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1 of 43 EO12866_ rin2070-AJ83_ BPA-Testing_ANPRM_ 2010- 12 - 10 2011-06-17 .doc 1 EO 12866 Review Draft as submitted. 2 Revised to address Interagency Comm ents received under EO 12866 review. 3 BILLING CODE 6560–50–P 4 ENVIRONMENTAL PROTECTION AGENCY 5 40 CFR Part 799 6 [EPA–HQ–OPPT–2010–0812; FRL–XXXX
–X ] 7 RIN 2070-AJ83 8 Testing of Bisphenol A 9 AGENCY: Environmental Protection Agency (EPA). 10 ACTION: Advance notice of proposed rulemaking. 11 SUMMARY : Bisphenol A (BPA, CASRN 80 -05-7), a high production volume 12 chemical, is a reproductive, developmental, and systemic toxicant in animal studies 13 and is weakly estrogenic. EPA is provid ing this advance notice of proposed 14 rulemaking to request comment on requi ring toxicity testing to determine the 15 potential for BPA to cause adverse effects, including endocrine-related and other 16 adverse effects , in environmental organisms at lo w concentrations. EPA is also 17 seeking comment on requiring environmental testing c onsisting of sampling and 18 monitoring for BPA in surface water, ground water, drinking water, soil, sediment, 19 sludge, and landfill leachate in the vicini ty of expected BPA releases to determine 20 whether environmental organisms may currently be exposed to concentrations of 21 BPA in the environment that are at or above levels of c oncern for adverse effects, 22 including endocrine-related effects. This notice is directed only toward the 23 environmental presence and environmental effe cts of BPA. EPA is working with the 24*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

2 of 43 Department of Health and Human Services (HHS) on potential human health issues, 25 but is not considering any additional test ing specifically in regard to human health 26 issues at this time. 27 DATES: Comments must be rece ived on or before [ insert date [ 60 ] days after date 28 of publication in the Federal Register ]. 29 ADDRESSES: Submit your comments, identifi ed by docket identification (ID) 30 number EPA–HQ–OPPT–2010–0812, by one of the following methods: 31

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line 32 instructions for submitting comments. 33

• Mail: Document Control Office (7407M), Office of Pollution Prevention and 34 Toxics (OPPT), Environmental Protecti on Agency, 1200 Pennsylvania Ave., NW., 35 Washington, DC 20460–0001. 36

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 37 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 38 EPA–HQ–OPPT–2010–0812. The DCO is open from 8 a.m. to 4 p.m., Monday 39 through Friday, excluding legal holidays. T he telephone number for the DCO is (202) 40 564–8930. Such deliveries are only accept ed during the DCO’s normal hours of 41 operation, and special arrangements s hould be made for deliveries of boxed 42 information. 43 Instructions : Direct your comments to docket ID number EPA–HQ–OPPT– 44 2010 –0812 . EPA's policy is that all comments received will be included in the docket 45 without change and may be m ade available on-line at http://www.regulations.gov , 46 including any personal information provided, unless the comment includes 47 information claimed to be Confidential Business Information (CBI) or other 48*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

3 of 43 information whose disclosure is restricted bystatute. Do not submit information that 49 you consider to be CBI or otherwise protected through regulations.gov or e-mail. 50 The regulations.gov website is an “ anonymous access” system, which means EPA 51 will not know your identity or contact info rmation unless you provide it in the body of 52 your comment. If you send an e-mail comment directly to EPA without going 53 through regulations.gov, your e-mail addr ess will be automatic ally captured and 54 included as part of the comment that is placed in the docket and made available on 55 the Internet. If you submit an elec tronic comment, EPA recommends that you 56 include your name and other contact informa tion in the body of your comment and 57 with any disk or CD-ROM you submit. If EPA cannot read your comment due to 58 technical difficulties and cannot contact you for clarification, EPA may not be able to 59 consider your comment. Electronic files should avoid the use of special characters, 60 any form of encryption, and be free of any defects or viruses. 61 Docket: All documents in the docket are list ed in the docket index available at 62 http://www.regulations.gov . Although listed in the index, some information is not 63 publicly available, e.g., CBI or other in formation whose disclosure is restricted by 64 statute. Certain other material, such as copyrighted material, will be publicly 65 available only in hard copy. Publicly available docket materials are available 66 electronically at http://www.regulations.gov , or, if only available in hard copy, at the 67 OPPT Docket. The OPPT Docket is loca ted in the EPA Docket Center (EPA/DC) at 68 Rm. 3334, EPA West Bldg., 1301 Constitu tion Ave., NW., Washington, DC. The 69 EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., 70 Monday through Friday, excluding legal ho lidays. The teleph one number of the 71 EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the 72*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

4 of 43 OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic 73 identification, pass through a metal detector, and sign the EPA visitor log. All visitor 74 bags are processed through an X-ray machine and subject to search. Visitors will 75 be provided an EPA/DC badge that must be vi sible at all times in the building and 76 returned upon departure. 77 FOR FURTHER INFORMATION CONTACT: For technical information contact: 78 Mary Dominiak, Chemical Control Division (7405M) , Office of Pollution Prevention 79 and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 80 Washington, DC 20460–0001; telephone number: 202-564-8104; e-mail address: 81 dominiak.mary @epa.gov

. 82 For general information contact : The TSCA-Hotline, ABVI-Goodwill, 422 83 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e84 mail address: TSCA-Hotline@epa.gov

. 85 SUPPLEMENTARY INFORMATION: 86 I. General Information 87 A. Does this Action Apply to Me? 88 You may be potentially affected by this action if you manufacture ( i de nti fi n ed 89 by statute to include import) or process BPA (CASRN 80-05-7). BPA is listed on the 90 TSCA Inventory under the nam e phenol, 4,4’-(1-methylethylid ene)bis-. Potentially 91 affected entities may include, but are not limited to: 92 • Chemical manufacturers (includi ng importers) (NAICS codes 325, 32411, 93 e.g., chemical manufacturing and petroleum refineries) of BPA. 94*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

5 of 43 • Plastics material and resin manufac turers (NAICS code 325211, e.g., 95 manufacturers and processors of BPA- based polycarbonate plastics and epoxy 96 resins). 97 • Foundries (NAICS codes 331512, 331524, 331528, e.g. steel investment 98 foundries, aluminum foundries, and other non-ferrous foundries, except die-casting) 99 using BPA in casting sands. 100 • Paint and coating manufacturers (N AICS code 325510), e.g. manufacturers 101 of epoxy-based paints and ot her coating products t hat may contain BPA. 102 • Paper recyclers (NAICS codes 322110, 322121, 3222, e.g. pulp mills, paper 103 (except newsprint) mills, and convert ed paper product manufacturers) that may 104 process waste thermal paper containing BPA. 105 • Materials recovery fa cilities (NAICS code 562920, e.g. facilities separating 106 and sorting recyclable material s), that may handle therma l paper, polycarbonates, or 107 food and beverage cans lined with BPA-based epoxy coatings. 108 • Custom compounders of purchased resins (NAICS code 325991, e.g. 109 facilities where resins are made from recycled polycarbonate plastics) that may 110 contain BPA. 111 This listing is not intended to be exhaustive, but rather provides a guide for 112 readers regarding entities likely to be affected by this action. Other types of entities 113 not listed in this unit could also be a ffected. The North American Industrial 114 Classification System (NAICS ) codes have been provided to assist you and others in 115 determining whether this action might apply to certain entities. If you have any 116 questions regarding the applicability of this ac tion to a particular entity, consult the 117 technical person listed under FOR FURTHER INFORMATION CONTACT

. 118*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

6 of 43 B. What Should I Consider as I Prepare My Comments for EPA? 119 1. Submitting CBI . Do not submit this information to EPA through 120 regulations.gov or e-mail. Clearly mark t he part or all of the information that you 121 claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, 122 mark the outside of the disk or CD-ROM as CBI and then identify electronically 123 within the disk or CD-ROM the specific in formation that is claimed as CBI. In 124 addition to one complete version of the comment that includes information claimed 125 as CBI, a copy of the comment that does not contain the information claimed as CBI 126 must be submitted for inclus ion in the public docket. Information so marked will not 127 be disclosed except in accordance with procedures set forth in 40 CFR part 2. 128 2. Tips for preparing your comments . When submitting co mments, remember 129 to: 130 i. Identify the document by docket ID number and other identifying information 131 (subject heading, Federal Registerdate and page number). 132 ii. Follow directions. The Agency may ask you to respond to specific 133 questions or organize comments by referencing a Code of Federal Regulations 134 (CFR) part or section number. 135 iii. Explain why you agree or disagr ee; suggest alternatives and substitute 136 language for your requested changes. 137 iv. Describe any assumptions and provide any technical information and/or 138 data that you used. 139 v. If you estimate potential costs or burdens, explain how you arrived at your 140 estimate in sufficient detail to allow for it to be reproduced. 141*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

7 of 43 vi. Provide specific examples to illustrate your concerns and suggest 142 alternatives. 143 vii. Explain your views as clearly as possible, avoiding the use of profanity or 144 personal threats. 145 viii. Make sure to submit your comments by the comment period deadline 146 identified. 147 II. Background 148 A. What Action is the Agency Taking? 149 As a follow-up to the BPA Action Plan released on March 29, 2010 (Ref. 1), 150 EPA is issuing this advance notice of proposed rulemaking under TSCA section 4(a) 151 (15 U.S.C. § 2603(a)) to solicit public input on the necessity for and best approach to 152 obtain environmental effects, exposure, and pathway information relevant to a 153 determination that BPA either does or does not present an unreasonable risk of 154 injury to the environment. In particular, EPA requests comment on: 155 1. Whether EPA should propose requiring spec ific toxicity testing to more fully 156 characterize the effects of BPA on environm ental organisms at low concentrations; 157 and 158 2. Whether EPA should propose requiring environmental testing consisting of 159 sampling and monitoring, particularly in the vicinity of reported releases of BPA into 160 the environment, and what des ign and protocol it should use for such sampling and 161 monitoring, in order to identify potential sources and pathways of exposure and 162 determine the extent to which environmental organisms may be exposed to BPA 163 concentrations of concern as determined byexisting data and by additional studies 164 that are either already underway or would be conducted under a proposed test rule. 165*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

