May 12, 2008 

Attention: Docket ID Number EPA–HQ–OPPT–2008–0273 

Environmental Assistance Division (7408M) 

Office of Pollution Prevention and Toxics 

Environmental Protection Agency 

1200 Pennsylvania Ave., NW 

Washington, DC 20460–0001 

Re: Comments on Mr. Michael Dochniak Section 21 TSCA Petition

Dear Sir or Madam: 

The Rubber Manufacturers Association (“RMA”) submits the following 

comments on the petition from Michael J. Dochniak filed pursuant to Section 21 of the Toxic 

Substance Control Act on March 6, 2008, requesting that the Environmental Protection Agency 

(“EPA”) “establish regulations prohibiting the use and distribution in commerce of Hevea 

brasiliensis natural rubber latex (NRL) adhesives having a total protein content greater than 200 

micrograms per dry weight of latex based on the American Society for Testing and Material’s 

method ASTM D1076–06 (Category 4)” because “implementation of an EPA regulation may 

affect the incidence and prevalence of latex allergy and allergy-induced autism in neonates.”1

(“Dochniak Petition”) 

 1

 EPA, Hevea brasiliensis Natural Rubber Latex Adhesives; TSCA Section 21 Petition; Notice of Receipt, 

73 Fed. Reg. 22,368 (April 25, 2008) [EPA–HQ–OPPT–2008–0273; FRL–8361–3] (“Dochinak Petition Fed. Reg. 

Notice”). 
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RMA is a not-for-profit national trade association, which represents 

approximately 80 member companies who manufacture goods made with rubber. A number 

RMA members use and distribute in commerce Hevea brasiliensis natural rubber latex adhesives 

and some members produce Hevea brasiliensis natural rubber latex that is used in the 

manufacture of adhesives. If EPA promulgates a regulation consistent with the relief requested in 

the Dochniak Petition, these companies would be banned from selling their products in the 

United States. Therefore, RMA members have a significant interest in this proceeding. 

In summary, autism can be a severe medical condition that presents significant 

obstacles to the individual who have the condition and daunting challenges to the relatives and 

friends of these individuals. Rightfully, the Federal government and private groups support 

research into this condition. However, the allegations in the Dochniak Petition that claim 

exposure to natural latex rubber allergens cause autism are not supported by any peer reviewed 

scientific article or any original data. The allegations also do not follow the criteria for reviewing 

scientific information provided in EPA’s Assessment Factors Document. Therefore, there is no 

unreasonable risk to health. Finally, the relief sought (a complete ban) is not the least 

burdensome requirement, as required by TSCA. 

Our comments are organized as follows. Section I provides a brief background on 

the Petition, including a discussion of the requirements of TSCA Section 21. Section II 

summarizes the weight of scientific opinion concerning the allegation and the reasons that EPA 
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should reject the Petition. Section III summarizes the lack of evidence linking latex exposure to 

autism. 

I. BACKGROUND ON THE PETITION

A. Introduction

EPA received the Dochniak Petition on March 6, 2008 and published notice of the 

petition on April 25, 2008. Subsection B describes the basic TSCA statutory framework. 

Subsection C discusses the Section 21 petition process. Subsection D summarizes the scientific 

factors that EPA uses in assessing such a petition. 

B. The Basic TSCA Framework

The Toxic Substances control Act, 15 U.S.C. §§ 2601-2629, was first enacted in 

1976. The overall purpose of the Act was to establish a comprehensive national system for 

“evaluating and regulating chemical substances to protect against unreasonable risks to human 

health and to the environment.” Chemical Mfrs. Ass’n v. EPA, 359 F.2d 977, 979 (D.C. Cir. 

1988); Ausimont U.S.A., Inc. v. EPA, 838 F.2d 93, 95 (3d cir. 1988). Section 6 of the Act 

authorizes EPA to impose controls on the production, distribution, use, and disposal of toxic 

substances if the evidence shows that such activity “presents or will present an unreasonable risk 

of injury to health or the environment.” 15 U.S.C.§ 2605(a). Regulatory controls may include 

labeling guidelines, notice requirements, or restrictions on the production and distribution of 

toxic substances. Id. Section 4 of the Act authorizes EPA to require testing of chemical 

substances or mixtures if it find that such substances “may present an unreasonable risk of injury 
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to health or the environment” and that “there are insufficient data and experience” upon which to 

predict the effects of such substances. 15 U.S.C. § 2603(a)(1)(A). Lastly, section 8 authorizes 

EPA to impose reporting and record-keeping requirements on the manufacturers and processors 

of toxic substances. 15 U.S.C. § 2607; see also Environmental Defense Fund v. Thomas, 657 F. 

