Richard M. Doyle 

President and CEO 

1737 King Street. Suite 390 

Alexandria, VA 22314 

office 571.970.3372 

fax 571.970.3271 

October 15, 2014 

Ms. Wendy Cleland-Hamnett, Director 

Office of Pollution Prevention and Toxics 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Mail Code: 7 401 M 

Washington, DC 20460 

cleland-hamnett.wendy@epa.gov 

Mr. Barnes Johnson, Director 

Office of Resource Conservation and Recovery 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Mail Code: 5301P 

Washington, DC 20460 

johnson.barnes@epa.gov 

Re: Center for Biological Diversity Petition of July 24, 2014 

Dear Ms. Cleland-Hamnett and Mr. Johnson: 

The Vinyl Institute, Inc} appreciates the opportunity to provide the U.S. Environmental 

Protection Agency (EPA) with information to assist the agency's evaluation of a July 24, 2014, Petition 

filed by the Center for Biological Diversity (CBD or Center). The Petition asks EPA to regulate 

discarded polyvinyl chloride (PVC) under the Resource Conservation and Recovery Act (RCRA) and the 

Toxic Substances Control Act (TSCA). 

The CBD Petition reflects a gross misunderstanding of PVC/vinyl as a material and is 

replete with errors and misinformation, particularly with regard to the vinyl products the Petition 

seeks to further regulate. These factual errors, coupled with the failure to recognize existing 

! The Vinyl Institute, founded in 1982, is a U.S. trade association representing the leading manufacturers of vinyl, vinyl 

chloride monomer, vinyl additives and modifiers, and vinyl packaging materials. For more information, please 

visit: http://vinylinfo.org/ 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page2 

regulatory restrictions, are the flawed basis for the Center's request for regulation under RCRA and 

TSCA. 

Our comments are organized into three sections. 

• The first section provides factual corrections with regard to vinyl products and markets. 

• The second section discusses RCRA and other pertinent regulations. 

• The third section explains why EPA action under TSCA Section 6 and Section 4 is not 

warranted. 

I. Vinyl Products and Markets 

Vinyl is one of the world's most versatile and highly used materials, providing tremendous value 

to consumers every day. Vinyl is material of choice for blood bags that preserve blood longer than 

competing materials and for medical tubing and other products that offer unparalleled flexibility along 

with toughness, kink resistance, and dependability; for pipe that delivers safe drinking water and removes 

sanitary wastes with significantly fewer leaks and breaks than traditional competing materials such as 

ductible iron and concrete; for jacketing and insulation of electric wire, protecting buildings against 

catastrophic failure; for the most cost-effective, energy-efficient and durable window frames and 

reflective roofing membranes on the market; for flooring and wall covering that are durable and 

decorative while easy to install and clean- extremely important in healthcare where these qualities help 

reduce the spread of pathogens. 

Fundamentally, CBD's petition erroneously characterizes vinyl products, their constituents, and 

their environmental fate. Although decades ago the production of certain vinyl materials employed low 

levels of various metals as heat stabilizers (lead, calcium, barium, cadmium), today it is not appropriate to 

characterize PVC waste as a significant contributor of these substances to the environment. First, the use 

of lead and cadmium as heat stabilizers in PVC compounds has been largely eliminated in the U.S., 

except for a limited number of specialty applications, and imported vinyl products use these substances 

less each year. Indeed, mono-type tin is the most commonly used heat stabilizer in the U.S. Second, 

vinyl chloride, lead, cadmium, and barium in waste streams are regulated under RCRA, such that PVC 

products cannot contain significant amounts of these substances. Third, CBD's petition fails to consider a 

number of references that have addressed the environmental fate of vinyl products, as discussed in the 

following sections.Z Lastly, not all vinyl materials contain phthalates. Roughly 80% of all vinyl material 

produced in the U.S. is rigid and does not contain any plasticizer. The remainder uses many different 

types of the nearly 100 plasticizers available including phthalate and non-phthalate varieties, to impart the 

Z Should they not already be available to the agency, the Vinyl Institute would be happy to provide EPA with 

a copy of any of these sources: 

• Wilkes, Summers, Daniels (Eds.). 2005. PVC Handbook. 

• Mersiowsky, Stegmann, Ejlertsson, Svensson. July 1999. Long-Term Behaviour of PVC Products Under 

Soil-Buried and Landfill Conditions (Final Report- 2nd Revised Edition). 

• Mersiowsky. January 2001. Long-Term Behavior of PVC Products and their Additives Under Landfill 

Conditions (Integrated Review and Evaluation). 

• Mersiowsky, Stegmann, Ejlertsson. Long-Term Behavior of PVC Products Under Soil-Buried and Landfill 

Conditions. 

