Environmental Protection Agency (EPA).
EPA is announcing the approval, under section 303 of the Clean Water Act, of West Virginia's decision not to adopt a water quality criterion for 3-methyl-4-chlorophenol. The Clean Water Act requires each state to adopt water quality standards to protect public health and welfare, enhance the quality of water and otherwise serve the purposes of the CWA. 33 U.S.C. 1313(a)-(c). New or revised water quality standards adopted by a state must be submitted to EPA for review and approval. 33 U.S.C. 1313(c)(2)(A).Start Further Info
FOR FURTHER INFORMATION CONTACT:
For questions about this approval, please contact Cheryl Atkinson at (215) 814-3392 or mail your questions to: Cheryl Atkinson, U.S. EPA Reg. III (3WP11), 1650 Arch St., Philadelphia, PA 19103.End Further Info End Preamble Start Supplemental Information
In July 1998, West Virginia removed from its Requirements Governing Water Quality Start Printed Page 18074Standards, the criteria for phenolic materials, which applied to, among others, the pollutant 3-methyl-4-chlorophenol. In June 22, 1999, EPA disapproved the removal of the phenolic material criteria. Recently West Virginia adopted several phenolic material criteria; however, West Virginia did not adopt a criterion for 3-methyl-4-chlorophenol. On April 17, 2003, EPA approved the newly adopted phenolic material criteria despite the lack of a 3-methyl-4-chlorophenol criterion because EPA's national recommended criterion for 3-methyl-4-chlorophenol is based on organoleptic effects (taste and odors) that have no demonstrated relationship to adverse human health effects.
On January 14, 2004, the Eastern District of Pennsylvania district court issued a mostly favorable opinion in a litigation challenging the 2003 EPA approval of several West Virginia WQSs. See West Virginia Rivers Coalition v. Environmental Protection Agency, No. 03-1022 (E.D. PA. Jan. 14, 2004). However, the court found EPA's approval of the State's decision not to adopt a criterion for 3-methyl-4-chlorophenol, arbitrary and capricious. The court remanded to EPA for review the omission of the 3-methyl-4-chlorophenol criterion. The court also ordered EPA to document its review in the Federal Register.
In accordance with the court's order, this notice announces EPA's decision on March 15, 2004, to approve West Virginia's decision not to adopt a criterion for 3-methyl-4-chlorophenol Appendix A to this notice discusses the rationale supporting the decision to approve.Start Signature
Dated: March 30, 2004.
Jon M. Capacasa,
Director of the Water Protection Division, Region III.
Appendix A—Environmental Protection Agency Approval Rationale for 3-methyl-4-chlorophenol, West Virginia Requirements Governing Water Quality Standards, March 15, 2004.
Document Summary: The following discussion provides a description and uses of 3-methyl-4-chlorophenol; analysis of the effects, exposure, and risks associated with 3-methyl-4-chlorophenol; information on its likely prevalence in West Virginia; and a conclusion of whether 3-methyl-4-chlorophenol could be “reasonably expected” to interfere with designated uses related to taste and odor and human heath in West Virginia. Based on this information and analysis, EPA concludes that 3-methyl-4-chlorophenol cannot reasonably be expected to interfere with those designated uses in West Virginia. Therefore, a numeric criteria value for 3-methyl-4-chlorophenol is not required in West Virginia's WQS.
I. Description and Uses of 3-Methyl-4-Chlorophenol
3-methyl-4-chlorophenol (CAS number: 59-50-7) is a priority toxic pollutant under section 307(a) of the CWA. As noted in EPA's Substance Registry Service CAS file for this chemical (available at: http://www.epa.gov/srs/), there are a number of synonyms for this chemical, including: parachlorometacresol (or p-chloro-m-cresol), 3-methyl-4-chlorophenol, or 4-chloro-3-methylphenol.
