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Background:
A citizen petition was filed under section 21 of the Toxic Substances Control Act (TSCA) on March 6, 2008
[EPA-HQ-OPPT-2008-0273; FRL-8368-4] requesting that the Director issue a regulation that prohibits the use and distribution in commerce of Hevea-Brasiliensis natural rubber latex adhesives having a total protein content greater than 200 micrograms per dry weight of latex.
The petitions intent is that implementation of an EPA regulation that guides adhesive manufacturer's to use Hevea brasiliensis natural rubber latex adhesives that satisfy[ies] such requirements may affect the incidence of latex allergy during pregnancy and allergy induced autism in neonates.
EPA Response:
The petition was denied on June 3rd, 2008: the petitioner thanks the EPA for the timely response.
EPA Reasons for Denial:
1) NRL adhesives comprise a very small portion of the adhesive industry. They are grouped by the U.S.
Census under the "natural base glues and adhesives" product category, which comprises the smallest (<
3%) of the U.S. adhesive manufacturing industry.
2) The petition does not present facts establishing that latex adhesives containing any specific level
of protein present an unreasonable risk.
3) According to ASTM, "although this method detects antigenic proteins, it should not be considered as a
measure of allergenic proteins because correlation of protein/antigen levels with the level of allergenic
proteins has not been fully established.
4) The petitioner only speculates that implementation of an EPA regulation may affect the incidence and
prevalence of latex allergy and allergy induced autism in neonates.
5) A U.S. Consumer Product Safety Commision (CPSC) determination suggests that the risks associated
with NRL, principally Hevea NRL, are relatively insubstantial, and does not support a conclusion that
any risk is unreasonable.
6) 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 why adhesives are of particularly concern.
7) The petition contains little information on the relative importance of Hevea NRL adhesives as a source of
infant exposure.
8) The petitioner has not provided evidence showing that prohibiting Hevea NRL adhesives that did not
meet this standard would be the least burdensome requirement.
9) A regulation requiring reduced protein content in Hevea NRL adhesives is unlikely to significantly
contribute to reducing Hevea NRL allergy in the general population.
10) Latex-free synthetic alternatives are available, but these alternatives are more expensive and may not
perform as well as Hevea NRL adhesives. As evidence that substitutes may create their own risk, 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.
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Petitioner Response:
The petitioner respectfully disagrees with the Assistant Administrator.
Petitioner Rebuttal:
Briefly, in the statement section of the petition it states, "Continued efforts in the United States have been undertaken to identify sources of Hevea Brasiliensis natural-rubber latex in order to minimize release into the environment. For example, in the medical industry, efforts continue to substantially eliminate natural rubber latex in the health care environment. Specifically, John Hopkins Hospital recently announced in 2008 that it will no longer use nearly all medical natural-rubber latex products." Medical products that contain Hevea NRL adhesives are targeted for exclusion.
In the petition denial, the Assistant Administrator fails to recognize or address the significant exclusionary practice described above.
In continuation, it was disclosed in the petition that consumer groups are calling for warning labels on food packaging containing latex (i.e., natural latex adhesives), saying the substance poses a potential threat to people with allergic sensitivities. A well published article entitled, "Deadly Latex Evading Lax Food Labeling Laws" presents a British study which shows that food-contamination from latex may be a dangerous health risk for both children and adults.
In the petition denial, the Assistant Administrator fails to recognize or address the health risk that natural latex adhesives pose when used in food packaging.
Innovative and forward thinking companies like Vytex™ have demonstrated that allergenic proteins can be substantially removed (e.g., < 20 micrograms total protein per gram dry latex) from Hevea Brasiliensis latex to provide adhesives having enhanced non-allergenicity and effective bonding characteristics - The petitioner submits that it would not be an undo burden for the Assistant Administrator to re-evaluate the validity of the Citizen Petition in light of the Vytex™ protein-extraction technology described above.
