BEFORE THE ENVIRONMENTAL PROTECTION AGENCY

PETITION FOR RULEMAKING PURSUANT TO SECTION 7004 (A) OF THE RESOURCE

CONSERVATION AND RECOVERY ACT , 42 U.S.C. § 6974(A), AND SECTION 21 OF THE TOXIC SUBSTANCES CONTROL ACT, 15 U.S.C. § 2620, CONCERNING

THE REGULATION OF DISCARDED POLYVINYL CHLORIDE AND

ASSOCIATED CHEMICAL ADDITIVES

Credit: NOAA ONMS

CENTER FOR BIOLOGICAL DIVERSITY

PETITIONER

JULY 24 , 2014i NOTICE OF PETITION

Gina McCarthy

Administrator U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460 Email: McCarthy.Gina@ epa .gov

PETITIONER

Center for Biological Diversity

351 California Street, Suite 600 San Francisco, CA 94104 Tel: (415) 436

- 9682

The Center for Biological Diversity (“Center”) is a non

- profit, public interest environmental organization dedicated to the protection of native species and their habitats through s cience, policy and enviro n mental law. The Center has over 7 7 5,000 members and online activists throughout the United States and around the world. The Center’s Ocean Program and its supporters are specifically concerned with the con servation of marine spe cies, the preservation of ocean ecosystems and the effective implementation of U.S. environmental laws

, including the Resource Conservation and Recovery Act and the Toxic Substances Control Act

. The Center submits this petition on its own behalf and on be half of its members and staff with an interest in protecting the marine environment.

ACTION REQUESTED

Pursuant to section 7004 (a) of the Resource Conservation and Recovery Act (“RCRA” ), 42 U.S.C. § 6974(a); RCRA’s implementing regulations, 40 C. F.R. § 260.20; section 21 of the Toxic Substances Control Act (“TSCA”), 15 U.S.C. § 2620; and section 553(e ) of the

Administrative Procedure Act (“APA”) , 5 U.S.C. § 553(e), the Center for Biological Diversity hereby petitions the Administrator of the U.S. Enviro nmental Protection Agency (“EPA”) to promulgate regulations governing the safe treatment , storage and disposal of polyvin yl chloride ( “ PVC ” ) , vinyl chloride and associated dialkyl

- and alkylarylesters of 1,2

- benzenedicarboxylic

acid , commonly known as phth alate plasticizers

.

The U.S. Constitution and various federal statutes, including both RCRA and TSCA

, explicitly guarantee a citizen’s right of petition. See U.S. Const. amend. I (“Congress shall make no law ... abridging the right of people ... to petition the Government for redress of grievances.”); see also United Mine Workers v. Ill. State Bar Ass’n , 389 U.S. 217, 222 (1967) (“[T]he right[] ... to petition for a redress of grievances [is] among the most precious of the liberties safeguarded by the Bill of Rights.”). Specifically , t he APA mandates that “[e]ach agency shall give an interested person the right to petition for the issuance ... of a rule.” 5 U.S.C. § 553(e). RCRA directs EPA to “provide[] for, encourage[], and assist [] ” public participation in the development of regulations

, and expressly authorizes “any person” to seekii promulgation of a new environmental rule . 42 U.S.C. § 6974. Similarly, TSCA empowers “[a]ny person [to] petition [EPA] to initiate a proceeding for the issuance” of more protec tive regulations. 15 U.S.C. § 2620.

T his petition imposes definite response requirements on EPA. Specifically, RCRA stipulates that the agency “ shall take action” with respect to this petition within a “reasonable time” following its receipt and “ shall publish notice of such action in the Federal Register, together with the reasons therefor

. ” Id

. § 6974(a) (emphasis added)

. Under TSCA, EPA must either grant or deny our petition for additional rulemaking within ninety days of filing, “promptly

com menc[ing] an appropriate proceeding if such action is warranted.” 15 U.S.C. § 2620(b)(3)

. Conversely, should the agency decline to regulate vinyl chloride and phthalate plasticizers under TSCA, EPA must publish the reasons for its decision in the Federal Register. Id. ; see also 5 U.S.C. § 555(e) (“Prompt notice shall be given of the denial in whole or in part of a written application, petition, or other request of an interested person made in connection with any agency proceeding.”).

The APA provides for judicial review of government decision making and permits courts to compel agency action unlawfully withheld or unreasonably delayed. 5 U.S.C. §§ 704, 706. Similarly , RCRA and TSCA authorize citizens to file suit against EPA to compel the completion

of a ny nondiscretionary duty , 42 U.S.C. § 6972(a)(2), an d to challenge an adverse or untimely

determination

, respectively

. 15 U.S.C. § 2620(b)(4)

.

As described in this petition, discarded PVC satisf ies both the criteria for hazardous waste designation

, as defined at 42 U.S.C. § 6903(5) and 40 C.F.R. §§ 261.3 & 261.11(3) , and the standard for regulation under TSCA, set forth at 15 U.S.C. §§ 2603 & 2605

. PVC contain s toxic constituents. Moreover, r ecent scie ntific research clearly demonstrates that the improper
management of this waste pose s a substantial threat and an unreasonable risk to human health and the environment, including endangered marine species

. I f EPA determines that neither

hazardous waste designation nor TSCA regulation is warranted, we alternatively request that the agency revise its solid waste management guidelines

, see 42 U.S.C. § 6907, to recommend management and operating practices sufficient to minimize the threats associated with

im properly discarded PVC.

Date d this 24th day of July , 2014

.

___________________________________________________ Alexis Andiman, Oceans Fellow Emily Jeffers, Attorney , Oceans Program Miyoko Sakashita, Senior Attorne y & Oceans Director Center for Biological Diversity 351 California St., Ste. 600 (41 5 ) 436

- 9682

AA ndiman@biologicaldiversity.org

EJ effers@biologicaldivers ity.org Miyoko@ biologicaldiversity.orgiii TABLE OF AU THORITIES

Cases

Am. Mining Congress v. U.S. Envtl. Prot. Agency, 907 F.2d 1179 (D.C. Cir. 1990)

.................... 4

Dithiocarbamate Task Force v. U.S. Envtl. Prot. Agency, 98 F.3d 1394 (D.C. Cir. 1996)

....... 4, 21

Hazardous Waste Treatment Council v. U.S. Envtl. Prot. Agency, 861 F.2d 270 (D.C. Cir. 1988)

................................ ................................ ................................ ......................... 4

Statutes

15 U.S.C. § 2057c

................................ ................................ ................................ .......................... 24

15 U.S.C. §§ 2601 et seq.

................................ ................................ ................................ ................. 1 15 U.S.C. § 2601(b)(1)

................................ ................................ ................................ .................. 26 15 U.S.C. § 2601(b)(2)

................................ ................................ ................................ .................. 26 15 U.S.C. § 2601(b)(3)

................................ ................................ ................................ .................. 26 15 U.S.C. § 2602(2)

................................ ................................ ................................ ....................... 26 15 U.S.C. § 2603

................................ ................................ ................................ ............................ 27 15 U.S.C. § 2605(a)

................................ ................................ ................................ ....................... 26 15 U.S.C. § 2605(a)(1)(B)

................................ ................................ ................................ ............. 26 15 U.S.C. § 2605(c)

................................ ................................ ................................ ....................... 26 16 U.S.C. §§ 1531 et seq

. ................................ ................................ ................................ ............... 17 42 U.S.C. §§ 6901 et seq.

................................ ................................ ................................ ................. 1 42 U.S.C. § 6901(a)

................................ ................................ ................................ ......................... 3 42 U.S.C. § 6901(b)

................................ ................................ ................................ ......................... 3 42 U.S.C. § 6902

................................ ................................ ................................ .............................. 5 42 U.S.C. § 6902(a)(5)

................................ ................................ ................................ ..................... 6 42 U.S.C. § 6903(5)

................................ ................................ ................................ ..................... 3, 6 42 U.S.C. § 6903(27)

................................ ................................ ................................ ................... 3, 6

42 U.S.C. § 6907

................................ ................................ ................................ .......................... 1, 5 42 U.S.C. § 6912(b)

................................ ................................ ................................ ......................... 5

42 U.S.C . § 6921

- 6939g

................................ ................................ ................................ .................. 3 42 U.S.C. § 6921(a)(1)

................................ ................................ ................................ ..................... 5 42 U.S.C. § 6922

................................ ................................ ................................ .............................. 3 42 U.S.C. § 6922

- 6924

................................ ................................ ................................ .................... 3 42 U.S.C. § 6923

................................ ................................ ................................ .............................. 3 42 U.S.C. § 6924

................................ ................................ ................................ .............................. 3 42 U.S.C. § 6925

................................ ................................ ................................ .............................. 3 42 U.S.C. § 6926

................................ ................................ ................................ .............................. 3 42 U.S.C. §§ 6941

- 6969a

................................ ................................ ................................ ................. 3 42 U.S.C. § 6961

................................ ................................ ................................ .............................. 5 42 U.S.C. § 6972

................................ ................................ ................................ .............................. 5 42 U.S.C. § 6974(a)

................................ ................................ ................................ ......................... 5

42 U.S.C. § 6974(b)(1)

................................ ................................ ................................ .................... 5iv Regulations

40 C.F.R. pt. 132

................................ ................................ ................................ ............................ 24 40 C.F.R. § 240

................................ ................................ ................................ ................................ 5 40 C.F.R. § 243

................................ ................................ ................................ ................................ 5 40 C.F.R. § 246

- 47

................................ ................................ ................................ ........................... 5 40 C.F.R. § 257

- 58

................................ ................................ ................................ ........................... 5 40 C.F.R. pt. 261

................................ ................................ ................................ .............................. 3 40 C.F.R. pt. 261, app. VIII

................................ ................................ ................................ ..... 4, 7, 8

40 C.F.R. § 2 61.4(b)(1)

................................ ................................ ................................ .................... 3 40 C.F.R. § 261.11(a)(3)

................................ ................................ ................................ ........ passim 50 C.F.R. § 17.11

................................ ................................ ................................ ..................... 17, 24

C AL

. C ODE R EGS

. tit. 27, § 25805

................................ ................................ ................................ .. 24

C AL

. H EALTH & S AFETY C ODE §108935

- 39

................................ ................................ .................. 24

V T

. S TAT

. A NN

. tit. 18, § 1511

................................ ................................ ................................ ....... 24

W ASH

. R EV

. C ODE § 70.240.020(1)( c )

................................ ................................ ........................... 24

Federal Register

Guidance for Petitioning the Environmental Protection Agency Under Section 21 of the Toxic

Substances Co ntrol Act, 50 Fed. Reg. 46,825 (Nov. 13, 1985)

................................ ............... 27

Identification and Listing of Hazardous Waste

, 45 Fed. Reg. 33

, 084 (May 19, 1980)

................................ ................................ ................................ ........ 4, 14, 20, 21

Recordkeeping of Refuse Discharges f rom Ships , 59 Fed. Reg. 18,700 ( Apr. 19, 1994)

............. 23

Lead Fishing Sinkers; Response to Citizens’ Petition and Proposed Ban , 59 Fed. Reg. 11,122 (Mar. 9, 1994)

................................ ................................ ................................ .......................... 26

Other Materials

M. Abdel daiem et al.

, Environmental Impact of Phthalic Acid Esters and their Removal fo rm Water and Sediments by Different Technologies

– A Review

, 109 J. OF E NVTL

. M GMT

. 164 (2012)

................................ ................................ ................................ .......................... 15, 16, 20

Safa Abdul

- Ghani et al.

, The Teratogenicity and Behavioral Teratogenicity of Di(2

- Ethylhexyl) Phthalate (DEHP) and Di

- Butyl Phthalate (DBP) in a Chick Model , 34 N EUROTOXICOLOGY

AND T ERATOLOGY 56 (2012)

................................ ................................ ................................ ... 10

Jennifer J Adibi et al.

, Prenatal Exposures to Phthalates Among Women in New York City and Krakow, Poland

, 111 E NVTL

. H E ALTH P ERSP

. 17 19 (2003)

................................ ................. 2, 25

Michael W. Allsop et al.

, Poly(Vinyl Chloride)

, in 28 U LLMANN ’ S E NCYCLOPEDIA OF I NDUS

. C HEMISTRY 441 ( Electronic ed. 2012)

................................ ................................ ................... 7, 8v Am. Chemistry Council

, U.S. Resins Industry Strengthens in 2013

, http://www. americanchemistry.com/Jobs/EconomicStatistics/Plastics

- Statistics/Year

- in

- Review.pdf (last visited May 13, 2014)

................................ ................................ ................................ 21

- 22

Am. Chemistry Council

, U.S. Resin Production & Sales 2013 vs. 2012 (Mar. 2014), http://www. americanchemistry.com/Job s/Economic Statistics/Plastics

- Statistics/ Production

- and

- Sales

- Data

by

- Resin.pdf.

................................ ................................ ................................ ............................ 21

Am. Med. Ass’n

, DEHP Use in Neonatal Intensive Care Units (2001), Health Care Without Harm, http://noharm.org/lib/downloads/pvc/PVC_Stmt_AMA_12

- 01.pdf

........................... 14

Heidi J. Auman et al.

, Plastic Ingestion by Laysan Albatross Chicks on Sand Island, Midway Atoll, in 1994 and 1995

, in A LBATROSS B IOLOGY AND C ONSERVATION 239 ( G. Robinson et al. eds., 1997)

................................ ................................ ................................ ........................... 18

Radwa A. Barakat et al.

, Early Investigation of Hepatocarcinogeni c Effect of Polyvinyl Chloride

in Rat , 12 G LOBAL V ETERINARIA 67 (2014)

................................ ................................ ............ 18

S. Barnabé et al., Plasticizers and Their Degradation Products in the Process Streams of a Large Urban Physicochemical Sewage Treatment Plant , 42 W ATER R ES

. 153 (2008)

..................... 17

David K. A. Barnes , et al., Accumulation and Fragmentation of Plastic Debris in Global

Environments , 364 P HIL

. T RANS ACTIONS OF THE R OYAL S OC

. B 1985 (2009)

........ 1, 19, 21, 23

Michael J. Bean

, Legal Strategies for Reducing Persistent Plastics in the Marine Environment

, 18 M ARINE P OLLUTION B ULL

. 357, 357 (1987)

................................ ................................ ....... 24

Michael Belliveau et al.

, PVC

– Bad News Comes in Threes: The Poison Plastic, Health Hazards and the Looming Waste Crisis 10 (Dec. 2004), http://chej.org/wp

- content/uploads/ Documents/PVC/bad_news_comes_in_threes.pdf

................................ ................................ .. 22

Priyanka Bhattacharya et al.

, Physic al Adsorption of Charged Plastic Nanoparticles Affects Algal Photosynthesis , 114 J. OF P HYSICAL C HEMISTRY C 16,556 (2010)

................................ 17

S.M. Bidoki et al.

, Environmental and Economic Acceptance of Polyvinyl Chloride (PVC) Coating Agents , 18 J. OF C LEANER P RODUCTION 219 (2010)

................................ .............. 2, 14

Paul Wesley Brandt

- Rauf et al.

, Plastics and Carcinogenesis: The Example of Vinyl Chloride 2,

J. C ARCINOGENESIS (2012), http://www.carcinogenesis.com/text.asp?2012/11/1/5/

93700

................................ ................................ ................................ ............................ 8, 13, 28

Mark A

. Browne et al.

, Ingested Microscopic Plastic Translocates to the Circulatory System of the Mussel, Mytilus edulis ( L. ), 42 E NVTL

. S CI

. AND T ECH

. 5026 (2008)

................................ 18

Mark Anthony Browne et al.

, Microplastic Moves Pollutants and Additives to Worms, Reducing Functions Linked to Health and Biodiversity

, 23 C URRENT B IOLOGY 2388 (2013)

................ 18vi Mark A. Browne et al.

, Spatial Patterns of Plastic Debris along Estuarine Shores , 44 E NVTL

. S CI

. AND T ECH

. 3404 (2010)

................................ ................................ ................................ ...... 1

David F. Cadogan et al.

, Plasticizers

, in 27 U LLMANN ’ S E NCYCLOPEDIA OF I NDUS

. C HEMISTRY 599 ( Electronic ed. 2012)

................................ ................................ ................................ ...... 7, 8

Oliana Carnevali et al.

, DEHP Impairs Zebrafish Reproduction by Affecting Critical Factors in Oogenesis

, 5 PL O S ONE e10201 (2010)

................................ ................................ ............ 10, 11

Henry S. Carson

, The Incidence of Plastic Ingestion by Fishes: From the Prey’s Perspective , 74

M ARINE P OLLUTION B ULL

. 170 (2013)

................................ ................................ .................... 17

Subjankar Chatterjee et al.

, Removal of the Endocrine Disrupter Butyl Benzyl Phthalate from the

Environment

, 87 A PPLIED M ICROBIOLOGY AND B IOTECH

. 61 (2010)

.............................. passim

Zhang Cheng et al.

