Final Statement of Reasons for Rulemaking Including Summary of Comments and Agency Responses

PUBLIC HEARING TO CONSIDER

ADOPTION OF THE PROPOSED AIRBORNE TOXIC CONTROL MEA SURE

TO REDUCE FORMALDEHYDE EMISSIONS FROM

COMPOSITE WOOD PRODUCTS

Public Hearing Date: April 26, 2007 Agenda Item No.: 07-4-3i 

### Table of Contents

I. GENERAL ........................................................................................1

II. MODIFICATIONS TO THE ORIGINAL PROPOSAL ...................... ............3

III. SUMMARY OF COMMENTS AND AGENCY RESPONSES ............. .........5

A. Combined List of Commenters ........................................................ ......7

1. Written Comments Submitted during the 45-day Com ment Period Before April 26, 2007 2. Written Comments Submitted at the April 26, 2007 Public Hearing 3. Oral Testimony Delivered at the April 26, 2007 P ublic Hearing 4. Written Comments Submitted during the 15-day Com ment Period – 31 January -15 February 2008

B. Abbreviations Used in the Comments and Agency Re sponses ..................11

C. Comments and Agency Responses: 45-day Comment Pe riod ...................17

Draft Regulation .........................................................................17

• Applicable Products and Exemptions

• Definitions

• Regulatory Authority

• Sell-through Provisions

Fabricators ...............................................................................31

• Chain-of-custody and Labeling

• Economic Impacts

• Enforcement and Fair Competition

• Exemptions

• Finished Product Test Method

Importers and Imported Products ................................................... 44

• Chain-of-custody

• Economic Impacts

• Enforcement and Fair Competition

• Third Party Certification

Manufacturers ...........................................................................55

• Enforcement and Fair Competition

• Formaldehyde Emissions Standards

• Industry-wide Costs

• Panel Costsii • Panel Emissions Testing

• Process Modifications and Operating Costs

• Quality Assurance

• Resin Costs

• Third Party Certification

Miscellaneous ........................................................................100

• Air District Concerns

• Consumer Costs

• Economic Impacts

• Emission Sources

• Green Building Products

• Outreach

• Resin Technology

• Support for Rulemaking

Public Health ...........................................................................123

• Cost of Health Care

• Health Effects and Risk Assessment

D. Comments and Agency Responses: 15-day Comment Pe riod .................1961 State of California

AIR RESOURCES BOARD

Final Statement of Reasons for Rulemaking, Including Summary of Comments and Agency Response

PUBLIC HEARING TO CONSIDER ADOPTION OF THE PROPOSED

AIRBORNE TOXIC CONTROL MEASURE TO REDUCE FORMALDEHY DE

EMISSIONS FROM COMPOSITE WOOD PRODUCTS

Public Hearing Date: April 26, 2007

Agenda Item No.: 07-4-3

I. GENERAL

On April 26, 2007, the Air Resources Board (CARB or Board) conducted a public hearing to consider an Airborne Toxic Control Measu re (ATCM) to reduce formaldehyde emissions from composite wood products . The Staff Report: Initial Statement of Reasons for Proposed Rulemaking, entit led “Proposed Airborne Toxic Control Measure to Reduce Formaldehyde Emissi ons from Composite Wood Products” (ISOR) was made available to the pub lic beginning March 9, 2007. This ISOR, which is incorporated by reference herein, contains a description of the rationale for the proposed ATCM. At the hearing, the Board approved the proposed ATCM with various modificatio ns to the original proposal. These modifications were made available for public comment beginning January 31, 2008, for a period of 15 days (15-day comment p eriod).

In accordance with section 11346.9(a)(1), this Fina l Statement of Reasons for Rulemaking (FSOR) updates the ISOR by identifying a nd explaining the modifications that were made to the original propos al. The FSOR also

summarizes the written and oral comments received d uring the 45-day comment period preceding the April 26, 2007 hearing; commen ts received at the public hearing on April 26, 2007; and comments received du ring the 15-day comment period. Agency responses to the comments are also included.

Economic and Fiscal Impacts. The CARB Executive Officer has determined that the proposed regulatory action will not create costs or savings, as defined in Government Code section 11346.5(a)(5) and 11346.5(a )(6), in federal funding to the state. However, the Executive Officer has dete rmined that the proposed regulatory action will create costs to state agenci es, and local agencies, but not school districts, whether or not reimbursable by th e state pursuant to part 72

(commencing with section 17500), division 4, title 2 of the Government Code, or other nondiscretionary savings to state or local ag encies.

The proposed regulatory action will impose a mandat e upon and create costs for local air districts. Under State law, air district s are required to implement and enforce ATCMs which are adopted by CARB, or adopt a nd enforce their own rules that are at least as stringent. However, suc h administrative costs to the air districts are recoverable by fees that are within t he air district’s authority to assess (see Health and Safety Code sections 42311 a nd 40510). Therefore, the Executive Officer has determined that the proposed regulatory action imposes no costs on local agencies that are required to be rei mbursed by the State pursuant to part 7 (commencing with section 17500), division 4, title 2 of the Government Code, and does not impose a mandate on local agenci es that is required to be reimbursed pursuant to Section 6 of Article XIII B of the California Constitution.

On March 9, 2007, staff released a public hearing n otice which included an assessment of costs to State agencies. At the time of the public hearing notice, staff determined that the proposed regulatory actio n would impose a mandate upon and create costs for one State agency: the Cal ifornia Prison Industries Authority (PIA). The PIA is a major fabricator of industrial and office furniture with a projected 2006-2007 fiscal year manufacturin g revenue exceeding $100 million. As a fabricator of composite wood finishe d products, the PIA will be required to work with composite wood product suppli ers to ensure that they use compliant products and comply with the recordkeepin g and labeling requirements of the ATCM. The California PIA would also pay mor e for the composite wood products used to make furniture, as described below

.

Since the release of the public hearing notice, sta ff has conducted a more detailed evaluation of the costs to State agencies. In addition to PIA’s expected cost increase of $460,000 to $570,000, staff determ ined that the proposed regulatory action will also impose costs for the Ca lifornia Department of Transportation (CDOT) ranging from $530,000 to $600 ,000 and additional costs for the California Department of Recreation and Par ks (CDRP) ranging from $100,000 to $120,000. As with PIA, both the CDOT a nd the CDRP will incur higher costs for the composite wood products they c urrently use for new projects, maintenance and services throughout California.

The Department of General Services (DGS) was also c onsidered in the assessment of cost impacts to state agencies becaus e of its role in purchasing office systems for state agencies throughout Califo rnia. It is estimated that the incremental cost increase to DGS for purchases of n ew office systems and workstations containing composite wood products (i. e., particleboard) will be approximately $260,000 per year.

Lastly, cost increases are anticipated for the impl ementation of the Airborne Toxic Control Measure by CARB. Additional staff wi ll be needed to review the3

applications from manufacturers and third party cer tifiers, inspect businesses involved with the sale, supply, or use of composite wood products, and for enforcement-related product emissions testing. Add itional equipment and contract funds will be needed for field-screening t ests by CARB inspectors and for operating and maintaining the composite wood pr oducts emissions testing complex and sample preparation laboratory. The tot al cost for staff and equipment to enforce the regulation is $1,240,000.

The Board’s Executive Officer has also determined t hat pursuant to Government Code section 11346.5(a)(5), the ATCM will affect sm all businesses. Staff estimates that profitability for these businesses c ould decline from 1 to about 65 percent in order to comply with the proposed amendm ents. A detailed description of these impacts is included in the ISOR. The adopt ed regulations are considered “major regulations” within the meaning of Health an d Safety Code section 57005 (enacted by Senate Bill 1082: Stats. 1993, ch. 418) . No reasonable alternative considered by the agency or that has otherwise been identified and brought to the attention of the agency would be more effective in carrying out the purpose for which the regulatory action was proposed, or wo uld be as effective and less burdensome to affected private persons or businesse s, including small businesses, than the action taken by the CARB.

In accordance with Government Code sections 11346.3 (c) and 11346.5(a)(11), the Executive Officer has found that the proposed r eporting requirements of the ATCM which apply to businesses are necessary for th e health, safety, and welfare of the people of the State of California.

II. MODIFICATIONS TO THE ORIGINAL PROPOSAL

Various modifications to the original proposal were made to address comments received during the 45-day comment period preceding the April 26, 2007 hearing; comments received at the April 26, 2007 hearing; an d to clarify the regulatory language. These modifications are described below. A “Notice of Public Availability of Modified Text,” together with a cop y of the modified sections of the ATCM, was mailed on January 31, 2008, to each of th e individuals described in subsections (a)(1) through (a)(4) of section 44, ti tle 1, California Code of Regulations (CCR), including all people who submitt ed written or oral comments. Additionally, this notice was made available on CAR B’s website on the same date. By these actions, the modified ATCM was made available to the public for a supplemental comment period from January 31, 2008 to February 15, 2008. After the close of the 15-day comment period, the B oard’s Executive Officer

determined that no additional modifications should be made to the ATCM. The Executive Officer subsequently issued Executive Ord er R-08-001, which adopted the ATCM. Following is a summary of the modificati ons made to the originally proposed regulation.4

Summary of Proposed Modifications

1. Compliance testing flexibility for ultra-low-emi tting formaldehyde (ULEF)

resins has been added. Section 93120.3 has been re vised so that manufacturers of composite wood products with ULEF resins that can demonstrate consistent average emissions below Phas e 2 standards will not be required to conduct emission tests of their products as frequently as otherwise required. Section 93120.7 and Appendi x 2 of the ATCM have been modified to clarify labeling and testing requirements associated

with ULEF resin use.

2. More specificity and flexibility has been added to the quality assurance requirements for manufacturers contained in Appendi x 2 of the ATCM.

3. More specificity and clarity has been added to t he requirements for third party certifiers contained in Appendix 3 of the ATC M.

4. Producers of architectural plywood and fabricato rs that apply a laminate to a composite wood product that complies with the app licable emission standards are proposed to be considered collectivel y as fabricators of “laminated products.” These fabricators only need to comply with the requirements of section 93120.7 by verifying that t hey use complying core materials. In section 93120.1, the definition of a rchitectural plywood has been deleted and a definition of “laminated product s” has been added.

5. In section 93120.1, a number of definitions have been added or modified.

6. In section 93120.1(a)(8), the definition of “c omposite wood products” has been modified to clarify which products do not fall under the definition of “composite wood products” and to include “composite wood products”

used inside of new recreational vehicles.

7. In section 93120.2(a), the Phase 2 implementatio n date for hardwood plywood with a veneer core (HWPW-VC) has been chang ed from January 1, 2011 to January 1, 2010. The sell-throu gh dates in Appendix 1

of section 93120.12 have been modified to be consis tent with this change.

8. In section 93120.3(c), specificity has been adde d to the special provisions for manufacturers of composite wood products that u se no-added formaldehyde based resins, including the informatio n required to apply for approval to use such resins and emissions performan ce criteria.

9. In section 93120.3(g), additional recordkeeping requirements were added for manufacturers that use no-added formaldehyde ba sed resins or ULEF

resins.5

10. In section 93120.4, criteria was added to allo w third party certifiers to reapply to continue to be an approved certifier.

11. In section 93120.7, exemptions have been added for local governments and school districts; and for exterior doors and ga rage doors that contain composite wood products. Requirements were clarifi ed for fabricators that manufacture composite wood products for use by the fabricator in making finished goods.

12. In section 93120.7(d), additional product label ing requirements have been

added for fabricators.

13. In section 93120.9, additional language has bee n added to allow the use of a secondary test method by third party certifier s in developing correlations with quality control test methods used by composite wood product manufacturers. Also, the section was modif ied to allow ARB to use the secondary test method for enforcement purpo ses.

14. In section 93120.12, Appendix 1, the sell-throu gh dates were changed for

manufacturers of raw boards from one month to three months, for importers of raw boards from five months to three m onths, and for fabricators of finished goods from twelve months to eighteen months.

15. In addition to the modifications described abov e, various modifications to the regulatory text have been made to improve clari ty.

III. SUMMARY OF COMMENTS AND AGENCY RESPONSES

The Board received written and oral comments during the 45-day public comment period for the proposed ATCM, at the April 26, 2007 public hearing, and during the 15-day comment period. A combined l ist of commenters is provided in subsection A below. Subsection B is a list of abbreviations used in the comments. Subsection C contains the comments, grouped by subject, and

agency responses.

In subsection C, a summary of the recommendations m ade regarding the proposed ATCM (i.e., Comment), along with an explan ation of how the proposed ATCM has been changed to accommodate the recommenda tion, as appropriate, or the reason why no change was made (i.e., Agency Response) is provided. Each comment and agency response is marked with ide ntification information in

brackets to denote:

• the number of comment letter or testimony as liste d in subsection A;

• the person(s) responsible for submitting/presentin g the comment(s);6

• the date the comment(s) was/were submitted or pres ented (i.e., 070314 [yymmdd] indicates the comment was submitted on 14 March 2007); and

• the organization(s) that submitted or presented th e comment.

For example, comments submitted from the comment le tter number 1 in subsection A are marked as: [1-Davis-070314-Regal A Q].7

A. Combined List of Commenters

Written Comments Submitted During the 45-day Commen t Period Before April 26, 2007 Public Hearing

1. Davis, Charles – 14 March 2007 (Regal Air Qualit y, Inc.) 2. Levin, Hal – 28 March 2007 (Building Ecology Res earch Group) 3. Hetzel, Joseph – 4 April 2007 (Door & Access Sys tem Manufacturers Assn.) 4. Sherman, Tom – 9 April 2007 (Cabinet Shop Owner) 5. Rink, Andrew – 13 April 2007 (Jeld-Wen) 6. Harmon, David – 13 April 2007 (Hexion Specialty Chemicals, Inc.) 7. Landry, Brock – 16 April 2007 (California Wood I ndustries Coalition) 8. Rose, Leah – 16 April 2007 (Formaldehyde Council ) 9. Haikala, Juhani – 16 April 2007 (Plywood & Door Manufacturers Group) 10. Higgins, Tom – 16 April 2007 (Formaldehyde-free Coalition) 11. Higgnis, Tom – 17 April 2007 (City of Los Angel es) 12. Higgins, Tom – 17 April 2007 (Support Letter) 13. Lent, Tom – 17 April 2007 (Healthy Building Net work) 14. Titus, Richard – 19 April 2007 (Kitchen Cabinet Manufacturers Assn.) 15. Alexeeff, George – 19 April 2007 (Office of Env iron. Health Hazard Assess.) 16. Overgard, Gail and Altman, Bill – 19 April 2007 (Hardwood Plywood & Veneer Assn.) 17. Whalen, Elizabeth – 19 April 2007 (Columbia For est Products) 18. Smith, Daniel– 19 April 2007 (Smith & Fong Comp any) 19. Cooper, Tom – 20 April 2007 (Kaiser Permanente) 20. Stensland, Jan – 20 April 2007 (Health Effects Expert) 21. Parker, Steven – 20 April 2007 (Architect) 22. Whalen, Elizabeth – 20 April 2007 (Columbia For est Products) 23. Zimmerman, Michael – 23 April 2007 (Sauder Wood working Co.) 24. Landry, Brock – 23 April 2007 (California Wood Industries Coalition) 25. Hubbard, Reginald – 23 April 2007 (Darlington V eneer Co.) 26. Stoler, Steve – 23 April 2007 (Boise Wood Produ cts) 27. Rush, Jim – 24 April 2007 (Temple Inland) 28. Maultsby, John P. – 24 April 2007 (Florida Plyw oods, Inc.) 29. Couture, Pierre-Yves – 24 April 2007 (CDM Décor Papers) 30. Hardy, Kelly – 24 April 2007 (Children Now) 31. Warberg, Will – 24 April 2007 (Plum Creek MDF) 32. Savage, Elliott – 24 April 2007 (SeeMac) 33. Wijnbergen, Peter – 24 April 2007 (Norbord Indu stries) 34. Keeling, Darrell – 24 April 2007 (Roseburg Fore st Products) 35. Guay, Phill – 24 April 2007 (Columbia Forest Pr oducts) 36. Perdue, Bill – 24 April 2007 (American Home Fur nishings Alliance) 37. Sein, Antonio – 24 April 2007 (Rexcel Particleb oard) 38. Morgan, Suzanne – 24 April 2007 (International Wood Products Assn.) 39. Maher, Gregory – 24 April 2007 (Composite Panel Assn.) 40. Smith, Michel (for James Hogg) – 24 April 2007 (Great Lakes MDF)8

41. Chaffin, John – 24 April 2007 (International Wo od Products Assn.) 42. Gustafson, Stanley – 24 April 2007 (Woodwork In stitute) 43. Raymer, Robert – 24 April 2007 (California Buil ding Industry Assn.) 44. Julia, Tom – 24 April 2007 (Composite Panel Ass n.) 45. Gregory, Wade – 24 April 2007 (SierraPine Compo site Solutions) 46. Gonyea, Joseph H., III – 24 April 2007 (Timber Products) 47. Steenson, Bruce and Dorries, Simon – 24 April 2 007 (Australian Wood Panels Assn. and Engineered Wood Products Assn. of Australasia) 48. Zeldin, Mel – 25 April 2007 (California Air Pol lution Control Officers Assn.) 49. Levin, Hal – 25 April 2007 (Building Ecology Re search Group) 50. Leverenz, Russell – 25 April 2007 (No Affiliati on) 51. Watson, Scott – 25 April 2007 (IPMG, Inc.) 52. Lent, Tom – 25 April 2007 (Healthy Building Net work) 53. Cassman, Joan and Howard, Ed – 25 April 2007 (H anson Bridgett Marcus Vlahos & Rudy) 54. Knox, James – 25 April 2007 (American Cancer So ciety) 55. Theg, Jill – 25 April 2007 (No Affiliation) 56. Carmichael, Tim – 25 April 2007 (Coalition for Clean Air) 57. Young, Jonathan – 25 April 2007 (Concerned Citi zen) 58. Blicker, David – 25 April 2007 (No Affiliation)

Written Comments Submitted at the April 26, 2007 Pu blic Hearing

59. Taylor, Carole (Veneer Products, Inc.) 60. Cassman, Joan (Hanson Bridgett Marcus Vlahos & Rudy) 61. Demorest, Harry (Columbia Forest Products) 62. Whalen, Elizabeth (Columbia Forest Products) 63. Li, Kaichang (Oregon State University) 64. Guay, Phill (Columbia Forest Products) 65. Royce, Richard (Hercules Inc.) 66. Mullen, Dave (Hercules Inc.) 67. Livingston, Gene (California Wood Industries Co alition) 68. Shull, Lee (California Wood Industries Coalitio n) 69. Murray, Jay (Formaldehyde Council, Inc.) 70. Woods, Ed (Columbia Forest Products) 71. Hunt, Jeff (Plywood & Lumber Sales) 72. Robson, Mike (Association of Woodworking & Furn ishings Suppliers) 73. Chappell, Gene (Columbia Forest Products) 74. Bradley, Doug (General Veneer Manufacturing Co. )9

Oral Testimony Delivered at the April 26, 2007 Publ ic Hearing 1

75. Carmichael, Tim (Coalition for Clean Air) – p. 110-113 76. Robson, Mike (Assn. of Woodworking & Furnishing s Suppliers) – p. 113-114 77. Natz, Betsy (Formaldehyde Council, Inc.) – p. 1 14-117 78. Murray, Jay (Formaldehyde Council, Inc.) – p. 1 17-121 79. Marsh, Gary (Formaldehyde Council, Inc.) – p. 1 21-123 80. Shull, Lee (California Wood Industries Coalitio n) – p. 123-126 81. Gregory, Wade (California Wood Industries Coali tion) – p. 126-129 82. Julia, Tom (Composite Panel Assn.) – p. 129-132 83. Warberg, Will (Plum Creek MDF) – p. 132-135 84. Keeling, Darrell (Roseburg Forest Products) – p . 135-137 85. Altman, Bill (Hardwood Plywood & Veneer Assn.) – p. 137-138 86. Compton, Charlie (Hambro Forest Products) – p. 138-141 87. Perdue, Bill (American Home Furnishings Allianc e) – p.141-144 88. Elias, Edward (APA – The Engineered Wood Assn.) – p. 144-145 89. Zimmerman, Mike (Sauder Woodworking Co.) – p. 1 45-148 90. Titus, Dick (Kitchen Cabinet Manufacturers Assn .) – p. 148-150 91. Raymer, Bob (California Building Industry Assn. ) – p. 150-152 92. Landry, Brock (California Wood Industries Coali tion) – p. 152-155 93. Livingston, Gene (California Wood Industries Co alition) – p. 155-158 94. Dopico, Pablo (Georgia-Pacific Chemicals, LLC) – p. 158-160 95. Kable, Mark (Setzer) – p. 160-164 96. Morgan, Suzanne (International Wood Products As sn.) – p. 164-167 97. Chaffin, John (International Wood Products Assn .) p. 167-169 98. Schroeder, Kelly (Wood Molding & Millwork Produ cers Assn.) – p. 169-173 99. Watson, Scott (Plywood salesman) – p. 173-176 100. Harmon, David (Hexion Specialty Chemicals) – p . 176-178 101. Korthof, Doug (No Affiliation) – p. 178-180 102. Higgins, Tom (Formaldehyde Free Coalition) – p . 180-181 103. Demorest, Harry (Columbia Forest Products) – p . 181-187 104. Woods, Ed (Columbia Forest Products) – p. 187- 189 105. Whalen, Elizabeth (Columbia Forest Products) – p. 189-192 106. Guay, Phill (Columbia Forest Products) – p. 19 2-195 107. Cassman, Joan (Hanson Bridgett Marcus Vlahos & Rudy) – p. 195-196 108. Li, Kaichang (Oregon State University) – p. 19 6-198 109. Grabiel, Charles (United Soybean Board) – p. 1 98-200 110. Royce, Richard (Hercules Inc.) – p. 200-202 111. Mullen, David (Hercules Inc.) – p. 202-206 112. Uhland, Jerry (CalAg MDF) – p. 206-208 113. Hooper, Pat (HooperWolfe) – p. 208-211 114. Fields, Rick (Neil Kelly Cabinets) – p. 211-21 3 115. Hunt, Jeff (Plywood & Lumber Sales) – p. 213-2 14 116. Gitt, Brian (Build It Green) – p. 214-217 117. Cooper, Tom (Kaiser Permanente) – p. 217-22010

118. Lent, Tom (Environmental Analyst) – p. 220-223 119. Makus, Eli (Children Now) – p. 223-225 120. Pung, Steve (Columbia Forest Products) – p. 22 5-226 121. Bradway, Dennis (Mannington) – p. 226-230 122. Schutfort, Erwin (Professional Services Indust ries, Inc.) – p. 230-233

(1) Page numbers taken from transcript at: http://www.arb.ca.gov/board/mt/2007/mt042607.txt (Accessed: 08 February 2008)

Written Comments Submitted During the 15-Day Commen t Period – 31 January - 15 February 2008

1. Davis, Charles - 03 February 2008 (Regal Air Qua lity Inc.) 2. Pardy, Linda - 05 February 2008 (No Affiliation) 3. Anderson, Michael - 12 February 2008 (Eastman Ko dak Company) 4. Hard af Segerstad, Krister - 13 February 2008 (I KEA NA Services, LLC) 5. Pitts, Eddie - 14 February 2008 (Bernhardt) 6. Lantman, Chris - 14 February 2008 (SRI Internati onal) 7. Perdue, Bill - 14 February 2008 (American Home Furnishings Alliance) 8. Titus, Dick – 14 February 2008 (Kitchen Cabinet Manufacturers Assn.) 9. Earnshaw, Scott – 14 February 2008 (Hexion, New Zealand) 10. Mann, Timothy – 15 February 2008 (IBM) 11. Zimmerman, Michael – 15 February 2008 (Sauder W oodworking Co.) 12. Fernandez, Sebastian – 15 February 2008 (Arauco ) 13. Morgan, Suzanne – 15 February 2008 (Internatio nal Wood Products Assn) 14. Julia, Thomas – 15 February 2008 (Composite Pan el Assn.) 15. Wald, Matt – 15 February 2008 (Recreational Veh icle Industry Assn.) 16. Harmon, David – 15 February 2008 (Hexion, Inc.) 17. Rabe, Jim – 15 February 2008 (Masonite Corp.) 18. Macedo, Sarah – 15 February 2008 (Formaldehyde Council, Inc.) 19. Miller, Brad – 15 February 2008 (Business & Ins titutional Furniture

Manufacturers Ass n.) 20. Bradway, Dennis – 15 February 2008 (Mannington Mills) 21. Cleet, Chris – 15 February 2008 (Information Te chnology Industry Council) 22. Howlett, Kip – 15 February 2008 (Hardwood Plywo od & Veneer Assn.) 23. Hodgson, Alfred – 15 February 2008 (Berkeley An alytical Associates) 24. Dennis, Patrick – 15 February 2008 (Gibson, Dun n, and Crutcher) 25. Clark, Randy – 15 February 2008 (Jeld-Wen, Inc .)11

B. Abbreviations Used in the Comments and Agency Re sponses

AB (California) Assembly Bill ACH Air Changes Per Hour ACS American Cancer Society ADH Alcohol Dehydrogenase AHFA American Home Furnishings Alliance

ANSI American National Standards Institute AOEC Association of Occupational and Environmenta l Clinics APA The Engineered Wood Association ARB (California) Air Resources Board ASTM American Society for Testing and Materials

ATCM Airborne Toxic Control Measure ATSDR Agency for Toxic Substances and Disease Regi stry

AuWPA Australian Wood Panels Association AWFS Association of Woodworking & Furnishings Sup pliers

BACT Best Available Control Technology BBDR Biologically Based Dose-response (model) BfR (German) Federal Institute for Risk Assessmen t BERG Building Ecology Research Group

BIFMA Business & Institutional Furniture Manufactu rers Assoc.

BMD Benchmark Dose

Boise Boise Wood Products

Build It Green Build It Green

14 C (Radioactive) Carbon-14 CalAg CalAg MDF

CAPCOA California Air Pollution Control Officers A ssociation

CARB California Air Resources Board CBIA California Building Industry Association CC (Hardwood Plywood) Composite Core

CCA Coalition for Clean Air

Children Now Children Now

CDC Centers for Disease Control CDMDP CEM Décor Papers CEGL Continuous Exposure Guidance Level CFR (or C.F.R.) Code of Federal Regulations CHPS Collaborative for High Performance Schools

CI Confidence Interval

CICAD Concise International Chemical Assessment Do cument CIIT Chemical Industries Institute of Toxicology

CO Carbon Monoxide CoLA City of Los Angeles

Columbia Columbia Forest Products CPA Composite Panel Association12

cREL Chronic Reference Exposure Level CSF Cancer Slope Factor

CWIC California Wood Industries Coalition

DASMA Door & Access System Manufacturers Associati on days/week Days per week Darlington Darlington Veneer Co. DNA Deoxyribonucleic Acid(s) DNPH Dinitrophenylhydrazine DPX DNA-protein crosslinks

E1 (European) E1 (Formaldehyde Emission Standard) E 1333 ASTM E 1333 (Emission Test Procedure) ECBI European Chemicals Bureau (report) e.g. exempli gratia (for example) EPA (U.S.) Environmental Protection Agency ES Executive Summary et al. et alii (and others)

ETS Environmental Tobacco Smoke EU European Union EWPAA Engineered Wood Products Association of Aust ralasia

F  (Japanese) F  (Formaldehyde Emission Standard) FCI Formaldehyde Council, Inc. FETEG Formaldehyde Epidemiology, Toxicology and Env ironmental

Group

FEV 1 Forced Expiratory Volume in 1-second FFC Formaldehyde-free Coalition FloPly Florida Plywoods, Inc. FRIM Forest Research Institute of Malaysia FSC Forest Stewardship Council

ft 2 /ft 3 Square Feet per Cubic Foot FVC Forced Vital Capacity

GC-MS Gas Chromatography-Mass Spectrometry g/L Grams per liter GP Georgia-Pacific Chemicals, LLC

Great Lakes Great Lakes MDF GVM General Veneer Manufacturing Co.

3 H (Radioactive) Tritium

H 2 S Hydrogen Sulfide

Hambro Hambro Forest Products HBMVR Hanson Bridgett Marcus Vlahos & Rudy HBN Healthy Building Network13

HCHO Formaldehyde

Hercules Hercules Inc. Hexion Hexion Specialty Chemicals, Inc. HooperWolfe HooperWolfe HPVA Hardwood Plywood & Veneer Association hr/day Hours per day HUD U.S. Dept. of Housing and Urban Development HWPW Hardwood Plywood HWPW-VC Hardwood Plywood-Veneer Core

IARC International Agency for Research on Cancer IBM International Business Machines Corp. i.e. id est (that is) IgE Immunoglobulin E

INRS Institut National de Recherche et de Securit e IPCS International Programme on Chemical Safety IPMG IPMG, Inc. IRIS Integrated Risk Information System

IRRST Institute of Research Robert-Sauve en santé e t en securite

du travail

ISOR Initial Statement of Reasons ITI Information Technology Industry Council

IWPA International Wood Products Association

Jeld-Wen Jeld-Wen

Kaiser Kaiser Permanente

KCMA Kitchen Cabinet Manufacturers Association kg Kilogram

LEED Leadership in Energy and Environmental Desig n LLC Limited Liability Corporation

m Meter MACT Maximum Achievable Control Technology Mannington Mannington MD (State of) Maryland MDI Methylene Diisocyanate MDF Medium Density Fiberboard mg/kg Milligrams per kilogram mg/m 3 Milligrams per cubic meter

ml/m 3 Milliliters per cubic meter Mn Manganese

MOA Mode of Action MUF Melamine Urea-formaldehyde (resin)14

NA No Affiliation (provided) NAC National Advisory Committee NAF No-added Formaldehyde (resin)

NCI National Cancer Institute Neil Kelly Neil Kelly Cabinets

NICNAS National Industrial Chemicals Notification a nd Assessment

Scheme

NIH National Institutes of Health NIOSH National Institute for Occupational Safety an d Health

NO Nitric Oxide

NO 2 Nitrogen Dioxide

Norbord Norbord Industries NPC Nasopharyngeal Cancer

NRC National Research Council NTP National Toxicology Program

NZE Near-zero Emissions

OAQPS (USEPA) Office of Air Quality Planning and S tandards OAR (USEPA) Office of Air and Radiation OECD Organisation for Economic Co-operation and D evelopment

OEHHA Office of Environmental Health Hazard Assess ment OEM Original Equipment Manufacturer

OR Odds Ratio OSU Oregon State University

PB Particleboard PDMG Plywood & Door Manufacturers Group PEC Priority Existing Chemical PEF Peak Expiratory Flow PF Phenol-formaldehyde (resin) PLS Plywood Lumber & Sales

Plum Creek Plum Creek MDF ppb Parts per billion ppm Parts per million PSI Professional Services Industries, Inc. p-trend p-trend (statistic) PVA Polyvinylacetate (resin)

RAST Radioallergosorbent Test

ref. Reference Regal AQ Regal Air Quality, Inc. REL (or RELs) Reference Exposure Level

Rexcel Rexcel Particleboard RNA Ribonucleic Acid(s) Roseburg Roseburg Forest Products

RR Relative Risk15

SB (California) Senate Bill S&F Smith & Fong Co. Sauder Sauder Woodworking Co.

SeeMac SeeMac

Setzer Setzer SIDS Screening Information Data Set SierraPine SierraPine Composite Solutions SMR Standardized Mortality Ratio SRA Society for Risk Analysis

SRP Scientific Review Panel for Toxic Air Contami nants

TAC (or TACs) Toxic Air Contaminant(s) Temple Inland Temple Inland

Timber Timber Products TWA Time-weighted Average UF Urea-formaldehyde (resin) Uniboard Uniboard, Inc. URE (Cancer) Unit Risk Estimate URF (Cancer) Unit Risk Factor U.S. (or US) United States (of America)

USA United States of America USB United Soybean Board

U.S.C. United States Code USEPA U.S. Environmental Protection Agency

VC (Hardwood Plywood) Veneer Core
Veneer Veneer Products, Inc. VOC Volatile Organic Compound(s)

vs. Versus

WHO World Health Organization WMMPA Wood Molding & Millwork Products Association

WWI Woodwork Institute

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x 10 -6 Multiplied by 0.000001

x 10 -7 Multiplied by 0.0000001

x 10 -8 Multiplied by 0.00000001

x 10 -9 Multiplied by 0.000000001

μ g Microgram(s)

μ g/g Micrograms per gram

μ g/kg Micrograms per kilogram

μ g/m 3 Micrograms per cubic meter16

μ M Micromolarity

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≥ Greater Than or Equal To

< Less Than = Equal(s) ’ Feet or Foot (e.g., 4’) ” Inch(es) (e.g., 1⁄2”) $ U.S. Dollar

% Percent

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C. Comments and Agency Responses: 45-day Comment P eriod

DRAFT REGULATION

APPLICABLE PRODUCTS and EXEMPTIONS

1) Comment [3-Hetzel-070404-DASMA] : “... we ask that garage doors be specifically excluded from the proposed regulation. ... garage doors are typically made with a variety of materials intended to meet exterior element resistance needs. These materials, also ut ilized in siding, soffits, and fascia boards, are typically low emitters of fo rmaldehyde.”

Agency Response [3-Hetzel-070404-DASMA] : We agree. An exemption has been added for exterior doors and garage doors (see section 93120.7(b)(2)).

2) Comment [5-Rink-070413-Jeld-Wen] : Modify the exemption for windows and garage doors.

Agency Response [5-Rink-070413-Jeld-Wen] : We agree. Exemptions have been provided for windows and exterior doors ( see sections 93120.7(b)(1) and 93120.7(b)(2)).

3) Comment [7-Landry-070416-CWIC] : Section 93120(d) – Applicability. We believe the wording of this new section for product s destined out-of-state presents some unintended consequences: “This ATCM d oes not apply to plywood, PB, MDF, and finished goods made from thes e materials, that

are manufactured , sold, offered for sale, or supplied for shipment and use

outside of California .” (emphasis added ). It is not clear that the clause “for shipment and use” applies to all of the antecedents . Read literally, this exempts all covered products manufactured outside o f the state. See also Section 93120.2(b)(1) which has similar language ex empting products from the emission requirements.

Agency Response [7-Landry-070416-CWIC] : We disagree. As written, the ATCM does not apply to plywood, PB, MDF, and finish ed goods made from these materials, that are manufactured for shi pment and use outside of California. In comparison, the language in Sect ion 93120.2 (b)(1) reads: “The emission standards in section 93120.2(a ) do not apply to composite wood products or finished goods containin g these materials that are manufactured, sold, offered for sale, or s upplied for shipment and

use outside of California.” We believe that both s ections convey the same point – that goods manufactured for shipment and us e outside of California are not subject to the requirements of t he ATCM.18

4) Comment [7-Landry-070416-CWIC] [14-Titus-070419- KCMA] : Section 93120.1(a) – Definition of “Fabricator.” We submit that school districts and local government agencies should not be exempted fr om the “fabricator”

definition.

Agency Response [7-Landry-070416-CWIC] [14-Titus-07 0419-KCMA] : We agree that the point made by the commenter is appro priate and modified the “fabricator” definition. In addition, pursuant to part 7 (commencing with section 17500), division 4, title 2 of the Governme nt Code, the State is required to reimburse school districts for costs im posed by state mandates.

Other than incremental costs incurred from the use compliant materials, we anticipate that school district costs may increa se due to our recordkeeping and labeling requirements. Therefore , we modified section 93120.7 to exempt school districts from the recordk eeping and labeling requirements, unless finished goods are being sold, offered for sale, or

manufactured for sale in California. School distri cts will still be subject to the emission standard-related requirements for comp osite wood product panels and finished goods containing those material s.

5) Comment [7-Landry-070416-CWIC] : Section 93120.2(b)(2) – the HUD exemption. We have pointed out in several previous submissions that under the current wording of the proposed regulatio n, a manufacturer of mobile home decking not meeting the CARB emission r equirements would be in violation when the product was offered for sa le or sold in the state. The CARB exemption only applies when the product is installed in the manufactured home. This regulation is preempted by federal law with respect to this application.

The following is our earlier commentary on this sub ject: “It is undeniable that the regulation of formaldehyde emissions from materials used in manufactured homes is preempted by federal occupati on of the area [42 U.S.C. section 5403(d). The federal occupation of this regulatory area by HUD is comprehensive and relates to all regulatory provisions, not just emission standards.] The draft includes a suggesti on from Columbia Forest Products and the Formaldehyde-free Coalition that the HUD exemption for composite wood products used in manuf actured homes be

limited to materials “... when installed in manufactu red homes...” Although the language may have been derived from th e HUD regulation itself, it does not work in the ARB regulation. On e must remember that HUD regulates manufactured homes, and therefore its regulation addresses components, as and when installed. In Ca lifornia, the ATCM would apply to manufacturers of composite wood prod ucts who would be selling their products to manufactured home produce rs prior to inclusion of the products in the structures. Under the current draft, these

manufacturers would be in violation when non-ARB co mplying product was manufactured, offered for sale and sold within the state.”19 We suggest the following language for the statutori ly required HUD exemption: “The regulatory provisions in this ATCM do not apply to composite wood products [panels] intended for use i n and sold or offered for sale for incorporation in manufactured homes su bject to regulations of the federal Department of Housing and Urban Develop ment (24 C.F.R. section 3280.308).”

Agency Response [7-Landry-070416-CWIC] : We agree that points raised by the commenter are appropriate. The language in the previous draft regulation was modified to make it clear that for t he stated application – producing manufactured homes, HUD-compliant HWPW an d PB may be

used.

6) Comment [9-Haikala-070416-PDMG] : “... Reading the regulation, it would appear that hardwood plywood panels used in formwor k would be regulated but that softwood plywood panels would no t be. This would create an uneven playing field without improving pu blic health. I hope that all panel products would fall under the regulation, if adopted.”

Agency Response [9-Haikala-070416-PDMG] : We disagree -- it would not create an uneven playing field. Based on our surve y and the emission test data presented on page 18 of the ISOR, due to the use of PF resins, the resultant HCHO emissions from softwood plywood are much lower than for HWPW, PB, and MDF, which are typically mad e with UF resins. We did not feel that it was necessary to set new em ission standards for products currently being made with low-emitting res ins. Those products will continue to be low-emitting and setting new st andards would not provide significant additional benefits.

7) Comment [16-Overgard-070419-HPVA] : “The architectural plywood exemption is the wrong approach to exempt small bus iness. Our preference would be for a small business exemption based on production. Accordingly, HPVA would recommend a small business exemption set at

≤ 500,000 ft 2 per month.”

Agency Response [16-Overgard-070419-HPVA] : In the revised regulation, the definition of architectural plywood has been de leted, and replaced by a broader concept referred to as manufacturers of “la minated products,” who are considered to be fabricators and subject to the requirements in section 93120.7. Using this approach, the platform materials would have to comply with the ATCM, but manufacturers of lamin ated products would not be required to have third party certification. Under the HPVA recommendation, the public could be exposed to very high levels of formaldehyde because HPVA proposed a full exemption for small

manufacturers.20

8) Comment [42-Gustafson-070424-WWI] : “... under the proposed changes, composite wood products would potentially not compl y with the current requirements for seismic fabrication...”

Agency Response [42-Gustafson-070424-WWI] : We disagree. Information contained on pages 73-82 of the ISOR in dicates that panel products meeting the lower HCHO emission levels wil l continue to meet the current requirements for seismic fabrication.

9) Comment [74-Bradley-070426-GVM] : “Consider the direct economic impact in California of restricting aircraft-grade plywood sales based on HCHO emissions. Most of the aircraft-grade plywood is used in cargo holds. The planes we sell plywood for cannot be le gally flown unless all the parts on them are delivered certified to federa l standards. An extensive bureaucracy and reams of paperwork suppor t this, along with decades of specifications and regulatory framework. General Veneer Manufacturing Co. recently has sold plywood to Boei ng in Long Beach (the former McDonnell Douglas) for use in an on-goi ng C-130 retrofit program. This program amounts to millions of dolla rs and hundreds of jobs in Long Beach. The retrofit could equally be done by other companies and/or in other locations, but Boeing bro ught these jobs here to Southern California. If the wood for the cargo decks (one element of an extensive retrofit) cannot be bought and installed in Long Beach, it makes more sense to send the planes elsewhere for the ret rofit, and the jobs with

them.”

Agency Response [74-Bradley-070426-GVM] : We agree the point raised by the commenter are appropriate and have provided an exemption for composite wood products used in aircraft.

10) Comment [74-Bradley-070426-GVM] : “By comparison to the amount of wood stocked in a single Home Depot, the amount of wood going into these huge cargo planes is tiny. If the wood is no t delivered to be installed in California, California’s benefit, in terms of re duced HCHO emissions, is miniscule. But the cost of dozens of jobs, months of labor, and long-term program viability, adds up very quickly and has a d irect and wide-reaching impact on Long Beach, Lakewood, and surrounding are as. I encourage your staff to eliminate all transport plywood from the ATCM.”

Agency Response [74-Bradley-070426-GVM] : We agree that the point raised by the commenter is appropriate and have pro vided an exemption for wood products used in transport vehicles.

11) Comment [99-Watson-070426-NA] : “Another part of this that was interesting was the HUD standard, the mobile home a nd RV standard,21 which as I understand it is the only U.S. standard on the emissions of HCHO, it’s exempted from the CARB regulation or pro posal. And that says to me we’ve already got a functioning standard . But all you folks are in a difficult position, because of this noble purs uit. I support the idea of trying to limit the HCHO emissions. But I’d like u s to do it in a fashion that makes sense. If HUD is exempt, that means it’s goo d enough, apparently.”

Agency Response [99-Watson-070426-NA] : The only reason that the HUD emission standards are upheld for manufactured home s is because state law cannot preempt federal law. It is not an endor sement of the HUD standard nor an affirmation of its safety. The HUD standard is less stringent than existing standards in other countrie s. Technology is available to manufacture composite wood products to lower emission standards than the HUD standard (see pages 101 to 1 07 of the ISOR). For clarification, the HUD standard does not apply to recreational vehicles. Recreational vehicles are subject to the ATCM.

DEFINITIONS

12) Comment [5-Rink-070413-Jeld-Wen] : Reinstate the definition for

“hardboard.”

Agency Response [5-Rink-070413-Jeld-Wen] : We agree that the point raised by the commenter is appropriate and have inc luded it in the revised regulation (see section 93120.1(a).

13) Comment [5-Rink-070413-Jeld-Wen] : Clarify the definition for “no-added formaldehyde resins.”

Agency Response [5-Rink-070413-Jeld-Wen] : We agree that the point raised by the commenter is appropriate and have inc luded it in the revised regulation (see section 93120.1(a)).

14) Comment [7-Landry-070416-CWIC] : Section 93120.1(a) – Definition of composite wood products – softwood plywood. Change s have been made from previous drafts to indicate that “structural p lywood, structural panels, structural composite lumber...” are not included. CA RB staff indicated that they could not reference to the new PS-1 stand ard, since they did not have a copy of the new version. Inclusion of the r eference to the product standards for exempted products would add clarity.

Agency Response [7-Landry-070416-CWIC] : We agree that the point raised by the commenter is appropriate and have ame nded the definition for composite wood products to read: “... Composite w ood products” does22 not include ... Structural Plywood (PS 1-07)...” We ha ve also included “PS 1-07. Voluntary Product Standard – Structural Plywood. National Institute of Standards and Technology, 2007,” as a reference in section

93120.10.

15) Comment [7-Landry-070416-CWIC] : Section 93120.1(a) – Definition of “hardwood plywood.” This section defines the produ ct as “... a composite wood product , panel, or other building material ...” [Note the first comma separation.] CARB removed the previous reference t o structural building material and also deleted “molding,” but problems r emain. There are now three separate and distinct approaches to this lang uage in the definitions for HWPW, MDF (“... a composite wood product, panel, molding, or other building material...”) and PB (“... a composite wood pr oduct panel, molding, or other building material...”) [Note, no co mma between product and panel.]. We recommend that there be a consiste nt and straightforward language for all three products: “... means a composite wood panel composed of ...”

If “composite wood product” stands alone, separated by a comma from “panel,” it literally suggests that any composite p roduct made of veneers, etc. is covered. Similarly, any “other building ma terial” made of veneers would similarly be within the definition. This con cept is directly at odds with the definition of “finished goods” in section 93120.1(a) – “any good or product, other than a panel , containing HWPW, PB, or MDF.” “Composite wood product” and “other building materials” would fit under both the product definition and finished good definition.

Agency Response [7-Landry-070416-CWIC] : We agree that points raised by the commenter are appropriate and that there sho uld be consistent and straightforward language for all three products. T he present definition of HWPW specifies what a HWPW panel is when it is manu factured at a certified plywood plant. Unless the panel, as defi ned, is modified, it is a panel and not a finished good. The revised regulat ion includes consistent and straightforward language for all three products

.

16) Comment [7-Landry-070416-CWIC] : Section 93120.1(a) – definition of “medium density fiberboard” and “particleboard.” I n the current draft, the word “molding” was removed from the definition of H WPW, but not from

the definitions of MDF or PB. The reference for MD F should be to the new standard -- ANSI A208.2-2002. This change should a lso be made in the

References in section 93120.10.

Agency Response [7-Landry-070416-CWIC] : We agree that points raised by the commenter are appropriate, and have deleted the reference to moldings within the definition of MDF and PB. To h elp assess the issue of molding, staff consulted with the Composite Panel A ssociation and the23 Hardwood Plywood and Veneer Association and upon in vestigation by staff, it appeared as though MDF molding was mainly produced from cutting and shaping of MDF panels. Moldings are fi nished goods that

should be fabricated for the California market from compliant MDF panels. In addition, the reference to ANSI A208.2 was updat ed to 2002 as suggested.

17) Comment [36-Perdue-070424-AHFA] : “Since we are introducing a new term in the suggested language, it will be necessar y to define “component part” and include that definition in 93120.1 (Defin itions). Component part ... a manufactured part that could have in its constr uction one or more composite wood products used in the assembly of fin ished goods.”

Agency Response [36-Perdue-070424-AHFA] : We agree that the point raised suggested by the commenter is appropriate an d have included a similar definition in the 26 April 2007 version of the draft regulation (see section 93120.1(a)).

18) Comment [38-Morgan-070424-IWPA] : “Section 93120.1(a)(17) We would ask for a clearer, more inclusive definition of veh icles as reference in this paragraph which defines “hardwood plywood”...”

Agency Response [38-Morgan-070424-IWPA] : We agree that the point raised by the commenter is appropriate. More clari ty is provided in section 93120.1(a) of the 26 April 2007 draft regulation or der in the “composite wood products” definition.

19) Comment [74-Bradley-070426-GVM] : “Architectural plywood means a custom-made finished product ... “Finished,” in woodw orking, has a specific meaning. It means something has had a fin ish applied to it. I would recommend removing that word from this defini tion to make the intent clear. I think the operative words in this definition are “custommade” and “special-order” and “to be used as produc ed.” I understand that within the context of the regulation “finished ” means something else, but it might be confusing here.”

Agency Response [74-Bradley-070426-GVM] : We agree that the point made by the commenter is appropriate. In addressin g the issue of “architectural plywood”, it became evident to staff that this definition had a broader implication. Initially, the concern was ov er the production of decorative flat panels that resemble hardwood plywo od, but are always sold as finished goods, such as aesthetic panels us ed inside elevators, hotel lobbies and libraries. Upon investigation by staff, it was apparent that these products are not only architectural plyw ood, but also would include any fabricated product that is made from a composite wood24 product and is laminated with a veneer, such as fur niture and cabinetry
components.

Thus, staff concluded that the most practical appro ach for these products is to group them all into one reference related to “laminated products.” The reference to architectural plywood has been del eted, and replaced by “laminated products,” which are finished goods th at are produced by fabricators and do not require third party certific ation. However, if a fabricator buys composite wood products to be used as a platform for the laminated products, then those composite wood produ cts need to be third party certified by the manufacturer.

20) Comment [74-Bradley-070426-GVM] : “... to be used as produced. Everything, in one way or another, is meant to be u sed as produced. I think what’s intended here is “... on a special order basis intended to be

installed or assembled on site with minor modificat ions from the form in which the fabricator delivers it.” In other words, our customer will probably apply a finish to our product; they’re likely to dr ill for hinges and knobs (if it’s a door), cut holes for switch plates (if it’s a wall panel), and so on. In the case of a custom cabinet shop, they’re likely t o deliver the panels in finished sizes, with edge-banding and so on, but no t assembled. Someone on site will have to add hinges, handles, d rawer tacks, etc. It’s surprisingly common, when a contractor receives a d oor that was built to a specific size, for him to find he needs to trim it a bit before it fits the opening it’s intended for. So this gives us latitu de for reasonable changes. I’m switching “produced” to “delivered,” because wh en we (or most custom cabinet shops) press a panel, it’s oversize – as a fabricator, we’re not sure whether that’s considered the “produced” product, o r whether it’s considered “produced” after we trim it to size, or after we sand it, or if it

needs to be finished with hardware attached ... so “d elivered” clarifies the form we’re talking about. This wording, I think, w ill better match common practice in the industry. And I don’t think it cha nges the meaning

intended.”

Agency Response [74-Bradley-070426-GVM] : In the revised regulation, the definition of architectural plywood has been de leted, and replaced by a broader concept referred to as “laminated products. ” Laminated products are made by fabricators and subject to the requirem ents in section

93120.7.

21) Comment [74-Bradley-070426-GVM] : “Composite wood products ... or composite wood products used inside of vehicles. I ’d tweak this a bit. Best bet: “used in transportation.” In other words , not in buildings. If that’s too broad, I’d consider “used inside of vehicles, b oats, or aircraft.” At General Veneer Manufacturing Co. we’re specifically concerned with aircraft, but someone pointed out that boats are an other hot topic with lots25 of rules and specifications already operating. I’m not sure my second suggestion would cover train cars, but I think you’ d want it too. Train cars typically are governed by federal rules because the y’re part of interstate commerce. And yes, they’ve been known to use plywo od, sometimes

rather nice stuff.”

Agency Response [74-Bradley-070426-GVM] : We agree that the point made by the commenter is appropriate and modified t he definition of “composite wood products” accordingly.

22) Comment [74-Bradley-070426-GVM] : “Hardwood plywood ... or military specified plywood (MIL-P-6070). I’d add “et al.” b ecause there are too many archaic military plywood specifications to inc lude them all. Annual usage is de minimis, but frequently one 24” x 48” p iece of plywood built to a certain specification is essential to operating a plane legally and safely. I feel confident that HCHO out-gassing from a piece that size is not enough to create a public health crisis. Examples of some other specifications that might get called out: Our compa ny has recently quoted customers pricing on MIL-DTL-6070C, and we’ve sold parts to that spec within the last year. There also are Lockheed spec s that are generally derived from MIL-P-6070 and used in military transp orts. We’ve recently quoted pricing for LAC27-903, which I believe gets used in the same C130s that flew rescue missions to Indonesia after t he tsunami (actually, it’s probably worth calling out MIL-DTL-6070 and LAC27-9 03 specifically, not just lumping them into “et al.”). Late last year w e quoted PS-1-83 – an unusual one. No matter how hard we try to come up with all the military specs, we’ll miss a few. So I’d add “MIL-DTL-6070, LAC27-903, et al.” and then you’re covered for military specified plyw ood. I think that still meets your intent.”

Agency Response [74-Bradley-070426-GVM] : We agree that the point made by the commenter is appropriate and modified t he definition of “composite wood products” to exempt military specif ied plywood.

23) Comment [121-Bradway-070426-Mannington] : “And finally, in terms of section 93120.1, the definition number 20, what we would suggest is or ask for clarification is that it includes flooring. And what we’re thinking and our position is that finished product flooring real ly puts us more into the category of a fabricator, not in terms of a manufac turer of composite products. And really would ask for that clarificat ion. And the only thing that would be required would be to simply remove th at one word, flooring, out of that definition and then it would basically describe hardwood plywood.”

Agency Response [121-Bradway-070426-Mannington] : The definition of hardwood plywood has been revised to state that it includes “hardwood26 plywood’ panels used in making flooring.” If floor ing is made as a laminated product, it would need to be made using c ompliant platforms (e.g., PB).

REGULATORY AUTHORITY

24) Comment [10-Higgins-070416-FFC] : “Does CARB have the necessary authority to implement the proposed reforms with th e improvements suggested by the Coalition? Yes, and we would argu e the obligation as

well.”

Agency Response [10-Higgins-070416-FFC] : We agree that the point made by the commenter is appropriate and that ARB h as the authority to adopt the ATCM. The basis of CARB’s regulatory aut hority is explained in detail in Chapter I of ISOR, pages 1-5.

25) Comment [42-Gustafson-070424-WWI] : “I was surprised to hear Ms. Catherine Witherspoon agree with me (on February 5, 2007) that the proposed ATCM standard may be outside of CARB’s leg al authority to enforce... How can CARB compromise an entire industry based on a

whim?”

Agency Response [42-Gustafson-070424-WWI] : Catherine Witherspoon was the Board’s Executive Officer during the develo pment of the ATCM and when the ATCM was brought before the Board in A pril 2007. While

we are not sure what statements the commenter is re ferring to, Catherine Witherspoon does not agree with the commenter, and does believe that ARB has the authority to adopt and enforce the ATCM

.

26) Comment [53-Cassman-070425-HBMVR] : “After a comprehensive review of the record, we easily conclude that the Board’s adoption of this ATCM, if it chooses to do so, will rest on solid legal au thority.”

Agency Response [53-Cassman-070425-HBMVR] : We agree.

27) Comment [60-Cassman-070426-HBMVR] : “In short, the statutory authority for the Board to adopt the proposed regulations is clear and unequivocal. Indeed, we are convinced that the Tanner Act direct s and requires this Board to adopt the recommendation before it or adop t even more stringent regulations, given the factual predicates in the re cord.”

Agency Response [60-Cassman-070426-HBMVR] : We agree that CARB has clear legal authority to adopt the ATCM.27

28) Comment [74-Bradley-070426-GVM] : “I still have grave concerns about the effect of the rule on the industry we work in, and I have my doubts about the legitimacy of the rule based on indoor/ou tdoor air issues and the fundamental medical justification for the rule.”

Agency Response [74-Bradley-070426-GVM] : The medical justification for this ATCM is contained in Chapter VII of the ISOR a nd in the responses to

the comments in the subsection on Public Health. R egarding “legitimacy,” the authority of ARB to adopt the ATCM is explained in Chapter I of the

ISOR.

29) Comment [107-Cassman-070426-HBMVR] : “In short, statutory authority for this Board to adopt the proposed regulations is clear and unequivocal. Indeed, it is our opinion and we are convinced that the Tanner Act directs and requires this Board to adopt the recommendation that is before it or to adopt even more stringent regulations given the fac tual predicates in this

record...”

Agency Response [107-Cassman-070426-HBMVR] : We agree and

believe that our ATCM is consistent with the intent of the Tanner Act.

SELL-THROUGH PROVISIONS

30) Comment [7-Landry-070416-CWIC] : Appendix 1 – Sell-through for importers. There is substantial discontinuity of s ell through time for importers, which if implemented, would lead to a tr emendous dumping of non-complying products at a time when domestic prod ucts must meet the new standards. This is an extraordinarily importan t issue that must be addressed. The sell through periods set forth in t he rule as drafted are as

follows:

Affected Party Proposed Rule CWIC Proposal 1
(a) Manufacturers of panels 1 month 3 months (b)(1) Distributors of panels 5 months (b)(2) Distributors of finished goods 18 months (c)(1) Importers of panels 5 months 3 months (c)(2) Importers of finished goods 18 months 18 mon ths (d) Fabricators of finished goods 12 months 18 mont hs (e)(1) Retailers of panels 12 months (e)(2) Retailers or finished goods 18 months

(1) See comment on “sell through timing.”

There are two fundamental problems with this schedu le. Imported panels, not meeting the standard will be able to be sold in the market for four months after the domestic panels have to be in comp liance. Compare (a)28 with (c)(1). By any measure the cost of complying with this rule will be huge. The retention of this advantage for imports will lead to an even greater cost advantage than what is currently enjoy ed by foreign producers. It will lead to a flooding of the marke t with non-complying panels for this grace period. It must be changed.

The second discontinuity relates to finished goods. American furniture and cabinet makers will be forced to use higher pri ced complying panels within 12 months of the respective deadlines. Thei r Chinese and other foreign competitors will have an extra six months – a full 18 months after the deadlines to continue to use non-complying comp onents in their products. The impact of this provision would be de vastating. A surge of dumped goods would be inevitable. The provision mu st be changed.

Agency Response [7-Landry-070416-CWIC] : We agree that the points made by the commenter are appropriate. The sell-th rough periods have been modified and we have made the changes requeste d by the

commenter.

31) Comment [7-Landry-070416-CWIC] [16-Overgard-070 419-HPVA] [24- Landry-070423-CWIC] [25-Hubbard-070423-Darlington] [46-Gonyea070424-Timber] : Appendix 1 – Sell-through timing. Although clear ly the equivalency of treatment of domestic and foreign in terests is of most importance, some modifications of the sell-through periods are recommended. First, given the multiplicity of SKU’ s for many composite wood products, we suggest that a 90-day sell throug h be permitted for both manufacturers and importers of these items. S imilarly, we suggest that fabricators and importers of finished goods be allowed to sell inventory for 18 months. The multiplicity of style s, finishes, and designs is even more notable in this industry sector.

Agency Response [7-Landry-070416-CWIC] [16-Overgard -070419-HPVA] [24-Landry-070423-CWIC] [25-Hubbard-070423-Darlingt on] [46-Gonyea070424-Timber] : We agree that the points made by the commenter ar e appropriate and have made changes reflecting the re quested

modifications.

32) Comment [14-Titus-070419-KCMA] [36-Perdue-07042 4-AHFA] : “Finally, the sell-through provisions in the ATCM require U.S . fabricators of cabinets to be in compliance within 12 months while importers are granted 18 months to come into compliance. This is very un fair to U.S. manufacturers and should be changed. This provisio n alone could force many U.S. companies out of business.”

Agency Response [14-Titus-070419-KCMA] : We agree that the point made by the commenter is appropriate. The sell-thr ough provisions, as29 also recommended by CWIC [7-Landry-070416-CWIC], ar e now the same for both U.S. fabricators and importers of finished goods – 18 months.

33) Comment [38-Morgan-070424-IWPA] : “Section 93120.12(c) – Sell through dates that apply to importers of HWPW, PB, and MDF ... we believe the proposed regulation should extend the sell-through period for importers from the proposed 5 months to a minimum of 12 month s for the following

reasons...”

Agency Response [38-Morgan-070424-IWPA] : We disagree. The rulemaking does not take effect until 2009; we beli eve that this is sufficient time for the importers to prepare for compliance.

34) Comment [38-Morgan-070424-IWPA] : “Importers purchase goods on speculation ... importers can be stuck with a large i nventory of slowmoving product, many times having to carry inventor y in select items for a year or longer... twelve months is the minimum sell-t hrough that should be

allowed...”

Agency Response [38-Morgan-070424-IWPA] : We disagree. We believe a three month sell-through period for panels and an 18 month sell-through period for finished goods is sufficient. We cannot afford to delay the requirement as it is important to introduce the use of lower emitting products into California at the earliest practicabl e date. Moreover, importers will still be able to sell those products to customers outside of

California.

35) Comment [42-Gustafson-070424-WWI] : “... How can anyone think it is acceptable to allow California woodworkers only 30 days to comply with this measure, while foreign business gets 18 months to comply?”

Agency Response [42-Gustafson-070424-WWI] : We disagree – the stated comparison is inaccurate. The comment compares the sell-through periods for manufacturers of panels and for importe d finished goods. Panel manufacturers, domestic and foreign, would ha ve 90-days to sell their inventories of non-compliant products. At th e retail level, retailers

would have 18-months to sell their inventories of n on-compliant finished goods made by either domestic or foreign fabricator s.

36) Comment [42-Gustafson-070424-WWI] : “... there is no “grandfather clause” to protect the businesses that will have mi llions of dollars in current product inventory...”

Agency Response [42-Gustafson-070424-WWI] : We have addressed this concern by including sell-through provisions that a llow sufficient time for30 businesses to clear their inventories. In addition , the first of the Phase 1 standards do not take effect until January 2009.

37) Comment [46-Gonyea-070424-Timber] : “In addition, we believe that the sell through dates for importers and domestic manuf acturers of panels should be exactly the same...”

Agency Response [46-Gonyea-070424-Timber] : We agree the point raised by the commenter is appropriate. The ATCM w as modified to reflect this change.

38) Comment [74-Bradley-070426-GVM] : “Appendix 1. Sell-through Dates... I’m going to let the Woodwork Institute tackle this ; they’ve been doing the research and I think have recently sent you folks s ome data. I’d make an observation: the back stock of particleboard that w e have on our floor, if it’s 45 days old, might still be emitting more HCHO than this regulation calls for. But material we’ve had in stock for 5 y ears, or 15 years (this is real stuff I’m talking about, not hypothetical), sh ould have breathed out several half-lives of HCHO long ago, according to t he charts in ARB’s presentation, so it should be safe to use again, ev en if it wasn’t produced under this regulation. I’d ask you to bear in mind as you work through the question of sell-through dates. I’m aware that you r intent is to prevent people from stockpiling particleboard in advance of the regulation’s

effective date.”

Agency Response [74-Bradley-070426-GVM] : We have addressed this concern by including sell-through provisions that a llow sufficient time for

businesses to clear their inventories. In the case of this commenter, who is also a fabricator, the commenter would have 18-m onths to clear old stocks, which is a reasonable amount of time. In a ddition, the first of the Phase 1 standards do not take effect until January 2009.

39) Comment [96-Morgan-070426-IWPA] : “The other concern we have is with the sell-through dates that apply to importers. We believe that they should be extended and not decrease like they have been in the past couple of days to a twelve-month period, not three months. I mported hardwood plywood goes through a series of stages before it r eaches the U.S. shores. The order is placed. Material is produced overseas , if not already in inventory. Material is then shipped. And that mea ns there has to be vessels available to be loaded and shipped. Materi al arrives in the U.S. That could be after four to five weeks in transit, longer if it’s delayed or if it’s break bulk shipping container. Material is th en held at a U.S. port. And in most cases, it’s outside of California until it is cleared by the U.S. government which could be one week or longer depend ing upon the backup... Material will be held at a warehouse and th en it will be sent to a distributor. So you have to understand the differe nce between importers31 and domestic manufacturers in this case, because im porters do buy on speculation. And we request that the sell-through period be increased to

twelve months...”

Agency Response [96-Morgan-070426-IWPA] : We disagree – to provide parity we would have to allow domestic manufacturer s the same sellthrough which would delay the sale of lower emittin g products to the

California market and the associated health benefit s. Importers are aware of this ATCM. They have had time to plan. We prov ide sell-through periods for panels and finished goods. Also, the f irst of the Phase 1 standards do not take effect until January 2009.

FABRICATORS

CHAIN-OF-CUSTODY and LABELING

40) Comment [14-Titus-070419-KCMA] : “... The certification requirements and so-called “paper trail” contained in the ATCM and r equired through the cabinet manufacturing/distributor chain should prov ide the necessary information for enforcement and notice purposes.”

Agency Response [14-Titus-070419-KCMA] : We disagree – more is needed than what is currently required through the present cabinet manufacturing/distributor chain. We need more info rmation to be able to definitively link products back to manufacturers an d emissions data on the materials that were used to fabricate the product. In our view, we must add a sufficient amount of rigor to the enforcement program to ensure that those who attempt to sell non-compliant products ca n be readily identified and subjected to the appropriate penalties.

41) Comment [14-Titus-070419-KCMA] : “... The proposed ATCM has the potential to disrupt existing supply chain relation ships, contribute to possible material shortages in the future, impose a significant paperwork burden on all manufacturers, and greatly increase l iability for cabinet manufacturers and their suppliers...”

Agency Response [14-Titus-070419-KCMA] : We do not believe that transitioning from HUD-compliant to Phase 1 and Pha se 1 to Phase 2 will pose problems with supply chain relationships. We consulted extensively with industry to develop the detailed sell-through provisions to address this concern. In addition, we are conducting a comprehe nsive outreach effort, and emphasis is being placed on helping people unde rstand the concept of sell-through. In terms of material shortages, w e feel that there is enough lead-time for businesses to clear their inve ntories of old products. We do not expect the additional paperwork to be sig nificant, as records of32 this kind are currently being maintained. The ATCM goes a step further in that verifications of purchases of compliant materi als and deliveries to customers will need to be supplied upon request. A s the ATCM requires cabinet manufacturers and their suppliers to docume nt their purchases of compliant materials and sales of compliant products to customers that request them, their liability does increase.

42) Comment [14-Titus-070419-KCMA] [36-Perdue-07042 4-AHFA] : We believe that requiring both product labeling and wr itten notice on contracts or bills-of-lading (93120.7 (d)(1) and (2)) is dupl icative and imposes an unnecessary additional paperwork burden, particular ly on smaller companies. We suggest that the labeling requiremen t, with the option to present the required information on the cardboard b oxes in which cabinets most often are shipped, is the best alternative.”

Agency Response [14-Titus-070419-KCMA] [36-Perdue-0 70424-AHFA] : We disagree that requiring both product labeling an d a written notice on bills-of-lading are duplicative. However, we agree that the option to label the cardboard boxes in which finished goods are shi pped is a good alternative and have included it as an option for t he labeling requirement.

43) Comment [23-Zimmerman-070423-Sauder] : “Enforcement: ... It is common, especially in Asian companies, to employ a network of subsuppliers each producing certain components that ar e then assembled into the finished product. Trying to police and ce rtify such a vast network of industry participants does not seem feasible giv en the test methods and

associated costs.”

Agency Response [23-Zimmerman-070423-Sauder] : We disagree.

Fabricators will need to obtain verification from t heir suppliers that they are being supplied with compliant products. For exampl e, if we inspect an importer and ask to see a statement of compliance f or a product, to verify that compliant materials were used, we would contac t the fabricator of the product and ask for statements showing that complia nt wood products were used to make the product. If the statements a ppear questionable, we would contact the third party certifier of the m anufacturer that produced the wood products used for the component parts.

44) Comment [36-Perdue-070424-AHFA] : “The AHFA realizes that the details of the chain of custody mechanism have not been det ailed and additional work remains to bring clarity. However, we don’t w ant the “straw man” language of (i) to incorrectly become the working l anguage of a possible enforcement protocol. We welcome the opportunity t o work with staff to “flesh out” the details of the chain of custody mec hanism and recognize the necessity of the “place holder” in the proposed rule... We suggest that this actually become Appendix 4 of the document. T his would better33 secure it as a “place holder” in the rule and provi de a clear home for this important compliance mechanism.”

