[Federal Register: June 9, 2008 (Volume 73, Number 111)]
[Notices]
[Page 32573-32577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn08-40]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2008-0273; FRL-8368-4]
Natural Rubber Latex Adhesives; Disposition of TSCA Section 21
Petition
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: On March 6, 2008, EPA received a petition from Michael J.
Dochniak under section 21 of the Toxic Substances Control Act (TSCA)
``to 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).'' The petition
states: ``Implementation of an EPA regulation that guides adhesive
manufacturer's [sic] to use Hevea [b]rasiliensis [italics added]
natural-rubber-latex that satisfy[ies] ASTM D1076-06 (Category 4) may
affect the incidence and prevalence of latex allergy and allergy-
induced autism in neonates.'' For the reasons set forth in this notice,
EPA has denied the petitioner's request.
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: Gerry Brown, Chemical Control
Division (7405M), Office Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-
0001; telephone number: (202) 564-8086; e-mail address:
brown.gerry@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 (Hevea) natural rubber latex
(NRL) adhesives. Potentially interested entities may include, but are
not limited to:
Adhesive manufacturing, NAICS code 325520.
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 that may be interested in this
action. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might be of interest to certain entities. If you
have any questions regarding this action, consult the technical person
listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2008-0273. All documents
in the docket are listed in the docket's 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
[[Page 32574]]
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal 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.
2. Electronic access. You may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
docket ID number EPA-HQ-OPPT-2008-0273 at http://www.regulations.gov.
II. Background
A. What Action is Requested Under this TSCA Section 21 Petition?
On March 6, 2008, EPA received a petition from Mr. Michael J.
Dochniak under section 21 of TSCA ``to 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).'' The petition states: ``Implementation of an
EPA regulation that guides adhesive manufacturer's [sic] to use Hevea
[b]brasiliensis [italics added] natural-rubber-latex that satisfy[ies]
ASTM D1076-06 (Category 4) may affect the incidence and prevalence of
latex allergy and allergy-induced autism in neonates'' (Ref. 1).
NRL is a naturally occurring polyisoprene elastomer obtained almost
exclusively from the Hevea tree indigenous to South America but now
grown for commercial purposes principally in Asia and Africa. NRL
adhesives comprise a very small portion of the adhesives industry. They
are grouped by the U.S. Census under the ``natural base glues and
adhesives'' product category, which comprises the smallest share (< 3%)
of the U.S. adhesive manufacturing industry. Adhesives manufacturers
produce a wide range of products, including adhesives, caulks,
lubricants, and sealants, and adhesives are used in a wide variety of
industries. The U.S. adhesive industry is dominated by synthetic
adhesives like acrylics, epoxide resins, vinyls, and synthetic rubbers
such as polychloroprene and styrene-butadiene, the most common
substitute for natural rubber adhesives. Most synthetic adhesives are
derived from coal, natural gas, oil, or petroleum (Ref. 2).
ASTM D1076-06, Standard Specification for Rubber-Concentrated,
Ammonia Preserved, Creamed, and Centrifuged Natural Latex, is a
standard specification, not a method, although methods are referenced
in the standard. ASTM International (ASTM), formerly the American
Society for Testing and Materials, is a voluntary standards development
organization, http://www.astm.org/ABOUT/aboutASTM.html (last visited
April 28, 2008). ASTM D1076-06 covers requirements for four categories
of ``first grade concentrated natural rubber latex'' (Ref. 3). Category
4, ``Centrifuged, or centrifuged and creamed, guayule latex, or other
natural rubber latex, containing less than 200 [micro]g total protein
per gram dry weight of latex, with ammonia or other hydroxide, with
other necessary preservatives and stabilizers,'' requires that the
latex contain no more than 200 micrograms ([micro]g) total protein per
gram (dry weight) of latex utilizing ASTM Test Method D5712 and no
detectable Hevea antigenic protein utilizing ASTM Test Method D6499-07
(Ref. 4). The latter test method, Standard Test Method for the
Immunological Measurement of Antigenic Protein in Natural Rubber and
Its Products, ``covers an immunological method to determine the amount
of antigenic protein in natural rubber and its products'' (Ref. 4).
