7586 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 

establish regulatory requirements to 

ensure that ozone-depleting substances 

(ODS) are replaced by alternatives that 

reduce overall risks to human health 

and the environment, and to promote an 

expedited transition to safe substitutes. 

To promote this transition, CAA 

specified that EPA establish an 

information clearinghouse of available 

alternatives, and coordinate with other 

Federal agencies and the public on 

research, procurement practices, and 

information and technology transfers. 

Since the program’s inception in 

1994, SNAP has reviewed over 400 new 

chemicals and alternative 

manufacturing processes for a wide 

range of consumer, industrial, space 

exploration, and national security 

applications. Roughly 90% of 

alternatives submitted to EPA for review 

have been listed as acceptable for a 

specific use, typically with some 

condition or limit to minimize risks to 

human health and the environment. 

Regulations promulgated under SNAP 

require that Motor Vehicle Air 

Conditioners (MVACs) retrofitted to use 

a SNAP substitute refrigerant include 

basic information on a label to be 

affixed to the air conditioner. The label 

includes the name of the substitute 

refrigerant, when and by whom the 

retrofit was performed, environmental 

and safety information about the 

substitute refrigerant, and other 

information. This information is needed 

so that subsequent technicians working 

on the MVAC system will be able to 

service the equipment properly, 

decreasing the likelihood of significant 

refrigerant cross-contamination and 

potential failure of air conditioning 

systems and recovery/recycling 

equipment. 

Burden Statement: The annual public 

reporting and recordkeeping burden for 

this collection of information is 

estimated to average 5 minutes per 

response. Burden means the total time, 

effort, or financial resources expended 

by persons to generate, maintain, retain, 

or disclose or provide information to or 

for a Federal agency. This includes the 

time needed to review instructions; 

develop, acquire, install, and utilize 

technology and systems for the purposes 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements which have subsequently 

changed; train personnel to be able to 

respond to a collection of information; 

search data sources; complete and 

review the collection of information; 

and transmit or otherwise disclose the 

information. 

The ICR provides a detailed 

explanation of the Agency’s estimate, 

which is only briefly summarized here: 

Estimated total number of potential 

respondents: 6,500. 

Frequency of response: Once per a 

retrofit done on a motor vehicle air 

conditioner. 

Estimated total annual burden hours: 

1,500 hours. 

Estimated total annual costs: 

$205,000 which includes an estimated 

burden cost of $100,000 for 

recordkeeping and an estimated cost of 

$105,000 for capital investment or 

maintenance and operational costs. 

The U.S. Department of Labor 

statistics indicated from the most 

current available data that there are 

approximately 650,000 automotive 

service technicians and mechanics (SOC 

Code Number 49–3023) in the US. Data 

from the Motor Air Conditioning 

Society (MACS) Worldwide, estimated 

that the mobile air conditioning service 

industry has over 170,000 service 

providers and over 600,000 technicians 

(MACS, 2008). EPA estimated that 

approximately 1% of the total 

automotive service technicians, or 

6,500, would be responsible for 

retrofitting the estimated 100,000 

MVACs over the three-year term of this 

ICR. 

EPA estimated the time to complete 

and apply the label at 5 minutes per 

MVAC, making the total burden 4500 

hours over three years (1,500 hours per 

year). At an estimated average labor rate 

of $70 per hour, the overall cost 

associated with the burden hours is 

$315,000 over three years ($105,000 per 

year). The cost for designing, 

typesetting, printing and distributing 

55,000 labels is estimated at $0.10 per 

label to be $5,500 ($1,833.33 per year). 

Adding the labor and capital costs 

together yields a total cost burden of 

$320,500 ($106,833.33 per year). 

The Agency welcomes public 

comment on the number of CFC–12 

MVACs that will undergo a retrofit, the 

number of MVAC service technicians 

performing such service, the average 

labor rate of MVAC service technicians 

from 2007 to 2010 and any other 

relevant information. 

Are There Changes in the Estimates 

From the Last Approval? 

Based on the decline of CFC–12 

MVACs in service today EPA estimates 

a continued reduction in the number of 

CFC–12 MVACs retrofits that will occur 

during the next three years. EPA 

estimated that the total percent of CFC– 

12 MVACs retrofitted in 2003 was 1.5%, 

which equals an estimated 500,000 

CFC–12 MVACs retrofitted to R–134a. 