Supp. 302, 304 (D.D.C. 1987). 

While seeking to eliminate “unreasonable risk,” Congress directed EPA to 

exercise its authority “in such a manner as not to impede unduly or create unnecessary economic 

barriers to technical innovation.” 15 U.S.C. § 2601(b)(3). EPA must carry out the provisions of 

the Act in a “reasonable and prudent manner” and must “consider the environmental, economic, 

and social impact of any action” taken. 15 U.S.C. § 2601(c); see also Ausimont U.S.A., Inc. v. 

EPA, 838 F.2d at 95.2 If EPA issues rules governing the production or disposal of any toxic 

substance, it must consider the “reasonably ascertainable economic consequences” of potential 

regulatory restrictions. 15 U.S.C. § 2605(c)(1)(D). The agency must also select “the least 

burdensome requirements” that would be effective. 15 U.S.C. § 2605(a); see also 122 Cong. Rec. 

32,828 (1976).3

 2

 Congress required EPA to carefully consider the costs and benefits of any regulatory restrictions imposed 

under the Act. See S. Rep No. 698, 94th Cong. 2d Sess. 13 (1976) (“It is important to note that in the testing and key 

regulatory provisions of the legislation, it is specifically required that the Administrator evaluate the risks and 

benefits of his actions before talking regulatory action. Thus, costs are not to be incurred unless they are offset by 

benefits of at least the same magnitude.”); 122 Cong. Rec. 32,852 (1976); see also 15 U.S.C. § 2605(c)(1). 

3

 As EPA has stated, a “basic principle embodied in TSCA is that the Agency must adopt regulatory 

requirements which impose the smallest social and economic burden possible . . . .” Guidance for Petitioning the 

Environmental Protection Agency Under Section 21 of the Toxic Substances Control Act, 50 Fed. Reg. 46,825, 

46,826 (1985) (“Petition Guidance”). 
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In addition to authorizing EPA to regulate the use and disposal of all toxic 

substances, the Act imposes specific restrictions on the use and disposal of polychlorinated 

biphenyls and asbestos. 

C. TSCA Section 21 Petition Process

TSCA specifically provides that “[a]ny person may petition the Administrator to 

initiate a proceeding for the issuance, amendment, or repeal of a rule under Sections 2603, 2605, 

or 2607 . . . .” 15 U.S.C. § 2620(a). Such a petition “shall set forth the facts” justifying the 

requested relief. EPA may “hold a public hearing or may conduct such investigation or 

proceeding” as may be necessary. 15 U.S.C. § 2620(b)(2). EPA must either grant or deny the 

petition within 90 days of its filing. 15 U.S.C. § 2620(b)(3).4 Section 21 itself does not impose a 

legal standard for the issuance of relief.5

 The agency’s decision, therefore, must be based upon 

the fundamental policies underlying the entire Act. EPA’s regulatory approach must be designed 

to eliminate any “unreasonable risk” using the least burdensome and least costly means 

available. 15 U.S.C. §§ 2601(b),(c), 2605(a), (c), (e). 

If EPA grants a citizens petition, it must promptly initiate a proceeding under the 

appropriate section. 15 U.S.C. § 2620(b)(3). If EPA denies the petition, it must publish its 

reasons for the denial in the Federal Register. Id. Where the petition is denied, or where EPA 

 4

 The “remedies under this section shall be in addition to and not in lieu of, other remedies provided by 

law.” 15 U.S.C. § 2620(b)(5). 

5

 EPA has issued “guidance” on section 21 petitions, but this guidance is non-binding and is mainly 

procedural in nature. See Petition Guidance, supra, note 3. In its guidance, however, EPA must “balance the benefits 

derived from risk reduction against the social and economic costs” of regulation. Id. at 46,826. 
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fails to act on the petition within the prescribed 90-day period, the petitioner may seek judicial 

review in federal district court. 15 U.S.C. § 2620(b)(4); Environmental Defense Fund v. Thomas, 

657 F. Supp. at 304-305. 

For the Dochniak Petition, EPA must respond by June 3, 2008. EPA is allowing 

public comment until Monday, May 12, 2008.6

D. EPA Uses Generally Accepted Sciencific Principles To Assess Data

EPA’s notice of the Latex Adhesive Petition states that EPA uses the “Assessment 

Factors Document” to evaluate data quality. These Factors include: 

“Soundness - The extent to which the scientific and technical procedures, 

measures, methods or models employed to generate the information are 

reasonable for, and consistent with, the intended application. 