According to ASTM, ``[a]lthough this method detects antigenic proteins,
it should not be considered as a measure of allergenic proteins,''
because ``[c]orrelation of protein/antigen levels with the level of
allergenic proteins has not been fully established'' (Ref. 4).
B. What Support Does the Petitioner Offer for this Request?
The petitioner provided the following exhibits to support his
petition:
1. Exhibit A: Ylitalo, Leea. Natural Rubber Latex Allergy in
Children. University of Tampere Medical School.
According to this study (abstract), the prevalence of NRL allergy in
children admitted for inhalant or food testing (total number of
children in the study, 3,269) was found to be 1%, based upon skin prick
test analysis. EPA recognizes that latex protein can cause
sensitization and allergic disease in certain children and adults, and
epidemiological studies show varying rates of prevalence in adults and
children.
2. Exhibit B: Blanco, Carlos, Latex-Fruit Syndrome, Current Allergy
and Asthma Reports. 3:47-53. 2003.
This publication reviews evidence indicating that latex and food
allergens cross react immunologically.
3. Exhibit C: Palomares, O. et al. 1,3 B-glucanases as candidates
in latex-pollen-vegetable food cross-reactivity. Clinical and
Experimental Allergy. 35:345. 2005.
This abstract also shows evidence of fruit, vegetables, and latex
cross-reactivity.
4. Exhibit D: Latex in Food Packaging Risk. Available on-line at:
http://www.consumeraffairs.com/news04/2006/08/latex.html.
This is a news article reporting that consumer groups were calling for
warning labels on food packaging containing latex.
5. Exhibit E: Dochniak, M.J. Autism spectrum disorders-Exogenous
protein insult Medical Hypothesis (2007), doi:10.1016/
j.mehy.2007.01.060.
This is an article written by the petitioner hypothesizing that
increased latex allergen exposure may have affected the incidence of
allergy-induced autism. The article presents only a hypothesis that is
unsupported by any scientific study or data.
6. Exhibit F: U.S. Patent 7,784,281 (Ichikawa, et al.).
This patent discusses a method for reducing the allergenic protein
content in Hevea NRL using digestive enzymes.
7. Exhibit G: Hayes, B. H. et al. Evaluation of Percutaneous
Penetration of Natural Rubber Latex Proteins. Toxicological Sciences.
56, 262-270. 2000.
According to this article, the skin can be a plausible route for latex
sensitization and a major exposure route when it is damaged (e.g., cuts
and abrasion). Other routes would include contact via mucosal surfaces
and inhalation exposure.
8. Exhibit H: H. B. Fuller Co. website literature on Hevea
brasiliensis water based adhesives. Available on-line at: http://
www.hbfuller.com/adhesives/technologies/water/000525.shtml#NR.
9. Exhibit I: Henkel Consumer adhesive literature. Natural rubber
latex adhesive.
Both Exhibit H and Exhibit I show that at least some manufacturers do
not display latex allergy protein warnings on their packaging.
10. Exhibit J: Niggeman, B. et al. Development of latex allergy in
children up to 5 years of age-a retrospective analysis of risk factors.
Pediatric Allergy [and] Immunology. 9:36-39. 1998
[[Page 32575]]
(International Standard Serial Number (Library of Congress) (ISSN):
0905-6157).
According to this study (abstract), besides the number of operations
and an atopic disposition, there were no other definite factors for
developing sensitization or allergy to latex in children up to 5 years
of age. In general, risk groups for latex allergy are atopics and
people frequently in contact with latex gloves, such as the medical
profession and patients needing multiple surgeries.
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 apply to the
requested actions. In addition, TSCA section 21 establishes standards a
court must use to decide whether to order EPA to initiate rulemaking in
the event of a lawsuit filed by the petitioner after denial of a TSCA
section 21 petition. 15 U.S.C. 2620(b)(4)(B). The petition does not
state under which provision of TSCA the request would be satisfied, and
only TSCA section 6 appears to be applicable. 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
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 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 ... is necessary to
protect health or the environment against an unreasonable risk of
injury,'' the court shall order the Administrator to initiate the
requested action. 15 U.S.C. 2620(b)(4)(B).
