Baled Natural Rubber in Tires; TSCA Section 21 Petition; Agency Response, 7586-7590 [2010-3414]

Download as PDF cprice-sewell on DSK2BSOYB1PROD with NOTICES 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; VerDate Nov<24>2008 15:26 Feb 19, 2010 Jkt 220001 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%, PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 E:\FR\FM\22FEN1.SGM 22FEN1 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 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 cprice-sewell on DSK2BSOYB1PROD with NOTICES 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. VerDate Nov<24>2008 15:26 Feb 19, 2010 Jkt 220001 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 https://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 https:// 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 7587 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 (https:// www.jacionline.org/article/S00916749(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., (https:// 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 1 The petition refers to antigenic proteins from Hevea brasiliensis as ‘‘Hev-b proteins.’’ E:\FR\FM\22FEN1.SGM 22FEN1 7588 Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices brasiliensis baled natural-rubber is available commercially’’ (Ref. 1). cprice-sewell on DSK2BSOYB1PROD with NOTICES 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. VerDate Nov<24>2008 15:26 Feb 19, 2010 Jkt 220001 • 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 for materials, products, systems, and services. See https://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 https://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 E:\FR\FM\22FEN1.SGM 22FEN1 cprice-sewell on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 75, No. 34 / Monday, February 22, 2010 / Notices 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 2 ASTM 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. VerDate Nov<24>2008 15:26 Feb 19, 2010 Jkt 220001 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, peer- PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 7589 reviewed 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 E:\FR\FM\22FEN1.SGM 22FEN1 cprice-sewell on DSK2BSOYB1PROD with NOTICES 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 https://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 VerDate Nov<24>2008 15:26 Feb 19, 2010 Jkt 220001 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 https:// 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, PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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). E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 75, Number 34 (Monday, February 22, 2010)]
[Notices]
[Pages 7586-7590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3414]


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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

[[Page 7587]]

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.'' 
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 
https://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 https://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 (https://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 inhalable-
black 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).
---------------------------------------------------------------------------

    \1\ The petition refers to antigenic proteins from Hevea 
brasiliensis as ``Hev-b proteins.''
---------------------------------------------------------------------------

    2. Exhibit B is a PDF of a webpage from the website of NOVA Science 
Publishers, Inc., (https://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 hyper-adaptive 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 
adaptive-immunity 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

[[Page 7588]]

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 natural-rubber latex having total protein 
content less than 200 [micro]g/dm\2\ and an antigenic Hev-b protein 
content less than 10 [micro]g/dm\2\'' (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 
https://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 
https://engineers.ihs.com/document/abstract/SKGGJBAAAAAAAAAA, 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 [micro]g/dm\2\ and an antigenic Hev-b 
protein content less than 10 [micro]g/dm\2\'' (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-induced-
autism 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 allergy-induced-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

[[Page 7589]]

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.
---------------------------------------------------------------------------

    \2\ ASTM 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.
---------------------------------------------------------------------------

    ``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 two-thirds 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, peer-
reviewed 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 
[micro]g/dm\2\ and an antigenic Hev-b protein content less than 10 
[micro]g/dm\2\.'' 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

[[Page 7590]]

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 https://www.vytex.com, last visited January 11, 2010.
    Nor does the petition provide evidence showing that prohibiting the 
use of ``Hevea brasiliensis baled natural-rubber'' that does not have a 
``total protein content less than 200 [micro]g/dm\2\ and an antigenic 
Hev-b protein content less than 10 [micro]g/dm\2\'' 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 [micro]g/dm\2\ 
and an antigenic Hev-b protein content less than 10 [micro]g/dm\2\'' 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 
https://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 Traffic-Related 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
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