• Borrelli, de Ia Cruz, Paradis. April 2005. Residual Vinyl Chloride Levels in US PVC Resins and Products: 

Historical Perspective and Update. Journal of Vinyl & Additive Technology. 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page3 

proper performance requirements needed for the application. The chart below indicates the most reliable 

data that the VI has available as far as the breakdown of applications where PVC materials are used:-3· 

Calendared 

Packaging 

Calendared 

Flooring 

Custom Other Uses 1% 

Compounders 9% \ 

10% \ 

Molding \ 

(Inc. 

Fittings), 

4% "' 

Extruded -·:��� ! 

Fence & =. 

Deck / 2% 

Extruded 

Windows 

and Doors 

5% 

l!xtrudad 

Pipe 

Extruded 

Sheet 

(Pkg. & 

NonPkg.) 

6% 

Extruded 

Siding 

9% 

By VI's estimates, flexible PVC would be attributable to 20% of the total uses of PVC material, 

determined as (half the volume of Custom Compounders + Other Uses + Calendared Packaging + 

Extruded Film & Sheet) along with (all the volume of Cable and Flooring). The remainder is rigid PVC 

material that does not use a plasticizer. 

The Center's petition also suffers from other mischaracterizations. The petition relies on articles 

that have themselves been criticized as biased or misinformed. For example, the assertion," ... experts 

continue to argue that the agency's risk assessments are inadequate," references a paper that was 

criticized in a letter to the editor of the publishing journal as "a case study in misrepresentation." The 

letter to the editor expressed surprise that, "The inclusion of such an article in this peer-reviewed 

publication stands in contrast to its stated mission to publish 'balanced' and 'objective' information.�" 

According to the letter, the referenced article "did not include or address recent studies in characterizing 

the weight of the scientific evidence related to vinyl chloride and made inaccurate and unsupported 

J. ACC Resin Report, May, 2014. 

�Price, Courtney, A erican Chemistry Council, Environmental Health Perspectives, Oct. 2005; 113(10): A653-

A654., http://www ncbi nlm.nih.gov/pmc/articles/PMC 1281299/ 
Ms. Wendy Cleland-Harnnett 

Mr. Barnes Johnson 

Page4 

allegations about the integrity of U.S. Environmental Protection Agency (EPA) scientists and the rigorous 

peer review process utilized by the U.S. EPA." 

In other instances, the petition's references appear not even to support the claims being made in 

the petition. For example: 

• A claim that PVC is "one of the most hazardous consumer products ever created" (p. 2) 

references a paper on the "Environmental and Economic Acceptance of Polyvinyl 

Chloride (PVC) Coating Agents," the abstract for which states, "It was concluded that 

PVC plastisol containing non-toxic plasticizer and less than 5 ppm free vinyl chloride 

monomer is an eco-efficient material which, when responsibly managed from cradle to 

grave, provides sustainable benefits to the society."-2. 

• The statement, "Marine plastic pollution harms ocean organisms, threatens ecological 

integrity and damages human health and prosperity" (p. 2) references a study that does 

not even mention PVC . .fi 

• The volume of PVC material discarded in the U.S. is misrepresented at over 7 billion 

pounds. The Michael Belliveau et al study referenced by CBD is conjecture and not 

substantiated by any data or studies. For a better understanding of the volume of PVC 

discarded, EPA should refer to its own studies on municipal solid waste, which determine 

the amount of PVC discarded at less than 1.74 billion pounds.1 Other volumes beyond 

this have not been formally quantified. 

II. RCRA and Other Regulatory Restrictions 

CBD's petition asks that EPA list PVC as a toxic hazardous waste on the basis of the presence of 

certain hazardous constituents in the waste under 40 C.F.R. § 261.11 (a)(3). To list a waste as a toxic 

hazardous waste under this provision, EPA must conclude that the waste is capable of posing a substantial 

present or potential hazard to human health or the environment when improperly treated, stored, 

transported or disposed of, or otherwise managed, considering 11 factors . .a 

As the petition notes, several substances that are components in some PVC compounds are 

hazardous constituents under RCRA Appendix VIII: vinyl chloride, butyl benzyl phthalate (CASRN 85-

68-7), dibutyl phthalate (CASRN 84-74-2), diethyl phthalate (CASRN 84-66-2), diethylhexyl phthalate 

(DEHP, CASRN 117-81-7), dimethyl phthalate (CASRN 131-11-3), di-n-octyl phthalate (CASRN 117-

84-0), lead (CASRN 7439-92-1), cadmium (CASRN 7440-43-9), and barium (CASRN 7440-39-3).2 

.2. M. Bidoki et a!., Environmental and Economic Acceptance of Polyvinyl Chloride (PVC) Coating Agents, 

18 J. of Cleaner Production 219 (201 0). 

2 M.H. Dep1edge et al., Plastic Litter in the Sea, 92 Marine Envtl. Res. 279 (2013). 

1 EPA MSW Characterization Report, 2014, Municipal Solid Waste Generation, Recycling, and Disposal in 

the United States, Tables and Figures for 2012, at 9 . 

