Daily News Archive
EPA Creosote Review Reveals Excessive Risks and Data Gaps,
Public Comments Must Be Received By February 3, 2004
(Beyond Pesticides, December 22, 2003) In a document that describes excessively high worker risks and potentially hazardous consumer exposure to the wood preservative creosote, EPA December 5, 2003 announced its preliminary risk findings, a public comment period through February 3, 2004, and confirmed health effects that have been known to the agency, the wood preservative industry and the scientific community for over 20 years.
Prior to releasing the document, EPA 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. Beyond Pesticides, prior and during that time, had a February 2002 petition pending with EPA requesting that creosote and the other heavy duty wood preservatives (chromated copper arsenate (CCA) and pentachlorophenol) be banned for all uses and had filed a lawsuit against EPA with the Communication Workers of America and others on December 10, 2002 in U.S. District Court (Washington, DC).
"On behalf of workers and the public, EPA has a statutory responsibility to immediately stop the use of creosote, pentachlorophenol, and CCA and not continue with a long drawn out regulatory process," said Jay Feldman, executive director of Beyond Pesticides in response to EPA's prelminary risk numbers.
According to EPA, "Creosote is a possible human carcinogen. . .primarily used on utility poles and railroad ties. Creosote, first registered in 1948 as a coal tar creosote active ingredient, is obtained from high temperature distillation of coal tar (itself a mixture of hundreds of organic substances), and over 100 components in creosote have been identified. It is used as a fungicide, insecticide, miticide, and sporicide to protect wood and is applied by pressure methods to wood products, primarily utility poles (about 70% of all creosote use) and railroad ties arms (about 15-20% of all creosote use). Assorted creosote-treated lumber products (e.g., timbers, poles, posts and ground-line support structures) account for the remaining uses of this wood preservative.
EPA is currently reassessing creosote as part of its ongoing reregistration program for older pesticides. As a part of that process, that EPA originally announced in 1998, it announced its Notice of Availability of the Preliminary Risk Assessment for Creosote Reregistration Eligibility Decision [Federal Register: December 5, 2003 (Volume 68, Number 234), pages 68042-68044]. EPA must receive comments, identified by Docket Number OPP-2003-0248, by February 3, 2004. The full preliminary assessment, Creosote: Risk Assessment and Science Support Branch's Revised Preliminary Risk Assessments and Science Chapters in Support of The Reregistration Eligibility Decision, is available for public inspection.
Controversial to EPA's assessment is the failure to evaluate the risks to utility pole installers, railroad workers and hazards associated with residential exposure to creosote-treated wood that is re-used in the form of garden borders and other uses. According to EPA, "No chemical-specific data for residential post-application exposure were submitted [by the wood preservative manufacturers or wood processors]. Therefore, exposure could not be estimated. Data were not adequate for use in the exposure assessment."
According to EPA, in its section on non-occupational (e.g., residential), exposure 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.). (Human Exposure chapter, page 4.)
However, with some clarity, EPA summarizes the extraordinary worker risks as follows: The results of the handler exposure and risk assessment indicate that the 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.] For dermal risks, only long-term exposures exceed the level of concern for the treatment operators. In addition, cancer risks for all handler scenarios exceed the level of concern (1 in 10,000 risk of cancer or 1E-04) for occupational handlers. Most estimated cancer risks are in the range of 1E-03 [1 in 1,000 people exposed will get cancer] or greater." (Human Exposure chapter, page 4.)
Residential Exposure to Creosote
Despite concerns about residential exposure, acknowledged in the past by EPA and expressed in the current document, the agency reverts to the position that since residential uses are not registered, the exposure (which it acknowledges) does not need to be evaluated. EPA says, "As there are no existing tolerances or other clearances for residues of creosote in food, an FQPA [Food Quality Protection Act] assessment is not necessary. Potential post-application exposures to residents, including children (e.g., from use of railroad ties by homeowners), could not be assessed due to lack of exposure data. The available evidence on developmental and reproductive effects of creosote was assessed by the Health Effects Division (HED) Hazard Identification Assessment Review Committee on April 1, 1999. The committee expressed concern for potential infants and children's susceptibility of creosote, based on the severity of offspring vs. maternal effects observed with testing of creosote in the P1/P13 blend developmental toxicity study in rats at the 175 mg/kg/day dose level as well as deficiencies observed in the 2-generation reproduction toxicity study in rats" (Human Exposure chapter, page 13.)
Then EPA acknowledges a lack of adequate data on neurotoxic effects, but reverts to the less stringent and comprehensive data requirements for non-food use pesticides, saying, "[R]ealizing that creosote is currently registered only for non-food use and is a restricted use pesticide, no additional neurotoxicity testing will be required at this time." (Human Exposure chapter, page 13.)
In its Questions & Answers factsheet, EPA acknowledges and 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." (Q&A, EPA, December 5, 2003.)
EPA position: 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 limited 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.)
