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Page 1 of 93 [RIN 2070-AJ44] EO12866_RIN2070-AJ44_Formaldehyde-TPCs_NPRM_2012-03-19.docx 1 

### Draft document as submitted for review under EO 12866/13563. 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 Certifica tion 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of the 25 TSCA Title VI implementing regulations in order to allow interested parties an 26***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***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 93 [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 93 [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 pa rt 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 93 [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 93 [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 93 [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. What Action is the Agency Taking? 133 Title VI of TSCA directs EPA to pr omulgate implementing regulations by 134 January 1, 2013 (Ref. 1). EPA is issuing this proposed rule under TSCA Title VI to 135 establish a framework for a TSCA Title VI Third-Party Certification Program whereby 136 TPCs are accredited by ABs so that they may certify composite wood product panel 137 producers under TSCA Title VI. This proposed rule id entifies the roles and 138 responsibilities of the groups involved in the TPC process (EPA, ABs, and TPCs), as well 139 as the criteria for participation in th e program. This proposal contains general 140 requirements for TPCs, such as conducting and verifying formaldehyde emission tests, 141***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 7 of 93 [RIN 2070-AJ44] inspecting and auditing panel producers, a nd ensuring that pane l producers’ quality 142 assurance and quality control pr ocedures comply with the regulations set forth in this 143 proposed rule. In a subsequent document, EPA will propose addi tional requirements 144 including the frequency of testing, means for showing test method equivalence, and other 145 implementing provisions as required under TSCA Title VI, such as labeling, chain of 146 custody requirements, sell-through provision s, recordkeeping, and enforcement. 147
B. What is the Agency’s Author ity for Taking this Action? 148 EPA is issuing this proposed rule pu rsuant to the Formaldehyde Standards for 149 Composite Wood Products Act (Ref. 1), which provides authority fo r the Administrator 150 to “promulgate regulations to implement the standards required unde r subsection (b) in a 151 manner that ensures compliance with the em ission standards desc ribed in subsection 152 (b)(2).” This provision includes authority to promulgate regul ations relating to “third153 party testing and certification” and “auditing and reporting of third-party certifiers.” 154
C. Formaldehyde Sources and Health Effects 155 Formaldehyde is a colorless, flammable gas at room temperature and has a strong 156 odor. It is found in resins used in the manufacture of composite wood products (e.g., 157 hardwood plywood, particleboard, and medium-density fiberboa rd). It is also found in 158 household products such as glues, permanen t press fabrics, carpets, antiseptics, 159 medicines, cosmetics, dishwashing liquids, fa bric softeners, shoe care agents, lacquers, 160 plastics, and paper product coatings. It is a by-product of combustion and certain other 161 natural processes. Examples of sources of formaldehyde gas inside homes include 162 cigarette smoke, unvented, fuel-burning applianc es (gas stoves, kerosene space heaters), 163 and composite wood products made usi ng formaldehyde-based resins (Ref. 2). 164***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 8 of 93 [RIN 2070-AJ44] Formaldehyde is both an irritant and a known human carcinogen (Ref. 3). 165 Depending on concentration, formaldehyde can cau se eye, nose, and throat irritation, 166 even when exposure is of relatively short duration. In the indoor environment, sensory 167 reactions and various symptoms resulting from mucous membrane irritation are potential 168 effects. There is also evidence that formal dehyde may be associated with changes in 169 pulmonary function and increased risk of asthma in children (Ref. 2). 170 The Integrated Risk Information System (IRIS) Program of EPA’s Office of 171 Research and Development (ORD) recently comp leted a draft assessment of the potential 172 cancer and non-cancer health e ffects that may result from chronic inhalation exposure to 173 formaldehyde (Ref. 4). This draft IRIS a ssessment was peer reviewed by the National 174 Academy of Sciences (NAS) (Ref. 5). EPA is currently considering the peer review 175

comments. 176
D. History of this Action 177
1. Legislative history . On July 7, 2010, President Obama signed into law the 178 Formaldehyde Standards for Composite Wood Products Act (Ref. 1). This legislation 179 adds Title VI to TSCA and establishes formaldehyde emission standards for hardwood 180 plywood, particleboard, and medium-density fiberboard. These emission standards are 181 identical to the California Air Resources Board’s (CARB) Airborne Toxic Control 182 Measure (ATCM) Phase II standards (Ref. 6). Title VI of TSCA directs EPA to 183 promulgate implementing regulations by Janua ry 1, 2013, that address: Labeling, chain of 184 custody requirements, sell-through provision s, ultra low-emitting formaldehyde (ULEF) 185 resins, no-added formaldehyde-based (NAF) re sins, finished goods, third-party testing 186 and certification, auditing a nd reporting of third-party certifiers, recordkeeping, 187***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 9 of 93 [RIN 2070-AJ44] enforcement, laminated products, and products containing de minimis amounts of 188 composite wood. 189 This proposed rule establishes a framew ork for a TSCA Title VI Third-Party 190 Certification Program to help ensure that regulated composite wood products consistently 191 meet the TSCA Title VI formaldehyde emi ssion standards. EPA will issue a separate 192 proposed rule at a later date that includes the rest of the TSCA Title VI implementing 193 regulations. That separate propos ed rule will include specific testing responsibilities of 194
TPCs. 195
2. The CARB ATCM . The CARB ATCM establishes emission standards for 196 composite wood products sold, offered for sale , supplied, used, or manufactured for sale 197 in California (Ref. 6). It includes requirem ents for manufacturers of composite wood 198 products, distributors, importers, fabricators, retailers, and TP Cs with provisions on sell199 through dates, labeling, recordk eeping, testing, and cer tification. It also includes special 200 provisions for manufacturers of composite wood products with ULEF and NAF resins. 201 Under the CARB ATCM, manufacturers of co mposite wood products must have their 202 compliance with the emission standards certified by a TPC approved by CARB (Ref. 7). 203 The CARB ATCM defines a third-party certif ier as “an organization or entity approved 204 by the Executive Officer that: (A) verifies th e accuracy of the emission test procedures 205 and facilities used by manufacturers to conduct formaldehyde emission tests, (B) 206 monitors manufacturer quality assurance and quality control programs, and (C) provides 207 independent audits and inspections.” In order to become a CARB approved TPC, 208 prospective certifiers must submit an a pplication to the CARB Executive Officer 209 containing: 210***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 10 of 93 [RIN 2070-AJ44] a. Evidence of actual field experience in the verificati on of laboratories and wood 211 products, to demonstrate how th e applicant will be able to competently perform the TPC 212 requirements under the CARB ATCM. 213 b. Evidence of the ability to properl y train and supervise inspectors. 214 c. Evidence of a current “product accre ditation body” accreditation issued by a 215 signatory to the Internati onal Laboratory Accreditati on Cooperation (ILAC) Mutual 216 Recognition Arrangement (MRA). 217 d. A list of the composite wood products th at the applicant is applying to verify 218 and evidence that the applicant is qualif ied to verify these products (Ref. 8). 219 If the TPC’s application is approved, the CARB Executive Officer issues a CARB 220 Executive Order with a duration of 2 years. Upon the expiration date of the CARB 221 Executive Order, a TPC may apply for re-accreditation by submitting an updated 222 application. The CARB Executive Officer ma y, “for good cause,” modify or revoke a 223 CARB Executive Order approvi ng a TPC after giving the TPC the opportunity for a 224 hearing. 225 Under the CARB ATCM, CARB approved TP Cs are required to verify that 226 composite wood product manufacturers are co mplying with the quality assurance and 227 quality control requirements, verify formal dehyde emission test results, work with 228 manufacturers to establish quality contro l limits for each product type and production 229 line, provide independent inspections and a udits of manufacturers and records, use 230 laboratories that are certified by an AB that is a signatory to the ILAC MRA, maintain 231 records for 2 years; and provi de an annual report to CARB . CARB maintains a list of 232 approved TPCs on its website (Ref. 7). The a nnual report must include: • A list of 233***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 11 of 93 [RIN 2070-AJ44] manufacturers certified by the TPC during th e previous calendar year, including the 234 resins used by the manufacturers and the av erage and range of formaldehyde emissions. 235 • A list of any non-complying events by manufacturers. 236 • Certified laboratories and primary or secondary test methods utilized by the 237
TPC. 238 • Results of inter-laborator y testing comparisons for la boratories used by the TPC. 239
3. Recent activities related to this proposed rule . In March 2008, the Sierra Club 240 and numerous other organizations and indi viduals petitioned EPA under TSCA section 241 21. The petitioners requested that EPA use TS CA section 6 to adopt nationally the CARB 242 ATCM formaldehyde emission standards fo r composite wood products (i.e., hardwood 243 plywood, particleboard, and medium-density fiberboard) (Ref. 9). The petitioners 244 expressed particular concern over the le vels of formaldehyde found in emergency 245 housing provided for persons displaced from their homes by Hurricane Katrina and noted 246 that there are no Federal re gulations on formaldehyde emissions from composite wood 247 products other than the Department of Housing and Urban Development’s (HUD) 248 regulations for manufactured housing at 24 CFR 3280.308. In response to the petition, 249 EPA announced in the Federal Register on June 27, 2008, that EPA would initiate a 250 proceeding to investigate whether and what t ype of regulatory or other action might be 251 appropriate to protect against risks that may be posed by formaldehyde emitted from 252 pressed wood products (Ref. 10). In the Federal Register of December 3, 2008, EPA 253 published an Advance Notice of Proposed Ru lemaking (ANPR) to publicly initiate the 254 investigation and obtain st akeholder input (Ref. 11). 255 E. Objectives of the Framework for the Third-Party Certification Program 256***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 12 of 93 [RIN 2070-AJ44] EPA believes that the TSCA Title VI Thir d-Party Certification Program must be 257 impartial and applicable uniformly to both domestically manufactured and imported 258 composite wood products. This proposed rule ai ms to ensure that these objectives are 259 met, along with ensuring the consistent application of the TPC requirements of TSCA 260 Title VI, by requiring the use of voluntary consensus standards for the TSCA Title VI 261 Third-Party Certification Program, and by leve raging the expertise of international ABs. 262 Additionally, this proposed rule is intended to be as consistent as practicable with the 263 TPC requirements under the CARB ATCM

. By aligning itself with the existing CARB 264 ATCM requirements, EPA seeks to avoi d differing or duplicative regulatory 265 requirements that would result in an in creased burden on the regulated community. 266 Qualified and experienced TPCs are e ssential to ensuring that domestic and 267 foreign panel producers supplying products to the United States have quality assurance 268 and quality control procedures, are having their products tested to determine that they are 269 compliant with formaldehyde emissions sta ndards, and are otherwise acting in manner 270 that is consistent with the requirement s of TSCA Title VI. The TSCA Title VI 271 formaldehyde emissions standards apply to hardwood plywood, particleboard, and 272 medium-density fiberboard sold, supplied, o ffered for sale, or manufactured (including 273 imported) in the United States. Because TSCA defines “manufacture” to include “import 274 into the customs territory of the United States ” the standards are applicable regardless of 275 whether the composite wood product is manuf actured domestically or imported from 276 abroad. 277 There are a substantial number of pane l producers and TPCs that operate solely 278 outside of the United States. Currently, 27 of the 36 CARB-approved TPCs are based 279***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 13 of 93 [RIN 2070-AJ44] outside the United States (Ref.7). To ensure that oversight of TPCs is as strong abroad as 280 it is domestically, EPA believes a TSCA Title VI Third-Party Certification Program 281 framework should include internationally opera ting ABs to overcome potential logistical 282 limitations that may hinder regular and rigorous inspection of TPCs operating outside the 283 United States. Many ABs have a global reac h, preexisting infrastructure, and experience 284 working in foreign countries, which EPA be lieves makes them ideal for evaluating the 285 qualifications of TPC candidates. Under EP A’s proposed TSCA Title VI Third-Party 286 Certification Program framework, ABs woul d review, accredit, oversee, audit, and 287 inspect both domestic and foreign TPCs--activi ties that would enable EPA to ensure the 288 legitimacy of both TPCs and panel producers inthe United States and abroad. The ABs’ 289 oversight and auditing functions verify th at TPCs are fulfilling their regulatory 290 obligations uniformly across the global mark etplace. EPA would reta in its statutorily 291 delegated roles in program design, establ ishing the standards, enforcement, and 292 oversight; and utilize ABs to st rengthen performance of TPCs. 293 F. What Background Information was Used to Develop the Framework for a Third-Party 294 Certification Program? 295 296 Effective and successful implementation of EPA’s TSCA Title VI Third-Party 297 Certification Program requires that pane l producers have in place formaldehyde 298 emissions testing programs and quality assurance and quality control programs for 299 product manufacturing. To achieve these outcome s, EPA is proposing to require the use 300 of voluntary consensus standards for those part icipating as a TPC in the TSCA Title VI 301 Third-Party Certification Program. In deve loping this proposed rule, EPA reviewed 302 established voluntary consensu s standards that are reliedon by industries around the 303 world as a means of ensuring the competency of third-parties in particular fields of 304***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 14 of 93 [RIN 2070-AJ44] technical activity such as testing, instrument calibration, and product performance 305 certification. In addition to reviewing ex isting voluntary consensus standards, EPA 306 reviewed other successful third-party certifi cation programs that us e voluntary consensus 307 standards to determine if such programs could be used as models for the TSCA Title VI 308 Third-Party Certification Program. 309 Third-party certification involves a process by which a product, process, or 310 service is reviewed by a reputab le and qualified independent th ird-party to verify that a 311 set of norms, criteria, claims, practices, or standards are being met. Third-party 312 certification has been widely and successfully used for decades by a number of industries 313 such as engineering, electronics, energy, so ftware, automotive, and food and consumer 314 products. The standards used in third-party certification are typically voluntary consensus 315 standards developed by nationa lly or internationally r ecognized standards-producing 316 organizations or industry groups. Voluntar y consensus standards establish uniform 317 engineering or technical crit eria, methods, processes, and practices for an industry 318 practice or product, and are developed by expe rts in the relevant field through a process 319 that allows input by all persons interested a nd affected by the scope or provisions of the 320 standard. Parties in that industry then c hoose to accept and voluntarily abide by the 321 consensus standards. Otherwise, the existe nce of multiple and non-harmonized standards 322 for similar products, processes, and services in different countries or regions can create 323 barriers to trade. 324
1. Voluntary consensus standards . In order for EPA to ensu re that the Third-Party 325 Certification Program under TSCA Title VI is effective in ensuring compliance with the 326 emission standards, impartial in its operat ions, and applicable both domestically and 327***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 15 of 93 [RIN 2070-AJ44] internationally, the Agency proposes requiri ng the use of voluntary consensus standards 328 as the basis for operating the TSCA Title VI Third-Party Certification Program. EPA 329 specifically proposes using In ternational Organization for Standardization (ISO) and 330 International Electrotechnical Commission (IEC) voluntary consensus standards and 331 guides as general requirements for third-part y certifications. In addition to industry 332 experts, international orga nizations--both governmental and non-governmental--work in 333 cooperation with ISO and IEC to develop thei r consensus standards. In the field of 334 conformity assessment, the ISO Committ ee on Conformity Assessment (CASCO) is 335 responsible for the development of international standards and guides. 336 The appropriate ISO/IEC standards and guide that EPA proposes requiring are: 337 • ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 338 Product Certification Systems. This is the inte rnational voluntary cons ensus standard that 339 specifies general requirements for a third-pa rty operating a product certification program 340 (Ref. 12). These general requirements would he lp ensure that the TPC is competent and 341 reliable in certifying comp liant composite wood products. 342 • ISO/IEC 17011:2004(E), Conformity A ssessments--General Requirements for 343 Accreditation Bodies Accrediting Conform ity Assessment Bodies. This international 344 voluntary consensus standard offers the general requirements for ABs assessing and 345 accrediting conformity assessment bodies (CABs). It is also appropriate as a requirement 346 document for the peer evaluation process fo r mutual recognition arrangements between 347 ABs (Ref. 13). These general requirements would help ensure that the ABs are competent 348 and reliable in accrediting TPCs. 349 • ISO/IEC 17025:2005(E), General Require ments for the Competence of Testing 350***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 16 of 93 [RIN 2070-AJ44] and Calibration Laboratories. This internati onal voluntary consensus standard specifies 351 the general requirements for competence in carrying out tests and/or calibrations, 352 including sampling (Ref. 14). EPA believes thatrequiring TPCs to use laboratories that 353 follow these requirements would help ensure th at reliable and accura te test results are 354 obtained. 355 • ISO/IEC 17020:1998(E), Gene ral Criteria for the Operat ion of Various Types of 356 Bodies Performing Inspections. This internat ional voluntary consensu s standard specifies 357 general criteria for the comp etence of impartial bodies performing inspection. It is 358 intended for use by inspection bodies and th eir accreditation bodies (Ref. 15). 359 EPA believes that requiring TPCs to follo w these requirements would help ensure 360 greater homogeneity of the inspection pr ocess among the TPCs recognized by EPA. 361 The appropriate use of each guide and standard and a description of the party responsible 362 under the proposed TPC framework for ensu ring compliance with the standard are 363 detailed in Unit III. The use of the guide a nd standards furthers th e goal of the National 364 Technology Transfer and Advancement Act (NTTAA), as discussed in Unit VI. 365
2 . International accred itation and inspection ov ersight organizations. In the 366 profession of conformity assessment (i.e., the process of ensu ring an organization 367 responsible for implementing a consensus st andard does so in conformance with the 368 standard) oversight of c onformity assessment bodies, such as TPCs, is done by 369 organizations known as ABs. An AB provi des an impartial verification of the 370 competency of conformity assessment bodies such as TPCs. The ABs themselves also 371 have oversight typically perf ormed by an association or cooperative of conformity 372 experts and other ABs through a peer evalua tion process. Because the proposed TPC 373***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 17 of 93 [RIN 2070-AJ44] framework is international in scope and will employ the use of internationally accepted 374 consensus standards, EPA reviewed th e structure and functions of well known 375 international organizations that were estab lished decades ago to specifically provide 376 oversight of ABs. 377 The two international AB oversight bodies that EPA examined for this proposed 378 rule are the International Accreditation Foru m, Inc. (IAF) and ILAC. EPA believes that 379 using a system where an AB’s qualifications are verified by inte rnational oversight 380 bodies such as these and in which the ABs in turn assess the conf ormity of TPCs to 381 international voluntary consensus standards woul d ensure that the requirements of TSCA 382 Title VI are met. The specific details of how EPA proposes to leverage this system to 383 ensure compliance with the TSCA Title VI are detailed in Unit III. 384 The IAF is an association of conform ity assessment bodies and other bodies. IAF 385 requires its member ABs to comply with appr opriate international conformity assessment 386 standards. The IAF Multilateral Recogniti on Arrangement (MLA) is an agreement 387 between AB members of the IAF whereby th e ABs conduct regular evaluations of each 388 other to assure the equivalence of their accreditation programs. This MLA agreement 389 allows companies with an accredited conform ity assessment certification in one part of 390 the world to have that certif ication recognized everywhere else in the world, thereby 391 facilitating international trade (Ref. 16). The MLA certification provides documentation 392 that a person or an organization has been acc redited to a specific standard or scheme by 393 an IAF MLA signatory AB. In addition, IAF through its MLA ensures that all ABs who 394 are capable of accrediting produc t certification bodies, such as TPCs, are in conformance 395 with ISO/IEC Guide 65:1996(E). By requiring a TPC to be accredited to ISO/IEC Guide 396***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 18 of 93 [RIN 2070-AJ44] 65:1996(E) by a qualified AB that has an IA F endorsement through level 3 of the IAF 397 Scope, or is a member of an equivalent oversight body, EPA believes that the TPC will 398 be in conformance with ISO/IEC Guide 65: 1996(E), the voluntary consensus standard 399 used to ensure proper product certification. Level 3 of the IAF Scope is the level of 400 accreditation which needs to be accomplished by a Product AB under that program to 401 ensure that the Product AB is qualified to accredit the TPC. 402 The ILAC is an international coopera tion of laboratory and inspection ABs 403 formed to help remove technical barriers to trade. ABs around the world, which have 404 been evaluated by peers as competent, have signed an MRA that enhances the acceptance 405 of products and services across national borders (Ref . 17). By requiring a TPC’s 406 emissions testing laboratory, or it s contract laboratory, to be a ccredited by an AB that is a 407 signatory to the ILAC MRA or equivalent oversight body , EPA believes that there will be 408 a greater assurance of compliance with ISO/IEC 17025:2005(E), the voluntary consensus 409 standard that is critical to ensuring adequa te verification of performance for TSCA Title 410 VI required laboratory form aldehyde emissions testing. 411
3. Other third-party certificati on programs that were evaluated

