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1 EO12866_rin2070-AJ83_BPA-Testing_ANPRM_2010-12-10 2011-06-17.doc 

2 EO 12866 Review Draft as submitted.

3 Revised to address Interagency Comments received under EO 12866 review.

4 BILLING CODE 6560–50–P 

5 ENVIRONMENTAL PROTECTION AGENCY 

6 40 CFR Part 799 

7 [EPA–HQ–OPPT–2010–0812; FRL–XXXX–X] 

8 RIN 2070-AJ83 

9 Testing of Bisphenol A 

10 AGENCY: Environmental Protection Agency (EPA). 

11 ACTION: Advance notice of proposed rulemaking. 

12 SUMMARY: Bisphenol A (BPA, CASRN 80-05-7), a high production volume 

13 chemical, is a reproductive, developmental, and systemic toxicant in animal studies 

14 and is weakly estrogenic. EPA is providing this advance notice of proposed 

15 rulemaking to request comment on requiring toxicity testing to determine the 

16 potential for BPA to cause adverse effects, including endocrine-related and other 

17 adverse effects, in environmental organisms at low concentrations. EPA is also 

18 seeking comment on requiring environmental testing consisting of sampling and 

19 monitoring for BPA in surface water, ground water, drinking water, soil, sediment, 

20 sludge, and landfill leachate in the vicinity of expected BPA releases to determine 

21 whether environmental organisms may currently be exposed to concentrations of 

22 BPA in the environment that are at or above levels of concern for adverse effects, 

23 including endocrine-related effects. This notice is directed only toward the 

24 environmental presence and environmental effects of BPA. EPA is working with the 
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25 Department of Health and Human Services (HHS) on potential human health issues, 

26 but is not considering any additional testing specifically in regard to human health 

27 issues at this time.

28 DATES: Comments must be received on or before [insert date [60] days after date 

29 of publication in the Federal Register]. 

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

31 number EPA–HQ–OPPT–2010–0812, by one of the following methods: 

32 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

33 instructions for submitting comments. 

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

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

36 Washington, DC 20460–0001. 

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

38 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 

39 EPA–HQ–OPPT–2010–0812. The DCO is open from 8 a.m. to 4 p.m., Monday 

40 through Friday, excluding legal holidays. The telephone number for the DCO is (202) 

41 564–8930. Such deliveries are only accepted during the DCO’s normal hours of 

42 operation, and special arrangements should be made for deliveries of boxed 

43 information. 

44 Instructions: Direct your comments to docket ID number EPA–HQ–OPPT–

45 2010–0812. EPA's policy is that all comments received will be included in the docket 

46 without change and may be made available on-line at http://www.regulations.gov, 

47 including any personal information provided, unless the comment includes 

48 information claimed to be Confidential Business Information (CBI) or other 
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49 information whose disclosure is restricted by statute. Do not submit information that 

50 you consider to be CBI or otherwise protected through regulations.gov or e-mail. 

51 The regulations.gov website is an “anonymous access” system, which means EPA 

52 will not know your identity or contact information unless you provide it in the body of 

53 your comment. If you send an e-mail comment directly to EPA without going 

54 through regulations.gov, your e-mail address will be automatically captured and 

55 included as part of the comment that is placed in the docket and made available on 

56 the Internet. If you submit an electronic comment, EPA recommends that you 

57 include your name and other contact information in the body of your comment and 

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

59 technical difficulties and cannot contact you for clarification, EPA may not be able to 

60 consider your comment. Electronic files should avoid the use of special characters, 

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

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

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

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

65 statute. Certain other material, such as copyrighted material, will be publicly 

66 available only in hard copy. Publicly available docket materials are available 

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

68 OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at 

69 Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The 

70 EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., 

71 Monday through Friday, excluding legal holidays. The telephone number of the 

72 EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the 
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73 OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic 

74 identification, pass through a metal detector, and sign the EPA visitor log. All visitor 

75 bags are processed through an X-ray machine and subject to search. Visitors will 

76 be provided an EPA/DC badge that must be visible at all times in the building and 

77 returned upon departure. 

78 FOR FURTHER INFORMATION CONTACT: For technical information contact: 

79 Mary Dominiak, Chemical Control Division (7405M), Office of Pollution Prevention 

80 and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

81 Washington, DC 20460–0001; telephone number: 202-564-8104; e-mail address: 

82 dominiak.mary@epa.gov.

83 For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 

84 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e85 mail address: TSCA-Hotline@epa.gov. 

86 SUPPLEMENTARY INFORMATION: 

87 I. General Information 

88 A. Does this Action Apply to Me? 

89 You may be potentially affected by this action if you manufacture (identifined 

90 by statute to include import) or process BPA (CASRN 80-05-7). BPA is listed on the 

91 TSCA Inventory under the name phenol, 4,4’-(1-methylethylidene)bis-. Potentially 

92 affected entities may include, but are not limited to: 

93 • Chemical manufacturers (including importers) (NAICS codes 325, 32411, 

94 e.g., chemical manufacturing and petroleum refineries) of BPA. 
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95 • Plastics material and resin manufacturers (NAICS code 325211, e.g., 

96 manufacturers and processors of BPA-based polycarbonate plastics and epoxy 

97 resins). 

98 • Foundries (NAICS codes 331512, 331524, 331528, e.g. steel investment 

99 foundries, aluminum foundries, and other non-ferrous foundries, except die-casting) 

100 using BPA in casting sands. 

101 • Paint and coating manufacturers (NAICS code 325510), e.g. manufacturers 

102 of epoxy-based paints and other coating products that may contain BPA. 

103 • Paper recyclers (NAICS codes 322110, 322121, 3222, e.g. pulp mills, paper 

104 (except newsprint) mills, and converted paper product manufacturers) that may 

105 process waste thermal paper containing BPA. 

106 • Materials recovery facilities (NAICS code 562920, e.g. facilities separating 

107 and sorting recyclable materials), that may handle thermal paper, polycarbonates, or 

108 food and beverage cans lined with BPA-based epoxy coatings. 

109 • Custom compounders of purchased resins (NAICS code 325991, e.g. 

110 facilities where resins are made from recycled polycarbonate plastics) that may 

111 contain BPA. 

112 This listing is not intended to be exhaustive, but rather provides a guide for 

113 readers regarding entities likely to be affected by this action. Other types of entities 

114 not listed in this unit could also be affected. The North American Industrial 

115 Classification System (NAICS) codes have been provided to assist you and others in 

116 determining whether this action might apply to certain entities. If you have any 

117 questions regarding the applicability of this action to a particular entity, consult the 

118 technical person listed under FOR FURTHER INFORMATION CONTACT. 
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119 B. What Should I Consider as I Prepare My Comments for EPA? 

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

121 regulations.gov or e-mail. Clearly mark the part or all of the information that you 

122 claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, 

123 mark the outside of the disk or CD-ROM as CBI and then identify electronically 

124 within the disk or CD-ROM the specific information that is claimed as CBI. In 

125 addition to one complete version of the comment that includes information claimed 

126 as CBI, a copy of the comment that does not contain the information claimed as CBI 

127 must be submitted for inclusion in the public docket. Information so marked will not 

128 be disclosed except in accordance with procedures set forth in 40 CFR part 2. 

129 2. Tips for preparing your comments. When submitting comments, remember 

130 to: 

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

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

133 ii. Follow directions. The Agency may ask you to respond to specific 

134 questions or organize comments by referencing a Code of Federal Regulations 

135 (CFR) part or section number. 

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

137 language for your requested changes. 

138 iv. Describe any assumptions and provide any technical information and/or 

139 data that you used. 

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

141 estimate in sufficient detail to allow for it to be reproduced. 
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142 vi. Provide specific examples to illustrate your concerns and suggest 

143 alternatives. 

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

145 personal threats. 

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

147 identified. 

148 II. Background 

149 A. What Action is the Agency Taking? 

150 As a follow-up to the BPA Action Plan released on March 29, 2010 (Ref. 1), 

151 EPA is issuing this advance notice of proposed rulemaking under TSCA section 4(a) 

152 (15 U.S.C. § 2603(a)) to solicit public input on the necessity for and best approach to 

153 obtain environmental effects, exposure, and pathway information relevant to a 

154 determination that BPA either does or does not present an unreasonable risk of 

155 injury to the environment. In particular, EPA requests comment on: 

156 1. Whether EPA should propose requiring specific toxicity testing to more fully 

157 characterize the effects of BPA on environmental organisms at low concentrations; 

158 and 

159 2. Whether EPA should propose requiring environmental testing consisting of 

160 sampling and monitoring, particularly in the vicinity of reported releases of BPA into 

161 the environment, and what design and protocol it should use for such sampling and 

162 monitoring, in order to identify potential sources and pathways of exposure and 

163 determine the extent to which environmental organisms may be exposed to BPA 

164 concentrations of concern as determined by existing data and by additional studies 

165 that are either already underway or would be conducted under a proposed test rule. 
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166 3. EPA additionally requests comment and supporting information regarding 

167 which section 4(a)(1) finding authority would be most appropriate for the purpose of 

168 a BPA test rule proposal, as discussed in Unit II.C. of this document. Any proposal 

169 would ultimately be based on EPA’s assessment of the relevant information 

170 available at the time of proposal.