8 of 43 3. EPA additionally requests comm ent and supporting information regarding 166 which section 4(a)(1) finding authority woul d be most appropriate for the purpose of 167 a BPA test rule proposal, as discussed in Un it II.C. of this document. Any proposal 168 would ultimately be based on EPA’s asse ssment of the relevant information 169 available at the time of proposal. 170 B. What Testing Is EPA Considering in this ANPRM? 171 In this ANPRM, EPA is considerin g requiring both toxicity testing for 172 environmental organisms exposed to BPA and env ironmental testing consisting of 173 sampling and monitoring in the vicinity of reported BPA releases to measure its 174 environmental presence. The toxicity testing is being proposed considered to resolve 175 existing uncertainties concerning the potent ial for BPA to elicit adverse effects in 176 ecologically relevant species, including endo crine-related impacts that could occur at 177 low doses. The environmental testing is being proposed considered to resolve 178 existing uncertainties conc erning potential sources of and pathways leading to 179 environmental exposures and to determine w hether or not the concentrations to 180 which organisms currently may be exposed in the environment are at or above 181 levels of concern for adverse effect s, including endocrine-related effects. 182 On May 17, 1985, EPA published a Proposed Rule (50 FR 20691) to require 183 human health and environmental testing in response to the Interagency Testing 184 Committee's (ITC's) designation of BPA for priority consideration for health and 185 environmental effects. EPA proposed standard freshwater and marine acute fish and 186 aquatic invertebrate toxicity tests, and freshw ater aquatic plant toxicity tests. Test 187 results were submitted in response to t he proposal for freshwater and marine acute 188 fish, acute aquatic invertebrate, and alga l toxicity. EPA’s Final Rule (51 FR 33047), 189*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

9 of 43 published September 18, 1986, terminated the test rule process for environmental 190 effects testing for bisphenol A. At the ti me, EPA determined that the test data were 191 adequate and that chronic freshwater organism testing was not needed because the 192 LC 50 values for the standard acute aquatic organi sm toxicity tests were greater than 193 1.0 ppm (1 mg/L), and the ra tio of 48-hour to 96-hour LC 50 values were not greater 194 than two. Since the 1986 Final Rule, however, several studies on BPA have raised 195 concerns about its environmental effects at concentrations less than 1.0 ppm (1 196 mg/L). 197 As stated in the BPA Action Plan (Ref. 1), EPA does not intend to initiate 198 regulatory action under TSCA at this ti me on the basis of human health. EPA 199 remains committed to protecting human health, but notes that most human 200 exposure, including exposure to children, comes through food packaging materials 201 under the jurisdiction of the Food and Drug Administration (FDA) in HHS. FDA, 202 together with the Centers for Disease Control and Prevention (CDC) and the 203 National Institute of Environmental Health Sciences (NIEHS), is investing in 204 important new health studies in both ani mals and humans to better determine and 205 evaluate the potential health consequences of BPA exposures. EPA will continue to 206 coordinate closely with FDA, CDC, and NIEHS on this activity. To the extent that 207 FDA may identify health concerns from BPA in food contact materials, EPA will work 208 with FDA to identify and assess potential subs titutes. Levels of exposure that may 209 be identified by the ongoing review as bei ng of concern to human health, including 210 children’s health, will affect the extent to which EPA would take additional action to 211 address potential risks to human health resulting from uses within TSCA jurisdiction. 212 1. What Is Currently Known Abou t the Environmental Hazard of BPA? 213*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

10 of 43 The toxicity of BPA has been studied extens ively, as indicated in the multiple 214 studies cited in the Action Plan (Ref. 1 ). ) 1

. There is general agreement among 215 multiple reviewers , including government regulatory agencies in the United States, 216 Japan, the European Union, and Canada, that BPA is a reproductive and 217 developmental toxicant at doses in animal studies of > 50 mg/kg-bw/day (delayed 218 puberty in male and female rats and ma le mice; discussed in Ref. 2-9); > 235 mg/kg219 bw/day (reduced fetal or birth weight or growth early in life, effects on testis of male 220 rats; Ref. 9); and > 500 mg/kg-bw/day (possible decreased fertility in mice, altered 221 estrous cycling in female rats, and reduced su rvival of fetuses; Ref. 9). Systemic 222 effects (reduction in body weight, changes in relative organ weights, and increases 223 in liver toxicity; Ref. 2-8) were observ ed at doses above 5 mg/kg-bw/day (identified 224 as a no observed adverse effect level (N OAEL); lowest observed adverse effect 225 level (LOAEL) of 50 mg/kg-bw/day). There are reports of endocrine-related low-dose 226 effects on puberty and neurological development (brain, behavio r; Ref. 9) at doses in 227 animal studies as low as 2 μ g/kg-bw/day. There is disagreementin the scientific 228 community at large about whether effects seen at doses in animals less than 1 229 mg/kg/day are meaningful and relevant to humans. The Food and Drug 230 Administration ( Within HHS, FDA ), , together with the National Institute of 231 Environmental Health Sciences ( NIEHS ) and the Centers for Disease Control and 232 Prevention ( and CDC ), is , are engaging in additional res earch to better determine 233 and evaluate the potential human health consequences of exposures to BPA, 234 including exposures at low doses (Ref. 10). EPA is working with FDA, NIEHS, and 235

1 EPA's response to the request fo r correction of the information provided in the Action Plan that was filed under the Agency's Information Quality Gui delines by the American Chemistry Council is available at www.epa.gov/quality/informationguidelines/iqg-list.html*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

11 of 43 CDC on this ongoing research, and is not proposing considering any additional 236 testing specifically in regard to human health issues at this time. 237 Many studies have been conducted to determine potential effects of BPA 238 exposure on invertebrates, fish, amphibi ans, reptiles, birds, and wild mammals, and 239 a review is provided by Crain et al. (R ef. 11). In general, studies have shown that 240 BPA can affect growth, reproduction and development in aquatic organisms. 241 Evidence of sub-lethal effects mediat ed through either endocrine or non-endocrine 242 related mechanisms in fish, amphibians, reptiles, and invertebr ate aquatic organisms 243 has been reported at potentially environmentally relevant exposure levels lower than 244 those required for acute toxicity. There is a widespread variation in reported values 245 for these sub-lethal effects, but many fall in the range of 1 μg/L to 1 mg/L. (Ref. 6; 246 also, see individual studies noted in Table 2). 247 The ecological hazard for BPA has been evaluated in three different risk 248 assessments performed by the European Un ion (EU), Canada, and Japan (Refs. 7, 249 6, and 8), as summarized in Table 1 below . The different methodologies, endpoints 250 and study results used by each country to der ive their ecological values highlight the 251 significant uncertainty in the estimat ed hazard values. Japan concluded that “the 252 current exposure levels of BPA will notpose unacceptable risks to the local 253 populations of aquatic life, particularly fish” (Ref. 8). In contrast , the EU concluded 254 that although the predicted exposure concen trations were significantly below its 255 hazard values, there was a need for further information and/or testing on such 256 organisms as freshwater snails (Ref. 7). 257 Canada used a study (Ref. 12) thatreported reduced sperm quality and 258 delayed ovulation in brown trout at a verylow concentration in water (1.75 μg/L). 259*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

12 of 43 Other effects such as the induction of inte rsex (or testes-ova in males and females), 260 decreased spermatogenesis, induction of vi tellogenin, delayed or ceased ovulation, 261 or histological liver changes were also repo rted in other studies referenced in the EU 262 and Japanese hazard evaluations. However, because there were no standardized 263 test guidelines or risk assessment guidanc e for evaluating some of these endocrine264 related effects at the time of t hese assessments, the EU and Japan set 265 ecotoxicological hazard values bas ed on conventional effects (mortality and 266 reproductive effects) from standardized studi es. In contrast, Canada concluded in its 267 hazard characterization that “[c]onsidered together, the data prov ide strong evidence 268 that bisphenol A is capable of eliciting adverse effects: (1) following prolonged 269 exposure at levels below those usually seen to elicit effects in standard toxicity tests 270 (i.e., tests based on recognized methods whic h evaluate endpoints such as survival, 271 reproduction and growth); (2) following br ief low-dose exposure, particularly at 272 sensitive developmental stages, with effect s apparent later in the life cycle; (3) on 273 filial generations following parental exposure; and (4) using more than one mode of 274 action.” (Ref. 6). 275 Canada concluded that BPA concentrations in water have the potential to 276 cause adverse effects on populations of pelagic organisms in Canada and 277 concentrations in biota have the potential to cause adverse effects in populations of 278 wildlife in Canada, but that t here is a low risk of direct adverse effects to sediment 279 organisms and to avian wildlife species in Canada. In the conclusion of its risk 280 assessment, Canada stated that it is considered appropriate to apply a 281 precautionary approach when characterizing risk, observing “it is concluded that 282 bisphenol A is entering t he environment in a quantity or concentration or under 283*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

13 of 43 conditions that have or may have an immedi ate or long-term harmful effect on the 284 environment or its biologica l diversity.” (Ref. 6). 285 Table 1: Summary of Bisphenol A Ecological Values Country Predicted No Effect Concentratio ns 1 (μg/L) Endpoints European Union 1.5 The predicted no effect concentration (PNEC) for aquatic organisms (derived by using a statistical analysis of data from available data on freshwater and marine aquatic organisms (in this case, 16 different studies, unpublished and published, from 10 different taxonomic groups)) to arrive at a value of 7.5 μg/ L, which is divided by an uncertainty factor of 5, resu lting in a PNEC of 1.5 μg/L (Ref. 7). Canada 0.175 This PNEC was derived by using a lowest observed effect concentration (LOEC) of 1.75 μg/L for reduced semen quality and delayed ovul ation in a brown trout study (Lahnsteiner et al, 2005) and applying an uncertainty factor of 10 (Ref. 6). Japan 1.6 The PNEC was derived by using the 16 μg/L no effect concentration (NOEC) for egg hatchability in fathead minnows from the unpublished 3 generation study by Sumpter, et al. (2001) mult igeneration fish study and dividing by an uncertainty factor of 10 (Ref. 8). 1 In Europe, Canada, and Japan, a predicted no effect concentration (PNEC) is compared directly with an exposure value to ev aluate risk. If the ra tio of environmental concentration to PNEC is less than one, the risk is generally considered acceptable. As noted in the table, countries use different approaches for generating PNECs, and the precise values may differ even when based on the same studies. 286 EPA considers that the unc ertainty demonstrated by these divergent opinions 287 concerning interpretation of the results of existing environmental toxicity studies, 288 particularly studies addressing potential effe cts at low levels of exposure, may 289 indicate further testing is necessary to resolve the question of whether or not BPA 290 presents an unreasonable risk of injury to the environment on t he basis of those 291 effects. This is due to the combination of the existence of measured values, as 292 discussed in Unit II.B.4 and shown in Table 3, for BPA in U.S. surface waters at a 293*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

