomes “recognized” by EPA as a Product 786 AB, Laboratory AB, or both. 787

a. Responsibilities of Product ABs in the TPC application process . The Product 788 AB’s key TSCA Title VI TPC applicati on review responsibilities would include: 789 i. Receiving and acting on TPC applicati ons for their participation in the TSCA 790 Title VI Third-Party Certification Program and thereby ensuring that the TPC is 791***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 35 of 101 [RIN 2070-AJ44] accredited to ISO/IEC Guide 65: 1996(E) and ISO/IEC 17020:1998(E). 792 ii. Transmitting copies of TPC applications and supporting documentation 793 requested in the application based on the TS CA Title VI implementing regulations to 794
EPA. 795 iii. Assigning the TPC a unique number. 796 b. General responsibilities of ABs after TPC accreditation into the TSCA Title VI 797 Third-Party Certification Program . The EPA recognized Product AB would be 798 responsible for: 799 i. Ensuring the TPC has a process in place to verify the accuracy of the 800 formaldehyde emission tests conducted by the TPC laboratory (incl uding any contract 801 laboratory that the TPC would use for form aldehyde testing under TSCA Title VI) and 802 the formaldehyde quality control tests conducte d by the producers of regulated composite 803 wood products. 804 ii. Ensuring the TPC has a process in place to monitor panel producer quality 805
assurance programs. 806 iii. Ensuring the TPC has a process in place to conduct independent audits and 807 inspections of panel producers and thei r quality control testing facilities. 808 vi. Conducting audits of TP Cs and their laboratories. 809 v. Recordkeeping. 810 The EPA recognized Laboratory ABs would be responsible for verifying that the 811 TPC laboratory is experienced and capable of conducting formaldehyde emissions tests 812 according to the requirements of TSCA Title VI and its implementing regulations. The 813 Laboratory ABs’ key respons ibilities would include: 814***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 36 of 101 [RIN 2070-AJ44] • Ensuring the laboratory’s conformance to the regulatory requirements, including 815 ISO/IEC 17025:2005(E). 816 • Verifying the accuracy of the formal dehyde emissions tests conducted by the 817 TPC laboratory through an inte r-laboratory comparison or proficiency testing program. 818 • Conducting audits of the laboratory. 819 • Recordkeeping. 820 EPA proposes to require TPCs to pa rticipate in an EPA recognized inter821 laboratory comparison program. If standard reference material is developed, EPA would 822 consider requiring TPCs to participate in an EPA recognized profic iency testing program. 823 In order to reduce duplicativ e requirements, EPA proposes that it would utilize the 824 preexisting CARB-administered inter-laborat ory comparison program to the extent 825 feasible. EPA requests comment on ways it mightintegrate with CARB's inter-laboratory 826 comparison program and on what criteria should be used to determine the adequacy of 827 performance. EPA also requests comment on how participating Laboratory ABs could 828 administer an inter-laboratory comparison prog ram or proficiency testing program for the 829 TPCs that it accredits. EPA would like information on the costs of such a program and 830 whether such an activity presents conflict of interest issues for Laboratory ABs. 831
4 . Revocation of EPA’s recognition of an AB. EPA is proposing that it may 832 suspend, revoke, or modify the recognition of an AB, if the AB is not complying with the 833 requirements promulgated for ABs under TSCA Title VI. If an AB is removed or 834 withdraws from the TSCA Title VI Third–Party Certification Program, that AB would be 835 responsible for promptly notifying EPA and all TPCs that receive its accreditation 836 services. If an AB is removed or withdr aws from the TSCA Title VI Third–Party 837***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 37 of 101 [RIN 2070-AJ44] Certification Program for reasons other than fraud or providing false or misleading 838 statements related to a particular TPC or TP Cs, or other than a re ason that implicates a 839 particular TPC or TPCs in a violation of TS CA Title VI or its implementing regulations, 840 EPA proposes to allow the TPCs that were accredited by that AB to have 365 days, or 841 180 days if less than 365 days were left on their 2 3 -year accreditation period, to be 842 accredited again by another EPA recognized AB . While it is seeking accreditation from 843 an alternate AB, a TPC would need to continue to comply with all other aspects of TSCA 844 Title VI and its implementing regulations, and the TPC would remain subject to 845 inspection by EPA. If an AB is rem oved from the TSCA Title VI Third-Party 846 Certification Program due to fraud or provi ding false or misleading statements with 847 respect to a particular TPC, or for any other reason that implicates a particular TPC in a 848 violation of TSCA Title VI or its implem enting regulations, that TPC would not be 849 allowed to provide any TSCA Title VI certif ication services until it has been accredited 850 by an alternate AB. Should this situation occur, EPA would provide notifications to the 851 affected TPCs at the time it commences fo rmal action against the AB. Any action EPA 852 would take against an AB would not preclud e an enforcement action against a TPC. EPA 853 believes it is appropriate to be more stri ngent in these situations because the AB’s 854 nonperformance or altered status under the recognition agreement may call into question 855 the legitimacy of the TPC’s underlying accr editation. EPA requests comment on whether 856 it has provided adequate time for a TPC to s eek an alternate AB’s accreditation under this 857 proposed rule. Issues related to the de-acc reditation of a TPC a nd the amount of time a 858 panel producer has to seek a new TPC are discussed in Unit III.B. 3 4

. 859 B. Requirements for Third-Party Ce rtifiers of Composite Wood Products 860***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 38 of 101 [RIN 2070-AJ44] 1. Requirements to apply for participation in the TSCA Title VI Third–Party 861 Certification Program . EPA is proposing that the TPC mu st apply to an EPA recognized 862 Product AB to certify composite wood products pursuant to TSCA Title VI. In its 863 application to an EPA recognized Product AB, the TPC would be required to demonstrate 864 experience and competency in certain areas that EPA believes are important in ensuring 865 the TPC’s ability to conduct audits, testing, and certificati on of composite wood products. 866 The application would be reviewed by the Product AB, who would provide EPA with a 867 copy of each application. TPC applications would provide information to document: 868 1. Experience in performing or verify ing formaldehyde emissions testing on 869 composite wood products. 870 2. That its laboratory or contract la boratory has been accredited by an EPA 871 recognized Laboratory AB in conf ormance with ISO/IEC 17025:2005(E). 872 3. The TPC laboratory’s or contract laboratory’s expe rience with test method 873 ASTM E 1333-96 (Reapproved 2002) (Ref. 19 20 ) or successor standards and experience 874 evaluating correlation between test methods. 875 4. Experience or ability in product cer tification and complying with ISO/IEC 876 Guide 65:1996(E). 877 5. Experience in the compos ite wood product industry. 878 6. The ability to inspect and properly tr ain and supervise inspectors according to 879 ISO/IEC 17020:1998(E). 880 The application would also specify whic h composite wood pro ducts the applicant 881 is applying to certify and evidence that the appl icant is qualified to certify these products. 882 EPA is proposing that TPCs would be requi red to renew their applications every 2 3 883***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 39 of 101 [RIN 2070-AJ44] years . EPA requests comment on the costs and be nefits of a 3-year renewal period as 884 compared to a 2-year renewal period (as under the CARB ATCM). The EPA also 885 requests comment on whether the proposed requirement for EPA-recognized ABs to 886 audit TPCs and laboratories used by TPCs ever y 2 years should be extended to every 3 887 years to align with the proposed 3-year TPC accreditation period

. 888 In order to facilitate co mmunication between EPA and TPCs, EPA is proposing to 889 require TPCs to designate an agent in United States in thei r applications. Any information 890 provided by an AB or EPA to the designated ag ent would be equivale nt to providing that 891 information directly to the TPC. The desi gnated agent could not be a mailbox, answering 892 machine, or other service where the agent is not physically present. The agent would need 893 to be capable of accepting service of notices and processes made in administrative and 894 judicial proceedings. EPA be lieves requiring a designated ag ent in the United States 895 would help ensure compliance with the emissi on standards by facili tating the ability to 896 enforce TSCA Title VI and its implementing regulations, which in turn encourages the 897 regulated entities to fulfill their obligati ons under the statute and regulations. EPA 898 requests comment on this proposed requirement. 899 Title VI of TSCA requires that comp liance with the formaldehyde emission 900 standards be measured by quarterly te sting using ASTM E1 333-96 (Reapproved 2002) 901 (Ref. 19 20 ) or under certain circumstances, AS TM D6007-02 (Reapproved 2008) (Ref. 902
20 21 ). For quality control testing, the st atute requires use of ASTM D6007-02 903 (Reapproved 2008), ASTM D5582-00 (Reapproved 2006) (Ref. 21 22 ), or other test 904 methods established by EPA through rulemaki ng. If a test method other than ASTM 905 E1333-96 (Reapproved 2002) is used for either quarterly testing or quality control 906***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 40 of 101 [RIN 2070-AJ44] testing, TSCA Title VI requires a demonstrat ion of equivalence by means established by 907 EPA. Therefore, EPA is proposing that a TPC laboratory or contract laboratory must 908 have experience with formaldehyde testi ng using ASTM E1333- 96 (Reapproved 2002) or 909 its successor standards as well as experien ce evaluating correlations between different 910 test methods. EPA intends to propose the mean s of showing test method equivalence in a 911 subsequent proposal with other implementati on provisions as required under TSCA Title 912
VI. 913 EPA is proposing to require that accred ited TPCs conduct the quarterly tests 914 required by TSCA Title VI. The statute requir es these tests to be performed using ASTM 915 E1333-96 (Reapproved 2002) or, under so me circumstances ASTM D6007-02 916 (Reapproved 2008). Section 601(d)(5) of TSCA allows EPA to subs titute, after public 917 notice and an opportunity for comment, a test method referenced in TSCA Title VI with 918 its successor version. The version of ASTM E1333-96 (R eapproved 2002) referenced in 919 TSCA Title VI is not the most current version. In this proposed rule, EPA is proposing to 920 incorporate the current version, ASTM E1333-10 (Ref. 22 23 ), into the testing 921 requirements in this proposed rule in place of ASTM E1333-96 (Reapproved 2002) 922 referenced in the statute. EPA notes that there are only relatively minor differences 923 between ASTM E1333-96 (Reapproved 2002) and ASTM E1333-10. For example, 924 referenced standards have been updated to cite the most recent version of the standards. 925 In addition, under Apparatus, Make-up Air , 6.1.2.2, a new requirement has been added, 926 specifying that the dry gas test meter or other airflow rate measuring device be 927 “permanently placed in the chamber air intake duct.” A new loading ratio was added for 928 “low density particleboard door core” and a note specifying that “Panel grades are 929***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 41 of 101 [RIN 2070-AJ44] defined in the ANSI standards referenced in 2.3.” Under 9.2 Conditioning , a note was 930 added stating “Test specimens with low levels of formaldehyde may absorb 931 formaldehyde from the air when the air form aldehyde content exceeds that of the text 932 [sic] specimen. Consideration should be taken to avoid such air cond itions during storage 933 and conditioning.” In addition, the following requirement was added: “Circulation of the 934 conditioning air shall be achieve d by fans that direct air flow horizontally in the direction 935 parallel to the primary surface of the test specimens.” Under Test Procedure for 936 Materials , 10.1.3, the following phrase was deleted: “as measured by a totalizing dry gas 937 meter permanently placed in the chamber air intake duct.” Under note 9, the following 938 clarifying phrase was added: “unless testing is extended and chamber concentrations in 939 air and emission rates are obtained for th e tested product at multiple chamber air 940 exchange rates or multiple product loading ratios, or both.” Under Report the Following 941 Information , 12.1.7, the following was added: “and th e air circulation conditions (for 942 example, air velocity or air exchange ra te.” Under (Nonmandatory Information) X1. 943 Reagents, Materials, and Equipment Found Su itable for Use, footnotes specifying where 944 apparatuses are available have been deleted. In addition, X1.3.2 Sulfuric Acid, has been 945 changed from “concentrated reagent grade. Nitrate concentration shall be less than 10 946 ppm.” to “ACS grade. Nitrate concentrati on shall be no greater than 0.2 ppm.” EPA 947 requests comment on whether ASTM E1333-10 s hould be incorporated into the testing 948 requirements under TSCA Title VI in pl ace of ASTM E1333-96 (Reapproved 2002). 949 EPA intends to propose the means of show ing test method equivalence for other 950 test methods as well as the number and fr equency of tests requi red to demonstrate 951 compliance with the formaldehyde emission st andards in a subse quent proposal along 952***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 42 of 101 [RIN 2070-AJ44] with the rest of the TSCA Title VI impleme nting regulations. EPA is proposing here that 953 TPC laboratories be responsible for conducting quarterly tests, verifying quality control 954 tests, and evaluating te st method equivalence. 955 EPA is proposing that TPCs must have e xperience operating or using laboratories 956 that follow ISO/IEC 17025:2005(E). This intern ational voluntary consensus standard 957 specifies the general requirements for th e competence to carry out tests and/or 958 calibrations, including sampling. EPA believes that requiring TPCs to use laboratories 959 that follow these requirements would help ensure that reliable and accurate test results are 960 obtained. 961 EPA is proposing that TPCs must ha ve experience or ability in product 962 certification and in complying with IS O/IEC Guide 65:1996(E) because certifying 963 compliant composite wood products would be one of the main functi ons of a TSCA Title 964 VI accredited TPC. ISO/IEC Guide 65:1996(E) is an international voluntary consensus 965 standard that specifies ge neral requirements for a th ird-party operating a product 966 certification system. These general requireme nts would help ensure that the TPC is 967 competent and reliable in certifyi ng compliant composite wood products. 968 EPA is proposing that the TPC must have experience in conducting inspections of 969 the manufacturers in conformity withISO/IEC 17020:1998(E). This international 970 voluntary consensus standard specifies genera l criteria for the operation of various types 971 of bodies performing inspections. EPA is also proposing that TPCs mu st have the ability 972 to properly train and supervise inspectors pursuant to conformity with ISO/IEC 973 17020:1998(E). Inspections by TPCs would be an important function of a TPC in helping 974 ensure compliance with the regulations under TSCA Title VI. 975***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 43 of 101 [RIN 2070-AJ44] EPA is proposing that TPCs must ha ve experience in the composite wood 976 products industry because EPA believes that understanding the processes used by panel 977 producers to produce composite wood products is crucial fo r the TPC to adequately 978 inspect and audit panel producers. Experien ce in the composite wood products industry 979 would help ensure that the TPC would know wh at to inspect and area s on which to focus 980 during inspections and audits of the panel producers. In addition, EPA is proposing to 981 require TPCs to have experience with the spec ific type of composite wood product(s) that 982 it would certify. EPA believes th at certain steps in the ma nufacture of composite wood 983 products are likely important in maintain ing low formaldehyde emissions and that 984 because manufacturing processes are different for the different types of regulated 985 composite wood products, it is important for a TPC to have knowledge and experience in 986 the manufacture of the specific type of com posite wood product(s) th at it would certify. 987 EPA requests comment on whether EPA should require that the TPC have experience 988 with the specific type of composite wood product that it w ould certify or if experience 989 with one type of product is sufficient to certify all types of composite wood product. 990
2. Denied TPC Applicants. If an AB denies a TPC’s application for accreditation 991 for failure to submit a complete application, the AB would be requi red to notify the TPC 992 or TPC laboratory in writing of the legal and factual basis for the denial, actions, if any, 993 which the affected TPC or TPC laboratory may take to receive accreditation in the future, 994 and the opportunity and method for requesting a hearing with EPA. “Failure to submit a 995 complete application” would not include failu re to pay any accreditation fee or reach a 996 fee agreement. 997
2 3