III. Disposition of Petition
The petition does not set forth facts sufficient to establish that
it is necessary to issue a rule prohibiting the use and distribution in
commerce of Hevea NRL adhesives having greater than 200 [micro]g total
protein per gram of latex and no detectable Hevea antigenic protein. In
particular, the petition does not set forth, as required by TSCA
sections 6 and 21, facts sufficient to support a finding that Hevea NRL
adhesives that do not meet the ASTM standard pose an unreasonable risk.
The petition does not present facts establishing that latex adhesives
containing any specific level of protein present an unreasonable risk.
Nor does the petition set forth facts indicating that prohibiting Hevea
NRL adhesives not meeting the ASTM standard would be effective in
reducing the incidence of latex allergies, or that doing so would be
the least burdensome requirement to protect against any unreasonable
risk from latex.
While the petitioner provides some documentation to support the
petition (see Unit II.B.), this documentation is minimal and
insufficient to show a reasonable basis to find unreasonable risk. For
example, while petition Exhibits A, G, and J seem to support the
assertion that NRL latex sensitization and allergies occur in children,
this information does not show that the NRL adhesives pose an
unreasonable risk. Moreover, the petitioner only speculates that
``[i]mplementation of an EPA regulation that guides adhesive
manufacturers to use Hevea [b]rasiliensis [italics added] natural-
rubber-latex that satisfy ASTM D1076-06 (Category 4) may [emphasis
added] affect the incidence and prevalence of latex allergy and
allergy-induced-autism in neonates.'' The only exhibit that purports to
show a link between Hevea NRL and infant autism is an article that was
written by the petitioner and published in Medical Hypotheses (Ref. 5).
The article presents only a hypothesis that is unsupported by any
scientific study or data. Moreover, neither this article nor any other
factual information provided in the petition address the contribution
of adhesives to any risk that might exist.
NRL allergies have been the subject of considerable Federal
Government evaluation. In March 2000, for example, the U.S. Consumer
Product Safety Commission (CPSC) received a petition requesting that
the CPSC issue a rule declaring that NRL and products containing NRL
are strong sensitizers under the Federal Hazardous Substances Act
(FHSA) so that these products would require labeling. See the Federal
Register issue of March 21, 2000 (65 FR 15133). The CPSC conducted an
extensive review and issued a decision in June 2004 rejecting the
petition (Ref. 6). Among other things, CPSC concluded that the
incidence of NRL allergy in the general population was very low (below
1%), that many consumer products contain NRL, and that ``in spite of
the prevalence of NRL in consumer products, there are few documented
cases of reactions to NRL-containing consumer products,'' most of which
involved medical devices\1\ (The CPSC did not distinguish between Hevea
and non-Hevea NRL, but nearly all commercial NRL is Hevea). The CPSC
noted that the U.S. Food and Drug Administration (FDA) had issued rules
requiring labeling for medical devices containing NRL, citing 21 CFR
801.437. FDA, however, has not limited protein content in, or
prohibited, NRL (Ref. 7). See also the Federal Register issue of
September 30, 1997 (62 FR 51021). In general, the CPSC concluded, most
individuals only experience mild symptoms and ``most incidents of life-
threatening NRL-induced anaphylaxis are associated with invasive
surgical or other medical procedures, not with consumer products''
(Ref. 6). The CPSC determination suggests that the risks associated
with NRL, principally Hevea
[[Page 32576]]
NRL, are relatively insubstantial, and does not support a conclusion
that any risk is unreasonable.