14 of 43 mean concentration range of up to 1. 78 μg/L (ppb) and a single maximum 294 concentration of 12 μg/L (ppb); in ground wate r at a mean concentration range of up 295 to 1.9 μg/L (ppb) and a maximum concentration of 2.55 μg/L (ppb); and in freshwater 296 sediments at a median concentration of 0. 6 μg/kg (ppb) dry weight and a maximum 297 concentration of 140 μg/kg (ppb) (See Table 3), and the existence of many hazard 298 studies describing a variety of effects in aquatic organisms at some of these 299 concentrations (See Table 2), leaving little or no room for a reasonable or 300 acceptable margin of exposure. 301 There are two principal, initial q uestions that need to be answered in In order 302 to assess the potential for BPA to harm the environment in the U.S .: ., EPA considers 303 it important to address two basic areas of inquiry relevant to identifying the hazard 304 and exposure components of a risk analysis: 305 a. What additional hazard information is needed to fully characterize the effects 306 of BPA in environmental organism s at low doses and potentially 307 environmentally relevant concentrations; and 308 b. What levels of BPA are present in the environment, particularly in areas 309 where environmental exposures are likely to be highest (e.g., near BPA 310 manufacturing facilities, polycarbonat e and epoxy resin manufacturing and 311 processing facilities, foundries, la ndfills, wastewater treatment plants 312 (WWTPs) and other locations associated with uses and/or releases of BPA)? 313 2. What Additional Hazard Information is Needed on the Effects of BPA on 314 Environmental Organisms? 315*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

15 of 43 EPA performed a literature search to ident ify relevant scientific information to 316 assess the acute and chronic toxicity of BPA to environmental organisms from 2007 2 317 to the present. A total of 645 articles were found (Ref. 13), of which 31 were found 318 to be of some relevance (Ref. 14). Si nce thorough analyses of acute and chronic 319 toxicity for “conventional endpoints” (which generally address immediate effects on 320 survival or reproduction) had already been conducted for BPA by Canada, the 321 European Union, and Japan (Ref. 6-8), EPA per formed a more detailed evaluation of 322 the scientific literature for sub-lethal effects at lowe r concentrations (< 100 μg/L). 323 These sub-lethal effects in both vertebrat es and invertebrates could be mediated 324 either through endocrine or non-endocrine-re lated mechanisms. There are many 325 studies indicating such sub-lethal effect s from BPA exposures at levels that, based 326 on the information discussed in Unit II.B.4 , appear to be potentially environmentally 327 relevant concentrations because they may o ccur in the environment. Some of these 328 studies are included in Table 2. 329 Table 2. Summary of Reported Hazard Effects of BPA at Potentially Environmentally Relevant Concentrations

Test Organism Endpoint Effect Conc. (μg/L) References (Listed in Ref. 14) Amphibians Xenopus laevis (African clawed frog) Inhibited metamorphosis via T3 pathways 22.8 Heimeier et al., 2009 Xenopus laevis High ratio of females to males-1st study 23 Levy et al., 2004 Xenopus laevis High ratio of females to males-2nd study only at 23 Levy et al., 2004
Avian

2 The starting date of 2007 was used to allow for some overlap between the thorough searches done by Canada, the EU and Japan*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

16 of 43 Table 2. Summary of Reported Hazard Effects of BPA at Potentially Environmentally Relevant Concentrations

Test Organism Endpoint Effect Conc. (μg/L) References (Listed in Ref. 14)
Gallus domesticus (chicken) Delayed development of wattle, comb and testes 2 Furuya et al., 2006

Gallus domesticus Inhibited development of seminiferous tubuli and spermatogenesis 20 Furuya et al., 2006
Fish Dicentrarchus labrax (seabass) Increased vitellogenin production 10 Correia et al., 2007 Misgurnus anguillicaudatus ( Chinese loach) Increased vitellogenin production 10 Lv et al., 2007 Orizias latipes (medaka) Egg hatchability delayed 13 only Yokota et al., 2000

Orizias latipes Loss of testicular structure, increased fibrotic tissue; decreased sperm cells. 50 Metcalfe et al., 2001 Orizias latipes Vitellogenin production 10 Kashiwada et al., 2002

Orizias latipes Increased female proteins (i.e. vitellogenin) 10 Tabata et al., 2001

Orizias latipes Decreased egg hatching in 2nd generation 2 only Japanese MOE, 2006 Orizias latipes Increased male hepatosomatic index 49.7 Japanese MOE, 2006 Pimephales promelas (fathead minnow) Increased vitellogenin production 52.8 Rhodes et al., 2007-unpublished Xiphophorus helleri (swordtail fish) Reduced sword tail length 20 Kwak et al., 2001

Cyprinus carpio (carp) Oviduct formation in males 32 Bowmer & Gimeno, 2001., unpublished

Cyprinus carpio Altered sex steroid levels; alterations in testes structure; oocyte atresia 1 Mandich et al., 2007*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

17 of 43 Table 2. Summary of Reported Hazard Effects of BPA at Potentially Environmentally Relevant Concentrations

Test Organism Endpoint Effect Conc. (μg/L) References (Listed in Ref. 14)

Invertebrates Bellamya purificata (snail) Enzyme activities in gills and digestive glands 1 Li et al., 2008 Marisa cornuarietis (ramshorn snail) Superfeminization 1 Oehlmann et al., 2000

Marisa cornuarietis Increased egg and clutch production per female 0.25 at 20 degrees C Oehlmann et al., 2006
Marisa cornuarietis Increased egg production 0.25 at 27 degrees C Oehlmann et al., 2006
Marisa cornuarietis Increased clutch production 5 at 27 degrees C Oehlmann et al., 2006 Potamopyrgus antipodarum (snail) Increased growth/embryo production 5 only Jobling et al., 2004 Potamopyrgus antipodarum Unshelled embryos 30 Duft et al., 2003 Potamopyrgus antipodarum Increased embryo production 1 Duft et al., 2003

Nucella lapillus (marine snail) Superfeminization; reduced sperm/penis length/prostrate gland in males 1 Oehlmann et al., 2000
Acartia tonsa (copepod) Increased egg production 20 (day 10 only) Andersen et al., 1999 Tigriopus japonicus (intertidal copepod) Delayed development (Parent) 0.1 Marcial et al., 2003 Tigriopus japonicus Delayed development (F1) 0.01 Marcial et al., 2003 Chironomus riparius Delayed emergence (2nd generation) 0.078 Watts et al., 2001 Chironomus riparius Mouthpart deformities 0.01 Watts et al., 2002 330 There is debate in the scientific literat ure on how best to interpret these low331 dose, sub-lethal effects of BPA and other chemicals on environmental organisms. 332*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

18 of 43 EPA is concerned that these sub-lethal effe cts may be having a detrimental effect on 333 populations of aquatic organi sms over time based on the reported increased 334 susceptibility of subsequent generations exposed to BPA in multigeneration 335 invertebrate and fish studies. For exam ple, in the intertidal copepod ( Tigriopus 336 japonicus ), delayed development was reported in the first generation at 0.1 μg/L, but 337 at a 10-fold lower concentration of 0.01 μg/ L in the next generation (Ref. 15). In the 338 freshwater midge ( Chironomus riparius ), the first generation did not have a 339 significant delay in emergence time from the egg, but in the second generation 340 emergence was delayed at 0.08 μg/L (Re f. 16). Egg hatchability decreased in 341 fathead minnows ( Pimephales promelas ) at 640 μg/L in the fi rst (F1) generation, 342 then at 160 μg/L in the second (F2) generat ion (Ref. 17). Although the mechanisms 343 of action leading to effects may be di fferent for vertebrate and invertebrate 344 organisms, this suggests the potentia l for increasing developmental and 345 reproductive effects in populations of aquatic organisms that have repeated 346 exposures to BPA for generations, even at very low concentrations. 347 Testing with BPA has been extensive at sub-lethal concentrations, but the 348 studies with effects across multiple specie s generally have flaws associated with 349 them, including lack of analytical moni toring, small sample size, inadequate 350 replication, or use of inappropriate statistical anal yses leading to incorrect 351 conclusions of study results. Studies in ramshorn snails, for example, resulted in 352 superfeminization (e.g., the formation of addi tional female organs, enlarged 353 accessory sex glands, gross malformations of the pallial oviduct, and a stimulation of 354 egg and clutch production) at very low concentrations in one lab (Ref. 18), but those 355 results were not found in studies byother researchers (Ref. 19-21). 356*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

19 of 43 In addition, in some studies, BPA demonstrated effects at very low 357 concentrations, but no effects were observed at the higher test concentrations. For 358 example, tadpoles exposed to 2.3, 23 and 230 μg/L of BPA (Ref. 22) before 359 metamorphosis had an increased female to male ratio at 23 μg/L only. These types 360 of anomalous responses have been reported across multiple species of fish and 361 invertebrates for BPA and are characteristicof endocrine-active chemicals. They 362 suggest inhibition of reproduction and dev elopment at low concentrations and 363 overcompensation by the organism at hi gher concentrations in response to a 364 toxicant (Ref. 23). 365 It is difficult to interpret this info rmation in a regulatory context, because the 366 scientific methods employed in individual ac ademic settings to test a hypothesis are 367 not necessarily geared toward meeti ng or establishing generally applicable 368 guidelines for evaluating ecotoxicity and setting corresponding regulatory limits or 369 controls. In terms of environmental toxicity, EPA considers the currently available 370 research as evidence that BPA has the potential to interact with the estrogen 371 hormone system. There is some evidence thatBPA is also active via the thyroid 372 hormone pathway in amphibians and fish (Ref. 24, 25). More recent evidence 373 indicates that BPA also acts as an androgen receptor antagonist in both mammals 374 and fish (Ref. 26). There are currently e fforts underway by the EPA Office of Science 375 Coordination and Policy (OSCP) through the Endocrine Disruptor Screening 376 Program (EDSP) and the Organization for Economic Cooperation and Development 377 (OECD) Endocrine Disrupter Testing and Assessment Work Group (EDTAWG), 378 among others, to determine the best approac h to evaluate and assess such effects. 379 (Ref. 27-29). 380*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