, Risk Assessments of Human Exposure to Bioaccessible Phthalate Esters through Market Fish Consumption

, 57

- 58 E NV ’ T I NT ’ L 75 (2013)

................................ ... 1 5, 20

Justin A. Colacino et al.

, Dietary Intake is Associated with Phthalate Body Burden in Nationally Representative Sample

, 118 E NVT L

. H EALTH P ERSP

. 998 (2010)

................................ ............ 20

Matthew Cole et al.

, Microplastic Ingestion by Zooplankton , 47 E NVTL

. S CI

. & T ECH

. 6 646 (2013)

................................ ................................ ................................ ................................ 17, 18

Ivelisse Col ό n
, Identification of Phthalate Esters in the Serum of Young Puerto Rican Girls with Premature Breast Development

, 108 E NVTL

. H EALTH P ERSP

. 895 (2000)

.............................. 12

Bruna Corradetti et al.

, Bis

- (2

- Ethylexhyl) Ph thalate Impairs Spermatogenesis in Zebrafish ( Danio rerio )

, 13 R EPROD

. B IOLOGY 195 (2013)

................................ ................................ ...... 11

Andrés C ό zar et al., Plastic Debris in the Open Ocean

, P ROCEEDINGS OF THE N AT ’ L A CADEMY

OF S CI

. 1 (2014)

................................ ................................ ................................ .......................... 1

Ctrs. for Disease Control and Prevention , Dep’t of Health and Human Servs., Fourth National Report on Human Exposure to Environmental Chemicals (2009)

................................ .......... 13

Martine Culty et al.

, In Utero Exposure to Di

- (2

- Ethylhexyl) Phthalate Exerts Both Short

- Term and Long

- Lasting Suppressive Effects on Testosterone Production in the Rat

, 78 B IOLOGY OF
R EPROD

. 1018 (2008)

................................ ................................ ................................ ......... 12

- 13

Peter Davison et al.

, Plastic Ingestion by Mesopelagic Fishes in the North Pacific Subtropical Gyre

, 432 M ARINE E COLOGY P ROGRESS S ERIES 173 (2011)

................................ .................... 19

M.H. Depledge et al.

, Plastic Litter in the Sea , 92 M ARINE E NVTL

. R ES

. 279 (2013)

............... 2, 15vii Di(2

- Ethylhexyl) Phthalate (DEHP) , U.S. Envtl. Prot. Agency, http://www.epa.gov/iris/subst/

0014.htm

................................ ................................ ................................ ................................ .. 14

José G. D ό rea
, Persistent, Bioaccumulative and Toxic Substances in Fish: Human Health

Considerations

, 400 S CI

. OF THE T OTAL E NV ’ T 93 (2008)

................................ ....................... 20

Susan M. Duty et al.

, Phthalate Exposure and Human Semen Parameters , 14 E PIDEMIOLOGY 269 (2003)

................................ ................................ ................................ ................................ ...... 13

Paul Farrell et al.

, Trophic Level Transfer of Microplastic: Mytilus edulis ( L. ) to Carcinus

maenas (L. ), 17 E NVTL

. P OLLUTION 1 (2013)

................................ ................................ ........... 18

T. Fierens et al.

, Phthalates in Belgian Cow’s Milk and the Role of Feed and Other Contamination Pathways at Farm Level

, 50 F OOD AND C HEMICAL T OXICOLOGY 2,945 (2012)

................................ ................................ ................................ ................................ ...... 20

Jane Fisher

, Environmental Anti

- Androgens and Male Reproductive Health: Focus on Phthalates and Testicular Dysgenesis Syndrome , 127 R EPROD

. 302 (2004)

................................ ....... 11, 22

Maria Cristina Fossi et al.

, Are Baleen Whales Exposed to the Threat of Microplastics? A Case Study of the Mediterranean Fin Whale ( Balaenoptera physalus )

, 64 M ARINE P OLLUTION
B ULL

. 2 374 (2012)

................................ ................................ ................................ ... 7, 10, 15, 19

Hanne Frederiksen et al.

, Metabolism of Phthalates in Humans , 51 M OLECULAR N UTRITION &

F OOD R ES

. 899 (2007)

................................ ................................ ................................ ...... passim

F. Galgani et al.

, Marine Litter within the European Marine Strategy Framework Directive , 70

ICES J. OF M ARINE S CI

. 1 055 (2013)

................................ ................................ ................... 1, 19

Michael O. Gaylor et al.

, House Crickets Can Accumulate Polybrominated Diphenyl Ethers (PBDEs) Directly from Polyurethane Foam Common in Consumer Products

, 86

C HEMOSPHERE 500 (2012)

................................ ................................ ................................ . 18

- 19

Nivedita Ghorpade et al.

, Toxicity Study of Diethyl Phthalate on Freshwater Fish Cirrhina mrigala, 53 E COTOXICOLOGY AND E NVTL

. S AFETY 255 (2002)

................................ .............. 10

Erin R. Graham et al.

, Deposit

- and Suspension

- Feeding Sea Cucumbers (Echinodermata) Ingest Plastic Fragments

, 368 J. OF E XPERIMENTAL M ARINE B IOLOGY AND E COLOGY
22 (2009)

................................ ................................ ................................ ................................ .. 18

Heather J. Hamlin

, Embryos as Targets of Endocrine Disrupting Contaminants in Wildlife , 93

B IRTH D EFECTS R ES

. P ART C: E MBRYO T ODAY : R EVIEWS 19 (2011)

.......................... 25, 27, 28

Bethany R. Hannas et al.

, In Utero Phthalate Effects in the Female Rat: A Mode for MRKH Syndrom e , 223 T OXICOLOGY L ETTERS 315 (2013)

................................ ................................ . 23viii Grant A. Harse

, Plastic, the Great Pacific Garbage Patch, and International Misfires at a Cure

, 29 UCLA J. E NVTL

. L. & P OL ’ Y 331 (2011)

................................ ................................ ............ 23

Daud Hassan

, International Conventions Relating to Land

- Based Sources of Marine Pollution Control: Applications and Shortcomings

, 16 G EO

. I NT ’ L E NVTL

. L. R EV

. 657 (2004)

............ 23

Russ Hauser et al.

, Altered Semen Quality in Relation to Urinary Concentrations of Phthalate

Monoester and Oxidative Metabolites , 17 E PIDEMIOLOGY 682 (2006)

................................ ... 13

John R. Henderson

, A Pre

- and Post

- MARPOL Annex V Summary of Hawaiian Monk Sea Entanglements and Marine Debris Accumulation in the Northwestern Hawaiian Islands,

1982

- 1998 , 42 M ARINE P OLLUTION B ULL

. 584 (2001)

................................ ...................... 23

- 24

Ursel Heudorf et al.

, Phthalates: Toxicology and Exposure , 210 I NT ’ L J. H YGIENE AND H EALTH 623 (2007)

................................ ................................ ................................ ............................ 8, 15

R. Hokanson et al.

, DEHP, Bis(2)

- Ethylhexyl Phthalate, Alters Gene Expressive in Human Cells: Possible Correlation with Initiation of Fetal Developmental Abnormalities , 25 H UMAN &

E XPERIMENTAL T OXICOLOGY 687 (2006)

................................ ................................ ................ 12

Owen Horn et al.

, Plasticizer Metabolites in the Environment

, 38 W ATER R ES

. 3693 (2004)

................................ ................................ ................................ ................................ 17, 27

Kembra L. Howdeshell et al., Mechanisms of Action of Phthalate Esters, Individually and in Combination, to Induce Abnormal Reproductive Development in Male Laboratory Rats , 108

E NVTL

. R ES

. 168 (2008)

................................ ................................ ............................... 11, 23, 25

Juliana A. Ivar do Sul et al.

, Pelagic Microplastics Around an Archipelago of the Equatorial

Atlantic

, 75 M ARINE P OLLUTION B ULL

. 305 (2013)

................................ ................................ . 17

Jeff K. Jacobsen et al., Fatal Ingestion of Floating Net Debris by Two Sperm Whales ( Physeter macrocephalus )

, 60 M ARINE P OLLUTION B ULL

. 765 (2010)

................................ .................... 17

Douglas C. Jones

, The Effects of Environmental Neurotoxicants on the Dopaminergic System: A Possible Role in Drug Addiction

, 76 B IOCHEMICAL P HARMACOLOGY 569 (2008)

.................. 12

Susan Jobling et al.

, A Variety of Environmentally Persi stent Chemicals, Including Some Phthalate Plasticizers, Are Weakly Estrogenic , 103 E NVTL

. H EALTH P ERSP

. 582 (1995)

................................ ................................ ................................ .................... 16, 25, 27

Ju

- Chan Kang et al.

, Anti

- Oxidative Status and Hepatic Enzymes Following Acute Administration of Diethyl Phthalate in Olive Flounder, Paralichthys olivaceus

, a Marine

Culture Fish

, 73 E COTOXICOLOGY AND E NVTL

. S AFETY 1 449 (2010)

................................ . 9, 21

Lisa A.E. Kaplan et al.

, Impact of Benzyl Butyl Phthalate on Shoa ling Behavior in Fundulus heteroclitus (Mummichog) Populations , 86 M ARINE E NVTL

. R ES

. 70 (2013)

................... 10, 15ix Joshua Kastner et al.

, Aqueous Leaching of Di

- 2

- Ethylhexyl Phthalate and “Green” Plasticizers from Poly(Vinyl Chloride) , 432 S CI

. OF THE T OTAL E NV ’ T 357 (2012)

................................ ..... 8, 28

Janet Kielhorn et al., Vinyl Chloride: Still a Cause for Concern , 108 E NVTL

. H EALTH P ERSP

. 579 (2000)

................................ ................................ ................................ ...................... 2, 22, 25, 28

Bung

- Nyun Kim et al.

, Phthalates Exposure and Attention

- Deficit/Hyperactivity Disorder in

School

- Age Children , 66 B IOLOGICAL P SYCHIATRY 958 (2009)

................................ ............. 12

Walter Klöpffer

, Environmental Hazard Assessment of Chemicals and Products. Part V. Anthropogenic Chemicals in Sewage Sludge, 33 C HEMOSPHERE 1067 (1996)

........................ 16

Holger M. Koch et al.

, Human Body Burdens of Chemic als Used in Plastic Manufacture , 364

P HIL

. T RAN SACTIONS OF THE R OYAL S O C

. B 2 063 (2009)

................................ ......................... 7

Barbara Kolarik et al.

, The Association Between Phthalates in Dust and Allergic Diseases Among Bulgarian Children , 116 E NVTL

. H EALTH P ERSP

. 98 (2008)

................................ ....... 12

M.R. Lasheen et al., Factors Influencing Lead and Iron Release from Some Egyptian Drinking Water Pipes , 160 J. OF H AZARDOUS M ATERIALS 675 (2008)

................................ .................. 15

Giuseppe Latini et al.

, Phthalate Exposure and Male Infertility , 226 T OXICOLOGY 90 (2006)

................................ ................................ ................................ .............................. passim

Giuseppe Latini et al.

, Plasticizers, Infant Nutrition and Reproductive Health , 19 R EPROD

. T OXICOLOGY 27 (2004)

................................ ................................ ................................ ............ 19

Margaret H. Lemos

, State Enforcement of Federal Law , 86 N.Y.U.L. R EV

. 698 (2011)

............. 25

Sally Ann Lentz

, Plastics in the Marine Environment: Legal Approaches for International

Action , 18 M ARINE P OLLUTION B ULL

. 361 (1987)

................................ ................................ ... 23

List of Contaminants and their (MCLs) , U.S. Envtl. Prot. Agency, http://water.epa.gov/drink/ contaminants/#List (last vis ited May 18, 2014)

................................ ................................ ... 7, 14

Delilah Lithner et al.

, Leachates from Plastic Consumer Products

– Screening for Toxicity with Daphnia magna, 74 C HEMOSPHERE 1195 (2009)

................................ ..................... 8, 13, 14, 25

S. Magdouli

, Di 2

- Ethylhexylphtalate in the Aquatic and Terrestrial Envi ronment: A Critical

Review , 127 J. OF E NVTL

. M GMT

. 36 (2013)

................................ ................................ 14, 16, 17

Katharina M. Main et al.

, Human Breast Milk Contamination with Phthalates and Alterations of Endogenous Reproductive Hormones in Infants Three Months of Age , 114 E NVTL

. H EALTH
P ERSP

. 270 (2006)

................................ ................................ ................................ .................... 12x Rishikesh Mankidy et al.

, Biological Impact of Phthalates , 217 T OXICOLOGY L ETTERS 50 (2013)

................................ ................................ ................................ .......................... 16, 25, 27

D.B. Martinez

- Arguelles et al.

, Fetal Origin of Endocrin e Dysfunction in the Adult: The

Phthalate Model

, 137 J. OF S TEROID B IOCHEMISTRY & M OLECULAR B IOLOGY 5 (2013)

.. 11, 13

D.B. Martinez

- Arguelles et al.

, Maternal In Utero Exposure to the Endocrine Disruptor Di

- (2

- Ehtylhexyl) Phthalate Affects the Blood Pressure of Adult Male Offspring , 266 T OXICOLOGY

AND A PPLIED P HARMACOLOGY 95 (2013)

................................ ................................ .......... 10, 11

B. Migliarini et al. , Review, Perspectives on Endocrine Disruptor Effects on Metabolic Sensors

, 170 G EN

. AND C OMPARATIVE E NDOCRINOLOGY 416 (2011)

................................ .................... 16

Ce

- Hui Mo et al.

, Polycyclic Aromatic Hydrocarbons and Phthalic Acid Esters in Vegetables from Nine Farms of the Pearl River Delta, South China

, 56 A RCHIVES OF E NVTL

. C ONTAMINATION AND T OXICOLOGY 181 (2009)

................................ ................................ ...... 20

Karl Mulder et al.

, PVC Plastic: A History of Systems Develo pment and Entrenchment , 23 T ECH

. IN S OC

. 265 (2001)

................................ ................................ ................................ ........... 1, 9, 22

Fiona Murray et al.

, Plastic Contamination in the Decapod Crustacean Nephrops norvegicus (Linnaeus, 1758) , 62 M ARINE P OLLUTION B ULL

. 1207 (2011)

................................ ................ 18

Sandro Nalli et al.

, Metabolites from the Degradation of Di

- Ester Plasticizers by Rhodococcus rhodochrous, 366 S CI

. OF THE T OTAL E NV ’ T 286 (2006)

................................ ......................... 17

National Oceanic and Atmospheric Administration

, I NTERAGENCY R EPORT ON M ARINE D EBRIS
S OURCES

, I MPACTS

, S TRATEGIES & R ECOMMENDATIONS (2008)

................................ ............. 21

Jörg Oehlmann et al.

, A Critical Analysis of the Biological Impacts of Plasticizers on Wildlife

, 364 P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2 047 (2009)

................................ ................ 1 0

Office of Inspector General , U.S. Envtl. Prot. Agency, EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal (2012)

................................ ............... 5

Office of Inspector General

, U.S. Envtl. Prot. Agency, EPA’s Endocrine Disruptor Screening Program Should Establish Management Controls to Ensure More Timely Results (2011)

.. 5

- 6

Office of Solid Waste and Emergency Response , U.S. Envtl. Prot. Agency, RCRA in Focus: Construction, Demolition, and Renovation (2004)

................................ ................................ .. 14

The Original List of Hazardous Air Pollutants , U .S. Envtl. Prot . Agency, http://www.epa.gov/ ttn/atw/188polls.html (last visited July 23, 2014)

................................ ................................ ...... 7

Phthalates Factsheet

, C TRS

. F OR D ISEASE C ONTROL AND P REVENTION (July 16, 2013), http://www.cdc.gov/biomonitoring/phthalates_factsheet.html

................................ ................ 12xi PVC Policies Across the World

, C TR

. FOR H EALTH

, E NV ’ T & J USTICE

, http://www.chej.org/ pvcfactsheets/PVC_Policies_Around_The_World.html (last visited Apr. 7, 2014)

............... 24

Mustafizur Rahman et al.

, The Plasticizer Market: An Assessment of Traditional Plasticizers and Research Trends to Meet New Challenges , 29 P ROGRESS IN P OLYMER S CI

. 1 223 (2004)

.. 8, 13

Rachael Rawlins

, Teething on Toxins: In Search of Regulatory Solutions for Toys and Cosmetics

, 20 F ORDHAM E NVTL

. L AW R EV

. 1 (2009)

................................ ................................ ................ 24

Chelsea M. Rochman et al.

, Classify Plastic Waste as Hazardous , 494 N ATURE 169 (2013)

..... 1, 2

Chelsea M. Rochman et al.

, Ingested Plastic Transfers Hazardous Chemicals to Fish an d Induces Hepatic Stress , 3 S CI

. R EP

. 3263 (2013)

................................ ................................ ..... 18

Chelsea M. Rochman et al.

