Document Control Office
Office of Pollution Prevention and Toxics (OPPT)
Environmental Protection Agency
1200 Pennsylvania Ave., NW.
Washington, DC 20460-0001
Federal Register: December 5, 2003 (68 FR 68042)
Re: Docket Number: OPP-2003-0248
EPA Revised Preliminary Risk Assessment of the wood preservative Creosote
The preliminary risk assessment of creosote describes excessively high worker risks and confirms health effects (including cancer) that have been known to the agency, the wood preservative industry, and the scientific community for more than 20 years. We respectfully request that the agency follow through with its statutory responsibility and immediately stop the use of creosote, deny reregistration, and avoid a long drawn out regulatory process.
In February 2002, Beyond Pesticides and fifteen national and statewide public interest groups filed a petition with the agency to suspend and cancel the registration of creosote (see attached). In light of the agency’s revised risk assessment, which supports even further the weight of literature showing adverse health effects and risks, we stand by our original petition and request that the agency immediately suspend and deny the reregistration of creosote based on the grounds that creosote-treated wood poses unreasonable adverse risks to public health and the environment and that less toxic economical alternatives are available.
of Creosote by EPA
We believe that the weight of evidence compiled on creosote from acute poisoning and epidemiologic studies and worker risk analyses, which link creosote exposure to adverse health effects, including cancer, are sufficient to result in agency action to deny reregistration. The EPA itself states in the preliminary assessment, “The toxicology database for Creosote is adequate to assess the hazard profile of creosote for use in a Preliminary Risk Assessment (PRA). Review of the database shows concern for the mutagenicity and carcinogenicity of creosote as well as cardiomyopathy after inhalation exposure and dermal inflammation after repeated dermal exposure. Results of developmental toxicity testing of creosote in experimental animal species shows qualitative evidence of susceptibility from creosote, thus raising concern for creosote as a potential developmental toxicant.” Therefore we urge the agency to change its position that, in the face of clear evidence, the health effects should be considered “tentative.”
The preliminary assessment failed to assess risks or require data for post-application classes of workers not provided by the Creosote Council II, such as utility pole installers, railroad line installers and other relevant railroad workers who also experience exposure. With the use of wipe methods to determine surface residue exposure, such data and corresponding risk assessment could be helpful in also assessing non-occupational post-application exposure.
The preliminary assessment does summarize with clarity the extraordinary worker risks from creosote in pressure treatment facilities. The results of the handler exposure and risk assessment indicate that creosote inhalation exposures exceed the level of concern for all handler scenarios. The target margin of exposure (MOE) is 100 or more and the MOEs are 10 for the treatment operator and 17 for the treatment assistant even with the use of current engineering controls. [For acute effects, EPA uses an MOE of 100 or above as the threshold for safety. By EPA standards, these risks are extraordinarily high.] Cancer risks for all occupational handler scenarios also exceed the level of concern (1 in 10,000 risk of cancer or 1E-04). Most estimated cancer risks are in the range of 1E-03 [1 in 1,000 people exposed will get cancer] or greater. This information alone should preclude the agency from issuing a reregistration.
Exposure to Creosote
The agency has shown on numerous occasions that it is well-aware of the problem of pressure-treated wood continuing to be used in residential settings and the potential dangers of such use. We also recognize that the agency is concerned about potential post-application exposures to creosote. Therefore, we find it distressing that the agency continue with the perverse assumption that just because residential uses are not registered (e.g. for crossties used in home gardens), that exposure does not need to be evaluated.
It is unacceptable for the EPA to turn a blind eye to the actual real-life uses of wood supplied to the public by the wood industry. The fact that the industry supplies this wood to the public without any warnings or safeguards shows that the industry is more interested in getting rid of the hazardous wood cheaply regardless of the health and welfare risks to the public. The public then unknowingly handles and re-uses the wood in exactly the same as they would regular, untreated wood, including sawing, handling, constructing, and various uses of the soil directly near and under the wood, which is most likely contaminated from leaching.
According to the agency, there are no data for children or adults regarding: (1) homeowner incidental ingestion and dermal contact with soil contaminated with creosote (e.g., soil contaminated by creosote treated telephone poles); (2) outdoor homeowner dermal contact with industry pressure treated wood products (e.g., utility poles, posts, shingles, fencing, lumber, piers, etc.); and, (3) outdoor homeowner hand-to-mouth and dermal contact with industry pressure treated wood products (e.g., utility poles, posts, shingles, fencing, lumber, piers, etc.).
The fact that there are data gaps for residential post-application exposure provided by the wood preservative manufacturers or wood processors should not preclude the agency from taking action – or at the VERY least, requiring such data based on its mandate to protect the public from unreasonable risk. The problem stems mostly from the illegal hazardous waste exemption provided to the industry which should be immediately reversed. We urge the agency to consider its experience with CCA and its recent findings on children’s exposure from playgrounds made with CCA-treated wood. Wipe tests and hand-to-mouth data have been collected for children’s exposure to CCA and should similarly be done for residential exposures to creosote.
