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Gesetzgebung USA
Legislation
All biocidal antifouling systems used within the USA, imported or transported across state lines must be registered federally as well as within the states they are to be used. Registration of pesticide products is done federally by the Environmental Protection Agency. Within the EPA the Office of Pesticides, Antimicrobial Division, is responsible to the registration of these pesticide products. State government can implement more stringent restrictions and choose not to register paints that are registered federally if they are inclined to, but cannot change labelling requirements.
The law governing the management of antifouling paints in America is the Federal, Insecticide, Fungicide and Rodenticide Act (FIFRA). Most of the registered antifouling paints in America contain some form of copper as the primary active ingredient with some using Sea-Nine, Irgarol or Zinc Pyrithione as a co-biocide. Only antifouling systems that contain a biocide need to be registered with the EPA.
ZPT was registered by the U.S. EPA for use as an antifouling biocide in 1997. Copper pyrithione is not yet registered for use by the U.S. EPA, but a registration application has been filed. The manufacturer obtained U.S. EPA registration for Sea-Nine 211 in 1994 and this was the first organic biocide registered for use in antifouling paints within the USA.
The U.S. EPA registered Irgarol as an antifouling biocide in 1994. After the submission of additional ecological effects data and environmental fate data, 7 antifouling paints containing Irgarol were registered for use in the US.
California have had a heightened interest in the use of antifouling paints since some parts of San Diego Bay have been found to contain higher levels of dissolved copper then the state and federal standards allow. The University of California's Sea Grant Extension project is now trying to promote the use of non toxic antifouling products through investigation of new biocide free antifouling systems and subsequent education of the target boating groups (seagrant.ucdavis.edu). The Regional Water Quality Control Board is currently carrying out analysis of the total maximum daily load of copper in the Shelter Island yacht basin and depending on the results of this study California may implement stricter rules concerning the use of copper-containing antifouling products in California.
More detailed information about pesticides registered for use in the USA is available by subscription to the National Pesticide Information Retrieval System (NPIRS), under the administration of the Center for Environmental and Regulatory Information Systems, Perdue University, Indiana (aboutnpirs.ceris.purdue.edu). Here you can access registered pesticide product information, the pesticide document management system, data submitters list, tolerance indexes, and the federal register archive.
All reports used or compiled by the EPA in the process of product registration are available through the Freedom of Information Office, with the exclusion of information designated as confidential by the manufacturing company involved.
Evaluation of efficacy of biocidal antifouling products
US EPA Pesticide Assessment Guidelines related to antifouling products
Efficacy data should be derived from testing conducted under conditions typical of actual or proposed use, or, where applicable, under controlled laboratory conditions which simulate actual use.
The test substance should be the formulated product evaluated at various dosage levels including those dosage rates associated with its proposed use. It should be tested under all techniques intended to be used in applying the product.
Data on the compatibility of the test substance with other sub-stances will be developed in accordance with OPPTS 810.1000 if the test substance will be used in sequence or with another substance.
Data should demonstrate the effect of the test substance on various life stages of pests and other significant factors. The data should clearly establish the method of action of the test substance in repelling, destroying, or mitigating pests.
The efficacy of the test substance should be established with reference to the applicable suggested performance standard.
The suggested performance standards contained in the following guidelines are generally stated in terms of percent control, based on a comparison of treated organisms and untreated control organisms. In certain situations, the test substance may be evaluated in comparison to a product of known efficacy. Under some other circumstances, the performance standards are expressed as acceptable levels of damage.
The conditions under which the suggested performance standards apply are listed in the following guidelines. These performance standards are not intended to be absolute or inflexible.
An analysis of variance and multiple range test or other appropriate statistical analysis should be conducted to determine the reliability of data, when a question of relative effectiveness occurs.
Dose response data should accompany applicable site/pest crop combinations. The benefits such as increased yield, unblemished fruit, reduction in nuisance pest levels to be derived from each dosage rate to be registered for control of a particular pest should be clearly defined and reported. Dose response data for crops other than the pesticide site/pest combination will be considered if submitted and referenced.
Data required for registration of biocidal antifouling products include:
Acute toxicology data on the formulated product
Product chemistry data
Chronic toxicology data on the active ingredient
Environmental fate data on the active ingredient
Phytotoxicity data if risks are suspected to non-target plant species
Fish and wildlife data, if applicable
Labelling requirements
There are 4 toxicity categories and a pesticide is assigned to a category based on its highest hazard potential. The Hazard indicators include Oral LD50, Inhalation LC50, Dermal LD50, eye effects and skin effects, physical and chemical Hazards. The substance is labelled with a signal word (danger, warning, caution) and precautionary statement for each hazard according to its respective category.