, Polybrominated Diphenyl Ethers (PBDEs) in Fish Tissue May Be an Indicator of Plastic Contamination in Marine Habitats

, 476

- 77 S CI

. OF THE T OTAL E NV ’ T 622 (2014)

................................ ................................ ................................ ................................ ...... 19

Roya Rozati et al

., Role of Environmental Estrogens in t he Deterioration of Male Factor Fertility

, 78 F ERTILITY AND S TERILITY 1187 (2002)

................................ ................................ 20

Ivan Rusyn

, Mechanistic Considerations for Human Relevance of Cancer Hazard of Di(2

- Ethylhexyl) Phthalate , 750 M UTATION R ES

. 141 (2012)

................................ .......................... 13

Mehdi Sadat

- Shojai et al.

, Recycling of PVC Wastes , 96 P OLYMER D EGRADATION AND S TABILITY 404 (2011)

................................ ................................ ................................ ................................ .. 2

Herman O. Sanders et al

., Toxicity, Residue Dynamics, and Reproductive Effects of Phthalate Esters in Aquatic Invertebrates , 6 E NVTL

. R ES

. 84 (1973)

................................ ............ 9, 10, 11

San Francisco Dept. of the Env’t

, Detailed Results of Phthalate Testing in Children’s Toys (2008), http://www.sfenvironment.org/sites/ default/files/fliers/files/sfe_th_phthalate_ testing_in_toys_detailed_results.pdf

................................ ................................ ........................ 13

Jennifer Beth Sass et al., Vinyl Chloride: A Case Study of Data Suppression and Misrepresentation , 113 E NVTL

. H EALTH P ERSP

. 809 (2005)

................................ ........... 2, 9, 13

Yvonne R. Shashoua, Effect of Indoor Climate on the rate and Degradation Mechanism of Plasticized Poly (Vinyl Chloride) , 81 P OLYMER D EGRADATION AND S USTAINABILITY 29 (2003)

................................ ................................ ................................ ................................ ...... 15

Outi Setälä et al.

, Ingestion and Transfer of Microplastics in the Planktonic Food Web

, 185

E NVTL

. P OLLUTION 77 (2014)

................................ ................................ ................................ .. 17xii Richard W. St ahlhut et al.

, Concentrations of Urinary Phthalate Metabolites Are Associated with Increased Waist Circumference and Insulin Resistant in Adult U.S. Males, 115 E NVTL

. H EALTH P ERSP

. 876 (2007)

................................ ................................ ......................... 12, 13, 21

Bonnie Ransom Stern et al.

, Are There Health Risks from the Migration of Chemical Substances from Plastic Pipes into Drinking Water? A Review , 14 H UMAN AND E COLOGICAL R ISK
A SSESSMENT 753 (2008)

................................ ................................ ................................ .. passim

Y. Suzuki et al.

, Foetal Exposure to Phthalate Esters and Anogenital Distance in Ma le

Newborns , 34 I NT ’ L J

. OF A NDROLOGY 236 (2012)

................................ ................................ . 12

Katherine Svensson et al.

, Phthalate Exposure Associated with Self

- Reported Diabetes Among

Mexican Women , 111 E NVTL

. R ES

. 792 (2011)

................................ ................................ ....... 13

Shanna H. Swan et al.

, Decrease in Anogenital Distance among Male Infants with Prenatal Phthalate Exposure

, 113 E NVTL

. H EALTH P ERSP

. 1056 (2005)

................................ ....... passim

S.H. Swan et al.

, Prenatal Phthalate Exposure and Reduced Masculine Play in Boys , 33 I NT ’ L J.

OF A NDROLOGY 259 (2010)

................................ ................................ .......................... 11, 12, 21

Shanna H. Swan et al.

, The Question of Declining Sperm Density Revisited: An Analysis of 101

Studies Published 1934

- 1996 , 108 E NVTL

. H EALTH P ERSP

. 961 (2000)

................................ .. 22

Chris E. Talsness et al.

, Components of Plastic: Experimental Studies in Animals and Relevance for Human Health , 364 P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2079 (2009)

............... 7

- 8

Kosuke Tanaka et al.

, Accumulation of Plastic

- Derived Chemicals in Tissues of Seabirds Ingesting Marine Plastics

, 69 M ARINE P OLLUTION B ULL

. 219 (2013)

................................ .... 19

Takashi Tanida et al.

, Fetal and Neonatal Exposure to Three Typical Environmental Chemicals with Different Mechanisms of Action: Mixed Exposure to Phenol, Phthalate, and Dioxin Cancels the Effects of Sole Exposure on Mouse Midbrain Dopaminergic Nuclei

, 189

T OXICOLOGY L ETTERS 40 (2009)

................................ ................................ ....................... 11, 12

Susan L. Teitelbaum et al.

, Associations Between Phthalate Metabolite Urinary Concentrations and Body Size Measures in New York City Children , 112 E NVTL

. R ES

. 186 (2012 )

......... 12, 21

Emma L. Teuten et al.

, Transport and Release of Chemicals from Plastics to the Environment and Wildlife , 364 P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2027 (2009)

........................... 15

Leonardo Trasande et al.

, Phthalates and the Diets of US Children and Adolescents , 126 E NVTL

. R ES

. 84 (2013)

................................ ................................ ................................ ................... 19

- 20

U .S. General Accounting Office

, Hazardous Waste: New Approach Needed to Manage the Resource Conservation and Recovery Act (1988)

................................ ................................ ..... 5xiii U

. S. Envtl. Prot. Agency

, Phthalates Action Plan (2012), http://www.epa.gov/oppt/ existingchemicals/pubs/actionplans/phthalates.html

................................ ................................ . 8

U.S. Envtl. Prot. Agency

, Plastics (Feb. 2012), http://www.epa.gov/epawaste/conserve/tools/ warm/pdfs/Plastics.pdf)

................................ ................................ ................................ ........... 22

A. Dick Vethaak et al.

, An Integrated Assessment of Estrogenic Contamination and Biological Effects in the Aquatic Environment of The Netherlands

, 59 C HEMOSPHERE 511 (2009)

......... 19

Vinyl Chloride , U.S. Envtl. Prot. Agency, http://www.epa.gov/ttn/atw/hlthef/vinylchl.html (last

visited J uly 23, 2014)

................................ ................................ ................................ ............. 2, 7

Ryan K. Walter et al., Investigation of Factors Affecting the Accumulation of Vinyl Chloride in Polyvinyl Chloride Piping Used in Drinking Water Distribution Systems , 45 W ATER R ES

. 2607 ( 2011)

................................ ................................ ................................ ........................ 14 , 15

T.J. Wams

, Diethylhexylphthalate as an Environmental Contaminant: A Review , 66 S CI

. OF THE
T OTAL E NV ’ T 1 (1987)

................................ ................................ ................................ . 13, 17, 21

Wen

- Xiong Wang et al.

, Dioxin and Phthalate Uptake and Assimilation by the Green Mussel Perna viridis, 178 E NVTL

. P OLLUTION 455 (2013)

................................ ................................ ... 17

Matthias Wormuth et al.

, What are the Sources of Exposure to Eight Frequently Used Phthalic Acid Esters in Europeans? , 26 R ISK A NALYSIS 803 (2006)

................................ .............. 20, 25

Stephanie L. Wright et al.

, The Physical Impacts of Microplastics on Marine Organisms: A

Review

, 178 E NVTL

. P OL LUTION 483 (2013)

................................ ................................ ............ 18

Ting Ye et al.

, Exposure to DEHP and MEHP from Hatching to Adulthood Causes Reproductive Dysfunction and Endocrine Disruption in Marine Medaka ( Oryzias melastigma ) , 146

A QUATIC T OXICOLOGY 115 (2014)

................................ ................................ ................ 9, 10, 11

L. Zhang et al., Investigation of Organic Compounds Migration from Polymeric Pipes into Drinking Water Under Long Retention Times , 70 P ROCEDIA E NGINEERING 1753 (2014)

................................ ................................ ................................ ................................ 14

- 15xiv TABLE OF CONTENTS

NOTICE OF PETITION

................................ ................................ ................................ ............... i

PETITIONER

................................ ................................ ................................ ................................ i

ACTION REQUESTED

................................ ................................ ................................ ................ i

TABLE OF AUTHORITIES

................................ ................................ ................................ ...... iii

INTRODUCTION

................................ ................................ ................................ .......................... 1

I. The Resource Conservation a nd Recovery Act

................................ ................................ ..... 3

A

. Statutory Background

................................ ................................ ................................ ....... 3

B

. Discarded PVC Satisfies the Criteria for Hazardous Waste

................................ ......... 6

1. Discarded PVC Contains Toxic Constituents

................................ ............................ 7

2. Discarded PVC Poses Significant Hazards to Human Health and
the Environment

................................ ................................ ................................ ........... 9

a. Nature of the Toxicity Presented by Constituent Chemicals

............................. 9

b. Concentration of Toxic Constituents in Discarded PVC

................................ . 13

c. Migration Potential

................................ ................................ .............................. 14

d. Persistence

................................ ................................ ................................ ............ 16

e. Degradation Potential and Rate of Degradation

................................ ............... 16

f. Bioaccumulation

................................ ................................ ................................ ... 17

g. Plausible Improper Management

................................ ................................ ....... 20

h. Quantities of Waste Generated

................................ ................................ ........... 21

i. Nature and Severity of the Human Health and Environmental Damage that

Has Occurred

................................ ................................ ................................ ....... 22 j. Action Taken by Other Governmental Agencies or Regulatory Programs Based on the Health or Environmental Hazard Posed by Discarded PVC

, Vinyl Chloride and Phthalate Plasticizers

................................ ......................... 23

k. Other Appropriate Factors

................................ ................................ ................. 25

II. The Toxic Substances Control Act

................................ ................................ ....................... 26

A

. Statutory Ba ckground

................................ ................................ ................................ ..... 26

B

. Vinyl Chloride and Phthalate Plasticizers Pose an Unreasonable Risk of Harm to

Human Health and the Environment

................................ ................................ ............. 27

CONCLUSION

................................ ................................ ................................ ............................ 281 INTRODUCTION

The Center for Biological Diversity (“the Center”) requests that the Environmental Protection Agency (“EPA”) classify discarded polyvinyl chloride (“PVC”) as hazardous waste under the Resource Conservation and Recovery Act (“RCRA”). 1 For the reasons discussed below, the agency must, at a minimum, revise its solid waste man agement guidelines to reduce the significant threats to human health and the environment arising from the improper disposal of this plastic trash. 2 In addition, the Center asks that EPA initiate rulemaking under the Toxic

Substances Control Act (“TSCA”) t o address the serious risks associated with PVC, vinyl

chloride and phthalate plasticizers. 3

, 4

Scientists, scholars and concerned citizens have long warned that inadequate waste management strategies are contributing to the widespread degradation of the marine

environment. 5 In recent years, plastic pollution has attracted increasing attention as an emerging problem of global proportions. As much as eighty percent of ocean litter consists of lightweight and durable plastic trash, which poses a range of serious threats to aquatic organisms and human beings. 6 A recent review of the scientific literature revealed that nearly four hundred species have ingested or become entangled in marine debris, representing an increase of more than forty
percent over the previous survey, published only sixteen years before. 7 Plastic consumption affects nearly half of existing seabird and cetacean species, all marine turtles and many ecologically and commercially important fish, shellfish, grasses and corals. 8

Improperly discarded PVC constitutes a substantial proportion of ocean litter and poses especially significant threats to human and environmental health. 9 Even before the production of

this material began to accelerate in the 1930s, researchers suspected that PVC’s primary building block, vinyl chloride, produced to xic effects in laboratory animals

. 10

1 42 U.S.C. §§ 6901 et seq. (2012). Although EPA has now

2 See 42 U.S.C . § 6907.

3 15 U.S.C. §§ 2601 et seq.

4 Our requests under RCRA and TSCA constitute two independent and fully severable petition s

. 5 See, e.g. , Andrés C ό zar et al., Plastic Debris in the Open Ocean

, P ROCEEDINGS OF THE N AT ’ L
A CADEMY OF S CI

. 1, 1, 5 (2014) (reporting that “the intense consumption and rapid disposal of plastic products” has contributed to the accumulation of “tens of thousands of tons” of plastic debris in surface waters of the open ocean); see also David K. A. Barnes et al., Accumulation and Fragmentation of Plastic Debris in Global Environments , 364 P HIL

. T RANS ACTIONS OF THE
R OYAL S OC

. B 1985, 1986 (2009) (explaining that “plastic persists in landfill sites and if not properly buried may later surface to become ‘debris’”).

6 Barnes et al., supra note 5, at 1986.

7 F. Galgani et al., Marine Litter within the European Marine Strategy Framework Directive , 70

ICES J. OF M ARINE S C

. 1055, 1057 (2013).

8 Id ; Chelsea M. Rochman et al., Classify Plastic Waste as Hazardous , 494 N ATURE 169, 169 (2013).

9 Mark A. Browne et al., Spatial P atterns of Plastic Debris along Estuarine Shores , 44 E NVTL

. S CI

. AND T EC H

. 3404, 3406 (2010).

10 Karl Mulder et al., PVC Plastic: A History of Systems Development and Entrenchment , 23

T ECH

. IN S OC

. 265, 275 (2001).2 acknowledged this substance as a human carcinogen, 11 experts continue to argue that the agency’s risk assessments are inadequate. 12 In addition to vinyl chloride , PVC contains significant concent rations of regulated and unregulated chemical additives, including phthalate plasticizers and heat stabilizers mixed from lead, calcium, barium and cadmium. 13 Recent

studies reveal that finished PVC products leach significant concentrations of these compou nds

into the environment as they deteriorate with age, threatening severe biological consequences. 14
For example, one

- quarter of U.S. women already exhibit concentrations of phthalate metabolites higher than those correlated with irregular sexual developme nt in male infants, 15 and scientific evidence indicates that contamination might be even more prevalent in urban settings. 16

Despite its status as “one of the most hazardous consumer products ever created,” 17 PVC

and its associated chemical additives are m anaged in much the same way as food scraps and grass clippings after disposal

. 18 Americans already discard billions of pounds of this plastic each year, and experts anticipate that annual waste generation will increase significantly in the near

future , as durable products and construction goods reach the end of their useful lives. 19 Marine plastic pollution harms ocean organisms, threatens ecological integrity and damages human health and prosperity. 20

11 See Vinyl Chloride , U.S. Envtl. Prot. Agency, http://www.epa.gov/ttn/atw/hlthef/vinylchl.html (last visited July 23, 2014). However, policy

- makers have implemented few practical m easures to address this problem. To protect future generations and preserve the marine environment, we urge EPA to promptly exercise its authority to ensure the safe disposal of discarded PVC and the protective management of associated chemical s ubstances , including vinyl chloride and phthalate plasticizers.

12 See Jennifer Beth Sass et al., Vinyl Chloride: A Case Study of Data Suppression and Misrepresentation , 113 E NVTL

. H EALTH P ERSP

. 809 , 811 (2005) ( finding that EPA’s assessment of vinyl chloride “downplay[s] risk” and reflects excessive industry participation) ; see also Janet Kielhorn et al., Vinyl Chloride: Still a Cause fo r Concern , 108 E NVTL

. H EALTH P ERS P

. 579 , 579 (2000) (explaining that vinyl chloride “remains a cause for concern because potential exposure to

this chemical and new cases of [related cancers] are still being reported” ).

13 Bonnie Ransom Stern et al., Are There Health Risks from the Migration of Chemical Substances from Plastic Pipes into Drinking Water? A Review , 14 H UMAN AND E COLOGICAL
R ISK A SSESSMENT 753, 755 (2008).

14 Id. at 773

- 74.

15 Shanna H. Swan et al., Decrease in Anogenital Distance Among Male Infants with Prenatal Phthalate Exposure

, 1 13 E NVTL

. H EALTH P ERSP

. 1056, 1 056 (2005).

16 Jennifer J Adibi et al., Prenatal Exposures to Phthalates Among Women in New York City and Krakow, Poland

, 111 E NVTL

. H EALTH P ERSP

. 1719, 1722 (2003) (reporting that pregnant women

in New York City “appear to be exposed [to phthalates] at levels above background levels in the United States, which may have implications for their pregnancy and/or the fetus”).

17 S.M. Bidoki et al., Environmenta l and Economic Acceptance of Polyvinyl Chloride (PVC) Coating Agents , 18 J. OF C LEANER P RODUCTION 219, 221 (2010).

18 See Rochman et al., supra note 8, at 169.

19 Mehdi Sadat

- Shojai et al., Recycling of PVC Wastes , 96 P OLYMER D EGRADATION AND
S TABILITY 404, 4 04 (2011).

