Pesticide Registration (PR) Notice 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products
PESTICIDE REGISTRATION (PR) NOTICE 2001-X
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for the Registration of Pesticide Products
Subject: Spray and Dust Drift Label Statements for Pesticide Products
This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation. The purpose of this new labeling guidance is to provide pesticide registrants, applicators, and other individuals responsible for pesticide applications with improved and more consistent product label statements for controlling pesticide drift in order to be protective of human health and the environment. This Notice also includes EPA's position on drift, a rationale for the label statements, and an implementation plan.
I. SCOPE AND PURPOSE
A. Affected Products and Uses
This PR Notice applies to all pesticide products labeled for use outdoors that can be applied as sprays or dusts, including applications with ground hydraulic, airblast, aerial, chemigation, handheld, or backpack equipment, except for products stated below. Application sites for affected products include, but are not limited to, agricultural crops, forestry, rights-of-way, recreational areas, lawns, and home gardens.
While most of the science and regulatory emphasis has been on off-target drift of sprays, the Agency recognizes that applications of dust formulations also drift. Many of the same concerns and principles apply to products that are applied as dusts. The Agency's use of the term "spray drift" in this notice also applies to drift of dust formulations unless stated otherwise.
This notice does not to apply to:
- products labeled solely for indoor use;
- products labeled for outdoor use which are applied in a form other than a spray or dust, such as a granular formulation;
- fumigant products, due to their different physical state and behavior (vapor rather than liquid or solid particles); and
- mosquito adulticide products labeled solely for use in public health programs. These and certain other products will require special consideration for appropriate labeling.
Many states and tribes have restrictions and policies for controlling spray drift, including requirements of no-spray zones for certain or all pesticides, maximum spray release heights, and allowing applications only during certain wind speeds. EPA does not intend for its new guidance to conflict with or supersede more stringent restrictions by states or tribes or which may currently be on product labels.
B. Applicable Definitions
The Agency's current focus on pesticide spray drift is within relatively short distances (up to 1Ú2 mile) from the application site in which most deposition occurs. However, EPA recognizes that under certain circumstances lower levels of pesticides may drift considerably farther. For the purpose of this draft notice, EPA limits the meaning of the term "spray (or dust) drift" to the following definition:
"Spray or dust drift is the physical movement of pesticide droplets or particles through the air at the time of pesticide application or soon thereafter from the target site to any non- or off-target site. Spray drift shall not include movement of pesticides to non- or off-target sites caused by erosion, migration, volatility, or windblown soil particles that occurs after application or application of fumigants unless specifically addressed on the product label with respect to drift control requirements."
This definition is based on a definition of spray drift composed by participants of the National Coalition on Drift Minimization, which include representatives from federal (including EPA and the U. S. Department of Agriculture) and state agencies and tribes, pesticide and equipment manufacturers, university scientists, and others, who have focused their attention on enhancing pesticide applicator education, application research, and regulatory initiatives to foster reductions in spray drift.
The Agency recognizes that pesticide vapor and the off-target movement of pesticides by other means, not included in this definition, can nevertheless present substantial risks to humans and the environment. EPA generally addresses these routes of exposure and associated risk at the individual pesticide level through its regulatory programs.
EPA defines the term "no-spray zone" (also known as "buffer zone") for the purposes of this notice as follows:
"A no-spray zone is an area in which direct application of the pesticide is prohibited; this area is specified in distance between the closest point of direct pesticide application and the nearest boundary of a site to be protected, unless otherwise specified on a product label."
For example, a no-spray zone of 100 feet to protect a specified site would require the applicator to leave a distance of 100 feet between the point of spray application and the nearest boundary of the specified protected site.
In summary, through this PR Notice, EPA provides its guidance to applicants and registrants of pesticide product registrations for appropriate labeling statements for controlling spray and dust drift. This approach represents EPA's interpretation of the labeling language generally appropriate to implement the requirements of 40 CFR Part 156 and section 2(q) of FIFRA, which if not met the Agency may find a product to be misbranded and may take appropriate enforcement and/or regulatory action. EPA generally expects to follow this approach in its individual licensing actions. This guidance does not itself impose any binding requirements. The requirement to adopt the approach provided here would be imposed in the context of individual licensing actions. And, EPA may depart from the guidance where circumstances warrant and without prior notice. Accordingly, changes to these statements or additional statements may be warranted for certain products depending on uses, product hazard potential, and other considerations, and may be proposed by the applicant or registrant or by the Agency in conjunction with any application for registration or amended registration. The Agency also provides here its underlying position on spray drift and how it plans to implement these and other label statements for new and currently registered pesticides.