Agency Response [36-Perdue-070424-AHFA] : After consultation with stakeholders, the ATCM was modified in various area s to require a statement of compliance to ensure traceability of p roducts in commerce that compliments the chain-of-custody process in us e today.

45) Comment [36-Perdue-070424-AHFA] : “... Chain-of-custody with a labeling requirement is an adequate approach to prevent “che ating” and ensure compliance... While there are clearly some hurdles to overcome, we believe the playing field is level and the ATCM cle arly provides an adequate mechanism to ensure and demonstrate compli ance...”

Agency Response [36-Perdue-070424-AHFA] : We agree – no response

necessary.

46) Comment [38-Morgan-070424-IWPA] : “Modify chain-of-custody requirement to use existing paperwork. ... The bill of lading is already identified in section 93120.6 (c)(2)(B) as an optio n for product labeling for modified finished goods containing hardwood plywood .”

Agency Response [38-Morgan-070424-IWPA] : We disagree. The current requirements of the ATCM are already based on curre ntly used commercial documentation. Specific requirements fo r chain-of-custody are a major element of the enforcement program, to help attest that finished products are compliant as they make their way through the

commercial chain.

47) Comment [87-Perdue-070426-AHFA] : “We’re also very concerned about the enforcement mechanism within this particular ru le. We know that there’s a lot of work that’s been accomplished and progress made during the last four-and-a-half years. There are a lot of unanswered questions and details to work through. As Ms. Berg indicated , we too are very reliant upon the chain-of-custody and feel the chain-of-cus tody will become one of the most important aspects of this particular en forcement protocol.”

Agency Response [87-Perdue-070426-AHFA] : The ATCM requires statements of compliance to be transferred from poi nt-to-point in the commercial chain to ensure traceability of products , which compliments the existing chain-of-custody process. We believe that this is a crucial element of the enforcement program that is critical to maintaining the integrity of the ATCM.

48) Comment [98-Schroeder-070426-WMMPA] : “Second, procedures on how compliance will be carried out is questionable to u s. My membership is34 also concerned there is not sufficient staff in pla ce to oversee and enforce the testing and compliance procedures of the propos ed regulations of all products coming into California. Our major concern and focus is finished moldings from off-shore manufacturing plants shippe d to the California marketplace. We are of the mind that a piece of pa per stating compliance is easy to come by in China without a certification process ever taking place.”

Agency Response [98-Schroeder-070426-WMMPA] : We appreciate the comment and will conduct a comprehensive enforcemen t program to identify and penalize unscrupulous manufacturers. We also affirm our commitment to work with industry, and to be proacti ve in terms of outreach and education about how the rulemaking will be enfo rced. In addition, samples will be obtained by our inspectors to verif y the emissions performance of composite wood products and finished goods.

ECONOMIC IMPACTS

49) Comment [14-Titus-070419-KCMA] : “It appears that the cost estimates both for cabinet manufacturers and home buyer/remod elers have been underestimated by 20% or more... cabinet manufacturer s typically are able to achieve approximately 80% efficiency from t he composite panel products used to produce the requisite cabinet part s; not the 100% yield assumed in the staff report.”

Agency Response [14-Titus-070419-KCMA] : We disagree. Our estimates are based on calculations made by commercially avai lable software used by people in the industry, which to our knowledge d o not assume that 100% of every panel can be used to make a cabinet. The point being made is that the cost of composite wood products us ed to build kitchen cabinets, etc. is a small cost driver in projects o f this kind. For projects costing in the tens of thousands of dollars, we do not believe that an estimated increase in material costs of less than $ 100 would be an overriding factor in who the project is awarded to or long-term economic viability (see page 215 of the ISOR).

50) Comment [14-Titus-070419-KCMA] : “... The industry is concerned that without the benefit of additional pilot studies or adequate time to effectively gauge the performance characteristics of the substi tute products against the real-life conditions typical for our products, the hard-won reputation for durable, fashionable and long-lasting cabinetry cou ld be lost or damaged...”

Agency Response [14-Titus-070419-KCMA] : We do not believe additional studies are needed. In Chapter V of the ISOR, staf f describes current35 resin technologies already being used to produce co mposite wood products for the cabinetry industry that meet the P hase 1 limits in the ATCM (see pages 101 to 107). We believe that the t wo-phase implementation schedule provides the industry with sufficient lead-time to ensure that the changes they elect to make to produ ce lower emitting products will still allow them to make products of the same quality that their customers have come to expect.

51) Comment [23-Zimmerman-070423-Sauder] : “Compliance cost: ... While it is impossible to accurately predict the price elast icity of consumers, there is no doubt that there will be a negative impact on sales volume. The result of higher retail prices will be a contractio n within the industry and a significant net loss of jobs...”

Agency Response [23-Zimmerman-070423-Sauder] : We disagree that there would be a significant net loss of jobs due t o higher retail prices. As we discussed in Chapter VIII of the ISOR, the overa ll costs to fabricators will depend on increases in material costs and need ed improvements in their recordkeeping systems. Overall, we do not ex pect a major economic impact from this rule since all competitors are man dated to meet the same emission standards. As mentioned in Chapter VIII, the overall cost to consumers of finished goods will be very low (pages 213 to 216). See also the response to comment #54.

52) Comment [42-Gustafson-070424-WWI] : “... A good portion of our membership is made up of small businesses that woul d be severely impacted by the regulation...”

Agency Response [42-Gustafson-070424-WWI] : We disagree that small businesses (which are mainly fabricators under the regulation) will be severely impacted. The rulemaking applies to all f abricators, in-state or out-of-state, that choose to sell products to Calif ornia. Because all entities need to use compliant products, small businesses in California will compete on an equal footing and should not be dispr oportionately affected.

During the rulemaking process, staff addressed many issues related to small fabricator businesses, including the main iss ue of fabricated components that are laid up similar to hardwood ply wood. As required by the regulation, hardwood plywood producers need to be third party

certified and this would have included fabricators who lay up certain finished good components. To address this concern, the reference to “architectural plywood” was removed from the origin ally proposed regulation and replaced by “laminated products” und er section 93120.1(25). The regulation was clarified to state that laminated products refer to finished good components that are produced by fabricators for finished goods and therefore, do not need third par ty certification. The36 regulation was also modified to clarify that if lam inated products contain composite wood product substrates, then those subst rates will need to be third party certified. This clarification greatly r educed the burden on small fabricators. Because of these reasons stated, we d o not believe that small businesses will be adversely affected.

53) Comment [87-Perdue-070426-AHFA] : “We are a very price point sensitive industry. Our margins are thin. You’ve heard a lo t of these folks talk behind me about the potential cost increase that wi ll be incurred. We will then in turn have to pass that along to the consume r. We are very concerned with how the consumer will react and resp ond to this price increase, especially if material costs force our me mbers to be moved out of price point. By moving one of our manufacturers out of price point, you will put them out of business. This is a real conc ern of ours.”

Agency Response [87-Perdue-070426-AHFA] : We appreciate the comment. In the event that price points shift for the California market relative to the rest of the nation, this will likel y affect all manufacturers that choose to sell products to California to the same d egree. However, it is our understanding that some fabricators will opt to produce California grade finished goods available to the entire U.S.

54) Comment [89-Zimmerman-070426-Sauder] : “You’ve heard a lot about cost. And I don’t want to dwell on it, but the CAR B document did not state fully an $8 roll-up on a bookcase would not be true . If you had a 30% cost in panel increase, cost to us, it would be a 15% co st to the consumer. As you know, increasing prices decreases demand. It w ould certainly shrink our markets drastically. A good example of this, l ast year 2006, we had a dramatic increase in board prices. We had units se lling for $300 at Office Depot and went to $315, 5% increase. We saw a dram atic reduction in sales of our products. So going back to the less f ortunate people who have to buy these products, they will be impacted g reatly. Economic impact of enforcing the regulation is dramatic. Th e impact of ineffective enforcement is devastating to us.”

Agency Response [89-Zimmerman-070426-Sauder] : We agree with the commenter that the composite wood product price inc rease may dampen the demand for the affected products in the short r un. However, we believe that the impact will not be as severe as st ated by the commenter for two reasons. First, the regulation affects all composite wood products sold in California, and therefore, manufacturers an d marketers are likely to incur similar cost increases for producing complian t products. Thus, the changes in prices for all products would be compara ble before and after the regulation if manufacturers are able to pass on the cost increase to the consumer. This limits the ability of consumers to substitute the product of one manufacturer or marketer for another. Thus, th e limited supply of37 good substitutes (i.e., products that can be used i n place of PB, MDF, or HWPW) to compliant products from all manufacturers will likely restrict consumer reaction to any price increase in the shor t run. In the long run, however, the increase in disposable income will lik ely increase the demand for the affected products, negating the impa ct of the regulatory price increase. Second, our enforcement program wi ll be strong and comprehensive, thus providing a level playing field for all manufacturers and marketers of these products in California. Aga in, the strong enforcement will limit the ability of consumers to substitute an unregulated product for a regulated product, thus; restricting the consumer reaction to the price increase. Our enforcement program includ es independent certification, chain-of-custody documentation, reco rdkeeping, and testing

validation.

55) Comment [90-Titus-070426-KCMA] : “We think take into account these CWIC numbers. They are our suppliers. We have wor ked with them closely. I supplied you with the information that our product’s, surprisingly enough, the highest on the list of what lasts in th e kitchen, 15 years. We have developed that because of our close relationsh ips with our suppliers

and the materials we use. It is for a reason that we use the urea formaldehyde glues with the way they have performed for us. There has been no discussion in this of performance. We’re a ll focused on emissions, rightly so. But let’s keep in mind so w hat’s the performance. How is the marketplace going to react to it? And s till green products, we are making progress in that area with our own ESP p rogram, environmental stewardship program, to move forward with our industry. But it’s still a niche product. So we need time an d we need to do it in a way that we won’t have these serious negative impac ts on an important part of the state’s economy...”

Agency Response [90-Titus-070426-KCMA] : We agree that performance is important, but believe that panels with lowered HCHO emissions can be made without compromising the performance that fabr icators require (see Chapter V of the ISOR). Even after implementation of the regulation, particleboard, medium density fiberboard, and hardw ood plywood will still meet the voluntary performance specifications conta ined within ANSI 208.1, ANSI 208.2, and ANSI/HPVA PS-1, respectively . Also, there are existing products that comply with ATCM standards t hat perform as well as products that have higher formaldehyde emissions than that required by the ATCM.

56) Comment [90-Titus-070426-KCMA] : “... Much of the impact you have heard on small business, we are terribly concerned about that. You’ve heard numbers. We know of at least 1,200 small cab inet establishments in California. And anything that changes their sup ply chain, their margins38 could mean the end of the business for them. So I implore you to take that into account as you look at it.”

Agency Response [90-Titus-070426-KCMA] : We agree that points raised by the commenter are appropriate. It is not our in tent to put small cabinet

establishments in California out of business. We b elieve that the requirement that all finished products manufactured for sale in California be made with complying products does not confer a c ompetitive advantage for any particular supplier. We have add ed a definition of “laminated products” under section 93120.1(25) to c larify that fabricators of finished good component parts do not need third party certification. This clarification greatly reduces the economic bur den on small fabricator

businesses.

ENFORCEMENT and FAIR COMPETITION

57) Comment [14-Titus-070419-KCMA] : “Key elements of the enforcement phase remain vague and incomplete...”

Agency Response [14-Titus-070419-KCMA] : We agree that at the time of the comment, some areas of the enforcement program required further clarity. Since then, the regulation was modified t o add clarity and more specificity to the TPC requirements to ensure trans parency and effectiveness. Round robin testing requirement was added to assess TPC laboratory capabilities. Likewise, chain-of-custod y requirements and additional recordkeeping requirements were added to aid in an enforcement investigation. Furthermore, CARB’s enf orcement test method will be operated consistent with the seconda ry test method, which will allow CARB to generate much more precise measu rements of field samples to strengthen any finding of non-compliance

.

58) Comment [23-Zimmerman-070423-Sauder] [89-Zimmer man-070426- Sauder] : “Enforcement: ... Even if reliable test methods wer e available, the sheer volume of products and sources would make effective auditing and enforcement extremely difficult...”

Agency Response [23-Zimmerman-070423-Sauder] [89-Zi mmerman070426-Sauder] : Reliable test methods are available and required to be used in the ATCM. We believe that the ATCM puts in place an effective enforcement program which includes third party cert ification of panels, chain-of-custody, labeling, and recordkeeping requi rements.

59) Comment [23-Zimmerman-070423-Sauder] : “Enforcement: ... It is entirely possible that a piece of furniture that is complian t as a whole could have individual components that are non-compliant...”39 Agency Response [23-Zimmerman-070423-Sauder] : We disagree, since compliance is not determined through testing of a p iece of furniture “as a whole.” Our program requires that compliant materi als be used to make finished goods such as furniture; hence, it is not possible for furniture made with non-compliant components to be legal for sale in California.

60) Comment [23-Zimmerman-070423-Sauder] : “Compliance cost: ... Problematic testing and ineffective enforcement wil l significantly tilt the playing field. Companies that comply voluntarily w ill be at a significant disadvantage to those who are able to “get around t he system.”...

Agency Response [23-Zimmerman-070423-Sauder] : We disagree because CARB will implement an effective enforcemen t program. Reliable test methods are available and required to be used in the ATCM. We believe that the ATCM puts in place an effective enforcement program which includes third party certification of panels, chain-of-custody, labeling, and recordkeeping requirements.

61) Comment [36-Perdue-070424-AHFA] : “As part of the enforcement protocol, CARB staff has suggested a field screenin g method and finished product testing to verify the validity of chain of custody... recommend that the use of the field screening method for enforceme nt is not considered. Field screening should be used as a pass/fail “brig ht line” that would trigger further investigation of the chain of custo dy...”

Agency Response [36-Perdue-070424-AHFA] : We agree that the field screening method should not be considered for enfor cement. The

enforcement test method in the ATCM will be used to enforce the emission standards on panels and finished goods. T he field screening method will complement the enforcement program for the ATCM and be used to identify gross violations, but will not be used for enforcement violation purposes.

62) Comment [36-Perdue-070424-AHFA] [87-Perdue-0704 26-AHFA] : “... The AHFA encourages CARB staff to stay engaged with key stakeholders and

work on the enforcement mechanism with the same foc us and attention to

detail used to establish the “front end” of the ATC M. There is simply too much at stake and the potential impact too great to relax and develop a marginal and ineffective enforcement program. Let’ s stay the course and be as diligent on the “back end” of the ATCM.”

Agency Response [36-Perdue-070424-AHFA] [87-Perdue- 070426-AHFA] : We believe the ATCM contains all the requirements n eeded for an effective enforcement program and will continue to work with stakeholders on implementation. See also the response to commen t #60.40

63) Comment [36-Perdue-070424-AHFA] : “AFHA is concerned that the Board will be voting on a proposed regulation that clearl y has not defined the scope or details of an enforcement strategy... we fee l clarification is needed to ensure that the compliance demonstration does not require the tracking of individual component parts manufactured with composite wood products in finished goods... We would suggest that t he language of (i) be changed to the following: “... made with complying co mposite wood products to verify through the distribution chain t hat the composite wood products used in the manufacture of component parts used in the assembly of finished goods comply with the appropri ate emission

standards.”

Agency Response [36-Perdue-070424-AHFA] : We believe that the ATCM contains all the requirements needed for an effecti ve enforcement program. See also the response to comment #60. Fo r fabricators, the compliance demonstration does not require the track ing of individual component parts, but rather requires that they be a ble to document their purchases of compliant materials used in their fini shed goods.

64) Comment [90-Titus-070426-KCMA] : “And enforcement, we want to compliment the staff -- this has been an open proce ss. They’ve listened. I compliment them. They put a lot of work into this. But as with everything, there are holes. And we think enforcement is a pla ce where we will work

with them. There needs to be some serious work don e there. The questions that you have raised are great. I think you’re heading to the point – I would tell you that.”

Agency Response [90-Titus-070426-KCMA] : We appreciate the comment but believe the ATCM contains all the requirements needed for an effective enforcement program. See response to com ment #60.

EXEMPTIONS

65) Comment [5-Rink-070413-Jeld-Wen] : Jeld-Wen proposed an exemption for exterior doors and garage doors.

Agency Response [5-Rink-070413-Jeld-Wen] : Exterior doors and garage

doors are made with water resistant resins that emi t very low levels of formaldehyde. We added an exemption to section 931 20.7 for exterior doors and garage doors in response to this comment.41

FINISHED PRODUCT TEST METHOD

66) Comment [5-Rink-070413-Jeld-Wen] : “... For this reason, and to the extent HCHO emission levels are regulated, JELD-WEN advocates an ATCM that regulates the HCHO emission levels for a finished product. Such a performance-based regulation for finished pr oducts would ease the testing, compliance and enforcement burdens on the state, while having a measurable impact on air quality in Califo rnia.”

Agency Response [5-Rink-070413-Jeld-Wen] : We disagree. This ATCM will achieve significant reductions in surface emis sions from composite wood products. The Health and Safety Code requires CARB to achieve the lowest emissions possible for a toxic air conta minant with no identifiable safe level of exposure. Thus, the emi ssion standards are reducing formaldehyde emissions at the source, the composite wood panels used to make a finished good. The ATCM sets emission limits for panels that are used to make finished goods like fu rniture. Under the commenter’s approach, high emitting panels could be used in finished goods and covered with paint or a laminate. Howeve r, at some point, the finished good will be scratched allowing formaldehy de to escape.

67) Comment [23-Zimmerman-070423-Sauder] : “Testing: ... Realistically, the only way to have any level of confidence that a com ponent is in compliance with the regulation would be to run a se ries of tests on the same component and look for a correlation within th e results...The scientific foundation for determining whether a non -compliant finding is due to the composite panel or due to any of a numbe r of other sources of HCHO has not been firmly established.”

Agency Response [23-Zimmerman-070423-Sauder] : We have revised the regulation and included requirements for demonstrat ing equivalence between the primary and secondary emission test met hods and for roundrobin testing, as well as specifying that CARB will use the secondary test method for enforcement purposes. Testing a majorit y of finished goods will be straightforward since many composite wood p roducts used in finished goods are only covered on one side. For t wo-sided laminated products, staff is developing the appropriate proto cols under the schedule presented in Table VI-7 on page 127 of the ISOR. S ee also the response

to comment #73.

68) Comment [24-Landry-070423-CWIC] : “... What is inside that piece of furniture or cabinet, and behind the paint or high pressure laminate? To check compliance, one will have to essentially dest roy the piece of furniture – to “deconstruct” it down to the panel i tself. Determining noncompliance in this setting is extremely difficult a s deconstruction will likely alter the physical nature or the underlying panel. There is great42 uncertainty in this regard since the full enforceme nt program will not be available until after the regulation is promulgated .”

Agency Response [24-Landry-070423-CWIC] : Yes it is correct that finished products must be deconstructed to test for compliance. But, we disagree that there is great uncertainty in the enf orcement program. Deconstructive testing is needed for finished goods to verify compliance with the emission standards. We are currently deve loping the sample preparation and testing protocols that we will use to enforce the ATCM (see page 127 of the ISOR). The sample preparation and emission testing protocol we use to enforce the ATCM will be technically sound and will be more than adequate to identify non-complian t composite wood products found in finished goods for California.

69) Comment [27-Rush-070424-Temple Inland] : “... Temple-Inland strongly recommends that the following be done: a level play ing field is required for all domestic and import players... that all finished products be tested in its final state (as used), not with the surface removed , that all resin systems be qualified based on performance of the emission r ate tests, not on its class or perception... that minor emission test excur sions be allowed that fall into the precision variation of the large scal e test...”

Agency Response [27-Rush-070424-Temple Inland] : We agree that a level playing field is required for domestic and im port players, but disagree that products be tested in their final state. Fini shed product testing would require an inordinate number of standards for the f ull range of finished products sold to California and not workable from a n enforcement standpoint. We believe that our public health goal s are best served by requiring the use of low emitting panel products to be used to make finished goods. Measures of this kind also address HCHO emissions once a product is disposed of – there are less emis sions, in total, if finished products are made with low emission panel products. See also the responses to comments #66 and #68.

70) Comment [36-Perdue-070424-AHFA] : “There has been a lot of discussion about how CARB staff would verify the use of compli ant board in finished goods. We support the idea of employing a deconstr uctive small chamber test of finished goods to accomplish this. It is i mperative that an accurate

correlation be established with this test and the l arge chamber...”

Agency Response [36-Perdue-070424-AHFA] : We agree that the point raised by the commenter is appropriate. This is wh y the ATCM was

modified to allow for the use of the small chamber under ASTM D 6007-02, as a secondary test method, and to demonstrate equi valence to the large chamber as measured under ASTM E 1333-96 (2002).43

71) Comment [36-Perdue-070424-AHFA] : “AFHA agrees with CARB staff that the focus of the proposed ATCM is on the “raw board ” used to make composite wood component parts and not on finished goods (furniture). It is important to realize that all furniture will con tain a mixture of various composite wood component parts. The complexity of design and diverse mix of component parts does not lend itself to fini shed product testing.”

Agency Response [36-Perdue-070424-AHFA] : We agree that there are too many variables to finished product testing that would require us to establish separate standards for a large number of products. It is more effective to limit the emissions of the components and require their use in finished products instead.

72) Comment [74-Bradley-070426] : The enforcement test method for finished goods is worded poorly and should be reworded to sa y “emission testing of samples of HWPW, PB, and MDF contained in finish ed goods . . .”

Agency Response [74-Bradley-070426] : We agree that the point raised by the commenter is appropriate and modified the wordi ng in the

enforcement test method.

73) Comment [88-Elias-070426-APA] : “The other concern we also have is the ability to actually recognize and identify products in composite or secondary materials such as furniture or cabinetry that are finished goods and how you actually deconstruct those products and be able to identify the products that are nonconforming. I think this is very onerous, very ambitious activity to try to pursue. As a particip ant in the California Wood Industry Coalition, we offer our support to the pre vious testimony by the

Coalition members...”

Agency Response [88-Elias-070426-APA] : The ATCM requires specific test methods to be used. In the ISOR, we committed to developing a sample preparation method for laminated products to address this comment. See page 126 in the ISOR.

74) Comment [89-Zimmerman-070426-Sauder] : “Our main concern is enforcement, as has been discussed much here. Alth ough we recognize that CARB has tried to maintain a level playing fie ld, we have grave

concerns about the measurement and enforcement of t he proposed regulation. The enforcement test method for finish ed products is complicated. It’s unproven. Our furniture is fini shed on one or multiple sides all within the same unit. Formaldehyde can b e found in the paper. It

can be found in the environment. It can be found i n our adhesives. It can be found in all levels throughout our production. Composite panels can act as a sink and absorb HCHO from the surrounding environment. It becomes virtually impossible (to tell) whether or n ot HCHO came from the44 non-compliant panel or from the environment. It co ncerns us no work has been done to validate the finished product that’s b eing proposed.”

Agency Response [89-Zimmerman-070426-Sauder] : See the response to

comment #73.

IMPORTERS and IMPORTED PRODUCTS

CHAIN-OF-CUSTODY

75) Comment [38-Morgan-070424-IWPA] : “Paperwork and new database systems. New systems will need to be developed to track the burdensome new paperwork requirements for chain-of- custody documentation that do not currently exist in the ma rketplace...”

Agency Response [38-Morgan-070424-IWPA] : The ATCM does require recordkeeping for products used, sold, or supplied to California, however, we do not believe that this will create significant ly more paperwork than what must already be maintained. To our knowledge, records of purchases and sales must already be maintained for a variety of reasons, for example, bills of lading and invoices are alrea dy routinely used. Thus, the addition of new recordkeeping requirements shou ld not require a complete overhaul of existing database and tracking systems.

76) Comment [41-Chaffin-070424-IWPA] : “The chain of custody documentation requirement is unworkable for the imp orted plywood industry... A significant percentage of the imported plywood is sold to

wholesalers and distributors who consider the ident ity of their importer to be proprietary.”

Agency Response [41-Chaffin-070424-IWPA] : The ATCM does not require wholesalers or distributors to divulge the name of their importer. Section 93120.3 and 93120.7 require labeling of pan els and finished goods, respectively. Sections 93120.5(c) and 6(c) state that if products or finished goods are not modified by the distributor or the importers, no additional labeling is required. This assumes that the label from the manufacturer or fabricator will remain on the produ ct or finished good throughout the commercial chain to the retailer. T he response to comment #77 describes why the manufacturer or fabri cator (as opposed to the importer) must be known.

77) Comment [97-Chaffin-070426-IWPA] : “The chain of custody documentation is also difficult for importers and d oesn’t take into account the difference between domestic plywood business an d imported plywood business. Imported plywood changes hands numerous times in between45 the time it’s produced and by the time it reaches i ts ultimate customer. Generally, importers consider their source as propr ietary information. They don’t want to share that information with thei r customers. And their customers, the distributors and wholesalers, don’t want to share the name of their supplier to their customers. This is a un ique feature with regard to imported business. In conclusion, I would ask that the Board seriously consider direction to the staff to spend some time before acting on this regulation to find out something about how the impo rted plywood business

works...”

Agency Response [97-Chaffin-070426-IWPA] : The ATCM requires a strict chain-of-custody program to allow us to enforce the program effectively. Staff does understand how the imported plywood busi ness works, but the integrity of the enforcement program depends on bei ng able to trace a product or finished good back to its manufacturer o r fabricator through chain-of-custody documentation. Thus, the identity of the manufacturer or fabricator must be known. See also the response to comment #76.

78) Comment [98-Schroeder-070426-WMMPA] : “When seeking this raw material, Mr. Morrison was confronted by the Presid ent of the Chinese company that said “whatever certification that you need or piece of paper that you require, fax me a copy and we will make su re that you have your paperwork.” Mr. Morrison went on to explain the pr ocess would have to come from the Forest Stewardship Council and they w ould have to be inspected. The President of the Chinese company ex plained “No. No. No. Sir, all we need is what you need from us. Se nd us a copy -- we will get you the paperwork.” That right there in itself scares us out of our wits. Being able to ship on shore into California without having the certification in place of an FSC certified wood product and selli ng it as such is taking place right now. Without the certification being t aken from Chinese on the Chinese side – I’m just lost...”

Agency Response [98-Schroeder-070426-WMMPA] : We are aware of violations to the voluntary FSC certification progr am, which has very little enforcement. ARB will put into place a vigorous en forcement program for the ATCM, including the construction of laboratory test chambers to conduct product emission testing verification as a major aspect of the enforcement program. The ATCM also includes third party certification of panels, chain-of-custody, labeling, and recordkeepi ng requirements. Overall, we believe that the enforcement program wi ll deter the type of conduct identified by the commenter.46

ECONOMIC IMPACTS

79) Comment [38-Morgan-070424-IWPA] : “Some of the items not properly valued in the staff report include: Construction of new laboratories, development, and training of new third party certif ying businesses. New overseas laboratories and additional testing capaci ty, including the hiring and training of new staff, would now be required in every country interested in selling products to California.”

Agency Response [38-Morgan-070424-IWPA] : Many third party certifiers already exist in most parts of the world, so no add itional expenses are necessary for these companies. The basis for the c ost analysis for the

Phase 1 and Phase 2 emission standards relate to th e resin technologies used as the main cost driver (see pages 205 to 209 of the ISOR). On a per board production cost, certification cost is a very small part. Additionally, certification costs are already a par t of today’s per board cost in North America as 85 percent of US mills are cert ified under the Composite Panel Association’s Grademark Program.

80) Comment [38-Morgan-070424-IWPA] : “Inventory costs. This regulation effectively doubles the required inventory for U.S. importers. These companies will now need to maintain duplicate inven tory for material destined for California and product available for s ale to the rest of the U.S., Canada, and Mexico.”

Agency Response [38-Morgan-070424-IWPA] : We agree that multiple inventories may need to be maintained in some cases . This is a business decision that must be made by the affected party as to whether to maintain dual inventories and sell to California, o r not. However, many domestic fabricators have indicated their plan to o nly produce CARBcompliant products for the entire U.S. market.

81) Comment [41-Chaffin-070424-IWPA] : “The staff report does not adequately address the impact of this regulation on importers and overseas mill suppliers...” “The Board should postpo ne action on these regulations until there has been further adequate s tudy and reporting of the impacts on importers . . .”

Agency Response [41-Chaffin-070424-IWPA] : We disagree that more time is necessary or that more analysis of impacts are n eeded. As all manufacturers will be required to meet the same pro duct emission standards, they will have to make the necessary mod ifications to achieve that specified level of product quality. To stem t he flow of high emitting panel products into California, we feel that it is important to require stringent quality control practices to provide assu rances that California47 receives products that meet its standards. Oversea s manufacturers must

make a business decision on whether to continue sel ling to California.

82) Comment [41-Chaffin-070424-IWPA] : “. . . This regulation will result in adverse impacts on business and consumers and the p ossible benefit will

not be measureable.”

Agency Response [41-Chaffin-070424-IWPA] : We disagree. California law requires CARB to reduce public exposure to form aldehyde as much as technically feasible while considering costs. T he ISOR has a full evaluation of impacts on business (see pages 178 to 216). The ISOR also

has a discussion of risk reduction benefits. See C hapter VII, pages 157- 159, the ATCM will achieve significant reductions i n cancer cases.

ENFORCEMENT and FAIR COMPETITION

83) Comment [4-Sherman-070409-NA] : “The proposal will still allow the importation of non-compliant panels for use in fabr ication of products

whose eventual destination is outside of the state. Just as there are unlicensed, uninsured shops in operation ... these sa me shops will likely find ways to procure and use these non-compliant pa nels for in-state distribution. Not only does this have the potentia l to undercut the small shops with whom these noncompliant shops would be i n competition with, but we compliant shops will be squeezed from the ot her side as well, sharing the costs of inspection/compliance/enforcem ent...”

Agency Response [4-Sherman-070409-NA] : We disagree. We will have an active enforcement program that includes collect ing samples of products for testing. If these tests show a violat ion of the emission standards, we can identify the shops making non-com pliant products and in-state purchasers of non-compliant products throu gh the ATCM chain-ofcustody requirements. Upon inspection of these sho ps, if statements of compliance cannot be produced, the buyers and suppl iers would both be in violation of the ATCM and subject to appropriate penalties.

84) Comment [29-Couture-070424-CDMDP] : “... we are concerned about the potential of non-conforming imports landing in Cali fornia from offshore.

The new rules will make it even harder for our indu stry to defend against

offshore manufacturers. This will lead to ... the er osion of a strong industry solidly entrenched particularly in the Wes t coast.”

Agency Response [29-Couture-070424-CDMDP] : We disagree. Currently, there are no restrictions of any kind on the HCHO e missions of wood products from offshore, so long as they are not use d in manufactured home construction. The ATCM sets limits beginning in 2009 that will48 create uniformity for all manufacturers, both forei gn and domestic, since they must all meet the new emission limits, and CAR B inspections will be made to ensure that those products are being sold t o the California market. In addition, many domestic producers currently have their products third party certified, and the ATCM requires that all man ufacturers, including offshore manufacturers, to go through the expense o f being third party

certified.

85) Comment [38-Morgan-070424-IWPA] : “Database of exempted adhesives... In addition to maintaining an online dat abase of approved certifying testing agencies and laboratories, ARB’s compilation of all exempted adhesives will allow companies to better u nderstand compliance options.”

Agency Response [38-Morgan-070424-IWPA] : While the commenter makes good suggestions, we may not have the resourc es to effectuate all of them. We will post all approved third party cer tifiers on our website, thereby providing transparency. In addition, we wi ll likely post the Executive Orders issued to manufacturers using eith er NAF or ULEF

based resins.

86) Comment [38-Morgan-070424-IWPA] : “Enforcement – include de minimis clause exemption: ... there needs to be a de minimis exemption that eliminates liability from companies that have shown they have undertaken best practices but end up with a small amount of no n-compliant

material...”

Agency Response [38-Morgan-070424-IWPA] : We disagree with a de minimis clause exemption. Upon determination of a violation, liability will be evaluated on a case-by-case basis. Liability wi ll depend on the particular circumstances and factors, such as wheth er there was any willful misconduct, or simply a minor inventory err or.

87) Comment [41-Chaffin-070424-IWPA] : “... These regulations represent an unauthorized, non-tariff trade barrier with regard to foreign suppliers and importers.”

Agency Response [41-Chaffin-070424-IWPA] : We disagree. The ATCM is designed to protect public health by reducing forma ldehyde emissions from composite wood products sold, supplied, or off ered for sale in California. See the response to comment #43 in Sec tion D, Comments and Agency Responses: 15-day Comment Period, which explains why the ATCM is not an “unauthorized, non-tariff trade barr ier.”

88) Comment [45-Gregory-070424-SierraPine] : “Without adequate enforcement, the flood of imported products made wi th non-compliant49 foreign MDF and PB will increase significantly... Thi s will have the unintended affect of actually worsening the environ mental impact, as many foreign producers do not comply with any local clean air regulations from their operations and emit significant amounts of greenhouse gasses...”

Agency Response [45-Gregory-070424-SierraPine] : We agree that points raised by the commenter are appropriate. That is w hy we have developed a comprehensive enforcement program. We will enfor ce the rulemaking on both foreign and domestic manufacturers. Initia lly, we expect that the ATCM will stem the flow of high emitting products t o California, which

should lower emissions in the state. See also the response to comment

#60.

89) Comment [51-Watson-070425-IPMG] : “... Under this proposal, we will still allow the materials to come through the ports of Ca lifornia and be stored there, as long as the material is to be sold out of state... If the objective is to reduce the amount of HCHO through California, th en why not ban it from arriving in the first place? Banning the impo rtation to the port of a dangerous substance altogether would make a lot mor e sense to me.”

Agency Response [51-Watson-070425-IPMG] : Health and Safety Code section 39666 mandates CARB to develop ATCMs that a re based on feasible control technologies. Banning the import of products containing HCHO may provide greater health benefits, but it is not commercially feasible and would be too disruptive to the viabili ty of the composite wood products industry and the businesses that rely on a n adequate supply of these products.

90) Comment [64-Guay-070426-Columbia] : “We think your implementation plan to focus on the importer is an excellent start . It will only take a few loads being rejected or heavy fines and the unscrup ulous importer will begin specifying to the new levels. After all, the offshore suppliers build to an order specification, rarely to inventory. When you control the importer and their direction to the manufacturers you will u ltimately affect a huge change in the industry.”

Agency Response [64-Guay-070426-Columbia] : We agree – no response

necessary.

91) Comment [72-Robson-070426-AWFS] : “CARB staff has not effectively addressed how finished products manufactured overse as and shipped into the state will be inspected and enforced.”

Agency Response [72-Robson-070426-AWFS] : We disagree. The enforcement program is based on third party certifi cation, chain-of-custody,50 and verification emissions testing. The enforcemen t program is well documented in the ATCM. For overseas goods, our in itial focus will be on importers, who will be responsible for securing the documentation that verifies that the panels and/or finished products f rom overseas meet
California standards.

92) Comment [72-Robson-070426-AWFS][76-Robson-07042 6-AWFS] : “The problems with enforcement will benefit imported goo ds and their suppliers – further jeopardizing jobs in California. There a re thousands of California based small businesses engaged in cabinet making – all of whom are buying machinery and equipment from AWFS ® companies. If these cabinet makers cannot compete with finished product s from overseas, then they will go out of business and our companies will no longer have customers who can buy new machinery and hardware.”

Agency Response [72-Robson-070426-AWFS][76-Robson-0 70426- AWFS] : We disagree that jobs in California will be jeopa rdized due to the ATCM. We will implement a robust enforcement progr am to prevent noncompliant products from being sold in California. There are many pressures on small businesses. The ATCM will creat e a level playing field so no advantage to foreign producers will occur.

93) Comment [81-Gregory-070426-CWIC] : “You can regulate us as our doors are open. We’ve worked with staff throughout this process. You can come in and get your products or you can go to Home Depot and buy our products. The products such as ours or products th at are fabricated with products like ours overseas where HCHO is not a con cern -- that concerns me. Because if we go away, then you’re at the merc y of those people and products that are harder to control. And you can – eventually, the

situation could even become worse than what it is t oday.”

Agency Response [81-Gregory-070426-CWIC] : We disagree. By enforcing the rulemaking on all manufacturers, fabr icators, distributors, importers, and retailers, we believe that compliant products will be sold in California, and the situation with respect to HCHO exposure will improve rather than get worse relative to today.

94) Comment [88-Elias-070426-APA] : “However, as you’ve heard from the previous speakers, the American composite wood pane l industry remains very concerned over the ceiling levels that are bei ng proposed for Phase 2 and the timing of these measures and particularly h ow these measures will be equitably applied to both the domestic manu facturers and those of the imported panel producers. Particularly, import ed panel products that actually come to these shores with misleading or fr audulent marking indicating compliance to these standards.”51 Agency Response [88-Elias-070426-APA] : See the responses to

comments #60 and #91.

95) Comment [91-Raymer-070426-CBIA] : “On the other hand, you’ve got an unscrupulous foreign-based supplier of product, who knows full well that their product represents a few grains of sand in th at beach of shipping containers entering the country. Eventually, these unscrupulous individuals can expect to get caught. But what abo ut the short-term, the next two to three years after the standards kick in ? Consequently, it’s not overreaching to suggest there will be a great deal of lower cost, noncompliant product that will have to be competing with California manufacturers who have gone forward and made the up grades necessary to comply with ARB’s proposal. And therein lies th e problem. Over the long haul, it will work out. The Contractor’s Stat e License Board has had very public enforcement actions. These have been i mmensely effective over the years of getting people to play straight, get the proper licenses, etc. But it always takes time to do that. If you’ re an out-of-country manufacturer, you can depend on the fact that it wi ll take time to gear-up for California’s enforcement action to really kick in.”

Agency Response [91-Raymer-070426-CBIA] : We appreciate the comment and will take whatever action is appropriat e to provide a level playing field in the initial years of the regulatio n. However, we believe that unscrupulous practices will be rare. When the emis sion standards go into effect and the sell-through periods have expired, o ur inspectors will go to retail stores to collect products to test. These s tores sell both imported and domestic products (i.e., Home Depot). Therefor e, we do not agree that there will be any lag time in being able to en force against unscrupulous foreign suppliers who may be competing against Californiabased manufacturers. In addition, the ATCM require s importers to purchase products that meet the emission standards and to add additional assurance to their supply chain management practice s to ensure that their products will comply. Also, foreign producers are subject to third party certification to ensure compliance with the emissio n standards, as products leave the manufacturing plant and before t hey arrive in California.

96) Comment [106-Guay-070426-Columbia] : “... Keep in mind the same factories that are sending this unsafe plywood to C alifornia are supplying most of Europe’s E1 and nearly all of Japan’s F3 an d F4 star. It can be measured, complied, and enforced. Those two parts of the world get their plywood from China using standards that are dramati cally different from those in the United States. We think your implemen tation plan to focus on the importer and the manufacturer is an excellent s tart. It will only take a few rejected loads of panels for the unscrupulous i mporter to begin to specify the new levels. After all, the off-shore s uppliers build to order specifications, rarely to inventory. When you cont rol the importer and their52 directions to the manufacturers, you will ultimatel y affect a huge change on this industry off-shore. It can be done. It’s happening today. We strongly encourage you to act today to stop this un necessary dumping of unhealthy imports in California by adopting the pro posal as amended...”

Agency Response [106-Guay-070426-Columbia] : We agree – no response needed.

THIRD PARTY CERTIFICATION

97) Comment [38-Morgan-070424-IWPA] : “Eliminate third party testing requirement. ... IWPA urges ARB to reconsider the re quirement for thirdparty testing and chain of custody...”

Agency Response [38-Morgan-070424-IWPA] : We strongly disagree.

These are critical enforcement elements in the ATCM

.

98) Comment [38-Morgan-070424-IWPA] : “As previously mentioned, this regulation places a significant requirement for thi rd-party certification – a requirement that does not currently exist in any wi despread form anywhere around the globe.”

Agency Response [38-Morgan-070424-IWPA] : We disagree. Third party certification around the globe is taking place in v arious forms and to ensure fair competition in the marketplace, this is a practice that needs to be implemented and enforced. We believe it is cruc ial for the integrity of this rulemaking.

99) Comment [38-Morgan-070424-IWPA] : “Furthermore, the requirements for third party certifiers – as detailed in 93120.4 (b) (1) – show evidence of past field experience is not workable given that th ere was not a need for this volume of third-party certifiers prior to the ATCM...”

Agency Response [38-Morgan-070424-IWPA] : We believe the field experience is necessary to demonstrate how applican ts will be able to perform the requirements of the ATCM for third part y certifiers. In some cases, it may be necessary for a candidate third pa rty certifier to contract out the product verification element of third party certification to another entity with the proper experience.

100) Comment [38-Morgan-070424-IWPA] : “... develop a database of existing laboratories with sufficient facilities for testing to the standards of the new regulation...”53 Agency Response [38-Morgan-070424-IWPA] : We agree that the point raised by the commenter is appropriate. We will de velop a listing of approved third party certifiers in the future and p ost on our website.

101) Comment [38-Morgan-070424-IWPA] : “... eliminate the previous work experience requirement for third party certifiers... It is unreasonable to expect these new businesses to have past work exper ience.”

Agency Response [38-Morgan-070424-IWPA] : The ATCM requires third party certifiers to work closely with manufacturing mills to establish operating parameters for the mill. Therefore, thir d party certifiers need to have working knowledge regarding composite wood pro duct manufacturing. See also the response to comment #9 9.

102) Comment [41-Chaffin-070424-IWPA] : “... The majority of the mills confirmed the HCHO levels required could be met but the third party certification would be a major impediment to meetin g all of the regulations. More time is needed than set out in the regulations to comply.”

Agency Response [41-Chaffin-070424-IWPA] : We disagree. All manufacturers must be third party certified and thi s is critical to ensuring fair competition in the marketplace. We believe su fficient time has been provided to comply with the ATCM.

103) Comment [41-Chaffin-070424-IWPA] : “There are inadequate third party

certifiers available for overseas mills... large chamber testing facilities are extremely rare in other plywood producing countries such as Malaysia and

Indonesia.”

Agency Response [41-Chaffin-070424-IWPA] : We disagree that there will be an insufficient number of third party certifiers (TPCs). Staff estimates

that about a dozen TPCs will be needed internationa lly to certify all California composite wood products. To date, we ha ve developed a list of about 30 reputable international organizations who are interested in applying to CARB to be an approved TPC. Therefore, we believe that a

sufficient number of TPCs will be available to meet global demands.

During the development of the ATCM, however, CARB s taff received numerous comments from manufacturers and prospectiv e TPCs that indicated that a lack of large chamber testing faci lities would present a significant testing bottleneck, which could negativ ely impact the implementation of the ATCM. To address these comme nts, staff investigated several alternative testing methods th at could be used to augment large chamber (i.e., primary method) availa bility. Staff determined that a suitable smaller dynamic chamber method, ASTM D 6007-02, should be considered as a secondary method . In order to be54 acceptable, however, the secondary method would nee d to perform equivalently to the large chamber. Consultation wi th industry and academic experts familiar with dynamic chamber test s confirmed that chamber tests will yield the same results, as long as the chambers are operated under similar test conditions. The ATCM w as revised to include this second testing option. Concise statistical cr iteria were developed that must be used to demonstrate that the primary and se condary methods are equivalent. The statistical criteria are based on an evaluation entitled “Supplemental Analysis Supporting the Test for Demo nstrating Equivalence between Primary and Secondary Methods f or Measuring Formaldehyde Emissions from Composite Wood Products ”, dated January 2008. The necessary modifications were made to 931 20.9(a) and the document above was made available for public review and comment during the 15-day comment period.

104) Comment [47-Steenson-070424-AuWPA] : “... Either the requirement for certification should be applied to products with “n o added formaldehyde” (NAF) or more preferably panels with low emissions regardless of binder type should qualify for exemption from the proposed rule.”

Agency Response [47-Steenson-070424-AuWPA] : We believe that the most effective approach in the long run is to promo te the use of NAF products, which is pollution prevention. There are inherent risks

associated with the continued use of binders with H CHO in terms of meeting the ATCM standards, and it becomes a busine ss decision, in our view, if manufacturers want to use those binders or switch to NAF resins. We have revised the regulation to allow an exemptio n from third party certification to manufacturers using formaldehyde-c ontaining resins (ULEF), if they can demonstrate consistently low em ission values.

105) Comment [96-Morgan-070426-IWPA] : “We have submitted written comments, but I’d like to touch on a couple things. We urge ARB to reconsider the requirement for third-party testing and chain of custody. This regulation can be judged on its effectiveness as a performancebased standard only. In other words, give us a sta ndard. We will meet it.

And if we do not meet the standard – if we do meet a standard and we do not have the third party testing requirement or the documentation, then we will be considered not in compliance. We still fee l like that is a tall order to achieve... But if we do have to meet the requirement of third party testing and certification and chain of custody documentatio n, we urge that you push back the effective dates to: Phase 1 – January 1, 2010; and Phase 2 – January 1, 2012, so that we might become on line. ”

Agency Response [96-Morgan-070426-IWPA] : We disagree – the third party certification and chain-of-custody requiremen ts are critical elements of the enforcement program. We believe that the av ailability of third party55 certifiers will be sufficient to meet the needs of manufacturers worldwide and do not see a need to push back the effective da tes of the emission

standards in the ATCM.

106) Comment [97-Chaffin-070426-IWPA] : “The next concern was with regard to third party certifiers. It is difficult at this point to determine who will do third party certification for mills in, for example , Malaysia. We assume the third party certifier has to be someone in country, and there are not enough third party certifiers in Malaysia today to handle the requirements of this particular proposal.”

Agency Response [97-Chaffin-070426-IWPA] : We disagree. We know that there are a number of testing laboratories wit h an international presence that will expand their present capabilitie s to service the needs of manufacturers worldwide. See also the response to comment #103.

MANUFACTURERS

ENFORCEMENT and FAIR COMPETITION

107) Comment [6-Harmon-070413-Hexion] : “It should be specified in the regulation that screening testing and enforcement t esting will be conducted on all products equally, including those granted exemption under applicable sections of the regulation order.”

Agency Response [6-Harmon-070413-Hexion] : We agree that all products in the ATCM are subject to enforcement testing. NA F products are not exempt from enforcement testing in the ATCM. Rathe r, because of the exemption from third party certification afforded t hese products if the ATCM criteria are met, they will be subject to enfo rcement testing just like products made with formaldehyde-containing resins.

108) Comment [24-Landry-070423-CWIC] : “Furniture imports have increased dramatically over the last decade... The chance for m ischief is too high to risk the severe impact on domestic manufacturers.”

Agency Response [24-Landry-070423-CWIC] : See the response to

comment #60.

109) Comment [34-Keeling-070424-Roseburg][82-Julia- 070426-CPA] : “Enforcement creates a competitive disadvantage for domestic producers. ... It seems unreasonable to promulgate such a rule w ithout the details of enforcement fully understood by all under which the re is opportunity to cheat the system in imported finished goods.” “CPA supports . . . rigorous

enforcement . . .”56 Agency Response [34-Keeling-070424-Roseburg][82-Jul ia-070426-CPA] : See the response to comment #60.

110) Comment [43-Raymer-070424-CBIA] : “... CBIA is especially concerned with the enforcement aspects related to the propose d regulation. It seems highly likely that the referenced proposal will, fo r at least the short-term, create an un-level playing field for those manufact urers located within

California with those located outside our state bor ders (especially those located in other countries).”

Agency Response [43-Raymer-070424-CBIA] : We disagree. We have

had extensive contact with manufacturers in other c ountries regarding the ATCM. See also the response to comment #95.

111) Comment [45-Gregory-070424-SierraPine][51-Wats on-070425-IPMG] : “The enforcement division has assured us they will be able to enforce this regulation on all producers of MDF and PB worldwide ... We do not share this optimism ... particularly due to the emphasis on implementing and enforcing AB 32.” Enforcement “will make very litt le difference.”

Agency Response [45-Gregory-070424-SierraPine][51-W atson-070425- IPMG] : We disagree. The Enforcement Division has the re sources to enforce the ATCM and the ATCM contains stringent re quirements that are the critical elements of the enforcement program. See also the response

to comment #60.

112) Comment [59-Taylor-070426-Veneer] : “Also, why would businesses – in other states and countries – be allowed to bring pl ywood – made into

furniture – into California and not have to adhere to the same standards as

the manufacturers in California?”

Agency Response [59-Taylor-070426-Veneer] : To clarify, businesses outside of California that sell their products in C alifornia must comply with the regulations, same as for businesses in Californ ia.

113) Comment [72-Robson-070426-AWFS] : “While CARB staff believes the regulation is economically feasible for the industr y, it appears the economic analysis does not take into account the ad ded costs to California business of trying to compete against no n-compliant, cheaper products from overseas that will still make their w ay into the market place.”

Agency Response [72-Robson-070426-AWFS] : The ATCM requirements apply to all manufacturers including the requiremen t for third party certification. Regarding enforcement of the ATCM r equirements on products manufactured overseas, see the response to comment #84.57

114) Comment [92-Landry-070426-CWIC] : “I’d also like to talk very briefly about the incentive for mischief by the unscrupulou s. The people you’ve been talking to, they’re going to find a way someho w to do this. Phase 2 is going to be incredibly hard. But with these kin ds of cost differentials, there is an incredible incentive for people to try to avoid it.”

Agency Response [92-Landry-070426-CWIC] : We appreciate the comment and will be aggressive in enforcing the ATC M. We believe the ATCM enforcement program is comprehensive and will greatly reduce malicious cheating. In addition, our testing capab ilities will allow us to verify the emissions performance of composite wood products and finished goods. See also the response to comment # 60.

115) Comment [95-Kable-070426-Setzer] : “We started out in business as a wooden box manufacturer, and now our sole product i s MDF moldings. Our raw material, the MDF boards, come 100 percent from domestic MDF board plants. And without these board plants, we w ill be out of business. We have tried to diversify our supply using interna tionally made boards. But in all cases, what we have found these manufact urers want to support their own domestic molding plants and have declined to sell us outright or charge us more for the board than they would charge us for the finished product. I believe you may be creating an uneven p laying field for domestic MDF board manufacturers, because the enfor cement approach suggested by ARB will not effectively verify compli ance by the off-shore suppliers.”

Agency Response [95-Kable-070426-Setzer] : We disagree. It is our intent to inspect chain-of-custody information and test pr oducts made both domestically and from overseas to prevent the sale of non-compliant products in California. In addition, overseas manu facturers of MDF must be third party certified and have their emissions p erformance verified even before they reach California.

116) Comment [95-Kable-070426-Setzer] : “I also believe the rules will allow domestic distributors to stock and sell cheaper non -performing foreign products for longer period of time than domestic MD F plants can manufacture the similar performing products, furthe r making domestic plants less competitive compared to international p lants. The CARB Board must make sure that they don’t inadvertently favor international MDF board plants over domestic board plants. For i f they do, this will clearly affect their customers, and put our Sacrame nto MDF molding plant

out of business.”

Agency Response [95-Kable-070426-Setzer] : We agree that the point raised by the commenter is appropriate and made cha nges to the sell-58 through provisions so that importers and panel manu facturers have the same amount of time. Previously, the panel manufac turers had one month and the importers had five months.

117) Comment [122-Schutfort-070426-PSI] : “... And I recommend to the Board to look into what worked in the European system, wh at worked in the Japanese system and what failed in those systems.”

Agency Response [122-Schutfort-070426-PSI] : We agree that points raised by the commenter are appropriate and did res earch those programs as shown in the ISOR (see Appendix H).

FORMALDEHYDE EMISSIONS STANDARDS

118) Comment [2-Levin-070328-BERG] : “The target levels of formaldehyde emissions for this regulation are far too high. ... Further reduction is technically feasible and should not be dismissed as the preferable option.”

Agency Response [2-Levin-070328-BERG] : We disagree. The ATCM’s Phase 2 emission standards are the most stringent p roduction-based standards in the world. We have, however, written incentives into the

ATCM that allows NAF and ULEF resin users who meet certain criteria to be exempt from third party certification or to have a reduced testing requirement (see sections 93120.3 (c) and (d)).

119) Comment [2-Levin-070328-BERG] : “State office buildings (Capitol Area East End Project) have been built during the past f ive years where far lower criteria were used for formaldehyde emissions . Proportional

reductions of more than a factor of three would be appropriate based on

the standards used for the State’s own office build ings.”

Agency Response [2-Levin-070328-BERG] : We appreciate the comment. The East End Project was specified as a “green buil ding” under state law. The legislation required very strict HCHO standards and the standard was not intended to be applicable to all buildings in C alifornia. The Phase 2 standards are most stringent production based stand ards in the world. In response to comments, the Board moved up the effect ive date for HWPWVC by one year from January 1, 2011 to January 1, 2 010.

120) Comment [7-Landry-070416-CWIC] : “We are particularly concerned with the ceiling values for Phase 2, which do not take i nto account that industry products must be manufactured substantially below t he regulatory ceilings because of the significant variability in raw mater ials, processing equipment and test methods – and hence emissions.”59 Agency Response [7-Landry-070416-CWIC] : The ceiling values for Phase

2 take into account the factors that contribute to variability that are mentioned by the commenter. Differences lie, betwe en our estimates and those of industry, insofar as the amounts that thes e factors contribute to consistently producing products that meet the stand ards. We believe that the established ceiling values are eminently feasib le.

121) Comment [10-Higgins-070416-FFC] : “Is this rulemaking necessary? Yes... California law clearly obligates the CARB to r egulate HCHO emissions from composite wood products. Currently we lag behind virtually every other developed nation in the world in this important matter of public health.”

Agency Response [10-Higgins-070416-FFC] : We agree that points raised by the commenter are appropriate. The ATCM enables California to be on par with other countries in terms of regulating hig h HCHO emissions from composite wood products.

122) Comment [10-Higgins-070416-FFC] : “Does the proposed ATCM go far enough? Regrettably no... We recommend moving to bac kground levels immediately in veneer-core hardwood plywood product s and adopting an aggressive timeline that reaches background levels in all composite products no later than 2010.”

Agency Response [10-Higgins-070416-FFC] : We disagree. For the industries other than HWPW-VC, moving to background levels should remain as a goal, but at this point in time, not re alistic given the economic hardship it could cause. In response to the commen t, however, the Board moved up the effective date for HWPW-VC from Januar y 1, 2011 to January 1, 2010. The two-phases of standards in th e ATCM give manufacturers the time to make the required reducti ons and achieve the greatest overall public health benefit.

123) Comment [11-Higgins-070417-CoLA] : City of Los Angeles Resolution in support of the “... California Air Resources Board’s proposal to regulate HCHO emissions from composite wood products, reduci ng emissions to zero by the year 2010.”

Agency Response [11-Higgins-070417-CoLA] : We disagree. “Zero (HCHO) emissions” is an unachievable goal because t here are natural HCHO emissions from wood. The Board moved up the e ffective date for HWPW-VC by one year from January 1, 2011 to January 1, 2010.

124) Comment [12-Higgins-070417-FFC] : “... We strongly support the CARB staff proposal to regulate HCHO emissions from comp osite wood products rapidly and bring them as close to zero as technica lly possible by 2010.”60 Agency Response [12-Higgins-070417-FFC] : The ATCM will bring HCHO emissions from HWPW, PB, and MDF as close to zero a s technically possible by 2012. We believe the extra time is nee ded for all the manufacturers worldwide to comply with the ATCM. S ee also the response to comment #123.

125) Comment [13-Lent-070417-HBN] : “... That said, I urge the Board to not only accept the ATCM concept presented by the staff , but to direct them to return to earlier stricter proposals for final HCHO levels in Phase 2... the technology is already available to move more rapidl y than proposed toward much more stringent levels.”

Agency Response [13-Lent-070417-HBN] : In response, the Board moved the effective date of HWPW-VC from January 1, 2011 to January 1, 2010. See also the response to comment #122.

126) Comment [13-Lent-070417-HBN] : “... We see no valid reason to set levels higher than the 0.03 ppm ambient and urge you not u nder any circumstances to accept any proposed endpoint over 0.05 ppm.”

Agency Response [13-Lent-070417-HBN] : We disagree. In our research, a 0.03 ppm standard is extremely difficult to meet consistently, even with no-added formaldehyde resins because wood itself co ntains some formaldehyde. We did not set an endpoint standard higher than 0.05 for

HWPW.

127) Comment [13-Lent-070417-HBN] : “... The historical chart prepared by

staff of the static nature of HCHO emissions since the HUD standard was set in 1985 is telling. It is time to move the bar again. That is why the EU and Japan decided years ago not to wait and hope th at the market would sort it out and that is why we support your efforts to do the same.”

Agency Response [13-Lent-070417-HBN] : We agree. From a public health protection standpoint, there are clear benef its that can be realized from reducing HCHO emissions from composite wood pr oducts from today’s levels.

128) Comment [13-Lent-070417-HBN] : “... Significant improvement in what we and our children are exposed to can only come by cl ear appropriate regulatory action that places the same expectations on all manufacturers.”

Agency Response [13-Lent-070417-HBN] : We agree. The ATCM sets standards that must be met by all manufacturers, fo reign and domestic.61

129) Comment [13-Lent-070417-HBN] : “We certainly agree with the industry that enforcement is important and something that sh ould be worked on earnestly by all parties – but in parallel, not as a delaying tactic to the overdue bar setting...”

Agency Response [13-Lent-070417-HBN] : We agree and believe there are strong enforcement elements in the ATCM.

130) Comment [13-Lent-070417-HBN] : “... It is time for the industry to stop complaining and get to work on how to best make thi s transition toward lower emitting products. Industry leaders like Col umbia Forest Products have shown how to do this in a cost neutral way. T here is no excuse for the rest of the industry not to follow.”

Agency Response [13-Lent-070417-HBN] : We agree and set the emission standard effective dates accordingly. We believe t hat the effective dates in the ATCM allow enough time for high quality low- emitting products to be manufactured and sold to the California marketplace

.

131) Comment [13-Lent-070417-HBN] : “We strongly urge you to guide the staff to return to earlier stronger approaches to this re gulation and keep levels

at or near ambient.”

Agency Response [13-Lent-070417-HBN] : We disagree. There are limits to panel manufacturing technology and what costs th e industry can assume. To move too far too quickly will only hurt the industry and jeopardize the public health benefits that would be realized by a timely transition to lower emitting products.

132) Comment [16-Overgard-070419-HPVA] : “We propose that the appropriate Phase 2 emissions levels should be 0.06 ppm rather than 0.05 ppm [for HWPW] proposed in the current version of the rule.”

Agency Response [16-Overgard-070419-HPVA] : We disagree. There are presently two cost-competitive options for manufact uring Phase 2 compliant HWPW – PVA and Purebond TM that are available for immediate use, and other options are likely to be developed i n the near-term. In our view, this supports the feasibility of the Phase 2 emission standards for HWPW (see p. 101 to 103 in the ISOR).

133) Comment [17-Whalen-070419-Columbia] : Recommended combining the

standards for HWPW-VC and HWPW-CC with the followin g effective dates: Voluntary Phase 1 standard of 0.07 ppm on Ja nuary 1, 2008; Mandatory Phase 1 standard of 0.07 ppm on January 1 , 2009; and mandatory Phase 2 standard on January 1, 2010.62 Agency Response [17-Whalen-070419-Columbia] : We disagree with combining the standards and effective dates for HWP W-VC and HWPWCC. We believe that the distinction between the tw o products should be preserved, as HWPW-CC contains core materials (i.e. , particleboard or MDF) that are allowed to have higher formaldehyde e mission limits in the ATCM. As such, we believe that it is important to allow lower emitting particleboard and MDF products to be available for use by manufacturers

of HWPW-CC to meet the Phase 1 and Phase 2 standard s. The Board did, however, move up the Phase 2 effective date fo r HWPW-VC from January 1, 2011 to January 1, 2010.

134) Comment [17-Whalen-070419-Columbia] : “California is already at risk of becoming a toxic dumping ground for high-fuming, fo rmaldehyde-based composite wood panels that cannot be sold into othe r global markets...”

Agency Response [17-Whalen-070419-Columbia] : We agree that the point raised by the commenter is appropriate. This is wh y we elected to set our standards in two phases. One important benefit of the timing of the Phase 1 standards is to prevent high emitting products fr om being sold in California – absent an emissions standard, products with emission values higher than the HUD standard can be sold legally in California since they may not be for use in manufactured homes.

135) Comment [17-Whalen-070419-Columbia] : “... Critics of the implementation timelines as “too swift” should be i gnored – California’s

intention to rid the air of HCHO toxic air contamin ants has been the “handwriting on the wall” since 1992.”

Agency Response [17-Whalen-070419-Columbia] : We agree that the point raised by the commenter is appropriate. We held ou r first public workshop in 2001 and indicated our intention to regulate HCH O emissions from composite wood products. It is clear that some par ties did not believe that

action would be taken and elected to continue with business as usual.

136) Comment [24-Landry-070423-CWIC] : “This ATCM is unlike any other that CARB has developed. It is not simply a “content” r egulation measuring

the amount of a chemical in a container – it restri cts dynamic emissions from a range of panel products and similarly from a host of household objects such as furniture and cabinets that are mad e from them. The emissions do not necessarily relate to the amount o f HCHO in the product.”

Agency Response [24-Landry-070423-CWIC] : We disagree – HCHO emissions from HWPW, PB, and MDF are related to the amount of free, unreacted HCHO within a panel product and is derive d from the resin used to bind the product.63

137) Comment [24-Landry-070423-CWIC][26-Stoler-0704 23-Boise] : “The use of ceiling values requires manufacturers to produce at substantially lower emission targets because of the inherent variabilit y in the raw materials, production processes and repeatability of the compl iance test itself. Assurance of compliance is essential. Modest chang es in the range of

1/100 th to 2/100 th of a ppm are absolutely essential in the Phase 2 c eiling levels. Even with those changes the CARB rule woul d be the most comprehensive, toughest HCHO control measure in the world.”

Agency Response [24-Landry-070423-CWIC][26-Stoler-0 70423-Boise] : While we recognize that the emission standards will be the toughest HCHO control measure in the world, the standards ar e based on the use of viable resin technologies. Therefore, we disagr ee that the additional

“1/100 th to 2/100 th of a ppm” are absolutely essential to meeting the Phase 2 ceiling levels. As indicated in Chapter V of the ISOR, resin options are

available for manufacturers to meet the standards i n the ATCM. We

believe that the Phase 2 emission standards are fea sible, achievable, and

necessary.

138) Comment [24-Landry-070423-CWIC] : “The proposal represents the toughest comprehensive standard in the world... Unlik e international standards that apply only in certain situations, bu t not others, the ATCM applies to all applications... The test used by CARB is a pass/fail ceiling limit with no exceedances or reclassification possi ble. There are very harsh penalties for non-compliance.”

Agency Response [24-Landry-070423-CWIC] : We agree – no response

necessary.

139) Comment [24-Landry-070423-CWIC][67-Livingston- 070426-CWIC] : “CWIC carefully evaluated the manufacturing process es, available technology, needed product properties and the signi ficant production variables in developing recommended levels for emis sion limits... Although CWIC’s proposals vary slightly from those proposed by CARB,

those differences are essential and would still res ult in the toughest

standard in the world.”

Agency Response [24-Landry-070423-CWIC][67-Livingst on-070426- CWIC] : We disagree that “those differences are essential .” We have identified more than one option for meeting the Pha se 2 standards and believe that the use of any of the specified option s will allow manufacturers to consistently meet the limit. We a lso set the Phase 2 effective dates between January 1, 2011 and July 1, 2012 to allow time for all the manufacturers to meet the limits (see pages 103 to 107 of the64 ISOR). Raising the standards only reduces the publ ic health benefit that would be achieved following implementation of the A TCM.

140) Comment [24-Landry-070423-CWIC] : “The changes in Phase 2 numbers are necessitated by the variability of emissions fr om the products as well as the lack of precision of the test method. For i nstance, to comply with the proposed Phase 2 limit for PB of 0.09 ppm, we e stimate that production will have to be targeted in the 0.04-0.0 5 ppm level or lower, to allow for the compounding variability of the test m ethod and product...”

Agency Response [24-Landry-070423-CWIC] : We disagree. The

numerical values of the standards considered our en gineering judgment of the variability that may result from the products a nd the test method (see pages 103 to 105 of the ISOR). We believe the targ et ppm level will be higher than what industry has stated.

141) Comment [26-Stoler-070423-Boise] [27-Rush-0704 24-Temple Inland] [31- Warberg-070424-Plum Creek] [32-Savage-070424-SeeMac ] [33- Wijnbergen-070424-Norbord] [37-Sein-070424-Rexcel] [40-Smith-070424- Uniboard] [44-Julia-070424-CPA] [45-Gregory-070424- SierraPine] [46- Gonyea-070424-Timber] [67-Livingston-070426-CWIC][8 1-Gregory070426-SierraPine][86-Compton-070426-Hambro] : “. . . we support the California Wood Industries Coalition (CWIC) recomme ndation to adjust the Phase II . . . limits . . .” “The meeting of these levels recommended by industry by 2011-2012 would represent the most subs tantial emission reduction by the North American composite panel ind ustry at any time in its history.” “Even with the changes recommended b y industry, the ARB rule will still be the most comprehensive, toughest HCHO control measure in the world thanks to its rigorous enforcement pro tocols.”

Agency Response [26-Stoler-070423-Boise] [27-Rush-0 70424-Temple Inland] [31-Warberg-070424-Plum Creek] [32-Savage-0 70424-SeeMac] [33-Wijnbergen-070424-Norbord] [37-Sein-070424-Rexc el] [40-Smith070424-Uniboard] [44-Julia-070424-CPA] [45-Gregory- 070424-SierraPine] [46-Gonyea-070424-Timber] [67-Livingston-070426-CWI C][81-Gregory070426-SierraPine][86-Compton-070426-Hambro] : We believe that resin technology allows for greater emission reductions t han industry suggests, which would allow for achieving the greatest public health benefit that we can as required by state law (Safety Code sections 39665-39666). See also pages 101 to 107 of the ISOR.

142) Comment [36-Perdue-070424-AHFA] : “... we are concerned that Phase 2 is overreaching and suggest the “de-listing” of cur rent UF resin technologies without evidence of feasibility and be nefit... We strongly advocate the common sense approach of conducting a “Technical and Feasibility Review” of Phase 1 with all concerned s takeholders before65 implementing Phase 2. This would give CARB staff t he opportunity to do an informed analysis of best available control tech nology (BACT) and evaluate the impact of Phase 1.”