3-methyl-4-chlorophenol was first registered as a pesticide in 1968 for use as an industrial preservative in the U.S. As of 1997, it has been registered for three products, including two manufacturing-use products and one end-use product, all of which are industrial uses only. Specifically, the chemical is used as a microbicide to control slime-forming bacteria and fungi that might develop in industrial products; these products are currently used in the manufacturing of industrial adhesives, industrial coatings, emulsions, leather processing liquors, metal cutting fluids, paints (in can), specialty industrial products, oil drilling muds/packer fluids, and wet-end adhesives/industrial processing chemicals. The chemical is also used in paper coatings and adhesives for food products, and as a preservative in pharmaceutical products and cutting oils (Ref. 4). The detection limit for 3-methyl-4-chlorophenol is 3.0 ug/L (ppb) using EPA Method 625 (40 CFR part 136, Table 5).
II. Human Health Effects, Exposure, and Risks Associated with 3-Methyl-4-Chlorophenol
EPA conducted a review of available information related to human health effects associated with exposure to 3-methyl-4-chlorophenol. This review includes searches of a number of databases providing information on human health effects associated with exposure to chemicals, and reviews of drinking water regulations. EPA also estimated human health risk screening values for evaluating human exposure to 3-methyl-4-chlorophenol in water and fish, applying peer-reviewed EPA guidance to derive this estimate.
(A) Taste and odor problems to humans in water and caught fish: EPA has published a national recommended water quality criteria value for 3-methyl-4-chlorophenol of 3,000 ug/L for organoleptic effects to address undesirable taste and odor in water potentially consumed by humans. EPA reported in the “Gold Book” (Quality Criteria for Water: 1986) that at a concentration of 3,000 ug/l in water, 3-methyl-4-chlorophenol causes a discernable odor. Where concentrations of 3-methyl-4 chlorophenol are below 3,000 ug/l, public water supplies are not affected by an undesirable odor or taste. EPA's recommended water quality criteria value of 3,000 ug/L for organoleptic effects in ambient water is also a reasonable screening value for taste and odor effects in caught fish because 3-methyl-4-chlorophenol is not highly bioaccumulative and would therefore not be expected to be present in fish tissues at concentrations that are much greater than those in water (EPA 2000; 2003).
(B) Human health effects: 3-methyl-4-chlorophenol is toxic when there is human exposure to skin and eyes at concentrations ranging between 200-50,000 mg/L. It can cause redness and pain when exposed to eyes and skin, and it can cause other health symptoms when ingested or inhaled. However, this chemical rapidly dissipates when exposed to air, and biodegrades readily in water under aerobic conditions. Studies on carcinogenicity and mutagenicity effects have been negative (Ref. 3).
For this evaluation, EPA estimated health risk screening values for evaluating protection against non-cancer effects associated with long-term human exposure to 3-methyl-4-chlorophenol in water and fish. The health risk screening values are: 5,200 ug/l (“water + organism”) and 27,000 ug/L (“organism only”). The “water and organism” value is to protect human health based on exposure to the pollutant via consumption of water and fish, while the “organism only” value is to be protective based on exposure via the consumption of fish.
