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1 EO12866_RIN2070-AJ44_Formaldehyde-TPCs_NPRM_2012-03-19.docx

2 Draft document as submitted for review under EO 12866/13563. 

3 ________________________________________________________________________ 

4 BILLING CODE 6560-50-P 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 40 CFR Part 770 

7 [EPA-HQ-OPPT-2011-0380; FRL-9342-4] 

8 RIN 2070-AJ44 

9 Formaldehyde; Third-Party Certification Framework for the Formaldehyde 

10 Standards for Composite Wood Products 

11 

12 AGENCY: Environmental Protection Agency (EPA). 

13 ACTION: Proposed rule. 

14 SUMMARY: The Formaldehyde Standards for Composite Wood Products Act (Title VI 

15 of the Toxic Substances Control Act (TSCA)) establishes formaldehyde emission 

16 standards for hardwood plywood, particleboard, and medium-density fiberboard 

17 (composite wood products) and directs EPA to promulgate implementing regulations by 

18 January 1, 2013. Pursuant to the requirements of TSCA Title VI, EPA is proposing a 

19 framework for a TSCA Title VI Third-Party Certification Program for composite wood 

20 products. Under the framework, third-party certifiers (TPCs) would be accredited by 

21 EPA-recognized accreditation bodies (ABs) so that TPCs may certify composite wood 

22 product panel producers under TSCA Title VI. This proposed rule identifies the roles 

23 and responsibilities of the TPCs and ABs involved, as well as the criteria for participation 

24 in the TSCA Title VI Third-Party Certification Program. The Agency is proposing the the 

25 TSCA Title VI Third-Party Certification Program framework prior to the rest of the 

26 TSCA Title VI implementing regulations in order to allow interested parties an 
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27 opportunity to comment and to begin identifying the business practices and infrastructure 

28 that may need to be modified or developed in order to effectively participate in the 

29 program.

30 DATES: Comments must be received on or before [insert date 60 days after date of 

31 publication in the Federal Register]. 

32 ADDRESSES: Submit your comments, identified by docket identification (ID) number 

33 EPA-HQ-OPPT-2011-0380, by one of the following methods: 

34 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 

35 instructions for submitting comments. 

36 • Mail: Document Control Office (7407M), Office of Pollution Prevention and 

37 Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

38 Washington, DC 20460-0001. ATTN: Docket ID Number EPA-HQ-OPPT-2011-0380. 

39 • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 

40 6428, 1201 Constitution Ave., NW., Washington, DC. ATTN: Docket ID Number EPA41 HQ-OPPT-2011-0380. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 

42 excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such 

43 deliveries are only accepted during the DCO’s normal hours of operation, and special 

44 arrangements should be made for deliveries of boxed information. 

45 • Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2011-

46 0380. EPA’s policy is that all comments received will be included in the docket without 

47 change and may be made available online at http://www.regulations.gov, including any 

48 personal information provided, unless the comment includes information claimed to be 

49 Confidential Business Information (CBI) or other information whose disclosure is 
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50 restricted by statute. Do not submit information that you consider to be CBI or otherwise 

51 protected through regulations.gov or email. The regulations.gov website is an 

52 “anonymous access” system, which means EPA will not know your identity or contact 

53 information unless you provide it in the body of your comment. If you send an email 

54 comment directly to EPA without going through regulations.gov, your email address will 

55 be automatically captured and included as part of the comment that is placed in the 

56 docket and made available on the Internet. If you submit an electronic comment, EPA 

57 recommends that you include your name and other contact information in the body of 

58 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 

59 comment due to technical difficulties and cannot contact you for clarification, EPA may 

60 not be able to consider your comment. Electronic files should avoid the use of special 

61 characters, any form of encryption, and be free of any defects or viruses. 

62 Docket: All documents in the docket are listed in the docket index available at 

63 http://www.regulations.gov. Although listed in the index, some information is not 

64 publicly available, e.g., CBI or other information whose disclosure is restricted by statute. 

65 Certain other material, such as copyrighted material, will be publicly available only in 

66 hard copy. Publicly available docket materials are available electronically at 

67 http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The 

68 OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 

69 Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading 

70 Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 

71 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-

72 1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
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73 are required to show photographic identification, pass through a metal detector, and sign 

74 the EPA visitor log. All visitor bags are processed through an X-ray machine and subject 

75 to search. Visitors will be provided an EPA/DC badge that must be visible at all times in 

76 the building and returned upon departure. 

77 FOR FURTHER INFORMATION CONTACT: For general information contact: 

78 The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; 

79 telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov. 

80 For technical information contact: Erik Winchester, National Program Chemicals 

81 Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 

82 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 

83 564-6450; email address: winchester.erik@epa.gov.

84 SUPPLEMENTARY INFORMATION: 

85 I. General Information 

86 A. Does this Action Apply to Me? 

87 You may be affected by this action if you certify domestic or international 

88 composite wood products. Potentially affected entities may include, but are not limited 

89 to: 

90 • Reconstituted wood product manufacturing (NAICS code 321219). 

91 • Engineering services (NAICS code 541330). 

92 • Testing laboratories (NAICS code 541380). 

93 • Administrative management and general management consulting services 

94 (NAICS code 541611). 

95 • All other professional, scientific, and technical services (NAICS code 541990). 
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96 • All other support services (NAICS code 561990). 

97 • Business associations (NAICS code 813910). 

98 • Professional organizations (NAICS code 813920). 

99 This list is not intended to be exhaustive, but rather provides a guide for readers 

100 likely to be affected by this action. To determine whether you, your business, or your 

101 agency is affected, you should carefully examine this proposed rule and the TSCA Title 

102 VI (Ref. 1). If you have any questions regarding the applicability of this action to a 

103 particular entity, consult the technical person listed under FOR FURTHER 

104 INFORMATION CONTACT.

105 B. What Should I Consider as I Prepare My Comments for EPA? 

106 1. Submitting CBI. Do not submit this information to EPA through 

107 regulations.gov or email. Clearly mark the part or all of the information that you claim to 

108 be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 

109 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 

110 CD-ROM the specific information that is claimed as CBI. In addition to one complete 

111 version of the comment that includes information claimed as CBI, a copy of the comment 

112 that does not contain the information claimed as CBI must be submitted for inclusion in 

113 the public docket. Information so marked will not be disclosed except in accordance with 

114 procedures set forth in 40 CFR part 2. 

115 2. Tips for preparing your comments. When submitting comments, remember to: 

116 i. Identify the document by docket ID number and other identifying information 

117 (subject heading, Federal Register date and page number). 

118 ii. Follow directions. The Agency may ask you to respond to specific questions or 
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119 organize comments by referencing a Code of Federal Regulations (CFR) part or section 

120 number. 

121 iii. Explain why you agree or disagree; suggest alternatives and substitute 

122 language for your requested changes. 

123 iv. Describe any assumptions and provide any technical information and/or data 

124 that you used. 

125 v. If you estimate potential costs or burdens, explain how you arrived at your 

126 estimate in sufficient detail to allow for it to be reproduced. 

127 vi. Provide specific examples to illustrate your concerns and suggest alternatives. 

128 vii. Explain your views as clearly as possible, avoiding the use of profanity or 

129 personal threats. 

130 viii. Make sure to submit your comments by the comment period deadline 

131 identified. 

132 II. Background 

133 A. What Action is the Agency Taking? 

134 Title VI of TSCA directs EPA to promulgate implementing regulations by 

135 January 1, 2013 (Ref. 1). EPA is issuing this proposed rule under TSCA Title VI to 

136 establish a framework for a TSCA Title VI Third-Party Certification Program whereby 

137 TPCs are accredited by ABs so that they may certify composite wood product panel 

138 producers under TSCA Title VI. This proposed rule identifies the roles and 

139 responsibilities of the groups involved in the TPC process (EPA, ABs, and TPCs), as well 

140 as the criteria for participation in the program. This proposal contains general 

141 requirements for TPCs, such as conducting and verifying formaldehyde emission tests, 
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142 inspecting and auditing panel producers, and ensuring that panel producers’ quality 

143 assurance and quality control procedures comply with the regulations set forth in this 

144 proposed rule. In a subsequent document, EPA will propose additional requirements 

145 including the frequency of testing, means for showing test method equivalence, and other 

146 implementing provisions as required under TSCA Title VI, such as labeling, chain of 

147 custody requirements, sell-through provisions, recordkeeping, and enforcement. 

148 B. What is the Agency’s Authority for Taking this Action? 

149 EPA is issuing this proposed rule pursuant to the Formaldehyde Standards for 

150 Composite Wood Products Act (Ref. 1), which provides authority for the Administrator 

151 to “promulgate regulations to implement the standards required under subsection (b) in a 

152 manner that ensures compliance with the emission standards described in subsection 

153 (b)(2).” This provision includes authority to promulgate regulations relating to “third154 party testing and certification” and “auditing and reporting of third-party certifiers.” 

155 C. Formaldehyde Sources and Health Effects 

156 Formaldehyde is a colorless, flammable gas at room temperature and has a strong 

157 odor. It is found in resins used in the manufacture of composite wood products (e.g., 

158 hardwood plywood, particleboard, and medium-density fiberboard). It is also found in 

159 household products such as glues, permanent press fabrics, carpets, antiseptics, 

160 medicines, cosmetics, dishwashing liquids, fabric softeners, shoe care agents, lacquers, 

161 plastics, and paper product coatings. It is a by-product of combustion and certain other 

162 natural processes. Examples of sources of formaldehyde gas inside homes include 

163 cigarette smoke, unvented, fuel-burning appliances (gas stoves, kerosene space heaters), 

164 and composite wood products made using formaldehyde-based resins (Ref. 2). 
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165 Formaldehyde is both an irritant and a known human carcinogen (Ref. 3). 

166 Depending on concentration, formaldehyde can cause eye, nose, and throat irritation, 

167 even when exposure is of relatively short duration. In the indoor environment, sensory 

168 reactions and various symptoms resulting from mucous membrane irritation are potential 

169 effects. There is also evidence that formaldehyde may be associated with changes in 

170 pulmonary function and increased risk of asthma in children (Ref. 2). 

171 The Integrated Risk Information System (IRIS) Program of EPA’s Office of 

172 Research and Development (ORD) recently completed a draft assessment of the potential 

173 cancer and non-cancer health effects that may result from chronic inhalation exposure to 

174 formaldehyde (Ref. 4). This draft IRIS assessment was peer reviewed by the National 

175 Academy of Sciences (NAS) (Ref. 5). EPA is currently considering the peer review 

176 comments. 

177 D. History of this Action 

178 1. Legislative history. On July 7, 2010, President Obama signed into law the 

179 Formaldehyde Standards for Composite Wood Products Act (Ref. 1). This legislation 

180 adds Title VI to TSCA and establishes formaldehyde emission standards for hardwood 

181 plywood, particleboard, and medium-density fiberboard. These emission standards are 

182 identical to the California Air Resources Board’s (CARB) Airborne Toxic Control 

183 Measure (ATCM) Phase II standards (Ref. 6). Title VI of TSCA directs EPA to 

184 promulgate implementing regulations by January 1, 2013, that address: Labeling, chain of 

185 custody requirements, sell-through provisions, ultra low-emitting formaldehyde (ULEF) 

186 resins, no-added formaldehyde-based (NAF) resins, finished goods, third-party testing 

187 and certification, auditing and reporting of third-party certifiers, recordkeeping, 
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188 enforcement, laminated products, and products containing de minimis amounts of 

189 composite wood. 

190 This proposed rule establishes a framework for a TSCA Title VI Third-Party 

191 Certification Program to help ensure that regulated composite wood products consistently 

192 meet the TSCA Title VI formaldehyde emission standards. EPA will issue a separate 

193 proposed rule at a later date that includes the rest of the TSCA Title VI implementing 

194 regulations. That separate proposed rule will include specific testing responsibilities of 

195 TPCs. 

196 2. The CARB ATCM. The CARB ATCM establishes emission standards for 

197 composite wood products sold, offered for sale, supplied, used, or manufactured for sale 

198 in California (Ref. 6). It includes requirements for manufacturers of composite wood 

199 products, distributors, importers, fabricators, retailers, and TPCs with provisions on sell200 through dates, labeling, recordkeeping, testing, and certification. It also includes special 

201 provisions for manufacturers of composite wood products with ULEF and NAF resins. 

202 Under the CARB ATCM, manufacturers of composite wood products must have their 

203 compliance with the emission standards certified by a TPC approved by CARB (Ref. 7). 

204 The CARB ATCM defines a third-party certifier as “an organization or entity approved 

205 by the Executive Officer that: (A) verifies the accuracy of the emission test procedures 

206 and facilities used by manufacturers to conduct formaldehyde emission tests, (B) 

207 monitors manufacturer quality assurance and quality control programs, and (C) provides 

208 independent audits and inspections.” In order to become a CARB approved TPC, 

209 prospective certifiers must submit an application to the CARB Executive Officer 

210 containing: 
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211 a. Evidence of actual field experience in the verification of laboratories and wood 

212 products, to demonstrate how the applicant will be able to competently perform the TPC 

213 requirements under the CARB ATCM. 

214 b. Evidence of the ability to properly train and supervise inspectors. 

215 c. Evidence of a current “product accreditation body” accreditation issued by a 

216 signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual 

217 Recognition Arrangement (MRA). 

218 d. A list of the composite wood products that the applicant is applying to verify 

219 and evidence that the applicant is qualified to verify these products (Ref. 8). 

220 If the TPC’s application is approved, the CARB Executive Officer issues a CARB 

221 Executive Order with a duration of 2 years. Upon the expiration date of the CARB 

222 Executive Order, a TPC may apply for re-accreditation by submitting an updated 

223 application. The CARB Executive Officer may, “for good cause,” modify or revoke a 

224 CARB Executive Order approving a TPC after giving the TPC the opportunity for a 

225 hearing. 

226 Under the CARB ATCM, CARB approved TPCs are required to verify that 

227 composite wood product manufacturers are complying with the quality assurance and 

228 quality control requirements, verify formaldehyde emission test results, work with 

229 manufacturers to establish quality control limits for each product type and production 

230 line, provide independent inspections and audits of manufacturers and records, use 

231 laboratories that are certified by an AB that is a signatory to the ILAC MRA, maintain 

232 records for 2 years; and provide an annual report to CARB. CARB maintains a list of 

233 approved TPCs on its website (Ref. 7). The annual report must include: • A list of 
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234 manufacturers certified by the TPC during the previous calendar year, including the 

235 resins used by the manufacturers and the average and range of formaldehyde emissions. 

236 • A list of any non-complying events by manufacturers. 

237 • Certified laboratories and primary or secondary test methods utilized by the 

238 TPC. 

239 • Results of inter-laboratory testing comparisons for laboratories used by the TPC. 

240 3. Recent activities related to this proposed rule. In March 2008, the Sierra Club 

241 and numerous other organizations and individuals petitioned EPA under TSCA section 

242 21. The petitioners requested that EPA use TSCA section 6 to adopt nationally the CARB 

243 ATCM formaldehyde emission standards for composite wood products (i.e., hardwood 

244 plywood, particleboard, and medium-density fiberboard) (Ref. 9). The petitioners 

245 expressed particular concern over the levels of formaldehyde found in emergency 

246 housing provided for persons displaced from their homes by Hurricane Katrina and noted 

247 that there are no Federal regulations on formaldehyde emissions from composite wood 

248 products other than the Department of Housing and Urban Development’s (HUD) 

249 regulations for manufactured housing at 24 CFR 3280.308. In response to the petition, 

250 EPA announced in the Federal Register on June 27, 2008, that EPA would initiate a 

251 proceeding to investigate whether and what type of regulatory or other action might be 

252 appropriate to protect against risks that may be posed by formaldehyde emitted from 

253 pressed wood products (Ref. 10). In the Federal Register of December 3, 2008, EPA 

254 published an Advance Notice of Proposed Rulemaking (ANPR) to publicly initiate the 

255 investigation and obtain stakeholder input (Ref. 11).

256 E. Objectives of the Framework for the Third-Party Certification Program 
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257 EPA believes that the TSCA Title VI Third-Party Certification Program must be 

258 impartial and applicable uniformly to both domestically manufactured and imported 

259 composite wood products. This proposed rule aims to ensure that these objectives are 

260 met, along with ensuring the consistent application of the TPC requirements of TSCA 

261 Title VI, by requiring the use of voluntary consensus standards for the TSCA Title VI 

262 Third-Party Certification Program, and by leveraging the expertise of international ABs. 

263 Additionally, this proposed rule is intended to be as consistent as practicable with the 

264 TPC requirements under the CARB ATCM. By aligning itself with the existing CARB 

265 ATCM requirements, EPA seeks to avoid differing or duplicative regulatory 

266 requirements that would result in an increased burden on the regulated community. 

267 Qualified and experienced TPCs are essential to ensuring that domestic and 

268 foreign panel producers supplying products to the United States have quality assurance 

269 and quality control procedures, are having their products tested to determine that they are 

270 compliant with formaldehyde emissions standards, and are otherwise acting in manner 

271 that is consistent with the requirements of TSCA Title VI. The TSCA Title VI 

272 formaldehyde emissions standards apply to hardwood plywood, particleboard, and 

273 medium-density fiberboard sold, supplied, offered for sale, or manufactured (including 

274 imported) in the United States. Because TSCA defines “manufacture” to include “import 

275 into the customs territory of the United States” the standards are applicable regardless of 

276 whether the composite wood product is manufactured domestically or imported from 

277 abroad. 