. As mentioned in 412 Unit II.E., EPA aims to develop a TSCA Title VI Third-Party Certification Program that 413 incorporates lessons learned from other third-party certific ation programs. In addition, 414 EPA is particularly interested in harmonizing, to the extent practicable, with the CARB’s 415 third-party certification program to a void differing or duplicative regulatory 416 requirements. 417 In developing the TSCA Title VI Third- Party Certification Program framework as 418 presented in this proposed rule, EPA starte d with a review of CARB’s program, as 419***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 19 of 93 [RIN 2070-AJ44] described in Unit II.D. This included mee ting with CARB, the composite wood industry, 420 and CARB-approved TPCs. 421 EPA also reviewed other EPA and Federal programs that have elements relevant 422 to EPA’s goals for this proposed program, such as the use of voluntary consensus 423 standards and/or a third-pa rty product certification pro cess. The following EPA and 424 Federal programs were reviewed during de velopment of the proposed TSCA Title VI 425 Third-Party Certificatio n Program framework: 426

a. National Lead Laboratory Accreditation Program . EPA established the 427 National Lead Laboratory Accreditation Program (NLLAP) in 1992, to provide protocols, 428 criteria, and minimum performance standards for analysis of lead in paint, dust, and soil, 429 as required under TSCA secti on 405 (Ref. 18). Section 405 of TSCA further directs EPA, 430 in consultation with the Department of Hea lth and Human Services (HHS), to develop a 431 program to certify qualified lead testing laboratories. The NLLAP provides the public 432 with a list of qualified labor atories that have met EPA cr iteria and demonstrated the 433 capability to accurately analyze paint chip, dust, and soil samples for lead. EPA ensures 434 that laboratories comply with these EPA crite ria by having them evaluated and accredited 435 by third-party laboratory ABs according to ISO/ IEC performance consensus standards. In 436 order to assure the public thata Laboratory AB is capable of performing an adequate 437 assessment of participating laboratories, EPA enters into a recognition agreement with 438 the AB in recognition of its capability to perform adequate laboratory assessments. 439 For a laboratory to qualify for recognition under the NLLAP, it must pass on-site 440 audits conducted by one of the four labor atory ABs with which EPA has a recognition 441 agreement. The Laboratory ABs recognize N LLAP laboratories in conformance with 442***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 20 of 93 [RIN 2070-AJ44] ISO/IEC 17025:2005(E). Laboratories recogn ized under the NLLAP must also 443 successfully perform, on a continuing basi s, in the Environmen tal Lead Proficiency 444 Analytical Testing (ELPAT) Pr ogram. The ELPAT is a profic iency testing program that 445 is designed to evaluate the analytical performance of laboratories by providing the 446 laboratory with standardized test samples on a quarterly basis and ev aluating their results 447 against consensus results from a set of reference laboratories. 448 The NLLAP has successfully demonstratedover the years that EPA recognized 449 laboratories are capable of accura tely analyzing for lead in pa int chips, dust wipes, and 450 soil samples. Therefore, EPA believes thatthe third-party processes employed by the 451 NLLAP, which include the use of third-party laboratory ABs th at accredit laboratories by 452 using voluntary consensus standards, along w ith additional specified laboratory testing 453 protocols, demonstrate that a similar thir d-party certification pr ogram can be used 454 successfully under TSCA Title VI. 455 b. National Voluntary Conformity A ssessment System Evaluation Program

. 456 Another program that EPA reviewed is th e National Voluntary Conformity Assessment 457 System Evaluation (NVCASE) Program at the Departme nt of Commerce’s National 458 Institute of Standards and Technology (NIS T). NIST, through its Standards Services 459 Division, offers this voluntary program to evaluate and recognize organizations which 460 support third-party conformity assessment activities. The NVCASE Program includes 461 activities related to third-party laboratory testing, third-party pr oduct certification, and 462 quality system registration. After an NVCASE Program evaluation, NIST provides 463 recognition to qualified U.S. or ganizations that effectively demonstrate conformance with 464 established criteria. The ultimate goal is to help U.S. manufacturers satisfy applicable 465***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 21 of 93 [RIN 2070-AJ44] product requirements mandated by foreign or U.S. regulatory authorities through 466 conformity assessment procedures. Under the NVCASE Program, NIST accepts requests 467 from only domestic TPCs for domestic and in ternational accreditation. The use of NIST’s 468 NVCASE Program in the United States would si gnificantly hamper the ability of foreign 469 TPC candidates to receive and maintain accr editation and would notallow EPA to meet 470 its goal of providing testing and certification and auditing and reporting of all TPCs, 471 domestic as well as international. 472

c. Other EPA programs. EPA also considered the product ce rtification 473 components of EPA’s WaterSens e and Energy Star programs. WaterSense is an EPA474 sponsored partnership program launched in 2006 that seeks to protect the future of our 475 nation's water supply by promoting water effi ciency and enhancing the market for water476 efficient products, programs, and practic es. WaterSense helps consumers identify 477 products and programs that meet WaterSense water efficiency and performance criteria. 478 Energy Star is a joint program of the EPA and the U.S. Department of Energy (DOE) 479 designed to help the consumers save money and protect the envir onment through the use 480 of energy efficient products and practices . In 1992, EPA introduced Energy Star as a 481 voluntary labeling program designed to identif y and promote energy-efficient products to 482 reduce greenhouse gas emissions. 483 Both the WaterSense and Energy Star certification programs specify the minimum 484 criteria that EPA licensed product ABs must observe when certifying product 485 conformance to specifications and when aut horizing the use of the program’s labels. 486 These programs provide specific criteria for the application of ISO/IEC Guide 487 65:1996(E) in order to satisfy th e criteria for certification of Energy Star and WaterSense 488***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 22 of 93 [RIN 2070-AJ44] products. They also provide the basis for c onsistent application of voluntary consensus 489 standards by licensed ABs. The ISO/IEC Guid e 65:1996(E) has been successfully used in 490 these two programs for auditing, certifying, a nd reporting of the status of certification. 491 The Energy Star and WaterSense programs ’ use of ABs who certify under voluntary 492 consensus standards for product certification al so demonstrates the u tility and workability 493 of this approach. 494 Each of the aforementioned program s informed EPA’s decision on how to 495 develop an appropriate and credible third-party certification program for TSCA Title VI. 496 EPA is proposing a framework under TSCA Title VI that incorporates elements of the 497 CARB third-party certificati on program, the use of recognition agreements with ABs 498 (e.g., as in NLAAP), and a product certification system element such as those used in the 499 WaterSense and Energy Star programs. 500 III. What Does this Proposed Rule Do? 501 502***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 23 of 93 [RIN 2070-AJ44] Illustration 1: TSCA Tile VI Proposed Third-Party Certification Framework 503
504 International Standards 505 Organizations 506 Develop consensus-ba sed international 507 standards for quality management 508 and conformity assessment 509 510 511 International Standards Bodies 512 Ensure competency of Accrediting 513 Bodies and their conformance with 514 international standards 515

 Ensures AB conformance to 516 ISO/IEC 17011 1 517

 Ensure ABs are qualified to oversee 518 TPC conformance to ISO/IEC Guide 65 519 ISO/IEC17020 and/or ISO/IEC 17025 520 521 522 Accrediting Bodies 523 Ensure competency of TPCs; verify accuracy 524 of emission test procedures, monitor TPC 525 quality assurance programs, audit and inspect 526 TPCs. 527

 Management systems conform to 528 ISO/IEC 17011 529

 Ensure TPC conformance to 530 applicable ISO/IEC Guide & Standards 531 532 533 Third-Party Certifiers 534 Ensure that panel producers are in 535 compliance with statutory 536 formaldehyde emission standards 537

 Management systems conform to 538 ISO/IEC Guide 65 539

 Conform to applicable ISO/IEC 540 Guide & Standards for 541 Product & Laboratory Certification 542 and Inspections 543 544 Composite Wood 545 Panel Producers 546 547 1 ISO/IEC 17011:2004(E) – Conformity Asse ssments--General Requirements for Accreditation Bodi es Accrediting 548 Conformity Assessment Bodies. 549 2 MLA – IAF’s Multilateral Recognition Arrangement requires AB signatories to demonstrate they are capable of 550 accrediting product certification bodies in conformance with ISO/IEC Guide 65:1996(E) – General Requirements for 551 Bodies Operating Product Certification Systems and ISO/IEC 17020:1998(E) – Gene ral Criteria for the Operation of 552 Various Types of Bodies Performing Inspections. 553 3 MRA – ILAC’s Mutual Recognition Arrangement requires AB signatories to demonstrate they are capable of 554 accrediting testing laboratories in conformance with ISO/IEC 17025:2005(E) – General Requirements for the 555 Competence of Testing and Calibration Laboratories. 556 557 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

AB Type #3 Product & Lab Accrediting 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 Accrediting Body

 Recognition agreement with EPA

 Signatory to ILAC MRA or equivalent

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

Product Accrediting Body

 Recognition agreement with EPA

 Signatory to IAF MLA or equivalent

 Ensure TPC conformance to ISO/IEC Guide 65 & ISO/IEC 17020

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

Page 24 of 93 [RIN 2070-AJ44] EPA is proposing a framework which it be lieves would enable implementation of 558 a credible third-party certification program that ensures that TPCs are impartial and 559 operate at the highest standards of compet ence. Although EPA’s proposed TSCA Title VI 560 Third-Party Certification Program framework, including the underlying requirements and 561 implementation process, are based on, orare the same as, CARB’s third-party 562 certification program, EPA is proposing to al so use qualified, intern ationally recognized 563 ABs in implementing the program to establis h a globally uniform process. Under EPA’s 564 proposed TSCA Title VI Third-Party Certif ication Program framework, ABs, recognized 565 by EPA through recognition agreements, would accredit TPCs based on the requirements 566 for TPCs established by EPA through this proposed rule. Like CARB, EPA would 567 require that TPCs provide evidence of competency in four key areas: 568 • Experience and ability to verify th e accuracy of formaldehyde emission testing 569 of composite wood products. 570 • Experience in the com posite wood product industry. 571 • Ability to monitor panel producer quali ty assurance programs for composite 572 wood products. 573 • Ability to conduct auditing and inspec tion of panel producer activities and 574 products. 575 However, unlike the CARB system, under whic h CARB evaluates and accredits TPCs 576 without the input of ABs, AB s would conduct the evaluation and determine if the TPCs 577 are competent in these four areas. Based on th e results of ABs’ evaluations that would be 578 conducted according to EPA’s requirements, including the standards for ABs in ISO/IEC 579 Guide 65:1996(E) (which includes inspecti on accreditation based on compliance with 580***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 25 of 93 [RIN 2070-AJ44] ISO/IEC 17020:1998(E)) and laboratory acc reditation based on compliance with 581 ISO/IEC 17025:2005(E), the ABs would accredit TP Cs that meet the requirements. The 582 ABs would also be required to particip ate in oversight ac tivities, including 583 recordkeeping, reporting to EPA, and auditing of TSCA Title VI accredited TPCs and 584 their formaldehyde emissions testing laborat ories. EPA would exercise authority to 585 conduct independent oversight and actions, including the authority to review the 586 determinations of ABs, and approve or re voke a TPC’s TSCA Title VI accreditations 587 based on the criteria laid out in this proposed rule. 588 While the AB component of EPA’s proposed TSCA Title VI Third-Party 589 Certification Program framework differs from the CARB program, EPA believes it will 590 enhance the implementation of TSCA Title VI . The proposed TSCA Title VI Third-Party 591 Certification Program framework is otherwis e generally consistent with CARB’s current 592 third-party certification program requirement s. Furthermore, EPA will work with CARB 593 to help promote compatibility and consistency within the programs. EPA believes that 594 compliance with the proposed the TSCA Title VI Third-Party Certification Program 595 would not require substantia l changes to procedures TP Cs, laboratories, and panel 596 producers currently use to conduct their TP C activities under the CARB ATCM (Ref. 6). 597 A. Requirements for Accreditation Bodies 598 Based on EPA’s understanding of how th e international c onsensus standards 599 oversight industry is structured, EPA envisions that two types of ABs could be involved 600 in implementation of the proposed TPC framew ork. The first type of AB is the “Product 601 AB.” The Product AB would be responsible for accrediting the TPCs, recordkeeping and 602 ensuring that a TPC is in conforman ce with ISO/IEC Guide 65:1996(E) (involving 603***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 26 of 93 [RIN 2070-AJ44] product certification systems) and ISO/IE C 17020:1998(E) (involving ge neral criteria for 604 inspections). The second type of AB is the “Laboratory AB.” The Laboratory AB would 605 be responsible for ensuring that the TPC’s formaldehyde emissions testing laboratory (or 606 its contracted laboratory) is of the highest quality and is in conf ormance with ISO/IEC 607 17025:2005(E) (involving the gene ral requirements for labor atories conducting testing 608 and/or calibrations, including sampling and calibration). EPA recognizes it is also 609 possible that a single AB may have the abil ity to accredit both pr oduct certification and 610 emissions testing, and therefore can accredit conformance to ISO/IEC Guide 65:1996(E), 611 ISO/IEC 17020:1998(E), and ISO/IEC 17025:2005(E). In such cases, a single AB would 612 be considered qualified to accredit TPCs for their product certification capabilities and 613 also accredit the TPC laboratories for conducting formaldehyde emissions testing, and 614 only that AB would need to be involved in accepting and reviewing TPC applications and 615 implementing the ABs’ roles under the proposed TSCA Title VI Third-Party Certification 616 Program framework. 617
1. Necessary qualifications of ABs to be candidates fo r participation in the EPA’s 618 Title VI Third-Party Certification Program -- a. Necessary qualifications of Product ABs

. 619 To ensure that Product ABs are qualified to accredit TPC’s for conformance with 620 ISO/IEC Guide 65:1996(E) and ISO/IEC 17020: 1998(E), the Product AB would have to 621 be a signatory to the IAF MLA, or a memb er of an equivalent oversight body. AB 622 members of IAF are admitted to the IAF MLA only after a highly st ringent evaluation of 623 their operations by an IAF peer evaluation team which is charged w ith ensuring that the 624 applicant member complies fully with bot h the international standards and IAF 625 requirements