Agency Response [36-Perdue-070424-AHFA] : We disagree. We believe the Phase 2 standards are technologically feasible and do not constitute a de-listing of current UF technologies. New formald ehyde based resin systems have shown promise insofar as meeting the P hase 2 standards for some composite wood products. Given the curren t availability of noadded formaldehyde resin systems for all three prod ucts subject to the ATCM, we are confident that the Phase 2 standards c an be met in the timeframe specified. Decisions will need to be mad e as to what the most cost-effective solution is for a given manufacturer . See also pages 101 to

107 of the ISOR.

143) Comment [38-Morgan-070424-IWPA] : “Proposed regulation implementation dates must be delayed: Phase 1 to Ju ly 1, 2010 and Phase 2 to January 1, 2012. ... outreach to foreign governments regarding implementation of new regulations and pol icies suggest that the time window for implementation of this regulation i s much too quick.”

Agency Response [38-Morgan-070424-IWPA] : We disagree. Many foreign manufacturers and importers participated in the development of

the ATCM. We believe sufficient time to meet the s tandards has been provided.

144) Comment [39-Maher-070424-Great Lakes] : “Specifically, we support the CWIC recommendation to adjust the Phase 2 emission level limits as

follows:

 Particleboard – a ceiling of 0.10 ppm rather than 0.09 recommended by agency staff

 MDF – a ceiling of 0.13 ppm rather than 0.11 as r ecommended by agency staff

 Thin MDF – a ceiling of 0.15 ppm rather than 0.13 as recommended by agency staff...”

Agency Response [39-Maher-070424-Great Lakes] : We disagree with the recommendation. The emission standards approved by the Board achieve the lowest practicable emissions in conside ration of costs. See response to comment #141.

145) Comment [39-Maher-070424-Great Lakes] : “... we urge the Board to amend the Phase 2 limits as presented above to assu re that the proposed regulation accomplishes its objective without placi ng unrealistic and unnecessary mandates on industry.”66 Agency Response [39-Maher-070424-Great Lakes] : We disagree. We

believe the Phase 2 standards are reasonable and ac hievable, and would not place an unrealistic and unnecessary mandate on industry. See response to comment #141.

146) Comment [46-Gonyea-070424-Timber] : “... We continue to advocate the adoption of the 0.06 ppm for Phase 2 [for HWPW].”

Agency Response [46-Gonyea-070424-Timber] : We understand the commenter’s position on this matter, but disagree o n what the numerical value of the standard for HWPW should be. As point ed out in Chapter V of the ISOR, it is technologically feasible to achi eve the standard adopted by the Board in the timeframe specified.

147) Comment [47-Steenson-070424-AuWPA] : “We recommend that the board adopt an emission standard that reflects the intern ationally accepted

standard of E1.”

Agency Response [47-Steenson-070424-AuWPA] : We disagree – in doing

so we would not be able to achieve the maximum heal th protection possible as required by the Health and Safety Code.

148) Comment [49-Levin-070425-BERG] : “I do not believe that the final regulatory targets in years 2011 and 2012 of 0.11 a nd 0.13 ppm for MDF and thin MDF, respectively, are sufficiently protec tive of the population... I believe the limit should be based on a target conce ntration no higher than that established by OEHHA for workplace exposure wh ich is only intended to protect workers during a 40-hour work week...”

Agency Response [49-Levin-070425-BERG] : We disagree. We believe that these limits provide an important public healt h benefit that is technologically achievable in the specified timefra me and in consideration

of cost. The Phase 2 emission standards for MDF ar e about half of emissions from current-day products. This does not preclude setting more stringent standards in future years. If technologi cal advances are made

that would allow for lower emission limits to be me t for those products we

can return to the Board with amendments to the ATCM

.

149) Comment [49-Levin-070425-BERG] : “... An emission rate (for MDF) far below the proposed limits will be required to provi de protection in energy efficient residential environments with typical ven tilation rates below 0.5 ach. Even at 0.5 ach, concentrations of 100 ppb or above are simply unacceptable given the health effects data on forma ldehyde exposure.”

Agency Response [49-Levin-070425-BERG] : We believe that the approved emission standards for composite wood prod ucts fulfill the67 requirement of Health and Safety Code section 93666 , are technologyforcing and represent the maximum achievable emissi on reductions, in consideration of cost. See response to comment #14 8.

150) Comment [56-Carmichael-070425-CCA] : “... We support the stringency of the standards and the “cap approach” proposed by st aff but we strongly believe the industry can and should meet these stan dards sooner... At a minimum, the Board should accelerate the portion of the regulation that covers hardwood plywood – veneer core and hardwood plywood – composite core.”

Agency Response [56-Carmichael-070425-CCA] : While the effective date for the Phase 2 standard for HWPW-VC was moved by t he Board from January 1, 2011 to January 1, 2010, we believe that the standard for HWPW-CC cannot be moved up. It is necessary to all ow for lower emitting particleboard and MDF products, produced t o comply with the Phase 2 standards, to become available as core mate rials used in HWPW-CC products. See also the response to comment #133.

151) Comment [61-Demorest-070426-Columbia] : “At the same time, because of what we know about the industry, we urge CARB to be more aggressive in establishing a California “background standard” and a swift implementation timeline – requiring a transition to low and noformaldehyde resin innovations before the end of th is decade.”

Agency Response [61-Demorest-070426-Columbia] : In our present view, a requirement of this kind is not practical for PB and MDF because natural wood can emit HCHO above background levels, but is achievable for HWPW-VC. However, the ATCM provides incentives for manufacturers to utilize no-added HCHO resins or ultra low emitting resins, which over time, we expect will assume a major market share for prod ucts sold to California. See also the response to comment #123.

152) Comment [64-Guay-070426-Columbia] : “One of the effects of the decline of domestic manufacturing is that the U.S. and Cali fornia have become a dumping ground for products with high UF emission l evels. Products that cannot be sold anywhere else in the developed world . I cannot emphasize that enough. California has become a dum ping ground.”

Agency Response [64-Guay-070426-Columbia] : We agree. Due to the lack of HCHO standards for composite wood products, it is currently legal to purchase low cost, high HCHO emitting products. However, with the ATCM’s emission standards and comprehensive enforce ment program, we believe that the flow of high emitting products into California will be curtailed upon implementation of the ATCM.68

153) Comment [64-Guay-070426-Columbia] : “At Columbia, we regular(ly) test for UF emissions of imports. In the tests submitte d in the record, the imports ranged from 0.29 ppm to 3.0 ppm. Keep in m ind the very same factories that are sending this unsafe plywood here are supplying most of Europe’s E1 plywood, nearly all of Japan’s F  and E1 for their own country. They dump here because they can. But the y can easily

manufacture at lower emission levels.”

Agency Response [64-Guay-070426-Columbia] : We agree and the ATCM requires that the products meet lower emission stan dards by specified

dates.

154) Comment [65-Royce-070426-Hercules] : “...We see these proposed regulations both as what consumers want and practic al.”

Agency Response [65-Royce-070426-Hercules] : We agree – no response

necessary.

155) Comment [70-Woods-070426-Columbia “In 2005, we began the

commercialization of PureBond and have now successf ully converted all seven of our North American plywood operations to t his UF-free resin technology. In the recent weeks, we have offered t o license this patented resin technology to others in the hardwood plywood industry, and are currently in discussions with two manufacturers. I n addition, we are now offering to sell PureBond veneer core blanks to com peting stock panel manufacturers, and have already started shipping th ese PureBond blanks to smaller architectural plywood producers. Subseq uent to PureBond’s commercialization, at least one major competitor, T imber Products, is now advertising its own “no-added UF” hardwood plywood line, utilizing yet another soy resin system offered by Hexion. So now , there are at least four different non-UF resin approaches for hardwood plywood, all available in the marketplace today and all are Phas e 2 compliant for

veneer core construction. The CARB staff also reco gnizes this, and has appropriately moved Phase 2 implementation for vene er core hardwood plywood to January 2010. We predict that the emiss ion testing data that CARB will be collecting following implementation wi ll further motivate you to continue to strengthen this regulation.”

Agency Response [70-Woods-070426-Columbia] : We appreciate the information and support. We agree that if data col lected following implementation shows that more stringent emission l imits can be met, then that information can be used to propose amendm ents to the ATCM at a point in the future.

156) Comment [72-Robson-070426-AWFS] : “Phase 2 standard to be implemented in 2011 for most products that is not c ommercially feasible69 for the wood product industry (Phase 2 levels are b eing achieved today, but for niche applications at a premium cost/price) .”

Agency Response [72-Robson-070426-AWFS] : We disagree. The availability of low emitting niche products in the U.S. and the production of

E1 and F  products in other countries is a strong indication that wide-scale production of comparable products for th e California market is feasible. See also the response to comment #132.

157) Comment [72-Robson-070426-AWFS][76-Robson-0704 26-AWFS] : “We are not opposed to a workable standard and the Wood Industry Coalition has proposed a workable standard.”

Agency Response [72-Robson-070426-AWFS][76-Robson-0 70426- AWFS] : We disagree that the Wood Industry Coalition prop osal is a workable standard. We believe that the industry is capable of meeting more stringent standards than what they proposed. See also the response to comment #141.

158) Comment [82-Julia-070426-CPA] : “But at the end of the day, CPA must oppose the rule as it’s drafted. As overreaching a nd unwarranted on the basis of the facts, specifically Phase 2 emission l evels are premised on erroneous assumptions about what is necessary and f easible and what it costs. The recommendations are based on technology that in some cases do not exist for all regulated products and in othe r cases on those that are cost prohibitive on a mass production basis. You a re about to put in place the toughest production standard in the world for e missions from composite panel products. And that’s if you adopt the levels proposed by the CPA and CWIC. The Phase 2 levels that we propo sed, so close to what the staff proposed, would result in the most d ramatic reduction in HCHO emission from our products ever over the next few years. They would stretch us to expand our R&D and to innovate still further.

Agency Response [82-Julia-070426-CPA] : We appreciate the comment, but disagree that the Phase 2 levels are premised o n erroneous assumptions. We have carefully reviewed the litera ture and information received from stakeholders. Chapter V and VIII of the ISOR discuss the technological feasibility and costs associated with the ATCM, which

conclude that the standards are feasible and of rea sonable cost. Factoring in the lead time provided in the rulemaki ng, we believe that costcompetitive Phase 2 compliant products will be avai lable for sale in

California.

159) Comment [83-Warberg-070426-Plum Creek] : “These might look very close to you. However, even at these levels, a 0.01 ppm change is huge when it comes to a manufacturer. And to get to the CARB Ph ase 2 numbers, we70 as a manufacturer believe we are going to have to i mplement a complete change in the resin technology we use and the way i t’s delivered.”

Agency Response [83-Warberg-070426-Plum Creek] : We appreciate the comment, but feel that modifications to existing UF resin systems can be made to produce Phase 2 compliant products. From o ur discussions with domestic resin manufacturers, we believe that they will be able to offer cost-competitive modified UF resins that can be use d to produce compliant products in the 2010-2012 timeframe. In addition, the ATCM

now contains incentives for the use of ultra low em itting formaldehyde (ULEF) resins, which may likely include modified UF resins (see pages 73 to 83 of the ISOR).

160) Comment [92-Landry-070426-CWIC] : “Consider this if you will. The base test for this regulation, E1333, has a section that says the repeatability of

the test is 0.03. Various tests that have been mad e on raw wood, various studies find in some species the HCHO content natur ally occurring is 0.02. And then you put on that the variability that Mr. W arberg talked about different species in urban wood and how resins inte ract with those. Please keep that in mind.”

Agency Response [92-Landry-070426-CWIC] : We appreciate the

comment and understand that manufacturers will need to contend with some variability due to HCHO emissions from natural wood, manufacturing process and test methods. The test m ethods in the ATCM account for this variability (see page 107 of the I SOR); the major factor is the use of the DNPH method for quantifying formalde hyde in place of the more widely used chromotropic acid-based test. The use of the DNPH method greatly improves test sensitivity. As for n atural wood, some studies suggest HCHO emissions of 0.02 ppm. Howeve r, this has little impact on the HCHO emissions of manufactured compos ite wood products because the wood is dried during the manuf acturing process. By drying the wood, the HCHO in wood is driven off, an d the resultant wood has very low HCHO emissions.

161) Comment [93-Livingston-070426-CWIC] : “As a consequence, when we sat down with your staff five-and-a-half years ago to start talking about the development of this rule, we had a lot of informati on, data, and experience to share, and we shared it all. And when it came t ime to develop a proposed standard, we convened scientists, engineer s, panel manufacturers, resin producers to talk about the lo west feasible standards that we can come up with that can reasonably be ach ieved. We put together a number, not to negotiate, but we put tog ether a number to implement what staff said was its stated intent, to allow panel manufacturers to continue using their existing resi n systems and equipment.”71 Agency Response [93-Livingston-070426-CWIC] : We appreciate the information that CWIC has shared with us during the rulemaking process. We concluded that there were opportunities for grea ter emission reductions than what was being suggested by the ind ustry and were open

about our view that more could and needed to be don e to reduce public exposures to HCHO (see pages 101 to 107 of the ISOR ). We did not accept or suggest that we would propose industry’s recommendation as the basis for the ATCM. See the response to commen t #141 regarding the technical feasibility of the ATCM’s emission st andards.

162) Comment [93-Livingston-070426-CWIC] : “Unfortunately, after we proposed our numbers, staff came up with lower numb ers. And the matrix that I handed out that hopefully you have before yo u sets out the numbers staff has proposed, and juxtaposed to that are the numbers that industry has proposed. As you’ll see, we have virtual agree ment in Phase 1. The problem does exist in Phase 2.”

Agency Response [93-Livingston-070426-CWIC] : The open literature and advertisements by Hexion, Sierra Pine, Flakeboard, Roseburg, Dynea, Columbia Forest Products and others suggest that so lutions are already commercially available (see Tables V-22, V-24, and V-26 on pages 103 to 106 of the ISOR). See the response to comment #141 regarding the technical feasibility of the ATCM’s emission standa rds.

163) Comment [93-Livingston-070426-CWIC] : “... We would urge you to amend the regulation to reflect the numbers that CWIC has proposed for Phase 2 and to do that with the recognition that if technol ogy evolves and in years in the future you can see that there is a way to lo wer the numbers even further, you can come back and take another look at this regulation. On the other hand, if we’re right and if we have to ex pend those enormous sums of money to try to achieve this, then as you h ave heard, there are many people whose businesses are jeopardized during that process, and there’s no opportunity for us to come back.”

Agency Response [93-Livingston-070426-CWIC] : The ATCM emissions standards for Phase 2 and the economic impacts of t he regulation are discussed in Chapters V and VIII of the ISOR. We f ound that the production cost increases were reasonable and that the standards were achievable in the timeframe specified. See also th e response to comment

#158.

164) Comment [51-Watson-070425-IPMG][99-Watson-0704 26-NA] : “Adopt the HUD regulation . . .” “So here’s my proposal for y ou folks today. If the HUD standard is acceptable – because what we’re fig hting about here is we’re fighting about off-gassing limits of HCHO. A nd we’re fighting about72 the regulation of it. And I want both. I say the regulation. I should say the enforcement. Excuse me. Adopt the HUD standard. Let CARB prove to us that they can truly regulate it. And let’s tabl e the final decision for the required levels of compliance.”

Agency Response [51-Watson-070425-IPMG][99-Watson-0 70426-NA] : We disagree. Adopting the HUD standard would be in consistent with the requirements of Health and Safety Code section 3966 6. See the response to comment #141 regarding the technical fe asibility of the

ATCM’s emission standards.

165) Comment [100-Harmon-070426-Hexion] : “Then there is another very real consideration is if there is a need and usually is to obtain an operating permit to run the manufacturing for the resin and f or the composite wood panel products, again that is no less than a two ye ar process. So we have some very real constraints that we have to look for ward to as we judge whether the proposed regulation is doable in the ti me frames if it pushes things into brand-new territory.”

Agency Response [100-Harmon-070426-Hexion] : We believe that the timetable for implementation is achievable since mo st composite wood product manufacturers will utilize “drop in” techno logy to meet the Phase 1 standards. These technologies are discussed in Cha pter V of the ISOR (pages 101 to 104). Meeting the Phase 2 standards could take longer and

so the ATCM has effective dates further into the fu ture than for Phase 1.

166) Comment [102-Higgins-070426-FFC] : “First of all, this is not a new issue. It has been around since 1992. More recently, in 2 004, as you heard earlier in the staff presentation, there has been a mple time for the industry to address this concern. I think you’ll hear that it’s imminently doable now in the market. That’s one of the reasons why the C ouncil, despite the fact that we have a great deal of admiration for the wor k product of the staff, the time, care, and attention they put into this pr oposed measure, we have nothing but praise for. Notwithstanding that, howe ver, on the crucial issue of timing, we believe it is imminently doable now, accessible now to move the timing forward. And we believe there is an urg ency to do that, as the previous speaker alluded to. When you have a known carcinogen with

deleterious effects on the environment and the safe ty and the health of Californians, then I think its incumbent on us to t ake all responsible measures to advance this timetable responsibly. An d we believe that that can be done. Indeed, we believe that the solutions which are affordable, accessible, and market competitive are here today. So we certainly

believe we could advance this to 2008 and we think Phase 2 can be completed by 2010.”73 Agency Response [102-Higgins-070426-FFC] : We appreciate the support, but disagree that the timing of the rulemaking can be accelerated for all of the products. It will take some time to develop re sins for PB and MDF given the technological challenges associated with production variables. See Chapter V of the ISOR on the technological feas ibility of the Phase 2 standards (pages 101 to 107). See also the respons e to comment #122.

167) Comment [103-Demorest-070426-Columbia] : “We believe the staff report presents overwhelming evidence for their conclusion . But at the same time, because of what we know about the industry, w e urge CARB to be more aggressive in establishing a California backgr ound standard and swift implementation time line before the end of th is decade.”

Agency Response [103-Demorest-070426-Columbia] : We appreciate the support, but feel that we have recommended an aggre ssive timeline in the ATCM. See Chapter V of the ISOR on the technologic al feasibility of the Phase 2 standards (pages 101 to 107).

INDUSTRY-WIDE COSTS

168) Comment [7-Landry-070416-CWIC] : “We are concerned about the cost of this rule. The cost of implementation was estimate d at $127 million a year in the agency’s ISOR, but we believe the cost will be many times that amount. A full evaluation of economic impacts reve als that the impact of this proposed rule on the economy, composite wood m anufacturers... will exceed $2.5 billion a year...”

Agency Response [7-Landry-070416-CWIC] : We disagree. The assumptions in the economic impacts analysis by CWI C reflect an extreme worse case scenario that vastly overestimat es the potential impacts of the ATCM. For example, it assumes that all products will be made to comply with the California standards, which we do not believe is the only option for manufacturers, especially those that do not currently produce products for sale in California.

169) Comment [10-Higgins-070416-FFC] : “Will these regulations have a positive effect on California’s business climate an d economic development? Yes. The overall effect on the Calif ornia economy will be beneficial... (California) is being flooded with wood products produced in China that have such high levels of formaldehyde em issions that they

cannot even be sold in China... If California takes t he lead in the U.S., it will give a tremendous boost to the entire green mo vement in the state and attract new design and building professionals.”74 Agency Response [10-Higgins-070416-FFC] : We agree – no response

necessary.

170) Comment [24-Landry-070423-CWIC] [27-Rush-07042 4-Temple Inland] [92-Landry-070426-CWIC] : “We believe that it is the most expensive ATCM in terms of cost per pound of reduced emission that CARB has ever promulgated. Even by CARB’s very conservative assumption, the cost would be $127 per pound, $254,000 per ton! We believe the actual cost is more likely to be four times that amount. The health benefits to the people of California from this extraordinarily cost ly regulation will be virtually nil.”

Agency Response [24-Landry-070423-CWIC] [27-Rush-07 0424-Temple Inland] [92-Landry-070426-CWIC] : We disagree. On a per pound basis, this is not the most expensive ATCM ever promulgate d. We believe our economic analyses accurately project the costs of t he ATCM in contrast to the $2.5-billion per year estimated by CWIC’s consu ltant. The health benefits, based on the use of OEHHA’s unit risk fac tor, are not “virtually nil,” as described in Chapter VII of the ISOR. For a projected 127 million dollars per year, the Phase 2 emission standards wi ll reduce excess adult

cancer cases in California between 35 to 97 excess cancer cases per million as pointed out in Chapter VII, page 158 of the ISOR.

171) Comment [24-Landry-070423-CWIC] : “Why the significant difference from the $127 million estimated by CARB? First, this ru le will have nationwide impact, not just costs to the California producers as assumed in the ISOR. Manufacturers of panels and finished products can’t effectively maintain multiple inventories, particularly when their out-o f-California customers,

such as furniture makers in North Carolina and Mich igan, have to use compliant products... The ISOR equates manufacturing costs with prices and assumes that this static number applies through the channel. This ignores commercial reality.”

Agency Response [24-Landry-070423-CWIC] : We disagree. While the rule may have a nationwide impact, this is not cert ain. Given that niche products and products to meet other worldwide stand ards are being made to order, manufacturers already have the capability to maintain multiple inventories, unless the same resins and furnishes a re being used to make all of the above products. Market forces will dict ate what portion of the cost increases will be passed on from manufacturer- to-distributor and so forth. We did not feel that applying an estimated increase in cost with each transfer in the distribution chain would provi de a more accurate projection of what costs would be at other points i n the distribution chain.

172) Comment [46-Gonyea-070424-Timber][51-Watson-07 0425-IPMG] : “The costs . . .especially in Phase 2, have been signifi cantly underestimated.”75 “... To put it in other words, I am flabbergasted at the explanations that

CARB staff has offered as fact. These are not fact s – these are opinions based upon assumptions.”

Agency Response [46-Gonyea-070424-Timber][51-Watson -070425- IPMG] : We disagree. We support, with analysis, our judg ments of what we believe is achievable and of reasonable cost (se e Chapter VIII of the ISOR, pages 205 to 209). The ISOR sets the technic al rationale for the proposed regulation (see Chapter V, pages 101 to 10 7).

173) Comment [51-Watson-070425-IPMG] : “Lastly, the cost of this program I had seen in the staff reports is estimated to swell from 154 million dollars per year to over 1.5 billion if I recall correctly... An expenditure of this size I would hope would require greater oversight by the state budget process.”

Agency Response [51-Watson-070425-IPMG] : We disagree. We estimate the cost of the ATCM to be $127 million per year fo r Phase 2, which we believe is an upper end estimate (see Chapter VIII, pages 205-209). With time and improvements in resin technology and the m anufacturing process, we expect that the cost could be lower in 2010-2012.

174) Comment [62-Whalen-070426-Columbia] [105-Whale n-070426-Columbia] : “One of the primary arguments the opposition has br ought forth relates to the economic devastation this regulation will have on California’s wood products fabricators and consumers’ pocketbooks. Y our staff did not believe these claims, and neither should you. Base d on Columbia’s extensive experience manufacturing and selling form aldehyde-free hardwood plywood, we contend that any cost increase s driven by this regulation will be negligible at best.”

Agency Response [62-Whalen-070426-Columbia] [105-Wh alen-070426- Columbia] : We agree. Our analyses indicate that the project ed cost increases are considerably lower than that estimate d by CWIC. See Chapter VIII of the ISOR.

175) Comment [62-Whalen-070426-Columbia] : “The staff report has more than adequately addressed the economic impact of this re gulation on the industry and there is ample testimony in the record that this regulation will have a negligible economic impact on consumers.”

Agency Response [62-Whalen-070426-Columbia] : We agree – no

response necessary.

176) Comment [85-Altman-070426-HPVA] : “I will call your attention to a slide that you’ve seen that says the change in owners’ eq uity averages 11.6 percent. I call your attention to a table on page 187 of the staff report that76 reflects that the reductions in owner equity for ha rdwood plywood as a product is 64 percent, again, indicative of the fin ancial burden that’s borne by hardwood plywood products. It is unfair after c onsiderable time and rule development to have a last-minute acceleration of the one year for Phase 2 requirements. And we respectfully request that the Phase 2 0.05 ppm emission level requirements be returned to Janu ary 1, 2011.”

Agency Response [85-Altman-070426-HPVA] : We appreciate the comment, but feel that with the present commercial availability of two noadded HCHO resin systems (at a 15% cost increase), the Phase 2

standard for HWPW-VC can be met with cost-effective resins by January 1, 2010. See also comment #155 and page 206 of the ISOR.

177) Comment [86-Compton-070426-Hambro] : “I urge you to . . . simplify compliance, reduce cost . . .”

Agency Response [86-Compton-070426-Hambro] : We believe the compliance elements are essential for the regulatio n to be fair, workable, and enforceable, and we believe the cost is not unf air to any particular industry sector. See also the response to comments #60 and #88.

178) Comment [92-Landry-070426-CWIC] : “We have proposed or submitted an economic model based on the Department of Commerce, Bureau of Economic Analysis Input/Output model. We believe t he true cost for California alone will be over $500 million a year a nd that nationwide it will be much higher.”

Agency Response [92-Landry-070426-CWIC] : We disagree. We do not agree with a number of the assumptions used in the industry analysis and favor our own analysis as more representative of th e actual cost to the industry (see pages 205 to 209 of the ISOR).

PANEL COSTS

179) Comment [14-Titus-070419-KCMA] : “Considering the huge additional cost and questionable ability of composite wood producer s to meet the extremely low emission levels of Phase 2 of the pro posed ATCM, we request the Board to lower the Phase 2 ceiling valu es to achievable levels requested by the California Wood Industry Coalition .”

Agency Response [14-Titus-070419-KCMA] : We disagree. We do not believe the cost of producing lower emitting produc ts will be excessive or that wood producers cannot meet the Phase 2 standar ds. See also the response to comment #176.77

180) Comment [34-Keeling-070424-Roseburg] : “Proposed ATCM Phase 2 will dramatically increase manufacturing costs. Our exp erience with manufacturing low emission composite panels validat es the claims of dramatically higher costs of compliance with the pr oposed ATCM. In fact, we have found that low emission panels cost at leas t 60% more to manufacture than panels made with commonly used ure a-formaldehyde

resins...”

Agency Response [34-Keeling-070424-Roseburg] : We disagree. We

estimate that cost increases will be less than 60% (see pages 205 to 209 of the ISOR). As more experience is gained and com petition increases, the estimated increases may not be as great as orig inally projected.

181) Comment [38-Morgan-070424-IWPA] : “... Even though it is our view that the staff report grossly underestimates the total c ost to the industry, a 30- percent increase in cost is not insignificant...”

Agency Response [38-Morgan-070424-IWPA] : We appreciate the comment, but disagree that the total cost to indust ry is grossly underestimated. The rulemaking principally applies to panel manufacturers and the costs that they may incur as a result of complying with the emission standards. The projected 30% pro duction cost increase is an upper-end estimate representing the greatest projected increase in price. In light of projected costs, the Board acce pted the costs as reasonable given the anticipated health benefits. In addition, future resin technology innovation, as discussed in Chapter V of the ISOR (p. 101 to 106), will likely mitigate compliance costs.

182) Comment [45-Gregory-070424-SierraPine] : “The cost differential is a reality and leads me to my next concern. Passing o n higher costs to our customers will further put them in an uncompetitive situation, particularly when foreign suppliers will be able to import produ cts that are not ARB compliant... The kitchen cabinet industry may be next .”

Agency Response [45-Gregory-070424-SierraPine] : We disagree. Upon implementation of the standards, both domestic and foreign manufacturers will both need to comply, therefore, no cost advant age will exist. See also the response to comment #88.

183) Comment [62-Whalen-070426-Columbia] [105-Whale n-070426-Columbia] : “Our business records confirm the increased cost fo r PVA plywood compared to UF plywood represents a cost increase o f no more than 15 percent to our distributor customers. When we use PVA glues to achieve formaldehyde-free, our average UF panel price was $ 38. With this cost increase, a PVA panel would sell for $44, a $6 per panel increase. Translating that into a consumer impact, the averag e kitchen remodel is78 about $25,000. And new cabinets use on average 15 panels to build these. At $6 more per panel, the cost impact of th ose 15 panels on this kitchen remodel would be only $90. This represents less than a one percent increase for the entire kitchen remodel. T he staff report corroborates our figures from their own research on PVAs as an alternative to urea-formaldehyde. And these figure s don’t take into

consideration the economies of scale or manufacturi ng advantages to switching from UF resins. For example, Columbia re duced air emissions by as much as 95 percent at our mill locations, neg ating the need for additional pollution equipment to convert to formal dehyde-free manufacturing.”

Agency Response [62-Whalen-070426-Columbia] [105-Wh alen-070426- Columbia] : We agree and fully expect that the cost impact of the ATCM to be less than the high-end estimate we presented in Chapter VIII of the ISOR (pages 205 to 209).

184) Comment [73-Chappell-070426-Columbia] : “Claims. As the leader of the Monday meetings on production sales, I was privy to the problems that were asserted by customers and distributors regardi ng the PureBond product. Claims were significantly higher than whe n UF resins were being used, one settlement in the high five figures. Sev eral customers changed to other suppliers. Also our internal reject rate increased from around 5% to almost 8% during 2006.”

Agency Response [73-Chappell-070426-Columbia] : We appreciate the information – no response necessary. See also the response to comment

#185.

185) Comment [84-Keeling-070426-Roseburg] : “We worked together with the resin supplier and formulated a product that we tho ught had a market appeal for a very small niche. And in fact, if you look at our total production today, our Sky Blend product, Sky Ply, a ccounts for two percent of our product. That is all the demand we have. We would make more, but the market demand is just simply not ther e.”

Agency Response [84-Keeling-070426-Roseburg] : We appreciate the comment, but believe that a requirement to purchase and use low emitting products will increase the demand for Phase 1 and P hase 2 compliant products as those standards become effective. The existence of the niche product demonstrates that such products are commerc ially viable; a requirement to produce and sell lower emitting prod ucts in California will create the demand for products like Sky Ply.

186) Comment [84-Keeling-070426-Roseburg] : “The cost of this product is very high. Our cost premium for the product is 60 perce nt. The resin is 7079 percent higher in cost. Manufacturing process slow s down at least 40 percent. That’s on a good day. Our business and w ood product business in general is a low margin business. An example of that is look at the exodus of public companies from wood products in th e wood products business. There’s only two public companies left.”

Agency Response [84-Keeling-070426-Roseburg] : We appreciate the comment, but disagree on the magnitude of the diffe rence in cost (see pages 205 to 209 of the ISOR). Other representativ es from Columbia Forest Products have stated that the product is cos t-neutral to products made with urea-formaldehyde resin. Staff believes that the exodus of public companies from the wood products business sh ould have improved the profitability of the remaining businesses.

187) Comment [98-Schroeder-070426-WMMPA] : “But, first, as presented earlier, moving this regulation forward will increa se the cost of MDF moldings and millwork. MDF molding manufacturers a re asking themselves how Phase 2 of the proposed regulations will be met and have pressed their suppliers for answers. The response is alternative resins during the manufacturing process of the MDF board a t significantly higher cost to the MDF manufacturer. MDF molding manufact urers will lose their competitiveness in the market against solid wood mo ldings immediately. MDF molding and millwork was born in the marketplac e years ago as a high quality economical alternative product to soli d wood. The cost associated with new regulations will disseminate th e advantages of MDF moldings to compete on the open market.”

Agency Response [98-Schroeder-070426-WMMPA] : We disagree. While we project that the price of Phase 2 compliant MDF will be more expensive than it is today (see pages 205 to 209 of the ISOR), competition among suppliers is likely to keep prices as low as possible. We believe that the price of MDF moldings will further decline as resin technology improves over time. Thus, we expect that MDF moldi ngs will remain as an economical alternative to solid wood moldings. See also the response to

comment #189.

188) Comment [103-Demorest-070426-Columbia] : “So you know that 40 percent of our industry is compliant with Phase 2 s tandards right now. And the next step that we have taken is we’ve offer ed to the rest of our industry that we will sell them our resin system at a nominal cost above what they’re paying now, certainly less than a doll ar a panel. So I’m here to tell you that our industry, the hardwood plywood industry, can be 100 percent compliant before the end of this year if th ey choose to do so.”

Agency Response [103-Demorest-070426-Columbia] : In response to this comment, the Board moved the effective date of the HWPW-VC standard80 from January 1, 2011 to January 1, 2010. We conclu de that the hardwood plywood industry as a whole needs more time to eval uate and test resin systems, including the use of Columbia’s no-added f ormaldehyde resin system. Therefore, we did not believe that the HWP W standards could be moved to January 1, 2008. See also the response to comment #133.

189) Comment [112-Uhland-070426-CalAg] : “I’m here today to lend my support to CARB’s comp wood ATCM as a composite panel manuf acturer. When the CalAg plant opens in 2008, we will produce a tr ue MDF using a formaldehyde-free MDI adhesive that can be sold at a price that is competitive with conventional wood-based MDF, a pro duct that’s currently manufactured with urea-formaldehyde. We have read and heard a great deal of testimony that CARB’s comp wood regulations will cause MDF prices to skyrocket. And I’m here today to tell yo u that CalAg will set formaldehyde-free MDF at a price that is very compe titive to its ureaformaldehyde based counterparts. Distributors, fab ricators, and customers will not be significantly affected, if af fected at all, by production

costs.”

Agency Response [112-Uhland-070426-CalAg] : We appreciate the information – no response needed.

PANEL EMISSIONS TESTING

190) Comment [1-Davis-070314-Regal AQ] : “I think the preferred Japanese test method is the JIS A 1901 (chamber method), not the desiccator method

JIS A 1460. ... The JIS A 1901 can also be more dir ectly compared with

the ASTM E1333 and EN 717-1. ... I have not tried t o account for differences in the way the edges of the samples are treated. ... The only way this can accurately be done is to run side by s ide tests with the same system.”

Agency Response [1-Davis-070314-Regal AQ] : We agree that points raised by the commenter are appropriate. The Japan ese are moving toward a surface emission test for their products, and it (JIS A 1901) is more directly comparable to the ASTM E1333 test. H owever, an exact comparison between the ATCM’s standards and the Jap anese standards can only be achieved with side-by-side testing. In estimating what an equivalent ASTM E1333 value would be for the Japane se standards based on the JIS A 1901 test, we estimate that a “F  ” panel would be 0.01 to 0.05 ppm (which agrees with Regal Air Quali ty, Inc.), and a

“F  ” panel would be < 0.01 ppm. While this would lead one to

conclude that the “F  ” standard is slightly more stringent than our proposed standards, the JIS A 1901 allows for edge sealing, since edge

emissions would not be “... the surface from which fo rmaldehyde shall be81 emitted into the interior of a room ...” (Building Ce nter of Japan, 2004). If you assume a 33 to 67% increase in emissions from e dges (not quantified

due to uncertainties in how much material is used i n a JIS A 1901 test), the ASTM E1333-equivalent test value would be about 0.07 to 0.09 ppm – comparable to Phase 2 standard for PB, but lower th an the Phase 2 standard for MDF. (Literature Cited : (The) Building Center of Japan. 2004. Performance testing and evaluation manual fo r emission rate of formaldehyde from building materials. Report No. B R-BO-11-02. 10 pp. Revised: 19 April 2004.) See also Appendix H of th e ISOR.

191) Comment [7-Landry-070416-CWIC] : Section 93120.9(a) – Compliance test methods. Three acceptable compliance test met hods are provided in this section: “... conducted using either (A) the AST M E-1333-96 (large chamber test method) or (B) a test method correlate d to ASTM E-1333-96. An alternate test procedure may also be used as spe cified in sections 93120.9(a)(1) through 93120.9(a)(3).”

What is the difference between the method allowed i n (B) and the method “also” allowed in the following sentence? Indeed, section 93120.9(a)(1), which is referenced in the second sentence, require s such correlation.

We recommend that the language be changed to read: “... conducted using either (A) the ASTM E-1333-96 (large chamber test method) or (B) a test method correlated to ASTM-E-1333-96 and approv ed as specified in sections 93120.9(a)(1) through 93120.9(a)(3).” The whole regulation is premised on the E-1333 test. All alternate test me thods should be shown

to correlate.

Methods other than the large chamber may be used fo r compliance testing if they can show “equivalent results.” What is the measure of equivalence?

Agency Response [7-Landry-070416-CWIC] : We agree that points raised by the commenter are appropriate. The final regula tion order was modified to clarify the use of compliance test meth ods. Section 93120.9(a) has been revised to allow the use of a s econdary method, demonstrated to be equivalent to the large chamber method. In addition, specific criteria have been added to outline how eq uivalency can be

demonstrated.

192) Comment [16-Overgard-070419-HPVA] : “We recommend that industrial panels and wall panels be tested at the industrial panel loading rate of

0.13 ft 2 /ft 3 .”

Agency Response [16-Overgard-070419-HPVA] : We disagree. The long record established using the prescribed loading rat es would be82 compromised by such a change. The hardwood plywood industry has developed many years of certification emissions dat a based on the prescribed loading rates. Furthermore, staff used this data to establish the HWPW emission standards. Therefore, any change to the loading rates would necessitate a corresponding change to the emi ssion standards. Since no data exist based on the requested 0.13 ft 2 /ft 3 loading rate, the standard cannot be adjusted.

193) Comment [22-Whalen-0704020-Columbia] : “None of the panels tested would have even passed under the U.S. HUD standard formaldehyde emission threshold of 0.30 ppm”

Agency Response [22-Whalen-0704020-Columbia] : Commenter was referring to independent testing that revealed high emissions from imports. We appreciate the information about imported plywoo d panels, which illustrates the need to curtail high emitting impor ts.

194) Comment [22-Whalen-0704020-Columbia] : “A panel which was represented as E-1 from China did test out at 0.105 ppm”

Agency Response [22-Whalen-0704020-Columbia] : We appreciate the information to further support our intent to addres s high emitting imports with our enforcement program.

195) Comment [24-Landry-070423-CWIC] : “... The homogeneity of the furnish, generally and particularly in the faces of panels, directly impacts the emission profiles.”

Agency Response [24-Landry-070423-CWIC] : We agree that the point raised by the commenter is appropriate. It is our understanding that differences in furnish homogeneity are overcome in large part by using different resins in the face and core layers of a p anel. The ATCM’s emission standards in 93120.2(a) already account fo r process and testing variability.

196) Comment [38-Morgan-070424-IWPA] : “Equivalent test methods are important... Overseas product that meets the requirem ents of this proposed regulation should not be discriminated aga inst due to language or procedure.”

Agency Response [38-Morgan-070424-IWPA] : We disagree. As there is no formal agreement among testing agencies as to th e “equivalency” of different test methods, the test methods in the ATC M must be used to demonstrate compliance with the emission standards. If overseas products meet the ATCM’s emission standards, then t hey would not be83 discriminated against. However, all panel products must be third party certified using referenced test methods.

197) Comment [47-Steenson-070424-AuWPA] : “We proposed that the board consider recognition of other internationally recog nized product certification schemes... In these schemes, emissions are monitored and products are stamped according to their emission cl ass. If recognition protocols were established, this would alleviate th e need for wasteful multiple certifications.”

Agency Response [47-Steenson-070424-AuWPA] : We disagree. While this might work for Phase 1, other internationally recognized product certification schemes do not require that products meet emission limits comparable to the low Phase 2 standards and do not contain as comprehensive an enforcement structure as the ATCM. In the mean time, multiple certifications are necessary.

198) Comment [47-Steenson-070424-AuWPA] : “We are also concerned by the

reliance of the rule on the emissions based on ASTM E1333, which is not readily available internationally. It would be use ful to allow other international standards to be recognized... allowing the use of already established international testing facilities.”

Agency Response [47-Steenson-070424-AuWPA] : We agree that the points raised by the commenter are appropriate. St aff evaluated the assertion that insufficient large chambers were ava ilable internationally.

While some countries like China and Indonesia did h ave large chambers due to the HUD requirements, most of those faciliti es were not in operation. According to import statistics, the top exporting countries into California are China, Canada, Malaysia, Indonesia a nd Brazil. While we are aware of some companies interested in being thi rd party certifiers in those countries, the demands on the large chamber w ould be very substantial given the number of individual mills th at currently supply

California.

To address this concern, staff evaluated current te st methods to determine precision and concluded that certain small chambers could achieve a very high correlation to the large chamber when tested i n accordance with ASTM D 6007-02. Based on this, staff has included an allowance to use a “secondary” test method that can be demonstrated to provide equivalent results to the “primary” or large chamber test meth od. This will dramatically reduce the dependence on the primary t est method and add to the effectiveness of third party certifiers sinc e the small chamber test is shorter to run and involves much smaller samples. In addition, international test methods may be used as alternati ve test methods if84 these methods are shown to be equivalent, as provid ed by the ATCM. See also the response to comment #103.

199) Comment [49-Levin-070425-BERG] : “ASTM Standard E1333 is inappropriate for the regulation... DNPH is included as an alternate in the standard, but it should be the required method. Th ere is an ASTM

standard for the DNPH method.”

Agency Response [49-Levin-070425-BERG] : Third party certifier laboratories have the option, under the primary or secondary test method, to use the DNPH method to ensure the sensitivity an d accuracy of their quarterly tests to show compliance with the Phase 2 emission standards. For the Phase 2 standards, we believe that laborato ries will favor the use

of the DNPH method due to the low emission levels t hat must be met.

200) Comment [74-Bradley-070426-GVM] : “93120.9(c) Enforcement Test Method ... The latest ATCM draft says “Emission testi ng of samples of finished goods containing HWPW, PB, and MDF shall b e conducted ...” I believe what the writers meant to say was “Emission testing of samples of HWPW, PB, and MDF contained in finished goods...” In other words, if there’s MDF in a chair back, you want to test a sam ple of the MDF, not a sample of the finished chair, with steel, fabric, p lastic, etc.”

Agency Response [74-Bradley-070426-GVM] : We agree that the point raised by the commenter is appropriate and have mod ified section 93120.9(c) to clarify that HWPW, PB and MDF contain ed in finished goods

will be tested for emissions.

201) Comment [85-Altman-070426-HPVA] : “Errors in the H1 loading rate table of the staff report make it clear that the emission reductions in Phase 1 for hardwood plywood is 77 percent rather than the 53 p ercent reported in the staff report. In Phase 2, the reduction is 86 perc ent rather than the 71 percent as reported. These are dramatic changes an d they’re difficult goals to meet.”

Agency Response [85-Altman-070426-HPVA] : The loading rate for hardwood plywood in Table H-1 is 0.425 m 2 m -3 while the factor in ASTM

E 1333-96 is 0.43 m 2 m -3 . Use of 0.43 m 2 m -3 in place of 0.425 m 2 m -3
does not result in the magnitude of change suggeste d by the commenter.

We believe that the Phase 2 standard for hardwood p lywood can be met with existing soy and PVA-based resin systems, and that it may even be achieved with modified UF resins that will require mill-testing in the coming years. See also pages 101 to 103 of the ISOR.85

202) Comment [121-Bradway-070426-Mannington] : “... If you’re dealing with ASTM standards, the review process says you need to review it within five years. If it’s not updated within eight years, it’ s out the door. So it just needs to really be reflected to say being E1333 and leave off the year so it

defaults to the most current version...”

Agency Response [121-Bradway-070426-Mannington] : We disagree. It is necessary to add the year designation to the ASTM E 1333-96 because the requirements of the regulation must be specific and not subject to change when ASTM updates the test method. If ASTM updates the test method, then CARB staff must evaluate the changes t o determine the appropriateness of proposing a regulatory amendment for a updated test

method reference.

203) Comment [121-Bradway-070426-Mannington] : “In terms of, you know, one of the things that has been brought up in terms of enforcement was being

able to use the FLEC to then screen to be able to t hen use the small chamber for determination in terms of compliance. What we would ask for is since obviously that correlation to the large ch amber E1333 must exist whether or not that would remove the requirement to go ahead and ask for

that correlation. So if it would allow the small c hamber – and we heard earlier the testimony that said with what is going on with CHPS, the California High Performance School systems, there a re several products that are complying to lower thresholds and they are using the small chamber. They are third party certified. What we are asking is basically if that would provide the compliance considerations to the E1333.”

Agency Response [121-Bradway-070426-Mannington] : We agree that the points raised by the commenter are appropriate and have modified the regulation to allow the use of small chambers (ASTM D 6007-02) as a secondary method by third party certifiers. For qu ality control programs, a correlated small chamber provides the most reliable data in terms of verifying the manufacture of compliant composite wo od products.

PROCESS MODIFICATIONS and OPERATING COSTS

204) Comment [14-Titus-070419-KCMA] : “...The regulation is certain to increase manufacturing cost, likely more than estim ated by the CARB staff, and therefore, is a major cause of concern when glo bal competition threatens all U.S. manufacturing. Today, cabinet m anufacturing remains a predominantly North American industry. That could change.”

Agency Response [14-Titus-070419-KCMA] : We disagree because compliance with the HCHO emission standards will be achieved mainly through “drop in” technology. However, we do expec t that manufacturing86 costs will increase to some degree (see pages 205-2 09 of the ISOR). We do not believe that costs will be higher than we es timated, as the estimates in the ISOR represent what we believe to be the upper limit cost increases. Rigorous enforcement is the key to ensu ring fair competition in the marketplace and it is our intent to carry out a n effective program to provide fair competition. See also the response to comment #84.

205) Comment [14-Titus-070419-KCMA] : “The Board needs to understand that

the ATCM will become a de facto national standard. KCMA members with production outside the state but who market in Cali fornia will be forced to use only ATCM compliant materials in order to insur e compliance... I am aware of no company, other than those operating in California, that could dedicate an entire plant’s operations exclusively t o products for the California market and remain competitive.”

Agency Response [14-Titus-070419-KCMA] : We disagree. It will take time for states and/or USEPA to evaluate our analys es and decide whether to adopt similar measures. Niche products are currently being made in response to the growing demand for Green Bu ilding products which suggests that multiple product lines are curr ently being produced and maintained. Also, as pointed out on page 215 o f the ISOR, an average kitchen remodel will increase the cost by o nly about 1%. It will be an individual business decision to carry two invent ories or just one.

206) Comment [24-Landry-070423-CWIC] : “... The composition of the resin is the factor that can be best controlled – these comp ounds are mixed in reactors with good quality control on inputs. Down stream, however, the control is more difficult. For example, the furnis h that goes into the production of PB and MDF can vary greatly... wood sup ply is a growing problem for the industry.”

Agency Response [24-Landry-070423-CWIC] : We agree that resin composition is the best controlled factor and that downstream control is more difficult. We believe that an adequate amount of lead time was provided before the emission standards take effect to allow manufacturers to identify what actions need to be taken to ensure that the furnish (i.e., wood particles and fibers used to make particleboar d and MDF, respectively) can be used to make low emitting prod ucts. The use of noadded HCHO resins may be a cost-competitive option for manufacturers to consider given their concerns over wood supplies . Also, future resin technologies such as fortified melamine-urea-formal dehyde resins may contain effective scavengers to mitigate formaldehy de emissions from natural wood. See also pages 101 to 107 of the ISO R where we discuss

in detail our assessment of best available control technology.87

207) Comment [25-Hubbard-070423-Darlington] : “The proposed Phase 2 ceiling limits for HCHO emissions should be higher to allow for the fact that the industry’s products must be manufactured s ignificantly below the regulatory ceiling to allow for variability in the raw materials, processing equipment and test methods... Additionally, it appear s that the costs to comply with Phase 2 are extremely unreasonable.”

Agency Response [25-Hubbard-070423-Darlington] : We disagree. The Phase 2 limits take into account variability in raw materials, testing and processing (see page 2 of Appendix D in the ISOR). As pointed out in Chapter VIII of the ISOR, the compliance cost estim ates consider changes

in resin formulations and other costs that could af fect the panel production cost (pages 205-209). However, the resin formulati ons used for the cost estimate were examples of expensive resin systems t hat would actually

achieve much lower emissions than the Phase 2 stand ards. For example, the MDF cost analysis assumed the use of methylene diisocyanate (i.e., the most expensive no-added formaldehyde resin opti on), which would achieve emissions at around 0.03 ppm well below the 0.11 ppm Phase 2 emission standard. Therefore, the cost estimates a re conservative.

208) Comment [59-Taylor-070426-Veneer] : “All of our plywood is made from PB or MDF as core – these cores contain very small amounts of formaldehyde – but under the new regulations could not be used in our product. If this measure passes, it WILL put us ou t of business.”

Agency Response [59-Taylor-070426-Veneer] : We disagree. Those materials can be used in a composite core product s o long as the plywood panel achieves a test value that meets the ATCM’s s tandards. In our view, the probability of producing a plywood panel that m eets the ATCM’s emissions standards is likely to be greater if lowe r emitting core materials are used, but this does not prevent manufacturers f rom using whatever core materials they choose to. If your products ar e to be sold to California, comparable products must also meet the ATCM’s emiss ion standards and would not confer a competitive advantage to other b usinesses insofar as

the cost of core materials.

209) Comment [62-Whalen-070426-Columbia] : “And these figures don’t take

into consideration economies of scale or the manufa cturing advantages to switching from UF resins. For example, Columbia re duced air emissions by as much as 95% at our mill locations, negating t he need for additional pollution equipment upgrades.”

Agency Response [62-Whalen-070426-Columbia] : We appreciate the information – no response necessary.88

210) Comment [66-Mullen-070426-Hercules] : “Yes – Hercules has successfully converted several hardwood plywood mills cost neutr al to ureaformaldehyde adhesives.”

Agency Response [66-Mullen-070426-Hercules] : We appreciate the

information. We accounted for the cost-neutral ass ertions made by Columbia Forest Products in developing the Phase 2 emission standards for HWPW and also in recommending to the Board at t he hearing that the

Phase 2 emission standard effective date for HWPW-V C be moved from

2011 to 2010.

211) Comment [72-Robson-070426-AWFS] : “California and other domestic wood product manufacturers will spend time and mone y trying to comply with the regulation, or go out of business trying. The added costs of compliance will affect every business in the wood p roducts supply chain, including machinery companies and fabric and fillin g companies.”

Agency Response [72-Robson-070426-AWFS] : While we agree that there will be added costs of compliance for manufacturers of raw composite wood product panels, we do not believe that every b usiness will be similarly affected.

212) Comment [83-Warberg-070426-Plum Creek] : “And recognizing that there is a small market for ultra-low emission products, we as a company set out to evaluate what might be required to operate below the CARB Phase 2 numbers just to see what it would take. And becaus e of the variability in our process – and this is a very important point. We have variations in wood species, wood moisture content. We have vario us temperatures in our manufacturing process. There are a number of t hings that create variability.”

Agency Response [83-Warberg-070426-Plum Creek] : We appreciate the information. If there are requirements to purchase and use low-emission products, the demand for these products will increa se. We are aware of industry concerns related to process and wood speci es variability and believe that adjustments in manufacturing controls and improvements in resin systems will allow for products to be made th at consistently comply with the standards. See also the response to comme nt #160.

213) Comment [83-Warberg-070426-Plum Creek] : “And also it creates operational concerns. It will significantly create capital challenges to put in the equipment to store, to convey, and to apply phe nol resins to our production process. And it will require much highe r press and dryer temperatures, which means burning more natural gas, more emissions. We believe it will lead to press temperatures under operations that will89 significantly increase the risk of fire in our plan ts and increase the risk of safety.”

Agency Response [83-Warberg-070426-Plum Creek] : We appreciate the comment, and as pointed out on pages 75 and 78 of t he ISOR, the use of hardeners or accelerators may allow for lower cure times for phenolformaldehyde resins. It is our understanding that PF resins are currently being used to manufacture products sold in the U.S. and the increased risk of fire was not brought to our attention. Fur thermore, future ultra low emitting formaldehyde (ULEF) resins may offer more options in the future to meet the prescribed emission performance levels of both no-added formaldehyde (NAF) resins and ULEF resins.

214) Comment [86-Compton-070426-Hambro] : “Both of our plants have probably the greatest experience running alternativ e resin systems of anybody in the United States. The Arcata plant at one time in the midseventies developed Red X, which was a PF bonded pr oduct. We

discontinued it in the ‘80s because of the instabil ity of the product and continuing product claims. At Crescent City, we de veloped a product called Cres X. That was developed in about 2000. We discontinued it in 2006 because of instability and product claims. Bo th of those products, the production rates were 50 percent longer, which means we would have a 50 percent reduction in our production capacity. The resin costs were 50 percent higher. It was only for niche markets. We could not operate our plant running those products. We would be out of business today based on the CARB proposal.”

Agency Response [86-Compton-070426-Hambro] : We appreciate the comment. In Chapter VIII of the ISOR (pages 205-20 9), our estimates for the cost increases to produce panels meeting the Ph ase 1 and Phase 2 standards were lower than the estimates provided. The estimates in the ISOR were upper-end estimates, representing what we believe to be the greatest projected increase in price.

215) Comment [92-Landry-070426-CWIC] : “We would submit, however, that the proposal is tremendously overstated for a numbe r of reasons. First of all, it takes into account only a very limited part of the industry. We believe that industry throughout the country will n ot be able to create double inventories when they’re selling, for instan ce, to furniture

manufacturers in North California who would be sell ing their product back into North Carolina. The purpose of enforcement wo uld drive many

manufacturers whether in California or not to have one approach, and therefore higher costs.”

Agency Response [92-Landry-070426-CWIC] : We disagree. California accounts for about 11 percent of the U.S. populatio n. Therefore, it is likely90 that some east coast markets will exist, which do n ot require the use of CARB compliant composite wood products. A business choice to comply with the rulemaking is an economic decision that th ey must decide for themselves. Multiple inventories are presently bei ng maintained for niche products, and it does not seem unreasonable that th is kind of approach could be used for purposes of complying with the ru lemaking. Our understanding is that some domestic composite wood product manufacturing plants will opt to continue to meet v oluntary industry formaldehyde standards established by the American Standards for Testing and Materials (ASTM), which are higher than the ATCM emissions standards, while others will switch to CARB complia nt products.

216) Comment [93-Livingston-070426-CWIC] : “And you may ask what is the significance and the difference between, for exampl e, in particleboard, 0.09 vs. 0.1. As Mr. Landry has just pointed out, the variability will require

manufacturers to aim much lower than that standard. So what you may be looking at is what’s the difference between a 0. 05 and 0.06? Well, the number is very small in terms of emissions and prob ably will make no difference at all as you have heard in terms of pub lic health. It has a significant technical complexity and a great increa se in cost. In fact, our conclusion is that panel manufacturers will not be able to continue to use the existing resin systems and equipment. And you saw some very, very large numbers about what mills will have to invest in order to achieve the

Phase 2 levels.”

Agency Response [93-Livingston-070426-CWIC] : We appreciate the comment, but disagree that the amount of variabilit y in panel emissions will remain at the same level that they presently a re. We understand that the emission results that a manufacturer may obtain for their products will exhibit some degree of variability. From submitted plant data, it appears that variability is a function of both test method and process variability. We understand that there is ample opportunity to re duce the test method variability by using more precise test methods. W e believe that the resins used to produce products compliant with Phase 2 sta ndards will have lower absolute variability given the lower amount o f HCHO used to make them. We do not agree that the operating margins w ill be as large as what manufacturers have stated they will be.

217) Comment [120-Pung-070426-Columbia] : “First on the conversion costs or what you call the tooling cost. We paid a lot of m oney to tool up our mills.

But most of that cost I’ll attribute to the cost of education. It was a learning experience. It was development cost. We know so m uch more today than we knew three years ago. And now we can implement systems much less expensively than we did in our first efforts. You heard Dave Mullen from Hercules mention second generation. There are some formulations that91 are now coming along that are going to take that ca pital cost down even

further.”

Agency Response [120-Pung-070426-Columbia] : We appreciate the information and the opportunity created for other m anufacturers that choose to use no-added formaldehyde resins.

218) Comment [120-Pung-070426-Columbia] : “The second is operating costs. All our seven hardwood plywood plants are running s oy-based adhesives today. One of these locations is running on a cost neutral basis with UF. The other six are all running at costs below curren t UF operating costs. So I am not suggesting all the alternatives can be as cost effective as this. I guess my point is it’s possible. And we’ve done it. We’ve shown it can

be done...”

Agency Response [120-Pung-070426-Columbia] : We appreciate the information indicating that the cost of the ATCM wi ll be in-line with the estimates made in Chapter VIII of the ISOR.

QUALITY ASSURANCE

219) Comment [5-Rink-070413-Jeld-Wen] : “... Rather than simply setting forth the emission limits for particular products, the pr oposed regulation dictates compliance methods and mandates certain employment functions within manufacturing facilities. The current draft even d ictates the chain-ofcommand within the manufacturing facility...”

Agency Response [5-Rink-070413-Jeld-Wen] : The ATCM’s requirements and specificity are needed to achieve product compl iance. This would apply to HWPW, PB, and MDF that Jeld-Wen makes for its own use, which we believe is necessary to ensure that panel emissions can be traced back to its corresponding in-plant and prima ry/secondary method

test results.

220) Comment [5-Rink-070413-Jeld-Wen] : Jeld-Wen provided suggested language with regard to modifying the record keepin g requirement, quality control facilities, quality control personnel, and testing frequency.

Agency Response [5-Rink-070413-Jeld-Wen] : We agree that points raised by the commenter are appropriate and modified the f inal proposed regulation order to address these points. See secti ons 93120.1 (a), 93120.3 (g), 93120.7 (b), and Appendix 2 (d), (e), and (g).

221) Comment [6-Harmon-070413-Hexion] : “Specifically, it is proposed to establish a common, performance-based category for third party92 certification exemption eligible “near-zero” formal dehyde emission products [“NZE”] as those having an ASTM E1333 meas ured or extrapolated formaldehyde emission meeting the appl icable Phase 2 emissions limit or some percentage thereof. This w ould replace the currently defined “no-added formaldehyde resins” in the body of the proposed regulation order, and would be exemption e ligible under application and performance terms as otherwise stat ed.”

Agency Response [6-Harmon-070413-Hexion] : We agree that the point raised by the commenter is appropriate and now desc ribe special provisions for the use of ultra-low-emitting formal dehyde (ULEF) resins, with reduced testing requirements in section 93120. 3(d)(1). In addition, we now include criteria in section 93120.3(d)(2) th at permits an exemption from third party certification for products manufac tured with ULEF resin upon satisfactory demonstration that the criteria a re met.

222) Comment [6-Harmon-070413-Hexion] : “We recommend that a level playing field be established for all adhesives (and panel products produced from those adhesives) that is performance- based and technology encouraging. A potential solution is to require all adhesive categories to comply with the testing protocol outl ined in the regulation and grant a panel manufacturer exempt status only o nce the third party

certified data obtained in accordance with 93120.3 (b) indicates that the combination of adhesive system and panel processing conditions yields the desired results (for example, achieving the app licable proposed Phase 2 level defined in the regulation or a percentage t hereof)...”

Agency Response [6-Harmon-070413-Hexion] : We agree that the point raised by the commenter is appropriate. The final regulation order has been modified to add sections 93120.3(c) and (d) to allow the use of NAF and ULEF resins systems. The ATCM specifies the fo rmaldehyde emissions performance levels for ULEF and NAF resin s in order for manufacturers to qualify for reduced testing or exe mption status from third party certification. The emission performance stan dards were based on staff analyses of the emission data reported for th e low-emission panel products in Tables V-22, V-24, and V-26 in the ISOR

.

223) Comment [7-Landry-070416-CWIC] : Appendix 2 (g)(7) – Treatment of non-complying lots. The CPA Grademark program allo ws for the use of a sealant as an approved method of treating non-compl ying lots. This is a useful technique and we recommend its inclusion: “P roduction which has failed the small scale test may be retested for cer tification if each panel is treated with a scavenger, sealant or handled by oth er means of reducing formaldehyde emissions (e.g., aging)...”93 Agency Response [7-Landry-070416-CWIC] : Section 93120.12, Appendix 2 (f)(3)(B)(3) allows the use of scavenger treatmen t to mitigate the emissions from non-complying lots in order to bring product emissions to compliant levels. Manufacturers still have the opt ion of using a scavenger or handled by other means of reducing formaldehyde emission such as aging their products before retesting non-complying lots.

224) Comment [7-Landry-070416-CWIC] : Appendix 2 (g)(8)(C) – Small scale retesting. The current CPA program allows for an a verage when retesting and we suggest that be included in the Appendix as well: “The average of the three representative samples must test at or be low the TOL.”

Agency Response [7-Landry-070416-CWIC] : The allowance for averaging was already allowed for under the staff’s original proposal, which is appendix A of the ISOR. The language is contained within section 93120.12, Appendix 2 (g)(8)(C).

225) Comment [7-Landry-070416-CWIC] : Appendix 2 (i) – Chain of custody – organization. This critical aspect of enforcement is stuck away in the appendix for Quality Assurance for manufacturers al most as an after thought. We suggest it be a separate section or ap pendix that elaborates on the several features of this chain of custody at the various levels of the supply chain.

Agency Response [7-Landry-070416-CWIC] : We believe that the critical elements of chain of custody are covered by require ments for product labeling and statements of compliance (sections 931 20.3 (e) and 93120.3 (f)) and deleted Appendix 2 (i) in the revised draf t regulation.

226) Comment [7-Landry-070416-CWIC] : Appendix 2 (i) – Chain of custody – certification number. There is also, we believe, a n inadvertent drafting error in this appendix. As written, a third party certification number would have to appear not only on composite wood products (HWPW, PB, and MDF) “... and goods made with complying composite woo d products...” As incorporated into each piece. These panel produ cts would likely come

from different sources and thus have been certified by different third parties. Having furniture and cabinet manufacturer s put multiple third party certifier numbers on a piece would not be hel pful. The representation of the third party is simply that th ey are using “compliant products.” This system is similar to the provision s of the USEPA’s wood

furniture MACT in which furniture makers must aver that they are using “complying coatings” and keep records on them.

Agency Response [7-Landry-070416-CWIC] : We agree that the point raised by the commenter is appropriate, and have re moved Appendix 2(i). Also, we have specified what information is needed regarding product94 labeling requirements for fabricators (section 9312 0.7(d)). Fabricators do not need to provide the TPC number to downstream cu stomers.
Fabricators must indicate the date of manufacture a nd affirm that the product meets CARB Phase 1 and/or Phase 2 emission requirements.

227) Comment [94-Dopico-070426-GP] : “We believe that a discrepancy remains between the intent of this regulation based on emissions testing and third-party certification and its language with regards to the exemption from on-going quality assurance through third party verification that is

available to boards made with no added HCHO binders and which is not equally available to boards made with HCHO based bi nders regardless of

their emissions level. We believe that this discre pancy may have an unintended consequence, as it incents the use of no n-formaldehyde binders without on-going quality assurance even if the emissions from boards made with those binders are higher than the emissions of boards made with formaldehyde-based binders.”

Agency Response [94-Dopico-070426-GP] : We disagree. If there is no

HCHO in the resin then whatever amount of natural H CHO from the wood used to make the product, will not be enough to exc eed the emission

standards. We believe that the use of no-added HCH O resins is aligned with our public health goals, as well as the use of ULEF resins over the typical urea-formaldehyde containing resin systems that have a greater potential for exceeding the emission standards. Th e ATCM does limit the exemption from third party certification for both N AF and ULEF based resins. Manufacturers may reapply for approval, bu t the application must

include test results and the chemical formulation o f the resin (see section 93120.3 (c)).

228) Comment [94-Dopico-070426-GP] : “Furthermore, the language in the regulation that would create the exemption does not specifically require demonstration of compliance with the regulation bas ed on a CARBapproved third party certifier. We proposed a leve l playing field be

established for all binders which is based on emiss ions performance. And we believe such a level playing field would encoura ge technology developments. Specifically, we recommend that the no-added HCHO language be removed from the regulation. And we pr opose if an exemption from ongoing third-party quality assuranc e is available in the regulation that it be based on emissions performanc e and not on adhesive formulation. We also propose that qualifying for s uch an exemption should require the same high standards of quality o f data based on CARB approved third-party certifiers that are upheld as in the regulation.”

Agency Response [94-Dopico-070426-GP] : We agree that the point raised by the commenter to base any third party certificat ion testing flexibility on resin emissions performance standards is appropriat e. We do not agree95 that the no-added formaldehyde language should be r emoved from the ATCM. We want to encourage the use of either no-ad ded formaldehyde resins or ultra low emitting formaldehyde resins to improve the health

benefits of the ATCM. The ATCM has been modified i n sections 93120.3(c) and (d) to establish emissions performan ce criterion and to require that all data be generated via CARB approve d third party certifiers when applying for NAF or ULEF use as recommended by the commenter.

Based on the level of emissions NAF and ULEF resins may qualify for reduced testing or full exemption from third party certification.

RESIN COSTS

229) Comment [6-Harmon-070413-Hexion] : “... The additional costs for formaldehyde-based resin bonded products due to QA testing requirements, third party certification, and the li ability of penalties for noncompliance that are not equally imposed on the no-a dded formaldehyde products may very well drive board manufacturers to select the no-added formaldehyde option even though the performance cri teria could be met with a formaldehyde-based resin (which is thereby “ deselected”).”

Agency Response [6-Harmon-070413-Hexion] : We disagree. The “costs” for using a formaldehyde containing resin, as outli ned above, are to some degree balanced by the “cost” of using a resin that has no-added formaldehyde. As it is impractical to ban the use of wood or wood byproducts (e.g., veneers, particles, or fibers) in c omposite wood products, which would be the only source of HCHO from no-adde d formaldehyde wood products, requiring the same degree of testing seems unnecessary and a potential deterrent to the use of those resin s. Individual manufacturers will have to decide for themselves, i f the cost savings incurred by using a lower per-pound formaldehyde co ntaining resin makes economic sense vs. using a potentially higher per-p ound no-added formaldehyde resin that does not require third part y certification and inplant quality assurance testing. Provisions for re duced testing and an exemption from third party certification have been included for manufacturers that use ULEF based resins (section 9 3120.3 (d)).

230) Comment [10-Higgins-070416-FFC] : “Would the ATCM give a monopoly to any manufacturer? Emphatically no... And the lead ing supplier of formaldehyde free products for the hardwood plywood veneer market, Columbia Forest Products, has offered to license it s resin technology at a reasonable cost to any other supplier.”