278 There are a substantial number of panel producers and TPCs that operate solely 

279 outside of the United States. Currently, 27 of the 36 CARB-approved TPCs are based 
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280 outside the United States (Ref.7). To ensure that oversight of TPCs is as strong abroad as 

281 it is domestically, EPA believes a TSCA Title VI Third-Party Certification Program 

282 framework should include internationally operating ABs to overcome potential logistical 

283 limitations that may hinder regular and rigorous inspection of TPCs operating outside the 

284 United States. Many ABs have a global reach, preexisting infrastructure, and experience 

285 working in foreign countries, which EPA believes makes them ideal for evaluating the 

286 qualifications of TPC candidates. Under EPA’s proposed TSCA Title VI Third-Party 

287 Certification Program framework, ABs would review, accredit, oversee, audit, and 

288 inspect both domestic and foreign TPCs--activities that would enable EPA to ensure the 

289 legitimacy of both TPCs and panel producers in the United States and abroad. The ABs’ 

290 oversight and auditing functions verify that TPCs are fulfilling their regulatory 

291 obligations uniformly across the global marketplace. EPA would retain its statutorily 

292 delegated roles in program design, establishing the standards, enforcement, and 

293 oversight; and utilize ABs to strengthen performance of TPCs.

294 F. What Background Information was Used to Develop the Framework for a Third-Party 

295 Certification Program? 

296 

297 Effective and successful implementation of EPA’s TSCA Title VI Third-Party 

298 Certification Program requires that panel producers have in place formaldehyde 

299 emissions testing programs and quality assurance and quality control programs for 

300 product manufacturing. To achieve these outcomes, EPA is proposing to require the use 

301 of voluntary consensus standards for those participating as a TPC in the TSCA Title VI 

302 Third-Party Certification Program. In developing this proposed rule, EPA reviewed 

303 established voluntary consensus standards that are relied on by industries around the 

304 world as a means of ensuring the competency of third-parties in particular fields of 
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305 technical activity such as testing, instrument calibration, and product performance 

306 certification. In addition to reviewing existing voluntary consensus standards, EPA 

307 reviewed other successful third-party certification programs that use voluntary consensus 

308 standards to determine if such programs could be used as models for the TSCA Title VI 

309 Third-Party Certification Program. 

310 Third-party certification involves a process by which a product, process, or 

311 service is reviewed by a reputable and qualified independent third-party to verify that a 

312 set of norms, criteria, claims, practices, or standards are being met. Third-party 

313 certification has been widely and successfully used for decades by a number of industries 

314 such as engineering, electronics, energy, software, automotive, and food and consumer 

315 products. The standards used in third-party certification are typically voluntary consensus 

316 standards developed by nationally or internationally recognized standards-producing 

317 organizations or industry groups. Voluntary consensus standards establish uniform 

318 engineering or technical criteria, methods, processes, and practices for an industry 

319 practice or product, and are developed by experts in the relevant field through a process 

320 that allows input by all persons interested and affected by the scope or provisions of the 

321 standard. Parties in that industry then choose to accept and voluntarily abide by the 

322 consensus standards. Otherwise, the existence of multiple and non-harmonized standards 

323 for similar products, processes, and services in different countries or regions can create 

324 barriers to trade. 

325 1. Voluntary consensus standards. In order for EPA to ensure that the Third-Party 

326 Certification Program under TSCA Title VI is effective in ensuring compliance with the 

327 emission standards, impartial in its operations, and applicable both domestically and 
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328 internationally, the Agency proposes requiring the use of voluntary consensus standards 

329 as the basis for operating the TSCA Title VI Third-Party Certification Program. EPA 

330 specifically proposes using International Organization for Standardization (ISO) and 

331 International Electrotechnical Commission (IEC) voluntary consensus standards and 

332 guides as general requirements for third-party certifications. In addition to industry 

333 experts, international organizations--both governmental and non-governmental--work in 

334 cooperation with ISO and IEC to develop their consensus standards. In the field of 

335 conformity assessment, the ISO Committee on Conformity Assessment (CASCO) is 

336 responsible for the development of international standards and guides. 

337 The appropriate ISO/IEC standards and guide that EPA proposes requiring are: 

338 • ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 

339 Product Certification Systems. This is the international voluntary consensus standard that 

340 specifies general requirements for a third-party operating a product certification program 

341 (Ref. 12). These general requirements would help ensure that the TPC is competent and 

342 reliable in certifying compliant composite wood products. 

343 • ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements for 

344 Accreditation Bodies Accrediting Conformity Assessment Bodies. This international 

345 voluntary consensus standard offers the general requirements for ABs assessing and 

346 accrediting conformity assessment bodies (CABs). It is also appropriate as a requirement 

347 document for the peer evaluation process for mutual recognition arrangements between 

348 ABs (Ref. 13). These general requirements would help ensure that the ABs are competent 

349 and reliable in accrediting TPCs. 

350 • ISO/IEC 17025:2005(E), General Requirements for the Competence of Testing 
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351 and Calibration Laboratories. This international voluntary consensus standard specifies 

352 the general requirements for competence in carrying out tests and/or calibrations, 

353 including sampling (Ref. 14). EPA believes that requiring TPCs to use laboratories that 

354 follow these requirements would help ensure that reliable and accurate test results are 

355 obtained. 

356 • ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types of 

357 Bodies Performing Inspections. This international voluntary consensus standard specifies 

358 general criteria for the competence of impartial bodies performing inspection. It is 

359 intended for use by inspection bodies and their accreditation bodies (Ref. 15). 

360 EPA believes that requiring TPCs to follow these requirements would help ensure 

361 greater homogeneity of the inspection process among the TPCs recognized by EPA. 

362 The appropriate use of each guide and standard and a description of the party responsible 

363 under the proposed TPC framework for ensuring compliance with the standard are 

364 detailed in Unit III. The use of the guide and standards furthers the goal of the National 

365 Technology Transfer and Advancement Act (NTTAA), as discussed in Unit VI. 

366 2. International accreditation and inspection oversight organizations. In the 

367 profession of conformity assessment (i.e., the process of ensuring an organization 

368 responsible for implementing a consensus standard does so in conformance with the 

369 standard) oversight of conformity assessment bodies, such as TPCs, is done by 

370 organizations known as ABs. An AB provides an impartial verification of the 

371 competency of conformity assessment bodies such as TPCs. The ABs themselves also 

372 have oversight typically performed by an association or cooperative of conformity 

373 experts and other ABs through a peer evaluation process. Because the proposed TPC 
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374 framework is international in scope and will employ the use of internationally accepted 

375 consensus standards, EPA reviewed the structure and functions of well known 

376 international organizations that were established decades ago to specifically provide 

377 oversight of ABs. 

378 The two international AB oversight bodies that EPA examined for this proposed 

379 rule are the International Accreditation Forum, Inc. (IAF) and ILAC. EPA believes that 

380 using a system where an AB’s qualifications are verified by international oversight 

381 bodies such as these and in which the ABs in turn assess the conformity of TPCs to 

382 international voluntary consensus standards would ensure that the requirements of TSCA 

383 Title VI are met. The specific details of how EPA proposes to leverage this system to 

384 ensure compliance with the TSCA Title VI are detailed in Unit III. 

385 The IAF is an association of conformity assessment bodies and other bodies. IAF 

386 requires its member ABs to comply with appropriate international conformity assessment 

387 standards. The IAF Multilateral Recognition Arrangement (MLA) is an agreement 

388 between AB members of the IAF whereby the ABs conduct regular evaluations of each 

389 other to assure the equivalence of their accreditation programs. This MLA agreement 

390 allows companies with an accredited conformity assessment certification in one part of 

391 the world to have that certification recognized everywhere else in the world, thereby 

392 facilitating international trade (Ref. 16). The MLA certification provides documentation 

393 that a person or an organization has been accredited to a specific standard or scheme by 

394 an IAF MLA signatory AB. In addition, IAF through its MLA ensures that all ABs who 

395 are capable of accrediting product certification bodies, such as TPCs, are in conformance 

396 with ISO/IEC Guide 65:1996(E). By requiring a TPC to be accredited to ISO/IEC Guide 
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397 65:1996(E) by a qualified AB that has an IAF endorsement through level 3 of the IAF 

398 Scope, or is a member of an equivalent oversight body, EPA believes that the TPC will 

399 be in conformance with ISO/IEC Guide 65:1996(E), the voluntary consensus standard 

400 used to ensure proper product certification. Level 3 of the IAF Scope is the level of 

401 accreditation which needs to be accomplished by a Product AB under that program to 

402 ensure that the Product AB is qualified to accredit the TPC. 

403 The ILAC is an international cooperation of laboratory and inspection ABs 

404 formed to help remove technical barriers to trade. ABs around the world, which have 

405 been evaluated by peers as competent, have signed an MRA that enhances the acceptance 

406 of products and services across national borders (Ref. 17). By requiring a TPC’s 

407 emissions testing laboratory, or its contract laboratory, to be accredited by an AB that is a 

408 signatory to the ILAC MRA or equivalent oversight body, EPA believes that there will be 

409 a greater assurance of compliance with ISO/IEC 17025:2005(E), the voluntary consensus 

410 standard that is critical to ensuring adequate verification of performance for TSCA Title 

411 VI required laboratory formaldehyde emissions testing.

412 3. Other third-party certification programs that were evaluated. As mentioned in 

413 Unit II.E., EPA aims to develop a TSCA Title VI Third-Party Certification Program that 

414 incorporates lessons learned from other third-party certification programs. In addition, 

415 EPA is particularly interested in harmonizing, to the extent practicable, with the CARB’s 

416 third-party certification program to avoid differing or duplicative regulatory 

417 requirements. 

418 In developing the TSCA Title VI Third-Party Certification Program framework as 

419 presented in this proposed rule, EPA started with a review of CARB’s program, as 
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420 described in Unit II.D. This included meeting with CARB, the composite wood industry, 

421 and CARB-approved TPCs. 

422 EPA also reviewed other EPA and Federal programs that have elements relevant 

423 to EPA’s goals for this proposed program, such as the use of voluntary consensus 

424 standards and/or a third-party product certification process. The following EPA and 

425 Federal programs were reviewed during development of the proposed TSCA Title VI 

426 Third-Party Certification Program framework: 

427 a. National Lead Laboratory Accreditation Program. EPA established the 

428 National Lead Laboratory Accreditation Program (NLLAP) in 1992, to provide protocols, 

429 criteria, and minimum performance standards for analysis of lead in paint, dust, and soil, 

430 as required under TSCA section 405 (Ref. 18). Section 405 of TSCA further directs EPA, 

431 in consultation with the Department of Health and Human Services (HHS), to develop a 

432 program to certify qualified lead testing laboratories. The NLLAP provides the public 

433 with a list of qualified laboratories that have met EPA criteria and demonstrated the 

434 capability to accurately analyze paint chip, dust, and soil samples for lead. EPA ensures 

435 that laboratories comply with these EPA criteria by having them evaluated and accredited 

436 by third-party laboratory ABs according to ISO/IEC performance consensus standards. In 

437 order to assure the public that a Laboratory AB is capable of performing an adequate 

438 assessment of participating laboratories, EPA enters into a recognition agreement with 

439 the AB in recognition of its capability to perform adequate laboratory assessments. 

440 For a laboratory to qualify for recognition under the NLLAP, it must pass on-site 

441 audits conducted by one of the four laboratory ABs with which EPA has a recognition 

442 agreement. The Laboratory ABs recognize NLLAP laboratories in conformance with 
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443 ISO/IEC 17025:2005(E). Laboratories recognized under the NLLAP must also 

444 successfully perform, on a continuing basis, in the Environmental Lead Proficiency 

445 Analytical Testing (ELPAT) Program. The ELPAT is a proficiency testing program that 

446 is designed to evaluate the analytical performance of laboratories by providing the 

447 laboratory with standardized test samples on a quarterly basis and evaluating their results 

448 against consensus results from a set of reference laboratories.

449 The NLLAP has successfully demonstrated over the years that EPA recognized 

450 laboratories are capable of accurately analyzing for lead in paint chips, dust wipes, and 

451 soil samples. Therefore, EPA believes that the third-party processes employed by the 

452 NLLAP, which include the use of third-party laboratory ABs that accredit laboratories by 

453 using voluntary consensus standards, along with additional specified laboratory testing 

454 protocols, demonstrate that a similar third-party certification program can be used 

455 successfully under TSCA Title VI. 

456 b. National Voluntary Conformity Assessment System Evaluation Program. 

457 Another program that EPA reviewed is the National Voluntary Conformity Assessment 

458 System Evaluation (NVCASE) Program at the Department of Commerce’s National 

459 Institute of Standards and Technology (NIST). NIST, through its Standards Services 

460 Division, offers this voluntary program to evaluate and recognize organizations which 

461 support third-party conformity assessment activities. The NVCASE Program includes 

462 activities related to third-party laboratory testing, third-party product certification, and 

463 quality system registration. After an NVCASE Program evaluation, NIST provides 

464 recognition to qualified U.S. organizations that effectively demonstrate conformance with 

465 established criteria. The ultimate goal is to help U.S. manufacturers satisfy applicable 
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466 product requirements mandated by foreign or U.S. regulatory authorities through 

467 conformity assessment procedures. Under the NVCASE Program, NIST accepts requests 

468 from only domestic TPCs for domestic and international accreditation. The use of NIST’s 

469 NVCASE Program in the United States would significantly hamper the ability of foreign 

470 TPC candidates to receive and maintain accreditation and would not allow EPA to meet 

471 its goal of providing testing and certification and auditing and reporting of all TPCs, 

472 domestic as well as international. 

473 c. Other EPA programs. EPA also considered the product certification 

474 components of EPA’s WaterSense and Energy Star programs. WaterSense is an EPA475 sponsored partnership program launched in 2006 that seeks to protect the future of our 

476 nation's water supply by promoting water efficiency and enhancing the market for water477 efficient products, programs, and practices. WaterSense helps consumers identify 

478 products and programs that meet WaterSense water efficiency and performance criteria. 

479 Energy Star is a joint program of the EPA and the U.S. Department of Energy (DOE) 

480 designed to help the consumers save money and protect the environment through the use 

481 of energy efficient products and practices. In 1992, EPA introduced Energy Star as a 

482 voluntary labeling program designed to identify and promote energy-efficient products to 

483 reduce greenhouse gas emissions. 

484 Both the WaterSense and Energy Star certification programs specify the minimum 

485 criteria that EPA licensed product ABs must observe when certifying product 

486 conformance to specifications and when authorizing the use of the program’s labels. 

487 These programs provide specific criteria for the application of ISO/IEC Guide 

488 65:1996(E) in order to satisfy the criteria for certification of Energy Star and WaterSense 
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489 products. They also provide the basis for consistent application of voluntary consensus 

490 standards by licensed ABs. The ISO/IEC Guide 65:1996(E) has been successfully used in 

491 these two programs for auditing, certifying, and reporting of the status of certification. 

492 The Energy Star and WaterSense programs’ use of ABs who certify under voluntary 

493 consensus standards for product certification also demonstrates the utility and workability 

494 of this approach. 

495 Each of the aforementioned programs informed EPA’s decision on how to 

496 develop an appropriate and credible third-party certification program for TSCA Title VI. 

497 EPA is proposing a framework under TSCA Title VI that incorporates elements of the 

498 CARB third-party certification program, the use of recognition agreements with ABs 

499 (e.g., as in NLAAP), and a product certification system element such as those used in the 

500 WaterSense and Energy Star programs. 

501 III. What Does this Proposed Rule Do? 

502 
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503 Illustration 1: TSCA Tile VI Proposed Third-Party Certification Framework 

504 

505 International Standards 

506 Organizations 

507 Develop consensus-based international 

508 standards for quality management 

509 and conformity assessment 

510 

511 

512 International Standards Bodies 

513 Ensure competency of Accrediting 

514 Bodies and their conformance with 

515 international standards 

516  Ensures AB conformance to 

ISO/IEC 170111 517 

518  Ensure ABs are qualified to oversee 

519 TPC conformance to ISO/IEC Guide 65 

520 ISO/IEC17020 and/or ISO/IEC 17025 

521 

522 

523 Accrediting Bodies 

524 Ensure competency of TPCs; verify accuracy 

525 of emission test procedures, monitor TPC 

526 quality assurance programs, audit and inspect 

527 TPCs. 

528  Management systems conform to 

529 ISO/IEC 17011 

530  Ensure TPC conformance to 

531 applicable ISO/IEC Guide & Standards 

532 

533 

534 Third-Party Certifiers 

535 Ensure that panel producers are in 

536 compliance with statutory 

537 formaldehyde emission standards 

538  Management systems conform to 

539 ISO/IEC Guide 65 

540  Conform to applicable ISO/IEC 

541 Guide & Standards for 

542 Product & Laboratory Certification 

543 and Inspections 

544 

545 Composite Wood 

546 Panel Producers 

547 1 548 ISO/IEC 17011:2004(E) – Conformity Assessments--General Requirements for Accreditation Bodies Accrediting 

549 Conformity Assessment Bodies. 

2 550 MLA – IAF’s Multilateral Recognition Arrangement requires AB signatories to demonstrate they are capable of 

551 accrediting product certification bodies in conformance with ISO/IEC Guide 65:1996(E) – General Requirements for 

552 Bodies Operating Product Certification Systems and ISO/IEC 17020:1998(E) – General Criteria for the Operation of 

553 Various Types of Bodies Performing Inspections. 

3 554 MRA – ILAC’s Mutual Recognition Arrangement requires AB signatories to demonstrate they are capable of 

555 accrediting testing laboratories in conformance with ISO/IEC 17025:2005(E) – General Requirements for the 

556 Competence of Testing and Calibration Laboratories. 

557 

International Organization for 

Standardization (ISO) 

International Electrotechnical 

Commission (IEC) 

International Accreditation 

Forum, Inc (IAF) 

or equivalent organization 

 Ensures AB conformance to 

ISO/IEC 170111

 Require member ABs to be a 

signatory to MLA2

International Laboratory 

Accreditation Cooperation (ILAC) 

or equivalent organization 

 Ensures AB conformance to 

ISO/IEC 170111

 Require member ABs to be a 

signatory to MRA3

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
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558 EPA is proposing a framework which it believes would enable implementation of 

559 a credible third-party certification program that ensures that TPCs are impartial and 

560 operate at the highest standards of competence. Although EPA’s proposed TSCA Title VI 

561 Third-Party Certification Program framework, including the underlying requirements and 

562 implementation process, are based on, or are the same as, CARB’s third-party 

563 certification program, EPA is proposing to also use qualified, internationally recognized 

564 ABs in implementing the program to establish a globally uniform process. Under EPA’s 

565 proposed TSCA Title VI Third-Party Certification Program framework, ABs, recognized 

566 by EPA through recognition agreements, would accredit TPCs based on the requirements 

567 for TPCs established by EPA through this proposed rule. Like CARB, EPA would 

568 require that TPCs provide evidence of competency in four key areas: 

569 • Experience and ability to verify the accuracy of formaldehyde emission testing 

570 of composite wood products. 

