February 21, 2007
CVM Update - Environmental Considerations and Limitations for Use of Hydrogen Peroxide in Aquaculture
The Food and Drug Administration today is providing additional information on the conditions for use of 35% PEROX-AID® (hydrogen peroxide), a waterborne drug for specified uses in aquaculture (see http://www.fda.gov/cvm/CVM_Updates/perox-aid.htm).
As part of the approval of 35% PEROX-AID, FDA’s Center for Veterinary Medicine (CVM) reviewed an Environmental Assessment (EA), which evaluated the potential environmental impact of this action. CVM concluded that this action would not have a significant effect on the quality of the human environment and a Finding of No Significant Impact (FONSI) was prepared (http://www.fda.gov/cvm/ea.htm.) The FONSI was based on inclusion of risk mitigation language in the label under “Limitations and Cautions for All Uses” which requests that users inform the appropriate authority of the National Pollutant Discharge Elimination System (NPDES) of their intent to use this drug and of a 0.7 mg/L acute water quality benchmark that has been derived for hydrogen peroxide.
The acute benchmark concentration is not an effluent discharge limit and should not be interpreted as such. However, it can be used by the appropriate NPDES authority in conjunction with site-specific information (e.g., allowable size of mixing zone and the extent of dilution in receiving water) to determine if a specific discharge limitation and/or effluent monitoring may be needed for hydrogen peroxide at specific aquaculture facilities.
The benchmark value was calculated using the toxicity database for hydrogen peroxide summarized in the EA and a procedure that was developed by the U.S. Environmental Protection Agency (EPA) for deriving numerical national water quality criteria for aquatic life. The complete procedure that was used is described in the EA.
Risk mitigation labeling was necessary because risk characterizations in the EA indicate that the effluent concentrations for some aquaculture facilities expected to use this drug could potentially result in adverse effects on aquatic life in receiving waters. Receiving water concentrations for most facilities are expected to be well below the effluent concentrations used in the risk characterizations in the EA, but many states do not allow the discharge of any substances in potentially toxic amounts and/or for any degradation in surface water quality due to effluent discharges. The risk mitigation labeling ensures that the type and extent of wastewater treatment (e.g., settling ponds) at individual facilities, as well as local site-specific conditions (e.g., dilution and degradation in receiving waters), are considered before use of the drug. It also ensures there is appropriate oversight to determine whether effluent discharge limits are needed at individual facilities after these factors are taken into account.
EPA’s NPDES regulations require that NPDES permits include limits necessary to achieve water quality standards under section 303 of the Clean Water Act. In cases where a State has not established a water quality criterion for a specific chemical pollutant such as a new animal drug that may be present in an effluent in a concentration that causes or has a reasonable potential to cause or contribute to an excursion above a narrative criterion (e.g., “no toxics in toxic amounts”), the permitting authority must establish an effluent limit for that pollutant. In developing such limits, the permitting authority may use a calculated numeric water criterion derived from a number of information sources, including “information on the pollutant from the Food and Drug Administration.” 40 CFR.§ 122.44(d)(1)(vi)(A). Water quality benchmarks and other information on drug labels are intended to alert users of the potential adverse effects of drug use on aquatic life in receiving waters. This information also provides a mechanism for alerting permit writers of the potential need to formally establish facility-specific numeric effluent limitations for aquaculture drug products as well as necessary information for complying with § 122.44(d).
For questions regarding reporting requirements or the environmental assessment of hydrogen peroxide for use in aquaculture, please contact Charles Eirkson Environmental Safety Team, FDA, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV-103, Rockville, MD 20855, 301-827-6653, charles.eirkson@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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