**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 (T** **SCA).**

**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, Ej** **lertsson, 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, Ej** **lertsson. 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%**  **Co m** **pounders 9** **%** 

# \ **10%**

# \ **Molding**

# \ **(Inc. Fittings)** **, 4%** **"' Extruded** 



# -·**:���**

**! Fence**  **& =.**  **Deck**

# / **2% Extruded**  **Windows and**  **Doors 5%**  **l!xtrudad Pipe**  **Extruded Sheet**  **(Pkg. &** **Non Pkg.)**  **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 'obje** **ctive' 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; 1**  **13(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 con**  **jecture 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.**  **§ 261.1**  **1 (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.**  **Dep 1** **edge 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..Q 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 /** **a ct** **i o** **nplans /** 

**phthalates.html**
**. 11**  **See 40**  **C.F.R. §**  **261.ll (a)(3).**  **il Dithiocar**  **b amate**  **Task Force**  **v. EPA,**  **98 F.3d**  **1398, 1402**  **(D.C. Cir.**  **1996)**

**. .L1**  **See Dithiocar**  **b amate**  **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. lll**  **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**  **/ safeharbor** **08 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** **:/ /** **www**

**. 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** 

**. :ill**  **Diethyl phthalate**  **(CASRN 84-74-2),**  **available at:**  **http: //** **www.epa**
**. gov** **/ iris** **/ subs** **t/ 0226.htm** 

**. 2.!**  **Dimethyl phthalate**  **(CASRN 131-11-3),**  **available at:**  **http: //** **www**
**. epa** 
**. gov** **/ iris** **/ subs** **t/ 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: //** **www**
**. epa** 
**. gov** **/ iris** **/ toxreviews** **/ OO** **l Otr.pdf.**  **n Cadmium**  **(CASRN 7440-43-9),**  **available at:**  **http :** **// www** 
**. epa** 
**. gov** **/ iris** **/ subst/014** **l . 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**  

### 0.1 **8 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. :ll**  **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**  **Devel opment-of-** **Estimated-Quantitation- Levels-for-the-Second-Six-Year-** **Review-of-National Primary-Drinking-** **Water-Regulations, p.4-31** **,October, 2009**  **found at:**  **http:/ /water.epa.** **gov/la wsregs/rulesregs/regulatingcontaminants/** **sixyearreview/ second**  **_review/ upload/Development**  **of- Estimated-Quantitation-** **Levels- for-the-Second-Six-Year-Review-of-** **National-Primary-Drinking-Water Regulations.pdf**  **:ill 21**  **C.F.R. §18** **1.27. 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."**  **.ll 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 iner** **t.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 Foundati** **on.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 "T** **he 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:// www** **.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: "T** **he 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: "T** **he bond**  **between PVC**  **and plasticizer**  **exists and**  **can be**  **measured. Analysis**  **of flexible**  **PVC by**  **FT IR**  **(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#6** **8515- 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 Agenc** **ies 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**  **of TSCA**  **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. ".ill**  

### As **an initial**  **matter, a**  **risk must**  **be posed**  **by the**  **chemical substance**  **or mixture** 

**. .ll**  

### 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**  **of TSCA**  **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** **)(i i** **) -(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 well**  **characterized 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**

**483 9-583** **2-4766,v. 10**