EPA observed from MACS survey data 

that for each year, starting from 2003, an 

approximate decrease of 1% of retrofits 

occurred. Therefore, every three years, 

the amount of retrofits decreases 

approximately 3%. Based on this trend 

analysis, EPA estimated that the total 

percent CFC–12 MVACs retrofits for 

2006, 2009, and 2012 are 0.5%, 0.2%, 

and a 0.1%, for an estimate of 62,000, 

7,000 and 700, respectively. These 

reductions are due to the decrease of 

CFC–12 MVACs available on the road 

for retrofitting. 

What Is the Next Step in the Process for 

This ICR? 

EPA will consider the comments 

received and amend the ICR as 

appropriate. The final ICR package will 

then be submitted to OMB for review 

and approval pursuant to 5 CFR 

1320.12. At that time, EPA will issue 

another Federal Register notice 

pursuant to 5 CFR 1320.5(a)(1)(iv) to 

announce the submission of the ICR to 

OMB and the opportunity to submit 

additional comments to OMB. If you 

have any questions about this ICR or the 

approval process, please contact the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

Dated: February 16, 2010. 

Brian J. McLean, 

Director, Office of Atmospheric Programs. 

[FR Doc. 2010–3363 Filed 2–19–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2010–0015; FRL–8810–4] 

Baled Natural Rubber in Tires; TSCA 

Section 21 Petition; Agency Response 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of EPA’s response to a 

petition it received under section 21 of 

the Toxic Substances Control Act 

(TSCA). The petition was received from 

an individual on November 19, 2009. 

The petitioner requested EPA to 

‘‘establish regulations prohibiting the 

use and distribution in commerce of 

Hevea brasiliensis baled natural-rubber 

for the manufacture of tires, wherein 

said rubber fails to satisfy The American 

Society for Testing Materials method 

ASTM D1076-06 (Category 5).’’ The 

petition states: ‘‘Implementation of an 

EPA regulation that guides tire 


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Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 7587 

1The petition refers to antigenic proteins from 

Hevea brasiliensis as ‘‘Hev-b proteins.’’ 

manufacturers to use Hevea brasiliensis 

baled natural-rubber that satisfies ASTM 

D1076-06 (Category 5) may affect the 

incidence of Hevea brasiliensis naturalrubber allergies and allergy induced 

autism.’’ After careful consideration, 

EPA has denied the TSCA section 21 

petition for the reasons discussed in this 

notice. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Linter, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

Robert Jones, Chemical Control Division 

(7405M), Office Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8161; e-mail address: 

jones.robert@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. This action may, however, be 

of interest to you if you manufacture, 

process, import, or distribute in 

commerce Hevea brasiliensis natural 

rubber. Potentially interested entities 

may include, but are not limited to: 

• Tire Manufacturing (NAICS code 

32621). 

• Tire Manufacturing, except 

retreading (NAICS code 326211). 

• Tire Retreading (NAICS code 

326212). 

• Tire and Tube Merchant 

Wholesalers (NAICS code 423130). 

• Tire Dealers (NAICS code 441320). 

• Recyclable Material Merchant 

Wholesalers (NAICS code 423930). 

• Other Chemical and Allied 

Products Merchant Wholesalers (NAICS 

code 424690). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

B. How Can I Access Information About 

this Petition? 

EPA has established a docket for this 

TSCA section 21 petition under docket 

identification (ID) number EPA–HQ– 

OPPT–2010–0015. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

electronically at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

II. Background 

A. What Action was Requested Under 

this TSCA Section 21 Petition? 

On November 19, 2009, an individual 

filed a petition with EPA to ‘‘establish 

regulations prohibiting the use and 

distribution in commerce of Hevea 

brasiliensis baled natural-rubber for the 

manufacture of tires, wherein said 

rubber fails to satisfy The American 

Society for Testing Materials method 

ASTM D1076-06 (Category 5),’’ because 

‘‘Implementation of an EPA regulation 

that guides tire manufacturers to use 

Hevea brasiliensis baled natural-rubber 

that satisfies ASTM D1076-06 (Category 

5) may affect the incidence of Hevea 

brasiliensis natural-rubber allergies and 

allergy induced autism’’ (Refs. 1 and 2). 