. Additionally, once an AB is a signatory to the IAF MLA, it is required to 626***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 27 of 93 [RIN 2070-AJ44] recognize the certificates issuedby conformity assessment bodi es accredited by all other 627 signatories of the IAF MLA, with the appr opriate scope (i.e., le vels 1 through 3). The 628 IAF MLA structure has 5 levels, and EPA w ould require the Product AB to be endorsed 629 by IAF through level 3. Level 1 endorsement ensu res that an AB is in conformity with 630 ISO/IEC 17011:2004(E) and maintains that confor mity; level 2 endorsement ensures that 631 the AB has demonstrated basic competence to perform accreditation ac tivities for product 632 certification according to ISO/IEC Guid e 65:1996(E) and ISO/IEC 17020:1998(E); and 633 level 3 ensures that the AB has policies and pr ocedures in place in their operations and 634 management plans to accredit a TPC for product certification in conformance with 635 ISO/IEC Guide 65:1996(E). In order to partic ipate in the TSCA Title VI Third-Party 636 Certification Program, a Product AB would have to provide EPA with documentation 637 verifying its IAF endorsement th at states the level of accred itation the AB received from 638 IAF, or with confirmation that the AB is a me mber of an equivalent organization with an 639 equivalent scope. 640 b. Necessary qualifications of Laboratory ABs . To ensure that the Laboratory 641 ABs are qualified to accredit TPC laborato ries, the proposed TPC framework would 642 require that the Laboratory AB is a signatory to the ILAC MRA, or a member of an 643 equivalent organization. To be a signatory to the ILAC MRA, an AB must pass an 644 intensive evaluation carried out by peers and in accordance with the relevant rules and 645 procedures contained in several ILAC public ations. Once a signatory to the ILAC MRA, 646 each Laboratory AB agrees to abide by its terms and conditions, and according to the 647 ILAC evaluation procedures shall: 648***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 28 of 93 [RIN 2070-AJ44] i. Maintain conformance with the ISO/IEC 17011:2004(E), related ILAC 649 guidance documents, and any ILAC supplementary requirements. 650 ii. Ensure that all laboratories th at they accredit comply with ISO/IEC 651 17025:2005(E) and related ILAC po licy and guidance documents. 652 Under the proposed TPC framework, a TPC would be required to work with its 653 Laboratory AB to provide th e Product AB with documentation verifying the Laboratory 654 AB’s endorsement and scope of accredita tion from ILAC, or documentation of 655 membership in an equivalent organization. 656 EPA understands that not all ABs are si gnatories to either IAF or ILAC. EPA 657 requests comment on what other oversight bodies or other orga nizations are equivalent to 658 IAF and ILAC. An equivalent organizati on would provide a pro cess of review and 659 evaluation with a level of scru tiny and assessment of an AB’s capabilities to ensure that 660 an AB is qualified to accredited organizati ons based on the relevant ISO/IEC standards 661 and guide. 662
2. Recognition agreement process and relationship between EPA and ABs. Under 663 this proposed rule, the Product ABs and Laboratory ABs that are interested in 664 participating in the TSCA Title VI Third-Party Certification Program would be required 665 to submit an application to EPA to be formally recognized by EPA. Once EPA has 666 reviewed the AB’s cr edentials and deemed that the AB is qualified, EPA proposes to 667 enter into a recognition agreement with Produc t and Laboratory ABs th at want to offer 668 services to accredit TPCs according to EP A’s requirements. The recognition agreement 669 would serve as a mechanism for EPA to form ally recognize either a Product AB or a 670 Laboratory AB (or both) as qualified to im plement their respective roles under the TSCA 671***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 29 of 93 [RIN 2070-AJ44] Title VI program. The recognition agreement w ith the Product AB would designate it as 672 the recipient of applications from candidate TPCs that want to participate in the TSCA 673 Title VI Third-Party Certification Progr am. As discussed in Unit II.F.3., similar 674 recognition agreement approaches have been successfully used in a number of EPA 675 programs. The recognition agreement is a signed agreement between EPA and each 676 Product AB or Laboratory AB that would state: 677 a. The regulatory requirements that have b een and must continue to be met to be 678 an EPA recognized AB. 679 b. The roles and responsibili ties of the AB under the TSCA Title VI Third-Party 680 Certification Program. 681 c. EPA’s role and interactions with the AB during implementation of the TSCA 682 Title VI Third-Party Certification Program. 683 d. Criteria and processes for revoking th e recognition agreemen t if either the 684 Product AB or Laboratory AB fails to adhere to the conditions of the regulations. 685 All of the requirements and act ions stated in the recogniti on agreement between EPA and 686 each type of AB would be derived from the fi nal rule requirements. If the AB applying to 687 EPA for recognition is qualified to perform as both a Product AB and a Laboratory AB, 688 then that AB would include both sets of cred entials in its application package and would 689 be recognized by EPA in the recognition agreement as performing both accreditation 690 roles. The recognition agreement would be effective for 3 years, provided the AB 691 continues to meet all of th e regulatory requirements. Af ter 3 years, the recognition 692 agreement would be eligible for renewal. 693 In order to facilitate communication between EPA and ABs, EPA is proposing to 694***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 30 of 93 [RIN 2070-AJ44] require ABs to designate an agent in United St ates in their applications. Any information 695 provided by an AB or EPA to the designated ag ent would be equivale nt to providing that 696 information directly to the AB. The designa ted agent could not be a mailbox, answering 697 machine, or other service where the agent is not physically present. The agent would need 698 to be capable of accepting service of notices and processes made in administrative and 699 judicial proceedings. EPA be lieves requiring a designated ag ent in the United States 700 would help ensure compliance with the fo rmaldehyde emission standards by facilitating 701 the ability to enforce TSCA Title VI and its implementing regulations, which in turn 702 encourages the regulated entities to fulf ill their obligations under the statute and 703 regulations. EPA requests comment on this proposed requirement. 704 EPA would designate an EPA recognition agreement Implementation Officer as a 705 point of contact for ABs to consult with on implementation of the recognition agreement. 706 EPA would be responsible for directly notif ying participating ABs of changes in the 707 TSCA Title VI Third-Party Certification Pr ogram. EPA would maintain a public list of 708 all ABs with which EPA has a recognition agr eement. The list would be posted on EPA’s 709 website and regularly updated. 710
3. Proposed requirements once an AB is recognized. Once EPA has entered into a 711 recognition agreement with an AB, that AB becomes “recognized” by EPA as a Product 712 AB, Laboratory AB, or both. 713