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\1\ A substantial proportion, if not most, products of concern
containing Hevea NRL may not be subject to TSCA. Among other things,
medical devices, food, food additives, food packaging, and cosmetics
do not fall within EPA's authority under TSCA section 6. TSCA
section 6 provides the authority to regulate chemical substances and
mixtures. The term ``chemical substance,'' however, ``does not
include - ... (vi) any food, food additive, drug, cosmetic, or
device (as such terms are defined in section 201 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C.A. 321]) when manufactured,
processed, or distributed in commerce for use as a food, food
additive, drug, cosmetic, or device.'' 15 U.S.C. 2602(2)(B)(vi).
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The petition provides little information on the factors that must
be considered for a TSCA section 6 rulemaking. The petition does not
explain why it specifically targets adhesives. The only documentation
supporting the petition related to NRL adhesives was a product brochure
and a Material Safety Data Sheet included as exhibits (petition
Exhibits H and I) to show that two companies had not included antigenic
protein warnings on their packaging. The petition does not discuss any
special risks posed by NRL adhesives (in comparison to other NRL
products or other adhesives), does not describe the contexts in which
one might be exposed to NRL adhesives or why those exposures are of
concern to the general population, and does not provide any other
information on why adhesives are of particular concern.
The petition does not provide any factual information on the
magnitude of exposure to Hevea NRL or Hevea NRL adhesives that do not
meet the ASTM standard or on the benefits of Hevea NRL or Hevea NRL
adhesives that do not meet the ASTM standard for various uses. Other
than noting the existence of substitutes, the petitioner provides no
factual information on the availability of substitutes. The petitioner
provides no factual information on the reasonably ascertainable
economic consequences of prohibiting the use and distribution in
commerce of Hevea NRL adhesives not meeting the ASTM standard. In
particular, the petition contains little information on the relative
importance of Hevea NRL adhesives as a source of infant exposure.
As for the regulation that the petition seeks (i.e., to prohibit
the use and distribution in commerce of Hevea NRL adhesives that do not
meet the ASTM Standard D1076-06 (Category 4)), the petition does not
provide any evidence that ASTM Standard D1076-06 represents a safe or
otherwise appropriate level of allergen in NRL. The threshold amount of
NRL allergen needed to sensitize a person, or to produce an allergic
reaction, is not known and, as ASTM Test Method D6499-07 states,
antigenic proteins should not be considered a measure of allergenic
proteins because a correlation between antigenic protein levels and the
level of allergenic proteins has not been fully established (Refs. 4,
8, 9, and 10). In addition, each NRL protein has different antigenic
properties, and individuals do not react uniformly to each allergenic
protein (Ref. 12). As the CPSC has pointed out, without knowing the
threshold amount, it is not possible to differentiate between products
that would cause sensitization or allergic reaction and products that
would not (Ref. 6). Moreover, it would be difficult for Hevea NRL
adhesives products to meet the ASTM standard because the referenced
test method for detecting antigenic Hevea proteins is very sensitive
and it is difficult to prepare Hevea NRL such that the level of
antigenic protein would be low enough to be undetectable by the
referenced method (Ref. 13). In addition, the petitioner has not
provided evidence showing that prohibiting Hevea NRL that did not meet
this standard would be the least burdensome requirement.
In addition, a regulation requiring reduced protein content in
Hevea NRL adhesives is unlikely to significantly contribute to reducing
Hevea NRL allergy in the general population. The groups considered most
at risk for Hevea NRL allergy are atopic individuals (who have a
genetic predisposition to allergies), individuals with certain food
allergies, and medical professionals and patients who undergo multiple
surgeries (who come into repeated contact with latex gloves or other
latex medical equipment) (Refs. 8, 9, 11, and 12).
Another factor to consider for a TSCA section 6 rulemaking is the
availability of substitutes. Petitioner has requested that EPA ban
products that do not meet the ASTM standard. Although, for some
products, there are substitutes to Hevea NRL that do meet the ASTM
standard, the petition does not present facts establishing that
substitutes of NRL meeting this standard are technically feasible to
use with or as adhesives, that they are safer than Hevea NRL, or that
the substitutes are effective or economical for use in or as adhesives.