According to EPA, "The Agency is concerned about potential post-application exposures to creosote. Since coal tar creosote is a blend of over 100 compounds, degradation is complicated. These compounds include volatile and semi-volatiles. The more soluble compounds in creosote include phenols, creosol, and N-heterocyclics. ("The Environmental Degradation of Creosote," 1998). Potential post-application exposure may occur following creosote applications in commercial, industrial, and residential settings. Post-application concerns exist in residential settings when pressurized treated wood (railroad crossties, cross planks, cross arms) is used for block flooring, and fence posts in residential areas. Although homeowner handler use is prohibited by the label, post-application exposures to creosote-treated wood are a potential homeowner concern." (Human Exposure, page 29.)
EPA's Closed-Door Meetings with Industry
In a February 28, 2003 letter, the attorney for the Creosote Council II (the lobby for creosote wood preservers) indicates that EPA has been sharing technical review documents with the industry for at least a year before making its analysis public. The letter states, "I am enclosing the Creosote Council's comments on the Antimicrobials Division's January 2003 draft preliminary risk assessment on creosote." Attorneys for the Creosote Council continued, "We further understand that such public release will not occur prior to the meeting between Creosote Council representatives and [EPA] Antimicrobials Division scientists scheduled for Tuesday, April 8, 2003" The letter goes on, "In addition to the comments that the Creosote Council is submitting today, please recall that by letter dated May 31, 2002, the Creosote Council provided to you and your colleagues a comprehensive written response to the NCAMP administrative cancellation/suspension "petition" on creosote. In pertinent part, that response and its attachments discussed the substantial body of scientific evidence regarding human and environmental risks of creosote and creosote-treated wood products. We previously requested you to include the Creosote Council's response (including attachments) in the RED bibliography. Since the Creosote Council's response is not referenced in the current EPA draft science chapters, we again make this request."
In its comments to EPA dated February 28, 2003, the Creosote Council II, which thanks EPA "for the opportunity to comment on the advance draft preliminary risk and associated draft science chapters, which the Antimicrobials Division provided to the Council in January 2003, issues a stern rebuke to the agency. In summary, the Council states, "As discussed below and in the appended expert reports, the current draft risk assessment and science chapters are riddled with serious errors, such as numerous assertions and conclusions based on inaccurate, inappropriate, or incomplete information and major flaws in scientific approach."
While in its debate with the Council EPA defends many of its positions on elevated worker risks and the inability to effectively mitigate them with engineering changes, the industry comments are seen by environmentalists and public health advocates as an attempt to subvert the regulatory process and keep it going for another 20 years, with comments such as 'needs a more in-depth review of the current literature, 'lack of data,' 'inappropriate models used,' etc. This EPA-industry discussion is captured in the November 26,2003, EPA Memorandum, Subject: Response to Registrant "Error Correction" Comments on the Preliminary Risk Assessment for Creosote
Hazard Profile of Creosote by EPA
According to EPA, "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.Cardiotoxicity was observed in a subchronic inhalation toxicity study in rats with the P1/P13 blend of creosote. [Typically, railroad ties/crossties are treated with a P2 blend, which is more viscous than the P1/P13 blend used for treating utility poles.] Diffuse myocardial degeneration affecting the right side of the heart as well as arterial medial hypertrophy of the small arterioles of the lung were observed after 13 weeks of exposure to 0.049 mg/L creosote. Exposure to the P2 blend of creosote by inhalation resulted in changes to the olfactory epithelium (inflammation, hyperplasia, metaplasia)."
The available evidence on developmental and reproductive effects of creosote was assessed by the [EPA's] Health Effects Division (HED) Hazard Identification Assessment Review Committee on April 1, 1999. The committee expressed concern for potential infants and children's susceptibility to creosote, based on the severity of offspring vs. maternal effects observed with testing of creosote in the P1/P13 blend developmental toxicity study in rats at the 175 mg/kg/day dose level as well as deficiencies observed in the 2-generation reproduction toxicity study in rats." (Human Risk Characterization chapter, page 3.)
The agency cites acute poisoning data and epidemiologic studies that link creosote exposure to adverse health effects. EPA finds that, '[A]mong the epidemiological studies on effects of creosote exposure, increased risks for development of a number of diseases have been observed. Diseases typically found to be in excess include skin cancer and nonmalignant skin disorders, bladder cancer, lung cancer and nonmalignant respiratory diseases." But then EPA concludes, "[C]onclusions regarding chronic health effects from exposure to creosote alone should be considered tentative."
FOR FURTHER EPA INFORMATION CONTACT: By mail: Bonaventure Akinlosotu, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Office location for commercial courier delivery, telephone number and e-mail address: Rm. 308, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703) 605-0653; e-mail: [email protected].Comments may be submitted to EPA's website.
For more general information on the struggle to protect public health from toxic wood preservatives:
See Beyond Pesticides' Fact Sheet on Chemically Treated Wood Utility Poles, State Legislation Toolkit, or
If links on this page fail to work, all EPA documents can be found under the edocket. Goto http://docket.epa.gov/edkpub/index.jsp, select "Quick Search" on the left side and and put the docket ID#: OPP-2003-0248 in the Quick Search field.