a. Responsibilities of Product ABs in the TPC application process . The Product 714 AB’s key TSCA Title VI TPC applicati on review responsibilities would include: 715 i. Receiving and acting on TPC applicati ons for their participation in the TSCA 716 Title VI Third-Party Certification Program and thereby ensuring that the TPC is 717***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 31 of 93 [RIN 2070-AJ44] accredited to ISO/IEC Guide 65: 1996(E) and ISO/IEC 17020:1998(E). 718 ii. Transmitting copies of TPC applications and supporting documentation 719 requested in the application based on the TS CA Title VI implementing regulations to 720
EPA. 721 iii. Assigning the TPC a unique number. 722 b. General responsibilities of ABs after TPC accreditation into the TSCA Title VI 723 Third-Party Certification Program . The EPA recognized Product AB would be 724 responsible for: 725 i. Ensuring the TPC has a process in place to verify the accuracy of the 726 formaldehyde emission tests conducted by the TPC laboratory (incl uding any contract 727 laboratory that the TPC would use for form aldehyde testing under TSCA Title VI) and 728 the formaldehyde quality control tests conducte d by the producers of regulated composite 729 wood products. 730 ii. Ensuring the TPC has a process in place to monitor panel producer quality 731
assurance programs. 732 iii. Ensuring the TPC has a process in place to conduct independent audits and 733 inspections of panel producers and thei r quality control testing facilities. 734 vi. Conducting audits of TP Cs and their laboratories. 735 v. Recordkeeping. 736 The EPA recognized Laboratory ABs would be responsible for verifying that the 737 TPC laboratory is experienced and capable of conducting formaldehyde emissions tests 738 according to the requirements of TSCA Title VI and its implementing regulations. The 739 Laboratory ABs’ key respons ibilities would include: 740***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 32 of 93 [RIN 2070-AJ44] • Ensuring the laboratory’s conformance to the regulatory requirements, including 741 ISO/IEC 17025:2005(E). 742 • Verifying the accuracy of the formal dehyde emissions tests conducted by the 743 TPC laboratory through an inte r-laboratory comparison or proficiency testing program. 744 • Conducting audits of the laboratory. 745 • Recordkeeping. 746 EPA proposes to require TPCs to pa rticipate in an EPA recognized inter747 laboratory comparison program. If standard reference material is developed, EPA would 748 consider requiring TPCs to participate in an EPA recognized profic iency testing program. 749 In order to reduce duplicativ e requirements, EPA proposes that it would utilize the 750 preexisting CARB-administered inter-laborat ory comparison program to the extent 751 feasible. EPA requests comment on ways it mightintegrate with CARB's inter-laboratory 752 comparison program and on what criteria should be used to determine the adequacy of 753 performance. EPA also requests comment on how participating Laboratory ABs could 754 administer an inter-laboratory comparison prog ram or proficiency testing program for the 755 TPCs that it accredits. EPA would like information on the costs of such a program and 756 whether such an activity presents conflict of interest issues for Laboratory ABs. 757
4 . Revocation of EPA’s recognition of an AB. EPA is proposing that it may 758 suspend, revoke, or modify the recognition of an AB, if the AB is not complying with the 759 requirements promulgated for ABs under TSCA Title VI. If an AB is removed or 760 withdraws from the TSCA Title VI Third–Party Certification Program, that AB would be 761 responsible for promptly notifying EPA and all TPCs that receive its accreditation 762 services. If an AB is removed or withdr aws from the TSCA Title VI Third–Party 763***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 33 of 93 [RIN 2070-AJ44] Certification Program for reasons other than fraud or providing false or misleading 764 statements related to a particular TPC or TP Cs, or other than a r eason that implicates a 765 particular TPC or TPCs in a violation of TS CA Title VI or its implementing regulations, 766 EPA proposes to allow the TPCs that were accredited by that AB to have 365 days, or 767 180 days if less than 365 days were lefton their 2-year accred itation period, to be 768 accredited again by another EPA recognized AB . While it is seeking accreditation from 769 an alternate AB, a TPC would need to continue to comply with all other aspects of TSCA 770 Title VI and its implementing regulations, and the TPC would remain subject to 771 inspection by EPA. If an AB is rem oved from the TSCA Title VI Third-Party 772 Certification Program due to fraud or provi ding false or misleading statements with 773 respect to a particular TPC, or for any other reason that implicates a particular TPC in a 774 violation of TSCA Title VI or its implem enting regulations, that TPC would not be 775 allowed to provide any TSCA Title VI certif ication services until it has been accredited 776 by an alternate AB. Should this situation occur, EPA would provide notifications to the 777 affected TPCs at the time it commences fo rmal action against the AB. Any action EPA 778 would take against an AB would not preclud e an enforcement action against a TPC. EPA 779 believes it is appropriate to be more stri ngent in these situations because the AB’s 780 nonperformance or altered status under the recognition agreement may call into question 781 the legitimacy of the TPC’s underlying accr editation. EPA requests comment on whether 782 it has provided adequate time for a TPC to s eek an alternate AB’s accreditation under this 783 proposed rule. Issues related to the de-acc reditation of a TPC a nd the amount of time a 784 panel producer has to seek a new TPC are discussed in Unit III.B.3. 785 B. Requirements for Third-Party Ce rtifiers of Composite Wood Products 786***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 34 of 93 [RIN 2070-AJ44] 1. Requirements to apply for participation in the TSCA Title VI Third–Party 787 Certification Program . EPA is proposing that the TPC mu st apply to an EPA recognized 788 Product AB to certify composite wood products pursuant to TSCA Title VI. In its 789 application to an EPA recognized Product AB, the TPC would be required to demonstrate 790 experience and competency in certain areas that EPA believes are important in ensuring 791 the TPC’s ability to conduct audits, testing, and certificati on of composite wood products. 792 The application would be reviewed by the Product AB, who would provide EPA with a 793 copy of each application. TPC applications would provide information to document: 794 1. Experience in performing or verify ing formaldehyde emissions testing on 795 composite wood products. 796 2. That its laboratory or contract la boratory has been accredited by an EPA 797 recognized Laboratory AB in conf ormance with ISO/IEC 17025:2005(E). 798 3. The TPC laboratory’s or contract laboratory’s expe rience with test method 799 ASTM E 1333-96 (Reapproved 2002) (Ref. 19) or successor standards and experience 800 evaluating correlation between test methods. 801 4. Experience or ability in product cer tification and complying with ISO/IEC 802 Guide 65:1996(E). 803 5. Experience in the compos ite wood product industry. 804 6. The ability to inspect and properly tr ain and supervise inspectors according to 805 ISO/IEC 17020:1998(E). 806 The application would also specify which composite wood products the applicant is 807 applying to certify and evidence that the a pplicant is qualified to certify these products. 808 EPA is proposing that TPCs would be required to renew their applications every 2 years. 809***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 35 of 93 [RIN 2070-AJ44] In order to facilitate co mmunication between EPA and TPCs, EPA is proposing to 810 require TPCs to designate an agent in United States in thei r applications. Any information 811 provided by an AB or EPA to the designated ag ent would be equivale nt to providing that 812 information directly to the TPC. The desi gnated agent could not be a mailbox, answering 813 machine, or other service where the agent is not physically present. The agent would need 814 to be capable of accepting service of notices and processes made in administrative and 815 judicial proceedings. EPA be lieves requiring a designated ag ent in the United States 816 would help ensure compliance with the emissi on standards by facili tating the ability to 817 enforce TSCA Title VI and its implementing regulations, which in turn encourages the 818 regulated entities to fulfill their obligati ons under the statute and regulations. EPA 819 requests comment on this proposed requirement. 820 Title VI of TSCA requires that comp liance with the formaldehyde emission 821 standards be measured by quarterly te sting using ASTM E1 333-96 (Reapproved 2002) 822 (Ref. 19) or under certain circumstances , ASTM D6007-02 (Reapproved 2008) (Ref. 20). 823 For quality control testin g, the statute requires use of ASTM D6007-02 (Reapproved 824 2008), ASTM D5582-00 (Reapproved 2006) (Ref. 21) , or other test methods established 825 by EPA through rulemaking. If a test met hod other than ASTM E1333-96 (Reapproved 826 2002) is used for either quarterly testing or quality control testing, TSCA Title VI 827 requires a demonstration of e quivalence by means established by EPA. Therefore, EPA is 828 proposing that a TPC laboratory or contractlaboratory must have experience with 829 formaldehyde testing using ASTM E1333- 96 (Reapproved 2002) or its successor 830 standards as well as experience evaluating correlations betw een different test methods. 831 EPA intends to propose the means of showing test method equivalence in a subsequent 832***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 36 of 93 [RIN 2070-AJ44] proposal with other implementation provisi ons as required under TSCA Title VI. 833 EPA is proposing to require that accred ited TPCs conduct the quarterly tests 834 required by TSCA Title VI. The statute requir es these tests to be performed using ASTM 835 E1333-96 (Reapproved 2002) or, under so me circumstances ASTM D6007-02 836 (Reapproved 2008). Section 601(d)(5) of TSCA allows EPA to subs titute, after public 837 notice and an opportunity for comment, a test method referenced in TSCA Title VI with 838 its successor version. The version of ASTM E1333-96 (R eapproved 2002) referenced in 839 TSCA Title VI is not the most current version. In this proposed rule, EPA is proposing to 840 incorporate the current version, ASTM E1333- 10 (Ref. 22), into the testing requirements 841 in this proposed rule in place of ASTM E1333-96 (Reapproved 2002) referenced in the 842 statute. EPA notes that there are only relatively minor differences between ASTM 843 E1333-96 (Reapproved 2002) and ASTM E1333-10. For example, referenced standards 844 have been updated to cite the most recent ve rsion of the standards. In addition, under 845 Apparatus, Make-up Air , 6.1.2.2, a new requirement has been added, specifying that the 846 dry gas test meter or other ai rflow rate measuring device be “permanently placed in the 847 chamber air intake duct.” A new loading ra tio was added for “low density particleboard 848 door core” and a note specifying that “Panel grades are defined in the ANSI standards 849 referenced in 2.3.” Under 9.2 Conditioning , a note was added st ating “Test specimens 850 with low levels of formaldehyde may absorb formaldehyde from the air when the air 851 formaldehyde content exceeds that of the text [sic] specimen. Consideration should be 852 taken to avoid such air conditions during st orage and conditioning.” In addition, the 853 following requirement was added: “Circulation of the conditio ning air shall be achieved 854 by fans that direct air flow horizontally in th e direction parallel to the primary surface of 855***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 37 of 93 [RIN 2070-AJ44] the test specimens.” Under Test Procedure for Materials , 10.1.3, the following phrase 856 was deleted: “as measured by a totalizing dry gas meter permanently placed in the 857 chamber air intake duct.” Under note 9, the following clarifying phrase was added: 858 “unless testing is extended and chamber c oncentrations in air and emission rates are 859 obtained for the tested product at multiple cham ber air exchange rates or multiple product 860 loading ratios, or both.” Under Report the Following Information , 12.1.7, the following 861 was added: “and the air circulat ion conditions (for example, ai r velocity or air exchange 862 rate.” Under (Nonmandatory Information) X1. Reagents, Materials, and Equipment 863 Found Suitable for Use, footnotes specifying wh ere apparatuses are available have been 864 deleted. In addition, X1.3.2 Sulfuric Acid, ha s been changed from “concentrated reagent 865 grade. Nitrate concentration shall be le ss than 10 ppm.” to “ACS grade. Nitrate 866 concentration shall be no greater than 0.2 ppm.” EPA requests comment on whether 867 ASTM E1333-10 should be incorporated into the testing requirements under TSCA Title 868 VI in place of ASTM E 1333-96 (Reapproved 2002). 869 EPA intends to propose the means of show ing test method equivalence for other 870 test methods as well as the number and fr equency of tests requi red to demonstrate 871 compliance with the formaldehyde emission st andards in a subse quent proposal along 872 with the rest of the TSCA Title VI impleme nting regulations. EPA is proposing here that 873 TPC laboratories be responsible for conducting quarterly tests, verifying quality control 874 tests, and evaluating te st method equivalence. 875 EPA is proposing that TPCs must have e xperience operating or using laboratories 876 that follow ISO/IEC 17025:2005(E). This intern ational voluntary consensus standard 877 specifies the general requirements for th e competence to carry out tests and/or 878***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 38 of 93 [RIN 2070-AJ44] calibrations, including sampling. EPA believes that requiring TPCs to use laboratories 879 that follow these requirements would help ensure that reliable and accurate test results are 880 obtained. 881 EPA is proposing that TPCs must ha ve experience or ability in product 882 certification and in complying with IS O/IEC Guide 65:1996(E) because certifying 883 compliant composite wood products would be one of the main functi ons of a TSCA Title 884 VI accredited TPC. ISO/IEC Guide 65:1996(E) is an international voluntary consensus 885 standard that specifies ge neral requirements for a th ird-party operating a product 886 certification system. These general requireme nts would help ensure that the TPC is 887 competent and reliable in certifyi ng compliant composite wood products. 888 EPA is proposing that the TPC must have experience in conducting inspections of 889 the manufacturers in conformity withISO/IEC 17020:1998(E). This international 890 voluntary consensus standard specifies genera l criteria for the operation of various types 891 of bodies performing inspections. EPA is also proposing that TPCs mu st have the ability 892 to properly train and supervise inspectors pursuant to conformity with ISO/IEC 893 17020:1998(E). Inspections by TPCs would be an important function of a TPC in helping 894 ensure compliance with the regulations under TSCA Title VI. 895 EPA is proposing that TPCs must ha ve experience in the composite wood 896 products industry because EPA believes that understanding the processes used by panel 897 producers to produce composite wood products is crucial fo r the TPC to adequately 898 inspect and audit panel producers. Experien ce in the composite wood products industry 899 would help ensure that the TPC would know wh at to inspect and area s on which to focus 900 during inspections and audits of the panel producers. In addition, EPA is proposing to 901***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 39 of 93 [RIN 2070-AJ44] require TPCs to have experience with the spec ific type of composite wood product(s) that 902 it would certify. EPA believes th at certain steps in the ma nufacture of composite wood 903 products are likely important in maintain ing low formaldehyde emissions and that 904 because manufacturing processes are different for the different types of regulated 905 composite wood products, it is important for a TPC to have knowledge and experience in 906 the manufacture of the specific type of com posite wood product(s) th at it would certify. 907 EPA requests comment on whether EPA should require that the TPC have experience 908 with the specific type of composite wood product that it w ould certify or if experience 909 with one type of product is sufficient to certify all types of composite wood product. 910 If an AB denies a TPC’s applicati on for accreditation for failure to submit a 911 complete application, the AB would be required to notify th e TPC or TPC laboratory in 912 writing of the legal and factua l basis for the denial, actions , if any, which the affected 913 TPC or TPC laboratory may take to rece ive accreditation in the future, and the 914 opportunity and method for requesting a hearing with EPA. “Failure to submit a complete 915 application” would not include failure to pay any accreditation fee or reach a fee 916 agreement. 917
2. Proposed requirements once a TPC is accredited. EPA is proposing that once 918 an applicant is accredited as a TP C under TSCA Title VI, the TPC must: 919 a. Verify that panel producers have ad equate quality assura nce controls and are 920 complying with any quality assurance and quality control requirements that EPA 921 promulgates pursuant to TSCA Title VI. 922 b. Verify quality control test results compared with ASTM E1333-10 test results 923 by having laboratories conduct qua rterly tests and evaluate test method equivalence 924***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 40 of 93 [RIN 2070-AJ44] pursuant to testing requirements pr omulgated under TSCA Title VI. 925 c. Review applications from panel pr oducers for reduced testing or third-party 926 certification requirements. 927 d. Establish quality control limits in c onsultation with pane l producers, and, if 928 applicable, shipping quality control or othe r limits for each product type and production 929 line. 930 e. Inform panel producers of the process th at will be used to determine if product 931 lots are exceeding the applicable quality control limit. 932 f. Inspect and audit panel producers and their records at least quarterly. 933 g. Use a testing laboratory or laboratories that comply with ISO/IEC 934 17025:2005(E). 935 h. Certify composite wood product types that comply with requirements under 936 TSCA Title VI following ISO/IEC Guide 65:1996(E). 937 i. Follow ISO/IEC 17020:1998(E) in the carry ing out of their inspections of the 938 panel producers. 939 j. Provide approved TPC number (supp lied by the accrediting AB) to the panel 940 producer for labeling and recordkeeping. 941 k. Use laboratories that participate in an inter-laborat ory comparison or 942 proficiency testing program. 943 l. Maintain records in electronic form for 5 years. 944 m. Provide an annual report to EPA and the AB(s) that provided it with its 945 accreditation. 946 n. Inform the AB(s) that provided it with its accreditation of any changes in key 947***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 41 of 93 [RIN 2070-AJ44] personnel qualifications, procedur es, or laboratories used by th e TPC that could affect the 948 TPC’s ability to fulfill its obligations under this unit. 949 One of the main functions of TPCs under this proposed rule would be to help 950 ensure that panel producers have adequate quality control of their manufacturing process, 951 are following appropriate quality assuran ce procedures, and are complying with any 952 quality assurance requirements that EPA may implement under TSCA Title VI. Under 953 the CARB ATCM, manufacturers are required to implement specific quality assurance 954 procedures as described in Appendix 2 of the ATCM. EPA anticipates promulgating 955 quality assurance requirements for panel pr oducers under TSCA Title VI in a subsequent 956 proposal with other implementation provisions as required under TSCA Title VI. EPA is 957 proposing to use TPCs to help ensure co mpliance with quality control and quality 958 assurance procedures. 959 EPA is proposing to require TPCs to ve rify quality control tests that measure 960 formaldehyde emissions by having labor atories conduct quarterly testing. 961 Under TSCA Title VI, EPA intends to pr omulgate specific formaldehyde testing 962 requirements. The subsequent proposal may also provide for reduced testing for specified 963 products such as those made with NAF or U LEF resins. In this proposed rule, EPA is 964 proposing to require TPCs to review and appr ove, when appropriate, applications from 965 panel producers for reduced te sting and third-party certifi cation requirements according 966 to EPA’s implementing regulations. The CARB ATCM allows for reduced testing for 967 products manufactured with NAF and ULEF resins, and CARB reviews and approves 968 NAF and ULEF applications. EPA is proposing to instead require TPCs to review these 969 applications because EPA believes they are best suited to determine whether the panel 970***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 42 of 93 [RIN 2070-AJ44] producers will be able to consistently comp ly with the emission standards even with 971 reduced testing requirements. EPA intends to further specify requirements for reduced 972 testing in a subsequent proposal with othe r implementation provisions as required under 973 TSCA Title VI. 974 EPA is proposing to require TPC laboratori es (including contractlaboratories) to 975 establish quality control limits in consultation with panel producers and, if applicable, 976 shipping quality control or other limits for each product type and production line to 977 ensure compliance with the emission standa rds. A quality control limit would be 978 established if test methods other than AS TM E1333-10 are being us ed to make it easier 979 for the panel producer to determine whethe r any products are likely to exceed the 980 emission standards. A quality control limit w ould be the value from a test other than 981 ASTM E1333-10 that is the correlative equiva lent to the applicable standard. A TPC may 982 also establish a limit to account for process a nd testing variation to help ensure that the 983 emission for a product would not exceed the applicable standard. EPA is proposing to 984 require TPCs to inform panel producers of the process that the TPC would use to 985 determine if product lots are ex ceeding the applicable quality control limit. In the broader 986 TSCA Title VI implementing regulations, EPA in tends to describe these limits in more 987 detail as well as implications and procedures for cases where tests exceed the limits in a 988 subsequent proposal with other implementati on provisions as required under TSCA Title 989
VI. 990 EPA is proposing to require that TPCs inspect and on-site audit panel producers 991 and their records at least quarterly an d comply with ISO/IEC 17020:1998(E) when 992 conducting their inspections. Quarterly inspections and on-site audits are consistent with 993***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 43 of 93 [RIN 2070-AJ44] requirements under the CARB ATCM, and EP A believes that requiring inspections 994 quarterly should be sufficiently frequent to allow TPCs to observe and mitigate any 995 potential violations. However, under certain circumstances, a TPC could determine that 996 more frequent inspections and on-site audi ts are necessary to ensure compliance.EPA 997 request comment on whether enhanced tes ting or inspection requirements should be 998 required where a TPC finds that a panel produc er has failed quality control or quarterly 999 tests at a certain frequency. 1000 EPA is proposing to require that TPCs use laboratories for formaldehyde testing 1001 that comply with ISO/IEC 17025:2005(E). As di scussed in Unit II.F.1., this international 1002 voluntary consensus standard specifies the general requirements for the competence to 1003 carry out tests and/or calibr ations, including sampling. EPA believes that requiring TPCs 1004 to use laboratories that follow these require ments would help ensu re that TPCs obtain 1005 reliable and accurate test results. 1006 EPA is proposing to require that TPCs pa rticipate in an EPA-recognized inter1007 laboratory comparison studies orproficiency testing, if deve loped. The inter-laboratory 1008 comparisons would involve the participation of laboratories that are provided composite 1009 wood product samples to test for formaldehyde; each laboratory would test the sample 1010 using the same test method (e.g., ASTM E 1333-10), and the results from all of the 1011 laboratories would be compared. If a sta ndard reference material for formaldehyde 1012 emissions is developed, EPA proposes to re quire annual proficienc y testing. The CARB 1013 ATCM requires laboratories to participate in an inter-laboratory comparison during the 1014 first year that the laboratory is used by a TPC, followed by participation in inter1015 laboratory comparisons every 2 years. EPA believes that ev aluating the performance of 1016***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 44 of 93 [RIN 2070-AJ44] laboratories used by the TPC by inter-laborator y comparisons or proficiency testing is 1017 vital to ensuring that laboratories are pe rforming the formaldehyde testing properly, and 1018 EPA is therefore proposing that this be an annual requirement. EPA requests comment on 1019 whether inter-laboratory comparisons should ta ke place more or less frequently. EPA is 1020 also seeking comment on criteria to use in evaluating performance in inter-laboratory 1021 comparisons. 1022 EPA is proposing to require TPCs to fo llow ISO/IEC Guide 65:1996(E) to certify 1023 composite wood product types that comply w ith requirements under TSCA Title VI. As 1024 discussed in Unit II.F.1., ISO/IEC Guide 65: 1996(E) is an intern ational voluntary 1025 consensus standard that specifies general requirements for a third-party operating a 1026 product certification system. EPA believes th at requiring TPCs to follow these general 1027 requirements for certifying products would help ensure that the TPC is properly 1028 certifying only compliant composite wood products. 1029 A TPC would be supplied with a TPC id entification number by the Product AB 1030 once it has been accredited for TSCA Title VI purposes. EPA is proposing to require that 1031 the TPC provide this number to panel producer s so that they can in clude the TPC number 1032 on the label of their certified products and include it in their records. 1033 EPA is proposing to require TPCs to main tain records in electronic form for 5 1034 years. TSCA Title VI directs EPA to address recordkeeping requirements in its 1035 implementing regulations and EPA believes that certain records will greatly assist the 1036 EPA in monitoring compliance with the emi ssions standards and other provisions. These 1037 records would be: 1038 •A list of panel producers and their resp ective product types, including resins 1039***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 45 of 93 [RIN 2070-AJ44] used, that the TPC has certified. 1040 •Results of inspections, audits, and em ission tests conducted for and linked to 1041 each panel producer and product type. 1042 •A list of laboratories used by the TPC, test methods, including test conditions 1043 and conditioning time, and test results. 1044 •Methods and results for establishing test method correlations and equivalence. 1045 EPA is proposing to require TPCs to subm it an annual report to EPA and the AB 1046 that accredits the TPC. Th e annual report would include: 1047 •A list of panel producers and their products that the TPC has certified during the 1048 previous year, including resins used a nd the average and range of formaldehyde 1049 emissions by panel producer, resin, and product type. 1050 • List of any non-complying products or events by panel producers. 1051 • A list of laboratories and te st methods used by the TPC. 1052 • Results of inter-laboratory comparison or proficiency testing for the laboratories 1053 used by the TPC. 1054 EPA is proposing to require that the TPC inform the AB(s) th at accredit the TPC 1055 of any changes in key personnel qualificati ons, procedures, or laboratories used that 1056 could affect the TPC's ability to fulfill its obligations under this un it. EPA believes such 1057 changes could impact the TPC’s ability to properly verify formaldehyde emissions, 1058 inspect and audit, and certif y compliant composite wood products. EPA is proposing that 1059 the AB review the changes to determine wh ether the changes would impact the TPC’s 1060 ability to perform its duties. 1061
3. Removal and reaccreditation of third-party certifiers. EPA is proposing to 1062***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 46 of 93 [RIN 2070-AJ44] exercise the authority to revoke the TSCA Title VI accreditation of a TPC or its 1063 laboratory, after notice and an opportunity for a hearing, if the TPC or its laboratory: 1064 Fails to meet any of the applicable require ments promulgated under TSCA Title VI (such 1065 as by failing to comply with ISO/IEC Guide 65:1996(E), ISO/IEC 17020:1998(E), or 1066 ISO/IEC 17025:2005(E)); makes false or misl eading statements on its application, 1067 records, or reports; or makes changes to key personnel qualifications, procedures, or 1068 laboratories that would make it unable to perf orm its duties. ABs woul d also be able to 1069 revoke an accreditation of a TPC, subject to an opportunity for a hearing with EPA. A 1070 TPC whose accreditation has been revoked may rea pply to an AB to be reaccredited as a 1071
TPC. 1072 If a TPC loses its accreditation or discontinues participation in the TSCA Title VI 1073 Third-Party Certification Program for any r eason, it would be responsible for promptly 1074 notifying EPA and all panel producers that it provides TSCA Title VI certification 1075 services to. If a TPC loses its accreditation or discontinues particip ation in the program 1076 for reasons other than fraud orproviding false or misleading statements, or other than a 1077 reason that implicates a particul ar panel producer in a violatio n of TSCA Title VI or its 1078 implementing regulations, the pa nel producers that used the TP C to certify their products 1079 would need to enlist another TPC to certify their products within 3 months (90 days). 1080 During the time a panel producer is seeking a new TPC, it would need to continue to 1081 comply with all other requirements of TSCA Title VI and its implementing regulations, 1082 including quality control test ing. During this period the panel producer would remain 1083 subject to inspection by EPA. If the panel producer is unable to comply with all other 1084 aspects of TSCA Title VI and its implementi ng regulations, the panel producer would not 1085***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 47 of 93 [RIN 2070-AJ44] be permitted to sell, offer for sale, or suppl y its products in the United States until its 1086 products are recertified as compliant. If a TPC loses its accredita tion due to fraud or 1087 providing false or misleading statements with respect to a particul ar panel producer, or 1088 for any other reason that implicates a partic ular panel producer in a violation of TSCA 1089 Title VI or the regulations promulgated th ereunder, that panel producer would not be 1090 permitted to offer regulated composite wood produc ts for sale in the United States until 1091 its composite wood products have been recert ified by another TPC. If such a situation 1092 does occur, EPA would notify affected pane l producer at the time it commences action 1093 against the TPC. EPA believes it is appropriate to be more stringent in these situations 1094 because the TPC’s behavior may call into qu estion the legitimacy of the manufacture’s 1095 product certification. Any action EPA would ta ke against a TPC would not preclude an 1096 enforcement action against a panel producer . EPA requests comment on whether it has 1097 provided adequate time for a panel producer to seek an alte rnate certification. 1098 H. Enforcement, Suspension, Revocation, and Modification 1099
1. Enforcement under TSCA sections 15-17. EPA may conduct inspections of 1100 participating TPCs and ABs and issue subpoenas according to the requirements for 1101 accreditation and recognition and/or pursuant to the provisions of TSCA section 11 (15 1102 U.S.C. 2610) to ensure compliance with TSCA Title VI and the regulations promulgated 1103 thereunder. Enforcement issues related to manufacturers, importe rs, distributors, and 1104 retailers will be covered in a subsequent proposal. 1105 EPA would exercise the aut hority to withdraw from a recognition agreement with 1106 an AB and pursue penalties under TSCA secti on15 (15 U.S.C. 2614) fo r any violation of 1107 TSCA Title VI or the regulations prom ulgated thereunder. In addition to an 1108***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 48 of 93 [RIN 2070-AJ44] administrative or judicial finding of violation, grounds for withdrawing from a 1109 recognition agreement and/or pursuing an enfo rcement action against an AB include if 1110 the AB: 1111 • Submits false or misleading information to EPA; 1112 • Fails to maintain or falsifies required records; or 1113 • Or otherwise fails to comply with TSCA Title VI or the regulations promulgated 1114 thereunder. 1115
2. Suspension, revocation and modification. EPA would exercise the authority to 1116 suspend, revoke, or modify a TPC’s TSCA Title VI accreditation, with or without the 1117 participation of the AB that provided the accredita tion, if the TPC fails to comply with 1118 TSCA Title VI or the regulations promulgate d thereunder. Any viol ation of TSCA Title 1119 VI or the regulations promulgated thereunde r would also be a pr ohibited act under TSCA 1120 section 15 (15 U.S.C. 2614). Grounds for su spending, modifying, or revoking a TPC’s 1121 accreditation include if the TPC: 1122 a. Submits false or misleading information to EPA or its AB; 1123 b. Fails to maintain or falsifies required records; or 1124 c. Fails to comply with TSCA Title VI or regulations promulgated thereunder. 1125 The ISO/IEC standards and guide that are re ferenced in this pr oposed rule require 1126 that policies and procedures be in place to identify and remedy nonconformities with the 1127 implementation of those standards (I SO/IEC 17025:2005(E), s ection 4.9; ISO/IEC 1128 17011:2004(E), section 5.5; ISO/IEC 17020:1998( E), section 7.8; ISO/IEC Guide 1129 65:1996(E), section 47). Should a TPC or AB identify a nonconformity or discrepancy 1130 with its implementation of one of the ISO sta ndards via an internal audit or other means, 1131***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 49 of 93 [RIN 2070-AJ44] that entity must take remedial action with in the timeframe specified by the AB or the 1132 time specified in the TPC’s quality management plan in order to avoi d the possibility of 1133 an enforcement action. 1134 Prior to withdrawal from a recognition ag reement with an AB, or the suspension, 1135 revocation, or modification of a TPC’s accred itation, EPA would provide notification to 1136 the affected AB or TPC of: 1137 • The legal and factual basis for the proposed action. 1138 • The anticipated commencement date and duration of any suspension, revocation, 1139 modification, or other action. 1140 • What actions, if any, the affected entity may take to avoid suspension, 1141 revocation, modification, or otherwise c ontinue participation in the program. 1142 • The opportunity and method for requesting a hearing prior to the final action. 1143 If an individual or organizati on requests a hearing, EPA would: 1144 • Provide the affected entity an opportunity to offer written statements in response 1145 to EPA’s assertions of the legal and factual basis for its proposed action. 1146 • Appoint an impartial official of EPA as Presiding Officer to conduct the hearing. 1147 The Presiding Officer would conduct a fair , orderly, and impart ial hearing within 1148 90 days of the request for a hearing. The Pr esiding Officer would c onsider all relevant 1149 evidence, explanations, comments, and arguments submitted and notify the affected 1150 entity in writing within 90 days of comple tion of the hearing of his or her decision and 1151 order. Such an order is a final agency action which may be subject to judicial review. The 1152 order must contain the commen cement date and duration of the suspension, revocation, or 1153 modification. 1154***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 50 of 93 [RIN 2070-AJ44] If EPA determines that the public healt h, interest, or welfar e warrants immediate 1155 action to suspend the recognition of an AB or the accreditation of a TPC prior to the 1156 opportunity for a hearing, it would notify the aff ected AB or TPC of its right to request a 1157 hearing on the immediate suspension within 15 days of the suspension taking place and 1158 the procedures for the co nduct of such a hearing. 1159 Any notice, decision, or order issued by EPA in response to a hearing, any 1160 transcript or other verbatim r ecord of oral testimony, and any documents filed in response 1161 to a hearing would be available to the pub lic, except as otherwise provided by TSCA 1162 section 14. Any such hearing at which oral testimony is presented would be open to the 1163 public, except that the Presiding Officer may ex clude the public to the extent necessary to 1164 allow presentation of information which may be entitled to confid ential treatment under 1165 TSCA section14. 1166 I. Status of CARB Approved TPCs 1167 EPA intends to propose that the formalde hyde emissions standards in TSCA Title 1168 VI become effective 365 days after the promulgation of the TSCA Title VI implementing 1169 regulations (which are required by TSCA T itle VI to be promulgated no later than 1170 January 1, 2013). EPA proposes that CARB approved TPCs would have 365 days after 1171 the promulgation of the TSCA Title VI implementing regulations to become accredited 1172 by an AB with which EPA has entered into a recognition agreement. EPA believes this is 1173 a sufficient period of time for EPA to enter into recognition agreements with ABs and for 1174 TPCs to seek accreditation from EPA rec ognized ABs, ensuring no interruption in a 1175 TPC’s services. During the transition period between when the final TSCA Title VI 1176 implementing regulations are promulgated a nd the date 365 days after promulgation, the 1177***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 51 of 93 [RIN 2070-AJ44] CARB approved TPCs may carry out certif ication activities under TSCA Title VI 1178 provided that they are compliant with all other aspects of TSCA Title VI and the 1179 regulations promulgated thereunder. TPCs th at are certifying products as compliant with 1180 TSCA Title VI are subject to inspecti on by EPA and enforcement actions for any 1181 violations of TSCA Title VI or th e regulations promulgated thereunder. 1182 J. Transparency 1183 EPA has a commitment to uphold the valu es of transparency and openness in 1184 conducting EPA operations (Ref. 23). Transparency promotes accountability and 1185 provides information for citizens about wh at their government is doing (Ref. 24). EPA 1186 would support its commitment by making docum entation of recognized ABs, TPCs, and 1187 panel producers available to the public. EPA is proposing to make the following 1188 information publically available on the internet: 1189 1. The names and addresses of all ABs th at EPA has a recognition agreement with 1190 and the status of that recognition agreement. 1191 2. A list of all accredited TPCs with th eir TPC number and accreditation status. 1192 3. Annual reports from ABs. 1193 4. A list of panel producers approved for reduced testing and reduced third-party 1194 certification requirements. 1195 EPA requests comment on what, if any, a dditional information should be made 1196 publically available (e.g., annual reports from TPCs and other required notifications) and 1197 on whether there are other ways EPA mi ght improve program transparency. EPA 1198 requests comment on whether making the follo wing information available publically on 1199 the internet would be useful to the public orpresent challenges for regulated entities: 1200***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 52 of 93 [RIN 2070-AJ44] • A list of panel producers and their products that each TPC has certified, 1201 including resins used and the average and range of formaldehyde emissions by panel 1202 producer, resin, and product type. 1203 • A list of any non-complying products or events by panel producer. 1204 • A list of laboratories and te st methods used by each TPC. 1205 • The results of inter-laboratory comparison or proficiency testing for the 1206 laboratories used by TPCs. 1207 EPA requests comment on whether su ch information might contain CBI. 1208 EPA is also considering requi ring some information to be reported into a publicly 1209 viewable database, should such a database be developed. Generally, EPA is considering 1210 requiring electronic reporting of the information proposed to be reported. In particular, 1211 EPA requests comment on whether the data elements in the ABs’ and TPCs’ annual 1212 reports, and the required no tifications should be reporte d into a publicly viewable 1213 database. 1214 IV. Request for Comment 1215 In addition to the areas on which EPA has specifically requested comment, EPA 1216 requests comment on all other aspe cts of this proposed rule. 1217 V. References 1218 As indicated under ADDRESSES , a docket has been established for this 1219 rulemaking under docket ID number EPA- HQ-OPPT-2011-0380. The following is a 1220 listing of the documents that are specifica lly referenced in this action. The docket 1221 includes these documents and other information considered by EPA, including 1222 documents that are referenced within the docum ents that are included in the docket, even 1223***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 53 of 93 [RIN 2070-AJ44] if the referenced document is not physically located in the docket. For assistance in 1224 locating these other documents, please c onsult the technical contact listed under FOR 1225 FURTHER INFORMATION CONTACT