. Proposed requirements once a TPC is accredited. EPA is proposing that once 998***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 44 of 101 [RIN 2070-AJ44] an applicant is accredited as a TP C under TSCA Title VI, the TPC must: 999 a. Verify that panel producers have ad equate quality assura nce controls and are 1000 complying with any quality assurance and quality control requirements that EPA 1001 promulgates pursuant to TSCA Title VI. 1002 b. Verify quality control test results compared with ASTM E1333-10 test results 1003 by having laboratories conduct qua rterly tests and evaluate test method equivalence 1004 pursuant to testing requirements pr omulgated under TSCA Title VI. 1005 c. Review applications from panel pr oducers for reduced testing or third-party 1006 certification requirements. 1007 d. Establish quality control limits in c onsultation with pane l producers, and, if 1008 applicable, shipping quality control or othe r limits for each product type and production 1009 line. 1010 e. Inform panel producers of the process th at will be used to determine if product 1011 lots are exceeding the applicable quality control limit. 1012 f. Inspect and audit panel producers and their records at least quarterly. 1013 g. Use a testing laboratory or laboratories that comply with ISO/IEC 1014 17025:2005(E). 1015 h. Certify composite wood product types that comply with requirements under 1016 TSCA Title VI following ISO/IEC Guide 65:1996(E). 1017 i. Follow ISO/IEC 17020:1998(E) in the carry ing out of their inspections of the 1018 panel producers. 1019 j. Provide approved TPC number (supp lied by the accrediting AB) to the panel 1020 producer for labeling and recordkeeping. 1021***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 45 of 101 [RIN 2070-AJ44] k. Use laboratories that participate in an inter-laborat ory comparison or 1022 proficiency testing program. 1023 l. Maintain records in electronic form for 5 3 years. 1024 m. Provide an annual report to EPA and the AB(s) that provided it with its 1025 accreditation. 1026 n. Inform the AB(s) that provided it with its accreditation of any changes in key 1027 personnel qualifications, procedur es, or laboratories used by th e TPC that could affect the 1028 TPC’s ability to fulfill its obligations under this unit. 1029 One of the main functions of TPCs under this proposed rule would be to help 1030 ensure that panel producers have adequate quality control of their manufacturing process, 1031 are following appropriate quality assuran ce procedures, and are complying with any 1032 quality assurance requirements that EPA may implement under TSCA Title VI. Under 1033 the CARB ATCM, manufacturers are required to implement specific quality assurance 1034 procedures as described in Appendix 2 of the ATCM. EPA anticipates promulgating 1035 quality assurance requirements for panel pr oducers under TSCA Title VI in a subsequent 1036 proposal with other implementation provisions as required under TSCA Title VI. EPA is 1037 proposing to use TPCs to help ensure co mpliance with quality control and quality 1038 assurance procedures. 1039 EPA is proposing to require TPCs to ve rify quality control tests that measure 1040 formaldehyde emissions by having labor atories conduct quarterly testing. 1041 Under TSCA Title VI, EPA intends to pr omulgate specific formaldehyde testing 1042 requirements. The subsequent proposal may also provide for reduced testing for specified 1043 products such as those made with NAF or U LEF resins. In this proposed rule, EPA is 1044***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 46 of 101 [RIN 2070-AJ44] proposing to require TPCs to review and appr ove, when appropriate, applications from 1045 panel producers for reduced te sting and third-party certifi cation requirements according 1046 to EPA’s implementing regulations. The CARB ATCM allows for reduced testing for 1047 products manufactured with NAF and ULEF resins, and CARB reviews and approves 1048 NAF and ULEF applications. EPA is proposing to instead require TPCs to review these 1049 applications because EPA believes they are best suited to determine whether the panel 1050 producers will be able to consistently comp ly with the emission standards even with 1051 reduced testing requirements. EPA intends to further specify requirements for reduced 1052 testing in a subsequent proposal with othe r implementation provisions as required under 1053 TSCA Title VI. 1054 EPA is proposing to require TPC laboratori es (including contractlaboratories) to 1055 establish quality control limits in consultation with panel producers and, if applicable, 1056 shipping quality control or other limits for each product type and production line to 1057 ensure compliance with the emission standa rds. A quality control limit would be 1058 established if test methods other than AS TM E1333-10 are being us ed to make it easier 1059 for the panel producer to determine whethe r any products are likely to exceed the 1060 emission standards. A quality control limit w ould be the value from a test other than 1061 ASTM E1333-10 that is the correlative equiva lent to the applicable standard. A TPC may 1062 also establish a limit to account for process a nd testing variation to help ensure that the 1063 emission for a product would not exceed the applicable standard. EPA is proposing to 1064 require TPCs to inform panel producers of the process that the TPC would use to 1065 determine if product lots are ex ceeding the applicable quality control limit. In the broader 1066 TSCA Title VI implementing regulations, EPA in tends to describe these limits in more 1067***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 47 of 101 [RIN 2070-AJ44] detail as well as implications and procedures for cases where tests exceed the limits in a 1068 subsequent proposal with other implementati on provisions as required under TSCA Title 1069
VI. 1070 EPA is proposing to require that TPCs inspect and on-site audit panel producers 1071 and their records at least quarterly an d comply with ISO/IEC 17020:1998(E) when 1072 conducting their inspections. Quarterly inspections and on-site audits are consistent with 1073 requirements under the CARB ATCM, and EP A believes that requiring inspections 1074 quarterly should be sufficiently frequent to allow TPCs to observe and mitigate any 1075 potential violations. However, under certain circumstances, a TPC could determine that 1076 more frequent inspections and on-site audits are necessary to ensure compliance. EPA 1077
requestrequests comment on whether enhanced testi ng or inspection requirements should 1078 be required where a TPC finds that a pane l producer has failed quality control or 1079 quarterly tests at a certain frequency

. , or upon other circumstances. In addition to failed 1080 test results, circumstances that EPA e nvisions possibly warranting increased TPC 1081 inspections and audits include a panel producer failing to comply with its quality control 1082 manual or inconsistencies in records. 1083 EPA is proposing to require that TPCs use laboratories for formaldehyde testing 1084 that comply with ISO/IEC 17025:2005(E). As discussed in Unit II. F G .1., this 1085 international voluntary consensus standard sp ecifies the general requirements for the 1086 competence to carry out tests and/or calibra tions, including sampli ng. EPA believes that 1087 requiring TPCs to use laboratories that follow these requirements would help ensure that 1088 TPCs obtain reliable and accurate test results. 1089 EPA is proposing to require that TPCs pa rticipate in an EPA-recognized inter- 1090***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 48 of 101 [RIN 2070-AJ44] laboratory comparison studies orproficiency testing, if deve loped. The inter-laboratory 1091 comparisons would involve the participation of laboratories that are provided composite 1092 wood product samples to test for formaldehyde; each laboratory would test the sample 1093 using the same test method (e.g., ASTM E 1333-10), and the results from all of the 1094 laboratories would be compared. If a sta ndard reference material for formaldehyde 1095 emissions is developed, EPA proposes to re quire annual proficienc y testing. The CARB 1096 ATCM requires laboratories to participate in an inter-laboratory comparison during the 1097 first year that the laboratory is used by a TPC, followed by participation in inter1098 laboratory comparisons every 2 years. EPA believes that ev aluating the performance of 1099 laboratories used by the TPC by inter-laborator y comparisons or proficiency testing is 1100 vital to ensuring that laboratories are pe rforming the formaldehyde testing properly, and 1101 EPA is therefore proposing that this be an annual requirement. EPA requests comment on 1102 whether inter-laboratory comparisons should take place more or less frequently. EPA is 1103 also seeking comment on criteria to use in evaluating performance in inter-laboratory 1104 comparisons. 1105 EPA is proposing to require TPCs to fo llow ISO/IEC Guide 65:1996(E) to certify 1106 composite wood product types that comply w ith requirements under TSCA Title VI. As 1107 discussed in Unit II. F G .1., ISO/IEC Guide 65:1996(E) is an international voluntary 1108 consensus standard that specifies general requirements for a third-party operating a 1109 product certification system. EPA believes th at requiring TPCs to follow these general 1110 requirements for certifying products would help ensure that the TPC is properly 1111 certifying only compliant composite wood products. 1112 A TPC would be supplied with a TPC id entification number by the Product AB 1113***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 49 of 101 [RIN 2070-AJ44] once it has been accredited for TSCA Title VI purposes. EPA is proposing to require that 1114 the TPC provide this number to panel producer s so that they can in clude the TPC number 1115 on the label of their certified products and include it in their records. 1116 EPA is proposing to require TPCs to ma intain records in electronic form for 5 3 1117 years. TSCA Title VI directs EPA to address recordkeeping requirements in its 1118 implementing regulations and EPA believes that certain records will greatly assist the 1119 EPA in monitoring compliance with the emi ssions standards and other provisions. These 1120 records would be: 1121 •A list of panel producers and their resp ective product types, including resins 1122 used, that the TPC has certified. 1123 •Results of inspections, audits, and em ission tests conducted for and linked to 1124 each panel producer and product type. 1125 •A list of laboratories used by the TPC, test methods, including test conditions 1126 and conditioning time, and test results. 1127 •Methods and results for establishing test method correlations and equivalence. 1128 EPA is proposing to require TPCs to subm it an annual report to EPA and the AB 1129 that accredits the TPC. Th e annual report would include: 1130 •A list of panel producers and their products that the TPC has certified during the 1131 previous year, including resins used a nd the average and range of formaldehyde 1132 emissions by panel producer, resin, and product type. 1133 • List of any non-complying products or events by panel producers. 1134 • A list of laboratories and te st methods used by the TPC. 1135 • Results of inter-laboratory comparison or proficiency testing for the laboratories 1136***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 50 of 101 [RIN 2070-AJ44] used by the TPC. 1137 EPA is proposing to require that the TPC inform the AB(s) th at accredit the TPC 1138 of any changes in key personnel qualificati ons, procedures, or laboratories used that 1139 could affect the TPC's ability to fulfill its obligations under this un it. EPA believes such 1140 changes could impact the TPC’s ability to properly verify formaldehyde emissions, 1141 inspect and audit, and certif y compliant composite wood products. EPA is proposing that 1142 the AB review the changes to determine wh ether the changes would impact the TPC’s 1143 ability to perform its duties. 1144
3 4