.a 40 C.F.R. § 261.11(a)(3) 

2 Appendix VIII to 40 C.F.R. Part 261. 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 5 

Although other phthalate plasticizers have been included in EPA's Phthalates Action Plan,J. as noted by 

CBD, these substances are not listed as hazardous constituents under RCRA. Consequently, the potential 

presence of these substances in PVC resins is irrelevant to consideration of whether PVC resins should be 

listed as hazardous waste under Part 261.!! 

EPA must address a11 11 factors if it decides to list a waste under section 261.11(a)(3).11 Some of 

the more egregious flaws in the information included in CBD's petition for these factors are discussed in 

the following sections. In short, CBD has failed to demonstrate that PVC waste poses a substantial 

hazard to human health or the environment. 

We also note that a significant deficiency in CBD's petition is that CBD refers to PVC as if it 

were a single product, substance, or mixture. This approach discounts the wide range of vinyl polymers 

and copolymers produced by the industry. As a general matter, PVC resin recipes vary widely, and are 

often specific to a particular customer's specifications (based on the ultimate product) as well as the 

particular machinery and processes used by a manufacturer to produce the resin. For example, vinyl pipe 

uses significantly different additives and manufacturing processes than flexible medical tubing. These 

recipes will have varying concentrations of additives, and cannot be assumed to have all (or any) of the 

hazardous constituents noted above. In fact, there are over a hundred unique PVC resins produced in the 

U.S. that are used in literally thousands of compounds for the myriad of applications that vinyl materials 

are used for. Consequently, CBD's monolithic view of "PVC" is entirely inappropriate, and EPA must 

consider the required 11 factors as they apply to particular PVC compounds, rather than with regard to all 

PVC compounds . .U For these reasons, it is far more sensible for EPA to adhere to the current regulatory 

structure, described in Section II.E, whereby PVC resins are regulated under RCRA only if they contain a 

hazardous waste constituent under the toxicity characteristic above the associated regulatory level. 

A. Nature of the Toxicity Presented by the Constituent 

CBD presents a variety of studies to support its allegations of hazard presented by PVC waste. 

As a general matter, EPA should begin its consideration of this criterion with robust risk assessments that 

have been completed with input from peer reviewers and the regulated community, rather than the 

piecemeal studies cited by CBD. For example, EPA has already assessed many of these substances 

through the Integrated Risk Assessment System (IRIS) program. 

lQ Diisobutyl phthalate, di-n-pentyl phthalate, diisononyl phthalate, and diisodecyl phthalate, see 

http://www.epa.gov/opptintr/existingchemicals/pubs/actionplans/phthalates.html. 

11 See 40 C.F.R. § 261.ll(a)(3). 

il Dithiocarbamate Task Force v. EPA, 98 F.3d 1398, 1402 (D.C. Cir. 1996) . 

.L1 See Dithiocarbamate Task Force v. EPA, 98 F.3d 1398, 1399 (D.C. Cir. 1996) ("Where it is reasonable to 

consider the factors in relation to a class of chemicals, EPA may do so. As we develop below in connection with the 

K wastes, that means essentially that if the known similarities of members of a class are such that it is reasonable to 

infer the presence of a disputed characteristic throughout the class (not just among members for which it has been 

shown), the EPA is free to draw that inference. Thus, if the agency is considering a class Ai-n, and members Ai-iv 

exhibit a specific attribute, and there is reason to believe that they do so because of some trait shared by the whole 

class, then the agency may draw the inference that all the members of the class exhibit the attribute."). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 6 

For the endpoint most appropriate to CBD's listing petition, the IRIS assessment determined an 

oral reference dose for vinyl chloride of 0.003 mg/kg-day.H The IRIS assessment for vinyl chloride also 

determined an inhalation reference concentration ofO.l mg/m3 . .u Similarly, under California's Safe 

Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), the No Significant Risk Level for 

vinyl chloride is 3 f..Lg/day . .!Q 

Several of the phthalates cited in the petition have been assessed under IRIS. IRIS determined an 

oral reference dose for DEHP of 0.02 mg/kg-day, but did not determine an inhalation reference 

concentration.J.l For dibutyl phthalate, the oral reference dose was determined to be 0.1 mg/kg-day; an 

inhalation reference concentration was not determined.JJi For butyl benzyl phthalate, the oral reference 

dose was determined to be 0.2 mg/kg-day; an inhalation reference concentration was not determined.l2 

For diethyl phthalate, the oral reference dose was determined to be 0.8 mg/kg-day; an inhalation reference 

concentration was not determined.ll Although an IRIS assessment is available for dimethyl phthalate, 

EPA did not determine an oral reference dose or an inhalation reference concentration.2..L An IRIS 

assessment has not been completed for di-n-octyl phthalate. 