. 1226 1. Public Law 111-199, Title VI--Formald ehyde Standards for Composite Wood 1227 Products Act, enacted July 7, 2010. (T SCA section 601(d), 15 U.S.C. 2601 et seq. ) 1228 2. Agency for Toxic Substances an d Disease Registry (ATSDR). 1999. 1229 Toxicological Profile for Formaldehyde and 2010 Addendum to the Profile. Atlanta, GA: 1230 U.S. Department of Health and Huma n Services, Public Health Service. 1231 3. National Toxicology Program , U.S. Department of H ealth and Human Services 1232 (HHS), 12 th Report on Carcinogens, June 10, 2011. 1233 4. EPA, ORD. Integrated Risk Information System (IRIS) Program. IRIS 1234 Toxicological Review of Formaldehyde-Inha lation Assessment (2010 External Review 1235 Draft). Available online at: 1236 http://cfpub.epa.gov/ncea/iris_dr afts/recordisplay.cfm?deid=223614

. 1237 5. National Academy of Sciences (NAS). Review of the Environmental Protection 1238 Agency's Draft IRIS Assessment of Formaldehyde. 2011. Available online at: 1239 http://www.nap.edu/catalog.php?record_id=13142. 1240 6. California Environmental Protec tion Agency Air Resource Board. CARB 1241 Airborne Toxic Control Measure . April 26, 2007. Available online at: 1242 http://www.arb.ca.gov/toxics/compwood/compwood.htm

. 1243 7. California Environmental Protection Ag ency Air Resources Board, Composite 1244 Wood Products ATCM, List of CARB Appr oved Third-party Certifiers (Accessed 1245***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 54 of 93 [RIN 2070-AJ44] August, 2011)

. Available online at: 1246 http://www.arb.ca.gov/toxics/compwood/listoftpcs.htm. 1247 8. California Environmental Protection Ag ency Air Resources Board, Application 1248 to be a Third-party Certifier (TPC) of Composite Wood Products

. Available online at: 1249 http://www.arb.ca.gov/toxics/com pwood/tpc/tpcapp lication.pdf. 1250 9. Sierra Club. Citizen Petition to EPA Regarding Formaldehyde in Wood 1251 Products. March 20, 2008. Available online at: 1252 http://www.epa.gov/opptintr/chemtest/formaldehyde/index.html. 1253 10. EPA. Formaldehyde Emissions from Composite Wood Products; Disposition 1254 of TSCA Section 21 Petition. Federal Register. (73 FR 36504, June 27, 2008) (FRL1255 8371-5). 1256 11. EPA. Formaldehyde Emissions from Composite Wood Products; Advanced 1257 notice of proposed rulemaking and notice of public meetings. Federal Register. (73 FR 1258 73620, December 3, 2008) (FRL-8386-3). 1259 12. ISO/IEC Guide 65:1996(E), General Re quirements for Bodies Operating 1260 Product Certification Systems (First Edition) 1996. 1261 13. ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements for 1262 Accreditation Bodies Accrediting Conformity Assessment Bodies (Corrected Version), 1263 February 15, 2005. 1264 14. ISO/IEC 17025:2005(E), General Requirements for the Competence of 1265 Testing and Calibration Laborat ories (Second Edition), May 15, 2005. 1266 15. ISO/IEC 17020:1998(E), General Criteria fo r the Operation of Various Types 1267 of Bodies Performing Inspections (First Edition) November 15, 1998. 1268***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 55 of 93 [RIN 2070-AJ44] 16. International Accreditation Forum. Available online at: http://www.iaf.nu/. 1269 17. International Laborator y Accreditation Cooperati on. Available online at: 1270 http://www.ilac.org. 1271 18. EPA. National Lead Laboratory A ccreditation (NLLAP) . Available at: 1272 http://www.epa.gov/lead/pubs/nllap.htm

. 1273 19. ASTM E1333-96 (Reapproved 2002). Standa rd Test Method for Determining 1274 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 1275 Large Chamber. 1276 20. ASTM D6007-02 (Reapproved 2008), Octo ber 1, 2008. Standard Test Method 1277 for Determining Formaldehyde Concentratio ns in Air from Wood Products Using a 1278 Small-Scale Chamber. 1279 21. ASTM D5582-00 (Reapproved 2006), Octo ber 1, 2006. Standard Test Method 1280 for Determining Formaldehyde Levels fr om Wood Products Us ing a Desiccator. 1281 22. ASTM E1333-10 (May 1, 2010). StandardTest Method for Determining 1282 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 1283 Large Chamber. 1284 23. EPA. Memorandum from Lisa Jackson to EPA Employees (April 23, 2009). 1285 Available online at: http://www.epa.gov/Administr ator/operationsmemo.html

. 1286 24. Memorandum from President Barack Obama to the Heads of Executive 1287 Departments and Agencies. January 21, 2009. Available online at: 1288 http://www.whitehouse.gov/the_press_of fice/TransparencyandOpenGovernment