The health risk screening values were calculated as described in EPA's Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000) (Ref 11 & 12). To account for the human exposure to the pollutant through the consumption of fish and other aquatic food, we calculated trophic level-specific bioaccumulation factors for trophic levels 2,3, and 4 aquatic organisms. The bioaccumulation factors (BAFs) were estimated from the octanol-water partition coefficient (Kow), based on procedures and methods provided in EPA guidance (EPA 2000; 2003). Using the log Kow reported for 3-methyl-4-chlorophenol in the 1997 EPA RED (where log Kow=3.02), we first determined the baseline BAF to be 1047 L/kg-tissue (baseline BAF ~ Kow = antilog of 3.02 = 1047). We did not use food chain multipliers in calculating BAFs, because for chemicals with a log Kow < 4.0, the chemical is classified as having low hydrophobicity and food chain accumulation is not considered to be an important factor in the calculation of BAFs (EPA 2000; 2003). Due to the lack of data on the metabolization rate of this chemical in fish, we used the conservative assumption that the chemical is metabolized slowly, although generally phenolic compounds do readily metabolize in fish tissue. In accordance with EPA guidance, trophic level-specific baseline Start Printed Page 18075BAFs are adjusted to conditions that are expected to affect the bioavailability of 3-methyl-4-chlorophenol (i.e., National BAFs derived). We adjusted the National BAFs to reflect percent lipid of the aquatic organisms consumed by humans (trophic level-specific) and the freely dissolved fraction of chemical in ambient waters. Using national default values for lipid content of consumed aquatic organisms and for particulate and dissolved organic carbon (to estimate the freely dissolved fraction of the chemical in water), the following national BAF values were calculated for 3-methyl-4-chlorophenol: trophic level 2 = 20.9L/kg-tissue; trophic level 3 = 28.2 L/kg-tissue; trophic level 4 = 32.4 L/kg-tissue. These national trophic level-specific BAFs are used in conjunction with national default trophic level fish ingestion rates (TL2 = 0.0038 kg/d, TL3 = 0.0080 kg/d, TL4 = 0.0057 kg/d) to calculate the ingestion of chemical that is due to consumption of fish (EPA 2000; 2003). In the case of this evaluation for 3-methyl-4-chlorophenol, the result was 0.4905 L/d.
For the next step in estimating the risk screening value, we used the non-cancer effect equation from the human health methodology. The reference dose (RfD) of 0.9 mg/kg/d was derived from the lowest observed effects level (LOEL = 28 mg/kg/d) data from a rat study presented in the EPA RED document and the EPA recommended uncertainty factors. We used the default “floor” relative source contribution (RSC) of 20% in this evaluation (EPA, 2000), because of lack of information available on potential exposures to 3-methyl-4-chlorophenol and hence for performing a quantitative RSC analysis. Using these input parameters, the health screening values for “water and organism” (5,200 ug/L) and “organism only” (27,000 ug/L) were estimated for comparison to the significantly lower organoleptic criteria (3,000 ug/L) and the effluent discharge monitoring data.
III. Prevalence of 3-Methyl-4-Chlorophenol in West Virginia Surface Waters
EPA searched for information or data relevant to the discharge or presence of 3-methyl-4-chlorophenol throughout the State of West Virginia. The results of this search indicate that 3-methyl-4-chlorophenol (p-chloro-m-cresol) is not likely to be present at levels above the analytical detection limit in any effluent or ambient surface water in West Virginia.
Under the technology-based effluent guidelines limitations, 3-methyl-4-chloro-henol (p-chloro-m-cresol) is regulated only as a member of a group of organic chemicals (“priority pollutants”) in 40 CFR parts 423 (Steam Electric Power Generating Point Source Category), 433 (Metal Finishing Point Source Category), 464 (Metal Molding and Casting Point Source Category), and 467 (Aluminum Forming Point Source Category). This organic chemical is not regulated as an individual parameter in EPA's effluent guidelines because data available at the time the effluent guidelines were developed indicated that this organic chemical was not detected at an elevated concentration in treated effluent being discharged by such facilities.
EPA conducted a review of permit information for dischargers associated with the numerous Standard Industrial Category (SIC) codes associated with the above effluent guidelines regulations, and for permit information on all parameter codes associated with 3-methyl-4-chlorophenol in EPA's Permit Compliance System (PCS) data base. The permit review described above indicated that all major permitted facilities required to analyze for the presence of 3-methyl-4-chlorophenol reported no detections above the detection limit for this chemical (or other synonym names associated with this chemical).
In addition, EPA searched several monitoring data bases and contacted authorities who conduct either surface water ambient monitoring or drinking water monitoring and found that these authorities do not monitor for this chemical (or other synonym names associated with this chemical). There are no fish advisories currently in effect for 3-methyl-4-chlorophenol in West Virginia.
Another private database (Ref. 7) online provided the following data regarding the presence of this chemical in the environment (although not specifically in West Virginia). Chlorinated municipal sewage effluents in the United Kingdom have been observed to contain 3-methyl-4-chlorophenol concentrations of approximately 2 ppb (ug/L).
