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1 EO12866_RIN2070-AJ44_Formaldehyde-TPCs-NPRM_Redline_Revisions_2012-09-21.docx 

2 Revised to address Interagency Comments received under EO 12866 Review.

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. Executive Summary

134 1. Purpose of the regulatory action. EPA is proposing a framework for a Toxic 

135 Substances Control Act (TSCA) Title VI Third-Party Certification Program for 

136 composite wood products. Under the framework, third-party certifiers (TPCs) would be

137 accredited by EPA-recognized accreditation bodies (ABs) so that TPCs may certify 

138 composite wood product panel producers under TSCA Title VI, 15 U.S.C. 2697. TSCA 

139 Title VI gives EPA the authority to promulgate regulations relating to “third-party testing 

140 and certification” and “auditing and reporting of third-party certifiers” with regards to 

141 composite wood products. EPA believes that third-party certification is an essential 
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142 component in ensuring compliance with the TSCA Title VI emission standards for 

143 composite wood products. 

144 2. Summary of the major provisions. This proposal provides a framework for the 

145 TSCA Title VI Third-Party Certification Program. It lists the qualifications for ABs that 

146 wish to participate in the program, the process for applying to participate in the program, 

147 and the responsibilities of participating ABs. It also lists the qualifications for TPCs that 

148 wish to become TSCA Title VI accredited, the process for applying to become TSCA 

149 Title VI accredited, and the responsibilities of TSCA Title VI accredited TPCs. 

150 3. Costs and impacts. Under section 3(f)(1) of Executive Order 12866 (58 FR 

151 51735, October 4, 1993), this is a “significant regulatory action” because it may raise 

152 novel legal or policy issues related to the establishment of a new regulatory program as 

153 mandated by a new statutory amendment. Accordingly, EPA submitted this action to the 

154 Office of Management and Budget (OMB) for review under Executive Orders 12866 and 

155 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB 

156 recommendations are documented in the docket for this action. 

157 EPA has prepared an analysis of the potential costs and impacts associated with this 

158 rulemaking. This analysis is summarized in greater detail in Unit VI.A. of this proposal. 

159 The following chart provides a brief outline of the costs and impacts of this proposal: 

160 

Category Description 

Costs The annualized costs of this proposed rule are estimated 

at approximately $34,000 per year using either a 3% 

discount rate or a 7% discount rate. 

Small Entity Impacts This rule would impact an estimated 9 small entities, of 

which 8 are expected to have impacts of less than 1% of 

revenues or expenses, and 1 is expected to have impacts 

between 1% and 3%. 
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Category Description 

Effects on State, Local, and 

Tribal Governments 

Government entities are not expected to be subject to the 

rule’s requirements, which apply to third-party certifiers 

and accreditation bodies. The rule does not have a 

significant intergovernmental mandate, significant or 

unique effect on small governments, or have Federalism 

implications. 

161 

162 

163 B. What Action is the Agency Taking? 

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

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

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

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

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

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

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

171 requirements for TPCs, such as conducting and verifying formaldehyde emission tests, 

172 inspecting and auditing panel producers, and ensuring that panel producers’ quality 

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

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

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

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

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

178 BC. What is the Agency’s Authority for Taking this Action? 

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

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

181 to “promulgate regulations to implement the standards required under subsection (b) in a 
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182 manner that ensures compliance with the emission standards described in subsection 

183 (b)(2).” This provision includes authority to promulgate regulations relating to “third184 party testing and certification” and “auditing and reporting of third-party certifiers.” 

185 CD. Formaldehyde Sources and Health Effects 

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

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

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

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

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

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

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

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

194 and composite wood products made using formaldehyde-based resins (Ref. 2). 

195 Formaldehyde is both an irritant and a known human carcinogen (Ref. 3). 

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

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

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

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

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

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

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

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

204 formaldehyde (Ref. 4). This draft IRIS assessment was peer reviewed by the National 
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205 Academy of Sciences (NAS) (Ref. 5). EPA is currently considering the peer review 

206 comments EPA is currently considering the peer review comments. Both the National 

207 Toxicology Program (Ref. 3) and the International Agency for Research on Cancer (Ref. 

208 6) have concluded that formaldehyde is a known human carcinogen. However, in 

209 revising the draft IRIS assessment, EPA is following the 2011 recommendation of the 

210 National Research Council to evaluate the weight of evidence for specific cancer types in 

211 multiple organs, including specific respiratory tract sites and specific 

212 lymphohematopoietic cancer subtypes. This analysis will be used to derive a unit risk 

213 estimate in the revised draft that reflects more recent data and an updated review of the 

214 cancer hazard in humans and animals. 

215 DE. History of this Action 

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

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

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

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

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

221 Measure (ATCM) Phase II standards (Ref. 67). Title VI of TSCA directs EPA to 

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

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

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

225 and certification, auditing and reporting of third-party certifiers, recordkeeping, 

226 enforcement, laminated products, and products containing de minimis amounts of 

227 composite wood. 
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228 This proposed rule establishes a framework for a TSCA Title VI Third-Party 

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

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

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

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

233 TPCs. 

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

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

236 in California (Ref. 67). It includes requirements for manufacturers of composite wood 

237 products, distributors, importers, fabricators, retailers, and TPCs with provisions on sell238 through dates, labeling, recordkeeping, testing, and certification. It also includes special 

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

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

241 compliance with the emission standards certified by a TPC approved by CARB (Ref. 78). 

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

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

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

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

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

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

248 containing: 

249 a. Evidence of actual field experience in the verification of laboratories and wood 

250 products, to demonstrate how the applicant will be able to competently perform the TPC 
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251 requirements under the CARB ATCM. 

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

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

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

255 Recognition Arrangement (MRA). 

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

257 and evidence that the applicant is qualified to verify these products (Ref. 89). 

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

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

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

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

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

263 hearing. 

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

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

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

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

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

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

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

271 approved TPCs on its website (Ref. 78). The annual report must include: 
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272 • A list of manufacturers certified by the TPC during the previous calendar year, 

273 including the resins used by the manufacturers and the average and range of 

274 formaldehyde emissions. 

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

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

277 TPC. 

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

279 3. Recent activities related to this proposed rule. InOn March 24, 2008, the Sierra 

280 Club and numerous other25 organizations and approximately 5,000 individuals petitioned 

281 EPA under TSCA section 21. The petitioners requested that EPA of TSCA to use TSCA 

282 its authority under section 6 of TSCA to adopt nationally the CARB ATCM nationally 

283 (Ref. 10). The petitioners asked EPA to assess and reduce the risks posed by 

284 formaldehyde emission standards for composite wood products (i.e.,emitted from

285 hardwood plywood, particleboard, and medium-density fiberboard) (Ref. 9). by 

286 exercising its authority under TSCA section 6 to adopt and apply nationwide the CARB 

287 formaldehyde emissions regulation for these composite wood products. In addition, 

288 petitioners requested EPA to extend this regulation to include composite wood products 

289 used in manufactured homes. The petitioners expressed particular concern over the levels 

290 of formaldehyde found in emergency housing provided for persons displaced from their 

291 homes by Hurricane Katrina and noted that there are no Federal regulations on 

292 formaldehyde emissions from composite wood products other than the Department of 

293 Housing and Urban Development’s (HUD) regulations for manufactured housing at 24 

294 CFR 3280.308. In response to the petition, EPA announced in the Federal Register on 
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295 June 27, 2008, that EPA would

296 On June 27, 2008, EPA issued a Federal Register notice explaining the Agency’s 

297 decision to grant in part and deny in part the petitioners’ request (Ref. 11). EPA denied 

298 the petitioners’ request to immediately pursue a TSCA section 6 rulemaking, stating that 

299 the available information at the time was insufficient to support an evaluation of whether 

300 formaldehyde emitted from hardwood plywood, particleboard, and medium-density

301 fiberboard presents or will present an unreasonable risk to human health (including 

302 cancer and non-cancer endpoints) under TSCA section 6. As discussed in detail in the 

303 Federal Register notice announcing EPA’s response to the petition, EPA’s evaluation of 

304 the data provided by the petitioners revealed significant information gaps that would have 

305 needed to be filled to support an evaluation of whether use of formaldehyde in these 

306 products presents or will present an unreasonable risk under TSCA section 6. However, 

307 EPA did agree to initiate a proceeding to investigate whether and what type of regulatory 

308 or other action might be appropriate to protect against risks that may be posed by 

309 formaldehyde emitted from pressed wood products (Ref. 10). In the Federal Register of

310 December 3, 2008, EPA published an Advance Notice of Proposed Rulemaking (ANPR) 

311 to publicly initiate the investigation and obtain stakeholder input (Ref. 11)..

312 EAccordingly, on December 3, 2008, EPA issued an Advance Notice of Proposed 

313 Rulemaking (ANPR) that announced EPA’s intention to investigate whether and what 

314 regulatory or other action might be appropriate to protect against risks posed by 

315 formaldehyde emitted from the products covered by the CARB ATCM as well as other 

316 pressed wood products (Ref 12). To help inform EPA’s decision on the best ways to 

317 address risks posed by formaldehyde emissions from pressed wood products, the Agency 
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318 requested public comments and held six half-day public meetings in Research Triangle 

319 Park, NC; Portland, OR; Chicago, IL; Dallas, TX; Washington, DC; and New Orleans, 

320 LA. EPA received and reviewed comments submitted during the ANPR comment 

321 period which can be found at regulations.gov under docket number EPA-HQ-OPPT322 2008-0627. 

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

324 EPA believes that the TSCA Title VI Third-Party Certification Program must be 

325 impartial and applicable uniformly to both domestically manufactured and imported 

326 composite wood products.composite wood products “sold, supplied, offered for sale, or 

327 manufactured in the United States” regardless of origin, whether domestic or 

328 international. TSCA section 601(b)(1). This proposed rule aims to ensure that these 

329 objectives are met, along with ensuring the consistent application of the TPC 

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

331 the TSCA Title VI Third-Party Certification Program, and by leveraging the expertise of 

332 international ABs. Additionally, this proposed rule is intended to be as consistent as 

333 practicable with the TPC requirements under the CARB ATCM. By aligning itself with 

334 the existing CARB ATCM requirements, EPA seeks to avoid differing or duplicative 

335 regulatory requirements that would result in an increased burden on the regulated 

336 community. 

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

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

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

340 compliant with formaldehyde emissions standards, and are otherwise acting in manner 
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341 that is consistent with the requirements of TSCA Title VI. The TSCA Title VI 

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

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

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

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

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

347 abroad. 

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

349 outside of the United States. Currently, 27 of the 36 CARB-approved TPCs are based 

350 outside the United States (Ref.78). To ensure that oversight of TPCs is as strong abroad 

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

352 framework should include internationally operating ABs to overcome potential logistical 

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

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

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

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

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

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

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

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

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

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

363 oversight; and utilize ABs to strengthen performance of TPCs.
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364 FG. What Background Information was Used to Develop the Framework for a Third365 Party Certification Program? 

366 

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

368 Certification Program requires that panel producers have in place formaldehyde 

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

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

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

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

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

374 world as a means of ensuring the competency of third-parties in particular fields of 

375 technical activity such as testing, instrument calibration, and product performance 

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

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

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

379 Third-Party Certification Program. 

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

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

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

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

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

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

386 standards developed by nationally or internationally recognized standards-producing 

387 organizations or industry groups. Voluntary consensus standards establish uniform 

388 engineering or technical criteria, methods, processes, and practices for an industry 
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389 practice or product, and are developed by experts in the relevant field through a process 

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

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

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

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

394 barriers to trade. 

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

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

397 emission standards, impartial in its operations, and applicable both domestically and 

398 internationally, the Agency proposes requiring the use of voluntary consensus standards 

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

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

401 International Electrotechnical Commission (IEC) voluntary consensus standards and 

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

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

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

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

406 responsible for the development of international standards and guides. 

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

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

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

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

411 (Ref. 1213). These general requirements would help ensure that the TPC is competent 
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412 and reliable in certifying compliant composite wood products. 

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

414 Accreditation Bodies Accrediting Conformity Assessment Bodies. This international 

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

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

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

418 ABs (Ref. 1314). These general requirements would help ensure that the ABs are 

419 competent and reliable in accrediting TPCs. 

420 • ISO/IEC 17025:2005(E), General Requirements for the Competence of Testing 

421 and Calibration Laboratories. This international voluntary consensus standard specifies 

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

423 including sampling (Ref. 1415). EPA believes that requiring TPCs to use laboratories that 

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

425 obtained. 

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

427 Bodies Performing Inspections. This international voluntary consensus standard specifies 

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

429 intended for use by inspection bodies and their accreditation bodies (Ref. 1516). 

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

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

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

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

434 detailed in Unit III. The use of the guide and standards furthers the goal of the National 
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435 Technology Transfer and Advancement Act (NTTAA), as discussed in Unit VI. These 

436 ISO standards and guide will be made available for viewing in EPA’s reading room and, 

437 during the public comment period, online at [Placeholder].

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

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

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

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

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

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

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

445 experts and other ABs through a peer evaluation process. Because the proposed TPC 

446 framework is international in scope and will employ the use of internationally accepted 

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

448 international organizations that were established decades ago to specifically provide 

449 oversight of ABs. 

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

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

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

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

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

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

456 ensure compliance with the TSCA Title VI are detailed in Unit III. 
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457 The IAF is an association of conformity assessment bodies and other bodies. IAF 

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

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

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

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

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

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

464 facilitating international trade (Ref. 1617). The MLA certification provides 

465 documentation that a person or an organization has been accredited to a specific standard 

466 or scheme by an IAF MLA signatory AB. In addition, IAF through its MLA ensures that 

467 all ABs who are capable of accrediting product certification bodies, such as TPCs, are in 

468 conformance with ISO/IEC Guide 65:1996(E). By requiring a TPC to be accredited to 

469 ISO/IEC Guide 65:1996(E) by a qualified AB that has an IAF endorsement through level 

470 3 of the IAF Scope, or is a member of an equivalent oversight body, EPA believes that 

471 the TPC will be in conformance with ISO/IEC Guide 65:1996(E), the voluntary 

472 consensus standard used to ensure proper product certification. Level 3 of the IAF Scope 

473 is the level of accreditation which needs to be accomplished by a Product AB under that 

474 program to ensure that the Product AB is qualified to accredit the TPC. 

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

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

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

478 of products and services across national borders (Ref. 1718). By requiring a TPC’s 

479 emissions testing laboratory, or its contract laboratory, to be accredited by an AB that is a 
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480 signatory to the ILAC MRA or equivalent oversight body, EPA believes that there will be 

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

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

483 VI required laboratory formaldehyde emissions testing.

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

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

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

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

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

489 requirements. 

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

491 presented in this proposed rule, EPA started with a review of CARB’s program, as 

492 described in Unit II.DE. This included meeting with CARB, the composite wood 

493 industry, and CARB-approved TPCs. 