Applicability and Utility - The extent to which the information is relevant for the 

Agency’s intended use. 

Clarity and Completeness - The degree of clarity and completeness with which 

the data, assumptions, methods, quality assurance, sponsoring organizations and 

analyses employed to generate the information are documented. 

Uncertainty and Variability - The extent to which the variability and uncertainty 

(quantitative and qualitative) in the information or in the procedures, measures, 

methods or models are evaluated and characterized. 

Evaluation and Review - The extent of independent verification, validation and 

peer review of the information or of the procedures, measures, methods or 

models.”7

 

(continued...)

6

 Dochinak Petition Fed. Reg. Notice, 73 Fed. Reg. at 22,369. 

7

 EPA Science Policy Council, A Summary of General Assessment Factors for Evaluating the Quality of 

Scientific and Technical Information at 4 (EPA 100/B-03/001, June 2003) (“Assessment Factors Document”) 

(available at <http://www.epa.gov/OSA/spc/pdfs/assess2.pdf>) was prepared under the auspices of the EPA Science 
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________________________ 

(continued...)

The Assessment Factors Document “complements the Guidelines for Ensuring 

and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by 

the Environmental Protection Agency.”8 The EPA Information Quality Guidelines “involves a 

‘weight-of-evidence’ approach that considers all relevant information and its quality, consistent 

with the level of effort and complexity of detail appropriate to a particular risk assessment.”9

 

EPA relies upon “the best available science and supporting studies conducted in accordance with 

sound and objective scientific practices, including, when available, peer reviewed science and 

supporting studies,” “data collected by accepted methods or best available methods, and use of 

comprehensive, informative information.10

Scientific causation “can be answered only through ... formulating a question that 

can be answered, designing a study that can answer it, collecting objectively verifiable evidence 

that will address the question, and drawing only those conclusions supported by the evidence.”11 

Policy Council (SPC) to describe the assessment factors and considerations generally used by the Agency to 

evaluate the quality and relevance of scientific and technical information. Id. at iv. 

8

 Id. at 1. 

9

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

Disseminated by the Environmental Protection Agency at 21 (EPA/260/R-02-008), available at 

<http://www.epa.gov/QUALITY/informationguidelines/documents/EPA_InfoQualityGuidelines.pdf.>. 

10 Id. at 22. 

11 Brief of Amicus Curiae The New England Journal of Medicine and Marcia Angell, M.D., In Support of 

Neither Petitioners Nor Respondents at 5, in General Electric Co. v. Joiner, 522 U.S. 136, 118 S. Ct. 512 (1997). 
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However, if the theory passes the test, it “is not confirmed, but merely corroborated.”12 

Causation is determined after an evaluation of the weight of all the scientific evidence in light of: 

(1) the temporal relationship;13 (2) consistency of the effect across different studies;14 (3) the 

magnitude of the theoretic incidence of disease in an exposed population compared to an 

unexposed or less exposed population (called relative risk) found in the studies (i.e., preferably 

there is a relative risk ratio15 of greater than 2.0);16 (4) whether there is a biological gradient 

between the level of exposure and the magnitude of the effect (that is, does higher exposure 

 12 National Academy of Sciences proceeding on scientific evidence workshop: Science, technology, and 

law program at 12 (September 2000), at http://www7.nationalacademies.org/stl/Scientific_Evidence_PDF.pdf

(“NAS Scientific Evidence Workshop”). 

13 The adverse health effect has to occur within a biologically reasonable time after initial exposure. 

Because some adverse health effects are believed to become manifest only after a latency period, the determination 

of temporal effect is not always straightforward. 

14 The strongest association occurs when the same effect in the same organ with the same biological 

mechanism is observed in several independent studies of a similar exposure in different populations. The 

association may be strong if it consistently occurs in different subgroups in the same study. Bias and confounding 

factors need to be taken into account in reviewing multiple studies. 

15 The relative risk is the ratio of the risk of disease or death among the exposed population to the risk in 

the unexposed population. 

16 A statistically significant relative risk of 2.0 means that the more exposed population had twice the rate 

of disease than expected from an examination of a population that was not exposed or significantly less exposed. 

