May 10, 2010

Information Quality Guidelines Staff

U.S. Environmental Protection Agency

1200 Pennsylvania Ave., N.W.

Washington, DC 20460

Re: Request from the Phthalate Esters Panel of the American Chemistry

Council for correction of EPA’s Action Plan for Phthalate Esters

(December 2009)

To Whom It May Concern:

The Phthalate Esters Panel (Panel) 1 of the American Chemistry Council submits this

Request for Correction to EPA under the Guidelines for Ensuring and Maximizing the Quality,

Objectivity, Utility, and Integrity, of Information Disseminated by the Environmental Protection

Agency (Guidelines). 2 This Request seeks the correction of numerous factual errors contained

in the Agency’s Phthalates Action Plan issued in December 2009. 3

As set forth in EPA’s Guidelines, information is objective when it is “presented in an

accurate, clear, complete, and unbiased manner, and as a matter of substance, is accurate,

reliable, and unbiased.” 4 In its Phthalates Action Plan, however, EPA presents information on

phthalates that is not accurate and fails to meet the requisite standard of objectivity.

As outlined in the introduction of the Phthalates Action Plan, the Plan “is intended to

describe the courses of action the Agency plans to pursue in the near term to address its

concerns.” The accuracy of the information presented in the Plan is commensurate to the

scientific integrity of EPA’s potential subsequent actions and the regulatory message these

actions convey to the market place and general public. The request for correction therefore is

of utmost significance to the members of the Phthalates Ester Panel.

1 The Panel members are: BASF Corporation, Eastman Chemical Company, ExxonMobil Chemical Company, and

Ferro Corporation. Teknor Apex Company, a major user of the materials, is an associate member.

2 EPA, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity, of Information

Disseminated by the Environmental Protection Agency, EPA/260R

‐ 02

‐ 008 (Oct. 2002).

3 http://www.epa.gov/oppt/existin gchemicals/pubs/actionplans/pht halates_ap_2009_1230_inal.pdf

4 Guidelines at 15.Information Quality Guidelines Staff

May 10, 2010

Page 2

The remainder of this letter delineates each instance of factual error and a recommend

‐

dation for corrective action. The inaccurate statements are presented in italics followed by the

Panel’s explanation of the inaccuracy and recommendation of corrective action.

The most sensitive health outcomes following exposure to some phthalates in animal studies are

the phthalate syndrome effects, which consist of changes in the fetal development of the

reproductive system. 5

Explanation of Inaccuracy

– “Phthalate syndrome” is not an accepted scientific

term or diagnosis. Reproductive development effects have been observed in

rats, but not mice, at relatively high doses. Data on the potential relevance of

these effects in rats to humans are conflicting, particularly at environmentally

relevant exposures. Much of the controversy surrounding phthalates and male

development is based on the research of Dr. Shanna Swan and her colleagues.

These researchers initially published an article in 2005 suggesting that maternal

exposure to certain phthalates resulted in a reduction in the anogenital index

(not distance) in male children. Dr. Swan was among the authors of a

commentary on this research in 2006 and she authored an additional article in

2008 that, in part, reanalyzed the data presented in the earlier publications.

More recently, Dr. Swan and her colleagues published a report suggesting

reduced male play behavior in the same male children.

The methodologies used by Dr. Swan to generate her data and the statistical

analysis she has employed to present her results are considered by most to be

controversial and require further, independent verification. The information

available from the publications, and from Dr. Swan, has not been sufficient to

allow a comprehensive assessment of the potential significance of her results.

As a consequence, the National Toxicology Program’s Center for the Evaluation

of Risks to Human Reproduction (CERHR) did not incorporate the results of the

Dr. Swan’s research into their 2005 evaluation of DEHP. In evaluating the

research, the CERHR report concluded

–

However there were no data presented on the reliability of the

measurement of anogenital distance [AGD] or other variables that

may be associated with anogenital distance. Methods used to

determine independent or combined effects of various phthalates

(creation of summary score) were not appropriate for that

purpose. A weakness of the study is that potential confounding

by clinic, education, and calendar time was not assessed. 6

5 Phthalates Action Plan at 4.

6 CERHR, Expert Panel Report on Update on the Reproductive and Developmental Toxicity of Di(2

‐ ethylhexyl)

Phthalate (November 2005), page 54.Information Quality Guidelines Staff

May 10, 2010

Page 3

Recommendation for Corrective Action : Remove discussion of Phthalate

Syndrome.