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

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

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

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

498 Third-Party Certification Program framework: 

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

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

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

502 as required under TSCA section 405 (Ref. 1819). Section 405 of TSCA further directs 
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503 EPA, in consultation with the Department of Health and Human Services (HHS), to 

504 develop a program to certify qualified lead testing laboratories. The NLLAP provides the 

505 public with a list of qualified laboratories that have met EPA criteria and demonstrated 

506 the capability to accurately analyze paint chip, dust, and soil samples for lead. EPA 

507 ensures that laboratories comply with these EPA criteria by having them evaluated and 

508 accredited by third-party laboratory ABs according to ISO/IEC performance consensus 

509 standards. In order to assure the public that a Laboratory AB is capable of performing an 

510 adequate assessment of participating laboratories, EPA enters into a recognition 

511 agreement with the AB in recognition of its capability to perform adequate laboratory 

512 assessments. 

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

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

515 agreement. The Laboratory ABs recognize NLLAP laboratories in conformance with 

516 ISO/IEC 17025:2005(E). Laboratories recognized under the NLLAP must also 

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

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

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

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

521 against consensus results from a set of reference laboratories.

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

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

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

525 NLLAP, which include the use of third-party laboratory ABs that accredit laboratories by 
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526 using voluntary consensus standards, along with additional specified laboratory testing 

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

528 successfully under TSCA Title VI. 

529 b. National Voluntary Conformity Assessment System Evaluation Program. 

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

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

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

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

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

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

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

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

538 established criteria. The ultimate goal is to help U.S. manufacturers satisfy applicable 

539 product requirements mandated by foreign or U.S. regulatory authorities through 

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

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

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

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

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

545 domestic as well as international. 

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

547 components of EPA’s WaterSense and Energy Star programs. WaterSense is an EPA548 sponsored partnership program launched in 2006 that seeks to protect the future of our 
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549 nation's water supply by promoting water efficiency and enhancing the market for water550 efficient products, programs, and practices. WaterSense helps consumers identify 

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

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

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

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

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

556 reduce greenhouse gas emissions. 

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

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

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

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

561 65:1996(E) in order to satisfy the criteria for certification of Energy Star and WaterSense 

562 products. They also provide the basis for consistent application of voluntary consensus 

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

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

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

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

567 of this approach. 

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

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

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

571 CARB third-party certification program, the use of recognition agreements with ABs 
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572 (e.g., as in NLAAP), and a product certification system element such as those used in the 

573 WaterSense and Energy Star programs. 

574 III. What Does this Proposed Rule Do? 

575 
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576 Illustration 1: TSCA Tile VI Proposed Third-Party Certification Framework 

577 

578 International Standards 

579 Organizations 

580 Develop consensus-based international 

581 standards for quality management 

582 and conformity assessment 

583 

584 

585 International Standards Bodies 

586 Ensure competency of Accrediting Accreditation

587 Bodies and their conformance with 

588 international standards 

589  Ensures AB conformance to 

ISO/IEC 170111 590 

591  Ensure ABs are qualified to oversee 

592 TPC conformance to ISO/IEC Guide 65 

593 ISO/IEC17020 and/or ISO/IEC 17025 

594 

595 

596 AccreditingAccreditation Bodies 

597 Ensure competency of TPCs; verify accuracy 

598 of emission test procedures, monitor TPC 

599 quality assurance programs, audit and inspect 

600 TPCs. 

601  Management systems conform to 

602 ISO/IEC 17011 

603  Ensure TPC conformance to 

604 applicable ISO/IEC Guide & Standards 

605 

606 

607 Third-Party Certifiers 

608 Ensure that panel producers are in 

609 compliance with statutory 

610 formaldehyde emission standards 

611  Management systems conform to 

612 ISO/IEC Guide 65 

613  Conform to applicable ISO/IEC 

614 Guide & Standards for 

615 Product & Laboratory Certification 

616 and Inspections 

617 

618 Composite Wood 

619 Panel Producers 

620 1 621 ISO/IEC 17011:2004(E) – Conformity Assessments--General Requirements for Accreditation Bodies Accrediting 

622 Conformity Assessment Bodies. 

2 623 MLA – IAF’s Multilateral Recognition Arrangement requires AB signatories to demonstrate they are capable of 

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

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

626 Various Types of Bodies Performing Inspections. 

3 627 MRA – ILAC’s Mutual Recognition Arrangement requires AB signatories to demonstrate they are capable of 

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

629 Competence of Testing and Calibration Laboratories. 

630 

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

TPC #2 

Accredited by AB #3 

TPC #1 

Accredited by AB #1 & AB 

#2 

Mfg #4 Product 

Certified by TPC 

#2

Mfg #3 Product 

Certified by TPC 

#2 

Mfg #2 Product 

Certified by TPC 

#1

Mfg #1 Product 

Certified by TPC 

#1

AB Type #3 

Product & Lab 

Accreditation Body 

 Recognition agreement 

with EPA 

 Signatory to IAF MLA and 

ILAC MRA or equivalents 

 Ensure TPC conformance to 

ISO/IEC Guide 65, ISO/IEC 

17020 & ISO/IEC 17025 

AB Type #2 

Laboratory 

Accreditation Body 

 Recognition agreement 

with EPA 

 Signatory to ILAC MRA 

or equivalent 

 Ensure TPC conformance 

to ISO/IEC 17025 

AB Type #1 

Product 

Accreditation Body 

 Recognition agreement 

with EPA 

 Signatory to IAF MLA or 

equivalent 

 Ensure TPC conformance 

to ISO/IEC Guide 65 & 

ISO/IEC 17020 
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631 EPA is proposing a framework which it believes would enable implementation of 

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

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

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

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

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

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

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

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

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

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

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

643 of composite wood products. 

644 • Experience in the composite wood product industry. 

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

646 wood products. 

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

648 products. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

667 to help promote compatibility and consistency within the programs. and to harmonize the 

668 third-party certification programs wherever practicable. EPA believes that compliance 

669 with the proposed the TSCA Title VI Third-Party Certification Program would not 

670 require substantial changes to procedures TPCs, laboratories, and panel producers 

671 currently use to conduct their TPC activities under the CARB ATCM (Ref. 67). 

672 A. Requirements for Accreditation Bodies 

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

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

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

676 AB.” The Product AB would be responsible for accrediting the TPCs, recordkeeping and 
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677 ensuring that a TPC is in conformance with ISO/IEC Guide 65:1996(E) (involving 

678 product certification systems) and ISO/IEC 17020:1998(E) (involving general criteria for 

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

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

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

682 17025:2005(E) (involving the general requirements for laboratories conducting testing 

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

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

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

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

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

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

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

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

691 Program framework. 

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

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

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

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

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

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

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

699 applicant member complies fully with both the international standards and IAF 
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700 requirements. Additionally, once an AB is a signatory to the IAF MLA, it is required to 

701 recognize the certificates issued by conformity assessment bodies accredited by all other 

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

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

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

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

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

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

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

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

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

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

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

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

714 equivalent scope. 

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

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

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

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

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

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

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

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

724 guidance documents, and any ILAC supplementary requirements. 

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

726 17025:2005(E) and related ILAC policy and guidance documents. 

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

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

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

730 membership in an equivalent organization. 

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

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

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

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

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

736 and guide. 

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

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

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

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

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

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

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

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

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

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

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

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

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

751 Product AB or Laboratory AB that would state: 

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

753 an EPA recognized AB. 

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

755 Certification Program. 

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

757 Title VI Third-Party Certification Program. 

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

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

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

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

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

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

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

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

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

767 agreement would be eligible for renewal. 

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

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

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

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

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

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

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

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

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

778 regulations. EPA requests comment on this proposed requirement. 

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

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

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

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

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

784 website and regularly updated.

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

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

787 AB, Laboratory AB, or both. 

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

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

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

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

793 ii. Transmitting copies of TPC applications and supporting documentation 

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

795 EPA. 

796 iii. Assigning the TPC a unique number. 

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

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

799 responsible for: 

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

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

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

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

804 wood products. 

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

806 assurance programs. 

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

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

809 vi. Conducting audits of TPCs and their laboratories. 

810 v. Recordkeeping. 

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

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

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

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

816 ISO/IEC 17025:2005(E). 

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

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

819 • Conducting audits of the laboratory. 

820 • Recordkeeping. 

821 EPA proposes to require TPCs to participate in an EPA recognized inter822 laboratory comparison program. If standard reference material is developed, EPA would 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

842 180 days if less than 365 days were left on their 23-year accreditation period, to be 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

859 panel producer has to seek a new TPC are discussed in Unit III.B.34.

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

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

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

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

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

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

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

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

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

870 composite wood products. 

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

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

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

874 ASTM E 1333-96 (Reapproved 2002) (Ref. 1920) or successor standards and experience 

875 evaluating correlation between test methods. 

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

877 Guide 65:1996(E). 

878 5. Experience in the composite wood product industry. 

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

880 ISO/IEC 17020:1998(E). 

881 The application would also specify which composite wood products the applicant 

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

883 EPA is proposing that TPCs would be required to renew their applications every 23
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884 years. EPA requests comment on the costs and benefits of a 3-year renewal period as 

885 compared to a 2-year renewal period (as under the CARB ATCM). The EPA also 

886 requests comment on whether the proposed requirement for EPA-recognized ABs to 

887 audit TPCs and laboratories used by TPCs every 2 years should be extended to every 3 

888 years to align with the proposed 3-year TPC accreditation period. 

889 In order to facilitate communication between EPA and TPCs, EPA is proposing to 

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

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

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

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

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

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

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

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

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

899 requests comment on this proposed requirement. 

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

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

902 (Ref. 1920) or under certain circumstances, ASTM D6007-02 (Reapproved 2008) (Ref. 

903 2021). For quality control testing, the statute requires use of ASTM D6007-02 

904 (Reapproved 2008), ASTM D5582-00 (Reapproved 2006) (Ref. 2122), or other test 

905 methods established by EPA through rulemaking. If a test method other than ASTM 

906 E1333-96 (Reapproved 2002) is used for either quarterly testing or quality control 
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907 testing, TSCA Title VI requires a demonstration of equivalence by means established by 

908 EPA. Therefore, EPA is proposing that a TPC laboratory or contract laboratory must 

909 have experience with formaldehyde testing using ASTM E1333-96 (Reapproved 2002) or 

910 its successor standards as well as experience evaluating correlations between different 

911 test methods. EPA intends to propose the means of showing test method equivalence in a 

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

913 VI. 

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

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

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

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

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

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

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

921 incorporate the current version, ASTM E1333-10 (Ref. 2223), into the testing 

922 requirements in this proposed rule in place of ASTM E1333-96 (Reapproved 2002) 

923 referenced in the statute. EPA notes that there are only relatively minor differences 

924 between ASTM E1333-96 (Reapproved 2002) and ASTM E1333-10. For example, 

925 referenced standards have been updated to cite the most recent version of the standards. 

926 In addition, under Apparatus, Make-up Air, 6.1.2.2, a new requirement has been added, 

927 specifying that the dry gas test meter or other airflow rate measuring device be 

928 “permanently placed in the chamber air intake duct.” A new loading ratio was added for 

929 “low density particleboard door core” and a note specifying that “Panel grades are 
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930 defined in the ANSI standards referenced in 2.3.” Under 9.2 Conditioning, a note was 

931 added stating “Test specimens with low levels of formaldehyde may absorb 

932 formaldehyde from the air when the air formaldehyde content exceeds that of the text 

933 [sic] specimen. Consideration should be taken to avoid such air conditions during storage 

934 and conditioning.” In addition, the following requirement was added: “Circulation of the 

935 conditioning air shall be achieved by fans that direct air flow horizontally in the direction 

936 parallel to the primary surface of the test specimens.” Under Test Procedure for 

937 Materials, 10.1.3, the following phrase was deleted: “as measured by a totalizing dry gas 

938 meter permanently placed in the chamber air intake duct.” Under note 9, the following 

939 clarifying phrase was added: “unless testing is extended and chamber concentrations in 

940 air and emission rates are obtained for the tested product at multiple chamber air 

941 exchange rates or multiple product loading ratios, or both.” Under Report the Following 

942 Information, 12.1.7, the following was added: “and the air circulation conditions (for 

943 example, air velocity or air exchange rate.” Under (Nonmandatory Information) X1. 

944 Reagents, Materials, and Equipment Found Suitable for Use, footnotes specifying where 

945 apparatuses are available have been deleted. In addition, X1.3.2 Sulfuric Acid, has been 

946 changed from “concentrated reagent grade. Nitrate concentration shall be less than 10 

947 ppm.” to “ACS grade. Nitrate concentration shall be no greater than 0.2 ppm.” EPA 

948 requests comment on whether ASTM E1333-10 should be incorporated into the testing 

949 requirements under TSCA Title VI in place of ASTM E1333-96 (Reapproved 2002). 

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

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

952 compliance with the formaldehyde emission standards in a subsequent proposal along 
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953 with the rest of the TSCA Title VI implementing regulations. EPA is proposing here that 

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

955 tests, and evaluating test method equivalence.

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

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

958 specifies the general requirements for the competence to carry out tests and/or 

959 calibrations, including sampling. EPA believes that requiring TPCs to use laboratories 

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

961 obtained. 

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

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

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

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

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

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

968 competent and reliable in certifying compliant composite wood products. 

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

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

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

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

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

974 17020:1998(E). Inspections by TPCs would be an important function of a TPC in helping 

975 ensure compliance with the regulations under TSCA Title VI. 
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976 EPA is proposing that TPCs must have experience in the composite wood 

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

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

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

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

981 during inspections and audits of the panel producers. In addition, EPA is proposing to 

982 require TPCs to have experience with the specific type of composite wood product(s) that 

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

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

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

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

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

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

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

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

991 2. Denied TPC Applicants. If an AB denies a TPC’s application for accreditation 

992 for failure to submit a complete application, the AB would be required to notify the TPC 

993 or TPC laboratory in writing of the legal and factual basis for the denial, actions, if any, 

994 which the affected TPC or TPC laboratory may take to receive accreditation in the future, 

995 and the opportunity and method for requesting a hearing with EPA. “Failure to submit a 

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

997 fee agreement. 

998 23. Proposed requirements once a TPC is accredited. EPA is proposing that once 
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999 an applicant is accredited as a TPC under TSCA Title VI, the TPC must: 

1000 a. Verify that panel producers have adequate quality assurance controls and are 

1001 complying with any quality assurance and quality control requirements that EPA 

1002 promulgates pursuant to TSCA Title VI. 

1003 b. Verify quality control test results compared with ASTM E1333-10 test results 

1004 by having laboratories conduct quarterly tests and evaluate test method equivalence 

1005 pursuant to testing requirements promulgated under TSCA Title VI. 

1006 c. Review applications from panel producers for reduced testing or third-party 

1007 certification requirements. 

1008 d. Establish quality control limits in consultation with panel producers, and, if 

1009 applicable, shipping quality control or other limits for each product type and production 

1010 line. 