20 of 43 EPA is inviting comment on the need to further determine the hazard of BPA 381 to various ecological species. The purpos e of further testing would be to produce 382 high quality data to identify and establish a dose

- response that could be used for risk 383 assessment purposes for any adverse reproductive or developmental effects in 384 different species that might result from the interactions identified through the 385 available research. 386 3. What are the Issues for Comm ent Concerning Toxicity Testing? 387 EPA invites comment on whether and what testing should be required to 388 further describe the hazard of BPA to various ecological species to resolve the low 389 dose effects issue. EPA particularly invites comment on the following, for which little 390 or no clarifying hazard information appears to be currently available or for which 391 much of the available data have been derived from studies of que stionable quality or 392 uncertain interpretation: 393 a. Effects of BPA on fish in long-term tests, including those that encompass 394 multiple generations. 395 b. Effects of BPA on amphibians at s ensitive life stages, specifically 396 metamorphosis (thyroid effects) a nd sexual development/differentiation 397 (hypothalamic-pituitary-gonadal axis effects). 398 c. Effects of BPA on birds over multiple generations. 399 d. Effects of BPA on aquatic invertebrate species 400 EPA further invites comment on the availab ility of current test guidelines that 401 could help address these issues. This ma y include, for example, considering the 402 recommendations for Aquatic Life Criteria For Contaminants Of Emerging Concern 403 (Ref. 30). Additionally EPA is inviting t he public to describe and define where they 404*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

21 of 43 believe there are data gaps concerning the env ironmental toxicity of BPA, especially 405 at low concentrations, or w hether and on what basis they believe the current data 406 are sufficient to determine whether BPA does or does not present an unreasonable 407 risk of injury to the environment. 408
4. What Levels of BPA Are Present in the U.S. Environment? 409 BPA is present in the environment as a result of direct releases from 410 manufacturing or processing facilities (R ef. 31). BPA also may be present in the 411 environment as a result of fugitive emissions during proc essing and handling, 412 release of unreacted monomer from products (Ref. 9), or possibly from degradation 413 of products under certain conditions. In addition, although no environmental studies 414 on thermal paper have been done in the U.S., based on information from EPA’s 415 review of European and Japanese studies, the use of unconjugated BPA in thermal 416 paper also may contribute to environm ental releases of BPA from paper 417 manufacturing and recycling plants and to th e presence of BPA in the stream of 418 recycled paper used in toilet paper, paper t ableware, and other products, and may 419 contribute to the presence of BPA in l andfills because paper products are a major 420 contributor to the U.S. solid waste stream (Ref. 32-37). Recent studies also indicate 421 thermal paper may contribute directly to human exposure to BPA through dermal 422 contact . In one U.S. study, for example, pregnant women who worked as cashiers , 423 who presumably had frequent contact with th ermal paper used in cash register 424 receipts, had the highest urinary BPA concentr ations compared with pregnant 425 women in other occupations (Ref. 38). 3 426

3 Recent studies also indicate thermal paper may contribute di rectly to human exposure to BPA through dermal contact. In one U.S. study, for example, pregnant women who worked as cashiers,*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

22 of 43 Significant research has been done to document widespread human 427 population exposures to BPA in the U.S. using biomonitoring (Ref. 39-42). Although 428 these studies and reports indicate that most people in the U.S. have measurable 429 levels of BPA in their bodies, these dat a do not identify the relative source 430 contributions to BPA exposure. Researchers generally accept that food contact uses 431 of materials containing BPA, such as pol ycarbonate bottles or epoxy linings in food 432 and beverage cans, are a likely major source of human exposure, but the relative 433 contributions of food contac t uses, potential TSCA uses , or other environmental 434 sources cannot be extrapolated reliably from these existing data. For information 435 about the multi-agency effortto evaluate the potentia l human health consequences 436 of BPA exposures, see the discussion in Unit II.B. of this document. 437 According to the Toxics Release Inv entory (TRI) Database, total release of 438 BPA in the U.S. in 2007 was 1,132,062 pounds , with releases of 122,965 pounds to 439 air, 6,246 pounds to water, 14,972 pounds released on-site to land, and 684,638 440 pounds transferred off-site to land. An additional 32,928 pounds were reported as 441 off-site water transfer to Publicly Ow ned Treatment Works (POTWs), with another 442 2,759,705 pounds transferred to in cineration (Ref. 31). 443 Some information is available for BPA concentrations in U.S. water and other 444 environmental media (see Table 3, providing values from the U.S. studies cited in 445 this discussion). Most environmental monito ring results show that the concentrations 446 of BPA in surface water bodies are lower than 1 μ g/L (ppb), mainly due to its 447 partitioning and biodegradabi lity properties (Ref. 39 43 ). BPA was detected at a 448 median concentration of 0.14 μ g/L (ppb) and a maximum concentration of 12 μ g/L 449

who presumably had frequent contact with thermal paper used in cash register receipts, had the highest urinary BPA concentrations compared with pregnant women in other occupations (Ref. 38).*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

23 of 43 (ppb) in 41.2% of 85 samples collect ed from U.S. streams in 1999 and 2000 (Ref. 450 40 44 ). The maximum concentration of 12 μ g/L (ppb) was much higher than any of 451 the other samples reported in the study; the next highest concentration reported was 452 5.2 μ g/L (ppb), and as indicated by the median concentration of 0.14 μ g/L (ppb), 453 BPA concentration in other U.S. waters was much lower. A recent review of reports 454 of BPA in surface water found that BPA was reported in 26 studies in North America 455 (2 in Canada and 24 in the United States) wi th detection in 80 percent (852 of 1068) 456 of surface water samples. The median co ncentration reported was 0.081 μg/L (ppb) 457 and the 95 th percentile concentration wa s 0.47 μg/L (ppb) (Ref. 41 45 ). 458 Two studies have addressed indivi dual wastewater treatment plants 459 (WWTPs) in two different parts of the U.S. In 2001 and 2002, BPA was not detected 460 above the detection limit of 0.0001 μ g/L (ppb) in Louisiana in effluent from a WWTP, 461 in samples collected from surface waters in Louisiana, or in drinking water at various 462 stages of treatment at pl ants in Louisiana (Ref. 42 46 ). A 2008 study sampled BPA in 463 treated wastewater from the East Bay Municipal Utilities WWTP in Oakland, 464 California, and in a variety of locati ons that discharge to this WWTP (Ref. 43 47 ). 465 This study reported detecting (limit of detection = 0.25 μg/L (ppb)) BPA in two of 466 three treated wastewater samples at 0. 38 and 0.31 μg/L (ppb). It also reported 467 detecting BPA in wastewater generated by a pharmaceutic al manufacturer (0.295 468 μg/L (ppb)), an industrial laundry (21.5 μg/L (ppb)), and a paper products 469 manufacturer (0.753 μg/L (ppb)). 470 While U.S. studies on wastewater are limited to only two state locations, a 471 Canadian study published in 2000 reported BPA concentrations ranging from 49.9 to 472 0.031 μg/L (ppb) in sewage influent and e ffluent (generally < 1 μg/L (ppb) in the 473*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

24 of 43 influent and < 0.3 μg/L (ppb) in the effl uent) and from 36.7 to 0.104 μg/g (ppm) in 474 raw and digested sewage sludge from multiple WWTPs in Canada (Ref. 44 48 ). The 475 same authors reported that BPA contami nation was detected in 100 percent of 476 sewage samples from 31 WWTPs across C anada with concentrations ranging from 477 0.080 to 4.98 μg/L (ppb) (medi an 0.329 μg/L (ppb)) for the influent and from 0.010 to 478 1.08 μg/L (ppb)(median 0.136 μg/L (ppb)) for the effluent (Ref. 45 49 ). Based on 479 comparison of influent and effluent levels, they estimated that BPA in the influent 480 was removed by the sewage treatment proc ess with a median reduction rate of 68 481 percent. BPA was detected in sludge sample s at concentrations ranging from 0.033 482 to 36.7 μg/g (ppm), on a dry weight basis . The authors also reported a wide range of 483 BPA in wastewater discharges from industr ial facilities in the Toronto area, with 484 concentrations ranging from 0.23 to 149.2 μg/L (ppb). Higher BPA levels in 485 wastewater were associated with facilit ies producing chemicals and chemical 486 products and packaging and paper products , and with commercial dry cleaning 487 establishments. BPA concentrations in pulp and paper mill sludge ranged from < 488 0.02 (below detection limit) to 3.33 μg/g (ppm), with a median value of 0.076 μg/g 489 (ppm), on a dry weight basis (Ref. 45 49 ). EPA notes that U.S. wastewater treatment 490 conditions and industrial and commercial discharges may differ from what was found 491 in Canada, but considers this C anadian study to be informative. 492 Municipal wastewater treatment produces solid byproducts, commonly 493 referred to as sewage sludge. After additional treatmentto meet regulatory 494 standards for pathogen, nutrient, and metal content, this treated sewage sludge, 495 now classified as biosolids, may be dispos ed of by land application; biosolids may 496 also be incinerated or disposed of in landfills. A U.S. study published in 2006 497*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

