EPA 730-N-00-006
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Pesticide Registration (PR) Notice 2000-9
September 29, 2000
Notice to Manufacturers, Producers, Formulators
and
Registrants of Pesticide Products
ATTENTION:
Persons Responsible for the Registration and
Reregistration of Pesticide Products
SUBJECT: Worker Risk Mitigation for OrganOphosphate Pesticides
This Pesticide Registration (PR) notice announces EPA's approach for managing risk to
workers who may be exposed to organophosphate (OP) pesticide products by mixing, loading,
applying, flagging or otherwise handling OP pesticides, or are exposed to residues of these
pesticides while performing tasks in recently treated areas. This approach generally provides
for basic protective measures such as closed mixing and loading systems, enclosed cab
equipment, or personal protective equipment, as well as increased restricted-entry intervals for
occupational situations where revised risk assessments indicate that they are necessary and
where these measures are feasible. Further, this notice outlines the steps that EPA intends to
take to address situations where baseline mitigation measures are not feasible, or situations
where maximum feasible mitigation is still inadequate to protect workers.
Recycled/Recyclable . Printed with Vegetable Oil Based Inks on 100% Recycled Paper (40% Postconsumer)
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The approach set out in this document is not final Agency action, but is intended solely
as guidance for manufacturers, producers, formulators, users and registrants. The notice itself
does not impose binding obligations on either the registrants or EPA. The measures described
in this notice will be implemented, as appropriate, through reregistration and other ongoing
processes. No registrant is required to respond to this notice, or to modify product labels at
this time.
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I. Background
This PR Notice is being issued in anticipation of the Agency's completion of
comprehensive risk assessments for the OP pesticides, as part of the larger process of
implementing the Food Quality Protection Act of 1996 (FQPA) amendments to the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic
Act (FFDCA), and the ongoing process of reregistration established by FIFRA. The
management of risks identified in the OP assessments is governed by both FIFRA and the
FFDCA. The "reasonable certainly of no harm" standard hi section 408 of the FFDCA (which
has been incorporated into FIFRA), applies to the establishment and reassessment of tolerances
under FFDCA, as well as the assessment of dietary risk under FIFRA. The FIFRA "risk-
benefit" standard includes consideration of the risks and benefits of all pesticide uses including
occupational and ecological risks under the risk-benefit standard. In managing these latter
risks, EPA must take into account the economic, social, and environmental costs and benefits
of the pesticide's use.
The implementation of the FQPA amendments has been the subject of a joint effort by
EPA, USDA, and interested stakeholders known as the Tolerance Reassessment Advisory
Committee (TRAC; recently replaced by the Committee to Advise on Reassessment and
Transition, CARAT). Among other initiatives, the TRAC has established a process for public
participation in the review and refinement of risk assessments for the OPs and for developing
risk management options. The public participation process consists of 6 phases. Phases 1
through 4 address the development and refinement of the risk assessments. Phases 5 and 6 are
concerned with the development and implementation of risk management plans. Phase 5 of the
public participation process is an opportunity for the registrants, user community, and the
general public to propose risk mitigation based on the revised risk assessments. During phase
6 of the TRAC process, the Agency prepares an interim Reregistration Eligibility Decision
(RED) Document or a Report on FQPA Tolerance Reassessment and Interim Risk
Management Decision Document, from which interim risk management will be implemented.
Throughout this process, USDA, stakeholders, and the public have the opportunity to
participate by submitting comments on the risk assessment and also by providing risk
management proposals. Prior to finalizing a risk management decision, the Agency typically
receives input from USDA, growers and registrants to assess the feasibility of mitigation
measures.
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It is important to note that worker risk mitigation is only one part of the comprehensive
mitigation strategy being developed during Phases 5 and 6 of the TRAC process. Much of the
work of the TRAC has focused on dietary risk and tolerance reassessment. EPA will develop
mitigation plans for all risks of concern identified for each OP pesticide, including risks from
food, drinking water, residential and other non-occupational risks, and ecological impacts as
well as occupational risk. The risks associated with residential and other non-occupational
exposures are evaluated and addressed as part of tolerance reassessment under FFDCA sec.
408 (q). This notice is intended to present EPA's policy for management of the occupational
risk associated with the use of OPs. Specific proposed measures for individual chemicals will
be announced through EPA's interim risk management decision documents, and will be
implemented shortly thereafter.