This petition is similar to a previous 

petition that the same individual filed 

with EPA in March 2008 requesting that 

EPA ‘‘establish regulations prohibiting 

the use and distribution in commerce of 

Hevea brasiliensis [italics added] 

natural rubber latex adhesives having a 

total protein content greater than 200 

micrograms per [gram] dry weight of 

latex based on the American Society for 

Testing and Materials method ASTM 

D1076-06 (Category 4).’’ EPA denied the 

petition in June 2008 (Ref. 3). 

B. What Support Does the Petitioner 

Offer for this Request? 

1. Exhibit A is a Portable Document 

Format (PDF) of a webpage from the 

website of the Journal of Allergy and 

Clinical Immunology (http:// 

www.jacionline.org/article/S0091- 

6749(95)70156-7/abstract), dated 

November 13, 2009, providing an 

abstract of an article entitled ‘‘Latex 

Allergen in Respirable Particulate Air 

Pollution’’ (Ref. 1). Exhibit A is offered 

to support the petition’s statements that 

‘‘tires contain ... Hevea brasiliensis baled 

natural-rubber,’’ ‘‘Hev-b proteins1 are 

extractable from tire natural-rubber 

dust,’’ ‘‘urban air samples have been 

shown to contain irregular inhalableblack particulates from airborne tire 

natural–rubber dust,’’ and ‘‘the impact of 

the particles should be considered in 

the issue of morbidity and mortality 

rates associated with respiratory 

diseases and air pollution.’’ For 

purposes of reviewing the petition, EPA 

obtained a full copy of the article (Ref. 

8). 

2. Exhibit B is a PDF of a webpage 

from the website of NOVA Science 

Publishers, Inc., (http:// 

www.novapublishers.com/catalog/ 

advanced_search_result.php?keywords=

allergies+and+autism&x=13+y=9) dated 

November 13, 2009, which advertises, 

and includes an abstract of, a 

publication written by the petitioner 

entitled ‘‘Allergies and Autism’’ (Ref. 1, 

Exhibit B) is offered to support the 

petitioner’s statements that ‘‘Hev-b 

proteins affect the incidence of hyperadaptive immunity and atypical 

neurological development in allergy 

sensitive children,’’ and ‘‘repeated 

exposure to the Hev-b proteins from 

Hevea brasiliensis baled natural-rubber 

has been shown to cause an increased 

incidence of allergies.’’ According to 

NOVA Science Publishers, Inc., 

‘‘Allergies and Autism’’ is scheduled to 

be published in the first quarter of 2010. 

At EPA’s request, the petitioner 

provided EPA with a copy of his 

publication, which ‘‘explores how 

certain proteins induce hyper adaptiveimmunity affecting Autism Spectrum 

Disorders’’ (Ref. 4). 

3. Exhibit C is a PDF of a photograph 

labeled ‘‘VYTEX-BALE.’’ Exhibit C is 

offered to support the petitioner’s 

statement that ‘‘ultra low-protein Hevea 


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7588 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 

brasiliensis baled natural-rubber is 

available commercially’’ (Ref. 1). 

C. What are the Legal Standards 

Regarding TSCA Section 21 Petitions 

and TSCA Section 6 Rules? 

Section 21(b)(1) of TSCA requires that 

the petition ‘‘set forth the facts which it 

is claimed establish that it is necessary’’ 

to issue the rule or order requested. 15 

U.S.C. 2620(b)(1). Thus, TSCA section 

21 implicitly incorporates the statutory 

standards that are required to issue the 

requested rule or order. In addition, 

TSCA section 21 establishes standards 

that a court must use to decide whether 

to order EPA to initiate rulemaking in 

the event of a lawsuit after denial of a 

TSCA section 21 petition. 15 U.S.C. 

2620(b)(4)(B). 

The petition asks EPA to ‘‘establish 

regulations prohibiting the use and 

distribution in commerce of Hevea 

brasiliensis baled natural-rubber for the 

manufacture of tires, wherein said 

rubber fails to satisfy The American 

Society for Testing Materials method 

ASTM D1076-06 (Category 5),’’ but does 

not state under which provision of 

TSCA the regulation should be issued. 