1011 e. Inform panel producers of the process that will be used to determine if product 

1012 lots are exceeding the applicable quality control limit. 

1013 f. Inspect and audit panel producers and their records at least quarterly. 

1014 g. Use a testing laboratory or laboratories that comply with ISO/IEC 

1015 17025:2005(E). 

1016 h. Certify composite wood product types that comply with requirements under 

1017 TSCA Title VI following ISO/IEC Guide 65:1996(E). 

1018 i. Follow ISO/IEC 17020:1998(E) in the carrying out of their inspections of the 

1019 panel producers. 

1020 j. Provide approved TPC number (supplied by the accrediting AB) to the panel 

1021 producer for labeling and recordkeeping. 
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1022 k. Use laboratories that participate in an inter-laboratory comparison or 

1023 proficiency testing program. 

1024 l. Maintain records in electronic form for 53 years. 

1025 m. Provide an annual report to EPA and the AB(s) that provided it with its 

1026 accreditation. 

1027 n. Inform the AB(s) that provided it with its accreditation of any changes in key 

1028 personnel qualifications, procedures, or laboratories used by the TPC that could affect the 

1029 TPC’s ability to fulfill its obligations under this unit. 

1030 One of the main functions of TPCs under this proposed rule would be to help 

1031 ensure that panel producers have adequate quality control of their manufacturing process, 

1032 are following appropriate quality assurance procedures, and are complying with any 

1033 quality assurance requirements that EPA may implement under TSCA Title VI. Under 

1034 the CARB ATCM, manufacturers are required to implement specific quality assurance 

1035 procedures as described in Appendix 2 of the ATCM. EPA anticipates promulgating 

1036 quality assurance requirements for panel producers under TSCA Title VI in a subsequent 

1037 proposal with other implementation provisions as required under TSCA Title VI. EPA is 

1038 proposing to use TPCs to help ensure compliance with quality control and quality 

1039 assurance procedures. 

1040 EPA is proposing to require TPCs to verify quality control tests that measure 

1041 formaldehyde emissions by having laboratories conduct quarterly testing. 

1042 Under TSCA Title VI, EPA intends to promulgate specific formaldehyde testing 

1043 requirements. The subsequent proposal may also provide for reduced testing for specified 

1044 products such as those made with NAF or ULEF resins. In this proposed rule, EPA is 
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1045 proposing to require TPCs to review and approve, when appropriate, applications from 

1046 panel producers for reduced testing and third-party certification requirements according 

1047 to EPA’s implementing regulations. The CARB ATCM allows for reduced testing for 

1048 products manufactured with NAF and ULEF resins, and CARB reviews and approves 

1049 NAF and ULEF applications. EPA is proposing to instead require TPCs to review these 

1050 applications because EPA believes they are best suited to determine whether the panel 

1051 producers will be able to consistently comply with the emission standards even with 

1052 reduced testing requirements. EPA intends to further specify requirements for reduced 

1053 testing in a subsequent proposal with other implementation provisions as required under 

1054 TSCA Title VI. 

1055 EPA is proposing to require TPC laboratories (including contract laboratories) to 

1056 establish quality control limits in consultation with panel producers and, if applicable, 

1057 shipping quality control or other limits for each product type and production line to 

1058 ensure compliance with the emission standards. A quality control limit would be 

1059 established if test methods other than ASTM E1333-10 are being used to make it easier 

1060 for the panel producer to determine whether any products are likely to exceed the 

1061 emission standards. A quality control limit would be the value from a test other than 

1062 ASTM E1333-10 that is the correlative equivalent to the applicable standard. A TPC may 

1063 also establish a limit to account for process and testing variation to help ensure that the 

1064 emission for a product would not exceed the applicable standard. EPA is proposing to 

1065 require TPCs to inform panel producers of the process that the TPC would use to 

1066 determine if product lots are exceeding the applicable quality control limit. In the broader 

1067 TSCA Title VI implementing regulations, EPA intends to describe these limits in more 
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1068 detail as well as implications and procedures for cases where tests exceed the limits in a 

1069 subsequent proposal with other implementation provisions as required under TSCA Title 

1070 VI. 

1071 EPA is proposing to require that TPCs inspect and on-site audit panel producers 

1072 and their records at least quarterly and comply with ISO/IEC 17020:1998(E) when 

1073 conducting their inspections. Quarterly inspections and on-site audits are consistent with 

1074 requirements under the CARB ATCM, and EPA believes that requiring inspections 

1075 quarterly should be sufficiently frequent to allow TPCs to observe and mitigate any 

1076 potential violations. However, under certain circumstances, a TPC could determine that 

1077 more frequent inspections and on-site audits are necessary to ensure compliance. EPA 

1078 requestrequests comment on whether enhanced testing or inspection requirements should 

1079 be required where a TPC finds that a panel producer has failed quality control or 

1080 quarterly tests at a certain frequency. , or upon other circumstances. In addition to failed 

1081 test results, circumstances that EPA envisions possibly warranting increased TPC 

1082 inspections and audits include a panel producer failing to comply with its quality control 

1083 manual or inconsistencies in records.

1084 EPA is proposing to require that TPCs use laboratories for formaldehyde testing 

1085 that comply with ISO/IEC 17025:2005(E). As discussed in Unit II.FG.1., this 

1086 international voluntary consensus standard specifies the general requirements for the 

1087 competence to carry out tests and/or calibrations, including sampling. EPA believes that 

1088 requiring TPCs to use laboratories that follow these requirements would help ensure that 

1089 TPCs obtain reliable and accurate test results. 

1090 EPA is proposing to require that TPCs participate in an EPA-recognized inter-
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1091 laboratory comparison studies or proficiency testing, if developed. The inter-laboratory 

1092 comparisons would involve the participation of laboratories that are provided composite 

1093 wood product samples to test for formaldehyde; each laboratory would test the sample 

1094 using the same test method (e.g., ASTM E1333-10), and the results from all of the 

1095 laboratories would be compared. If a standard reference material for formaldehyde 

1096 emissions is developed, EPA proposes to require annual proficiency testing. The CARB 

1097 ATCM requires laboratories to participate in an inter-laboratory comparison during the 

1098 first year that the laboratory is used by a TPC, followed by participation in inter1099 laboratory comparisons every 2 years. EPA believes that evaluating the performance of 

1100 laboratories used by the TPC by inter-laboratory comparisons or proficiency testing is 

1101 vital to ensuring that laboratories are performing the formaldehyde testing properly, and 

1102 EPA is therefore proposing that this be an annual requirement. EPA requests comment on 

1103 whether inter-laboratory comparisons should take place more or less frequently. EPA is 

1104 also seeking comment on criteria to use in evaluating performance in inter-laboratory 

1105 comparisons. 

1106 EPA is proposing to require TPCs to follow ISO/IEC Guide 65:1996(E) to certify 

1107 composite wood product types that comply with requirements under TSCA Title VI. As 

1108 discussed in Unit II.FG.1., ISO/IEC Guide 65:1996(E) is an international voluntary 

1109 consensus standard that specifies general requirements for a third-party operating a 

1110 product certification system. EPA believes that requiring TPCs to follow these general 

1111 requirements for certifying products would help ensure that the TPC is properly 

1112 certifying only compliant composite wood products. 

1113 A TPC would be supplied with a TPC identification number by the Product AB 
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1114 once it has been accredited for TSCA Title VI purposes. EPA is proposing to require that 

1115 the TPC provide this number to panel producers so that they can include the TPC number 

1116 on the label of their certified products and include it in their records. 

1117 EPA is proposing to require TPCs to maintain records in electronic form for 53

1118 years. TSCA Title VI directs EPA to address recordkeeping requirements in its 

1119 implementing regulations and EPA believes that certain records will greatly assist the 

1120 EPA in monitoring compliance with the emissions standards and other provisions. These 

1121 records would be: 

1122 •A list of panel producers and their respective product types, including resins 

1123 used, that the TPC has certified. 

1124 •Results of inspections, audits, and emission tests conducted for and linked to 

1125 each panel producer and product type. 

1126 •A list of laboratories used by the TPC, test methods, including test conditions 

1127 and conditioning time, and test results. 

1128 •Methods and results for establishing test method correlations and equivalence. 

1129 EPA is proposing to require TPCs to submit an annual report to EPA and the AB 

1130 that accredits the TPC. The annual report would include: 

1131 •A list of panel producers and their products that the TPC has certified during the 

1132 previous year, including resins used and the average and range of formaldehyde 

1133 emissions by panel producer, resin, and product type. 

1134 • List of any non-complying products or events by panel producers. 

1135 • A list of laboratories and test methods used by the TPC. 

1136 • Results of inter-laboratory comparison or proficiency testing for the laboratories 
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1137 used by the TPC. 

1138 EPA is proposing to require that the TPC inform the AB(s) that accredit the TPC 

1139 of any changes in key personnel qualifications, procedures, or laboratories used that 

1140 could affect the TPC's ability to fulfill its obligations under this unit. EPA believes such 

1141 changes could impact the TPC’s ability to properly verify formaldehyde emissions, 

1142 inspect and audit, and certify compliant composite wood products. EPA is proposing that 

1143 the AB review the changes to determine whether the changes would impact the TPC’s 

1144 ability to perform its duties. 

1145 34. Removal and reaccreditation of third-party certifiers. EPA is proposing to 

1146 exercise the authority to revoke the TSCA Title VI accreditation of a TPC or its 

1147 laboratory, after notice and an opportunity for a hearing, if the TPC or its laboratory: 

1148 Fails to meet any of the applicable requirements promulgated under TSCA Title VI (such 

1149 as by failing to comply with ISO/IEC Guide 65:1996(E), ISO/IEC 17020:1998(E), or 

1150 ISO/IEC 17025:2005(E)); makes false or misleading statements on its application, 

1151 records, or reports; or makes changes to key personnel qualifications, procedures, or 

1152 laboratories that would make it unable to perform its duties. ABs would also be able to 

1153 revoke an accreditation of a TPC, subject to an opportunity for a hearing with EPA. A 

1154 TPC whose accreditation has been revoked may reapply to an AB to be reaccredited as a 

1155 TPC. 

1156 If a TPC loses its accreditation or discontinues participation in the TSCA Title VI 

1157 Third-Party Certification Program for any reason, it would be responsible for promptly 

1158 notifying EPA and all panel producers that it provides TSCA Title VI certification 

1159 services to. If a TPC loses its accreditation or discontinues participation in the program 
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1160 for reasons other than fraud or providing false or misleading statements, or other than a 

1161 reason that implicates a particular panel producer in a violation of TSCA Title VI or its 

1162 implementing regulations, the panel producers that used the TPC to certify their products 

1163 would need to enlist another TPC to certify their products within 3 months (90 days). In 

1164 these cases, the panel producers would not be required to recall or recertify their products 

1165 merely because the certifying TPC lost its accreditation. During the time a panel producer 

1166 is seeking a new TPC, it would need to continue to comply with all other requirements of 

1167 TSCA Title VI and its implementing regulations, including quality control testing. 

1168 During this period the panel producer would remain subject to inspection by EPA. If the 

1169 panel producer is unable to comply with all other aspects of TSCA Title VI and its 

1170 implementing regulations, the panel producer would not be permitted to sell, offer for 

1171 sale, or supply its products in the United States until its products are recertified as 

1172 compliant. If a TPC loses its accreditation due to fraud or providing false or misleading 

1173 statements with respect to a particular panel producer, or for any other reason that 

1174 implicates a particular panel producer in a violation of TSCA Title VI or the regulations 

1175 promulgated thereunder, that panel producer would not be permitted to offer regulated 

1176 composite wood products for sale in the United States until its composite wood products 

1177 have been recertified by another TPC. If such a situation does occur, EPA would notify 

1178 affected panel producer at the time it commences action against the TPC. EPA believes it 

1179 is appropriate to be more stringent in these situations because the TPC’s behavior may 

1180 call into question the legitimacy of the manufacture’s product certification. Any action 

1181 EPA would take against a TPC would not preclude an enforcement action against a panel 

1182 producer. EPA requests comment on whether it has provided adequate time for a panel 
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1183 producer to seek an alternate certification.

1184 H. Enforcement, Suspension, Revocation, and Modification 

1185 1. Enforcement under TSCA sections 15-17. EPA may conduct inspections of 

1186 participating TPCs and ABs and issue subpoenas according to the requirements for 

1187 accreditation and recognition and/or pursuant to the provisions of TSCA section 11 (15 

1188 U.S.C. 2610) to ensure compliance with TSCA Title VI and the regulations promulgated 

1189 thereunder. Enforcement issues related to manufacturers, importers, distributors, and 

1190 retailers will be covered in a subsequent proposal. 

1191 EPA would exercise the authority to withdraw from a recognition agreement with 

1192 an AB and pursue penalties under TSCA section15 (15 U.S.C. 2614) for any violation of 

1193 TSCA Title VI or the regulations promulgated thereunder. In addition to an 

1194 administrative or judicial finding of violation, grounds for withdrawing from a 

1195 recognition agreement and/or pursuing an enforcement action against an AB include if 

1196 the AB: 

1197 • Submits false or misleading information to EPA; 

1198 • Fails to maintain or falsifies required records; or 

1199 • Or otherwise fails to comply with TSCA Title VI or the regulations promulgated 

1200 thereunder. 

1201 2. Suspension, revocation and modification. EPA would exercise the authority to 

1202 suspend, revoke, or modify a TPC’s TSCA Title VI accreditation, with or without the 

1203 participation of the AB that provided the accreditation, if the TPC fails to comply with 

1204 TSCA Title VI or the regulations promulgated thereunder. Any violation of TSCA Title 

1205 VI or the regulations promulgated thereunder would also be a prohibited act under TSCA 
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1206 section 15 (15 U.S.C. 2614). Grounds for suspending, modifying, or revoking a TPC’s 

1207 accreditation include if the TPC: 

1208 a. Submits false or misleading information to EPA or its AB; 

1209 b. Fails to maintain or falsifies required records; or 

1210 c. Fails to comply with TSCA Title VI or regulations promulgated thereunder. 

1211 The ISO/IEC standards and guide that are referenced in this proposed rule require 

1212 that policies and procedures be in place to identify and remedy nonconformities with the 

1213 implementation of those standards (ISO/IEC 17025:2005(E), section 4.9; ISO/IEC 

1214 17011:2004(E), section 5.5; ISO/IEC 17020:1998(E), section 7.8; ISO/IEC Guide 

1215 65:1996(E), section 47). Should a TPC or AB identify a nonconformity or discrepancy 

1216 with its implementation of one of the ISO standards via an internal audit or other means, 

1217 that entity must take remedial action within the timeframe specified by the AB or the 

1218 time specified in the TPC’s quality management plan in order to avoid the possibility of 

1219 an enforcement action. 

1220 Prior to withdrawal from a recognition agreement with an AB, or the suspension, 

1221 revocation, or modification of a TPC’s accreditation, EPA would provide notification to 

1222 the affected AB or TPC of: 

1223 • The legal and factual basis for the proposed action. 