Several of the heavy metals cited in CBD's petition have also been assessed under IRIS. IRIS 

determined an oral reference dose for barium of 0.2 mg/kg-day, but did not determine an inhalation 

reference concentration.ll For cadmium, IRIS determined oral reference doses of 0.0005 mg/kg-day 

(water) and 0.001 mg/kg-day (food), but did not determine an inhalation reference concentration.n The 

IRIS assessment for lead did not calculate an oral reference dose or an inhalation reference 

concentration.M 

1.1 EPA, Toxicological Review of Vinyl Chloride in Support of Summary Information on the Integrated Risk 

Information System (IRIS) (May 2000) at 40, available at: http://www.epa.gov/iris/toxreviews/1 00 I tr pdf. 

.U !d. at 44. 

lQ Office of Environmental Health Hazard Assessment Proposition 65 No Significant Risk Levels (NSRLs) 

for Carcinogens and Maximum Allowable Dose Levels (MADLs) for Chemicals Causing Reproductive Toxicity 

(Aug. 20 13), available at: http://www.oehha.ca.gov/prop65/pdf/safeharbor08 1513 .pdf. 

l1 Di(2-ethylhexyl)phthalate (DEHP) (CASRN 117-81-7), available at: 

http://www.epa.gov/iris/toxreviews/l 001 tr.pdf. 

l.! Dibutyl phthalate (CASRN 84-74-2), available at: http://ww

.epa.gov/iris/subst/0038.htm. 

1.2 Butyl benzyl phthalate (CASRN 85-68-7), available at: http://www.epa.gov/iris/subst/0293.htm. 

:il Diethyl phthalate (CASRN 84-74-2), available at: http://www.epa.gov/iris/subst/0226.htm. 

2.! Dimethyl phthalate (CASRN 131-11-3), available at: http://ww

.epa.gov/iris/subst/0353.htm. 

ll Toxicological Review of Barium and Compounds in Support of Summary Information on the 

Integrated Risk Information System (IRIS) at 47, available at: http://ww

.epa.gov/iris/toxreviews/OOl Otr.pdf. 

n Cadmium (CASRN 7440-43-9), available at: http://ww

.epa.gov/iris/subst/014l .htm. 

11 Lead and compounds (inorganic) (CASRN 7439-92-1), available at: 

http:/ /www.epa. gov/iris/subst/0?77 .htm. 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 7 

B. Concentration of the Constituent in the Waste 

Contrary to CBD's allegations, PVC resin does not include "significant" concentrations of vinyl 

chloride. Production of PVC has been regulated under the Clean Air Act via the National Emission 

Standard for Vinyl Chloride ("VCM NESHAP") since 1976.22 Further decreases in residual vinyl 

chloride have occurred since, as demonstrated during the rulemaking process for EPA's 2012 adoption of 

the National Emissions Standard for Hazardous Air Pollutants for Polyvinyl Chloride and Copolymers 

Production rulemaking ("PVC MACT").2.2 Indeed, the results of the Vinyl Institute survey for the year 

2000 indicated residual vinyl chloride levels of below 1 ppm on a weighted industry average basis for all 

PVC resins.ll With regard to PVC pipe resin, which constitutes approximately 45 percent of the vinyl 

market, a 2001 report by NSF International found that there was no detectable VCM (detection level 0.1 

mg/kg) in 86 percent of the PVC pipe sampled and in 88 percent of the PVC fitting sampled.� According 

to EPA's Second Six Year Review of Drinking Water Contaminants, the minimum detection limit (MDL) 

for test method 502.2 for vinyl chloride is 0.18 ug/1.22 

With regard to plasticizers, the CBD's petition assumes that all plasticizers used in PVC resins 

are phthalate esters. In truth, a number of other compounds are used. The Food and Drug 

Administration, for example, has cleared a number of non-phthalate plasticizers that may be used in 

flexible vinyl formulations.lQ These include a number of citrate plasticizers, such as triethyl citrate. 