571 • Experience in the composite wood product industry. 

572 • Ability to monitor panel producer quality assurance programs for composite 

573 wood products. 

574 • Ability to conduct auditing and inspection of panel producer activities and 

575 products. 

576 However, unlike the CARB system, under which CARB evaluates and accredits TPCs 

577 without the input of ABs, ABs would conduct the evaluation and determine if the TPCs 

578 are competent in these four areas. Based on the results of ABs’ evaluations that would be 

579 conducted according to EPA’s requirements, including the standards for ABs in ISO/IEC 

580 Guide 65:1996(E) (which includes inspection accreditation based on compliance with 
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581 ISO/IEC 17020:1998(E)) and laboratory accreditation based on compliance with 

582 ISO/IEC 17025:2005(E), the ABs would accredit TPCs that meet the requirements. The 

583 ABs would also be required to participate in oversight activities, including 

584 recordkeeping, reporting to EPA, and auditing of TSCA Title VI accredited TPCs and 

585 their formaldehyde emissions testing laboratories. EPA would exercise authority to 

586 conduct independent oversight and actions, including the authority to review the 

587 determinations of ABs, and approve or revoke a TPC’s TSCA Title VI accreditations 

588 based on the criteria laid out in this proposed rule. 

589 While the AB component of EPA’s proposed TSCA Title VI Third-Party 

590 Certification Program framework differs from the CARB program, EPA believes it will 

591 enhance the implementation of TSCA Title VI. The proposed TSCA Title VI Third-Party 

592 Certification Program framework is otherwise generally consistent with CARB’s current 

593 third-party certification program requirements. Furthermore, EPA will work with CARB 

594 to help promote compatibility and consistency within the programs. EPA believes that 

595 compliance with the proposed the TSCA Title VI Third-Party Certification Program 

596 would not require substantial changes to procedures TPCs, laboratories, and panel 

597 producers currently use to conduct their TPC activities under the CARB ATCM (Ref. 6). 

598 A. Requirements for Accreditation Bodies 

599 Based on EPA’s understanding of how the international consensus standards 

600 oversight industry is structured, EPA envisions that two types of ABs could be involved 

601 in implementation of the proposed TPC framework. The first type of AB is the “Product 

602 AB.” The Product AB would be responsible for accrediting the TPCs, recordkeeping and 

603 ensuring that a TPC is in conformance with ISO/IEC Guide 65:1996(E) (involving 
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604 product certification systems) and ISO/IEC 17020:1998(E) (involving general criteria for 

605 inspections). The second type of AB is the “Laboratory AB.” The Laboratory AB would 

606 be responsible for ensuring that the TPC’s formaldehyde emissions testing laboratory (or 

607 its contracted laboratory) is of the highest quality and is in conformance with ISO/IEC 

608 17025:2005(E) (involving the general requirements for laboratories conducting testing 

609 and/or calibrations, including sampling and calibration). EPA recognizes it is also 

610 possible that a single AB may have the ability to accredit both product certification and 

611 emissions testing, and therefore can accredit conformance to ISO/IEC Guide 65:1996(E), 

612 ISO/IEC 17020:1998(E), and ISO/IEC 17025:2005(E). In such cases, a single AB would 

613 be considered qualified to accredit TPCs for their product certification capabilities and 

614 also accredit the TPC laboratories for conducting formaldehyde emissions testing, and 

615 only that AB would need to be involved in accepting and reviewing TPC applications and 

616 implementing the ABs’ roles under the proposed TSCA Title VI Third-Party Certification 

617 Program framework. 

618 1. Necessary qualifications of ABs to be candidates for participation in the EPA’s 

619 Title VI Third-Party Certification Program --a. Necessary qualifications of Product ABs. 

620 To ensure that Product ABs are qualified to accredit TPC’s for conformance with 

621 ISO/IEC Guide 65:1996(E) and ISO/IEC 17020:1998(E), the Product AB would have to 

622 be a signatory to the IAF MLA, or a member of an equivalent oversight body. AB 

623 members of IAF are admitted to the IAF MLA only after a highly stringent evaluation of 

624 their operations by an IAF peer evaluation team which is charged with ensuring that the 

625 applicant member complies fully with both the international standards and IAF 

626 requirements. Additionally, once an AB is a signatory to the IAF MLA, it is required to 
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627 recognize the certificates issued by conformity assessment bodies accredited by all other 

628 signatories of the IAF MLA, with the appropriate scope (i.e., levels 1 through 3). The 

629 IAF MLA structure has 5 levels, and EPA would require the Product AB to be endorsed 

630 by IAF through level 3. Level 1 endorsement ensures that an AB is in conformity with 

631 ISO/IEC 17011:2004(E) and maintains that conformity; level 2 endorsement ensures that 

632 the AB has demonstrated basic competence to perform accreditation activities for product 

633 certification according to ISO/IEC Guide 65:1996(E) and ISO/IEC 17020:1998(E); and 

634 level 3 ensures that the AB has policies and procedures in place in their operations and 

635 management plans to accredit a TPC for product certification in conformance with 

636 ISO/IEC Guide 65:1996(E). In order to participate in the TSCA Title VI Third-Party 

637 Certification Program, a Product AB would have to provide EPA with documentation 

638 verifying its IAF endorsement that states the level of accreditation the AB received from 

639 IAF, or with confirmation that the AB is a member of an equivalent organization with an 

640 equivalent scope. 

641 b. Necessary qualifications of Laboratory ABs. To ensure that the Laboratory 

642 ABs are qualified to accredit TPC laboratories, the proposed TPC framework would 

643 require that the Laboratory AB is a signatory to the ILAC MRA, or a member of an 

644 equivalent organization. To be a signatory to the ILAC MRA, an AB must pass an 

645 intensive evaluation carried out by peers and in accordance with the relevant rules and 

646 procedures contained in several ILAC publications. Once a signatory to the ILAC MRA, 

647 each Laboratory AB agrees to abide by its terms and conditions, and according to the 

648 ILAC evaluation procedures shall: 
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649 i. Maintain conformance with the ISO/IEC 17011:2004(E), related ILAC 

650 guidance documents, and any ILAC supplementary requirements. 

651 ii. Ensure that all laboratories that they accredit comply with ISO/IEC 

652 17025:2005(E) and related ILAC policy and guidance documents. 

653 Under the proposed TPC framework, a TPC would be required to work with its 

654 Laboratory AB to provide the Product AB with documentation verifying the Laboratory 

655 AB’s endorsement and scope of accreditation from ILAC, or documentation of 

656 membership in an equivalent organization. 

657 EPA understands that not all ABs are signatories to either IAF or ILAC. EPA 

658 requests comment on what other oversight bodies or other organizations are equivalent to 

659 IAF and ILAC. An equivalent organization would provide a process of review and 

660 evaluation with a level of scrutiny and assessment of an AB’s capabilities to ensure that 

661 an AB is qualified to accredited organizations based on the relevant ISO/IEC standards 

662 and guide. 

663 2. Recognition agreement process and relationship between EPA and ABs. Under 

664 this proposed rule, the Product ABs and Laboratory ABs that are interested in 

665 participating in the TSCA Title VI Third-Party Certification Program would be required 

666 to submit an application to EPA to be formally recognized by EPA. Once EPA has 

667 reviewed the AB’s credentials and deemed that the AB is qualified, EPA proposes to 

668 enter into a recognition agreement with Product and Laboratory ABs that want to offer 

669 services to accredit TPCs according to EPA’s requirements. The recognition agreement 

670 would serve as a mechanism for EPA to formally recognize either a Product AB or a 

671 Laboratory AB (or both) as qualified to implement their respective roles under the TSCA 
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672 Title VI program. The recognition agreement with the Product AB would designate it as 

673 the recipient of applications from candidate TPCs that want to participate in the TSCA 

674 Title VI Third-Party Certification Program. As discussed in Unit II.F.3., similar 

675 recognition agreement approaches have been successfully used in a number of EPA 

676 programs. The recognition agreement is a signed agreement between EPA and each 

677 Product AB or Laboratory AB that would state: 

678 a. The regulatory requirements that have been and must continue to be met to be 

679 an EPA recognized AB. 

680 b. The roles and responsibilities of the AB under the TSCA Title VI Third-Party 

681 Certification Program. 

682 c. EPA’s role and interactions with the AB during implementation of the TSCA 

683 Title VI Third-Party Certification Program. 

684 d. Criteria and processes for revoking the recognition agreement if either the 

685 Product AB or Laboratory AB fails to adhere to the conditions of the regulations. 

686 All of the requirements and actions stated in the recognition agreement between EPA and 

687 each type of AB would be derived from the final rule requirements. If the AB applying to 

688 EPA for recognition is qualified to perform as both a Product AB and a Laboratory AB, 

689 then that AB would include both sets of credentials in its application package and would 

690 be recognized by EPA in the recognition agreement as performing both accreditation 

691 roles. The recognition agreement would be effective for 3 years, provided the AB 

692 continues to meet all of the regulatory requirements. After 3 years, the recognition 

693 agreement would be eligible for renewal. 

694 In order to facilitate communication between EPA and ABs, EPA is proposing to 
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695 require ABs to designate an agent in United States in their applications. Any information 

696 provided by an AB or EPA to the designated agent would be equivalent to providing that 

697 information directly to the AB. The designated agent could not be a mailbox, answering 

698 machine, or other service where the agent is not physically present. The agent would need 

699 to be capable of accepting service of notices and processes made in administrative and 

700 judicial proceedings. EPA believes requiring a designated agent in the United States 

701 would help ensure compliance with the formaldehyde emission standards by facilitating 

702 the ability to enforce TSCA Title VI and its implementing regulations, which in turn 

703 encourages the regulated entities to fulfill their obligations under the statute and 

704 regulations. EPA requests comment on this proposed requirement. 

705 EPA would designate an EPA recognition agreement Implementation Officer as a 

706 point of contact for ABs to consult with on implementation of the recognition agreement. 

707 EPA would be responsible for directly notifying participating ABs of changes in the 

708 TSCA Title VI Third-Party Certification Program. EPA would maintain a public list of 

709 all ABs with which EPA has a recognition agreement. The list would be posted on EPA’s 

710 website and regularly updated.

711 3. Proposed requirements once an AB is recognized. Once EPA has entered into a 

712 recognition agreement with an AB, that AB becomes “recognized” by EPA as a Product 

713 AB, Laboratory AB, or both. 

714 a. Responsibilities of Product ABs in the TPC application process. The Product 

715 AB’s key TSCA Title VI TPC application review responsibilities would include: 

716 i. Receiving and acting on TPC applications for their participation in the TSCA 

717 Title VI Third-Party Certification Program and thereby ensuring that the TPC is 
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718 accredited to ISO/IEC Guide 65:1996(E) and ISO/IEC 17020:1998(E). 

719 ii. Transmitting copies of TPC applications and supporting documentation 

720 requested in the application based on the TSCA Title VI implementing regulations to 

721 EPA. 

722 iii. Assigning the TPC a unique number. 

723 b. General responsibilities of ABs after TPC accreditation into the TSCA Title VI 

724 Third-Party Certification Program. The EPA recognized Product AB would be 

725 responsible for: 

726 i. Ensuring the TPC has a process in place to verify the accuracy of the 

727 formaldehyde emission tests conducted by the TPC laboratory (including any contract 

728 laboratory that the TPC would use for formaldehyde testing under TSCA Title VI) and 

729 the formaldehyde quality control tests conducted by the producers of regulated composite 

730 wood products. 

731 ii. Ensuring the TPC has a process in place to monitor panel producer quality 

732 assurance programs. 

733 iii. Ensuring the TPC has a process in place to conduct independent audits and 

734 inspections of panel producers and their quality control testing facilities. 

735 vi. Conducting audits of TPCs and their laboratories. 

736 v. Recordkeeping. 

737 The EPA recognized Laboratory ABs would be responsible for verifying that the 

738 TPC laboratory is experienced and capable of conducting formaldehyde emissions tests 

739 according to the requirements of TSCA Title VI and its implementing regulations. The 

740 Laboratory ABs’ key responsibilities would include: 
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741 • Ensuring the laboratory’s conformance to the regulatory requirements, including 

742 ISO/IEC 17025:2005(E). 

743 • Verifying the accuracy of the formaldehyde emissions tests conducted by the 

744 TPC laboratory through an inter-laboratory comparison or proficiency testing program.

745 • Conducting audits of the laboratory. 

746 • Recordkeeping. 

747 EPA proposes to require TPCs to participate in an EPA recognized inter748 laboratory comparison program. If standard reference material is developed, EPA would 

749 consider requiring TPCs to participate in an EPA recognized proficiency testing program. 

750 In order to reduce duplicative requirements, EPA proposes that it would utilize the 

751 preexisting CARB-administered inter-laboratory comparison program to the extent 

752 feasible. EPA requests comment on ways it might integrate with CARB's inter-laboratory 

753 comparison program and on what criteria should be used to determine the adequacy of 

754 performance. EPA also requests comment on how participating Laboratory ABs could 

755 administer an inter-laboratory comparison program or proficiency testing program for the 

756 TPCs that it accredits. EPA would like information on the costs of such a program and 

757 whether such an activity presents conflict of interest issues for Laboratory ABs. 

758 4. Revocation of EPA’s recognition of an AB. EPA is proposing that it may 

759 suspend, revoke, or modify the recognition of an AB, if the AB is not complying with the 

760 requirements promulgated for ABs under TSCA Title VI. If an AB is removed or 

761 withdraws from the TSCA Title VI Third–Party Certification Program, that AB would be 

762 responsible for promptly notifying EPA and all TPCs that receive its accreditation 

763 services. If an AB is removed or withdraws from the TSCA Title VI Third–Party 
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764 Certification Program for reasons other than fraud or providing false or misleading 

765 statements related to a particular TPC or TPCs, or other than a reason that implicates a 

766 particular TPC or TPCs in a violation of TSCA Title VI or its implementing regulations, 

767 EPA proposes to allow the TPCs that were accredited by that AB to have 365 days, or 

768 180 days if less than 365 days were left on their 2-year accreditation period, to be 

769 accredited again by another EPA recognized AB. While it is seeking accreditation from 

770 an alternate AB, a TPC would need to continue to comply with all other aspects of TSCA 

771 Title VI and its implementing regulations, and the TPC would remain subject to 

772 inspection by EPA. If an AB is removed from the TSCA Title VI Third-Party 

773 Certification Program due to fraud or providing false or misleading statements with 

774 respect to a particular TPC, or for any other reason that implicates a particular TPC in a 

775 violation of TSCA Title VI or its implementing regulations, that TPC would not be 

776 allowed to provide any TSCA Title VI certification services until it has been accredited 

777 by an alternate AB. Should this situation occur, EPA would provide notifications to the 

778 affected TPCs at the time it commences formal action against the AB. Any action EPA 

779 would take against an AB would not preclude an enforcement action against a TPC. EPA 

780 believes it is appropriate to be more stringent in these situations because the AB’s 

781 nonperformance or altered status under the recognition agreement may call into question 

782 the legitimacy of the TPC’s underlying accreditation. EPA requests comment on whether 

783 it has provided adequate time for a TPC to seek an alternate AB’s accreditation under this 

784 proposed rule. Issues related to the de-accreditation of a TPC and the amount of time a 

785 panel producer has to seek a new TPC are discussed in Unit III.B.3.

786 B. Requirements for Third-Party Certifiers of Composite Wood Products
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787 1. Requirements to apply for participation in the TSCA Title VI Third–Party 

788 Certification Program. EPA is proposing that the TPC must apply to an EPA recognized 

789 Product AB to certify composite wood products pursuant to TSCA Title VI. In its 

790 application to an EPA recognized Product AB, the TPC would be required to demonstrate 

791 experience and competency in certain areas that EPA believes are important in ensuring 

792 the TPC’s ability to conduct audits, testing, and certification of composite wood products. 

793 The application would be reviewed by the Product AB, who would provide EPA with a 

794 copy of each application. TPC applications would provide information to document: 

795 1. Experience in performing or verifying formaldehyde emissions testing on 

796 composite wood products. 

797 2. That its laboratory or contract laboratory has been accredited by an EPA 

798 recognized Laboratory AB in conformance with ISO/IEC 17025:2005(E). 

799 3. The TPC laboratory’s or contract laboratory’s experience with test method 

800 ASTM E 1333-96 (Reapproved 2002) (Ref. 19) or successor standards and experience 

801 evaluating correlation between test methods. 

802 4. Experience or ability in product certification and complying with ISO/IEC 

803 Guide 65:1996(E). 

804 5. Experience in the composite wood product industry. 

805 6. The ability to inspect and properly train and supervise inspectors according to 

806 ISO/IEC 17020:1998(E). 

807 The application would also specify which composite wood products the applicant is 

808 applying to certify and evidence that the applicant is qualified to certify these products. 