1224 • The anticipated commencement date and duration of any suspension, revocation, 

1225 modification, or other action. 

1226 • What actions, if any, the affected entity may take to avoid suspension, 

1227 revocation, modification, or otherwise continue participation in the program. 

1228 • The opportunity and method for requesting a hearing prior to the final action. 
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1229 If an individual or organization requests a hearing, EPA would: 

1230 • Provide the affected entity an opportunity to offer written statements in response 

1231 to EPA’s assertions of the legal and factual basis for its proposed action. 

1232 • Appoint an impartial official of EPA as Presiding Officer to conduct the hearing. 

1233 The Presiding Officer would conduct a fair, orderly, and impartial hearing within 

1234 90 days of the request for a hearing. The Presiding Officer would consider all relevant 

1235 evidence, explanations, comments, and arguments submitted and notify the affected 

1236 entity in writing within 90 days of completion of the hearing of his or her decision and 

1237 order. Such an order is a final agency action which may be subject to judicial review. The 

1238 order must contain the commencement date and duration of the suspension, revocation, or 

1239 modification. 

1240 If EPA determines that the public health, interest, or welfare warrants immediate 

1241 action to suspend the recognition of an AB or the accreditation of a TPC prior to the 

1242 opportunity for a hearing, it would notify the affected AB or TPC of its right to request a 

1243 hearing on the immediate suspension within 15 days of the suspension taking place and 

1244 the procedures for the conduct of such a hearing. 

1245 Any notice, decision, or order issued by EPA in response to a hearing, any 

1246 transcript or other verbatim record of oral testimony, and any documents filed in response 

1247 to a hearing would be available to the public, except as otherwise provided by TSCA 

1248 section 14. Any such hearing at which oral testimony is presented would be open to the 

1249 public, except that the Presiding Officer may exclude the public to the extent necessary to 

1250 allow presentation of information which may be entitled to confidential treatment under 

1251 TSCA section14.
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1252 I. Status of CARB Approved TPCs 

1253 EPA intends to propose that the formaldehyde emissions standards in TSCA Title 

1254 VI become effective 365 days after the promulgation of the TSCA Title VI implementing 

1255 regulations (which are required by TSCA Title VI to be promulgated no later than 

1256 January 1, 2013). EPA proposes that CARB approved TPCs would have 365 days after 

1257 the promulgation of the TSCA Title VI implementing regulations to become accredited 

1258 by an AB with which EPA has entered into a recognition agreement. EPA believes this In 

1259 order to determine which TPCs are CARB approved, EPA will consult the listing of 

1260 TPC’s that CARB maintains on its internet site. EPA believes that 365 days is a sufficient 

1261 period of time for EPA to enter into recognition agreements with ABs and for TPCs to 

1262 seek accreditation from EPA recognized ABs, ensuring no interruption in a TPC’s 

1263 services. During the transition period between when the final TSCA Title VI 

1264 implementing regulations are promulgated and the date 365 days after promulgation, the 

1265 CARB approved TPCs may carry out certification activities under TSCA Title VI 

1266 provided that they are compliant with all other aspects of TSCA Title VI and the 

1267 regulations promulgated thereunder. TPCs that are certifying products as compliant with 

1268 TSCA Title VI are subject to inspection by EPA and enforcement actions for any 

1269 violations of TSCA Title VI or the regulations promulgated thereunder. To reduce 

1270 burden on existing CARB approved TPCs, the EPA requests comment on ways to better 

1271 synchronize the timing for the TSCA Title VI accreditation period for existing CARB 

1272 approved TPCs. For example, one option might be to extend the allowable time period 

1273 for acquiring accreditation from 1 to 2 years. Another option might be to align the TSCA 

1274 Title VI accreditation requirement for CARB approved TPCs with their existing CARB 
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1275 accreditation renewal, such that they could use the same information to be accredited by 

1276 EPA and CARB at the same time. Alternatively, the TPCs could be required to obtain 

1277 accreditation from an EPA-Recognized AB no later than one year after the first EPA1278 recognized AB enters into a recognition agreement with the EPA under the TSCA Title 

1279 VI. EPA expects to communicate with CARB regarding its third-party certification 

1280 program and to collaborate, where possible, in order to promote the mutual acceptance of 

1281 TPCs. 

1282 J. Transparency 

1283 EPA has a commitment to uphold the values of transparency and openness in 

1284 conducting EPA operations (Ref. 2324). Transparency promotes accountability and 

1285 provides information for citizens about what their government is doing (Ref. 2425). EPA 

1286 would support its commitment by making documentation of recognized ABs, TPCs, and 

1287 panel producers available to the public. EPA is proposing to make the following 

1288 information publically available on the internet: 

1289 1. The names and addresses of all ABs that EPA has a recognition agreement with 

1290 and the status of that recognition agreement. 

1291 2. A list of all accredited TPCs with their TPC number and accreditation status. 

1292 3. Annual reports from ABs. 

1293 4. A list of panel producers approved for reduced testing and reduced third-party 

1294 certification requirements. 

1295 EPA requests comment on what, if any, additional information should be made 

1296 publically available (e.g., annual reports from TPCs and other required notifications) and 

1297 on whether there are other ways EPA might improve program transparency. EPA 
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1298 requests comment on whether making the following information available publically on 

1299 the internet would be useful to the public or present challenges for regulated entities: 

1300 • A list of panel producers and their products that each TPC has certified, 

1301 including resins used and the average and range of formaldehyde emissions by panel 

1302 producer, resin, and product type. 

1303 • A list of any non-complying products or events by panel producer. 

1304 • A list of laboratories and test methods used by each TPC. 

1305 • The results of inter-laboratory comparison or proficiency testing for the 

1306 laboratories used by TPCs. 

1307 EPA requests comment on whether such information might contain CBI. EPA is

1308 also considering requiring some information to be reported into a publicly viewable 

1309 database, should such a database be developed. Generally, EPA is considering requiring 

1310 electronic reporting of the information proposed to be reported. In particular, EPA 

1311 requests comment on whether the data elements in the ABs’ and TPCs’ annual reports, 

1312 and the required notifications should be reported into a publicly viewable database. 

1313 EPA is proposing a 3 year record retention period for all TSCA Title VI AB and 

1314 TPC record keeping requirements. While EPA is proposing a 3 year record retention 

1315 period as is common under the Paperwork Reduction Act, EPA requests comments on 

1316 ways to reduce the burden and costs of hard-copy record keeping over multiple years on 

1317 the regulated community, such as by requiring that the entities regulated under this rule 

1318 be allowed to keep required records electronically and make them available to the 

1319 Agency and others via their business website, or other electronic media. 
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1320 Under the proposed rule-making, composite wood products would be regulated 

1321 starting with the manufacture (including import) of panels, through their incorporation 

1322 into component parts and finished goods, the distribution of those products, and the retail 

1323 sale of those products. This can be a lengthy process and the amount of time composite 

1324 wood panels are held in inventory and the amount of time before they are incorporated 

1325 into finished goods is variable. This variability can result from prevailing economic 

1326 conditions, the complexity of the individual products, the origin of the products, and 

1327 other factors. This point was illustrated by the fact that CARB had to extend its “sell1328 through dates” multiple times. CARB found that these extensions were necessary because 

1329 the recession increased the amount of time manufacturers needed to clear preexisting 

1330 inventory. As CARB found that items remained in inventory for extended periods, it is 

1331 possible that an issue could arise with a particular composite wood item several years 

1332 after it was manufactured. Learning the source of the item may be important in order to 

1333 identify and correct a problem. Because retail companies receive composite wood items 

1334 from many sources and the third party certifier could vary with each item, retaining 

1335 records for 3 years would help assure that problems can be identified and corrected. 

1336 Third party certifiers of compliance with formaldehyde emissions from composite 

1337 wood products would need to maintain certain records long enough to assure that their 

1338 oversight role in the system is operating properly to protect human health. An adequate 

1339 record retention period is essential to fair and efficient enforcement of the regulatory 

1340 requirements and allows EPA and interested downstream consumers to be assured that 

1341 finished goods are made from compliant composite wood panels. EPA seeks to avoid the 

1342 situation where records surrounding the certification of regulated products that remain 
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1343 available for retail sale in the U.S. have already been disposed of because of the passage 

1344 of time. To that end, EPA requests comment on the length of time composite wood 

1345 panels may take to reach their end user, whether incorporated into a finished good or not. 

1346 EPA also requests comment on the amount of time ABs and TPCs, during their 

1347 ordinary course of business, typically retain records of their accreditation or certification 

1348 activities and whether this is due to any external factors such as, industry standards, 

1349 customer demand, customary business practices, or other.

1350 K. Electronic Reporting

1351 The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3504) provides 

1352 that, when practicable, Federal organizations use electronic forms, electronic filings, and 

1353 electronic signatures to conduct official business with the public. EPA’s Cross-Media 

1354 Electronic Reporting Regulation (CROMERR) (40 CFR part 3), published in the Federal 

1355 Register on October 13, 2005 (70 FR 59848) (FRL–7977–1), provides that any 

1356 requirement in title 40 of the Code of Federal Regulations (CFR) to submit a report 

1357 directly to EPA can be satisfied with an electronic submission that meets certain 

1358 conditions once the Agency publishes a regulation that an electronic document 

1359 submission process is available for that requirement.

1360 EPA is considering requiring information reported to EPA from TPCs and ABs be 

1361 reported electronically through EPA’s Central Data Exchange (CDX). CDX provides the 

1362 capability for submitters to access their data through the use of web services. For more 

1363 information about CDX, go to http://epa.gov/cdx. 

1364 Should EPA adopt a mandatory electronic reporting requirement, submitters 

1365 would be required to register with EPA’s CDX, complete an electronic signature 
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1366 agreement, and to prepare a data file for submission. To submit electronically to EPA via 

1367 CDX, individuals must first register with that system at, 

1368 http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant agrees to the 

1369 Terms and Conditions, provides information about the submitter and organization, selects 

1370 a user name and password, and follows the procedures outlined in the guidance document 

1371 for CDX available at https://cdx.epa.gov/TSCA/eTSCA-RegistrationGuide.pdf. The 

1372 registrant would also select a role and complete an electronic signature agreement either 

1373 through electronic validation using the LexisNexis services or through wet ink signature. 

1374 Once registration and the electronic signature agreement are complete, the user would 

1375 prepare a submission. 

1376 Most of the information requested in the reporting requirements of these 

1377 collections is not of a confidential nature. Nonetheless, the application would be 

1378 designed to support TSCA Confidential Business Information needs by providing a 

1379 secure environment that meets Federal standards. 

1380 EPA is considering requiring mandatory electronic reporting requirement 

1381 because such a requirement would streamline the reporting process and reduce the 

1382 administrative costs associated with information submission and recordkeeping. The 

1383 effort to eliminate paper-based submissions in favor of CDX reporting is part of broader 

1384 government efforts to move to modern, electronic methods of information gathering. 

1385 Electronic reporting allows for more efficient data transmittal and a reduction in errors 

1386 with the built-in validation procedures. EPA believes the adoption of electronic reporting 

1387 reduces the reporting burden for submitters by reducing the cost and time required to 

1388 review. EPA requests comment on whether it should require mandatory electronic
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1389 reporting. For more information on how a TSCA Title VI electronic reporting 

1390 application would function and the burdens and benefits associated with electronic 

1391 reporting please see Refs. [Placeholder] and 27.

1392 IV. Request for Comment

1393 In addition to the areas on which EPA has specifically requested comment, EPA 

1394 requests comment on all other aspects of this proposed rule. 

1395 V. References

1396 As indicated under ADDRESSES, a docket has been established for this 

1397 rulemaking under docket ID number EPA-HQ-OPPT-2011-0380. The following is a 

1398 listing of the documents that are specifically referenced in this action. The docket 

1399 includes these documents and other information considered by EPA, including 

1400 documents that are referenced within the documents that are included in the docket, even 

1401 if the referenced document is not physically located in the docket. For assistance in 

1402 locating these other documents, please consult the technical contact listed under FOR 

1403 FURTHER INFORMATION CONTACT. 

1404 1. Public Law 111-199, Title VI--Formaldehyde Standards for Composite Wood 

1405 Products Act, enacted July 7, 2010. (TSCA section 601(d), 15 U.S.C. 2601 et seq.) 

1406 2. Agency for Toxic Substances and Disease Registry (ATSDR). 1999. 

1407 Toxicological Profile for Formaldehyde and 2010 Addendum to the Profile. Atlanta, GA: 

1408 U.S. Department of Health and Human Services, Public Health Service. 

1409 3. National Toxicology Program, U.S. Department of Health and Human Services 

(HHS), 12th 1410 Report on Carcinogens, June 10, 2011. 
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1411 4. EPA, ORD. Integrated Risk Information System (IRIS) Program. IRIS 

1412 Toxicological Review of Formaldehyde-Inhalation Assessment (2010 External Review 

1413 Draft). Available online at:

1414 http://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=223614. 

1415 5. National Academy of Sciences (NAS). Review of the Environmental Protection 

1416 Agency's Draft IRIS Assessment of Formaldehyde. 2011. Available online at:

1417 http://www.nap.edu/catalog.php?record_id=13142. 

1418 6.6. International Agency for Research on Cancer (June 2006). IARC 

1419 Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 88 (2006): 

1420 Formaldehyde, 2-Butoxyethanol and 1-tert-Butoxypropan-2-ol

1421 7. California Environmental Protection Agency Air Resource Board. CARB 

1422 Airborne Toxic Control Measure. April 26, 2007. Available online at:

1423 http://www.arb.ca.gov/toxics/compwood/compwood.htm. 

1424 78. California Environmental Protection Agency Air Resources Board, Composite 

1425 Wood Products ATCM, List of CARB Approved Third-party Certifiers (Accessed 

1426 August, 2011). Available online at:

1427 http://www.arb.ca.gov/toxics/compwood/listoftpcs.htm.

1428 89. California Environmental Protection Agency Air Resources Board, 

1429 Application to be a Third-party Certifier (TPC) of Composite Wood Products. Available 

1430 online at: http://www.arb.ca.gov/toxics/compwood/tpc/tpcapplication.pdf. 

1431 910. Sierra Club. Citizen Petition to EPA Regarding Formaldehyde in Wood 

1432 Products. March 20, 2008. Available online at:

1433 http://www.epa.gov/opptintr/chemtest/formaldehyde/index.html.
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1434 1011. EPA. Formaldehyde Emissions from Composite Wood Products; 

1435 Disposition of TSCA Section 21 Petition. Federal Register. (73 FR 36504, June 27, 

1436 2008) (FRL-8371-5). 

1437 1112. EPA. Formaldehyde Emissions from Composite Wood Products; Advanced 

1438 notice of proposed rulemaking and notice of public meetings. Federal Register. (73 FR 

1439 73620, December 3, 2008) (FRL-8386-3). 