In the final effluent and soil leachate from a treatment works in the United Kingdom, 3-methyl-4-chlorophenol concentrations of 73 ng/L (0.073 ug/L) and 154 ng/L (0.154 ug/L), respectively, were reported. In summary, detections were reported in some effluent discharges in England at levels at or below 2 ug/l. The data base notes that environmental release of 3-methyl-4-chlorophenol may occur through inadvertent formation in waters (potable water, wastewater, cooling water) which have undergone chlorination treatment and by evaporation or waste releases from product formulation or end-products containing 3-methyl-4-chlorophenol. However, also according to the database, if the chemical is released to water, photolysis and biodegradation appear to be capable of degrading this chemical. Various screening tests have demonstrated that this chemical is readily biodegradable under aerobic conditions. If released to the atmosphere, 3-methyl-4-chlorophenol will degrade rapidly (half-life of 1.1 days).
IV. Is 3-Methyl-4-Chlorophenol “Reasonably Expected” To Interfere With Human Health Designated Uses in West Virginia?
As described further below, based on this information and analysis, EPA concludes that 4-chloro-3-methylphenol cannot reasonably be expected to interfere with designated uses related to taste and odor and human heath in West Virginia. Therefore, a numeric criteria value for 3-methyl-4-chlorophenol is not required in West Virginia's WQS.
Section 303(c)(2)(B) of the CWA requires adoption of numeric criteria for priority toxic pollutants where the discharge or presence of priority toxics may interfere with designated uses. Where the discharge or presence of priority toxics cannot “reasonably be expected” to interfere with designated uses, a numeric criterion is not required.
EPA's WQS regulation, at 40 CFR 131.11(a)(2), provides requirements for adoption of priority toxic pollutants in WQS, and notes that: “States must review water quality data and information on discharges to identify specific water bodies where toxic pollutants may be adversely affecting water quality or the attainment of the designated water use or where the levels of toxic pollutants are at a level to warrant concern and must adopt criteria for [toxic pollutants including 3-methyl-4-chlorophenol] applicable to the water body sufficient to protect the designated use.”
As discussed in section II above (II. Effects, Exposure, and Risks Associated with 3-methyl-4-chlorophenol), an appropriate action level to control undesirable taste and odor problems associated with human exposure to 3-methyl-4-chlorophenol is 3,000 μg/L. Appropriate screening levels to protect against non-cancer effects associated with human exposure to 3-methyl-4-chlorophenol in water and fish are: 5,200 μg/l (“water + organism” exposure) and 27,000 μg/L (“organism only” exposure). Carcinogenicity and mutagenicity studies were negative for effects.
EPA reviewed, assembled and documented available information or data relevant to the discharge or presence of 3-methyl-4-chlorophenol throughout the State. As discussed in section III above (Prevalence of 3-methyl-4-chlorophenol in West Virginia surface waters), 3-methyl-4-chlorophenol (p-chloro-m-cresol) is not indicated to be present at detectible levels in effluent or ambient surface water monitoring data throughout the State.
Since 4-chloro-3-methylphenol is not indicated to be present in effluent or ambient surface water monitoring data throughout West Virginia, the chemical has not been shown to be present in surface waters at levels above action levels that would be protective of human health (i.e., 3,000 μ/L, to protect from undesirable taste and odor problems; 5,250 μ/L, to protect against non-cancer effects associated with “water + organism” exposure; and 26,600 μ/L, to protect against non-cancer effects associated with “organism only” exposure).
The lack of detection in effluent and surface waters is consistent with our knowledge of the uses of this compound. If releases to surface waters occur from industrial practices, the concentration of this chemical would be further diluted and degraded by photolysis and biodegradation.