Thus, in those situations where, based on the weight of the evidence, the exposure caused an increased relative risk 

of 2.0, any one individual in the exposed population would have a 50% probability of having their disease caused by 

the exposure. J. Rosenbaum, Lessons from Litigation over Silicone Breast Implants: A Call for Activism By 

Scientists, Vol. 276, SCIENCE, No. 5318, Issue 6, p. 1524 (June 6, 1997), at

http://www.sciencemag.org/content/vol276/issue5318/. 

According to US EPA, “when a relative risk is less than 2, if confounders [i.e., other potential causes of the 

disease being studied]... are having an effect on the observed risk increases, it could be enough to account for the 

increased risk.” US EPA, Health Assessment Document for Diesel Engine Exhaust at 7-138 (EPA/600/8-90/057F, 

May 2002), at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=29060. 
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result in a higher incidence of disease);17 (5) the specificity of the association;18 (6) the 

biological plausibility that the exposure could cause the effect;19 and (7) coherence.20 Thus, a 

statistical association in one or even a few studies is typically not sufficient to determine that an 

exposure caused cancer, unless the cancer is rare and the risk ratio is very large. 

Thus, there are well established data evaluation rules that EPA must follow. 

E. The Requested Relief – Banning the Use or Impact of “Latex Adhesives” 

In this case, the Petitioners request that EPA totally ban the use or sale in 

interstate commerce of “latex adhesives”. Even if there were a risk, which, in any event, is not 

supported by the scientific evidence, there are many less burdensome approaches than a ban. 

 17 Generally, the risk ratio should increase with increasing exposure or dose. 

18 For most chemicals, exposure results in a specific type of disease or adverse health outcome. It is 

generally considered less biologically plausible to hypothesize a substance that would cause an increase in all 

diseases or all cancers. 

19 Biological plausibility is the factor that is both conceptually simple to understand, yet difficult to apply. 

The mechanism for many diseases is not yet fully understood. Generally, toxicologists evaluate data from animal 

studies, the toxicokinetics of the substance (i.e., how the chemical moves through the body and interacts with cells), 

the structure-activity relationship compared to other known carcinogens, and the data from short-term studies of the 

agent’s influence on biological steps known or believed to occur. 

20 Evaluating coherence involves comparing the assumed cause-and-effect relationship with what is known 

about the history and biology of the disease, i.e., the entire body of knowledge about the agent. Some authors do not 

include coherence as a separate factor. The A.B. Hill. criteria have long been recognized as the key criteria to assess 

causality. 
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II. THE WEIGHT OF SCIENTIFIC OPINION FAVORS A FINDING THAT 

EXPOSURE TO NATURAL LATEX RUBBER DOES NOT CAUSE 

AUTISM

The Dochniak Petition alleges that: (a) natural rubber latex "has seen a dramatic 

increase in usage over the last 30-years;" (b) this timing coincides with an increase in the 

diagnoses of autism; and (c) natural rubber latex causes allergic reactions in the general 

population. The petition also makes a number of unsupportable statements such as "an immune 

response associated with Hev-b proteins may induce IgE-secreting lymphocytes to form 

antibodies that target dissimilar exogenous/endogenous proteins through the cross-react 

mechanisms." Autism spectrum disorders Exogenous protein insult article at 545-46. 

The risk assessment process generally requires: (a) a hazard identification (i.e., 

the substance at some plausible exposure level is capable of causing the adverse health impact), 

(b) evidence of exposure; (c) a dose-response (i.e., evidence that there is scientific correlation 

between exposure and the adverse response); and (4) the risk characterization (i.e., the 

quantitative risk from the likely exposure). None of these elements have been met. 

The allegations in the Dochniak Petition are just that -- unsupported and 

unsupportable allegations. Given the short period of time available to review the material, the 

RMA provides the following preliminary list of fundamental problems with the allegations. This 

list is not complete. 

1. The paper attached to the Dochniak Petition is not a peer reviewed journal ("TSCA 

Petition Paper"). 
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The TSCA Petition Paper is published in "Medical Hypotheses." The editors of 

Medical Hypothesis candidly state that this publication takes a deliberately different approach to 

review. Most contemporary practice tends to discriminate against radical ideas that conflict with 

current theory and practice. “Medical Hypotheses will publish radical ideas, so long as they 

are coherent and clearly expressed. Furthermore, traditional peer review can oblige authors to 

distort their true views to satisfy referees, and so diminish authorial responsibility and 

accountability. In Medical Hypotheses, the authors' responsibility for the integrity, precision and 

accuracy of their work is paramount.”21 (bold face and red highlighting added). 