. Removal and reaccreditation of third-party certifiers. EPA is proposing to 1145 exercise the authority to revoke the TSCA Title VI accreditation of a TPC or its 1146 laboratory, after notice and an opportunity for a hearing, if the TPC or its laboratory: 1147 Fails to meet any of the applicable require ments promulgated under TSCA Title VI (such 1148 as by failing to comply with ISO/IEC Guide 65:1996(E), ISO/IEC 17020:1998(E), or 1149 ISO/IEC 17025:2005(E)); makes false or misl eading statements on its application, 1150 records, or reports; or makes changes to key personnel qualifications, procedures, or 1151 laboratories that would make it unable to perf orm its duties. ABs woul d also be able to 1152 revoke an accreditation of a TPC, subject to an opportunity for a hearing with EPA. A 1153 TPC whose accreditation has been revoked may rea pply to an AB to be reaccredited as a 1154
TPC. 1155 If a TPC loses its accreditation or discontinues participation in the TSCA Title VI 1156 Third-Party Certification Program for any r eason, it would be responsible for promptly 1157 notifying EPA and all panel producers that it provides TSCA Title VI certification 1158 services to. If a TPC loses its accreditation or discontinues particip ation in the program 1159***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 51 of 101 [RIN 2070-AJ44] for reasons other than fraud orproviding false or misleading statements, or other than a 1160 reason that implicates a particul ar panel producer in a violatio n of TSCA Title VI or its 1161 implementing regulations, the pa nel producers that used the TP C to certify their products 1162 would need to enlist another TPC to certify their products within 3 months (90 days). In 1163 these cases, the panel producers would not be re quired to recall or recertify their products 1164 merely because the certifyi ng TPC lost its accreditation. During the time a panel producer 1165 is seeking a new TPC, it would need to conti nue to comply with all other requirements of 1166 TSCA Title VI and its implementing regula tions, including quality control testing. 1167 During this period the panel producer would re main subject to inspection by EPA. If the 1168 panel producer is unable to comply with all other aspects of TSCA Title VI and its 1169 implementing regulations, the panel producer would not be permitted to sell, offer for 1170 sale, or supply its products in the United States until its products are recertified as 1171 compliant. If a TPC loses its accreditation due to fraud or providi ng false or misleading 1172 statements with respect to a particular pa nel producer, or for any other reason that 1173 implicates a particular panel producer in a violation of TSCA Title VI or the regulations 1174 promulgated thereunder, that panel producer would not be permitted to offer regulated 1175 composite wood products for sale in the Unite d States until its composite wood products 1176 have been recertified by another TPC. If su ch a situation does occur, EPA would notify 1177 affected panel producer at the time it comme nces action against the TPC. EPA believes it 1178 is appropriate to be more stringent in thes e situations because the TPC’s behavior may 1179 call into question the legitimacy of the ma nufacture’s product certi fication. Any action 1180 EPA would take against a TPC would not prec lude an enforcement action against a panel 1181 producer. EPA requests comment on whether it has provided adequate time for a panel 1182***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 52 of 101 [RIN 2070-AJ44] producer to seek an a lternate certification. 1183 H. Enforcement, Suspension, Revocation, and Modification 1184
1. Enforcement under TSCA sections 15-17. EPA may conduct inspections of 1185 participating TPCs and ABs and issue subpoenas according to the requirements for 1186 accreditation and recognition and/or pursuant to the provisions of TSCA section 11 (15 1187 U.S.C. 2610) to ensure compliance with TSCA Title VI and the regulations promulgated 1188 thereunder. Enforcement issues related to manufacturers, importe rs, distributors, and 1189 retailers will be covered in a subsequent proposal. 1190 EPA would exercise the aut hority to withdraw from a recognition agreement with 1191 an AB and pursue penalties under TSCA secti on15 (15 U.S.C. 2614) fo r any violation of 1192 TSCA Title VI or the regulations prom ulgated thereunder. In addition to an 1193 administrative or judicial finding of violation, grounds for withdrawing from a 1194 recognition agreement and/or pursuing an enfo rcement action against an AB include if 1195 the AB: 1196 • Submits false or misleading information to EPA; 1197 • Fails to maintain or falsifies required records; or 1198 • Or otherwise fails to comply with TSCA Title VI or the regulations promulgated 1199 thereunder. 1200
2. Suspension, revocation and modification. EPA would exercise the authority to 1201 suspend, revoke, or modify a TPC’s TSCA Title VI accreditation, with or without the 1202 participation of the AB that provided the accredita tion, if the TPC fails to comply with 1203 TSCA Title VI or the regulations promulgate d thereunder. Any viol ation of TSCA Title 1204 VI or the regulations promulgated thereunde r would also be a pr ohibited act under TSCA 1205***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 53 of 101 [RIN 2070-AJ44] section 15 (15 U.S.C. 2614). Grounds for su spending, modifying, or revoking a TPC’s 1206 accreditation include if the TPC: 1207 a. Submits false or misleading information to EPA or its AB; 1208 b. Fails to maintain or falsifies required records; or 1209 c. Fails to comply with TSCA Title VI or regulations promulgated thereunder. 1210 The ISO/IEC standards and guide that are re ferenced in this pr oposed rule require 1211 that policies and procedures be in place to identify and remedy nonconformities with the 1212 implementation of those standards (I SO/IEC 17025:2005(E), s ection 4.9; ISO/IEC 1213 17011:2004(E), section 5.5; ISO/IEC 17020:1998( E), section 7.8; ISO/IEC Guide 1214 65:1996(E), section 47). Should a TPC or AB identify a nonconformity or discrepancy 1215 with its implementation of one of the ISO sta ndards via an internal audit or other means, 1216 that entity must take remedial action with in the timeframe specified by the AB or the 1217 time specified in the TPC’s quality management plan in order to avoi d the possibility of 1218 an enforcement action. 1219 Prior to withdrawal from a recognition ag reement with an AB, or the suspension, 1220 revocation, or modification of a TPC’s accred itation, EPA would provide notification to 1221 the affected AB or TPC of: 1222 • The legal and factual basis for the proposed action. 1223 • The anticipated commencement date and duration of any suspension, revocation, 1224 modification, or other action. 1225 • What actions, if any, the affected entity may take to avoid suspension, 1226 revocation, modification, or otherwise c ontinue participation in the program. 1227 • The opportunity and method for requesting a hearing prior to the final action. 1228***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 54 of 101 [RIN 2070-AJ44] If an individual or organizati on requests a hearing, EPA would: 1229 • Provide the affected entity an opportunity to offer written statements in response 1230 to EPA’s assertions of the legal and factual basis for its proposed action. 1231 • Appoint an impartial official of EPA as Presiding Officer to conduct the hearing. 1232 The Presiding Officer would conduct a fair , orderly, and impart ial hearing within 1233 90 days of the request for a hearing. The Pr esiding Officer would c onsider all relevant 1234 evidence, explanations, comments, and arguments submitted and notify the affected 1235 entity in writing within 90 days of comple tion of the hearing of his or her decision and 1236 order. Such an order is a final agency action which may be subject to judicial review. The 1237 order must contain the commen cement date and duration of the suspension, revocation, or 1238 modification. 1239 If EPA determines that the public healt h, interest, or welfar e warrants immediate 1240 action to suspend the recognition of an AB or the accreditation of a TPC prior to the 1241 opportunity for a hearing, it would notify the aff ected AB or TPC of its right to request a 1242 hearing on the immediate suspension within 15 days of the suspension taking place and 1243 the procedures for the co nduct of such a hearing. 1244 Any notice, decision, or order issued by EPA in response to a hearing, any 1245 transcript or other verbatim r ecord of oral testimony, and any documents filed in response 1246 to a hearing would be available to the pub lic, except as otherwise provided by TSCA 1247 section 14. Any such hearing at which oral testimony is presented would be open to the 1248 public, except that the Presiding Officer may ex clude the public to the extent necessary to 1249 allow presentation of information which may be entitled to confid ential treatment under 1250 TSCA section14. 1251***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 55 of 101 [RIN 2070-AJ44] I. Status of CARB Approved TPCs 1252 EPA intends to propose that the formalde hyde emissions standards in TSCA Title 1253 VI become effective 365 days after the promulgation of the TSCA Title VI implementing 1254 regulations (which are required by TSCA T itle VI to be promulgated no later than 1255 January 1, 2013). EPA proposes that CARB approved TPCs would have 365 days after 1256 the promulgation of the TSCA Title VI implementing regulations to become accredited 1257 by an AB with which EPA has ente red into a recognition agreement. EPA believes this In 1258 order to determine which TPCs are CARB approved, EPA will consult the listing of 1259 TPC’s that CARB maintains on its inte rnet site. EPA believes that 365 days is a sufficient 1260 period of time for EPA to en ter into recognition agreements with ABs and for TPCs to 1261 seek accreditation from EPA recognized AB s, ensuring no interruption in a TPC’s 1262 services. During the transition period between when the final TSCA Title VI 1263 implementing regulations are promulgated a nd the date 365 days after promulgation, the 1264 CARB approved TPCs may carry out certif ication activities under TSCA Title VI 1265 provided that they are compliant with all other aspects of TSCA Title VI and the 1266 regulations promulgated thereunder. TPCs th at are certifying products as compliant with 1267 TSCA Title VI are subject to inspecti on by EPA and enforcement actions for any 1268 violations of TSCA Title VI or th e regulations promulgated thereunder. To reduce 1269 burden on existing CARB approved TPCs, the EPA requests comment on ways to better 1270 synchronize the timing for the TSCA Title VI accreditation period for existing CARB 1271 approved TPCs. For example, one option might be to extend the allowable time period 1272 for acquiring accreditation from 1 to 2 years. Another option might be to align the TSCA 1273 Title VI accreditation requirement for CARB approved TPCs with their existing CARB 1274***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 56 of 101 [RIN 2070-AJ44] accreditation renewal, such that they could us e the same information to be accredited by 1275 EPA and CARB at the same time. Alternativel y, the TPCs could be required to obtain 1276 accreditation from an EPA-Recognized AB no la ter than one year after the first EPA1277 recognized AB enters into a recognition ag reement with the EPA under the TSCA Title 1278 VI. EPA expects to communicate with CARB regarding its third-party certification 1279 program and to collaborate, where possible, in order to promote the mutual acceptance of 1280
TPCs. 1281 J. Transparency 1282 EPA has a commitment to uphold the valu es of transparency and openness in 1283 conducting EPA operations (Ref. 23 24 ). Transparency promotes accountability and 1284 provides information for citizens about what their government is doing (Ref. 24 25 ). EPA 1285 would support its commitment by making docum entation of recognized ABs, TPCs, and 1286 panel producers available to the public. EPA is proposing to make the following 1287 information publically available on the internet: 1288 1. The names and addresses of all ABs th at EPA has a recognition agreement with 1289 and the status of that recognition agreement. 1290 2. A list of all accredited TPCs with th eir TPC number and accreditation status. 1291 3. Annual reports from ABs. 1292 4. A list of panel producers approved for reduced testing and reduced third-party 1293 certification requirements. 1294 EPA requests comment on what, if any, a dditional information should be made 1295 publically available (e.g., annual reports from TPCs and other required notifications) and 1296 on whether there are other ways EPA mi ght improve program transparency. EPA 1297***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 57 of 101 [RIN 2070-AJ44] requests comment on whether making the follo wing information available publically on 1298 the internet would be useful to the public orpresent challenges for regulated entities: 1299 • A list of panel producers and their products that each TPC has certified, 1300 including resins used and the average and range of formaldehyde emissions by panel 1301 producer, resin, and product type. 1302 • A list of any non-complying products or events by panel producer. 1303 • A list of laboratories and te st methods used by each TPC. 1304 • The results of inter-laboratory comparison or proficiency testing for the 1305 laboratories used by TPCs. 1306 EPA requests comment on whether such information might contain CBI. EPA is 1307 also considering requiring some information to be reported into a publicly viewable 1308 database, should such a database be devel oped. Generally, EPA is considering requiring 1309 electronic reporting of the in formation proposed to be reported. In particular, EPA 1310 requests comment on whether the data elements in the ABs’ and TPCs’ annual reports, 1311 and the required notifications should be reported into a publicly viewable database. 1312 EPA is proposing a 3 year record retenti on period for all TSCA Title VI AB and 1313 TPC record keeping requirements. While EP A is proposing a 3 year record retention 1314 period as is common under the Paperwor k Reduction Act, EPA requests comments on 1315 ways to reduce the burden and costs of hard-copy record keeping over multiple years on 1316 the regulated community, such as by requiring that the entities regul ated under this rule 1317 be allowed to keep required records elec tronically and make them available to the 1318 Agency and others via their business website, or other electronic media. 1319***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 58 of 101 [RIN 2070-AJ44] Under the proposed rule-making, compos ite wood products would be regulated 1320 starting with the manufacture (including import) of panels , through their incorporation 1321 into component parts and finished goods, the distribution of those pr oducts, and the retail 1322 sale of those products. This can be a le ngthy process and the amount of time composite 1323 wood panels are held in inventory and the am ount of time before th ey are incorporated 1324 into finished goods is variable. This variab ility can result from prevailing economic 1325 conditions, the complexity of the individual products, the origin of the products, and 1326 other factors. This point was illustrated by the fact that CARB had to extend its “sell1327 through dates” multiple times. CARB found thatthese extensions were necessary because 1328 the recession increased the amount of time manufacturers needed to clear preexisting 1329 inventory. As CARB found that items remained in inventory for extended periods, it is 1330 possible that an issue could arise with a particular composite wood item several years 1331 after it was manufactured. L earning the source of the item ma y be important in order to 1332 identify and correct a problem. Because re tail companies receive composite wood items 1333 from many sources and the third party certifi er could vary with each item, retaining 1334 records for 3 years would help assure that problems can be identified and corrected. 1335 Third party certifiers of compliance with formaldehyde emissions from composite 1336 wood products would need to maintain certain records long enough to assure that their 1337 oversight role in the system is operating pr operly to protect human health. An adequate 1338 record retention period is esse ntial to fair and efficient enforcement of the regulatory 1339 requirements and allows EPA and interested downstream consumers to be assured that 1340 finished goods are made from compliant co mposite wood panels. EPA seeks to avoid the 1341 situation where records surr ounding the certification of regul ated products that remain 1342***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 59 of 101 [RIN 2070-AJ44] available for retail sale in the U.S. have alr eady been disposed of because of the passage 1343 of time. To that end, EPA requests co mment on the length of time composite wood 1344 panels may take to reach their end user, whet her incorporated into a finished good or not. 1345 EPA also requests comment on the amountof time ABs and TPCs, during their 1346 ordinary course of business, typically retain records of their accreditation or certification 1347 activities and whether this is due to any external factors such as, industry standards, 1348 customer demand, customary business practices, or other. 1349 K. Electronic Reporting 1350 The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) provides 1351 that, when practicable, Federal organizations use electronic forms, electronic filings, and 1352 electronic signatures to conduct official bus iness with the public. EPA’s Cross-Media 1353 Electronic Reporting Regulation (CROMERR) ( 40 CFR part 3), published in the Federal 1354 Register on October 13, 2005 (70 FR 59848) (FRL–7977–1), provides that any 1355 requirement in title 40 of the Code of Federal Regulations (CFR) to submit a report 1356 directly to EPA can be satisfied with an electronic submission that meets certain 1357 conditions once the Agency publishes a re gulation that an electronic document 1358 submission process is availa ble for that requirement. 1359 EPA is considering requiring informati on reported to EPA from TPCs and ABs be 1360 reported electronically through EPA’s Centra l Data Exchange (CDX). CDX provides the 1361 capability for submitters to access their data through the use of web services. For more 1362 information about CDX, go to http://epa.gov/cdx