809 EPA is proposing that TPCs would be required to renew their applications every 2 years. 
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810 In order to facilitate communication between EPA and TPCs, EPA is proposing to 

811 require TPCs to designate an agent in United States in their applications. Any information 

812 provided by an AB or EPA to the designated agent would be equivalent to providing that 

813 information directly to the TPC. The designated agent could not be a mailbox, answering 

814 machine, or other service where the agent is not physically present. The agent would need 

815 to be capable of accepting service of notices and processes made in administrative and 

816 judicial proceedings. EPA believes requiring a designated agent in the United States 

817 would help ensure compliance with the emission standards by facilitating the ability to 

818 enforce TSCA Title VI and its implementing regulations, which in turn encourages the 

819 regulated entities to fulfill their obligations under the statute and regulations. EPA 

820 requests comment on this proposed requirement. 

821 Title VI of TSCA requires that compliance with the formaldehyde emission 

822 standards be measured by quarterly testing using ASTM E1333-96 (Reapproved 2002) 

823 (Ref. 19) or under certain circumstances, ASTM D6007-02 (Reapproved 2008) (Ref. 20). 

824 For quality control testing, the statute requires use of ASTM D6007-02 (Reapproved 

825 2008), ASTM D5582-00 (Reapproved 2006) (Ref. 21), or other test methods established 

826 by EPA through rulemaking. If a test method other than ASTM E1333-96 (Reapproved 

827 2002) is used for either quarterly testing or quality control testing, TSCA Title VI 

828 requires a demonstration of equivalence by means established by EPA. Therefore, EPA is 

829 proposing that a TPC laboratory or contract laboratory must have experience with 

830 formaldehyde testing using ASTM E1333-96 (Reapproved 2002) or its successor 

831 standards as well as experience evaluating correlations between different test methods. 

832 EPA intends to propose the means of showing test method equivalence in a subsequent 
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833 proposal with other implementation provisions as required under TSCA Title VI. 

834 EPA is proposing to require that accredited TPCs conduct the quarterly tests 

835 required by TSCA Title VI. The statute requires these tests to be performed using ASTM 

836 E1333-96 (Reapproved 2002) or, under some circumstances ASTM D6007-02 

837 (Reapproved 2008). Section 601(d)(5) of TSCA allows EPA to substitute, after public 

838 notice and an opportunity for comment, a test method referenced in TSCA Title VI with 

839 its successor version. The version of ASTM E1333-96 (Reapproved 2002) referenced in 

840 TSCA Title VI is not the most current version. In this proposed rule, EPA is proposing to 

841 incorporate the current version, ASTM E1333-10 (Ref. 22), into the testing requirements 

842 in this proposed rule in place of ASTM E1333-96 (Reapproved 2002) referenced in the 

843 statute. EPA notes that there are only relatively minor differences between ASTM 

844 E1333-96 (Reapproved 2002) and ASTM E1333-10. For example, referenced standards 

845 have been updated to cite the most recent version of the standards. In addition, under 

846 Apparatus, Make-up Air, 6.1.2.2, a new requirement has been added, specifying that the 

847 dry gas test meter or other airflow rate measuring device be “permanently placed in the 

848 chamber air intake duct.” A new loading ratio was added for “low density particleboard 

849 door core” and a note specifying that “Panel grades are defined in the ANSI standards 

850 referenced in 2.3.” Under 9.2 Conditioning, a note was added stating “Test specimens 

851 with low levels of formaldehyde may absorb formaldehyde from the air when the air 

852 formaldehyde content exceeds that of the text [sic] specimen. Consideration should be 

853 taken to avoid such air conditions during storage and conditioning.” In addition, the 

854 following requirement was added: “Circulation of the conditioning air shall be achieved 

855 by fans that direct air flow horizontally in the direction parallel to the primary surface of 
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856 the test specimens.” Under Test Procedure for Materials, 10.1.3, the following phrase 

857 was deleted: “as measured by a totalizing dry gas meter permanently placed in the 

858 chamber air intake duct.” Under note 9, the following clarifying phrase was added: 

859 “unless testing is extended and chamber concentrations in air and emission rates are 

860 obtained for the tested product at multiple chamber air exchange rates or multiple product 

861 loading ratios, or both.” Under Report the Following Information, 12.1.7, the following 

862 was added: “and the air circulation conditions (for example, air velocity or air exchange 

863 rate.” Under (Nonmandatory Information) X1. Reagents, Materials, and Equipment 

864 Found Suitable for Use, footnotes specifying where apparatuses are available have been 

865 deleted. In addition, X1.3.2 Sulfuric Acid, has been changed from “concentrated reagent 

866 grade. Nitrate concentration shall be less than 10 ppm.” to “ACS grade. Nitrate 

867 concentration shall be no greater than 0.2 ppm.” EPA requests comment on whether 

868 ASTM E1333-10 should be incorporated into the testing requirements under TSCA Title 

869 VI in place of ASTM E1333-96 (Reapproved 2002). 

870 EPA intends to propose the means of showing test method equivalence for other 

871 test methods as well as the number and frequency of tests required to demonstrate 

872 compliance with the formaldehyde emission standards in a subsequent proposal along 

873 with the rest of the TSCA Title VI implementing regulations. EPA is proposing here that 

874 TPC laboratories be responsible for conducting quarterly tests, verifying quality control 

875 tests, and evaluating test method equivalence.

876 EPA is proposing that TPCs must have experience operating or using laboratories 

877 that follow ISO/IEC 17025:2005(E). This international voluntary consensus standard 

878 specifies the general requirements for the competence to carry out tests and/or 
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879 calibrations, including sampling. EPA believes that requiring TPCs to use laboratories 

880 that follow these requirements would help ensure that reliable and accurate test results are 

881 obtained. 

882 EPA is proposing that TPCs must have experience or ability in product 

883 certification and in complying with ISO/IEC Guide 65:1996(E) because certifying 

884 compliant composite wood products would be one of the main functions of a TSCA Title 

885 VI accredited TPC. ISO/IEC Guide 65:1996(E) is an international voluntary consensus 

886 standard that specifies general requirements for a third-party operating a product 

887 certification system. These general requirements would help ensure that the TPC is 

888 competent and reliable in certifying compliant composite wood products. 

889 EPA is proposing that the TPC must have experience in conducting inspections of 

890 the manufacturers in conformity with ISO/IEC 17020:1998(E). This international 

891 voluntary consensus standard specifies general criteria for the operation of various types 

892 of bodies performing inspections. EPA is also proposing that TPCs must have the ability 

893 to properly train and supervise inspectors pursuant to conformity with ISO/IEC 

894 17020:1998(E). Inspections by TPCs would be an important function of a TPC in helping 

895 ensure compliance with the regulations under TSCA Title VI. 

896 EPA is proposing that TPCs must have experience in the composite wood 

897 products industry because EPA believes that understanding the processes used by panel 

898 producers to produce composite wood products is crucial for the TPC to adequately 

899 inspect and audit panel producers. Experience in the composite wood products industry 

900 would help ensure that the TPC would know what to inspect and areas on which to focus 

901 during inspections and audits of the panel producers. In addition, EPA is proposing to 
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902 require TPCs to have experience with the specific type of composite wood product(s) that 

903 it would certify. EPA believes that certain steps in the manufacture of composite wood 

904 products are likely important in maintaining low formaldehyde emissions and that 

905 because manufacturing processes are different for the different types of regulated 

906 composite wood products, it is important for a TPC to have knowledge and experience in 

907 the manufacture of the specific type of composite wood product(s) that it would certify. 

908 EPA requests comment on whether EPA should require that the TPC have experience 

909 with the specific type of composite wood product that it would certify or if experience 

910 with one type of product is sufficient to certify all types of composite wood product. 

911 If an AB denies a TPC’s application for accreditation for failure to submit a 

912 complete application, the AB would be required to notify the TPC or TPC laboratory in 

913 writing of the legal and factual basis for the denial, actions, if any, which the affected 

914 TPC or TPC laboratory may take to receive accreditation in the future, and the 

915 opportunity and method for requesting a hearing with EPA. “Failure to submit a complete 

916 application” would not include failure to pay any accreditation fee or reach a fee 

917 agreement. 

918 2. Proposed requirements once a TPC is accredited. EPA is proposing that once 

919 an applicant is accredited as a TPC under TSCA Title VI, the TPC must: 

920 a. Verify that panel producers have adequate quality assurance controls and are 

921 complying with any quality assurance and quality control requirements that EPA 

922 promulgates pursuant to TSCA Title VI. 

923 b. Verify quality control test results compared with ASTM E1333-10 test results 

924 by having laboratories conduct quarterly tests and evaluate test method equivalence 
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925 pursuant to testing requirements promulgated under TSCA Title VI. 

926 c. Review applications from panel producers for reduced testing or third-party 

927 certification requirements. 

928 d. Establish quality control limits in consultation with panel producers, and, if 

929 applicable, shipping quality control or other limits for each product type and production 

930 line. 

931 e. Inform panel producers of the process that will be used to determine if product 

932 lots are exceeding the applicable quality control limit. 

933 f. Inspect and audit panel producers and their records at least quarterly. 

934 g. Use a testing laboratory or laboratories that comply with ISO/IEC 

935 17025:2005(E). 

936 h. Certify composite wood product types that comply with requirements under 

937 TSCA Title VI following ISO/IEC Guide 65:1996(E). 

938 i. Follow ISO/IEC 17020:1998(E) in the carrying out of their inspections of the 

939 panel producers. 

940 j. Provide approved TPC number (supplied by the accrediting AB) to the panel 

941 producer for labeling and recordkeeping. 

942 k. Use laboratories that participate in an inter-laboratory comparison or 

943 proficiency testing program. 

944 l. Maintain records in electronic form for 5 years. 

945 m. Provide an annual report to EPA and the AB(s) that provided it with its 

946 accreditation. 

947 n. Inform the AB(s) that provided it with its accreditation of any changes in key 
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948 personnel qualifications, procedures, or laboratories used by the TPC that could affect the 

949 TPC’s ability to fulfill its obligations under this unit. 

950 One of the main functions of TPCs under this proposed rule would be to help 

951 ensure that panel producers have adequate quality control of their manufacturing process, 

952 are following appropriate quality assurance procedures, and are complying with any 

953 quality assurance requirements that EPA may implement under TSCA Title VI. Under 

954 the CARB ATCM, manufacturers are required to implement specific quality assurance 

955 procedures as described in Appendix 2 of the ATCM. EPA anticipates promulgating 

956 quality assurance requirements for panel producers under TSCA Title VI in a subsequent 

957 proposal with other implementation provisions as required under TSCA Title VI. EPA is 

958 proposing to use TPCs to help ensure compliance with quality control and quality 

959 assurance procedures. 

960 EPA is proposing to require TPCs to verify quality control tests that measure 

961 formaldehyde emissions by having laboratories conduct quarterly testing. 

962 Under TSCA Title VI, EPA intends to promulgate specific formaldehyde testing 

963 requirements. The subsequent proposal may also provide for reduced testing for specified 

964 products such as those made with NAF or ULEF resins. In this proposed rule, EPA is 

965 proposing to require TPCs to review and approve, when appropriate, applications from 

966 panel producers for reduced testing and third-party certification requirements according 

967 to EPA’s implementing regulations. The CARB ATCM allows for reduced testing for 

968 products manufactured with NAF and ULEF resins, and CARB reviews and approves 

969 NAF and ULEF applications. EPA is proposing to instead require TPCs to review these 

970 applications because EPA believes they are best suited to determine whether the panel 
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971 producers will be able to consistently comply with the emission standards even with 

972 reduced testing requirements. EPA intends to further specify requirements for reduced 

973 testing in a subsequent proposal with other implementation provisions as required under 

974 TSCA Title VI. 

975 EPA is proposing to require TPC laboratories (including contract laboratories) to 

976 establish quality control limits in consultation with panel producers and, if applicable, 

977 shipping quality control or other limits for each product type and production line to 

978 ensure compliance with the emission standards. A quality control limit would be 

979 established if test methods other than ASTM E1333-10 are being used to make it easier 

980 for the panel producer to determine whether any products are likely to exceed the 

981 emission standards. A quality control limit would be the value from a test other than 

982 ASTM E1333-10 that is the correlative equivalent to the applicable standard. A TPC may 

983 also establish a limit to account for process and testing variation to help ensure that the 

984 emission for a product would not exceed the applicable standard. EPA is proposing to 

985 require TPCs to inform panel producers of the process that the TPC would use to 

986 determine if product lots are exceeding the applicable quality control limit. In the broader 

987 TSCA Title VI implementing regulations, EPA intends to describe these limits in more 

988 detail as well as implications and procedures for cases where tests exceed the limits in a 

989 subsequent proposal with other implementation provisions as required under TSCA Title 

990 VI. 

991 EPA is proposing to require that TPCs inspect and on-site audit panel producers 

992 and their records at least quarterly and comply with ISO/IEC 17020:1998(E) when 

993 conducting their inspections. Quarterly inspections and on-site audits are consistent with 
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994 requirements under the CARB ATCM, and EPA believes that requiring inspections 

995 quarterly should be sufficiently frequent to allow TPCs to observe and mitigate any 

996 potential violations. However, under certain circumstances, a TPC could determine that 

997 more frequent inspections and on-site audits are necessary to ensure compliance.EPA 

998 request comment on whether enhanced testing or inspection requirements should be 

999 required where a TPC finds that a panel producer has failed quality control or quarterly 

1000 tests at a certain frequency. 

1001 EPA is proposing to require that TPCs use laboratories for formaldehyde testing 

1002 that comply with ISO/IEC 17025:2005(E). As discussed in Unit II.F.1., this international 

1003 voluntary consensus standard specifies the general requirements for the competence to 

1004 carry out tests and/or calibrations, including sampling. EPA believes that requiring TPCs 

1005 to use laboratories that follow these requirements would help ensure that TPCs obtain 

1006 reliable and accurate test results. 

1007 EPA is proposing to require that TPCs participate in an EPA-recognized inter1008 laboratory comparison studies or proficiency testing, if developed. The inter-laboratory 

1009 comparisons would involve the participation of laboratories that are provided composite 

1010 wood product samples to test for formaldehyde; each laboratory would test the sample 

1011 using the same test method (e.g., ASTM E1333-10), and the results from all of the 

1012 laboratories would be compared. If a standard reference material for formaldehyde 

1013 emissions is developed, EPA proposes to require annual proficiency testing. The CARB 

1014 ATCM requires laboratories to participate in an inter-laboratory comparison during the 

1015 first year that the laboratory is used by a TPC, followed by participation in inter1016 laboratory comparisons every 2 years. EPA believes that evaluating the performance of 
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1017 laboratories used by the TPC by inter-laboratory comparisons or proficiency testing is 

1018 vital to ensuring that laboratories are performing the formaldehyde testing properly, and 

1019 EPA is therefore proposing that this be an annual requirement. EPA requests comment on 

1020 whether inter-laboratory comparisons should take place more or less frequently. EPA is 

1021 also seeking comment on criteria to use in evaluating performance in inter-laboratory 

1022 comparisons. 

1023 EPA is proposing to require TPCs to follow ISO/IEC Guide 65:1996(E) to certify 

1024 composite wood product types that comply with requirements under TSCA Title VI. As 

1025 discussed in Unit II.F.1., ISO/IEC Guide 65:1996(E) is an international voluntary 

1026 consensus standard that specifies general requirements for a third-party operating a 

1027 product certification system. EPA believes that requiring TPCs to follow these general 

1028 requirements for certifying products would help ensure that the TPC is properly 

1029 certifying only compliant composite wood products. 

1030 A TPC would be supplied with a TPC identification number by the Product AB 

1031 once it has been accredited for TSCA Title VI purposes. EPA is proposing to require that 

1032 the TPC provide this number to panel producers so that they can include the TPC number 

1033 on the label of their certified products and include it in their records. 

1034 EPA is proposing to require TPCs to maintain records in electronic form for 5 

1035 years. TSCA Title VI directs EPA to address recordkeeping requirements in its 

1036 implementing regulations and EPA believes that certain records will greatly assist the 

1037 EPA in monitoring compliance with the emissions standards and other provisions. These 

1038 records would be: 

1039 •A list of panel producers and their respective product types, including resins 
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1040 used, that the TPC has certified. 

1041 •Results of inspections, audits, and emission tests conducted for and linked to 

1042 each panel producer and product type. 

1043 •A list of laboratories used by the TPC, test methods, including test conditions 

1044 and conditioning time, and test results. 

1045 •Methods and results for establishing test method correlations and equivalence. 

1046 EPA is proposing to require TPCs to submit an annual report to EPA and the AB 

1047 that accredits the TPC. The annual report would include: 

1048 •A list of panel producers and their products that the TPC has certified during the 

1049 previous year, including resins used and the average and range of formaldehyde 

1050 emissions by panel producer, resin, and product type. 

1051 • List of any non-complying products or events by panel producers. 

1052 • A list of laboratories and test methods used by the TPC. 

1053 • Results of inter-laboratory comparison or proficiency testing for the laboratories 

1054 used by the TPC. 

1055 EPA is proposing to require that the TPC inform the AB(s) that accredit the TPC 

1056 of any changes in key personnel qualifications, procedures, or laboratories used that 

1057 could affect the TPC's ability to fulfill its obligations under this unit. EPA believes such 

1058 changes could impact the TPC’s ability to properly verify formaldehyde emissions, 

1059 inspect and audit, and certify compliant composite wood products. EPA is proposing that 

1060 the AB review the changes to determine whether the changes would impact the TPC’s 

1061 ability to perform its duties. 