Several human studies have reported associations of exposure of some phthalates with adverse

reproductive outcomes and developmental effects similar to those in the rat, although no casual

link has been established (Swan et al., 2005, Huang et al., 2009). 7

Explanation of Inaccuracy

– The beginning of this statement, “several human

studies have reported associations of exposure with adverse reproductive

outcomes,” is not accurate. The reports cited in this statement

– Swan et al.

(2005) and Huang et al. (2009)

– do not make any claims that reproductive

outcomes are affected by phthalates. No adverse reproductive effects in

humans are attributable to phthalates. Furthermore, the paper by Huang et al.

(2009) does not report any adverse effects in male infants

– the population of

concern.

Recommendation for Corrective Action : Remove the phrase “with adverse

reproductive outcomes” from the statement.

The reproductive developmental effects observed in humans include shortened anogenital

distance observed in newborn boys; and shortened pregnancy, lower sex and thyroid hormones,

and reduced sperm quality in adults. 8

Explanation of Inaccuracy

– The Phthalates Action Plan does not provide a

citation for the specific references used to support this statement. The sources

EPA is presumably referencing are small, clinical studies that require

independent verification. The Action Plan fails to indicate that the observed

effects are quite controversial and are contradicted by other research. The

suggestion of shortened anogenital index (not distance) by Swan et al., (2005)

was determined to be “novel” by the NTP

‐ CERHR whose relevance in humans

“has not been established.” The anogenital distances reported by Swan and her

colleagues, moreover, appear to be within the normal population distribution

reported by Thankamony et al., (2009) 9 and may be more reflective of the

differences in age between Swan’s groups than of exposures to certain

phthalates. Reports of shortened pregnancy are contradicted by suggestions of

7 Phthalates Action Plan at 4.

8 Id. at 4.

9 Thankamony A et al. Anogenital Distance from Birth to 2 Years: a Population Study. Environ Health Persp

117(11): 1786

‐ 1790 (2009).Information Quality Guidelines Staff

May 10, 2010

Page 4

longer pregnancies in other studies (Wolff et al.

, 2008; Adibi et al.

, 2009), 10,11 as

have the suggestions of lower sex hormones (Rais

‐ Bahrami et al.

, 2004) 12 and

reduced sperm quality (Herr et al.

, 2009). 13

Recommendation for Corrective Action : Revise statement to read “The

reproductive developmental effects reported in humans include shortened

anogenital index in newborn boys, lower sex and thyroid hormones, and reduced

sperm quality in adults, although other studies have failed to find an association

with phthalate exposure.”

In addition, recent studies in animals evaluating the cumulative effects of mixtures of

several active phthalates on testosterone production, fetal mortality, and male and

female reproductive development later in life showed all mixtures were cumulative for

all endpoints (Rider et al., 2008, 2009; Howdeshell, et al., 2007, 2008a, 2008b; Gray et

al., 2006; Hotchkiss et al., 2004). 14

Explanation of Inaccuracy

– The results of cumulative exposure studies have

been mixed. The research conducted by Gray and his coworkers have suggested

dose

‐ additivity in laboratory animals at relatively high

‐ dose levels (~150 mg/kg

body weight), but Foster et al. 15 were unable to produce additivity at lower

doses (~100 mg/kg). More recent studies have suggested response additivity

whereby substances may have the same effect by different mechanisms. These

studies also have been conducted at high doses that are not reflective of

environmental exposures.

Christensen et al., (2009) acknowledge that “our developmental rat model would

not have produced any responses, had we combined all mixture components at

[low, environmentally relevant exposure levels.]” 16 This finding is supported by

10 Wolff MS et al. Prenatal phenol and phthalate exposure and birth outcomes. Environ Health Persp 116(8):

1092–1097 (2008).

11 Adibi JJ et al. Maternal urinary metabolites of di

‐ (2

‐ ethylhexyl) phthalate in relation to the timing of labor in a

US multi

‐ center pregnancy cohort. Am J Epidemiol 69(8): 1015–1024 (2009).

12 Rais

‐ Bahrami K et al. Follow

‐ up study of adolescents exposed to di(2

‐ ethylhexyl) phthalate (DEHP) as neonates

on extracorporeal membrane oxygenation (ECMO) support. Environ Health Persp 112: 1339

‐ 40 (2004).