. 1363 Should EPA adopt a mandatory electroni c reporting requirement, submitters 1364 would be required to register with EPA’ s CDX, complete an electronic signature 1365***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 60 of 101 [RIN 2070-AJ44] agreement, and to prepare a data file for submission. To submit electronically to EPA via 1366 CDX, individuals must first re gister with that system at, 1367 http://cdx.epa.gov/epa_home.asp . To register in CDX, the C DX registrant agrees to the 1368 Terms and Conditions, provides information about the submitter and organization, selects 1369 a user name and password, and follows the pr ocedures outlined in the guidance document 1370 for CDX available at https://cdx.epa.gov/TSCA/ eTSCA-RegistrationGuide.pdf . The 1371 registrant would also select a role and comp lete an electronic signature agreement either 1372 through electronic validation using the LexisNex is services or through wet ink signature. 1373 Once registration and the electr onic signature agreement are complete, the user would 1374 prepare a submission. 1375 Most of the information requested in the reporting requi rements of these 1376 collections is not of a confidential nature . Nonetheless, the application would be 1377 designed to support TSCA Confidential Bu siness Information needs by providing a 1378 secure environment that meets Federal standards. 1379 EPA is considering requiring mandato ry electronic reporting requirement 1380 because such a requirement would streamline the reporting process and reduce the 1381 administrative costs associated with inform ation submission and recordkeeping. The 1382 effort to eliminate paper-based submissions in favor of CDX reporting is part of broader 1383 government efforts to move to modern, elec tronic methods of information gathering. 1384 Electronic reporting allows for more efficien t data transmittal and a reduction in errors 1385 with the built-in validation pr ocedures. EPA believes the adop tion of electronic reporting 1386 reduces the reporting burden for submitters by reducing the cost and time required to 1387 review. EPA requests comment on whether it should require mandatory electronic 1388***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 61 of 101 [RIN 2070-AJ44] reporting. For more information on how a TSCA Title VI el ectronic reporting 1389 application would function and the burdens a nd benefits associated with electronic 1390 reporting please see Refs. [Placeholder] and 27. 1391 IV. Request for Comment 1392 In addition to the areas on which EPA has specifically requested comment, EPA 1393 requests comment on all other aspe cts of this proposed rule. 1394 V. References 1395 As indicated under ADDRESSES , a docket has been established for this 1396 rulemaking under docket ID number EPA- HQ-OPPT-2011-0380. The following is a 1397 listing of the documents that are specifica lly referenced in this action. The docket 1398 includes these documents and other information considered by EPA, including 1399 documents that are referenced within the docum ents that are included in the docket, even 1400 if the referenced document is not physically located in the docket. For assistance in 1401 locating these other documents, please c onsult the technical contact listed under FOR 1402 FURTHER INFORMATION CONTACT

. 1403 1. Public Law 111-199, Title VI--Formald ehyde Standards for Composite Wood 1404 Products Act, enacted July 7, 2010. (T SCA section 601(d), 15 U.S.C. 2601 et seq. ) 1405 2. Agency for Toxic Substances an d Disease Registry (ATSDR). 1999. 1406 Toxicological Profile for Formaldehyde and 2010 Addendum to the Profile. Atlanta, GA: 1407 U.S. Department of Health and Huma n Services, Public Health Service. 1408 3. National Toxicology Program , U.S. Department of H ealth and Human Services 1409 (HHS), 12 th Report on Carcinogens, June 10, 2011. 1410***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 62 of 101 [RIN 2070-AJ44] 4. EPA, ORD. Integrated Risk Information System (IRIS) Program. IRIS 1411 Toxicological Review of Formaldehyde-Inha lation Assessment (2010 External Review 1412 Draft). Available online at: 1413 http://cfpub.epa.gov/ncea/iris_dr afts/recordisplay.cfm?deid=223614

. 1414 5. National Academy of Sciences (NAS). Review of the Environmental Protection 1415 Agency's Draft IRIS Assessment of Formaldehyde. 2011. Available online at: 1416 http://www.nap.edu/catalog.php?record_id=13142. 1417
6. 6. International Agency for Research on Cancer (June 2006). IARC 1418 Monographs on the Evaluation of Carcinogeni c Risks to Humans Volume 88 (2006): 1419 Formaldehyde, 2-Butoxyethanol and 1-tert-Butoxypropan-2-ol 1420
7. California Environmental Protec tion Agency Air Resource Board. CARB 1421 Airborne Toxic Control Measure . April 26, 2007. Available online at: 1422 http://www.arb.ca.gov/toxics/compwood/compwood.htm

. 1423
7 8 . California Environmental Protection Ag ency Air Resources Board, Composite 1424 Wood Products ATCM, List of CARB Appr oved Third-party Certifiers (Accessed 1425 August, 2011)

. Available online at: 1426 http://www.arb.ca.gov/toxics/compwood/listoftpcs.htm. 1427
8 9 . California Environmental Protection Agency Air Resources Board, 1428 Application to be a Third-party Cert ifier (TPC) of Co mposite Wood Products

. Available 1429 online at: http://www.arb.ca.gov/toxics/com pwood/tpc/tpcapplication.pdf. 1430
9 10 . Sierra Club. Citizen Petition to EPA Regarding Formaldehyde in Wood 1431 Products. March 20, 2008. Available online at: 1432 http://www.epa.gov/opptintr/chemtest/formaldehyde/index.html. 1433***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 63 of 101 [RIN 2070-AJ44] 10 11 . EPA. Formaldehyde Emissions from Composite Wood Products; 1434 Disposition of TSCA Section 21 Petition. Federal Register. (73 FR 36504, June 27, 1435 2008) (FRL-8371-5). 1436
11 12 . EPA. Formaldehyde Emissions from Composite Wood Products; Advanced 1437 notice of proposed rulemaking and notice of public meetings. Federal Register. (73 FR 1438 73620, December 3, 2008) (FRL-8386-3). 1439
12 13 . ISO/IEC Guide 65:1996(E), General Re quirements for Bodies Operating 1440 Product Certification Systems (First Edition) 1996. 1441
13 14 . ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements 1442 for Accreditation Bodies Accrediting C onformity Assessment Bodies (Corrected 1443 Version), February 15, 2005. 1444
14 15 . ISO/IEC 17025:2005(E), General Requir ements for the Competence of 1445 Testing and Calibration Laborat ories (Second Edition), May 15, 2005. 1446 15 16 . ISO/IEC 17020:1998(E), General Criteri a for the Operation of Various 1447 Types of Bodies Performing Inspecti ons (First Edition) November 15, 1998. 1448
16 17 . International Accreditation Forum. Available online at: http://www.iaf.nu/. 1449
17 18 . International Laboratory Accredita tion Cooperation. Available online at: 1450 http://www.ilac.org. 1451
18 19 . EPA. National Lead Laboratory A ccreditation (NLLAP). Available at: 1452 http://www.epa.gov/lead/pubs/nllap.htm

. 1453 19 20 . ASTM E1333-96 (Reapproved 2002). Standard Test Method for 1454 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 1455 Products Using a Large Chamber. 1456***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 64 of 101 [RIN 2070-AJ44] 20 21 . ASTM D6007-02 (Reapproved 2008), October 1, 2008. Standard Test 1457 Method for Determining Formaldehyde Concen trations in Air from Wood Products 1458 Using a Small-Scale Chamber. 1459
21 22 . ASTM D5582-00 (Reapproved 2006), October 1, 2006. Standard Test 1460 Method for Determining Formaldehyde Levels from Wood Products Us ing a Desiccator. 1461
22 23 . ASTM E1333-10 (May 1, 2010). Standard Test Method for Determining 1462 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 1463 Large Chamber. 1464
23 24 . EPA. Memorandum from Lisa Jack son to EPA Employees (April 23, 1465 2009). Available online at: http://www.epa.gov/Administr ator/operationsmemo.html

. 1466
24 25 . Memorandum from President Barack Obama to the Heads of Executive 1467 Departments and Agencies. January 21, 2009. Available online at: 1468 http://www.whitehouse.gov/the_press_of fice/TransparencyandOpenGovernment

. 1469 25 26 . EPA. Economic Analysis of the Th ird-Party Certification Framework for 1470 the Formaldehyde Standards for Composite Wood Products Act Proposed Rule 1471 (Economic Analysis). OMB Draft March 9, 2012. 1472
26 27 . EPA. Information Collection Request (ICR) for the Formaldehyde 1473 Emissions From Composite Wood Products, Third-Party Certification Framework, 1474 Recordkeeping and Reporting; Proposed Ru le, (RIN 2070-AJ44). EPA ICR No. 2441.01 1475 and OMB No. 2070-[NEW]. OMB Draft March 12, 2012. 1476
27 28 . EPA. Report of the Small Business Advocacy Review Panel on EPA’s 1477 Planned Proposed Rule Implementing the Formaldehyde Standards for Composite Wood 1478 Products Act (TSCA Title VI). April 4, 2011. 1479***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 65 of 101 [RIN 2070-AJ44] VI. Statutory and Executive Order Reviews 1480 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 1481 13563: Improving Regulation and Regulatory Review 1482 1483 Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), 1484 this is a “significant regulatory action” b ecause it may raise novel legal or policy issues 1485 related to the establishment of a new regul atory program as manda ted by a new statutory 1486 amendment. Accordingly, EPA submitted this action to the Office of Management and 1487 Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, 1488 January 21, 2011), and any changes made in response to OMB recommendations are 1489 documented in the docket for this action. 1490 EPA prepared an analysis of the potential costs and benefits associated with this 1491 action. A copy of this Ec onomic Analysis (Ref. 25 26 ) is available in the docket for this 1492 action and the analysis is briefly summarized here. 1493 The proposed rule would require ABs to submit an application and enter into a 1494 recognition agreement with EPA, provide notif ications and annual reports, and maintain 1495 records. A typical AB is estimated to incur an annualized cost of approximately 1496 $775 nearly $800 per year. For the purposes of cost estimation EPA assumes that eight 1497 organizations in the United States will beco me ABs in the TSCA Title VI Third-Party 1498 Certification Program, so total costs to U.S. ABs are estimated to be approximately 1499 $6, 200 300 per year. 1500 The proposed rule would require TPCs to submit an application, submit 1501 notifications and annual reports, and maintain records. These requirements are estimated 1502 to cost an average TPC about $1, 200 100 per year. The proposed rule also would require 1503 TPCs to be accredited for certain ISO/IEC guide and standards. Most potential TPCs that 1504***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 66 of 101 [RIN 2070-AJ44] are likely to participate in the TSCA Title VI Third-Party Certification Program are 1505 expected to already have all the necessary accreditations, bu t some TPCs are assumed to 1506 need an additional acc reditation at a cost of $25,000 in the first year and $5,000 per year 1507 in subsequent years. For the purposes of costestimation EPA assumes that there will be 1508 nine U.S. TPCs under this proposed rule. To tal costs to U.S. TPCs due to the proposed 1509 rule are estimated to be approximately $94,000 in the first year and $24,000 to $28,000 1510 per year in subsequent years. A nnualized costs to U.S. TPCs are $ 28 27 ,000 and 1511 $ 29 28 ,000 per year, using a 3% and 7% discount rate, respectively. 1512 The combined total cost for accreditati on bodies and TPCs is estimated to be 1513 $107,000 in the first year. Annualized costs are estimated at approximately $34,000 and 1514 $35,000 per year , using either a 3% and 7 or7 % discount rate , respectively