Agency Response [10-Higgins-070416-FFC] : We agree that the point raised by the commenter is appropriate. For HWPW-V C, with Columbia

Forest Products’ offer to license its resin technol ogy, there are at least two96 no-added formaldehyde options for HWPW manufacturer s to consider with respect to meeting the Phase 2 standard for HWPW-VC in 2010. To our knowledge, there is no monopoly in terms of using P VA resin, and it will

be a business decision as to how manufacturers will choose to produce products that meet the Phase 2 standard.

231) Comment [24-Landry-070423-CWIC] : “The 0.05 ppm level for PB represents a technological “tipping point,” at or b elow which manufacturers would have to go to much different, non-UF based re sin systems that would likely require different plant and equipment setups at substantial capital investment, present totally different cost structure for the resins, slow production cycles, and increase energy costs a nd CO 2 emissions.

CARB estimates a 30-40% cost increase from their Ph ase 2 proposal; based on extensive experience we believe it would b e 50% to 60%...”

Agency Response [24-Landry-070423-CWIC] : We disagree. The Phase 2 standard for PB is 0.09 ppm. Staff estimates that manufacturers will need to target an operating level of 0.06 ppm to ensure compliance. UF resins can be used to meet the Phase 2 standards, but thei r market share may

be reduced if manufacturers choose to use no-added HCHO resins which are exempt from third party certification. Therefo re, if manufacturers choose to use UF based resin systems, then plant-le vel costs could be more economical (see pages 196 to 201 in the ISOR). As noted in the ISOR (page 104), the use of accelerators or hardene rs is a well-known practice that will likely be tested as a means to r educe production cycletimes for some resin types such as phenol-formaldeh yde resin systems. In spite of the costs, the Board approved the regul ation at the April 26, 2007 public hearing due to the need to realize the intended health benefit.

232) Comment [27-Rush-070424-Temple Inland] : “The emission rates in Phase 2 are not required to meet safe indoor air quality and should be abandoned... they: are cost prohibitive... exclude UF r esins from use, there are no replacement resins that can compete wi th UF resins in regard to quantity available... costs, and the ease and simp licity of use.”

Agency Response [27-Rush-070424-Temple Inland] : We disagree. The Phase 2 standards will reduce total daily average e xposures by about 40% and provide much needed improvements in indoor and ambient air quality. While there will be increases in the cost to produce compliant panels, we do not believe that the cost is prohibit ive and would not exclude the use of UF based resins. Presently, rep lacements exist that in time, are expected to be competitive with UF in ter ms of cost, ease, and simplicity of use (see page 105 of the ISOR). Sier ra Pine advertises Arreis medium density fiberboard product, which is made with methylene diisocyanate resin and is cost competitive in compa rison to UF based resins (see page 106 of the ISOR).97

233) Comment [39-Maher-070424-Great Lakes] : “The economic feasibility of alternative resin systems has been ignored by ARB... In the end this dependence on alternative resin systems and unreali stic emission levels will harm the one group you are working very hard t o protect and that is

the consumer.”

Agency Response [39-Maher-070424-Great Lakes] : We disagree. Our analyses indicate that the Phase 2 standards are re asonable and achievable in the time frames provided (see pages 1 01-107 of the ISOR). The reduction in HCHO emissions provides a long-ter m health benefit to consumers, who we expect will continue to buy the p roducts subject to the

ATCM. Increased costs to consumers were estimated to be minor for new home construction and remodeling projects (see page s 214-215 of the ISOR).

234) Comment [59-Taylor-070426-Veneer] : “We have managed to stay in business, even with the influx of Asian products, b y being able to buy core at competitive prices. But if we must go to no for maldehyde – then there is no competitive pricing – only one source. This will drive our prices up and we will not be able to compete with plywood man ufacturers in other states and other countries – who are not having to follow the same regulations.”

Agency Response [59-Taylor-070426-Veneer] : We disagree. First, compliance with the emission standards does not nec essarily require NAF resins. For products sold to California, all manuf acturers, foreign and domestic, must meet the same standards, thus we do not believe that any manufacturer has an unfair competitive advantage ov er an in-state producer. Furthermore, resin suppliers are now dev eloping ultra low emitting formaldehyde (ULEF) resin systems which wi ll offer other choices rather than NAF resins (see pages 103-106 of the IS OR).

235) Comment [61-Demorest-070426-Columbia] : “As a businessman, the issue is very simple: urea-formaldehyde is a dangerous, t oxic air contaminant. There is no safe threshold for exposure to this kno wn carcinogen. And we know how to eliminate it from the products we make ... with negligible costs to the consumer. So we just have to do it.”

Agency Response [61-Demorest-070426-Columbia] : We appreciate the
comment – no response necessary.

236) Comment [83-Warberg-070426-Plum Creek] : In order to achieve the 0.11 ppm ceiling imposed by CARB Phase 2, we’re going to have to average operating rates of 0.06 to 0.07 ppm, extraordinaril y low numbers. And the only resin formulation that we’re able to use achie ve this is phenol98 formaldehyde. And here are the results that we got from actual production trials. It did slow our press speeds down by 25 pe rcent or more. It did nearly double our resin costs of not readily availa ble resin formulation. It did result in quality and performance issues that w ere not resolved, primarily water absorption in the panels. And it d id result in a 70 percent plus increase in our manufacturing costs that we’ll be forced to pass along

to our customers and our consumers.”

Agency Response [83-Warberg-070426-Plum Creek] : We appreciate the information, but disagree on the extent of impacts to production rates and cost. It is likely that modified UF resins (examp le of a ULEF resin) will also be commercially available for producing Phase 2 compliant products (see pages 103 to 106 of the ISOR) possibly even mo re economically than staff projections as stated in Chapter VIII of the ISOR (see pages 201- 202). See also the response to comment #213.

237) Comment [109-Grabiel-070426-USB] : “Because of the growing demand for soybean oil as a substitute for petroleum in bi odiesel fuels, soybean production is expected to increase, thereby providi ng additional supplies of soy meal. And the ensuing over-supply of soy me al will serve to maintain a low price for the soy meal. As I stated at the outset, the adequate supply and the low price of soy meal in th e future is indeed

assured.”

Agency Response [109-Grabiel-070426-USB] : We appreciate the information – no response needed.

238) Comment [111-Mullen-070426-Hercules] : “Yes, Hercules has successfully converted several hardwood plywood mills, cost neut ral to ureaformaldehyde adhesives. Yes, we have developed and validated a second generation adhesive that is sprayable and ef fective for the particleboard composite panel. Minimal capital inv estment is required for second generation technology. Commercial particleb oard results are positive, and we are close to meeting all performan ce targets. We are committed to achieving a minimal cost premium vs. u rea-formaldehyde.”

Agency Response [111-Mullen-070426-Hercules] : We appreciate the information – no response needed.

THIRD PARTY CERTIFICATION

239) Comment [16-Overgard-070419-HPVA] : “The current version of the rule has significantly underestimated the cost to the ha rdwood plywood industry, especially in the area of third-party cer tification and in-plant quality control testing.”99 Agency Response [16-Overgard-070419-HPVA] : We disagree. The rulemaking estimated that there would be additional costs for third party certification for selected manufacturers. However, the major cost of the ATCM will be the necessary technology for complianc e with the standards for those HWPW manufacturing facilities that use UF resins. As indicated on pages 205-206 of the ISOR, about 40 percent of H WPW produced for California already complies with Phase 2 emission s tandards. For manufacturers that use UF resins, they will likely need to improve their manufacturing processes, utilize scavenger technolo gy, use lower mole ratio UF resins, or co-blend their base UF resins w ith very low mole ratio (e.g., < 1.0) resins.

As indicated on page ES-7 of the ISOR, the incremen tal production cost of Phase 1 compliance will be about 1 percent. The in cremental production cost of Phase 2 compliance is estimated to range fr om 8 percent to 19 percent. This would depend on the resin type used, whether UF, ULEF or NAF resin systems.

240) Comment [25-Hubbard-070423-Darlington] : “I believe the current version of the rule has significantly underestimated the ad ditional costs to domestic hardwood plywood manufacturers like our co mpany... hardwood plywood manufacturers like us will have to set up a quality control laboratory, purchase testing equipment and find or train additional personnel to conduct the testing that will be requi red. I estimate those costs to be more than $100,000 in the first year an d at least 70% of that amount each year thereafter...”

Agency Response [25-Hubbard-070423-Darlington] : We believe that the overall costs will not be significant on a per pane l basis. The major cost of compliance relates to the technology used to meet t he formaldehyde emission standards (see pages 203-204 and 205-206 o f the ISOR). On a per panel basis, the cost of third party certificat ion will be less significant. Furthermore, if a manufacturer opts to use a ULEF o r NAF resin then they may avoid any expenditure to set up testing facilit ies since they could apply and be given an exemption from third party ce rtification.

241) Comment [51-Watson-070425-IPMG] : “Secondly, the cost to administer this program as well as the reduced production cycl es and third party administration costs are going to be enormous. The se factors have not been addressed in my opinion and added to the cost models that CARB staff is providing...”

Agency Response [51-Watson-070425-IPMG] : We disagree. Reduced production cycles and third party certification cos ts were considered in our economic analysis (see page 198 of the ISOR).100 MISCELLANEOUS

AIR DISTRICT CONCERNS

242) Comment [48-Zeldin-070425-CAPCOA] : “The ATCM as proposed is very complex and would be very difficult to enforce at t he air district level due to the diverse and diffuse nature of the product.”

Agency Response [48-Zeldin-070425-CAPCOA] : There are a very limited number of manufacturers in California, but a large number of importers, distributors, fabricators, and retailers. For dist ricts, the initial focus may likely be retailers, fabricators, and importers, to determine if statements of compliance and compliant products are being used, p urchased and/or sold to consumers. There are a number of potential enforcement actions that a district may opt to take which are not overl y complex, but may require coordination with CARB enforcement staff. Some actions could include procurement of samples or retailer and/or f abricator labeling and recordkeeping audits. CARB staff briefed the Calif ornia Air Pollution Control Officers Association (CAPCOA) Enforcement M anagers group regarding this new ATCM on November 8, 2007. CARB enforcement staff intends to continue working with the CAPCOA Enforce ment Managers group to help facilitate any district enforcement e fforts.

243) Comment [48-Zeldin-070425-CAPCOA] : “If air districts are to enforce this ATCM, compliance evaluations would likely have to b e structured similar to the architectural coatings rule, with inspectors focusing on noting labeling at retail and wholesale sale points.”

Agency Response [48-Zeldin-070425-CAPCOA] : We agree that the point raised by the commenter is appropriate. We believe that retailers and wholesalers may likely be the initial focus for ins pection efforts. If a particular district has laboratory capabilities, sa mple testing could also be

done at the district level. Interested districts w ould need to work with

CARB to ensure use of accredited laboratories.

244) Comment [48-Zeldin-070425-CAPCOA] : “Enforcement at manufacturing facilities and at ports is also possible; however, only a few air districts have such facilities within their jurisdiction.”

Agency Response [48-Zeldin-070425-CAPCOA] : We agree that the point raised by the commenter is appropriate. Only those air districts with ports and manufacturing facilities will need to be involv ed in those enforcement efforts at the ports.101

245) Comment [48-Zeldin-070425-CAPCOA] : “There are no provisions in the ATCM for district funding to enforce the regulation ; enforcement by districts is not possible without funding to suppor t it. Given this, and the fact that this is a consumer product typically regu lated by ARB, it seems most appropriate for ARB to enforce the ATCM.”

Agency Response [48-Zeldin-070425-CAPCOA] : We understand the basis for this comment. Under state law, local districts are mandated to adopt CARB approved ATCMs for implementation within their respective districts. As mentioned in other comment responses, CARB will enforce the regulation as with consumer products, so districts can decide their appropriate level of enforcement.

246) Comment [48-Zeldin-070425-CAPCOA] : “It is also likely that most air districts would be unfamiliar with the laboratory t esting method required in the ATCM and would not be able to perform this test , with the possible exception of the South Coast AQMD.”

Agency Response [48-Zeldin-070425-CAPCOA] : We agree that the point raised by the commenter is appropriate. We are in the process of developing an enforcement plan, which will include more information about sample collection and laboratory testing. As we anticipate that most air districts may choose to not establish their own wood product testing laboratories. However, CARB would have the necessa ry sampling and testing expertise to be able to consult with intere sted districts.

247) Comment [48-Zeldin-070425-CAPCOA] : “It is unclear how SB 509 (Simitian), if adopted and signed, will affect impl ementation of this regulation.”

Agency Response [48-Zeldin-070425-CAPCOA] : As SB 509 has been

withdrawn from consideration it will not affect the implementation of this regulation.

CONSUMER COSTS

248) Comment [4-Sherman-070409-NA] : “On page 215, under the subsection titled “Remodeling Project,” you suggest that the p anel costs for a $25,000 kitchen are $600. This subsection refers to Tables VIII-18 and VIII-19, which appear to have been omitted from the proposal . Using Table VIII17 as a reference, one can extrapolate that a $25,0 00 kitchen, using 3⁄4” maple plywood pre-compliance pricing of $38, should only require 15 3⁄4” sheets of plywood for the entire job, including cou ntertops. Both the price per sheet and the number of sheets are understated here, likely by around102 20-25% at a guess. This obviously understates, the n, the cost impact of the subsequent implementation of Phase 2 standards. ”

Agency Response [4-Sherman-070409-NA] : We acknowledge the

omission of Tables VIII-18 and VIII-19 in the ISOR. These omissions do not alter the conclusions presented on page 215, bu t rather omit the details showing how our estimates were calculated. The data in Table VIII-17 provides estimates of per panel production cost increases for HWPW, PB, and MDF in a range of panel thicknesses, following the effective date of their applicable Phase 2 standard s. Data of this kind

were used to estimate the increase in material cost after implementation of the Phase 2 standards for remodeling projects in si te-built 800 ft 2 and 2,000 ft 2 homes.

Detailed information on the amounts of composite wo od products that would be needed to fabricate the cabinets, countert ops, shelving, and doors in the two site-built homes are listed in App endix E, Tables F-4 and F-5 (these tables are a modified version of the omi tted Tables VIII-18 and VIII-19). To develop an estimate of the remodeling project of a kitchen, we used a building plan for a two bedroom, one bath house (800 ft 2 ) and a four bedroom, three bathroom (2000 ft 2 ) home (Dream Home Source, Not Dated) along with a commercially available software program (Cabnetware) to calculate the amount of composite w ood material that would be used to remodel a kitchen. In doing this calculation, we also consulted with cabinet shops (e.g., Silver Walker S tudios, Richmond, CA), and received guidance from industry representatives including the Kitchen Cabinet Manufacturers Association (KCMA).

To calculate the increase in cost for composite woo d product materials used in a remodeling project, we calculated the tot al present-day cost for the materials listed in Tables F-4 and F-5 using cu rrent-day prices, and applied average estimated cost increases of 30% for PB, 40% for MDF,

and 15% for HWPW to calculate the increase in mater ial cost after the

Phase 2 standards take effect. This information wa s derived from typical pricing information based on composite wood product prices of standardsize panels sold in 2006/2007 (Pittsburgh Forest Pr oducts Company, 2007 and Random Lengths 2007). Depending on the size of the site-built house, the present-day cost of composite wood product mate rials used to fabricate the cabinets, countertops, shelving and d oors was calculated to be $400 to $600. In a remodeling project of this k ind, we assumed that the greater portion of costs would result from labo r, appliances, insurance, non-wood materials, and overhead, and that the cost of the composite wood materials only , would be about $600. This portion, for the compo site wood products used in the project, is about 2.5% of the total project cost.

The increase in material cost after the Phase 2 sta ndards was determined to be $104 to $160, depending on the size of the si te-built home. In the103 context of a $25,000 remodeling project, an increas e in material cost of $160 represents an increase of less than 1 percent.

While we agree that there is price variation per sh eet of composite wood products, even the 20-25% increase in the increment al cost the commenter suggested would still be at or less than a 1% increase to the cost of a remodeling project. Please also note tha t in our estimates, we assumed that a typical kitchen remodel would be com prised of particleboard (50-55%), medium density fiberboard ( 25-30%), and hardwood plywood (15-20%), which would translate in to approximately 20- 25 sheets of composite wood products panels, which in turn is in accordance with KCMA’s and other independent cabine t shop’s suggestion.

249) Comment [10-Higgins-070416-FFC] : “Is the cost impact on consumer negligible? Yes... Even for manufacturers who make t he switch in resins, the cost increase is reasonable (from 5-15% without taking into

consideration economies of scale and other manufact uring advantages to be achieved) and, for the future sustainability of their markets, if necessary.”

Agency Response [10-Higgins-070416-FFC] : We agree that the point raised by the commenter is appropriate. For HWPW-V C, our analyses indicate that the potential cost increase would be about 15%. With time, manufacturing processes will improve and costs are likely to go down (see page 188 of the ISOR).

250) Comment [14-Titus-070419-KCMA] : “It was difficult to fully address this issue since two tables (VIII-18 and VIII-19, p. 215 ) referenced in the report

were not available for review...”

Agency Response [14-Titus-070419-KCMA] : We apologize for the typographical error. The two tables were used in a previous version, and were deleted from the staff report that was release d on March 9, 2007. See also the response to comment #248.

251) Comment [17-Whalen-070419-Columbia] : “... As our real-world examples of kitchen-remodeling costs show [additional costs to an average kitchen would be $40.35], industry claims of 40-50% up-char ges are completely

unfounded.”

Agency Response [17-Whalen-070419-Columbia] : We agree. We have not received a complete description of how the indu stry costs were calculated but our own estimates are aligned with t hose presented by the

commenter.104

252) Comment [23-Zimmerman-070423-Sauder] : “Compliance cost: CARB acknowledged that there would be a cost increase at the panel manufacturing level as well as the product manufact uring, and retail levels as a result of the proposed regulations. However, CARB did not accurately reflect the cost build-up and ultimate i mpact on the increased

cost at the consumer or retail level.”

Agency Response [23-Zimmerman-070423-Sauder] : We disagree.

Market forces will dictate how much of the costs ca n be passed on from

manufacturer-to-distributor and so forth. Rather t han offer an estimate that could not be determined with a large degree of certainty, we assumed that there would be a 20% increase in panel cost at the retail level on top of what was incurred at the production level (see p age 213 of the ISOR).

253) Comment [117-Cooper-070426-Kaiser] : “We have an active campaign to reduce HCHO in the furniture, fabricated casework, and building insulation we use in our facilities. However, the cost of man y of the alternative materials is significantly higher than those produc ts containing HCHO. We find this primarily due to the fact that these a lternatives do not have a significant enough market share to be cost competit ive with those products that pose a health risk...”

Agency Response [117-Cooper-070426-Kaiser] : We appreciate the comment and agree with the commenter. Current pric ing on low emitting composite wood products are higher due to its “nich e” market status. As more manufacturers comply with the Phase 2 emission standards of the ATCM by using NAF or ULEF resins systems, the marke tplace will have more options available (see pages 103 to 106 of the ISOR for lists of currently available niche products). We believe th is ATCM promotes the availability of cost-competitive low emitting produ cts that could be used to reduce toxic exposures in Kaiser-Permanente facilit ies.

ECONOMIC IMPACTS

254) Comment [2-Levin-070328-BERG] : “The economic analysis is flawed in

that it does not take into account the cost of vent ilation necessary to reduce airborne concentrations of formaldehyde by d ilution ventilation to

achieve levels that could be achieved more effectiv ely at the one-time first cost of lower emitting CWP. This ventilation has a n impact not only on operating costs but also on carbon emissions due to electric power plant operation and emissions. ... significantly increased ventilation would be necessary to provide the same protection to the pub lic as would be provided by a reduction in the initial source stren gth of formaldehyde

emissions.”105 Agency Response [2-Levin-070328-BERG] : As indicated in Chapter VIII of the ISOR, the economic analysis of the proposed reg ulation was primarily based on reducing the “source” of composite wood pr oduct HCHO emissions by imposing technology forcing emission s tandards, commensurate with the approach suggested by the com menter. Higher ventilation is not considered as a control option f or this regulation and is

therefore not included in the ISOR cost calculation s.

255) Comment [2-Levin-070328-BERG] : “... While energy cost and carbon emission limitations are important to current and f uture constraints on energy consumption to ventilate and to heat and coo l outdoor air used for ventilation, the incentives for source strength red uction are likely to increase considerably in the coming years in order to achieve a given level of general population exposure to indoor source pol lutants.”

Agency Response [2-Levin-070328-BERG] : We agree that the point raised by the commenter is appropriate. This ATCM could lead to incentives for source strength reductions. We do n ot have a comprehensive understanding of the relative contrib utions of dilution ventilation, etc., so we are not able to assess wha t differences in energy costs that may result and at what point source stre ngth reductions would be examined as an approach for lowering energy usag e.

256) Comment [2-Levin-070328-BERG] : “CARB has had a relatively forwardlooking guideline and target for indoor formaldehyd e concentrations for many years now. This proposed regulation is far le ss stringent than what would be necessary to achieve that target. CARB sh ould take more effective action now on this well-known and widely distributed substance to reduce the future costs of reduction by ventilat ion or removal and replacement of strong sources, especially the widel y used CWP.

Agency Response [2-Levin-070328-BERG] : We disagree. The proposed regulation, if adopted, will significantly reduce f ormaldehyde emissions and achieve important health benefits. As mandated under section 39666(c) of the Health and Safety Code, ATCMs are t o be developed to

achieve lowest levels achievable in consideration o f costs. We believe

that this ATCM achieves the lowest HCHO levels achi evable in consideration of projected advancements in resin te chnology and manufacturing processes. If lower emitting technol ogies are developed and used in future years, we have the authority to pursue further emission reductions, as warranted, and return to the Board w ith amendments to the

ATCM.

257) Comment [51-Watson-070425-IPMG] : “These products are commodities. Their value is determined by only two things – supp ly and demand... As demand increases for the product so does the price... What is behind this106 effort is perhaps a sense of goodwill to reduce HCH O emissions, but in my opinion it is really about profit...”

Agency Response [51-Watson-070425-IPMG] : We disagree. The intent is to reduce emissions of a known human carcinogen to the lowest extent practicable, in consideration of technology and cos t.

258) Comment [59-Taylor-070426-Veneer] : “If you look at the MSDS’s (material safety data sheets) that we are required to keep on file, you will see that particleboard and MDF have only 0.1% of formaldehyd e – that is 1/10 of 1% -- very minimal – but that minimal amount can pu t us out of business.”

Agency Response [59-Taylor-070426-Veneer] : We disagree. The HCHO content within the MSDS relates to HCHO in proporti on to total weight of wood furnish in the particleboard panel. It does n ot have a direct relationship to potential health effects from expos ure to HCHO surface emissions associated with particleboard products. The proposed emission standards provide an emission rate that will reduce public exposure by 40% from composite wood products. Furthermore, if the plywood panel is measured to have an ASTM E1333 value that complies with the standards,

the PB and MDF that the commenter has can be used a s platforms to make hardwood plywood composite core panels that ar e legal for sale in

California.

259) Comment [72-Robson-070426-AWFS] : “And of course without customers,

the AWFS ®

companies will have no reason to hire the thousand s of young people who graduate from industry sponsored Career and Technical Education programs in our public high schools and c ommunity colleges.”

Agency Response [72-Robson-070426-AWFS] : We believe that the minor cost increases to consumers (see pages 213 to 215 o f the ISOR) will not

decrease the amount of customers.

EMISSION SOURCES

260) Comment [4-Sherman-070409-NA] : “I recently read an article in one of the trade journals (I will be happy to hunt this up and send it along to you, although I suspect you already have it) which conte nds that the average person emits more formaldehyde from his body than d o all the wood products combined in his residence. I mention this , assuming it is true, as a point of interest and reference.”

Agency Response [4-Sherman-070409-NA] : While it may be true that people emit formaldehyde, if you fill a room with p eople and measure the formaldehyde concentration in the room versus an em pty room, there107 would be little difference in measured formaldehyde concentration between the crowded and empty rooms. In contrast, if you compare the formaldehyde concentration in a room filled with pa rticleboard vs. one without any, there would be a marked difference in formaldehyde

concentration. This is not consistent with stateme nts claiming that an average person emits more formaldehyde than all the wood products in

his residence.

261) Comment [90-Titus-070426-KCMA] : “For example, I think the question was raised about low end and impact on low volume. I would just tell by a study that we’ve done, a laminated cabinet as you h ave in the report give the lowest emissions. And I mean the lowest, from anything you heard about, the green cabinets, etc. This is lower. An d we perform the tests, same standards, etc. I give you a little reinforce ment on the numbers.”

Agency Response [90-Titus-070426-KCMA] : We appreciate the comment; however, lamination does not address the root probl em of unacceptable amounts of HCHO in the resins and gradual releases to air over time. By lowering the amount of HCHO in the resins, fewer re leases to air can occur, regardless of whether the product is laminat ed.

GREEN BUILDING PRODUCTS

262) Comment [13-Lent-070417-HBN] : “... The sustainable building industry is growing and hungry for formaldehyde free product bu t the industry is resisting providing it. We need the help of the re gulatory mechanism to get the industry moving.”

Agency Response [13-Lent-070417-HBN] : We agree that the point raised by the commenter is appropriate. While we develope d the ATCM for reasons of public health protection, if market forc es increase and sustain the demand for low-emitting composite wood products , the health benefits of the proposed regulation may be even greater than we projected due to accelerated market penetration.

263) Comment [13-Lent-070417-HBN] : “These design and construction firms understand that HCHO is causing harm now to the hea lth of their workers and their customers. They also know that a steadil y increasing number of their customers are seeking safer materials in thei r buildings and there are technologies available that work – but that they ar en’t going to have the selection of products they need while manufacturers continue to view healthy building materials as just another green bu ilding niche market.”

Agency Response [13-Lent-070417-HBN] : We believe that manufacturers will choose to meet the standards in the ATCM using different approaches,108 and the array of products available to design and c onstruction firms will likely increase. In California, low-emission compo site wood products will no longer be a niche product, but rather the baseli ne product in the 2009-

2012 timeframe.

264) Comment [56-Carmichael-070425-CCA] : “The bottom line is that various private sector wood product firms are currently cap able of – or already producing and marketing – formaldehyde free product s. In the best interests of California, formaldehyde free products should no longer be a small, niche market; these building materials shoul d be made widely

available.”

Agency Response [56-Carmichael-070425-CCA] : We have listed the low emission products we are aware of on pages 103 to 1 06 of the ISOR. With the incentives for reduced testing and exempti on from third party certification in the revised regulation, Phase 2 co mpliant products may be

available before the effective dates for all three panel products (see section 93120.3 (c) and (d)).

265) Comment [71-Hunt-070426-PLS] : “Arreis is manufactured using a proprietary formaldehyde-free binding system and co ntains 100 percent recycled wood fiber from sustainable forestry opera tions. It is certified by Emeryville, California-based Scientific Certificati on Systems, is an Environmentally Preferable Product, has passed the California CHPS 01350 test, and provides LEED credit support for Ma terials & Resources and Indoor Environmental Quality” (Eco-Structure, A pril 2007).

Agency Response [71-Hunt-070426-PLS] : We appreciate the information

– no response necessary.

266) Comment [71-Hunt-070426-PLS] : “Greener Plywood: Three kinds of plywood panels manufactured by Timber Products Co. reportedly meet or exceed requirements of the primary green building p rograms, including LEED. Green T Arreis is a MDF core product produce d with a formaldehyde-free adhesive and 100% post industrial recycled wood fiber...” (Eco-Structure, April 2007).

Agency Response [71-Hunt-070426-PLS] : We appreciate the information

– no response necessary.

267) Comment [71-Hunt-070426-PLS] : “Hardwood Plywood is Eco-friendly:

Timber Products Co. has introduced its environmenta lly friendly line of Green T panels that meet requirements of the Sustai nable Forestry Initiative, LEED and KCMA Environmental Stewardship Program, as well as federal and state requirements for HCHO emission s. The hardwood109 plywood panels are manufactured using an innovative , no-added urea formaldehyde resin” (Eco-Structure, April 2007).

Agency Response [71-Hunt-070426-PLS] : We appreciate the information

– no response necessary.

268) Comment [71-Hunt-070426-PLS] : “FSC, Formaldehyde-free Flooring to Hit Market: Danville, Virginia-based Columbia Comme rcial Flooring plans to roll out formaldehyde-free, FSC-certified engine ered hardwood flooring to the commercial segment in 2007. Available by sp ecial order at first with plans for a wholesale conversion of its engineered hardwood flooring plant in Danville, Columbia Commercial Flooring will mark et the flooring as PureBond, the brand created by parent company Colum bia Forest Products, Portland Oregon” (Eco-Structure, April 20 07).

Agency Response [71-Hunt-070426-PLS] : We appreciate the information

– no response necessary.

269) Comment [112-Uhland-070426-CalAg] : “I’m telling you to make this point, that sustainable environmentally friendly manufactu ring is not only socially responsible, but economically viable. As a side ba r, this first CalAg plant will operate producing one-tenth of the air polluta nts produced by a conventional wood-based MDF plant of similar size. And I’m not talking about HCHO emissions. By using 120,000 acres of ri ce straw each year, we’ll be preventing 120,000 tons of methane gas fro m being freely released into the atmosphere.”

Agency Response [112-Uhland-070426-CalAg] : We appreciate the information – no response necessary.

270) Comment [112-Uhland-070426-CalAg] : “As for product performance, CalAg MDF has exceeded wood-based MDF standards in every end use application everywhere MDF is used. This is moldin g, cabinetry, laminate flooring, millwork, office, home furniture, everyth ing. To approve this, Metsil Panel Board, the world’s largest equipment s upply company within the forest products industry, is guaranteeing with their balance sheet that this plant produce such a product. California curr ently consumes approximately 400 million square feet of MDF annual ly. Our plant will produce 150 million square feet representing approx imately 30% of the

California market.”

Agency Response [112-Uhland-070426-CalAg] : We appreciate the information – no response necessary.

271) Comment [113-Hooper-070426-HooperWolfe] : “The commercial design market is already driving the demand for low-emitti ng composite wood110 products. There are composite wood products out on the market that do meet their specifications, but there is not enough. And you have heard from some manufacturers earlier today that it’s a s mall niche. The commercial designers are struggling to find product s to meet their specifications. This rulemaking will create a larg e number of products in which they can specify cost competitively.”

Agency Response [113-Hooper-070426-HooperWolfe] : We agree – no

response necessary.

272) Comment [114-Fields-070426-Neil Kelly] : “... I’m one of those poor little cabinet makers everybody is trying to defend today. But I can tell you that we pioneered green and healthy cabinetry back in 19 98. And our company is now seven times larger than it was befor e. We’ve signed up an OEM manufacturer down the street from us in Oreg on, and I’m on my way to the east coast to find capacity there. We h ave never had in these nine years a warranty issue or health liability iss ue using the formaldehyde-free PureBond products and other alter native supplies available in my industry. The growth is absolutely phenomenal. And the suppliers of these materials are sitting in this ro om, some on the other side of the argument, which I have a hard time understan ding why they manufacture and advertise those products and I’m ma king money at it. So there is some part of that argument we need to re-s tudy.”

Agency Response [114-Fields-070426-Neil Kelly] : We appreciate the information – no response necessary.

273) Comment [114-Fields-070426-Neil Kelly] : “Neil Kelly has shown sustainable, environmentally friendly, and healthy cabinetry is not only feasible but readily available today. I urge the B oard to impose the highest standards in pulling your timelines, and le t’s get started fixing up not only California, but the rest of the United Sta tes as they follow your

trail...”

Agency Response [114-Fields-070426-Neil Kelly] : We agree – no

response necessary.

274) Comment [115-Hunt-070426-PLS] : “I just want to say that we have not had trouble in getting supply from most of the larg e companies. Most of the large companies that are making plywood today a re also advertising they have formaldehyde-free products and they’re se lling it to people like

me...”

Agency Response [115-Hunt-070426-PLS] : We appreciate the information

– no response necessary.111

275) Comment [116-Gitt-070426-Build It Green] : “So there is immense demand for this product out there. I can speak to that, b ecause we have our pulse on the ground of what’s going on in California. Ta lking with consumers directly, talking with architects and builders. We get hundreds – actually

thousands of calls. We have a hot line. We have s erviced over 5,500 calls just in the last couple years of people askin g for products such as this. And oftentimes, you know, there’s a few comp anies that are doing it. I found it interesting that a couple of companies h ere talking on the other side actually are selling compliant products today that meet the quality. Supervisor Hill asked a really relevant question ea rlier. Do you sell a product today that complies? And the answer was ye s. If they’re selling product today, they’re meeting the quality standard s in those issues that are there. They’re not having those kinds of quali ty problems. So you know, home builders, cabinet makers, manufacturers are to benefit by this regulation.”

Agency Response [116-Gitt-070426-Build It Green] : We appreciate the information – no response necessary.

276) Comment [118-Lent-070426-NA] : “In our green guide for health care, over 110 pilot projects participated last year. In pilo ting this, three-quarters of them took the action of going no-added formaldehyde -free in the products they installed in their building. The concern is d eep and wide for the issues that are raised by this action, and you’ll g et a lot of support for doing it. Last year, in the course of just a coupl e of weeks, I circulated a letter of support for this action. In very short t ime, we had 84 organizations sign on to that letter that was submi tted to you earlier. These represented a wide range of industry and publ ic support including 56 firms that design, construct, and sell buildings . These are the users of these products that you’re about to regulate. They ’re the ones that are going to pay the most for the cost of these regulat ions and they want to see the regulation happen.”

Agency Response [118-Lent-070426-NA] : We appreciate the information

– no response necessary.

OUTREACH

277) Comment [38-Morgan-070424-IWPA] : “... work with the U.S. Department of State, overseas embassies, and other appropriate organizations on an education campaign to inform foreign governments, f oreign trade associations, and foreign laboratory testing facili ties on the process to become an ARB-approved certifier...”112 Agency Response [38-Morgan-070424-IWPA] : We agree that points raised by the commenter are appropriate. We will f ollow-up on as many opportunities as possible to provide information to offshore parties about the rulemaking. CARB staff visited China and Malay sia in fall 2007 to inform the Asian wood industry of the newly approve d CARB formaldehyde regulation. In addition, fact sheets are available in five languages to assist in outreach efforts.

278) Comment [38-Morgan-070424-IWPA] : “... conduct training sessions for overseas auditors to bring these companies up to sp eed on the requirements of the ATCM...”

Agency Response [38-Morgan-070424-IWPA] : We agree that this would be helpful but cannot commit to undertake this work because we do not have the budget to do this. Furthermore, this trai ning is likely better supplied by private companies who already currently provide product certification services. We do, however, respond to all public inquiries on the requirements of the ATCM routinely.

279) Comment [38-Morgan-070424-IWPA] : “... translate the regulation and staff report into, at a minimum, Mandarin, French, Spanish, Portuguese, and Japanese...”

Agency Response [38-Morgan-070424-IWPA] : Fact sheets on the ATCM are now available in Spanish, English, Chinese, Por tuguese, Indonesian and Russian. We will consider translating the fina l ATCM, but must be assured first that the translations accurately refl ect the ATCM requirements.

280) Comment [48-Zeldin-070425-CAPCOA] : “It is likely that most air districts are unfamiliar with the technical aspects of the AT CM requirements, such as Japan F standards, HUD standards, ppm levels in raw vs. finished products, etc.”

Agency Response [48-Zeldin-070425-CAPCOA] : We agree that the point raised by the commenter is appropriate, and this is why CARB staff

conducted focused outreach to districts via the Cal ifornia Air Pollution Officers Association to explain the ATCM requiremen ts as they were developed. Additional outreach to the air district s will address a range of technical issues that may arise.

281) Comment [86-Compton-070426-Hambro] : “One of the things we’ve been disappointed in is nowhere during the process of re view and development of the proposal has anybody on the CARB staff conta cted our company to discuss with us our experience, the results of thes e runs, nor our opinions on this issue. And yet, we’re a California based o rganization.”113 Agency Response [86-Compton-070426-Hambro] : We disagree. Hambro has participated in public workshops and we extende d an open invitation to any stakeholder that wanted to share information or discuss issues with us. Until now, we have no record of Hambro contact ing our staff or requests to meet with us on issues.

282) Comment [97-Chaffin-070426-IWPA] : “... We did reach out to importers and ask questions about how this would affect them. We received resounding responses that even though they could ov er time meet the requirements with regard to HCHO levels, Phase 1 an d Phase 2, the chain of custody, labeling, and the third party certifica tion was indeed a difficult task. So we’ve asked the Board to spend some – dir ect the staff to spend some time talking to importers and overseas supplie rs and get a realistic approach for that.”

Agency Response [97-Chaffin-070426-IWPA] : We appreciate the information. We have had a number of meetings and conference calls

with IWPA and will continue to work with the affect ed parties to educate them on the specific requirements of the ATCM. See also the responses

to comments #33 and #143.

RESIN TECHNOLOGY

283) Comment [2-Levin-070328-BERG] : “Alternative (non-formaldehyde based) adhesives are also available for the proposed regul ated products in which formaldehyde is widely used. It is difficult to ju stify continued population exposure to formaldehyde at the levels contemplated in the proposed regulation in light of this fact and the carcinogen status of formaldehyde.”

Agency Response [2-Levin-070328-BERG] : We agree that the point raised by the commenter is appropriate. Alternativ e adhesives are available, but it will take time and additional tes ting to ensure a timely and

effective transition to those adhesives on an indus try wide basis. We did not accelerate, any further, with the exception of HWPW-VC, the effective date(s) of the standards to allow industry enough t ime to adequately test and assure that future compliant products would ach ieve the projected emission reductions and health benefits. Upon full implementation, the ATCM will achieve major reductions in formaldehyde emissions, especially in indoor settings, where people spend the major pa rt of their daily lives. See also the response to comment #151.

284) Comment [6-Harmon-070413-Hexion] : “... Given that California consumes about 10% of the products made with UF-based resins , this translates into about 300 million pounds to meet current market dem ands – not counting114 imports. There is not enough existing resin manufa cturing capacity, especially among NAF sources, to replace this volum e. Even converting existing UF manufacturing capacity to manufacture t he performanceequivalent replacement amount of PF production woul d be highly unlikely in the timeframe allowed under the proposed regulat ion order...”

Agency Response [6-Harmon-070413-Hexion] : We disagree. Manufacturers have several options for meeting the standards in the ATCM (see pages 101 to 106 in the ISOR). Currently , resin companies and research facilities are developing new resin sy stems for composite wood manufacturing which could offer the market eve n more choices (see pages 83-100 of the ISOR). For soy resins, Columbi a Forest Products has offered to license its resin technology at a re asonable cost to any other supplier (see comment #230). Several polyvin yl acetate resins are currently available from Franklin International (se e page 89 of the ISOR).

285) Comment [10-Higgins-070416-FFC] : “Can manufacturers meet more aggressive timelines? Yes... CARB regulations should boldly drive technology – giving businesses and consumers clear signals about California’s intention to lead in ridding the air o f this carcinogen.”

Agency Response [10-Higgins-070416-FFC] : We agree that some manufacturers can meet more aggressive timelines bu t many can’t. In our view, manufacturers of HWPW-VC are in the best posi tion to make the technology-forcing changes in the ATCM and we have moved up the effective date of the Phase 2 standard for this pro duct. See also the response to comment #151.

286) Comment [14-Titus-070419-KCMA] : “We question the wisdom of a regulatory approach that rewards unproven or questi onable substitute adhesives, many of which have safety and health iss ues of their own... there have been reports of de-lamination problems f rom formaldehydefree soy substitute touted in several of the public workshops...”

Agency Response [14-Titus-070419-KCMA] : We disagree. While not all of the resin formulations specified as “BACT” in th e ISOR are being used
on an industrial-scale, all have been used to eithe r produce niche products (e.g., PVA and MDI) or share similar compositions t o resins used to produce exterior grade products (e.g., PF or MUF re sins). We are aware of workplace related safety issues associated with some of the products, but to our knowledge, for those products that have known safety concerns, occupational regulations assure worker safety. Mor eover, all the substitutes would have significantly lower HCHO emi ssions, a known human carcinogen, after they were produced than pro ducts made with UF

resins. We believe de-lamination occurs to some de gree regardless of the resin system used and is a cost that all manufactur ers must bear. There115 is no evidence to suggest that the rate of delamina tion of soy composite wood panels is any higher than typical UF based com posite wood panels.

287) Comment [17-Whalen-070419-Columbia] : “... Industry claims that these (low or no-formaldehyde resin) alternatives, which meet the CARB rule, are not readily available are not to be believed.”

Agency Response [17-Whalen-070419-Columbia] : We agree. We believe that some are already available and some will take a few years to refine and mill test to meet the proposed Phase 2 standard s.

288) Comment [22-Whalen-0704020-Columbia] : “PVA-constructed fir/pine VC panels tested below the CARB phase II VC threshold of 0.03 ppm”

Agency Response [22-Whalen-0704020-Columbia] : We appreciate the information – no response necessary.

289) Comment [22-Whalen-0704020-Columbia] : “UF bonded MDF with PVA decorative veneers also passed CARB Phase II CC thr eshold of 0.05 ppm”

Agency Response [22-Whalen-0704020-Columbia] : We appreciate the information – no response necessary.

290) Comment [22-Whalen-0704020-Columbia] : “Emissions levels could conceivably be driven lower by using PF-bonded plyw ood platforms and PF-bonded particleboard cores laminated with decora tive veneers using

PVA adhesives”

Agency Response [22-Whalen-0704020-Columbia] : We agree. There are a variety of ways that plywood manufacturers could reduce their use of HCHO-containing resins to meet the emission standar ds.

291) Comment [26-Stoler-070423-Boise] [27-Rush-0704 24-Temple Inland] [31- Warberg-070424-Plum Creek] [32-Savage-070424-SeeMac ] [33- Wijnbergen-070424-Norbord] [37-Sein-070424-Rexcel] [40-Smith-070424- Uniboard] [44-Julia-070424-CPA] [45-Gregory-070424- SierraPine] [46- Gonyea-070424-Timber] : “...Simply put, soy adhesive technology is incompatible with MDF and is commercially unproven for particleboard.”

Agency Response [26-Stoler-070423-Boise] [27-Rush-0 70424-Temple Inland] [31-Warberg-070424-Plum Creek] [32-Savage-0 70424-SeeMac] [33-Wijnbergen-070424-Norbord] [37-Sein-070424-Rexc el] [40-Smith070424-Uniboard] [44-Julia-070424-CPA] [45-Gregory- 070424-SierraPine] [46-Gonyea-070424-Timber] : We disagree. On page 86 of the ISOR, Westcott and Frihart used a soy-PF resin to make or iented strand board116 and postulated that sprayable soy resins of this ki nd may have applications to producing low-emitting PB and MDF. There are reportedly PB and MDF products being made with the Ecobind  soy/PVA resin (see pages 104-106 of the ISOR) and Columbia Forest Prod ucts reported the availability of Purebond  particleboard in 2007 (see page 98 of the ISOR).

See also comment #295.

292) Comment [28-Maultsby-070424-FloPly] : Meeting the Phase 2 limits with its not-to-exceed levels basically says no HCHO may be added to the product.”

Agency Response [28-Maultsby-070424-FloPly] : We disagree. There are advertised UF based resins with catcher systems tha t reportedly can be used to meet the Japanese F  standard (see page 104 of the ISOR). These products could likely be used to meet the Phase 2

standards.

293) Comment [28-Maultsby-070424-FloPly] : “... The soy resin used by Columbia Forest Products has its limitations, espec ially for PB where it has not been proven. And even so, it is not availa ble to other plywood

manufacturers...”

Agency Response [28-Maultsby-070424-FloPly] : Based on the work by Westcott and Frihart, we believe that sprayable for ms of soy-based resins could potentially be used to make PB (see pages 85- 86 of the ISOR). At the public hearing on 26 April 2007 in Sacramento, Columbia indicated their willingness to provide the PurebondTM technolo gy to their competitors at a modest cost. In addition, other resin technol ogies can be used to meet the standards in the ATCM (see pages 103 to 10 5 of the ISOR). See also comment #295 and the response to comment # 291.

294) Comment [34-Keeling-070424-Roseburg] : “No suitable resin substitute is available to meet proposed standards... The reality o f the situation is there is not enough phenolic, soy flour or PVA resin to s atisfy current production levels under Phase 2 of the proposed ATCM...”

Agency Response [34-Keeling-070424-Roseburg] : We disagree. Franklin International offers several types of PVA resins th at could be used to meet the Phase 2 standards (see page 89 of the ISOR). A t the April 26, 2007 Board hearing, we heard from the United Soybean Boa rd that there is an ample supply of soy to meet the needs of the wood p roducts industry (see pages 108-110 of the transcript for the Board Heari ng). In the case of phenol, a petroleum-based resin system, we have not heard that shortages exist or if there are concerns about supp ly in the coming years. In addition, with the inclusion of ULEF resin exemp tions, their117 development may be accelerated to meet the Phase 2 emission standards (see page 75 of the ISOR). See also comment #295.

295) Comment [35-Guay-070424-Columbia] : “... To the contrary, we are regularly moving railcar quantities of PB from our single PB mill in Canada to our HWPW mills and customers throughout North Am erica... Several distributors and end users of those products will t estify at the Board meeting Thursday about their satisfaction with the performance of our products.”

Agency Response [35-Guay-070424-Columbia] : We appreciate your response on this issue. This addresses questions r egarding the commercial utility of soy resins in the manufacture of PB.

296) Comment [61-Demorest-070426-Columbia] : “Regrettably, some members of our industry have a high degree of resistance to the proposed ATCM and will go to great lengths to delay or derail it – already they have undertaken a campaign to actively discredit product s made from nonformaldehyde-based resins. Their claims are simply false. The real question remains – if they are desperate enough to make these phony statements about our products, can you believe anyt hing they say?”

Agency Response [61-Demorest-070426-Columbia] : We have listened to stakeholders, conducted a survey and literature sea rch – all sources were considered in the development of the ATCM (see Chap ter II of the ISOR).

297) Comment [63-Li-070426-OSU] : “... Wood composite panels bonded with our adhesive have excellent strength properties and excellent water resistance. Our soy-based adhesive is able to bond virtually all woody materials. It doesn’t matter whether these woody m aterials are in the form of veneer, particles, or fibers. For example, our soy-based adhesive can bond pine to pine very well while urea-formaldehyde resins cannot. Our soy-based adhesive is a very robust and versatile a dhesive technology.”

Agency Response [63-Li-070426-OSU] : We appreciate the comment – no

response necessary.

298) Comment [63-Li-070426-OSU] [108-Li-070426-OSU] : “I still remember what my department head told me about three years a go when we had (a) successful application of our soy-based adhesive in a mill scale. He said we would be very lucky if our adhesive technology c ould hold the technology advantage for five years. He was absolu tely right. In less than three years, many wood composite panels bonded with other formaldehyde-free adhesives from different companie s already flood the market. This tells you how fast the adhesive techn ology can be advanced118 and how well the wood composite industry can respon d (to) CARB’s potential regulation on formaldehyde emission(s).”

Agency Response [63-Li-070426-OSU] [108-Li-070426-O SU] : We have shown in the ISOR (pages 101 to 107) that the compo site wood industry, manufacturers and resin producers, will be able to meet the standards in the recommended time frame using resin systems know n today and under development.

299) Comment [65-Royce-070426-Hercules] [110-Royce- 070426-Hercules] : “This soy-based adhesive requires a curing agent wh ich is well known, well understood, and has been widely used commercia lly for 50 years. Although, Hercules invented this curing agent, curr ently we are only one of several suppliers. The point here is that there is a readily available supply

chain.”

Agency Response [65-Royce-070426-Hercules] [110-Roy ce-070426- Hercules] : We appreciate the information – no response neces sary.

300) Comment [65-Royce-070426-Hercules] : “These resins afforded the industry proven and well documented benefits, in te rms of both paper properties and paper machine productivity gains tha t have gone far beyond simply the elimination of formaldehyde. We are seeing similar trends today in hardwood plywood, where again, thes e resins in combination with soy, are providing not only the el imination of formaldehyde, but also the potential to improve bot h board properties and plant productivity. Based on worldwide availabilit y of these curing resins and their nearly 50 year history of widespread use and commercial acceptance, our industry is well positioned to meet the needs of the wood composite industry.”

Agency Response [65-Royce-070426-Hercules] : We appreciate the
comment – no response necessary.

301) Comment [66-Mullen-070426-Hercules] [111-Mulle n-070426- Hercules] : ”Yes – Hercules soy-based adhesives can be succes sfully utilized. To date, we have produced over 15 millio n panels of decorative hardwood plywood that has been accepted commerciall y. Word is out and we receive numerous inquiries weekly from the globa l wood products community. Further development is underway to ensu re that this technology can be transferred to particleboard and other composite panel segments.”

Agency Response [66-Mullen-070426-Hercules] [111-Mu llen-070426- Hercules] : We appreciate the information – no response neces sary.119

302) Comment [66-Mullen-070426-Hercules] : “Yes – we have developed and

validated a 2 nd generation adhesive that is sprayable and cost eff ective for the particleboard market. Commercial particleboard results are positive as we are close to meeting all performance targets. W e are committed to achieving a minimal cost premium vs. UF.”

Agency Response [66-Mullen-070426-Hercules] : We appreciate the information – no response necessary.

303) Comment [66-Mullen-070426-Hercules] [111-Mulle n-070426-Hercules] : “I want to very clear here. Contrary to the rumors, H ercules intends to make soy adhesive technology available to the entire glo bal wood products market. Initial validation of the technology with a key industry leader was critical to insure its long term viability in this industry. With 23 production sites around the world, Hercules has more than enou gh capacity to handle our global customer needs, including China.”

Agency Response [66-Mullen-070426-Hercules] [111-Mu llen-070426- Hercules] : We appreciate the information – no response neces sary.

304) Comment [73-Chappell-070426-Columbia] : “I also understand that various test results including Type I glue bond tests were submitted. This is totally inappropriate for a water resistant resin such as u rea formaldehyde. Internal bond test or IB tests should be performed on this adhesive system.”

Agency Response [73-Chappell-070426-Columbia] : We appreciate the

information. We did not consider the test results for the reason suggested by the commenter.

305) Comment [100-Harmon-070426-Hexion] : “I think something that we haven’t really gone into very much is what kind of resin product volumes are we talking about that are available in North Am erica being used now and may come under impact by this proposed regulati on. There’s around three billion pounds of UF resin and around five bi llion pounds of phenolformaldehyde resin. Depending upon how far this pr oposed regulation would domino, it could impact 10, 25 percent, I don ’t know. Depends on the business response to it. Trying to replace tha t magnitude of product volume currently available with available manufactu ring capacity and technology is truly a formidable undertaking, huge capital investments. Could be foreseen if there were a need to undergo a major shift.”

Agency Response [100-Harmon-070426-Hexion] : We disagree. It is our understanding that the demand for composite wood pr oduct resins can be met by existing sources worldwide. Most likely, ma nufacturers will comply120 with the Phase 2 emission standards by using a comb ination of various NAF, ULEF or modified UF resin systems.

306) Comment [104-Woods-070426-Columbia] : “So now there are at least four different non-UF resin approaches for hardwood plyw ood, all available in the marketplace today and all are Phase 2 compliant for veneer core hardwood plywood. So the CARB staff appropriately recognized this and moved Phase 2 implementation for veneer core hardwo od plywood to January 2010. And we predict that the emission tes ting data that CARB will be collecting starting with Phase 1 will furth er motivate you to continually strengthen this long-awaited regulation ...”

Agency Response [104-Woods-070426-Columbia] : We appreciate the support and plan to monitor emissions data when it becomes available.

307) Comment [109-Grabiel-070426-USB] : “Now, you’ve had testimony

submitted into the record which tries to cast doubt on the availability of the soy beans as an alternative adhesive. I stand here to assure you that the amount of soybeans available is fully ample to supp ly these adhesive requirements. Manufacture of all composite wood pa nels with a soy adhesive would require 80 million bushels... Current U.S. production is
3,200 million bushels. That’s over 3,000 million b ushels a year. U.S. consumption is about 2,000 million, and the other 1 ,000 million is exported. In other words, only 8% of the exported beans would be required for the total adhesive market. So there is no shortage of soybeans to supply the

adhesive market.”

Agency Response [109-Grabiel-070426-USB] : We appreciate the information – no response necessary.

308) Comment [110-Royce-070426-Hercules] : “The key point is that in the paper industry, this curing agent replaced both ure a and melamine formaldehyde chemistry several decades ago, althoug h the industry also dealt with similar change issues we’re looking at t oday. By the mid-1980’s, resins based on this curing agent had all but repla ced UF resins in those markets for wet strength and paper at equal to or l ower costs. Those new resins afforded the industry proven and well-docume nted benefits in terms of paper properties and paper machine productivity gains that have gone far beyond simply elimination of HCHO. We’re seein g similar trends today, even in the early stages. In hardwood plywood wher e these new resin systems in combination with soy are providing not o nly the elimination of HCHO, but also the potential to improve both water properties and plant productivity.”

Agency Response [110-Royce-070426-Hercules] : We appreciate the information – no response necessary.121

309) Comment [110-Royce-070426-Hercules] : “Based on the worldwide availability of these curing resins and their nearl y 50-year history of widespread use and commercial acceptance, our indus try is well positioned to meet the needs of the wood composite industry...”

Agency Response [110-Royce-070426-Hercules] : We appreciate the information – no response necessary.

310) Comment [111-Mullen-070426-Hercules] : “... Hercules has 23 sites around the world with enough capacity to handle our global customer needs, including China. Hercules looks forward to our global reach to make an impact in California and the wood-based com munity...”

Agency Response [111-Mullen-070426-Hercules] : We appreciate the information – no response necessary.

SUPPORT FOR RULEMAKING

311) Comment [18-Smith-070419-S&F] : “Today, we produce a coconut palm flooring and panel good product with zero added for maldehyde and all our flooring and bamboo panels meet and exceed the phas e II standards for HWPW proposed by CARB... In conclusion, we support an d applaud CARB’s work in advancing the interests of a cleaner and healthier environment for our children and for generations to come.”

Agency Response [18-Smith-070419-S&F] : We appreciate the support –

no response necessary.

312) Comment [20-Stensland-070420-NA] : “Given that there are no formaldehyde exposure standards in the U.S. for chi ldren, the proposed effort by CARB is a major move forward in the realm of prevention in children’s should be applauded.”

Agency Response [20-Stensland-070420-NA] : We appreciate the support

– no response necessary.

313) Comment [30-Hardy-070424-Children Now] : “Children Now earnestly encourages CARB to put in place HCHO emissions redu ction regulations as an overdue health prevention measure, to protect all people, including

our children.”

Agency Response [30-Hardy-070424-Children Now] : We appreciate the encouragement – no response necessary.122

314) Comment [35-Guay-070424-Columbia] : “... some of the flawed assertions, misrepresentations and outright falsehoods containe d in the CWIC submittal dated April 23, 2007, require an immediat e response.”

Agency Response [35-Guay-070424-Columbia] : We appreciate the information on the accuracy of the comments from CW IC.

315) Comment [50-Leverenz-070425-NA] : “... I expect that over time, the cost

of HCHO free material will decrease as economies of scale and new technologies are developed, further benefiting the consumer. Stay with the highest and best standard. It ultimately is th e best result for consumers, manufacturers and materials producers.”

Agency Response [50-Leverenz-070425-NA] : We appreciate the information – no response necessary.

316) Comment [54-Knox-070425-ACS] : “The Society believes that reducing exposure to HCHO is desirable and that reduced emis sions will benefit public health. We support the proposed formaldehyd e ATCM, and commend the Board for its actions to protect the he alth of all Californians.”

Agency Response [54-Knox-070425-ACS] : No response necessary.

317) Comment [57-Young-070425-NA] : “Please support the measure to reduce formaldehyde emissions.”

Agency Response [57-Young-070425-NA] : No response necessary.

318) Comment [58-Blicker-070425-NA] : “Do the right thing. Adopt the regulations to establish new low emitting standards . Thank you.”

Agency Response [58-Blicker-070425-NA] : No response necessary.

319) Comment [60-Cassman-070426-HBMVR] : “We have carefully reviewed the staff report and applaud the manner in which th e CARB staff has ably and comprehensively addressed the applicable legal as well as the policy

issues for this ATCM. We have submitted for the re cord a letter brief that reinforces the staff’s legal findings and demonstra tes how the salient facts in the record support these findings.”

Agency Response [60-Cassman-070426-HBMVR] : We appreciate the
comments – no response necessary.

320) Comment [61-Demorest-070426-Columbia] : “We believe that your staff report presents overwhelming evidence that the prop osed ATCM is the123 right path for California’s future – achieving mean ingful environmental benefits, with proven and readily-available technol ogy.”

Agency Response [61-Demorest-070426-Columbia] : We appreciate the
comment – no response necessary.

321) Comment [116-Gitt-070426-Build It Green] : “CARB under its legislative mandate, as you all know, has to impose the stricte st regulations possible to limit and ultimately eliminate the dangerous and unnecessary toxics from kitchen cabinets and other composite wood prod ucts. That’s why we’re here today, and that’s what I’m urging you to do.” “I would urge the Board to actually shorten that time frame for imple mentation.”

Agency Response [116-Gitt-070426-Build It Green] : We appreciate the support and have made a recommendation that we feel is technologyforcing and essential to reducing public exposure t o formaldehyde. While we accelerated the compliance date for Phase 2 HWPW -VC, we did not believe it was appropriate to shorten the implement ation for the other products. See also the response to comment #151.

PUBLIC HEALTH

COST OF HEALTH CARE

322) Comment [19-Cooper-070420-Kaiser] [117-Cooper- 070426-Kaiser] : “If we look at the larger picture and include the health c are cost to the State as a whole in treating cancer patients and others whose condition may be impacted by their exposure to HCHO, then the cost o f inaction is far greater to all of us. We urge CARB to adopt strict er guidelines for HCHO

levels as this sets the climate for manufacturers t o develop formaldehydefree alternatives that will be competitive in the m arketplace. As a large purchaser in California, we can’t make this market change to safer materials without your support...”

Agency Response [19-Cooper-070420-Kaiser] : We appreciate the
comment – no response necessary.

323) Comment [62-Whalen-070426-Columbia] : “Moreover, there is abundant evidence and testimony demonstrating that the cost to public health by not regulating this known carcinogen will be far greate r and should be the primary concern.”

Agency Response [62-Whalen-070426-Columbia] : We agree that the health risk from exposure to composite wood product s is substantial. See pages 157-159 of the ISOR.124

324) Comment [101-Korthof-070426-NA] : “So what we’re really talking about here is the voided cost that these people are looki ng for -- the cheapest possible manufacturing are skirting. They’re avoid ing the health care costs. They’re avoiding some of the other costs co nnected with the HCHO leaking. Now we’ve heard conflicting testimon y that HCHO is good for you. It really isn’t that bad. Cancer isn’t s uch a bad thing. This is something you have to consider. But it’s clearly H CHO does not exist in nature in this same way. And I think it’s legitima tely something you have to regulate. I think if it’s difficult to regulate , put more resources on it. This is the kind of thing we want the Board to do as the general public.”

Agency Response [101-Korthof-070426-NA] : See the response to

comment #323 and the health effects discussion in C hapter VII of the

ISOR.

HEALTH EFFECTS and RISK ASSESSMENT

325) Comment [2-Levin-070328-BERG] : It is difficult to justify continued population exposure to HCHO at the levels contempla ted in the proposed regulation in light of this fact and the carcinogen status of formaldehyde.

Agency Response [2-Levin-070328-BERG] : We agree with the point raised by the commenter – no response necessary.

326) Comment [4-Sherman-070409-NA] : I recently read an article in one of the trade journals (I will be happy to hunt this up and send it along to you, although I suspect you already have it) which conte nds that the average person emits more HCHO from his body than do all th e wood products combined in his residence. I mention this, assuming it is true, as a point of

interest and reference.

Agency Response [4-Sherman-070409-NA] : Many normal products of metabolism in plants, fungi, and animals are in fac t toxic – being natural does not mean being non-toxic or even less toxic th an synthetic chemicals. Furthermore, many toxic chemicals are also constitu ents of living systems including nickel, a known human carcinogen which ha ppens also to be an

essential trace nutrient.

Formaldehyde is indeed a natural constituent found in cells being produced during normal human intermediary metabolis m, and as a result of certain disease processes such as lipid peroxida tion. But HCHO is still a carcinogen and additional exposure should be avoi ded. Organisms have evolved ways to handle HCHO produced during in termediary metabolism to control the reactive compound in our cells. However, these125 protective mechanisms may be overwhelmed with exoge nous HCHO from the air we breathe. In addition, it is recognized that some human disease such as cancer may result from our “carbonyl” body burden of which HCHO is a component. It should be noted that there are data to suggest that an elevated HCHO body burden may occur due to human disease

states such as cancer and diabetes.

Formaldehyde in cells is mostly bound to a cofacto r or enzyme during intermediary metabolism and is not free in the cell . Endogenously produced HCHO is in the aqueous phase and therefore hydrated (demonstrably less harmful than inhaled from extern al sources, although not necessarily harmless). In both cases, this is n ot chemically the same as free vapor-phase HCHO. Finally, most recent and reliable methodology indicates HCHO levels in breath in the low ppb range in healthy people: higher levels appear to be associat ed with disease states such as inflammation or cancer which enhance lipid peroxidation. The values from Moser (1.2 to 72.7 ppb; median = 4.26 p pb) for human breath are compared with values CARB has for conventional homes of 13.9 ppb on average, with the maximum greater than 200 ppb ( Moser et al., 2005).

327) Comment [7-Landry-070416-CWIC] : “Last, but most importantly, we are extremely disappointed that CARB did not even evalu ate the substantial and highly regarded new science that has been condu cted around the world on formaldehyde – research that has been endo rsed by regulatory officials around the world including by the USEPA a nd Health Canada. The research shows that there is virtually no risk to the population of California from industry products in the manner the y are produced and used by consumers.”

Agency Response [7-Landry-070416-CWIC] : USEPA retains its original

risk assessment as the official IRIS assessment. W hile their assessment is currently undergoing re-review, they have not in fact endorsed the model proposed by the Chemical Industries Institute of Toxicology (CIIT). Only one group in the USEPA has used CIIT’s model. The document by Health Canada was written in conjunction with CIIT and does not represent an independent assessment. OEHHA evaluat ed the CIIT model document as part of the established petition proces s and rejected the utility of the model for risk assessment due to mod el uncertainty (also see response to comment #341).

328) Comment [8.1-Rose-070416-FCI] : Formaldehyde is a ubiquitous and natural constituent of all living systems, from bac teria and fish to rodents and humans. As such, HCHO is essential to basic met abolic processes and, as a consequence, is naturally present in the human body with blood concentrations of approximately 1-2 ppm and is a na tural part of exhaled breath. Similar concentrations are found in monkeys and in rats.126

Agency Response [8.1-Rose-070416-FCI] : Many normal products of metabolism in plants, fungi, and animals are in fac t toxic – being natural does not mean being non-toxic or even less toxic th an synthetic chemicals. Furthermore, many toxic chemicals are also constitu ents of living systems including nickel, a known human carcinogen which ha ppens also to be an

essential trace nutrient.

Formaldehyde is indeed a natural constituent found in cells being produced during normal human intermediary metabolis m, and as a result of certain disease processes such as lipid peroxida tion. But HCHO is still a carcinogen and additional exposure should be avoi ded. Organisms have evolved ways to handle HCHO produced during in termediary metabolism to control the reactive compound in our cells. However, these protective mechanisms may be overwhelmed with exoge nous HCHO from the air we breathe. In addition, it is recognized that some human disease such as cancer may result from our “carbonyl” body burden of which HCHO is a component. It should be noted that there are data to suggest elevated HCHO body burden due to human disease stat es such as cancer

and diabetes.

Formaldehyde in cells is mostly bound to a cofacto r or enzyme during intermediary metabolism and is not free in the cell . Endogenously produced HCHO is in the aqueous phase and therefore hydrated (demonstrably less harmful than inhaled from extern al sources, although not necessarily harmless). In both cases, this is n ot chemically the same as free vapor-phase HCHO. Finally, most recent and reliable methodology indicates HCHO levels in breath in the low ppb range in healthy people: higher levels appear to be associat ed with disease states such as inflammation or cancer which enhance lipid peroxidation. The values from Moser (1.2 to 72.7 ppb; median = 4.26 p pb) for human breath are compared with values CARB has for conventional homes of 13.9 ppb on average, with the maximum greater than 200 ppb ( Moser et al., 2005).

329) Comment [8.2-Rose-070416-FCI] : Exposure of humans, monkeys or rats to HCHO by inhalation has not been found to alter t he concentration of

HCHO in the blood.

Agency Response [8.2-Rose-070416-FCI] : Alteration of the concentration of HCHO in blood after inhalation appears to be the case for the average effect, as shown by Heck and Casanova (2004) (i.e., cited by FCI in their comment letter of 16 April 2007). See also the res ponse to comment #338. However, one would not expect inhalation of low levels of HCHO to affect systemic blood concentrations, and this is n owhere argued as a

factor in the mechanism of the observed adverse hea lth effects of inhaled HCHO. Formaldehyde traveling across the respirator y epithelium does127 damage to the cells lining the respiratory tract an d does not need to be absorbed into the systemic circulation to damage th e respiratory tract.

The estimation of the acute and chronic Reference Exposure Levels (cREL) determined by OEHHA were based on locally ob served effects in the respiratory system after inhalation, not on sys temic effects. In the summary of the non-cancer health effects of inhaled HCHO presented in the ISOR (pages 133 to 142), the focus was on local effects.

330) Comment [8.3-Rose-070416-FCI] : Solid wood inherently emits very low, but detectable, HCHO because of natural metabolic p rocesses in trees. Ignoring the scientific reality of endogenous chemi cals and determinations by the USEPA, the World Health Organization (WHO) a nd European governments, the staff report concludes that “there is no known safe threshold exposure level for formaldehyde” (see p. ES-2 in the ISOR). In contrast, the WHO 2004 Guidelines for drinking-wate r quality sets a tolerable daily intake of 150 μg /kg of body weight , which would be 9,000 μg for a person weighing 60 kg (123 pounds). USEPA ’s Office of Air Quality Planning and Standards (OAQPS) tabulated th e dose-response

values used in the risk assessment of hazardous air pollutants. OAQPS' chronic inhalation cancer risk assessment of exposu re to HCHO is 5.5 μg/m 3 x 10 -9 . Based on this unit risk factor, the benchmark am bient concentration for HCHO, a concentration representat ive of an additional lifetime cancer risk of 1 in 1,000,000 (1 x 10 -6 ) is 0.1497 ppm (183 μg/m 3 ). USEPA relied on a biologically based dose-response model (BBDR model) in its updated estimate of formaldehyde’s ch ronic inhalation risk for in the development of two rules issued under the Ma ximum Achievable Control Technology (MACT) provisions of the federal Clean Air Act.