20 See M.H. Depledge et al., Plastic Litter in the Sea , 92 M ARINE E NVTL

. R ES

. 279, 279, 280 (2013)

.3 I. The Resource Conservation and Recovery Act

A. Statutory Background

In 1976, Congress enacted RCRA , recognizing that economic and population growth, accompanied by widespread improvements in the national standard of living, “ha[d] resulted in a rising tide of scrap, discarded, and waste materials,” leading to the “needless[] pollut[ion]” of the

environ ment and endangering public health. 21 Accordingly, the statute established guidelines concerning the proper management of “solid waste,” 22 and imposed a comprehensive framework to ensure the safe treatment, storage and disposal of especially hazardous mater ials. 23

Within the meaning of RCRA, “hazardous waste” includes any discarded material or “solid waste

, ”

which because of its quantity, concentration, or physical, chemical or infectious

characteristics may

— (A) cause, or significantly contribute to an inc rease in mortality or an increase in serious irreversible, or incapacitating reversible, illness; or (B) pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or

othe rwise managed. 24

To minimize the present and future threats associated with these materials, lawmakers directed EPA to impose stringent regulatory safeguards, including standards applicable to generators and
transporters; 25 requirements governing treatment, storage and disposal; 26 and an extensive, “cradle to grave” manifest system, tracking the generation, transport and receipt of hazardous

wastes. 27 States may assume these regulatory responsibilities upon developing program s that are at least equivalent to federal guidelines, consistent with management practices in neighboring jurisdictions and subject to adequate enforcement. 28

To implement the Act, EPA has developed criteria governing the identification and listing of haza rdous wastes. 29

21 42 U.S.C. § § 6901(a), (b). In relevant part, these regulations authorize EPA to classify as

22 See id . §§ 6941

- 6969a. Subject to certain exclusions, “solid waste” encompasses “any garbage, refuse, sludge from a waste treatment plant, water supply treatment plant, or air pollution control facility and other discarded material, including solid, liquid, semisolid, or

conta ined gaseous material resulting from industrial, commercial, mining, and agricultural operations, and from community activities.” Id . § 6903(27).

23 See id. §§ 6921

- 6939g.

24 Id. § 6903(5) (emphasis added); see also id. § 6903(27). By regulation, EPA h as excluded certain solid wastes from this definition, including those “derived from ... single and multiple residences, hotels and motels, bunkhouses, ranger stations, crew quarters, campgrounds, picnic grounds and day

- use recreation areas.” 40 C.F.R. § 26 1.4(b)(1) (2013).

25 Id. §§ 6922, 6923.

26 Id. §§ 6924, 6925.

27 Id. §§ 6922

- 6924.

28 Id. § 6926.

29 See 40 C.F.R. pt. 261.4 hazardous any solid waste that typically contains a designated “toxic constituent, ” provided that the agency’s analysis of eleven enumerated factors reveals that “the waste is ca pable of posing a

substantial present or potential hazard to human health or the environment when improperly ... managed.” 30 EPA has compiled an inventory of known “toxic constituents,” including substances that have been scientifically demonstrated “to h ave toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms.” 31 In assessing the hazards associated with wastes containing one or more of these substances , EPA must consider:

(i) The nature of the toxicity presented by the c onstituent. (ii) The concentration of the constituent in the waste. (iii) The potential of the constituent or any toxic degradation product of the constituent to migrate from the waste into the environment under [plausible types of improper management]. (iv) The persistence of the constituent or any toxic degradation product of the

constituent. (v) The potential for the constituent or any toxic degradation product of the constituent to degrade into non

- harmful constituents and the rate of degradation. ( vi) The degree to which the constituent or any degradation product of the constituent bioaccumulates in ecosystems. (vii) The plausible types of improper management to which the waste could be subjected. (viii) The quantities of the waste generated at indi vidual generation sites or on a regional

or national basis. (ix) The nature and severity of the human health and environmental damage that has occurred as a result of the improper management of wastes containing the

constituent. (x) Action taken by other governmental agencies or regulatory programs based on the health or environmental hazard posed by the waste or waste constituent. (xi) Such other factors as may be appropriate. 32

In every instance, t he agency must limit its analysis to the se enumerated factors, consider each factor fully and adequately explain its final listing decision. 33

30 Id. § 261.11(a)(3).

31 Id. ; see id. pt. 261, app. VIII. In other words, “the presence of any [toxic] constituent is presumed to be sufficient to list the waste unless after consideration of the designated multiple factors, EPA concludes that the waste is not hazardous.” Identification and Listing of Hazardous Waste, 45 Fed. Reg. 33,084, 33,107 (May 19, 1980) (emphasis added).

32 40 C.F.R. § 261.11(a)(3).

33 See Hazardous Waste Treatment Council v. U.S. Envtl. Prot. Agency, 861 F.2d 270, 277 (D.C. Cir. 1988) (limiting agency discretion to the listed factors); see also Dithiocarbamate Task Force v. U.S. Envtl. Prot. Agency, 98 F.3d 1394, 1398 (D.C. Cir. 1996) (requiring EPA to consider each factor); Am. Mining Congress v. U.S. Envtl. Prot. Agency, 907 F.2d 1179, 1189

- 90 (D.C. Cir. 1990) (remanding a listing decision because the agency relied on conclusory statements to

dismiss relevant scientific data and otherwise failed to explain its decision).5 In addition to expanding federal oversight of hazardous materials, RCRA requires EPA to promulgate “suggested guidelines for solid waste management.” 34 Existing re gulations address issues pertaining to the thermal processing, collection, storage, and recycling of wastes , and prescribe minimum criteria for state

- operated disposal facilities. 35 Although states retain primary authority to regulate non

- hazardous materia ls under the Act, EPA’s guidelines are binding upon government agencies and contractors with “jurisdiction over any [federal] solid waste management facility or disposal site.” 36 M embers of the public may enforce these guidelines against appropriate entities pursuant to the statute’s citizen suit provision. 37

Under RCRA, EPA has broad authority to prescribe all regulations necessary to “promote improved solid waste management techniques” and to “assur[e] that hazardous waste pract ices are conducted in a manner which protects human health and the environment.” 38 Lawmakers explicitly directed the agency to “provide[] for, encourage[], and assist[]” public participation in the “development, revision, implemen tation, and enforcement of any regulation, guideline, information, or program.” 39 In addition , Congress empowered “[a]ny person” to seek further safeguards by petitioning the agency for “ the promulgation, amendment or repeal of any regulation” under the Act. 40 EPA must “take action ” with respect to citizen petitions “[w]ithin a reasonable time following receipt.” 41

As the General Accounting Office observed over twenty

- five years ago, “[t]he first steps to successful nationwide management of hazardous waste are identifying which wa stes present a clear threat to human health and the environment and then expeditiously bringing these wastes under regulatory control.” 42 Although Congress explicitly directed EPA to “review[] and, where necessary, revise[]” its RCRA regulations at least o nce every three years

, 43 the agency has largely failed to protect against emerging contaminants. 44

34 42 U.S.C. § 6907. As this petition describes, substantial

35 40 C.F.R. §§ 240, 243, 246

- 47, 257

- 58.

36 42 U.S.C. § 6961.

37 Id. § 6972.

38 Id. §§ 6902, 6921(a)(1).

39 Id. § 6974(b)(1).

40 Id. § 6974(a).

41 Id.

42 U.S. General Accounting Office, Hazardous Waste: New Approach Needed to Manage the Resource Conservation and Recovery Act 17 (1988).

43 42 U.S.C. § 6912(b) (“Each regulation promulgated under this chapter shall be reviewed and, where necessary, revised not less frequently than every three years.”).

44 See, e.g. , U.S. General Accounting Office, supra note 42 , at 18 (explaining that EPA had made little progress in identifying hazardous wastes by 1988, despite the fact that “EPA [then] believe[d] that potenti ally large numbers of hazardous wastes may need to be brought under some form of regulatory control”); see also Office of Inspector General, U.S. Envtl. Prot. Agency, EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal 7 (2012) (“Although EPA has the authority under RCRA, it has [neither] added to its regulations pharmaceuticals that may qualify as hazardous since 1980,” nor “established a process for the regular identification and review of pharmaceuticals that may qua lify for regulation.”); see also Office of Inspector General, U.S. Envtl. Prot. Agency, EPA’s Endocrine6 scientific evidence now shows that the widespread mismanagement of discarded PVC has

distributed toxic chemicals throu ghout our environment, threatening ecosystem health and endangering vulnerable portions of the human population. To reduce the need for future corrective action, EPA must promptly revise its regulations to ensure the proper disposal of

discarded PVC

. 45

B. Discarded PVC Satisfies the Criteria for Hazardous Waste

As discussed above, 46 the term “hazardous waste” describes any “solid waste, or combination of solid wastes,” which possesses characteristics capable of harming human health

or the environment. 47 After disposal, PVC necessarily qualifies as “solid waste,” a category that is broadly defined to include all “garbage, refuse, ... and other discarded material.” 48 For the reasons set forth below, discarded PVC also satisfies the regulatory criteria gover ning the identification of “hazardous” materials. Specifically, finished PVC products contain vinyl chloride, as well as significant concentrations of chemical additives, such as phthalate plasticizers

, known “to have toxic, carcinogenic, mutagenic [and] teratogenic effects on humans [and] other life forms.” 49 In addition , application of EPA’s multi

- factor test, as set forth in detail below, clearly demonstrates that the mismanagement of discarded PVC could “pos[e] a substantial present or potential hazard to human health or the environment.” 50 Indeed, recent

scientific studies reveal that significant damage has already occurred. 51

Exposure to vinyl chloride, p hthalate plasticizers and other chemical additives is associated with a broad array of developmen tal and behavioral abnormalities in humans and wildlife species. 52 Depending on desired characteristics, PVC products frequently contain

substantial quantities of these compounds

, 53 which naturally migrate into the environment following disposal

. 54 Once dis sociated from plastic waste , phthalates resist physical and chemical degradation

, 55 ultimately accumulating in the tissues of aquatic and terrestrial organisms , including human beings

. 56 Conventional waste management practices allow substantial quantities o f discarded PVC to reach the marine environment, 57

Disruptor Screening Program Should Establish Management Controls to Ensure More Timely

Results 9 (2011) (reporting that EPA “has not determined whether any chemical is a potential endocrine disruptor,” despite the expiration of relevant deadlines under several environmental laws). thereby contributing

45 See 42 U.S.C. § 6902 (a) (5).

46 See § I.A

, supra

. 47 42 U.S.C. § 6903(5).

48 Id. § 6903(27).

49 40 C.F.R. § 261.11(a)(3); see §§ I

. B.1, I .B.2 .a
, infra

. 50 40 C.F.R. § 261.11(a)(3) ; see § I.B.2, infra

. 51 See sources cited infra § I.B.2. i

. 52 See § I.B.2.a

, infra

. 53 See § I .B.2 .b

, infra

. 54 See § I.B.2.c

, infra

. 55 See §§ I.B.2.d

- e
, infra.

56 See § I.B.2.f

, infra

. 57 See § I .B. 2.g

, infra

.7 to the toxic contamination of vulnerable ocean species. 58 According to recent estimates, Americans discard over seven billion pounds of PVC each year

, 59 and e xperts suspect that virtually universal exposure to phthalate plasticizers “could be the leading cause of reproductive

disorders in humans.” 60 Existing regulations are inadequate to manage the risks associated with the widespread use and improper disposal of PVC

. 61 Indeed, re cent research indicates that the

actual extent of phthalate contamination likely exceeds previously published estimates. 62

1

. Discarded PVC Contains Toxic Constituents Because discarded PVC satisfies the criteria for hazardous waste designation, w e urge EPA to promptly exercise its authority to ensur e the s afe disposal of this plastic trash

.

As described above, EPA may classify as hazardous any solid waste that contains a “toxic constituent” and threatens to “pos[e] a substantial present or potential hazard to human health or the environment when improperly ... managed.” 63 V inyl chloride , which forms the

base of finished PVC, is a known human carcinogen and designa ted toxic constituent. 64

Moreover, because PVC is intrinsically unstable

, the commercial viability and almost unlimited versatility of this material derive from complex formulation s of chemical additives

, which frequently includ e multiple toxic constituent s

. 65 For example, stabilizers mixed from l ead,

barium and cadmium are often employed to facilitate high

- temperature manufacturing

processes

. 66 In addition, the industry relies heavily upon dialkyl

- and alkylarylesters of 1,2

- benzenedicarboxylic acid , commonly known as phthalate plasticizers

, to impart a range of

ben eficial properties to myriad consumer, construction and industrial goods

. 67

58 Maria Cristina Fossi et al., Are Baleen Whales Exposed to the Threat of Microplastics? A T hese compounds

Case Study of the Mediterranean Fin Whale ( Balaenoptera physalus )

, 64 M ARINE P OLLUTION
B ULL

. 2 374, 2 378 (2012)

. 59 See § I.B.2.h

, infra.

60 Giuseppe Latini et al., Phthalate Exposure and Male Infertility , 226 T OXICOLOGY 90, 90 (2006); see also § I.B. 2.i

, infra

. 61 See § I.B.2.j

, infra.

62 See § I.B.2.k

, infra.

63 40 C.F.R. § 261.11(a)(3 ).

64 Vinyl Chloride , U.S. Envtl. Prot. Agency, http://www.epa.gov/ttn/atw/hlthef/vinylchl.html (last visited July 23, 2014) ; see 40 C.F.R. pt. 261, app. VIII. EPA has also listed vinyl chloride as a drinking water contaminant and hazardous air pollutant. See List of Contaminants and their (MCLs) , U.S. Envtl. Prot. Agency, http://water.epa.gov/drink/contaminants/# L ist (last visite d May 18, 2014); see also The Original List of Hazardous Air Pollutants , U.S. Envtl. Prot. Agency, http://www.epa.gov/ttn/atw/188polls.html (last visited July 23, 2014).

65 Michael W. Allsop et al., Poly(Vinyl Chloride)

, in 28 U LLMANN ’ S E NCYCLOPEDIA OF I NDUS

. C HEMISTRY 441, 441, 442, 463 ( Electronic ed. 2012) ; see also David F. Cadogan et al.,
Plasticizers

, in 27 U LLMANN ’ S E NCYCLOPEDIA OF I NDUS

. C HEMISTRY 599

, 607 ( Electronic ed. 2012) (“ PVC would be of little use” as a commodi ty polymer “[w]ithout the wide range of additives available.”).

66 Stern et al., supra note 13 , at 755.

67 Holger M. Koch et al., Human Body Burdens of Chemicals Used in Plastic Manufacture , 364

P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2063, 2 064 (2009); Cadogan et al., supra note 65 , at 599; see also see also Chris E. Talsness et al., Components of Plastic: Experimental Studies in8 may comprise up to eighty percent of finished PVC , depending upon desir ed characteristics. 68
Despite the availability of less harmful alternatives, 69 the industry consumes over fifteen billion pounds of vinyl chloride 70 and sixteen billion pounds of phthalate plasticizers each year. 71

According to EPA

, many commercially impo rtant chemical additives, including phthalates

, “have toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life

forms.” 72 Specifically, the agency’s list of known toxic constituents includes butyl benzyl phthalate (“BBP”) , dibutyl phthalate (“DBP”) , diethyl phthalate, diethylhexyl phthalate (“DEHP”), dimethyl phthalate, and di

- n

- octyl phthalate (“DnOP”). 73 EPA has also expressed concern about diisobutyl phthalate (“DIBP”), di

- n

- pentyl phthalate, diisononyl phthalate (“DINP”) and di isodecyl phthalate (“DIDP”). 74 T hese substances are not chemically bound to

PVC and, thus, enter the environment naturally as discarded plastic s deteriorate with age

, resulting in pervasive contamination. 75 As described below, mounting scientific evidence links phthalate exposure to a broad array of health and behavioral problems among human beings and

wildlife

. 76 To prevent further harm associated with the widespread dispersal of these toxic constituents, EPA must promptly revise its regulations to ensure t he safe management of

discarded PVC.

Animals and Relevance for Human Health , 364 P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2079, 2080 (2009) (explaining that “the addition of phthalates makes brittle [PVC] soft”).

68 Mustafizur Rahman et al., The Plasticizer Market: An Assessment of Traditional Plasticizers and Research Trends to Meet New Challenges , 29 P ROGRESS IN P OLYMER S CI

. 1223, 1 231 (2004); see also Allsop et al., supra note 65 , at 442 (“Each producer makes a range of PVC polymers which vary in morphology and in molecular mass, depending on the intended end use.”).

69 Joshua Kastner et al., Aqueous Leaching of Di

- 2

- Ethylhexyl Phthalate and “Green” Plasticizers from Poly(Vinyl Chloride) , 432 S CI

. OF THE T OTAL E NV ’ T 357

, 363 (2012).

70 Paul Wesley Brandt

- Rauf et al., Plastics and Carcinogenesis: The Example of Vinyl Chloride 2, J. C ARCINOGENESIS (2 012), http://www.carcinogenesis.com/text.asp?2012/11/1/5/93700.

71 Subjankar Chatterjee et al., Removal of the Endocrine Disrupter Butyl Benzyl Phthalate from

the Environment

, 87 A PPLIED M ICROBIOLOGY AND B IOTECH

. 61, 62 (2010); Delilah Lithner et al., Leachates from Plastic Consumer Products

– Screening for Toxicity with Daphnia magna, 74

C HEMOSPHERE 1195, 1199 (2009)

. 72 40 C.F.R. § 261.11(a)(3 )

. 73 See id. pt. 261

, app. VIII; see also Cadogan et al., supra note 65 , at 600, 601 (listing phthalate plasticizers in common use).