25 of 43 measured BPA in nine treated biosolids products from WWTPs in seven states and 498 found that all cont ained between 1,090 and 14,400 μg/kg (ppb) (median 4,690 μg/kg 499 (ppb)) (Ref. 46 50 ). A 2008 study reported BPA in treated biosolids from a municipal 500 U.S. WWTP at 4,600 μg/kg ( ppb) and reported 81 μg/kg (ppb) in soil that received 501 the land-applied biosolids (Ref. 47 51 ). That study detected BPA at 81 μg/kg (ppb) in 502 earthworms living in treated soil. The authors also reported detecting 147 μg/kg 503 (ppb) in a nearby “control” soil that did notreceive treatment with biosolids. That 504 anomalous result was not explained. 505 In 2000, the U.S. Geological Survey (USGS) collected samples from 47 506 ambient groundwater sites (notdrinking water wells) in 18 states and analyzed them 507 for 65 organic wastewater c ontaminants. BPA was detected in 29.8% of the sampled 508 groundwater sites, with a mean det ected concentration of 1.78 μ g/L (ppb) and a 509 range of 1.06 to 2.55 μ g/L (ppb). BPA was among the top five most frequently 510 detected organic compounds in this study (Ref. 48, 49 52, 53 ). 511 In the summer of 2001, the USGS colle cted samples from 74 sources of raw, 512 untreated, drinking water in 25 states and Puerto Rico, in areas that were known or 513 suspected to have at least some human and/or animal wastewater sources in 514 upstream or upgradient areas. These s ources comprise 25 groundwater and 49 515 surface water sources of drinking water se rving populations ranging from one family 516 to more than 8 million people. BPA was detec ted in 9.5% of these samples at a 517 reporting level of 1 μ g/L (ppb). The maximum concentration measured in these 518 samples was 1.9 μ g/L (ppb) (Ref. 48, 50 52, 54 ). 519 Landfill leachate from one U.S. study reported maximum BPA concentrations 520 of 1.7 μ g/L (ppb) in landfill leachate and 1.4 μ g/L (ppb) in the receiving groundwater 521*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

26 of 43 plume at a landfill on Cape Cod that was known to be leaking (Ref. 51 55 ). Data for 522 other landfill sites in the Unit ed States were not available, and this single point is not 523 representative of the country . Landfill leachate from other countries contained more 524 than 500 μ g/L (ppb) of BPA (Ref. 39 43 ). Studies conducted at Japanese landfills 525 resulted in maximum untreated l eachate concentrations of 17,200 μ g/L (ppb) and 526 treated leachate concentrations of 5.1 μ g/L (ppb) (Ref. 11). 527 Wilson et al. (Ref. 52 56 ) reported that BPA concentrations in soil samples 528 taken from outdoor play ar eas of homes and daycare centers ranged from 4-14 ppb 529 dry weight, with means of 6-7 ppb dry weight. Klecka et al. (Ref. 41 45 ) reported a 530 median concentration of 0.6 ppb BPA in No rth American freshwater sediments, 531 including nondetected samples; BPA concen trations in samples from the United 532 States ranged from 1.4 to 140 ppb dry weigh t. Levels in U.S. marine sediments were 533 reported to have a median of 3.5 ppb of BPA and to range from 1.5 to 5 ppb dry 534 weight (Ref. 53 57 ). 535
Table 3: U.S. Reported Environmental Concentrations of BPA Location Mean or Range of Means (ppb) Range (ppb) References

Surface Water <0.0001 to 0.14* <0.0001 to 12 Barnes et al. (2008a) (Ref. 48 52 ) Boyd et al. (2003) (Ref. 42 46 ) Boyd et al. (2004) (Ref. 54 58 ) Focazio et al. (2008) (Ref. 50 54 ) Klecka et al. (2009) (Ref. 41 45 ) Kolpin et al. (2002) (Ref. 40 44 ) Staples et al. (2000) (Ref. 55 59 ) Zhang et al. (2007) (Ref. 56 60 )

Groundwater NR** to 1.78 † <0.003 to 2.55 Barnes et al. (2008a) (Ref. 48 52 ) Barnes et al. (2008b) (Ref. 49 53 ) Focazio et al. (2008) (Ref. 50 54 ) Rudel et al. (1998) (Ref. 51 55 ) Drinking Water <0.0001 <0.0001 to 0.42 Boyd et al. (2003) (Ref. 42 46 ) Stackelberg et al. (2004) (Ref. 57 61 ) Wastewater <0.0001 <0.0001 to 25 Boyd et al. (2003) (Ref. 42 46 )*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

27 of 43 Table 3: U.S. Reported Environmental Concentrations of BPA Location Mean or Range of Means (ppb) Range (ppb) References Drewes et al. (2005) (Ref. 58 62 ) Jackson and Sutton (2008) (Ref. 43 47 ) Rudel et al. (1998) (Ref. 51 55 ) Tsai (2006) (Ref. 39 43 ) Soils 6 to 7 4 to 147 Kinney et al. (2008) (Ref. 47 51 ) Wilson et al. (2003) (Ref. 52 56 ) Sediment, Fresh 0.6* †† 1.4 to 140 †† Klecka et al. (2009) (Ref. 41 45 ) Sediment, Marine 3.5* 1.5 to 5.0 Stuart et al. (2005) (Ref. 53 57 ) Biosolids 4600 to 4690* 1090-14,400 Kinney et al. (2006) (Ref. 46 50 ) Kinney et al. (2008) (Ref. 47 51 ) * Value is median 536 ** Not Reported 537 † Mean of values above Reporting Limit (1 ppb) 538 †† Median value includes nondetected values below the MDL, while the reported 539 range includes only detected values. 540 541 Although there is disagreem ent in interpreting some of the effects observed in 542 studies performed to date with BPA, as descr ibed in Unit II.B.1 and 2, a comparison 543 of the range of the effect levels observed in many studies and the predicted no effect 544 concentration (PNEC) values used in three international regul atory risk assessments 545 (0.175 to 1.6 μg/L, Table 1) with measured concentrations in some U.S. waters and 546 sediments, which included values as high as 12 μg/L (ppb) (surface water), 2.55 547 μg/L (ppb) (ground water), and 140 ppb sediment (freshwa ter sediment) (Table 2), 548 indicate possible risk of injury to aquatic organisms. The single available 549 measurement of BPA in leachate from one U.S. landfill site is not sufficient to 550 represent or characterize the United Stat es as a whole, and landfill leachate data 551 from other countries suggest that BPA concentrations in leachate may be 552 significantly higher than concentrations in surface water bodies. The direct exposure 553*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

28 of 43 pathway from wastewater to environment al organisms, along with the widespread 554 detection of BPA in WWTP sludges, further suggest that land application of WWTP 555 sludges may be a significant environmental exposure pathway that needs to be 556 better understood. 4 557 Although most currently available environmental monitoring results show that 558 the concentrations of BPA in U.S. water bodies are lower than 1 μg/L (ppb) (median 559 concentration of 0.14 μg/L (ppb)), these environmental measurements represent 560 isolated snapshots in time. Because these re sults come from a variety of studies 561 designed for very different purposes and conditions (for example, laboratory 562 analytical development contrasted with fi eld monitoring), the data are not readily 563 comparable and cannot be assembled into a nationally or regional ly representative 564 picture. Particularly in lightof the corresponding uncertainti es described in Unit II.B.1 565 and 2 concerning potential BPA hazards at low doses, the existing data do not allow 566 EPA to determine how many areas may exceed potential concentrations of concern, 567 how often or how long such concentrations may be exceeded, or the sources or 568 pathways leading to BPA presence in the environment from manufacturing, 569 processing, distribution in commerce, use, or disposal that may result in human and 570 environmental exposures. EPA considers that these existing data would not be 571 sufficient to determine whether or not an unreasonable risk to the environment 572 exists. To help resolve these uncertainti es, EPA is considering requiring that 573 manufacturers and processors of BPA con duct environmental testing consisting of 574 targeted sampling and monitoring of surfac e water, groundwater, sediment, soil, 575

4 EPA's response to the request fo r correction of the information provided in the Action Plan that was filed under the Agency's Information Quality Gui delines by the American Chemistry Council is available at www.epa.gov/quality/informationguidelines/iqg-list.html*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

29 of 43 landfill leachate, and drinking water on and adj acent to their properties, specifically 576 in the vicinity of manufacturing facilities and such processing facilities as foundries, 577 WWTPs, paper and plastics recycling facilitie s, and other sources of BPA releases 578 as identified through TRI reporting and other information. These test data could also 579 help guide development of effective ri sk management actions if it should be 580 determined that activities involving BPA pr esent an unreasonable risk of injury to 581 aquatic or other environmental systems. 582 Fully understanding exposure pathways and in particular the magnitude, 583 frequency, and duration of ex posure could require a na tionwide survey of the 584 occurrence of the chemical in environmental media associated with production, 585 processing, use, disposal and recycling facilities. However, at this time, EPA is 586 proposing that selected monitoring of a more limited scope be conducted to help 587 identify the most likely locations of hi gh exposure and the sources and pathways of 588 exposure, to determine whether BPA may be present in those locations at 589 concentrations that pose a risk of concern to aquatic or other syst ems. Monitoring of 590 aquatic sites and sediments near releases (effluents and sludge) from manufacturing 591 and processing sites (including on-site WWT Ps) reporting high releases under TRI 592 or associated with high releases identif ied from other information, as well as 593 monitoring of sites that receive runo ff from landfills, would be included. 594 EPA believes these targeted monitoring data may provide information 595 relevant both to the characterization of environmental risk and to the potential focus 596 of future risk management activities such as those under section 6 of TSCA, if the 597 data indicate such activities are warrant ed. EPA also considers these data would 598 further inform the issue of potential human exposure levels attributable to sources 599*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

30 of 43 other than the direct food contact uses belie ved to be the principal source of human 600 exposure, which are regulated by the FDA. As noted earlier in Unit II.B., EPA is 601 working with FDA, NIEHS, and CDC on addit ional research to better determine and 602 evaluate the potential human hea lth consequences of expos ures to BPA, including 603 exposures at low doses. Levels of exposure that may be identified by FDA as being 604 of concern to human health, including childr en’s health, would affect the extent to 605 which EPA would take additional action to address potential risks to human health 606 resulting from uses within TSCA jurisd iction, but EPA is not considering any 607 additional testing specifically in regard to human health issues at this time. 5 608 In order to be useful to an investigation of potentia l environmental risks posed 609 by BPA, environmental testing must be representative and of known quality. To 610 accomplish this, data should be collected us ing approved or recognized sampling, 611 preparation, and analytical techniques. A ppropriate quality a ssurance and quality 612 controls also should be incorporated in the protocols for collection and analyses. 613 A further complicating factor in the assessment of potential environmental 614 risks posed by BPA is that organisms in t he environment, rather than being exposed 615 to a single chemical at a time, are likel y to be exposed simultaneously to multiple 616 chemicals. The presence of other endocrine-active c hemicals, including other 617 estrogenic chemicals, for example, coul d affect the potential for effects on 618 environmental organisms. It ma y be useful, when monitoring for BPA, to identify the 619 total estrogenicity of a sample along with the amountof BPA present. 620 Potential methodologies and protocols for use in monitoring programs may 621 include ASTM D7574-09 Standard Test Method for Determination of Bisphenol A in 622