Moreover, only flexible vinyl applications use significant amounts of plasticizers. According to IHS data, 

the total plasticizer consumption in the U.S. in 2012 was roughly 1.8 billion pounds, practically 1/9th the 

16 billion pound volume that CBD contends.ll About 90% of all plasticizer volume went into PVC, and 

about 62% of that amount was the phthalate type.:l 

Although CBD cites an article that erroneously contends that dialysis tubing may contain as much 

as 80 percent DEHP by weight, such materials are medical devices and the Food and Drug Administration 

evaluates these materials for safety. Medical bags and tubing contain only 80 parts per hundred of resin, 

or about 45% DEHP. Eighty percent DEHP would not be a functional product, but practically liquid 

40 C.F.R. Part 61 Subpart F. 

40 C.F.R. Part 63 Subpart HHHHHHH. 

n Borrelli, de Ia Cruz, Paradis, Residual Vinyl Chloride Levels in US PVC Resins and Products: Historical 

Perspective and Update, Journal of Vinyl Additive Technology, 65-66 (April, 2005). 

II! C.J. McLellan, "Test results of residual vinyl chloride monomer (RVCM) measurements from polyvinyl 

(PVC) pipes and fittings: 2001" (NSF International). 

22 U.S. EPA Development-of-Estimated-Quantitation-Levels-for-the-Second-Six-Year-Review-of-NationalPrimary-Drinking-Water-Regulations, p.4-31 ,October, 2009 found at: 

http:/ /water.epa. gov/la wsregs/rulesregs/regulatingcontaminants/ sixyearreview/ second _review/ upload/Developmentof-Estimated-Quantitation-Levels-for-the-Second-Six-Year-Review-of-National-Primary-Drinking-WaterRegulations.pdf 

:il 21 C.F.R. §181.27. 

1!. Plasticizers, Chemical Economics Handbook, IHS Chemical, 2013. 

J1 !d. 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 8 

plasticizer. Baxter Healthcare supports the use of PVC in certain medical devices as illustrated in this 

statement from their website: 

"Based on more than 40 years of safe and effective clinical use, and the large body of scientific 

data that supports its use, Baxter believes that PVC is an appropriate material for many products. 

PVC has a long history of use in a variety of medical products, such as contact lenses, 

intravenous bags, oxygen tents and catheters. These products have undergone strict regulatory 

review by many government and independent health agencies throughout the world, including the 

U.S. Food and Drug Administration. The safety of these materials has been confirmed by more 

than 40 years of use, with approximately eight billion patient days of acute and chronic exposure 

without report of significant adverse effects.".l 

We also note that lead and cadmium have been essentially eliminated from PVC production in the 

U.S., although these substance may appear in imported products or a small number of specialty 

applications. 

C. Potential for Constituents to Migrate under Improper Management 

Contrary to CBD's petition, PVC is not "intrinsically unstable." Rather, most finished PVC 

products, such as PVC pipe, are inert.M Samples of PVC pipe extracted from underground use after 20 

years of service indicate the material looks like new. In fact, due to its non-corrosive nature, the 

estimated life for PVC pipe has been increased to 110 years by the American Water Works Association 

Research Foundation.ll For example, studies of workplace exposure found that vinyl chloride was 

undetectable near equipment processing rigid and flexible vinyl polymers.l! Because typical process 

conditions take place at a melt temperature of greater than 350°F and under greater than 2,000 psi 

machine pressure, it is clear that PVC does not degrade into vinyl chloride monomer even under the most 

intense conditions. Moreover, the low level of vinyl chloride in today's PVC products, as discussed in 

Section II.B, ensures that little migration can occur. 

In his report to the Australian Government on environmental impacts of PVC materials at their 

end of life, Dr. John Scheirs summarized the work oflvo Mersiowsky and his colleagues in this manner:lZ 

"The long-term behaviour of plasticised PVC products (cable material and a flooring with 

different combinations of plasticisers) was investigated by Mersiowsky (200 1 b) in landfill 

simulation reactors. The behaviour of the various plasticisers was found to differ significantly. 

Losses of DEHP and BBP from the flooring were too low for analytical quantification. No loss of 

DIDP from the cable was detectable whereas DINA in the same product showed considerable 

n Baxter Healthcare website: http://ww

.baxter.com/press _room/positions _policies/pvc _position.html. 

.:H Wilkes, Charles, Summers, James W., and Daniels, Charles A. (eds.), PVC Handbook (2005) at 657. 

� Bum, S. et. a!., "Long-term Performance Prediction for PVC Pipes," A WW ARF Report 91 092F, May 2006. 

lJi PVC Handbook at 652-53. 