1062 3. Removal and reaccreditation of third-party certifiers. EPA is proposing to 
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1063 exercise the authority to revoke the TSCA Title VI accreditation of a TPC or its 

1064 laboratory, after notice and an opportunity for a hearing, if the TPC or its laboratory: 

1065 Fails to meet any of the applicable requirements promulgated under TSCA Title VI (such 

1066 as by failing to comply with ISO/IEC Guide 65:1996(E), ISO/IEC 17020:1998(E), or 

1067 ISO/IEC 17025:2005(E)); makes false or misleading statements on its application, 

1068 records, or reports; or makes changes to key personnel qualifications, procedures, or 

1069 laboratories that would make it unable to perform its duties. ABs would also be able to 

1070 revoke an accreditation of a TPC, subject to an opportunity for a hearing with EPA. A 

1071 TPC whose accreditation has been revoked may reapply to an AB to be reaccredited as a 

1072 TPC. 

1073 If a TPC loses its accreditation or discontinues participation in the TSCA Title VI 

1074 Third-Party Certification Program for any reason, it would be responsible for promptly 

1075 notifying EPA and all panel producers that it provides TSCA Title VI certification 

1076 services to. If a TPC loses its accreditation or discontinues participation in the program 

1077 for reasons other than fraud or providing false or misleading statements, or other than a 

1078 reason that implicates a particular panel producer in a violation of TSCA Title VI or its 

1079 implementing regulations, the panel producers that used the TPC to certify their products 

1080 would need to enlist another TPC to certify their products within 3 months (90 days). 

1081 During the time a panel producer is seeking a new TPC, it would need to continue to 

1082 comply with all other requirements of TSCA Title VI and its implementing regulations, 

1083 including quality control testing. During this period the panel producer would remain 

1084 subject to inspection by EPA. If the panel producer is unable to comply with all other 

1085 aspects of TSCA Title VI and its implementing regulations, the panel producer would not 
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1086 be permitted to sell, offer for sale, or supply its products in the United States until its 

1087 products are recertified as compliant. If a TPC loses its accreditation due to fraud or 

1088 providing false or misleading statements with respect to a particular panel producer, or 

1089 for any other reason that implicates a particular panel producer in a violation of TSCA 

1090 Title VI or the regulations promulgated thereunder, that panel producer would not be 

1091 permitted to offer regulated composite wood products for sale in the United States until 

1092 its composite wood products have been recertified by another TPC. If such a situation 

1093 does occur, EPA would notify affected panel producer at the time it commences action 

1094 against the TPC. EPA believes it is appropriate to be more stringent in these situations 

1095 because the TPC’s behavior may call into question the legitimacy of the manufacture’s 

1096 product certification. Any action EPA would take against a TPC would not preclude an 

1097 enforcement action against a panel producer. EPA requests comment on whether it has 

1098 provided adequate time for a panel producer to seek an alternate certification.

1099 H. Enforcement, Suspension, Revocation, and Modification 

1100 1. Enforcement under TSCA sections 15-17. EPA may conduct inspections of 

1101 participating TPCs and ABs and issue subpoenas according to the requirements for 

1102 accreditation and recognition and/or pursuant to the provisions of TSCA section 11 (15 

1103 U.S.C. 2610) to ensure compliance with TSCA Title VI and the regulations promulgated 

1104 thereunder. Enforcement issues related to manufacturers, importers, distributors, and 

1105 retailers will be covered in a subsequent proposal. 

1106 EPA would exercise the authority to withdraw from a recognition agreement with 

1107 an AB and pursue penalties under TSCA section15 (15 U.S.C. 2614) for any violation of 

1108 TSCA Title VI or the regulations promulgated thereunder. In addition to an 
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1109 administrative or judicial finding of violation, grounds for withdrawing from a 

1110 recognition agreement and/or pursuing an enforcement action against an AB include if 

1111 the AB: 

1112 • Submits false or misleading information to EPA; 

1113 • Fails to maintain or falsifies required records; or 

1114 • Or otherwise fails to comply with TSCA Title VI or the regulations promulgated 

1115 thereunder. 

1116 2. Suspension, revocation and modification. EPA would exercise the authority to 

1117 suspend, revoke, or modify a TPC’s TSCA Title VI accreditation, with or without the 

1118 participation of the AB that provided the accreditation, if the TPC fails to comply with 

1119 TSCA Title VI or the regulations promulgated thereunder. Any violation of TSCA Title 

1120 VI or the regulations promulgated thereunder would also be a prohibited act under TSCA 

1121 section 15 (15 U.S.C. 2614). Grounds for suspending, modifying, or revoking a TPC’s 

1122 accreditation include if the TPC: 

1123 a. Submits false or misleading information to EPA or its AB; 

1124 b. Fails to maintain or falsifies required records; or 

1125 c. Fails to comply with TSCA Title VI or regulations promulgated thereunder. 

1126 The ISO/IEC standards and guide that are referenced in this proposed rule require 

1127 that policies and procedures be in place to identify and remedy nonconformities with the 

1128 implementation of those standards (ISO/IEC 17025:2005(E), section 4.9; ISO/IEC 

1129 17011:2004(E), section 5.5; ISO/IEC 17020:1998(E), section 7.8; ISO/IEC Guide 

1130 65:1996(E), section 47). Should a TPC or AB identify a nonconformity or discrepancy 

1131 with its implementation of one of the ISO standards via an internal audit or other means, 
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1132 that entity must take remedial action within the timeframe specified by the AB or the 

1133 time specified in the TPC’s quality management plan in order to avoid the possibility of 

1134 an enforcement action. 

1135 Prior to withdrawal from a recognition agreement with an AB, or the suspension, 

1136 revocation, or modification of a TPC’s accreditation, EPA would provide notification to 

1137 the affected AB or TPC of: 

1138 • The legal and factual basis for the proposed action. 

1139 • The anticipated commencement date and duration of any suspension, revocation, 

1140 modification, or other action. 

1141 • What actions, if any, the affected entity may take to avoid suspension, 

1142 revocation, modification, or otherwise continue participation in the program. 

1143 • The opportunity and method for requesting a hearing prior to the final action. 

1144 If an individual or organization requests a hearing, EPA would: 

1145 • Provide the affected entity an opportunity to offer written statements in response 

1146 to EPA’s assertions of the legal and factual basis for its proposed action. 

1147 • Appoint an impartial official of EPA as Presiding Officer to conduct the hearing. 

1148 The Presiding Officer would conduct a fair, orderly, and impartial hearing within 

1149 90 days of the request for a hearing. The Presiding Officer would consider all relevant 

1150 evidence, explanations, comments, and arguments submitted and notify the affected 

1151 entity in writing within 90 days of completion of the hearing of his or her decision and 

1152 order. Such an order is a final agency action which may be subject to judicial review. The 

1153 order must contain the commencement date and duration of the suspension, revocation, or 

1154 modification. 
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1155 If EPA determines that the public health, interest, or welfare warrants immediate 

1156 action to suspend the recognition of an AB or the accreditation of a TPC prior to the 

1157 opportunity for a hearing, it would notify the affected AB or TPC of its right to request a 

1158 hearing on the immediate suspension within 15 days of the suspension taking place and 

1159 the procedures for the conduct of such a hearing. 

1160 Any notice, decision, or order issued by EPA in response to a hearing, any 

1161 transcript or other verbatim record of oral testimony, and any documents filed in response 

1162 to a hearing would be available to the public, except as otherwise provided by TSCA 

1163 section 14. Any such hearing at which oral testimony is presented would be open to the 

1164 public, except that the Presiding Officer may exclude the public to the extent necessary to 

1165 allow presentation of information which may be entitled to confidential treatment under 

1166 TSCA section14.

1167 I. Status of CARB Approved TPCs 

1168 EPA intends to propose that the formaldehyde emissions standards in TSCA Title 

1169 VI become effective 365 days after the promulgation of the TSCA Title VI implementing 

1170 regulations (which are required by TSCA Title VI to be promulgated no later than 

1171 January 1, 2013). EPA proposes that CARB approved TPCs would have 365 days after 

1172 the promulgation of the TSCA Title VI implementing regulations to become accredited 

1173 by an AB with which EPA has entered into a recognition agreement. EPA believes this is 

1174 a sufficient period of time for EPA to enter into recognition agreements with ABs and for 

1175 TPCs to seek accreditation from EPA recognized ABs, ensuring no interruption in a 

1176 TPC’s services. During the transition period between when the final TSCA Title VI 

1177 implementing regulations are promulgated and the date 365 days after promulgation, the 
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1178 CARB approved TPCs may carry out certification activities under TSCA Title VI 

1179 provided that they are compliant with all other aspects of TSCA Title VI and the 

1180 regulations promulgated thereunder. TPCs that are certifying products as compliant with 

1181 TSCA Title VI are subject to inspection by EPA and enforcement actions for any 

1182 violations of TSCA Title VI or the regulations promulgated thereunder. 

1183 J. Transparency 

1184 EPA has a commitment to uphold the values of transparency and openness in 

1185 conducting EPA operations (Ref. 23). Transparency promotes accountability and 

1186 provides information for citizens about what their government is doing (Ref. 24). EPA 

1187 would support its commitment by making documentation of recognized ABs, TPCs, and 

1188 panel producers available to the public. EPA is proposing to make the following 

1189 information publically available on the internet: 

1190 1. The names and addresses of all ABs that EPA has a recognition agreement with 

1191 and the status of that recognition agreement. 

1192 2. A list of all accredited TPCs with their TPC number and accreditation status. 

1193 3. Annual reports from ABs. 

1194 4. A list of panel producers approved for reduced testing and reduced third-party 

1195 certification requirements. 

1196 EPA requests comment on what, if any, additional information should be made 

1197 publically available (e.g., annual reports from TPCs and other required notifications) and 

1198 on whether there are other ways EPA might improve program transparency. EPA 

1199 requests comment on whether making the following information available publically on 

1200 the internet would be useful to the public or present challenges for regulated entities: 
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1201 • A list of panel producers and their products that each TPC has certified, 

1202 including resins used and the average and range of formaldehyde emissions by panel 

1203 producer, resin, and product type. 

1204 • A list of any non-complying products or events by panel producer. 

1205 • A list of laboratories and test methods used by each TPC. 

1206 • The results of inter-laboratory comparison or proficiency testing for the 

1207 laboratories used by TPCs. 

1208 EPA requests comment on whether such information might contain CBI. 

1209 EPA is also considering requiring some information to be reported into a publicly 

1210 viewable database, should such a database be developed. Generally, EPA is considering 

1211 requiring electronic reporting of the information proposed to be reported. In particular, 

1212 EPA requests comment on whether the data elements in the ABs’ and TPCs’ annual 

1213 reports, and the required notifications should be reported into a publicly viewable 

1214 database. 

1215 IV. Request for Comment

1216 In addition to the areas on which EPA has specifically requested comment, EPA 

1217 requests comment on all other aspects of this proposed rule. 

1218 V. References

1219 As indicated under ADDRESSES, a docket has been established for this 

1220 rulemaking under docket ID number EPA-HQ-OPPT-2011-0380. The following is a 

1221 listing of the documents that are specifically referenced in this action. The docket 

1222 includes these documents and other information considered by EPA, including 

1223 documents that are referenced within the documents that are included in the docket, even 
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1224 if the referenced document is not physically located in the docket. For assistance in 

1225 locating these other documents, please consult the technical contact listed under FOR 

1226 FURTHER INFORMATION CONTACT. 

1227 1. Public Law 111-199, Title VI--Formaldehyde Standards for Composite Wood 

1228 Products Act, enacted July 7, 2010. (TSCA section 601(d), 15 U.S.C. 2601 et seq.) 

1229 2. Agency for Toxic Substances and Disease Registry (ATSDR). 1999. 

1230 Toxicological Profile for Formaldehyde and 2010 Addendum to the Profile. Atlanta, GA: 

1231 U.S. Department of Health and Human Services, Public Health Service. 

1232 3. National Toxicology Program, U.S. Department of Health and Human Services 

(HHS), 12th 1233 Report on Carcinogens, June 10, 2011. 

1234 4. EPA, ORD. Integrated Risk Information System (IRIS) Program. IRIS 

1235 Toxicological Review of Formaldehyde-Inhalation Assessment (2010 External Review 

1236 Draft). Available online at:

1237 http://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=223614. 

1238 5. National Academy of Sciences (NAS). Review of the Environmental Protection 

1239 Agency's Draft IRIS Assessment of Formaldehyde. 2011. Available online at:

1240 http://www.nap.edu/catalog.php?record_id=13142. 

1241 6. California Environmental Protection Agency Air Resource Board. CARB 

1242 Airborne Toxic Control Measure. April 26, 2007. Available online at:

1243 http://www.arb.ca.gov/toxics/compwood/compwood.htm. 

1244 7. California Environmental Protection Agency Air Resources Board, Composite 

1245 Wood Products ATCM, List of CARB Approved Third-party Certifiers (Accessed 
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1246 August, 2011). Available online at:

1247 http://www.arb.ca.gov/toxics/compwood/listoftpcs.htm.

1248 8. California Environmental Protection Agency Air Resources Board, Application 

1249 to be a Third-party Certifier (TPC) of Composite Wood Products. Available online at: 

1250 http://www.arb.ca.gov/toxics/compwood/tpc/tpcapplication.pdf. 

1251 9. Sierra Club. Citizen Petition to EPA Regarding Formaldehyde in Wood 

1252 Products. March 20, 2008. Available online at:

1253 http://www.epa.gov/opptintr/chemtest/formaldehyde/index.html.

1254 10. EPA. Formaldehyde Emissions from Composite Wood Products; Disposition 

1255 of TSCA Section 21 Petition. Federal Register. (73 FR 36504, June 27, 2008) (FRL1256 8371-5). 

1257 11. EPA. Formaldehyde Emissions from Composite Wood Products; Advanced 

1258 notice of proposed rulemaking and notice of public meetings. Federal Register. (73 FR 

1259 73620, December 3, 2008) (FRL-8386-3). 

1260 12. ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 

1261 Product Certification Systems (First Edition) 1996. 

1262 13. ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements for 

1263 Accreditation Bodies Accrediting Conformity Assessment Bodies (Corrected Version), 

1264 February 15, 2005. 

1265 14. ISO/IEC 17025:2005(E), General Requirements for the Competence of 

1266 Testing and Calibration Laboratories (Second Edition), May 15, 2005. 

1267 15. ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types 

1268 of Bodies Performing Inspections (First Edition) November 15, 1998. 
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1269 16. International Accreditation Forum. Available online at: http://www.iaf.nu/.

1270 17. International Laboratory Accreditation Cooperation. Available online at: 

1271 http://www.ilac.org. 

1272 18. EPA. National Lead Laboratory Accreditation (NLLAP). Available at: 

1273 http://www.epa.gov/lead/pubs/nllap.htm. 

1274 19. ASTM E1333-96 (Reapproved 2002). Standard Test Method for Determining 

1275 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 

1276 Large Chamber. 

1277 20. ASTM D6007-02 (Reapproved 2008), October 1, 2008. Standard Test Method 

1278 for Determining Formaldehyde Concentrations in Air from Wood Products Using a 

1279 Small-Scale Chamber. 

1280 21. ASTM D5582-00 (Reapproved 2006), October 1, 2006. Standard Test Method 

1281 for Determining Formaldehyde Levels from Wood Products Using a Desiccator. 

1282 22. ASTM E1333-10 (May 1, 2010). Standard Test Method for Determining 

1283 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 

1284 Large Chamber.

1285 23. EPA. Memorandum from Lisa Jackson to EPA Employees (April 23, 2009). 

1286 Available online at: http://www.epa.gov/Administrator/operationsmemo.html. 

1287 24. Memorandum from President Barack Obama to the Heads of Executive 

1288 Departments and Agencies. January 21, 2009. Available online at: 

1289 http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment. 
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1290 25. EPA. Economic Analysis of the Third-Party Certification Framework for the 

1291 Formaldehyde Standards for Composite Wood Products Act Proposed Rule (Economic 

1292 Analysis). OMB Draft March 9, 2012. 

1293 26. EPA. Information Collection Request (ICR) for the Formaldehyde Emissions 

1294 From Composite Wood Products, Third-Party Certification Framework, Recordkeeping 

1295 and Reporting; Proposed Rule, (RIN 2070-AJ44). EPA ICR No. 2441.01 and OMB No. 

1296 2070-[NEW]. OMB Draft March 12, 2012. 

1297 27. EPA. Report of the Small Business Advocacy Review Panel on EPA’s 

1298 Planned Proposed Rule Implementing the Formaldehyde Standards for Composite Wood 

1299 Products Act (TSCA Title VI). April 4, 2011. 

1300 VI. Statutory and Executive Order Reviews 

1301 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 

1302 13563: Improving Regulation and Regulatory Review 

1303 

1304 Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), 

1305 this is a “significant regulatory action” because it may raise novel legal or policy issues 

1306 related to the establishment of a new regulatory program as mandated by a new statutory 

1307 amendment. Accordingly, EPA submitted this action to the Office of Management and 

1308 Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, 

1309 January 21, 2011), and any changes made in response to OMB recommendations are 

1310 documented in the docket for this action. 

1311 EPA prepared an analysis of the potential costs and benefits associated with this 

1312 action. A copy of this Economic Analysis (Ref. 25) is available in the docket for this 

1313 action and the analysis is briefly summarized here. 

1314 The proposed rule would require ABs to submit an application and enter into a 
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1315 recognition agreement with EPA, provide notifications and annual reports, and maintain 

1316 records. A typical AB is estimated to incur an annualized cost of approximately $775 per 

1317 year. For the purposes of cost estimation EPA assumes that eight organizations in the 

1318 United States will become ABs in the TSCA Title VI Third-Party Certification Program, 

1319 so total costs to U.S. ABs are estimated to be approximately $6,200 per year. 

1320 The proposed rule would require TPCs to submit an application, submit 

1321 notifications and annual reports, and maintain records. These requirements are estimated 

1322 to cost an average TPC about $1,200 per year. The proposed rule also would require 

1323 TPCs to be accredited for certain ISO/IEC guide and standards. Most potential TPCs that 

1324 are likely to participate in the TSCA Title VI Third-Party Certification Program are 

1325 expected to already have all the necessary accreditations, but some TPCs are assumed to 

1326 need an additional accreditation at a cost of $25,000 in the first year and $5,000 per year 

1327 in subsequent years. For the purposes of cost estimation EPA assumes that there will be 

1328 nine U.S. TPCs under this proposed rule. Total costs to U.S. TPCs due to the proposed 

1329 rule are estimated to be approximately $94,000 in the first year and $24,000 to $28,000 

1330 per year in subsequent years. Annualized costs to U.S. TPCs are $28,000 and $29,000 

1331 per year, using a 3% and 7% discount rate, respectively. 