EPA has been working to improve the underlying science of pesticide spray drift, its understanding of the science, and the most effective means to control or mitigate spray drift. These and other related efforts are discussed below and in the publication "For Your Information-Spray Drift of Pesticides," December 1999 (ww.epa.gov/pesticides/factsheets/spraydrift.htm).
A. EPA's Concern About Off-target Spray Drift
Pesticide spray drift has been and continues to be of concern to EPA in its responsibility to ensure that pesticide use does not cause unreasonable adverse effects to human health and the environment. Each year, states receive about 2,500 complaints of drift from individuals. These complaints are investigated and, if appropriate, enforcement action is taken (1999 AAPCO Pesticide Drift Enforcement Survey, (http://aapco.ceris.purdue.edu ) Other reports of drift incidents are reported to EPA under adverse reporting requirements, the National Pesticide Telecommunications Network (NPTN 1999 Annual Report, (http://ace.orst.edu/info/nptn/ ) and to agriculture insurers. The Agency believes many incidents are unreported.
B. Drift Labeling Statements Prior to This Notice
At the time of registration and reregistration, EPA has and currently requires various product label statements for preventing or controlling spray drift. EPA has required more detailed label statements, including the use of no-spray zones and maximum application heights, for certain products, especially those which can be applied aerially. Additionally, agricultural products to which worker protection regulations (40 CFR, Part 170) apply bear labeling which includes the required statement "Do not apply this product in a way that will contact workers or other persons either directly or through drift." This PR Notice does not alter this worker protection requirement and is not expected to guide in circumstances where other label statements are more stringent than the guidance in this Notice. The Agency and many other stakeholders believe product labeling for spray drift control should be improved and standardized to the degree possible to provide applicators with more consistent and appropriate directions for controlling drift. Such changes are consistent with the requirements of 40 CFR Part 156 and section 2 (q) of FIFRA.
C. Data Availability
Under 40 CFR part 158, EPA may require data on drift to support the registration or reregistration of certain products. In recent years, the Agency has received a new collection of studies conducted by a group of registrants, named the "Spray Drift Task Force" (SDTF), to satisfy generic data requirements (see PR Notice 90-3, dated April 6, 1990, entitled "Announcing the Formation of an Industry-Wide Spray Drift Task Force"). Also, the SDTF in collaboration with EPA and USDA co-developed AgDRIFT, a new model, to provide estimates of spray drift deposition under different pesticide application and meteorological conditions. The Agency reviewed these new studies, AgDRIFT, and other scientific reports from the open literature and a data set from Germany. EPA's conclusions from its review of this collection of data and the utility of AgDRIFT were peer reviewed in 1997 and 1999 by independent scientific experts, including the FIFRA Scientific Advisory Panel (SAP). These independent scientists generally agreed with the Agency's conclusions regarding the data and the usefulness of AgDRIFT. EPA intends to use its conclusions from the review of these data , new data it may receive, and AgDRIFT or other appropriate models in its assessments of pesticides.
D. Collaborations with Stakeholders
EPA has communicated with other federal, state, and tribal government agencies and other stakeholders, including registrants, pesticide applicators, and equipment manufacturers, to gain a better understanding of their needs and concerns regarding pesticide application and the control of spray drift. The Agency has also discussed with regulatory authorities of other countries their approaches to assessing and regulating off-target spray drift. The Agency has carefully considered the concerns and suggestions expressed by these stakeholders in formulating this notice.
III. EPA'S POSITION ON PESTICIDE DRIFT
The Agency has the responsibility to ensure that the use of pesticides will not cause unreasonable adverse effects to human health and the environment. Those involved in pesticide application decisions have an important responsibility to protect people, domestic animals, wildlife, and the environment from pesticide exposures and potential harm from drift. States, tribes, and EPA have responsibilities to carry out enforcement to ensure compliance with pesticide use requirements.