Agency Response [8.3-Rose-070416-FCI] : The value for the unit risk

factor mentioned herein is based on the unit risk f actor developed by the CIIT Centers for Health Research (CIIT), not by USE PA. Although

USEPA used the CIIT model in their recent MACT rule (a risk management measure), this is not currently accepted as a consensus value for risk assessment. Therefore, the assertio n herein that it was developed by USEPA is incorrect. The USEPA’s curre nt consensus unit

risk value is 1.3 x 10 -5 as published on IRIS. This number is much closer to (and slightly higher than) the Cal/EPA value for the potency of HCHO. The USEPA is officially re-evaluating HCHO, but a f inal reassessment is not expected to be completed for another two years.

There are major uncertainties in the predictions o f the CIIT model depending on choice of input parameters (see respon se to comment 8.4). An extensive review of the strengths and weaknesses of that model by OEHHA was performed and reviewed by the Scientific Review Panel on Toxic Air Contaminants (SRP) in 2004, which led to the recommendation128 by the SRP not to change the California potency est imate. The California potency estimate is not a typical default model and OEHHA considered several model types, including inclusion of cell pr oliferation data. Publications since that date have not added signifi cantly to the information provided in the (then unpublished) report considere d in that review.

The International Agency for Research on Cancer (I ARC) recently reconsidered the status of HCHO and upgraded it to a Group 1 – known human carcinogen. The listing basis by IARC was na sopharyngeal cancer – not confined to the very specific site evaluated in the rat study and the CIIT model. Several other sites (especially lung c ancer and leukemia) are

also of substantial concern. Risks at other sites in the respiratory system (mechanistically plausible in humans due to differe nt nasal geometry), and for leukemia raises the question of whether the CII T model (which arbitrarily assumes a number of key parameters are the same in humans and rats, including the exact site of tumorigenesis ) is relevant to human

cancer risk.

Several of the citations of other national and int ernational authorities endorsing the CIIT model are in fact quoting the sa me authors, and in some cases the same document, and are not independe nt or disinterested

comments.

331) Comment [8.4-Rose-070416-FCI] : The German Federal Institute for Risk Assessment (BfR) concluded in 2006: “Concerning the tumors in the upper respiratory tract, the steps in the induction of tumors are understood and include non-genotoxic mechanisms, which in the low concentration range are the most critical events. Hence, it seem s well founded that a safe level can be derived despite the fact that gen otoxicity also plays a role in tumor formation. Our analysis of the availa ble human data suggests that a level of 0.1 ppm HCHO is “safe” for the gene ral population.” A July 2005 classification dossier prepared by France and lodged with the European Commission (EC Environment 2005) concludes : “In rats, tumour induction is associated with cytotoxicity and regen erative cell proliferation as a predominant feature with a clear threshold and it should therefore be noted that a threshold is also likely in humans.” Both the USEPA and WHO positions are consistent with and based on the leading and internationally-accepted model for formaldehyde can cer risk assessment (BBDR model), which predicts no additional risk of cancer risk from exposures of about 1 ppm. In stark contrast to thi s global consensus, the staff report claims that reductions from 16 or 42 μ g/m 3 to 9 to 25 μg/m 3 will

reduce cancer.

Agency Response [8.4-Rose-070416-FCI] : Formaldehyde is a genotoxic known human carcinogen. With regard to the carcino genicity of HCHO,

the ISOR relied on IARC’s extensive review of the l iterature in their re-129 evaluation of HCHO in 2004. IARC addressed all the arguments with regard to the current literature and use of current models and concluded that HCHO is a proven, known human carcinogen.

With regard to the model by CIIT mentioned in the response to comment #330, the model developed by CIIT does not assume a threshold but indicates a hockey-stick shape for the dose-respons e curve. The inflection point of the hockey stick is highly depe ndent upon assumptions that are not well characterized. Changing those as sumptions changes the risks below 1 ppm by several orders of magnitude. These issues were considered at length by OEHHA in its evaluation of the petition by the Formaldehyde Epidemiology, Toxicology and Environme ntal Group in 2002, and the Scientific Review Panel on Toxic Air Contaminants

endorsed OEHHA’s conclusion that CIIT’s model was n ot reliable for determining cancer risk at low exposure concentrati ons of HCHO.

The USEPA has not accepted this value as Agency co nsensus, contrary to the position portrayed in this comment. Further more, scientists at USEPA recently presented data at scientific meeting s which supports our conclusion that the CIIT model has a very uncertain inflection point.

Environmental levels of HCHO are low but not zero (CARB measures up to about 5 ppb ambient – maybe a lot higher in buil dings and vehicles) – so any substantial increment in ambient concentrati on of HCHO may be

adverse.

332) Comment [8.5-Rose-070416-FCI] : Regarding asthma and immune system effects, the ISOR (p. 134-135) continues to assume an association with low-level formaldehyde exposure. In doing so, it ignores conflicting comments submitted by OEHHA in 2004 on the draft in door air report.

Agency Response [8.5-Rose-070416-FCI] : The comments submitted by

OEHHA on the indoor REL are not in conflict with wh at is presented in the ISOR. The comments on the draft indoor air report point out to CARB that at the time of the draft report, the data on whethe r lower exposures to

HCHO result in immune sensitization were limited. Thus, OEHHA suggested a change to a sentence in the indoor air report that was too definitive. There were a few reports in the litera ture and now more studies since the indoor air report was drafted suggesting that lower environmental exposure to HCHO may exacerbate respo nse to allergens, increase atopy in children, exacerbate asthma sympt oms, or result in formaldehyde-specific IgE (Wantke et al., 1996; Gar rett et al., 1999; Smedje and Norback, 2001a; Rumchev et al., 2002). Thus, there is no conflict between the comments by OEHHA on the CARB’ s indoor air report and what is in Chapter VII of the ISOR.130

333) Comment [8.6-Rose-070416-FCI] : The following end points and associated thresholds, which result from expert rev iews, should be used. Sensory Irritation

– The weight of the evidence supports a level of 0 .75 to 1.0 ppm. Skin Sensitization Threshold – As ATSDR (1999) concluded, exposure-response relationships for skin irritation and dermal allergic responses from acute exposure are well characterize d (under patch testing conditions) in both normal and sensitized i ndividuals, indicating that 1% solutions are not expected to be irritating to most people, and it is likely that dose-response relationships for dermal irritation from acute exposure may not be widely different from relations hips for intermediate and chronic-duration exposures. Odor Threshold – The USEPA and

ATSDR concluded that the odor threshold for HCHO is approximately 1

ppm.

Agency Response [8.6-Rose-070416-FCI] : OEHHA developed acute and chronic RELs, which underwent public comment and pe er review by the Scientific Review Panel on Toxic Air Contaminants ( TACs) before being adopted for use by OEHHA. These RELs are based on irritancy (acute REL) (OEHHA, 1999) and histological damage to the n asal epithelium (chronic REL) (OEHHA, 2000). Odor threshold is irr elevant to the development of a REL for HCHO. In addition, the se nsory irritation threshold does not account for the tissue damage fr om long-term exposure to HCHO observed in workers, and this is n ot an appropriate endpoint to use in developing a REL for chronic exp osure.

334) Comment [8.7-Rose-070416-FCI] : Based on an estimated population of 35 million people in California and OEHHA’s estimat e of a reduction of 35 cancer cases per million people over a 70-year life time, OEHHA’s estimated number of cancer cases prevented per year in California is 18. In contrast, using the cancer potency factors of th e other agencies, the estimated number of cancer cases prevented per year in California ranges from 0.0005 to 0.008 (Table 1). In other words, the estimated time required to prevent one case of cancer in the entire population of California after implementing Phase 2 ranges from 1 25 to 2,000 years. OEHHA’s estimated cancer potency for HCHO is 2,250- 36,000 times greater than that of the other agencies. Either OE HHA has greatly overestimated the risk or USEPA, Health Canada, WHO , and Australia all have greatly underestimated the risk.

Agency Response [8.7-Rose-070416-FCI] : As detailed in the responses to comments #330 and #331, several of the citations of other national and international authorities endorsing the CIIT model are quoting the same authors, and in some cases the same document, and t hus are not independent or disinterested comments.131

As mentioned in the response to comment #331, the USEPA has not, in fact, accepted this value as agency consensus, cont rary to the position portrayed in these comments. Well respected scient ists from the USEPA recently presented data at scientific meetings whic h supports our conclusion that the CIIT model has a very uncertain inflection point. See comments below on the cancer potency factor propose d by the FCI and CIIT (see also the responses to comments #340 and # 341).

335) Comment [8.8-Rose-070416-FCI] : FCI recognizes that there may be social values or preferences that support the reduc tion of HCHO emissions. For the purposes of these comments, FCI has not undertaken a comprehensive review of California law and preced ent to determine whether the staff proposal could be justified in so me other fashion under state law. We are certain, however, that the reason s articulated as the health bases for the current proposal arise from a skewed presentation of

the scientific literature that cannot be reconciled with an objective review or accepted science. This, in turn, leads to an ina ccurate, if not misleading,

characterization of HCHO health risks. FCI does not expect any health effects, including cancer avoidance, pre-phase 1 or after phase 1 or 2.

From a health-basis there are no differences in the proposed changes. FCI promotes good product stewardship and is aware of the large body of scientific literature indicating that HCHO exposure at sufficiently high

levels can cause serious or severe acute and chroni c effects. But, based on the vast differences between prevailing science on HCHO health effects and the positions presented in the ISOR, th e Board should direct

CARB staff to make extensive revisions to the ISOR so that it is consistent with current science and current risk assessment pr actices. The Board has an obligation to ensure that final agency decis ions are based on a sound and objective evaluation of requisite quality and quantity.

Agency Response [8.8-Rose-070416-FCI] : The health effects of exposure to formaldehyde were well documented in 1992 when t he Board identified it as toxic air contaminant (TAC). The health effe ct findings from 1992

were reaffirmed in 2005. Because of the health eff ects related to formaldehyde exposure, the Board approved the ATCM to require the use of best available control technology for composite wood products. As further background, the TAC Program is purposely di vided into two phases. As defined by legislation (AB 1807; Tanner 1983) and regulations (Health and Safety Code section 39660 et seq.), the first phase involves identification of TACs, and the second phase evalua tes necessary

controls.

During the identification of TACs, OEHHA develops a risk assessment of the candidate TAC which undergoes public review and review by the Scientific Review Panel on TACs (SRP). The SRP eva luates the adequacy of the science behind the risk assessment. They reviewed and132 approved the CARB and OEHHA report initially in 199 2, and again recently, following a petition by FETEG for re-revi ew of the risk assessment, they approved OEHHA’s analysis and reco mmendation for denial of the petition.

Once a substance is listed formally in regulation as a TAC, the second phase of the TAC program applies. In the second ph ase, CARB adopts appropriate regulations, such as this ATCM, to cont rol TAC emissions. Health and Safety Code section 39665 (5) requires t hat a report on the need for control discuss the magnitude of risks pos ed by the substance as reflected by the amount of emissions, and the reduc tion in risk which can be attributed to each ATCM. The risk assessment pr epared in the first phase of the TAC program contains health values tha t are used by CARB staff in the second phase of the program to charact erize the risk

reductions which can be attributed to the ATCM as r equired by the Health and Safety Code. The review of the health effects and basis of the cancer potency estimate in the ISOR is provided as backgro und on how

estimates of risk are derived. It is not a formal reevaluation of the risk assessment prepared in the first phase of the TAC p rogram that is the legal basis for a TAC listing. See also the respon se to comment #336.

336) Comment [8.9-Rose-070416-FCI] : The only seeming consistency in the ISOR is that CARB staff appears to have actively so ught to reach findings of adverse effects at any level. This is reflected , for example, in the

ISOR's reliance on an outdated OEHHA assessment of carcinogenicity, while simultaneously rejecting OEHHA's comments tha t HCHO is not

associated with asthma and immune effects at antici pated exposure levels. The differences between the prevailing science and the ISOR science rationale are so great that a rule based on such as sumptions would be unscientific, arbitrary, capricious and an abuse of discretion.

Agency Response [8.9-Rose-070416-FCI] : OEHHA’s summary on the health effects of HCHO presented in Chapter VII of the ISOR are in accordance with the TAC risk assessment, which foun d no threshold for formaldehyde’s carcinogenic effects, and with curre nt scientific literature, including the IARC (2004a, b) assessment of HCHO an d recent publications on HCHO and asthma.

The comments submitted by OEHHA on the indoor REL are not in conflict with what is presented in the ISOR. The comments o n the draft indoor air report point out to CARB that at the time of the dr aft report, the data on whether lower exposures to HCHO result in immune se nsitization were limited. Thus, OEHHA suggested a change to a sente nce in the indoor air report that was too definitive. There were a few r eports in the literature and now more studies since the indoor air report wa s drafted suggesting that lower environmental exposure to HCHO may exace rbate response to133 allergens, increase atopy in children, exacerbate a sthma symptoms, or result in formaldehyde-specific IgE (Wantke et al., 1996; Garrett et al., 1999; Smedje and Norback, 2001a; Rumchev et al., 20 02). Thus, there is no conflict between the comments by OEHHA on CARB’s indoor air report and what is in Chapter VII of the ISOR.

337) Comment [8.10-Rose-070416-FCI] : Formaldehyde is one of the simplest biological forms of carbon. Even the most primitive organisms rely on HCHO as a one-carbon building block for the synthes is of more complex molecules. As a result of its importance in various metabolic processes, HCHO is naturally present in the human body with co ncentrations of approximately 1 to 2 ppm in the blood. Formaldehyd e is exhaled in the breath, with studies suggesting that breath levels may range from the low parts per billion (1.2 to 72.7 ppb) to 0.3 to 1.2 p pm (Moser et al. 2005; Ebeler et al. 1997).

Agency Response [8.10-Rose-070416-FCI] : Formaldehyde, like many other toxic compounds, is indeed a natural constitu ent found in cells being produced during intermediary metabolism as well as during cell damage via lipid peroxidation. Formaldehyde in cells is u sually bound to a cofactor or enzyme during intermediary metabolism and is not free in the cell. Likewise, it is not free HCHO in the blood but rath er hydrated in solution. Organisms have evolved ways to handle HCHO produced during intermediary metabolism to control the reactive com pound in our cells. However, these protective mechanisms may be overwhe lmed with exogenous HCHO, especially via the inhalation route where the surface of the respiratory tract is directly impacted. In add ition, it is recognized that some human disease such as cancer may result from o ur “carbonyl” body burden of which HCHO is a component. It should be noted that there are data to suggest elevated HCHO body burden due to hu man disease

states such as cancer and diabetes.

338) Comment [8.11-Rose-070416-FCI] : Due to the highly efficient activity of a variety of aldehyde dehydrogenase (ADH) enzyme syst ems, HCHO is rapidly metabolized. For example, blood was collec ted immediately following exposure of F-344 rats to 14.4 ppm of HCH O for 2 hours. Blood from eight unexposed rats served as controls. Anal ysis showed HCHO concentrations of 2.24 and 2.25 μg/g blood in expos ed and controls, respectively (Heck et al., 1985). Formaldehyde con centrations in human

venous blood from four males and two females were d etermined by analyzing blood samples collected before and after exposure to 1.9 ppm of HCHO for 40 minutes. Average HCHO concentrations before and after exposure were 2.61 and 2.77 μg/g blood, respectivel y. In neither rats nor humans was there a statistically significant effect of HCHO exposure on the average concentrations in the blood.134

In a similar study, three rhesus monkeys were expo sed to HCHO at 6 ppm (6 hours/day, 5 days/week for 4 weeks) and the HCHO concentration in the blood measured by gas chromatography - mass spe ctrometry (GCMS). The HCHO concentrations immediately after the final exposure in the three exposed and three unexposed animals were 1.84 and 2.42 μg/g blood, respectively. These results demonstrate that sub-chronic inhalation exposure of non-human primates to HCHO has no signi ficant effect on the concentration in the blood, and that the average co ncentration of HCHO in the blood of monkeys is similar to that observed in human studies (Casanova et al. 1988).

California risk assessments should recognize and a ccount for the status of substances that the body naturally generates and fo r which there are highly efficient detoxification pathways, in contra st to substances for which metabolic detoxification pathways are absent or lim ited.

Agency Response [8.11-Rose-070416-FCI] : Formaldehyde is a water soluble reactive compound and so is “scrubbed” by t he tissues lining the respiratory passages. This is why cell damage occu rs in the nasal epithelium in rodents and humans and further down t he respiratory tract in humans (who are not as efficient in scrubbing HCHO from inhaled air as the rodent due to different morphology of the upper respiratory tract). Furthermore, examination of Heck’s data in Table 1A for individuals shows that following HCHO exposure, the changes in blood HCHO levels on an
individual basis were -29%, +29%, +40%, -26%, +34%, 0% (Heck and Casanova, 2004) (i.e., cited by FCI in their commen t letter of 16 April 2007). Thus, due to individual variation, there ma y be substantial changes in blood HCHO for individuals following inhalation that are masked by the group average effect. In addition, the blood leve l analyses used GC-MS that reportedly measured free and reversibly bound HCHO. This method

would not detect the HCHO bound to cellular macromo lecules as stable or

less reversible adducts.

In this paper, Casanova reports that there was sig nificant variation in blood levels among monkeys. Again, the average res ponse hides individual variability (Casanova et al., 1988).

Genetic and biochemical variability results in som e individuals in whom the detoxification pathways are not highly efficien t. Additional, exogenous HCHO further stresses detoxification pathways. Fur ther, DNA protein cross-links (DPX) and DNA mutations seen in genotox icity tests clearly indicate that not all HCHO is detoxified by aldehyd e dehydrogenases.

339) Comment [8.12-Rose-070416-FCI]: In the context of this rule making, it is worth noting that solid, untreated wood emits very low, but detectable, levels of HCHO because HCHO is a metabolism product that is naturally135 present (Meyer and Boehm, 1997). Thus, a value of “ zero” cannot be attained for HCHO emissions from wood products.

Once HCHO enters the environment, it begins to bre ak down through natural processes and does not persist or bio-accum ulate (Chenier, 2003). From a regulatory and public policy perspective, it always is necessary to differentiate and recognize the relative importance of substances that are naturally occurring, biogenic chemical components, especially those that have multiple and highly efficient pathways existin g for their conversion

into a usable source. Such is the case with HCHO a nd its conversion to a carbon source, formate. Formaldehyde’s role in our environment is vastly

different from substances that have no roles in nor mal metabolism and physiology.

Agency Response [8.12-Rose-070416-FCI] : The ATCM seeks to reduce HCHO emissions from composite rather than solid woo d products. In addition, the ATCM does not seek to achieve a value of “zero”.

It is not clear to what environmental role for HCH O this comment refers. Many substances with normal roles in physiology are recognized as toxic at moderately higher levels (e.g., CO, Mn, and NO). Furthermore, formate is quite toxic and is the metabolite responsible fo r the ocular toxicity of methanol (see the responses to comments #328 and #3 29).

340) Comment [8.13-Rose-070416-FCI]: Formaldehyde is one of the most studied chemicals, with literally hundreds of studi es on metabolism, toxicity and effects in animals and humans. Formal dehyde is a wellknown sensory irritant to the eyes, nose, and throa t. Controlled studies demonstrate that the general irritation threshold i n a normal population is around 1.0 ppm. With the discovery in 1979 that HC HO caused nasal cancer in rats following lifetime exposure to very high levels, an extensive effort was undertaken, and continues today, to unde rstand better the potential for similar effects in humans. After dec ades of serious study, the state of the science is robust. Highly regarded exp erts in the field of toxicology have concluded that HCHO is not likely t o be carcinogenic to humans under low exposure conditions, specifically, those exposures that do not cause cytotoxic effects. Lacking sufficient evidence showing cancer in humans exposed to HCHO, assessors have hi storically made predictions of hypothetical cancer risk posed by lo w-dose HCHO exposure using the highly conservative linear multi-stage mo del and numerous default assumptions to extrapolate potential risks to humans from laboratory animal data. However, estimates of the risk of developing cancer as the result of exposure to HCHO have been lowered over time as new experimental data replaces default assumptio ns and mathematical models for extrapolating from animals to humans and high doses to low doses have become more sophisticated. Risk estimat es associated with136 exposure to HCHO have continually decreased as scie ntific knowledge increased and newer, more complete scientific studi es have become available. For example, for a lifetime exposure to 0.1 ppm, the 1987 and 1991 USEPA risk value declined from 1.6 in 1,000 to 3.3 in 100,000. In 1999, the BBDR risk assessment model estimated the risk from the same exposure to be 3.3 in 10,000,000. In other words, as the mode of action became better understood, the risk levels were adju sted to be consistent with this evolving body of knowledge.

Agency Response [8.13-Rose-070416-FCI] : Newer data have been reviewed recently by IARC. This widely-respected s cientific agency has developed a system of classifying chemicals as to t heir carcinogenicity. Previous evaluations by IARC placed HCHO in the cat egory of “probable human carcinogen”. The 2004 review resulted in upg rading the classification of HCHO to “known human carcinogen” (IARC, 2004a, b). This is different from the direction described by t his comment. This comment only refers to the risk levels based on CII T’s BBDR model, which is the model presented in the FCI petition to re-op en the TAC risk assessment. As noted above in the response to comm ents #330, #331, #334, #336, #341, and #343, there is considerable m odel uncertainty.

341) Comment [8.14-Rose-070416-FCI] : In promulgating the National

Emissions Standard for Hazardous Air Pollutants for Plywood and Composite Wood Products, the USEPA stated: We beli eve that the CIIT modeling effort represents the best available appli cation of the available mechanistic and dosimetric science on the dose-resp onse for portal of entry cancers due to HCHO exposures. The CIIT mode l incorporates state-of-the-art analysis for species-specific dosi metry, and encompasses more of the available biological data than any othe r currently available model. FCI supports this scientific decision by US EPA, which is also consistent with the USEPA position in the gas turbi ne MACT rulemaking.

The BBDR model has been accepted and used by sever al international and national standards-setting bodies and is widely respected. These widely respected organizations, listed below, draw heavily on the BBDR approach and several characterizations state that H CHO is likely to be carcinogenic in humans only at doses that cause cel l proliferation, not at

low doses.

The National Academy of Sciences (2004) endorsed t he BBDR risk assessment, over USEPA’s 1987 Integrated Risk Infor mation System (IRIS) number, in its review of indoor air contamin ants on submarines. A subcommittee of the National Research Council (NRC) developed exposure guidance levels for HCHO (assuming an expo sure of 24 hours per day for several weeks at a time). The report c ontains a thorough discussion of the literature discussing the relevan t epidemiologic and137 toxicologic studies on HCHO, and, with regard to ca ncer endpoints, states,

“The more recent CIIT assessment results in a theor etical cancer risk well below the U.S. Department of Defense “acceptable” r isk level of 1 in 10,000, even for a lifetime exposure at the 0.3 ppm 90-day continuous exposure guidance level (CEGL). The subcommittee co ncluded that the

CIIT assessment more accurately reflects the scientific weight of the evidence for formaldehyde than does EPA’s approach .” (Emphasis added.)

In its review of HCHO under its Existing Chemicals program, the Organization for Economic Cooperation and Developme nt (OECD, 2002) issued a Screening Information Data Set (SIDS) Init ial Assessment Report which stated: “The increasing severity of damage in higher concentrations is a function of the concentration. Another way of expressing this result is that HCHO toxicity is independent of the total dose (c x t) but that it depends on the dose rate [(c x t)/t = c] or concent ration. This can be explained by saturation of detoxification pathways for HCHO at high concentrations. Strong non-linearity in the inducti on of cell proliferation, DNA-protein-cross-links, cytotoxic effects and carc inogenicity are observed (CIIT, 1999). The observed non-linearity is likely attributable to a large extent to mechanisms present in biological systems to deal with low levels of HCHO” (OECD, 2002). In sum, the repo rt found that “[t]aking

into account the extensive information on its mode of action, HCHO is not likely to be a potent carcinogen to humans under lo w exposure conditions” (OECD, 2002). OECD found no further research on hu man health was

needed.

In an updated assessment of HCHO, Environment Cana da and Health Canada stated that it considered the BBDR dose-resp onse model “to provide the most defensible estimates of cancer ris k, on the basis that it encompasses more of the available biological data, thereby offering considerable improvement over default” (Environment Canada and Health Canada, 2002).

In finalizing the Concise International Chemical A ssessment Document on Formaldehyde (CICAD), the WHO (2002) relied on the BBDR cancer risk assessment for HCHO and concluded that HCHO exposur e poses a carcinogenic hazard only under conditions that both induce toxicity and cause sustained regenerative proliferation.

Agency Response [8.14-Rose-070416-FCI] : As noted above, the current consensus value for cancer potency factor at USEPA is their unit risk

factor of 1.3 x 10 -5 as published on IRIS, consistent with and actually higher than the value developed by OEHHA. OEHHA do es not agree that the CIIT model is the appropriate model for estimat ing cancer risk to humans at low levels of exposure. USEPA scientists have further138 evaluated the CIIT model and express the same conce rn with the low dose predictions as noted by OEHHA.

The document by Health Canada was written in conju nction with CIIT and does not represent an independent assessment. OEHH A did not use a

default model in our HCHO risk assessment. Rather our model evaluated some of the same parameters as CIIT, namely DNA-pro tein cross-links and cellular proliferation. Finally, as noted in t he other responses (e.g., comments #331 and #335), both OEHHA and the Scienti fic Review Panel

on Toxic Air Contaminants considered the CIIT model and rejected it as a basis for protecting public health.

Regarding WHO and the CICAD, CIIT wrote the risk a ssessment portion of the WHO (2002) report. It was not an independen t assessment as implied by the comment.

342) Comment [8.15-Rose-070416-FCI] : The German MAK Commission, which sets occupational exposure values, reviewed H CHO and concluded: “In the low dose range, which does not lead to an i ncrease in cell proliferation, the Commission therefore considers t hat the genotoxicity of HCHO plays no or at most a minor part in its carcin ogenic potential so that no significant contribution to human cancer risk is expected” (German MAK Commission, 2001). This conclusion is supporte d by the results of a risk assessment which, for persons exposed to conce ntrations of 0.3

ml/m 3 (0.37 mg/m 3 ) at the workplace for 40 years, yielded a very low

additional cancer risk for non-smokers of 1.3 x 10 -8 and for smokers of 3.8

x 10 -7 (CIIT, 1999; German MAK Commission, 2001).

In November 2006, the Australian National Industri al Chemicals Notification and Assessment Scheme (NICNAS) issued a final Priority Existing Chemical (PEC) Assessment Report on Formal dehyde. 6 NICNAS was formed in 1990 to “provide a national notificat ion and assessment scheme to protect the health of the public, workers and the environment from the harmful effect of industrial chemicals; an d assesses all chemicals

new to Australia and assesses those chemicals alrea dy used (existing chemicals) on a priority basis, in response to conc erns about their safety on environmental grounds.” The formaldehyde PEC pr ovides a summary of the BBDR model, on which the report relies. 7

Collectively, these applications of the BBDR risk assessment model reflect its broad, international acceptance among expert ag encies. The results of the BBDR model and the human implications indicate that: (1) cancer risks

associated with inhaled HCHO are de minimis (i.e., one in a million or less) at relevant human exposure levels, and (2) pr otection from the noncancer irritant effects of HCHO also should be suff icient to protect for any potential carcinogenic effects. There is widespread agreement in the139 scientific community that the BBDR model represents the future of biologically-based cancer risk assessment. Like an y new methodology, particularly one with this degree of complexity, th ere are opportunities for improving the certainty of the modeled predictions. This is already underway with research to elucidate additional deta ils concerning the mode of action of formaldehyde-induced tumors and d eveloping better

data for use in the model. The results of these st udies, the most recent of which we discuss below, should result in even great er confidence that the BBDR model provides the best and most scientificall y defensible methodology for determining whether HCHO poses an i ncreased risk of cancer to humans at levels that are protective for its well-characterized

irritant effects.

With input from USEPA, Health Canada, and peer rev iewers, a team of

researchers at the CIIT Centers for Health Research published a thorough evaluation of potential cancer risk from HCHO in 19 99, incorporating over 20 years of research and integrating various toxico logical, mechanistic, and dosimetric data (CIIT, 1999). That evaluation was refined and restated in 2004. A list of references supporting or comprising the body of knowledge underlying the CIIT work appears at the e nd of these

comments.

CIIT used the detailed understanding about how HCH O causes cancer in animals to construct a biologically-based model to describe these effects.

Combined with the data on the similarities and diff erences between animals and humans, findings in animals can be extr apolated to humans with increased confidence. Biologically-based mode ling greatly minimizes the need for the unfounded assumptions and uncertai nties inherent in currently used regulatory approaches for carcinogen s (i.e., the so-called no threshold model), which assumes (based on no dat a whatsoever) that cancer risk is linear to zero. The model developed by CIIT for formaldehyde-induced upper respiratory tract tumors is the best model to predict the doses of HCHO required to produce tumor s in animals and in

humans.

The most recent application of the BBDR model comb ines animal data with human respiratory tract cancer to smokers, non -smokers, and a mixed population of non-smokers and smokers to pred ict the likelihood of cancer occurring in humans at various levels of HCH O exposure. When the animal data were used in one way, the model pre dicted no additional risks of respiratory tract cancer up to about 1 ppm HCHO for all three

cases. When the animal data were used in an even m ore conservative way, the estimate of additional cancer risk was up to 1,000 times less than estimates based on presently used methods for extra polating animal data

to humans.140

Even when elevated breathing rates due to differen t levels of physical activity were put into the model (which could lead to increased uptake of HCHO), this did not make large differences in predi cted additional risks. As shown below in Figure 1, the evolution of predic ted cancer risks associated with exposure to 0.1 ppm HCHO for 6 hr/d ay, 5 days/week has dramatically decreased as the scientific basis for using the animal data to predict potential risks to humans has improved. Th e BBDR model shows that cancer risk is negligible until HCHO exposures reach levels associated with cytotoxicity and resulting cellular proliferation. Assuming 80 years of continuous exposure to HCHO at 100 ppb, the BBDR model predicts an increased risk of developing cancer at 3.3 x 10 -7 (i.e., 3.3 in 10,000,000) for non-smokers, well below the one in a million risk level typically used by regulators to establish an accept able level of exposure. The same model predicts a risk of 5.3 x 10 -6 in smokers.

Agency Response [8.15-Rose-070416-FCI] : OEHHA evaluated the CIIT model document as part of the established petition process under the TAC Program. See the response to comment #335. The mo del used a more complex analysis of the likely carcinogenic dose-re sponse based on analysis of deposition of HCHO in the rodent nasal cavity, and the role of DNA damage and cell proliferation. OEHHA reviewed the materials submitted by the petitioner and presented our concl usions to the Scientific Review Panel on Toxic Air Contaminants (SRP). The SRP declined to

recommend reconsideration of OEHHA’s 1992 HCHO unit risk factor. This was largely due to the uncertainties in the mo del surrounding the HCHO concentration at which, according to the CIIT model, the unit risk “switched” from low to high. This modeled inflecti on point could vary considerably depending on the choice of some poorly characterized input parameters, and might reasonably be low enough that environmental and indoor exposures were in the “high potency” range. OEHHA concluded that this model was not adequate to protect public health. OEHHA reported that the model produced a dose-response th at was flat at the low-end and that the model was flawed. This report was submitted to the SRP. The CIIT model was used by one group within U SEPA, but there was not an agency consensus. Well respected scient ists from USEPA recently presented data at scientific meetings whic h supports our conclusion that the CIIT model has a very uncertain inflection point and is

therefore unsuitable for low dose risk estimation.

In addition, IARC states that some epidemiological and experimental studies indicate that different agents may act at d ifferent stages in the carcinogenic process, and several different mechani sms may be involved.

The aim of the Monographs has been, from their inception, to evaluate evidence of carcinogenicity at any stage in the car cinogenesis process, independently of the underlying mechanisms. Informa tion on mechanisms may, however, be used in making the overall evaluat ion. As mechanisms of carcinogenesis are elucidated, IARC convenes int ernational scientific141 conferences to determine whether a broad-based cons ensus has emerged on how specific mechanistic data can be use d in an evaluation of human carcinogenicity.

343) Comment [8.16-Rose-070416-FCI] : In a state-of-the-art, three-week inhalation study at CIIT that was sponsored by FCI, F344 rats were exposed to provide information on the time-course a nd concentration dependence of genomic changes produced by HCHO in t issues of the upper respiratory tract of the rat. Exposures were conducted at three concentrations plus controls. The concentrations m irrored the lower concentrations in the Monticello study (0.7, 2.0, a nd 6.0 ppm) to provide further biological information concerning the patho logy changes that begin at the upper end of this dose regime. Genomic evalu ations (four animals per concentration/time point) were conducted at fou r time-points: 6 hours, 24 hours (6 hours plus 18 hours recovery), 5 days, and 19 days. The initial genomic evaluation focused on respiratory and trans itional epithelium from the anterior nose, the region of the highest tumor frequency.

The CIIT study was intended to provide initial inf ormation on doseresponse trends for genes or gene families and to a ssociate these changes with toxicity, metaplasia, and proliferatio n in these nasal tissues. The following points summarize the preliminary find ings of the CIIT study. A longer-term study (sub-chronic, 90-day) is expect ed to be conducted in

2007 at CIIT to link this short-term work with the results from the 2-year

Monticello results.

Gene changes were noted for a variety of genes at the 6 hour, 5-day and 19-day sampling times for some, but not all dose le vels. The pattern of gene transcription changes and the groups of genes significantly affected by exposure differed markedly for the four sampling times. Immediately after the first exposure, up-regulation (i.e., incr eased activity) and downregulation (decreased activity) was noted for many genes at 6 ppm, while only a few genes showed changes at 2 ppm, and there were no gene changes observed at 0.7 ppm. At 6 ppm, up-regulati on was observed for a gene associated with oxidative stress signaling a nd a gene associated with inflammatory signaling, while down-regulation was noted with several kinase and phosphatase genes. At the 24 hour sampl ing time, representing an 18 hour recovery after a single 6 h our exposure, no evidence of any gene change was noted at any concen tration. Immediately after the exposure on day 5, there were more changes in genes at the 2 ppm exposure level than at 6 ppm. A gain, no changes were observed at 0.7 ppm. A preliminary gene ontol ogy analysis showed significant enrichment in genes associated with cel l adhesion (i.e., the ability for cells to stay together). Positive tren ds were also seen for several genes involved in the degradation of the ex tra-cellular matrix and the inflammatory response. The changes in cell adhe sion and142 inflammatory signaling genes are likely reflections of cellular alterations associated with adaptive responses and tissue toxic ity. Immediately after the exposure on day 19, response trends were consis tent with those observed after the first exposure. No statisticall y significant gene changes were observed at either 0.7 ppm or 2 ppm, while sig nificant gene changes were again observed at 6 ppm.

This research represents a first attempt to evalua te the genomic alterations occurring upon single and repeated expo sures to HCHO in the rat. While a more robust analysis (i.e., 90-day su b-chronic) is being planned to better understand these changes in relat ion to toxicity, proliferation, and metaplasia, this initial study s hows a pattern of changes in a variety of genes and gene families. In this p reliminary evaluation, pathological changes were restricted to the 2 ppm a nd 6 ppm concentrations and primarily consisted of inflammat ion and hyperplasia, with some squamous metaplasia observed at the highe st concentration. The three types of endpoints show relatively consis tent dose-response gene expression patterns for the 3 week exposure pe riod evaluated, with no changes noted at 0.7 ppm, primarily transient ch anges at 2 ppm, and more notable changes at 6 ppm.

In summary, the results of this study of genomic c hanges indicate a highly concentration and time dependent response. An imme diate response in a number of genes was observed at 6 ppm, and a simila r response was still observed after 3 weeks suggesting that cells had ad apted to this exposure concentration. In contrast, the response at 2 ppm was highest after one week of exposure, but was no longer observed at 3 w eeks. No consistent genomic responses were observed at 0.7 ppm at any t ime point suggesting a clear biological threshold for formald ehyde-related effects. 9

Agency Response [8.16-Rose-070416-FCI]: Genomics provide a potentially useful tool to look at mechanism of act ion (although to a large degree, this is still under development), but not t o determine levels that produce effects. Also, these studies were done in rats and require extrapolation to humans. Furthermore, changes in g ene transcription following acute exposure do not suggest a clear bio logical threshold for HCHO effects or whether or not hyperplasia may occu r at chronic low levels of exposure.

This report (i.e., CIIT (1999) cited by FCI in the ir comment letter of 16 April 2007) describes rates of transcription of genes int o RNA. As such it probably represents the activity of genes involved in adaptive responses and repair following tissue damage by inhaled HCHO. Although interesting from the biological point of view this does not appear to add any new information for risk assessment purposes be yond what has already been learned from the earlier histological and cell proliferation143 data. Many of the same limitations (sensitivity, l imited time scale of treatment and lack of follow-up over longer time pe riods) apply. Further, the study does not translate into a “threshold” for biological activity as the reported changes in gene expression are quite remov ed from tumor formation, and says nothing about responses followi ng chronic exposure

in humans.

344) Comment [8.17-Rose-070416-FCI] : The German Federal Institute for Risk Assessment (BfR) prepared a Toxicological Assessmen t of Formaldehyde

in 2006. While FCI does not endorse the entire ana lysis, the conclusions in BfR (2006) are noteworthy. Concerning the tumor s in the upper respiratory tract, the steps in the induction of tu mors are understood and include non-genotoxic mechanisms, which in the low concentration range are the most critical events. Hence, it seems well founded that a safe level can be derived despite the fact that genotoxi city also plays a role in tumor formation. Our analysis of the available hum an data suggests that a level of 0.1 ppm HCHO is “safe” for the general p opulation. The proposed level of 0.1 ppm is 2-fold lower than the level derived from animal data by applying appropriate safety factors. In the literature, a physiologically based model has been reported which has been applied to the animal data. From the reported calculations an d their extrapolation to the human situation a level of 1 ppm, 10 times the level proposed by us, was considered to be safe. Therefore, the recommend ed level of 0.1 ppm

seems to be a conservative estimate.

A classification dossier prepared by the Toxicolog y Unit of INRS (France) for the Commission of the European Communities Envi ronment (DG XI)[Classification and Labelling of Dangerous Subst ances (ECBI/38/05)(July 2005)](EC Environment 2005) also conflicts with the conclusion of the ISOR with regard to the question of whether a threshold exists for toxicological effects from HCHO exposure . With regard to animal data, the dossier states (italics added): Experimen tal results and

mechanistic data therefore support a threshold type dose-response for induction of nasal tumours with regenerative cell p roliferation being the predominant feature in the carcinogenic process. T he mechanism of tumour induction through chronic persistent irritat ion, cytotoxicity and regenerative proliferation is clearly identified. Finally, there is no convincing evidence of a carcinogenic effect at dis tant sites or via other routes of exposure.

With regard to human and animal data, the dossier concludes that: tumors are only found at the site of direct contact (i.e. in the nasal tissue of rats), nasal tumors were only significantly increased in r ats, in mice there was no significant response and in hamsters no tumors w ere observed at all, and tumor formation after inhalation exposure to HC HO only occurs at144 doses with massive cytotoxicity leading to a clear increase in regenerative cell proliferation.

With regard to the mode of action and its relevanc e for humans, such as mutagenicity, cytotoxicity with growth stimulation, tumors are only to be expected at dose levels with massive cytotoxicity i n conjunction with growth stimulation (regenerative cell proliferation ) and mitogenesis. Such high doses cannot be tolerated by humans under any realistic conditions

because such irritation will not be tolerated. Thi s threshold identified in animals and by mechanistic experiments is also like ly to be operative in humans. “In rats, tumour induction is associated w ith cytotoxicity and regenerative cell proliferation as a predominant fe ature with a clear

threshold and it should therefore be noted that a t hreshold is also likely in

humans ” (p. 43, italics added).

Non-genotoxic chemicals such as chloroform have ha d mode of action (MOA) risk assessments completed (Golden et al., 19 97; Lipscomb and Kedderis, 2006). A challenge in the risk assessmen t of HCHO has been to understand how best to perform a dose-response a ssessment of a chemical that has both inflammatory or cytotoxic an d mutagenic or clastogenic properties. Traditional approaches to risk assessment separate these endpoints for non-cancer versus canc er evaluation. However, for HCHO, the MOA is likely dependent on, and secondary to the cytotoxicity of the chemical. For chemicals su ch as HCHO, an appropriate assessment is based on systems biology and a detailed understanding of the biochemical events leading to toxicity, which describes and relies on a common MOA to integrate t he various observed endpoints of toxicity. The MOA approach can serve as a platform to harmonize approaches to non-cancer and cancer toxic ity at the point of contact (i.e., no significant entry into the body). The harmonized risk

characterization is based on an evaluation of the d ose-response continuum and relies on epithelial changes that hav e recognized prognostic value for more overt toxicity and that s hould be recognized as sentinel information, applicable to both cancer and non-cancer effects. These observations are necessary to conclude that a sufficiently robust understanding of the mode of action exists, based u pon the explicit criteria spelled out in USEPA’s most recent guidelines for C arcinogen Risk Assessment (USEPA, 2005).

Agency Response [8.17-Rose-070416-FCI] : OEHHA evaluated the CIIT model document as part of the established petition process under the TAC Program. See also the responses to comments #327, #330, and #331. The model used a more complex analysis of the likel y carcinogenic doseresponse based on analysis of deposition of HCHO in the rodent nasal cavity, and the role of DNA damage and cell prolife ration. OEHHA reviewed the materials submitted by the petitioner and presented our145 conclusions to the Scientific Review Panel on Toxic Air Contaminants (SRP). The SRP declined to recommend reconsiderati on of OEHHA’s 1992 HCHO unit risk factor. This was largely due t o the uncertainties in the model surrounding the HCHO concentration at whi ch, according to the CIIT model, the unit risk “switched” from low to hi gh. This modeled inflection point could vary considerably depending on the choice of some poorly characterized input parameters, and might re asonably be low enough that environmental and indoor exposures were in the “high potency” range. OEHHA concluded that this model wa s not adequate to protect public health. OEHHA reported that the mod el produced a doseresponse that was flat at the low-end and that the model was flawed. This report was submitted to the SRP. The CIIT model wa s used by one group within USEPA, but there was not agency consensus. Well respected scientists from USEPA recently presented data at sc ientific meetings which supports our conclusion that the CIIT model h as a very uncertain inflection point and is therefore unsuitable for lo w dose risk estimation.

In addition, IARC states that some epidemiological and experimental studies indicate that different agents may act at d ifferent stages in the carcinogenic process, and several different mechani sms may be involved.

The aim of the Monographs has been, from their inception, to evaluate evidence of carcinogenicity at any stage in the car cinogenesis process, independently of the underlying mechanisms. Informa tion on mechanisms may, however, be used in making the overall evaluat ion. As mechanisms of carcinogenesis are elucidated, IARC convenes int ernational scientific

conferences to determine whether a broad-based cons ensus has emerged on how specific mechanistic data can be use d in an evaluation of human carcinogenicity.

345) Comment [8.18-Rose-070416-FCI] : Additionally, HCHO is naturally produced and an important component of various meta bolic processes. As a result, it is a constituent of living systems, fr om bacteria and fish to rodents and humans. Because there are naturally ev olved, highly efficient detoxification pathways to manage HCHO, it should b e assessed differently than an agent that has no role in norma l metabolism and physiology. Standard risk assessment methodology d oes not account for this important distinction. In contrast, the BBDR risk assessment model, used by USEPA in the plywood MACT, overcomes this l imitation. This biologically-based model has garnered broad recogni tion from national and international expert agencies as the best avail able science for evaluating the chronic health effects of HCHO. Ris k assessments should recognize the biochemical and physiological implica tions of substances that are naturally generated in the body and for wh ich highly efficient metabolic pathways have evolved.146

Agency Response [8.18-Rose-070416-FCI] : As mentioned above, HCHO, like many other toxic compounds, is indeed a natura l constituent found in cells being produced during intermediary metabolism as well as during cell damage via lipid peroxidation. Formaldehyde in cel ls is usually bound to a cofactor or enzyme during intermediary metabolism a nd is not free in the cell. Likewise, it is not free HCHO in the blood b ut rather hydrated in solution. Organisms have evolved ways to handle HC HO produced during intermediary metabolism to control the reactive com pound in our cells. However, these protective mechanisms may be overwhe lmed with exogenous HCHO by the inhalation route. In additio n, it is recognized that some human disease such as cancer may result from o ur “carbonyl” body burden of which HCHO is a component. It should be noted that there are data to suggest elevated HCHO body burden due to hu man disease

states such as cancer and diabetes.

With respect to the use of CIIT’s BBDR model, for reasons mentioned earlier (see responses to comments #330 and #331), OEHHA concluded that this model was not adequate to protect public health. While the USEPA used this model in their recent MACT rule, it was not used to develop their current consensus risk value. The mo del was used to identify low risk facilities which would be exempt from the MACT rules. However, the USEPA was sued regarding the use of th e CIIT model and lost the lawsuit. An analysis of the CIIT model by scientists at USEPA notes that the model has a very uncertain inflectio n point that substantially affects the dose-response curve making the model un suitable for predictions at low doses.

346) Comment [8.19-Rose-070416-FCI] : There is a robust database on the dose-response characteristics of HCHO induced senso ry irritation.

Reviews of the HCHO literature have noted that the most sensitive endpoints reported are for eye and upper respirator y tract irritation (USEPA/NAC, 2003; Arts et. al., 2006). A concentra tion of 1 ppm appears to be the approximate threshold for complaints of s ymptoms ranging from

none to mild to moderate with no clear concentratio n-response relationship or increase in complaints among expose d subjects compared

with controls.

For example, a study in asthmatics (Harving et al. , 1990) found no association between subjective ratings of sensory i rritation and increasing HCHO exposures at concentrations of 0, 0.01, 0.1, a nd 0.69 ppm. USEPA/NAC (2003) identified 0.9 ppm as the highest exposure concentration at which the responses of subjects wh ose eyes were sensitive to formaldehyde were not significantly di fferent from controls. Even at 3 ppm, however, the majority of subjects re ported only mild (typically defined as present but not annoying) to moderate (annoying)

irritation.147

Agency Response [8.19-Rose-070416-FCI] : The ISOR summarizes some of the sensory irritation effects of HCHO (pages 13 4-135). Sensory

irritation is irrelevant to consideration of the no n-cancer health effects of concern, which are based on histological changes in the upper respiratory tract, not sensory responses. In determination of a cREL for the noncancer effects of HCHO, irritation was not used as the endpoint of concern. Short-term experiments do not provide adequate info rmation on long-term chronic effects of HCHO exposure. Sensory irritati on and odor threshold, although important, are not relevant to OEHHA’s der ivation of a cREL for HCHO (OEHHA, 2000).

The discussion of sensory irritation in the commen ts from FCI revolves around articles developed for the purpose of evalua ting and setting occupational standards of workers to avoid moderate eye irritation. Occupational standards are not relevant to communit y exposures due to the presence of children, the elderly, etc., in the general population. OEHHA agrees that sensory irritation is a sensitive endpoint. OEHHA is concerned with the protection of sensitive subpopul ations, including

children and asthmatics. Other studies have also r eported complaints of irritation at doses less than 1 ppm. ATSDR (1999) reported at concentrations as low as 0.4 ppm sensory irritation was observed in humans. Several studies, including Gorski et al. ( 1992) showed respiratory or irritative properties of HCHO at 0.4 ppm. Arts et al. (2006) states “In literature, a concentration as low as 0. 24 ppm has been reported to be irritating to the respiratory tract in humans .”

Beyond the irrelevancy, chamber studies are insens itive due to small sample size, population selection (not necessarily sensitive people in the sample), inability to evaluate prior and concurrent exposure which is important in a community setting, and inability to evaluate longer term

exposures.

Most importantly, the threshold for changes in the nasal epithelium in workers exposed to HCHO appears to be lower than th e alleged sensory threshold. Nasal epithelial damage occurs in long- term occupational exposures, and sensory irritation is not relevant t o this endpoint. It should be noted that many irritants including HCHO are not only sensory irritants but also cause tissue damage. Sensory irritants ca n also cause irritation via other mechanisms and can damage tissue. Finall y, HCHO is not purely a sensory irritant.

347) Comment [8.20-Rose-070416-FCI] : In only one study, again in asthmatics at 3 ppm, did any subject rate the eye irritation a s severe (1 of 180 subjects) (Sauder et al., 1987). This same study ( Sauder et al., 1987) illuminates why well conducted studies are necessar y in order to properly148 understand and quantify the irritant properties of HCHO. In this study, 22% of subjects exposed to air containing no HCHO repor ted eye irritation, and 33% reported nose or throat irritation. Such a lar ge incidence of false positive reporting would likely have an influence o n any study for which it

was not accounted.

Agency Response [8.20-Rose-070416-FCI] : The study by Sauder et al. (1987) had only 9 subjects, not 180 as indicated in this comment. Thus, one person out of nine indicating severe eye irrita tion is a much larger proportion of the responses than one in 180 would b e. While it is true that false positives may be a concern in studies of this size and nature, given the confusion in the comment, it is not clear how t he mentioned percentages of false positives were derived.

348) Comment [8.21-Rose-070416-FCI] : Many of the controlled inhalation studies included potentially sensitive individuals. These studies either excluded less sensitive individuals (e.g., those wi thout complaints of eye irritation at 1.3 to 2.2 ppm or smokers) or focused on potentially sensitive individuals (e.g., asthmatic individuals and those with formaldehyderelated contact dermatitis or previous HCHO sensiti vity). As summarized by USEPA/NAC (2003), Bender (2002), and Paustenbach et al. (1997),

the results of these studies indicate that sensitiv e individuals might experience eye irritation at 1 ppm.

Below 3 ppm, the chemical appears to be rapidly el iminated in the upper airways, because asthmatics (who normally react to mid-and lowerrespiratory airway irritants) engaging in moderate exercise showed no decrements in several pulmonary function parameters when exposed at concentrations up to 3 ppm. Thus, asthmatics expos ed to airborne HCHO at exposure concentrations at or below 3 ppm do not appear to be at greater risk of suffering airway dysfunction than n on-asthmatics. In addition, the short-term chamber studies indicate t hat adaptation or accommodation to irritation can develop over time ( NRC, 2004). These studies support that HCHO irritancy does not follow Haber’s law (concentration x exposure time = response) for extr apolating between short-term and long-term time periods. Generally, concentrations that do not produce short-term sensory irritation also do n ot produce sensory irritation after repeated exposure. Consequently, conventional safety factors applied to a non-cancer risk assessment for HCHO are

unnecessary.

Agency Response [8.21-Rose-070416-FCI] : OEHHA agrees that HCHO does not follow Haber’s Law. The comments by FCI a rgue that sensory irritation does not follow Haber’s Law and conseque ntly non-cancer risk assessment should not use conventional safety facto rs for HCHO. Sensory effects do not follow Haber’s law over peri ods of more than a few149 minutes at most. But histological damage does, and histological damage

is the basis for OEHHA’s chronic REL.

349) Comment [8.22-Rose-070416-FCI] : There are several explanations for reported eye irritation levels by HCHO below 1.0 pp m, the primary one, however, is associated with the substance’s odor. Formaldehyde has a pungent odor and the odor of HCHO is detected and/o r recognized by most human beings at concentrations below 1.2 mg/m 3 (1 ppm) (IPCS, 1989). In general, odor detection is not regarded as a toxicologically relevant endpoint -- annoyance does not represent a sensory or psychological effect, but rather a psychological di scomfort from the presence and increasing concentration of an odor (A rts et al., 2006b).

Foul odors are detected by both olfactory and trig eminal stimulation. The olfactory stimulation relays messages to the brain using the first cranial nerve for odor perception while trigeminal stimulat ion is responsible for sensing the ocular and nasal irritation of a chemic al using the fifth cranial nerve (Paustenbach and Gaffney 2006). In other wor ds, olfactory receptors detect odor threshold, while trigeminal n erve endings in the cornea and nasal mucosa signal sensory irritation t hresholds in the eyes and upper respiratory tract, respectively. Olfacto ry receptors respond to chemical stimuli usually at lower concentrations an d with greater selectivity than do the trigeminal endings and are responsible for the discrimination of different odorous substances (Art s et al., 2006b). Although anatomically distinct, both pathways help people to distinguish

and characterize inhaled air.

Studies have shown that even a pure odorous substa nce, lacking any trigeminal stimulation, elicited reports of sensory irritation (van Thriel, 2006). For the majority of chemicals, odor has a z ero correlation with actual exposure risk, but odor may have a substanti al correlation with perceived exposure risk. However, as Paustenbach a nd Gaffney (2006) note: “detection of odors by workers may tap into t he person’s aversions to unpleasant odors, in general.” Because the vast majority of volatile chemicals stimulate the olfactory system at concent rations well below that at which they will elicit trigeminal activation, th e evaluation of irritation from volatiles is often confounded by the perception of odor (Arts et al., 2006b). Formaldehyde is not an irritant at its odor thresho ld; however, much of the public immediately perceives the substance and its odor as harmful, which strongly influences individuals to indicate irritat ion where only odor exists. Thus, the results of measurements of sensory irrita tion can strongly be biased by subjective feelings and interpretations, in many instances caused by the odor of the compound. Therefore, the perception of odor intensity is an important factor that must be consi dered when evaluating a substance for an occupational exposure limit, espec ially substances that like HCHO have odors perceived as unpleasant.150

Agency Response [8.22-Rose-070416-FCI] : OEHHA recognizes the perception of foul odor as an “effect”. Detection of foul odor may lead to other irritant effects even if the discomfort is ps ychologically-induced. In addition, patho-physiological effects have been see n in response to odor (e.g., by pregnant women and for other chemicals li ke H 2 S). OEHHA does not disagree that odor perception is distinct from trigeminal nerve stimulation. OEHHA is not using odor perception or odor threshold to set

a cREL.

Occupational standards are not used to set standar ds for the general public, which includes infants and children, the el derly, pregnant women, ill people and more sensitive individuals. Occupat ional standards are recognized to protect some but not all workers and are set at higher risks than environmental standards for the general public . Also, in an occupational setting, workers may be less likely to complain and may be “acclimated” to odor or irritation from low doses ( 1 ppm or less) of HCHO.

350) Comment [8.23-Rose-070416-FCI] : Several expert reviews have been conducted of the HCHO literature relating to sensor y irritation. Based on the reviews by the National Academy of Sciences’ Na tional Research Council (NRC, 2004), Arts et al. (2006), Bender (20 02), and Paustenbach et al. (1997), the weight of the scientific evidenc e demonstrates that the threshold for HCHO sensory irritation of the most s ensitive endpoint (i.e., eye and respiratory tract irritation) is in the ran ge of 0.75 to 1 ppm.

(a) NRC (2004): In reviewing the exposure of U.S. N avy personnel in submarines to several different contaminants, a sub committee of the NRC developed exposure guidance levels for HCHO (assumi ng exposure for 24 hours per day for several weeks at a time). The re port contains a thorough discussion of the literature on the releva nt epidemiologic and toxicologic studies on HCHO, and concludes: A conce ntration of 1 ppm appears to be the approximate threshold between com plaints of symptoms ranging from none to mild to moderate with no clear concentration-response relationship or increase in complaints among exposed subjects compared with controls (subjects e xposed to clean air) and definite symptoms of discomfort in a number of exposed subjects.

(b) Arts et al. (2006a) : Arts et al. (2006a) evaluated literature related to critical health effects of HCHO exposure including sensory irritation and the potential to induce tumors in the upper respira tory tract. The authors reviewed the subjectively measured sensory irritati on threshold levels in humans and compared this with findings obtained in animal experiments. In addition, a benchmark dose (BMD) analysis of sen sory irritation was used to estimate response incidences at different H CHO concentrations. The BMD method used by the authors takes all indivi dual data into151 account by means of a curve based on all the data p oints. 12 Arts et al. concluded that: when minimal/mild/slight irritation , which is still not annoying, is taken as a cut off level, eye and nasa l irritation were found at

HCHO levels of ≥ 1 and ≥ 2 ppm, the minimal/mild/slight irritation level

would be ≥ 3 ppm HCHO for throat irritation, whereas levels o f up to 3 ppm did not result in dyspnoea (chest tightness/dis comfort) or cough. 13
The authors were sensitive to the challenge of sett ing appropriate exposure levels based on sensory irritation. Becau se human perception of sensory irritation can be influenced strongly by subjective feelings and interpretations, the authors contend that it would be better to base the sensory irritation threshold on objective measureme nts. In the authors’ view, the only study that reported objectively meas ured eye irritation (but not nasal irritation), viz. an increase in eye blin king frequency at a concentration of 1.7 ppm HCHO (Weber-Tschopp et al. , 1977), is in line with minimal/mild/slight eye irritation reported at levels of 1 ppm and higher. It was noted that the increase in eye blin king frequency was not doubled yet at 3.2 ppm (Weber-Tschopp et al., 1977) . Collectively, Arts et al.’s review leads to the conclusion that: “Sensory irritation is first observed at levels of 1 ppm and higher. From both human and animal

studies it was concluded that at airborne levels fo r which the prevalence of sensory irritation is minimal both in incidence and degree (i.e. < 1 ppm), risks of respiratory tract cancer are considered to be negligibly low.

(c) Bender (2002): Bender (2002) reviewed whether h uman sensory irritation data found in controlled/chamber studies and workplace studies are sufficiently robust for use in establishing a R eference Concentration for HCHO. Bender (2002) determined that chamber st udies provided the highest quality data for determining the presence o f eye, nose or throat

irritation at a known level of HCHO. Chamber studi es show that individuals began to sense eye irritation at about 0.5 ppm HCHO; 5% to 20% reported eye irritation at about 0.5 to 1 ppm, and greater certainty for sensory irritation appeared at 1 ppm or greater. B ender et al., also evaluated reports of eye irritation among controlle d studies, and found that it is not unusual to have a 20 to 30% response rate for eye, nose, or throat

irritation associated with controls. Bender et al. concluded that sensory irritation at levels below 1 ppm is often difficult to distinguish from effects

that occurred in controls.

(d) Paustenbach et al. (1997): Paustenbach et al. ( 1997) represents the results of deliberations of this panel of experts c onvened to review the literature on sensory irritation. The expert panel reviewed approximately 150 published scientific articles and concluded tha t the most sensitive adverse effect of HCHO is eye irritation. Eye irri tation “does not become significant until a concentration of at least 1.0 p pm is reached, and, based on most studies, for most people this level of irri tation rapidly subsides.152 Moderate to severe eye, nose, and throat irritation does not occur until airborne concentrations exceed 2.0 to 3.0 ppm.

According to the expert panel, the weight of the e vidence showed that reports of irritation below 0.3 to 0.5 ppm HCHO wer e too unreliable to attribute the findings solely to HCHO. Specificall y, response rates below 20% were assumed to be too near the background leve l of irritation among the general population to be able to attribut e that level of response to exposure to a specific contaminant. In response to studies that showed irritation response at concentrations below 0.1 ppm , the panel explained: “it is likely that this level of response was attri butable to other environmental factors, the background incidence of eye irritation, selfselection bias, or the effects of interviewer inter action.

(e) IRSST (2006): The Québec Institute of Research Robert-Sauvé en santé et en sécurité du travail (IRSST) recently co mpleted a thorough evaluation on the Impacts of a Lowering of the Perm issible Exposure Value to Formaldehyde: Impacts of Formaldehyde Expo sure on Health. IRSST is a private, non-profit scientific research organization known for the quality of its work and the expertise of its pe rsonnel. The Board of Directors is composed of an equal number of trade u nion and employers' representatives. With respect to the issue of sens ory irritation, this evaluation critically considered all available stud ies with the notable inclusion of a rigorous dose-response analysis of t he available data. Unlike other evaluations, based on pre-established criteria, this analysis considered sensory irritation effects (e.g., eye ir ritation, moderate and severe, and moderate nose and throat irritation), t he percentage of workers who might experience such effects, and most importantly, the associated dose-response relationships.

The relationship between acute HCHO exposure and th e appearance of

effects was established based on the collection of all rough data from each of the studies considered to have a degree of confidence moderately high to high. Hence, these studies are all led in a controlled setting. Moreover, the effects selected for the establishmen t of a dose-response relationship are the irritating effects to the eyes and airway mucosa (nose and throat) as well as perception of odor. These e ffects are most frequently reported following an acute exposure to HCHO suggesting that they are the critical effects (those that appear wi th the lowest concentrations).

For each of the controlled studies, the number of subjects presenting irritating effects, according to the class of expos ure and the severity of the effect, was listed. The degree of exposure was fra ctioned into six distinct classes: from 0 to < 0.3 ppm, from 0.3 to < 0.75 pp m, from 0.75 to < 1.0153 ppm, from 1.0 to < 2.0 ppm, from 2.0 to < 3.0 ppm, and > 3.0 ppm (which in fact combined the exposures between 3.0 and 4.0 ppm).

By combining the data from the different controlle d studies, a global doseresponse relationship was established. More specif ically, the total number and the proportion of subjects presenting irritatin g effects by type of effects, severity of effects and class of exposure were compiled in the form of a table by adding the numbers of the differ ent studies. This data allowed the creation of dose-response curves where the background noise value, that is to say the frequency of irritations in the absence of exposure,

was subtracted.

The conclusions of the IRSST review are noteworthy . Our analysis indicates that, for concentrations less than 0.75 p pm, the frequency of irritation in workers exposed to HCHO was about the same as the one observed in individuals without occupational exposu re. This means that appearance of irritation at such concentrations can hardly be associated with occupational exposure to HCHO. For concentrati ons between 0.75 and 3 ppm, the estimated proportion of workers who may experience moderate irritating effects to the eyes, nose, and throat, attributed to

HCHO is between 1.6 and 14.9%.

Agency Response [8.23-Rose-070416-FCI] : Occupational standards are not used to set standards for the general public, w hich includes infants and children, the elderly, pregnant women, ill peop le and more sensitive individuals. Occupational standards are recognized to protect some but not all workers, and are set at higher risks than e nvironmental standards for the general public. OEHHA recognizes these pre vious reviews have been performed and have taken into account informat ion found therein. However, OEHHA relies on primary sources of peer-re viewed literature in

its non-cancer health risk assessments.

With regard to the National Research Council (NRC) paper mentioned in the above comment, Navy personnel are less likely t o complain and may

be able to withstand more odor or irritation becaus e of their training, especially those trained to spend months at a time on submarines. They may be acclimated to the many odors found on submar ines. Also, Navy personnel on submarines would be of much better hea lth than a “normal” person, and therefore, are not an adequate sample o f the general population. The studies mentioned above are of occ upational exposure and do not include infants, children, and pregnant women.

The conclusions by Arts et al. (2006) are based on only one paper found in the “historical” literature, which qualified to them as an “objective” endpoint (eye blinking frequency). This one study (Weber-Tschopp et al., 1977) had the limitation that 1 ppm was the lowest dose used. Therefore,154 a conclusion that sensory irritation was first obse rved at levels of 1 ppm and higher is erroneous, if lower doses were not te sted. In addition, Arts et al. (2006) states, “...there is not a large discre pancy between subjectively reported symptoms and objectively meas ured nasal sensory irritation.” In any event, the observation of sens ory irritation at these levels is not particularly relevant given that hyperplasia has been reported in exposed workers at about 0.26 mg/m 3 (0.2 ppm) in studies by Wilhelmsson and Holmstrom (1992), and Edling et al. (1988). This effect

is the basis of the OEHHA cREL.

With regard to the comments on chamber studies men tioned in the Bender review section above, it should be noted tha t chamber studies typically involve healthy individuals, and so, won’ t detect effects on sensitive members of the population. In addition, chamber studies are insensitive due to small sample size, population se lection (not necessarily sensitive people in the sample), inability to evalu ate prior and concurrent exposure which is important in a community setting, and inability to evaluate longer term exposures.

The purpose of the analyses by Paustenbach et al. (1997) and IRSST (2006) was to set occupational exposure limits. OE HHA seeks to protect the general public, including sensitive subpopulati ons, and occupational standards are not appropriate to use for the genera l public. In the introduction to the summary of health effects in th e ISOR (pages 133-134), OEHHA states that studies have reported the irritan t properties of HCHO at 0.25 to 1.39 ppm, not to concentrations below 0. 1 ppm. Further, the

FCI comments footnote 24 states “Paustenbach notes that 1 ppm for 15 minutes was meant to prevent moderate eye irritatio n in 75% of workers”. This would be totally inappropriate to apply to the general population for longer term exposures.

351) Comment [8.24-Rose-070416-FCI] : While odor is not a toxicological effect,

we mention odor because it is sometimes confused wi th sensory irritation, particularly in self-reporting studies or evaluatio ns. The odor threshold for HCHO is approximately 1 ppm.

In its toxicological profile for HCHO, the ATSDR ( 1999) states that the odor threshold for HCHO in humans has been reported to be 1 ppm, but others have noted that it may range as low as 0.05 ppm. ATSDR then describes the odor threshold as 0.5 to 1.0 ppm.

USEPA (1988) concluded that the odor threshold for HCHO is 0.83 ppm.

Agency Response [8.24-Rose-070416-FCI] : The odor threshold is

irrelevant to the determination of OEHHA’s cREL to protect public health.155 See also the response to comments #333, #346, and # 349 with regard to

the issue of odor threshold.

352) Comment [8.25-Rose-070416-FCI] : Total Daily Formaldehyde Exposure as the Basis for Risk Assessment (Page 132). Avera ge and Elevated Formaldehyde Concentrations (Page 132). While expo sure assessments appear in the ISOR, FCI does not address the validi ty of exposure assessments in these comments. We note, however, t hat in Table VII-1, the 46.7 ppb figure for the high end is doubtful. Additionally, the 17.2 ppb under conventional homes only accounts for newly bu ilt homes, which artificially inflates the exposure amounts. There is no discussion of concentrations in an average home. More important, however, is the use of significant number assumptions in the table that give the illusion that these concentrations represent precise measurements when they do not.

Agency Response [8.25-Rose-070416-FCI] : The values referred to in this comment are reported in Table VII-1 of the ISOR as 17.2 μg/m 3 and 46.7 μg/m 3 , respectively for average and elevated HCHO concen trations. The average value is based on concentrations measured i n both newly built and existing homes. The elevated value represents the average concentration measured in newly built homes reporte d in Sherman and Hodgson (2003). Maximum formaldehyde concentration s in new homes have been reported in the 200 ppb range (CARB, 2005 ). These concentrations are based on published results in ag ency reports and peerreviewed journals; thus, we believe that they are a ccurate representations of what average and elevated formaldehyde concentra tions in a home

would be.