According to the author's web site, the "costs of publication of the Med. 

Hypotheses article were defrayed in part by the payment of page charges. This article must 

therefore be hereby marked advertisement in accordance with 18 U.S.C.Section 1734 solely to 

indicate this fact.)"22 In short, this is a radical theory propounded by the author. By definition, 

publication in Medical Hypothesis means that this “radical” allegation in the TSCA Petition 

Paper is not generally accepted and does not follow scientifically sound, reproducible 

methodology. The TSCA Petition Paper does not even attempt to statistically correlate increased 

use (however defined) with increases in autism. In the field of Autism diagnosis, there has been 

considerable increase in physicians’ ability to detect autism in the last 30 years. But even if there 

21 Available at 

<http://www.elsevier.com/wps/find/journaldescription.cws_home/623059/description#description>). 

22 Available at (http://www.autismdoc.org/page2.html). 
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is a component of increased risk that is not due to better diagnoses, it could be due to other 

confounding factors, not latex. 

2. The TSCA Petition Paper provides no new data, but paraphrases other published 

articles, newspaper articles and web sites. 

The TSCA Petition Paper cites no original data, and citations to newspaper 

articles, press releases and other nonscientific sources of information are not the type of 

“scientific evidence” that EPA’s Assessment Factors Document and Information Quality 

Guidelines permit EPA to be rely upon in promulgating a TSCA rule. 

3. No peer reviewed scientific articles support a relationship between exposure to 

natural latex rubber and autism. 

The assertions made in the Dochniak Petition are not supported by any scientific 

evidence or generally accepted scientific methodology. A search of Medline yielded no peer 

reviewed scientific studies that found a correlation between exposure to natural latex proteins 

and autism. Similarly, a search of the National Institute of Environmental Research and EPA 

web sites found no research investigating a hypothetical link between exposure to allergenic 

natural rubber latex proteins and autism.23 RMA is not aware of any other article (peer reviewed 

or not) that demonstrates a correlation between exposure to natural latex proteins and autism. 

23 Obviously, there is research on autism generally and nothing in this comment on the Dochniak Petition 

suggests otherwise. However, no researcher, as far as RMA can determine, has deemed testing this allegation worth 

the expenditure of limited research funds. 
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The Food and Drug Administration,24 the Consumer Product Safety 

Commission,25 the National Institute of Occupational Safety and Health,26 the American 

Conference of Governmental and Industrial Hygenists (“ACGIH”) (2008),27 and the 

Occupational Safety and Health Administration28 have investigated allergic reactions to natural 

rubber latex proteins, primarily from dipped rubber products (discussed below). None of these 

agencies (although focused on allergic reactions from exposure to natural rubber latex) found a 

link to autism. Natural rubber latex has been utilized for over a hundred years without any 

observation of a link (even among the rubber farms and latex processor workers who have 

significantly higher levels of exposure). 

24 FDA, Natural Rubber-Containing Medical Devices; User Labeling, 62 Fed. Reg. 51,021 (September 30, 

1997). This rule covers medical adhesives that are in contact with humans. Id. at 51,024. 

On 12/20/2007, Michael J. Dochniak (the author of the Dochniak TSCA Petition that is the subject of this 

comment) also filled a petition (2007P-0486) requesting the issuance of a regulation for Hevea Basiliensis naturalrubber-latex, used in the manufacture of infant products (available at 

<http://www.fda.gov/ohrms/dockets/CITPETS/07citpetlist.htm>. It is pending. 

25 Letter from Todd Stevenson, Secretary of CPSC to Ms. Debra Adkins, Petitioner, re: Denying the 

petition requesting the CPSC to declare natural latex rubber a strong sensitizer at 2 (June 4, 2004), in part because 

exposure to consumer products containing natural latex rubber (including adhesives) resulted in few documented 

cases of allergic reactions and most were from medical devices within the jurisdiction of the FDA. 

26 NIOSH, Alert, Preventing Allergic Reactions to Natural Rubber Latex in the Workplace (June 1997, 

DHHS (NIOSH) Publication No. 97-135), available at <http://www.cdc.gov/niosh/latexalt.html>. 