74 See U. S. Envtl. Prot. Agency, Phthalates Action Plan 2 (2012), http://www.epa.gov/oppt/ existingchemicals/pubs/actionplans/phthalates.html.

75 Ursel Heudorf et al., Phthalates: Toxicology and Exposure , 210 I NT ’ L J. H YGIENE AND
H EALTH 623, 624 (2007).

76 See § I. B. 2

. a
, infra

.9 2

. Discarded PVC Poses Significant Hazards to Human Health and the

Environmen t

Before classifying a solid waste as hazardous, EPA must determine both that the material contains a designated toxic constituent and that its improper management could “pos[e] a substantial present or potential hazard to human health or the environment.” 77 As discussed above, the agency has acknowledged that vinyl chloride, phthalate plasticizers and additional

chemical compounds “ have toxic, carcinogenic, mutagenic [and] teratogenic effects on humans [and] other life forms.” 78 In assessing the present and potential hazards arising from the widespread use and improper disposa l of discarded PVC , EPA must consider eleven regulatory

factors , set forth below

. 79

a

. Nature of the Toxicity Presented by Constituent Chemicals The following paragraphs summarize existing scientific knowledge concerning the toxicity, persistence a nd bioaccumulation of vinyl chloride, phthalates and other

chemical additives . To reduce the serious harm to public health and the environment associated

with these toxic constituents , EPA must immediately initiate rulemaking to ensure the safe disposal of discarded PVC.

Researchers, regulators and industry representatives have long known that vinyl chloride causes cancer in laboratory animals and human beings. 80

I nadequate waste management has already contributed to the extensive chemical pollution of the marine environment. Now, mounting scientific evidence

demonstrate s that phthalate plasticizers interfere with the endocrine system, which governs the production and distribution of hormones in humans and wildlife species

. S tricter regulation of discarded PVC is necessary to minimize environmental exposure to these chem icals.

81 Aquatic organisms accumulate phthalate plasticizers directly from the surrounding water, as well as through the con sumption of contaminated food and particles, giving rise to significant concerns about far

- reaching biological consequences. 82

77 40 C.F.R. § 261.11(a)(3). R esearchers have hypothesized that endangered whales may be chronically exposed to phthalates

78 Id. ; see also § I.B. 1

, infra

. 79 40 C. F.R. § 261.11(a)(3).

80 See Mulder et al., supra note 10 , at 275

- 76; see also Sass et al., supra note 12 , at 809 (arguing

that

, although industry toxicologists had reason to know of the “deadly hazards” of vinyl chloride by 1960, manufacturers “delayed public release of [these] findings ” until 1974, when

three factory workers died from a n otherwise rare ca ncer associated with vinyl chloride

exposure ).

81 Ting Ye et al., E xposure to DEHP and MEHP from Hatching to Adulthood Causes Reproductive Dysfunction and Endocrine Disruption in Marine Medaka ( Oryzias melastigma )

, 146 A QUATIC T OXICOLOGY 115, 116 (2014); Ju

- Chan Kang et al., Anti

- Oxidative Status and Hepatic Enzymes Following Acute Administration of Diethyl Phthalate in Olive Flounder, Paralichthys olivaceus

, a Marine Culture Fish

, 73 E COTOXICOLOGY AND E NVTL

. S AFETY 1449,

1 449 (2010).

82 See, e.g. , Herman O. Sanders et al., Toxicity, Residue Dynamics, and Reproductive Effects of Phthalate Esters in Aquatic Invertebrates , 6 E NVTL

. R ES

. 84, 88 (1973) (reporting that “[i]nvertebrates exposed continuously to [phthalate esters in water rapidly accumulated total body residues many times greater than the concentrations in water”).10 as a result of plastic fragment ing estion. 83 In addition , laboratory evidence links environmentally relevant concentrations of these compounds to behavioral and developmental abnormalities in a range of aquatic species, 84 demonstrating a “concrete risk” for populations living in polluted

reg ions and threatening a cascade of effects throughout the ocean ecosystem. 85

Relative salinity may influence the toxicity of aquatic contaminants. 86 Thus, although phthalate exposure alters enzyme activity in the vital organs of certain freshwater fish, contributing to “sluggish, non

- motile behavior,” these compounds appear to produce opposite effects among some brackish species. 87 Specifically, a re cent study found that mummichogs ( Fundulus heteroclitus ) were approximately twice as likely to engage in agitated swimming patterns after brief exposure to low phthalate concentrations. 88 In addition, the contaminated

individuals exhibited altered social b ehavior, tending to shoal with relatively small fish, rather than joining similarly sized conspecifics. 89 Because shoaling helps fish to evade predation, while also minimizing competition for food, these effects have “serious negative implications” for exp osed individuals and, ultimately, may threaten population viability. 90

A considerable body of scientific literature indicates that phthalates are potent endocrine disruptors, 91 which interfere with hormone regulation and reduce reproductive success among multiple aquatic and terrestrial species, including human beings. 92

83 See Fossi et al., supra note 58 at 2 378. For example, environmentally relevant concentrations of phthalate plasticizers exert estrogenic effects in zebrafish ( Danio rerio ), quickly compromising reproductive cell development and t hereby

84 See, e.g. , Jörg Oehlmann et al., A Critical Analysis of the Biological Impacts of Plasticizers on Wildlife , 364 P HIL

. T RANSACTIONS OF THE R OYAL S OC

. B 2 047, 2 051 (2009) (“ Exposures to phthalates have ... been shown to alter behavior in fish.”) ; see also Ye, supra note 81 , at 1 1 6 (explaining that “DEHP has been extensively characterized as a developmental and reproductive toxicant in many aquatic toxicological studies,” and reviewing relevant research).

85 Oliana Carnevali et al., DEHP Impairs Zebrafish Reproduction by Affecting Critical Factor s in Oogenesis

, 5 PL O S ONE e10201, 5 (2010); Sanders et al., supra note 82 , at 89 (1973).

86 Ye, supra note 81 , at 116.

87 Nivedita Ghorpade et al., Toxicity Study of Diethyl Phthalate on Freshwater Fish Cirrhina mrigala, 53 E COTOXICOLOGY AND E NVTL

. S AFE TY 255, 258 (2002).

88 Lisa A.E. Kaplan et al., Impact of Benzyl Butyl Phthalate on Shoaling Behavior in Fundulus heteroclitus (Mummichog) Populations , 86 M ARINE E NVTL

. R ES

. 70, 74 (2013).

89 Id.

90 Id.

91 See, e.g. , D.B. Martinez

- Arguelles et al., Maternal In Utero Exposure to the Endocrine Disruptor Di

- (2

- Ehtylhexyl) Phthalate Affects the Blood Pressure of Adult Male Offspring , 266

T OXICOLOGY AND A PPLIED P HARMACOLOGY 95, 95 (2013).

92 See, e.g. , Safa Abdul

- Ghani et al., The Teratogenicity and Behavi oral Teratogenicity of Di(2

- Ethylhexyl) Phthalate (DEHP) and Di

- Butyl Phthalate (DBP) in a Chick Model , 34

N EUROTOXICOLOGY AND T ERATOLOGY 56, 60 (2012) (observing that “phthalate

- induced DNA damage [among fetal chicks was] consistent with those found in mi ce and humans”); see also Swan et al., supra note 15 , at 1060 ( “[O]ur data suggest that the end points affected by ... phthalates are quite consistent across species.”).11 impairing fecundity. 93 These results are particularly alarming because the genetic structure of zebrafish closely mirrors that of human beings. 94 Similarly, low phthalate doses, corresponding to observed levels of human exposure, 95 lead to abnormal s exual differentiation in laboratory

animals when administered during the “sensitive window” of fetal development. 96 Among male offspring, prenatal phthalate contamination causes genital malformations, including undescended testicles and urethra displacemen t, impaired sperm production and significantly reduced testosterone levels, which persist into adulthood. 97 Exposed females may experience excessive breast tissue growth and altered fertility cycles, in addition to various reproductive organ

abnormalities

. 98 Recent laboratory studies demonstrate that phthalate metabolites induce similar or more severe effects among marine animals 99 and rodents. 100

In the United States and other industrialized nations, human exposure to multiple phthalate plasticizers is “vi rtually universal,” 101 beginning in the womb 102

93 Bruna Corradetti et al., Bis

- (2

- Ethylexhyl) Phthalate Impairs Spermatogenesis in Zebrafish ( Danio rerio )

, 13 R EPROD

. B IOLOGY 195, 200 (2013); Carnevali et al., supra note 85, at 5; cf. Sanders, supra note 82 , at 88 (concluding that chronic exposure to low phthalates concentrations significantly reduces rates of reproduction among ecologically important aquatic invertebrates). and continuing

94 Carnevali et al., supra note 85, at 2.

95 See Martinez

- Arguelles et al., supra note 91 , at 98.

96 D.B. Martinez

- Arguelles et al., Fetal Origin of Endocrine Dysfunction in the Adult: The

Phthalate Model

, 137 J. OF S TEROID B IOCHEMISTRY & M OLECULAR B IOLOGY 5, 8 (2013) [ hereinafter Fetal Origin ] ; Jane Fisher, Environmental Anti

- Androgens and Male Reproductive Health: Focus on Phthalates and Testicular Dysgenesis Syndrome , 127 R EPROD

. 302, 305

- 06 (2004); see also Takashi Tanida et al., Fetal and Neonatal Exposure to Three Typical

Enviro nmental Chemicals with Different Mechanisms of Action: Mixed Exposure to Phenol, Phthalate, and Dioxin Cancels the Effects of Sole Exposure on Mouse Midbrain Dopaminergic

Nuclei

, 189 T OXICOLOGY L ETTERS 40, 40 (2009) (reporting that “pre

- and neonatal expos ure to [endocrine disruptors] can disturb development even though the amounts of exposure are lower

than the no

- observed

- adverse

- effect level determined by toxicological tests using adult animals”).

97 Fetal Origin

, supra note 96

, at 8; Hanne Frederiksen et al., Metabolism of Phthalates in

Humans , 51 M OLECULAR N UTRITION & F OOD R ES

. 899, 905 (2007); Latini et al., supra note 60

, at 93.

98 Fetal Origin

, supra note 92, at 12.

99 Ye, supra note 81 , at 125.

100 See Martinez

- Arguelles et al., supra note 91 , at 95.

101 S.H. Swan et al., Prenatal Phthalate Exposure and Reduced Masculine Play in Boys , 33 I NT ’ L
J. OF A NDROLOGY 259, 2 (2010) [ hereinafter Masculine Play ] ; Kembra L. Howdeshell et al., Mechanisms of Action of Phthalate Esters, Individually and in Combination, to Induce Abnormal Reproductive Development in Male Laboratory Rats , 108 E NVTL

. R ES

. 168 , 16 9 (2008)

. 102 Frederiksen et al., supra note 97 , at 906; see also Martinez

- Arguelles et al., supra note 91 , at 95 (explaining that phthalates and their metabolites are present in amniotic fluid, umbilical cord blood and breast milk).12 throughout life,

and obesity, 103 thereby raising concerns about negative health consequences at every age. 104
For example, experimental and epidemiological evidence demonstrates that low levels of prenatal phthalate exposure influence fetal hormone regulation, resulting in abnormal development of the brain 105 and reproductive organs. 106 Additional adverse effects, such as

altered gender

- specific play behaviors 107 and the potential for increased susceptibility to drug

addi c tion, may become apparent only later in life. 108 Ingestion of contaminated breast milk interferes with androgenic hormone production in male infants, potentially affecting sexual development, 109 and childhood exposure may contribute to rising rates of attention deficit hyperactivity disorder, 110 asthma 111 113 as well as premature breast development in girl s. 114 These results are consistent with laboratory data indicat ing that low doses of DEHP, including levels not previously associated with any adverse effect, “irreversibly” disturb brain development among fetal mice, subsequently inducing hyperactivity. 115

103 Phthalates Factsheet

, C TRS

. F OR D ISEASE C ONTROL AND P REVENTION (July 16, 2013), http://www.cdc.gov/biomonitoring/phthalates_f actsheet.html (confirming that phthalate contamination is widespread among all age groups). Among adult men,

104 See, e.g.

, Richard W. Stahlhut et al., Concentrations of Urinary Phthalate Metabolites Are Associated with Increased Waist Circumference and Insulin Resistant in Adult U.S. Males, 115

E NVTL

. H EALTH P ERSP

. 876, 880 (2007) (explaining that phthalate exposure might affect different segments of the population differently).

105 R. Hokanson et al., DEHP, Bis(2)

- Ethylhexyl Phthalate, Alters Gene Expressive in Human

C ells: Possible Correlation with Initiation of Fetal Developmental Abnormalities , 25 H UMAN &

E XPERIMENTAL T OXICOLOGY 687, 694 (2006).

106 Y. Suzuki et al., Foetal Exposure to Phthalate Esters and Anogenital Distance in Male

Newborns , 34 I NT ’ L J

. OF A NDROLOGY 236, 243 (2012); Swan, supra note 15 , at 1 061

. 107 Masculine Play

, supra note 101

, at 8.

108 See Douglas C. Jones, The Effects of Environmental Neurotoxicants on the Dopaminergic System: A Possible Role in Drug Addiction , 76 B IOCHEMICAL P HARMACOLOGY 569, 576 (2008) ( explaining that “exposure to environmental estrogens during development can impact adult behaviors and sensitivity to the rewarding effects of drug abuse”).

109 Katharina M. Main et al., Human Breast Milk Contamination with Phthalates and Altera tions of Endogenous Reproductive Hormones in Infants Three Months of Age , 114 E NVTL

. H EALTH
P ERSP

. 270, 272

- 73 (2006).

110 Bung

- Nyun Kim et al., Phthalates Exposure and Attention

- Deficit/Hyperactivity Disorder in

School

- Age Children , 66 B IOLOGICAL P SYCHIATRY 958, 960

- 61 (2009).

111 Barbara Kolarik et al., The Association Between Phthalates in Dust and Allergic Diseases Among Bulgarian Children , 116 E NVTL

. H EALTH P ERSP

. 98, 102 (2008).

113 Susan L. Teitelbaum et al., Associations Between Phthalate Metabolite Urinary Concentrations and Body Size Measures in New York City Children , 112 E NVTL

. R ES

. 186, 189 (2012).

114 Ivelisse Col ό n, Identification of Phthalate Esters in the Serum of Young Puerto Rican Girls with Premature Breast Development

, 108 E NVTL

. H EALTH P ERSP

. 895, 899 (2000).

115 Tanida et al., supra note 96 , at 45; cf. Martine Culty et al., In Utero Exposure to Di

- (2

- Ethylhexyl) Phthalate Exerts Both Short

- Term and Long

- Lasting Suppressive Effects on

Testosterone Production in the Rat , 78 B IOLOGY OF R EPROD

. 1018, 1025 (2008) (reporting that13 urinary concentrations of phthalate plasticizers correlate with poor semen quality, 116 abdominal obesity and insulin resistance. 117 Exposed women may be more likely to suffer pregnancy complications 118 and contract diabetes. 119 In addition, s cientific studies indicate that phthalate plasticizers may exert carcinogenic effects in the liver and other organs. 120

b

. Concentration of Toxic Constituents in Discarded PVC In light of well

established scientific evidence concerning the toxicity of discarded PVC , vinyl chloride and

associated che mical additives , we ur ge EPA to take prompt action to ensure the safe disposal of

this material.

Discarded PVC contain s substantial concentrations of vinyl chloride and phthalate plasticizers , thus illustrating the need for more protective regulations

. As a whole , the PVC industry consumes over 98 percent of global vinyl chloride production and at least 90 percent of phthalate output worldwide

, 121 which respectively exceed 16 and 18 billion pounds each year. 122
These substances are essential components of a wide variety of goods, ranging from artificial leather and traffic cones to plastic bags, children’s toys and construction supplies. 123 Depending on desired characteristics, p hthalate plasticizers may constitute up to 80 percent of finished PVC products, thereby posing significant risks to human health and the environment. 124

“behavioral and other deficits ... might occur during early de velopment if the brain is not exposed to adequate androgen levels”). For example, over a decade ago, the American Medical Associatio n warned that PVC treatment devices

116 Russ Hauser et al., Altered Semen Quality in Relation to Urinary Concentrations of Phthalate

Monoester and Oxidative Metabolites , 17 E PIDEMIOLOGY 682, 687 (2006); Susan M. Duty et al., Phthalate Exposure and Human Semen Parameters , 14 E PIDEMIOLOGY 269, 274 (2003).

117 Stahlhut et al., supra note 104 , at 800.

118 Fetal Origin

, supra note 96

, at 12.