TI Scheirs, Dr. John, ExcelPlas Polymer Technology, End-of-Life Environmental Issues with PVC in 

Australia, June 1 7, 2003. 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 9 

losses of up to 70% compared to the original contents. The loss of DINA was attributed to 

biodegradation rather than leaching (Mersiowsky, 2001 b)."� 

In its submission for REACH Authorization, Exxon Mobil identified key qualities of plasticizer 

volatility and water solubility, highlighting the differences between certain grades of phthalate plasticizers 

used in PVC: 

"The factors that will affect the choice of plasticizers for specific uses include plasticizer vapor 

pressure, boiling point but also viscosity and diffusion coefficient. These physico-chemical 

properties alter with increasing molecular weight and level of branching."l2 

Of note is their remark that polar bonds between PVC resin and plasticizers used in flexible 

applications aid in their long term retention: 

"The bond between PVC and plasticizer exists and can be measured. Analysis of flexible PVC by 

FTIR (Fourier transform Infrared) spectrography shows that when plasticizers exhibit their 

plasticizing properties, there is a spectral shift of the plasticizer carbonyl bond in the ester and the 

carbon-chlorine bond in PVC (frequency of the carbonyl bond is reduced). The lower frequency 

is a result of the physical interaction. The bond is at the heart of the physical properties of 

flexible PVC. ... In absence of durable bonds or interactions, flexible PVC would not be used to 

produce durable goods like cables, roofing, geo-membranes, etc."40 

D. Nature and Severity of Past Human Health and Environmental Damage 

CBD's petition engages in unsupported speculation that fails to establish any causal connection 

between PVC waste, exposure to phthalates, and harm to health or the environment. In addition, CBD's 

petition fails to distinguish between exposure due to improper disposal and exposure due to use of 

substances that contain phthalates, which is not relevant to the listing of hazardous waste under section 

261.11 (a)(3).11 

For further consideration, EPA should weigh heavily more evidence that humans and mammals 

metabolize phthalates differently than rodents. The most recent study, conducted by Brown University 

researchers sponsored by the National Institute of Health, indicated that dibutyl phthalate, one of the more 

� Fate of PVC Polymer, Plasticizers, and Stabilizers in Landfilled Waste, lvo Mersiowsky, Journal of Vinyl 

and Additive Technology, March, 2002, Vol 8, No. 1. 

Submission of information on DINP CAS#68515-48-0, EC#271-090-9 as an alternative to DEHP 

Applications for Authorisation, ExxonMobil Petroleum and Chemical B.V.B.A., Jan. 7, 2014. 

� !d. at 6. 

il Dithiocarbamate Task Force v. EPA, 98 F.3d 1398, 1401 (D.C. Cir. 1996) ("Hazards from the proper use 

of such chemicals might justify a ban under FIFRA, 7 U.S.C. § 136a(c)(5)(D) (requiring, as predicate to registration 

of a pesticide, determination that 'when used in accordance with widespread and commonly recognized practice it 

will not generally cause unreasonable adverse affects [sic] on the environment'), but that is not the purpose of 

RCRA. Outside the area of increases in mortality or serious illnesses, see 42 U.S.C. § 6903(5)(A), which EPA does 

not appear to invoke here, the statute is concerned with the hazards of a substance when 'improperly treated, stored, 

transported, or disposed of, or otherwise managed.' !d. at § 6903(5)(B)") (error in original). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 10 

active phthalates as far as rodent effect data, did not affect male infant reproductive stem cells implanted 

into rodents in a manner as previously believed:12 

"Importantly, ex vivo fetal testis phthalate exposure does not recapitulate the species-specific 

[rodent] endocrine disruption, demonstrating the need for a new bioassay to assess the human 

response to phthalates . .... 

Conclusions: Phthalate exposure of grafted human fetal testis alters fetal germ cells, but does not 

reduce expression of genes regulating fetal testosterone biosynthesis."11 

E. Action Taken By Other Government Agencies or Regulatory Programs 

Several of the constituents mentioned in CBD's petition are already RCRA hazardous waste 

constituents under the toxicity characteristic: vinyl chloride (CASRN 75-01-4), lead (CASRN 7439-92-

1 ), cadmium (CASRN 7440-43-9), and barium (CASRN 7440-39-3).� As a result, any solid waste 

(including discarded PVC materials) is regulated as hazardous waste if one of these substances is present 

in the solid waste above the regulatory level for that substance. For these substances, EPA has already 

made a determination on the relevant regulatory level under RCRA and it is entirely unnecessary for EPA 

to further regulate these substances in PVC materials under RCRA. 

Additionally, and as discussed above, residual vinyl chloride is currently regulated in PVC resin 

under the Clean Air Act by the VCM NESHAP, and the more stringent PVC MACT has been 

promulgated, which will also limit the content of other hazardous air pollutants in resin. 