1440 1213. ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 

1441 Product Certification Systems (First Edition) 1996. 

1442 1314. ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements 

1443 for Accreditation Bodies Accrediting Conformity Assessment Bodies (Corrected 

1444 Version), February 15, 2005. 

1445 1415. ISO/IEC 17025:2005(E), General Requirements for the Competence of 

1446 Testing and Calibration Laboratories (Second Edition), May 15, 2005. 

1447 1516. ISO/IEC 17020:1998(E), General Criteria for the Operation of Various 

1448 Types of Bodies Performing Inspections (First Edition) November 15, 1998. 

1449 1617. International Accreditation Forum. Available online at: http://www.iaf.nu/.

1450 1718. International Laboratory Accreditation Cooperation. Available online at: 

1451 http://www.ilac.org. 

1452 1819. EPA. National Lead Laboratory Accreditation (NLLAP). Available at: 

1453 http://www.epa.gov/lead/pubs/nllap.htm. 

1454 1920. ASTM E1333-96 (Reapproved 2002). Standard Test Method for 

1455 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 

1456 Products Using a Large Chamber. 
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1457 2021. ASTM D6007-02 (Reapproved 2008), October 1, 2008. Standard Test 

1458 Method for Determining Formaldehyde Concentrations in Air from Wood Products 

1459 Using a Small-Scale Chamber. 

1460 2122. ASTM D5582-00 (Reapproved 2006), October 1, 2006. Standard Test 

1461 Method for Determining Formaldehyde Levels from Wood Products Using a Desiccator. 

1462 2223. ASTM E1333-10 (May 1, 2010). Standard Test Method for Determining 

1463 Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a 

1464 Large Chamber.

1465 2324. EPA. Memorandum from Lisa Jackson to EPA Employees (April 23, 

1466 2009). Available online at: http://www.epa.gov/Administrator/operationsmemo.html. 

1467 2425. Memorandum from President Barack Obama to the Heads of Executive 

1468 Departments and Agencies. January 21, 2009. Available online at: 

1469 http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment. 

1470 2526. EPA. Economic Analysis of the Third-Party Certification Framework for 

1471 the Formaldehyde Standards for Composite Wood Products Act Proposed Rule 

1472 (Economic Analysis). OMB Draft March 9, 2012. 

1473 2627. EPA. Information Collection Request (ICR) for the Formaldehyde 

1474 Emissions From Composite Wood Products, Third-Party Certification Framework, 

1475 Recordkeeping and Reporting; Proposed Rule, (RIN 2070-AJ44). EPA ICR No. 2441.01 

1476 and OMB No. 2070-[NEW]. OMB Draft March 12, 2012. 

1477 2728. EPA. Report of the Small Business Advocacy Review Panel on EPA’s 

1478 Planned Proposed Rule Implementing the Formaldehyde Standards for Composite Wood 

1479 Products Act (TSCA Title VI). April 4, 2011. 
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1480 VI. Statutory and Executive Order Reviews 

1481 A. Executive Order 12866: Regulatory Planning and Review and Executive Order 

1482 13563: Improving Regulation and Regulatory Review 

1483 

1484 Under section 3(f)(1) of Executive Order 12866 (58 FR 51735, October 4, 1993), 

1485 this is a “significant regulatory action” because it may raise novel legal or policy issues 

1486 related to the establishment of a new regulatory program as mandated by a new statutory 

1487 amendment. Accordingly, EPA submitted this action to the Office of Management and 

1488 Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, 

1489 January 21, 2011), and any changes made in response to OMB recommendations are 

1490 documented in the docket for this action. 

1491 EPA prepared an analysis of the potential costs and benefits associated with this 

1492 action. A copy of this Economic Analysis (Ref. 2526) is available in the docket for this 

1493 action and the analysis is briefly summarized here. 

1494 The proposed rule would require ABs to submit an application and enter into a 

1495 recognition agreement with EPA, provide notifications and annual reports, and maintain 

1496 records. A typical AB is estimated to incur an annualized cost of approximately 

1497 $775nearly $800 per year. For the purposes of cost estimation EPA assumes that eight 

1498 organizations in the United States will become ABs in the TSCA Title VI Third-Party 

1499 Certification Program, so total costs to U.S. ABs are estimated to be approximately 

1500 $6,200300 per year. 

1501 The proposed rule would require TPCs to submit an application, submit 

1502 notifications and annual reports, and maintain records. These requirements are estimated 

1503 to cost an average TPC about $1,200100 per year. The proposed rule also would require 

1504 TPCs to be accredited for certain ISO/IEC guide and standards. Most potential TPCs that 
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1505 are likely to participate in the TSCA Title VI Third-Party Certification Program are 

1506 expected to already have all the necessary accreditations, but some TPCs are assumed to 

1507 need an additional accreditation at a cost of $25,000 in the first year and $5,000 per year 

1508 in subsequent years. For the purposes of cost estimation EPA assumes that there will be 

1509 nine U.S. TPCs under this proposed rule. Total costs to U.S. TPCs due to the proposed 

1510 rule are estimated to be approximately $94,000 in the first year and $24,000 to $28,000 

1511 per year in subsequent years. Annualized costs to U.S. TPCs are $2827,000 and 

1512 $2928,000 per year, using a 3% and 7% discount rate, respectively. 

1513 The combined total cost for accreditation bodies and TPCs is estimated to be 

1514 $107,000 in the first year. Annualized costs are estimated at approximately $34,000 and 

1515 $35,000 per year, using either a 3% and 7or7% discount rate, respectively. 

1516 B. Paperwork Reduction Act (PRA)

1517 The information collection requirements in this proposed rule have been 

1518 submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information 

1519 Collection Request (ICR) document prepared by EPA has been assigned EPA ICR No. 

1520 2441.01. 

1521 This action proposes to require TPCs to provide EPA and ABs with pertinent 

1522 information necessary for accreditation. Also, this action proposes to require ABs to 

1523 provide EPA with necessary information through a recognition agreement in order to 

1524 qualify them to function as an AB pursuant to the regulations. EPA has therefore 

1525 prepared and submitted to OMB an Information Collection Request (ICR) document 

1526 entitled “Formaldehyde Emissions From Composite Wood Products, Third-Party 

1527 Certification Framework, Recordkeeping and Reporting; Proposed Rule (RIN 2070-
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1528 AJ44),” identified under EPA ICR No. 2441.01 and OMB Control No. 2070-[NEW], 

1529 which is also available for review in the docket for this action (Ref. 2627). The ICR 

1530 describes the information collection activities and the estimated burden hours and costs, 

1531 which are briefly summarized here. 

1532 Because the approval requirements for information collection requests under PRA 

1533 is not limited to U.S. entities, the reporting and recordkeeping burden of the proposed 

1534 rule is calculated for both foreign and domestic entities. 

1535 The average reporting and recordkeeping burden for ABs is estimated at 

1536 approximately 1821 hours per year. EPA assumes that 8 U.S. ABs and 17 foreign ABs 

1537 will participate in the TSCA Title VI program, so the annual burden for ABs is estimated 

1538 to be 450500 hours. The average reporting and recordkeeping burden for TPCs is 

1539 estimated at approximately 2825 hours per year. EPA assumes there will be nine 

1540 domestic TPCs and 27 foreign TPCs that participate in the TCA Title VI program, so the 

1541 annual burden for ABs is estimated at approximately 1,000900 hours. Total respondent 

1542 burden for ABs and TPCs combined is estimated at approximately 1,450400 hours per 

1543 year. The total cost to United States and foreign TPCs that need to obtain additional 

1544 accreditation is estimated to average $140,000 per year. Burden is defined at 5 CFR 

1545 1320.3(b). 

1546 An agency may not conduct or sponsor, and a person is not required to respond to 

1547 an information collection request unless it displays a currently valid OMB control 

1548 number, or is otherwise required to submit the specific information by a statute. The 

1549 OMB control numbers for EPA’s regulations codified in title 40 of the Code of Federal 

1550 Regulations, after appearing in the preamble of the final rule, are further displayed either 
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1551 by publication in the Federal Register or by other appropriate means, such as on the 

1552 related collection instrument or form, if applicable. The display of OMB control numbers 

1553 for certain EPA regulations is consolidated in a list at 40 CFR 9.1. 

1554 To comment on the Agency's need for this information, the accuracy of the 

1555 provided burden estimates, and any suggested methods for minimizing respondent 

1556 burden, EPA has established a public docket for this proposed rule, which includes this 

1557 ICR, under docket ID number EPA-HQ-OPPT-2011-0380; FRL-9342-4. Submit any 

1558 comments related to the ICR to EPA and OMB. See ADDRESSES at the beginning of 

1559 this proposed rule for where to submit comments to EPA. Send comments to OMB at the 

1560 Office of Information and Regulatory Affairs, Office of Management and Budget, 725 

17th 1561 St., NW, Washington, DC 20503, ATTN: Desk Office for EPA. Since OMB is 

1562 required to make a decision concerning the ICR between 30 and 60 days after [insert date 

1563 of publication in the Federal Register], a comment to OMB is best assured of having its 

1564 full effect if OMB receives it by [insert date 30 days after date of publication in the

1565 Federal Register]. The final rule will respond to any OMB or public comments on the 

1566 information collection requirements contained in this proposed rule. 

1567 C. Regulatory Flexibility Act (RFA)

1568 The RFA, 5 U.S.C. 601 et seq., generally requires an agency to prepare a 

1569 regulatory flexibility analysis of any rule subject to notice and comment rulemaking 

1570 requirements under the Administrative Procedure Act or any other statute unless the 

1571 agency certifies that the rule will not have a significant economic impact on a substantial 

1572 number of small entities. Small entities include small businesses, small organizations, 

1573 and small governmental jurisdictions. 
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1574 For purposes of assessing the impacts of this proposed rule on small entities, a 

1575 small entity is defined as: 

1576 1. A small business, as defined by the Small Business Administration’s (SBA) 

1577 regulations at 13 CFR 121.201. The SBA’s definitions typically are based upon either a 

1578 sales or an employment level, depending on the nature of the industry. 

1579 2. A small governmental jurisdiction that is a government of a city, county, town, 

1580 school district, or special district with a population of less than 50,000. 

1581 3. A small organization that is any not-for-profit enterprise which is 

1582 independently owned and operated and is not dominant in its field. 

1583 Since the regulated community does not include small governmental jurisdictions, 

1584 the Agency’s analysis focuses on small businesses and small non-profits organizations. 

1585 After considering the economic impacts of this proposed rule on small entities, I 

1586 certify that this action will not have a significant economic impact on a substantial 

1587 number of small entities. The Agency’s basis is briefly summarized here and is detailed 

1588 in the Economic Analysis (Ref. 26). 

1589 EPA evaluated two factors in its analysis of the proposed rule’s requirements on 

1590 small entities, the number and type of small entities potentially affected, and the extent of 

1591 the rule’s potential economic impact on those entities as measured by the cost-to-revenue 

1592 ratio for businesses and the cost-to-expenses ratio for non-profit organizations. This ratio 

1593 is a good measure of entities’ ability to afford the costs attributable to a regulatory 

1594 requirement, because comparing compliance costs to revenues or expenses provides a 

1595 reasonable indication of the magnitude of the regulatory burden relative to a commonly 

1596 available measure of economic activity. Where regulatory costs represent a small fraction 
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1597 of a typical entity’s revenues or expenses, the financial impacts of the regulation on such 

1598 entities may be considered as not significant. The impact ratios were calculated using 

1599 annualized costs, because these costs are more representative of the continuing costs 

1600 entities would face to comply with this proposed rule. 

1601 EPA assumed that 5 small non-profit organizations and 4 small businesses in the 

1602 United States will participate as ABs or TPCs in the TSCA Title VI program. All of the 

1603 small non-profit organizations are expected to have cost impacts below the 1% level. 

1604 Three of the small businesses are expected to have cost impacts below the 1% level, and 

1605 one is expected to have cost impacts between 1% and 3%. So of the 9 total small entities 

1606 assumed to be affected by the final rule, 8 are expected to have impacts under 1%, and 1 

1607 is expected to have impacts between 1% and 3%. 

1608 In general, EPA strives to minimize potential adverse impacts on small entities 

1609 when developing regulations to achieve the environmental and human health protection 

1610 goals of the statute and the Agency. EPA solicits comments specifically about the 

1611 potential economic impacts that this proposed rule may impose on small entities. 

1612 Although not required by RFA to convene a Small Business Advocacy Review 

1613 (SBAR) Panel for this particular proposed rule because EPA has determined that this 

1614 proposal would not have a significant economic impacts on a substantial number of small 

1615 entities, EPA convened a SBAR Panel to obtain advice and recommendations from small 

1616 entities representatives potentially subject to the proposed rule’s requirements. The 

1617 SBAR Panel covered the proposed regulations and the broader TSCA Title VI 

1618 implementing regulations proposal which will follow. The SBAR Panel was convened by 

1619 EPA's Small Business Advocacy Chairperson on February 3, 2011. In addition to the 
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1620 chairperson, the Panel consisted of the Assistant Administrator of the Office of Chemical 

1621 Safety and Pollution Prevention, the Administrator of the Office of Information and 

1622 Regulatory Affairs within OMB, and the Chief Counsel for Advocacy of the SBA. 

1623 Seventeen potentially impacted small entities served as Small Entity 

1624 Representatives (SERs), representing a broad range of small entities from diverse 

1625 geographic locations and five association representatives. EPA hosted two meetings with 

1626 the SERs to obtain feedback. During the Pre-Panel Outreach Meeting on January 6, 2011, 

1627 and the Panel Outreach Meeting on February 17, 2011, EPA reviewed the major areas of 

1628 regulation, including options for the proposed framework of the TSCA Title VI Third1629 Party Certification Program, with the SBAR Panel and the SERs. The SBAR Panel 

1630 solicited comments from the SERs on the options presented by EPA, their experiences 

1631 with the CARB ATCM, any additional concerns they might have, and the costs of 

1632 regulatory options. Several SERs submitted written comments to EPA following the 

1633 meetings. The Panel evaluated the assembled materials and small entity comments on 

1634 issues related to the elements of an IRFA. A copy of the SBAR Panel report is included 

1635 in the docket for this proposed rule (Ref. 2728). As a result of its deliberations, the Panel 

1636 made a number of recommendations. With regards to the proposed TSCA Title VI Third1637 Party Certification Program, the Panel recommended that EPA continue to explore how it 

1638 can capitalize on the expertise of international ABs, while at the same time maintaining 

1639 control over the design and implementation of its certification system. 