27 The ACGIH threshold limit value ("TLV") for natural latex is 0.0001 mg/m3

, as Inhalable allergenic 

proteins. ACGIH, Natural Rubber Latex: TLV® Chemical Substances 7th Edition Documentation (Publication 

#7DOC-720)(2008), available at <http://www.acgih.org/store/ProductDetail.cfm?id=1706>). This review did not 

find any relationship between autism and natural latex rubber. 

28 OSHA, Technical Information Bulletin – Potential for Allergy to Natural Rubber Latex Gloves and other 

Natural Rubber Products (April 12, 1999). See OSHA, Hospital eTool - HealthCare Wide Hazards Module 

Latex Allergy, available at <http://www.osha.gov/SLTC/etools/hospital/hazards/latex/latex.html >. 
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4. The TSCA Petition Paper does not define, quantify or correlate exposure to 

allergenic natural rubber latex proteins and autism (even though the Dochniak 

Petition repeatedly claims some relationship between allergenic natural rubber latex 

proteins and the increase in the diagnosis of autism) 

Exposure is essential both to identifying a hazard, as well as calculating the risk. 

Here, there simply is no effort to define or calculate exposure and correlate that exposure to the 

rates of autism. Even some of the allegations concerning exposure to natural latex rubber are 

incorrect, imprecise or unavailable. 

First, contrary to the statements in the Petition, use of natural rubber latex in the 

US has not dramatically increased.29 

Second, the Dochniak Petition does not provide any evidence that natural rubber 

latex allergens are transported from natural latex rubber adhesives into humans and, if so, at what 

levels. Exposure requires evidence that there is a significant release of latex allergens from 

adhesives and that these allergens enter the human body at significant level. 

Third, the TSCA Petition Paper fails to distinguish between natural latex proteins 

from dry rubber and dipped rubber, which are the two basic types of materials used to produce 

NRL products. The different processes involved in producing dry rubber or dipped latex rubber 

29 According to the Rubber Manufacturers Association, Factbook 2006, US Tire Shipment Activity Report 

For Statistical Year 2005, the use of total US rubber consumption has increased 18.6% from 1970 to 2003 (an 

average of 0.56% per year). Similarly, FAO indicated that use of natural rubber in US would decrease from 2000 to 

2010. The Food and Agricultural Organization of the United Nations, FAO Corporate Document Repository, 

available at http://www.fao.org/docrep/006/y5143e/y5143e1d.htm>). Much of these long term increases are due to 

increases in population and, therefore, would not necessarily result in an increase in the average exposure to 

individuals. 
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products result in dry rubber products having very low levels of bioavailable NRL proteins 

compared to most dipped latex products. 

Products made from liquid latex are usually very thin, pliant, and elastic. 

Examples of these types of products include gloves, condoms, and balloons. These products are 

made by dipping glass or porcelain molds into the liquid latex and allowing the latex to dry on 

the mold. The dipping process is repeated a defined number of times to achieve the desired 

thickness (Subramaniam 1995). It has been demonstrated that dipped latex products contain 

extractable NRL allergens that may become bioavailable under certain conditions (Alenius et al. 

1994; Yip et al. 1994; Yunginger et al. 1994; Lu et al. 1995; Yunginger 1995). 

Products made from dry rubber are thicker, less pliant, and sometimes very rigid. 

Examples of dry rubber products include tires, hoses, belts, ^ sports equipment, balls, and some 

baby pacifiers and bottle nipples. Dry rubber products are produced via a process that includes 

extremes of heat and pH, extensive processing, and the addition of a large proportion of fillers 

(Subramaniam 1995). NRL proteins in dry rubber products are largely denatured, diluted, and 

immobilized to a far greater extent than in products formed from liquid latex (Yip et al. 1994; 

Yunginger et al. 1994; Yunginger 1995). In fact, most dry rubber products that have been tested 

have had no detectable levels of latex allergens (Yip et al. 1994; Yunginger et al. 1994; 

Yunginger 1995; Thomsen and Burke 2000) and did NOT elicit strong allergic reactions in 

sensitized patients when challenged with a skin prick test with an extract from the various dry 

rubber products and dry rubber compound mixtures (Yip et al. 1994) (see Table 1 below). 
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Table 1: Extractable Latex Allergens from Rubber Products 

RUBBER PRODUCT ALLERGENIC RESPONSE 

(skin-prick test) 

ALLERGEN (AU/ml) 