Other countries such as Australia have studied end-of-life PVC materials disposition and have 

concluded that the risk is so low, that they would not take any action to regulate its disposal.� A 

comprehensive study for Europe's Vinyl 2010 project was prepared by PE Europe GMBH and included a 

section that studied alternative dispositions to PVC wire and cable at its end of life in a landfill scenario.� 

While this study is more about energy recovery, it provides a good analysis of the low risk of PVC 

materials disposed in a landfill. 

III. Toxic Substances Control Act 

A petition under section 21 (b )(1) of TSCA must "set forth the facts which it is claimed establish 

that it is necessary" to issue the rule or order requested.£ Consequently, section 21 incorporates the 

� Heger, N. E., et.al, Human Fetal Testis Xenografts Are Resistant To Phthalate-Induced Endocrine 

Disruption, National Institute of Environmental Health Sciences - NIH, Environmental Health Perspectives, April 

17,2012. 

11 !d. at 4. 

� 40 C.F.R. § 261.24. 

il Scheirs, Dr. John, Exce!Plas Polymer Technology, End-of-Life Environmental Issues with PVC in 

Australia, June 17, 2003. 

� PVC Recovery Operations, Environmental and Economic Systems Analysis, J. Kreissig et a!, PE Europe 

GmbH, April 2003. 

fZ 15 U.S.C. § 2620(b){l). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 11 

statutory standards that apply to the requested actions. 1li Thus, for a petition for rulemaking under section 

6 or section 4 ofTSCA to be granted, the petitioner must demonstrate that the facts presented meet the 

standard for rulemaking under section 6 or section 4. The claims by CBD do not even begin to meet the 

requirements for rulemaking under TSCA, and the petition must be denied. 

A. TSCA Section 6 

The standard for rulemaking under TSCA section 6 requires that the Agency find that "there is a 

reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal 

of a chemical substance or mixture ... presents or will present an unreasonable risk."12 This finding 

cannot be based on risk alone; rather, EPA is "required to consider both alternatives to a ban and the costs 

of any proposed actions and to carry out this chapter in a reasonable and prudent manner [after 

considering] the environmental, economic, and social impact of any action. ".il 

As an initial matter, a risk must be posed by the chemical substance or mixture . .l The key factors 

that EPA must consider when assessing risk are (1) effects on human health or the environment; and (2) 

the magnitude of the exposure to humans and the environment. if. Once EPA has determined "an 

acceptable level of non-zero risk ... [EPA must] choose the least burdensome method of reaching that 

levei."iJ. In doing so, EPA must consider (1) the benefits of the substance or mixture and the availability 

of substitutes; and (2) the economic consequences of the rule, including the effect on the national 

economy, small business, technological innovation, the environment, and public health.l1 

Furthermore, EPA cannot issue a rule under TSCA section 6 if the risk to human health or the 

environment can be sufficiently eliminated or reduced by taking action under a different law administered 

by EPA, unless EPA finds the TSCA §6(a) action in the public interest. To find that taking section 6 

action is in the public interest in such circumstances, EPA must (1) consider all aspects of the risk; (2) 

compare the estimated costs of complying with the section 6 rule with the estimated costs of complying 

with a rule under the other law; and (3) compare the relative efficiency of reducing risk by a section 6 

action and action under a different law . .u 

CBD's petition falls woefully short of the stringent standard for rulemaking described above. 

CBD refers to a "growing body of scientific evidence" but falls short of making the case of "unreasonable 

risk." CBD states that "no specific factual determination is necessary to establish unreasonable risk"; this 

78 Fed. Reg. 48,845 (Aug. 12, 2013). 

15 U.S.C. § 2605(a). 

iQ Corrosion Proof Fittings v. EPA, 947 F.2d 1201, 1215 (5th Cir. 1991) (internal citations omitted); see also 

15 U.S.C. § 2605(a). 

21. It is not at all clear whether CBD is petitioning for individual section 6 actions for PVC, vinyl chloride and 

phthalates, or whether CBD's petition assumes that PVC is a mixture of PVC, vinyl chloride, and phthalates (this 

section of the petition makes no reference to any other substance mentioned in other sections of the petition). 

g 15 U.S.C. §§ 2605(c)(1)(A)-(B). 

� Corrosion Proof Fittings, 947 F.2d at 1215. 

21 15 U.S.C. §§ 2605(c)(1)(C)-(D). 

� 15 U.S.C. § 2605(c). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 12 

is not true, as EPA must have a "reasonable basis" to determine that the substance or mixture "presents or 

will present" an unreasonable risk. 