1640 D. Unfunded Mandates Reform Act (UMRA) 

1641 Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for Federal 

1642 agencies to assess the effects of their regulatory actions on State, local, and tribal 
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1643 governments and the private sector. This proposed rule does not contain a Federal 

1644 mandate that may result in expenditures of $100 million or more for State, local, or tribal 

1645 governments, in the aggregate, or the private sector in any 1 year. No State, local, or 

1646 tribal governments currently acts as accreditation bodies or TPCs, and none are 

1647 anticipated to do so in the future, so the proposed rule would not result in expenditures by 

1648 these government bodies. The costs of the proposed rule to the private sector are 

1649 expected to be approximately $100,000 in the first year, and significantly less costly in 

1650 subsequent years. Thus, this proposed rule is not subject to the requirements of sections 

1651 202 or 205 of UMRA. This proposed rule is also not subject to the requirements of 

1652 section 203 of UMRA because it contains no regulatory requirements that might 

1653 significantly or uniquely affect small governments. Since no State, local, or tribal 

1654 governments are expected to act as accreditation bodies or TPCs. 

1655 E. Executive Order 13132: Federalism

1656 This action does not have federalism implications because it will not have 

1657 substantial direct effects on the States, on the relationship between the national 

1658 government and the States, or on the distribution of power and responsibilities among the 

1659 various levels of government, as specified in Executive Order 13132 (64 FR 43255, 

1660 August 10, 1999). No States are expected to act as accreditation bodies or TPCs, and 

1661 EPA would administer these requirements not the States. The proposed rule would not 

1662 impose substantial direct compliance costs on States. Furthermore, the proposed rule 

1663 would not preempt State or local law. Thus, Executive Order 13132 does not apply to this 

1664 action. Nonetheless, since California also has a program to regulate formaldehyde 

1665 emissions from composite wood products, EPA held numerous consultations with 
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1666 representatives of the California Air Resources Board while developing this proposed 

1667 rule. 

1668 In the spirit of Executive Order 13132, and consistent with EPA policy to promote 

1669 communications between EPA and State and local governments, EPA specifically solicits 

1670 comments on this proposed action from State and local officials. 

1671 F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

1672 Governments 

1673 

1674 This action does not have tribal implications as specified in Executive Order 

1675 13175 (65 FR 67249, November 9, 2000). No Tribes are expected to act as accreditation 

1676 bodies or TPCs, and EPA would administer these requirements not Tribes. Thus, 

1677 Executive Order 13175 does not apply to this action. EPA specifically solicits additional 

1678 comment on this proposed action from tribal officials. 

1679 G. Executive Order 13045: Protection of Protection of Children from Environmental 

1680 Health Risks and Safety Risks 

1681 

1682 EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as 

1683 applying only to those regulatory actions that concern health or safety risks, such that the 

1684 analysis required under section 5-501 of the Executive Order has the potential to 

1685 influence the regulation. This action is not subject to Executive Order 13045, because it 

1686 would not establish an environmental standard intended to mitigate health or safety risks. 

1687 H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect 

1688 Energy Supply, Distribution, or Use 

1689 

1690 This action is not a “significant energy action” as defined in Executive Order 

1691 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse 

1692 effect on the supply, distribution, or use of energy. Further, we have concluded that this 

1693 rule is not likely to have any adverse energy affects because it sets up a framework for a 
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1694 TSCA Title VI Third-Party Certification Program, and does not require any action related 

1695 to the supply, distribution, or use of energy. 

1696 I. National Technology Transfer and Advancement Act (NTTAA) 

1697 Section 12(d) of NTTAA, 15 U.S.C. 272 note, directs EPA to use voluntary 

1698 consensus standards in its regulatory activities unless to do so would be inconsistent with 

1699 applicable law or otherwise impractical. Voluntary consensus standards are technical 

1700 standards (e.g., materials specifications, test methods, sampling procedures, business 

1701 practices, etc.) that are developed or adopted by voluntary consensus standards bodies. 

1702 NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency 

1703 decides not to use available and applicable voluntary consensus standards. 

1704 This proposed rule involves technical standards. EPA proposes to use voluntary 

1705 consensus standards. The proposed framework of this TSCA Title VI Third-Party 

1706 Certification Program is based on the ability of ABs to review TPCs for their conformity 

1707 to ISO/IEC Guide 65:1996(E), ISO/IEC 17025:2005(E), and ISO/IEC 17020:1998(E). 

1708 Both Product ABs and Laboratory ABs would be required to maintain their conformity to 

1709 ISO/IEC 17011:2004(E). 

1710 EPA welcomes comments on this aspect of the proposed rule, and specifically 

1711 invites the public to identify potentially applicable voluntary consensus standards and to 

1712 explain why such standards should be used in the final rule. 

1713 J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

1714 Populations and Low-Income Populations 

1715 

1716 Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal 

1717 executive policy on environmental justice. Its main provision directs federal agencies, to 

1718 the greatest extent practicable and permitted by law, to make environmental justice part 
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1719 of their mission by identifying and addressing, as appropriate, disproportionately high 

1720 and adverse human health or environmental effects of their programs, policies, and 

1721 activities on minority populations and low-income populations in the United States. 

1722 EPA has determined that this proposed rule will not have disproportionately high 

1723 and adverse human health or environmental effects on minority or low-income 

1724 populations because it does not affect the level of protection provided to human health or 

1725 the environment. This action proposes a system whereby ABs accredits TPCs, and TPCs 

1726 certify composite wood products in order to ensure compliance with the emissions 

1727 standards in TSCA Title VI. This action does not relax a pollution control measure and 

1728 therefore will not cause emissions increases. 

1729 List of Subjects in 40 CFR Part 770 

1730 Environmental protection, Composite wood products, Formaldehyde, Reporting 

1731 and recordkeeping, Third-party certification. 

1732 

1733 Dated: ____________________ 

1734 

1735 _________________________________________________ 

1736 Administrator. 

1737 
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1738 Therefore, it is proposed that 40 CFR chapter I, subchapter R, be amended by 

1739 adding a new part 770 to read as follows: 

1740 PART 770--FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD 

1741 PRODUCTS 

1742 

1743 Subpart A--General Provisions

1744 Sec. 

1745 770.1 Scope and applicability. 

1746 770.2 Effective dates. 

1747 770.3 Definitions. 

1748 Subpart B--Third-Party Certification Program

1749 770.7 Third-party certification. 

1750 770.9 Prohibited acts. 

1751 Subpart C--[Reserved] 

1752 Subpart D--Incorporation by Reference 

1753 770.99 Incorporation by reference. 

1754 

1755 Authority: 15 U.S.C. 2697(d). 

1756 Subpart A--General Provisions

1757 § 770.1 Scope and applicability.

1758 (a) This subpart applies to: 

1759 (1) Laboratory Accreditation Bodies (ABs) and Product ABs that are accrediting 

1760 third-party certifiers (TPCs) for TSCA Title VI (15 U.S.C. 2697(d)) purposes and those 

1761 that wish to commence accrediting third-party certifiers for TSCA Title VI purposes.

1762 (2) TPCs that are certifying composite wood products for TSCA Title VI 

1763 compliance and those that wish to commence certifying composite wood products for 

1764 TSCA Title VI compliance. 

1765 (b) [Reserved] 

1766 § 770.2 Effective dates. 

1767 (a) Laboratory and Product ABs that wish to accredit TPCs for TSCA Title VI 

1768 purposes may apply to EPA to become recognized beginning on [date of publication of 
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1769 the final rule in the Federal Register]. Laboratory and Product ABs must be recognized 

1770 by EPA before they begin providing TSCA Title VI accreditation services. 

1771 (b) TPCs that wish to provide TSCA Title VI certification services must meet all 

1772 the requirements of this subpart before they commence providing TSCA Title VI 

1773 certification services. 

1774 (c) Notwithstanding any other provision of this subpart, TPCs that are approved 

1775 by the California Air Resources Board to certify composite wood products have until 

1776 [date 1 year after date of publication of the final rule in the Federal Register] to become 

1777 accredited pursuant to the requirements of this subpart. During the year following [date of 

1778 publication of the final rule in the Federal Register], the California Air Resources 

1779 Board-approved TPCs may carry out certification activities under TSCA Title VI, 

1780 provided that they are compliant with all other aspects of TSCA Title VI and the 

1781 regulations promulgated thereunder. Third-party certifiers that are certifying products as 

1782 compliant with TSCA Title VI are subject to enforcement actions for any violations of 

1783 TSCA Title VI or the regulations promulgated thereunder. 

1784 § 770.3 Definitions.

1785 Accreditation Body or AB means an organization that provides an impartial 

1786 verification of the competency of conformity assessment bodies such as TPCs. 

1787 Composite wood product means hardwood plywood, medium-density fiberboard, 

1788 and particleboard. 

1789 EPA Recognized Laboratory Accreditation Body or EPA Recognized Laboratory 

1790 AB means a Laboratory AB that has a recognition agreement with EPA under the TSCA 

1791 Title VI Third-Party Certification Program. 
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1792 EPA Recognized Product Accreditation Body or EPA Recognized Product AB

1793 means a Product AB that has a recognition agreement with EPA under the TSCA Title VI 

1794 Third-Party Certification Program. 

1795 Laboratory Accreditation Body or Laboratory AB means an accreditation body 

1796 that accredits laboratories to ISO/IEC 17025:2005(E) (incorporated by reference, see § 

1797 770.99). 

1798 Panel producer means a manufacturing plant or other facility that manufactures 

1799 (excluding imports) hardwood plywood, particle board, or medium density fiberboard. 

1800 Product Accreditation Body or Product AB means an accreditation body that 

1801 accredits conformity assessment bodies to ISO/IEC Guide 65:1996(E) (incorporated by 

1802 reference, see § 770.99) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 

1803 770.99). 

1804 TSCA Title VI Accredited Third-Party Certifier or TSCA Title VI Accredited TPC

1805 means an organization or entity that is accredited by an EPA recognized Product AB and 

1806 an EPA recognized Laboratory AB pursuant to § 770.7 (c)(1).

1807 Subpart B—TSCA Title VI Third-Party Certification Program 

1808 § 770.7 Third-party certification. 

1809 (a) Product ABs--(1) Qualifications. To apply to be recognized by EPA as a 

1810 Product AB, a candidate Product AB must: 

1811 (i) Be a signatory to the International Accreditation Forum, Inc.’s (IAF) 

1812 Multilateral Recognition Arrangement (MLA) through level 3, or an equivalent 

1813 organization. 

1814 (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference, 
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1815 see § 770.99) and maintain that conformity. 

1816 (iii) Demonstrate basic competence to perform accreditation activities for product 

1817 certification according to ISO/IEC Guide 65:1996(E) (incorporated by reference, see § 

1818 770.99). 

1819 (iv) Demonstrate competence to perform accreditation activities for inspection 

1820 certification according to ISO/IEC 17020:1998(E) (incorporated by reference, see § 

1821 770.99). 

1822 (2) Recognition. To be recognized by EPA, a Product AB must apply to EPA by 

1823 fulfilling the requirements in the paragraphs (a)(2)(i)-(ii) of this section: 

1824 (i) Submitting an application to the EPA with the following information: 

1825 (A) Name, address, telephone number, and email address of primary contact. 

1826 (B) Documentation of its IAF MLA signatory status, or equivalent. 

1827 (C) If not a domestic entity, name and address of an agent for service located in 

1828 the United States. Service on this agent constitutes service on the AB or any of its 

1829 officers or employees for any action by EPA or otherwise by the United States related to 

1830 the requirements of this subpart. 

1831 (D) Description of any other qualifications related to its experience in performing 

1832 product accreditation of conformity assessment bodies or TPCs of manufactured 

1833 products. 

1834 (ii) Entering into a recognition agreement with EPA that describes the Product 

1835 AB’s responsibilities under this subpart. 

1836 (A) Each recognition agreement will be valid for 3 years. 
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1837 (B) To renew a recognition agreement for additional 3 year periods, the Product 

1838 AB must submit an application for renewal (before the 3 year period of the recognition 

1839 agreement lapses) that indicates any changes from the Product AB’s initial application. 

1840 (C) If a Product AB fails to submit an application for renewal prior to the 

1841 expiration of the previous recognition agreement, its recognition will lapse and the 

1842 Product AB may not provide TSCA Title VI accreditation services. 

1843 (D) If the Product AB does submit an application for renewal prior to the 

1844 expiration of the previous recognition agreement, it may continue to provide TSCA Title 

1845 VI accreditation services under the terms of its previous recognition agreement until EPA 

1846 has taken action on its application for renewal of the recognition agreement. 

1847 (3) Responsibilities. EPA recognized Product ABs must fulfill the requirements in 

1848 paragraphs (a)(3)(i)-(xiv) of this section: 

1849 (i) Receive and act on applications for accreditation from TPCs. 

1850 (ii) Assign a unique number to each accredited TPC. 

1851 (iii) Forward a copy of a TPC’s application for TSCA Title VI accreditation to 

1852 EPA at the address identified in the recognition agreement within 90 days of the date of 

1853 receipt. 

1854 (iv) Perform an in-depth systems audit, as described in this unit, on each TPC 

1855 applicant who submits a complete application at the time of initial application. The 

1856 systems audit must include the components described in paragraphs (3)(iv)(A)-(F) of this 

1857 section: 

1858 (A) An on-site assessment by the Product AB to determine whether the TPC 

1859 applicant’s program requirements are consistent with ISO/IEC Guide 65:1996(E) and 
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1860 ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99). The Product AB must 

1861 develop a checklist that lists all of the key conformity elements of ISO/IEC Guide 

1862 65:1996(E) and ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99) and 

1863 the Product ABs must use the checklist for each on-site assessment. 

1864 (B) A review of the approach that the TPC applicant will use to verify the 

1865 accuracy of the formaldehyde emissions tests conducted by the TPC laboratory or 

1866 contract laboratory and the formaldehyde quality control tests conducted by the panel 

1867 producers producing composite wood products that are subject to the requirements of 

1868 TSCA Title VI. 

1869 (C) A review of the approach that the TPC applicant will use for evaluating a 

1870 panel producer’s quality assurance and quality control processes, the qualifications of the 

1871 panel producer’s quality assurance and quality control personnel, the required elements of 

1872 a panel producer’s quality assurance and quality control manual, and sufficiency of on1873 site testing facilities as applicable. 

1874 (D) A review of the approach that the TPC applicant’s laboratory will use for 

1875 establishing correlation or equivalence between alternative formaldehyde test methods 

1876 and ASTM E1333-10 (incorporated by reference, see § 770.99). 

1877 (E) A review of the approach that the TPC applicant will use for evaluating the 

1878 process for sample selection, handling, and shipping procedures, if applicable, that the 

1879 panel producer will use for quality control testing. 

1880 (F) A review of the accreditation credentials of the laboratory that the TPC 

1881 applicant will use. The review must ensure that the laboratory has been accredited to 

1882 ISO/IEC 17025:2005(E) (incorporated by reference, see § 770.99) by a Laboratory AB 
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1883 that is a signatory to the ILAC MRA or equivalent. 

1884 (v) Upon request, allow EPA representatives to accompany its assessors during an 

1885 on-site assessment to observe the audit of a TPC. 

1886 (vi) Accredit TPCs that submit a complete application as described in § 

1887 770.7(c)(1)(i) and that meet the requirements of § 770.7(c). 