171 B. What Testing Is EPA Considering in this ANPRM? 

172 In this ANPRM, EPA is considering requiring both toxicity testing for 

173 environmental organisms exposed to BPA and environmental testing consisting of 

174 sampling and monitoring in the vicinity of reported BPA releases to measure its 

175 environmental presence. The toxicity testing is being proposedconsidered to resolve 

176 existing uncertainties concerning the potential for BPA to elicit adverse effects in 

177 ecologically relevant species, including endocrine-related impacts that could occur at 

178 low doses. The environmental testing is being proposedconsidered to resolve 

179 existing uncertainties concerning potential sources of and pathways leading to 

180 environmental exposures and to determine whether or not the concentrations to 

181 which organisms currently may be exposed in the environment are at or above 

182 levels of concern for adverse effects, including endocrine-related effects. 

183 On May 17, 1985, EPA published a Proposed Rule (50 FR 20691) to require 

184 human health and environmental testing in response to the Interagency Testing 

185 Committee's (ITC's) designation of BPA for priority consideration for health and 

186 environmental effects. EPA proposed standard freshwater and marine acute fish and 

187 aquatic invertebrate toxicity tests, and freshwater aquatic plant toxicity tests. Test 

188 results were submitted in response to the proposal for freshwater and marine acute 

189 fish, acute aquatic invertebrate, and algal toxicity. EPA’s Final Rule (51 FR 33047), 
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190 published September 18, 1986, terminated the test rule process for environmental 

191 effects testing for bisphenol A. At the time, EPA determined that the test data were 

192 adequate and that chronic freshwater organism testing was not needed because the 

193 LC50 values for the standard acute aquatic organism toxicity tests were greater than 

194 1.0 ppm (1 mg/L), and the ratio of 48-hour to 96-hour LC50 values were not greater 

195 than two. Since the 1986 Final Rule, however, several studies on BPA have raised 

196 concerns about its environmental effects at concentrations less than 1.0 ppm (1 

197 mg/L). 

198 As stated in the BPA Action Plan (Ref. 1), EPA does not intend to initiate 

199 regulatory action under TSCA at this time on the basis of human health. EPA 

200 remains committed to protecting human health, but notes that most human 

201 exposure, including exposure to children, comes through food packaging materials 

202 under the jurisdiction of the Food and Drug Administration (FDA) in HHS. FDA, 

203 together with the Centers for Disease Control and Prevention (CDC) and the 

204 National Institute of Environmental Health Sciences (NIEHS), is investing in 

205 important new health studies in both animals and humans to better determine and 

206 evaluate the potential health consequences of BPA exposures. EPA will continue to 

207 coordinate closely with FDA, CDC, and NIEHS on this activity. To the extent that 

208 FDA may identify health concerns from BPA in food contact materials, EPA will work 

209 with FDA to identify and assess potential substitutes. Levels of exposure that may 

210 be identified by the ongoing review as being of concern to human health, including 

211 children’s health, will affect the extent to which EPA would take additional action to 

212 address potential risks to human health resulting from uses within TSCA jurisdiction.

213 1. What Is Currently Known About the Environmental Hazard of BPA? 
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214 The toxicity of BPA has been studied extensively, as indicated in the multiple 

studies cited in the Action Plan (Ref. 1).)

1 215 . There is general agreement among 

216 multiple reviewers, including government regulatory agencies in the United States, 

217 Japan, the European Union, and Canada, that BPA is a reproductive and 

218 developmental toxicant at doses in animal studies of > 50 mg/kg-bw/day (delayed 

219 puberty in male and female rats and male mice; discussed in Ref. 2-9); > 235 mg/kg220 bw/day (reduced fetal or birth weight or growth early in life, effects on testis of male 

221 rats; Ref. 9); and > 500 mg/kg-bw/day (possible decreased fertility in mice, altered 

222 estrous cycling in female rats, and reduced survival of fetuses; Ref. 9). Systemic 

223 effects (reduction in body weight, changes in relative organ weights, and increases 

224 in liver toxicity; Ref. 2-8) were observed at doses above 5 mg/kg-bw/day (identified 

225 as a no observed adverse effect level (NOAEL); lowest observed adverse effect 

226 level (LOAEL) of 50 mg/kg-bw/day). There are reports of endocrine-related low-dose 

227 effects on puberty and neurological development (brain, behavior; Ref. 9) at doses in 

228 animal studies as low as 2 μg/kg-bw/day. There is disagreement in the scientific 

229 community at large about whether effects seen at doses in animals less than 1 

230 mg/kg/day are meaningful and relevant to humans. The Food and Drug 

231 Administration (Within HHS, FDA),, together with the National Institute of 

232 Environmental Health Sciences (NIEHS) and the Centers for Disease Control and 

233 Prevention ( and CDC), is, are engaging in additional research to better determine 

234 and evaluate the potential human health consequences of exposures to BPA, 

235 including exposures at low doses (Ref. 10). EPA is working with FDA, NIEHS, and 

 

1

 EPA's response to the request for correction of the information provided in the Action Plan that was 

filed under the Agency's Information Quality Guidelines by the American Chemistry Council is 

available at www.epa.gov/quality/informationguidelines/iqg-list.html
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236 CDC on this ongoing research, and is not proposingconsidering any additional 

237 testing specifically in regard to human health issues at this time. 

238 Many studies have been conducted to determine potential effects of BPA 

239 exposure on invertebrates, fish, amphibians, reptiles, birds, and wild mammals, and 

240 a review is provided by Crain et al. (Ref. 11). In general, studies have shown that 

241 BPA can affect growth, reproduction and development in aquatic organisms. 

242 Evidence of sub-lethal effects mediated through either endocrine or non-endocrine 

243 related mechanisms in fish, amphibians, reptiles, and invertebrate aquatic organisms 

244 has been reported at potentially environmentally relevant exposure levels lower than 

245 those required for acute toxicity. There is a widespread variation in reported values 

246 for these sub-lethal effects, but many fall in the range of 1 μg/L to 1 mg/L. (Ref. 6; 

247 also, see individual studies noted in Table 2). 

248 The ecological hazard for BPA has been evaluated in three different risk 

249 assessments performed by the European Union (EU), Canada, and Japan (Refs. 7, 

250 6, and 8), as summarized in Table 1 below. The different methodologies, endpoints 

251 and study results used by each country to derive their ecological values highlight the 

252 significant uncertainty in the estimated hazard values. Japan concluded that “the 

253 current exposure levels of BPA will not pose unacceptable risks to the local 

254 populations of aquatic life, particularly fish” (Ref. 8). In contrast, the EU concluded 

255 that although the predicted exposure concentrations were significantly below its 

256 hazard values, there was a need for further information and/or testing on such 

257 organisms as freshwater snails (Ref. 7). 

258 Canada used a study (Ref. 12) that reported reduced sperm quality and 

259 delayed ovulation in brown trout at a very low concentration in water (1.75 μg/L). 
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260 Other effects such as the induction of intersex (or testes-ova in males and females), 

261 decreased spermatogenesis, induction of vitellogenin, delayed or ceased ovulation, 

262 or histological liver changes were also reported in other studies referenced in the EU 

263 and Japanese hazard evaluations. However, because there were no standardized 

264 test guidelines or risk assessment guidance for evaluating some of these endocrine265 related effects at the time of these assessments, the EU and Japan set 

266 ecotoxicological hazard values based on conventional effects (mortality and 

267 reproductive effects) from standardized studies. In contrast, Canada concluded in its 

268 hazard characterization that “[c]onsidered together, the data provide strong evidence 

269 that bisphenol A is capable of eliciting adverse effects: (1) following prolonged 

270 exposure at levels below those usually seen to elicit effects in standard toxicity tests 

271 (i.e., tests based on recognized methods which evaluate endpoints such as survival, 

272 reproduction and growth); (2) following brief low-dose exposure, particularly at 

273 sensitive developmental stages, with effects apparent later in the life cycle; (3) on 

274 filial generations following parental exposure; and (4) using more than one mode of 

275 action.” (Ref. 6). 

276 Canada concluded that BPA concentrations in water have the potential to 

277 cause adverse effects on populations of pelagic organisms in Canada and 

278 concentrations in biota have the potential to cause adverse effects in populations of 

279 wildlife in Canada, but that there is a low risk of direct adverse effects to sediment 

280 organisms and to avian wildlife species in Canada. In the conclusion of its risk 

281 assessment, Canada stated that it is considered appropriate to apply a 

282 precautionary approach when characterizing risk, observing “it is concluded that 

283 bisphenol A is entering the environment in a quantity or concentration or under 
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284 conditions that have or may have an immediate or long-term harmful effect on the 

285 environment or its biological diversity.” (Ref. 6). 