. 1289***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 56 of 93 [RIN 2070-AJ44] 25. EPA. Economic Analysis of the Thir d-Party Certification Framework for the 1290 Formaldehyde Standards for Composite W ood Products Act Proposed Rule (Economic 1291 Analysis). OMB Draft March 9, 2012. 1292 26. EPA. Information Collection Request (ICR) for the Formaldehyde Emissions 1293 From Composite Wood Products, Third-Party Certification Framew ork, Recordkeeping 1294 and Reporting; Proposed Rule, (RIN 2070- AJ44). EPA ICR No. 2441.01 and OMB No. 1295 2070-[NEW]. OMB Draft March 12, 2012. 1296 27. EPA. Report of the Small Busi ness Advocacy Review Panel on EPA’s 1297 Planned Proposed Rule Implementing the Formaldehyde Standards for Composite Wood 1298 Products Act (TSCA Title VI). April 4, 2011. 1299 VI. Statutory and Executive Order Reviews 1300 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 1301 13563: Improving Regulation and Regulatory Review 1302 1303 Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), 1304 this is a “significant regulatory action” b ecause it may raise novel legal or policy issues 1305 related to the establishment of a new regul atory program as manda ted by a new statutory 1306 amendment. Accordingly, EPA submitted this action to the Office of Management and 1307 Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, 1308 January 21, 2011), and any changes made in response to OMB recommendations are 1309 documented in the docket for this action. 1310 EPA prepared an analysis of the potential costs and benefits associated with this 1311 action. A copy of this Economic Analysis (Ref . 25) is available in the docket for this 1312 action and the analysis is briefly summarized here. 1313 The proposed rule would require ABs to submit an application and enter into a 1314***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 57 of 93 [RIN 2070-AJ44] recognition agreement with EPA, provide notif ications and annual reports, and maintain 1315 records. A typical AB is estimated to incu r an annualized cost of approximately $775 per 1316 year. For the purposes of cost estimation EP A assumes that eight organizations in the 1317 United States will become ABs in the TSCA Title VI Third-Party Certification Program, 1318 so total costs to U.S. ABs are estimat ed to be approximately $6,200 per year. 1319 The proposed rule would require TPCs to submit an application, submit 1320 notifications and annual reports, and maintain records. These requirements are estimated 1321 to cost an average TPC about $1,200 per year . The proposed rule also would require 1322 TPCs to be accredited for certain ISO/IEC guide and standards. Most potential TPCs that 1323 are likely to participate in the TSCA Title VI Third-Party Certification Program are 1324 expected to already have all the necessary accreditations, bu t some TPCs are assumed to 1325 need an additional acc reditation at a cost of $25,000 in the first year and $5,000 per year 1326 in subsequent years. For the purposes of costestimation EPA assumes that there will be 1327 nine U.S. TPCs under this proposed rule. To tal costs to U.S. TPCs due to the proposed 1328 rule are estimated to be approximately $94,000 in the first year and $24,000 to $28,000 1329 per year in subsequent years. Annuali zed costs to U.S. TPCs are $28,000 and $29,000 1330 per year, using a 3% and 7% discount rate, respectively. 1331 The combined total cost for accreditati on bodies and TPCs is estimated to be 1332 $107,000 in the first year. Annualized costs are estimated at $34,000 and $35,000 per 1333 year, using a 3% and 7% di scount rate, respectively. 1334 B. Paperwork Reduction Act (PRA) 1335 The information collection requirements in this proposed rule have been 1336 submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq . The Information 1337***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 58 of 93 [RIN 2070-AJ44] Collection Request (ICR) document preparedby EPA has been assigned EPA ICR No. 1338
2441.01. 1339 This action proposes to require TPCs to provide EPA and ABs with pertinent 1340 information necessary for accreditation. Also, this action proposes to require ABs to 1341 provide EPA with necessary information th rough a recognition agreement in order to 1342 qualify them to function as an AB pursuan t to the regulations. EPA has therefore 1343 prepared and submitted to OMB an Information Collection Request (ICR) document 1344 entitled “Formaldehyde Emissions From Composite Wood Products, Third-Party 1345 Certification Framework, Recordkeeping and Reporting; Proposed Rule (RIN 2070- 1346 AJ44),” identified under EPA ICR No. 2441.01 and OMB Control No. 2070-[NEW], 1347 which is also available for review in th e docket for this actio n (Ref. 26). The ICR 1348 describes the information collection activitie s and the estimated burden hours and costs, 1349 which are briefly summarized here. 1350 Because the approval requirements for in formation collection requests under PRA 1351 is not limited to U.S. entities, the repor ting and recordkeeping burden of the proposed 1352 rule is calculated for both fore ign and domestic entities. 1353 The average reporting and recordkeeping burden for ABs is estimated at 1354 approximately 18 hours per year. EPA assume s that 8 U.S. ABs and 17 foreign ABs will 1355 participate in the TSCA Title VI program, so the annual burden for ABs is estimated to 1356 be 450 hours. The average reporting and record keeping burden for TPCs is estimated at 1357 approximately 28 hours per year. EPA assume s there will be nine domestic TPCs and 27 1358 foreign TPCs that participate in the TCA T itle VI program, so the annual burden for ABs 1359 is estimated at approximately 1,000 hours. Total respondent burden for ABs and TPCs 1360***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 59 of 93 [RIN 2070-AJ44] combined is estimated at approximately 1,450 hours per year. The to tal cost to United 1361 States and foreign TPCs that need to obt ain additional accreditation is estimated to 1362 average $140,000 per year. Burden is defined at 5 CFR 1320.3(b). 1363 An agency may not conduct or sponsor, and a person is not required to respond to 1364 an information collection request unless itdisplays a currently valid OMB control 1365 number, or is otherwise required to submit the specific information by a statute. The 1366 OMB control numbers for EPA’s regulations codi fied in title 40 of the Code of Federal 1367 Regulations, after appearing in the preamble of the final rule, are further displayed either 1368 by publication in the Federal Register or by other appropriate means, such as on the 1369 related collection instrument or form, if applicable. The display of OMB control numbers 1370 for certain EPA regulations is consol idated in a list at 40 CFR 9.1. 1371 To comment on the Agency's need for this information, the accuracy of the 1372 provided burden estimates, and any sugge sted methods for minimizing respondent 1373 burden, EPA has established a public docket fo r this proposed rule, which includes this 1374 ICR, under docket ID number EPA- HQ-OPPT-2011-0380; FRL-9342-4. Submit any 1375 comments related to the ICR to EPA and OMB. See ADDRESSES at the beginning of 1376 this proposed rule for where to submit comments to EPA. Send comments to OMB at the 1377 Office of Information and Regulatory Affair s, Office of Management and Budget, 725 1378
17 th St., NW, Washington, DC 20503, ATTN: De sk Office for EPA. Since OMB is 1379 required to make a decision concerning the ICR between 30 and 60 days after [ insert date 1380 of publication in the Federal Register] , a comment to OMB is best assured of having its 1381 full effect if OMB receives it by [ insert date 30 days after date of publication in the 1382 Federal Register] . The final rule will respond to any OMB or public comments on the 1383***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 60 of 93 [RIN 2070-AJ44] information collection requirements c ontained in this proposed rule. 1384
C. Regulatory Flexibility Act (RFA) 1385 The RFA, 5 U.S.C. 601 et seq. , generally requires an agency to prepare a 1386 regulatory flexibility analysis of any rule subject to notice and comment rulemaking 1387 requirements under the Administrative Proce dure Act or any other statute unless the 1388 agency certifies that the rule will not have a significant ec onomic impact on a substantial 1389 number of small entities. Small entities include small businesses, small organizations, 1390 and small governmental jurisdictions. 1391 For purposes of assessing the impacts of this proposed rule on small entities, a 1392 small entity is defined as: 1393 1. A small business, as defined by the Small Business Administration’s (SBA) 1394 regulations at 13 CFR 121.201. The SBA’s defin itions typically are based upon either a 1395 sales or an employment level, depe nding on the nature of the industry. 1396 2. A small governmental jurisdiction that is a government of a city, county, town, 1397 school district, or spec ial district with a popul ation of less than 50,000. 1398 3. A small organization that is a ny not-for-profit enterprise which is 1399 independently owned and operated and is not dominant in its field. 1400 Since the regulated community does not in clude small governmental jurisdictions, 1401 the Agency’s analysis focuses on small bus inesses and small non-profits organizations. 1402 After considering the economi c impacts of this proposed rule on small entities, I 1403 certify that this action will not have a significant economic imp act on a substantial 1404 number of small entities. The Agency’s basi s is briefly summarized here and is detailed 1405 in the Economic Analysis (Ref. 26). 1406***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 61 of 93 [RIN 2070-AJ44] EPA evaluated two factors in its analysis of the proposed rule’s requirements on 1407 small entities, the number and type of small en tities potentially affected, and the extent of 1408 the rule’s potential economic impact on those entities as me asured by the cost-to-revenue 1409 ratio for businesses and the cost-to-expenses ratio for non-profit orga nizations. This ratio 1410 is a good measure of entities’ ability to affo rd the costs attributable to a regulatory 1411 requirement, because comparing compliance co sts to revenues or expenses provides a 1412 reasonable indication of the magnitude of th e regulatory burden relative to a commonly 1413 available measure of economic activity. Where regulatory costs represent a small fraction 1414 of a typical entity’s revenues or expenses, the financial impacts of the regulation on such 1415 entities may be considered as not significan t. The impact ratios were calculated using 1416 annualized costs, because these costs are mo re representative of the continuing costs 1417 entities would face to comply with this proposed rule. 1418 EPA assumed that 5 small non-profit orga nizations and 4 small businesses in the 1419 United States will participate as ABs or TPCs in the TSCA Title VI program. All of the 1420 small non-profit organizations ar e expected to have cost im pacts below the 1% level. 1421 Three of the small businesses are expected to have cost impacts below the 1% level, and 1422 one is expected to have cost impacts between 1% and 3%. So of the 9 total small entities 1423 assumed to be affected by the final rule, 8 are expected to have impacts under 1%, and 1 1424 is expected to have impacts between 1% and 3%. 1425 In general, EPA strives to minimize pot ential adverse impacts on small entities 1426 when developing regulations to achieve the environmental and human health protection 1427 goals of the statute and the Agency. EP A solicits comments specifically about the 1428 potential economic impacts th at this proposed rule may impose on small entities. 1429***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 62 of 93 [RIN 2070-AJ44] Although not required by RFA to convene a Small Business Advocacy Review 1430 (SBAR) Panel for this particular proposed rule because EPA has determined that this 1431 proposal would not have a significant economic impacts on a substantial number of small 1432 entities, EPA convened a SBAR Panel to obta in advice and recommendations from small 1433 entities representatives potenti ally subject to the proposed rule’s requirements. The 1434 SBAR Panel covered the proposed regulat ions and the broader TSCA Title VI 1435 implementing regulations proposal which will follow. The SBAR Panel was convened by 1436 EPA's Small Business Advocacy Chairperson on February 3, 2011. In addition to the 1437 chairperson, the Panel consiste d of the Assistant Administrato r of the Office of Chemical 1438 Safety and Pollution Prevention, the Administ rator of the Office of Information and 1439 Regulatory Affairs within OMB, and the Ch ief Counsel for Advocacy of the SBA. 1440 Seventeen potentially impacted small entities served as Small Entity 1441 Representatives (SERs), representing a br oad range of small entities from diverse 1442 geographic locations and five association repr esentatives. EPA hosted two meetings with 1443 the SERs to obtain feedback. During the Pr e-Panel Outreach Meet ing on January 6, 2011, 1444 and the Panel Outreach Meeting on February 17, 2011, EPA reviewed the major areas of 1445 regulation, including options for the proposed framework of the TSCA Title VI Third1446 Party Certification Program, with the SB AR Panel and the SERs. The SBAR Panel 1447 solicited comments from the SE Rs on the options presented by EPA, their experiences 1448 with the CARB ATCM, any addi tional concerns they might have, and the costs of 1449 regulatory options. Several SERs submitted written comments to EPA following the 1450 meetings. The Panel evaluated the assembled materials and small entity comments on 1451 issues related to the elements of an IRFA. A copy of the SBAR Panel report is included 1452***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 63 of 93 [RIN 2070-AJ44] in the docket for this proposed rule (Ref. 27) . As a result of its deliberations, the Panel 1453 made a number of recommendations. With rega rds to the proposed TSCA Title VI Third1454 Party Certification Program, the Panel recomm ended that EPA continue to explore how it 1455 can capitalize on the expertise of international ABs, while at the same time maintaining 1456 control over the design and implemen tation of its certification system. 1457 D. Unfunded Mandates Reform Act (UMRA) 1458 Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for Federal 1459 agencies to assess the effects of their re gulatory actions on State, local, and tribal 1460 governments and the private sector. This proposed rule does not contain a Federal 1461 mandate that may result in expenditures of $100 million or more for State, local, or tribal 1462 governments, in the aggregate, or the private sector in any 1 year. No State, local, or 1463 tribal governments currently acts as accreditation bodies or TPCs, and none are 1464 anticipated to do so in the future, so the pr oposed rule would not re sult in expenditures by 1465 these government bodies. The costs of the proposed rule to the private sector are 1466 expected to be approximately $100,000 in the first year, and significantly less costly in 1467 subsequent years. Thus, this proposed rule is not subject to the re quirements of sections 1468 202 or 205 of UMRA. This proposed rule is also not subject to the requirements of 1469 section 203 of UMRA because it contains no regulatory requirements that might 1470 significantly or uniquely aff ect small governments. Since no State, local, or tribal 1471 governments are expected to act as accreditation bodies or TPCs. 1472 E. Executive Order 13132: Federalism 1473 This action does not have federalism implications because it will not have 1474 substantial direct effects on the States , on the relationship between the national 1475***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 64 of 93 [RIN 2070-AJ44] government and the States, or on the distribut ion of power and res ponsibilities among the 1476 various levels of government, as speci fied in Executive Order 13132 (64 FR 43255, 1477 August 10, 1999). No States are expected to act as accreditation bodies or TPCs, and 1478 EPA would administer these requirements notthe States. The proposed rule would not 1479 impose substantial direct compliance costs on States. Furthermore, the proposed rule 1480 would not preempt State or local law. Thus , Executive Order 13132 does not apply to this 1481 action. Nonetheless, since Ca lifornia also has a program to regulate formaldehyde 1482 emissions from composite wood products, EPA held numerous consultations with 1483 representatives of the California Air Res ources Board while developing this proposed 1484 rule. 1485 In the spirit of Executive Order 13132, and consistent with EPA policy to promote 1486 communications between EPA and State and lo cal governments, EPA specifically solicits 1487 comments on this proposed action fro m State and local officials. 1488 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 1489 Governments 1490 1491 This action does not have tribal impli cations as specified in Executive Order 1492 13175 (65 FR 67249, November 9, 2000). No Tribes are expected to act as accreditation 1493 bodies or TPCs, and EPA would administer these requirements not Tribes. Thus, 1494 Executive Order 13175 does not apply to this ac tion. EPA specifically solicits additional 1495 comment on this proposed acti on from tribal officials. 1496 G. Executive Order 13045: Protection of Protection of Children from Environmental 1497 Health Risks and Safety Risks 1498 1499 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as 1500 applying only to those regulatory actions that concern health or safety risks, such that the 1501***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 65 of 93 [RIN 2070-AJ44] analysis required under sect ion 5-501 of the Executive Or der has the potential to 1502 influence the regulation. This action is not subject to Executive Order 13045, because it 1503 would not establish an environmental standard intended to mitigate health or safety risks. 1504 H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect 1505 Energy Supply, Distribution, or Use 1506 1507 This action is not a “significant energy action” as defined in Executive Order 1508 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse 1509 effect on the supply, distribution, or use of energy. Further, we have concluded that this 1510 rule is not likely to have any adverse ener gy affects because it sets up a framework for a 1511 TSCA Title VI Third-Party Certification Pr ogram, and does not require any action related 1512 to the supply, distribution, or use of energy. 1513 I. National Technology Transfer and Advancement Act (NTTAA) 1514 Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use voluntary 1515 consensus standards in its regul atory activities unless to do so would be inconsistent with 1516 applicable law or otherwise impractical. Vo luntary consensus standards are technical 1517 standards (e.g., materials sp ecifications, test methods, sampling procedures, business 1518 practices, etc.) that are de veloped or adopted by voluntary consensu s standards bodies. 1519 NTTAA directs EPA to provide Congress, thro ugh OMB, explanations when the Agency 1520 decides not to use available and appli cable voluntary consensus standards. 1521 This proposed rule involves technical stan dards. EPA proposes to use voluntary 1522 consensus standards. The proposed framew ork of this TSCA Title VI Third-Party 1523 Certification Program is based on the ability of ABs to review TPCs for their conformity 1524 to ISO/IEC Guide 65:1996(E), ISO/ IEC 17025:2005(E), and ISO/IEC 17020:1998(E). 1525 Both Product ABs and Laboratory ABs would be required to maintain their conformity to 1526***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 66 of 93 [RIN 2070-AJ44] ISO/IEC 17011:2004(E). 1527 EPA welcomes comments on this aspect of the proposed rule , and specifically 1528 invites the public to identify potentially ap plicable voluntary consen sus standards and to 1529 explain why such standards shoul d be used in the final rule. 1530 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 1531 Populations and Low-Income Populations 1532 1533 Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal 1534 executive policy on environmental justice. It s main provision directs federal agencies, to 1535 the greatest extent practicable and permitted by law, to make environmental justice part 1536 of their mission by identifying and addressi ng, as appropriate, disproportionately high 1537 and adverse human health or environmental effects of their programs, policies, and 1538 activities on minority populations and low-income populations in the United States. 1539 EPA has determined that this proposed rule will not have disproportionately high 1540 and adverse human health or environmen tal effects on minority or low-income 1541 populations because it does not affect the leve l of protection provided to human health or 1542 the environment. This action proposes a sy stem whereby ABs accredits TPCs, and TPCs 1543 certify composite wood products in order to ensure compliance with the emissions 1544 standards in TSCA Title VI. This action does not relax a pollution control measure and 1545 therefore will not cause emissions increases. 1546 List of Subjects in 40 CFR Part 770 1547 Environmental protection, Composite wood products, Formaldehyde, Reporting 1548 and recordkeeping, Thir d-party certification. 1549
1550 Dated: ____________________ 1551***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 67 of 93 [RIN 2070-AJ44] 1552