. 1515 B. Paperwork Reduction Act (PRA) 1516 The information collection requirements in this proposed rule have been 1517 submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq . The Information 1518 Collection Request (ICR) document preparedby EPA has been assigned EPA ICR No. 1519
2441.01. 1520 This action proposes to require TPCs to provide EPA and ABs with pertinent 1521 information necessary for accreditation. Also, this action proposes to require ABs to 1522 provide EPA with necessary information th rough a recognition agreement in order to 1523 qualify them to function as an AB pursuan t to the regulations. EPA has therefore 1524 prepared and submitted to OMB an Information Collection Request (ICR) document 1525 entitled “Formaldehyde Emissions From Composite Wood Products, Third-Party 1526 Certification Framework, Recordkeeping and Reporting; Proposed Rule (RIN 2070- 1527***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 67 of 101 [RIN 2070-AJ44] AJ44),” identified under EPA ICR No. 2441.01 and OMB Control No. 2070-[NEW], 1528 which is also available for review in the docket for this action (Ref. 26 27 ). The ICR 1529 describes the information collection activitie s and the estimated burden hours and costs, 1530 which are briefly summarized here. 1531 Because the approval requirements for in formation collection requests under PRA 1532 is not limited to U.S. entities, the repor ting and recordkeeping burden of the proposed 1533 rule is calculated for both fore ign and domestic entities. 1534 The average reporting and recordkeeping burden for ABs is estimated at 1535 approximately 18 21 hours per year. EPA assumes that8 U.S. ABs and 17 foreign ABs 1536 will participate in the TSCA T itle VI program, so the annual burden for ABs is estimated 1537 to be 450 500 hours. The average reporting and recordkeeping burden for TPCs is 1538 estimated at approximately 28 25 hours per year. EPA assu mes there will be nine 1539 domestic TPCs and 27 foreign TPCs that participate in the TCA Title VI program, so the 1540 annual burden for ABs is estimated at approximately 1,000 900 hours. Total respondent 1541 burden for ABs and TPCs combined is estimated at approximately 1, 450 400 hours per 1542 year. The total cost to United States and foreign TPCs that need to obtain additional 1543 accreditation is estimated to average $140,000 per year. Burden is defined at 5 CFR 1544 1320.3(b). 1545 An agency may not conduct or sponsor, and a person is not required to respond to 1546 an information collection request unless itdisplays a currently valid OMB control 1547 number, or is otherwise required to submit the specific information by a statute. The 1548 OMB control numbers for EPA’s regulations codi fied in title 40 of the Code of Federal 1549 Regulations, after appearing in the preamble of the final rule, are further displayed either 1550***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 68 of 101 [RIN 2070-AJ44] by publication in the Federal Register or by other appropriate means, such as on the 1551 related collection instrument or form, if applicable. The display of OMB control numbers 1552 for certain EPA regulations is consol idated in a list at 40 CFR 9.1. 1553 To comment on the Agency's need for this information, the accuracy of the 1554 provided burden estimates, and any sugge sted methods for minimizing respondent 1555 burden, EPA has established a public docket fo r this proposed rule, which includes this 1556 ICR, under docket ID number EPA- HQ-OPPT-2011-0380; FRL-9342-4. Submit any 1557 comments related to the ICR to EPA and OMB. See ADDRESSES at the beginning of 1558 this proposed rule for where to submit comments to EPA. Send comments to OMB at the 1559 Office of Information and Regulatory Affair s, Office of Management and Budget, 725 1560
17 th St., NW, Washington, DC 20503, ATTN: De sk Office for EPA. Since OMB is 1561 required to make a decision concerning the ICR between 30 and 60 days after [ insert date 1562 of publication in the Federal Register] , a comment to OMB is best assured of having its 1563 full effect if OMB receives it by [ insert date 30 days after date of publication in the 1564 Federal Register] . The final rule will respond to any OMB or public comments on the 1565 information collection requirements c ontained in this proposed rule. 1566
C. Regulatory Flexibility Act (RFA) 1567 The RFA, 5 U.S.C. 601 et seq. , generally requires an agency to prepare a 1568 regulatory flexibility analysis of any rule subject to notice and comment rulemaking 1569 requirements under the Administrative Proce dure Act or any other statute unless the 1570 agency certifies that the rule will not have a significant ec onomic impact on a substantial 1571 number of small entities. Small entities include small businesses, small organizations, 1572 and small governmental jurisdictions. 1573***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 69 of 101 [RIN 2070-AJ44] For purposes of assessing the impacts of this proposed rule on small entities, a 1574 small entity is defined as: 1575 1. A small business, as defined by the Small Business Administration’s (SBA) 1576 regulations at 13 CFR 121.201. The SBA’s defin itions typically are based upon either a 1577 sales or an employment level, depe nding on the nature of the industry. 1578 2. A small governmental jurisdiction that is a government of a city, county, town, 1579 school district, or spec ial district with a popul ation of less than 50,000. 1580 3. A small organization that is a ny not-for-profit enterprise which is 1581 independently owned and operated and is not dominant in its field. 1582 Since the regulated community does not in clude small governmental jurisdictions, 1583 the Agency’s analysis focuses on small bus inesses and small non-profits organizations. 1584 After considering the economi c impacts of this proposed rule on small entities, I 1585 certify that this action will not have a significant economic imp act on a substantial 1586 number of small entities. The Agency’s basi s is briefly summarized here and is detailed 1587 in the Economic Analysis (Ref. 26). 1588 EPA evaluated two factors in its analysis of the proposed rule’s requirements on 1589 small entities, the number and type of small en tities potentially affected, and the extent of 1590 the rule’s potential economic impact on those entities as me asured by the cost-to-revenue 1591 ratio for businesses and the cost-to-expenses ratio for non-profit orga nizations. This ratio 1592 is a good measure of entities’ ability to affo rd the costs attributable to a regulatory 1593 requirement, because comparing compliance co sts to revenues or expenses provides a 1594 reasonable indication of the magnitude of th e regulatory burden relative to a commonly 1595 available measure of economic activity. Where regulatory costs represent a small fraction 1596***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 70 of 101 [RIN 2070-AJ44] of a typical entity’s revenues or expenses, the financial impacts of the regulation on such 1597 entities may be considered as not significan t. The impact ratios were calculated using 1598 annualized costs, because these costs are mo re representative of the continuing costs 1599 entities would face to comply with this proposed rule. 1600 EPA assumed that 5 small non-profit orga nizations and 4 small businesses in the 1601 United States will participate as ABs or TPCs in the TSCA Title VI program. All of the 1602 small non-profit organizations ar e expected to have cost impacts below the 1% level. 1603 Three of the small businesses are expected to have cost impacts below the 1% level, and 1604 one is expected to have cost impacts between 1% and 3%. So of the 9 total small entities 1605 assumed to be affected by the final rule, 8 are expected to have impacts under 1%, and 1 1606 is expected to have impacts between 1% and 3%. 1607 In general, EPA strives to minimize pot ential adverse impacts on small entities 1608 when developing regulations to achieve the environmental and human health protection 1609 goals of the statute and the Agency. EP A solicits comments specifically about the 1610 potential economic impacts th at this proposed rule may impose on small entities. 1611 Although not required by RFA to convene a Small Business Advocacy Review 1612 (SBAR) Panel for this particular proposed rule because EPA has determined that this 1613 proposal would not have a significant economic impacts on a substantial number of small 1614 entities, EPA convened a SBAR Panel to obta in advice and recommendations from small 1615 entities representatives potenti ally subject to the proposed rule’s requirements. The 1616 SBAR Panel covered the proposed regulat ions and the broader TSCA Title VI 1617 implementing regulations proposal which will follow. The SBAR Panel was convened by 1618 EPA's Small Business Advocacy Chairperson on February 3, 2011. In addition to the 1619***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 71 of 101 [RIN 2070-AJ44] chairperson, the Panel consiste d of the Assistant Administrato r of the Office of Chemical 1620 Safety and Pollution Prevention, the Administrator of the Office of Information and 1621 Regulatory Affairs within OMB, and the Ch ief Counsel for Advocacy of the SBA. 1622 Seventeen potentially impacted small entities served as Small Entity 1623 Representatives (SERs), representing a br oad range of small entities from diverse 1624 geographic locations and five association repr esentatives. EPA hosted two meetings with 1625 the SERs to obtain feedback. During the Pr e-Panel Outreach Meet ing on January 6, 2011, 1626 and the Panel Outreach Meeting on February 17, 2011, EPA reviewed the major areas of 1627 regulation, including options for the proposed framework of the TSCA Title VI Third1628 Party Certification Program, with the SB AR Panel and the SERs. The SBAR Panel 1629 solicited comments from the SE Rs on the options presented by EPA, their experiences 1630 with the CARB ATCM, any addi tional concerns they might have, and the costs of 1631 regulatory options. Several SERs submitted written comments to EPA following the 1632 meetings. The Panel evaluated the assembled materials and small entity comments on 1633 issues related to the elements of an IRFA. A copy of the SBAR Panel report is included 1634 in the docket for this proposed rule (Ref. 27 28 ). As a result of its deliberations, the Panel 1635 made a number of recommendations. With rega rds to the proposed TSCA Title VI Third1636 Party Certification Program, the Panel recomm ended that EPA continue to explore how it 1637 can capitalize on the expertise of international ABs, while at the same time maintaining 1638 control over the design and implemen tation of its certification system. 1639 D. Unfunded Mandates Reform Act (UMRA) 1640 Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for Federal 1641 agencies to assess the effects of their re gulatory actions on State, local, and tribal 1642***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 72 of 101 [RIN 2070-AJ44] governments and the private sector. This proposed rule does not contain a Federal 1643 mandate that may result in expenditures of $100 million or more for State, local, or tribal 1644 governments, in the aggregate, or the private sector in any 1 year. No State, local, or 1645 tribal governments currently acts as accreditation bodies or TPCs, and none are 1646 anticipated to do so in the future, so the pr oposed rule would not re sult in expenditures by 1647 these government bodies. The costs of the proposed rule to the private sector are 1648 expected to be approximately $100,000 in the first year, and significantly less costly in 1649 subsequent years. Thus, this proposed rule is not subject to the re quirements of sections 1650 202 or 205 of UMRA. This proposed rule is also not subject to the requirements of 1651 section 203 of UMRA because it contains no regulatory requirements that might 1652 significantly or uniquely aff ect small governments. Since no State, local, or tribal 1653 governments are expected to act as accreditation bodies or TPCs. 1654 E. Executive Order 13132: Federalism 1655 This action does not have federalism implications because it will not have 1656 substantial direct effects on the States , on the relationship between the national 1657 government and the States, or on the distribut ion of power and res ponsibilities among the 1658 various levels of government, as speci fied in Executive Order 13132 (64 FR 43255, 1659 August 10, 1999). No States are expected to act as accreditation bodies or TPCs, and 1660 EPA would administer these requirements notthe States. The proposed rule would not 1661 impose substantial direct compliance costs on States. Furthermore, the proposed rule 1662 would not preempt State or local law. Thus , Executive Order 13132 does not apply to this 1663 action. Nonetheless, since Ca lifornia also has a program to regulate formaldehyde 1664 emissions from composite wood products, EPA held numerous consultations with 1665***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 73 of 101 [RIN 2070-AJ44] representatives of the California Air Res ources Board while developing this proposed 1666 rule. 1667 In the spirit of Executive Order 13132, and consistent with EPA policy to promote 1668 communications between EPA and State and lo cal governments, EPA specifically solicits 1669 comments on this proposed action fro m State and local officials. 1670 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 1671 Governments 1672 1673 This action does not have tribal impli cations as specified in Executive Order 1674 13175 (65 FR 67249, November 9, 2000). No Tribes are expected to act as accreditation 1675 bodies or TPCs, and EPA would administer these requirements not Tribes. Thus, 1676 Executive Order 13175 does not apply to this ac tion. EPA specifically solicits additional 1677 comment on this proposed acti on from tribal officials. 1678 G. Executive Order 13045: Protection of Protection of Children from Environmental 1679 Health Risks and Safety Risks 1680 1681 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as 1682 applying only to those regulatory actions that concern health or safety risks, such that the 1683 analysis required under sect ion 5-501 of the Executive Or der has the potential to 1684 influence the regulation. This action is not subject to Executive Order 13045, because it 1685 would not establish an environmental standard intended to mitigate health or safety risks. 1686 H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect 1687 Energy Supply, Distribution, or Use 1688 1689 This action is not a “significant energy action” as defined in Executive Order 1690 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse 1691 effect on the supply, distribution, or use of energy. Further, we have concluded that this 1692 rule is not likely to have any adverse ener gy affects because it sets up a framework for a 1693***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 74 of 101 [RIN 2070-AJ44] TSCA Title VI Third-Party Certification Pr ogram, and does not require any action related 1694 to the supply, distribution, or use of energy. 1695 I. National Technology Transfer and Advancement Act (NTTAA) 1696 Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use voluntary 1697 consensus standards in its regul atory activities unless to do so would be inconsistent with 1698 applicable law or otherwise impractical. Vo luntary consensus standards are technical 1699 standards (e.g., materials sp ecifications, test methods, sampling procedures, business 1700 practices, etc.) that are de veloped or adopted by voluntary consensu s standards bodies. 1701 NTTAA directs EPA to provide Congress, thro ugh OMB, explanations when the Agency 1702 decides not to use available and appli cable voluntary consensus standards. 1703 This proposed rule involves technical stan dards. EPA proposes to use voluntary 1704 consensus standards. The proposed framew ork of this TSCA Title VI Third-Party 1705 Certification Program is based on the ability of ABs to review TPCs for their conformity 1706 to ISO/IEC Guide 65:1996(E), ISO/ IEC 17025:2005(E), and ISO/IEC 17020:1998(E). 1707 Both Product ABs and Laboratory ABs would be required to maintain their conformity to 1708 ISO/IEC 17011:2004(E). 1709 EPA welcomes comments on this aspect of the proposed rule , and specifically 1710 invites the public to identify potentially ap plicable voluntary consen sus standards and to 1711 explain why such standards shoul d be used in the final rule. 1712 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 1713 Populations and Low-Income Populations 1714 1715 Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal 1716 executive policy on environmental justice. It s main provision directs federal agencies, to 1717 the greatest extent practicable and permitted by law, to make environmental justice part 1718***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 75 of 101 [RIN 2070-AJ44] of their mission by identifying and addressi ng, as appropriate, disproportionately high 1719 and adverse human health or environmental effects of their programs, policies, and 1720 activities on minority populations and low-income populations in the United States. 1721 EPA has determined that this proposed rule will not have disproportionately high 1722 and adverse human health or environmen tal effects on minority or low-income 1723 populations because it does not affect the leve l of protection provided to human health or 1724 the environment. This action proposes a sy stem whereby ABs accredits TPCs, and TPCs 1725 certify composite wood products in order to ensure compliance with the emissions 1726 standards in TSCA Title VI. This action does not relax a pollution control measure and 1727 therefore will not cause emissions increases. 1728 List of Subjects in 40 CFR Part 770 1729 Environmental protection, Composite wood products, Formaldehyde, Reporting 1730 and recordkeeping, Thir d-party certification. 1731
1732 Dated: ____________________ 1733