1332 The combined total cost for accreditation bodies and TPCs is estimated to be 

1333 $107,000 in the first year. Annualized costs are estimated at $34,000 and $35,000 per 

1334 year, using a 3% and 7% discount rate, respectively. 

1335 B. Paperwork Reduction Act (PRA)

1336 The information collection requirements in this proposed rule have been 

1337 submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information 
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1338 Collection Request (ICR) document prepared by EPA has been assigned EPA ICR No. 

1339 2441.01. 

1340 This action proposes to require TPCs to provide EPA and ABs with pertinent 

1341 information necessary for accreditation. Also, this action proposes to require ABs to 

1342 provide EPA with necessary information through a recognition agreement in order to 

1343 qualify them to function as an AB pursuant to the regulations. EPA has therefore 

1344 prepared and submitted to OMB an Information Collection Request (ICR) document 

1345 entitled “Formaldehyde Emissions From Composite Wood Products, Third-Party 

1346 Certification Framework, Recordkeeping and Reporting; Proposed Rule (RIN 2070-

1347 AJ44),” identified under EPA ICR No. 2441.01 and OMB Control No. 2070-[NEW], 

1348 which is also available for review in the docket for this action (Ref. 26). The ICR 

1349 describes the information collection activities and the estimated burden hours and costs, 

1350 which are briefly summarized here. 

1351 Because the approval requirements for information collection requests under PRA 

1352 is not limited to U.S. entities, the reporting and recordkeeping burden of the proposed 

1353 rule is calculated for both foreign and domestic entities. 

1354 The average reporting and recordkeeping burden for ABs is estimated at 

1355 approximately 18 hours per year. EPA assumes that 8 U.S. ABs and 17 foreign ABs will 

1356 participate in the TSCA Title VI program, so the annual burden for ABs is estimated to 

1357 be 450 hours. The average reporting and recordkeeping burden for TPCs is estimated at 

1358 approximately 28 hours per year. EPA assumes there will be nine domestic TPCs and 27 

1359 foreign TPCs that participate in the TCA Title VI program, so the annual burden for ABs 

1360 is estimated at approximately 1,000 hours. Total respondent burden for ABs and TPCs 
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1361 combined is estimated at approximately 1,450 hours per year. The total cost to United 

1362 States and foreign TPCs that need to obtain additional accreditation is estimated to 

1363 average $140,000 per year. Burden is defined at 5 CFR 1320.3(b). 

1364 An agency may not conduct or sponsor, and a person is not required to respond to 

1365 an information collection request unless it displays a currently valid OMB control 

1366 number, or is otherwise required to submit the specific information by a statute. The 

1367 OMB control numbers for EPA’s regulations codified in title 40 of the Code of Federal 

1368 Regulations, after appearing in the preamble of the final rule, are further displayed either 

1369 by publication in the Federal Register or by other appropriate means, such as on the 

1370 related collection instrument or form, if applicable. The display of OMB control numbers 

1371 for certain EPA regulations is consolidated in a list at 40 CFR 9.1. 

1372 To comment on the Agency's need for this information, the accuracy of the 

1373 provided burden estimates, and any suggested methods for minimizing respondent 

1374 burden, EPA has established a public docket for this proposed rule, which includes this 

1375 ICR, under docket ID number EPA-HQ-OPPT-2011-0380; FRL-9342-4. Submit any 

1376 comments related to the ICR to EPA and OMB. See ADDRESSES at the beginning of 

1377 this proposed rule for where to submit comments to EPA. Send comments to OMB at the 

1378 Office of Information and Regulatory Affairs, Office of Management and Budget, 725 

17th 1379 St., NW, Washington, DC 20503, ATTN: Desk Office for EPA. Since OMB is 

1380 required to make a decision concerning the ICR between 30 and 60 days after [insert date 

1381 of publication in the Federal Register], a comment to OMB is best assured of having its 

1382 full effect if OMB receives it by [insert date 30 days after date of publication in the

1383 Federal Register]. The final rule will respond to any OMB or public comments on the 
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1384 information collection requirements contained in this proposed rule. 

1385 C. Regulatory Flexibility Act (RFA)

1386 The RFA, 5 U.S.C. 601 et seq., generally requires an agency to prepare a 

1387 regulatory flexibility analysis of any rule subject to notice and comment rulemaking 

1388 requirements under the Administrative Procedure Act or any other statute unless the 

1389 agency certifies that the rule will not have a significant economic impact on a substantial 

1390 number of small entities. Small entities include small businesses, small organizations, 

1391 and small governmental jurisdictions. 

1392 For purposes of assessing the impacts of this proposed rule on small entities, a 

1393 small entity is defined as: 

1394 1. A small business, as defined by the Small Business Administration’s (SBA) 

1395 regulations at 13 CFR 121.201. The SBA’s definitions typically are based upon either a 

1396 sales or an employment level, depending on the nature of the industry. 

1397 2. A small governmental jurisdiction that is a government of a city, county, town, 

1398 school district, or special district with a population of less than 50,000. 

1399 3. A small organization that is any not-for-profit enterprise which is 

1400 independently owned and operated and is not dominant in its field. 

1401 Since the regulated community does not include small governmental jurisdictions, 

1402 the Agency’s analysis focuses on small businesses and small non-profits organizations. 

1403 After considering the economic impacts of this proposed rule on small entities, I 

1404 certify that this action will not have a significant economic impact on a substantial 

1405 number of small entities. The Agency’s basis is briefly summarized here and is detailed 

1406 in the Economic Analysis (Ref. 26). 
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1407 EPA evaluated two factors in its analysis of the proposed rule’s requirements on 

1408 small entities, the number and type of small entities potentially affected, and the extent of 

1409 the rule’s potential economic impact on those entities as measured by the cost-to-revenue 

1410 ratio for businesses and the cost-to-expenses ratio for non-profit organizations. This ratio 

1411 is a good measure of entities’ ability to afford the costs attributable to a regulatory 

1412 requirement, because comparing compliance costs to revenues or expenses provides a 

1413 reasonable indication of the magnitude of the regulatory burden relative to a commonly 

1414 available measure of economic activity. Where regulatory costs represent a small fraction 

1415 of a typical entity’s revenues or expenses, the financial impacts of the regulation on such 

1416 entities may be considered as not significant. The impact ratios were calculated using 

1417 annualized costs, because these costs are more representative of the continuing costs 

1418 entities would face to comply with this proposed rule. 

1419 EPA assumed that 5 small non-profit organizations and 4 small businesses in the 

1420 United States will participate as ABs or TPCs in the TSCA Title VI program. All of the 

1421 small non-profit organizations are expected to have cost impacts below the 1% level. 

1422 Three of the small businesses are expected to have cost impacts below the 1% level, and 

1423 one is expected to have cost impacts between 1% and 3%. So of the 9 total small entities 

1424 assumed to be affected by the final rule, 8 are expected to have impacts under 1%, and 1 

1425 is expected to have impacts between 1% and 3%. 

1426 In general, EPA strives to minimize potential adverse impacts on small entities 

1427 when developing regulations to achieve the environmental and human health protection 

1428 goals of the statute and the Agency. EPA solicits comments specifically about the 

1429 potential economic impacts that this proposed rule may impose on small entities. 
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1430 Although not required by RFA to convene a Small Business Advocacy Review 

1431 (SBAR) Panel for this particular proposed rule because EPA has determined that this 

1432 proposal would not have a significant economic impacts on a substantial number of small 

1433 entities, EPA convened a SBAR Panel to obtain advice and recommendations from small 

1434 entities representatives potentially subject to the proposed rule’s requirements. The 

1435 SBAR Panel covered the proposed regulations and the broader TSCA Title VI 

1436 implementing regulations proposal which will follow. The SBAR Panel was convened by 

1437 EPA's Small Business Advocacy Chairperson on February 3, 2011. In addition to the 

1438 chairperson, the Panel consisted of the Assistant Administrator of the Office of Chemical 

1439 Safety and Pollution Prevention, the Administrator of the Office of Information and 

1440 Regulatory Affairs within OMB, and the Chief Counsel for Advocacy of the SBA. 

1441 Seventeen potentially impacted small entities served as Small Entity 

1442 Representatives (SERs), representing a broad range of small entities from diverse 

1443 geographic locations and five association representatives. EPA hosted two meetings with 

1444 the SERs to obtain feedback. During the Pre-Panel Outreach Meeting on January 6, 2011, 

1445 and the Panel Outreach Meeting on February 17, 2011, EPA reviewed the major areas of 

1446 regulation, including options for the proposed framework of the TSCA Title VI Third1447 Party Certification Program, with the SBAR Panel and the SERs. The SBAR Panel 

1448 solicited comments from the SERs on the options presented by EPA, their experiences 

1449 with the CARB ATCM, any additional concerns they might have, and the costs of 

1450 regulatory options. Several SERs submitted written comments to EPA following the 

1451 meetings. The Panel evaluated the assembled materials and small entity comments on 

1452 issues related to the elements of an IRFA. A copy of the SBAR Panel report is included 
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1453 in the docket for this proposed rule (Ref. 27). As a result of its deliberations, the Panel 

1454 made a number of recommendations. With regards to the proposed TSCA Title VI Third1455 Party Certification Program, the Panel recommended that EPA continue to explore how it 

1456 can capitalize on the expertise of international ABs, while at the same time maintaining 

1457 control over the design and implementation of its certification system. 

1458 D. Unfunded Mandates Reform Act (UMRA) 

1459 Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for Federal 

1460 agencies to assess the effects of their regulatory actions on State, local, and tribal 

1461 governments and the private sector. This proposed rule does not contain a Federal 

1462 mandate that may result in expenditures of $100 million or more for State, local, or tribal 

1463 governments, in the aggregate, or the private sector in any 1 year. No State, local, or 

1464 tribal governments currently acts as accreditation bodies or TPCs, and none are 

1465 anticipated to do so in the future, so the proposed rule would not result in expenditures by 

1466 these government bodies. The costs of the proposed rule to the private sector are 

1467 expected to be approximately $100,000 in the first year, and significantly less costly in 

1468 subsequent years. Thus, this proposed rule is not subject to the requirements of sections 

1469 202 or 205 of UMRA. This proposed rule is also not subject to the requirements of 

1470 section 203 of UMRA because it contains no regulatory requirements that might 

1471 significantly or uniquely affect small governments. Since no State, local, or tribal 

1472 governments are expected to act as accreditation bodies or TPCs. 

1473 E. Executive Order 13132: Federalism

1474 This action does not have federalism implications because it will not have 

1475 substantial direct effects on the States, on the relationship between the national 
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1476 government and the States, or on the distribution of power and responsibilities among the 

1477 various levels of government, as specified in Executive Order 13132 (64 FR 43255, 

1478 August 10, 1999). No States are expected to act as accreditation bodies or TPCs, and 

1479 EPA would administer these requirements not the States. The proposed rule would not 

1480 impose substantial direct compliance costs on States. Furthermore, the proposed rule 

1481 would not preempt State or local law. Thus, Executive Order 13132 does not apply to this 

1482 action. Nonetheless, since California also has a program to regulate formaldehyde 

1483 emissions from composite wood products, EPA held numerous consultations with 

1484 representatives of the California Air Resources Board while developing this proposed 

1485 rule. 

1486 In the spirit of Executive Order 13132, and consistent with EPA policy to promote 

1487 communications between EPA and State and local governments, EPA specifically solicits 

1488 comments on this proposed action from State and local officials. 

1489 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

1490 Governments 

1491 

1492 This action does not have tribal implications as specified in Executive Order 

1493 13175 (65 FR 67249, November 9, 2000). No Tribes are expected to act as accreditation 

1494 bodies or TPCs, and EPA would administer these requirements not Tribes. Thus, 

1495 Executive Order 13175 does not apply to this action. EPA specifically solicits additional 

1496 comment on this proposed action from tribal officials. 

1497 G. Executive Order 13045: Protection of Protection of Children from Environmental 

1498 Health Risks and Safety Risks 

1499 

1500 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as 

1501 applying only to those regulatory actions that concern health or safety risks, such that the 
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1502 analysis required under section 5-501 of the Executive Order has the potential to 

1503 influence the regulation. This action is not subject to Executive Order 13045, because it 

1504 would not establish an environmental standard intended to mitigate health or safety risks. 

1505 H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect 

1506 Energy Supply, Distribution, or Use 

1507 

1508 This action is not a “significant energy action” as defined in Executive Order 

1509 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse 

1510 effect on the supply, distribution, or use of energy. Further, we have concluded that this 

1511 rule is not likely to have any adverse energy affects because it sets up a framework for a 

1512 TSCA Title VI Third-Party Certification Program, and does not require any action related 

1513 to the supply, distribution, or use of energy. 

1514 I. National Technology Transfer and Advancement Act (NTTAA) 

1515 Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use voluntary 

1516 consensus standards in its regulatory activities unless to do so would be inconsistent with 

1517 applicable law or otherwise impractical. Voluntary consensus standards are technical 

1518 standards (e.g., materials specifications, test methods, sampling procedures, business 

1519 practices, etc.) that are developed or adopted by voluntary consensus standards bodies. 

1520 NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency 

1521 decides not to use available and applicable voluntary consensus standards. 

1522 This proposed rule involves technical standards. EPA proposes to use voluntary 

1523 consensus standards. The proposed framework of this TSCA Title VI Third-Party 

1524 Certification Program is based on the ability of ABs to review TPCs for their conformity 

1525 to ISO/IEC Guide 65:1996(E), ISO/IEC 17025:2005(E), and ISO/IEC 17020:1998(E). 

1526 Both Product ABs and Laboratory ABs would be required to maintain their conformity to 
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1527 ISO/IEC 17011:2004(E). 

1528 EPA welcomes comments on this aspect of the proposed rule, and specifically 

1529 invites the public to identify potentially applicable voluntary consensus standards and to 

1530 explain why such standards should be used in the final rule. 

1531 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

1532 Populations and Low-Income Populations 

1533 

1534 Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal 

1535 executive policy on environmental justice. Its main provision directs federal agencies, to 

1536 the greatest extent practicable and permitted by law, to make environmental justice part 

1537 of their mission by identifying and addressing, as appropriate, disproportionately high 

1538 and adverse human health or environmental effects of their programs, policies, and 

1539 activities on minority populations and low-income populations in the United States. 

1540 EPA has determined that this proposed rule will not have disproportionately high 

1541 and adverse human health or environmental effects on minority or low-income 

1542 populations because it does not affect the level of protection provided to human health or 

1543 the environment. This action proposes a system whereby ABs accredits TPCs, and TPCs 

1544 certify composite wood products in order to ensure compliance with the emissions 

1545 standards in TSCA Title VI. This action does not relax a pollution control measure and 

1546 therefore will not cause emissions increases. 

1547 List of Subjects in 40 CFR Part 770 

1548 Environmental protection, Composite wood products, Formaldehyde, Reporting 

1549 and recordkeeping, Third-party certification. 

1550 

1551 Dated: ____________________ 
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1552 

1553 _________________________________________________ 

1554 

1555 Administrator. 

1556 

1557 

1558 

1559 

1560 

1561 

1562 

1563 

1564 

1565 

1566 

1567 

1568 

1569 

1570 

1571 

1572 

1573 

1574 Therefore, it is proposed that 40 CFR chapter I, subchapter R, be amended by 
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1575 adding a new part 770 to read as follows: 

1576 PART 770--FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD 

1577 PRODUCTS 

1578 

1579 Subpart A--General Provisions

1580 Sec. 

1581 770.1 Scope and applicability. 

1582 770.2 Effective dates. 

1583 770.3 Definitions. 

1584 Subpart B--Third-Party Certification Program

1585 770.7 Third-party certification. 

1586 770.9 Prohibited acts. 

1587 Subpart C--[Reserved] 

1588 Subpart D--Incorporation by Reference 

1589 770.99 Incorporation by reference.

1590 Authority: 15 U.S.C. 2697(d). 

1591 Subpart A--General Provisions

1592 § 770.1 Scope and applicability.

1593 (a) This subpart applies to: 

1594 (1) Laboratory Accreditation Bodies (ABs) and Product ABs that are accrediting 

1595 third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 2697(d)) purposes and those 

1596 that wish to commence accrediting third-party certifiers for TSCA Title VI purposes.

1597 (2) TPCs that are certifying composite wood products for TSCA Title VI 

1598 compliance and those that wish to commence certifying composite wood products for 

1599 TSCA Title VI compliance. 
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1600 (b) [Reserved] 

1601 § 770.2 Effective dates. 

1602 (a) Laboratory and Product ABs that wish to accredit TPCs for TSCA Title VI 

1603 purposes may apply to EPA to become recognized beginning on [date of publication of 

1604 the final rule in the Federal Register]. Laboratory and Product ABs must be recognized 

1605 by EPA before they begin providing TSCA Title VI accreditation services. 

1606 (b) TPCs that wish to provide TSCA Title VI certification services must meet all 

1607 the requirements of this subpart before they commence providing TSCA Title VI 

1608 certification services. 

1609 (c) Notwithstanding any other provision of this subpart, TPCs that are approved 

1610 by the California Air Resources Board to certify composite wood products have until 

1611 [date 1 year after date of publication of the final rule in the Federal Register] to become 

1612 accredited pursuant to the requirements of this subpart. During the year following [date of 

1613 publication of the final rule in the Federal Register], the California Air Resources 

1614 Board-approved TPCs may carry out certification activities under TSCA Title VI, 

1615 provided that they are compliant with all other aspects of TSCA Title VI and the 

1616 regulations promulgated thereunder. Third-party certifiers that are certifying products as 

1617 compliant with TSCA Title VI are subject to enforcement actions for any violations of 

1618 TSCA Title VI or the regulations promulgated thereunder. 

1619 § 770.3 Definitions.