Table 1: Summary of Bisphenol A Ecological Values 

Country 

Predicted No 

Effect 

Concentratio

ns1 (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, resulting 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 ovulation 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) multigeneration 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 evaluate risk. If the ratio 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 

287 EPA considers that the uncertainty demonstrated by these divergent opinions 

288 concerning interpretation of the results of existing environmental toxicity studies, 

289 particularly studies addressing potential effects at low levels of exposure, may 

290 indicate further testing is necessary to resolve the question of whether or not BPA 

291 presents an unreasonable risk of injury to the environment on the basis of those 

292 effects. This is due to the combination of the existence of measured values, as 

293 discussed in Unit II.B.4 and shown in Table 3, for BPA in U.S. surface waters at a 
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294 mean concentration range of up to 1.78 μg/L (ppb) and a single maximum 

295 concentration of 12 μg/L (ppb); in ground water at a mean concentration range of up 

296 to 1.9 μg/L (ppb) and a maximum concentration of 2.55 μg/L (ppb); and in freshwater 

297 sediments at a median concentration of 0.6 μg/kg (ppb) dry weight and a maximum 

298 concentration of 140 μg/kg (ppb) (See Table 3), and the existence of many hazard 

299 studies describing a variety of effects in aquatic organisms at some of these 

300 concentrations (See Table 2), leaving little or no room for a reasonable or 

301 acceptable margin of exposure. 

302 There are two principal, initial questions that need to be answered inIn order 

303 to assess the potential for BPA to harm the environment in the U.S.:., EPA considers 

304 it important to address two basic areas of inquiry relevant to identifying the hazard

305 and exposure components of a risk analysis: 

306 a. What additional hazard information is needed to fully characterize the effects 

307 of BPA in environmental organisms at low doses and potentially 

308 environmentally relevant concentrations; and 

309 b. What levels of BPA are present in the environment, particularly in areas 

310 where environmental exposures are likely to be highest (e.g., near BPA 

311 manufacturing facilities, polycarbonate and epoxy resin manufacturing and 

312 processing facilities, foundries, landfills, wastewater treatment plants 

313 (WWTPs) and other locations associated with uses and/or releases of BPA)? 

314 2. What Additional Hazard Information is Needed on the Effects of BPA on 

315 Environmental Organisms? 
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316 EPA performed a literature search to identify relevant scientific information to 

assess the acute and chronic toxicity of BPA to environmental organisms from 20072 317 

318 to the present. A total of 645 articles were found (Ref. 13), of which 31 were found 

319 to be of some relevance (Ref. 14). Since thorough analyses of acute and chronic 

320 toxicity for “conventional endpoints” (which generally address immediate effects on 

321 survival or reproduction) had already been conducted for BPA by Canada, the 

322 European Union, and Japan (Ref. 6-8), EPA performed a more detailed evaluation of 

323 the scientific literature for sub-lethal effects at lower concentrations (< 100 μg/L). 

324 These sub-lethal effects in both vertebrates and invertebrates could be mediated 

325 either through endocrine or non-endocrine-related mechanisms. There are many 

326 studies indicating such sub-lethal effects from BPA exposures at levels that, based 

327 on the information discussed in Unit II.B.4, appear to be potentially environmentally 

328 relevant concentrations because they may occur in the environment. Some of these 

329 studies are included in Table 2. 

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 
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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 
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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 

331 There is debate in the scientific literature on how best to interpret these low332 dose, sub-lethal effects of BPA and other chemicals on environmental organisms. 
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333 EPA is concerned that these sub-lethal effects may be having a detrimental effect on 

334 populations of aquatic organisms over time based on the reported increased 

335 susceptibility of subsequent generations exposed to BPA in multigeneration 

336 invertebrate and fish studies. For example, in the intertidal copepod (Tigriopus 

337 japonicus), delayed development was reported in the first generation at 0.1 μg/L, but 

338 at a 10-fold lower concentration of 0.01 μg/L in the next generation (Ref. 15). In the 

339 freshwater midge (Chironomus riparius), the first generation did not have a 

340 significant delay in emergence time from the egg, but in the second generation 

341 emergence was delayed at 0.08 μg/L (Ref. 16). Egg hatchability decreased in 

342 fathead minnows (Pimephales promelas) at 640 μg/L in the first (F1) generation, 

343 then at 160 μg/L in the second (F2) generation (Ref. 17). Although the mechanisms 

344 of action leading to effects may be different for vertebrate and invertebrate 

345 organisms, this suggests the potential for increasing developmental and 

346 reproductive effects in populations of aquatic organisms that have repeated 

347 exposures to BPA for generations, even at very low concentrations. 

348 Testing with BPA has been extensive at sub-lethal concentrations, but the 

349 studies with effects across multiple species generally have flaws associated with 

350 them, including lack of analytical monitoring, small sample size, inadequate 

351 replication, or use of inappropriate statistical analyses leading to incorrect 

352 conclusions of study results. Studies in ramshorn snails, for example, resulted in 

353 superfeminization (e.g., the formation of additional female organs, enlarged 

354 accessory sex glands, gross malformations of the pallial oviduct, and a stimulation of 

355 egg and clutch production) at very low concentrations in one lab (Ref. 18), but those 

356 results were not found in studies by other researchers (Ref. 19-21). 
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357 In addition, in some studies, BPA demonstrated effects at very low 

358 concentrations, but no effects were observed at the higher test concentrations. For 

359 example, tadpoles exposed to 2.3, 23 and 230 μg/L of BPA (Ref. 22) before 

360 metamorphosis had an increased female to male ratio at 23 μg/L only. These types 

361 of anomalous responses have been reported across multiple species of fish and 

362 invertebrates for BPA and are characteristic of endocrine-active chemicals. They 

363 suggest inhibition of reproduction and development at low concentrations and 

364 overcompensation by the organism at higher concentrations in response to a 

365 toxicant (Ref. 23). 

366 It is difficult to interpret this information in a regulatory context, because the 

367 scientific methods employed in individual academic settings to test a hypothesis are 

368 not necessarily geared toward meeting or establishing generally applicable 

369 guidelines for evaluating ecotoxicity and setting corresponding regulatory limits or 

370 controls. In terms of environmental toxicity, EPA considers the currently available 

371 research as evidence that BPA has the potential to interact with the estrogen 

372 hormone system. There is some evidence that BPA is also active via the thyroid 

373 hormone pathway in amphibians and fish (Ref. 24, 25). More recent evidence 

374 indicates that BPA also acts as an androgen receptor antagonist in both mammals 

375 and fish (Ref. 26). There are currently efforts underway by the EPA Office of Science 

376 Coordination and Policy (OSCP) through the Endocrine Disruptor Screening 

377 Program (EDSP) and the Organization for Economic Cooperation and Development 

378 (OECD) Endocrine Disrupter Testing and Assessment Work Group (EDTAWG), 

379 among others, to determine the best approach to evaluate and assess such effects. 

380 (Ref. 27-29). 
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381 EPA is inviting comment on the need to further determine the hazard of BPA 

382 to various ecological species. The purpose of further testing would be to produce 

383 high quality data to identify and establish a dose-response that could be used for risk 

384 assessment purposes for any adverse reproductive or developmental effects in 

385 different species that might result from the interactions identified through the 

386 available research. 

387 3. What are the Issues for Comment Concerning Toxicity Testing? 

388 EPA invites comment on whether and what testing should be required to 

389 further describe the hazard of BPA to various ecological species to resolve the low 

390 dose effects issue. EPA particularly invites comment on the following, for which little 

391 or no clarifying hazard information appears to be currently available or for which 

392 much of the available data have been derived from studies of questionable quality or 

393 uncertain interpretation: 

394 a. Effects of BPA on fish in long-term tests, including those that encompass 

395 multiple generations. 

396 b. Effects of BPA on amphibians at sensitive life stages, specifically 

397 metamorphosis (thyroid effects) and sexual development/differentiation 

398 (hypothalamic-pituitary-gonadal axis effects). 

399 c. Effects of BPA on birds over multiple generations. 

400 d. Effects of BPA on aquatic invertebrate species 

401 EPA further invites comment on the availability of current test guidelines that 

402 could help address these issues. This may include, for example, considering the 

403 recommendations for Aquatic Life Criteria For Contaminants Of Emerging Concern 

404 (Ref. 30). Additionally EPA is inviting the public to describe and define where they 
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405 believe there are data gaps concerning the environmental toxicity of BPA, especially 

406 at low concentrations, or whether and on what basis they believe the current data 

407 are sufficient to determine whether BPA does or does not present an unreasonable 

408 risk of injury to the environment.

409 4. What Levels of BPA Are Present in the U.S. Environment?

410 BPA is present in the environment as a result of direct releases from 

411 manufacturing or processing facilities (Ref. 31). BPA also may be present in the 

412 environment as a result of fugitive emissions during processing and handling, 

413 release of unreacted monomer from products (Ref. 9), or possibly from degradation 

414 of products under certain conditions. In addition, although no environmental studies 

415 on thermal paper have been done in the U.S., based on information from EPA’s 

416 review of European and Japanese studies, the use of unconjugated BPA in thermal 

417 paper also may contribute to environmental releases of BPA from paper 

418 manufacturing and recycling plants and to the presence of BPA in the stream of 

419 recycled paper used in toilet paper, paper tableware, and other products, and may 

420 contribute to the presence of BPA in landfills because paper products are a major 

421 contributor to the U.S. solid waste stream (Ref. 32-37). Recent studies also indicate 

422 thermal paper may contribute directly to human exposure to BPA through dermal 

423 contact. In one U.S. study, for example, pregnant women who worked as cashiers, 

424 who presumably had frequent contact with thermal paper used in cash register 

425 receipts, had the highest urinary BPA concentrations compared with pregnant 

women in other occupations (Ref. 38).3 426 

 

3

 Recent studies also indicate thermal paper may contribute directly to human exposure to BPA 

through dermal contact. In one U.S. study, for example, pregnant women who worked as cashiers, 
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427 Significant research has been done to document widespread human 

428 population exposures to BPA in the U.S. using biomonitoring (Ref. 39-42). Although 

429 these studies and reports indicate that most people in the U.S. have measurable 

430 levels of BPA in their bodies, these data do not identify the relative source 

431 contributions to BPA exposure. Researchers generally accept that food contact uses 

432 of materials containing BPA, such as polycarbonate bottles or epoxy linings in food 

433 and beverage cans, are a likely major source of human exposure, but the relative 

434 contributions of food contact uses, potential TSCA uses, or other environmental 

435 sources cannot be extrapolated reliably from these existing data. For information 

436 about the multi-agency effort to evaluate the potential human health consequences 

437 of BPA exposures, see the discussion in Unit II.B. of this document.