The non-differentiation of antigenic protein (innate and/or adaptive immune response) versus an allergenic protein (adaptive immune response), according to the ASTM, is moot in that both protein classifications elicit an adverse immune response.
The petitioner agrees with a public comment by a manufacturer of latex and latex-free bandages that stated, " because it would go a long way in preventing allergic reactions that have become more common....".
The Rubber Manufacturers Association noted 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 petitioner agrees and states, "When we let down a child that has atopy we're all to blame."
Furthermore, the Rubber Manufacturers Association responded to the petition as follows: "Latex rubber may even reduce the symptoms of autism, according to one member of the Autistic Society who has successfully used 'trance suits' i.e., inflatable natural latex rubber suits".
In a recent study entitled, "Allergic manifestations in autistic children: Relations to disease severity", researchers concluded that allergy may play a role in the pathogenesis of autism wherein allergic immune responses to some proteins (e.g., dietary protein and natural latex) may induce the production of brain autoantibodies, which are found in many autistic children.
In 2004, the U.S. Consumer Product Safety Commission (CPSC) denied petition HP00-2 requesting a rule declaring natural rubber latex to be a strong sensitizer. The Honorable Thomas H. Moore (Commissioner) stated, "Nevertheless, it would behoove manufacturers of NRL to take steps to reduce the level of proteins that consumers can come into contact with, whether or not the end product is a medical device.
Finally, as part of its focus on children's exposure to the antigenic/allergenic proteins in Hevea Brasiliensis, the petitioner would welcome the opportunity to discuss potential partnership approaches to data collection and product stewardship.
Sincerely,
Michael J. Dochniak
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Child Exposure:
In a letter dated July 18th, 2008, Charles M. Auer (Director - Office of Pollution Prevention and Toxics) responded to the rebuttal described above and stated:
"EPA was aware that it is possible to produce low-allergen NRL";
"Please be assured that EPA carefully considered this information, as well as much other information, during its review of your petition"; and
"EPA does not have any current plans to collect data or conduct a product stewardship program on NRL adhesives".
Legal Inquiry:
In the public interest a request has been made to the Minnesota Attorney General (Lori Swanson) to file a lawsuit, on behalf of the State of Minnesota, in an effort to reverse the EPA denial of the petition.
In a letter dated August 5th, 2008, Angela Skarda (Citizen Research Specialist) responded to the legal inquiry and stated, "Because the Attorney General's Office is not authorized to represent private citizens, I cannot file a lawsuit on your behalf".
Malcontent:
It is well known that the EPA is proactively participating in the recycling of Hevea-Brasiliensis natural rubber latex, without regard for the antigenic protein content therein.
The ambiguous phrase "unreasonable risk", used to deny the citizen petition, appears to be burdened with a conflict of interest. Specifically, the EPA promotes the use of ground rubber tires in recreational applications and states, "The material can absorb much of the impact from falls providing added safety for children".
The EPA should be exploring ways to reduce child exposure to the antigenic proteins (i.e., Hev-b proteins) that are inherent in ground rubber tires and natural rubber latex adhesives (i.e., practice what you preach - CEHCs ).
Finally, the petitioner respectfully requests that the EPA reconsider their participation in the continuous proliferation of Hevea-Brasiliensis natural rubber latex.
Centers for Disease Control (CDC)
An editorial was submitted entitled "Antigenic Proteins and Government Policy" (Preventing Chronic Disease - Manuscript PCD-08-0168) in an effort to communicate issues with Government policy related to the antigenic proteins inherent in Hevea Brasiliensis natural rubber latex.
Briefly, the editorial is a review on how Goverment agencies, who have been emboldened to guide health & safety, have shown contradictions in policy with Hevea-Brasiliensis natural rubber latex.
On August 27, 2008 the article was rejected and Marta Gwinn (Acting Editor-in-Chief) stated, "It has been evaluated by the editors, and unfortunately the topic is outside the scope of this journal".
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