EPA's position on pesticide drift is that applicators must not allow pesticide spray or dust to drift from the application site and contact people, animals, and certain sensitive sites, including structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, or rangelands. The Agency believes this is prudent public policy. It sets high but appropriate standards for applicators to protect people and the environment. Applicators must consider and use necessary application practices and measures required by states or tribes in addition to mandatory drift control measures that are stated on product labels. EPA believes the suggested labeling in this Notice will reduce risks associated with pesticide drift without a significant reduction in product efficacy. Accordingly, EPA believes that these label statements will help ensure that the requirements of FIFRA are met and, specifically, that pesticides are used in a manner that does not result in "unreasonable adverse effects on the environment."
The Agency's understanding of drift and available means to control it has significantly improved; however, EPA recognizes there will always exist controllable and uncontrollable factors which lead to drift, potential exposures, and risks of harm. The factors that contribute to drift are unique to each application and depend on weather, the application site, application equipment, and applicator behavior. EPA takes very seriously the potential adverse impact drift can have on human health and the environment. For these reasons, labeling for applicators must be clear and enable enforcement authorities, including states, tribes, and EPA, to take action when appropriate.
EPA recognizes that some de minimus level of drift would occur from most or all applications as a result of the uses of pesticides. The Agency believes the approach set forth here will not have an undue impact on agriculture or other uses of pesticides. EPA believes many responsible applicators already take added measures to control drift. This position and new labeling will clarify expectations for applicators and set definitive standards for application practices. For many years EPA and many states and tribes have had requirements or policies prohibiting drift. Wording to this effect (e.g., "Do not allow drift." and "A person may not apply a pesticide when wind speed exceeds 10 miles per hour.") appears on many pesticide product labels and/or in state laws (see Theodore A. Feitshans, An Analysis of State Pesticide Drift Laws, San Joaquin Agricultural Law Review, vol. 9(1), 1999). Enforcement authorities have carried out their actions to enforce such language in a reasonable manner. That position and label wording prohibiting drift are at least as, if not more, restrictive than the position and new wording expressed in this notice.
The Agency believes that the new labeling statements provides improvements over current labeling which is inconsistent or inadequate and for many products unclear to applicators and others. Use of the new statements, or some variation, by registrants for all affected products will provide a level of consistency among product labels. The statements also address for each application method specific application requirements that are key to drift mitigation. These application requirements are based on the Agency's conclusions of the supporting science of drift. And, the Agency has written the labeling statements in a manner that it believes the meaning is clear and enforceable and allows flexibility for the use of new application technology. These are labeling characteristics that meet the interests expressed by stakeholders as mentioned above.
IV. LABEL STATEMENTS
The Agency has developed a set of labeling statements as guidance for use on agricultural, home lawn and garden, and other outdoor use product labels. EPA considers these statements to be generally appropriate for all pesticides affected by this notice. These mitigation measures generally can be implemented for most products, regardless of the active ingredient and formulation chemistry. However, the Agency acknowledges that this guidance may not be appropriate for all products and their uses and that for certain products there may be exceptions to the wording of these statements in which some part(s) should not apply and/or other wording may be more appropriate. For example, while this notice applies to biopesticides applied as sprays or dusts, label statements will be determined on a case-by-case basis due to their usual low risk characteristics.
A. Label Statement Guidance
1. Products Applied as Sprays--All Affected Products, Except Home and Garden Products:
"Do not allow spray to drift from the application site and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.
For ground boom applications, apply with nozzle height no more than 4 feet above the ground or crop canopy and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use _____ (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles.
For orchard/vineyard airblast applications, do not direct spray above trees/vines and turn off outward pointing nozzles at row ends and outer rows. Apply only when wind speed is 3 -10 mph at the application site as measured by an anemometer outside of the orchard/vineyard on the upwind side.
For aerial applications, the boom width must not exceed 75% of the wingspan or 90% of the rotary blade. Use upwind swath displacement and apply only when wind speed is 3 -- 10 mph as measured by an anemometer. Use _____ (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles. If application includes a no-spray zone, do not release spray at a height greater than 10 feet above the ground or the crop canopy.