5 EPA notes, however, that information obtained on the environmental presence of BPA would be relevant to understanding the environme ntal component of human exposures.*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

31 of 43 Environmental Waters by Liquid Chromatography/Tandem Mass Spectrometry (Ref. 623 59 63 ); ASTM D5730-04 Standard Guide for Site Characterization for Environmental 624 Purposes With Emphasis on Soil, Rock, the Vadose Zone and Ground Water (Ref. 625 60 64 ); EPA Method 8270D (SW-846), Semivo latile Organic Compounds by Gas 626 Chromatography/Mass Spectrometry(GC/MS), Revision 4 (Ref. 61 65 ); and other 627 methods cited and described in such publicat ions as Barnes et al. (2008) (Ref. 48 52 ) 628 and Focazio et al. (2008) (Ref. 50 54 ). 629 5. What are the Issues for Comment Concerning Environmental Testing Consisting 630 of Sampling and Monitoring? 631 EPA particularly invites comment on: 632 a. The extent and type of environmental testing that may be sufficient to 633 characterize the environm ental presence of BPA. 634 b. The extent and type of environmental testing that may be sufficient to 635 understand sources of and exposure from the high concentrations of BPA 636 found in treated biosolids from WWTPs. 637 c. Whether environmental testing should be conducted now, or should be tiered 638 to occur after the uncertainties asso ciated with the hazards of BPA at low 639 concentrations in the environment have been resolved. 640 d. The locations where such environm ental testing should be undertaken, such 641 as manufacturing, processing, recycli ng, foundry, and other use, treatment, 642 and disposal sites identified with BPA re leases reported under TRI or other 643 information. 644*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

32 of 43 e. The media (e.g., soil, sediment, sludge, WWTP influent and effluent, landfill 645 leachate, drinking water, surface wate r, ground water) to be sampled at each 646 such site. 647 f. Which parties should be required to conduct the testing and/or be potentially 648 responsible for providing reimbursement to those w ho conduct specific tests. 649 g. The appropriate methods and protocol s to use in such a environmental 650 testing program. 651 h. Whether such an environmental testing program should include 652 measurements for the total estrogenicity of samples collected as well as for 653 the concentration of BPA, and what me thods and protocols may be suitable 654 for generating and interpreting such data. 655 h. i. Whether and what additional environment al testing activities may be 656 necessary to understand and characterize non-food-contact uses, sources, 657 and environmental pathways that may contribute to human exposure to BPA. 658 exposure to BPA. Though, as indicat ed in Unit II.B. of this document, the 659 current focus of this ANPRM is on env ironmental effects, this information 660 would inform the multi-agency effort to evaluate the potential human health 661 consequences of BPA exposures. 662 i. j. Other information that may provide insight into sources and pathways of 663 environmental and human exposure to BPA released into the environment. 664 Though, as indicated in Unit II.B. of th is document, the current focus of this 665 ANPRM is on environmental effects, th is information would inform the multi666 agency effort to evaluate the potent ial human health consequences of BPA 667
exposures. 668*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

33 of 43 j. k. The cost and economic feasibility of su ch environmental testing, for the 669 different types of sites. 670 B C . What is the Agency's Authority for Taking this Action? 671 EPA is issuing this advance notice of proposed rulemaking on certain toxicity 672 testing and on certain environmental testi ng consisting of sampling and monitoring 673 for the chemical substance BPA under TSCA section 4(a)(15 U. S.C. § 2603(a)). 674 Section 2(b)(1) of TSCA (15 U.S.C. § 2601(b)) states t hat it is the policy of the 675 United States that “adequate data should be developed with respect to the effect of 676 chemical substances and mixtures on health and the environment and that the 677 development of such data should be the re sponsibility of thos e who manufacture 678 [which is defined by statue to include import] and those who process such chemical 679 substances and mixtures[.]” To implementthis policy, TSCA subsection 4(a)(1) 680 provides that EPA shall require by rule thatmanufacturers or processors or both of 681 chemical substances and mixtures conduct testing if the Administrator finds in a final 682 rule that: 683 (A)(i) the manufacture, dist ribution in commerce, processing, use, or disposal 684 of a chemical substance or mi xture, or that any combinat ion of such activities, may 685 present an unreasonable risk of injuryto health or t he environment, 686 (ii) there are insufficient data and ex perience upon which the effects of such 687 manufacture, distribution in commerce, processing, use, or disposal of such 688 substance or mixture or any combinatio n of such activities on health or the 689 environment can reasonably be det ermined or predicted, and 690 (iii) testing of such substances or mixture with respect to such effects is 691 necessary to develop such data; or 692*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

34 of 43 (B)(i) a chemical substance or mixture is or will be produced in substantial 693 quantities, and (I) it enters or may reasonably be anticipated to enter the 694 environment in substantial quantities or (I I) there is or may be significant or 695 substantial human exposure to such substance or mixture, 696 (ii) there are insufficient data and ex perience upon which the effects of the 697 manufacture, distribution in commerce, processing, use, or disposal of such 698 substance or mixture or of any combinatio n of such activities on health or the 699 environment can reasonably be det ermined or predicted, and 700 (iii) testing of such substance or mi xture with respect to such effects is 701 necessary to develop such data and 702 (C) in the case of a mixture, the effects which the mixture’s manufacture, 703 distribution in commerce, processing, use or disposal or any combination of such 704 activities may have on health or the env ironment may not be reasonably and more 705 efficiently determined or predicted by te sting the chemical substances which 706 comprise the mixture[.] (15 U.S.C. § 2603(a)). 707 If EPA makes these findings in a final rule makes an appropriate finding under 708 section 4(a)(1)(A) or (B) for a chemical substance or mi xture, the Administrator shall 709 require that testing be c onducted on that chemical s ubstance or mixture. The 710 purpose of the testing would be to devel op data with respect to the health and 711 environmental effects for which there is an insufficiency of data and experience, and 712 which are relevant to a determination that the manufacture, distribution in 713 commerce, processing, use, or disposal of the substance or mixture, or any 714 combination of such activities, does or does not present an unreasonable risk of 715 injury to health or the environment. Id. As indicated in Unit II.A.3. of this document, 716*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

35 of 43 EPA requests comment and supporting information regarding which section 4(a)(1) 717 finding authority would be mo st appropriate for the pur pose of a BPA test rule 718 proposal. Any proposal would ultimatelybe based on EPA’s assessment of the 719 relevant information availabl e at the time of proposal. 720 Once the Administrator has made t he relevant findings under TSCA section 721 4(a), EPA may require any health or environment al effects testing for which data are 722 insufficient and which are necessary to develop the data. EPA need not limit the 723 scope of testing required to the factual basis for the section 4(a )(1)(A)(i) or (B)(i) 724 findings as long as EPA also finds that there are insufficient data and experience 725 upon which the effects of t he manufacture, distribution in commerce, processing, 726 use, or disposal of such substance or mixture or of any combination of such 727 activities on health or the environmentcan reasonably be determined or predicted, 728 and that testing is necessary to develop such data. This approach is explained in 729 more detail in EPA’s TSCA section 4(a)(1)( B) Final Statement of Policy published in 730 the Federal Register at 58 FR 28736, 28738-28739, May 14, 1993 (B Policy). 731 Authority for requiring sampling and m onitoring for a chemical substance or 732 mixture can be found within TSCA section 4. Section 4(a) authorizes EPA to require 733 the development of data “which are relevant to a determination that the manufacture, 734 distribution in commerce, processing, use, or disposal of such substance or mixture, 735 or that any combination of such activiti es, does or does not present an unreasonable 736 risk of injury to health and the environment.” The extent to which such activities may 737 affect health or the environment is dependent in part upon the human and 738 environmental exposures to the chemical su bstance occasioned by those activities. 739 As an example, section 4(a)(2)(A) specific ally addresses testing for persistence of a 740*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

36 of 43 substance. Testing to identify where and in what concentrations a chemical 741 substance or mixture may become presentin the environment contributes to an 742 understanding of human and env ironmental exposures resulting from those 743 activities. As stated in Unit II.B. of this document, EPA does not intend to initiate 744 regulatory action under TSCA at this time on the basis of human health. 745 III. References 746 1. EPA. 2010. Bisphenol A Action Plan. Available online at 747 http://www.regulations.gov/search/Regs /home.html#documentDetail?R=0900006480 748 ad7e0c 749 2. EPA. 1993. Integrated Risk Informati on System (IRIS) ( 1993). Accessed at 750 http://www.epa.gov/ncea/iris/subst/0356.htm. 751 3. FDA. 2008. U. S. Food and Drug Administration. Draft Assessment of 752 Bisphenol A for Use in Food Contact Applications. 753 http://www.fda.gov/ohrms/ dockets/AC/08/briefing/2008- 754 0038b1_01_02_FDA%20BPA%20Draft%20Assessment .pdf; peer review report and 755 additional information available at 756 http://www.fda.gov/Food/FoodIngr edientsPackaging/ucm166145.htm. 757 4. European Food and Safety Author ity (EFSA). 2006. Scientific Panel on 758 Food Additives, Flavourings, Processing Aids and Materials in Contact with Food . 759 Summary Opinion of the Scientific Panel on food additives, flavourings, processing 760 aids and materials in contact with food (AFC) related to 2,2-BIS(4- 761 HYDROXYPHENYL) PROPANE. Ques tion number EFSA-Q- 2005-100 November. 762 5. European Food and Safety Authority (EFSA). 2008. Scientific Opinion of 763 the Panel on Food additives, Flavourings, Processing aids and Materials in Contact 764*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