The petitioner mentions in the petition that procedures, such as
aqueous washing or treatment with digestive enzymes can be used to
reduce the antigenic protein content in Hevea NRL (see Exhibit F). This
washing or treatment could be a substitute to Hevea NRL that does not
meet the ASTM standard, but these methods can be expensive, may produce
latex with inferior physical, chemical, or mechanical properties, or
significant quantities of proteins may still remain in the latex (Ref.
14). As for other substitutes (that do not involve procedures for
reducing protein content), sources other than Hevea trees can be used
to make NRL. For example, NRL can be obtained from the guayule plant
(Parthenium argentatum). Petitioner has provided no information on the
cost or feasibility of producing guayule NRL. In addition, guayule NRL
may not be a satisfactory substitute for Hevea NRL for purposes of
reducing the incidences of allergic reactions. Although, the proteins
present in guayule NRL may not cross-react with IgE antibodies from
subjects allergic to NRL obtained from Hevea NRL, there is still some
concern that the proteins present in guayule NRL could also sensitize
some individuals and cause allergic reactions (Refs. 15 and 16).
Finally, latex-free synthetic alternatives are also available, but
these alternatives are more expensive and may not perform as well as
Hevea NRL (Ref. 14). As evidence that substitutes may create their own
risks, many synthetic elastomers contain traces of carcinogens, and the
production of vinyl gloves, a major substitute for latex gloves,
increases the risk of dioxin releases into the atmosphere (Ref. 2).
IV. Comments Received
EPA published a notice in the Federal Register announcing receipt
of this TSCA section 21 petition and inviting public comment on or
before May 12, 2008 (Ref. 17). EPA received seven timely comments. Of
the seven comments received, two were from trade groups, three were
from manufacturers, one was from ASTM International, and one from an
individual.
One brief comment, from a manufacturer of latex and latex-free
bandages, supported the petition ``because it would go a long way in
preventing allergic reactions that have become more common among health
care workers,'' but did not provide any additional information (Ref.
18).
Another comment, from a manufacturer of guayule natural rubber
latex products, commented that it is presently not possible for Hevea
NRL to meet the ASTM D1076-06 Category 4 standard, that only guayule
can meet the standard, and that, even if the total protein present in
Hevea NRL could be reduced to the level in the Category 4 standard,
remaining proteins could still present a risk of allergic reaction to
the final product. The commenter suggested that a ban is, therefore,
not practical and that any proposed ban should, at least, be phased in
to permit time for development of substitutes and/or only target
adhesives to which children are exposed (Ref. 19).
The other five comments opposed the petitioned action and/or
discussed the inappropriateness of the ASTM standard for addressing the
concerns stated in the petition.
The comment from ASTM International (from the Chairman of the
[[Page 32577]]
subcommittee that maintains ASTM D1076-06), for example, noted that the
Category 4 standard specified in the petition was added for NRL from
botanical sources other than Hevea and that ASTM D1076-06 does not
apply to ``compounded latex concentrates,'' such as adhesives (Ref.
20).
The Pressure Sensitive Tape Council noted many of the same issues
discussed in this unit, including concerns similar to ASTM's regarding
the appropriateness of the standard, the lack of facts supporting the
petitioner's autism hypothesis, and the unexplained focus on Hevea NRL
adhesives as opposed to the many other uses of Hevea NRL (gloves,
sports equipment, carpet backing, balloons, rubber bands, handles on
tools, and clothing elastics) (Ref. 21).
The Rubber Manufacturers Association (RMA) noted the lack of
evidence of a link between Hevea NRL exposure and autism, commenting
that in the long history of NRL harvest and use, and in the course of
multiple government inquiries into latex allergy, no one had observed a
link between NRL and autism. The RMA also commented that the petition
did not cite any evidence that allergens in NRL adhesives are being
transported to the human body and described differences in exposure
potential between dipped latex products (such as medical gloves,
balloons, and condoms) and dry rubber products (such as tires, hoses,
belts, and balls). The RMA also commented that the primary route of
consumer exposure to adhesives would be through medical bandages,
which, as a medical device, would fall under the jurisdiction of FDA.