1734

_________________________________________________ 1735 Administrator. 1736
1737***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 76 of 101 [RIN 2070-AJ44] Therefore, it is proposed that 40 CFR ch apter I, subchapter R, be amended by 1738 adding a new part 770 to read as follows: 1739 PART 770--FORMALDEHYDE STAN DARDS FOR COMPOSITE WOOD 1740 PRODUCTS 1741 1742 Subpart A--General Provisions 1743 Sec. 1744 770.1 Scope and applicability. 1745 770.2 Effective dates. 1746 770.3 Definitions. 1747 Subpart B--Third-Party Certification Program 1748 770.7 Third-party certification. 1749 770.9 Prohibited acts. 1750 Subpart C--[Reserved] 1751 Subpart D--Incorporation by Reference 1752 770.99 Incorporation by reference. 1753 1754 Authority : 15 U.S.C. 2697(d). 1755 Subpart A--General Provisions 1756 § 770.1 Scope and applicability. 1757 (a) This subpart applies to: 1758 (1) Laboratory Accreditation Bodies (A Bs) and Product ABs that are accrediting 1759 third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 2697(d)) purposes and those 1760 that wish to commence accrediting third-part y certifiers for TSCA Title VI purposes. 1761 (2) TPCs that are certifying compos ite wood products for TSCA Title VI 1762 compliance and those that wish to comme nce certifying composite wood products for 1763 TSCA Title VI compliance. 1764 (b) [Reserved] 1765 § 770.2 Effective dates. 1766 (a) Laboratory and Product ABs that wish to accredit TPCs for TSCA Title VI 1767 purposes may apply to EPA to become recognized beginning on [ date of publication of 1768***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 77 of 101 [RIN 2070-AJ44] the final rule in the Federal Register ]. Laboratory and Product ABs must be recognized 1769 by EPA before they begin providing TSCA Title VI accreditation services. 1770 (b) TPCs that wish to provide TSCA Title VI certification services must meet all 1771 the requirements of this subpart before they commence providing TSCA Title VI 1772 certification services. 1773 (c) Notwithstanding any othe r provision of this subpart , TPCs that are approved 1774 by the California Air Resources Board to certify composite wood products have until 1775 [ date 1 year after date of publica tion of the final rule in the Federal Register ] to become 1776 accredited pursuant to the requirements of this subpart. During the year following [ date of 1777 publication of the final rule in the Federal Register ], the California Air Resources 1778 Board-approved TPCs may carry out certi fication activities under TSCA Title VI, 1779 provided that they are compliant with all other aspects of TSCA Title VI and the 1780 regulations promulgated thereunder. Third-pa rty certifiers that ar e certifying products as 1781 compliant with TSCA Title VI are subject to enforcement actions for any violations of 1782 TSCA Title VI or the regulat ions promulgated thereunder. 1783 § 770.3 Definitions. 1784 Accreditation Body or AB means an organization that provides an impartial 1785 verification of the competen cy of conformity assessment bodies such as TPCs. 1786 Composite wood product means hardwood plywood, medium-density fiberboard, 1787 and particleboard. 1788 EPA Recognized Laboratory Accreditation Body or EPA Recognized Laboratory 1789
AB means a Laboratory AB that has a rec ognition agreement with EPA under the TSCA 1790 Title VI Third-Party Certification Program. 1791***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 78 of 101 [RIN 2070-AJ44] EPA Recognized Product Accreditation Body or EPA Recognized Product AB 1792 means a Product AB that has a recognition ag reement with EPA under the TSCA Title VI 1793 Third-Party Certification Program. 1794 Laboratory Accreditation Body orLaboratory AB means an accreditation body 1795 that accredits laboratories to ISO/IEC 17025:2005(E) (incorporat ed by reference, see § 1796 770.99). 1797 Panel producer means a manufacturing plant or other facility that manufactures 1798 (excluding imports) hardwood plywood, particle board, or medium density fiberboard. 1799 Product Accreditation Body or Product AB means an accreditation body that 1800 accredits conformity assessment bodies to ISO/IEC Guide 65:1996(E) (incorporated by 1801 reference, see § 770.99) and ISO/IEC 17020:1998( E) (incorporated by reference, see § 1802 770.99). 1803 TSCA Title VI Accredited Third-Party Certifier orTSCA Title VI Accredited TPC 1804 means an organization or entity that is accredited by an EPA recognized Product AB and 1805 an EPA recognized Laboratory AB pursuant to § 770.7 (c)(1). 1806 Subpart B—TSCA Title VI Third- Party Certification Program 1807 § 770.7 Third-party certification. 1808 (a) Product ABs-- (1) Qualifications. To apply to be recognized by EPA as a 1809 Product AB, a candidate Product AB must: 1810 (i) Be a signatory to th e International Accreditation Forum, Inc.’s (IAF) 1811 Multilateral Recognitio n Arrangement (MLA) through level 3, or an equivalent 1812 organization. 1813 (ii) Be in conformance with ISO/IE C 17011:2004(E) (incorporated by reference, 1814***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 79 of 101 [RIN 2070-AJ44] see § 770.99) and maintain that conformity. 1815 (iii) Demonstrate basic competence to pe rform accreditation activities for product 1816 certification according to ISO/IEC Guide 65:199 6(E) (incorporated by reference, see § 1817 770.99). 1818 (iv) Demonstrate competence to perform accreditation activities for inspection 1819 certification according to ISO/IEC 17020:1998(E) (incorporated by reference, see § 1820 770.99). 1821 (2) Recognition. To be recognized by EPA, a Product AB must apply to EPA by 1822 fulfilling the requirements in the paragraphs (a)(2)(i)-(ii) of this section: 1823 (i) Submitting an application to the EPA with the following information: 1824 (A) Name, address, telephone number, and email address of primary contact. 1825 (B) Documentation of its IAF MLA signatory status, or equivalent. 1826 (C) If not a domestic entity, name and a ddress of an agent for service located in 1827 the United States. Service on this agent cons titutes service on the AB or any of its 1828 officers or employees for any action by EPA or otherwise by the United States related to 1829 the requirements of this subpart. 1830 (D) Description of any other qualifications related to its experience in performing 1831 product accreditation of conf ormity assessment bodies or TPCs of manufactured 1832 products. 1833 (ii) Entering into a recognition agreem ent with EPA that describes the Product 1834 AB’s responsibilities under this subpart. 1835 (A) Each recognition agreemen t will be valid for 3 years. 1836***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 80 of 101 [RIN 2070-AJ44] (B) To renew a recognition agreement fo r additional 3 year periods, the Product 1837 AB must submit an application for renewal (before the 3 year period of the recognition 1838 agreement lapses) that indicates any changes from the Product AB’s initial application. 1839 (C) If a Product AB fails to submit an application for renewal prior to the 1840 expiration of the previous recognition agr eement, its recognition will lapse and the 1841 Product AB may not provide TSCA Title VI accreditation services. 1842 (D) If the Product AB does submit an application for renewal prior to the 1843 expiration of the previous recognition agreemen t, it may continue to provide TSCA Title 1844 VI accreditation services under the terms of its previous recognition agreement until EPA 1845 has taken action on its app lication for renewal of th e recognition agreement. 1846 (3) Responsibilities . EPA recognized Product ABs must fulfill the requirements in 1847 paragraphs (a)(3)(i)-(xiv) of this section: 1848 (i) Receive and act on applicati ons for accreditation from TPCs. 1849 (ii) Assign a unique number to each accredited TPC. 1850 (iii) Forward a copy of a TPC’s applic ation for TSCA Title VI accreditation to 1851 EPA at the address identified in the recognition agreement with in 90 days of the date of 1852 receipt. 1853 (iv) Perform an in-depth systems audit, as described in this unit, on each TPC 1854 applicant who submits a complete applicati on at the time of initial application. The 1855 systems audit must include the components desc ribed in paragraphs (3 )(iv)(A)-(F) of this 1856 section: 1857 (A) An on-site assessment by the Produc t AB to determine whether the TPC 1858 applicant’s program requirements are cons istent with ISO/IEC Guide 65:1996(E) and 1859***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 81 of 101 [RIN 2070-AJ44] ISO/IEC 17020:1998(E) (incorporated by refere nce, see § 770.99). The Product AB must 1860 develop a checklist that list s all of the key conformity elements of ISO/IEC Guide 1861 65:1996(E) and ISO/IEC 17020:1998( E) (incorporated by refe rence, see § 770.99) and 1862 the Product ABs must use the checkl ist for each on-site assessment. 1863 (B) A review of the approach that th e TPC applicant will use to verify the 1864 accuracy of the formaldehyde emissions tests conducted by the TPC laboratory or 1865 contract laboratory and the formaldehyde qua lity control tests conducted by the panel 1866 producers producing composite wood products th at are subject to the requirements of 1867 TSCA Title VI. 1868 (C) A review of the approach that th e TPC applicant will use for evaluating a 1869 panel producer’s quality assuranc e and quality control processes, the qualifications of the 1870 panel producer’s quality assuranc e and quality control personnel, the required elements of 1871 a panel producer’s quality a ssurance and quality control ma nual, and sufficiency of on1872 site testing facilities as applicable. 1873 (D) A review of the approach that th e TPC applicant’s laboratory will use for 1874 establishing correlation or e quivalence between alternative formaldehyde test methods 1875 and ASTM E1333-10 (incorporated by reference, see § 770.99). 1876 (E) A review of the approach that th e TPC applicant will use for evaluating the 1877 process for sample selection, handling, and sh ipping procedures, if applicable, that the 1878 panel producer will use for quality control testing. 1879 (F) A review of the accreditation creden tials of the laboratory that the TPC 1880 applicant will use. The review must ensure that the laboratory ha s been accredited to 1881 ISO/IEC 17025:2005(E) (incorporated by refere nce, see § 770.99) by a Laboratory AB 1882***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 82 of 101 [RIN 2070-AJ44] that is a signatory to th e ILAC MRA or equivalent. 1883 (v) Upon request, allow EPA representative s to accompany its assessors during an 1884 on-site assessment to observe the audit of a TPC. 1885 (vi) Accredit TPCs that submit a co mplete application as described in § 1886 770.7(c)(1)(i) and that meet the requirements of § 770.7(c). 1887 (vii) Conduct a follow-up systems audit, in cluding an on-site assessment, of each 1888 TPC that the AB has accredited at least every 2 years. 1889 (viii) Suspend, modify, or revoke the accreditation of a TPC in accordance with § 1890 770.7(e). 1891 (ix) Provide written notifications to EPA at the address identified in the 1892 recognition agreement, as follows: 1893 (A) Notification of loss of its status as a signatory to the IAF MLA (or 1894 membership in an equivalent organization) must be provided to EPA within 5 business 1895 days of the date that the body receives notification of the loss of its signatory status. 1896 (B) Notification of the TSCA Title VI acc reditation of a TPC must be provided to 1897 EPA within 5 business days of the date that the TPC is accredited. 1898 (C) Notification that an accredited TPC ha s failed to comply with any provision 1899 of this section must be provided to EPA within 24 hours of the time the Product AB 1900 identifies the failure. 1901 (D) Notification of suspension or revo cation of a TPC’s accreditation must be 1902 provided to EPA within 24 hours of the time that the suspension or revocation takes 1903 effect. 1904 (E) Notification of a decision to make changes in its organizational policies or 1905***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 83 of 101 [RIN 2070-AJ44] management structure that could adversely a ffect the TPC accreditation program must be 1906 provided to EPA within 30 days of th e decision to make the changes. 1907 (x) If the Product AB is removed or withdraws from the TSCA Title VI Third1908 Party Certification Program, notification must be given to all of the TPCs that receive its 1909 accreditation services within 5 business days. 1910 (xi) Maintain the checklists and other records documenting compliance with the 1911 requirements for systems audits and on-site assessments of TPCs for as long as the TPC 1912 is accredited or for 5 years, whichever is lon ger. 3 years. These records must be in 1913 electronic form, and the Product AB must provide them to EPA within 30 days upon 1914 request. 1915 (xii) Provide a report to EPA at least once each year (12 months from the 1916 anniversary of the date of the recognition agreement), that incl udes the number and 1917 locations of systems audits a nd on-site assessments performed. 1918 (xiii) Meet with EPA at least once ever y 2 years to discuss the implementation of 1919 the TPC accreditation program. 1920 (xiv) Allow inspections by EPA, conducte d at reasonable times, within reasonable 1921 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and a 1922 written notification to the Product AB. 1923 (b) Laboratory ABs --(1) Qualifications. To apply to be recognized by EPA as a 1924 Laboratory AB, a candidate Laboratory AB must: 1925 (i) Be a signatory to the ILAC MR A, or an equivale nt organization. 1926 (ii) Be in conformance with ISO/IE C 17011:2004(E) (incorporated by reference. 1927 see § 770.99) and maintain that conformity. 1928***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 84 of 101 [RIN 2070-AJ44] (iii) Demonstrate competence to perfor m accreditation activities for laboratory 1929 accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see § 1930 770.99). 1931 (2) Recognition. To be recognized by EPA, a Labo ratory AB must apply to EPA 1932 by fulfilling the requirements in paragra phs (b)(2)(i)-(ii) of this section: 1933 (i) Submit an application to the EPA with the information listed in paragraphs 1934 (b)(2)(i)(A)-(D) of this section (if the accredita tion body is also applying to be recognized 1935 as a Product AB, this application may be submitted in conjunction with the Product AB 1936 application): 1937 (A) Name, address, telephone number, and email address of primary contact. 1938 (B) Documentation of ILAC MRA si gnatory status, or equivalent. 1939 (C) If not a domestic entity, name and a ddress of an agent for service located in 1940 the United States. Service on this agent cons titutes service on the AB or any of its 1941 officers or employees for any action by EPA or otherwise by the United States related to 1942 the requirements of this subpart. 1943 (D) Description of any other qualifications related to the Laboratory AB’s 1944 experience in performing laboratory accred itation and inspection certification of 1945 conformity assessment bodies or TPCs. 1946 (ii) Enter into a recognition agreement with EPA that describes the Laboratory 1947 AB’s responsibilities under this subpart. 1948 (A) Each recognition agreement will be valid for 3 years. 1949 (B) To renew a recognition agreemen t for additional 3 year periods, the 1950 Laboratory AB must submit an application fo r renewal (before the 3 year period of the 1951***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 85 of 101 [RIN 2070-AJ44] recognition agreement lapses) that indicates any changes from the Laboratory AB’s 1952 initial application. 1953 (C) If the Laboratory AB does submit an application for renewal prior to the 1954 expiration of the previous recognition agreemen t, it may continue to provide TSCA Title 1955 VI accreditation services under the terms of its previous recognition agreement until EPA 1956 has taken action on its app lication for renewal of th e recognition agreement. 1957 (3) Responsibilities . EPA recognized Laborator y ABs must fulfill the 1958 requirements in paragraphs (b)(3)( i)-(xiii) of this section: 1959 (i) Receive and act on applications for laboratory accreditation from TPC 1960 laboratories (including c ontract laboratories). 1961 (ii) Within 15 days of a request by a TPC or their EPA recognized Product AB, 1962 forward copies of a TPC’s TSCA Title VI laboratory application and accreditation 1963 documentation to the applicable EPA recogni zed Product AB (if the Laboratory AB is 1964 not also recognized as a Product AB) at the address identified by the TPC. 1965 (iii) Perform an in-depth systems audit on the laboratory of each TPC applicant 1966 who submits a complete application at the time of initial applicat ion. The systems audit 1967 must include: 1968 (A) An on-site assessment by the Laborat ory AB to determine whether the TPC 1969 applicant’s laboratory is consistent with all regulatory requirements and ISO/IEC 1970 17025:2005(E) (incorporated by reference, see § 770.99). 1971 (B) Include a checklist that lists all of the key conformity elements of ISO/IEC 1972 17025:2005(E) (incorporated by reference, see § 770.99) and the Laboratory AB’s 1973 assessors must use the checklist for each on-site assessment. 1974***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 86 of 101 [RIN 2070-AJ44] (iv) Upon request, allow EPA representa tives to accompany its assessors during 1975 an on-site assessment to obs erve the audit of a TPC. 1976 (v) Accredit laboratories that submit a complete application as described in 1977 § 770.7(c)(1)(ii) and that continue to meet the requirements of § 770.7(c). 1978 (vi) Verify the accuracy of the form aldehyde emissions tests conducted by the 1979 TPC laboratory through an inter- laboratory comparison or prof iciency testing program if 1980 available. 1981 (vii) Conduct a follow-up systems audit at least every 2 years, including an on-site 1982 assessment, of each TPC laboratory that the accreditation body has accredited. TPCs’ 1983 laboratories that have not adequately pe rformed an inter-laboratory comparison or 1984 proficiency testing must be audited at least once each year for a period of 2 years from 1985 the date of the latest poor proficiency test or inter-laboratory comparison. 1986 (viii) Suspend, modify, or revoke the accreditation of TPCs’ laboratories in 1987 accordance with § 770.7(e). 1988 (ix) Provide the following written notifi cations to EPA and to the applicable EPA 1989 recognized Product AB (if the Laboratory AB is not also recognized as a Product AB) at 1990 the address identified in the recognition agreement: 1991 (A) Notification of loss of its status as a signato ry to the ILAC MRA, or 1992 membership in an equivalent organization, mu st be provided within 5 business days of 1993 the date that the body receives notice of the loss of its signatory status. 1994 (B) Notice of accreditation of a TPC’s laboratory must be provided within 5 1995 business days of the date that the laboratory is accredited. 1996 (C) Notice that an accredited laboratory ha s failed to comply with any provision 1997***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 87 of 101 [RIN 2070-AJ44] of this section must be pr ovided within 24 hours of the tim e the Laboratory AB identifies 1998 the failure. 1999 (D) Notice that an accredited TPC has faile d to comply with any provision of this 2000 section must be provided within 24 hours of the time the Laboratory AB identifies the 2001 failure. 2002 (E) Notice of a decision to make cha nges in its organizational policies or 2003 management structure that could adversely affect the laboratory accreditation program 2004 must be provided to EPA within 30 days of the decision to make the changes. 2005 (F) Notice if the Laboratory AB suspends or revokes a labora tory’s accreditation 2006 must be provided within 24 hours of the ti me that the suspension or revocation takes 2007 effect. 2008 (x) Maintain checklists and other records documenting compliance with the 2009 requirements for systems audits and on-site a ssessments of laboratorie s must be retained 2010 for as long as the laboratory is accredited or for 5 years, whichever is longer. 3 years. 2011 These records must be in electronic form and provided to EPA within 30 days of request. 2012 (xi) Provide a report to EPA at least once each year (12 months from the date of 2013 the recognition agreement) that in cludes the following information: 2014 (A) The names and contact information of all the TSCA Title VI accredited TPC 2015 laboratories. 2016 (B) Number and locations of systems a udits and on-site assessments performed. 2017 (C) Results of inter-laboratory comparis ons or proficiency testing for each of the 2018 AB’s TSCA Title VI accredited TPC laborat ories, if such an EPA recognized inter2019 laboratory comparisons orproficiency testing program is available. 2020***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 88 of 101 [RIN 2070-AJ44] (xii) Meet with EPA at least once every 2 years to discuss the implementation of 2021 the laboratory accreditation program. 2022 (xiii) Allow inspections by EPA, conduc ted at reasonable times, within reasonable 2023 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and 2024 written notice to the labo ratory accreditation body. 2025 (c) Third-party certifiers-- (1) Qualifications . In order to participate as a TPC of 2026 composite wood products under TSCA Title VI, a TPC must apply to an EPA recognized 2027 Product AB. In its application the TPC must demonstrate that it has been accredited by an 2028 EPA recognized Laboratory AB, unless the TPC is applying to an EPA recognized 2029 Product AB that is also an EPA recognized Laboratory AB and the TPC is seeking both 2030 accreditations from this single AB. In such a case, the TPC will obtain the required 2031 product and laboratory accr editations pursuant to IS O/IEC Guide 65:1996(E) and 2032 ISO/IEC 17025:2005(E), respectively, from the EPA recognized Product AB. 2033 (i) To participate in the TSCA Title VI Third-Party Certification Program, a TPC 2034 must submit an application to an EPA recognized Product AB every 2 3 years that 2035 includes the elements in paragraphs (c)(1)(i)(A)-(D) of this section: 2036 (A) Name, address, telephone number, and email address of primary contact. 2037 (B) If not a domestic entity, name and a ddress of an agent for service located in 2038 the United States. Service on this agent cons titutes service on the TPC or any of its 2039 officers or employees for any action by EPA or otherwise by the United States related to 2040 the requirements of this subpart. 2041 (C) Type of composite wood products th at the applicant in tends to certify if 2042 accredited. 2043***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 89 of 101 [RIN 2070-AJ44] (D) Description of the TPC’s qualifica tions, including indica tions that the TPC 2044 has: 2045 ( 1 ) Experience or ability in product certification and complying with ISO/IEC 2046 Guide 65:1996(E) (incorporatedby reference, see § 770.99). 2047 ( 2 ) Experience in the composite wood product industr y with the specific 2048 product(s) the applicant intends to certify. 2049 ( 3 ) Ability to conduct inspections and pr operly train and supervise inspectors 2050 pursuant to ISO/IEC 17020:1998(E) (incor porated by referen ce, see § 770.99). 2051 (ii) To be accredited by a laborat ory accreditation body under TSCA Title VI, a 2052 TPC or its laboratories must submit an app lication to an EPA r ecognized Laboratory AB 2053