37 of 43 with Food (AFC) on a request from the Commission on the toxicokinetics of 765 Bisphenol A. The EFSA Journal (2008) 759, 1-10. 766 6. Canada. 2008. Environm ent Canada, Health Canada. Screening 767 Assessment for the Challenge Phenol, 4,4' (1-methylethylidene)bis- (Bisphenol A) 768 CAS 80-05-7 . October 2008. 769 http://www.ec.gc.ca/substances/ese/ eng/challenge/batch2/batch2_80-05-7_en.pdf 770 7. EU. 2008. European Union Updated Risk Asse ssment Report. Bisphenol 771 A, CAS No: 80-05-7 . Institute for Health and C onsumer Protection, European 772 Chemicals Bureau, European Commission Joint Research Centre, 3rd Priority List, 773 Luxembourg: Office for O fficial Publications of the European Communities. 774 8. AIST (Japan’s National Institut e of Advanced Industrial Science and 775 Technology). 2007. AIST Risk Assessment Document Series 4. Bisphenol A. 776 9. NTP/CERHR. 2008. NTP-CER HR Monograph on the Potential Human 777 Reproductive and Developmental Effects of Bisphenol A. US Department of Health 778 and Human Services. National Toxicology Program. Center for the Evaluation of 779 Risks to Human Reproduction. 780 http://cerhr.niehs.nih.gov/evals/bisphenol/bisphenol.pdf 781 10. FDA. 2010. U.S. Food and Drug Administration. Update on Bisphenol A 782 for Use in Food Contact Applications: January 2010. Accessed at 783 http://www.fda.gov/NewsEvents/ PublicHealthFocus/ucm197739.htm

. 784 11. Crain, D.A.; Eriksen, M.; Iguchi, T.; Jobling, S.; Laufer, H.; LeBlanc, G.A.; 785 Guillette, Jr., L.J. 2007. An ecological a ssessment of Bisphenol A: evidence from 786 comparative biology. Reprod. Toxicology (24): 225-239. 787*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

38 of 43 12. Lahnsteiner, F.; Berger, B.; Kletzl, M.: Weismann, T. 2005. Effect of 788 Bisphenol A on Maturation and Quality of Semen and Eggs in the Brown Trout, 789 Salmo trutta f. fario

. Aquatic Tox. 75: 213-224. 790 13. Reference to RAD bibliographical lis t of 645 articles found; list will 791 appear in docket. 792 14. Reference to RAD bibliographical list of 31 articles deemed relevant; 793 list will appear in docket. 794 15. Marcial, H.S.; Hagiwara, A.; S nell, T.W. 2003. Estrogenic compounds 795 affect development of harpacticoid copepod Tigriopus Japonicus

. Env. Tox. and 796 Chem . 22(12), 3025–3030. 797 16. Watts, M.M.; Pascoe, D.; Carro ll, K. 2001. Chronic exposure to 17 α 798 ethinylestradiol and bisphenol A-effect s on development and reproduction in the 799 freshwater invertebrate Chironomus riparius (Diptera: Chironomidae). Aquat. Tox. 800 55, 113–124. 801 17. Sumpter, J.P.; Tyler, C.R. ; Sherazi, A. 2001. Bisphenol-A: 802 Multigeneration study with the fathead minnow ( Pimephales promelas ). Brunel 803 University (unpublished; part of study published as Sohoni et al , 2001). 804 18. Oehlmann, J.; Schulte-Oehlmann, U .; Werner, K.; Jagnytsch, O.; Lutz, I.; 805 Kresten, K.; Wollenberger, L.; Sant os, E. M.; Paull, G.C.; Van Look, K.J.W.; Tyler, 806 C.R. 2008. A Critical Analysis of the Biol ogical Impacts of Plasticizers on Wildlife. 807 Philos. Trans. R. Soc ., B: Biol. Sci. 364(1526): 2047–2062. 808 19. Forbes, V.E.; Selck, H.; Palmqv ist, A.; Aufderheide, J.; Warbritton, R.; 809 Pounds, N.; Thompson, R.; van der Hoeven, N .; Caspers, N. 2007. Does bisphenol 810*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

39 of 43 A induce superfeminization in Marisa cornuarietis? Part I: Intra- and inter-laboratory 811 variability in test endpoints. Ecotox. and Env. Safe . 66, 309–318. 812 20. Forbes, V.E.; Aufderheide, J.; Warbritton, R.; Thompson, R.; van der 813 Hoeven, N.; Caspers, N. 2007. Does bisphenol A indu ce superfeminization in 814 Marisa cornuarietis? Part I: Intra- and inter-laborator y variability in test endpoints. 815 Ecotox. and Env. Safe . 66, 319–325. 816 21. Forbes, V.E; Aufderheide, J.; Warbritton, R.; Thompson, R.; van der 817 Hoeven, N.; Caspers, N. 2008. Effe cts of bisphenol A on fecundity, egg 818 hatchability, and juvenile growth of Maris Cornuarietis

. Env. Tox. and Chem . 27 819 (11), 2332–2340. 820 22. Levy, G.; Lutz, I.; Krüger, A.; Kloas, W. 2004. Bisphenol A induces 821 feminization in Xenopus laevis tadpoles. Environ. Res. 94, 102-111. 822 23. Calabrese, E.J.; Baldwin, L.A. 2003. Hormesis at the National 823 Toxicology Program (NTP): evidence of hormetic dose responses in NTP dose824 range studies. Nonlinearity Biol. Toxicol. Med. 1, 455–467. 825 24. Heimeier, R.A.; Das, B.; Bu chholz, D.R.; Shi, Y. 2009. The 826 Xenoestrogen Bisphenol A inhibits poste mbryonic vertebrate development by 827 antagonizing gene regulation by thyroid hormone. Endocrinology , 150, 2964-2973. 828 25. Ramakrishnan, S.; Wayne, N.L. 2008. Impact of bisphenol-A on early 829 embryonic development and reproductive maturation. Reproductive Toxicology 25, 830 177–183. 831 26. Ankley, G.T., K.M. Jensen, M.D. Kahl, E.J. Durhan, E.A. Makynen, J.E. 832 Cavallin, D. Martinovic, L.C. Wehmas, N.D. Mueller and D.L. Villeneuve. 2010. Use 833*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

40 of 43 of chemical mixtures to differentiate me chanisms of endocrine action in a small fish 834 model. Aquat. Toxicol. 99, 389-396. 835 27. EPA. Endocrine Disruptor Screening Program; Policies and Procedures 836 for Initial Screening. 74 F ed.Reg. 17560. April 15, 2009. 837 28. EPA. Endocrine Disruptor Screening Program website. Accessed at 838 http://www.epa.gov/scipoly/oscpendo/

. 839 29. Organization for Economic Co- operation and Development Environment 840 Directorate. Endocrine Disruptor Te sting and Assessment. Accessed at 841 http://www.oecd.org/document/ 62/0,3343,en_2649_34377_2348606_1_1_1_1,00.ht 842 ml 843 30. EPA. 2008. Aquatic Life Criteria for Contaminants of Emerging Concern 844 (Part 1) & Illustration of Re commendations using Data for 17 α -Ethinylestradiol 845 (EE2). USEPA Office of Water, Washington, DC. 846 31. EPA. 2009a. Toxic Release Invent ory. 2007 Public Data Release, 847 Released March 14, 2009. http://www.epa.gov/tri/tridata/index.htm#pdr 848 32. European Union. 2010. Risk Assessment Report, 4,4'- 849 Isopropylidenediphenol (Bisphenol-A), CAS No: 80-05-7, (February 2010). 850 33. Vinggaard, A.M.: Kör ner, W.; Lund, K.H.; Bolz, U. ; Petersen, J.H. 2000. 851 Identification and quantification of estrogenic compounds in recycled and virgin 852 paper for household use as determined by an in vitro yeast estrogen screen and 853 chemical analysis. Chem Res Toxicol. 13(12):1214-22. 854 34. Gehring, M.; Vogel, D.; Tennhardt, L. ; Weltin, D.; Bilite wski, B. Undated. 855 Bisphenol A contaminati on of wastepaper, ellulose and recycled paper products. 856 http://rcswww.urz.tu-dresden.de/ ~gehring/deutsch /dt/vortr/040929ge.pdf 857*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

41 of 43 35. Ozaki, A.; Yamaguc hi, Y.; Fujita, T.; Kuroda, K.; Endo, G. 2004. 858 Chemical analysis and genotoxicologica l safety assessment of paper and 859 paperboard used for food packaging. Food Chem Toxicol. 42(8):1323-37. 860 36. Fukazawa, H.; Hoshino, K.; Shio zawa, T.; Matsushita, H.; Terao, Y. 861 2001. Identification and quantif ication of chlorinated bispheno l A in wastewater from 862 wastepaper recycling plants. Chemosphere . 44(5):973-9. 863 37. Terasaki, M.; Shiraishi, F.; Fu kazawa, H.; Makino, M. 2007. Occurrence 864 and estrogenicity of phenolics in paper-re cycling process water: pollutants 865 originating from therma l paper in waste paper. Environ Toxicol Chem. 26(11):2356- 866 66. 867 38. Braun J.M., Kalkbrenner A.E., Cala fat A.M., Bernert J.T., Ye X., et al. 868 2010 Variability and Predictors of Uri nary Bisphenol A Concentrations during 869 Pregnancy. Environ Health Perspect doi:10.1289/ehp.1002366. 870 39. Calafat AM, Kuklenyik Z, Reidy JA, et al (2005). Urinary concentrations of 871 bisphenol A and 4

‐ nonylphenol in a human reference population. Environmental 872 Health Perspectives , 113:391

‐ 395 Tsai, W. 2006. Human Health Risk on 873 Environmental Exposure to Bisphenol

- A: A Review. Journal of Environmental 874 Science and Health Part C, 24:225

- 255

. 875 40. Calafat AM, Ye S, Wong LY, et al (2008). Exposure of the US population 876 to bisphenol A and 4-tert iarty-octylphenol: 2003-2004. Environmental Health 877 Perspectives , 116(1): 39-44. 878 41. Calafat AM, Weuve J, Ye X, etal (2009). Exposure to bisphenol A and 879 other phenols in neonatal intensive care unit premature infants. Environmental 880 Health Perspectives , 117(4):639-644. 881*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