_________________________________________________ 1553
1554 Administrator. 1555
1556
1557
1558 1559
1560
1561
1562
1563
1564 1565
1566
1567
1568 1569
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1571
1572
1573 Therefore, it is proposed that 40 CFR ch apter I, subchapter R, be amended by 1574***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 68 of 93 [RIN 2070-AJ44] adding a new part 770 to read as follows: 1575 PART 770--FORMALDEHYDE STAN DARDS FOR COMPOSITE WOOD 1576 PRODUCTS 1577 1578 Subpart A--General Provisions 1579
Sec. 1580 770.1 Scope and applicability. 1581 770.2 Effective dates. 1582 770.3 Definitions. 1583 Subpart B--Third-Party Certification Program 1584 770.7 Third-party certification. 1585 770.9 Prohibited acts. 1586 Subpart C--[Reserved] 1587 Subpart D--Incorporation by Reference 1588 770.99 Incorporation by reference. 1589 Authority : 15 U.S.C. 2697(d). 1590 Subpart A--General Provisions 1591 § 770.1 Scope and applicability. 1592 (a) This subpart applies to: 1593 (1) Laboratory Accreditation Bodies (A Bs) and Product ABs that are accrediting 1594 third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 2697(d)) purposes and those 1595 that wish to commence accrediting third-part y certifiers for TSCA Title VI purposes. 1596 (2) TPCs that are certifying compos ite wood products for TSCA Title VI 1597 compliance and those that wish to comme nce certifying composite wood products for 1598 TSCA Title VI compliance. 1599***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 69 of 93 [RIN 2070-AJ44] (b) [Reserved] 1600 § 770.2 Effective dates. 1601 (a) Laboratory and Product ABs that wish to accredit TPCs for TSCA Title VI 1602 purposes may apply to EPA to become recognized beginning on [ date of publication of 1603 the final rule in the Federal Register ]. Laboratory and Product ABs must be recognized 1604 by EPA before they begin providing TSCA Title VI accreditation services. 1605 (b) TPCs that wish to provide TSCA Title VI certification services must meet all 1606 the requirements of this subpart before they commence providing TSCA Title VI 1607 certification services. 1608 (c) Notwithstanding any othe r provision of this subpart , TPCs that are approved 1609 by the California Air Resources Board to certify composite wood products have until 1610 [ date 1 year after date of publica tion of the final rule in the Federal Register ] to become 1611 accredited pursuant to the requirements of this subpart. During the year following [ date of 1612 publication of the final rule in the Federal Register ], the California Air Resources 1613 Board-approved TPCs may carry out certi fication activities under TSCA Title VI, 1614 provided that they are compliant with all other aspects of TSCA Title VI and the 1615 regulations promulgated thereunder. Third-pa rty certifiers that ar e certifying products as 1616 compliant with TSCA Title VI are subject to enforcement actions for any violations of 1617 TSCA Title VI or the regulat ions promulgated thereunder. 1618 § 770.3 Definitions. 1619 Accreditation Body or AB means an organization that provides an impartial 1620 verification of the competen cy of conformity assessment bodies such as TPCs. 1621***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 70 of 93 [RIN 2070-AJ44] Composite wood product means hardwood plywood, medium-density fiberboard, 1622 and particleboard. 1623 EPA Recognized Laboratory Accreditation Body or EPA Recognized Laboratory 1624
AB means a Laboratory AB that has a rec ognition agreement with EPA under the TSCA 1625 Title VI Third-Party Certification Program. 1626 EPA Recognized Product Accreditation Body or EPA Recognized Product AB 1627 means a Product AB that has a recognition ag reement with EPA under the TSCA Title VI 1628 Third-Party Certification Program. 1629 Laboratory Accreditation Body orLaboratory AB means an accreditation body 1630 that accredits laboratories to ISO/IEC 17025:2005(E) (incorporat ed by reference, see § 1631 770.99). 1632 Panel producer means a manufacturing plant or other facility that manufactures 1633 (excluding imports) hardwood plywood, particle board, or medium density fiberboard. 1634 Product Accreditation Body or Product AB means an accreditation body that 1635 accredits conformity assessment bodies to ISO/IEC Guide 65:1996(E) (incorporated by 1636 reference, see § 770.99) and ISO/IEC 17020:1998( E) (incorporated by reference, see § 1637 770.99). 1638 TSCA Title VI Accredited Third-Party Certifier orTSCA Title VI Accredited TPC 1639 means an organization or entity that is accredited by an EPA recognized Product AB and 1640 an EPA recognized Laboratory AB pursuant to § 770.7 (c)(1). 1641 Subpart B—TSCA Title VI Third- Party Certification Program 1642 § 770.7 Third-party certification. 1643 (a) Product ABs-- (1) Qualifications. To apply to be recognized by EPA as a 1644***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 71 of 93 [RIN 2070-AJ44] Product AB, a candidate Product AB must: 1645 (i) Be a signatory to th e International Accreditation Forum, Inc.’s (IAF) 1646 Multilateral Recognitio n Arrangement (MLA) through level 3, or an equivalent 1647 organization. 1648 (ii) Be in conformance with ISO/IE C 17011:2004(E) (incorporated by reference, 1649 see § 770.99) and maintain that conformity. 1650 (iii) Demonstrate basic competence to pe rform accreditation activities for product 1651 certification according to ISO/IEC Guide 65:199 6(E) (incorporated by reference, see § 1652 770.99). 1653 (iv) Demonstrate competence to perform accreditation activities for inspection 1654 certification according to ISO/IEC 17020:1998(E) (incorporated by reference, see § 1655 770.99). 1656 (2) Recognition. To be recognized by EPA, a Product AB must apply to EPA by 1657 fulfilling the requirements in the paragraphs (a)(2)(i)-(ii) of this section: 1658 (i) Submitting an application to the EPA with the following information: 1659 (A) Name, address, telephone number, and email address of primary contact. 1660 (B) Documentation of its IAF MLA signatory status, or equivalent. 1661 (C) If not a domestic entity, name and a ddress of an agent for service located in 1662 the United States. Service on this agent cons titutes service on the AB or any of its 1663 officers or employees for any action by EPA or otherwise by the United States related to 1664 the requirements of this subpart. 1665 (D) Description of any other qualifications related to its experience in performing 1666 product accreditation of conf ormity assessment bodies or TPCs of manufactured 1667***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 72 of 93 [RIN 2070-AJ44] products. 1668 (ii) Entering into a recognition agreem ent with EPA that describes the Product 1669 AB’s responsibilities under this subpart. 1670 (A) Each recognition agreemen t will be valid for 3 years. 1671 (B) To renew a recognition agreement fo r additional 3 year periods, the Product 1672 AB must submit an application for renewal (before the 3 year period of the recognition 1673 agreement lapses) that indicates any changes from the Product AB’s initial application. 1674 (C) If a Product AB fails to submit an application for renewal prior to the 1675 expiration of the previous recognition agr eement, its recognition will lapse and the 1676 Product AB may not provide TSCA Title VI accreditation services. 1677 (D) If the Product AB does submit an application for renewal prior to the 1678 expiration of the previous recognition agreemen t, it may continue to provide TSCA Title 1679 VI accreditation services under the terms of its previous recognition agreement until EPA 1680 has taken action on its app lication for renewal of th e recognition agreement. 1681 (3) Responsibilities . EPA recognized Product ABs must fulfill the requirements in 1682 paragraphs (a)(3)(i)-(xiv) of this section: 1683 (i) Receive and act on applicati ons for accreditation from TPCs. 1684 (ii) Assign a unique number to each accredited TPC. 1685 (iii) Forward a copy of a TPC’s applic ation for TSCA Title VI accreditation to 1686 EPA at the address identified in the recognition agreement with in 90 days of the date of 1687 receipt. 1688 (iv) Perform an in-depth systems audit, as described in this unit, on each TPC 1689 applicant who submits a complete applicati on at the time of initial application. The 1690***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 73 of 93 [RIN 2070-AJ44] systems audit must include the components desc ribed in paragraphs (3 )(iv)(A)-(F) of this 1691 section: 1692 (A) An on-site assessment by the Produc t AB to determine whether the TPC 1693 applicant’s program requirements are cons istent with ISO/IEC Guide 65:1996(E) and 1694 ISO/IEC 17020:1998(E) (incorporated by refere nce, see § 770.99). The Product AB must 1695 develop a checklist that list s all of the key conformity elements of ISO/IEC Guide 1696 65:1996(E) and ISO/IEC 17020:1998( E) (incorporated by refe rence, see § 770.99) and 1697 the Product ABs must use the checkl ist for each on-site assessment. 1698 (B) A review of the approach that th e TPC applicant will use to verify the 1699 accuracy of the formaldehyde emissions tests conducted by the TPC laboratory or 1700 contract laboratory and the formaldehyde qua lity control tests conducted by the panel 1701 producers producing composite wood products th at are subject to the requirements of 1702 TSCA Title VI. 1703 (C) A review of the approach that th e TPC applicant will use for evaluating a 1704 panel producer’s quality assuranc e and quality control processes, the qualifications of the 1705 panel producer’s quality assuranc e and quality control personnel, the required elements of 1706 a panel producer’s quality a ssurance and quality control ma nual, and sufficiency of on1707 site testing facilities as applicable. 1708 (D) A review of the approach that th e TPC applicant’s laboratory will use for 1709 establishing correlation or e quivalence between alternative formaldehyde test methods 1710 and ASTM E1333-10 (incorporated by reference, see § 770.99). 1711***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 74 of 93 [RIN 2070-AJ44] (E) A review of the approach that th e TPC applicant will use for evaluating the 1712 process for sample selection, handling, and sh ipping procedures, if applicable, that the 1713 panel producer will use for quality control testing. 1714 (F) A review of the accreditation creden tials of the laboratory that the TPC 1715 applicant will use. The review must ensure that the laboratory ha s been accredited to 1716 ISO/IEC 17025:2005(E) (incorporated by refere nce, see § 770.99) by a Laboratory AB 1717 that is a signatory to th e ILAC MRA or equivalent. 1718 (v) Upon request, allow EPA representative s to accompany its assessors during an 1719 on-site assessment to observe the audit of a TPC. 1720 (vi) Accredit TPCs that submit a co mplete application as described in § 1721 770.7(c)(1)(i) and that meet the requirements of § 770.7(c). 1722 (vii) Conduct a follow-up systems audit, in cluding an on-site assessment, of each 1723 TPC that the AB has accredited at least every 2 years. 1724 (viii) Suspend, modify, or revoke the accreditation of a TPC in accordance with § 1725 770.7(e). 1726 (ix) Provide written notifications to EPA at the address identified in the 1727 recognition agreement, as follows: 1728 (A) Notification of loss of its status as a signatory to the IAF MLA (or 1729 membership in an equivalent organization) must be provided to EPA within 5 business 1730 days of the date that the body receives notification of the loss of its signatory status. 1731 (B) Notification of the TSCA Title VI acc reditation of a TPC must be provided to 1732 EPA within 5 business days of the date that the TPC is accredited. 1733 (C) Notification that an accredited TPC ha s failed to comply with any provision 1734***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 75 of 93 [RIN 2070-AJ44] of this section must be provided to EPA within 24 hours of the time the Product AB 1735 identifies the failure. 1736 (D) Notification of suspension or revo cation of a TPC’s accreditation must be 1737 provided to EPA within 24 hours of the time that the suspension or revocation takes 1738 effect. 1739 (E) Notification of a decision to make changes in its organizational policies or 1740 management structure that could adversely a ffect the TPC accreditation program must be 1741 provided to EPA within 30 days of th e decision to make the changes. 1742 (x) If the Product AB is removed or withdraws from the TSCA Title VI Third1743 Party Certification Program, notification must be given to all of the TPCs that receive its 1744 accreditation services within 5 business days. 1745 (xi) Maintain the checklists and other records documenting compliance with the 1746 requirements for systems audits and on-site a ssessments of TPCs for as long as the TPC 1747 is accredited or for 5 years, whichever is l onger. These records must be in electronic 1748 form, and the Product AB must provide them to EPA within 30 days upon request. 1749 (xii) Provide a report to EPA at least once each year (12 months from the 1750 anniversary of the date of the recognition agreement), that incl udes the number and 1751 locations of systems audits a nd on-site assessments performed. 1752 (xiii) Meet with EPA at least once ever y 2 years to discuss the implementation of 1753 the TPC accreditation program. 1754 (xiv) Allow inspections by EPA, conducte d at reasonable times, within reasonable 1755 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and a 1756 written notification to the Product AB. 1757***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 76 of 93 [RIN 2070-AJ44] (b) Laboratory ABs --(1) Qualifications. To apply to be recognized by EPA as a 1758 Laboratory AB, a candidate Laboratory AB must: 1759 (i) Be a signatory to the ILAC MR A, or an equivale nt organization. 1760 (ii) Be in conformance with ISO/IE C 17011:2004(E) (incorporated by reference. 1761 see § 770.99) and maintain that conformity. 1762 (iii) Demonstrate competence to perfor m accreditation activities for laboratory 1763 accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see § 1764 770.99). 1765 (2) Recognition. To be recognized by EPA, a Labo ratory AB must apply to EPA 1766 by fulfilling the requirements in paragra phs (b)(2)(i)-(ii) of this section: 1767 (i) Submit an application to the EPA with the information listed in paragraphs 1768 (b)(2)(i)(A)-(D) of this section (if the accredita tion body is also applying to be recognized 1769 as a Product AB, this application may be submitted in conjunction with the Product AB 1770 application): 1771 (A) Name, address, telephone number, and email address of primary contact. 1772 (B) Documentation of ILAC MRA si gnatory status, or equivalent. 1773 (C) If not a domestic entity, name and a ddress of an agent for service located in 1774 the United States. Service on this agent cons titutes service on the AB or any of its 1775 officers or employees for any action by EPA or otherwise by the United States related to 1776 the requirements of this subpart. 1777 (D) Description of any other qualifications related to the Laboratory AB’s 1778 experience in performing laboratory accred itation and inspection certification of 1779 conformity assessment bodies or TPCs. 1780***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 77 of 93 [RIN 2070-AJ44] (ii) Enter into a recognition agreement with EPA that describes the Laboratory 1781 AB’s responsibilities under this subpart. 1782 (A) Each recognition agreement will be valid for 3 years. 1783 (B) To renew a recognition agreemen t for additional 3 year periods, the 1784 Laboratory AB must submit an application fo r renewal (before the 3 year period of the 1785 recognition agreement lapses) that indicates any changes from the Laboratory AB’s 1786 initial application. 1787 (C) If the Laboratory AB does submit an application for renewal prior to the 1788 expiration of the previous recognition agreemen t, it may continue to provide TSCA Title 1789 VI accreditation services under the terms of its previous recognition agreement until EPA 1790 has taken action on its app lication for renewal of th e recognition agreement. 1791 (3) Responsibilities . EPA recognized Laborator y ABs must fulfill the 1792 requirements in paragraphs (b)(3)( i)-(xiii) of this section: 1793 (i) Receive and act on applications for laboratory accreditation from TPC 1794 laboratories (including c ontract laboratories). 1795 (ii) Within 15 days of a request by a TPC or their EPA recognized Product AB, 1796 forward copies of a TPC’s TSCA Title VI laboratory application and accreditation 1797 documentation to the applicable EPA recogni zed Product AB (if the Laboratory AB is 1798 not also recognized as a Product AB) at the address identified by the TPC. 1799 (iii) Perform an in-depth systems audit on the laboratory of each TPC applicant 1800 who submits a complete application at the time of initial applicat ion. The systems audit 1801 must include: 1802 (A) An on-site assessment by the Laborat ory AB to determine whether the TPC 1803***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 78 of 93 [RIN 2070-AJ44] applicant’s laboratory is consistent with all regulatory requirements and ISO/IEC 1804 17025:2005(E) (incorporated by reference, see § 770.99). 1805 (B) Include a checklist that lists all of the key conformity elements of ISO/IEC 1806 17025:2005(E) (incorporated by reference, see § 770.99) and the Laboratory AB’s 1807 assessors must use the checklist for each on-site assessment. 1808 (iv) Upon request, allow EPA representa tives to accompany its assessors during 1809 an on-site assessment to obs erve the audit of a TPC. 1810 (v) Accredit laboratories that submit a complete application as described in 1811 § 770.7(c)(1)(ii) and that continue to meet the requirements of § 770.7(c). 1812 (vi) Verify the accuracy of the form aldehyde emissions tests conducted by the 1813 TPC laboratory through an inter- laboratory comparison or prof iciency testing program if 1814 available. 1815 (vii) Conduct a follow-up systems audit at least every 2 years, including an on-site 1816 assessment, of each TPC laboratory that the accreditation body has accredited. TPCs’ 1817 laboratories that have not adequately pe rformed an inter-laboratory comparison or 1818 proficiency testing must be audited at least once each year for a period of 2 years from 1819 the date of the latest poor proficiency test or inter-laboratory comparison. 1820 (viii) Suspend, modify, or revoke the accreditation of TPCs’ laboratories in 1821 accordance with § 770.7(e). 1822 (ix) Provide the following written notifi cations to EPA and to the applicable EPA 1823 recognized Product AB (if the Laboratory AB is not also recognized as a Product AB) at 1824 the address identified in the recognition agreement: 1825 (A) Notification of loss of its status as a signato ry to the ILAC MRA, or 1826***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 79 of 93 [RIN 2070-AJ44] membership in an equivalent organization, mu st be provided within 5 business days of 1827 the date that the body receives notice of the loss of its signatory status. 1828 (B) Notice of accreditation of a TPC’s laboratory must be provided within 5 1829 business days of the date that the laboratory is accredited. 1830 (C) Notice that an accredited laboratory ha s failed to comply with any provision 1831 of this section must be pr ovided within 24 hours of the tim e the Laboratory AB identifies 1832 the failure. 1833 (D) Notice that an accredited TPC has faile d to comply with any provision of this 1834 section must be provided within 24 hours of the time the Laboratory AB identifies the 1835 failure. 1836 (E) Notice of a decision to make cha nges in its organizational policies or 1837 management structure that could adversely affect the laboratory accreditation program 1838 must be provided to EPA within 30 days of the decision to make the changes. 1839 (F) Notice if the Laboratory AB suspends or revokes a labora tory’s accreditation 1840 must be provided within 24 hours of the ti me that the suspension or revocation takes 1841 effect. 1842 (x) Maintain checklists and other records documenting compliance with the 1843 requirements for systems audits and on-site a ssessments of laboratorie s must be retained 1844 for as long as the laboratory is accredited or for 5 years, whichever is longer. These 1845 records must be in electronic form and pr ovided to EPA within 30 days of request. 1846 (xi) Provide a report to EPA at least once each year (12 months from the date of 1847 the recognition agreement) that in cludes the following information: 1848 (A) The names and contact information of all the TSCA Title VI accredited TPC 1849***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 80 of 93 [RIN 2070-AJ44] laboratories. 1850 (B) Number and locations of systems a udits and on-site assessments performed. 1851 (C) Results of inter-laboratory comparis ons or proficiency testing for each of the 1852 AB’s TSCA Title VI accredited TPC laborat ories, if such an EPA recognized inter1853 laboratory comparisons orproficiency testing program is available. 1854 (xii) Meet with EPA at least once every 2 years to discuss the implementation of 1855 the laboratory accreditation program. 1856 (xiii) Allow inspections by EPA, conduc ted at reasonable times, within reasonable 1857 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and 1858 written notice to the labo ratory accreditation body. 1859 (c) Third-party certifiers-- (1) Qualifications . In order to participate as a TPC of 1860 composite wood products under TSCA Title VI, a TPC must apply to an EPA recognized 1861 Product AB. In its application the TPC must demonstrate that it has been accredited by an 1862 EPA recognized Laboratory AB, unless the TPC is applying to an EPA recognized 1863 Product AB that is also an EPA recognized Laboratory AB and the TPC is seeking both 1864 accreditations from this single AB. In such a case, the TPC will obtain the required 1865 product and laboratory accr editations pursuant to IS O/IEC Guide 65:1996(E) and 1866 ISO/IEC 17025:2005(E), respectively, from the EPA recognized Product AB. 1867 (i) To participate in the TSCA Title VI Third-Party Certification Program, a TPC 1868 must submit an application to an EPA rec ognized Product AB every 2 years that includes 1869 the elements in paragraphs (c)(1)(i)(A)-(D) of this section: 1870 (A) Name, address, telephone number, and email address of primary contact. 1871***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 81 of 93 [RIN 2070-AJ44] (B) If not a domestic entity, name and a ddress of an agent for service located in 1872 the United States. Service on this agent cons titutes service on the TPC or any of its 1873 officers or employees for any action by EPA or otherwise by the United States related to 1874 the requirements of this subpart. 1875 (C) Type of composite wood products th at the applicant in tends to certify if 1876 accredited. 1877 (D) Description of the TPC’s qualifica tions, including indica tions that the TPC 1878 has: 1879 ( 1 ) Experience or ability in product certification and complying with ISO/IEC 1880 Guide 65:1996(E) (incorporated by reference, see § 770.99). 1881 ( 2 ) Experience in the composite wood product industr y with the specific 1882 product(s) the applicant intends to certify. 1883 ( 3 ) Ability to conduct inspections and pr operly train and supervise inspectors 1884 pursuant to ISO/IEC 17020:1998(E) (incor porated by referen ce, see § 770.99). 1885 (ii) To be accredited by a laborat ory accreditation body under TSCA Title VI, a 1886 TPC or its laboratories must submit an app lication to an EPA re cognized Laboratory AB 1887 every 2 years that includes the elements in paragraphs (c)(1)(ii)(A)-(C ) of this section: 1888 (A) Name, address, telephone number, and email address of primary contact. 1889 (B) If not a domestic entity, name and a ddress of an agent for service located in 1890 the United States. Service on this agent cons titutes service on the TPC or any of its 1891 officers or employees for any action by EPA or otherwise by the United States related to 1892 the requirements of this subpart. 1893***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 82 of 93 [RIN 2070-AJ44] (C) Description of the TPC’s laborator y’s qualifications, including indications 1894 that the TPC’s laboratory has: 1895 ( 1 ) Experience in performing or verifying formaldehyde testing on composite 1896 wood products. 1897 ( 2 ) Experience complying with IS O/IEC 17025:2005(E) (incorporated by 1898 reference, see § 770.99). 1899 ( 3 ) Experience with test method ASTM E 1333-10 (incorporated by reference, see 1900 § 770.99) and experience evaluating correlation between test methods. 1901 (2) Responsibilities. To maintain participation in the TPC TSCA Title VI 1902 program, TSCA Title VI accredited TPCs must fulfill the requirements in 1903 paragraphs(c)(2)(i)-(xvi) of this section: 1904 (i) Verify that panel producers have adequate quality assurance and quality 1905 control procedures and are complying with applicable quality assurance and quality 1906 control requirements pursuant to TSCA Title VI, including the requirements of this 1907 subpart. 1908 (ii) Verify quality control test results compared with ASTM E1333-10 1909 (incorporated by reference, s ee § 770.99) test results by ha ving TPC laboratories conduct 1910 quarterly tests and evaluate test method equivalence. 1911 (iii) Review applications from panel producers for reduced testing, approve an 1912 application within 90 days of receipt if it demonstrates that the requirements for reduced 1913 testing under TSCA Title VI are met, and notif y EPA of all approvals for reduced testing 1914 within 5 days of the approval, and forward copies of all approved applications for 1915 reduced test to EPA within 30 days of receipt. 1916***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 83 of 93 [RIN 2070-AJ44] (iv) Establish quality co ntrol limits in consultation with panel producers and, if 1917 applicable, shipping quality control or othe r limits for each panel producer, product type, 1918 and production line. 1919 (v) Establish for each panel producer the pr ocess that will be us ed to determine if 1920 product lots are exceeding the a pplicable quality control limit. 1921 (vi) Inspect and audit pa nel producers and products a nd their records at least 1922 quarterly and pursuant to ISO/IEC 17020:1998( E) (incorporated by reference, see § 1923 770.99). 1924 (vii) Use only laboratories that have been accredited by an EPA recognized 1925 Laboratory AB and participat e in an EPA-approved inter-laboratory comparison or 1926 proficiency testing program and ensure the results of the EPA-a pproved inter-laboratory 1927 comparison or proficiency testing progr am are provided to the Laboratory AB. 1928 (viii) Certify composite wood product t ypes that comply with the emission 1929 standards of TSCA Title VI and this subpart, following ISO/IEC Guide 65:1996(E) 1930 (incorporated by refere nce, see § 770.99). 1931 (ix) Provide its accred itation number to the panel producer for labeling and 1932 recordkeeping. 1933 (x) Maintain the following records, in electronic form, for 5 years from the date 1934 the record is created, and provide them to EPA within 30 days of the request: 1935 (A) A list of panel producers and their re spective product types, including resins 1936 used, that the TPC has certified. 1937 (B) Results of inspections , audits, and emission tests conducted for and linked to 1938 each panel producer and product type. 1939***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 84 of 93 [RIN 2070-AJ44] (C) A list of laboratories used by the TPC, as well as test methods, including test 1940 conditions and conditioning time, and test results. 1941 (D) Methods and results for establishing test method corr elations and equivalence. 1942 (xi) Provide an annual re port to its accreditation b ody or bodies (Product AB and 1943 Laboratory AB) and to EPA th at contains the following: 1944 (A) A list of panel producers and their pr oducts that the TPC has certified during 1945 the previous year, including resins used and the average and range of formaldehyde 1946 emissions by panel producer, resin, and product type. 1947 (B) A list of any non-complying produc ts or events by panel producers. 1948 (C) A list of laboratories and te st methods used by the TPC. 1949 (xii) Inform its accred itation body or bodies (ProductAB and Laboratory AB) 1950 within 30 days of any changes in personnel qualifications, procedur es, or laboratories 1951 used by the TPC. 1952 (xiii) Allow inspections by EPA, conduc ted at reasonable times, within reasonable 1953 limits, and in a reasonable manner, upon the pr esentation of appropriate credentials and 1954 of a written notice to the TPC. 1955 (xiv) If not a domestic entity, the TPC mu st maintain an agent for service located 1956 in the United States and notify EPA of any ch anges in the name or address of that agent 1957 within 5 business days. 1958 (xv) Participate an inte r-laboratory comparison or pr oficiency testing program 1959 annually, or use only contract laboratories that partic ipate in such a program. 1960 (xvi) If a TPC or its labo ratory loses its accreditation or discontinues participation 1961 in the program for any reason, it must notify EP A and all the panel pr oducers it provides 1962***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 85 of 93 [RIN 2070-AJ44] TSCA Title VI certification services to within 3 business days. 1963 (d) Third-party certifiers approved by th e California Air Resources Board. TPCs 1964 approved by the California Ai r Resources Board as of [ date 60 days after date of 1965 publication of the final rule in the Federal Register ] may certify composite wood 1966 products under TSCA Title VI until [ date 1 year after date of pub lication of the final rule 1967 in the Federal Register ] as long as they remain approved by the California Air 1968 Resources Board for that period and comply with all aspects of this subpart other than the 1969 accreditation requirements of paragraph (c)(1) of this section. In lieu of the accreditation 1970 number required to be provided according to paragraph (c)(2)(ix) of this section, a TPC 1971 approved by CARB according to this section must provide the panel producer with the 1972 TPC number issued by CARB. For a TPC a pproved by CARB according to this section, 1973 the annual report under paragraph (c )(2)(xi) of this section must be provided to CARB in 1974 lieu of the AB. After [ date 1 year after date of publica tion of the final rule in the Federal 1975 Register ], no TPC may certify composite wood pr oducts under TSCA Title VI unless the 1976 TPC is accredited in accordance with pa ragraph (c)(1) of this section. 1977 (e) Suspension, revocation, or modification of recognition or accreditation-- (1) 1978 Third-party certifiers. EPA or an AB may suspend, revoke, or modify the accreditation of 1979 a TPC or a TPC laboratory, if the TPC or TPC laboratory: 1980 (i) Fails to comply with any requirement of TSCA T itle VI or this subpart; 1981 (ii) Makes any false or misleading stat ements on its applic ation, records, or 1982 reports; or 1983 (iii) Makes substantial changes to personnel qualifications, procedures, or 1984 laboratories that make the TPC or TPC laborat ory unable to comply with any applicable 1985***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 86 of 93 [RIN 2070-AJ44] requirements of this subpart. 1986 (2) ABs. EPA may suspend, revoke, or modify th e recognition of an AB if the AB: 1987 (i) Fails to comply with the requi rements of the applicable recognition 1988 agreement(s) (the International Accreditation Forum Multilateral Recognition 1989 Arrangement and the International Labor atory Accreditation Cooperation Mutual 1990 Recognition Agreement or equivalent(s)); 1991 (ii) Fails to comply with any requireme nt of TSCA Title VI or this subpart; 1992 (iii) Makes any false or misleading stat ements on its applic ation, records, or 1993 reports; or 1994 (iv) Makes substantial ch anges to personnel qualificati ons or procedures that 1995 make the TPC unable to comply with any a pplicable requirements of this subpart. 1996 (3) Process for suspending, revoking, or modifying accreditation or recognition. 1997 (i) Prior to taking action to susp end, revoke, or modify accreditation or 1998 recognition, EPA or the accreditation body w ill notify the recognized AB or the 1999 accredited TPC or TPC laboratory in writing of the following: 2000 (A) The legal and factual basis for the proposed suspension, revocation, or 2001 modification. 2002 (B) The anticipated commencement date and duration of the suspension, 2003 revocation, or modification. 2004 (C) Actions, if any, which the affected AB or TPC or TPC laboratory may take to 2005 avoid suspension, revocation, or modification, or to receive accreditation in the future. 2006 (D) The opportunity and method for request ing a hearing with EPA prior to final 2007 suspension, revocation, or modification. 2008***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 87 of 93 [RIN 2070-AJ44] (ii) If the affected AB or TPC or TPC laboratory requests a he aring in writing to 2009 EPA within 30 days of receipt of the notification, EPA will: 2010 (A) Provide the affected accreditatio n body or TPC or TPC laboratory an 2011 opportunity to offer written statements in re sponse to EPA’s or the accreditation body’s 2012 assertions of the legal and fact ual basis for the proposed action. 2013 (B) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 2014 The Presiding Officer will: 2015 ( 1 ) Conduct a fair, orderly, and impartial hearing within 90 days of the request for 2016 a hearing. 2017 ( 2 ) Consider all relevant evidence, explanation, comment, and argument 2018 submitted. 2019 ( 3 ) Notify the affected AB or TPC or TPC laboratory in writing within 90 days of 2020 completion of the hearing of his or her decisi on and order. Such an order is a final EPA 2021 action which may be subject to judicial review. The order must contain the basis, 2022 commencement date, and duration of the suspension, revocation, or modification. 2023 (iii) If EPA determines that the publi c health, interest, or welfare warrants 2024 immediate action to suspend the recognition of an AB or the accreditation of a TPC or 2025 TPC laboratory prior to the opportunity for a hearing, it will notify the affected AB, TPC, 2026 or TPC laboratory of its rightto request a hearing on the immediate suspension within 15 2027 days of the suspension taking place and the pr ocedures for the conduct of such a hearing. 2028 (iv) Any notification, decision, or order issued by EPA under this section, any 2029 transcript or other verbatim record of or al testimony, and any documents filed by a 2030 certified individual or firm in a hearing under th is section will be available to the public, 2031***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 88 of 93 [RIN 2070-AJ44] except as otherwise provided by TSCA sec tion 14. Any such hearing at which oral 2032 testimony is presented will be open to the publ ic, except that the Presiding Officer may 2033 exclude the public to the extent necessary to allow presentation of information which 2034 may be entitled to confidential treatment under TSCA section 14. 2035 (v) EPA will maintain a publicly ava ilable list of accreditation bodies whose 2036 recognition has been suspended, revoked, modifie d, or reinstated and a publicly available 2037 list of TPCs and laboratories whose accredita tion has been suspended, revoked, modified, 2038 or reinstated. 2039 (vi) Unless the decision and order issu ed under this paragraph (d)(3) of this 2040 section specify otherwise, an AB whose r ecognition has been revoked or a TPC or TPC 2041 laboratory whose accreditation has been revoked must reapply for recognition or 2042 accreditation after the revocation ends in order to become recognized or accredited under 2043 this subpart again. 2044 (vii) Unless the decision and order issued under paragraph (d)(3) of this section 2045 specifies otherwise, an AB whose rec ognition has been revoked or a TPC or TPC 2046 laboratory whose accreditation has been revoke d, must immediately notify all TPCs or 2047 panel producers to which it provides TSCA Title VI accreditation or certification services 2048 of the revocation. 2049 (f) Process for denying a TSCA Title VI accreditation-- (1) Upon denying to 2050 accredit a TPC or a TPC laboratory for failure to submit a complete application, the 2051 accreditation body will notify the TPC or TPC laboratory in writing of the following: 2052 (i) The legal and factua l basis for the denial. 2053 (ii) Actions, if any, which the affected TPC or TPC laboratory may take to receive 2054***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 89 of 93 [RIN 2070-AJ44] accreditation in the future. 2055 (iii) The opportunity and method fo r requesting a hearing with EPA. 2056 (2) If the affected TPC or TPC laborat ory requests a hearing in writing to EPA 2057 within 30 days of receipt of the notice, EPA will: 2058 (i) Provide the affected TPC or TPC la boratory an opportunity to offer written 2059 statements in response to the lega l and factual basis for the denial. 2060 (ii) Appoint an impartial EPA official as Presiding Of ficer to conduct the hearing. 2061 The Presiding Officer will: 2062 (A) Conduct a fair, orderly, and impartial hearing within 90 days of the request 2063 for a hearing. 2064 (B) Consider all relevant eviden ce, explanation, comment, and argument 2065 submitted. 2066 (C) Notify the affected TPC or TPC laboratory in writing within 90 days of 2067 completion of the hearing of his or her decision and order. Such an order is a final agency 2068 action which may be subject to judicial review. The order mu st contain the basis for the 2069 denial. 2070 (3) Any notification , decision, or order issued by EPA under this section, any 2071 transcript or other verbatim record of or al testimony, and any documents filed by a 2072 certified individual or firm in a hearing under th is section will be available to the public, 2073 except as otherwise provided by TSCA sec tion 14. Any such hearing at which oral 2074 testimony is presented will be open to the publ ic, except that the Presiding Officer may 2075 exclude the public to the extent necessary to allow presentation of information which 2076 may be entitled to confidential treatment under TSCA section 14. 2077***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 90 of 93 [RIN 2070-AJ44] (g) Process of seeking alternate accreditations or certification s--(1) If AB is 2078 removed or withdraws from the TSCA Title VI Third-Party Certification Program: 2079 (i) For reasons other than fraud or providing false ormisleading statements, or 2080 other than a reason that implicates a particular TPC in a violation of TSCA Title VI or its 2081 implementing regulations, TPCs accredited by th at AB have 365 days, or 180 days if less 2082 than 365 days were left on th eir 2 year accreditation period, to be accredited again by an 2083 alternate EPA recognized AB. 2084 (ii) Due to fraud or providing false or misleading statements with respect to a 2085 particular TPC, or for any other reason that im plicates a particular TPC in a violation of 2086 TSCA Title VI or its implementing regulat ions, that TPC may not provide any TSCA 2087 Title VI certification services until it has b een accredited by an alternate EPA recognized 2088
AB. 2089 (2) If a TPC loses its accr editation or discontinues part icipation in the program: 2090 (i) For reasons other than fraud or pr oviding false or misleading statements, or 2091 other than a reason that impli cates a particular panel produc er in a violation of TSCA 2092 Title VI or its implementing regulations, the panel producers that used the TPC to certify 2093 their products must enlist another TPC to certi fy their products within 3 months (90 days) 2094 . During the time a panel producer is seeking a new TPC, it must continue to comply with 2095 all other requirements of TSCA Title VI and its implementing regulations, including 2096 quality control testing. 2097 (ii) Due to fraud or providing false or misleading statements with respect to a 2098 particular panel producer, or for any other r eason that implicates a particular panel 2099 producer in a violation of TSCA Title VI or its implementing regulations, that panel 2100***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 91 of 93 [RIN 2070-AJ44] producer may not offer regulated composite w ood products for sale in the United States 2101 until its composite wood products have been recertified by another TPC. 2102 § 770.9 Prohibited Acts. 2103 (a) Failure or refusal to comply with any requirement of TSCA section 601 (15 2104 U.S.C. 2697) or this subpart part is a vi olation of TSCA section 15 (15 U.S.C. 2614). 2105 (b) Failure or refusal to establish and ma intain records or to make available or 2106 permit access to or copying of records, as requir ed by this subpart, is a violation of TSCA 2107 section 15 (15 U.S.C. 2614). 2108 (c) Violators may be subject to civil a nd criminal sanctions pursuant to TSCA 2109 section 16 (15 U.S.C. 2615) for each violation. 2110 Subpart C--[Reserved] 2111 Subpart D--Incorporation by reference 2112 § 770.99 Incorporation by reference. 2113 The materials listed in this section are in corporated by reference into this part 2114 with the approval of the Director of the Fe deral Register under 5 U.S.C. 552(a) and 1 2115 CFR part 51. To enforce any edition other than that specified in th is section, a document 2116 must be published in the Federal Register and the material must be available to the 2117 public. All approved materials are available fo r inspection at the OPPT Docket in the 2118 EPA Docket Center (EPA/DC) at Rm. 3334, EPA, West Bldg., 1301 Constitution Ave., 2119 NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 2120 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 2121 number of the EPA/DC P ublic Reading room is (202) 566-1744, and the telephone 2122 number for the OPPT Docket is (202) 566-0280. In addition, these materials are 2123***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 92 of 93 [RIN 2070-AJ44] available for inspection at the National Ar chives and Records Ad ministration (NARA). 2124 For information on the availability of this material at NARA, call (202) 741-6030 or go to 2125 http://www.archives.gov/federal_regi ster/code_of_fede ral_regulations/ 2126 ibr_locations.html. These materials may also be obtaine d from the sources listed in this 2127 section. 2128 (a) [Reserved] 2129 (b) ASTM material . Copies of these materials may be obtained from ASTM 2130 International, 100 Barr Harbor Dr., PO Box C700, West Conshohocken, PA, 19428-2959, 2131 or by calling (877) 909-ASTM, or at http://www.astm.org