every 2 3 years that includes the elements in para graphs (c)(1)(ii)(A)-(C) of this section: 2054 (A) Name, address, telephone number, and email address of primary contact. 2055 (B) If not a domestic entity, name and a ddress of an agent for service located in 2056 the United States. Service on this agent cons titutes service on the TPC or any of its 2057 officers or employees for any action by EPA or otherwise by the United States related to 2058 the requirements of this subpart. 2059 (C) Description of the TPC’s laborator y’s qualifications, including indications 2060 that the TPC’s laboratory has: 2061 ( 1 ) Experience in performing or verifying formaldehyde testing on composite 2062 wood products. 2063 ( 2 ) Experience complying with IS O/IEC 17025:2005(E) (incorporated by 2064 reference, see § 770.99). 2065 ( 3 ) Experience with test method ASTM E 1333-10 (incorporated by reference, see 2066***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 90 of 101 [RIN 2070-AJ44] § 770.99) and experience evaluating correlation between test methods. 2067 (2) Responsibilities. To maintain participation in the TPC TSCA Title VI 2068 program, TSCA Title VI accredited TPCs must fulfill the requirements in 2069 paragraphs(c)(2)(i)-(xvi) of this section: 2070 (i) Verify that panel producers have adequate quality assurance and quality 2071 control procedures and are complying with applicable quality assurance and quality 2072 control requirements pursuant to TSCA Title VI, including the requirements of this 2073 subpart. 2074 (ii) Verify quality control test results compared with ASTM E1333-10 2075 (incorporated by reference, s ee § 770.99) test results by ha ving TPC laboratories conduct 2076 quarterly tests and evaluate test method equivalence. 2077 (iii) Review applications from panel producers for reduced testing, approve an 2078 application within 90 days of receipt if it demonstrates that the requirements for reduced 2079 testing under TSCA Title VI are met, and notif y EPA of all approvals for reduced testing 2080 within 5 days of the approval, and forward copies of all approved applications for 2081 reduced test to EPA within 30 days of receipt. 2082 (iv) Establish quality co ntrol limits in consultation with panel producers and, if 2083 applicable, shipping quality control or othe r limits for each panel producer, product type, 2084 and production line. 2085 (v) Establish for each panel producer the pr ocess that will be us ed to determine if 2086 product lots are exceeding the a pplicable quality control limit. 2087 (vi) Inspect and audit pa nel producers and products a nd their records at least 2088 quarterly and pursuant to ISO/IEC 17020:1998( E) (incorporated by reference, see § 2089***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 91 of 101 [RIN 2070-AJ44] 770.99). 2090 (vii) Use only laboratories that have been accredited by an EPA recognized 2091 Laboratory AB and participat e in an EPA-approved inter-laboratory comparison or 2092 proficiency testing program and ensure the results of the EPA-a pproved inter-laboratory 2093 comparison or proficiency testing progr am are provided to the Laboratory AB. 2094 (viii) Certify composite wood product t ypes that comply with the emission 2095 standards of TSCA Title VI and this subpart, following ISO/IEC Guide 65:1996(E) 2096 (incorporated by refere nce, see § 770.99). 2097 (ix) Provide its accred itation number to the panel producer for labeling and 2098 recordkeeping. 2099 (x) Maintain the following records, in electronic form, for 5 3 years from the date 2100 the record is created, and provide them to EPA within 30 days of the request: 2101 (A) A list of panel producers and their re spective product types, including resins 2102 used, that the TPC has certified. 2103 (B) Results of inspections , audits, and emission tests conducted for and linked to 2104 each panel producer and product type. 2105 (C) A list of laboratories used by the TPC, as well as test methods, including test 2106 conditions and conditioning time, and test results. 2107 (D) Methods and results for establishing test method corr elations and equivalence. 2108 (xi) Provide an annual re port to its accreditation b ody or bodies (Product AB and 2109 Laboratory AB) and to EPA th at contains the following: 2110 (A) A list of panel producers and their pr oducts that the TPC has certified during 2111 the previous year, including resins used and the average and range of formaldehyde 2112***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 92 of 101 [RIN 2070-AJ44] emissions by panel producer, resin, and product type. 2113 (B) A list of any non-complying produc ts or events by panel producers. 2114 (C) A list of laboratories and te st methods used by the TPC. 2115 (xii) Inform its accred itation body or bodies (ProductAB and Laboratory AB) 2116 within 30 days of any changes in personnel qualifications, procedur es, or laboratories 2117 used by the TPC. 2118 (xiii) Allow inspections by EPA, conduc ted at reasonable times, within reasonable 2119 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and 2120 of a written notice to the TPC. 2121 (xiv) If not a domestic entity, the TPC mu st maintain an agent for service located 2122 in the United States and notify EPA of any ch anges in the name or address of that agent 2123 within 5 business days. 2124 (xv) Participate an inte r-laboratory comparison or pr oficiency testing program 2125 annually, or use only contract laboratories that partic ipate in such a program. 2126 (xvi) If a TPC or its labo ratory loses its accreditation or discontinues participation 2127 in the program for any reason, it must notify EP A and all the panel pr oducers it provides 2128 TSCA Title VI certification services to within 3 business days. 2129 (d) Third-party certifiers approved by th e California Air Resources Board. TPCs 2130 approved by the California Ai r Resources Board as of [ date 60 days after date of 2131 publication of the final rule in the Federal Register ] may certify composite wood 2132 products under TSCA Title VI until [ date 1 year after date of pub lication of the final rule 2133 in the Federal Register ] as long as they remain approved by the California Air 2134 Resources Board for that period and comply with all aspects of this subpart other than the 2135***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 93 of 101 [RIN 2070-AJ44] accreditation requirements of paragraph (c)(1) of this section. In lieu of the accreditation 2136 number required to be provided according to paragraph (c)(2)(ix) of this section, a TPC 2137 approved by CARB according to this section must provide the panel producer with the 2138 TPC number issued by CARB. For a TPC a pproved by CARB according to this section, 2139 the annual report under paragraph (c )(2)(xi) of this section must be provided to CARB in 2140 lieu of the AB. After [ date 1 year after date of publica tion of the final rule in the Federal 2141 Register ], no TPC may certify composite wood pr oducts under TSCA Title VI unless the 2142 TPC is accredited in accordance with pa ragraph (c)(1) of this section. 2143 (e) Suspension, revocation, or modification of recognition or accreditation-- (1) 2144 Third-party certifiers. EPA or an AB may suspend, revoke, or modify the accreditation of 2145 a TPC or a TPC laboratory, if the TPC or TPC laboratory: 2146 (i) Fails to comply with any requirement of TSCA T itle VI or this subpart; 2147 (ii) Makes any false or misleading stat ements on its applic ation, records, or 2148 reports; or 2149 (iii) Makes substantial changes to personnel qualifications, procedures, or 2150 laboratories that make the TPC or TPC laborat ory unable to comply with any applicable 2151 requirements of this subpart. 2152 (2) ABs. EPA may suspend, revoke, or modify th e recognition of an AB if the AB: 2153 (i) Fails to comply with the requi rements of the applicable recognition 2154 agreement(s) (the International Accreditation Forum Multilateral Recognition 2155 Arrangement and the International Labor atory Accreditation Cooperation Mutual 2156 Recognition Agreement or equivalent(s)); 2157 (ii) Fails to comply with any requireme nt of TSCA Title VI or this subpart; 2158***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 94 of 101 [RIN 2070-AJ44] (iii) Makes any false or misleading stat ements on its applic ation, records, or 2159 reports; or 2160 (iv) Makes substantial ch anges to personnel qualificati ons or procedures that 2161 make the TPC unable to comply with any a pplicable requirements of this subpart. 2162 (3) Process for suspending, revoking, or modifying accreditation or recognition. 2163 (i) Prior to taking action to susp end, revoke, or modify accreditation or 2164 recognition, EPA or the accreditation body w ill notify the recognized AB or the 2165 accredited TPC or TPC laboratory in writing of the following: 2166 (A) The legal and factual basis for the proposed suspension, revocation, or 2167 modification. 2168 (B) The anticipated commencement date and duration of the suspension, 2169 revocation, or modification. 2170 (C) Actions, if any, which the affected AB or TPC or TPC laboratory may take to 2171 avoid suspension, revocation, or modification, or to receive accreditation in the future. 2172 (D) The opportunity and method for request ing a hearing with EPA prior to final 2173 suspension, revocation, or modification. 2174 (ii) If the affected AB or TPC or TPC laboratory requests a he aring in writing to 2175 EPA within 30 days of receipt of the notification, EPA will: 2176 (A) Provide the affected accreditatio n body or TPC or TPC laboratory an 2177 opportunity to offer written statements in re sponse to EPA’s or the accreditation body’s 2178 assertions of the legal and fact ual basis for the proposed action. 2179 (B) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 2180 The Presiding Officer will: 2181***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 95 of 101 [RIN 2070-AJ44] ( 1 ) Conduct a fair, orderly, and impartial hearing within 90 days of the request for 2182 a hearing. 2183 ( 2 ) Consider all relevant evidence, explanation, comment, and argument 2184 submitted. 2185 ( 3 ) Notify the affected AB or TPC or TPC laboratory in writing within 90 days of 2186 completion of the hearing of his or her decisi on and order. Such an order is a final EPA 2187 action which may be subject to judicial review. The order must contain the basis, 2188 commencement date, and duration of the suspension, revocation, or modification. 2189 (iii) If EPA determines that the publi c health, interest, or welfare warrants 2190 immediate action to suspend the recognition of an AB or the accreditation of a TPC or 2191 TPC laboratory prior to the opportunity for a hearing, it will notify the affected AB, TPC, 2192 or TPC laboratory of its rightto request a hearing on the immediate suspension within 15 2193 days of the suspension taking place and the pr ocedures for the conduct of such a hearing. 2194 (iv) Any notification, decision, or order issued by EPA under this section, any 2195 transcript or other verbatim record of or al testimony, and any documents filed by a 2196 certified individual or firm in a hearing under th is section will be available to the public, 2197 except as otherwise provided by TSCA sec tion 14. Any such hearing at which oral 2198 testimony is presented will be open to the publ ic, except that the Presiding Officer may 2199 exclude the public to the extent necessary to allow presentation of information which 2200 may be entitled to confidential treatment under TSCA section 14. 2201 (v) EPA will maintain a publicly ava ilable list of accreditation bodies whose 2202 recognition has been suspended, revoked, modifie d, or reinstated and a publicly available 2203 list of TPCs and laboratories whose accredita tion has been suspended, revoked, modified, 2204***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 96 of 101 [RIN 2070-AJ44] or reinstated. 2205 (vi) Unless the decision and order issu ed under this paragraph (d)(3) of this 2206 section specify otherwise, an AB whose r ecognition has been revoked or a TPC or TPC 2207 laboratory whose accreditation has been revoked must reapply for recognition or 2208 accreditation after the revocation ends in order to become recognized or accredited under 2209 this subpart again. 2210 (vii) Unless the decision and order issuedunder paragraph (d)(3) of this section 2211 specifies otherwise, an AB whose rec ognition has been revoked or a TPC or TPC 2212 laboratory whose accreditation has been revoke d, must immediately notify all TPCs or 2213 panel producers to which it provides TSCA Title VI accreditation or certification services 2214 of the revocation. 2215 (f) Process for denying a TSCA Title VI accreditation-- (1) Upon denying to 2216 accredit a TPC or a TPC laboratory for failure to submit a complete application, the 2217 accreditation body will notify the TPC or TPC laboratory in writing of the following: 2218 (i) The legal and factua l basis for the denial. 2219 (ii) Actions, if any, which the affected TPC or TPC laboratory may take to receive 2220 accreditation in the future. 2221 (iii) The opportunity and method fo r requesting a hearing with EPA. 2222 (2) If the affected TPC or TPC laborat ory requests a hearing in writing to EPA 2223 within 30 days of receipt of the notice, EPA will: 2224 (i) Provide the affected TPC or TPC la boratory an opportunity to offer written 2225 statements in response to the lega l and factual basis for the denial. 2226 (ii) Appoint an impartial EPA official as Presiding Of ficer to conduct the hearing. 2227***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 97 of 101 [RIN 2070-AJ44] The Presiding Officer will: 2228 (A) Conduct a fair, orderly, and impartial hearing within 90 days of the request 2229 for a hearing. 2230 (B) Consider all relevant eviden ce, explanation, comment, and argument 2231 submitted. 2232 (C) Notify the affected TPC or TPC laboratory in writing within 90 days of 2233 completion of the hearing of his or her decision and order. Such an order is a final agency 2234 action which may be subject to judicial review. The order mu st contain the basis for the 2235 denial. 2236 (3) Any notification , decision, or order issued by EPA under this section, any 2237 transcript or other verbatim record of or al testimony, and any documents filed by a 2238 certified individual or firm in a hearing under th is section will be available to the public, 2239 except as otherwise provided by TSCA sec tion 14. Any such hearing at which oral 2240 testimony is presented will be open to the publ ic, except that the Presiding Officer may 2241 exclude the public to the extent necessary to allow presentation of information which 2242 may be entitled to confidential treatment under TSCA section 14. 2243 (g) Process of seeking alternate accreditations or certification s--(1) If AB is 2244 removed or withdraws from the TSCA Title VI Third-Party Certification Program: 2245 (i) For reasons other than fraud or providing false ormisleading statements, or 2246 other than a reason that implicates a particular TPC in a violation of TSCA Title VI or its 2247 implementing regulations, TPCs accredited by th at AB have 365 days, or 180 days if less 2248 than 365 days were left on their 2 3 year accreditation period, to be accredi ted again by an 2249 alternate EPA recognized AB. 2250***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 98 of 101 [RIN 2070-AJ44] (ii) Due to fraud or providing false or misleading statements with respect to a 2251 particular TPC, or for any other reason that im plicates a particular TPC in a violation of 2252 TSCA Title VI or its implementing regulat ions, that TPC may not provide any TSCA 2253 Title VI certification services until it has b een accredited by an alternate EPA recognized 2254
AB. 2255 (2) If a TPC loses its accr editation or discontinues part icipation in the program: 2256 (i) For reasons other than fraud or pr oviding false or misleading statements, or 2257 other than a reason that impli cates a particular panel produc er in a violation of TSCA 2258 Title VI or its implementing regulations, the panel producers that used the TPC to certify 2259 their products must enlist another TPC to certi fy their products within 3 months (90 days) 2260 . During the time a panel producer is seeking a new TPC, it must continue to comply with 2261 all other requirements of TSCA Title VI and its implementing regulations, including 2262 quality control testing. 2263 (ii) Due to fraud or providing false or misleading statements with respect to a 2264 particular panel producer, or for any other r eason that implicates a particular panel 2265 producer in a violation of TSCA Title VI or its implementing regulations, that panel 2266 producer may not offer regulated composite w ood products for sale in the United States 2267 until its composite wood products have been recertified by another TPC. 2268 § 770.9 Prohibited Acts. 2269 (a) Failure or refusal to comply with any requirement of TSCA section 601 (15 2270 U.S.C. 2697) or this subpart part is a vi olation of TSCA section 15 (15 U.S.C. 2614). 2271***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 99 of 101 [RIN 2070-AJ44] (b) Failure or refusal to establish and ma intain records or to make available or 2272 permit access to or copying of records, as requir ed by this subpart, is a violation of TSCA 2273 section 15 (15 U.S.C. 2614). 2274 (c) Violators may be subject to civil a nd criminal sanctions pursuant to TSCA 2275 section 16 (15 U.S.C. 2615) for each violation. 2276 Subpart C--[Reserved] 2277 Subpart D--Incorporation by reference 2278 § 770.99 Incorporation by reference. 2279 The materials listed in this section are in corporated by reference into this part 2280 with the approval of the Director of the Fe deral Register under 5 U.S.C. 552(a) and 1 2281 CFR part 51. To enforce any edition other than that specified in th is section, a document 2282 must be published in the Federal Register and the material must be available to the 2283 public. All approved materials are available fo r inspection at the OPPT Docket in the 2284 EPA Docket Center (EPA/DC) at Rm. 3334, EPA, West Bldg., 1301 Constitution Ave., 2285 NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 2286 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 2287 number of the EPA/DC P ublic Reading room is (202) 566-1744, and the telephone 2288 number for the OPPT Docket is (202) 566-0280. In addition, these materials are 2289 available for inspection at the National Ar chives and Records Ad ministration (NARA). 2290 For information on the availability of this material at NARA, call (202) 741-6030 or go to 2291 http://www.archives.gov/federal_regi ster/code_of_fede ral_regulations/ 2292 ibr_locations.html. These materials may also be obtaine d from the sources listed in this 2293 section. 2294***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 100 of 101 [RIN 2070-AJ44] (a) [Reserved] 2295 (b) ASTM material . Copies of these materials may be obtained from ASTM 2296 International, 100 Barr Harbor Dr., PO Box C700, West Conshohocken, PA, 19428-2959, 2297 or by calling (877) 909-ASTM, or at http://www.astm.org