119 Katherine Svensson et al., Phthalate Exposure Associated with Self

- Reported Diabetes Among Mexican Women , 111 E NVTL

. R ES

. 792, 795 (2011).

120 Ivan Rusyn, Mechanistic Considerations for Human Relevance of Cancer Hazard of Di(2

- Ethylhexyl) Phthalate , 750 M UTATION R ES

. 141, 154 (2012).

121 Brandt

- Rauf et al., supra note 70 , at 2; Lithner et al., supra note 71 , at 1 199 ; cf. Sass et al.,

supra note 12 , at 809 (reporting that “[v]inyl chloride ... is manufactured exclusively for polymerization into [PVC]”).

122 Brandt

- Rauf et al., supra note 70 , at 2; Chatterjee et al., supra note 71 , at 62.

123 Chatterjee et al., supra note 71 , at 62 ; Ctrs. for Disease Control and Prevention, Dep’t of Health and Human Servs., Fourth National Report on Human Exposure to Environmental

Chemicals 258 (2009); T.J. Wams, Diethylhexylphthalate as an Environmental Contaminant: A

Review , 66 S CI

. OF THE T OTAL E NV ’ T 1, 2 (1987).

124 See, e.g. , Rahman et al., supra note 68 , at 1 231 (explaining that certain medical plastics, such as dialysis tubing, contain as much as 80 percent DEHP by weight); San Francisco Dept. of the Env’t, Detailed Results of Phthalate Testing in Children’s Toys 2 (2008), http://www. sfenvironment.org/sites/ default/files/fliers/files/sfe_th_phthalate_testing_in_toys_detailed_result s.pdf (presenting test results indicating that phthalate plasticizers comprise over 77 percent of certain children’s toys).14 expose critically ill infants to levels of DEHP likely to impair reproductive development. 125 In addition, scientific research demonstrates that a number of PVC consumer products, including bath toys and inflatable swim r ings, release phthalate plasticizers and ot her chemical additives to

water in concentrations which may produce acutely toxic effects. 126 EPA itself has acknowledged that DEHP is a “probable human carcinogen.” 127

Despite these risks, existing regulations fa il to ensure the safe disposal of discarded PVC. For instance, a lthough the construction sector accounts for approximately one

- half of PVC

demand 128 and one

- third of national DEHP consumption, 129 an EPA guidance document identifies most industry waste as nonhazardous, and fails to include any instructions for the proper management of discarded PVC. 130

c

. Migration P otential Stricter regulation is necessary to minimize the potential for additional harm.

Because vinyl chloride, phthalate plasticizers and other chemical additives migrate into the environment as discarded PVC deteriorates with age, EPA must immediately impose additional regulations to protect human health and the environment from f urther chemical

contamination. As the agency has explained

, any waste that includes a toxic constituent is “presum[ptively]” hazardous. 131 Indeed, with respect to discarded materials containing vinyl

chloride and other drinking water contaminants, such as barium, cadmium, DEHP and lead

, 132
EPA “treat[s] ... factors such as migration potential as essentially mitigating considerations

which might render the waste non

- hazardous .” 133

In the present situation, a review of existing scientific literature clearly supports the

stricter regulation of discarded PVC. R ecent scientific evidence demonstrates that PVC pipe, which constitutes a growing percentage of the nation’s water system, leaches increasing concentrations of vinyl chloride and other chemical compounds during use and after dis posal. 134

125 Am. Med. Ass’n, DEHP Use in Neonatal Intensive Care Uni ts (2001), Health Care Without Harm, http://noharm.org/lib/downloads/pvc/PVC_Stmt_AMA_12

- 01.pdf.

126 Lithner, supra note 71 , at 1199.

127 Di(2

- Ethylhexyl) Phthalate (DEHP) , U.S. Envtl. Prot. Agency, http://www.epa.gov/iris/subst/

0014.htm.

128 Bidoki, supra note 17 , at 220.

129 S. Magdouli, Di 2

- Ethylhexylphtalate in the Aquatic and Terrestrial Environment: A Critical

Review , 127 J. OF E NVTL

. M GMT

. 36, 39 (2013).

130 See generally Office of Solid Waste and Emergency Response, U.S. Envtl. Prot. Agency, RCRA in Focus: Construction, Demolition, and Renovation (2004).

131 See Identification and Listing of Hazardous Waste, 45 Fed. Reg. 33,084, 33,107 (May 19, 1980).

132 See List of Contaminants and their (MCLs) , U.S. Envtl. Prot. Agency, http://water.epa.gov/

drink/contaminants/# List (last visited May 18, 2014).

133 Identification and Listing of Hazardous Waste, 45 Fed. Reg. at 33,107 (emphasis added).

134 Ryan K. Walter et al., Investigation of Factors Affecting the Accumulation of Vinyl Chloride in Polyvin yl Chloride Piping Used in Drinking Water Distribution Systems , 45 W ATER R ES

. 2607, 2614 (2011); Stern et al., supra note 13 , at 755, 758, 761 ; see also L. Zhang et al., Investigation of Organic Compounds Migration from Polymeric Pipes into Drinking Water15 The rate of accumulation varies significantly according to the conditions of use , as well as the age, origin and manufacturer of the pipe

. 135 For example, “early era” pipes , which were built

before 1977 and remain in use today

, may be especially likely to r elease dangerous quantities of vinyl chloride

. 136 Moreover, as described above

, 137 p hthalate plasticizers are not chemically bound to the plastic matrix and thus “leach, migrate or evaporate” into surrounding media and the atmosphere even under ideal conditions, 138 resulting in pervasive contamination. 139 H igh concentrations of these compounds seep into soil and groundwater following conventional landfill disposal, 140 ultimately collecting in aquatic ecosystems and entering marine food

webs. 141

Under Long Retention Times , 70 P ROCEDIA E NGINEERING 1753, 1754 (2014) (reporting that “the main leachates from PVC pipe are metal stabilizers like lead, tin, barium, [and] calcium

... , vinyl chloride monomers

... and other contaminants related with plastici zers, antioxidants and lubricants commonly used in pipe manufacturing processes ”); see also M.R. Lasheen et al., Factors Influencing Lead and Iron Release from Some Egyptian Drinking Water Pipes , 160 J. OF
H AZARDOUS M ATERIALS 675, 676 (2008) ( finding that PVC pipes release more lead than other common varieties)

. As a result of their wide spread use and significant tendency to migrate , phthalates are

135 Walter et al., supra note 134 , at 2614; Stern et al., supra note 13 , at 758.

136 Stern et al., supra note 13 , at 758, 761.

137 See § 1.B.1, supra

. 138 Heudorf et al., supra note 75 , at 624 ; see also Yvonne R. Shashoua, Effect of Indoor Climate on the rate and Degradation Mechanism of Plasticized Poly (Vinyl Chloride) , 81 P OLYMER
D EGRADATION AND S USTAINABILITY 29, 29 (2003) (reporting that “[i]n many international museum collections, degradation o f plasticized PVC materials ... has been detected as early as 5 years after acquisition,” and concluding that “[t]he rate and extent of deterioration of plasticized PVC and the migration and loss of DEHP plasticizer [are] related”).

139 See, e.g. , Fossi et al., supra note 58 , at 2 375 ( “[Phthalates] are not covalently bound to plastic and migrate from the products to the environment, thus becoming ubiquitous contaminants.”);

see also Kaplan et al., supra note 88, at 71 (reporting that “[p]hthalates have been detected in all aspects of the environmental [sic]: water, air, sediment, biota, marine, and freshwater ecosystems”); see also M. Abdel daiem et al., Environmental Impact of Phthalic Acid Esters and their Removal form Water and Sediments by Diff erent Technologies

– A Review

, 109 J. OF
E NVTL

. M GMT

. 164, 167 (2012) 167 (explaining that “the slow release of phthalates from plastics and other phthalate containing materials due to weathering” accounts for much of the presence of these compo unds in the environment).

140 Abdel daiem et al., supra note 139, at 165, 168; see also Chatterjee et al., supra note 71 , at 68 (“Appreciable amounts of phthalates have been detected in liquid samples withdrawn from

landfills and in landfill leachates .”) ; see also Emma L. Teuten et al., Transport and Release of Chemicals from Plastics to the Environment and Wildlife , 364 P HIL

. T RANSACTIONS OF THE
R OYAL S OC

. B 2027, 2028 (2009) (reporting that discarded PVC and other plastics waste release phthalate plasticizers “after their disposal, for example in landfills”).

141 Depledge et al., supra note 20 , at 280 ; see also Zhang Cheng et al., Risk Assessments of Human Exposure to Bioaccessible Phthalate Esters through Market Fish Consumption

, 57

- 58

E NVT

. I NT ’ L 75, 75 (2013) (“Human exposure to phthalate ester mainly occurs through dietary intake, due [in part] to the bioaccumulation of phthalate esters in food chains.”).16 the most abundant anthropogenic chemicals in the environment. 142

d

. Persistence To reduce the need for future corrective action, we urge EPA to promptly revise its regulations so as to ensure the safe disposal

of discarded PVC.

The environmental persistence of phthalate plasticizers indicates the urgent need for more protective regulation. By definition, persistent pollutants resist physical, chemical and biological degradation, t hus remaining in the environment for years. Multiple researchers have acknowledged the persistent nature of phthalate plasticizers, 143 and the widespread occurrence of these compounds clearly demonstrates that their massive rate of synthesis outpaces natural removal processes. 144 For example, DEHP is abundant in surface waters, despite its medium

specific half

- life of fewer than five weeks. 145 Further, a s a consequence of its “highly hydrophobic” character, this compound also tends to form strong bonds w ith suspended particulates and ultimately accumulates in aquatic sediments, where estimates indicate it will persist for more than 100 years. 146

e

. Degradatio n Potential and Rate of Degradation T he environmental ubiquity of phthalate plasticizers serves both to reflect the extensive production of these co mpounds

, and to demonstrate their resistance to degradation. Because existing levels phthalate contamination will continue to threaten humans and wildlife species indefinitely, EPA must promptly take action to minimize future

exposure.

An examination of the process by which phthalate plasticizers degrade clearly demonstrates the need for stricter regulation. As discussed above, 147

142 Susan Jobling et al., A Variety of Environmentally Persistent Chemicals, Including Some Phthalate Plasticizers, Are Weakly Estrogenic , 103 E NVTL

. H EALTH P ERSP

. 582, 58 5 (1995)

. these compounds are ubiquitous in the environment. Once released from di scarded PVC, phthalate s resist physical

143 See , e.g. , Abdel daiem et al., supra note 139, at 166 (listing phthalates among “persis tent toxic organic compounds”); see also Walter Klöpffer, Environmental Hazard Assessment of Chemicals and Products. Part V. Anthropogenic Chemicals in Sewage Sludge, 33 C HEMOSPHERE 1067, 1072 (1996) (arguing that D EHP “should be considered as a persistent chemical,” because

“it is not de graded in anaerobic media”); see also Jobling et al., supra note 142

, at 582 (describing phthalate plasticizers as “environmentally persistent chemicals”)

. 144 Rishikesh Mankidy et al., Biological Impact of Phthalates , 217 T OXICOLOGY L ETTERS 50, 56 (2013).

145 B. Migliarini et al., Perspectives on Endocrine Disruptor Effects on Metabolic Sensors

, 170

G EN

. AND C OMPARATIVE E NDOCRINOLOGY 416, 417 (2011); see also Magdouli, supra note 129

, at 42 (observing that “[t]he abundance of DEHP in [the] aqueous environment is mainly related to its extensive utilization and production” because, “[d]ue to its highly hydrophobic properties, the principal fate of DEHP in water and wast ewater could be adsorption to the suspended solids”).

146 Migliarini et al., supra note 145 , at 417.

147 See § I.B. 2.c

, supra.17 and chemical degradation

. 148 S cientists have long recognized that the biological transformation of phthalate plasticizers “comes to a standstill” under anaerobic conditions , such as those found in deep soils, aquatic sediments, and most landfills. 149 In aerobic environments, the partial degradation of these chemicals yields metabolites that are more harmful than the original plasticizers , including 2

- ethylhexanoic acid, 2

- ethylhexanal and 2

- ethylhexanol

. 150 Field studies have detected these acutely toxic metabolites in surface waters, river sediment, freshly fallen snow and even tap water, giving rise to significant concern about potential consequences for

human health and the environment. 151

f

. Bioaccumulation

Scientific evidence clearly shows that phthalate plasticizers concentrate in animal tissues and vegetable matter, posing a significant threat to human and ecosystem health. Fish and other aquatic organisms accumulate phthalates directly from the environment and as a consequence of ingesting contaminated food and particles. 152 For example, scientific evidence indicates that certain microscopic plastic fragments enter the marine food web by adhering to algae. 153 In addition, studies have documented plastic consumption a mong vertebrates and invertebrates from every feeding guild, 154 ranging from zooplankton 155 to large, predatory sharks 156 and endangered sperm whales ( Physeter macrocephalus ). 157

148 Wams, supra note 123, at 1; see also, e.g. , Magdouli et al., supra note 129 , at 42 (reporting

that the half

- life of DEHP under sunlight irradiation in aquatic environments may exceed four years). Nearly a decade ago, researchers found that over 97 percent of dead and injured Lays an Albatross ( Phoebastria immutabilis ) chicks contained plastics, and concluded that the incidence and quantity of ingestion was likely

149 Wams, supra note 123 , at 6.

150 Owen Horn et al., Plasticizer Metabolites in the Environment

, 38 W ATER R ES

. 3693 , 3695 (2 004); Sandro Nalli et al., Metabolites from the Degradation of Di

- Ester Plasticizers by Rhodococcus rhodochrous, 366 S CI

. OF THE T OTAL E NV ’ T 286, 293 (2006).

151 Horn et al., supra note 150 , at 3695 ; see S. Barnabé et al., Plasticizers and Their Degradation Products in the Process Streams of a Large Urban Physicochemical Sewage Treatment Plant , 42

W ATER R ES

. 153, 154 (2008) (summarizing existing data).

152 See, e.g.

, Wen

- Xiong Wang et al., Dioxin and Phthalate Uptake and Assimilation by the

Green Mussel Perna viridis, 178 E NVTL

. P OLLUTION 455, 461 (2013).

153 Priyanka Bhattacharya et al., Physical Adsorption of Charged Plastic Nanoparticles Affects Algal Photosynthesis , 114 J. OF P HYSICAL C HEMISTRY C 16,556, 16,558

- 60 (2010).

154 Juliana A. Ivar do Sul et al., Pelagic Microplastics Around an Archipelago of the Equatorial

Atlantic

, 75 M ARINE P OLLUTION B ULL

. 305, 305 (2013).

155 See, e.g. , Matthew Cole et al., Microplastic Ingestion by Zooplankton , 47 E NVTL

. S CI

. &

T ECH

. 6646, 6 647 (2013); see also Outi Setälä et al., Ingestion and Transfer of Microplastics in

the Planktonic Food Web

, 185 E NVTL

. P OLLUTION 77, 80 (2014)

. 156 Henry S. Carson, The Incidence of Plastic Ingestion by Fishes: From the Prey’s Perspective

, 74 M ARINE P OLLUTION B ULL

. 170, 173 (2013).

157 Jeff K. Jacobsen et al., Fatal Ingestion of Floating Net Debris by Two Sperm Whales ( Physeter macrocephalus )

, 60 M ARINE P OLLUTION B ULL

. 765, 766 (2010) ; see also 50 C.F.R. § 17.11 (listing P. macr ocephalus as endangered under the Endangered Species Act, 16 U.S.C. §§

1531 et seq .).18 increasing. 158 Although most organisms seem to mistake plastic debris for natural prey or passively ingest particles duri ng normal feeding behavior, 159 certain species preferentially consume PVC and other plastic waste. 160

Once ingested by lower trophic organisms, plastic fragments and associated chemical additives pass to aquatic predators, ultimately affecting commerciall y

- harvested fish and endangering human health. Scientific evidence demonstrates that ingested plastics can remain in an organism’s body for weeks, accumulating in the digestive tract or translocating to the circulatory system, thereby facilitating trophic transfer and increasing the risk that phthalate s and

other toxic chemicals will migrate into the organism’s tissues

. 161 Indeed, a recent study

demonstrated that shore crabs ( Carcinus maenas ) ingest and retain plastic fragments originally consumed by prey. 162 Moreover, n ew experimental evidence confirms what scientists have long suspected : additive chemicals transfer from plastics to organisms following ingestion. 163

158 Heidi J. Auman et al., Plastic Ingestion by Laysan Albatross Chicks on Sand Island, Midway Atoll, in 1994 and 1995

, in A LBATROSS B IOLOGY AND C ONSERVATION 239, 240, 243 (G. Robinson et al. eds., 1997). These

159 Stephanie L. Wright et al., The Physical Impacts of Microplastics on Marine Organisms: A

Review

, 178 E NVTL

. P OLLUTION 483, 484 (2013).