1888 (vii) Conduct a follow-up systems audit, including an on-site assessment, of each 

1889 TPC that the AB has accredited at least every 2 years. 

1890 (viii) Suspend, modify, or revoke the accreditation of a TPC in accordance with § 

1891 770.7(e). 

1892 (ix) Provide written notifications to EPA at the address identified in the 

1893 recognition agreement, as follows: 

1894 (A) Notification of loss of its status as a signatory to the IAF MLA (or 

1895 membership in an equivalent organization) must be provided to EPA within 5 business 

1896 days of the date that the body receives notification of the loss of its signatory status. 

1897 (B) Notification of the TSCA Title VI accreditation of a TPC must be provided to 

1898 EPA within 5 business days of the date that the TPC is accredited. 

1899 (C) Notification that an accredited TPC has failed to comply with any provision 

1900 of this section must be provided to EPA within 24 hours of the time the Product AB 

1901 identifies the failure. 

1902 (D) Notification of suspension or revocation of a TPC’s accreditation must be 

1903 provided to EPA within 24 hours of the time that the suspension or revocation takes 

1904 effect. 

1905 (E) Notification of a decision to make changes in its organizational policies or 
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1906 management structure that could adversely affect the TPC accreditation program must be 

1907 provided to EPA within 30 days of the decision to make the changes. 

1908 (x) If the Product AB is removed or withdraws from the TSCA Title VI Third1909 Party Certification Program, notification must be given to all of the TPCs that receive its 

1910 accreditation services within 5 business days. 

1911 (xi) Maintain the checklists and other records documenting compliance with the 

1912 requirements for systems audits and on-site assessments of TPCs for as long as the TPC 

1913 is accredited or for 5 years, whichever is longer.3 years. These records must be in 

1914 electronic form, and the Product AB must provide them to EPA within 30 days upon 

1915 request. 

1916 (xii) Provide a report to EPA at least once each year (12 months from the 

1917 anniversary of the date of the recognition agreement), that includes the number and 

1918 locations of systems audits and on-site assessments performed. 

1919 (xiii) Meet with EPA at least once every 2 years to discuss the implementation of 

1920 the TPC accreditation program. 

1921 (xiv) Allow inspections by EPA, conducted at reasonable times, within reasonable 

1922 limits, and in a reasonable manner, upon the presentation of appropriate credentials and a 

1923 written notification to the Product AB. 

1924 (b) Laboratory ABs--(1) Qualifications. To apply to be recognized by EPA as a 

1925 Laboratory AB, a candidate Laboratory AB must: 

1926 (i) Be a signatory to the ILAC MRA, or an equivalent organization. 

1927 (ii) Be in conformance with ISO/IEC 17011:2004(E) (incorporated by reference. 

1928 see § 770.99) and maintain that conformity. 
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1929 (iii) Demonstrate competence to perform accreditation activities for laboratory 

1930 accreditation according to ISO/IEC 17025:2005(E) (incorporated by reference, see § 

1931 770.99). 

1932 (2) Recognition. To be recognized by EPA, a Laboratory AB must apply to EPA 

1933 by fulfilling the requirements in paragraphs (b)(2)(i)-(ii) of this section: 

1934 (i) Submit an application to the EPA with the information listed in paragraphs 

1935 (b)(2)(i)(A)-(D) of this section (if the accreditation body is also applying to be recognized 

1936 as a Product AB, this application may be submitted in conjunction with the Product AB 

1937 application): 

1938 (A) Name, address, telephone number, and email address of primary contact. 

1939 (B) Documentation of ILAC MRA signatory status, or equivalent. 

1940 (C) If not a domestic entity, name and address of an agent for service located in 

1941 the United States. Service on this agent constitutes service on the AB or any of its 

1942 officers or employees for any action by EPA or otherwise by the United States related to 

1943 the requirements of this subpart. 

1944 (D) Description of any other qualifications related to the Laboratory AB’s 

1945 experience in performing laboratory accreditation and inspection certification of 

1946 conformity assessment bodies or TPCs. 

1947 (ii) Enter into a recognition agreement with EPA that describes the Laboratory 

1948 AB’s responsibilities under this subpart. 

1949 (A) Each recognition agreement will be valid for 3 years. 

1950 (B) To renew a recognition agreement for additional 3 year periods, the 

1951 Laboratory AB must submit an application for renewal (before the 3 year period of the 
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1952 recognition agreement lapses) that indicates any changes from the Laboratory AB’s 

1953 initial application. 

1954 (C) If the Laboratory AB does submit an application for renewal prior to the 

1955 expiration of the previous recognition agreement, it may continue to provide TSCA Title 

1956 VI accreditation services under the terms of its previous recognition agreement until EPA 

1957 has taken action on its application for renewal of the recognition agreement. 

1958 (3) Responsibilities. EPA recognized Laboratory ABs must fulfill the 

1959 requirements in paragraphs (b)(3)(i)-(xiii) of this section: 

1960 (i) Receive and act on applications for laboratory accreditation from TPC 

1961 laboratories (including contract laboratories). 

1962 (ii) Within 15 days of a request by a TPC or their EPA recognized Product AB, 

1963 forward copies of a TPC’s TSCA Title VI laboratory application and accreditation 

1964 documentation to the applicable EPA recognized Product AB (if the Laboratory AB is 

1965 not also recognized as a Product AB) at the address identified by the TPC. 

1966 (iii) Perform an in-depth systems audit on the laboratory of each TPC applicant 

1967 who submits a complete application at the time of initial application. The systems audit 

1968 must include: 

1969 (A) An on-site assessment by the Laboratory AB to determine whether the TPC 

1970 applicant’s laboratory is consistent with all regulatory requirements and ISO/IEC 

1971 17025:2005(E) (incorporated by reference, see § 770.99). 

1972 (B) Include a checklist that lists all of the key conformity elements of ISO/IEC 

1973 17025:2005(E) (incorporated by reference, see § 770.99) and the Laboratory AB’s 

1974 assessors must use the checklist for each on-site assessment. 
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1975 (iv) Upon request, allow EPA representatives to accompany its assessors during 

1976 an on-site assessment to observe the audit of a TPC. 

1977 (v) Accredit laboratories that submit a complete application as described in 

1978 § 770.7(c)(1)(ii) and that continue to meet the requirements of § 770.7(c). 

1979 (vi) Verify the accuracy of the formaldehyde emissions tests conducted by the 

1980 TPC laboratory through an inter-laboratory comparison or proficiency testing program if 

1981 available. 

1982 (vii) Conduct a follow-up systems audit at least every 2 years, including an on-site 

1983 assessment, of each TPC laboratory that the accreditation body has accredited. TPCs’ 

1984 laboratories that have not adequately performed an inter-laboratory comparison or 

1985 proficiency testing must be audited at least once each year for a period of 2 years from 

1986 the date of the latest poor proficiency test or inter-laboratory comparison. 

1987 (viii) Suspend, modify, or revoke the accreditation of TPCs’ laboratories in 

1988 accordance with § 770.7(e). 

1989 (ix) Provide the following written notifications to EPA and to the applicable EPA 

1990 recognized Product AB (if the Laboratory AB is not also recognized as a Product AB) at 

1991 the address identified in the recognition agreement: 

1992 (A) Notification of loss of its status as a signatory to the ILAC MRA, or 

1993 membership in an equivalent organization, must be provided within 5 business days of 

1994 the date that the body receives notice of the loss of its signatory status. 

1995 (B) Notice of accreditation of a TPC’s laboratory must be provided within 5 

1996 business days of the date that the laboratory is accredited. 

1997 (C) Notice that an accredited laboratory has failed to comply with any provision 
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1998 of this section must be provided within 24 hours of the time the Laboratory AB identifies 

1999 the failure. 

2000 (D) Notice that an accredited TPC has failed to comply with any provision of this 

2001 section must be provided within 24 hours of the time the Laboratory AB identifies the 

2002 failure. 

2003 (E) Notice of a decision to make changes in its organizational policies or 

2004 management structure that could adversely affect the laboratory accreditation program 

2005 must be provided to EPA within 30 days of the decision to make the changes. 

2006 (F) Notice if the Laboratory AB suspends or revokes a laboratory’s accreditation 

2007 must be provided within 24 hours of the time that the suspension or revocation takes 

2008 effect. 

2009 (x) Maintain checklists and other records documenting compliance with the 

2010 requirements for systems audits and on-site assessments of laboratories must be retained 

2011 for as long as the laboratory is accredited or for 5 years, whichever is longer.3 years. 

2012 These records must be in electronic form and provided to EPA within 30 days of request. 

2013 (xi) Provide a report to EPA at least once each year (12 months from the date of 

2014 the recognition agreement) that includes the following information: 

2015 (A) The names and contact information of all the TSCA Title VI accredited TPC 

2016 laboratories. 

2017 (B) Number and locations of systems audits and on-site assessments performed. 

2018 (C) Results of inter-laboratory comparisons or proficiency testing for each of the 

2019 AB’s TSCA Title VI accredited TPC laboratories, if such an EPA recognized inter2020 laboratory comparisons or proficiency testing program is available. 
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2021 (xii) Meet with EPA at least once every 2 years to discuss the implementation of 

2022 the laboratory accreditation program. 

2023 (xiii) Allow inspections by EPA, conducted at reasonable times, within reasonable 

2024 limits, and in a reasonable manner, upon the presentation of appropriate credentials and 

2025 written notice to the laboratory accreditation body. 

2026 (c) Third-party certifiers--(1) Qualifications. In order to participate as a TPC of 

2027 composite wood products under TSCA Title VI, a TPC must apply to an EPA recognized 

2028 Product AB. In its application the TPC must demonstrate that it has been accredited by an 

2029 EPA recognized Laboratory AB, unless the TPC is applying to an EPA recognized 

2030 Product AB that is also an EPA recognized Laboratory AB and the TPC is seeking both 

2031 accreditations from this single AB. In such a case, the TPC will obtain the required 

2032 product and laboratory accreditations pursuant to ISO/IEC Guide 65:1996(E) and 

2033 ISO/IEC 17025:2005(E), respectively, from the EPA recognized Product AB. 

2034 (i) To participate in the TSCA Title VI Third-Party Certification Program, a TPC 

2035 must submit an application to an EPA recognized Product AB every 23 years that 

2036 includes the elements in paragraphs (c)(1)(i)(A)-(D) of this section: 

2037 (A) Name, address, telephone number, and email address of primary contact. 

2038 (B) If not a domestic entity, name and address of an agent for service located in 

2039 the United States. Service on this agent constitutes service on the TPC or any of its 

2040 officers or employees for any action by EPA or otherwise by the United States related to 

2041 the requirements of this subpart. 

2042 (C) Type of composite wood products that the applicant intends to certify if 

2043 accredited. 
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2044 (D) Description of the TPC’s qualifications, including indications that the TPC 

2045 has: 

2046 (1) Experience or ability in product certification and complying with ISO/IEC 

2047 Guide 65:1996(E) (incorporated by reference, see § 770.99). 

2048 (2) Experience in the composite wood product industry with the specific 

2049 product(s) the applicant intends to certify. 

2050 (3) Ability to conduct inspections and properly train and supervise inspectors 

2051 pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 770.99). 

2052 (ii) To be accredited by a laboratory accreditation body under TSCA Title VI, a 

2053 TPC or its laboratories must submit an application to an EPA recognized Laboratory AB 

2054 every 23 years that includes the elements in paragraphs (c)(1)(ii)(A)-(C) of this section: 

2055 (A) Name, address, telephone number, and email address of primary contact. 

2056 (B) If not a domestic entity, name and address of an agent for service located in 

2057 the United States. Service on this agent constitutes service on the TPC or any of its 

2058 officers or employees for any action by EPA or otherwise by the United States related to 

2059 the requirements of this subpart. 

2060 (C) Description of the TPC’s laboratory’s qualifications, including indications 

2061 that the TPC’s laboratory has: 

2062 (1) Experience in performing or verifying formaldehyde testing on composite 

2063 wood products. 

2064 (2) Experience complying with ISO/IEC 17025:2005(E) (incorporated by 

2065 reference, see § 770.99). 

2066 (3) Experience with test method ASTM E1333-10 (incorporated by reference, see 
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2067 § 770.99) and experience evaluating correlation between test methods. 

2068 (2) Responsibilities. To maintain participation in the TPC TSCA Title VI 

2069 program, TSCA Title VI accredited TPCs must fulfill the requirements in 

2070 paragraphs(c)(2)(i)-(xvi) of this section: 

2071 (i) Verify that panel producers have adequate quality assurance and quality 

2072 control procedures and are complying with applicable quality assurance and quality 

2073 control requirements pursuant to TSCA Title VI, including the requirements of this 

2074 subpart. 

2075 (ii) Verify quality control test results compared with ASTM E1333-10 

2076 (incorporated by reference, see § 770.99) test results by having TPC laboratories conduct 

2077 quarterly tests and evaluate test method equivalence. 

2078 (iii) Review applications from panel producers for reduced testing, approve an 

2079 application within 90 days of receipt if it demonstrates that the requirements for reduced 

2080 testing under TSCA Title VI are met, and notify EPA of all approvals for reduced testing 

2081 within 5 days of the approval, and forward copies of all approved applications for 

2082 reduced test to EPA within 30 days of receipt. 

2083 (iv) Establish quality control limits in consultation with panel producers and, if 

2084 applicable, shipping quality control or other limits for each panel producer, product type, 

2085 and production line. 

2086 (v) Establish for each panel producer the process that will be used to determine if 

2087 product lots are exceeding the applicable quality control limit. 

2088 (vi) Inspect and audit panel producers and products and their records at least 

2089 quarterly and pursuant to ISO/IEC 17020:1998(E) (incorporated by reference, see § 
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2090 770.99). 

2091 (vii) Use only laboratories that have been accredited by an EPA recognized 

2092 Laboratory AB and participate in an EPA-approved inter-laboratory comparison or 

2093 proficiency testing program and ensure the results of the EPA-approved inter-laboratory 

2094 comparison or proficiency testing program are provided to the Laboratory AB. 

2095 (viii) Certify composite wood product types that comply with the emission 

2096 standards of TSCA Title VI and this subpart, following ISO/IEC Guide 65:1996(E) 

2097 (incorporated by reference, see § 770.99). 

2098 (ix) Provide its accreditation number to the panel producer for labeling and 

2099 recordkeeping. 

2100 (x) Maintain the following records, in electronic form, for 53 years from the date 

2101 the record is created, and provide them to EPA within 30 days of the request: 

2102 (A) A list of panel producers and their respective product types, including resins 

2103 used, that the TPC has certified. 

2104 (B) Results of inspections, audits, and emission tests conducted for and linked to 

2105 each panel producer and product type. 

2106 (C) A list of laboratories used by the TPC, as well as test methods, including test 

2107 conditions and conditioning time, and test results. 