Only TSCA section 6, however, appears 

to be applicable, because it authorizes 

the promulgation of regulations on 

chemical substances and mixtures to the 

extent necessary to protect adequately 

against unreasonable risk, including 

prohibiting the manufacture or 

distribution in commerce of a chemical 

substance for a particular use. 

Accordingly, EPA has relied on the 

standards in TSCA section 21 and 

section 6 to evaluate this petition. 

In order to promulgate a rule under 

TSCA section 6, the EPA Administrator 

must 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 of injury to health 

or the environment.’’ 15 U.S.C. 2605(a). 

This finding cannot be made 

considering risk alone. In promulgating 

any rule under TSCA section 6(a), the 

statute requires that the EPA 

Administrator consider: 

• The effects of such substance or 

mixture on health and the magnitude of 

the exposure of human beings to such 

substance or mixture. 

• The effects of such substance or 

mixture on the environment and the 

magnitude of the exposure of the 

environment to such substance or 

mixture. 

• The benefits of such substance or 

mixture for various uses and the 

availability of substitutes for such uses. 

• The reasonably ascertainable 

economic consequences of the rule, after 

consideration of the effect on the 

national economy, small business, 

technological innovation, the 

environment, and public health. 15 

U.S.C. 2605(c)(1). 

Furthermore, the control measure 

adopted is to be the ‘‘least burdensome 

requirement’’ that adequately protects 

against the unreasonable risk. 15 U.S.C. 

2605(a). 

Section 21(b)(4)(B) of TSCA provides 

the standard for judicial review should 

EPA deny a request for rulemaking 

under TSCA section 6(a): ‘‘If the 

petitioner demonstrates to the 

satisfaction of the court by a 

preponderance of the evidence that ... 

there is a reasonable basis to conclude 

that the issuance of such a rule or order 

is necessary to protect health or the 

environment against an unreasonable 

risk of injury to health or the 

environment,’’ the court shall order the 

EPA Administrator to initiate the 

requested action. 15 U.S.C. 

2620(b)(4)(B). 

III. Disposition of the TSCA Section 21 

Petition 

A. What is EPA’s Response? 

After careful consideration, EPA has 

denied the petition. A copy of the 

Agency’s response, which consists of a 

letter to the petitioner, is available in 

the docket for this TSCA section 21 

petition. 

B. What is EPA’s Reason for this 

Response? 

The petition asks EPA to ‘‘establish 

regulations prohibiting the use and 

distribution in commerce of Hevea 

brasiliensis baled natural-rubber for the 

manufacture of tires, wherein said 

rubber fails to satisfy The American 

Society for Testing Materials method 

ASTM D1076-06 (Category 5),’’ because 

‘‘Implementation of an EPA regulation 

that guides tire manufacturers to use 

Hevea brasiliensis baled natural-rubber 

that satisfies ASTM D1076-06 (Category 

5) may affect the incidence of Hevea 

brasiliensis natural-rubber allergies and 

allergy induced autism.’’ According to 

the petition, ASTM D1076-06 (Category 

5) ‘‘defines Hevea brasiliensis naturalrubber latex having total protein content 

less than 200 μg/dm2 and an antigenic 

Hev-b protein content less than 10 μg/ 

dm2’’ (Ref. 1). 

However, there is at present no ASTM 

D1076-06 (Category 5). ASTM refers to 

ASTM International (formerly the 

American Society for Testing Materials), 

which is a voluntary organization that 

develops consensus technical standards 

for materials, products, systems, and 

services. See http://www.astm.org, 

ASTM D 1076-06, ‘‘Standard 

Specification for Rubber–Concentrated, 

Ammonia Preserved, Creamed, and 

Centrifuged Natural Latex,’’ is a 

specification that ‘‘covers requirements 

for first grade concentrated natural 

rubber latex’’ in only four categories. An 

ASTM D1076-06 (Category 5) does not 

yet exist. See http://engineers.ihs.com/ 

document/abstract/SKGG

JBAAAAAAAAAA, last visited 

December 9, 2009. 

For the following reasons, the petition 

does not set forth facts sufficient to 

establish that it is necessary to issue a 

rule that prohibits the use and 

distribution in commerce of Hevea 

brasiliensis baled natural rubber for the 

manufacture of tires that has a ‘‘total 

protein content less than 200 μg/dm2

and an antigenic Hev-b protein content 

less than 10 μg/dm2’’ (Ref. 1) in order to 

protect human health or the 

environment against unreasonable risk 

of injury. 