160 Erin R. Graham et al., Deposit

- and Suspension

- Feeding Sea Cucumbers (Echinodermata ) Ingest Plastic Fragments

, 368 J. OF E XPERIMENTAL M ARINE B IOLOGY AND E COLOGY 22, 25, 27, 28 (2009).

161 See, e.g. , Mark A

. Browne et al., Ingested Microscopic Plastic Translocates to the Circulatory System of the Mussel, Mytilus edulis ( L. ), 42 E NVTL

. S CI

. AND T ECH

. 5026, 5 028 (2008) (noting that “particles of plastic have been shown to accumulate in the gut cavity of birds,

fi sh, and polychaete worms,” and reporting data indicating that plastic particles “translocated from gut cavity [of m ussels] to the circulatory system in as little as 3 days and persisted in the circulatory system for over 48 days”).

162 Paul Farrell et al., Trophic Level Transfer of Microplastic: Mytilus edulis ( L. ) to Carcinus

maenas (L. ), 17 E NVTL

. P OLLUTION 1, 3 (201 3); see also Fiona Murray et al., Plastic Contamination in the Decapod Crustacean Nephrops norvegicus (Linnaeus, 1758) , 62 M ARINE
P OLLUTION B ULL

. 1207, 1212 (2011) (reporting that commercially

- harvested Norway lobsters ( Nephrops norvegicus ) accumulated plastic transported by prey items).

163 See Radwa A. Barakat et al., Early Investigation of Hepatocarcinogenic Effect of Polyvinyl

Chloride in Rat , 12 G LOBAL V ETERINARIA 67, 72 (2014) (finding that , after consuming PVC, rats exhibit symptoms similar to those associated with direct exposure to vinyl chloride); see also Mark Anthony Browne et al., Microplastic Moves Pollutants and Additives to Worms, Reducing Functions Linked to Health and Biodiversity

, 23 C U RRENT B IOLOGY 2388, 2390 (2013) (presenting “the first suitably controlled experimental evidence showing that eating of plastics can move pollutants and additives into the tissues of animals” ); see also Cole et al., supra note
155 , at 6 653 (reporting that “[t]he leaching of additives and disassociation of toxic chemicals
post

- ingestion has been modeled in polychaete worms and demonstrated in streaked shearwaters”) ; see also Chelsea M. Rochman et al., Ingested Plastic Transfers Hazardous Chemicals to Fish and Induces Hepatic Stress , 3 S CI

. R EP

. 3263, 5 (2013) (finding that fish absorb chemical constituents and other pollutants from ingested plastic debris); see also Michael O. Gaylor et al., House Crickets Can Accumulate Pol ybrominated Diphenyl Ethers (PBDEs) Directly from Polyurethane Foam Common in Consumer Products

, 86 C HEMOSPHERE 500, 50419 data bolster field observations indicating that fish, 164 seabirds 165 and endangered fin whal es ( Balaenoptera physalus ) 166 accumulate contaminants, including phthalate plasticizers

, as a result of exposure to plastic debris . Thus, scientific evidence strongly indicates that the consumption

of PVC and other plastic waste constitutes an important vec tor of chemical additives into the

marine food web

. 167

After dissociating from PVC, phthalates accumulate in the tissues of aquatic organisms, 168 including those targeted by commercial fisheries. 169 Scientific evidence indicates that humans acquire these chemi cals primarily as a result of dietary exposure, 170

(2012) ( concluding that soil

- dwelling insects may “accumulate appreciable .. burdens” of additive chemicals as a result of plastic inge stion). including the

164 Chelsea M. Rochman et al., Polybrominated Diphenyl Ethers (PBDEs) in Fish Tissue May Be an Indicator of Plastic Contamination in Marine Habitats

, 476

- 77 S CI

. OF THE T OTAL E NV ’ T 622, 623 (2014).

165 Kosuke Tanaka et al., Accumulation of Plastic

- Deri ved Chemicals in Tissues of Seabirds Ingesting Marine Plastics

, 69 M ARINE P OLLUTION B ULL

. 219, 221 (2013)

. 166 Fossi, supra note 58 , at 2 378; see also 50 C.F.R. § 17.11 (listing B. physalus as endangered under the Endangered Species Act, 16 U.S.C. §§ 1531 et seq .).

167 Because many plastic additives are ubiquitous in the environment, scientists have struggled to establish that the bioaccumulation of these substances results from ingestion, rather than some other form of exposure. See, e.g. , Rochman et al., supra note 164 , at 632. Despite the surprising lack of data, experts have hypothesized that plastic consumption spreads chemical contamination throughout the food web. See, e.g.

, id. (concluding that existing evidence “suggests that the ingestion of plastic debri s may be an important mechanism for the bioaccumulation of hazardous chemicals in wildlife”); see also Galgani et al., supra note 7

, at 1 057 (“Ingestion of microplastic material ... presents a route by which chemicals could pass from plastics into the food chain.”);

see also Peter Davison et al., Plastic Ingestion by Mesopelagic Fishes in the North Pacific Subtropical Gyre

, 432 M ARINE E COLOGY P ROGRESS S ERIES 173, 173 (2011) (“[ Ingestion of plastic by fishes may] serve as a point of entry of plastic

- associate d toxins into the food chain.”);

see also Barnes et al., supra note 5 , at 1995 (“Small and microscopic plastic fragments present a likely route for the transfer of [additive] chemicals.”).

168 See, e.g. , A. Dick Vethaak et al., An Integrated Assessment of Estrogenic Contamination and Biological Effects in the Aquatic Environment of The Netherlands

, 59 C HEMOSPHERE 511, 516 (2009) ( detecting nine phthalates and other endocrine

- disrupting chemicals in the muscle tissue

of wild

- caught bream ( Abramis brama ) and European flounder ( Platichthys flesus )).

169 See generally Davison et al.

, supra note 167 , at 173 (observing that “[m]any commercially harvested fish feed at a high trophic level and may be subject to biomagnification of the toxins ingested by their prey” ); see also Chatterjee, supra note 71 , at 62 (“[Certain phthalates] can

accumulate in the food chain via biomagnifications as one organism consumes food lower in the food chain and is subsequently consumed by an organisms higher in the food chain; humans are generally at the top of such chains and this increases their exposure.”).

170 See, e.g. , Giuseppe Latini et al., Plasticizers, Infant Nutrition and Reproductive Health , 19

R EPRODUCTIVE T OXICOLOGY 27, 28 (2004) ( explaining that dietary exposure is the main source of DEHP contamination among the general population) ; see also Leonardo Trasande et al., Phthalates and the Diets of US Children and Adolescents , 126 E NVTL

. R ES

. 84, 84 (2013)20 consumption of contaminated fish and seafood. 171 A recent analysis of marine and freshwater fish purchased from Hong Kong markets detected multiple phthalates in each sample, raising

concerns th at fish

- heavy diets might lead to an increased incidence of cancer. 172 Similarly , in a study evaluating infertile men, researchers determined that phthalate concentrations were highest among regular fish

- eaters, regardless of other lifestyle factors. 173 Scientific research reveals that phthalates also accumulate in terrestrial ecosystems, 174 contributing to the contamination of fruit, vegetables

, meat, poultry, eggs and dairy products. 175 In addressing the dangers associated with

the bioaccumulation of PVC

- d erived chemicals, EPA must account for all sources of human

exposure 176 and consider the additive , synergistic and multiplicative toxic effects of other pervasive pollutants. 177

g

. Plausible Improper Management

As this petition explains, the mismanagement of discarded PVC is not only “ plausible

, ” but typical . Accordingly, this factor strongly supports the issuance of more protective regulations. In evaluating the risks associated with the plausible mismanagement of a potentially hazardous waste, EPA considers whether improper disposal could result in a “substantial hazard”

to human health or the environment. 178

(“[D]ietary intake from contaminated food is the largest con tributor of [DEHP] exposure in children.”). T he agency will consider the possibility of harm even if

171 Cheng et al.

, supra note 141 , at 78

. 172 Id. at 79.

173 Roya Rozati et al., Role of Environmental Estrogens in the Deterioration of Male Factor Fertility

, 78 F ERTILITY AND S TERILITY 1187, 1191 (2002).

174 See, e.g. , Abdel daiem et al., supra note 139 , at 166 (observing that “[t]he use of sewage sludge in agriculture ... poses a growing threat to ecosystems and human health,” because it introduces phthalates into the food chain).

175 See generally Justin A. Colaci no et al., Dietary Intake is Associated with Phthalate Body Burden in a Nationally Representative Sample

, 118 E NVT L

. H EALTH P ERSP

. 998, 1002 (2010) (assessing the contribution of various foods to phthalate exposure); see also T. Fierens et al., Phthalates in Belgian Cow’s Milk and the Role of Feed and Other Contamination Pathways at

Farm Level

, 50 F OOD AND C HEMICAL T OXICOLOGY 2945, 2 950 (2012) (explaining that phthalates present in raw cow’s milk might derive from contaminated feed, including pas ture plants); see also Ce

- Hui Mo et al., Polycyclic Aromatic Hydrocarbons and Phthalic Acid Esters in Vegetables from Nine Farms of the Pearl River Delta, South China

, 56 A RCHIVES OF E NVTL

. C ONTAMINATION AND T OXICOLOGY 181, 186

- 87 (2009) ( explaining that v egetables accumulate phthalates “from soil

- to

- root transfer and subsequently root

- to

- shoot translocation”).

176 See, e.g. , Matthias Wormuth et al., What are the Sources of Exposure to Eight Frequently Used Phthalic Acid Esters in Europeans? , 26 R ISK A NALYSIS 803, 816 (2006) (analyzing various “oral, dermal, and inhalation pathways causing consumer exposure to phthalates”).

177 See Colacino, supra note 175 , at 1002; see also José G. D ό rea, Persistent, Bioaccumulative

and Toxic Substances in Fish: Human Healt h Considerations

, 400 S CI

. OF THE T OTAL E NV ’ T 93,

94 (2008) ( explaining that “human exposure to pollutants, when consuming fish or seafood, is rarely limited to a single chemical, especially when consuming large predatory species coming

from a marine envir onment”).

178 Identification and Listing of Hazardous Waste, 45 Fed. Reg. 33,084, 33,113 (May 19, 1980).21 “most or all generators ... dispose of [a given] waste properly.” 179 Moreover, t he presen ce of potential carcinogens or “significant concentrations” of other toxic constituents give rise to a presumption in favor of listing. 180 In certain situations, “actual damage incidents involving the waste or waste constituents demonstrate empirically that waste constituents may migrate, persist, and cause substantial harm if mismanaged,” thus eliminating the need for this theoretical analysis. 181

As described below, existing environmental regulations are inadequate to ensure the safe disposal of discarded PVC. 182 Experts attribute a large portion of marine plastic pollution to flawed waste management techniques, 183 including the careless transport and improper burial of plastic trash. 184 Similarly, scientific evidence indicates that phthalate plastici zers may percolate into groundwater through poorly lined landfills or enter the atmosphere as a consequence of PVC incineration, resulting in widespread contamination. 185 Indeed, “virtually universal” human exposure may already have contributed to a variety of public health crises, 186 including the increased incidence of obesity 187 and declining fertility rates throughout the Western world. 188

h

. Quantities of Waste Generated Because the improper management of discarded PVC continues to damage human health and the environment, EPA must promptly r egulate this waste as hazardous.

The vast quantities of PVC fabricated and discarded each year demonstrate the need for an improved management regime

. Despite slow economic growth, United States manufacturers produc ed over 100 billion pounds of plastics in 2013, including nearly 15.5 billion pounds of

PVC 189 and approximately 4.7 billion pounds of associated DEHP

. 190 Experts expect these totals to increase in coming years, as “the surge in unconventional oil and gas development” lowers production costs, and the continued recovery of the construction industry and other important

markets gives rise to increasing demand. 191

179 Id. ; but see Dithiocarbamate Task Force v. U.S. Envtl. Prot. Agency, 98 F.3d 1394, 1401 (D.C. Cir. 1996) (concluding that “simple accidents” do not con stitute plausible mismanagement). According to EPA, PVC is “not widely recycled in

180 Identification and Listing of Hazardous Waste, 45 Fed. Reg. at 33,113.

181 Id.

182 See §§ I.B.2.j, infra

. 183 National Oceanic and Atmospheric Administration, I NTERAGENCY R EPORT ON M ARINE
D EBRIS S OURCES

, I MPACTS

, S TRATEGIES & R ECOMMENDATIONS 19

- 20 (2008).

184 Barnes et al., supra note 5, at 1 986.

185 Chatterjee et al., supra note 71 , at 62; Kang et al., supra note 81 , at 1 440.

186 Masculine Play

, supra note 101 , at 2. Latini, supra note 60 , at 90.

187 Teitelbaum et al., supra note 113 , at 189; Stahlhut et al., supra note 104 , at 800.

188 See § I .B. 2.i

, infra

. 189 Am. Chemistry Council, U.S. Resin Production & Sales 2013 vs. 2012 (Mar. 2014), http://www.americanchemistry.com/Jobs/EconomicStatistics/Plastics

- Statistics/ Production

- and

Sales

- Data

- by

- Resin.pdf.

190 See Wams, supra note 123 , at 2 (explaining that, on average, DEHP constitutes 30 percent of finished PVC).

191 Am. Chemi stry Council, U.S. Resins Industry Strengthens in 2013 1, http://www.22 practice. ” 192 Indeed, estimates indicate that more than 7.2 billion pounds of this material enter
landfills throughout the United States each year. 193

i

. Nature and Severity of the Human Health and Environmental Damage that

Has Occurred We urge the agency to promptly revise its regulations so as to ensure the safe management of this increasing volume of waste.

The improper disposal of PVC has likely already caused significant harm to human

health. By the mid

- 1970s, vinyl chloride had contributed to nearl y one dozen worker deaths

, 194
and experts warn that the continued widespread use of this substance “remains a cause for

concern.” 195 A s described above, 196 prenatal exposure to phthalate plasticizers and their metabolites interferes with hormone regulation and alters sexual development in male laboratory animals, inducing a suite of abnormalities known to scientists as “phthalate syndrome.” 197
Among humans, chronic contamination begins even before birth, 198 posing grave biological

consequences. 199 Moreover, a gr owing body of experimental and epidemiological evidence suggests that widespread exposure to phthalates and other endocrine

- disrupting chemicals has already contributed to significant declines in semen quality 200 and deteriorating reproductive

health across the industrialized world. 201

Within the past decade, researchers have identified a spectrum of increasingly prevalent disorders, collectively termed “testicular dysgenesis syndrome,” which likely arise from impaired hormone production during fetal developm ent. 202

americanchemistry.com/Jobs/EconomicStatistics/Plastics

- Statistics/Year

- in

- Review.pdf (last visited May 13, 2014). Specific symptoms, including genital

192 U.S. Envtl. Prot. Agency, Plastics 3 (Feb. 2012), http://www.epa.gov/ epawaste/ conserve/tools/warm/pdfs/Plastics.pdf.

193 Michael Belliveau et al., PVC

– Bad News Comes in Threes: The Poison Plastic, Health Hazards and the Looming Waste Crisis 10, 12 (Dec. 2004), http://chej.org/wp

- content/ uploads/Documents/PVC/bad_news_come s_in_threes.pdf (calculating, on the basis of existing data, that annual PVC disposal ranges up to 7.2 billion pounds, but observing that “[t]he amount of PVC [generated by the construction industry] may be seriously underestimated”).

194 Mulder et al., supra note 10 , at 275

. 195 Kielhorn et al., supra note 12 , at 579.

196 See § I.B.2.a

, supra

. 197 Latini et al., supra note 60 , at 93.

198 Frederiksen et al., supra note 97 , at 906.

199 See Swan et al., supra note 15 , at 1 060 (“[H]umans may be more sensitive to prenatal phthalate exposure than rodents.”).

200 See Shanna H. Swan et al., The Question of Declining Sperm Density Revisited: An Analysis of 101 Studies Published 1934

- 1996 , 108 E NVTL

. H EALTH P ERSP

. 961, 964 (2000); see also Fisher, supra note 96 , at 306 (reporting that 48 percent of young Danish men reporting for military service between 1996 and 1998 exhibited sperm counts associated with impaired fertility, while one

- quarter qualified as “abnormal,” according to World Health Organization guidelines).

201 Latini et al., supra note 60 , at 90.

202 Fisher, supra note 96 , at 307.23 malformations, such as undescended testicles and displaced urethras, poor semen quality and testicular cancer, mirror the effects of prenatal phthalate contamination in laboratory animals, 203
leading experts to con clude that “phthalate exposures could be the leading cause of reproductive

disorders in humans.” 204 Moreover, t he analogous “female phthalate syndrome,” characterized by various reproductive tract abnormalities and reduced fecundity, is “striking[ly] similar” to the effects of Mayer

- Rokitansky

- Kuster

- Hauser syndrome in women. 205

j

. Action Taken by Other Governmental Agencies or Regulatory Programs Based on the Health or Environmental Hazard Posed by Discarded PVC

, Vinyl Chloride and Phthalate Plasticizers We urge EPA to promptly revise its regulation of discarded PVC to prevent additional damage to public health.