13 Herr C et al. Urinary di(2

‐ ethylhexyl) phthalate (DEHP)

– metabolites and male human markers of reproductive

function. Intl J Hyg Environ Health 212(6): 648

‐ 653 (2009).

14 Phthalates Action Plan at 4.

15 Foster PMD et al. Antiandrogenic effects of a phthalate combination on in utero male reproductive

development in the Sprague

‐ Dawley rat: additivity of response?, Poster presentation at Society of Toxicology

Annual Meeting (2002).

16 Christiansen S et al. Synergistic disruption of external male sex organ development by a mixture of four

antiandrogens. Environ Health Persp 117(2): 1839

‐ 1846 (2009).Information Quality Guidelines Staff

May 10, 2010

Page 5

earlier studies of up to 25 chemicals at environmental dose levels by Chapin et

al., (1989) 17 and Heindel et al., (1995). 18

The absence of a cumulative effect at environmental relevant levels is further

supported by the evaluation conducted by Benson (2009) who concluded that “it

is unlikely that humans are suffering adverse developmental effects from current

environmental exposure to these phthalate esters.

Recommendation for Corrective Action : Revise statement to read “ In addition,

recent studies in animals evaluating the cumulative effects of mixtures of several

active phthalates on testosterone production, fetal mortality, and male

reproductive development later in life have suggested dose additivity at relatively

high

‐ dose levels (Rider et al., 2008, 2009; Howdeshell, et al., 2007, 2008a, 2008b;

Gray et al., 2006; Hotchkiss et al., 2004). Similar effects have not been observed

at environmentally

‐ relevant exposure levels.”

For example, inhalation exposure for adults and children could be of concern in vehicle

interiors, particularly in summer due to elevated temperatures in vehicles given the

vapor pressure range of these chemicals. 19

Explanation of Inaccuracy

– EPA fails to cite any references to support this

assertion. Moreover, the suggestion in the Phthalates Action Plan of concern

about phthalate exposure from off

‐ gassing from vehicle interiors is contradicted

by the available data. Limited measured data are available from a survey

conducted in 2000. 20 Samples (n

= 3) were collected from car interiors and

analyzed for selected phthalates. The concentrations of DINP and DIDP did not

exceed 20 nanograms per cubic meter (ng/m 3 ). A study conducted in 2001 by

Australia’s Commonwealth Scientific and Industrial Research Organization

(CSIRO) 21 identified nine contaminants in the interior air of three new

automobile. None of the contaminants were phthalates.

17 Chapin RE et al. Toxicology studies of a chemical mixture of 25 groundwater contaminants. III. Male

reproduction study in B6C3F1 mice. Fund Appl Toxicol

. 13(3): 388

‐ 98 (1989).

18 Heindel JJ et al. Assessment of the reproductive toxicity of a complex mixture of 25 groundwater

contaminants in mice and rats. Fund Appl Toxicol 25(1): 9

‐ 19 (1995).

19 Phthalates Action Plan at 6.

20 Research Institute for Chromatography. Report: Overview of Phthalate Measurements in Air. Research

Institute for Chromatography, Ref. ECPI\2000

‐ 12

‐ S, Kortrijk, Belgium (2000). (Cited in ECB. European Union

Risk Assessment Report

– 1,2

‐ benzenedicarboxylic acid, di

‐ C9

‐ 11

‐ branched alkyl esters, C10

‐ rich and di

‐ “isodecyl” phthalate, 2003). Available at http://ecb.jrc.ec.europa .eu/DOCUMENTS/Existing

‐ Chemicals/RISK_ASSESSMENT/REPORT/didpreport041.pdf.

21 Available at http://www.csiro.au/files/medi aRelease/mr2001/newcars.htm

.Information Quality Guidelines Staff

May 10, 2010

Page 6

More recently, Buters et al., (2007) tested the health effects of emissions from

two vehicles (one new, one used) under conditions simulating being parked in

sunshine. 22 The researchers identified about 50 contaminants, none of which

were phthalates. They report that “phthalates” were low in both the new and

used vehicle. Importantly, the study employed halogen lamps to mimic

environmental sunshine exposure and sampled the interior air at 65 degrees C

(150 degrees F).

Contrary to EPA’s suggestion, in fact, the phthalates used in car interiors have

very low vapor pressures and would not be expected to result in inhalation

exposure.

Recommendation of Corrective Action : Remove discussion of potential

exposure due to vehicle interiors.