For overhead chemigation, apply only when wind speed is 10 mph or less.
The applicator also must use all other measures necessary to control drift."
2. Products Applied as Dusts--All Affected Products, Except Home and Garden Products:
"Do not allow dust to drift from the application site and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.
For ground rig applications, apply product no more than 4 feet above the ground or the crop canopy and only when wind speed is 10 mph or less at the application site as measured by an anemometer.
For orchard/vineyard ground applications, do not direct dust above trees/vines and shut off application at row ends and toward outer rows. Apply only when wind speed is 3 -10 mph at the application site as measured by an anemometer outside of the orchard/vineyard on the upwind side.
For aerial applications, use upwind swath displacement and apply only when wind speed is 3 -- 10 mph as measured by an anemometer. If application includes a no-spray zone, do not release dust at a height greater than 10 feet above the ground or the crop canopy.
The applicator also must use all other measures necessary to control drift."
3. Hand-applied Products, Including Home and Garden Products, to be Applied as Sprays or Dusts:
"Do not allow spray (or dust) to drift from the application site and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals. Apply only when wind speed is not more than 10 mph. For sprays, apply largest size droplets possible."
B. Possible Additional Product-Specific Labeling
Other labeling statements may be appropriate for certain products depending on the potential risks from the labeled uses. In EPA's human health and environmental risk assessments, the Agency may identify reported adverse effects or potential significant risks associated with drift from use(s) of a product or group of similar products. Such incidents and risks could include adverse effects to humans, plants, and wildlife or contamination of surface water. EPA will consider the available information on a pesticide's incident history, current uses, and estimated exposures and risks, including estimates of deposition from available models, to determine the need for additional drift mitigation measures. Examples of such measures include limiting application height, spray quality (droplet size), use of no-spray zones, and prohibition of an application method.
If the Agency determines that a no-spray zone is necessary for a product, the following label statement will be used:
"Do not apply this product within ____ (distance to be determined) of ____ (sensitive areas to be determined for the product). Under no circumstances apply this product within ____ (distance to be determined) of people or these areas."
EPA may find that the addition of no-spray zones to the above labeling statements is prudent as an additional drift management tool for applicators to protect people and sensitive areas from drift. EPA in its risk management decisions will determine whether one or more no-spray zones and their distance(s) are necessary for products using available information about the pesticide's uses and risk assessments.
C. Rationale for Label Statements:
EPA believes these label statements, if adopted, will generally be adequate to protect people and the environment from unreasonable adverse effects. These statements are also written in a clear, concise, and readily understood manner that address the most influential factors in cause and control of spray drift--wind speed, placement of nozzles, spray quality or droplet size, and application height. The Agency believes it is important to require applicators to measure wind speed at the application site and with an anemometer, an inexpensive instrument for this purpose, in order to obtain an accurate measurement. Measuring wind speed outside of orchards and vineyards and on the upwind side, rather than inside, gives a measure before the wind is obstructed by trees, vines or bushes and is relevant to drift that may move above the orchard canopy or beyond the rows. Specific application technology, which is constantly changing, was not incorporated into the label statements in order to give applicators greater flexibility in using a choice of evolving technology to achieve the desired results. EPA supports the development and use of new application equipment and methods to improve pesticide applications and reduce risks. EPA encourages registrants to submit information that support engineering controls that contribute to reducing drift.
Because of the importance of these factors and applicator/operator decision-making, the Agency believes it is prudent for these label statements generally to apply to labels of all affected pesticide products. Some stakeholders have expressed concerns that specific application restrictions may be impractical in certain application situations, such as in areas where windy conditions are very typical. Also, some enforcement authorities may be unable to determine whether or not an applicator followed certain specific application requirements, such as proper application height. However, the Agency believes the importance of these application restrictions generally outweighs these concerns because when followed these application practices will significantly reduce drift and therefore potential risks to people and the environment.