1620 Accreditation Body or AB means an organization that provides an impartial 

1621 verification of the competency of conformity assessment bodies such as TPCs. 
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1622 Composite wood product means hardwood plywood, medium-density fiberboard, 

1623 and particleboard. 

1624 EPA Recognized Laboratory Accreditation Body or EPA Recognized Laboratory 

1625 AB means a Laboratory AB that has a recognition agreement with EPA under the TSCA 

1626 Title VI Third-Party Certification Program. 

1627 EPA Recognized Product Accreditation Body or EPA Recognized Product AB

1628 means a Product AB that has a recognition agreement with EPA under the TSCA Title VI 

1629 Third-Party Certification Program. 

1630 Laboratory Accreditation Body or Laboratory AB means an accreditation body 

1631 that accredits laboratories to ISO/IEC 17025:2005(E) (incorporated by reference, see § 

1632 770.99). 

1633 Panel producer means a manufacturing plant or other facility that manufactures 

1634 (excluding imports) hardwood plywood, particle board, or medium density fiberboard. 

1635 Product Accreditation Body or Product AB means an accreditation body that 

1636 accredits conformity assessment bodies to ISO/IEC Guide 65:1996(E) (incorporated by 

1637 reference, see § 770.99) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 

1638 770.99). 

1639 TSCA Title VI Accredited Third-Party Certifier or TSCA Title VI Accredited TPC

1640 means an organization or entity that is accredited by an EPA recognized Product AB and 

1641 an EPA recognized Laboratory AB pursuant to § 770.7 (c)(1).

1642 Subpart B—TSCA Title VI Third-Party Certification Program 

1643 § 770.7 Third-party certification. 

1644 (a) Product ABs--(1) Qualifications. To apply to be recognized by EPA as a 
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1645 Product AB, a candidate Product AB must: 

1646 (i) Be a signatory to the International Accreditation Forum, Inc.’s (IAF) 

1647 Multilateral Recognition Arrangement (MLA) through level 3, or an equivalent 

1648 organization. 

1649 (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference, 

1650 see § 770.99) and maintain that conformity. 

1651 (iii) Demonstrate basic competence to perform accreditation activities for product 

1652 certification according to ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 

1653 770.99). 

1654 (iv) Demonstrate competence to perform accreditation activities for inspection 

1655 certification according to ISO/IEC 17020:1998(E) (incorporated by reference, see § 

1656 770.99). 

1657 (2) Recognition. To be recognized by EPA, a Product AB must apply to EPA by 

1658 fulfilling the requirements in the paragraphs (a)(2)(i)-(ii) of this section: 

1659 (i) Submitting an application to the EPA with the following information: 

1660 (A) Name, address, telephone number, and email address of primary contact. 

1661 (B) Documentation of its IAF MLA signatory status, or equivalent. 

1662 (C) If not a domestic entity, name and address of an agent for service located in 

1663 the United States. Service on this agent constitutes service on the AB or any of its 

1664 officers or employees for any action by EPA or otherwise by the United States related to 

1665 the requirements of this subpart. 

1666 (D) Description of any other qualifications related to its experience in performing 

1667 product accreditation of conformity assessment bodies or TPCs of manufactured 
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1668 products. 

1669 (ii) Entering into a recognition agreement with EPA that describes the Product 

1670 AB’s responsibilities under this subpart. 

1671 (A) Each recognition agreement will be valid for 3 years. 

1672 (B) To renew a recognition agreement for additional 3 year periods, the Product 

1673 AB must submit an application for renewal (before the 3 year period of the recognition 

1674 agreement lapses) that indicates any changes from the Product AB’s initial application. 

1675 (C) If a Product AB fails to submit an application for renewal prior to the 

1676 expiration of the previous recognition agreement, its recognition will lapse and the 

1677 Product AB may not provide TSCA Title VI accreditation services. 

1678 (D) If the Product AB does submit an application for renewal prior to the 

1679 expiration of the previous recognition agreement, it may continue to provide TSCA Title 

1680 VI accreditation services under the terms of its previous recognition agreement until EPA 

1681 has taken action on its application for renewal of the recognition agreement. 

1682 (3) Responsibilities. EPA recognized Product ABs must fulfill the requirements in 

1683 paragraphs (a)(3)(i)-(xiv) of this section: 

1684 (i) Receive and act on applications for accreditation from TPCs. 

1685 (ii) Assign a unique number to each accredited TPC. 

1686 (iii) Forward a copy of a TPC’s application for TSCA Title VI accreditation to 

1687 EPA at the address identified in the recognition agreement within 90 days of the date of 

1688 receipt. 

1689 (iv) Perform an in-depth systems audit, as described in this unit, on each TPC 

1690 applicant who submits a complete application at the time of initial application. The 
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1691 systems audit must include the components described in paragraphs (3)(iv)(A)-(F) of this 

1692 section: 

1693 (A) An on-site assessment by the Product AB to determine whether the TPC 

1694 applicant’s program requirements are consistent with ISO/IEC Guide 65:1996(E) and 

1695 ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99). The Product AB must 

1696 develop a checklist that lists all of the key conformity elements of ISO/IEC Guide 

1697 65:1996(E) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99) and 

1698 the Product ABs must use the checklist for each on-site assessment. 

1699 (B) A review of the approach that the TPC applicant will use to verify the 

1700 accuracy of the formaldehyde emissions tests conducted by the TPC laboratory or 

1701 contract laboratory and the formaldehyde quality control tests conducted by the panel 

1702 producers producing composite wood products that are subject to the requirements of 

1703 TSCA Title VI. 

1704 (C) A review of the approach that the TPC applicant will use for evaluating a 

1705 panel producer’s quality assurance and quality control processes, the qualifications of the 

1706 panel producer’s quality assurance and quality control personnel, the required elements of 

1707 a panel producer’s quality assurance and quality control manual, and sufficiency of on1708 site testing facilities as applicable. 

1709 (D) A review of the approach that the TPC applicant’s laboratory will use for 

1710 establishing correlation or equivalence between alternative formaldehyde test methods 

1711 and ASTM E1333-10 (incorporated by reference, see § 770.99). 
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1712 (E) A review of the approach that the TPC applicant will use for evaluating the 

1713 process for sample selection, handling, and shipping procedures, if applicable, that the 

1714 panel producer will use for quality control testing. 

1715 (F) A review of the accreditation credentials of the laboratory that the TPC 

1716 applicant will use. The review must ensure that the laboratory has been accredited to 

1717 ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99) by a Laboratory AB 

1718 that is a signatory to the ILAC MRA or equivalent. 

1719 (v) Upon request, allow EPA representatives to accompany its assessors during an 

1720 on-site assessment to observe the audit of a TPC. 

1721 (vi) Accredit TPCs that submit a complete application as described in § 

1722 770.7(c)(1)(i) and that meet the requirements of § 770.7(c). 

1723 (vii) Conduct a follow-up systems audit, including an on-site assessment, of each 

1724 TPC that the AB has accredited at least every 2 years. 

1725 (viii) Suspend, modify, or revoke the accreditation of a TPC in accordance with § 

1726 770.7(e). 

1727 (ix) Provide written notifications to EPA at the address identified in the 

1728 recognition agreement, as follows: 

1729 (A) Notification of loss of its status as a signatory to the IAF MLA (or 

1730 membership in an equivalent organization) must be provided to EPA within 5 business 

1731 days of the date that the body receives notification of the loss of its signatory status. 

1732 (B) Notification of the TSCA Title VI accreditation of a TPC must be provided to 

1733 EPA within 5 business days of the date that the TPC is accredited. 

1734 (C) Notification that an accredited TPC has failed to comply with any provision 
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1735 of this section must be provided to EPA within 24 hours of the time the Product AB 

1736 identifies the failure. 

1737 (D) Notification of suspension or revocation of a TPC’s accreditation must be 

1738 provided to EPA within 24 hours of the time that the suspension or revocation takes 

1739 effect. 

1740 (E) Notification of a decision to make changes in its organizational policies or 

1741 management structure that could adversely affect the TPC accreditation program must be 

1742 provided to EPA within 30 days of the decision to make the changes. 

1743 (x) If the Product AB is removed or withdraws from the TSCA Title VI Third1744 Party Certification Program, notification must be given to all of the TPCs that receive its 

1745 accreditation services within 5 business days. 

1746 (xi) Maintain the checklists and other records documenting compliance with the 

1747 requirements for systems audits and on-site assessments of TPCs for as long as the TPC 

1748 is accredited or for 5 years, whichever is longer. These records must be in electronic 

1749 form, and the Product AB must provide them to EPA within 30 days upon request. 

1750 (xii) Provide a report to EPA at least once each year (12 months from the 

1751 anniversary of the date of the recognition agreement), that includes the number and 

1752 locations of systems audits and on-site assessments performed. 

1753 (xiii) Meet with EPA at least once every 2 years to discuss the implementation of 

1754 the TPC accreditation program. 

1755 (xiv) Allow inspections by EPA, conducted at reasonable times, within reasonable 

1756 limits, and in a reasonable manner, upon the presentation of appropriate credentials and a 

1757 written notification to the Product AB. 
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1758 (b) Laboratory ABs--(1) Qualifications. To apply to be recognized by EPA as a 

1759 Laboratory AB, a candidate Laboratory AB must: 

1760 (i) Be a signatory to the ILAC MRA, or an equivalent organization. 

1761 (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference. 

1762 see § 770.99) and maintain that conformity. 

1763 (iii) Demonstrate competence to perform accreditation activities for laboratory 

1764 accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see § 

1765 770.99). 

1766 (2) Recognition. To be recognized by EPA, a Laboratory AB must apply to EPA 

1767 by fulfilling the requirements in paragraphs (b)(2)(i)-(ii) of this section: 

1768 (i) Submit an application to the EPA with the information listed in paragraphs 

1769 (b)(2)(i)(A)-(D) of this section (if the accreditation body is also applying to be recognized 

1770 as a Product AB, this application may be submitted in conjunction with the Product AB 

1771 application): 

1772 (A) Name, address, telephone number, and email address of primary contact. 

1773 (B) Documentation of ILAC MRA signatory status, or equivalent. 

1774 (C) If not a domestic entity, name and address of an agent for service located in 

1775 the United States. Service on this agent constitutes service on the AB or any of its 

1776 officers or employees for any action by EPA or otherwise by the United States related to 

1777 the requirements of this subpart. 

1778 (D) Description of any other qualifications related to the Laboratory AB’s 

1779 experience in performing laboratory accreditation and inspection certification of 

1780 conformity assessment bodies or TPCs. 
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1781 (ii) Enter into a recognition agreement with EPA that describes the Laboratory 

1782 AB’s responsibilities under this subpart. 

1783 (A) Each recognition agreement will be valid for 3 years. 

1784 (B) To renew a recognition agreement for additional 3 year periods, the 

1785 Laboratory AB must submit an application for renewal (before the 3 year period of the 

1786 recognition agreement lapses) that indicates any changes from the Laboratory AB’s 

1787 initial application. 

1788 (C) If the Laboratory AB does submit an application for renewal prior to the 

1789 expiration of the previous recognition agreement, it may continue to provide TSCA Title 

1790 VI accreditation services under the terms of its previous recognition agreement until EPA 

1791 has taken action on its application for renewal of the recognition agreement. 

1792 (3) Responsibilities. EPA recognized Laboratory ABs must fulfill the 

1793 requirements in paragraphs (b)(3)(i)-(xiii) of this section: 

1794 (i) Receive and act on applications for laboratory accreditation from TPC 

1795 laboratories (including contract laboratories). 

1796 (ii) Within 15 days of a request by a TPC or their EPA recognized Product AB, 

1797 forward copies of a TPC’s TSCA Title VI laboratory application and accreditation 

1798 documentation to the applicable EPA recognized Product AB (if the Laboratory AB is 

1799 not also recognized as a Product AB) at the address identified by the TPC. 

1800 (iii) Perform an in-depth systems audit on the laboratory of each TPC applicant 

1801 who submits a complete application at the time of initial application. The systems audit 

1802 must include: 

1803 (A) An on-site assessment by the Laboratory AB to determine whether the TPC 
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1804 applicant’s laboratory is consistent with all regulatory requirements and ISO/IEC 

1805 17025:2005(E) (incorporated by reference, see § 770.99). 

1806 (B) Include a checklist that lists all of the key conformity elements of ISO/IEC 

1807 17025:2005(E) (incorporated by reference, see § 770.99) and the Laboratory AB’s 

1808 assessors must use the checklist for each on-site assessment. 

1809 (iv) Upon request, allow EPA representatives to accompany its assessors during 

1810 an on-site assessment to observe the audit of a TPC. 

1811 (v) Accredit laboratories that submit a complete application as described in 

1812 § 770.7(c)(1)(ii) and that continue to meet the requirements of § 770.7(c). 

1813 (vi) Verify the accuracy of the formaldehyde emissions tests conducted by the 

1814 TPC laboratory through an inter-laboratory comparison or proficiency testing program if 

1815 available. 

1816 (vii) Conduct a follow-up systems audit at least every 2 years, including an on-site 

1817 assessment, of each TPC laboratory that the accreditation body has accredited. TPCs’ 

1818 laboratories that have not adequately performed an inter-laboratory comparison or 

1819 proficiency testing must be audited at least once each year for a period of 2 years from 

1820 the date of the latest poor proficiency test or inter-laboratory comparison. 

1821 (viii) Suspend, modify, or revoke the accreditation of TPCs’ laboratories in 

1822 accordance with § 770.7(e). 

1823 (ix) Provide the following written notifications to EPA and to the applicable EPA 

1824 recognized Product AB (if the Laboratory AB is not also recognized as a Product AB) at 

1825 the address identified in the recognition agreement: 

1826 (A) Notification of loss of its status as a signatory to the ILAC MRA, or 
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1827 membership in an equivalent organization, must be provided within 5 business days of 

1828 the date that the body receives notice of the loss of its signatory status. 

1829 (B) Notice of accreditation of a TPC’s laboratory must be provided within 5 

1830 business days of the date that the laboratory is accredited. 

1831 (C) Notice that an accredited laboratory has failed to comply with any provision 

1832 of this section must be provided within 24 hours of the time the Laboratory AB identifies 

1833 the failure. 

1834 (D) Notice that an accredited TPC has failed to comply with any provision of this 

1835 section must be provided within 24 hours of the time the Laboratory AB identifies the 

1836 failure. 

1837 (E) Notice of a decision to make changes in its organizational policies or 

1838 management structure that could adversely affect the laboratory accreditation program 

1839 must be provided to EPA within 30 days of the decision to make the changes. 

1840 (F) Notice if the Laboratory AB suspends or revokes a laboratory’s accreditation 

1841 must be provided within 24 hours of the time that the suspension or revocation takes 

1842 effect. 

1843 (x) Maintain checklists and other records documenting compliance with the 

1844 requirements for systems audits and on-site assessments of laboratories must be retained 

1845 for as long as the laboratory is accredited or for 5 years, whichever is longer. These 

1846 records must be in electronic form and provided to EPA within 30 days of request. 

1847 (xi) Provide a report to EPA at least once each year (12 months from the date of 

1848 the recognition agreement) that includes the following information: 

1849 (A) The names and contact information of all the TSCA Title VI accredited TPC 
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1850 laboratories. 

1851 (B) Number and locations of systems audits and on-site assessments performed. 

1852 (C) Results of inter-laboratory comparisons or proficiency testing for each of the 

1853 AB’s TSCA Title VI accredited TPC laboratories, if such an EPA recognized inter1854 laboratory comparisons or proficiency testing program is available. 

1855 (xii) Meet with EPA at least once every 2 years to discuss the implementation of 

1856 the laboratory accreditation program. 

1857 (xiii) Allow inspections by EPA, conducted at reasonable times, within reasonable 

1858 limits, and in a reasonable manner, upon the presentation of appropriate credentials and 

1859 written notice to the laboratory accreditation body. 

1860 (c) Third-party certifiers--(1) Qualifications. In order to participate as a TPC of 

1861 composite wood products under TSCA Title VI, a TPC must apply to an EPA recognized 

1862 Product AB. In its application the TPC must demonstrate that it has been accredited by an 

1863 EPA recognized Laboratory AB, unless the TPC is applying to an EPA recognized 

1864 Product AB that is also an EPA recognized Laboratory AB and the TPC is seeking both 

1865 accreditations from this single AB. In such a case, the TPC will obtain the required 

1866 product and laboratory accreditations pursuant to ISO/IEC Guide 65:1996(E) and 

1867 ISO/IEC 17025:2005(E), respectively, from the EPA recognized Product AB. 

1868 (i) To participate in the TSCA Title VI Third-Party Certification Program, a TPC 

1869 must submit an application to an EPA recognized Product AB every 2 years that includes 

1870 the elements in paragraphs (c)(1)(i)(A)-(D) of this section: 

1871 (A) Name, address, telephone number, and email address of primary contact. 
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1872 (B) If not a domestic entity, name and address of an agent for service located in 

1873 the United States. Service on this agent constitutes service on the TPC or any of its 

1874 officers or employees for any action by EPA or otherwise by the United States related to 

1875 the requirements of this subpart. 

1876 (C) Type of composite wood products that the applicant intends to certify if 

1877 accredited. 

1878 (D) Description of the TPC’s qualifications, including indications that the TPC 

1879 has: 

1880 (1) Experience or ability in product certification and complying with ISO/IEC 

1881 Guide 65:1996(E) (incorporated by reference, see § 770.99). 

1882 (2) Experience in the composite wood product industry with the specific 

1883 product(s) the applicant intends to certify. 

1884 (3) Ability to conduct inspections and properly train and supervise inspectors 

1885 pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99). 

1886 (ii) To be accredited by a laboratory accreditation body under TSCA Title VI, a 

1887 TPC or its laboratories must submit an application to an EPA recognized Laboratory AB 

1888 every 2 years that includes the elements in paragraphs (c)(1)(ii)(A)-(C) of this section: 

1889 (A) Name, address, telephone number, and email address of primary contact. 