EPA therefore concludes that, based on this information and analysis, 3-methyl-4-chlorophenol cannot reasonably be expected to interfere with designated uses related to taste and odor and human heath in West Virginia. Therefore, a numeric criteria value for 3-methyl-4-chlorophenol is not required in West Virginia's WQS. The narrative criteria in the West Virginia regulations Start Printed Page 18076concerning toxics, and pollutants affecting taste and odor, in sewage and effluent still apply. This decision is consistent with other Agency's decisions involving organoleptic pollutants. In December 1992, EPA promulgated numeric criteria for priority toxic pollutants for fourteen states at 40 CFR part 131 (57 FR 60848). The CWA requires that states adopt water quality standards for toxic pollutants. EPA excluded from this rulemaking criteria that are based on taste and odor effects, not on toxic effects. EPA noted that the purpose of the rulemaking was to protect public health and aquatic life from toxicity, and organoleptic pollutants are not toxic (57 FR 60864). Similarly, in May 2000, EPA promulgated numeric criteria for priority toxic pollutants for California, also at 40 CFR part 131. This rulemaking also excluded criteria for organoleptic pollutants because they are not based on toxicity to humans or aquatic life (65 FR 31698).
1. EPA's Substance Registry Service CAS file (http://oaspub.epa.gov/srs/srs_proc_qry.navigate?P_SUB_ID=3103).
2. Office of Pollution, Pesticides and Toxics (OPPT)'s Reregistration Eligibility Decisions (REDs) database (http://www.epa.gov/pesticides/reregistration/).
3. The REDs fact sheet for this chemical (http://www.epa.gov/REDs/factsheets/3046fact.pdf) (EPA-738-F-96-008, January 1997) and the REDs full document for this chemical (EPA-738-R-96-008, January 1997) is available at: http://www.epa.gov/REDs/3046red.pdf.
4. National Institute for Occupational Safety and Health (NIOSH) “RTECs” (http://www.cdc.gov/niosh/rtecs/go6c5660.html#Y) and NIOSH's Chemical Data Safety Card for this chemical (http://www.cdc.gov/niosh/ipcsneng/neng0131.html).
5. EPA Method 625 (40 CFR part 136, Table 5).
6. EPA's Permit Compliance System (PCS) data base, found at: http://www.epa.gov/compliance/planning/data/water/pcssys.html, using searches on the following Web site: http://www.epa.gov/enviro/html/pcs/pcs_query_java.html.
7. Spectrum Laboratories maintains a database at: (http://www.speclab.com/compound/c59507.htm).
8. West Virginia Fish advisory Web site (http://www.wvdhhr.org/fish/current.asp) searched on February 19, 2004.
9. EPA “Gold Book” (Quality Criteria for Water: 1986, EPA 440/5-86-001).
10. EPA's Ambient Water Quality Criteria for Chlorinated Phenols (EPA, 1980, EPA 405-80-032).
11. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000), EPA-822-B-00-004, October 2000.
12. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000)-Technical Support Document Vol. 2 Development of National Bioaccumulation Factors, EPA-822-R-03-030, December 2003.End Supplemental Information
1. EPA's Office of Pesticide Programs (OPP)'s Reregistration Eligibility Decisions (REDs) documents contain the results of EPA's regulatory reviews of pesticides initially registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The REDs database is found at: http://www.epa.gov/pesticides/reregistration/. The REDs fact sheet for this chemical is available at: http://www.epa.gov/REDs/factsheets/3046fact.pdf (EPA-738-F-96-008, January 1997) and in the REDs full document for this chemical (EPA-738-R-96-008, January 1997) found at: http://www.epa.gov/REDs/3046red.pdf.Back to Citation
2. Trophic levels in the aquatic food chain go from algae to zooplankton and benthic filter feeders to forage fish to predatory fish.Back to Citation
3. In applying the uncertainty factors, the LOEL is divided by a factor of 3 to account for the lack of NOEL—no observed effects level-in the chronic rat study and further is divided the result by 10 to account for the limited number of species tested)(EPA RED 1997; EPA 2000).Back to Citation
4. West Virginia Requirements Governing Water Quality Standards sections 46-1-3.2.d-3.2.e.Back to Citation
[FR Doc. 04-7780 Filed 4-5-04; 8:45 am]
BILLING CODE 6560-50-P