353) Comment [8.26-Rose-070416-FCI] : Health Effects Values for Formaldehyde (Page 133). The reference to potentia l immune function effects is accompanied by few references and should be rewritten with a

broader review of the literature. This section has semi-quantitative language, "very low doses" that are simply not usef ul. The concentrations should be supplied. Are these case reports? The in formation in this

section is scant.

Agency Response [8.26-Rose-070416-FCI] : The Chapter in the ISOR on health effects is meant to be a summary and not a c omprehensive review of all the literature on formaldehyde (see pages 13 3 to 155). In addition, immunological effects are not the focus of our summ ary and were not the basis for determining OEHHA’s cREL.

354) Comment [8.27-Rose-070416-FCI] : Health Effects in Humans (Page 133). In this section, the references stop at 1994. As m ention in the first section of these comments, there are several good papers si nce that time that are available. This section should be updated. The pro blems with this section156 are common throughout. Without controlled studies, the cited outcomes have little probative value and lack the scientific rigor necessary for regulation.

Agency Response [8.27-Rose-070416-FCI] : The last sentence of this section on studies pertaining to the health effects in humans cites a number of studies that are more recent than 1994 (W antke et al., 1996; Smedje et al., 1997; Garrett et al., 1999; Smedje a nd Norback, 2001a; 2001b; Delfino et al., 2003). There are other exam ples throughout the document (Franklin et al., 2000; Kriebel et al., 20 01; Rumchev et al., 2002; Erdei et al., 2003; Arts et al., 2006). See also t he response to comment

#335.

355) Comment [8.28-Rose-070416-FCI] : Respiratory Effects and Irritation – Acute Exposure (Page 134). Regarding asthma and im mune system effects, the ISOR fails to address comments by OEHH A in its 2004 comments to CARB on the draft indoor air report. OE HHA commented that "our understanding of the data is that HCHO is not associated with non-occupational asthma. Although the literature i s inconsistent, most occupational health scientists would say that high occupational exposures are needed to see formaldehyde-specific asthma." In another section of comments, OEHHA goes on to say: "There is little ev idence that allergic sensitization occurs at typical indoor exposures. A ny statement on sensitization should be qualified by indicating tha t sensitization has been described following relatively high occupational ex posures." OEHHA also states that "we do not support the statement that c oncentrations above 27 ppb might result in initiation of an immune respons e in a sensitive

individual. The scientific evidence for initiation of immune response at levels below workplace exposures is not strong." T he ISOR should be revised to reflect the OEHHA position or provide a well-articulated basis for a differing conclusion.

The presentation on eye irritation and uncertainty development is not used by the rest of the world or by the NRC (2004). The ISOR basically says

that irritation occurs at ambient levels in the hom e based on calculations. This calculated "finding" is not supported by empir ical data.

Average exposures are not very useful unless avera ge and peak exposures are basically identical. In some of the referenced studies, the average concentrations are around 0.2 ppm while pea ks can go higher than 20 ppm. The existing knowledge regarding the m ode of action for these end points makes the discussion of averages u seless.

Agency Response [8.28-Rose-070416-FCI] : With respect to comments OEHHA made to CARB on the draft indoor air report, the comments submitted by the OEHHA on the indoor REL are in fac t not in conflict with157 what is presented in the ISOR. The comments on the draft indoor air report point out to CARB that at the time of the dr aft report the data on whether lower exposures to HCHO result in immune se nsitization were limited. Thus, a change was suggested to a sentenc e in the draft indoor air report that we felt was too definitive. There were a few reports in the

literature and now more studies since the indoor ai r report was drafted suggesting that lower environmental exposure to HCH O may exacerbate response to allergens, increase atopy in children, exacerbate asthma symptoms, or result in formaldehyde-specific IgE (W antke et al., 1996; Garrett et al., 1999; Smedje and Norback, 2001a; Ru mchev et al., 2002). Thus, there is no conflict between the comments by OEHHA on the CARB draft indoor air report and what is in Chapter VII of the ISOR on health effects. However, OEHHA recognizes there was a typ ographical error and the above quote should read, “below 27 ppb”.

Regarding eye irritation, the NRC uses an approach different from OEHHA’s since they are addressing emergency exposur es and military

situations. In the context of ambient HCHO levels in the home, in the ISOR, OEHHA makes no explicit claim regarding the o ccurrence of eye

irritation at these levels.

356) Comment [8.29-Rose-070416-FCI] : This section has semi-quantitative language, such as "very low doses" (page 135) that is not useful. The concentrations should be supplied. Are these case r eports? The

information in this section is scant.

Agency Response [8.29-Rose-070416-FCI] : Contrary to the assertion of the use of semi-quantitative language, the next sen tence after the mention of “very low doses” states “(e.g., 0.3 ppm)”. Conc entrations used in the individual studies are reported in the ISOR clearly

.

357) Comment [8.30-Rose-070416-FCI] : Green et al. (1987) is used to claim that there are lung function deficits at 3 ppm; how ever, there are other papers that show no change in normal or asthmatics at 2 ppm. There are better conducted studies then Green et al. (1987) a nd the ISOR needs to

review the literature with less bias.

Occupational Exposures (Pages 137-138). This sect ion on irritancy studies in workers has the same problems as the pre ceding home studies. On what basis does one isolate an irritant response for HCHO in pulp mill workers? There is an unstated assumption that HCHO is the only potential occupational irritant at these locations, which is obviously untrue.

The report references Srivastava et al. (1992), wh ich reported worker complaints of a variety of problems that the worker s attributed to occupational exposure to HCHO concentrations estima ted to be 0.03158 mg/m 3 in air as an 8-hour time-weighted average (TWA) an d described as 0.025 ppm in the ISOR. First, we note that the rep orted exposure levels

are near those associated with ambient air rather t hen occupational settings. The exposure levels raise a question as t o whether this study really assesses responses to occupational exposure to HCHO. Second, the type of self-reporting involved in this study m ay be helpful in preparing for objective research, but these subjective evalua tions are unreliable. CARB must consider biological consistency and proba bility in reviewing papers reporting on subjective self-evaluations. T he reported symptoms include respiratory, gastrointestinal, musculoskele tal, and cardiovascular problems, suggesting some other agent than HCHO, as suming that the

self-evaluations are accurate. The references to th is study should be

deleted from the ISOR.

The draft report referenced Gorski and Karkowiak ( 1991) and summarized that study as "showing no significant association b etween HCHO exposure, pulmonary function (FVC, FEV 1 and PEF) in normal or asthmatic workers, and occurrence of specific IgE a ntibodies to HCHO" (Draft ISOR at 136). Rather then comparing and con trasting to other

studies that show health effects at doses where non e should be expected, the ISOR deletes the reference to this study altoge ther in an apparent decline from scientific review to simple advocacy.

Immunological Effects in Humans (Page 138-139). T he discussion on the immune system is flawed and fails to address recent studies using

controlled chamber concentrations that contradict m ost of the historical

literature that is referenced. The ISOR does not co nsider whether these data are the result of HCHO exposure or some other chemical/substance/protocol issue. For example, th ere is no discussion of any potential confounders, such as mold, in the ent ire document. On page 139, the report states: "while the human studi es are not entirely consistent with each other, and there is a potentia l for confounding in each, nevertheless, taken together, they suggest that chi ldren are more sensitive to HCHO toxicity than adults." The ISOR d oes not mention the confounding factors, how or why the studies may dis agree, or how the staff developed an outcome "taken together."

The section on immune functions contains few refer ences and should be

rewritten with a broader review of the literature. Similarly, this section has semi-quantitative language, "very low doses" that i s simply not useful. The concentrations should be supplied. Are these case r eports? The

information in this section is scant.

Agency Response [8.30-Rose-070416-FCI]: With respect to lung function deficits, Green et al. (1987) is only one of the s tudies cited under respiratory effects (Hendrick and Lane, 1977; Walle nstein et al., 1978;159 Burge et al., 1985; Nordman et al., 1985; Kilburn e t al., 1989; Kriebel et al., 2001).

Pulp mill workers are but one group that has been studied. OEHHA does not make the assumption that HCHO is the only possi ble cause of irritation. However, HCHO is a known irritant common to and pro minent in the

diverse studies mentioned.

OEHHA does not necessarily disagree with the probl ems raised with the study by Srivastava et al. (1992). The only use of “significant” is with reference to the chest X-rays.

As mentioned previously, Chapter VII in the ISOR o n health effects is meant to be a summary and not a comprehensive revie w of all the literature on HCHO. In addition, immunological eff ects are not the focus of our summary and were not the basis for determining OEHHA’s cREL.

358) Comment [8.31-Rose-070416-FCI] : Reproductive and Developmental Effects in Humans (Page 139). The weight of the ev idence demonstrates that HCHO does not result in reproductive and devel opmental effects.

Both the ATSDR and WHO reviews concluded that HCHO is not associated with adverse reproductive and related ou tcomes. Although some animal and human studies have reported non-spe cific reproductive or developmental effects (Taskinen et al. 1999; Zel jenkova and Szabova 2004), the weight of available scientific data pres ents insufficient evidence to conclude that HCHO causes reproductive or develo pmental effects.

A comprehensive review of all the available data, including the metaanalysis data evaluating the relationship between s pontaneous abortions and occupational exposure to formaldehyde, was cond ucted by Collins et al. (2001). For studies that showed an increased r elative risk (RR), some important limitations in study design were highligh ted, such as the use of self-reported data or judgment on the level of expo sure with no attempt to validate the exposure estimates with measurements. Collins et al. (2001) examined the potential for reproductive and develop mental effects from HCHO exposure. The authors note that HCHO is unlike ly to reach the reproductive system in humans in concentrations suf ficient to cause damage since it is rapidly metabolized and detoxifi ed upon contact with the respiratory tract. While there are effects see n in in-vitro studies or after injection, there is little evidence of reprod uctive or developmental toxicity in animal studies under exposure levels an d routes relevant to humans. Most of the epidemiology studies examined s pontaneous
abortion and showed some evidence of increased risk (meta-RR = 1.4, 95% CI = 0.9 to 2.1).160

We found evidence of reporting biases and publicat ion biases among the epidemiology studies and when these biases were tak en into account, we found no evidence of increased risk of spontaneous abortion among workers exposed to HCHO (meta-RR = 0.7, 95% CI = 0. 5 to 1.0). The small number of studies on birth defects, low birth weight, and infertility among HCHO workers; the limitations in the design o f these studies; and the inconsistent findings across these studies make it difficult to draw conclusions from the epidemiology data alone. Howe ver, information from experimental studies and studies of metabolism indi cate reproductive impacts are unlikely at HCHO exposures levels obser ved in the epidemiology studies.

Agency Response [8.31-Rose-070416-FCI] : The ISOR makes it clear that there appear to be no reproductive or developmental effects. Therefore, we do not state anything contrary to this comment.

With respect to confounding, confounders, as repor ted in individual studies, are included in the study descriptions in the ISOR. OEHHA recognizes that there is more information available , however, this is only a summary and immunological endpoints are not the end point used as the basis for the cREL. This summary was taken from ex isting reviews on HCHO which underwent public comment and were review ed by the Scientific Review Panel on Toxic Air Contaminants ( SRP). In OEHHA (2001), “Prioritization of Toxic Air Contaminants - - Children’s Health Protection Act – Final Report,” confounders are add ressed in more detail.

359) Comment [8.32-Rose-070416-FCI] : Infants and Children (Pages 139-142). These studies of infants and children can have many confounding variables, such as environmental tobacco smoke (ETS ), mold, etc. The ISOR does not mention any of these potential issues when reviewing the data. In discussing Garrett et al. (1999), the ISO R states that "no

evidence of an association between asthma in the ch ildren and HCHO levels." Without any substantive explanation, the I SOR jumps to the conclusion that "these data do suggest that HCHO le vels commonly found

in homes can enhance sensitization of children to c ommon aeroallergens." There is no explanation for this assumption. The s taff apparently suggests that HCHO exposure is required prior to an allergic event, an untested and unsupported theory that cannot serve a s a basis for regulation. Garrett et al. (1999) is a study of as thmatic and non-asthmatic children in two small towns in Victoria, Australia. This paper does not address differences in adult and children’s respons es, since relevant data

for adults were not collected.

It does characterize the Wantke et al. (1996) stud y relevance as “unclear”

because the sensitization was not associated with s ymptoms. Several factors compel caution in relying on this study: Th e paper likely was based161 on a graduate student thesis (the acknowledgements note a postgraduate publication award), and the paper presents extensiv e multivariate analysis. Of all the analyses performed, the study notes: 1) a crude odds ratio for atopy of about 1.4 with an increase in bedroom leve ls of HCHO of 10 μg/m 3 (adjusted for parental asthma and sex); however, t he confidence interval for this finding is 0.99 to 2.00; and 2) a n adjusted odds ratio of 1.42 for atopy with an increase in the highest reco rded HCHO level by 20 μg/m 3 (confidence interval 0.99 to 2.04). (As the majorit y of scientists and researchers recognize, odds ratios of 1.4 are gener ally not considered to be strong evidence of a causal connection.) The st udy took place in two small towns “surrounded by open-cut brown coal mine s and power stations, which provide considerable employment.” The authors had difficulty locating non-asthmatic children to parti cipate in the study. Outdoor measurements were taken but not reported.

The authors note there was no significant associat ion between HCHO levels and house age. This is surprising, since an y off gassing of HCHO from wood products or other formaldehyde-containing materials would be expected to decline over time. Thus, the accuracy o f HCHO measurements could be open to question.

In discussing the implications of their findings, Garrett et al. note the increased prevalence of allergic diseases in many w estern countries, and suggest that materials emitting HCHO have become in creasingly popular at the same time. The authors apparently do not ap preciate that HCHO resin technologies have been improved substantially over the last two decades, and that releases of HCHO have been greatl y reduced. It is difficult to rule out systematic recall or selectio n bias in this case-control study. With respect to exposure issues, no persona l monitors were used,

and there were no associations or trends for levels reported for the bedrooms, which are the one place in the house wher e some form of continuous exposure is likely to occur. The distri bution of results claimed by the investigators hardly seems to be persuasive evidence of a systematic health risk. There was no significant in crease in the adjusted risk for either asthma or respiratory symptoms with increasing HCHO exposure. Wantke et al

. (1996) studied 62 students in Austria and reported finding IgE specific to HCHO. However, am ong 24 of the 62 children who had elevated IgE specific to HCHO, onl y 3 had RAST scores over 2.0. There was no dose-response relationship between HCHO levels

and RAST scores. The three classrooms studied had 4 3, 69 and 75 ppb of formaldehyde measured, respectively. RAST scores we re not elevated at 69 ppb compared to the 43 ppb classroom, as shown b elow. Thus, there does not appear to be dose-response relationship be tween HCHO and IgE. Moreover, the IgE levels in the study did not correlate with either number or severity of reported symptoms. The author s acknowledge that “IgE-mediated sensitization to HCHO is rare and a m atter of controversy.”162 They further state: “Our data as well as the litera ture [ref. omitted] do not conclusively explain the clinical relevance of spec ific IgE against HCHO.” The Wantke et al. study did not compare children an d adults, and thus also does not speak to any differential sensitivity

.

Franklin et al. (2000) measured exhaled nitric oxide as an indicator of subclinical inflammatory response in 224 Australian children. The authors report increased nitric oxide in the breath of chil dren in homes with over 50 ppb vs. under 50 ppb HCHO. The range and mean e xposure values are not provided. There were no measurements of th e outdoors or school exposures to these children. The nitric oxide resu lts were independent of atopy, and thus their significance is unclear. The study showed HCHO

concentrations in the home had no effect on FVC or FEV 1 measures of pulmonary function in the children. The study does not compare children and adults, since relevant data for adults were not collected.

The same section references Krzyzanowski et al. (1 990) for the absence of a "threshold for HCHO effects on ventilatory fun ction in children" and adverse health effects "as low as at 30 ppb in nona sthmatic children" (pages 140-141). In Krzyzanowski et al. (1990), re searchers questioned a group of 298 children (ages 6 to 15) and 613 adults using a selfadministered respiratory questionnaire. Using regr ession analysis, the investigators found no significant association betw een exposures in children and self-reported chronic respiratory symp toms. Prevalence rates of chronic bronchitis or asthma reportedly di agnosed by a physician were significantly higher when residential concentr ations of HCHO exceeded 60 ppb, especially in the presence of toba cco smoke. However, the study itself fails to point out an obvious diff iculty from the data displayed in Tables 3 and 4 of the study. There wa s no dose-response relationship with HCHO: More than 83 percent of th e subjects in the study lived in homes in which the two-week average HCHO c oncentrations were less than 4 ppb. The average concentration measure d was 26 ppb, with only a few homes exceeding 9 ppb. Thus, average co ncentrations appear to be driven by a few outliers. Findings of this s tudy are questionable in

view of these levels of HCHO found in the home envi ronment. In addition, there were no measurements of allergens, or other a gents present in the home. The authors did report greater changes in pe ak expiratory flow rate in children than in adults. The use of peak expirat ory flow rates does not confirm the presence or absence of asthma or bronch itis. This finding is the only data in any of the studies cited in the Pu blic Review Draft document to suggest differential effects in childre n vs. adults -- hardly a convincing basis for concluding that children are m ore sensitive to HCHO. In sum, it appears that this study is at odds with the weight of the literature, and should not be relied upon absent some further v erification.163

In Rumchev, et al. (2002), household HCHO levels w ere determined by passive sampling in the homes of 88 children aged 6 months to 3 years who were diagnosed at a hospital with asthma, and c ompared with 104 community controls. Cases had a statistically sign ificant higher mean HCHO exposure compared to controls, 32 ppb (38 μg/m 3 ) and 20 ppb (24 μg/m 3 ), respectively. After adjustment for confounding factors, such as indoor air pollutants, relative humidity, indoor te mperature, atopy, family history of asthma, age, sex socioeconomic status, p ets and ETS, Rumchev et al. (2002) reported that children expose d to HCHO levels of 60 μg/m 3 had a 39% increase in odds of having asthma compar ed to children exposed to less than 10 μg/m 3 (OR estimated to be approximately 1.4, 95% CI = 1.1 to 1.7 from data presented in a g raph). However, considering the marginally increased risk observed, together with the number of potential sources of bias, such as select ion bias and validity of diagnosis in the young, this study should not be co nsidered sufficiently robust evidence of an association between HCHO expo sure and increased risk of asthma in children or an appropri ate basis for regulation or governmental guidance.

In addition, as noted previously, HCHO is exhaled in the breath, with studies suggesting that breath levels may range fro m 1.2 to 72.7 ppb to 300 to 1,200 ppb (Moser et al. 2005; Ebeler et al. 1997). Based on the existing literature, the exposure levels reported i n Rumchev et al. (2002) are in the range of HCHO expected to be found in ex haled breath. This raises questions of causation, association, and how one might reasonably differentiate self-exposure from an exogenous sourc e of exposure at approximately the same concentration.

Those limitations and weaknesses are validated by a second report by Rumchev, et al. (2004), which was not referenced in the ISOR and which raises questions regarding whether Rumchev (2002) i s an adequate basis for the derivation of a reference concentration spe cifically for HCHO. Rumchev et al. (2004) used the same cohort of child ren and evaluated the same asthma endpoint as Rumchev et al. (2002), but focused on the association with the other chemicals and particulat es rather than HCHO. As for HCHO, Rumchev, et al. (2004), found that ast hmatic cases were exposed to higher levels of VOCs.

An editorial was published concurrently (Brunekree f, B. 2004) with Rumchev et al. (2004), which focused on NO 2 , VOCs, and particulates. The editorial indicates that: (1) diagnosis of asth ma in children is "notoriously difficult," and (2) case-control studi es, as used by Rumchev, inherently are rife with potential and actual sourc es of confounding and bias. An example given is that Rumchev et al. (200 4) did not attempt to evaluate the impact of recent indoor painting. The se issues raise serious questions regarding the adequacy of the study as a sole source for164 deriving a reference exposure. As Brunekreef (2004 ) noted in his comments on Rumchev et al. (2004) and other studies : The issue of

whether indoor VOCs are a risk factor for asthma in children therefore seems still to be largely undecided. In view of th e methodological difficulties outlined above, prospective studies ar e more likely to produce progress in deciding whether we need to worry about indoor VOCs as determinants of asthma at the relatively low concen trations typically

encountered in the home environment. In view of th e issues raised by Rumchev (2004) showing that a number of VOCs were a ssociated with

asthma as well as the inherent and broader limitati ons associated with Rumchev, et al. (2002), Rumchev, et al. (2002) does not provide a reasonable basis for adopting a new level. A caref ul reading of the studies cited as the basis for concluding that chil dren are differentially sensitive to HCHO shows essentially no support for that proposition. 26

The ISOR never provides a substantive discussion t hat shows how the staff collectively interprets or resolves apparentl y conflicting data through an analysis of the strengths and weaknesses of the studies, such as the Garrett et al. (1999) and Krzyzanowski et al. (1990 ). These inconsistencies in the data should be explained. C onfounders in the Garrett et al. (1999) and Rumchev et al. (2002) stu dies are listed in the ISOR in the descriptions of the individual studies. With regards to Garrett

et al

. (1999), the ISOR accurately report the findings of this study by stating: “The risk of atopy increased by 40% with e ach 10 μg/m 3 increase

in HCHO measured in the bedroom. Two measures of a llergic sensitization to 12 common environmental allergens, the number of positive skin prick tests and maximum wheal size, b oth showed linear associations with increasing maximum HCHO exposure levels.” Garrett et al. (1999) is not used as the basis for regulation and a significant effect of objective measure (positive skin prick test and max imum wheal size) was observed in this study. The ISOR does not try to c ompare children and adults based on Garret et al. (1999).

Agency Response [8.32-Rose-070416-FCI] : The ISOR did not state that it was relying on the results of the Wantke et al. (19 96) study. The Wantke et al. (1996) study mentioned, “There was a good co rrelation between symptoms and the HCHO concentrations in the classro oms.” The conclusion of the Wantke et al. (1996) study stated , “Gaseous HCHO, besides its irritant action, leads to IgE-mediated sensitization. As children are more sensitive to toxic substances than adults, threshold levels for indoor HCHO should be reduced for children.” By it self, the odds ratio referenced above is taken as suggestive of an assoc iation. The ISOR does not assert statistical significance associated with this result. However, this study does suggest a strong associati on. These studies are used as supportive studies not the basis for causal evidence. The p-trend measured in this study was substantive. The study did report that outdoor165 measurements were lower than indoor. With respect to the off-gassing of

HCHO over time and whether the HCHO measurements ar e questionable as a result, no supporting evidence is provided for this speculation. Regarding the assertion that HCHO resin technologie s have improved over time, OEHHA does not see the relevancy of this statement to the

ISOR. The concern about selection and recall bias is not particularly germane as the study was investigating the associat ion between measured levels of HCHO and objective measures of a llergic response (atopy, positive skin prick tests and maximum wheal size).

Regarding the assertion that there was no signific ant increase in adjusted risk for asthma or respiratory symptoms, there is a p-trend for this that, although not statistically significant, indicated a biologically important association. As for the lack of a dose-response, t he ISOR’s review of the Wantke et al. (1996) study states nothing to the co ntrary.

Exhaled nitric oxide (NO) is not equal to measurem ents of atopy. Franklin et al. (2000) states that exhaled NO was used as an indicator of inflammation of the lower airways.” The ISOR does not assert that a comparison between adults and children was performe d in this study.

In the study by Krzyzanowski et al. (1990), it is mentioned: “The authors

note no threshold was found for HCHO effects on ve ntilatory function in the children, and that a 10% decrease in PEF was as sociated with exposures as low as 30 ppb in non-asthmatic childre n with an even larger effect in asthmatic children at 30 ppb.” Regarding the absence of a doseresponse in this study, we state in the ISOR that n o statistically significant association was found in this study. We also noted that the sample size in the 40 to 60 group was small compared to the contro ls. There was a response in the no ETS group for the greater than 6 0 ppb group (10%). We accurately summarized the findings of this study including mentioning that the association was not statistically signific ant. However, there was a significant p-trend reported.

The ISOR lists the confounders mentioned in the Ru mchev study (“Estimates of the relative risk for asthma (odds r atios) were adjusted for measured indoor air pollutants, relative humidity, temperature, atopy (hereditary allergy), family history of asthma, age , gender, socioeconomic status, pets, smoke exposure, air conditioning, and gas appliances”)(Rumchev et al., 2002) and we recognize the potential for bias.

It should be noted that OEHHA does not base its chr onic non-cancer REL on this study.

The comment makes extensive remarks about both the paper by Rumchev et al. (2002), which is cited in the staff report, and Rumchev et al. (2004), which was not cited in the ISOR. Neith er paper appears in the166 list of references provided with the comments, so w e are assuming the second citation refers to: Rumchev K, Spickett J, B ulsara M, Phillips M, Stick S, 2004, Association of domestic exposure to volatile organic compounds with asthma in young children, Thorax 59( 9):746-51. We are aware of this paper because of our general interest in childhood asthma,

but did not cite it in the ISOR because it concerns only volatile organic compounds (VOCs) other than HCHO. The comment misq uotes the paper in implying that the finding of links between asthma and VOCs undermine the earlier finding of an association wit h HCHO. The authors note in the discussion that they specifically exami ned this question by comparing their VOC data with the previously publis hed HCHO data. They concluded that the two effects were independen t.

Regarding the issue of exogenous vs. self exposure , an individual’s total exposure includes both. It is possible the variabi lity in individual responses to given ambient levels of HCHO in part r eflects individual variation in the amount of HCHO produced endogenous ly. Regardless of the proportion of endogenous and exogenous sources, the risk of adverse effects increases with increasing ambient HCHO to w hich exogenous

sources contribute.

With respect to risk factors, a risk factor for as thma versus increased risk

in asthmatics should be differentiated. The ISOR s tates that asthmatic children may be at higher risk of adverse effects w hen exposed to HCHO. Regarding the absence of a substantive discussion o f the way in which data were interpreted in the ISOR, it is not the pu rpose of this Chapter to

review the data in detail or undertake a risk asses sment, but rather to provide to the Board and the public an outline of b ackground information. See also the response to comment #335.

360) Comment [8.33-Rose-070416-FCI] : Human Carcinogenicity (Page 147): With regard to carcinogenicity, the weight of evide nce points to a threshold mode of action, with cytotoxicity/cell replication as the driving force. Formaldehyde is a low potency carcinogen in light o f the: (1) relationship of the concentrations leading to tumor formation an d pre-tumorigenic changes, and (2) steep sub-linear dose-response cur ve for various effects associated with the carcinogenic response.

Agency Response [8.33-Rose-070416-FCI] : As more extensively noted in previous responses (see comments #341 to #344, inte r alia), OEHHA has previously evaluated these assertions based on CIIT ’s model and concluded that this is not an appropriate basis on which to assess the risk to public health from formaldehyde.

361) Comment [8.34-Rose-070416-FCI] : Sufficient evidence of a causal relationship or an association with asthma only exi sts for cats,167 cockroaches, house dust mites, ETS (preschoolers), dogs, fungi or molds (Rhinovirus) and high-level exposures to nitrogen o xides, not HCHO or other VOCs. See the National Research Council (2004 ) Emergency and Continuous Exposure Guidance Levels for Selected Su bmarine Contaminants, p. 87.

Agency Response [8.34-Rose-070416-FCI]: OEHHA does not accept the assertion about sufficiency (or otherwise) of evide nce made in this comment. OEHHA has already pointed out (see the re sponse to comment #348) that the NRC’s consideration of safety in sub marines is of very little value in considering health impacts on the general population, particularly

children.

362) Comment [8.35-Rose-070416-FCI] : Genotoxicity (Page 147). The cited studies by Shaham have been further discredited wit h new published data beyond prior work by Heck. Neither Schmid and Spei t nor Heck's work is addressed in this regard, nor is there any discussi on relating the human and animal genotoxicity sections of the report. Sch mid and Speit (2007) concludes that the data gathered from human bio-mon itoring of blood from workers exposed to HCHO and relating this informati on to systemic genotoxic effects of HCHO is not plausible. Schmid and Speit (2007) demonstrate that the DNA-protein crosslinks, associ ated with HCHO exposure which is integral to further DNA damage, i s quickly reversed in the blood cells. It is only at higher HCHO concent rations ( ≥ 200 μM) that enough DNA-protein crosslinks were formed resulting in DNA damage and cytotoxicity. Since such high levels of HCHO are n ot seen in human blood of exposed workers and any DNA-protein crosslinks c reated as a result of lower HCHO exposure are quickly reversed, the repor ted effects seen in the sister chromatid exchange tests, in Shaham et a l. (1997, 2002), Yager et al. (1986), He et al. (1998) and Ye et al. (2005 ), are highly unlikely to be related to HCHO exposure.

Agency Response [8.35-Rose-070416-FCI] : OEHHA is aware of the various citations given in this comment, but does n ot consider that these add any major insight into the issues addressed by the ISOR. The various, possibly conflicting, data on HCHO genotoxicity are clearly complex and subject to various scientific interpretations. It was not the aim of the brief descriptive paragraph in the ISOR to address these problems in detail since that has already been undertaken in previous discussions presented

to the Scientific Review Panel on Toxic Air Contami nants (SRP). The observation of formaldehyde-related DNA damage at a ny site or dose level in humans is clearly of interest since this e ndpoint (in rodent nasal epithelium) is also the basis of the CIIT model. S tudies of such effects by blood bio-monitoring can clearly only provide an in dicator of possible impacts. A primary concern is the extent of formal dehyde-caused DNA damage in the epithelial cells of the respiratory t ract that are exposed to168 HCHO before it enters the bloodstream. The relativ ely stronger association of HCHO with nasopharyngeal cancer comp ared with cancers at other sites reflects the higher HCHO concentrati ons, and hence damage, in the tissues at the site of contact. The observations of DNAprotein cross-links, mutations and chromosomal effe cts in cells exposed to

HCHO in vitro and in vivo which were noted in the o riginal summary are

consistent with this concern.

363) Comment [8.36-Rose-070416-FCI] : Nasopharyngeal Cancer (Pages 147- 149) A comparison of the ISOR discussion of NPC wi th the summary presented in the general comments section above ref lects a pattern of ignoring newer work, such as that of Marsh et al. ( 2002, 2004, 2005). The "recent occupational studies" mentioned in this sec tion are 17 years old and are stretched to find "some indication of possi ble histological change due to HCHO exposure." Marsh et al. (2006) conclud es that the NCI analysis was misleading because an important intera ction term between the plant group and exposure variable was not taken into account and, due to the low numbers of tumors, there were consid erable uncertainties in the risk estimates. Adami and Chang (2006) revi ewed the literature on the occurrence of NPC and concluded that, for this specific tumor type, there are several risk factors that may lead to an appreciable increase (e.g., specific diets or familial history). For HC HO, the authors stated that “epidemiologic evidence” is limited.

Cohort studies. In an update of a mortality study of approximately 14,000 British industrial workers from 1941 (Acheson et al ., 1984) up to 2000 (Coggon et al., 2003), only one case of NPC was ide ntified in the cohort vs. two expected, although estimated HCHO exposures were highest compared to the other two studies listed below. Co ggon et al. (2003) concluded that: ”The evidence for human carcinogeni city of HCHO remains unconvincing.” In an update of a mortality study involving a cohort of approximately 11,000 garment workers in t he U.S. from 1955 to 1982 (Stayner et al., 1985; 1988) and then to 1998 (Pinkerton et al., 2004), no cases of NPC were identified (0.96 expected). Pi nkerton et al. (2004)

states: ”We found no evidence of an association bet ween HCHO exposure and mortality from respiratory cancers.” An update of the largest mortality study of over 25,000 workers in HCHO industries in 10 different plants in the U.S. initially followed up through 1980 (Blair et al., 1986) and now up to 1994 (Hauptmann et al. 2004) is frequently refer enced as the "NCI study." In this study, eight cases of NPC compared to four expected, were observed in the exposed workforce. Six of these we re located in one single plant (Plant 1) out of the ten plants examin ed. Later, one of these eight cases turned out to be an oropharyngeal cance r; in addition, there have been two additional NPC cases among the worker s employed in these plants but not exposed to HCHO. Even if the misclassified case remains included, NPC rates are not significantly i ncreased compared with169 those of the general U.S. population (Standardized Mortality Ratio (SMR) = 2.1; exact 95% CI = 0.91 to 4.14). If this miscl assified case would be excluded, the association would be even weaker. Ta king all cohort studies with a total of approximately 50,000 expose d workers together, nine cases (only eight being true NPC) have been ob served vs. seven expected; not a relevant difference. These three s tudies are the most relevant, but there is no reason to give particular preference to the NCI study. As early as 1996, Marsh et al. (1996) ident ified a specific feature of the former NCI-study comprising workers of 10 diffe rent plants. There

was no even distribution of the observed NPC cases between the different plants; they were concentrated in one plant. Speci fically, four of the total of five exposed cases observed arose in one of the 10 plants. A detailed analysis of the “suspected clustering in this one p lant” showed that “only one case had any appreciable exposure to HCHO.” In a second follow-up (up to 1998) by Marsh et al. (2002), the clustering of NPC was confirmed as three additional cases were found, leading now t o seven exposed cases in a single plant. In addition, inconsistenc ies in the exposure effect relationship were identified pointing against a cau sal connection with HCHO: The majority of the seven NPC cases in the si ngle plant was found in short-term workers with an exposure duration of less than one year. Only three of seven were exposed to HCHO longer tha n one year and each had low average intensities of exposure (rangi ng from 0.02 to 0.60 ppm). Six of the seven NPC cases were hired betwee n 1947 and 1956, again an indication of a cluster. Standardized Mor tality Ratios for nasopharyngeal cancer were greater among short-term (< 1 year) than among long-term workers. Marsh and Youk (2005) ree valuated the NPC cases of the new NCI study (Hauptmann et al., 2004) . Six of the eight exposed cases came from a single plant, leading to a regional-rate based SMR of 10.32 (95% CI = 3.79 to 22.47). The other t wo exposed and the two non-exposed cases each came from different plan ts of the remaining nine plants of the NCI study. For these other nine plants, the SMR was calculated to be 0.65 (0.08 to 2.33). In addition, the exposure association reported by Hauptmann et al. (2004) with peak and a verage intensity was driven entirely by the data from this single plant. Marsh and Youk (2005)

concluded that there was little evidence for a caus al association between NPC and HCHO; the NCI conclusion of a possible asso ciation was mainly driven by the Wallingford plant; and the large NPC mortality at the Wallingford plant may reflect non-occupational or o ccupational risk factors associated with employment outside of this specific plant. Overall, the detailed analysis of the NCI findings, especially i n relation to the single plant, casts doubt on a causal association indicate d by the NCI study between HCHO and NPC development.

Case-control studies. The case-control studies on NPC and HCHO are hampered by weak exposure assessments, in particula r for the probably more relevant periods several decades ago. The pot ential impact of170 selection and information bias seems to be even hig her than for the cohort studies. Thus, their results in general are not ve ry reliable and far from conclusive: The relative risk in the Olsen et al. ( 1984) study was nonsignificantly decreased in men, and non-significant ly increased in the much smaller group of women (negative study). Vaug han et al. (1986) found a slightly but not significantly increased ri sk for occupational HCHO exposure. Besides very weak exposure information t here are several limitations of this study (e.g., lack of adjustment even for age, the strongest predictor of cancer). Thus, this study c annot be considered as one supporting an association (non-informative stud y). Roush et al. (1987) did not find an elevated risk for workers pr obably exposed for most of their working lives, but a non-significantly ele vated risk for the highest exposure category. However, potential selection an d information biases as well as very weak exposure information based on resident directories are major shortcomings of this study (non-informati ve study). West (1993) reported partly significant increases only for sele cted exposure categories in a study performed in the Philippines. He found even stronger associations for other exposures such as dust and/o r exhaust, antimosquito coils or herbal medicines. The IARC Worki ng Group (1995) noted with regard to this study that the authors di d not control for the presence of Epstein-Barr virus antibodies, which sh owed a strong association with NPC in another study in the same r egion (non-informative study). The study of Armstrong et al. (2000) is de finitely negative. Hildesheim et al. (2001) report a modest and not si gnificantly increased risk (RR = 1.4; 95% CI = 0.93 to 2.2). However, no dose response was observed with increasing duration or cumulative use (slightly positive). Vaughan et al. (2000) detected a slightly, but not significantly elevated odds ratio of 1.3 (95% CI = 0.8 to 2.1). They obse rved a significant trend with cumulative exposure, but in contrast to the NC I study not for the maximum exposure concentration. In contrast to othe r authors, an increased risk for wood dust exposure could not be observed in this study (slightly positive study). Thus, if a positive stu dy is considered as one in which a clear and significant association is demons trated, none of the case-control studies can be regarded as positive. In summary, the results of these case-control studies should be regarded as equivocal, two of them being clearly negative, three not contributing much information and two showing some slightly elevated risk.

Meta-analyses. The most recent meta-analysis by Collins et al. ( 1997) is quoted inappropriately as if it would demonstrate a significantly elevated risk. Collins et al. point out the relevance of co rrecting for underreporting of expected numbers of death when dealing with a ra re and frequently underreported cancer such as NPC. After correcting , they calculated a meta-RR of 1.0 (95% CI = 0.5 to 1.8) for the cohort studies and 1.3 (95% CI = 0.9 to 2.1) for the case-control studies. The authors emphasize that it is unlikely that the few cases in the case-control studies had meaningful171 HCHO exposures because only a minority of the jobs classified as having it actually entailed such exposure. In their paper , Collins et al. emphasize the weaknesses of the previous meta-analyses leadin g to conflicting results (see page 648). It is instructive to contr ast the short and inaccurate treatment of Collins et al. (1997) in th e ISOR with that presented in the November 2006 Priority Existing Ch emical Assessment on HCHO prepared by the Australian Department of Ag ing, National

Industrial Chemicals Notification Assessment Scheme (NICNAS), which was previously referenced with regard to NICNAS’ us e of the BBDR model. In a more recent and comprehensive meta-analysis, C ollins et al. (1997) initially considered 47 epidemiology studies. Seve ral of these studies were not included in the analysis, because workers who had HCHO exposure were not evaluated separately or the study only reported relative risks, the study population was included in a more recent study, or the methodology and results were insufficiently describ ed. In total the metaanalysis was based on the results from 11 cohort, t hree proportionate mortality and 18 case-control studies, and included new data published since Partanen (1993). Furthermore, the authors of studies were contacted to obtain data not included in their publ ications. The exposure potential of jobs that were classified as having HC HO exposure in the community-based case-control studies was also revie wed, as exposure

assessment was much more uncertain in these studies than in cohort studies. When all studies were included, no increa sed risk of lung cancer was seen with exposure to HCHO (meta-RR = 1.0, 95% CI = 0.9 to 1.0). In cohort studies, a very small borderline, though significant, increased risk was seen for industrial workers (meta-RR = 1.1 , 95% CI = 1.0 to 1.2), while no increased risk was seen for pathologists ( meta-RR = 0.5, 95% CI = 0.4 to 0.6) or embalmers (meta-RR = 1.0, 95% CI = 0.9 to 1.1). Similarly,

no increased risk was seen in the case-control stud ies (meta-RR = 0.8, 95% CI = 0.7 to 0.9). No increased risk of sinonas al cancers was seen with exposure to HCHO (meta-RR = 1.0, 95% CI = 1.0 to 1.1). Evaluating by study design revealed no increased risk for coho rt studies (meta-RR = 0.3, 95% CI = 0.1 to 0.9) but a significantly incre ased risk for case-control studies (meta-RR = 1.8, 95% CI = 1.4 to 2.3). This increased risk was attributable to a significantly increased risk for the combined six European case-control studies (meta-RR = 2.9, 95% CI = 2.2 t o 4.0), whereas no

increased risk was seen for the combined five U.S. case-control studies (meta-RR = 1.0, 95% CI = 0.7 to 1.5). Collins et a l. (1997) report that it is difficult to reconcile European findings with other findings, unless it is assumed that confounding factors, or bias, were aff ecting the results. A significantly increased risk of NPC was seen with e xposure to HCHO (meta-RR = 1.3, 95% CI = 1.2 to 1.5). However, eva luation of NPC was hampered in some industrial cohort studies, as expe cted numbers were not reported when there were no observed deaths. T o overcome this, the expected number of deaths was estimated based on th e ratio of expected lung cancers to NPC in the study by Blair et al. (1 986) that reported172 nasopharyngeal deaths. Expected numbers were also not reported in the cohort studies of embalmers and medical specialists . Using a similar approach, based on the ratio of expected lung cance rs to NPC in the study by Hayes et al. (1990), a non-significant inc reased risk was found for NPC and exposure to HCHO when all industrial co hort studies were combined (meta-RR = 1.2, 95% CI = 0.4 to 2.5). Whi le no increased risk of NPC was seen for all cohort studies combined (me ta-RR = 1.0, 95% CI = 0.4 to 2.5), a non-significant increased risk of such cancers was seen for all case-control studies combined (meta-RR = 1.3, 9 5% CI = 0.9 to 2.1). 27
Collins et al. (1997) concluded that the data did n ot provide convincing evidence of a casual relationship between HCHO expo sure and NPC.

The authors attributed the differences in their res ults to the two earlier meta-analyses to be mainly due to the inclusion of a number of recently published negative cohort studies. FCI includes th is excerpt not because we agree with all of the evaluations in the NICNAS PEC on HCHO. Rather, we reference this passage as an example of the type of summary that allows everyone with an interest to understand how one agency read the study and what elements the agency viewed as no table. This type of summary also serves to distinguish clearly the auth or’s conclusions from those of the reviewing agency.

Summary on epidemiology study evaluation. Recapitulating, the available epidemiological studies on HCHO consistently show n o or a minimally increased risk for NPC with one clear exception of the remarkably elevated risk in plant 1 of the NCI study. A serio us critique to the Hauptmann (2004) study is the fact that the author disregards the peculiar results at this specific plant. Instead of focusin g only on HCHO, it would have been important to try to identify other risk f actors, which may have played a relevant role in particular in those three cases exposed to low levels of HCHO for much less than one year.

Local genotoxicity in humans. With regard to possible NPC formation in humans, local genotoxicity observed in workers has to be assessed. There are several investigations on micronuclei for mation in nasal and buccal cells in exposed humans with both positive a nd negative results. These data have to be interpreted with caution sinc e the methods used are still quite investigative and have several meth odological problems as noted by Fenech et al. (1999): high variability of the results when the same subjects are tested repeatedly; large differen ces between healthy subjects; protocols are not yet standardized; probl ems to differentiate between epithelial cells and leucocytes; and possib ility for misinterpretation of degenerative epithelial cells. Therefore such study results cannot be interpreted with confidence prese ntly.

The recent IARC evaluation for NPC basically relie s on the outcome of the study of Hauptmann et al. (2004), which has only be en carried through up173 to 1994 whereas Pinkerton et al. (2004) and Coggon et al. (2003) performed updates up to 1998 and 2000, respectively . Therefore the NCI has decided to carry out a mortality analysis in th is cohort up to the most recent years. The results of this latest update ar e to be expected in 2007. The update will comprise approximately an additiona l 10 years of mortality experience and lead to a much clearer picture becau se the significance of mortality data will sharply increase in mortality s tudies with the aging of

the workforce.

In conclusion, the three large industrial worker c ohort studies are most relevant for a decision as regards classification f or carcinogenicity in humans. There was no significant increase for NPC in association with HCHO exposure in general. The association seen wit h two of four exposure metrics in the NCI study only is driven by just one of 10 plants (SMR 10.3). For this specific plant there may well be other factors relevant for NPC development apart from HCHO exposu re. Even the authors of the NCI study argue cautiously: “In this cohort of HCHO workers, some evidence was found of an exposure-res ponse relation with mortality from NPC (based on small numbers)...” In S iemiatycki et al. (2004), three of the co-authors being affiliated wi th IARC, the strength of evidence regarding nasopharynx and HCHO has also on ly been considered as suggestive only but not as strong.

Leukemia (Pages 149-150). The report characterizes Collins and Lineker (2004) as being supportive of an increase risk of l eukemia. As discussed above, this is an incorrect reading of the paper. Golden et al. (2005) report that chemically-induced leukemia is a well-s tudied phenomenon with benzene and a number of cancer chemotherapeuti c drugs recognized as capable of causing this effect. Abundant in vitr o and in vivo data in animals and humans demonstrate that exposure to suf ficient doses of these recognized leukemogens can initiate a cascade of events leading to hematopoietic toxicity and the subsequent developme nt of leukemia. Golden et al. (2005) addresses the biological plaus ibility that HCHO might be capable of causing any type of leukemia by provi ding a broad overview

of the scientific data that must be considered in o rder to support or refute a conclusion that a particular substance might be l eukemogenic. Data on benzene and selected chemotherapeutic cancer drugs are used as examples and are briefly summarized to demonstrate the similar biological events thought to result in leukemogenesis. These data are compared

and contrasted with the available data on HCHO in o rder to judge whether they fulfill the criteria of biological plausibilit y that HCHO would be capable of inducing leukemia as suggested by the epidemiolo gical data. Based on the epidemiological data, it is reasonable to expec t that if HCHO was capable of inducing leukemia in vivo and in vitro data would offer supporting evidence for biological plausibility. I n particular, the authors conclude that there is: (1) no evidence to suggest that HCHO reaches any174 target organ beyond the site of administration incl uding the bone marrow, (2) no indication that HCHO is toxic to the bone ma rrow/hematopoietic system in in vivo or in vitro studies, and (3) no credible evidence that HCHO induces leukemia in experimental animals. As discussed in the review, based on the key biological events that occ ur in the process of chemically-induced leukemia, there is inadequate bi ological evidence currently available to corroborate existing weak ep idemiological associations. This provides an insufficient databa se to conclude that there is a causal relationship for HCHO and leukemia risk . Golden et al. (2005) is consistent with Heck and Casanova (2004), in whi ch the authors report the following: The possibility that inhaled HCHO m ight induce various forms of distant-site toxicity has been proposed, b ut no convincing evidence for such toxicity has been obtained in exp erimental studies. This review summarizes the biological evidence that pert ains to the issue of leukemia induction by HCHO, which includes: (1) th e failure of inhaled

HCHO to increase the HCHO concentration in the bloo d of rats, monkeys, or humans exposed to concentrations of 14.4, 6, or 1.9 ppm, respectively; (2) the lack of detectable protein adducts or DNA-p rotein cross-links (DPX) in the bone marrow of normal rats exposed to [ 3 H]- and [ 14 C]formaldehyde at concentrations as high as 15 ppm; (3) the lack of detectable protein adducts or DPX in the bone marro w of glutathionedepleted (metabolically inhibited) rats exposed to [ 3 H]- and [ 14 C]-HCHO at concentrations as high as 10 ppm; (4) the lack of detectable DPX in the bone marrow of Rhesus monkeys exposed to [ 14 C]formaldehyde at concentrations as high as 6 ppm; (5) the failure o f HCHO to induce leukemia in any of seven long-term inhalation bioas says in rats, mice, or hamsters; and (6) the failure of HCHO to induce ch romosomal aberrations in the bone marrow of rats exposed to a irborne concentrations as high as 15 ppm or of mice injected intraperitone ally with HCHO at doses as high as 25 mg/kg. Biological evidence tha t might be regarded as supporting the possibility of leukemia induction by HCHO includes: (1) the detection of cytogenetic abnormalities in circulati ng lymphocytes in seven studies of human subjects exposed to ambient concen trations in the workplace (but not in seven other studies of human subjects or in rats exposed to 15 ppm); (2) the induction of leukemia i n rats in a single questionable drinking water study with HCHO concent rations as high as 1.5 g/L (but not in three other drinking water stud ies with concentrations as high as 1.9 or 5 g/L); (3) the detection of chro mosomal aberrations in the bone marrow of rats exposed to very low concent rations of HCHO (0.4 or 1.2 ppm) (but not in another study at concentrat ions as high as 15 ppm); and (4) an apparent increase in the fraction of protein-associated DNA (assumed to be due to DPX) in circulating lymph ocytes of humans exposed to ambient concentrations in the workplace (1 to 3 ppm). This evidence is regarded as inconsequential for several reasons, including lack of reproducibility, inadequate reporting of ex perimental methods, inconsistency with other data, or insufficient anal ytical sensitivity, and175 therefore, it provides little justification for or against the possibility that inhaled HCHO may be a leukemogen. In contrast to t hese inconclusive findings, the abundance of negative evidence mentio ned above is undisputed and strongly suggests that there is no d elivery of inhaled

HCHO to distant sites. Combined with the fact that HCHO naturally occurs throughout the body, and that multiple inhal ation bioassays have not induced leukemia in animals, the negative findi ngs provide convincing evidence that HCHO is not leukemogenic.

Lung Cancer (Pages 150-151). The report cites Blair et al. (19 86), but seems to have forgotten that there are several upda tes to this study. Relying on only one of a series of updated studies on the same cohort disregards good practice in evaluating epidemiologi cal studies.

Animal Carcinogenicity (Page 152). During the 1980s, studies

demonstrated that HCHO leads to nasal tumors in rat s after exposure to

concentrations associated with severe irritation an d compensatory cell replication in the respiratory epithelium of rats. In mice there was a slight, non-significant nasal tumor response of about 1% at 15 ppm (a concentration that led to approximately 50 % nasal tumor bearing rats; Kerns et al.,1983) while no tumors were found in ha msters at 10 (5days/week) or 36 ppm (1day/week) (Dalbey, 1982). Thus, there is a clear difference in sensitivity for the three speci es investigated. In vitro, HCHO is genotoxic/mutagenic in various test systems exhibiting high cytotoxicity. In vivo, DPX occur at the site of di rect contact (predominantly nasal mucosa), but no genotoxic effects were found at distant sites (i.e., no systemic effects were demonstrated). Over the l ast 20 years, the large number of scientific studies has not changed the pi cture for nasal carcinogenicity in rodents. The new data strengthe ned the evidence that the decisive factor for HCHO carcinogenicity is cyt otoxic irritation and compensatory cell proliferation besides genotoxicit y as manifested by DNA protein binding. See prior discussion and CIIT report (Sept. 28, 1999); Conolly et al. (2002; 2003; 2004).

Agency Response [8.36-Rose-070416-FCI] : The conclusion that HCHO is carcinogenic in humans was reached by IARC in their 2004 documents. In that document, IARC asserts that genotoxicity an d cytotoxicity both play important roles in nasal carcinogenicity. They als o note that cell proliferation is stimulated by HCHO and that this a ppears to amplify the genotoxic effects. With regards to NPC, IARC state s that for HCHO, there

is sufficient evidence

in epidemiological studies for NPC, strong but not sufficient evidence for leukemia, and limited evidence for sinonasal cancer.

The extensive scientific database on the mechanisms by which HCHO can

induce nasal-tract cancer in humans is considered. These data provide strong support for the empirical observation of NPC in humans (IARC, 2004a, 2004b).176

Furthermore, the IARC (2004a, 2004b) Working Group considered it improbable that all of the positive findings for na sopharyngeal cancer that were reported from the epidemiological studies, and particularly from the large study of industrial workers in the USA, could be explained by bias or unrecognized confounding effects. Overall, the Wor king Group concluded that the results of the study of industrial workers in the USA, supported by the largely positive findings from other studies, p rovided sufficient epidemiological evidence that formaldehyde causes n asopharyngeal cancer in humans (IARC, 2004a, 2004b).

An excess of nasopharyngeal cancer was observed in a proportionate mortality analysis for the largest U.S. cohort of e mbalmers (Hayes et al., 1990) although not statistically significant, and i n a Danish study of proportionate cancer incidence among workers at com panies which used or manufactured HCHO (Hansen and Olsen, 1995). Hay es et al. (1986) showed a relative risk for nasal tumors of 2.5 (90% CI 1.5-4.3) independent of wood dust exposure, tobacco use, and patient age.

The following will address the comments regarding individual studies. With respect to Coggon et al. (2003), they also not ed that a limitation of their analysis was unrecognized losses to follow-up with missed deaths leading to underestimation of risks. Vaughn et al. (1986) adjusted for effects of cigarettes, alcohol, age, sex, socioecon omic status, and race. According to the analysis of this data by Blair et al. (1990), a significant RR was observed in this study. Hauptmann et al. (2 004) found an increase in relative risks for nasopharyngeal cance r (nine deaths) increased with average exposure intensity (p-trend = 0.033), cumulative exposure (p-trend = 0.025), highest peak exposure ( p-trend < 0.001), and duration of exposure to formaldehyde (p-trend = 0.1 47). Blair et al. (1990) reviewed the epidemiological evidence and showed th at three studies had statistically significant relative risks (RR) for n asopharyngeal cancer: Blair et al. (1987); Roush et al. (1987) and Vaughan et a l. (1986).

A review of the epidemiological evidence by Feinma n (1988) states three studies show clear dose-response data and provide s trong evidence for

the association of HCHO with cancer of the nasal si nuses or nasopharynx

in humans.

364) Comment [8.37-Rose-070416-FCI] : IV. FORMALDEHYDE AND

REGULATORY RISK MANAGEMENT

The Board is considering a proposal to limit forma ldehyde emissions from composite wood products. This action is driven by a cancer risk assessment of formaldehyde performed by the OEHHA. This cancer risk assessment of formaldehyde was conducted in 1992 an d reissued177 essentially unchanged by OEHHA in 2005 as part of t he Air Toxics Hot Spots Program. 28 However, more sophisticated and biologically-base d risk assessments of formaldehyde by other respected regulatory agencies, including USEPA and Health Canada, conflict with th e conclusions of OEHHA’s risk assessment. More importantly, these as sessments indicate that the proposed reductions in formaldehyde emissi ons would not produce the reductions in cancer cases in Californi a predicted by

OEHHA’s risk assessment.

OEHHA performed a conservative cancer risk assessm ent, designed to estimate the cancer risk to humans at low exposure levels of formaldehyde by extrapolating the results of cancer in laboratory rats at higher levels of exposure. Based on the OEHHA risk assessment using the 95% upper-bound confidence limit, the estimated cancer risk over a 70-year lifetime from the current average exposure to formaldehyde in California is 35 cancer cases per million people (T able 1). CARB also estimated that the benefit of implementing Phases 1 and 2 of the proposal

would result in a net reduction of cancer cases of 12 and 35 per million people, respectively, over a 70 year lifetime. Assu ming a steady population of 35 million in California, this would amount to reduction in cancer cases of 18 per year in California. If OEHHA ’s estimates were accurate, the proposed reductions in formaldehyde e missions would have a small (but not insignificant) benefit. By compari son, over 100,000 Californians are expected to die from cancer annual ly.

Notably, OEHHA’s estimates are at odds with more r ealistic risk assessments by other respected agencies. Since OEHH A conducted its risk assessment in 1992, new and relevant scientifi c data on formaldehyde has been published, which has not been incorporated in OEHHA’s risk assessment despite requests to re-open the risk ass essment process. Using this information, a robust, biologically-base d approach to estimating the potential cancer risk of formaldehyde to humans was developed and published. Importantly, this approach to assessing the potential cancer risk of formaldehyde has been embraced and adopted by regulatory agencies in the US and internationally, including U SEPA (2006) 29 , Health Canada (2001) 30 , the World Health Organization (WHO, 2002) 31 , and the Australian Government (2006) 32

.

Table 1 compares the estimated cancer risks of for maldehyde exposure in California using the cancer potency estimates (i.e. , the inhalation unit risk per μg/m 3 ) for formaldehyde adopted by OEHHA and the other a gencies. The cancer potency estimates in Table 1 are all bas ed on the same study of formaldehyde in rats. With the exception of the choice of the cancer potency factor, all assumptions and calculations we re exactly the same as those used by OEHHA. So, the only reason for the di fference in the results

in Table 1 is the different estimates of the cancer potency of formaldehyde.178

As noted above, based on OEHHA’s estimates of form aldehyde’s cancer potency and the average exposure to formaldehyde in California, the implementation of Phase 2 is estimated by OEHHA to prevent 35 cancer cases per million people. In contrast, the other ag encies’ cancer potency factors, combined with OEHHA’s estimates of average exposure to formaldehyde in California, produce an estimated re duction of cancer cases much smaller than one in a million. For examp le, only 0.001 cancer cases per million people (or one cancer case per billion people) would be prevented using the cancer potency factors adopted by Health Canada and WHO (Table 1). Similarly, USEPA’s (2006) cancer potency factor predicts a reduction of only 0.016 cancer cases per million people.

Based on an estimated population of 35 million peo ple in California and

OEHHA’s estimate of a reduction of 35 cancer cases per million people over a 70-year lifetime, OEHHA’s estimated number o f cancer cases prevented per year in California is 18. 33 In contrast, using the cancer potency factors of the Other Agencies, the estimate d number of cancer cases prevented per year in California ranges from 0.0005 to 0.008 (Table 1). In other words, the estimated time required to prevent one case of cancer in the entire population of California after implementing Phase 2 ranges from 125 to 2000 years

.

OEHHA’s estimated cancer potency for formaldehyde is 2,250 to 36,000 times greater than that of the other agencies. Eith er OEHHA has greatly overestimated the risk or USEPA, Health Canada, WHO , and Australia all have greatly underestimated the risk. These other a gencies have expressed a strong preference for using the risk as sessment methodology of Conolly et al. (1999), such as USEPA’s decision to use this risk assessment model for formaldehyde when it establish ed emission standards for plywood and composite wood products.

In the case of formaldehyde, we have determined th at the cancer potency derived using the approach developed by [Conolly et al., 1999] and peerreviewed by an independent expert peer review panel sponsored by EPA and the Canadian government represents an appropria te alternative to EPA’s current IRIS URE for formaldehyde, and is the refore the best available peer-reviewed science at this time.” 34

The cancer risk assessment of HCHO by OEHHA does n ot rely on what USEPA calls “the best available peer-reviewed scien ce at this time.” In fact, the OEHHA risk assessment of HCHO does not ev en mention the work upon which USEPA, Health Canada, WHO and Austr alia rely for

their risk assessments of HCHO. CARB should carefu lly evaluate the proposal to reduce exposure to HCHO in light of the tenuous public health benefits represented by the estimated reduction in cancer cases in179 California. If reducing exposure to HCHO will not r esult in any meaningful reduction in cancer risk in California, the propose d action must be questioned. Given the fact that over 100,000 Califo rnians are expected to die from cancer annually, it is especially importan t to focus the State’s resources on strategies that will result in real re duction in cancer and improvement in public health.

Agency Response [8.37-Rose-070416-FCI] : As described above in comments #341 to #344, OEHHA reviewed CIIT’s model and concluded that this model was not adequate to protect public health. The inflection point depends on assumptions put into the model. T he outcomes of the model will be different based on these assumptions. Based on this analysis, this model was considered inappropriate a s a basis for decisions affecting public health under the Toxic Air Contami nants regulations. This conclusion was reviewed by the Scientific Review Pa nel on Toxic Air Contaminants. On this basis, Board staff has prese nted cancer risk/benefit comparisons in the ISOR, on the basis of which they conclude that the control measure provides a significant and worthwhile health benefit, particularly for certain more heavily expo sed individuals as opposed to regarding solely the statewide average r isk numbers presented in this comment.

365) Comment [8.38-Rose-070416-FCI] : V. CONCLUSION: In these comments, FCI has endeavored to address the proper scientific

framework for the health risk assessment for formal dehyde in this rulemaking. FCI and its members have continued to i nvest heavily in toxicological research to support the scientific co mmunity’s efforts to better understand the toxicological properties of formalde hyde and refine risk assessment methodologies to continue to protect hum an the environment with increasing levels of certainty.

The Board has an obligation to ensure that the fin al agency decisions are based on evidence of requisite quality and quantity and that a reviewing court must enforce that duty. The differences betwe en prevailing science

and the ISOR are so severe that a rule based on suc h assumptions would be arbitrary and capricious and an abuse of discret ion.

Agency Response [8.38-Rose-070416-FCI] : OEHHA has been aware of the toxicological studies to which the comment refe rs for some time, and

with the advice of the Scientific Review Panel on T oxic Air Contaminants has given them detailed consideration in the proper forum; specifically, the response to a petition to reconsider the unit risk value for formaldehyde. See also the responses to comments #335 and #341 to #344.

366) Comment [11-Higgins-070417-FFC] : The California Office of Environmental Health Hazard Assessment (OEHHA) has listed180 formaldehyde as a known carcinogen on the Propositi on 65 list, and the World Health Organization’s International Agency fo r Research on Cancer has classified formaldehyde as a known human carcin ogen. In light of these classifications and bearing in mind formaldeh yde’s asthmagenic effects, there is sufficient reason to be very conc erned about the estimated 400 tons emitted by composite wood produc ts each year in

California.

Agency Response [11-Higgins-070417-FFC] : We appreciate the comment

– no response necessary.

367) Comment [14-Titus-070419-KCMA] : “Absent, however, is reference to the ongoing effort at the U.S. EPA, the National Cancer Institute, and others in the scientific community to better measure and asse ss the risk from exposure to low levels of formaldehyde.”

Agency Response [14-Titus-070419-KCMA] : With reference to the CIIT model, OEHHA evaluated the Chemical Industries Inst itute for Toxicology (CIIT) model document as part of the established pe tition process. The model used a more complex analysis of the likely ca rcinogenic doseresponse based on analysis of deposition of formald ehyde in the rodent nasal cavity, and the role of DNA damage and cell p roliferation. OEHHA reviewed the materials submitted by the petitioner and presented the

conclusions to the Scientific Review Panel on Toxic Air Contaminants (SRP). The SRP declined to recommend reconsiderati on of OEHHA’s 1992 formaldehyde unit risk factor (OEHHA, 2005). This was largely due to the uncertainties in the model surrounding the f ormaldehyde concentration at which, according to the CIIT model , the unit risk “switched” from low to high. This modeled inflecti on point could vary considerably depending on the choice of some poorly characterized input parameters, and might reasonably be low enough that environmental and indoor exposures were in the “high potency” range. The model was not developed by the USEPA. The USEPA’s current consen sus unit risk

value is 1.3 x 10 -5 as published on IRIS. They are officially re-eval uating formaldehyde but a final reassessment is not expect ed for at least another year or two. The document by Health Canada was wri tten in conjunction with CIIT and does not represent an independent ass essment. See also the responses to comments #341 to #344.

368) Comment [15-Alexeeff-070419-OEHHA] : “Since that time OEHHA has continued to monitor developments in the scientific understanding of HCHO toxicity, regarding both its carcinogenicity, and its non-cancer effects. Concern for the carcinogenicity of HCHO h as increased. The IARC held a meeting in June 2004 at which evidence for HCHO carcinogenicity was reviewed and the conclusions an d classification were updated... Formaldehyde was upgraded from its previou s ... status of181 probably carcinogenic to humans (Group 2A) to carci nogenic to humans (Group 1), based on the determination that the evid ence of carcinogenicity in humans (from epidemiological studies) is now suf ficient. OEHHA
concurs with this evaluation... Thus, our concerns wi th the reliability and applicability of the CIIT model, which is not relev ant to leukemia in particular, have increased rather than decreased si nce 2005.”

Agency Response [15-Alexeeff-070419-OEHHA] : No response necessary.

369) Comment [15-Alexeeff-070419-OEHHA] : “Finally, OEHHA reviewed and agrees with the risk assessment of HCHO exposure pr esented in the composite wood ATCM staff report, which utilizes OE HHA’s unit risk factor. The risk assessment in the staff report reflects cu rrent science on HCHO exposure and risk from composite wood products.”

Agency Response [15-Alexeeff-070419-OEHHA] : No response necessary.

370) Comment [17-Whalen-070419-Columbia] : “... Industry claims that there are no ill health-effects from exposure to urea for maldehyde are not to be taken seriously.”

Agency Response [17-Whalen-070419-Columbia] : We agree that the point raised by the commenter is appropriate. Formaldehy de is a known human carcinogen and there is clear documentation that un reacted HCHO in UF

resins is released to the air.

371) Comment [19-Cooper-070420-Kaiser] : California has recognized that there is no known safe level of formaldehyde, as th e Office of Environmental Health Hazards Assessment (OEHHA) det ermined that the safe reference exposure level (CREL) for formaldehy de was lower than the level of formaldehyde already in the ambient ai r. Less than three years ago, in 2004, the World Health Organization’s Inter national Agency for Research on Cancer (IARC) updated its report on for maldehyde. Based on new information from studies of persons exposed to formaldehyde, IARC changed its position that formaldehyde was a " probable carcinogen" to conclude that formaldehyde is "carcinogenic to h umans". And as we all know cancer is one of the leading causes of illness and deaths in California and in the nation. In addition to IARC, other national and international regulatory agencies have determined t hat formaldehyde is a public occupational concern. The list includes The National Toxicology Program (NTP), The National Institute for Occupatio nal Safety and Health (NIOSH), and The Association of Occupational and En vironmental Clinics (AOEC). The EPA Integrated Risk Information System (IRIS) found that formaldehyde is a probable human carcinogen in anim al studies. Moreover, the EPA under the Clean Air Act has concl uded that formaldehyde is a hazardous air pollutant.182

Agency Response [19-Cooper-070420-Kaiser] : We appreciate the
comment – no response necessary.

372) Comment [20-Stensland-070420-NA] : Given that there are no formaldehyde exposure standards in the United State s for children, the proposed effort by CARB is a major move forward in the realm of prevention in children’s should be applauded.

Agency Response [20-Stensland-070420-NA] : We appreciate the
comment – no response necessary.

373) Comment [21-Parker-070420] : “I am an architect of public schools here in California and I am very much in favor or any reduc tion of HCHO emissions. One of the greatest contributors of the se emissions in a school classroom is the casework... This problem is exacerba ted by the fact that classroom standards require more casework for eleme ntary schools than standards for upper level classrooms...There are many reasons for adopting these reductions but the most important is the benefit it will have

for California students.”

Agency Response [21-Parker-070420] : We agree that points raised by the commenter are appropriate. The ATCM standards will lower HCHO emissions from the composite wood products typicall y used to make bookcases, etc.