Finally, the RMA criticized the use of some of the references in
petitioner's Medical Hypotheses paper, commenting that several
references did not in fact support the petitioner's hypothesis (Ref.
22).
V. References
1. Dochniak, Michael J. Citizen Petition under TSCA to prohibit the
use of Hevea-Brasiliensis natural rubber latex adhesives in the United
States, wherein said adhesives have a protein content greater than 200
micrograms per dry weight of latex. February 26, 2008.
2. EPA, OPPT, Economics, Exposure and Technology Division (EETD).
Profile: Natural Rubber Latex Adhesives. May 7, 2008.
3. ASTM. ASTM D1076-06. Standard Specification for Rubber-
Concentrated, Ammonia Preserved, Creamed, and Centrifuged Natural
Latex. June 2006.
4. ASTM. Active Standard: D6499-07. Standard Test Method for the
Immunological Measurement of Antigenic Protein in Natural Rubber and
Its Products. Available on-line at: http://enterprise.astm.org/
REDLINE--PAGES/D6499.htm (last visited May 13, 2008).
5. Dochniak, Michael J. Autism spectrum disorders-Exogenous protein
insult, Medical Hypotheses (2007), doi:10.1016/j.mehy.2007.01.060.
6. CPSC. Letter from Todd Stevenson, Secretary, U.S. Consumer
Product Safety Commission, to Debra Adkins, responding to her petition
HP 00-2 requesting CPSC to issue a rule adding NRL to the list of
strong sensitizers. June 4, 2004.
7. FDA. FDA Clears Glove Made from New Type of Latex. FDA News.
April 23, 2008.
8. National Institute of Occupational Safety and Health (NIOSH),
NIOSH Publication No. 97-135: Preventing Allergic Reactions to Natural
Rubber Latex in the Workplace (June 1997).
9. Center for Food Safety and Applied Nutrition, Food Advisory
Committee Meeting, Additives and Ingredients Subcommittee. Latex Glove
Background Report. August 2003.
10. Northwestern University, Office for Research Safety, Laboratory
Safety, Office of the Vice President for Research. Allergic Reactions
to Latex Gloves. Available on-line at: http://
www.research.northwestern.edu/ors/labsafe/latex.htm (last visited May
13, 2008).
11. CPSC. Memorandum from Jacqueline Elder, Assistant Executive
Director for Hazard Identification and Reduction, to Todd Stevenson,
Secretary, re: Additional Information on Petition on the Natural Rubber
Latex (HP 00-2). April 1, 2004.
12. CPSC. Briefing Package, Petition Requesting that Natural Rubber
latex be declared a Strong Sensitizer (HP00-2). October 2003.
13. European Commission, Scientific Committee on Medicinal Products
and Medical Devices. Opinion on natural rubber latex allergy. June
2000.
14. U.S. Patent 5,741,885.
15. Siler, D.J.; Cornish, K.; and Hamilton, R.G. Absence of cross-
reactivity of IgE antibodies from subjects allergic to Hevea
brasiliensis latex with a new source of natural rubber latex from
guayule (Parthenium argentatum). Journal of Allergy Clinical
Immunology. 98: 895-902. 1996.
16. U.S. Patent 6,054,525.
17. EPA. Hevea brasiliensis Natural Rubber Latex Adhesives; TSCA
Section 21 Petition; Notice of Receipt. Federal Register (73 FR 22368,
April 25, 2008) (FRL-8361-3). Available on-line at: http://www.epa.gov/
fedrgstr.
18. Comment from Andover Healthcare, Inc. May 12, 2008.
19. Letter from the Yulex Corp. May 7, 2008.
20. Letter from ASTM International. May 7, 2008.
21. Letter from the Pressure Sensitive Tape Council. May 9, 2008.
22. Letter from the Rubber Manufacturers Association. May 12, 2008.
List of Subjects
Environmental protection, Antigenic proteins, Asperger syndrome,
Autism, Health, Hevea brasiliensis natural rubber latex adhesives,
Infants and children.
Dated: June 3, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E8-12850 Filed 6-6-08; 8:45 am]
BILLING CODE 6560-50-S