SMR CV/vulcanisatea 0 NA 

SMR L/vulcanisatea 0 NA 

SMR 10/vulcanisatea 0 NA 

SMR 20/vulcanisatea 0 NA 

Hot Water Bottle 0 NA 

Divers Flippers 0 NA 

Latex Glove (dipped) 100 NA 

Baby pacifier NA <5 

Baby bottle nipples NA <5 

Intravenous tubing NA <5 

Rubber ballons (dipped) NA 4,7000 

a. Yip et al. 1994 

b. Yunginger et al. 1994 

NA: Not assessed 

SMR: Standardized Malaysian Rubber 

SMR CV: Standardized Malaysian Rubber – viscosity stabilized rubber 

SMR L: Standardized Malaysian Rubber – light-colored rubber 

SMR 10 and 20: Standardized Malaysian Rubber that is graded based on the amount of dirt in 

the rubber sample. 

As noted below, the difference in the level of potential exposure to bioavailable 

NRL between dipped latex products in the health-care setting and dry rubber products in 

consumer products is magnified even more by the differences in the exposure scenarios. 

Precisely because a small percentage of individuals in the population are allergic 

to natural latex rubber, there is less likelihood that significant exposure can occur from natural 

latex rubber adhesives. Either the adhesive is not in contact with the public or the adhesive 

contacts the skin and contact dermatitis alerts the person wearing the adhesive of the allergy. As 

a result, there is unlikely to be long term exposure to natural latex rubber in adhesives. Finally, 
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if there was exposure to adhesives, it would primarily be through medical bandages that use 

adhesives and RMA believes that FDA, not EPA, would have jurisdiction. 

In summary, it is not clear there has been a significant increase in the use of 

natural latex rubber in adhesives. Although there was an increase in the use of latex surgical 

gloves (a dipped rubber product) to protect the health of health care workers, this does not mean 

that there was a similar increase in the use of dry rubber products (which have not had a dramatic 

increase in use). The TSCA Petition Paper fails to acknowledge that there has been a dramatic 

decrease in the use of latex gloves. 

5. More generally, the allegation in the Dochniak Petition is that all allergens may be 

related to autism, not just allergenic natural latex rubber proteins, therefore, any 

evaluation would need to examine (equally) all allergenic substances (natural and 

manmade), rather than focus on just natural latex rubber. 

The allegation presented in the TSCA Petition Paper is that there is a link between 

any allergic reaction and autism. Many substances including ragweed and other prevalent 

allergens stimulate the same type of allergic reactions as allergenic natural latex rubber proteins. 

Ignoring the lack of evidence for this allegation, the implication is that every allergic reaction 

would impact autism. Additionally, the fact that the Dochniak Petition supports multiple 

allergens undercuts the allegations in the Petition that natural latex rubber in adhesives cause 

autism. 

6. The Dochniak Petition does not demonstrate a dose-response between natural latex 

rubber allergens and autism 
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It is essential to a determination of an unreasonable risk to develop a doseresponse. No such demonstration is even attempted in the Dochniak Petition. 

7. The Dochniak Petition fails to address the numerous confounding factors that would 

need to be assessed in determining whether exposure to natural latex rubber 

allergens causes autism. 

8. In many cases, the citations provided in the TSCA Petition do not support the 

corresponding allegations in the text. 

For example, the paper states that "In humans, repeated exposure to the Hev-b 

proteins during pregnancy may affect the genetic code of immune cells possibly making the fetus 

more susceptible to ASD [7]" at 546. Reference 7, however, is a newspaper article about a study 

that found "Expectant mothers suffering from asthma, allergies or a type of skin disease have a 

higher risk of giving birth to an autistic child" and "there was no statistical link between autism 

in children and 44 auto-immune diseases in mothers, including rheumatoid arthritis, lupus and 

multiple sclerosis." The article states that the researchers "speculated that there may be a 

common underlying genetic cause to such ailments as asthma and autism." Nothing in this news 

article refers to repeated exposure to Hev-b proteins. 

Also, the TSCA Petition Paper states: 

In genetic research, studies continue to find mutations associated 

with immunity that may affect the incidence of allergy induced 

autism. Several candidate gene loci are described below: 

Chromosome-1 [1q23, Fc fragment of IgE] [30]; Chromosome-11 

[11q12-q13, IgE responsiveness][31]; and Chromosome-19 

[19p13.3, CD23] [32]. 

Reference 31 (which has a slightly different title) does not discuss natural rubber, latex or 

autism. Rather the article cited in Reference 31 describes "the chromosomal localization of the 
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gene for squamous cell carcinoma-associated reactive antigen for cytotoxic T cells (SART-1)." 