All biocidal antifouling systems used within the USA, imported or transported across state lines must be registered federally as well as within the states they are to be used. Registration of pesticide products is done federally by the Environmental Protection Agency. Within the EPA the Office of Pesticides, Antimicrobial Division, is responsible to the registration of these pesticide products. State government can implement more stringent restrictions and choose not to register paints that are registered federally if they are inclined to, but cannot change labelling requirements.
The law governing the management of antifouling paints in America is the Federal, Insecticide, Fungicide and Rodenticide Act (FIFRA). Most of the registered antifouling paints in America contain some form of copper as the primary active ingredient with some using Sea-Nine, Irgarol or Zinc Pyrithione as a co-biocide. Only antifouling systems that contain a biocide need to be registered with the EPA.
ZPT was registered by the U.S. EPA for use as an antifouling biocide in 1997. Copper pyrithione is not yet registered for use by the U.S. EPA, but a registration application has been filed. The manufacturer obtained U.S. EPA registration for Sea-Nine 211 in 1994 and this was the first organic biocide registered for use in antifouling paints within the USA.
The U.S. EPA registered Irgarol as an antifouling biocide in 1994. After the submission of additional ecological effects data and environmental fate data, 7 antifouling paints containing Irgarol were registered for use in the US.
California have had a heightened interest in the use of antifouling paints since some parts of San Diego Bay have been found to contain higher levels of dissolved copper then the state and federal standards allow. The University of California's Sea Grant Extension project is now trying to promote the use of non toxic antifouling products through investigation of new biocide free antifouling systems and subsequent education of the target boating groups (seagrant.ucdavis.edu). The Regional Water Quality Control Board is currently carrying out analysis of the total maximum daily load of copper in the Shelter Island yacht basin and depending on the results of this study California may implement stricter rules concerning the use of copper-containing antifouling products in California.
More detailed information about pesticides registered for use in the USA is available by subscription to the National Pesticide Information Retrieval System (NPIRS), under the administration of the Center for Environmental and Regulatory Information Systems, Perdue University, Indiana (aboutnpirs.ceris.purdue.edu). Here you can access registered pesticide product information, the pesticide document management system, data submitters list, tolerance indexes, and the federal register archive.
All reports used or compiled by the EPA in the process of product registration are available through the Freedom of Information Office, with the exclusion of information designated as confidential by the manufacturing company involved.
Evaluation of efficacy of biocidal antifouling products
US EPA Pesticide Assessment Guidelines related to antifouling products
Efficacy data should be derived from testing conducted under conditions typical of actual or proposed use, or, where applicable, under controlled laboratory conditions which simulate actual use.
The test substance should be the formulated product evaluated at various dosage levels including those dosage rates associated with its proposed use. It should be tested under all techniques intended to be used in applying the product.
Data on the compatibility of the test substance with other sub-stances will be developed in accordance with OPPTS 810.1000 if the test substance will be used in sequence or with another substance.
Data should demonstrate the effect of the test substance on various life stages of pests and other significant factors. The data should clearly establish the method of action of the test substance in repelling, destroying, or mitigating pests.
The efficacy of the test substance should be established with reference to the applicable suggested performance standard.
The suggested performance standards contained in the following guidelines are generally stated in terms of percent control, based on a comparison of treated organisms and untreated control organisms. In certain situations, the test substance may be evaluated in comparison to a product of known efficacy. Under some other circumstances, the performance standards are expressed as acceptable levels of damage.
The conditions under which the suggested performance standards apply are listed in the following guidelines. These performance standards are not intended to be absolute or inflexible.
An analysis of variance and multiple range test or other appropriate statistical analysis should be conducted to determine the reliability of data, when a question of relative effectiveness occurs.
Dose response data should accompany applicable site/pest crop combinations. The benefits such as increased yield, unblemished fruit, reduction in nuisance pest levels to be derived from each dosage rate to be registered for control of a particular pest should be clearly defined and reported. Dose response data for crops other than the pesticide site/pest combination will be considered if submitted and referenced.
Data required for registration of biocidal antifouling products include:
Acute toxicology data on the formulated product
Product chemistry data
Chronic toxicology data on the active ingredient
Environmental fate data on the active ingredient
Phytotoxicity data if risks are suspected to non-target plant species
Fish and wildlife data, if applicable
Labelling requirements
There are 4 toxicity categories and a pesticide is assigned to a category based on its highest hazard potential. The Hazard indicators include Oral LD50, Inhalation LC50, Dermal LD50, eye effects and skin effects, physical and chemical Hazards. The substance is labelled with a signal word (danger, warning, caution) and precautionary statement for each hazard according to its respective category.