. 2298 (1) ASTM D6007-02 ( Reapproved 2008) , October 1, 2008, Standard Test 2299 Method for Determining Formaldehyde Concen trations in Air from Wood Products 2300 Using a Small-Scale Chamber, IBR approved for § 770.7(a)-(c). 2301 (2) ASTM D5582-00 (Reapproved 2006), Oc tober 1, 2006, Standard Test Method 2302 for Determining Formaldehyde Levels from Wood Products Using a Desiccator, IBR 2303 approved for § 770.7(a)-(c). 2304 (3) ASTM E1333-10 (Approved May 1, 2010), Standard Test Method for 2305 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 2306 Products Using a Large Chamber, IBR approved for § 770.7(a)-(c). 2307 (c) ISO material. Copies of these materials may be obtained from the 2308 International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 2309 Geneve 20, Switzerland, or by calling +41-22-749-01-11, or at http://www.iso.org

. 2310 (1) ISO/IEC 17011:2004(E), Conformity A ssessments--General Requirements for 2311 Accreditation Bodies Accrediting Confor mity Assessment Bodies (First Edition) 2312 February 15, 2005, IBR approved for § 770.7(a)-(c). 2313 (2) ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types 2314 of Bodies Performing Inspections (First Edition), November 15, 1998, IBR approved for 2315 § 770.7(a)-(c). 2316 (3) ISO/IEC 17025:2005(E), General Requirements for the Competence of 2317***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 101 of 101 [RIN 2070-AJ44] Testing and Calibration Laboratories (S econd Edition), May 15, 2005, IBR approved for 2318 § 770.7(a)-(c). 2319 (4) ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 2320 Product Certification Systems (First Editio n), 1996, IBR approved for § 770.7(a)-(c). 2321 ## 2322