In the Questions & Answers factsheet, the agency acknowledges but then dismisses residential exposure, telling the public to fend for itself.
"Are railroad ties safe for me to use for landscaping around my home?”
"There are no approved uses of creosote to treat wood for residential use. The Agency is aware that creosote-treated railroad ties are being used in the residential setting for landscape purposes and, in some instances, as a border around gardens. Such uses in residential settings are not intended uses of creosote and have not been considered in the preliminary risk assessment. If you do have creosote-treated wood in your yard, you are reminded to consult the handling precautions outlined above in this document.”
Not only is this a contradictory message to the public, but it also does not acknowledge that the agency has no data to actually answer the question it poses and then dismisses. Until residential exposure data gaps are filled, the agency must stop ignoring the unregistered uses of pressure-treated wood.
EPA concludes that creosote is a "complete" carcinogen, has teratogenic potential, and adversely affects reproduction. Creosote is rated as a B1 probable human carcinogen based on evidence of the association between occupational creosote contact and subsequent tumor formation. Further, while a specific quantitative risk assessment on carcinogenicity of creosote has not been performed by the agency, a quantitative cancer risk assessment exists for benzo(a)pyrene, one of the components of creosote. Administration of benzo(a)pyrene by inhalation has been shown to result in respiratory tract tumors, and administration by the dermal route results in skin tumor production, similar to creosote. Benzo(a)pyrene has also been shown to be a "complete" carcinogen similar to creosote, and also tests positive for mutagenicity on a variety of assays. (Human Exposure chapter, page 27.)
Meetings with Industry
Lastly, we encourage the EPA to enforce its mandate of transparency. The agency engaged in nearly a year of closed-door meetings with the wood preservative industry, requested industry comments on draft documents, and locked the public out of the review process. Meanwhile, Beyond Pesticides and fifteen other public interest groups filed a 23-page petition to EPA and received no response.
In a February 28, 2003 letter, the attorney for the Creosote Council II indicates that the agency has been sharing technical review documents with the industry for at least a year before making its analysis public. We do, however, applaud the agency for defending its assessments of elevated worker risks and the inability to effectively mitigate them with engineering changes despite the efforts of the Creosote Council to pressure the agency to downgrade the risk. We also strongly oppose the industry’s attempts to subvert and prolong the regulatory process with comments like: 'Needs a more in-depth review of the current literature, 'Lack of data,' 'Inappropriate models used,' etc.
Exposure And Modeling
The section on Environmental Exposure and Modeling models the chemical concentration in a one hectare (ha) pond from runoff from a 10 ha field of a railroad installation using creosote-treated crossties and concludes that, “the effect of creosote on ground water and drinking water is expected to be minimal.” We expect that if creosote production is allowed to continue similar modeling and actual sampling will be done near and on pressure treatment facilities where storage of chemically treated wood is very high in order for the agency to get a proper and comprehensive understanding of the environmental exposure levels. The potential of creosote to leach into soil and ground water from stored treated poles on facility sites poses significant concern of additional exposure rates for workers, the surrounding ecology, and the public living near the treatment plants.
Given the documented hazards of creosote, (like CCA and Pentachlorophenol), EPA is obliged to proceed as rapidly as possible and not delay another 20 years. Without causing significant economic disruption, EPA could easily order the cancellation of creosote and industry could replace it with economical, less toxic alternatives in a period of months. Steel, concrete or composite, recycled plastic with steel-core, and naturally resistant woods are all effective long-term alternatives to creosote-treated wood. These alternatives do not pose such high hazards to workers, handlers, users, treatment sites and transportation, and they have longer product lives, reduced disposal costs (and potential gains from scrap income), and less environmental impacts – including leachate pollution.
The agency has unreasonably delayed in re-reviewing or reregistering creosote after years of review under the special review program. Clearly, some of the new findings of the agency’s current review only confirm the findings of over two decades ago which found that creosote use and exposure exceeded acceptable risk criteria. By years of inaction EPA has allowed the wood treatment industry to undergo an explosion of growth, thus exposing millions more people and creating wider environmental contamination. It is now way past the time for regulatory action on chemicals like creosote that are an antiquated technology and excessively hazardous, particularly when alternative materials and approaches are available in the 21st century. EPA is compelled to stop further exposure to and use of creosote by virtue of elevated and unacceptable risk levels and in light of no availability of alternatives that are economically feasible.
Special Projects Director
cc: Agricultural Resources
Center, Center for Environmental Health, Clean Water Action, Farmworker
Justice Fund Inc., GreenCAPE, Greenpeace U.S.A., Haverhill Environmental
League, Learning Disabilities Association of America, MCS: Health &
Environment, Northwest Coalition For Alternatives to Pesticides, Ohio
Network for the Chemically Injured, Pesticide Action Network North America,
U.S. PIRG, and Vermont PIRG