374) Comment [24-Landry-070423-CWIC] : The Health Effects Presented Do Not Reflect Current Science. Formaldehyde is one o f the most widely studied compounds in the world. It has been serious ly mischaracterized in the Initial Statement of Reasons for two principal reasons: (1) major new information adopted by USEPA, Health Canada, German y and other jurisdictions has been ignored by CARB and OEHHA st aff, and (2) high range "statistical bounds" of the OEHHA risk assess ment have been deemed "cancer cases reduced" contrary to all profe ssional guidance on the use of risk assessment numbers. The Formaldehyd e Council, Inc. will submit detailed information on these topics. It is undeniable that formaldehyde at very high exposure levels (above le vels that could be tolerated by humans) results in cancers in laborato ry animals. Since the 1992 OEHHA risk assessment, however, major strides have been made in understanding the mechanism of formaldehyde carcino genicity – its interaction with cell material, its delivered dose to the cells, and the role of cytotoxicity in the process. These and other discov eries have led to new biologically-based risk assessments which show virt ually no risk at the

levels involved in residences. It has a virtual thr eshold. Much of the information was developed with the guidance and inp ut of the Environmental Protection Agency and Health Canada. This information183 was submitted to CARB several years ago. CARB decid ed not to consider the new science in its rule-making, arguing that th ere was nothing new! The USEPA and Health Canada disagree – they have us ed this new scientific information in rule makings. It has also been endorsed in Germany and other countries. The staff report sugg ests that its regulation would result in a specific number of "reduced cance r cases." This is a

total misuse of risk assessment numbers. The unit r isk is based on an upper 95% confidence level expression of a computer ized model. The 1992 Final Report identifying formaldehyde as a tox ic Air contaminant noted; "These 95 percent upper confidence limits fo r excess lifetime risks are health-protective estimates; the actual risk ma y be significantly lower." It is widely accepted that statistical expressions are not appropriate for use as point estimates of risk. These are ranging numb ers of risk, the new risk assessments show virtually no risk of exposure to f ormaldehyde in the indoor environment even using a 95% upper confidenc e limit.

Agency Response [24-Landry-070423-CWIC]: The value for the unit risk factor mentioned here and in the Formaldehyde Counc il’s comments is based on the unit risk factor developed by the CIIT Centers for Health Research (CIIT), not by the United States Environme ntal Protection Agency (USEPA). Although USEPA used the CIIT model in their recent MACT rule (a risk management measure), this is not currently accepted as

a consensus value for risk assessment at USEPA. Th erefore, the assertion that it was developed by the USEPA is inc orrect. USEPA’s

current consensus unit risk value is 1.3 x 10 -5 as published on IRIS. This number is much closer to and a bit higher than the Cal/EPA value for the potency of formaldehyde.

The USEPA is officially re-evaluating HCHO but a f inal reassessment is not expected to be completed for another two years. In fact, the Office of Air Quality Planning and Standards (OAQPS), a sub-d ivision of the Office of Air and Radiation (OAR) within the USEPA, went a round the agency’s normal process of evaluating cancer potency estimat es in its decision to use the industry-sponsored CIIT potency value. Thu s, the CIIT model is not the official USEPA position. Well respected sc ientists from the USEPA recently presented data at scientific meeting s which supports our conclusion that the CIIT model has a very uncertain inflection point.

There are major uncertainties in the predictions o f the CIIT model depending on choice of input parameters (see respon se to comment #331). An extensive review of the strengths and we aknesses of that model by OEHHA was performed and reviewed by the Sc ientific Review Panel on Toxic Air Contaminants (SRP) in 2004, whic h led to the recommendation by the SRP not to change the Califor nia potency estimate. The California potency estimate is not a typical default model and OEHHA considered several model types, including inclusion of cell184 proliferation data. Publications since that date h ave not added significantly to the information provided in the (t hen unpublished) report

considered in that review.

IARC recently reconsidered the status of HCHO and upgraded it to a Group 1 – known human carcinogen. The listing basi s by IARC was nasopharyngeal cancer – not confined to the very sp ecific site evaluated in the rat study and the CIIT model. Several other sites (especially lung cancer and leukemia) are also of substantial concer n. Concern for risks at other sites in the respiratory system (mechanistica lly plausible in humans due to different nasal geometry), and for leukemia raises the question of whether the CIIT model (which arbitrarily assumes a number of key parameters are the same in humans and rats, includi ng the exact site of tumorigenesis) is relevant to human cancer risk.

Several of the citations of other national and int ernational authorities endorsing the CIIT model are in fact quoting the sa me authors, and in some cases the same document, and are not independe nt or disinterested

comments.

With regard to the comment on “the ISOR's reliance on an outdated OEHHA assessment of carcinogenicity,” OEHHA’s asses sment of carcinogenicity for HCHO uses established methods o f cancer risk assessment, and in addition included information on HCHO – induced DNA-protein cross linking and evaluated the effect of cell proliferation on the estimates of cancer potency. The risk estimate was peer reviewed and approved by the Scientific Review Panel on Toxi c Air Contaminants (SRP) in 1992. In addition, in 2002 the CARB recei ved a petition from the Formaldehyde Council requesting a review of the HCH O risk assessment, based on a model of the cancer potency developed by the CIIT. OEHHA evaluated the materials submitted by the petition a nd worked with a copy of the model developed by CIIT. After spending man y hours working with the model, OEHHA determined that model uncertainty was too great for use in estimating cancer risk to humans from formal dehyde exposure at low levels. The SRP reviewed the OEHHA analysis as well as the materials submitted with the petition. They conclu ded that the model was not ready for use and also concluded that model unc ertainty was a serious problem. They declined to recommend to CARB that t he HCHO risk

assessment conducted under the Toxic Air Contaminan t program be reopened. Furthermore, USEPA staff recently presente d data at scientific meetings which supports the conclusion that the mod el is overly reliant on poorly characterized parameters that have a major i nfluence on the final slope fits.

375) Comment [27-Rush-070424-Temple Inland] : “... The emission rate reductions in Phase 2 will not improve the health f or California residents185 and the cancer rates stated are grossly over stated by a factor of about

1000 times...”

Agency Response [27-Rush-070424-Temple Inland] : We disagree. Formaldehyde is a no-threshold carcinogen and emiss ion reductions will lead to reduced exposure and health benefits. The cancer rates in the ISOR were calculated using OEHHA’s unit risk factor , which we believe is

the correct factor to use for calculations of this kind.

376) Comment [28-Maultsby-070424-FloPly] : Here is the kicker – what real benefit is there to be gained by the change from th e Phase I to the Phase II levels? I’ve seen no sound evidence that exposu re to formaldehyde at the proposed Phase I levels poses a risk. I am not aware that any of your referenced studies show this. Older data from peop le exposed in years past was from when formaldehyde levels were excepti onally high, and these did not show a strong correlation to health i ssues (weak correlation to nasal cancer I believe?). The limits you conside r now are all just supposition and gross overkill.

Agency Response [28-Maultsby-070424-FloPly] : The benefit of the move from Phase 1 to Phase 2 is enhanced protection of h ealth measured in reduction of formaldehyde-related cancer cases. Al though not included in these calculations, there are also other potential health benefits associated with the reduction in HCHO exposure such as the reduction in allergy and asthma exacerbation. Based on the esti mates provided in the ISOR, implementation of Phase 1 would result in a r eduction in HCHO emissions of 180 tons per year which, in turn, is p rojected to reduce excess cancer cases by 12-35 per million over a 70- year life span. Implementation of Phase 2 is projected to reduce th ese cancer cases 2-3- fold (35-97 cases per million) over the same life s pan.

377) Comment [29-Couture-070424-CDMDP] : “... In fact, recent credible research around the world including the USEPA and H ealth Canada shows that there is virtually no risk to the popula tion of California from industry products in the manner they are produced a nd used by

consumers.”

Agency Response [29-Couture-070424-CDMDP] : We disagree. See the responses to comments #341 to #344.

378) Comment [30-Hardy-070427-Children Now] : Children Now earnestly encourages CARB to put in place HCHO emissions redu ction regulations as an overdue health prevention measure, to protect all people, including

our children.186

Agency Response [30-Hardy-070427-Children Now] : We appreciate the
comment – no response necessary.

379) Comment [38-Morgan-070424-IWPA] : IWPA applauds the California Air Resources Board’s (ARB) intentions to reduce human exposure to toxic air contaminants as mandated by state law.

Agency Response [38-Morgan-070424-IWPA] : We appreciate the
comment – no response necessary.

380) Comment [42-Gustafson-070424-WWI] : “I have sat in CARB public meetings and watched scientists and toxicologists t ell the CARB board that their needs assessment is potentially flawed a nd thus their conclusions are potentially based on fallacies...”

Agency Response [42-Gustafson-070424-WWI] : We disagree. The arguments raised by industry toxicologists are subj ect to interpretation, and there is no consensus interpretation. See also the responses to

comments #341 to #344.

381) Comment [47-Steenson-070424-AuWPA] : 1. Underlying Health science. “We support the data and interpretations of the sci ence of the health effects of Formaldehyde presented by the FCI that:

(a) there are safe levels of formaldehyde as modell ed by the CIIT. (b) the most sensitive health end-point for formald ehyde is sensory irritation to the eyes. (c) at or below the levels where sensory irritation occurs there is adequate protection of human health from other potential hea lth endpoints such as

cancer. (d) there is inadequate evidence to suggest that fo rmaldehyde causes

asthma or that asthmatics are more sensitive to for maldehyde.

We therefore recommend to the board that they revi ew their risk assessment based on the most recent science as pres ented by the FCI.

Agency Response [47-Steenson-070424-AuWPA] : See the responses to

comments #341 to #344. OEHHA evaluated the CIIT mo del under the established process to re-evaluate risk assessments under the Toxic Air Contaminants program, but found it unsatisfactory t o predict risks at low levels of exposure. This was largely due to the unc ertainties in the model surrounding the HCHO concentration at which, accord ing to the CIIT model, the unit risk “switched” from low to high. This modeled inflection point could vary considerably depending on the choi ce of some poorly characterized input parameters, and might reasonabl y be low enough that environmental and indoor exposures were in the “hig h potency” range.187 OEHHA concluded that this model was not adequate to protect public health. OEHHA reported that the model produced a d ose-response that

was flat at the low-end and that the model was flaw ed, thus calling into question assertions of the ‘safe’ level of HCHO. O EHHA agrees that irritancy is a sensitive endpoint for short-term ex posure and use it in the development of its acute REL (OEHHA, 1999). Howeve r, the sensory

irritation threshold does not account for the tissu e damage from long-term exposure to HCHO observed in workers, and this is n ot an appropriate endpoint to use in developing a REL for chronic exp osure. For the chronic REL, OEHHA used histological damage to the nasal ep ithelium (OEHHA, 2000).

382) Comment [52-Lent-070425-HBN] : At the October 23rd public hearing,

there was some concern raised about California Air Resources Board’s (CARB) reliance on the Office of Environmental Heal th Hazard Assessment’s (OEHHA) position on HCHO, its toxicolo gy and health effects. Members of industry expressed the opinion that the current science shows HCHO is not as great of a concern as OEHHA’s 1992 analysis indicates.

As you are probably aware, this is not a new argum ent from industry.

Given the current state of the science on the healt h effects of HCHO, however, we strongly believe that a careful review of the most updated peer-reviewed science indicates that CARB’s relianc e on OEHHA’s risk

assessment on HCHO is well-founded. 1

Less than three years ago, in 2004, the World Heal th Organization’s International Agency for Research on Cancer (IARC) updated its report on HCHO. Before 2004 (1987 and 1995) based on limited available peerreviewed studies, IARC concluded HCHO was a “probab le carcinogen.” In 2004, however, IARC changed its position based o n new information from studies of persons exposed to HCHO. In the mo st recent classification from IARC, the expert working group found that evidence

was sufficient to increase the level of concern abo ut HCHO. In 2004,

IARC found sufficient evidence to conclude that HCH O is “carcinogenic to humans.” In addition to IARC, other national and i nternational regulatory agencies have determined that HCHO is a public occu pational concern. The National Toxicology Program (NTP) has classifie d HCHO as “reasonably anticipated to be a human carcinogen.” The National Institute for Occupational Safety and Health (NIOSH) has dete rmined that HCHO is a “potential occupational carcinogen.” The Associa tion of Occupational and Environmental Clinics (AOEC) concluded that HCH O is a potential asthmagen. The EPA Integrated Risk Information Syst em (IRIS) found that HCHO is a probable human carcinogen in animal studies. Moreover,

the EPA under the Clean Air Act has concluded that HCHO is a hazardous air pollutant. The record is clear. Increased stu dy of HCHO reiterates188 concerns about its impact on public and occupationa l health. Consensus exists in the peer-reviewed science that the risks from HCHO

substantiates the basis for the CARB action based o n the OEHHA analysis.

We strongly support the CARB staff proposal to reg ulate HCHO emissions from composite wood products rapidly and bring them as close to zero as is technically possible by 2012 in order to protect public and occupational health. Please continue to press for the most stri ngent regulations you can implement with a meaningfully rapid timeline.

1 Much of the industry push to re-evaluate HCHO is sp urred by a mathematical model of HCHO toxicity developed by CIIT (Chemical Industry Institute of Toxicology). The CIIT model is limited in a number of significant ways, b ut, most obviously, it fails to account for

the risk of cancers in tissues other than the nose and throat. In particular, the model ignores leukemia risks identified in two robust ind ependent epidemiology studies of exposed workers, by NIH/NCI (Hauptmann M, Lubin JH, Stewart PA, Hayes RB, Blair A. Mortality from solid cancers among workers in forma ldehyde industries. Am J Epidemiol. 2004 Jun 15; 159(12):1117-30) and CDC/NIOSH (Pinker ton LE, Hein MJ, Stayner LT. Mortality among a cohort of garment workers exposed to formaldehyde: an update. Occup Environ Med. 2004 Mar; 61(3):193-200.). At a 2004 meeting of IARC’s chemical evaluation program, 26 scientists from 10 countries evaluated all the available evidence on the carcinogenicity of HCHO, including the CIIT model and the NCI and NIOSH occupational studies. In addition to definite evide nce of nasopharyngeal cancers, IARC

also found limited evidence for cancer of the nasal cavity and paranasal sinuses and "strong but not sufficient evidence" for leukemia. (The finding for leukemia reflects the epidemiologists’ finding of strong evidence in huma n studies coupled with an inability to identify a mechanism for induction of leukemia, bas ed on the data available at this time. Press Release No. 153. World Health Organization, J une 15, 2004. IARC Classifies Formaldehyde As Carcinogenic to Humans .)”

Agency Response [52-Lent-070425-HBN] : We appreciate the comment –

no response necessary.

383) Comment [53-Cassman-070425-HBMVR] : The ISOR provides overwhelming evidence regarding the health risks of HCHO exposure given that no safe threshold exposure exists and th e diverse sources of emissions from CWP. (See ISOR VII, I, p. 130) As the ISOR notes, Californians are exposed to HCHO emissions in the a mbient air from a multitude of sources, including “hot spots,” such a s near lumber yards, through indoor-outdoor air exchanges, from newly ma de standing stock of CWP stored at manufacturing facilities, and during transport of CWP by rail, truck, and ship. (See ISOR I.B., p. 3) The ISOR also notes that Californians are exposed to HCHO exposures through indoor air sources, and that CWP such as particleboard and medium densi ty fiberboard panels are subject to regulation not only under the Tanner Act, but also as consumer products under Section 41712. The statewi de annual average

HCHO concentration in ambient air exceeds the chron ic reference exposure level for HCHO that presents a known risk to public health.189 (ISOR I.B.) As outlined in Chapter VII.F, the ATCM will have substantial impact in reducing common exposure to HCHO emission s.

Agency Response [53-Cassman-070425-HBMVR] : We appreciate the
comment – no response necessary.

384) Comment [54-Knox-070425-ACS] : The Society believes that reducing exposure to HCHO is desirable and that reduced emis sions will benefit public health. We support the proposed formaldehyd e ATCM, and commend the Board for its actions to protect the he alth of all Californians.

Agency Response [54-Knox-070425-ACS] : We appreciate the comment –

no response necessary.

385) Comment [55-Theg-070425-NA] : I care very deeply about reducing HCHO emissions and urge you take whatever actions you ca n to reduce HCHO emissions to background levels. This is a health i ssue of great importance.

Agency Response [55-Theg-070425-NA] : We appreciate the comment –

no response necessary.

386) Comment [56-Carmichael-070425-CCA][75-Carmicha el-070426-CCA] : The Coalition for Clean Air and the American Lung A ssociation of California support the California Air Resources Boa rd’s (CARB) plan to require the wood products industry to develop forma ldehyde free and low HCHO products. We support the stringency of the st andards and the “cap approach” proposed by staff but we strongly believe the industry can and should meet these standards sooner... Again, we appr eciate CARB’s work in developing this regulation. To better prot ect public health we urge an acceleration of the requirements proposed by you r staff.

Agency Response [56-Carmichael-070425-CCA][75-Carm ichael-070426]-

CCA : We appreciate the comment. See also the response to comment

#123.

387) Comment [57-Young-070425-NA] : Please support the measure to reduce formaldehyde emissions.

Agency Response [57-Young-070425-NA] : We appreciate the comment –

no response necessary.

388) Comment [58-Blicker-070425-NA] : Do the right thing. Adopt the regulations to establish new low emitting standards . Thank you.

Agency Response [58-Blicker-070425-NA] : We appreciate the comment –

no response necessary.190

389) Comment [68.1-Shull-070426-CWIC] [80-Shull-070 426-CWIC] : The introductory statement to Section VII states “This chapter presents an overview of the health risk assessment process...” C hapter VII falls grossly short in presenting a transparent, clear, consistent and reasonable overview of CARB’s risk assessment. For example, i t lacks a standard uncertainty analysis as part of the risk characteri zation (Step 4) component. Also, it completely excludes any discus sion of the current scientific discussion/debate on the cancer slope fa ctor (CSF), which has

more influence on estimated cancer risks in humans than any other single factor. In my opinion, it fails all four quality c riteria, is biased, and will mislead risk management decision makers.

Agency Response [68.1-Shull-070426-CWIC] [80-Shull -070426-CWIC] : Other than the absence of an uncertainty analysis, it is not clear why the

commenter feels that the ISOR falls short in terms of transparency, clarity, consistency or reasonableness. This document was n ot written to defend the CSF. In responding to FCI’s petition to have H CHO re-examined, the

Scientific Review Panel on Toxic Air Contaminants e ffectively endorsed

the continued use of the current values. See also the responses to

comments #341 to #344.

390) Comment [68.2-Shull-070426-CWIC] : The introductory statement also

states that “As HCHO has been identified as a toxic air contaminant (CARB, 1992), there is no threshold exposure level below which adverse health effects are not anticipated.” This statemen t is blatantly wrong, has no scientific basis, and has no basis in either USE PA or Cal/EPA’s designation of formaldehyde as a likely human carci nogen.

Agency Response [68.2-Shull-070426-CWIC] : Formaldehyde is a genotoxic carcinogen: all such compounds are consid ered to be nonthreshold carcinogens for TAC regulatory listings. The comment does not suggest a threshold level or the scientific basis f or one. See also the responses to comments #335 and #336.

391) Comment [68.3-Shull-070426-CWIC] : Whereas Section 2 of Chapter VII presents a relatively comprehensive, 21-page summar y of the toxicology and human epidemiology literature on formaldehyde, no attempt is made to relate the information directly to the proposed ATCM standard.

Agency Response [68.3-Shull-070426-CWIC] : The first part of Chapter

VII summarizes studies of the adverse health effect s of HCHO, including cancer. In Section F of Chapter VII, OEHHA’s unit risk factors are applied to show the effects of reducing HCHO exposures as r equired by the ATCM. See also the responses to comments #337 and #340.191

392) Comment [68.4-Shull-070426-CWIC] [80-Shull-070 426-CWIC] : Also, Section 2 of Chapter VII makes no mention of the me tabolism of formaldehyde in biological systems including humans . It is a well-known fact that virtually all cells in the body possess a ldehyde dehydrogenase enzymes that detoxify formaldehyde at air concentra tions less than about 2 ppm. For the CARB report to ignore this fact sho ws blatant bias and misuse of science (i.e., including the science that supports the proposed ATCM standard and excluding the science that doesn’ t support the proposed standard).

Agency Response [68.4-Shull-070426-CWIC] [80-Shull -070426-CWIC] : The metabolism of HCHO has been considered in other supporting documents including those in which OEHHA developed reference exposure levels (RELs). The assertion that “...virtu ally all cells...detoxify HCHO at air concentration less than about 2 ppm” im plies that 100% of the HCHO is detoxified before it can cause damage. This has not been demonstrated. This comment also ignores the variab ility among individuals in the ability to metabolize HCHO, and variations in endogenous HCHO formation.

393) Comment [68.5-Shull-070426-CWIC] : Chapter VII (Section 2) presents no discussion of OEHHA’s CSF or Unit Risk Factor (URF) , even though this

factor affects the risk assessment results as much or more than any other single factor in the assessment. The fact that the CSF is not listed among

the seven “factors that affect the outcome of a hea lth risk assessment” (Section C, Chapter VII) shows bias, misleads CARB’ s risk managers, and is yet another failure of the report to meet the fo ur risk assessment quality

standards.

Agency Response [68.5-Shull-070426-CWIC] : The factors listed in Section C are the generic factors that apply to bot h cancer and noncancer health risk assessment. The CSF and the URF are determined independently of the ATCM and the factors in Sectio n C. This was conducted under Phase 1, Identification of Toxic Ai r Contaminants in the TAC program. See also the response to comment #335

.

394) Comment [68.6-Shull-070426-CWIC] [77-Natz-0704 26-FCI] : Chapter VII makes no mention of key reports in the published sc ientific literature that have challenged the underlying assumptions and scie ntific bases of OEHHA’s CSF; notably Conolly et al. (2004). The sc ientific controversy

associated with the CSF and URF factor for formalde hyde is well known. The complete silence of CARB’s report on this impor tant scientific controversy shows bias, misleads CARB’s risk manage rs, and is yet another failure of the report to meet the four risk assessment quality

standards.192

Agency Response [68.6-Shull-070426-CWIC] [77-Natz- 070426-FCI] : It is not clear what underlying assumptions or scientific bases of OEHHA’s CSF are challenged by Connolly et al. The ISOR was not written to defend the CSF or URF, but rather to apply these nu mbers in a risk management context. The mentioned scientific contr oversy indicates that the evidence is still evolving and, while the evolv ing evidence may eventually suggest different values, the ISOR uses what OEHHA and the

Scientific Review Panel on Toxic Air Contaminants c onsider to be the best available numbers. See also the responses to comme nts #335 and #341

to #344.

395) Comment [68.7-Shull-070426-CWIC] [77-Natz-0704 26-FCI] [80-Shull070426-CWIC] : Whereas the proposed ATCM standard may reduce exposure of Californians to HCHO to some unknown de gree, there is no scientific basis for concluding that a reduction in the incidence of cancer in California will result. The primary reasons are: 1 ) HCHO is completely detoxified at low levels of exposure; levels curren tly associated with emissions from composite wood products, and 2) ther e is no scientific evidence of human carcinogenesis in the already low air concentrations of HCHO that are typically emitted from composite wood products

manufactured in California.

Agency Response [68.7-Shull-070426-CWIC] [77-Natz- 070426-FCI] [80- Shull-070426-CWIC] : The comment asserts that HCHO is completely detoxified at low levels of exposure, a proposition that has not been demonstrated, and would be difficult to do so. In addition, since HCHO is continuously released from composite wood products into confined spaces, such as homes, it can reach high levels (> 200 μg/m 3 ). It thus contributes to an individual’s exposure from all sources, and i s a significant source for individuals spending the bulk of their time in rece ntly fabricated homes.

396) Comment [69-Murray-070426-FCI] [77-Natz-070426 -FCI] [78-Murray070426-FCI] : Will CARB’s Proposal on Formaldehyde Really Reduce Cancer? Summary. The health benefits of CARB’s pr oposal to lower HCHO emissions have been overestimated by a cancer risk assessment that does not use the most current peer-reviewed sc ientific information. Importantly, more recent and sophisticated risk ass essments of HCHO by other respected regulatory agencies, including USEP A, Health Canada, and the World Health Organization (WHO), predict th e cancer risk is as much as 36,000 times lower than the estimate relied upon by CARB. These assessments indicate that the proposed reduct ions in HCHO emissions will not produce any meaningful reduction in cancer cases in

California.

CARB’s estimate is based on OEHHA’s cancer potency factor. CARB

estimated the cancer risk of HCHO based on an estim ated cancer potency193 factor from a 1992 risk assessment by the Office of Environmental Health Hazard Assessment (OEHHA); this assessment was reis sued essentially unchanged by OEHHA in 2005 as part of the Air Toxic s Hot Spots Program. 1 CARB estimated that the benefit of implementing P hases 1 and 2 of the proposal would result in a theoretical net reduction of 12 and 35 cancer cases per million people, respectively, o ver a 70-year lifetime. Assuming a steady population of 35 million in Calif ornia and assuming CARB’s estimates are accurate, this would amount to a theoretical reduction in of about 6 and 18 cancer cases per yea r in California from Phases 1 and 2, respectively.

USEPA, Health Canada, and WHO estimate a dramatica lly lower cancer potency for HCHO. OEHHA’s cancer potency estimate is at odds with more recent risk assessments by USEPA, Health Canad a, and WHO. Substituting these cancer potency estimates in CARB ’s equations indicates that Phase 2 would prevent 0.001-0.016 ca ncer cases per million people, which is 0.0005-0.008 cancer cases per year in the entire population of California (Table 1). In other words , implementation of Phase 2 is unlikely to prevent one cancer case in t he entire population of

California in our lifetime.

Why such a big difference in estimates? OEHHA’s c ancer potency estimate does not rely on what USEPA calls “the bes t peer-reviewed

science at this time. “ 2 In fact, the OEHHA risk assessment of HCHO does not even mention the work which USEPA, Health Canada, and WHO relied upon for their risk assessments of HCHO.

OEHHA’s estimated cancer potency for formaldehyde is 2,250-36,000 times greater than that of USEPA, Health Canada, an d WHO. Formaldehyde does not become 36,000 times more carc inogenic when it crosses the state border. Either OEHHA has greatly overestimated the risk or USEPA, Health Canada, and WHO all have grea tly underestimated

the risk.

Conclusion : CARB should carefully evaluate the proposal to r educe exposure to HCHO, particularly the extremely low li mits proposed in Phase 2, in light of the tenuous public health bene fits represented by the

estimated reduction in cancer cases in California. If reducing exposure to HCHO will not result in any meaningful reduction in cancer risk in California, the proposed action must be questioned. Given the fact that over 100,000 Californians are expected to die annua lly from cancer, it is especially important to focus the State’s resources on actions that will result in real reduction in cancer and improvement in public health.

Agency Response [69-Murray-070426-FCI] [77-Natz-07 0426-FCI] [78- Murray-070426-FCI] : As noted in the comment, and unlike the agencies194 mentioned, OEHHA does not use the model from CIIT o n which the

cancer risk described in the comment is based. OEH HA evaluated this model and found it to be interesting and representa tive of a major effort on the part of CIIT. However, we think this model (1) has not been adequately analyzed for model uncertainty, and (2) has important yet not well characterized assumptions that influence the e stimate of risk at low levels of exposure. This model does not adequately protect public health.

The Scientific Review Panel on Toxic Air Contaminan ts agreed with

OEHHA’s assessment and declined to recommend to the CARB that the risk assessment be re-opened. Based on the numbers from OEHHA, the proposed reductions in HCHO are expected to result in meaningful reductions in cancer cases. Regarding Table 1, CII T wrote the section of the WHO and the USEPA documents. And, EPA's consen sus potency
values are on IRIS and still have their 1991 value. They are officially reevaluating but are about two years out from a final reassessment. Finally, scientists at USEPA recently presented data at scie ntific meetings which supports the conclusion that the CIIT model has a v ery uncertain inflection point. See also the responses to comments #341 to #344.

397) Comment [77-Natz-070426-FCI] : “The members of the Formaldehyde Council are concerned that with this proposed HCHO rule, CARB is embarking down a path that is completely out of syn c with the current and best available science on formaldehyde’s potential human health effects. Today, you will be hearing from experts who will po int out the flaws in both the analyses and the drafting of this proposed rule . Simply put, we believe that this proposed rule to reduce HCHO in wood prod ucts is not based on

the best available science and health effects data and will not provide appreciable health protection to the people in Cali fornia.”

Agency Response [77-Natz-070426-FCI] : We disagree. We have consulted with the toxicologists from OEHHA whose w ork was peerreviewed by the Scientific Review Panel on Toxic Ai r Contaminants. See also the responses to comments #341 to #344.

398) Comment [79-Marsh-070426-FCI] : “... our reanalysis of the NCI cohort data do not support their suggestion of a causal as sociation with HCHO and NPC (nasopharyngeal cancer). I believe that th e 2004 decision by IARC to reclassify HCHO as a group one substance wa s premature considering the small number of NPC deaths, the mis sing evidence from the British and NIOSH cohort studies, NCI’s anomalo us finding for NPC in a single plant, and now our new evidence that the N PC risk in this very influential plant may be related to not HCHO, but t o previous work in the local metal industry.”195

Agency Response [79-Marsh-070426-FCI] : We disagree. We stand with the decision by IARC to classify HCHO as a known hu man carcinogen. See also the response to comment #340.

399) Comment [118-Lent-070426-NA] : “So why are they doing this in the face of the blitz of warnings prices are going up for th e product? Because they recognize that their workers and their customers ar e suffering now from the impact of this. These actions as the CARB staf f – statistics have shown we’re talking about thousands of cancer cases here a wide range of other impacts. And the people who have signed t hat letter recognize that we’re not going to get this change in the indu stry through the green building movement alone or through individuals conc erned. So we have a classic case of market failure here where people do n’t get to choose the casework that they’re exposed to... The ones who pay for health impacts are not the ones necessarily making the most of the decisions. So this is a public health issue that requires your action...”

Agency Response [118-Lent-070426-NA] : We appreciate the comment –

no response necessary.

400) Comment [119-Makus-070426-Children Now] : “Recently OEHHA studies suggest that formaldehyde likely presents different ial health impacts on infants and children from carcinogenicity to respir atory effects including decreased lung function and exacerbated asthma... Wha t is especially tragic about this disproportionate health impact is that children have very little control over their environment. They seldom exercise any choices to where they live, where to attend school, or what ma terials are utilized or located in their surroundings. They must breathe i n the environment in which others place them.”

Agency Response [119-Makus-070426-Children Now] : We appreciate the
comment – no response necessary.

401) Comment [119-Makus-070426-Children Now] : “Further, the many children

in our state from low-income families are far more likely to be exposed to an environment with higher levels of HCHO emissions which raises the profound issue of environmental justice.”

Agency Response [119-Makus-070426-Children Now] : We agree. By requiring the sale and use of lower emitting produc ts in California, HCHO exposures of all Californians will be reduced.196

D. Comments and Agency Responses: 15-day Comment P eriod

1) Comment [1.1-Davis-080203-Regal AQ] : “The process of testing and certifying CWP . . . is a bit complicated. I think a graphic or two showing the various steps that have to be followed . . . wo uld help everyone understand how all the pieces fit together.”

Agency Response [1.1-Davis-080203-Regal AQ] : We appreciate the suggestion and will add a flow chart to our composi te wood products web page. No changes are necessary to the regulation.

2) Comment [1.2-Davis-080203-Regal AQ] : “Has there been any thought to the importance of internet sales of finished produc ts made from CWP that

do not meet emission standards?”

Agency Response [1.2-Davis-080203-Regal AQ] : The Internet sale of noncomplying finished goods into California will be il legal after the respective effective dates. As part of our enforcement effort s, we may purchase finished goods from the Internet for verification t esting and subsequent enforcement investigations, such as is currently do ne for other ARB regulations (e.g., consumer products).

3) Comment [2-Pardy-080205-NA] : “I support efforts to reduce formaldehyde emissions from composite wood products.”

Agency Response [2-Pardy-080205-NA] : Thank you. No response

necessary.

4) Comment [3-Anderson-080212-Eastman Kodak] : “We respectfully request that you and members of the composite wood product implementation team give careful consideration to packaging materi als and pallets. We believe that the most logical approach is to exempt these materials from the ARB requirements.”

Agency Response [3-Anderson-080212-Eastman Kodak] : We disagree. While some pallets and shipping crates are used in warehouses away from exposure to the general public, there are many instances in which there is potential for public exposure to formaldeh yde emissions from wood used in making such packaging materials and pa llets. In addition,

all such material will emit into ambient air in Cal ifornia, and it is those emissions and the resultant public exposure to form aldehyde that we are seeking to reduce by the ATCM. Thus, if packaging materials and pallets are made with composite wood products for use in Ca lifornia, the composite wood products will need to comply with th e emission standards in the ATCM. Pallets and shipping crates made prio r to the effective date197 of the emission standards can still be used. For t he purposes of the ATCM, pallets and crates are considered finished go ods. Pallets made after 2009 will need to be constructed from complyi ng composite wood products and labeled as specified in the ATCM.

5) Comment [4.1-Hard-af-Segerstad-080213-IKEA] : “We would like to suggest that for consumer products which consist of only small surface areas made of composite wood products, there should be a lower limit as to size. Products below this size may be exempted from this regulation.” “The risk of contribution of formaldehyde emission from the small objects could reasonably be considered to be insignificant and not motivate the elaborate measures and third party certification sc hemes which are appropriate for larger panels.”

Agency Response [4.1-Hard-af-Segerstad-080213-IKEA ] : While we agree that emissions of formaldehyde from a small object made of a composite wood product will contribute little to public expos ure, each small object contributes to cumulative public exposure to formal dehyde. Therefore, in lieu of determining the appropriate exemption size, we concluded that it was more fair and comprehensive to not include an e xemption based on size. Also, third party certification is required of manufacturers of composite wood products, not of fabricators of fini shed goods. In this way, when fabricators cut panels into pieces to make fin ished goods, they’ll be assured of using complying composite wood products.

6) Comment [4.2-Hard-af-Segerstad-080213-IKEA] : Curved plywood is not included in the definition of hardwood plywood. “W e would suggest to include a definition of the term ‘curved plywood’ t o indicate that this refers

to material which is manufactured in a curved form from the outset, i.e.

that it does not refer to material which is first m anufactured as panels and only thereafter treated to achieve a curved shape.”

Agency Response [4.2-Hard-af-Segerstad-080213-IKEA ] : After consultation with manufacturers of curved plywood, it is our understanding that most of it is made in a curved press, typicall y with radio frequency curing. Therefore, since there is a standard metho d of manufacture, we assume there is a universal understanding of the de finition. Hence, we

see no need to include a definition.

7) Comment [4.3-Hard-af-Segerstad-080213-IKEA] : “We suggest that this statement (of compliance) can be omitted from the b ill of lading and invoice when transferring panels and finished produ cts between units within the one and the same Corporation (group), on the condition that the required statements of compliance can be made avail able to the enforcement inspector on request.”198 Agency Response [4.3-Hard-af-Segerstad-080213-IKEA] : There are situations in which a corporate business unit in on e part of the country may supply panels or finished goods to a fabricator that is owned by the same corporation, but operated by a manager who nee ds to know whether the materials comply with California standards. Wh ile there may be some situations or supply chains where such knowledge is not necessary, there is no realistic way to craft an exemption that woul d be appropriately limited to such situations. Also, information on the invoi ce or bill of lading is necessary for inspectors to effectively enforce the regulation. Therefore, it is not appropriate to change the requirement.

8) Comment [4.4-Hard-af-Segerstad-080213-IKEA] : “As most furniture consists of a mix of materials . . . we suggest all owing the label to state only the ‘worst’ or most onerous level.”

Agency Response [4.4-Hard-af-Segerstad-080213-IKEA] : We agree. We do not expect a fabricator’s label on a finished go od to identify the emission level for each component part within the f inished good, only the least protective. So, for example, if a finished g ood contained component parts made using Phase 2 composite wood and other c omponent parts made with a ULEF resin, we would expect the label t o state that the finished good is made with composite wood that comp lies with the applicable Phase 2 emission standards. If all of t he component parts used in making the finished good are made with a ULEF re sin, then the finished good can be labeled as having been made with ULEF r esins.

9) Comment [4.5-Hard-af-Segerstad-080213-IKEA] : The commenter interprets Appendix 2 of the regulation to assume “ the Quality Control Manager to be a chemist.” The commenter suggests t hat we modify this section to allow the chemistry specialist to be a d ifferent individual.

Agency Response [4.5-Hard-af-Segerstad-080213-IKEA] : Appendix 2 requires each manufacturing plant to have adequate facilities and staff to perform routine quality control testing of manufact ured composite wood products. Appendix 2 does not specify that the qua lity control manager or staff need to be chemists, just that they have the experience or training to fulfill the role. Alternatively, the quality contr ol testing can be performed by a contract laboratory.

10) Comment [4.6-Hard-af-Segerstad-080213-IKEA] : The regulation requires that each plant have a “plant test facility. For ‘ no formaldehyde added systems,’ this seems a high cost for very few tests . We suggest allowing the use of an accredited laboratory for the initial testing and for whatever test from production that may be needed.”199

Agency Response [4.6-Hard-af-Segerstad-080213-IKEA ] : Appendix 2 of the regulation already allows for the testing to be conducted by “a contract laboratory or a laboratory operated by an approved third party certifier.” Therefore, no change is necessary.

11) Comment [4.7-Hard-af-Segerstad-080213-IKEA] : “We would therefore like to ask for a postponement of the ‘Effective Dates’ with six months. The main issues necessitating a postponement for our co mpany, as well as presumably for other companies with a large part of production located outside the U.S., are the time needed to implement this particular model for quality assurance as well as the time to get ap provals of the third party

certifiers.”

Agency Response [4.7-Hard-af-Segerstad-080213-IKEA] : For many months, we have been actively conducting outreach t o associations and individual companies that represent manufacturers, distributors, importers, fabricators, retailers, and third party certifiers to help inform affected industries of the need to prepare to comply with th e regulation by the effective dates. Our understanding is that several organizations are poised to assume certification responsibilities wel l in advance of the January 1, 2009, effective date. We do not believe that a postponement is

necessary.

12) Comment [5.1-Pitts-080214-Bernhardt] : “The way the ruling is drafted it unfairly affects importers of some product.” “The furniture importers in the

United States who deal with Fabricators in the Far East . . . who buy board from an exponential amount of board manufacturers. These manufacturers are set up to adhere to US, European, Japanese and other

board standards. These standards are similar in na ture to the phase 1 ruling but have a very different test protocol. Th e large chamber test requirement without sufficient lab facilities in th ese areas will create a manufactured demand and bottleneck for procurement. ”

Agency Response [5.1-Pitts-080214-Bernhardt] : We disagree. We believe that all manufacturers will be affected equally. A lso, we modified the originally proposed ATCM to include the option of u sing the secondary test method to address the potential shortage of large c hambers abroad. This should address the issue raised by the commenter.

13) Comment [5.2-Pitts-080214-Bernhardt] : “The cost work that has been provided by the ARB . . . is understated . . . It d oes not take into consideration the body of work in the fabricators, the importer and the

retailer to accommodate the data for chain of custo dy . . . There will be

some board manufacturers who decide that . . . to a ccommodate one state in another country is not worth the extra effort. When these factors other200 than resin cost come into consideration, the real c ost will be substantially greater.”

Agency Response [5.2-Pitts-080214-Bernha rdt] : We disagree and believe that the ISOR accurately identifies the cost of the ATCM, including the costs for out-of-state and out-of-country companies

.

14) Comment [5.3-Pitts-080214-Bernhardt] : “There are several companies who maintain a large inventory in Fabricator wareho uses in the Far East. There is no good mechanism to allow these inventori es to contain specialty products specific to California.”

Agency Response [5.3-Pitts-080214-Bernha rdt] : There are similar

warehouses in the U.S. that also maintain inventori es for different geographic areas. The sell-through provisions in t he ATCM will apply to all such inventories, regardless of location. Beyo nd the sell-through periods, all composite wood products and finished g oods containing composite wood products must comply with the ATCM. It is up to each individual company to either find a way to modify t heir current operations to supply complying products to California, or with draw from the California

market.

15) Comment [5.4-Pitts-080214-Bernhardt] : “The chain of custody as stated is going to overwhelm fabricators and retailers alike. ” “A problem with this flow is the volume of data when the shipment is a c ontainer of product that is consolidated with product from various fabricato rs who have dealt with multiple manufacturers. It would be simpler to sup port a chain of custody that has added verbiage to the BOL (bill of lading) or invoice identifying product compliance and to let this and the label on the finished goods

suffice for the retailer.”

Agency Response [5.4-Pitts-080214-Bernhardt] : We disagree. The chain of custody required by the regulation is consistent with documentation currently used in commerce. Furthermore, the retai ler must keep records to “document the precautions taken to ensure that t he composite wood products and composite wood products contained in f inished goods comply with applicable emission standards.” Withou t such records, the retailer will not be able to demonstrate that they have informed their suppliers of the need for products and goods to com ply with the ATCM and more weight of enforcement would fall on the re tailer rather than the supplier in a situation in which a retailer is foun d to be selling noncomplying products and goods.

16) Comment [5.5-Pitts-080214-Bernhardt] : “The enforcement of the program is always going to be in question.” “The enforceme nt arm is going to raise red flags by using a FLEC device. As of today ther e is no direct201 correlation between the readings of the FLEC cell a nd the large chamber. You have then said that you will use a deconstructi ve test protocol for a final judgment.” “There is still the chance that t he original conditioning period of the board and the secondary test will giv e inaccurate results.” “The number you get for the test will not reflect ‘ real life’ of the finished goods.”

Agency Response [5.5-Pitts-080214-Bernhardt] : Published studies exist that show a good correlation between the FLEC and t raditional chambers. Our enforcement staff will use the FLEC and a porta ble formaldehyde analyzer as a screening tool to help decide whether to purchase panels or finished goods for more comprehensive emissions tes ting at ARB’s lab using one of our enforcement test methods (sections 93120.9(c) and (d)). We have studies underway to allow us to develop a p rotocol for using the FLEC and portable formaldehyde analyzer at manufact urers, distributors, importers, fabricators, and retailers. The results of the FLEC and portable analyzer will not be used as the legal basis for a violation.

17) Comment [5.6-Pitts-080214-Bernhardt] : “They (ARB) could serve humanities interest better by not imposing this rul ing as it is stated within the defined time frame. Or even better, by not goi ng alone and to join with the other states and international agencies in defi ning one acceptable standard that will not create unfair monopolies and actually do the good

that was intended.”

Agency Response [5.6-Pitts-080214-Bernhardt] : While we agree that there is need for international standardization with rega rd to formaldehyde emission standards and testing requirements, the ne ed to protect public health dictates that our ATCM process move forward, rather than waiting

for other states or countries to reach consensus. We will track international developments that relate to standardi zing formaldehyde emission standards and testing requirements, and wi ll modify the regulation at a later date, if warranted due to int ernational standardization.

18) Comment [6-Lantman-080214-SRI] : “As a not-for-profit research institute, we are developing alternative resins and glues to h elp the composite wood product industry meet these new standards. On e example is our new polyketone wood adhesive” “To ensure that our development is aligned with the ATCM and industry needs, we would like to discuss implementation.”

Agency Response [6-Lantman-080214-SRI] : Thank you for your letter. We would be happy to meet with the commenter to dis cuss implementation of the ATCM.202

19) Comment [7-Perdue-080214-AHFA] : “AHFA supports the ‘Proposed Modifications’ as detailed in the ‘15 Day’ version of the ATCM dated

01/31/08.”

Agency Response [7-Perdue-080214-AHFA ]: We appreciate the support

– no response necessary.

20) Comment [8.1-Titus-080214-KCMA] : “We support the revised definition of

‘fabricator’ . . . the revised definition of ‘lamin ated product’ . . . is also supported.”

Agency Response [8.1-Titus-080214-KCMA] : We appreciate the support

– no response necessary.

21) Comment [8.2-Titus-080214-KCMA] : “Currently, the regulation lacks a clear summary page of the effective dates fabricato rs must satisfy in order to be in compliance such as was developed for compw ood manufacturers. We request that such a chart be developed and added to the regulation or made available as soon as possible to assist compan ies in developing their compliance strategy.”

Agency Response [8.2-Titus-080214-KCMA] : We believe the regulation clearly defines the specific requirements affecting fabricators. To assist in clarity, the regulation is organized by affected bu sinesses such as manufacturers, third party certifiers, fabricators, importers, distributors and retailers. However, we will consider adding a char t to our webpage if we determine that it would be useful for the industry.

22) Comment [8.3-Titus-080214-KCMA] : “It is suggested that the clarification provided in Section 93120.7(b)(3) regarding the res ponsibilities of local government agencies and school districts clearly be made applicable to all state government agencies.”

Agency Response [8.3-Titus-080214-KCMA] : The section is appropriate as worded. It was included to comply with state la w regarding the imposition of non-reimbursable costs on local agenc ies and school districts. At least one state agency (the Prison I ndustry Authority, PIA) would be affected if we made the requested change. PIA is a large furniture fabricator. Exempting PIA and other stat e agencies could compromise public health protection.

23) Comment [8.4-Titus-080214-KCMA] : “KCMA generally supports the 18- month sell-through provisions of the regulation.”

Agency Response [8.4-Titus-080214-KCMA] : We appreciate the support –

no response necessary.203

24) Comment [8.5-Titus-080214-KCMA] : “CARB staff deserves recognition for the openness and fairness with which this long and difficult process has been conducted. We anticipate many challenges when the actual enforcement phase begins. Hopefully, the same appr oach will continue.”

Agency Response [8.5-Titus-080214-KCMA] : We appreciate the comment. We fully intend to continue our interacti ve approach.

25) Comment [9.1-Earnshaw-080214-Hexion-NZ] : “The MDF manufacturers currently export Composite Wood Panels both as raw board and as finished goods to California at E1 emission levels (equivalent to CARB P2). In addition these manufacturers already utilize ULE F resin technology for product exported to Japan. We believe the Board sh ould acknowledge the use of this technology in the new regulations. If there was appropriate recognition these products would be immediately ava ilable to Californian consumers, which in turn would drive industry more quickly to the lower

emission levels.”

Agency Response [9.1-Earnshaw-080214-Hexion-NZ] : We understand that many composite wood products that comply with other international standards may meet the CARB P2 standard and the ATC M does not restrict the use of a particular technology used to produce complying products. However, key components of the ATCM, suc h as third party certification, quality assurance requirements, and chain of custody, are either lacking or greatly diminished in alternate i nternational certification schemes. Furthermore, the Phase 1 and Phase 2 stan dards are based on emissions testing conducted in dynamic testing cham bers. We strongly believe it is necessary to base certification of co mposite wood products on dynamic emissions tests, not by static emissions me thods or measurements of formaldehyde content as is done in the other programs. See also the Agency Response to comment # 26 in sec tion D of the

FSOR.

26) Comment [9.2-Earnshaw-080214-Hexion-NZ] : “The requirement for each plant to provide a correlation for the QC method to the primary or secondary method is costly and unnecessary in many cases, in particular
where the QC method is well established and an acce pted method documented in a recognised [sic] standard (eg JIS 1 460). Our

recommendation is that the Board set limit values f or these known and accepted QC test methods which form part of nationa l and international standard test methods for composite wood panels. A lso to ensure consistency among QC standard methods the manufactu rer would conduct a series of tests in conjunction with the t hird party certifier. We agree that the primary, secondary or alternative se condary methods should be used for compliance testing.”204

Agency Response [9.2-Earnshaw-080214-Hexion-NZ] : We disagree. There is a need to develop plant by plant correlati ons to account for process variability. Also, given that violations w ill be issued for emissions standard exceedances, it is necessary for plants to accurately target their operations limits to ensure compliance. Although w e recognize the validity of other test methods (e.g., JIS 1460 or EN- 120), as mentioned in the Agency Response to comment # 25 in section D of the FSOR, the

Phase 1 and Phase 2 standards are based on values d etermined from dynamic chambers, which are operated under differen t conditions and loading rates. The European EN-120 and the Japanes e JIS 1460 are test methods which achieve the intent of their respectiv e certification programs. The ARB regulation limits surface emissions from co mposite wood products and the dynamic chambers offer the most ac curate measure of surface emission rates under realistic testing cond itions as they relate to actual exposure. Furthermore, manufacturers can re quest from ARB the use of alternative QC test methods under 93120.12, Appendix 2 (g)(1)(c).

27) Comment [9.3-Earnshaw-080214-Hexion-NZ] : “We believe that CARB should recognize other product certification scheme s that provide for emission specifications lower than the Phase 2 limi ts. Our belief is that

the JIS Mark certification scheme for Particleboard and MDF offers this equivalency and request that CARB offer exemptions from the requirement to have third party certification if a panel product is certified to

the JIS Standard F*** and F  emission levels.”

Agency Response [9.3-Earnshaw-080214-Hexion-NZ] : We disagree. If products meet the JIS F** * and F**** rating, then t he resin technology will be adequate, so confirmatory testing is all that is necessary. See also the Agency Responses to comments # 25 and 26 in section D of the FSOR.

28) Comment [9.4-Earnshaw-080214-Hexion-NZ] : “The board has made changes to the requirement for exemption to the thi rd party certification

scheme and has identified that both NAF and ULEF bi nders can apply for exemption. We agree with this approach. However w e have concerns that the clauses relating to the application approv al process and to terms of the exemption for these two classes of binders a re different. In the provisions 93120.3 C (1) for exemption from the thi rd party certification requirements for NAF resins the manufacturer has to supply QC data for 3 months demonstrating acceptable emissions. However in the provision 93120.3 d (2) for exemption from third party certif ication for ULEF resins the manufacturer has to supply 6 months of data. T here is a further discrepancy in the wording of provision 93120.3 d f or ULEF resins. This section also states that if the exemption from thir d party certification is granted the manufacturer still has to meet all the other provisions of 93120.3 d (1). This is problematic in two ways. F irstly this is not a205 requirement for exempt NAF resins and secondly the meaning is ambiguous given that the requirement in 93120.3 d ( 1) is for reduction in testing frequency. We believe that there is no jus tification for this discrimination and request that CARB modify the reg ulation to have the same requirement for ULEF and NAF resins. There is also a need to clarify what requirements of provision 93120.3 d (1 ) still apply to manufacturers who are exempt from third party certi fication if indeed this

is the intention of the board.”

Agency Response [9.4-Earnshaw-080214-Hexion-NZ] : We disagree that the requirements for exemption discriminate against ULEF resins. First, it must be understood that no-added formaldehyde (NAF) based resins and ULEF resins are chemically distinct and represent d ifferent approaches to lowering or eliminating formaldehyde emissions from composite wood products. ULEF resins are subject to more scrutiny for the very fact that they still contain formaldehyde as a major componen t of the resin mixture. Given this fact, emissions could vary significantly based on factors such as errors in resin formulation by the end user (mil l), changes in press times or changes in press temperature. We feel the se factors warrant more rigorous qualifying criteria than no-added for maldehyde based resins. With respect to the wording of provision 93120.3(d) , the section indicates that “all other requirements of section 93120.3(d)( 1) apply,” in reference to the requirements other than testing requirements. This reference is in relation to the contents of the ULEF application. In other words, 93120.3(d)(1) applies in that it defines the elemen ts of the application, including a statement of product types, chemical fo rmulation and name of the ARB approved third party certifier.

29) Comment [9.5-Earnshaw-080214-Hexion-NZ] : “It may well be the case that a manufacturer could apply for an exemption fr om third party certification and we believe that it is unnecessary for manufacturers to include third party certification bodies when apply ing for exemption. This may be critical in some regions given the potential lack of third party certifiers. However there are likely to be far mor e laboratories that have the necessary competencies to carry out emission te sting to the required primary or secondary testing methods. We therefore request that CARB modify the regulation to allow applications from ma nufacturers to be exempt from third party certification who provide t he required data for formaldehyde emissions that have been analysed [sic ] by a laboratory certified by an accreditation body signatory to ILA C 2000. This will provide the board with the requisite assurance that the emission values

are valid.”

Agency Response [9.5-Earnshaw-080214-Hexion-NZ] : We disagree. Involvement of third party certifiers is a crucial component that adds enforceability to the ATCM. Only third party certi fiers that can206 demonstrate the ability to generate high quality da ta will be ARB approved. Given that an approval will exempt manufacturers fr om independent testing, it is appropriate to require high quality emissions data.

30) Comment [9.6-Earnshaw-080214-Hexion-NZ] : “We also seek clarification or rectification of an apparent error in Appendix 2 . In section 4 A the regulation states: ‘. . . Manufacturers of PB and MDF that use ULEF resins and have received ARB approval under section 93120.3(d) must conduct routine quality control tests at least week ly for each production line for each product type’. This requirement seem s at odds with the requirements of section 4B: ‘Testing frequency may be reduced to no less frequently than one test per 48-hour production per iod when the plant or production line demonstrates consistent operations and low variability of test values to the satisfaction of the third party certifier, based on criteria established by the certifier.’ ”

Agency Response [9.6-Earnshaw-080214-Hexion-NZ] : Section 93120.12, Appendix 2, subsection (g)(4)(A) describes basic te sting frequency for PB and MDF, which is once per shift. The subsection a lso includes the reduced testing frequency for PB and MDF made using ULEF resins, which is at least weekly. Subsection (g)(4)(B) des cribes reduced testing frequency for PB and MDF made with traditional UF r esins. Hence, there is no inconsistency.

31) Comment [9.7-Earnshaw-080214-Hexion-NZ]: “We have concern about the availability of resources to service internatio nal manufacturers. Currently there is no indication that there are any third party certifiers in the Asia-Pacific region. This will be a major prob lem in the ability of manufacturers to meet the requirements of this regu lation. The ability to use US resources is impractical (shipping to the US for testing is not an option as the 30 day test period could not be met) and currently there are no chambers compliant with the E1333 method availab le in our region.”

Agency Response [9.7-Earnshaw-080214-Hexion-NZ]: We believe there

will be sufficient resources available. It is our understanding that several certified testing facilities exist globally, and we are aware of third party certifiers that have expressed interest in providin g services to the AsiaPacific region. Also, we understand there may be l imited availability of large chambers, which is why the regulation was mod ified to allow the use of a secondary method that is demonstrated as equiv alent to the large chamber method. See also the Agency Response to co mment # 103 in

section C of the FSOR.

32) Comment [9.8-Earnshaw-080214-Hexion-NZ]: “The sell through dates of 1st of April are impractical for importers and over seas manufacturers and207 we therefore request that the sell through date of 1 July 2009 be established for these categories.”

Agency Response [9.8-Earnshaw-080214-Hexion-NZ]: We disagree. In order to be as fair as possible to both manufacture rs and importers of panels, we modified the sell-through periods for ma nufacturers and importers of panels so that both would have a sell through period of three months. We feel this provides a reasonable comprom ise, which

addresses the concerns of stakeholders that an inco nsistency between the sell-through periods for manufacturers and impo rters would have created unfair advantages for some.

33) Comment [9.9-Earnshaw-080214-Hexion-NZ]: “Compliance testing requires correlations to be determined between alte rnative secondary methods and the primary method. These correlations are not required for enforcement testing. This is inconsistent. In add ition, for enforcement testing of finished goods, the primary method is no t applicable and is therefore not included in 93120.9(c). In order for enforcement and compliance to be consistent this would require ARB to demonstrate equivalence between secondary or alternative second ary methods and the primary method. If ARB is required to develop corr elations for enforcement testing then it would be recommended th at these correlations are published as standards.”

Agency Response [9.9-Earnshaw-080214-Hexion-NZ]: The ATCM specifies that the secondary test method or alterna te secondary test method may be used for enforcement testing. For a small chamber to be used as a secondary test method, the equivalence re quirements of section 93120.9(a) must be met. Because the small chamber used for enforcement testing must be deemed equivalent to th e primary method, we deleted the correlation requirement for the enfo rcement method.

34) Comment [10-Mann-080215-IBM] : “While IBM supports the goals of the ATCM to reduce formaldehyde emissions, we believe t hat the application of the requirements to pallets and crates . . . wil l be extremely burdensome . . . and unnecessarily conservative giv en the expected use and exposures . . . Pallets and crates may be reuse d many times making it difficult if not impossible to track their origi nal manufacturer . . . pallets and crates used in packaging applications do not be come a permanent part of the indoor environment . . . we do not beli eve that potential emissions from these materials contribute significa ntly to a person’s total daily exposures, and request that they be exempted from the ATCM requirements.”

Agency Response [10-Mann-080215-IBM] : We disagree. Although it is true that pallets and crates do not become a perman ent part of the indoor208 environment, pallets or crates made from composite wood products have the potential for high formaldehyde emissions while they are in California. See also the Agency Response to comment # 4 in sect ion D of the FSOR.

35) Comment [11.1-Zimmerman-080215-Sauder] : “Changes in the language for sell-through for the Fabricator section page 45 may be more confusing . . . This wording change seems to allow a Fabricator to continue using non-complying composite panels in th eir manufacturing processes till June 30th 2010 and sell into Califor nia. Do we as a Fabricator have till June 30th 2010 to comply?”

Agency Response [11.1-Zimmerman-080215-Sauder] : That is correct. The intent of this sell-through provision is to all ow fabricators to continue producing goods with their existing stocks of non-c omplying composite wood products that were produced prior to the Phase 1 and Phase 2 implementation dates. This gives fabricators time to completely deplete their stocks of non-complying product. If a fabric ator has non-complying product left over after expiration of their respect ive sell-through period, they can no longer use that product to produce good s that would be sold

in California.

36) Comment [11.2-Zimmerman-080215-Sauder] : “The proposed finished product enforcement testing still lacks validation scientifically . . . it may be impossible to know whether or not a finished compos ite panel was or was not compliant to the Regulation.”

Agency Response [11.2-Zimmerman-080215-Sauder] : We disagree. The finished product enforcement testing will be capabl e of detecting composite wood products which do not meet our emiss ion standards.

37) Comment [11.3-Zimmerman-080215-Sauder] : “The regulation does not promote the use of lower emitting composite product s use by the Fabricators . . . Is there not an off-set possible by reducing the paper work or tracing requirements or recognition?”

Agency Response [11.3-Zimmerman-080215-Sauder] : We appreciate the comment; however, at this time we do not feel it wo uld be prudent to weaken the chain of custody requirements in exchang e for the exclusive use of products made with no-added formaldehyde bas ed resins or ULEF resins. Without adequate documentation, fabricator s would not be able to provide evidence that they purchased complying comp osite wood products. In terms of recognition, in addition to the ARB label, fabricators could certainly indicate on a product brochure, tag , or company website that they use exclusively no-added formaldehyde bas ed resins or ULEF resins in the production of their product. If a fi nished good contains only HWPW, MDF and/or PB that is made from no-added form aldehyde based209 resins or ULEF resins, fabricators must label the f inished good as such (see section 93120.7(d)(1)).

38) Comment [11.4-Zimmerman-080215-Sauder] : “Will there be more specific labeling requirements, such as font and size and sp ecific wording for the CARB Phase I Compliant? Will there be specific wor ding for Bill of Lading

and Invoices?”

Agency Response [11.4-Zimmerman-080215-Sauder] : The specific details of labeling will be up to the fabricator bu t the label must be legible and contain, at a minimum, the information specifie d in section 93120.7(d)(1).

39) Comment [12.1-Fernandez-080215-Arauco] : “We notice that MDF moldings are not considered to be part of the defin ition of ‘Medium density fiberboard (MDF)’, thus it is considered to be a ‘F inished good’ and not a ‘Composite wood product.’ Therefore, we understand that producers of MDF moldings are considered to be ‘Fabricators’ and not
‘Manufacturers.’ ”

Agency Response [12.1-Fernandez-080215-Arauco] : A producer of molding is considered to be a fabricator by cutting molding from MDF manufactured by an MDF manufacturer. Conceivably, a company could

be both a manufacturer of MDF and a fabricator of m olding. In either case, at a minimum the MDF used to make the molding must comply with the emission standards in 93120.2(a).

40) Comment [12.2-Fernandez-080215-Arauco] : “We think the ATCM is not clear enough in describing what a ‘Laminated produc t’ is. In the case of our MDF moldings, we use a Jesso coating as a prime r for all of them. Should we consider our MDF moldings to be a ‘Lamina ted product’ since the primer can be considered to be affixed to our p roduct?”

Agency Response [12.2-Fernandez-080215-Arauco] : We disagree. We feel the ATCM is clear in defining both a “laminate ” and a “laminated product.” It is our understanding that Jesso is ap plied as a coating (more like paint) and is not a distinct veneer or other m aterial that is “affixed” to the MDF substrate. As such, manufactures of MDF co ated with Jesso

would not be considered fabricators of a laminated product.

41) Comment [12.3-Fernandez-080215-Arauco] : “We think that for a fabricator that manufactures composite wood products exclusive ly to produce laminated products, there is no certainty on whethe r being required to comply or not with section 93120.3.”210 Agency Response [12.3-Fernandez-080215-Arauco] : If a fabricator is also a manufacturer of the composite wood substrate, the n the fabricator would also be considered a manufacturer and would be requ ired to comply with

section 93120.3.

42) Comment [12.4-Fernandez-080215-Arauco] : “For foreign fabricators that manufacture composite wood products used to produce finished goods, we think that it is unnecessary to require these CW P to comply with the ATCM standards. Instead, we think that the standar d should apply to the final goods being introduced into California. Form aldehyde emissions are reduced from the time the composite wood products a re produced until they are finally transformed into finished goods an d shipped . . . Samples are taken before packaging and after the primer is applied, to have a

closer estimation of what the final customer will b e perceiving. At this stage is where we think the tests should be done, s ince formaldehyde

emissions are known to be reduced in time.”

Agency Response [12.4-Fernandez-080215-Arauco] : We disagree. Section 93120.12, Appendix 2, subsection (g) states that “each manufacturing plant shall conduct small scale quali ty control tests for each product type and production line to ascertain that its certified panels do not exceed the applicable emission standard.” Manufact urers of composite wood products are required to comply with the appli cable sections of the ATCM. We understand that a significant amount of t ime may elapse between the production of a composite wood product and its arrival for sale in California. However, off-gassing of produc t is no guarantee that it will comply with the Phase 1 or Phase 2 standards o nce it arrives in California. Data show that off-gassing can occur o ver several months or years. Additionally, the fundamental approach to t he regulation is to reduce surface emissions by eliminating the source.

43) Comment [13.1-Morgan-080215-IWPA] : “U.S. importers have no concerns about the ability of overseas manufacturers to meet the ATCM formaldehyde emissions levels. However, none of th e other formaldehyde

emissions standards in the world have the same cert ification requirement.” “The ATCM places significant new requirements on pr oducers around the world.” “Our major concern to IWPA members is the unnecessary, burdensome, costly, and inefficient requirement of third-party testing and certification.” “Requiring large-scale and small-s cale chamber testing and third-party auditing in all countries supplying har dwood plywood to the U.S. places a significant non-tariff barrier against tra de with those countries and raises possible WTO violations.” “It is highly unl ikely that developing countries that do not have the same economy of scal e of larger countries (e.g., China) will still be able to compete and sup ply these high-quality products to the U.S. market.” “The ATCM can be jus t as effective as a performance-based standard only.” “Product can mee t the standard, but if211 certain chain-of-custody documentation is not met s howing third-party testing, then enforcement would still occur. This is specifically why IWPA feels the third-party certification requirement add s cost but not gain for California taxpayers.” “If the third-party testing requirement cannot be eliminated, IWPA strongly urges ARB to consider oth er testing methods.” “ARB’s standard . . . requiring developing countrie s to construct largescale or small-scale chamber tests . . . (which) do not currently exist in all the countries that export to the U.S., requiring si gnificant investment and potentially creating a WTO non-tariff barrier to tr ade.”

Agency Response [13.1-Morgan-080215-IWPA] : This ATCM is designed to address a serious public health concern. We bel ieve that third party certification is essential to ensure that complying composite wood products are sold and used in California. It is th erefore not appropriate to eliminate or weaken this requirement. However, the ATCM does allow alternate test methods to be used if approved by th e Executive Officer. This should provide flexibility for many manufactur ers.

The commenter suggests that the ATCM may violate Wo rld Trade Organization (WTO) agreements because it “places a significant non-tariff barrier against trade.” We do not agree that the A TCM violates any WTO rules. The ATCM does not discriminate against enti ties in other countries because all affected parties -- both domestic and f oreign -- are subject to the same requirements. While we do not believe tha t the ATCM constitutes a trade restriction, the WTO recognizes that member nations may adopt their own environmental regulations to pr otect public health

even if such regulations restrict trade. Article XX of th e General Agreement on Tariffs and Trade (GATT) outlines the general exceptions to

WTO rules -- the conditions under which trade restr ictions are exempt from legal challenge. Under this Article, WTO memb ers may adopt traderestrictive measures for a variety of specified rea sons, including

measures:

i) necessary to protect human, animal or plant life or health; [and]

ii) relating to the conservation of exhaustible nat ural resources, if such measures are made in conjunction with restrict ions on domestic production and consumption.

Environmental regulations imposed under Article XX must not be "arbitrary or unjustifiable discrimination between countries w here the same conditions apply" or "a disguised restriction on in ternational trade." These qualifiers are designed to prevent a nation from im posing environmental regulations that are simply disguised protectionism

.212 We believe that the ATCM meets these criteria and i s a valid regulation under WTO rules. The ATCM has been adopted to prot ect public health, is based on sound science, and is not a disguised t rade restriction. It is worth pointing out that many other WTO member natio ns (e.g., Japan and European Union countries) have also adopted their o wn regulations to limit formaldehyde emissions from composite wood pr oducts. Since other WTO members have adopted such regulations in recogn ition of the health problem posed by formaldehyde emissions, it is diff icult to argue that a similar regulation adopted in California is an ille gal trade barrier under

WTO rules.

44) Comment [13.2-Morgan-080215-IWPA] : “ARB staff knows that they are behind in the implementation schedule and recognize the importance of overseas outreach, including translating the standa rd. However, more than 20 countries supply product to the U.S., and o nly the ARB Fact Sheets have been translated (not the ATCM) and thos e Fact Sheets have been translated into only three languages. IWPA st rongly urges ARB to delay implementation until twelve months after ARB approves a third-party certifier.” “Has ARB officially contacted each cou ntry through its embassy

and related trade associations to inform them of ne w requirements? Has ARB determined the existing large-scale chamber cap acity in each country? Has ARB developed a timeline for how long it will take to construct/certify acceptable facilities?” “Will th e regulation also be translated into foreign languages? Has ARB begun e ducating composite wood fabricators, customers, and consumers in Calif ornia about the regulation?” “An alternative for importers could b e a moratorium on enforcement of the third-party certification requir ement if the product is otherwise compliant. Therefore, product entering C alifornia with formaldehyde levels below the emissions levels but not certified would not be considered in violation of the regulation for th e first year, through 2009. This would provide more time for third-party certif iers to come on line.” “The effective date for Phase 1 is January 1, 2009. Can this target date still be justified given that the regulations are n ot finalized yet, that no overseas auditors are approved, and that we have no clear understanding for capacity that exists overseas to meeting the st andard nor do we know if each country has been informed by ARB of the sta ndard?”