. 2132 (1) ASTM D6007-02 ( Reapproved 2008) , October 1, 2008, Standard Test 2133 Method for Determining Formaldehyde Concen trations in Air from Wood Products 2134 Using a Small-Scale Chamber, IBR approved for § 770.7(a)-(c). 2135 (2) ASTM D5582-00 (Reapproved 2006), Oc tober 1, 2006, Standard Test Method 2136 for Determining Formaldehyde Levels from Wood Products Using a Desiccator, IBR 2137 approved for § 770.7(a)-(c). 2138 (3) ASTM E1333-10 (Approved May 1, 2010), Standard Test Method for 2139 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 2140 Products Using a Large Chamber, IBR approved for § 770.7(a)-(c). 2141 (c) ISO material. Copies of these materials may be obtained from the 2142 International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 2143 Geneve 20, Switzerland, or by calling +41-22-749-01-11, or at http://www.iso.org

. 2144 (1) ISO/IEC 17011:2004(E), Conformity A ssessments--General Requirements for 2145 Accreditation Bodies Accrediting Confor mity Assessment Bodies (First Edition) 2146***EO 12866 Review Draft – Do Not Cite, Quote or Release During the Review***

Page 93 of 93 [RIN 2070-AJ44] February 15, 2005, IBR approved for § 770.7(a)-(c). 2147 (2) ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types 2148 of Bodies Performing Inspections (First Edition), November 15, 1998, IBR approved for 2149 § 770.7(a)-(c). 2150 (3) ISO/IEC 17025:2005(E), General Requirements for the Competence of 2151 Testing and Calibration Laboratories (S econd Edition), May 15, 2005, IBR approved for 2152 § 770.7(a)-(c). 2153 (4) ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 2154 Product Certification Systems (First Editio n), 1996, IBR approved for § 770.7(a)-(c). 2155 ## 2156