438 According to the Toxics Release Inventory (TRI) Database, total release of 

439 BPA in the U.S. in 2007 was 1,132,062 pounds, with releases of 122,965 pounds to 

440 air, 6,246 pounds to water, 14,972 pounds released on-site to land, and 684,638 

441 pounds transferred off-site to land. An additional 32,928 pounds were reported as 

442 off-site water transfer to Publicly Owned Treatment Works (POTWs), with another 

443 2,759,705 pounds transferred to incineration (Ref. 31). 

444 Some information is available for BPA concentrations in U.S. water and other 

445 environmental media (see Table 3, providing values from the U.S. studies cited in 

446 this discussion). Most environmental monitoring results show that the concentrations 

447 of BPA in surface water bodies are lower than 1 μg/L (ppb), mainly due to its 

448 partitioning and biodegradability properties (Ref. 3943). BPA was detected at a 

449 median concentration of 0.14 μg/L (ppb) and a maximum concentration of 12 μg/L 

 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).
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450 (ppb) in 41.2% of 85 samples collected from U.S. streams in 1999 and 2000 (Ref. 

451 4044). The maximum concentration of 12 μg/L (ppb) was much higher than any of 

452 the other samples reported in the study; the next highest concentration reported was 

453 5.2 μg/L (ppb), and as indicated by the median concentration of 0.14 μg/L (ppb), 

454 BPA concentration in other U.S. waters was much lower. A recent review of reports 

455 of BPA in surface water found that BPA was reported in 26 studies in North America 

456 (2 in Canada and 24 in the United States) with detection in 80 percent (852 of 1068) 

457 of surface water samples. The median concentration reported was 0.081 μg/L (ppb) 

and the 95th 458 percentile concentration was 0.47 μg/L (ppb) (Ref. 4145). 

459 Two studies have addressed individual wastewater treatment plants 

460 (WWTPs) in two different parts of the U.S. In 2001 and 2002, BPA was not detected 

461 above the detection limit of 0.0001 μg/L (ppb) in Louisiana in effluent from a WWTP, 

462 in samples collected from surface waters in Louisiana, or in drinking water at various 

463 stages of treatment at plants in Louisiana (Ref. 4246). A 2008 study sampled BPA in 

464 treated wastewater from the East Bay Municipal Utilities WWTP in Oakland, 

465 California, and in a variety of locations that discharge to this WWTP (Ref. 4347). 

466 This study reported detecting (limit of detection = 0.25 μg/L (ppb)) BPA in two of 

467 three treated wastewater samples at 0.38 and 0.31 μg/L (ppb). It also reported 

468 detecting BPA in wastewater generated by a pharmaceutical manufacturer (0.295 

469 μg/L (ppb)), an industrial laundry (21.5 μg/L (ppb)), and a paper products 

470 manufacturer (0.753 μg/L (ppb)). 

471 While U.S. studies on wastewater are limited to only two state locations, a 

472 Canadian study published in 2000 reported BPA concentrations ranging from 49.9 to 

473 0.031 μg/L (ppb) in sewage influent and effluent (generally < 1 μg/L (ppb) in the 
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474 influent and < 0.3 μg/L (ppb) in the effluent) and from 36.7 to 0.104 μg/g (ppm) in 

475 raw and digested sewage sludge from multiple WWTPs in Canada (Ref. 4448). The 

476 same authors reported that BPA contamination was detected in 100 percent of 

477 sewage samples from 31 WWTPs across Canada with concentrations ranging from 

478 0.080 to 4.98 μg/L (ppb) (median 0.329 μg/L (ppb)) for the influent and from 0.010 to 

479 1.08 μg/L (ppb)(median 0.136 μg/L (ppb)) for the effluent (Ref. 4549). Based on 

480 comparison of influent and effluent levels, they estimated that BPA in the influent 

481 was removed by the sewage treatment process with a median reduction rate of 68 

482 percent. BPA was detected in sludge samples at concentrations ranging from 0.033 

483 to 36.7 μg/g (ppm), on a dry weight basis. The authors also reported a wide range of 

484 BPA in wastewater discharges from industrial facilities in the Toronto area, with 

485 concentrations ranging from 0.23 to 149.2 μg/L (ppb). Higher BPA levels in 

486 wastewater were associated with facilities producing chemicals and chemical 

487 products and packaging and paper products, and with commercial dry cleaning 

488 establishments. BPA concentrations in pulp and paper mill sludge ranged from < 

489 0.02 (below detection limit) to 3.33 μg/g (ppm), with a median value of 0.076 μg/g 

490 (ppm), on a dry weight basis (Ref. 4549). EPA notes that U.S. wastewater treatment 

491 conditions and industrial and commercial discharges may differ from what was found 

492 in Canada, but considers this Canadian study to be informative. 

493 Municipal wastewater treatment produces solid byproducts, commonly 

494 referred to as sewage sludge. After additional treatment to meet regulatory 

495 standards for pathogen, nutrient, and metal content, this treated sewage sludge, 

496 now classified as biosolids, may be disposed of by land application; biosolids may 

497 also be incinerated or disposed of in landfills. A U.S. study published in 2006 
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498 measured BPA in nine treated biosolids products from WWTPs in seven states and 

499 found that all contained between 1,090 and 14,400 μg/kg (ppb) (median 4,690 μg/kg 

500 (ppb)) (Ref. 4650). A 2008 study reported BPA in treated biosolids from a municipal 

501 U.S. WWTP at 4,600 μg/kg (ppb) and reported 81 μg/kg (ppb) in soil that received 

502 the land-applied biosolids (Ref. 4751). That study detected BPA at 81 μg/kg (ppb) in 

503 earthworms living in treated soil. The authors also reported detecting 147 μg/kg 

504 (ppb) in a nearby “control” soil that did not receive treatment with biosolids. That 

505 anomalous result was not explained. 

506 In 2000, the U.S. Geological Survey (USGS) collected samples from 47 

507 ambient groundwater sites (not drinking water wells) in 18 states and analyzed them 

508 for 65 organic wastewater contaminants. BPA was detected in 29.8% of the sampled 

509 groundwater sites, with a mean detected concentration of 1.78 μg/L (ppb) and a 

510 range of 1.06 to 2.55 μg/L (ppb). BPA was among the top five most frequently 

511 detected organic compounds in this study (Ref. 48, 4952, 53). 

512 In the summer of 2001, the USGS collected samples from 74 sources of raw, 

513 untreated, drinking water in 25 states and Puerto Rico, in areas that were known or 

514 suspected to have at least some human and/or animal wastewater sources in 

515 upstream or upgradient areas. These sources comprise 25 groundwater and 49 

516 surface water sources of drinking water serving populations ranging from one family 

517 to more than 8 million people. BPA was detected in 9.5% of these samples at a 

518 reporting level of 1 μg/L (ppb). The maximum concentration measured in these 

519 samples was 1.9 μg/L (ppb) (Ref. 48, 5052, 54). 

520 Landfill leachate from one U.S. study reported maximum BPA concentrations 

521 of 1.7 μg/L (ppb) in landfill leachate and 1.4 μg/L (ppb) in the receiving groundwater 
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522 plume at a landfill on Cape Cod that was known to be leaking (Ref. 5155). Data for 

523 other landfill sites in the United States were not available, and this single point is not 

524 representative of the country. Landfill leachate from other countries contained more 

525 than 500 μg/L (ppb) of BPA (Ref. 3943). Studies conducted at Japanese landfills 

526 resulted in maximum untreated leachate concentrations of 17,200 μg/L (ppb) and 

527 treated leachate concentrations of 5.1 μg/L (ppb) (Ref. 11). 

528 Wilson et al. (Ref. 5256) reported that BPA concentrations in soil samples 

529 taken from outdoor play areas of homes and daycare centers ranged from 4-14 ppb 

530 dry weight, with means of 6-7 ppb dry weight. Klecka et al. (Ref. 4145) reported a 

531 median concentration of 0.6 ppb BPA in North American freshwater sediments, 

532 including nondetected samples; BPA concentrations in samples from the United 

533 States ranged from 1.4 to 140 ppb dry weight. Levels in U.S. marine sediments were 

534 reported to have a median of 3.5 ppb of BPA and to range from 1.5 to 5 ppb dry 

535 weight (Ref. 5357). 