Likewise, Reference 32 is a press release entitled: “Key molecular signaling switch involved in 

allergic disease identification.”30 Finally, Reference 30 is an abstract of a poster of a study of the 

genetic component or nature of autism. In fact, the study connected 21 Finnish autism families 

by genealogical links extending to 17th century. It does not mention natural rubber or latex. 

In other cases, the text of the paper cites a series of statements and implies that 

they lead to a conclusion that there is a connection between natural latex protein exposure and 

autism. For example, the paper states that 

homologous enolases from yeasts, molds, and fungi are known to 

cross-react with Hev-b 9 [22]. Studies indicate that elevated levels 

of Candida Albicans in some autistic individuals may exacerbate 

many behavior and health problems, especially those with lateonset autism [23]. A Hev-b 9 induced cross-react immune response 

to exogenous enolases may further affect allergy induced autism. 

Reference 23, however, does not even mention Hev-b 9. As the quote indicates, the web site in 

Reference 23 simply states that exposure to Candida Albicans in some people may aggravate 

symptoms. In fact, the web site states that "treatment for candida albicans infrequently results in 

a cure for autism." As written, the paper is misleading. 

30 Available at <http://hmg.oxfordjournals.org/cgi/content/full/11/18/2143>). 

<www.sciencedaily.com/releases/2006/10/061029174930.htm/> (October 30, 2006). 
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III. THERE IS NO EVIDENCE TO DEMONSTRATE A CAUSAL LINK 

BETWEEN EXPOSURE TO NATURAL LATEX RUBBER 

ADHESIVES AND AUTISM 

EPA guidance requires sound, applicable, and complete evidence that follows 

generally accepted scientific principles. The evidence on the Petition fails to meet any of these 

criteria. In fact, there is no scientific evidence of an unreasonable risk of autism from exposure to 

natural latex rubber allergens from adhesives.31 The relief being sought in the Dochniak Petition 

on natural rubber latex adhesive products does not meet TSCA’s “least burdensome” 

requirement. For example, in the case of latex used in health care (e.g., rubber gloves), the FDA 

simply required labeling latex containing items to warn health care workers of the potential for 

an allergic reaction. 

RMA appreciates the opportunity to comment and urges EPA to consider these 

comments. Please feel free to contact us if we can provide you with any further information. 

Yours truly, 

Tracey J. Norberg 

Senior Vice President 

Rubber Manufacturers Association 

 31 Latex rubber may even reduce the symptoms of autism, according to one member of the Autistic Society 

who has successfully used "trance suits," i.e., inflatable natural latex rubber suits. Autistic Society Internet Page, 

available at <www.autisticsociety.org/Forums/viewtopic/t=1920/view=previous.html>.
Docket ID Number EPA–HQ–OPPT–2008–0273 

May 12, 2008 

Page 21 

cc: Colby Linter, Regulatory Coordinator, Environmental Assistance Division 

(7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency 

Gerry Brown, Chemical Control Division (7405M),Office of Pollution Prevention and 

Toxics, Environmental Protection Agency 
Docket ID Number EPA–HQ–OPPT–2008–0273 

May 12, 2008 

Page 22 

REFERENCES

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Reunala. 1994. Allergen and protein content of latex gloves. Ann. Allergy 73(4):315–320. 

Lu et al. 1995: Lu, L.J., V.P. Kurup, J.N. Fink, and K.J. Kelly. 1995. Comparison of latex 

antigens from surgical gloves, ammoniated and nonammoniated latex: Effect of ammonia 

treatment on natural rubber latex proteins. J. Laboratory Clin. Med. 126(ISS 2):161–168. 

Subramaniam, A. 1995. The chemistry of natural rubber latex. Latex Allergy 15(1):1–20. 

Yip et al. 1994: Yip, E., K. Turjanmaa, K.P. Ng, and K.L. Mok. 1994. Allergic responses and 

levels of extractable proteins in NR latex gloves and dry rubber products. J. Nat. Rubb. Res. 

9(2):79–86. 

Yunginger, J.W. 1995. Variances in antigenicity of latex Products. Immunology and Allergy 

Clinics of North America 15(1):61–70. 

Yunginger, J.W., R.T. Jones, A.F. Fransway, J.M. Kelso, M.A. Warner, and L.W. Hunt. 1994. 

Extractable latex allergens and proteins in disposable medical gloves and other rubber products. 

J. Allergy Clin. Immun. 93(5):836–842.