1890 (B) If not a domestic entity, name and address of an agent for service located in 

1891 the United States. Service on this agent constitutes service on the TPC or any of its 

1892 officers or employees for any action by EPA or otherwise by the United States related to 

1893 the requirements of this subpart. 
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1894 (C) Description of the TPC’s laboratory’s qualifications, including indications 

1895 that the TPC’s laboratory has: 

1896 (1) Experience in performing or verifying formaldehyde testing on composite 

1897 wood products. 

1898 (2) Experience complying with ISO/IEC 17025:2005(E) (incorporated by 

1899 reference, see § 770.99). 

1900 (3) Experience with test method ASTM E1333-10 (incorporated by reference, see 

1901 § 770.99) and experience evaluating correlation between test methods. 

1902 (2) Responsibilities. To maintain participation in the TPC TSCA Title VI 

1903 program, TSCA Title VI accredited TPCs must fulfill the requirements in 

1904 paragraphs(c)(2)(i)-(xvi) of this section: 

1905 (i) Verify that panel producers have adequate quality assurance and quality 

1906 control procedures and are complying with applicable quality assurance and quality 

1907 control requirements pursuant to TSCA Title VI, including the requirements of this 

1908 subpart. 

1909 (ii) Verify quality control test results compared with ASTM E1333-10 

1910 (incorporated by reference, see § 770.99) test results by having TPC laboratories conduct 

1911 quarterly tests and evaluate test method equivalence. 

1912 (iii) Review applications from panel producers for reduced testing, approve an 

1913 application within 90 days of receipt if it demonstrates that the requirements for reduced 

1914 testing under TSCA Title VI are met, and notify EPA of all approvals for reduced testing 

1915 within 5 days of the approval, and forward copies of all approved applications for 

1916 reduced test to EPA within 30 days of receipt. 
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1917 (iv) Establish quality control limits in consultation with panel producers and, if 

1918 applicable, shipping quality control or other limits for each panel producer, product type, 

1919 and production line. 

1920 (v) Establish for each panel producer the process that will be used to determine if 

1921 product lots are exceeding the applicable quality control limit. 

1922 (vi) Inspect and audit panel producers and products and their records at least 

1923 quarterly and pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 

1924 770.99). 

1925 (vii) Use only laboratories that have been accredited by an EPA recognized 

1926 Laboratory AB and participate in an EPA-approved inter-laboratory comparison or 

1927 proficiency testing program and ensure the results of the EPA-approved inter-laboratory 

1928 comparison or proficiency testing program are provided to the Laboratory AB. 

1929 (viii) Certify composite wood product types that comply with the emission 

1930 standards of TSCA Title VI and this subpart, following ISO/IEC Guide 65:1996(E) 

1931 (incorporated by reference, see § 770.99). 

1932 (ix) Provide its accreditation number to the panel producer for labeling and 

1933 recordkeeping. 

1934 (x) Maintain the following records, in electronic form, for 5 years from the date 

1935 the record is created, and provide them to EPA within 30 days of the request: 

1936 (A) A list of panel producers and their respective product types, including resins 

1937 used, that the TPC has certified. 

1938 (B) Results of inspections, audits, and emission tests conducted for and linked to 

1939 each panel producer and product type. 
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1940 (C) A list of laboratories used by the TPC, as well as test methods, including test 

1941 conditions and conditioning time, and test results. 

1942 (D) Methods and results for establishing test method correlations and equivalence. 

1943 (xi) Provide an annual report to its accreditation body or bodies (Product AB and 

1944 Laboratory AB) and to EPA that contains the following: 

1945 (A) A list of panel producers and their products that the TPC has certified during 

1946 the previous year, including resins used and the average and range of formaldehyde 

1947 emissions by panel producer, resin, and product type. 

1948 (B) A list of any non-complying products or events by panel producers. 

1949 (C) A list of laboratories and test methods used by the TPC. 

1950 (xii) Inform its accreditation body or bodies (Product AB and Laboratory AB) 

1951 within 30 days of any changes in personnel qualifications, procedures, or laboratories 

1952 used by the TPC. 

1953 (xiii) Allow inspections by EPA, conducted at reasonable times, within reasonable 

1954 limits, and in a reasonable manner, upon the presentation of appropriate credentials and 

1955 of a written notice to the TPC. 

1956 (xiv) If not a domestic entity, the TPC must maintain an agent for service located 

1957 in the United States and notify EPA of any changes in the name or address of that agent 

1958 within 5 business days. 

1959 (xv) Participate an inter-laboratory comparison or proficiency testing program 

1960 annually, or use only contract laboratories that participate in such a program. 

1961 (xvi) If a TPC or its laboratory loses its accreditation or discontinues participation 

1962 in the program for any reason, it must notify EPA and all the panel producers it provides 
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1963 TSCA Title VI certification services to within 3 business days. 

1964 (d) Third-party certifiers approved by the California Air Resources Board. TPCs 

1965 approved by the California Air Resources Board as of [date 60 days after date of 

1966 publication of the final rule in the Federal Register] may certify composite wood 

1967 products under TSCA Title VI until [date 1 year after date of publication of the final rule 

1968 in the Federal Register] as long as they remain approved by the California Air 

1969 Resources Board for that period and comply with all aspects of this subpart other than the 

1970 accreditation requirements of paragraph (c)(1) of this section. In lieu of the accreditation 

1971 number required to be provided according to paragraph (c)(2)(ix) of this section, a TPC 

1972 approved by CARB according to this section must provide the panel producer with the 

1973 TPC number issued by CARB. For a TPC approved by CARB according to this section, 

1974 the annual report under paragraph (c)(2)(xi) of this section must be provided to CARB in 

1975 lieu of the AB. After [date 1 year after date of publication of the final rule in the Federal 

1976 Register], no TPC may certify composite wood products under TSCA Title VI unless the 

1977 TPC is accredited in accordance with paragraph (c)(1) of this section. 

1978 (e) Suspension, revocation, or modification of recognition or accreditation--(1) 

1979 Third-party certifiers. EPA or an AB may suspend, revoke, or modify the accreditation of 

1980 a TPC or a TPC laboratory, if the TPC or TPC laboratory: 

1981 (i) Fails to comply with any requirement of TSCA Title VI or this subpart; 

1982 (ii) Makes any false or misleading statements on its application, records, or 

1983 reports; or 

1984 (iii) Makes substantial changes to personnel qualifications, procedures, or 

1985 laboratories that make the TPC or TPC laboratory unable to comply with any applicable 
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1986 requirements of this subpart. 

1987 (2) ABs. EPA may suspend, revoke, or modify the recognition of an AB if the AB: 

1988 (i) Fails to comply with the requirements of the applicable recognition 

1989 agreement(s) (the International Accreditation Forum Multilateral Recognition 

1990 Arrangement and the International Laboratory Accreditation Cooperation Mutual 

1991 Recognition Agreement or equivalent(s)); 

1992 (ii) Fails to comply with any requirement of TSCA Title VI or this subpart; 

1993 (iii) Makes any false or misleading statements on its application, records, or 

1994 reports; or 

1995 (iv) Makes substantial changes to personnel qualifications or procedures that 

1996 make the TPC unable to comply with any applicable requirements of this subpart. 

1997 (3) Process for suspending, revoking, or modifying accreditation or recognition.

1998 (i) Prior to taking action to suspend, revoke, or modify accreditation or 

1999 recognition, EPA or the accreditation body will notify the recognized AB or the 

2000 accredited TPC or TPC laboratory in writing of the following: 

2001 (A) The legal and factual basis for the proposed suspension, revocation, or 

2002 modification. 

2003 (B) The anticipated commencement date and duration of the suspension, 

2004 revocation, or modification. 

2005 (C) Actions, if any, which the affected AB or TPC or TPC laboratory may take to 

2006 avoid suspension, revocation, or modification, or to receive accreditation in the future. 

2007 (D) The opportunity and method for requesting a hearing with EPA prior to final 

2008 suspension, revocation, or modification. 
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2009 (ii) If the affected AB or TPC or TPC laboratory requests a hearing in writing to 

2010 EPA within 30 days of receipt of the notification, EPA will: 

2011 (A) Provide the affected accreditation body or TPC or TPC laboratory an 

2012 opportunity to offer written statements in response to EPA’s or the accreditation body’s 

2013 assertions of the legal and factual basis for the proposed action. 

2014 (B) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 

2015 The Presiding Officer will: 

2016 (1) Conduct a fair, orderly, and impartial hearing within 90 days of the request for 

2017 a hearing. 

2018 (2) Consider all relevant evidence, explanation, comment, and argument 

2019 submitted. 

2020 (3) Notify the affected AB or TPC or TPC laboratory in writing within 90 days of 

2021 completion of the hearing of his or her decision and order. Such an order is a final EPA 

2022 action which may be subject to judicial review. The order must contain the basis, 

2023 commencement date, and duration of the suspension, revocation, or modification. 

2024 (iii) If EPA determines that the public health, interest, or welfare warrants 

2025 immediate action to suspend the recognition of an AB or the accreditation of a TPC or 

2026 TPC laboratory prior to the opportunity for a hearing, it will notify the affected AB, TPC, 

2027 or TPC laboratory of its right to request a hearing on the immediate suspension within 15 

2028 days of the suspension taking place and the procedures for the conduct of such a hearing. 

2029 (iv) Any notification, decision, or order issued by EPA under this section, any 

2030 transcript or other verbatim record of oral testimony, and any documents filed by a 

2031 certified individual or firm in a hearing under this section will be available to the public, 
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2032 except as otherwise provided by TSCA section 14. Any such hearing at which oral 

2033 testimony is presented will be open to the public, except that the Presiding Officer may 

2034 exclude the public to the extent necessary to allow presentation of information which 

2035 may be entitled to confidential treatment under TSCA section 14. 

2036 (v) EPA will maintain a publicly available list of accreditation bodies whose 

2037 recognition has been suspended, revoked, modified, or reinstated and a publicly available 

2038 list of TPCs and laboratories whose accreditation has been suspended, revoked, modified, 

2039 or reinstated. 

2040 (vi) Unless the decision and order issued under this paragraph (d)(3) of this 

2041 section specify otherwise, an AB whose recognition has been revoked or a TPC or TPC 

2042 laboratory whose accreditation has been revoked must reapply for recognition or 

2043 accreditation after the revocation ends in order to become recognized or accredited under 

2044 this subpart again. 

2045 (vii) Unless the decision and order issued under paragraph (d)(3) of this section 

2046 specifies otherwise, an AB whose recognition has been revoked or a TPC or TPC 

2047 laboratory whose accreditation has been revoked, must immediately notify all TPCs or 

2048 panel producers to which it provides TSCA Title VI accreditation or certification services 

2049 of the revocation. 

2050 (f) Process for denying a TSCA Title VI accreditation--(1) Upon denying to 

2051 accredit a TPC or a TPC laboratory for failure to submit a complete application, the 

2052 accreditation body will notify the TPC or TPC laboratory in writing of the following: 

2053 (i) The legal and factual basis for the denial. 

2054 (ii) Actions, if any, which the affected TPC or TPC laboratory may take to receive 
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2055 accreditation in the future. 

2056 (iii) The opportunity and method for requesting a hearing with EPA. 

2057 (2) If the affected TPC or TPC laboratory requests a hearing in writing to EPA 

2058 within 30 days of receipt of the notice, EPA will: 

2059 (i) Provide the affected TPC or TPC laboratory an opportunity to offer written 

2060 statements in response to the legal and factual basis for the denial. 

2061 (ii) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 

2062 The Presiding Officer will: 

2063 (A) Conduct a fair, orderly, and impartial hearing within 90 days of the request 

2064 for a hearing. 

2065 (B) Consider all relevant evidence, explanation, comment, and argument 

2066 submitted. 

2067 (C) Notify the affected TPC or TPC laboratory in writing within 90 days of 

2068 completion of the hearing of his or her decision and order. Such an order is a final agency 

2069 action which may be subject to judicial review. The order must contain the basis for the 

2070 denial. 

2071 (3) Any notification , decision, or order issued by EPA under this section, any 

2072 transcript or other verbatim record of oral testimony, and any documents filed by a 

2073 certified individual or firm in a hearing under this section will be available to the public, 

2074 except as otherwise provided by TSCA section 14. Any such hearing at which oral 

2075 testimony is presented will be open to the public, except that the Presiding Officer may 

2076 exclude the public to the extent necessary to allow presentation of information which 

2077 may be entitled to confidential treatment under TSCA section 14. 
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2078 (g) Process of seeking alternate accreditations or certifications--(1) If AB is 

2079 removed or withdraws from the TSCA Title VI Third-Party Certification Program: 

2080 (i) For reasons other than fraud or providing false or misleading statements, or 

2081 other than a reason that implicates a particular TPC in a violation of TSCA Title VI or its 

2082 implementing regulations, TPCs accredited by that AB have 365 days, or 180 days if less 

2083 than 365 days were left on their 2 year accreditation period, to be accredited again by an 

2084 alternate EPA recognized AB. 

2085 (ii) Due to fraud or providing false or misleading statements with respect to a 

2086 particular TPC, or for any other reason that implicates a particular TPC in a violation of 

2087 TSCA Title VI or its implementing regulations, that TPC may not provide any TSCA 

2088 Title VI certification services until it has been accredited by an alternate EPA recognized 

2089 AB. 

2090 (2) If a TPC loses its accreditation or discontinues participation in the program: 

2091 (i) For reasons other than fraud or providing false or misleading statements, or 

2092 other than a reason that implicates a particular panel producer in a violation of TSCA 

2093 Title VI or its implementing regulations, the panel producers that used the TPC to certify 

2094 their products must enlist another TPC to certify their products within 3 months (90 days) 

2095 . During the time a panel producer is seeking a new TPC, it must continue to comply with 

2096 all other requirements of TSCA Title VI and its implementing regulations, including 

2097 quality control testing. 

2098 (ii) Due to fraud or providing false or misleading statements with respect to a 

2099 particular panel producer, or for any other reason that implicates a particular panel 

2100 producer in a violation of TSCA Title VI or its implementing regulations, that panel 
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2101 producer may not offer regulated composite wood products for sale in the United States 

2102 until its composite wood products have been recertified by another TPC. 

2103 § 770.9 Prohibited Acts.

2104 (a) Failure or refusal to comply with any requirement of TSCA section 601 (15 

2105 U.S.C. 2697) or this subpart part is a violation of TSCA section 15 (15 U.S.C. 2614). 

2106 (b) Failure or refusal to establish and maintain records or to make available or 

2107 permit access to or copying of records, as required by this subpart, is a violation of TSCA 

2108 section 15 (15 U.S.C. 2614). 

2109 (c) Violators may be subject to civil and criminal sanctions pursuant to TSCA 

2110 section 16 (15 U.S.C. 2615) for each violation. 

2111 Subpart C--[Reserved] 

2112 Subpart D--Incorporation by reference 

2113 § 770.99 Incorporation by reference. 

2114 The materials listed in this section are incorporated by reference into this part 

2115 with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 

2116 CFR part 51. To enforce any edition other than that specified in this section, a document 

2117 must be published in the Federal Register and the material must be available to the 

2118 public. All approved materials are available for inspection at the OPPT Docket in the 

2119 EPA Docket Center (EPA/DC) at Rm. 3334, EPA, West Bldg., 1301 Constitution Ave., 

2120 NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 

2121 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 

2122 number of the EPA/DC Public Reading room is (202) 566-1744, and the telephone 

2123 number for the OPPT Docket is (202) 566-0280. In addition, these materials are 
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2124 available for inspection at the National Archives and Records Administration (NARA). 

2125 For information on the availability of this material at NARA, call (202) 741-6030 or go to 

2126 http://www.archives.gov/federal_register/code_of_federal_regulations/ 

2127 ibr_locations.html. These materials may also be obtained from the sources listed in this 

2128 section. 

2129 (a) [Reserved] 

2130 (b) ASTM material. Copies of these materials may be obtained from ASTM 

2131 International, 100 Barr Harbor Dr., PO Box C700, West Conshohocken, PA, 19428-2959, 

2132 or by calling (877) 909-ASTM, or at http://www.astm.org. 

2133 (1) ASTM D6007-02 ( Reapproved 2008) , October 1, 2008, Standard Test 

2134 Method for Determining Formaldehyde Concentrations in Air from Wood Products 

2135 Using a Small-Scale Chamber, IBR approved for § 770.7(a)-(c). 

2136 (2) ASTM D5582-00 (Reapproved 2006), October 1, 2006, Standard Test Method 

2137 for Determining Formaldehyde Levels from Wood Products Using a Desiccator, IBR 

2138 approved for § 770.7(a)-(c). 

2139 (3) ASTM E1333-10 (Approved May 1, 2010), Standard Test Method for 

2140 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 

2141 Products Using a Large Chamber, IBR approved for § 770.7(a)-(c). 

2142 (c) ISO material. Copies of these materials may be obtained from the 

2143 International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 

2144 Geneve 20, Switzerland, or by calling +41-22-749-01-11, or at http://www.iso.org. 

2145 (1) ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements for 

2146 Accreditation Bodies Accrediting Conformity Assessment Bodies (First Edition) 
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2147 February 15, 2005, IBR approved for § 770.7(a)-(c). 

2148 (2) ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types 

2149 of Bodies Performing Inspections (First Edition), November 15, 1998, IBR approved for 

2150 § 770.7(a)-(c). 

2151 (3) ISO/IEC 17025:2005(E), General Requirements for the Competence of 

2152 Testing and Calibration Laboratories (Second Edition), May 15, 2005, IBR approved for 

2153 § 770.7(a)-(c). 

2154 (4) ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 

2155 Product Certification Systems (First Edition), 1996, IBR approved for § 770.7(a)-(c). 

2156 ##