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. 4852) 

Boyd et al. (2003) (Ref. 4246) 

Boyd et al. (2004) (Ref. 5458) 

Focazio et al. (2008) (Ref. 5054) 

Klecka et al. (2009) (Ref. 4145) 

Kolpin et al. (2002) (Ref. 4044) 

Staples et al. (2000) (Ref. 5559) 

Zhang et al. (2007) (Ref. 5660) 

Groundwater NR** to 1.78† <0.003 to 2.55

Barnes et al. (2008a) (Ref. 4852) 

Barnes et al. (2008b) (Ref. 4953) 

Focazio et al. (2008) (Ref. 5054) 

Rudel et al. (1998) (Ref. 5155) 

Drinking 

Water <0.0001 <0.0001 to 0.42 

Boyd et al. (2003) (Ref. 4246) 

Stackelberg et al. (2004) (Ref. 

5761) 

Wastewater <0.0001 <0.0001 to 25 Boyd et al. (2003) (Ref. 4246) 
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Table 3: U.S. Reported Environmental Concentrations of BPA 

Location Mean or Range 

of Means (ppb) 

Range (ppb) References 

Drewes et al. (2005) (Ref. 5862) 

Jackson and Sutton (2008) (Ref. 

4347) 

Rudel et al. (1998) (Ref. 5155) 

Tsai (2006) (Ref. 3943) 

Soils 6 to 7 4 to 147 Kinney et al. (2008) (Ref. 4751) 

Wilson et al. (2003) (Ref. 5256) 

Sediment, 

Fresh 0.6*†† 1.4 to 140†† Klecka et al. (2009) (Ref. 4145) 

Sediment, 

Marine 3.5* 1.5 to 5.0 Stuart et al. (2005) (Ref. 5357) 

Biosolids 4600 to 4690* 1090-14,400 Kinney et al. (2006) (Ref. 4650) 

Kinney et al. (2008) (Ref. 4751) 

536 * Value is median 

537 ** Not Reported 

† 538 Mean of values above Reporting Limit (1 ppb) 

†† 539 Median value includes nondetected values below the MDL, while the reported 

540 range includes only detected values. 

541 

542 Although there is disagreement in interpreting some of the effects observed in 

543 studies performed to date with BPA, as described in Unit II.B.1 and 2, a comparison 

544 of the range of the effect levels observed in many studies and the predicted no effect 

545 concentration (PNEC) values used in three international regulatory risk assessments 

546 (0.175 to 1.6 μg/L, Table 1) with measured concentrations in some U.S. waters and 

547 sediments, which included values as high as 12 μg/L (ppb) (surface water), 2.55 

548 μg/L (ppb) (ground water), and 140 ppb sediment (freshwater sediment) (Table 2), 

549 indicate possible risk of injury to aquatic organisms. The single available 

550 measurement of BPA in leachate from one U.S. landfill site is not sufficient to 

551 represent or characterize the United States as a whole, and landfill leachate data 

552 from other countries suggest that BPA concentrations in leachate may be 

553 significantly higher than concentrations in surface water bodies. The direct exposure 
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554 pathway from wastewater to environmental organisms, along with the widespread 

555 detection of BPA in WWTP sludges, further suggest that land application of WWTP 

556 sludges may be a significant environmental exposure pathway that needs to be 

better understood.4 557 

558 Although most currently available environmental monitoring results show that 

559 the concentrations of BPA in U.S. water bodies are lower than 1 μg/L (ppb) (median 

560 concentration of 0.14 μg/L (ppb)), these environmental measurements represent 

561 isolated snapshots in time. Because these results come from a variety of studies 

562 designed for very different purposes and conditions (for example, laboratory 

563 analytical development contrasted with field monitoring), the data are not readily 

564 comparable and cannot be assembled into a nationally or regionally representative 

565 picture. Particularly in light of the corresponding uncertainties described in Unit II.B.1 

566 and 2 concerning potential BPA hazards at low doses, the existing data do not allow 

567 EPA to determine how many areas may exceed potential concentrations of concern, 

568 how often or how long such concentrations may be exceeded, or the sources or 

569 pathways leading to BPA presence in the environment from manufacturing, 

570 processing, distribution in commerce, use, or disposal that may result in human and 

571 environmental exposures. EPA considers that these existing data would not be 

572 sufficient to determine whether or not an unreasonable risk to the environment 

573 exists. To help resolve these uncertainties, EPA is considering requiring that 

574 manufacturers and processors of BPA conduct environmental testing consisting of 

575 targeted sampling and monitoring of surface water, groundwater, sediment, soil, 

 

4

 EPA's response to the request for correction of the information provided in the Action Plan that was 

filed under the Agency's Information Quality Guidelines by the American Chemistry Council is 

available at www.epa.gov/quality/informationguidelines/iqg-list.html
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576 landfill leachate, and drinking water on and adjacent to their properties, specifically 

577 in the vicinity of manufacturing facilities and such processing facilities as foundries, 

578 WWTPs, paper and plastics recycling facilities, and other sources of BPA releases 

579 as identified through TRI reporting and other information. These test data could also 

580 help guide development of effective risk management actions if it should be 

581 determined that activities involving BPA present an unreasonable risk of injury to 

582 aquatic or other environmental systems. 

583 Fully understanding exposure pathways and in particular the magnitude, 

584 frequency, and duration of exposure could require a nationwide survey of the 

585 occurrence of the chemical in environmental media associated with production, 

586 processing, use, disposal and recycling facilities. However, at this time, EPA is 

587 proposing that selected monitoring of a more limited scope be conducted to help 

588 identify the most likely locations of high exposure and the sources and pathways of 

589 exposure, to determine whether BPA may be present in those locations at 

590 concentrations that pose a risk of concern to aquatic or other systems. Monitoring of 

591 aquatic sites and sediments near releases (effluents and sludge) from manufacturing 

592 and processing sites (including on-site WWTPs) reporting high releases under TRI 

593 or associated with high releases identified from other information, as well as 

594 monitoring of sites that receive runoff from landfills, would be included. 

595 EPA believes these targeted monitoring data may provide information 

596 relevant both to the characterization of environmental risk and to the potential focus 

597 of future risk management activities such as those under section 6 of TSCA, if the 

598 data indicate such activities are warranted. EPA also considers these data would 

599 further inform the issue of potential human exposure levels attributable to sources 
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600 other than the direct food contact uses believed to be the principal source of human 

601 exposure, which are regulated by the FDA. As noted earlier in Unit II.B., EPA is 

602 working with FDA, NIEHS, and CDC on additional research to better determine and 

603 evaluate the potential human health consequences of exposures to BPA, including 

604 exposures at low doses. Levels of exposure that may be identified by FDA as being 

605 of concern to human health, including children’s health, would affect the extent to 

606 which EPA would take additional action to address potential risks to human health 

607 resulting from uses within TSCA jurisdiction, but EPA is not considering any 

additional testing specifically in regard to human health issues at this time.5 608 

609 In order to be useful to an investigation of potential environmental risks posed 

610 by BPA, environmental testing must be representative and of known quality. To 

611 accomplish this, data should be collected using approved or recognized sampling, 

612 preparation, and analytical techniques. Appropriate quality assurance and quality 

613 controls also should be incorporated in the protocols for collection and analyses. 

614 A further complicating factor in the assessment of potential environmental 

615 risks posed by BPA is that organisms in the environment, rather than being exposed 

616 to a single chemical at a time, are likely to be exposed simultaneously to multiple 

617 chemicals. The presence of other endocrine-active chemicals, including other 

618 estrogenic chemicals, for example, could affect the potential for effects on 

619 environmental organisms. It may be useful, when monitoring for BPA, to identify the 

620 total estrogenicity of a sample along with the amount of BPA present. 

621 Potential methodologies and protocols for use in monitoring programs may 

622 include ASTM D7574-09 Standard Test Method for Determination of Bisphenol A in 

 

5

 EPA notes, however, that information obtained on the environmental presence of BPA would be 

relevant to understanding the environmental component of human exposures.
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623 Environmental Waters by Liquid Chromatography/Tandem Mass Spectrometry (Ref. 

624 5963); ASTM D5730-04 Standard Guide for Site Characterization for Environmental 

625 Purposes With Emphasis on Soil, Rock, the Vadose Zone and Ground Water (Ref. 

626 6064); EPA Method 8270D (SW-846), Semivolatile Organic Compounds by Gas 

627 Chromatography/Mass Spectrometry (GC/MS), Revision 4 (Ref. 6165); and other 

628 methods cited and described in such publications as Barnes et al. (2008) (Ref. 4852) 

629 and Focazio et al. (2008) (Ref. 5054). 

630 5. What are the Issues for Comment Concerning Environmental Testing Consisting 

631 of Sampling and Monitoring?

632 EPA particularly invites comment on: 

633 a. The extent and type of environmental testing that may be sufficient to 

634 characterize the environmental presence of BPA. 

635 b. The extent and type of environmental testing that may be sufficient to 

636 understand sources of and exposure from the high concentrations of BPA 

637 found in treated biosolids from WWTPs. 

638 c. Whether environmental testing should be conducted now, or should be tiered 

639 to occur after the uncertainties associated with the hazards of BPA at low 

640 concentrations in the environment have been resolved. 

641 d. The locations where such environmental testing should be undertaken, such 

642 as manufacturing, processing, recycling, foundry, and other use, treatment, 

643 and disposal sites identified with BPA releases reported under TRI or other 

644 information. 
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645 e. The media (e.g., soil, sediment, sludge, WWTP influent and effluent, landfill 

646 leachate, drinking water, surface water, ground water) to be sampled at each 

647 such site. 