42 of 43 42. Centers for Disease Control and Prevention. Department of Health and 882 Human Services. Fourth National Report on Human Exposure to Environmental 883 Chemicals, Update Tables. July 2010. 884 http://www.cdc.gov/exposurer eport/pdf/Update_Tables.pdf . 885 43. Tsai, W. 2006. Human Health Ri sk on Environmental Exposure to 886 Bisphenol-A: A Review. Journal of Environmental Science and Health Part C, 887 24:225-255 40

. . 888 44. Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E. M.; Zaugg, S.D.; 889 Barber, L.B.; Buxton, H.T. 2002. Pharmaceuticals, hormones, and other organic 890 wastewater contaminants in U.S. streams, 1999–2000: a national survey. Environ 891 Sci Technol 36:1202–1211. 892 41 45 . Klecka, G.M.; Staples, C.A.; Clark , K.E.; van der Hoeven, N.; Thomas, 893 D.E.; Hentges, S.G. 2009. Exposure Analysis of Bisphenol A in Surface Water 894 Systems in North Am erica and Europe. Environ. Sci. Technol . 2009, 43(16):6145– 895 6150. 896 42 46 . Boyd G.R.; Reemtsma, H.; Grimm, D.A.; Mitra, S. 2003. 897 Pharmaceuticals and personal care products (PPCPs) in surface and treated waters 898 of Louisiana, U.S.A. and Ontario, Canada. Sci Total Environ 311: 135-149. 899 43 47 . Jackson, J.; Sutton, R. 2008. Sources of endocrine-disrupting 900 chemicals in an urban wastewater, Oakland, CA. Sci. Total Env ., vol. 405:153-160. 901 44 48 . Lee, H-B; Peart, T.E. 2000. De termination of bisphenol A in sewage 902 effluent and sludge by solid-phase and superc ritical fluid extraction and gas 903 chromatography/mass spectrometry. J AOAC Int. vol. 83:290-7. 904*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

43 of 43 45 49 . Lee, H-B; Peart, T.F. 2000. Bis phenol A contaminat ion in Canadian 905 municipal and industrial wa stewater and sludge samples. Water Quality Res. J 906 Canada. vol. 35: 283-298. 907 46 50 . Kinney, C.A.; Furlong, E.T.; Z augg, S.D.; Burkhard t, M.R.; Werner, 908 S.L.; Cahill, J.D.; Jorgensen, G.R. 2006. Survey of Organic Wastewater 909 Contaminants in Biosolids Destined for Land Application. Environ. Sci. Technol. Vol. 910 40:7207–7215. 911 47 51 . Kinney, C.A; Furlong, E.T.; Ko lpin, D.W.; Burkhardt, M.R.; Zaugg, 912 S.D.; Werner, S.L.; Bossi o, J.P.; Benotti, M.J. 2008. Bioaccumulation of 913 pharmaceuticals and other anthropogenic wa ste indicators in earthworms from 914 agricultural soil amended with bi osolid or swine manure. Environ. Sci. Technol. 915 2008, vol. 42: 1863–1870. 916 48 52 . Barnes, K.K.; Kolpin, D.W.; Focazi o, M.J.; Furlong, E. T.; Meyer, M.T.; 917 Zaugg, S.D.; Haack, S.K.; Barber, L.B.; T hurman, E.M. 2008a. U. S. Geological 918 Survey. Water-Quality Data for Pharma ceuticals and Other Organic Wastewater 919 Contaminants in Ground Water and in Untreated Drinking Water Sources in the 920 United States, 2000-01. Available at: http://pubs.usgs.gov/of/2008/1293/

. 921 49 53 . Barnes, K.K.; Kolpin, D.W.; Furl ong, E.T.; Zaugg, S.D.; Meyer, M.T.; 922 Barber, L.B. 2008b. A National Reconna issance of Pharmaceuticals and Other 923 Organic Wastewater Contaminants in the United States: (I) Groundwater. Sci.Total 924 Enviro . 402 (2–3), 192–200. 925 50 54 . Focazio, M.J.; Kolpin, D.W.; Bar nes, K.K.; Furlong, E.T.; Meyer, M.T.; 926 Zaugg, S.D.; Barber, L.B.; Thurman, E.M. 2008. A National Reconnaissance for 927 Pharmaceuticals and Other Organic Wast ewater Contaminants in the United 928*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

44 of 43 States—(II) Untreated Drin king Water Sources. Sci. Total Environ . 402(2–3), 201– 929 216. 930 51 55 . Rudel, R.A.; Melly, S.J.; Geno, P. W.; Sun, G.; Brody, J.G. 1998. 931 Identification of Alkylphenols and Other Estrogenic Phenolic Compounds in 932 Wastewater, Septage, and Groundwater on Cape Cod, MA. Environ. Sci. Technol 933 32:861-9. 934 52 56 . Wilson, N.K.; Chuang, J.C.; Lyu, C.; Menton, R.; Morgan, M.K. 2003. 935 Aggregate exposures of nine preschool child ren to persistent organic pollutants at 936 day care and home. J. Expo. Anal. Environ. Epidemiol. 13:187-202. 937 53 57 . Stuart, J.D.; Capulong, C.P.; Launer , K.D.; Pan, X. 2005. Analyses of 938 phenolic endocrine disrupting chemicals in marine samples by both gas and liquid 939 chromatography-mass spectrometry. J. Chromatogr. A. 1079:136-145. 940 54 58 . Boyd, G.R.; Palmerib , J.M.; Grimm, D.A. 2004. Pharmaceuticals and 941 Personal Care Products (PPCPs) and Endocrine Disrupting Chemicals (EDCs) in 942 Stormwater Canals and Bayou St. John in New Orleans, Louisiana, USA. Sci. Total 943 Environ. 333:137-48. 944 55 59 . Staples, C.A.; Dorn, P.B.; Klecka, G.M .; O’Block, S.T.; Branson, D.R.; 945 Harris, L.R. 2000. Bisphenol A Concentrati ons in Receiving Waters Near U.S. 946 Manufacturing and Processing Facilities. Chemosphere 40:521-525. 947 56 60 . Zhang, S.; Zhang, Q.; Darisaw, S.; Ehie, O.; Wang, G. 2007. 948 Simultaneous Quantification of Polycycl ic Aromatic Hydrocarbons (PAHs), 949 Polychlorinated Biphenyls (PCBs), and Pharmaceuticals and Personal Care 950 Products (PPCPs) in Mississippi River Wate r, in New Orleans, Louisiana, USA. 951 Chemosphere 66:1057-69. 952*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

45 of 43 57 61 . Stackelberg, P.E.; Furlong, E.T.; Me yer, M.T.; Zaugg, S.D.; Henderson, 953 A.K.; Reissman, D.B. 2004. Persistence of Pharmaceutical Compounds and Other 954 Organic Wastewater Contaminants in a Conventional Drinking-Water-Treatment 955 Plant. Sci. Total Environ. 329:99-113. 956 58 62 . Drewes, J.E.; Hemming, J.; Ladenburger , S.J.; Schauer, J.; Sonzogni, 957 W. 2005. An Assessment of Endocrine Disrupting Activity Changes during 958 Wastewater Treatment through the Use of Bioassays and Chemical Measurements. 959 Water Environ. Res. 77:12–23. 960 59 63 . ASTM. 2009. ASTM Internati onal. ASTM D7574-09 Standard Test 961 Method for Determination of Bisphenol A in Environmental Waters by Liquid 962 Chromatography/Tandem Mass Spectrometry. 963 http://www.astm.org/Standards/D7574.htm

. 964 60 64 . ASTM. 2004. ASTM International . ASTM D5730-04 Standard Guide for 965 Site Characterization for Environmental Pu rposes With Emphasis on Soil, Rock, the 966 Vadose Zone and Ground Water. http: //www.astm.org/Standards/D5730.htm

. 967 61 65 . USEPA. 1998. U.S. Environment al Protection Agency. EPA Method 968 8270D (SW-846), Semivolatile Organic Co mpounds by Gas Chromatography/Mass 969 Spectrometry (GC/MS), Revision 4. http://www.epa.gov/ sam/pdfs/EPA-8270d.pdf

. 970 IV. Statutory and Executive Order Reviews 971 Under Executive Order 12866, entitled “Regulatory Planning and Review” (58 972 FR 51735, October 4, 1993), this action was submitted to the Office of Management 973 and Budget (OMB) for review . Any changes made to this document in response to 974 OMB comments received by EPA during thatreview have been documented in the 975 docket as required by the Executive Order. 976*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

46 of 43 Since this document does not impos e or propose any requirements, and 977 instead seeks comments and suggestions for the Agency to consider in possibly 978 developing a subsequent proposed rule, the va rious other review requirements that 979 apply when an agency imposes requirements do not apply to this action. 980 Nevertheless, as part of your comments on this notice, you may include any 981 comments or information that you have regarding this action. 982 In particular, any comments or info rmation that would help the Agency to 983 assess the potential impact of a rule on sm all entities pursuant to the Regulatory 984 Flexibility Act (RFA) (5 U. S.C. 601 et seq.); to cons ider voluntary consensus 985 standards pursuant to section 12(d) of the National Technology Transfer and 986 Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note); to consider environmental 987 health or safety effects on children purs uant to Executive Order 13045, entitled 988 “Protection of Children from Environment al Health Risks and Safety Risks” (62 FR 989 19885, April 23, 1997); or to consider hum an health or environmental effects on 990 minority or low-income populations purs uant to Executive Order 12898, entitled 991 “Federal Actions to Address Environmental Justice in Minority Populations and Low992 Income Populations” (59 FR 7629, February 16, 1994). 993 The Agency will consider such comments during the development of any 994 subsequent proposed rule as it takes approp riate steps to address any applicable 995 requirements. 996 List of Subjects in 40 CFR Part 799 997 Environmental protection, Bisphenol A, BPA, Chemical testing, Chemicals, 998 Hazardous substances, Reports a nd recordkeeping requirements. 999 Dated: _________
___________ 1000*** EO 12866 Review Draft – Do Not Cit e, Quote or Release During Review ***

47 of 43 1001 1002

_______________ ____________ _______________ 1003 1004

________________________ __________________ 1005 Assistant Administrator, Office of Chemical Safe ty and Pollution Prevention. 1006