First, the petitioner has not presented 

or identified any direct evidence that 

Hevea brasiliensis natural rubber 

antigens, or any other antigens, cause, 

induce, or affect autism. Based on the 

evidence provided by the petitioner 

(Exhibit B and the petitioner’s 

publication entitled ‘‘Allergies and 

Autism’’) and evidence otherwise 

available to EPA, this idea is an 

unproven hypothesis (Refs. 1, 5, and 6). 

In ‘‘Allergies and Autism,’’ the petitioner 

states that ‘‘[a]llergy induced Autism is 

an area of research wherein immune 

responses to certain environmental 

proteins, and foodstuff proteins, may 

affect the development and intensity of 

atypical behaviors within the Autism 

Spectrum.’’ Thus, the petitioner 

recognizes that the allergy-inducedautism proposition remains indefinite 

and unproven. Moreover, reviewing 

different paths of research, the 

petitioner repeatedly characterizes 

‘‘allergy induced autism’’ as a 

‘‘hypothesis.’’ The petitioner also asserts 

that ‘‘research has shown that allergy 

may play a role in the pathogenesis of 

Autism,’’ and cited a study that 

purported to find ‘‘a significant positive 

association between autistic severity 

and the frequency of allergic 

manifestations.’’ However, the cited 

study does not directly test the allergyinduced-Autism hypothesis, notes that 

the causes of autism are ‘‘an area of 

significant controversy,’’ and only 

concludes that the ‘‘significant positive 

association between these 

manifestations and important disease 

characteristics ... may shed light on the 

possible causal role of allergy in some 


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Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 7589 

2ASTM D1076-06 uses the term ‘‘Hevea antigenic 

protein’’ to refer to antigenic proteins in natural 

rubber and its products as measured by test method 

ASTM D6499. EPA uses Hevea brasiliensis 

antigenic proteins throughout this notice to refer to 

any antigenic proteins from Hevea brasiliensis and 

not just those measured by test method ASTM 

D6499. 

autistic children’’ (Ref. 5). A recent 

consensus report published in 

Pediatrics, the official peer-reviewed 

journal of the American Academy of 

Pediatrics, concludes that a direct 

cause-and-effect relationship between 

immune dysfunction and Autism 

Spectrum Disorders has yet to be proven 

(Ref. 6). Based on its controversial 

nature, the allergy-induced-Autism 

hypothesis and the supporting evidence 

are insufficient to sustain a finding of 

unreasonable risk required to support a 

regulation under TSCA section 6. 

In addition, as noted in the Federal 

Register notice (Ref. 3) denying the 

petitioner’s previous petition, Hevea 

brasiliensis natural rubber latex allergies 

have already been the subject of 

considerable Federal Government 

evaluation. For example, the Consumer 

Protect Safety Commission concluded 

that the incidence of natural rubber 

latex allergy in the general population 

was very low (below 1%), that many 

consumer products contain natural 

rubber latex, and that ‘‘in spite of the 

prevalence of [natural rubber latex] in 

consumer products, there are few 

documented cases of reactions to 

[natural rubber latex]-containing 

consumer products,’’ most of which 

involved medical devices. See EPA’s 

response to the petitioner’s previous 

petition for a more detailed discussion 

(Ref. 3). 