Agency Response [13.2-Morgan-080215-IWPA] : ARB staff has already given presentations at two IWPA workshops and confe rences, and held numerous meetings with member companies for over tw o years. We will continue our outreach efforts to affected groups, i ncluding third party certifiers to facilitate implementation. We believ e there should be sufficient capacity for third party certification l ater this year in advance of

the Phase 1 effective date.213

45) Comment [13.3-Morgan-080215-IWPA] : “IWPA again requests . . . that ARB lengthens the ‘sell-through’ period in the ATCM to six months for importers and 12 months for distributors.” “Import ers need much more time than just a three-month sell-through period to move product.”

Agency Response [13.3-Morgan-080215-IWPA] : We disagree. We discussed the length of the sell-through period for importers prior to our Board hearing in April 2007. At that time, the Boa rd decided to provide the same sell-through period for manufacturers and importers of panels: three months. This was done to provide fairness to domestic producers and to accelerate the health benefit from imported composite wood products. The sell-through period for distributors of panels is not subject to comment because it was not modified prior to our Board hearing. Hence, it must remain five months.

46) Comment [13.4-Morgan-080215-IWPA] : “The world measures formaldehyde concentration in water in milligrams ( mg) and milliliters (ml).” “Has ARB analyzed the capacity of overseas producer s to measure in ppm?” “Is ARB prepared to develop a correlation va lue for use by world producers? IWPA requests that ARB allow for a meas ure of formaldehyde concentration in water in milligrams per liter and urges that a specified standard be included in the regulation.”

Agency Response [13.4-Morgan-080215-IWPA] : If overseas producers and third party certifiers follow ASTM methods for routine quality control testing and quarterly testing, the results of testi ng will be in parts per million (ppm), so this should not be an issue. How ever, section 93120.12, Appendix 2, subsection (g)(1)(C) would allow an ove rseas producer to be approved by the Executive Officer to use an alterna te test method which could measure concentrations in mg or ml. In that case, the third party certifiers will need to work with overseas producer s to develop such correlations so the results may be reported to the certifier in ppm for comparison to the emission standards.

47) Comment [13.5-Morgan-080215-IWPA] : “There is a requirement that the bundle or panel must be labeled with the ‘Manufactu rer name.’ IWPA suggests that the regulation be amended so that a c ode for the manufacturer’s name may be used. That code would b e maintained by the third-party certifier and the importer.”

Agency Response [13.5-Morgan-080215-IWPA] : For the chain of custody system to work for enforcement of the ATCM, the man ufacturer must be identified on each panel or bundle of panels. See also the Agency Response to comment # 76 in section C of the FSOR.214

48) Comment [14.1-Julia-080215-CPA] : “CPA respectfully requests that the sell-through period for distributors, importers and fabricators of finished goods be established at twelve months rather than t he eighteen months.”

Agency Response [14.1-Julia-080215-CPA] : Prior to the Board hearing in April 2007, we were asked to extend the sell-throug h of finished goods from twelve months to eighteen months. We made tha t change in the modified regulation that was presented to the Board in light of inventory turnover concerns by fabricators and we see no reas on to reduce the period back to twelve months.

49) Comment [14.2-Julia-080215-CPA] : “Accreditation of Third Party certification agencies, may not occur until at leas t April 22 nd .” “ULEF manufacturers need to work with an approved third p arty agency to collect six months of quality data and conduct two ‘quarter ly’ compliance tests, presumably three months apart.” “CPA has three sug gestions that could resolve this potential bottleneck. First, grant ‘p rovisional’ ULEF approval . . . prior to December 31, 2008. Second, shorten the quality control test requirement period to 3 months, matchi ng the requirement for No Added Formaldehyde (NAF) products. Third, requi re that the full data

set of information be submitted for final evaluatio n and approval within a year of receiving provisional approval. If these s uggestions are accepted, similar treatment should also be given to NAF appli cants.” “A secondary issue relating to both ULEF and NAF product manufac turers preparing an application for approval regards the frequency of t esting . . . Testing frequency for ULEF/NAF products is not set forth in Appendix 2.” “CPA believes that excessive sampling is unnecessary to prove that emissions from these products are very low. We believe quali ty control testing frequency should be no more often than once per wee k per production line or once with every new lot of purchased adhesive, w hichever is less frequent, as long as at least 6-10 data points are developed.”

Agency Response [14.2-Julia-080215-CPA] : We appreciate the suggestions, but do not believe that granting “prov isional” approvals is appropriate. The requirement for quality control d ata is longer for ULEF (six months) than no-added formaldehyde based resin s (three months) because while these are ultra-low emitting resins, the resins still contain formaldehyde. See also the Agency Response to comm ent # 28 in

section D of the FSOR.

It is important to collect adequate data for such r esins. Frequency of testing is the same for all manufacturers. The fre quency only changes if a manufacturer using ULEF resins is allowed to test l ess frequently, or a manufacturer using a no-added formaldehyde based re sin or ULEF resin is granted exemption from third party certification and routine QC testing. Manufacturers may at their own risk work with reput able potential215 candidate third party certifiers prior to ARB appro val. If ARB approves the third party certifier, then all data generated by t he approved certifier will be acceptable.

50) Comment [14.3-Julia-080215-CPA] : “CARB has . . . inserted . . . provisions for laminated products.” “Although we b elieve that the concept is sound . . . there are four potential problems in the way in which the change has been implemented in Section 93120.7.” “ The definition of fabricator in Section 93120.1(12) already includes ‘producers of laminated products.’ The reference to both in the new sectio n (93120.7(a)(2)) is superfluous and potentially confusing.” “If lamina tion is being conducted by the same company that produced the platform, the literal language in Section 93120.7(a) would make the underlying produc tion of the substrate exempt from third party certification. This is a h uge loop hole.” “Even if one were to favor the exemption from third party ce rtification, the language as drafted is overly broad.” “It should be clarifi ed that Subsection 2 does not apply in situations in which the fabricator als o manufactures the

substrate.”

Agency Response [14.3-Julia-080215-CPA] : We believe the definition of a fabricator is clear and that section 93120.7(a)(4) clarifies any possible confusion raised by the wording in section 93120.7( a)(2). Fabricators that manufacture composite wood products for use as a pl atform must comply with the manufacturer requirements in section 93120 .3, except the product labeling requirements. Fabricators that apply a la minate to a platform to make a laminated product do not need to comply with third party certification requirements in section 93120.3(b) fo r those laminated products.

51) Comment [14.4-Julia-080215-CPA] : The modified regulation states in the definition of “finished goods” that “component part s are not ‘finished goods.’ ” “A potential problem could arise in the situation in which panels are sent to a separate facility for the production of furniture or cabinet components. As a result of the proposed change, su ch a facility would neither be a manufacturer of composite wood product s . . . nor a fabricator of finished goods.” “We suggest that this sentence be eliminated.”

Agency Response [14.4-Julia-080215-CPA] : We disagree. The regulatory language is clear. The language regarding componen t parts not being finished goods was added so that intermediate compo nent parts do not need to be labeled, as required for finished goods.

52) Comment [14.5-Julia-080215-CPA] : “There are at least two areas that require immediate attention if there is to be smoot h implementation of the rule: accreditation of third party certification p rograms and the completion of an enforcement testing protocol for rule complia nce.” “It is therefore216 critical to the affected industries that the accred itation of third party certification programs and the completion of an enf orcement testing protocol for rule compliance be finalized no later than the end of the second quarter of 2008.”

Agency Response [14.5-Julia-080215-CPA] : We are continuing to work with potential third party certifiers to be able to start reviewing their applications to be approved by ARB as soon as possi ble after the ATCM is codified in the California Code of Regulations. Our Enforcement and Monitoring & Laboratory Divisions continue to prepa re for completing an enforcement testing protocol this year. Table VI-7 on page 127 of the ISOR includes an implementation schedule to address this concern. At this time, we are on track to achieve the schedule.

53) Comment [14.6-Julia-080215-CPA] : Regarding section 93120.12, Appendix 2, (f)((3)(A), “CPA submits that there is an unnecessarily large number of chamber tests required in the ATCM.” “Th e daily quality control tests collected every eight to twelve hours will ve rify that the plant is in control; it should not be necessary to collect more than one quarterly test (randomly sampled) from each plant.”

Agency Response [14.6-Julia-080215-CPA] : We believe that it is essential to verify a plant’s operations for each product typ e, rather than just each plant.

54) Comment [14.7-Julia-080215-CPA] : For clarification: “Section 93120.9(a)(2)(A). The second sentence should read: ‘In addition, when testing panels the secondary method shall be operat ed by testing nine specimens representing evenly distributed portions of an entire panel or set of panels selected for verification .’ ”

Agency Response [14.7-Julia-080215-CPA] : We believe that this is clear

as written and that no additional clarification is needed.

55) Comment [14.8-Julia-080215-CPA] : For clarification: “Section 93120.9(a)(2)(B)(2). The first sentence should rea d: ‘For the secondary method, each comparison sample shall consist of tes ting nine specimens representing evenly distributed portions of an enti re panel or set of panels selected for verification .’ ”

Agency Response [14.8-Julia-080215-CPA] : We believe that this is clear

and that no additional clarification is needed.

56) Comment [14.9-Julia-080215-CPA] : For clarification: “Appendix 2(a). The note at the end of the second paragraph should read : ‘Note: All panels217 must be tested in an unfinished condition, prior to application of a laminate, finish

or topcoat.’ ”

Agency Response [14.9-Julia-080215-CPA] : The note reads: “prior to application of a finishing or topcoat.” In the cas e of HWPW, a veneer or laminate would have already been applied before it would be considered a panel. We see no need for clarification.

57) Comment [15.1-Wald-080215-RVIA] : “Until very recent drafts of the ATCM, wood products used to fabricate RVs were exempt fro m the regulation.” “The RV industry uses a great deal of very thin and lightweight but durable luan and meranti product that can only be produced from trees that grow in Asia and therefore must be imported from Asia.” “Because RVs as a fabricated product are being added to the ATCM so c lose to the implementation date of the standard, because the RV industry is so dependent on thin Asian wood products and because o f the longer salescycle of the RV industry especially in today’s diff icult economic environment, the effective date of the ATCM should be: 1) Delayed for one year or 2) The RV industry should be exempt fro m the first phase of the implementation and come under the regulation fu lly compliant at the

Phase 2 standards and timetable.”

Agency Response [15.1-Wald-080215-RVIA] : We believe that with the sell-through provisions for fabricators, which appl y to manufacturers of recreational vehicles, there will be no need for ad ditional time and see no need to delay the implementation date for the RV in dustry.

58) Comment [15.2-Wald-080215-RVIA] : “The luan and meranti wood is currently certified to meet JIS and/or European E-1 standards . . . CARB should simply accept these equivalent or better sta ndards and certifications rather than insisting all wood produ cts meet the expensive CARB third-party certification requirements.” “CAR B’s recognition and acceptance of equivalent or better international st andards such as JIS A1460 without additional third-party testing will a llow an efficiency of manufacture, testing and certification for Asian lu an and meranti producers that will significantly reduce the RV ind ustry’s concerns about adequate supply of compliant wood products used in the RV fabrication process under the ATCM.”

Agency Response [15.2-Wald-080215-RVIA] : The enforcement and certification requirements for international formal dehyde standards are less stringent and different from those required in the ATCM. Accepting

those standards could weaken the benefits of the AT CM and lead to sale of non-complying wood in California. See also the Agency Response to

comment # 25 in section D of the FSOR.218

59) Comment [15.3-Wald-080215-RVIA] : “When final stage fabricators such as RV manufacturers in good faith purchase and use wood products that meet the CARB standard and have the required chain of evidence of ATCM compliance, the ATCM should explicitly state t hat the fabricator is not subject to enforcement should the wood product not live up to the CARB standard for emissions.” “While a November 2, 2007, draft of a

letter from CARB to fabricators describes minimum r ecord-keeping requirements as guidance for compliance, this type of clear guidance for

fabricators is absent in the ATCM itself and should be incorporated.”

Agency Response [15.3-Wald-080215-RVIA] : We disagree. Each instance in which non-complying wood products are f ound will prompt a case-by-case investigation by our enforcement staff . The result of the investigation will determine which entity or entiti es in the chain of

commerce from manufacturer to retailer warrant enfo rcement action.

60) Comment [15.4-Wald-080215-RVIA] : “Some RV fabricators may choose to fabricate products that do not comply with the CARB standard but not sell or offer for sale those products in California. CA RB should explicitly state that the final stage fabricator is not subject to e nforcement should an RV dealer or other individual offer such a non-complyi ng product for sale in California without the knowledge of the final stage fabricator.”

Agency Response [15.4-Wald-080215-RVIA] : We disagree. Each instance in which non-complying wood products are f ound will prompt an enforcement investigation to determine which entity or entities receive

enforcement action. If a retailer is found to be k nowingly selling noncomplying products without the knowledge of the fab ricator, and the fabricator had not labeled the products as being co mplying for sale in California, such a retailer will likely be held dir ectly responsible for

violations of the emission standards.

61) Comment [16.1-Harmon-080215-Hexion] : In section 93120.1(a)(19), “hardwood plywood,” “the inclusion of ‘lumber core, special core material and special back material’ in this definition excee ds the scope of composite wood products. Further, the formaldehyde emission characteristics of ‘lumber core, special core mater ial and special back material’ are not adequately addressed in limitatio ns expressed elsewhere in the regulation.”

Agency Response [16.1-Harmon-080215-Hexion] : We included those materials in the definition of “hardwood plywood” t o improve the completeness of the definition, in response to comm ents by stakeholders. We see no need to refer to these materials with reg ard to limitations

elsewhere in the ATCM.219

62) Comment [16.2-Harmon-080215-Hexion] : Regarding section 93120.1(a)(34), “platform,” “as this ATCM provides emissions limitations only for particleboard, medium density fiberboard a nd hardboard plywood, it is inappropriate to include lumber core or speci al core materials in this definition – as there are no guidelines regarding e missions for these exotic combinations. Additionally, no guidance is given i n the primary or secondary testing methods to cover these materials. ”

Agency Response [16.2-Harmon-080215-Hexion] : Those materials are included in the definition for the completeness of the definition. See also the Agency Response to comment # 61 in section D of the FSOR.

63) Comment [16.3-Harmon-080215-Hexion] : Regarding section 93120.1(a)(36), “plywood,” “for clarity, plywood ha s been historically made

from veneers. Previous definitions have covered th e use of particleboard, MDF and other materials (§ 93120.1(a)(4 & 6) in pla tforms, and it is recommended that reference to adhesively-bonded com ponents other

than veneer be eliminated from this definition.”

Agency Response [16.3-Harmon-080215-Hexion] : We believe the definition is sufficiently clear, complete, and app ropriate. No change is necessary to the definition.

64) Comment [16.4-Harmon-080215-Hexion] : Regarding section 93120.1(a)(37), “product type,” “it is recommended that this definition be expanded to clarify at this point that the option e xists to group individual products by major characteristics. Such regrouping into classes is most commonly based on identifying those products that h ave similar emission characteristics, based on both QC testing and TPC t esting results.” “This is an issue and practice with which the US manufact urers and US TPC agencies are generally accustomed and comfortable. It is reasonable that

this be clarified for others.”

Agency Response [16.4-Harmon-080215-Hexion] : We believe this is clear in the testing requirements described in section 93 120.12, Appendix 2.

65) Comment [16.5-Harmon-080215-Hexion] : Regarding section 93120.1(a)(43), “third party certifier,” “it is rec ommended to add to this definition: ‘. . . and operates, and/or contracts testing with, a laboratory that is accredited by a signatory to the Internatio nal Laboratory Accreditation Cooperation Mutual Recognition Arrang ement (ILAC, 2000).”

Agency Response [16.5-Harmon-080215-Hexion] : We believe that this is sufficiently clear in the requirements for third pa rty certifiers specified in section 93120.12, Appendix 3.220

66) Comment [16.6-Harmon-080215-Hexion] : Regarding section 93120.1(a)(44), “ULEF resins,” “this definition is too restricted to adequately address component influence factors.” “ Therefore, it is recommended to modify this definition to include re sin system components. This would include base resins, formal dehyde scavenger resins, formaldehyde scavenger additives, catalyst systems and other additives that will (or may) affect overall composi te wood product manufacturing processes and/or resulting emission c haracteristics.”

Agency Response [16.6-Harmon-080215-Hexion] : We believe the current definition is adequate. All of the additional info rmation the commenter is suggesting to include is already required under the criteria for applications in section 93120.3(d)(1).

67) Comment [16.7-Harmon-080215-Hexion] : “It is recommended to add a definition for an ARB-approved and accredited testi ng laboratory (TPC or contracted).”

Agency Response [16.7-Harmon-080215-Hexion] : ARB will approve third party certifiers, as described in section 93120.4. ARB will not approve testing laboratories. ARB-approved third party cer tifiers must use

accredited laboratories as described in section 931 20.12, Appendix 3.

68) Comment [16.8-Harmon-080215-Hexion] : Regarding the footnote to Table 1 in section 93120.2(a), “it is recommended t o modify this footnote to read as follows: ‘Based on the primary test met hod [ASTM E1333-96 (2002)] or equivalent value from the approved secon dary test method [e.g. ASTM D6007-02] in parts per million (ppm). . . .’ This would provide clarity and be in conformity with other portions of this regulation.”

Agency Response [16.8-Harmon-080215-Hexion] : The emission

standards are related to the concentrations based o n the primary test method (the large chamber method). Reference to th e secondary method is an option for determination of compliance with t he emission standards.

69) Comment [16.9-Harmon-080215-Hexion] : Regarding section 93120.3(d)(7), “it is recommended that already cert ified mills be allowed the flexibility to perform trials that may involve modifications to their resins, additive systems and/or manufacturing processes. I t is recommended that flexibility to accommodate mill trials be incorpora ted into this section. Product manufactured during those trials would have to be isolated and QC testing performed. If testing results indicate that the emissions from the trial product meet requirements, the material m ay be certified and sold as such. Obviously, product that does not meet emi ssion requirements cannot be certified.” “Examples of conditions that might require trialing include (but are not limited to) resin modification s to meet seasonal221 processing changes, evaluation of a different formu lation (same or different supplier), evaluation of a newer (or diff erent) technology resin or scavenger product, influence of other additives on emissions (such as fireretardant, mold/mildew-resistant additive, termitic ide, etc.).”

Agency Response [16.9-Harmon-080215-Hexion] : We believe that trials may be conducted under the current language of the regulation since all composite wood products still need to comply with t he applicable emission standards. The intent of section 93120.3(d)(7) app lies to a manufacturer that changes to a non-ULEF resin.

70) Comment [16.10-Harmon-080215-Hexion] : Regarding section 93120.3(e)(4), the text states that the ARB assigne d number of the approved third party certifier shall be included on the product label, except for “manufacturers using no-added formaldehyde base d resins that have obtained ARB approval . . . or products manufacture d using ULEF resins as provided in section 93120.3(d)(2).” The comment er states that “this requirement should apply to all, as their verifying data originates under an approved TPC.”

Agency Response [16.10-Harmon-080215-Hexion] : The requirement to label products with the number of the ARB-approved third party certifier applies when a manufacturer is undergoing the appro val process to use a candidate no-added formaldehyde based resins or for manufacturers using ULEF resins that are applying for an exemptio n from third party certification for their product types. Once approv ed, we see no need to require inclusion of the third party certifier’s nu mber when such a manufacturer is only working with the certifier for verification data every
two years.

71) Comment [16.11-Harmon-080215-Hexion] : Regarding section 93120.3(f),

the text states that the manufacturer must include on the bill of lading or invoice the ARB assigned number of the approved thi rd party certifier, “if applicable.” The commenter states that “the assign ed number . . . should apply to all, as their verifying data originates un der an approved TPC.”

Agency Response [16.11-Harmon-080215-Hexion] : See the Agency Response to comment # 70 in section D of the FSOR.

72) Comment [16.12-Harmon-080215-Hexion] : Regarding section 93120.3(g)(2)(E), the text states that manufacturer s must maintain records, including the name of the ARB approved third party certifier, but that the subsection does not apply to products manufactured with no-added formaldehyde based resins or ULEF resins as specifi ed in section 93120.3(d)(2). The commenter states that “the assi gned number of the222 approved third party certifier . . . should apply t o all, as their verifying data originates under an approved TPC.”

Agency Response [16.12-Harmon-080215-Hexion] : Recordkeeping is part of the chain of custody system. Manufacturers need to keep records including the name of the approved certifier. Simi larly, certifiers will maintain a list of all manufacturers they certify a nd will provide that list to

ARB on an annual basis. ARB will be aware of manuf acturers that use no-added formaldehyde based resins or ULEF resins, because ARB will be approving of those manufacturers’ uses of those resins. Therefore, we see no need to further track them or have them keep records of the name of the certifier that they use for their verificati on data, especially since section 93120.3(g)(1) requires manufacturers to kee p documentation to demonstrate approval to use no-added formaldehyde b ased resins or

ULEF resins.

73) Comment [16.13-Harmon-080215-Hexion] : Section 93120.3(g)(2)(F) requires manufacturers using no-added formaldehyde based resins and

ULEF resins to maintain records. The commenter sta tes that “there are a number of issues with this subsection requirement d escription and of several of its specific elements . . .” “It is sug gested that the manufacturer be allowed to combine the information under product types, as agreed upon with his respective third party certifier duri ng the performance demonstration data collection period.” “At issue i s the ability to track use to the individual product level. This is not pract ical at the mill level.” “Individual approved resins used at all points in t he manufacturing process is difficult to tie in.” “Contact information requ irements need to be better defined, considering the shifting economy and fluid nature of the business workforce.” “Changes in press time by more than 20 percent record requirements are particularly challenging.” “Many mills record elapsed clock time for a press cycle (thin is less and thic k is greater) – while other mills record press time in seconds per millimeter o f board thickness. The latter method of expressing press cycle would be mo re amendable for meeting the 20% requirement.”

Agency Response [16.13-Harmon-080215-Hexion] : We believe that it is important that such manufacturers use a practical a pproach to recordkeeping to be able to track production of pro duct types at their plants. The requirement for contact information do es not need to be prescriptive, just sufficient to allow tracking to resin manufacturers and suppliers. Recordkeeping with regard to press time can be expressed either as elapsed time or press time per millimeter , so long as that can be related to a percentage change compared to previous press times.

74) Comment [16.14-Harmon-080215-Hexion] : In section 93120.9, the commenter requests that we “clarify that all compli ance testing and223 performance demonstration testing for NAFs and ULEF s must be done by an ARB-approved TPC using accredited laboratories. Also clarify that mill QC testing does not have to be done by a TPC or an accredited laboratory.”

Agency Response [16.14-Harmon-080215-Hexion] : We believe that this is already sufficiently clear as specified in sections 93120.3(c)(1) and (d)(1).

75) Comment [16.15-Harmon-080215-Hexion] : “Large scale chambers (E1333) must be accurately compared to the one used by CARB, as this is the gold standard for both compliance and enforceme nt testing.”

Agency Response [16.15-Harmon-080215-Hexion] : Interlaboratory comparison testing is already required in section 9 3120.12, Appendix 3. The ARB laboratory will participate in the initial interlaboratory comparison.

76) Comment [16.16-Harmon-080215-Hexion] : “The provisions in 93120.9 for equivalency are potentially appropriate for demonst rating equivalence among large chambers. Use a “C” constant of 0.026 for all emissions measurement ranges. This is absolutely critical to establishing performance capability among those using large cham bers.”

Agency Response [16.16-Harmon-080215-Hexion] : We are relying on the interlaboratory comparisons, required in section 93 120.12, Appendix 3, to establish performance capability, rather than an eq uivalence demonstration among large chambers. We believe the interlaboratory comparison will provide sufficient evaluation of th e performance of large

chambers.

77) Comment [16.17-Harmon-080215-Hexion] : “It is recommended to establish a round robin testing of the large chambe rs using five or six sets during 2008 (or the first year that the TPC lab par ticipates), and following up with two or three sets every year or two thereaf ter.”

Agency Response [16.17-Harmon-080215-Hexion] : Thank you for the suggestion. The ATCM requires that all laboratorie s operating primary and secondary test methods participate in interlabo ratory comparison testing (also referred to as round robin testing) d uring the first year the laboratory is used by a third party certifier and e very two years thereafter. As ARB will participate in the initial interlaborat ory comparison, we will work out the specific testing details at a later da te.

78) Comment [16.18-Harmon-080215-Hexion] : “Do not need to require a different equivalence demonstration for different p roduct types.”224 Agency Response [16.18-Harmon-080215-Hexion] : The ATCM does not require a different equivalence demonstration for d ifferent product types. Equivalence is required to be demonstrated for emis sion levels to represent the range in emissions based on the emiss ion standards for composite wood products that a certifier is approve d to verify.

79) Comment [16.19-Harmon-080215-Hexion] : “Once equivalence has been

demonstrated it is reasonable to demonstrate contin ued performance on a reduced number of samples per year.”

Agency Response [16.19-Harmon-080215-Hexion] : We disagree. Annual equivalence must be demonstrated in the same manner as the initial

demonstration. Given that certification could be b ased on a secondary method, then ARB should appropriately require a hig h degree of demonstration in lieu of the use of the primary met hod.

80) Comment [16.20-Harmon-080215-Hexion] : “Small chamber tests do not have to be run in multiple sets to develop a good c orrelation against a large chamber.” “It may not be practical to requir e a fixed number of samples in two or three different ranges shown.”

Agency Response [16.20-Harmon-080215-Hexion] : We believe that the framework we included in the ATCM for the operation of the small chamber as a secondary test method is statistically valid and reducing the number of samples would decrease the validity of th e secondary method. The secondary test method is an option that was add ed to the regulation to facilitate compliance. It is voluntary and thir d party certification can always be performed using the primary test method ( ATSM E 1333-96 (2002)).

81) Comment [16.21-Harmon-080215-Hexion] : “Many of the small scale chambers are operated at or near one air change per hour. Given the
chamber volume range requirement (0.02 to 1 m 3 ) and reviewing the requirements relating air change rates to total exp osed specimen surface area per product, it is not highly practical to req uire three samples per test set. Therefore, it is recommended to edit the abov e to ‘. . . In addition, the secondary method will be operated by testing up to three specimen sets. Single or multiple sets shall consist of up to thre e samples, representing evenly spaced portions of an entire panel. The spe cimen set(s) shall be tested and averaged (for multiple sample sets) to r epresent one data point as the panel emission result for comparison with a quality control test result from the same batch of panels tested by a ma nufacturer. Additionally, the same sample set distribution (and grouping) shall be used in 93120.9(a)(2)(B)2. below.’ This modification wi ll thus allow use of both conventional and high air change rate small scale c hambers such as the

DMC.”225 Agency Response [16.21-Harmon-080215-Hexion] : The current requirements for testing are appropriate. See the Agency Response to

comment # 80 in section D of the FSOR.

82) Comment [16.22-Harmon-080215-Hexion] : In section 93120.9(a)(2)(B) regarding demonstrating equivalence between the sec ondary method and the primary method, the commenter recommends clarif ying the text by adding the following: “Performance equivalence bet ween the secondary method and the primary method must be established a nd/or updated for each testing laboratory operated or contracted by t he third party certifier at a minimum frequency of annually. This will require testing of the small versus large chambers using ten sets during 2008 (o r the first year that the TPC lab participates), and following up with fi ve sets every following year. The following parameters must be met in the comparison:”

“For the secondary method, each comparison sample w ill consist of testing up to three specimen sets. Single or multi ple sets shall consist of up to three samples, representing evenly spaced por tions of an entire panel. The specimen set(s) shall be tested and ave raged (for multiple sample sets) to represent one data point as the pan el emission result, and matched to their respective primary method comparis on sample result.”

Agency Response [16.22-Harmon-080215-Hexion] : We believe that the framework we included in the ATCM for establishing equivalence of the secondary test method is appropriate, statistically valid, and reducing the number of samples would decrease the validity of th e secondary method. See also the Agency Response to comment # 80 in sec tion D of the

FSOR.

83) Comment [16.23-Harmon-080215-Hexion] : Regarding section 93120.12, Appendix 2, section (a), “Purpose,” the commenter s tates that “it would be appropriate to clarify that manufacturers using no- added formaldehyde

based resins and ULEF resins will need to follow th ese requirements as they develop their performance demonstration data, and until an exemption is granted by the Executive Officer. On granting of an exemption, these provisions are also exempted.”

Agency Response [16.23-Harmon-080215-Hexion] : We believe that this is clear in sections 93120.3(c)(1) and (d)(1).

84) Comment [16.24-Harmon-080215-Hexion] : Regarding section 93120.12, Appendix 2, section (b), “Responsibility for Produc t Performance,” the commenter states that “this responsibility exists o utside the scope of just this appendix. It would be more appropriate to sta te this in the main body of the regulation.”226 Agency Response [16.24-Harmon-080215-Hexion] : This requirement is already stated in section 93120.3(b) of the main bo dy of the ATCM. It is simply reiterated in section 93120.12, Appendix 2, to emphasize the point.

85) Comment [16.25-Harmon-080215-Hexion] : Regarding section 93120.12, Appendix 2, section (f)(2), “Correlation of Primary or Secondary Method and Small Scale Test Values,” the commenter asks “i s it feasible to allow the use of existing correlations between the mill a nd their TPC, as long as the TPC becomes ARB-approved? I believe that exist ing TPCs are already using E1333 large chambers and have establi shed correlations for

each of their customer mills. This would allow the mills and TPCs that do not currently have correlations established the pri ority access of testing facilities, and help assure that compliance timelin es are met by the largest possible number of composite panel manufacturers.”

Agency Response [16.25-Harmon-080215-Hexion] : This is acceptable now under the ATCM. Therefore, no changes are need ed.

86) Comment [16.26-Harmon-080215-Hexion] : Regarding section 93120.12, Appendix 2, section (f)(3)(A)2, quarterly chamber t ests are required for hardwood plywood product determined by the third pa rty certifier “ after review of routine quality control data, to have the highest potential to emit formaldehyde. ” The commenter states that “records review and

evaluation is covered under the duties of the third party certifier in Appendix 3. It is recommended to eliminate the ita licized portion of this

section reference.”

Agency Response [16.26-Harmon-080215-Hexion] : We believe it is appropriate to include this in the requirements for manufacturers in section 93120.12, Appendix 2, so that it is clear that manu facturers will need to work with certifiers to determine which product has the highest potential to emit formaldehyde for the purpose of sample selecti on for testing.

87) Comment [16.27-Harmon-080215-Hexion] : Regarding section 93120.12, Appendix 2, subsection (g)(4)(A), basic testing fre quency for PB and MDF,

the commenter notes that this subsection states man ufacturers that use ULEF resins and have received ARB approval must con duct routine quality control tests “at least weekly.” The comme nter states that “this is addressed in a following section covering reduced t esting frequency for

PB and MDF. It is also inconsistent with that sect ion, i.e. once per week versus once per 48 hours. Recommend that the above . . . be moved to the appropriate subsection, and reconciled with reg ard to frequency.”

Agency Response [16.27-Harmon-080215-Hexion] : See the Agency Response to comment # 30 in section D of the FSOR.227

88) Comment [17.1-Rabe-080215-Masonite] : “Masonite proposes the qualification period for the ‘Exempt ULEF’ status ( 6 months of QC testing) be made consistent with that required for ‘no added -formaldehyde’ status (3 months of QC tests).”

Agency Response [17.1-Rabe-080215-Masonite] : We disagree. See the Agency Response to comment # 28 in section D of the FSOR.

89) Comment [17.2-Rabe-080215-Masonite] : “Masonite plant personnel are concerned that testing one sample per shift . . . w ill be too burdensome on production if required to perform this many tests.” “Masonite proposes a reduction in QC test frequency from one per shift t o one per day.” Similarly, “the test frequency for standard product ion for components that

do not meet the ULEF standard should be reduced fro m once per shift to one per day.” “QC test frequency should be reduced for products that attain the ULEF, but not ‘exempt ULEF,’ designation to once per week, rather than once every 48 hours.”

Agency Response [17.2-Rabe-080215-Masonite] : We believe it is crucial that adequate testing frequency is in place to dete rmine whether shift to shift variability in emissions exists, which may re sult from changes in factors such as operating parameters or resin formu lation. That said, the ATCM does provide flexibility with this requirement . Section 93120.12, Appendix 2, subsection (g)(4)(B) allows for a reduc tion in testing frequency to no less than one test per 48 hour prod uction period once the plant or production line demonstrates consistent op erations and formaldehyde emissions values. Per subsection (g)( 4)(A), manufacturers of PB and MDF that use ULEF resins and are approved by ARB under section 93120.3(d) will be required to conduct rout ine QC tests at least weekly.

90) Comment [17.3-Rabe-080215-Masonite] : “Exterior doors can be made

with laminated veneer lumber stiles and rails made with hardwood or softwood and capped with finger jointed softwood. Masonite proposes this type of material does not fall under the definition of HWPW and is exempt from the regulations.”

Agency Response [17.3-Rabe-080215-Masonite] : We agree. Such

material would not be considered HWPW and would be exempt from the ATCM. In addition, other exterior doors would be e xempt as long as the door meets the requirements of section 93120.7(b)(2 ).

91) Comment [17.4-Rabe-080215-Masonite] : “Masonite proposes that a 2-ply HWPW-CC panel have the same emissions level as thin MDF.”228 Agency Response [17.4-Rabe-080215-Masonite] : We disagree. Those are two separate products. As pointed out in pages 42-44 of the ISOR, the manufacturing processes are substantially diffe rent for plywood versus MDF, and this would also be true of thin MDF. The Phase 1 emission standards were primarily developed in light of curr ent product emission levels, manufacturing process technology, and resin systems. Our 2003 product survey found an emissions difference among PB, HWPW, and MDF, as discussed on pages 70-74 of the ISOR. This is due to many factors such as wood furnish type (i.e., veneers, p articles, or fibers), resin systems, resin application rates, use of catalysts or scavengers, and process variability.

92) Comment [17.5-Rabe-080215-Masonite] : “CARB’s definition of a ‘window’ includes jambs. The definition of a ‘door’ is not specific as to its components. The definition should be revised to in clude framing members for pre-hung doors.”

Agency Response [17.5-Rabe-080215-Masonite] : We disagree. The definition is sufficiently clear. In developing th e door definition, we consulted with window and door industry representat ives. We do not agree that we should include “framing members for p re-hung doors” because part of the basis for the door exemption is de minimus use of composite wood products in an exterior door.

93) Comment [17.6-Rabe-080215-Masonite] : Section 93120.7(b)(2) provides an exemption for “exterior doors.” The commenter p araphrases this exemption with regard to “if the doors are made for exterior use” and asks

for a definition of “exterior use.”

Agency Response [17.6-Rabe-080215-Masonite] : The commenter was looking at an old staff working draft of the regula tions dated December 21, 2007. The modified regulation that was subject to the comment period was revised and no longer refers to “exterior use.”

94) Comment [17.7-Rabe-080215-Masonite] : Section 93120.7(b)(2) provides an exemption for exterior doors if the doors “conta in less than three percent by volume of HWPW, PB, or MDF.” Masonite r equests that “exterior doors be exempt if the HWPW, PB or MDF co mponents make up 15% or less by volume of the finished door, if the component is sealed entirely inside the door or has only one exposed ed ge. The basis for this is that the smallest components of a door such as c omposite wood lock blocks are totally encased inside a door and rails which are only exposed on one edge can make up to 15% by volume of the doo r.”

Agency Response [17.7-Rabe-080215-Masonite] : We disagree. The three percent by volume exemption criteria is intended to represent a229 de minimus use level for an exterior door, which, b ecause it is made for exterior use, will most likely be made with lower e mitting phenol formaldehyde resins. The suggestion by the comment er would allow for an increase in the amount of composite wood product s in exterior doors. We do not agree with the suggestion that encasing t he composite wood products within the door will control emissions. E ncasing the source of the emissions will only delay the formaldehyde emission s.

95) Comment [18-Macedo-080215-FCI] : “While FCI appreciates the

refinements that ARB endeavors to achieve in the im plementation of the rule, ARB has failed to address the deficiencies in the foundation for the rule itself.” “CARB should carefully evaluate the proposal to reduce exposure to formaldehyde in light of the tenuous pu blic health benefits represented by the estimated reduction in cancer ca ses in California.”

Agency Response [18-Macedo-080215-FCI] : The foundation of the ATCM was discussed at the Board hearing in April 2007 an d in responses to comments received prior to and at the Board hearing . The foundation of the ATCM was not a subject of the modifications tha t were out for the 15-day public review.

96) Comment [19.1-Miller-080215-BIFMA] : “BIFMA strongly supports the changes related to laminated products as produced b y fabricators . . . BIFMA also strongly supports the exemption for curv ed plywood.”

Agency Response [19.1-Miller-080215-BIFMA] : We appreciate the support

– no response necessary.

97) Comment [19.2-Miller-080215-BIFMA] : “Another issue to come forward from one of our members concerned having enough tim e to meet the California requirements by the end of the year. If no mechanism is in place to find out if that is a widespread reality, we recommend a midsummer review to determine if an extension is warra nted.”

Agency Response [19.2-Miller-080215-BIFMA] : We believe that there is enough time for BIFMA members to meet the Californi a requirements by the end of the year. ARB staff found that the nece ssary resin technology is available to meet the formaldehyde emission stan dards. ARB staff

believes there will be a sufficient number of third party certifiers for manufacturers to certify their products before the end of the year. At this time, staff believes that an extension is not warra nted.

98) Comment [19.3-Miller-080215-BIFMA] : “Specific to the testing methods, in section 93120.9 (a)(2)(B), the requirement to demon strate equivalence between the primary and secondary method every year appears excessive . . . it appears to be a wasteful exercis e to repeat the extensive230 equivalence determination testing every year. We r espectfully suggest it is more efficient to define any changes, which woul d trigger more frequent determinations of equivalence, but otherwise defaul t to a frequency of every three, four or even five years.”

Agency Response [19.3-Miller-080215-BIFMA] : We disagree. While there is limited data to affirm the equivalence of the se condary method to the primary method, we feel that this demonstration mus t be done on an

annual basis until we are certain that the secondar y method is performing as expected. The secondary test method is an optio n that was added to the regulation to facilitate compliance. It is vol untary and third party certification can always be performed using the pri mary test method (ATSM E 1333-96(2002)). As the public health benef it of the ATCM depends on the sale and use of compliant composite wood products in California, we believe that it is important to have stringent test method requirements to ensure that the projected reduction s in formaldehyde emissions are achieved and that the enforcement pro gram has the utmost integrity.

99) Comment [19.4-Miller-080215-BIFMA] : “Similarly, mandating interlaboratory comparisons be conducted every two years is extremely onerous and expensive, as required in Appendix 3 (b )(1)(F) . . . The requirement for inter-laboratory comparison studies would be much more appropriate if it was required every five years or anytime there was a significant change in the standard testing methods. ”

Agency Response [19.4-Miller-080215-BIFMA] : We disagree. See the Agency Response to comment # 98 in section D of the FSOR.

100) Comment [20.1-Bradway-080215-Mannington] : “On page 1-58 there is reference to (a) testing method and frequency for h ardwood plywood which spells out a specified criteria based upon we ekly sq(uare) feet of production. There should be a level of flexibility regarding reduced testing requirements if one can demonstrate statistical com pliance at a reduced level of testing burden.”

Agency Response [20.1-Bradway-080215-Mannington] : We appreciate the comment, but believe that a reduced level of te sting for hardwood plywood cannot provide the level of certainty neede d to ensure compliance with the Phase 1 and Phase 2 emission st andards.

101) Comment [20.2-Bradway-080215-Mannington] : “A manufacturer should be able to submit a statistically sound sampling and t esting scheme utilizing (an) approved methodology in order to demonstrate c ompliance . . . We would simply request the additional statement below the table under231 paragraph ‘C’ on page 1-58: ‘Or sufficient samplin g frequency utilizing (an) approved methodology in order to demonstrate c ompliance.’ ”

Agency Response [20.2-Bradway-080215-Mannington] : We appreciate the comment, but until there is enough data to demo nstrate the sufficiency of the required testing scheme, there is no basis f or evaluating the sufficiency of other compliance testing regimes. T herefore, we disagree with the suggestion.

102) Comment [20.3-Bradway-080215-Mannington] : “Since the testing methods call for a seven day conditioning time period, I as sume even for field compliance verification testing, it would be mandat ed to follow the same protocol of sampling, appropriate conditioning then testing.”

Agency Response [20.3-Bradway-080215-Mannington] : Conditioning of samples will be done prior to testing. However, on ly the primary method calls for a seven day conditioning time period. Se ction 93120.9(a)(2)(A) stipulates that operation of the secondary method, which is the method ARB plans to use as an enforcement test method (sec tions 93120.9(c) and (d)), will use the conditioning time used to es tablish equivalence to the primary method.

103) Comment [20.4-Bradway-080215-Mannington] : “To us it would seem appropriate that compliance testing should be on a product or article as sold for point of use and tested in a manner consis tent with recommended use (i.e., horizontal, finished side up). Reducing of that product to its component parts to test would render the product no n-serviceable and would almost certainly reduce the accuracy and appl icability of the test

results.”

Agency Response [20.4-Bradway-080215-Mannington] : We disagree because it would require establishing emission stan dards for an inordinate number of finished products that are sold in the Ca lifornia market. We believe that if products are made with compliant co mposite wood products,

this ensures that the desired reduction in formalde hyde emissions from composite wood product panels and finished goods th at contain those

materials will be achieved as the source of formald ehyde emissions will be reduced. To determine if compliant materials are b eing used to make finished goods, we must deconstruct the finished go od and test its component parts. Table VI-7 on page 127 of the ISO R includes an implementation schedule. At this time, we are on t rack to achieve the

schedule.

104) Comment [20.5-Bradway-080215-Mannington] : “We believe we should be able to start the exemption application in parallel to the generation of the232 data collection process, with approval contingent u pon satisfactory

demonstration of the data.”

Agency Response [20.5-Bradway-080215-Mannington] : We agree. Manufacturers may apply for an exemption while comp leting their collection of data. However, ARB will not issue an Executive Order until the data requirement is fulfilled and ARB reviews t he data. In addition, manufacturers may at their risk work with reputable candidate third party certifiers prior to ARB approval of the certifiers. If ARB approves the certifier, then all data generated while working wi th the certifier will be acceptable.

105) Comment [21.1-Cleet-080215-ITI] : “Information Technology Institute Council (ITI) members often import products, parts, and components manufactured globally that are packaged in wooden c rates or distributed using wood pallets. While ITI supports the goals o f the ATCM to reduce formaldehyde emissions, we believe this approach wi ll result in a premature disposition of packaging materials that h ad many more years of useful life, generating significant amounts of prev entable wastes.” “Pallets and packaging products do not pose the same risks o r exposure pathways as fabricated products containing composite wood pr oducts.” “In order to avoid the possibility of a noncompliant, reusable p allet or crate being shipped into California, we may be forced to discar d the existing inventory and replace it with new packaging. This will resul t in a premature disposition of packaging materials that had many mo re years of useful life. In addition to generating waste it would increase s hipping costs, as new crates and pallets would have to be purchased to re place the existing inventory.” “We believe the most logical approach is to exempt these materials from the requirements to meet the applica ble performance

standard.”

Agency Response [21.1-Cleet-080215-ITI] : We disagree. See the Agency Response to comment # 4 in section D of the FSOR.

106) Comment [21.2-Cleet-080215-ITI] : “ITI also believes that the certification process for home furnishings and furniture is overl y burdensome and certification should focus on composite wood produc ts installed as part of a building or structure.”

Agency Response [21.2-Cleet-080215-ITI] : We disagree. Formaldehyde

emissions need to be reduced from all sources to ac hieve the public health benefit that we are seeking. In the ATCM, f abricators of home furnishings and furniture are required to exercise reasonable prudent precaution in securing compliant materials from the ir suppliers. In addition, they must maintain records documenting their purcha ses of compliant materials and label their products as compliant wit h the Phase 1 or233 Phase 2 standards. We do not believe the additiona l recordkeeping and labeling requirements are overly burdensome. We be lieve the requirement is necessary to track a noncompliant pr oduct back to the responsible party.

107) Comment [22.1-Howlett-080215-HPVA] : “We continue to object to the exemption that is provided for a ‘Fabricator’ who a pplies a face and back to a core (platform) because CARB has arbitrarily d efined that product to be a laminated product.” “CARB needs to provide si mple, straightforward definitions of the products that are covered.” “We offered a simple and straightforward recommendation to treat what is the same, identical product under a common and consistent definition bu t adjust the compliance regime for fabricators to insure that th e rule’s requirements are met but adjusting some of the compliance requir ements. This is accomplished by the use of a ‘prototype product’ th at would use the resins and adhesives that have the same potential to emit formaldehyde without sacrificing very expensive face veneers which some fabricators claimed would be destroyed permanently.” “ We urge CARB to maintain a single and consistent definition for hardwood plywood as c ontained in

ANSI/HPVA-HP-1 and remove the artifice of ‘laminate d product’ and ‘platform’ from the rule entirely.”

Agency Response [22.1-Howlett-080215-HPVA] : We appreciate the comment, but believe that the definition for hardwo od plywood as contained in ANSI/HPVA-HP-1 is too broad, for purpo ses of the ATCM.

We believe that there are substantial differences b etween the bundles of hardwood plywood panels produced by a hardwood plyw ood manufacturer versus a fabricated laminated product made by a fab ricator for exclusive use in finished goods. The two products are clearl y not interchangeable in terms of their intended uses. In addition, the sur vey of composite wood products that was used as a basis for establishing the emission limits in

the ATCM did not include emissions from a fabricate d laminated product. If we find in the future that these products are em itting higher levels of formaldehyde than we expect, we can amend the ATCM.

108) Comment [22.2-Howlett-080215-HPVA] : “We also object to an exemption for curved plywood. There is certainly a potential to emit a significant amount of formaldehyde from curved plywood. CARB s hould initiate an immediate evaluation of the potential for curved pl ywood to emit formaldehyde to insure there is a level playing fie ld, especially for imports. We understand CARB will evaluate curved plywood for future amendments . . . In the interim, curved plywood sho uld be subject to at

least the emission limits established in section 93 120.2 (a).”

Agency Response [22.2-Howlett-080215-HPVA] : We appreciate the comment. In discussions with industry stakeholders , it is our234 understanding that there are differences between cu rved plywood and industrial-grade hardwood plywood manufacturing. T ypically, curved plywood is produced using urea formaldehyde resins that have been cured with a radio frequency press. Due to a lack of emissions data for curved plywood and because of the difference in the curing process, we decided to exempt curved plywood. If we find in th e future that curved plywood is emitting higher levels of formaldehyde t han we expect, we can

amend the ATCM.

109) Comment [22.3-Howlett-080215-HPVA] : “For the purposes of 93120.12, Appendix 2 (g)(4)(c), which sets out the testing fr equency for HWPW, we recommend inserting the word ‘each’ before ‘product type’ and ‘product line’ in the headings of the table on Page 1-58 to make the wording in the table conform with the wording in paragraph C above the table. Depending on the product types being manufactured, the production rates should differentiate between each product type as c lassified by a manufacturer (consistent with 93120.12, Appendix 2 (f)(3)(A)(2) page 55) and the production volume in square feet, which the n determines the frequency of the testing.”

Agency Response [22.3-Howlett-080215-HPVA] : We appreciate the comment, but the current regulatory language is suf ficiently clear to mean that routine test frequency is based on each produc t type and each product line.

110) Comment [22.4-Howlett-080215-HPVA] : “It should be clarified that quarterly chamber testing for hardwood plywood is n ot required for each product type or product line, but only required for the product type or product line determined by the third party certifie r to have the highest potential to emit based on routine quality control data (see 93120.12, Appendix 2 (f)(3)(A)(2) on page 1-55).”

Agency Response [22.4-Howlett-080215-HPVA] : We believe that the current regulatory language is sufficiently clear. Section 93120.12, Appendix 2, subsection (f)(3)(A)2. states that a qu arterly test “shall be conducted on randomly selected samples of the HWPW product determined by the third party certifier . . . to ha ve the highest potential to

emit.”

111) Comment [22.5-Howlett-080215-HPVA] : “For hardwood plywood, we recommend simplifying the definition of a batch or lot as the production between one quality control test and the next as st ipulated in Definition 26(b) for a lot.”

Agency Response [22.5-Howlett-080215-HPVA] : We disagree. Although most lots will likely be defined by production runs between quality control235 tests, the simplification would not encompass lots produced by a new manufacturing facility or lots produced prior to ha ving to shut down a facility for an extended time period.

112) Comment [22.6-Howlett-080215-HPVA] : “To require a hardwood plywood manufacturer to keep records with respect to the am ount of resin used by volume and weight for a particular product type wou ld be impossible for the following reasons: (1) No measuring device for the resin being applied... (2) The possibility of running numerous ad hesive applicators from the same batch mix and the fact that some appl icators may be running CARB compliance product and some non-CARB c ertified product... (3) Difficult, if not impossible, to quant ify the amount of resin

and adhesive lost due to waste... Accurate records of adhesive application rates, resin content of the adhesive mi x and panel production

volumes could be used to estimate the resin consume d during a given product run or manufacturing period.”

Agency Response [22.6-Howlett-080215-HPVA] : We disagree that it would be impossible to keep records of resin use by product type. As suggested, we believe that records of this kind can be maintained based on accurate records of adhesive application rates, contents of the adhesive mix, and panel production volumes, to esti mate the amount of resin consumed during a product run or manufacturin g period.

113) Comment [22.7-Howlett-080215-HPVA] : “We object to inclusion of the

smallest size chambers allowed in the ASTM D6007 fo r certification of composite wood products (as small as 0.02 m 3 ) that would result in testing ‘postage size’ specimens . . . This change in the r egulation was significant and the 15-day comment period did not allow us to e valuate data to recommend a minimum size small chamber . . . We req uest that the comment period for this aspect of the regulation be extended seven days to give us an opportunity to evaluate minimum chamb er size and make a

recommendation.”

Agency Response [22.7-Howlett-080215-HPVA] : The commenter appears to be concerned with the allowance of small (0.02 m 3 ) chambers under the secondary test method in section 93120.9(a)(2). Th e regulation will not result in testing “postage size” specimens. Operat ion of a small chamber as a secondary method requires following ASTM D 600 7-02 (the small chamber method) and is based on specified ratios of the air flow to the surface area of specimens, with the ratios specifie d in ASTM D 6007-02 by product type. The size of specimens can be incr eased as long as the air flow is increased to keep the flow to surface a rea ratio specified in the

method.236 The regulation provides flexibility with regard to size of small chambers that can be used as secondary methods, in a manner consistent with ASTM D 6007-02, but the regulation also contains st rict statistical criteria for demonstrating that a secondary method is equiva lent to the primary

test method before a small chamber can be used as a secondary method. In addition, the secondary test method is an option that was added to the regulation to facilitate compliance. It is volunta ry and third party certification can always be performed using the pri mary test method (ATSM E 1333-96(2002)).

114) Comment [22.8-Howlett-080215-HPVA] : “Our members are concerned with the potential length of time it takes (up to f ive months or more) to get CARB approval for the TPC exemption for HWPW manufa ctured with NAF or ULEF resins. We suggest CARB allow manufacturer s to begin the application process before the three-month (NAF) or six-month (ULEF) data collection process is completed, with final ap proval from the Executive Officer dependent on submission of the fu ll data set. Approval would then be virtually instantaneous, since the da ta will either show compliance or not.”

Agency Response [22.8-Howlett-080215-HPVA] : See the Agency Response to comment # 104 in section D of the FSOR.

115) Comment [22.9-Howlett-080215-HPVA] : “In 93120.12, Appendix 2 (g)(4)(C) that states ‘quality control samples shal l be analyzed within a period of time specified in the manufacturer’s qual ity control manual to avoid distribution of non-complying lots’ (page 1-5 8). We are concerned that this does not recognize the current industry p ractice of just-in-time delivery. We recommend that the wording in this se ction be changed to say if a manufacturer has substantial quality contr ol data indicating compliance with the formaldehyde emission limits, a n untested lot may be shipped while the QC test from that lot is being co nducted provided there is sufficient time to recall the shipment before it gets into production at the customer’s manufacturing facility if this lot fails .”

Agency Response [22.9-Howlett-080215-HPVA] : We appreciate the comment, but the regulation is clear regarding this matter. It is up to the manufacturer as to whether to ship an untested lot to a customer, but if a violation occurs, both the manufacturer and the cus tomer may be subject to penalties under the ATCM.

116) Comment [23.1-Hodgson-080215-Berkeley Analytic al] : “Are manufacturers of engineered flooring products that contain a composite

wood base material considered to be fabricators of laminated products?”237 Agency Response [23.1-Hodgson-080215-Berkeley Analy tical] : If the engineered flooring products consist of a compliant composite wood platform to which the flooring manufacturer applies a laminate, then the flooring manufacturer would be considered to be a f abricator of laminated products.

117) Comment [23.2-Hodgson-080215-Berkeley Analytic al] : “If a fabricator’s entire production of a product or product line is m ade in compliance with

the ATCM and records are maintained to demonstrate compliance, is the fabricator still required to individually label eac h piece and/or shipping

box?”

Agency Response [23.2-Hodgson-080215-Berkeley Analy tical] : Yes, if the product is sold, offered for sale, supplied, or use d in California. Labeling is a critical piece of the enforcement program to i dentify products subject to the ATCM and to track back to the source any non compliant products.

118) Comment [23.3-Hodgson-080215-Berkeley Analytic al] : “We believe that certain details of how the Secondary Method is to b e validated and implemented should be modified to make this pathway more competitive.” “The requirement to cut nine specimens evenly distr ibuted over a panel and to test these in groups of three may lead to bi ased results and may not be necessary . . . The requirement for three pi eces to be placed in each chamber results in small specimen sizes to ach ieve the required loading ratios . . . Compared to single specimens w ith the equivalent

surface area . . . there are about a factor of two additional product edge area that must be sealed. Depending upon the effec tiveness of edge sealing, the additional edge areas may lead to incr eased bias. Nine specimens and even three individual tests may, in f act, not be necessary.” “We recommend that the requirement be amended to al low D 6007 testing in triplicate using single specimens randomly selec ted from a panel. Further, we recommend that the Certifier be allowed to require less than three individual tests per panel if analysis of the validation data for the Secondary Method shows acceptable agreement can be obtained using fewer D 6007 replicate tests of single specimens.”

Agency Response [23.3-Hodgson-080215-Berkeley Analy tical] : We disagree. We believe that the requirement, as writ ten, provides the level of certainty that we need to ensure that compliant products are being

manufactured and sold to the California market. Us ing nine specimens and then averaging results will provide an accurate average emission rate which can be compared to the large chamber results. Until a demonstration of equivalence between the proposed t est procedure and the procedure in the ATCM is achieved, we believe t hat the test procedure, as written, must be followed. The secondary test m ethod is an option that was added to the ATCM to facilitate compliance. It is voluntary and third238 party certification can always be performed using t he primary test method. See also the Agency Response to comment # 113 in se ction D of the

FSOR.

119) Comment [23.4-Hodgson-080215-Berkeley Analytic al] : “The requirement for annual validation of the Secondary Method is ex cessive . . . We recommend that the validation of the Secondary Meth od be conducted once every two or three years unless a significant detail of the Secondary Method is changed (e.g., switching to a different a nalytical method or chamber size). If such a change is proposed, the l aboratory should be required to perform validation tests before being a llowed to use the

modified method.”

Agency Response [23.4-Hodgson-080215-Berkeley Analy tical] : We disagree. See the Agency Response to comment # 98 in section D of the

FSOR.

120) Comment [23.5-Hodgson-080215-Berkeley Analytic al] : “We also recommend that any existing data on the bias and un certainty of the Primary Method be published as an appendix to the A TCM.”

Agency Response [23.5-Hodgson-080215-Berkeley Analy tical] : We agree that information of this kind would be insightful a nd should be shared; however, another mechanism for disseminating this i nformation is needed, as it is not appropriate to include as an appendix to the ATCM.

121) Comment [23.6-Hodgson-080215-Berkeley Analytic al] : “To establish the credibility of the ATCM’s enforcement function, the ARB and local air district laboratories performing the enforcement te sts should meet the same requirements as the laboratories performing Pr imary or Secondary Method testing including accreditation (ILAC, 2000) , validation of Secondary Methods, and participation in inter-labor atory studies. The enforcement test method(s) should be defined and ve rified prior to implementation of the ATCM as deconstruction of fin ished goods to determine if core materials meet the ATCM requireme nts is likely a difficult task subject to considerable uncertainty. The ARB should support research and development of valid enforcement test methods if such methods are not currently available.”

Agency Response [23.6-Hodgson-080215-Berkeley Analy tical] : We agree. In order for small chambers that ARB plans to use f or enforcement to be considered secondary methods, the chambers must be demonstrated to be equivalent to a primary test method. ARB’s labo ratory also plans to participate in interlaboratory comparison studies w ith our secondary test method chambers. The integrity of the enforcement program depends on all parties being committed to using the required p rocedures and following239 defined quality assurance protocols. Table VI-7 on page 127 of the ISOR includes an implementation schedule. At this time, we are on track to

achieve the schedule.

122) Comment [23.7-Hodgson-080215-Berkeley Analytic al] : “Often laboratory accreditation is valid for a two year period with a requirement for an annual audit by the accreditation body . . . The re quirement for participation in some inter-laboratory studies is r easonable. However, such studies cannot be approached casually. It is better to focus on efforts on a few quality studies.” “The requiremen t should be modified to state that each laboratory shall maintain a valid a ccreditation for the relevant methods. The responsibility for inter-lab oratory studies should be formalized by identifying a lead organization respo nsible for planning, coordination, implementation, data analysis, and re porting. The requirement should be scaled back to participation in a single interlaboratory study every two or three years. The req uirement for biennial participation in an inter-laboratory study for each test method and each wood product type should be removed.”

Agency Response [23.7-Hodgson-080215-Berkeley Analy tical] : We believe that participation in inter-laboratory stud ies is important. Initially, ARB will lead the first interlaboratory comparison study. Also, we believe that until we have a robust data base on laboratory performance, participation every two years is important.

123) Comment [23.8-Hodgson-080215-Berkeley Analytic al] : “Appendix 3 (d)(3): Comment – The wording of this requirement is unclea r . . . The wording should be revised to state that ‘the third party ce rtifier shall, at its own discretion, have the right to witness any and all p arts of tests conducted at a laboratory under contract to the certifier for pe rformance of Primary and Secondary Method tests.’ ”

Agency Response [23.8-Hodgson-080215-Berkeley Analy tical] : We appreciate the comment, but disagree. The wording of Appendix 3 (d)(3), as written, conveys the intent of this comment.

124) Comment [23.9-Hodgson-080215-Berkeley Analytic al] : “Attachment 2 . . . This attachment is a scholarly presentation of a so mewhat unconventional statistical technique. Many readers may have diffi culty following the development of the technique . . . This attachment should be treated as an

academic article in order to establish its credibil ity. The author(s) should be identified, appropriate references to statistica l texts and journal articles should be added, and the article should be subjecte d to review by peers.”

Agency Response [23.9-Hodgson-080215-Berkeley Analy tical] : The statistical technique was developed in consultation with academic and240 industry experts, and the work was subject to peer review under the 15-day comment period. For purposes of the ATCM, w e believe that the analysis provides solid technical support as the ba sis for the demonstration of equivalence between the primary an d secondary

methods in the ATCM.

125) Comment [24-Dennis-080215-Gibson Dunn Crutcher ] : “Virco manufactures a product called Hard Plastic at its A rkansas facility . . . It appears that the definition of ‘particleboard’ in t he Proposed Formaldehyde ATCM does not include Virco’s Hard Pla stic product, but that is not completely clear . . . The primary ingr edients of Hard Plastic are powdered melamine formaldehyde resin and maple wood flour . . . Given that the cellulosic material used in making Hard Pl astic is a finely ground and sieved flour, it does not appear to meet the de finition of ‘particleboard’ because the finely ground flour is smaller in size than fibers . . . Given that the Hard Plastic product made by Virco uses a wood flour and not chips or shavings, it does not appear to meet the definition of ‘particleboard.’ If you concur with our interpretation of the definition of ‘particleboard’ and that it does not apply to Virco’s Hard Plastic, then would like a written confirmation of that . . . Virco only makes individ ual sheets . . . If CARB

staff concludes that Hard Plastic meets the definit ion of ‘particleboard’ in the Proposed Formaldehyde ATCM, then we need to eit her amend Appendix 3 or seek an interpretation as to how it w ill be applied to Virco’s Hard Plastic product . . . Virco believes that its Hard Plastic is not ‘particleboard’ as that term is used in the Propose d Formaldehyde ATCM and would therefore not be subject to the requireme nts of the proposed regulations. However, if CARB concludes otherwise, then the testing method in Appendix 3 would need to be amended, or V irco will need an interpretation that would address the impracticabli ty of a rigid application to those provisions to its product.”

Agency Response [24-Dennis-080215-Gibson Dunn Crutc her] : We appreciate the information provided on Hard Plastic , but cannot make a determination as to whether the product is subject to the ATCM based on the information provided. We invite the commenter to meet with us so that we can discuss this product.

126) Comment [25.1-Clark-080215-Jeld-Wen] : “In section 93120.1 (a)(8) the definition for Composite Wood Products states that “hardboard” is an exempted product from this regulation. Definitions (17) and (28) of the

same section describe ‘hardboard’ and ‘Medium Densi ty Fiberboard.’

These definitions need to be defined further to cle arly state a difference between the two product types. If these definition s are left as-is, then it is likely that manufacturers of fiberboard will simply call their product ‘hardboard’ and state that they do not need to comp ly with the regulation. JELD-WEN has proposed definitions to CARB in previo us correspondence.241 Any definition could be used, provided that it incl udes a statement that ‘hardboard’ will have emissions less than 0.04 ppm so it meets the same criteria of other products exempted from third part y certification.”

Agency Response [25.1-Clark-080215-Jeld-Wen] : We disagree that if these definitions are left as-is, that manufacturer s will call their products “hardboard” and state that they do not need to comp ly with the ATCM. We believe that the two products have different int ended end-uses and as such, will continue to be separate products. No ad ditional clarification is

needed.

127) Comment [25.2-Clark-080215-Jeld-Wen] : “Section 93120.1 (a)(19) has a definition for ‘Hardwood Plywood’ that includes the statement ‘The face veneer may be composed of a hardwood or decorative softwood species.’ The phrase ‘. . . or decorative softwood’ should be deleted. If this remains, then the title of the definition should change to i nclude softwood species. This would require several editorial changes throug hout the document.”

Agency Response [25.2-Clark-080215-Jeld-Wen] : We disagree. It is our understanding that in some cases, decorative softwo od veneers are used by hardwood plywood manufacturers to make industria l-grade “hardwood plywood,” and the end-product is essentially “hardw ood plywood” as we have defined it. Furthermore, ANSI/HPVA HP-1-2004 refers to decorative softwood veneers in the industry specifications for hardwood plywood. We believe that the phrase is needed in the definit ion to address this contingency.

128) Comment [25.3-Clark-080215-Jeld-Wen] : “The regulation needs a section added to describe how a new start-up plant that use s NAF or ULEF resins can comply with this regulation. There will be ins tances where a new plant will be built which are very similar to exist ing manufacturing facilities that already produce products approved by CARB. Th e products made from this new plant should not have to go through t he same requirement of months of QC data and third party certifications to demonstrate compliance. This will delay the ability to sell pr oducts into California by a minimum of 3 months. Where appropriate, it should be possible to demonstrate compliance by equivalencies for new pla nts on an expedited basis, as approved by CARB.”

Agency Response [25.3-Clark-080215-Jeld-Wen] : We disagree that a new section needs to be added to the regulation to addr ess new plants. In such cases, we believe that the manufacturer will l ikely use a no-added formaldehyde (NAF) based resin or ULEF resin with a proven track record at existing facilities. While it is a manufacturer ’s prerogative to produce products for California, approval to be designated as a manufacturer using NAF or ULEF resins will be decided on a case-by-cas e basis by the242 Executive Officer. If a new start up plant uses a NAF or ULEF resin, then resultant production should have emissions that wil l be well below the Phase 2 emission standards. Therefore, quality con trol data would support certification by an approved third party ce rtifier. A new plant will be able to sell Phase 2 compliant panels using a NA F or ULEF resin. After the required quality control emissions data a re collected, then an application can be submitted for an approved Execut ive Order for reduced testing or an exemption from third party certificat ion.

129) Comment [25.4-Clark-080215-Jeld-Wen] : “Section 93120.3 (d)(7) should be clarified. Currently it states that any change in the resin system requires the manufacturer to comply with section 93 120.3 (b). This would require the manufacturer to complete six months of QC testing before the product with the modified resin can be sold to Cali fornia. If this is not the intent of this section, it should be modified to st ate that the manufacturer must demonstrate that the change in the resin syste m will still produce a product that continues to meet the ULEF requirement s to be exempt from third party certification.”

Agency Response [25.4-Clark-080215-Jeld-Wen] : We understand the comment. The intent of section 93120.3(d)(7) appli es to a manufacturer that changes to a non-ULEF resin. Operational flex ibility for ULEF resins will be addressed through the conditions applied to an approved ARB Executive Order. The current regulatory language i s sufficiently clear.

130) Comment [25.5-Clark-080215-Jeld-Wen] : Regarding the requirements for retailers, the commenter states that “section 93120 .8 is vague and should be clarified to provide an advantage for NAF produc ts. This section of the regulation should provide for less onerous labeling and recordkeeping requirements for NAF products.”

Agency Response [25.5-Clark-080215-Jeld-Wen] : We disagree. Because of the advantages already being afforded to product s made with no-added formaldehyde based resins and the contribution thes e products are estimated to provide from a public health standpoin t, we believe that rigorous requirements for recordkeeping and labelin g are needed to ensure that those products are in fact what manufac turers claim they are. Recordkeeping is also essential for enforcement to allow tracing noncomplying products back to the fabricator or manufa cturer. See also the Agency Response to comment # 15 in section D of the FSOR.