2108 (D) Methods and results for establishing test method correlations and equivalence. 

2109 (xi) Provide an annual report to its accreditation body or bodies (Product AB and 

2110 Laboratory AB) and to EPA that contains the following: 

2111 (A) A list of panel producers and their products that the TPC has certified during 

2112 the previous year, including resins used and the average and range of formaldehyde 
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2113 emissions by panel producer, resin, and product type. 

2114 (B) A list of any non-complying products or events by panel producers. 

2115 (C) A list of laboratories and test methods used by the TPC. 

2116 (xii) Inform its accreditation body or bodies (Product AB and Laboratory AB) 

2117 within 30 days of any changes in personnel qualifications, procedures, or laboratories 

2118 used by the TPC. 

2119 (xiii) Allow inspections by EPA, conducted at reasonable times, within reasonable 

2120 limits, and in a reasonable manner, upon the presentation of appropriate credentials and 

2121 of a written notice to the TPC. 

2122 (xiv) If not a domestic entity, the TPC must maintain an agent for service located 

2123 in the United States and notify EPA of any changes in the name or address of that agent 

2124 within 5 business days. 

2125 (xv) Participate an inter-laboratory comparison or proficiency testing program 

2126 annually, or use only contract laboratories that participate in such a program. 

2127 (xvi) If a TPC or its laboratory loses its accreditation or discontinues participation 

2128 in the program for any reason, it must notify EPA and all the panel producers it provides 

2129 TSCA Title VI certification services to within 3 business days. 

2130 (d) Third-party certifiers approved by the California Air Resources Board. TPCs 

2131 approved by the California Air Resources Board as of [date 60 days after date of 

2132 publication of the final rule in the Federal Register] may certify composite wood 

2133 products under TSCA Title VI until [date 1 year after date of publication of the final rule 

2134 in the Federal Register] as long as they remain approved by the California Air 

2135 Resources Board for that period and comply with all aspects of this subpart other than the 
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2136 accreditation requirements of paragraph (c)(1) of this section. In lieu of the accreditation 

2137 number required to be provided according to paragraph (c)(2)(ix) of this section, a TPC 

2138 approved by CARB according to this section must provide the panel producer with the 

2139 TPC number issued by CARB. For a TPC approved by CARB according to this section, 

2140 the annual report under paragraph (c)(2)(xi) of this section must be provided to CARB in 

2141 lieu of the AB. After [date 1 year after date of publication of the final rule in the Federal 

2142 Register], no TPC may certify composite wood products under TSCA Title VI unless the 

2143 TPC is accredited in accordance with paragraph (c)(1) of this section. 

2144 (e) Suspension, revocation, or modification of recognition or accreditation--(1) 

2145 Third-party certifiers. EPA or an AB may suspend, revoke, or modify the accreditation of 

2146 a TPC or a TPC laboratory, if the TPC or TPC laboratory: 

2147 (i) Fails to comply with any requirement of TSCA Title VI or this subpart; 

2148 (ii) Makes any false or misleading statements on its application, records, or 

2149 reports; or 

2150 (iii) Makes substantial changes to personnel qualifications, procedures, or 

2151 laboratories that make the TPC or TPC laboratory unable to comply with any applicable 

2152 requirements of this subpart. 

2153 (2) ABs. EPA may suspend, revoke, or modify the recognition of an AB if the AB: 

2154 (i) Fails to comply with the requirements of the applicable recognition 

2155 agreement(s) (the International Accreditation Forum Multilateral Recognition 

2156 Arrangement and the International Laboratory Accreditation Cooperation Mutual 

2157 Recognition Agreement or equivalent(s)); 

2158 (ii) Fails to comply with any requirement of TSCA Title VI or this subpart; 
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2159 (iii) Makes any false or misleading statements on its application, records, or 

2160 reports; or 

2161 (iv) Makes substantial changes to personnel qualifications or procedures that 

2162 make the TPC unable to comply with any applicable requirements of this subpart. 

2163 (3) Process for suspending, revoking, or modifying accreditation or recognition.

2164 (i) Prior to taking action to suspend, revoke, or modify accreditation or 

2165 recognition, EPA or the accreditation body will notify the recognized AB or the 

2166 accredited TPC or TPC laboratory in writing of the following: 

2167 (A) The legal and factual basis for the proposed suspension, revocation, or 

2168 modification. 

2169 (B) The anticipated commencement date and duration of the suspension, 

2170 revocation, or modification. 

2171 (C) Actions, if any, which the affected AB or TPC or TPC laboratory may take to 

2172 avoid suspension, revocation, or modification, or to receive accreditation in the future. 

2173 (D) The opportunity and method for requesting a hearing with EPA prior to final 

2174 suspension, revocation, or modification. 

2175 (ii) If the affected AB or TPC or TPC laboratory requests a hearing in writing to 

2176 EPA within 30 days of receipt of the notification, EPA will: 

2177 (A) Provide the affected accreditation body or TPC or TPC laboratory an 

2178 opportunity to offer written statements in response to EPA’s or the accreditation body’s 

2179 assertions of the legal and factual basis for the proposed action. 

2180 (B) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 

2181 The Presiding Officer will: 
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2182 (1) Conduct a fair, orderly, and impartial hearing within 90 days of the request for 

2183 a hearing. 

2184 (2) Consider all relevant evidence, explanation, comment, and argument 

2185 submitted. 

2186 (3) Notify the affected AB or TPC or TPC laboratory in writing within 90 days of 

2187 completion of the hearing of his or her decision and order. Such an order is a final EPA 

2188 action which may be subject to judicial review. The order must contain the basis, 

2189 commencement date, and duration of the suspension, revocation, or modification. 

2190 (iii) If EPA determines that the public health, interest, or welfare warrants 

2191 immediate action to suspend the recognition of an AB or the accreditation of a TPC or 

2192 TPC laboratory prior to the opportunity for a hearing, it will notify the affected AB, TPC, 

2193 or TPC laboratory of its right to request a hearing on the immediate suspension within 15 

2194 days of the suspension taking place and the procedures for the conduct of such a hearing. 

2195 (iv) Any notification, decision, or order issued by EPA under this section, any 

2196 transcript or other verbatim record of oral testimony, and any documents filed by a 

2197 certified individual or firm in a hearing under this section will be available to the public, 

2198 except as otherwise provided by TSCA section 14. Any such hearing at which oral 

2199 testimony is presented will be open to the public, except that the Presiding Officer may 

2200 exclude the public to the extent necessary to allow presentation of information which 

2201 may be entitled to confidential treatment under TSCA section 14. 

2202 (v) EPA will maintain a publicly available list of accreditation bodies whose 

2203 recognition has been suspended, revoked, modified, or reinstated and a publicly available 

2204 list of TPCs and laboratories whose accreditation has been suspended, revoked, modified, 
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2205 or reinstated. 

2206 (vi) Unless the decision and order issued under this paragraph (d)(3) of this 

2207 section specify otherwise, an AB whose recognition has been revoked or a TPC or TPC 

2208 laboratory whose accreditation has been revoked must reapply for recognition or 

2209 accreditation after the revocation ends in order to become recognized or accredited under 

2210 this subpart again. 

2211 (vii) Unless the decision and order issued under paragraph (d)(3) of this section 

2212 specifies otherwise, an AB whose recognition has been revoked or a TPC or TPC 

2213 laboratory whose accreditation has been revoked, must immediately notify all TPCs or 

2214 panel producers to which it provides TSCA Title VI accreditation or certification services 

2215 of the revocation. 

2216 (f) Process for denying a TSCA Title VI accreditation--(1) Upon denying to 

2217 accredit a TPC or a TPC laboratory for failure to submit a complete application, the 

2218 accreditation body will notify the TPC or TPC laboratory in writing of the following: 

2219 (i) The legal and factual basis for the denial. 

2220 (ii) Actions, if any, which the affected TPC or TPC laboratory may take to receive 

2221 accreditation in the future. 

2222 (iii) The opportunity and method for requesting a hearing with EPA. 

2223 (2) If the affected TPC or TPC laboratory requests a hearing in writing to EPA 

2224 within 30 days of receipt of the notice, EPA will: 

2225 (i) Provide the affected TPC or TPC laboratory an opportunity to offer written 

2226 statements in response to the legal and factual basis for the denial. 

2227 (ii) Appoint an impartial EPA official as Presiding Officer to conduct the hearing. 
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2228 The Presiding Officer will: 

2229 (A) Conduct a fair, orderly, and impartial hearing within 90 days of the request 

2230 for a hearing. 

2231 (B) Consider all relevant evidence, explanation, comment, and argument 

2232 submitted. 

2233 (C) Notify the affected TPC or TPC laboratory in writing within 90 days of 

2234 completion of the hearing of his or her decision and order. Such an order is a final agency 

2235 action which may be subject to judicial review. The order must contain the basis for the 

2236 denial. 

2237 (3) Any notification , decision, or order issued by EPA under this section, any 

2238 transcript or other verbatim record of oral testimony, and any documents filed by a 

2239 certified individual or firm in a hearing under this section will be available to the public, 

2240 except as otherwise provided by TSCA section 14. Any such hearing at which oral 

2241 testimony is presented will be open to the public, except that the Presiding Officer may 

2242 exclude the public to the extent necessary to allow presentation of information which 

2243 may be entitled to confidential treatment under TSCA section 14. 

2244 (g) Process of seeking alternate accreditations or certifications--(1) If AB is 

2245 removed or withdraws from the TSCA Title VI Third-Party Certification Program: 

2246 (i) For reasons other than fraud or providing false or misleading statements, or 

2247 other than a reason that implicates a particular TPC in a violation of TSCA Title VI or its 

2248 implementing regulations, TPCs accredited by that AB have 365 days, or 180 days if less 

2249 than 365 days were left on their 23 year accreditation period, to be accredited again by an 

2250 alternate EPA recognized AB. 
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2251 (ii) Due to fraud or providing false or misleading statements with respect to a 

2252 particular TPC, or for any other reason that implicates a particular TPC in a violation of 

2253 TSCA Title VI or its implementing regulations, that TPC may not provide any TSCA 

2254 Title VI certification services until it has been accredited by an alternate EPA recognized 

2255 AB. 

2256 (2) If a TPC loses its accreditation or discontinues participation in the program: 

2257 (i) For reasons other than fraud or providing false or misleading statements, or 

2258 other than a reason that implicates a particular panel producer in a violation of TSCA 

2259 Title VI or its implementing regulations, the panel producers that used the TPC to certify 

2260 their products must enlist another TPC to certify their products within 3 months (90 days) 

2261 . During the time a panel producer is seeking a new TPC, it must continue to comply with 

2262 all other requirements of TSCA Title VI and its implementing regulations, including 

2263 quality control testing. 

2264 (ii) Due to fraud or providing false or misleading statements with respect to a 

2265 particular panel producer, or for any other reason that implicates a particular panel 

2266 producer in a violation of TSCA Title VI or its implementing regulations, that panel 

2267 producer may not offer regulated composite wood products for sale in the United States 

2268 until its composite wood products have been recertified by another TPC. 

2269 § 770.9 Prohibited Acts.

2270 (a) Failure or refusal to comply with any requirement of TSCA section 601 (15 

2271 U.S.C. 2697) or this subpart part is a violation of TSCA section 15 (15 U.S.C. 2614). 
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2272 (b) Failure or refusal to establish and maintain records or to make available or 

2273 permit access to or copying of records, as required by this subpart, is a violation of TSCA 

2274 section 15 (15 U.S.C. 2614). 

2275 (c) Violators may be subject to civil and criminal sanctions pursuant to TSCA 

2276 section 16 (15 U.S.C. 2615) for each violation. 

2277 Subpart C--[Reserved] 

2278 Subpart D--Incorporation by reference 

2279 § 770.99 Incorporation by reference. 

2280 The materials listed in this section are incorporated by reference into this part 

2281 with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 

2282 CFR part 51. To enforce any edition other than that specified in this section, a document 

2283 must be published in the Federal Register and the material must be available to the 

2284 public. All approved materials are available for inspection at the OPPT Docket in the 

2285 EPA Docket Center (EPA/DC) at Rm. 3334, EPA, West Bldg., 1301 Constitution Ave., 

2286 NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 

2287 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone 

2288 number of the EPA/DC Public Reading room is (202) 566-1744, and the telephone 

2289 number for the OPPT Docket is (202) 566-0280. In addition, these materials are 

2290 available for inspection at the National Archives and Records Administration (NARA). 

2291 For information on the availability of this material at NARA, call (202) 741-6030 or go to 

2292 http://www.archives.gov/federal_register/code_of_federal_regulations/ 

2293 ibr_locations.html. These materials may also be obtained from the sources listed in this 

2294 section. 
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2295 (a) [Reserved] 

2296 (b) ASTM material. Copies of these materials may be obtained from ASTM 

2297 International, 100 Barr Harbor Dr., PO Box C700, West Conshohocken, PA, 19428-2959, 

2298 or by calling (877) 909-ASTM, or at http://www.astm.org. 

2299 (1) ASTM D6007-02 ( Reapproved 2008) , October 1, 2008, Standard Test 

2300 Method for Determining Formaldehyde Concentrations in Air from Wood Products 

2301 Using a Small-Scale Chamber, IBR approved for § 770.7(a)-(c). 

2302 (2) ASTM D5582-00 (Reapproved 2006), October 1, 2006, Standard Test Method 

2303 for Determining Formaldehyde Levels from Wood Products Using a Desiccator, IBR 

2304 approved for § 770.7(a)-(c). 

2305 (3) ASTM E1333-10 (Approved May 1, 2010), Standard Test Method for 

2306 Determining Formaldehyde Concentrations in Air and Emission Rates from Wood 

2307 Products Using a Large Chamber, IBR approved for § 770.7(a)-(c). 

2308 (c) ISO material. Copies of these materials may be obtained from the 

2309 International Organization for Standardization, 1, ch. de la Voie-Creuse, CP 56, CH-1211 

2310 Geneve 20, Switzerland, or by calling +41-22-749-01-11, or at http://www.iso.org. 

2311 (1) ISO/IEC 17011:2004(E), Conformity Assessments--General Requirements for 

2312 Accreditation Bodies Accrediting Conformity Assessment Bodies (First Edition) 

2313 February 15, 2005, IBR approved for § 770.7(a)-(c). 

2314 (2) ISO/IEC 17020:1998(E), General Criteria for the Operation of Various Types 

2315 of Bodies Performing Inspections (First Edition), November 15, 1998, IBR approved for 

2316 § 770.7(a)-(c). 

2317 (3) ISO/IEC 17025:2005(E), General Requirements for the Competence of 
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2318 Testing and Calibration Laboratories (Second Edition), May 15, 2005, IBR approved for 

2319 § 770.7(a)-(c). 

2320 (4) ISO/IEC Guide 65:1996(E), General Requirements for Bodies Operating 

2321 Product Certification Systems (First Edition), 1996, IBR approved for § 770.7(a)-(c). 

2322 ##