648 f. Which parties should be required to conduct the testing and/or be potentially 

649 responsible for providing reimbursement to those who conduct specific tests. 

650 g. The appropriate methods and protocols to use in such a environmental 

651 testing program. 

652 h. Whether such an environmental testing program should include 

653 measurements for the total estrogenicity of samples collected as well as for 

654 the concentration of BPA, and what methods and protocols may be suitable 

655 for generating and interpreting such data.

656 h.i. Whether and what additional environmental testing activities may be 

657 necessary to understand and characterize non-food-contact uses, sources, 

658 and environmental pathways that may contribute to human exposure to BPA. 

659 exposure to BPA. Though, as indicated in Unit II.B. of this document, the 

660 current focus of this ANPRM is on environmental effects, this information

661 would inform the multi-agency effort to evaluate the potential human health 

662 consequences of BPA exposures.

663 i.j. Other information that may provide insight into sources and pathways of 

664 environmental and human exposure to BPA released into the environment. 

665 Though, as indicated in Unit II.B. of this document, the current focus of this 

666 ANPRM is on environmental effects, this information would inform the multi667 agency effort to evaluate the potential human health consequences of BPA 

668 exposures.
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669 j.k. The cost and economic feasibility of such environmental testing, for the 

670 different types of sites. 

671 BC. What is the Agency's Authority for Taking this Action? 

672 EPA is issuing this advance notice of proposed rulemaking on certain toxicity 

673 testing and on certain environmental testing consisting of sampling and monitoring 

674 for the chemical substance BPA under TSCA section 4(a)(15 U.S.C. § 2603(a)). 

675 Section 2(b)(1) of TSCA (15 U.S.C. § 2601(b)) states that it is the policy of the 

676 United States that “adequate data should be developed with respect to the effect of 

677 chemical substances and mixtures on health and the environment and that the 

678 development of such data should be the responsibility of those who manufacture 

679 [which is defined by statue to include import] and those who process such chemical 

680 substances and mixtures[.]” To implement this policy, TSCA subsection 4(a)(1) 

681 provides that EPA shall require by rule that manufacturers or processors or both of 

682 chemical substances and mixtures conduct testing if the Administrator finds in a final 

683 rule that: 

684 (A)(i) the manufacture, distribution in commerce, processing, use, or disposal 

685 of a chemical substance or mixture, or that any combination of such activities, may 

686 present an unreasonable risk of injury to health or the environment, 

687 (ii) there are insufficient data and experience upon which the effects of such 

688 manufacture, distribution in commerce, processing, use, or disposal of such 

689 substance or mixture or any combination of such activities on health or the 

690 environment can reasonably be determined or predicted, and 

691 (iii) testing of such substances or mixture with respect to such effects is 

692 necessary to develop such data; or 
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693 (B)(i) a chemical substance or mixture is or will be produced in substantial 

694 quantities, and (I) it enters or may reasonably be anticipated to enter the 

695 environment in substantial quantities or (II) there is or may be significant or 

696 substantial human exposure to such substance or mixture, 

697 (ii) there are insufficient data and experience upon which the effects of the 

698 manufacture, distribution in commerce, processing, use, or disposal of such 

699 substance or mixture or of any combination of such activities on health or the 

700 environment can reasonably be determined or predicted, and 

701 (iii) testing of such substance or mixture with respect to such effects is 

702 necessary to develop such data and 

703 (C) in the case of a mixture, the effects which the mixture’s manufacture, 

704 distribution in commerce, processing, use or disposal or any combination of such 

705 activities may have on health or the environment may not be reasonably and more 

706 efficiently determined or predicted by testing the chemical substances which 

707 comprise the mixture[.] (15 U.S.C. § 2603(a)). 

708 If EPA makes these findingsin a final rule makes an appropriate finding under 

709 section 4(a)(1)(A) or (B) for a chemical substance or mixture, the Administrator shall 

710 require that testing be conducted on that chemical substance or mixture. The 

711 purpose of the testing would be to develop data with respect to the health and 

712 environmental effects for which there is an insufficiency of data and experience, and 

713 which are relevant to a determination that the manufacture, distribution in 

714 commerce, processing, use, or disposal of the substance or mixture, or any 

715 combination of such activities, does or does not present an unreasonable risk of 

716 injury to health or the environment. Id. As indicated in Unit II.A.3. of this document, 
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717 EPA requests comment and supporting information regarding which section 4(a)(1) 

718 finding authority would be most appropriate for the purpose of a BPA test rule 

719 proposal. Any proposal would ultimately be based on EPA’s assessment of the 

720 relevant information available at the time of proposal.

721 Once the Administrator has made the relevant findings under TSCA section 

722 4(a), EPA may require any health or environmental effects testing for which data are 

723 insufficient and which are necessary to develop the data. EPA need not limit the 

724 scope of testing required to the factual basis for the section 4(a)(1)(A)(i) or (B)(i) 

725 findings as long as EPA also finds that there are insufficient data and experience 

726 upon which the effects of the manufacture, distribution in commerce, processing, 

727 use, or disposal of such substance or mixture or of any combination of such 

728 activities on health or the environment can reasonably be determined or predicted, 

729 and that testing is necessary to develop such data. This approach is explained in 

730 more detail in EPA’s TSCA section 4(a)(1)(B) Final Statement of Policy published in 

731 the Federal Register at 58 FR 28736, 28738-28739, May 14, 1993 (B Policy). 

732 Authority for requiring sampling and monitoring for a chemical substance or 

733 mixture can be found within TSCA section 4. Section 4(a) authorizes EPA to require 

734 the development of data “which are relevant to a determination that the manufacture, 

735 distribution in commerce, processing, use, or disposal of such substance or mixture, 

736 or that any combination of such activities, does or does not present an unreasonable 

737 risk of injury to health and the environment.” The extent to which such activities may 

738 affect health or the environment is dependent in part upon the human and 

739 environmental exposures to the chemical substance occasioned by those activities. 

740 As an example, section 4(a)(2)(A) specifically addresses testing for persistence of a 
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741 substance. Testing to identify where and in what concentrations a chemical 

742 substance or mixture may become present in the environment contributes to an 

743 understanding of human and environmental exposures resulting from those 

744 activities. As stated in Unit II.B. of this document, EPA does not intend to initiate 

745 regulatory action under TSCA at this time on the basis of human health. 

746 III. References 

747 1. EPA. 2010. Bisphenol A Action Plan. Available online at 

748 http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480

749 ad7e0c 

750 2. EPA. 1993. Integrated Risk Information System (IRIS) (1993). Accessed at 

751 http://www.epa.gov/ncea/iris/subst/0356.htm. 

752 3. FDA. 2008. U. S. Food and Drug Administration. Draft Assessment of 

753 Bisphenol A for Use in Food Contact Applications. 

754 http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-

755 0038b1_01_02_FDA%20BPA%20Draft%20Assessment.pdf; peer review report and 

756 additional information available at 

757 http://www.fda.gov/Food/FoodIngredientsPackaging/ucm166145.htm. 

758 4. European Food and Safety Authority (EFSA). 2006. Scientific Panel on 

759 Food Additives, Flavourings, Processing Aids and Materials in Contact with Food . 

760 Summary Opinion of the Scientific Panel on food additives, flavourings, processing 

761 aids and materials in contact with food (AFC) related to 2,2-BIS(4-

762 HYDROXYPHENYL) PROPANE. Question number EFSA-Q-2005-100 November. 

763 5. European Food and Safety Authority (EFSA). 2008. Scientific Opinion of 

764 the Panel on Food additives, Flavourings, Processing aids and Materials in Contact 
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765 with Food (AFC) on a request from the Commission on the toxicokinetics of 

766 Bisphenol A. The EFSA Journal (2008) 759, 1-10. 

767 6. Canada. 2008. Environment Canada, Health Canada. Screening 

768 Assessment for the Challenge Phenol, 4,4' (1-methylethylidene)bis- (Bisphenol A) 

769 CAS 80-05-7. October 2008. 

770 http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_80-05-7_en.pdf

771 7. EU. 2008. European Union Updated Risk Assessment Report. Bisphenol 

772 A, CAS No: 80-05-7. Institute for Health and Consumer Protection, European 

773 Chemicals Bureau, European Commission Joint Research Centre, 3rd Priority List, 

774 Luxembourg: Office for Official Publications of the European Communities. 

775 8. AIST (Japan’s National Institute of Advanced Industrial Science and 

776 Technology). 2007. AIST Risk Assessment Document Series 4. Bisphenol A. 

777 9. NTP/CERHR. 2008. NTP-CERHR Monograph on the Potential Human 

778 Reproductive and Developmental Effects of Bisphenol A. US Department of Health 

779 and Human Services. National Toxicology Program. Center for the Evaluation of 

780 Risks to Human Reproduction. 

781 http://cerhr.niehs.nih.gov/evals/bisphenol/bisphenol.pdf

782 10. FDA. 2010. U.S. Food and Drug Administration. Update on Bisphenol A 

783 for Use in Food Contact Applications: January 2010. Accessed at 

784 http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197739.htm. 