Second, the petition fails to 

demonstrate that there is a sufficient 

level of exposure to Hevea brasiliensis 

antigenic proteins2 from the use of 

Hevea brasiliensis baled natural rubber 

in tires to cause adverse effects from this 

exposure. Available data are ambiguous 

and do not support the position that the 

general population is subject to 

widespread exposure to natural rubber 

latex proteins from tires. EPA obtained 

the full article referenced in Exhibit A 

and considered it in light of this petition 

(Ref. 7). In the study, particulates were 

collected and analyzed from ambient air 

samples from the Denver metropolitan 

area. The size of the particles was 

determined using optical microscopy, 

and it was reported that a significant 

portion (58.5%) was in the respirable 

range. The particles were also 

characterized using chemical solubility 

tests and mass spectrometry. The 

authors of the study hypothesized that 

the particles represent abraded tire 

fragments and concluded that their 

hypothesis was supported by the mass 

spectroscopic, physical, and chemical 

data. In the study, the authors also 

demonstrated that Hevea brasiliensis 

antigenic proteins can be extracted from 

rubber tire fragments. The authors 

speculated that airborne tire fragments 

‘‘could contribute, through direct and 

indirect mechanisms, to the increase in 

both latex sensitization and asthma,’’ but 

did not investigate the hypothesis or 

demonstrate that airborne tire fragments 

directly or indirectly contribute to an 

increase in, or have any impact on, latex 

sensitization and asthma. Moreover, the 

study only showed that Hevea 

brasiliensis antigenic proteins could be 

extracted from rubber tire fragments, not 

from particles that were collected from 

air samples. 

‘‘Allergies and Autism’’ describes a 

study that reports the presence of 

extractable Hevea brasiliensis antigenic 

proteins in ambient samples of 

sedimented freeway dust and airborne 

particulate matter from two locations 

within the Los Angeles basin (Ref. 8). 

However, in a subsequent study 

examining paved road dust and 

atmospheric particulate matter for 

allergen exposure in three sites within 

the greater Los Angeles area, the same 

authors reported no Hevea brasiliensis 

antigenic proteins were detected in 

paved road dust samples (Ref. 9). The 

authors concluded that the different 

results could be explained by 

‘‘differences in driving conditions and 

sampling locations for the roadways 

examined in each of the two studies.’’ 

The authors also reported that material 

collected from guardrails contained 

about 75% rubber particles, but paved 

road dust collected from the center twothirds of straight sections of city surface 

streets did not contain rubber particles. 

EPA identified another study that 

investigated whether exposure to road 

traffic in a large city in Germany 

(Dresden) is associated with allergic 

sensitization to latex in children (Ref. 

10). In this study, immunoglobulin E 

(IgE) levels against Hevea brasiliensis 

antigenic proteins and a panel of 

common aeroallergens were measured 

in 2,505 children, ages 5–11, and an 

analysis was conducted to determine 

whether there was any correlation 

between latex sensitization and 

exposure to road traffic as measured by 

parental self-reporting, traffic counts, 

and measurements of benzene. The 

authors concluded that their data 

suggest exposure to road traffic is not 

associated with allergic sensitization to 

latex in children. 

Finally, a letter published in 

Epidemiology, the official, peerreviewed journal of the International 

Society of Environmental Epidemiology, 

reported that ‘‘[o]btaining solid natural 

rubber (NR) out of latex,’’ unlike 

‘‘production and use of dipped latex 

products’’ used in personal products and 

medical devices, ‘‘involves intensive 

heating, which destroys many, [though] 

not all, proteins,’’ and that, ‘‘[i]n the 

rubber manufacturing industry, 

exposure to inhalable NR particles can 

be orders of magnitude higher ..., 

without producing any evidence of latex 

allergies,’’ and concluded that, ‘‘[b]ased 

on these results[,] an association 

between heavy traffic and sensitization 

to NRL in the general population seems 

to be unlikely’’ (Ref. 11). This letter is 

consistent with comments submitted by 

the Rubber Manufacturers Association 

in response to the petitioner’s previous 

petition to ban antigenic natural rubber 

latex adhesives. According to the 

Rubber Manufacturers Association, 

natural rubber latex ‘‘proteins in dry 

rubber products [including tires] are 

largely denatured, diluted, and 

immobilized to a far greater extent than 

in products formed from liquid latex’’ 

and ‘‘most dry rubber products that have 

been tested have had no detectable 

levels of latex allergens’’ (Ref. 12). 

Third, the petition provides little 

information on the specific factors listed 

in TSCA section 6(c) that must be 

considered for a TSCA section 6 

rulemaking. See Unit II.C. 

For example, the petition provides 

little specific information on the 

magnitude of exposure of human beings 

or the environment. Exhibit A 

concludes that Hevea brasiliensis latex 

antigens are extractible from rubber tire 

fragments, which are abundant in urban 

air samples, but provides little factual 

information on the magnitude of 

exposure of human beings to the Hevea 

brasiliensis antigenic proteins from the 

tire fragments. See discussion in Unit 

II.B.1. concerning natural rubber latex 

proteins in tire particles, as referenced 

in Exhibit B (Ref. 4). 