Further, CBD does not even attempt to address the requirement that regulation under section 6 

must be the least burdensome alternative, and fails to provide any information on the availability of 

substitutes; the benefits provided by PVC; the costs associated with regulation. Given the important and 

widespread uses of PVC in construction, health care, electronics, packaging, and many other industries, 

regulation under section 6 would have significant costs in terms of identifying replacements, which may 

be more costly and provide less performance. In addition, any restriction on PVC will likely negatively 

impact technological innovation and public health by eliminating highly beneficial uses. 

Finally, as described in Section II, there are other, existing regulatory restrictions in place which 

currently address PVC, phthalates, and vinyl chloride (i.e., RCRA, CWA, SDWA, and CAA). CBD does 

not even mention these requirements and the potential to address the alleged risk, as required by section 

6(c). Section 6 ofTSCA is described as a gap-filler provision because the statute requires that the agency 

to explore potential action under other statutes before taking action under section 6. As a fundamental 

matter, because the CBD petition is focused on the disposal of PVC or vinyl products, the agency must 

first consider whether action, if appropriate, can be taken under waste-regulating statutes, such as RCRA. 

Because the CBD petition itself raises RCRA questions, action under TSCA is particularly inappropriate 

or premature. 

B. TSCA Section 4 

In a throw-in, one-sentence request, CBD's petition asks that EPA issue a TSCA section 4 test 

rule if EPA determines that "there are insufficient data and experience upon which to determine or predict 

the effects of ubiquitous contamination"-that is, if EPA determines a section 6 rule is not appropriate. 

CBD's petition must be denied for failing to even discuss the standard for rulemaking under section 4, let 

alone meet its burden under section 21 to establish the facts necessary for such a rulemaking. 

The standard for rulemaking under section 4 requires that EPA make an initial finding that either 

( 1) "the manufacture, distribution, processing, use or disposal of a chemical substance or mixture ... may 

present an unreasonable risk of injury to health or the environment" (known as the "hazard" finding);i6 or 

(2) a chemical substance or mixture is or will be produced in substantial quantities, and (i) it enters or 

may reasonably be anticipated to enter the environment in substantial quantities, or (ii) there is or may be 

significant or substantial human exposure to such substance or mixture (known as the "exposure" 

finding).ll In addition to making either a "hazard" or "exposure" finding, EPA must find that insufficient 

data and experience exist to reasonably determine or predict the health or environmental effects of the 

manufacture, distribution, processing, use and/or disposal of such substance or mixture; and that testing of 

such substance or mixture with respect to such effects is necessary.2! 

Thus, under section 4, EPA must still make a fmding of unreasonable risk. EPA is not authorized 

to issue a section 4 rule simply because available data do not support a section 6 rulemaking. Rather, 

EPA must find that there may be an unreasonable risk and that existing data are insufficient to evaluate 

22 15 U.S.C. § 2603(a)(l)(A)(i). 

� 15 U.S.C. § 2603(a)(1)(B)(i). 

i!i 15 U.S.C. §§ 2603(a)(l)(A)(ii)-(iii), 2603(a)(l)(B)(ii)-(iii). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 13 

the possibility of that unreasonable risk. Here, existing data is sufficient, and the available data do not 

support a fmding that PVC may present an unreasonable risk to health or the environment; PVC is wellcharacterized and understood, as discussed in Section I. Moreover, CBD does not identify any data gaps 

or suggest the type(s) of testing that should be required. Therefore, CBD's petition is not a request for an 

identifiable rule under TSCA section 4, as required by TSCA section 21 ,J2. and must be denied. 

IV. Conclusion 

In summary, CBD's petition is based on inaccurate information and does not include all of the 

literature on PVC or its constituents. CBD's petition also fails to account for existing regulatory 

requirements for PVC and the constituents cited in the petition. As a result, CBD's arguments for 

regulation under RCRA and TSCA fail to meet the standards for rulemaking under these statutes. The 

petition should be denied. 

If you have any questions or require additional information regarding this submission, please do 

not hesitate to contact me. 

12 See, e.g., 78 Fed. Reg. 41,768, 41,770 (July 11, 2013). 
Ms. Wendy Cleland-Hamnett 

Mr. Barnes Johnson 

Page 14 

cc: 

Jodi Howard 

Office of Air Quality Planning and Standards 

U.S. Environmental Protection Agency 

109 T.W. Alexander Drive 

Mail Code: E143-01 

Research Triangle Park, NC 27709 

howard.jodi@epa.gov 

Paul Lewis, Chief 

Office of Pollution Prevention and Taxies 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Mail Code: 7405M 

Washington, DC 20460 

lewis.paul@epa.gov 

Schatzi Fitz-James, Chief 

Office of Resource Conservation and Recovery 

U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Mail Code: 5304P 

Washington, DC 20460 

fitz-james.schatzi@epa.gov 

4839-5832-4766,v. 10