785 11. Crain, D.A.; Eriksen, M.; Iguchi, T.; Jobling, S.; Laufer, H.; LeBlanc, G.A.; 

786 Guillette, Jr., L.J. 2007. An ecological assessment of Bisphenol A: evidence from 

787 comparative biology. Reprod. Toxicology (24): 225-239. 
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788 12. Lahnsteiner, F.; Berger, B.; Kletzl, M.: Weismann, T. 2005. Effect of 

789 Bisphenol A on Maturation and Quality of Semen and Eggs in the Brown Trout, 

790 Salmo trutta f. fario. Aquatic Tox. 75: 213-224. 

791 13. Reference to RAD bibliographical list of 645 articles found; list will 

792 appear in docket. 

793 14. Reference to RAD bibliographical list of 31 articles deemed relevant; 

794 list will appear in docket.

795 15. Marcial, H.S.; Hagiwara, A.; Snell, T.W. 2003. Estrogenic compounds 

796 affect development of harpacticoid copepod Tigriopus Japonicus. Env. Tox. and 

797 Chem. 22(12), 3025–3030. 

798 16. Watts, M.M.; Pascoe, D.; Carroll, K. 2001. Chronic exposure to 17α799 ethinylestradiol and bisphenol A-effects on development and reproduction in the 

800 freshwater invertebrate Chironomus riparius (Diptera: Chironomidae). Aquat. Tox.

801 55, 113–124. 

802 17. Sumpter, J.P.; Tyler, C.R.; Sherazi, A. 2001. Bisphenol-A: 

803 Multigeneration study with the fathead minnow (Pimephales promelas). Brunel 

804 University (unpublished; part of study published as Sohoni et al, 2001). 

805 18. Oehlmann, J.; Schulte-Oehlmann, U.; Werner, K.; Jagnytsch, O.; Lutz, I.; 

806 Kresten, K.; Wollenberger, L.; Santos, E. M.; Paull, G.C.; Van Look, K.J.W.; Tyler, 

807 C.R. 2008. A Critical Analysis of the Biological Impacts of Plasticizers on Wildlife. 

808 Philos. Trans. R. Soc., B: Biol. Sci. 364(1526): 2047–2062. 

809 19. Forbes, V.E.; Selck, H.; Palmqvist, A.; Aufderheide, J.; Warbritton, R.; 

810 Pounds, N.; Thompson, R.; van der Hoeven, N.; Caspers, N. 2007. Does bisphenol 
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811 A induce superfeminization in Marisa cornuarietis? Part I: Intra- and inter-laboratory 

812 variability in test endpoints. Ecotox. and Env. Safe. 66, 309–318. 

813 20. Forbes, V.E.; Aufderheide, J.; Warbritton, R.; Thompson, R.; van der 

814 Hoeven, N.; Caspers, N. 2007. Does bisphenol A induce superfeminization in 

815 Marisa cornuarietis? Part I: Intra- and inter-laboratory variability in test endpoints. 

816 Ecotox. and Env. Safe. 66, 319–325. 

817 21. Forbes, V.E; Aufderheide, J.; Warbritton, R.; Thompson, R.; van der 

818 Hoeven, N.; Caspers, N. 2008. Effects of bisphenol A on fecundity, egg 

819 hatchability, and juvenile growth of Maris Cornuarietis. Env. Tox. and Chem. 27 

820 (11), 2332–2340. 

821 22. Levy, G.; Lutz, I.; Krüger, A.; Kloas, W. 2004. Bisphenol A induces 

822 feminization in Xenopus laevis tadpoles. Environ. Res. 94, 102-111. 

823 23. Calabrese, E.J.; Baldwin, L.A. 2003. Hormesis at the National 

824 Toxicology Program (NTP): evidence of hormetic dose responses in NTP dose825 range studies. Nonlinearity Biol. Toxicol. Med. 1, 455–467. 

826 24. Heimeier, R.A.; Das, B.; Buchholz, D.R.; Shi, Y. 2009. The 

827 Xenoestrogen Bisphenol A inhibits postembryonic vertebrate development by 

828 antagonizing gene regulation by thyroid hormone. Endocrinology, 150, 2964-2973. 

829 25. Ramakrishnan, S.; Wayne, N.L. 2008. Impact of bisphenol-A on early 

830 embryonic development and reproductive maturation. Reproductive Toxicology 25, 

831 177–183. 

832 26. Ankley, G.T., K.M. Jensen, M.D. Kahl, E.J. Durhan, E.A. Makynen, J.E. 

833 Cavallin, D. Martinovic, L.C. Wehmas, N.D. Mueller and D.L. Villeneuve. 2010. Use 
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834 of chemical mixtures to differentiate mechanisms of endocrine action in a small fish 

835 model. Aquat. Toxicol. 99, 389-396. 

836 27. EPA. Endocrine Disruptor Screening Program; Policies and Procedures 

837 for Initial Screening. 74 Fed.Reg. 17560. April 15, 2009. 

838 28. EPA. Endocrine Disruptor Screening Program website. Accessed at 

839 http://www.epa.gov/scipoly/oscpendo/. 

840 29. Organization for Economic Co-operation and Development Environment 

841 Directorate. Endocrine Disruptor Testing and Assessment. Accessed at 

842 http://www.oecd.org/document/62/0,3343,en_2649_34377_2348606_1_1_1_1,00.ht

843 ml

844 30. EPA. 2008. Aquatic Life Criteria for Contaminants of Emerging Concern 

845 (Part 1) & Illustration of Recommendations using Data for 17α-Ethinylestradiol 

846 (EE2). USEPA Office of Water, Washington, DC.

847 31. EPA. 2009a. Toxic Release Inventory. 2007 Public Data Release, 

848 Released March 14, 2009. http://www.epa.gov/tri/tridata/index.htm#pdr

849 32. European Union. 2010. Risk Assessment Report, 4,4'-

850 Isopropylidenediphenol (Bisphenol-A), CAS No: 80-05-7, (February 2010). 

851 33. Vinggaard, A.M.: Körner, W.; Lund, K.H.; Bolz, U.; Petersen, J.H. 2000. 

852 Identification and quantification of estrogenic compounds in recycled and virgin 

853 paper for household use as determined by an in vitro yeast estrogen screen and 

854 chemical analysis. Chem Res Toxicol. 13(12):1214-22. 

855 34. Gehring, M.; Vogel, D.; Tennhardt, L.; Weltin, D.; Bilitewski, B. Undated. 

856 Bisphenol A contamination of wastepaper, ellulose and recycled paper products. 

857 http://rcswww.urz.tu-dresden.de/~gehring/deutsch/dt/vortr/040929ge.pdf 
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858 35. Ozaki, A.; Yamaguchi, Y.; Fujita, T.; Kuroda, K.; Endo, G. 2004. 

859 Chemical analysis and genotoxicological safety assessment of paper and 

860 paperboard used for food packaging. Food Chem Toxicol. 42(8):1323-37. 

861 36. Fukazawa, H.; Hoshino, K.; Shiozawa, T.; Matsushita, H.; Terao, Y. 

862 2001. Identification and quantification of chlorinated bisphenol A in wastewater from 

863 wastepaper recycling plants. Chemosphere. 44(5):973-9. 

864 37. Terasaki, M.; Shiraishi, F.; Fukazawa, H.; Makino, M. 2007. Occurrence 

865 and estrogenicity of phenolics in paper-recycling process water: pollutants 

866 originating from thermal paper in waste paper. Environ Toxicol Chem. 26(11):2356-

867 66. 

868 38. Braun J.M., Kalkbrenner A.E., Calafat A.M., Bernert J.T., Ye X., et al. 

869 2010 Variability and Predictors of Urinary Bisphenol A Concentrations during 

870 Pregnancy. Environ Health Perspect doi:10.1289/ehp.1002366. 

871 39. Calafat AM, Kuklenyik Z, Reidy JA, et al (2005). Urinary concentrations of 

872 bisphenol A and 4‐nonylphenol in a human reference population. Environmental 

873 Health Perspectives, 113:391‐395Tsai, W. 2006. Human Health Risk on 

874 Environmental Exposure to Bisphenol-A: A Review. Journal of Environmental 

875 Science and Health Part C, 24:225-255. 

876 40. Calafat AM, Ye S, Wong LY, et al (2008). Exposure of the US population 

877 to bisphenol A and 4-tertiarty-octylphenol: 2003-2004. Environmental Health 

878 Perspectives, 116(1): 39-44.

879 41. Calafat AM, Weuve J, Ye X, et al (2009). Exposure to bisphenol A and 

880 other phenols in neonatal intensive care unit premature infants. Environmental 

881 Health Perspectives, 117(4):639-644.
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882 42. Centers for Disease Control and Prevention. Department of Health and 

883 Human Services. Fourth National Report on Human Exposure to Environmental 

884 Chemicals, Update Tables. July 2010. 

885 http://www.cdc.gov/exposurereport/pdf/Update_Tables.pdf .

886 43. Tsai, W. 2006. Human Health Risk on Environmental Exposure to 

887 Bisphenol-A: A Review. Journal of Environmental Science and Health Part C, 

888 24:225-255 40..