The petition provides little factual 

information on the reasonably 

ascertainable economic consequences of 

prohibiting the use and distribution in 

commerce of Hevea brasiliensis baled 

natural-rubber in tires that does not 

have a ‘‘total protein content less than 

200 μg/dm2 and an antigenic Hev-b 

protein content less than 10 μg/dm2.’’ In 

‘‘Allergies and Autism,’’ for example, the 

petitioner recounts who are the major 

natural rubber latex consuming and 

producing countries, the percentage of 

natural rubber latex consumed today, 

and rates of natural latex consumption 

in the past 43 years. However, this 

information fails to offer specific factual 


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7590 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 

information on the ‘‘reasonably 

ascertainable economic consequences’’ 

that would occur as a result of enacting 

the proposed regulation (Ref. 4). 

The petition states that ‘‘proteins 

inherent in Hevea brasiliensis baled 

natural-rubber can be substantially 

eliminated’’ and that ‘‘ultra low-protein 

natural-rubber latex (e.g., Vytex-NRL) 

that can be used to make Hevea 

brasiliensis baled natural-rubber that 

satisfies ASTM D 1076-06 (Category 5)’’ 

is available, but provides little other 

information on the availability and 

suitability of substitutes. In ‘‘Allergies 

and Autism,’’ the petitioner reports that 

non-Hevea brasiliensis latex does not 

provide a suitable substitute. According 

to the petitioner: ‘‘Efforts have been 

made to commercialize alternative latex 

having inherently lower antigenic 

protein content (i.e., guayule rubber 

latex and the Russian dandelion), but 

such materials are reported to be higher 

in cost and presently are available only 

in limited quantities’’ and ‘‘both of these 

materials have their own unique set of 

proteins with potential allergenic 

behavior not yet clearly understood.’’ 

With respect to Vytex, the petitioner 

reports that it ‘‘can be used for making 

surgical and examination gloves, 

condoms, foam, tubing, breather bags, 

balloons, adhesives as well as many 

other natural–latex based products 

across a wide range of industries’’ (Ref. 

4). Vytex does not appear to be a viable 

substitute for use in tires, however, at 

this time. Vytex was developed and is 

produced by the Vystar Corp. According 

to the Vystar Corp. website, Vytex is 

Vystar Corp.’s first commercial product 

and is presently used only in Envy 

condoms, which were introduced 

commercially only in October of 2009. 

In addition, Vystar Corp.’s webpage 

focuses on Vytex’s suitability for the 

specialty use of medical devices. See 

http://www.vytex.com, last visited 

January 11, 2010. 

Nor does the petition provide 

evidence showing that prohibiting the 

use of ‘‘Hevea brasiliensis baled naturalrubber’’ that does not have a ‘‘total 

protein content less than 200 μg/dm2

and an antigenic Hev-b protein content 

less than 10 μg/dm2’’ in the manufacture 

of tires would be the least burdensome 

requirement to address the potential 

risks the petition identifies. 

Finally, the petition has not 

demonstrated that a regulation 

prohibiting the use of ‘‘Hevea 

brasiliensis baled natural-rubber’’ that 

does not have a ‘‘total protein content 

less than 200 μg/dm2 and an antigenic 

Hev-b protein content less than 10 μg/ 

dm2’’ in the manufacture of tires is 

likely to be successful in reducing the 

incidence of latex allergy or autism. 

IV. References 

The following is a list of the 

documents that are specifically 

referenced in this notice and placed in 

the docket that was established under 

docket ID number EPA–HQ–OPPT– 

2010–0015. For information on 

accessing the docket, refer to Unit I.B. 

1. Dochniak, M. ‘‘Citizen Petition 

under TSCA to prohibit the use of 

Hevea brasiliensis baled natural-rubber 

for the manufacture of tires, wherein 

said baled natural-rubber fails to satisfy 

The American Society for Testing and 

Materials method ASTM D1076-06 

(Category 5).’’ November 19, 2009. 

2. EPA. Letter from OPPT, to Michael 

Dochniak, acknowledging receipt of his 

petition under TSCA section 21: 

‘‘Citizen Petition under TSCA to 

prohibit the use of Hevea brasiliensis 

baled natural-rubber for the 

manufacture of tires, wherein said baled 

natural-rubber fails to satisfy The 

American Society for Testing and 

Materials method ASTM D1076-06 

(Category 5).’’ December 8, 2009. 