Due to their pervasive use and release, as well as its propensity for global transport, phthalates

are found in most environmental media, for example ambient air, surface water, soil, sediment,

etc (EC, 2003a

‐ b; 2008a

‐ b; NTP

‐ CERHR, 2003 a

‐ e; 2006). 23

Explanation of Inaccuracy

– It is not clear what EPA is using as its source in

suggesting that phthalates have a “propensity for global transport.” The

references cited in the Phthalates Action Plan suggest, in fact, that phthalates

are rapidly broken down in the environment. As noted elsewhere in the Action

Plan, phthalates are not considered to be either persistent or bioaccumulative.

Notably, none of the phthalates are candidates for listing under the UN

Stockholm POPs Convention, the international instrument under which

chemicals whose properties for global transport would be expected to be

addressed. None are listed under EPA’s Resource Conservation and Recovery

Act Waste Minimization Persistent, Bioaccumulative and Toxic (PBT) Chemical

List. 24

Phthalate esters are readily biodegradable, and therefore not persistent, based

on “ready” biodegradation testing that involves stringent methods of assessing

the potential for the biodegradation of a substance. Passing a ready

biodegradation test indicates that the substance will be rapidly biodegraded in

the environment. Phthalates also have been shown to rapidly biodegrade in test

systems that used the natural microbial consortia found in soil and water.

22 Buters JTM et al. Toxicity of Parked Motor Vehicle Indoor Air. Environ. Sci. Technol. 41(7): 2622

‐ 29 (2007).

23 Phthalates Action Plan at 7.

24 http://www.epa.gov/osw/hazard/wastemin/priority.htm.Information Quality Guidelines Staff

May 10, 2010

Page 7

Recommendation for Corrective Action : Remove “ as well as its propensity for

global transport ” from the statement.

Among other provisions, the Consumer Product Safety Improvement Act of 2008 (CPSIA) banned

the use of six phthalates in toys and child care articles at concentrations greater than 0.1

percent: DEHP, DBP, BBP, DINP, DIDP and DnOP. 25

Explanation of Inaccuracy

– The Phthalates Action Plan misstates the

requirements of the CPSIA. Three phthalates

‐ DEHP, DBP, and BBP

‐ have been

permanently prohibited by Congress in concentration of more than 0.1% in

“children’s toys” or “child care articles.” The other three phthalates

‐ DINP,

DIDP, and DnOP

‐ have been prohibited only in child care articles and toys that

can be placed in a child’s mouth pending scientific review by a group of outside

experts and the Commission.

A more complete review of the requirements can be found at

http://www.cpsc.gov/about/cpsia/sect108.html.

Recommendation for Corrective Action : Change to read, “Among other

provisions, the Consumer Product Safety Improvement Act of 2008 (CPSIA)

banned the use of DEHP, DBP, and BBP in children’s toys and child care articles at

concentrations greater than 0.1 percent. The act also imposes an interim

prohibition on DINP, DIDP, and DnOP in toys and child care articles that can be

placed in a child’s mouth.”

As part of a statute concerning chemicals in children’s products generally, Washington prohibits

a manufacturer, wholesaler, or retailer from manufacturing, knowingly selling, offering for sale,

or distributing for sale or for use in the state a children’s product or product component

containing phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) individually or in combination, at a

concentration exceeding 0.1% by weight (CRS, 2008). 26

Explanation of Inaccuracy

– This is not an accurate statement. Washington’s

Department of Ecology (DOE) withdrew the proposal to implement the

Children’s Safe Products Act (CPSA) that would have adopted several enacted

sections of the CPSA and clarified the requirements as they pertained to

electronic components. DOE determined that the phthalate standards

established by the state’s CPSA were preempted by the passage of the federal

Consumer Product Safety Improvement Act. 27

25 Phthalates Action Plan at 8.

26 Id. at 10.

27 Washington DOE, Notice from Laurie Davies, Program Manager

– Solid Waste and Financial Assistance, WSR

08

‐ 23

‐ 040 (November 5, 2008). Available from http://www.ecy.wa.gov.Information Quality Guidelines Staff

May 10, 2010

Page 8

Recommendation for Corrective Action : Remove the discussion of the

Washington statute.

Please feel free to contact me at steve_risotto@americanchemistry.com or 703

‐ 741

‐

5501 if you have any questions on this submission.

Sincerely,



## Steve Risotto

Stephen P. Risotto

Senior Director, Phthalate Esters