Existing regulations are inadequate to manage the risks associated with the widespread use and improper disposal of PV C. Government officials have recognized the problem of marine pollution for nearly a century, 206 and have implemented a variety of international agreements, federal legislation, and state laws to curb this growing threat. 207 In the four decades since

researc hers first reported the presence of plastic litter in the oceans, however, these measures have proven insufficient to prevent the further contamination of the marine environment. 208 For example, although the International Convention for the Prevention of Po llution from Ships, commonly known as MARPOL, explicitly prohibits vessels from dumping plastic waste at

sea, 209 “large amounts of [illegally

- discharged] plastic continue to wash ashore, obstruct navigation, and entangle marine life,” 210 including endangered H awaiian monk seals ( Monachus

schauinslandi ). 211

203 Howdeshell et al., supra note 101 , at 168 ; see also Frederiksen et al., supra note 97 , at 899,

905. In addition to suffering from inadequate enforcement, MARPOL and other

204 Latini et al., supra note 60, at 90.

205 Bethany R. Hannas et al., In Utero Phthalate Effects in the Female Rat: A Mode for MRKH Syndrome, 223 T OXICOLOGY L ETTERS 315, 320 (2013).

206 See Daud Hassan, International Conventions Relating to Land

- Based Sources of Marine Pollution Control: App lications and Shortcomings

, 16 G EO

. I NT ’ L E NVTL

. L. R EV

. 657, 660 n.19 (2004) (reporting that expserts from thirteen maritime powers, including the United States, met in June 1926 to discuss measures to prevent ocean

- going vessels from contaminating the ma rine environment).

207 See generally Grant A. Harse, Plastic, the Great Pacific Garbage Patch, and International Misfires at a Cure , 29 UCLA J. E NVTL

. L. & P OL ’ Y 331, 344

- 353 (2011) ( reviewing international agreements and federal laws pertaining to problem of marine plastic pollution, and observing that “for all of these, plastics continue to reach our oceans”).

208 See, e.g. , Barnes, supra note 5 , at 1985 (observing that “the ubiquity and abundance of plastic debris ... is still growing and even if stopped immediately will persist for centuries”).

209 See Sally Ann Lentz, Plastics in the Marine Environment: Legal Approaches for

International Action , 18 M ARINE P OLLUTION B ULL

. N 361, 362 (1987).

210 Recordkeeping of Refuse Discharges from Ships, 59 Fed. Re g. 18,700, 18,700 (Apr. 19, 1994).

211 See John R. Henderson, A Pre

- and Post

- MARPOL Annex V Summary of Hawaiian Monk Sea Entanglements and Marine Debris Accumulation in the Northwestern Hawaiian Islands, 1982

- 1998 , 42 M ARINE P OLLUTION B ULL

. 584, 58 7, 588 (2001) (observing that the amount of plastic24 existing legal regimes fail to address the major source of plastic pollution. Specifically, according to data collected by the National M arine Debris Monitoring Program, as much as 82 percent of shoreline litter may result from activities on land that fall outside the scope of international conventions, including plastics manufacturing and improper waste management. 212

In 2008, Congress res tricted the use of certain phthalates in children’s toys and childcare articles, and mandated further testing to ascertain the risks associated with human exposure to

these substances. 213 Legislators have enacted similar provisions in California, 214 Vermont 215 and Washington. 216 In addition, several state and federal agencies have sought to limit levels of these compounds in the environment. 217

debris washing ashore in the Northwestern Hawaiian Islands “show[ed] no sign of diminishing” between 1982 and 1998, “despite implementation of MARPOL Annex V in 1989,” and reporting

that “Hawaiian monk se als continue to become entangled in marine debris”); see also 50 C.F.R. § 17.11 (listing M. schauinslandi as endangered under the ESA). However, as this petition describes, the current regulatory scheme is wholly inadequate to prevent the harm likely to result from the continued

212 National Oceanic and Atmospheric Administration, supra note 183 , at 19

- 20 ; but see Michael
J. Bean, Legal Strategies for Reducing Persistent Plastics in the Marine Environment , 18

M ARINE P OLLUTION B ULL

. 357, 357 (1987) (estimating that 90 percent “of the total pollution entering the oceans ... enters from land

- based sources via rivers, estuaries and oth er avenues ”).

213 See 15 U.S.C. § 2057c (mandating, inter alia , that “it shall be unlawful for any person to manufacture for sale, distribute in commerce, or import into the United States any children’s toy or child car article that contains concentrations of more than 0.1 percent of [DEHP, DBP, or BBP]”). Controls intended to reduce exposure among children also exist in Argentina, Fiji, Japan and Mexico, as well as throughout the European Union. Rachael Rawlins, Teething on Toxins: In Search of Regulatory Solutions for Toys and Cosmetics , 20 F ORDHAM E NVTL

. L AW
R EV

. 1, 5 (2009) (noting the existence of relevant laws in Austria, Denmark, Finland, France, Germany, Greece, Norway and Sweden). In addition, Germany, Spain and Sweden have enacted broader bans on the use and disposal of PVC. See PVC Policies Across the Wo rld

, C TR

. FOR
H EALTH

, E NV ’ T & J USTICE

, http://www.chej.org/pvcfactsheets/PVC_Policies_Around_The_ World.html (last visited Apr. 7, 2014).

214 C AL

. H EALTH & S AFETY C ODE §108935

- 39 ( restricting the manufacture, sale and distribution of certain toys and child c are articles containing more than 0.1 percent of DEHP, DBP, BBP, DINP, DIDP, or DnOP).

215 V T

. S TAT

. A NN

. tit. 18, § 1511 ( restricting the manufacture, sale and distribution of certain toys and child care articles containing more than 0.1 percent of DEHP, D BP, BBP, DINP, DIDP, or DnOP).

216 W ASH

. R EV

. C ODE § 70.240.020(1)( c ) ( restricting the manufacture, sale and distribution of “children’s product[s] or product component[s]” containing, inter alia , “[p]hthalates, individually or in combination, at more th a n 0 .10 percent by weight (one thousand parts per million)”)

. 217 See, e.g. , 40 C.F.R. pt. 132 (requiring Great Lakes States and Tribes to adopt, inter alia

, provisions sufficient to protect local wildlife from “bioaccumulative chemicals of concern,” including s ix phthalate plasticizers); see also C AL

. C ODE R EGS

. tit. 27, § 25805 (prohibiting businesses from knowingly discharging “chemicals causing reproductive toxicity,” including five phthalate plasticizers, into any source of drinking water).25 widespread use and improper disposal of PVC. , and exposure to vinyl chloride “remains a cause

for concern.” 218 Phthalate contamination is now ubiquitous among the population of industrialized nations

220 According to a 2005 study, one

- quarter of U.S. women exhibit concentrations of phthalate metabolites higher than those correlated with irregular sexual development in male

infants

, 221 and evidence indicates that contamination might be even more prevalent among pregnant wo men in urban settings. 222

k

. Other Appropriate Factors To protect the next generation and preserve the marine environment, EPA must promptly take action to manage discarded PVC as hazardous waste.

As this petition explains, a considerable body of scien tific research implicates discarded

PVC , vinyl chloride and associated phthalate plasticizers in a range of threats to human health and the environment. Moreover, recent research indicates that exposure pathways “outside the scope of traditional toxicity testing” might result in additional harm.

or to a single phthalate mixed 223 For example , low doses of phthalates and other endocrine

- disrupting chemicals often produce health effects different from or more severe than those associated with higher concentrations. 224 Simultaneous exposure to multiple phthalates with other environmental pollutants, might elicit a synergistic response. 226 In addition, the recent discovery of additional phthalate metabolites indicates that human exposure probably exceeds previously published estimates. 228
Because the majority of chemical compounds used in PVC production remain untested , existing toxicity data likely underestimate risks arising from the improper disposal of discarded PVC. 229

218 In addition to ignoring significant sources of human and environmental exposure to phthalate plasticizers, existing laws may suffer from inadequate enforcement. See, e.g. , Margaret H. Lemos, State Enforcement of Federal Law , 86 N .Y.U.L. R EV . 698, 738 (20 11) (explaining that federal phthalate restrictions “allow[] states to influence policy by adjusting the intensity of enforcement and hence the degree to which manufacturers are deterred from using phthalates,” and observing that an elected attorney genera l from a “conservative” state might have little incentive to take action in the consumer protection field).

220 Wormuth et al., supra note 176 , at 803; K ielhorn et al., supra note 12 , at 579.

221 Swan et al., supra note 15

, at 1 056.

222 Adibi et al., supra note 16 , at 1722 (reporting that pregnant women in New York City “appear to be exposed [to phthalates] at levels above background levels in the United States, which may have implications for their pregnancy and/or the fetus”).

223 Heather J. Hamlin, Embryos as Targets of Endocrine Disrupting Contaminants in Wildlife , 93

B IRTH D EFECTS R ES

. P ART C: E MBRYO T ODAY : R EV

. 19, 23 (2011).

224 Id. at 21, 25.

226 Mankidy et al., supra note 144 , at 56; Hamlin et al., supra note 223 , at 25; Howdeshell et al.,

su

pra note 101 , at 175; see also Jobling et al., supra note 142 , at 586 (noting that scientific literature suggests that “measuring the total estrogenic burden due to environmental contaminants may have more relevance than assessing exposure by measuring levels of individual estrogens alone,” be cause “environmental estrogens may act cumulatively”).

228 Frederiksen et al., supra note 97 , at 902

- 03, 906.

229 Stern et al., supra note 13, at 774.26 II. The Toxic Substances Control Act

A. Statutory Background

In 1976, Congress enacted the Toxic Substances Control Act (“TSCA”), 15 U.S.C. §§

2601 et seq. , “to assure that ... innovation and commerce in ... chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment.” 230

A ccordingly, lawmakers required manufacturers and processors to develop “adequate data” concerning the effects of these compounds, and granted the U.S. Environmental Protection Agency (“EPA”) “authority ... to regulate [those] chemical substances and mixtures which present an unreasonable risk.” 231

Pursuant to section 6 of TSCA, EPA “ shall ” regulate a chemical substance if “there is a reasonable basis to conclude” that the compound “presents or will present an unreasonable risk of injury to health or the environment.” 232 Permissible regulations include requirements prohibiting or “limiting the amount of such substance ... which may be manufactured, processed,

or distributed in commerce.” 233

(A) the effects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture, In assessing risk, EPA must consider:

(B) the effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture, (C) the benefits o f such substance or mixture for various uses and the availability of substitutes for such uses, and (D) the reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological inn ovation, the environment, and public health. 234

Factual certainty is not required; instead, the agency may “base its action on scientific theories, consideration of projections from available data, modeling using reasonable assumptions, and extrapolations fr om limited data.” 235 Even if EPA determines that another federal law “could [sufficiently] eliminate[] or reduce[]” the risk associated with a particular chemical substance, the agency may elect to regulate the substance under TSCA, provided that a “compari son of the estimated costs” and “relative efficiency” reveals that such action promotes the public interest. 236

In the event that EPA lacks adequate data and experience upon which to determine the health and environmental risks associated with a particu lar chemical substance, the agency “ shall

230 15 U.S.C. § 2601(b)(3) ( 2012). Within the meaning of TSCA, the term “chemical substance” includes “any organic or inorganic substance of a particular molecular identity.” Id. § 2602(2).

231 Id. § 2601( b)(1) & (2 ).

232 Id. § 2605(a) (emphasis add ed).

233 Id. § 2605(a)(1)(B).

234 Id. § 2605(c).

235 Lead Fishing Sinkers; Response to Citizens’ Petition and Proposed Ban, 59 Fed. Reg. 11,122, 11,138 (Mar. 9, 1994) ( citing H.R. Rep. No. 1341, 9th Cong., 2d Sess. 32 (1976)).

236 Id.27 by rule require that testing be conducted on such substance.” 237 Specifically, under 15 U.S.C. § 2603, EPA may compel manufacturers and processors to evaluate the safety of substances that “may present an unreasonab le risk of injury to health or the environment” or that “[are] or will be produced in substantial quantities” and, thus, “may reasonably be anticipated to enter the environment in substantial quantities” or result in “significant or substantial human expos ure.” 238

B. Vinyl Chloride and Phthalate Plasticizers Pose an Unreasonable Risk of Harm to

Human Health and the Environment

Although Congress did not define the phrase “unreasonable risk,” EPA has interpreted relevant legislative history to require tha t the agency:

balance the benefits derived from risk reduction against the social and economic costs incurred, taking into account such factors as the extent and magnitude of risk posed; the societal consequences of removing or restricting use of products ; availability and potential hazards of substitutes; and impacts on industry, employment, and international trade. 239

No specific factual determination is necessary to establish “unreasonable risk.” For example, even under the stricter standard of 15 U.S.C. § 2606, EPA need not present evidence of actual injury before obtaining emergency injunctive relief to control “immanently hazardous chemical substance[s] or mixture[s].” 240

A growing body of scientific evidence clearly shows that the inadequate man agement of PVC, vinyl chloride and phthalate plasticizers poses significant threats to human and ecosystem health. As a result of their widespread use, significant tendency to migrate, and resistance to degradation, phthalates are the most abundant anthro pogenic chemicals in the environment, 241
contaminating even freshly fallen snow. 242 Once dissociated from PVC, t hese compounds accumulate in the tissues of aquatic and terrestrial organisms, 243 interfering with hormone regulation and altering sexual development in laboratory animals and human beings. 244

Moreover, recent research indicates that human contamination probably exceeds previously published estimates, 245 and exposure pathways “outside the scope of traditional toxicity testing” might result in additional harm. 246 For example, simultaneous exposure to multiple phthalates, 247

237 15 U.S.C. § 2603 (emphasis added). or to a single phthalate mixed with other environmental pollutants, likely elicit s a

238 Id.

239 Guidance for Petitioning the Environmental Protection Agency Under Section 21 of the Toxic Substances Control Act, 50 Fed. Reg. 46,825, *2 (Nov. 13, 1985).

240 See H.R. Conf. Rep. No. 94

- 1679 78 (1976).

241 Jobling et al., supra note 142, at 58 5

. 242 Horn et al., supra note 150 , at 3695.

243 See §§ I.B.2.f

, supra

. 244 Latini et al., supra note 60 , at 93.

245 Frederiksen et al., supra note 97 , at 902

- 03, 906.

246 Hamlin, supra note 223 , at 23.

247 Mankidy et al., supra note 144 , at 56

.28 synergistic response. 248 Expert s suspect that virtually universal exposure to phthalate plasticizers “could be the leading cause of reproductive disorders in humans ” and vinyl chloride also

“remains a cause for concern.” 249 Despite the availability of less harmful alternatives, 250 the

PVC industry consumes over 32 billion pounds of these toxic chemicals each year. 251

We urge EPA to promptly initiate rulemaking under 15 U.S.C. § 2605 to reduce the unreasonable risk to public health and the environment associated with continued depe ndence on PVC, vinyl chloride and phthalate plasticizers. In the event that the agency concludes that there are insufficient data and experience upon which to determine or predict the effects of ubiquitous contamination, we alternatively request that the agency adopt a rule under section 4 of the Act, 15 U.S.C. § 2603, requiring manufacturers and processors responsible for the generation of these compounds to undertake additional toxicity testing.

CONCLUSI ON

As this petition explains, inadequate management strategies have permitted substantial quantities of discarded PVC to accumulate in the marine environment, contributing to a broad array of social, economic and environmental harms. Conventional landfill disposal practices also

fail to contain vinyl chloride and plastic additives, including designated toxic constituents, which easily migrate from discarded PVC and ultimately infiltrate aquatic and terrestrial ecosystems. The environmental persistence of t hese chemicals, combined with the massive rate of PVC production, has resulted in nearly universal human exposure, raising concerns about a range of associated health problems, including birth defects, cancers and diabetes.

Discarded PVC satisfies the sta tutory definition of “hazardous waste.” After disposal, this material necessarily qualifies as potentially hazardous “solid waste.” Moreover, because PVC typically contains substantial concentrations of toxic constituents, the improper disposal of

this m aterial poses a substantial present and future threat to human health and the environment.

The analysis of EPA’s regulatory criteria set forth in detail above supports the listing of

discarded PVC as hazardous waste

, and demonstrates that continued wide spread use of PVC, vinyl chloride and phthalate plasticizers pose s an unreasonable risk to human health and the

environment

. Immediate action is necessary to reduce the need for future corrective action and prevent additional harm

. Accordingly, we urge EPA to promptly exercise its authority to ensure the safe disposal of discarded PVC.

248 Hamlin et al., supra note 223

. 249 Latini et al., supra note 60 , at 9 0 ; Kielhorn et al., supra note 12 , at 579.

250 Kastner et al., supra note 69 , at 363

. 251 Brandt

- Rauf et al., supra note 70, at 2; Chatterjee et al., supra note 71, at 62 ; Lithner et al.,

supra note 71 , at 1199.