3. EPA. Natural Rubber Latex 

Adhesives; Disposition of TSCA Section 

21 Petition; Notice. Federal Register (73 

FR 32573, June 9, 2008) (FRL–8368–4). 

Docket ID number EPA–HQ–OPPT– 

2008–0273. Available on-line at http:// 

www.regulations.gov. 

4. Dochniak, M. and Dunn, D. 

Allergies and Autism. Nova Science 

Publishers, Inc. 2008. 

5. Mostafa, G. A.; Hamza, R. T.; and 

El-Shahawi, H. H. Allergic 

manifestations in autistic children: 

Relation to disease severity. Journal of 

Pediatric Neurology. 2008. 6(2):115– 

123. 

6. Buie, T., et al., Evaluation, 

Diagnosis, and Treatment of 

Gastrointestinal Disorders in 

Individuals With ASDs: A Consensus 

Report. Pediatrics. 2010. 125:S1–S18. 

7. Williams, P. B.; Buhr, M. P.; Weber, 

R. W.; Volz, M. A.; Koepke, J. W.; and 

Selner, J. C. Latex Allergen in Respirable 

Particulate Air Pollution. Journal of 

Allergy and Clinical Immunology. 1995. 

95:88–95. 

8. Miguel, A. G.; Cass, G. R.; Weiss, 

J.; and Glovsky, M. M. Latex Allergens 

in Tire Dust and Airborne Particles. 

Environmental Health Perspectives. 

November 1996. 104(11):1180–1186. 

9. Miguel, A. G., Cass, G. R., Weiss, 

J., and Glovsky, M. M. Allergens in 

Paved Road Dust and Airborne Particles. 

Environmental Science Technology. 

1999. 33:4159–4168. 

10. Hirsch, T.; Neumeister, V.; 

Weiland, S. K.; von Mutius, E.; Hirsch, 

D.; Grafe, H.; Duhme, H.; and Leupold, 

W. Traffic exposure and allergic 

sensitization against latex in children. 

Journal of Allergy and Clinical 

Immunology. 2000. 106:573–8. 

11. Vermeulen, R.; Doekes, G.; and 

Kromhout, H. Latex Allergy Risk among 

the General Population due to TrafficRelated Airborne Dust? Epidemiology. 

Cambridge, MA. 2000. 11(1):92. 

12. Rubber Manufacturers Association 

Letter to EPA (Docket ID number EPA– 

HQ–OPPT–2008–0273), Comments on 

Mr. Michael Dochniak TSCA Section 21 

Petition. May 12, 2008. 

List of Subjects 

Environmental protection, Antigenic 

proteins, Autism, Health, Hevea 

brasiliensis baled natural rubber, Latex, 

Tires. 

Dated: February 16, 2010. 

Stephen A. Owens, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. 2010–3414 Filed 2–19–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–9114–9] 

North Carolina Waters Along the Entire 

Length of New Hanover County; Final 

No Discharge Zone Determination 

On August 24, 2009, the 

Environmental Protection Agency (EPA) 

published a notice that the North 

Carolina Department of Environment 

and Natural Resources (DENR) Division 

of Water Quality (DWQ) had petitioned 

the Region 4 Regional Administrator to 

determine that adequate and reasonably 

available pumpout facilities exist for the 

designation of New Hanover County, 

North Carolina, Coastal Waters as a No 

Discharge Zone (NDZ). One comment in 

favor of this designation was received. 

Specifically, these waters extend three 

nautical miles (nm) into the Atlantic 

Ocean along the entire length of New 

Hanover County, including Futch Creek, 

Pages Creek, Bradley Creek, Hewlett’s 

Creek, Howe Creek, Whiskey Creek, 

Snow’s Cut, as well as unnamed 

tributaries and all unnamed tidal creeks 

to those waters. 

The geographic description including 

latitudes and longitudes are as follows: 

northern border of New Hanover County 

with southern border of Pender County 

(34°17′53.5′′ N 77°42′32.2′′ W), to a point 

3 nm off the coast at the intersection of 

New Hanover and Pender Counties 

(34°16′01.9′′ N 77°40′20.5′′ W). 


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