The Agency intends to use the above considerations for any additional label statements that are beyond the generic statements for specific products. These additional statements may be applicable for certain products depending on their levels of toxicity, use patterns, predicted spray drift deposition and reported incident history in order to meet the Agency's responsibility for ensuring that products do not result in unreasonable adverse effects to humans or the environment.
As stated above, the Agency may see the need for no-spray zones or other risk reduction measures for products associated with higher risks from drift. As defined above, the purpose of a no-spray zone is to provide a distance for drifting pesticide particles to dissipate before contacting sensitive areas or people. Since higher wind speeds generally result in higher levels of drift from the target site, a no-spray zone would be calculated for a product label using the highest wind speed allowed by the label. Conversely, lower wind speeds result in lower drift; however spray drift modeling suggests that applications under these conditions still may result in unacceptable deposition for certain pesticides. Also, low winds are generally highly variable in direction--gusts frequently blow contrary to the predominant wind direction.
V. WHAT REGISTRANTS SHOULD DO
A. Applications for Registration, Amendment, and Reregistration
EPA will begin immediately evaluating the use of these label statements in reviewing applications for registration, amendments, and reregistration of existing products subject to this Notice. The Agency's goal is to have the process of approving drift statements substantially complete by October 1, 2003.
Accordingly, registrants should be prepared to address drift considerations and the application of the above generic statements for labels of their affected products when submitting applications for new and amended product registration. As a general matter, EPA believes that for currently registered products, existing statements pertaining to drift should be removed and the suggested new generic statements should be incorporated. Exceptions are the required label statement "Do not apply this product in a way that will contact workers or other persons either directly or through drift." to comply with the worker protection regulations and any current drift label statement that is more restrictive than the generic statements in this notice. The new generic statements should be placed near the beginning of the Directions for Use section after the misuse statement.
Registrants may submit an application for amendment for each product. Applications should be directed to the appropriate Product Managers. An application should include the following: a completed EPA application form 8570-1; three copies of the revised draft label, and a description on the application, such as, "Response to PR Notice 2001-__." Because individual products must be evaluated according to formulation and use, and because individual circumstances may apply, EPA must review and approve the labeling of each product. Notification is not permitted for adding, revising, or deleting drift statements on the label.
B. Existing Products
EPA will evaluate the need to include the label statements in this notice in Reregistration Eligibility Decision (RED) documents and to product labels submitted in response to a RED document issued prior to this PR Notice. Registrants of affected products that currently are subject to reregistration submission requirements do not need to file a separate application for amendment as above. Rather, appropriate draft statements along with any other actions necessary can be included in their response to product reregistration.
C. Alternative Wording
For either registration or reregistration, if a registrant believes that alternate text is more appropriate than the above generic statements for their product(s), the company should submit a rationale for the alternate text along with the application and draft product label. If approved, the registrant may then use the alternate text.
D. Previous Labeling
Once the spray drift mitigation statements are approved by the Agency, registrants will generally have up to eighteen (18) months from the date of the new, approved label to distribute and sell products bearing old labeling unless the Agency establishes an alternative date pursuant to 40 CFR section 152.130(d). Persons other than the registrant may continue to distribute or sell such products until supplies are exhausted.
E. Address for Submission
Registrants should send or deliver their applications for amendment to either of the following addresses:
U.S. Postal Service Mail Delivery-
Document Processing Desk (AMEND)
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave., N.W.
Washington, D.C. 20460-0001
Personal/Courier Service Hand-Carried Delivery
(Monday - Friday, 8:00 AM - 4:30 PM, excluding Federal holidays-
Document Processing Desk (AMEND)
Office of Pesticide Programs (7504-C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall Building 2
1921 Jefferson Davis Highway
Arlington, VA 22202
VI. STATE APPROVALS MAY BE NEEDED
Please note that some states conduct label reviews prior to approving a modified product. Various states' requirements should be taken into consideration when deciding on the timing of your amendment submission to EPA. Some states may require a review of the modified label by EPA prior to submission to the state for state approval purposes.
VII. FOR FURTHER INFORMATION
For further information about this notice, contact Jay Ellenberger, Field and External Affairs Division, by telephone at 703-305-7099 or by e-mail at email@example.com.
Marcia E. Mulkey
Office of Pesticide Programs