889 44. Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg, S.D.; 

890 Barber, L.B.; Buxton, H.T. 2002. Pharmaceuticals, hormones, and other organic 

891 wastewater contaminants in U.S. streams, 1999–2000: a national survey. Environ 

892 Sci Technol 36:1202–1211. 

893 4145. Klecka, G.M.; Staples, C.A.; Clark, K.E.; van der Hoeven, N.; Thomas, 

894 D.E.; Hentges, S.G. 2009. Exposure Analysis of Bisphenol A in Surface Water 

895 Systems in North America and Europe. Environ. Sci. Technol. 2009, 43(16):6145–

896 6150. 

897 4246. Boyd G.R.; Reemtsma, H.; Grimm, D.A.; Mitra, S. 2003. 

898 Pharmaceuticals and personal care products (PPCPs) in surface and treated waters 

899 of Louisiana, U.S.A. and Ontario, Canada. Sci Total Environ 311: 135-149. 

900 4347. Jackson, J.; Sutton, R. 2008. Sources of endocrine-disrupting 

901 chemicals in an urban wastewater, Oakland, CA. Sci. Total Env., vol. 405:153-160. 

902 4448. Lee, H-B; Peart, T.E. 2000. Determination of bisphenol A in sewage 

903 effluent and sludge by solid-phase and supercritical fluid extraction and gas 

904 chromatography/mass spectrometry. J AOAC Int. vol. 83:290-7. 
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905 4549. Lee, H-B; Peart, T.F. 2000. Bisphenol A contamination in Canadian 

906 municipal and industrial wastewater and sludge samples. Water Quality Res. J 

907 Canada. vol. 35: 283-298. 

908 4650. Kinney, C.A.; Furlong, E.T.; Zaugg, S.D.; Burkhardt, M.R.; Werner, 

909 S.L.; Cahill, J.D.; Jorgensen, G.R. 2006. Survey of Organic Wastewater 

910 Contaminants in Biosolids Destined for Land Application. Environ. Sci. Technol. Vol. 

911 40:7207–7215. 

912 4751. Kinney, C.A; Furlong, E.T.; Kolpin, D.W.; Burkhardt, M.R.; Zaugg, 

913 S.D.; Werner, S.L.; Bossio, J.P.; Benotti, M.J. 2008. Bioaccumulation of 

914 pharmaceuticals and other anthropogenic waste indicators in earthworms from 

915 agricultural soil amended with biosolid or swine manure. Environ. Sci. Technol. 

916 2008, vol.42: 1863–1870. 

917 4852. Barnes, K.K.; Kolpin, D.W.; Focazio, M.J.; Furlong, E.T.; Meyer, M.T.; 

918 Zaugg, S.D.; Haack, S.K.; Barber, L.B.; Thurman, E.M. 2008a. U. S. Geological 

919 Survey. Water-Quality Data for Pharmaceuticals and Other Organic Wastewater 

920 Contaminants in Ground Water and in Untreated Drinking Water Sources in the 

921 United States, 2000-01. Available at: http://pubs.usgs.gov/of/2008/1293/. 

922 4953. Barnes, K.K.; Kolpin, D.W.; Furlong, E.T.; Zaugg, S.D.; Meyer, M.T.; 

923 Barber, L.B. 2008b. A National Reconnaissance of Pharmaceuticals and Other 

924 Organic Wastewater Contaminants in the United States: (I) Groundwater. Sci.Total 

925 Enviro. 402 (2–3), 192–200. 

926 5054. Focazio, M.J.; Kolpin, D.W.; Barnes, K.K.; Furlong, E.T.; Meyer, M.T.; 

927 Zaugg, S.D.; Barber, L.B.; Thurman, E.M. 2008. A National Reconnaissance for 

928 Pharmaceuticals and Other Organic Wastewater Contaminants in the United 
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929 States—(II) Untreated Drinking Water Sources. Sci. Total Environ. 402(2–3), 201–

930 216. 

931 5155. Rudel, R.A.; Melly, S.J.; Geno, P.W.; Sun, G.; Brody, J.G. 1998. 

932 Identification of Alkylphenols and Other Estrogenic Phenolic Compounds in 

933 Wastewater, Septage, and Groundwater on Cape Cod, MA. Environ. Sci. Technol

934 32:861-9. 

935 5256. Wilson, N.K.; Chuang, J.C.; Lyu, C.; Menton, R.; Morgan, M.K. 2003. 

936 Aggregate exposures of nine preschool children to persistent organic pollutants at 

937 day care and home. J. Expo. Anal. Environ. Epidemiol. 13:187-202. 

938 5357. Stuart, J.D.; Capulong, C.P.; Launer, K.D.; Pan, X. 2005. Analyses of 

939 phenolic endocrine disrupting chemicals in marine samples by both gas and liquid 

940 chromatography-mass spectrometry. J. Chromatogr. A. 1079:136-145. 

941 5458. Boyd, G.R.; Palmerib, J.M.; Grimm, D.A. 2004. Pharmaceuticals and 

942 Personal Care Products (PPCPs) and Endocrine Disrupting Chemicals (EDCs) in 

943 Stormwater Canals and Bayou St. John in New Orleans, Louisiana, USA. Sci. Total 

944 Environ. 333:137-48. 

945 5559. Staples, C.A.; Dorn, P.B.; Klecka, G.M.; O’Block, S.T.; Branson, D.R.; 

946 Harris, L.R. 2000. Bisphenol A Concentrations in Receiving Waters Near U.S. 

947 Manufacturing and Processing Facilities. Chemosphere 40:521-525. 

948 5660. Zhang, S.; Zhang, Q.; Darisaw, S.; Ehie, O.; Wang, G. 2007. 

949 Simultaneous Quantification of Polycyclic Aromatic Hydrocarbons (PAHs), 

950 Polychlorinated Biphenyls (PCBs), and Pharmaceuticals and Personal Care 

951 Products (PPCPs) in Mississippi River Water, in New Orleans, Louisiana, USA. 

952 Chemosphere 66:1057-69. 
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953 5761. Stackelberg, P.E.; Furlong, E.T.; Meyer, M.T.; Zaugg, S.D.; Henderson, 

954 A.K.; Reissman, D.B. 2004. Persistence of Pharmaceutical Compounds and Other 

955 Organic Wastewater Contaminants in a Conventional Drinking-Water-Treatment 

956 Plant. Sci. Total Environ. 329:99-113. 

957 5862. Drewes, J.E.; Hemming, J.; Ladenburger, S.J.; Schauer, J.; Sonzogni, 

958 W. 2005. An Assessment of Endocrine Disrupting Activity Changes during 

959 Wastewater Treatment through the Use of Bioassays and Chemical Measurements. 

960 Water Environ. Res. 77:12–23. 

961 5963. ASTM. 2009. ASTM International. ASTM D7574-09 Standard Test 

962 Method for Determination of Bisphenol A in Environmental Waters by Liquid 

963 Chromatography/Tandem Mass Spectrometry. 

964 http://www.astm.org/Standards/D7574.htm. 

965 6064. ASTM. 2004. ASTM International. ASTM D5730-04 Standard Guide for 

966 Site Characterization for Environmental Purposes With Emphasis on Soil, Rock, the 

967 Vadose Zone and Ground Water. http://www.astm.org/Standards/D5730.htm. 

968 6165. USEPA. 1998. U.S. Environmental Protection Agency. EPA Method 

969 8270D (SW-846), Semivolatile Organic Compounds by Gas Chromatography/Mass 

970 Spectrometry (GC/MS), Revision 4. http://www.epa.gov/sam/pdfs/EPA-8270d.pdf. 

971 IV. Statutory and Executive Order Reviews 

972 Under Executive Order 12866, entitled “Regulatory Planning and Review” (58 

973 FR 51735, October 4, 1993), this action was submitted to the Office of Management 

974 and Budget (OMB) for review. Any changes made to this document in response to 

975 OMB comments received by EPA during that review have been documented in the 

976 docket as required by the Executive Order. 
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977 Since this document does not impose or propose any requirements, and 

978 instead seeks comments and suggestions for the Agency to consider in possibly 

979 developing a subsequent proposed rule, the various other review requirements that 

980 apply when an agency imposes requirements do not apply to this action. 

981 Nevertheless, as part of your comments on this notice, you may include any 

982 comments or information that you have regarding this action. 

983 In particular, any comments or information that would help the Agency to 

984 assess the potential impact of a rule on small entities pursuant to the Regulatory 

985 Flexibility Act (RFA) (5 U.S.C. 601 et seq.); to consider voluntary consensus 

986 standards pursuant to section 12(d) of the National Technology Transfer and 

987 Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note); to consider environmental 

988 health or safety effects on children pursuant to Executive Order 13045, entitled 

989 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 

990 19885, April 23, 1997); or to consider human health or environmental effects on 

991 minority or low-income populations pursuant to Executive Order 12898, entitled 

992 “Federal Actions to Address Environmental Justice in Minority Populations and Low993 Income Populations” (59 FR 7629, February 16, 1994). 

994 The Agency will consider such comments during the development of any 

995 subsequent proposed rule as it takes appropriate steps to address any applicable 

996 requirements. 

997 List of Subjects in 40 CFR Part 799 

998 Environmental protection, Bisphenol A, BPA, Chemical testing, Chemicals, 

999 Hazardous substances, Reports and recordkeeping requirements. 

1000 Dated: ____________________ 
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1001 

1002 

1003 __________________________________________

1004 

1005 __________________________________________

1006 Assistant Administrator, Office of Chemical Safety and Pollution Prevention.