In a number of cases the OP risk assessments show that, even with maximum feasible
personal protective equipment (PPE) and engineering controls, including all provisions
currently required by the Worker Protection Standard, risks to workers still exceed the
Agency's levels of concern. Although each OP risk management decision and any associated
mitigation measures will be implemented on a case-by-case basis, the Agency is outlining its
decision process in this notice, because early notification to registrants will help to ensure that
occupational risk management decisions for the OPs will be approached consistently and
implemented quickly and equitably. The Agency also encourages registrants to demonstrate
stewardship of their chemicals by adopting the protective measures described in this notice
prior to the issuance of the interim RED, and to develop new packaging and application
technologies that reduce worker exposures to pesticides. EPA is in the process of developing
and implementing chemical specific mitigation strategies for the OPs.
The FQPA amendments to FFDCA direct the Agency to evaluate food tolerances on the
basis of cumulative risk from pesticides sharing a common mechanism of toxicity, such as the
toxicity expressed by the organophosphates through a common biochemical interaction with the
enzyme, cholinesterase. The Agency will evaluate the cumulative dietary risk posed by the
entire OP class of chemicals after certain policy and scientific issues for conducting cumulative
assessments are resolved. While these policies and methodologies are being developed, the
Agency has decided to move forward with individual assessments and identify mitigation
measures that the Agency believes are necessary to address the human health risks and
ecological risks associated with the current use of the individual OP chemicals. The Agency
will issue its final decision on the OP class of chemicals following completion of the
methodology for cumulative assessments. The cumulative assessment may result in further
dietary risk mitigation measures for OP chemicals, such as lower application rates, longer pre-
harvest intervals, fewer applications, elimination of uses etc., which may also further reduce
worker and ecological exposure and risk.
This interim evaluation of OPs does not limit the Agency from making further FFDCA
determinations and tolerance-related rulemakings that may be required on these pesticides or
any others hi the future. If the Agency determines, as a result of this later implementation
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process, that any of the determinations described in the interim REDs or Interim Tolerance
Reassessment Evaluation and Risk Management Document, are no longer appropriate, the
Agency will pursue appropriate action.
While this notice focuses on workers exposed to organophosphate pesticides, EPA
envisions that risks to workers exposed to other classes of pesticides with similar risks, e.g.,
carbamate pesticides, would be managed in a similar manner.
H. EPA's Approach to Occupational Risk Mitigation for OPs
A. Scope
The approach described in this notice applies to both workers and handlers as defined
by the Worker Protection Standard (WPS), and other persons not specifically covered by WPS
(such as people who handle pesticides or are exposed following applications to rangeland,
rights-of-way, structures, livestock, golf courses, parks, public spaces, etc.), who nonetheless
perform similar activities and are exposed to pesticides in a similar manner to agricultural
workers. EPA is particularly concerned for workers and handlers because of the relatively
high risks indicated by current assessments, the acute toxicity of these compounds coupled with
the large volume of chemicals handled, and the potential for accidental exposure to
concentrated products frequently used hi commercial applications.
B. Worker Protection Standard
EPA's Worker Protection Standard for Agricultural Pesticides, 40 CFR Parts 156 and
170, is intended to reduce the risk of pesticide poisonings and injuries among agricultural
workers and pesticide handlers who are occupationally exposed to pesticides. WPS affects all
pesticide products whose labeling reasonably permits use in the commercial or research
production of agricultural plants on any farm, forest, nursery, or greenhouse. The WPS
labeling requirements pertaining to personal protective equipment (PPE), restricted-entry
intervals (REI), and notification may be reviewed and revised as appropriate, on a case-by-case
basis, during reregistration and other Agency review processes.
C. Level of Concern
EPA estimates worker risk by evaluating occupational exposure levels, including both
dermal and inhalation exposures, against the No Observed Adverse Effect Level (NOAEL)
demonstrated hi toxicity studies. The ratio of the estimated exposure to the NOAEL is
referred to as the Margin of Exposure (MOE). Generally, MOEs that are less than 100 exceed
the Agency's level of concern for worker risk. An MOE of 100 represents uncertainty factors
(UFs) of 10X to account for differences in species sensitivity between animals and humans and
another factor of 10X to account for differences in sensitivity to toxic effects within the human
population. Additional UFs may'be added to account for the use of a Lowest Observed
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Adverse Effect Level (LOAEL), the severity of the effect observed, the lack of certain data, or
other such concerns.
The occupational risk assessments completed thus far for the OPs have shown that, with
only a few exceptions, worker and handler MOEs for these pesticides exceed the Agency's
level of concern (i.e., have MOEs < 100). In a number of cases, even with maximum
personal protective equipment (PPE), such as double-layer clothing, chemical resistant gloves,
and appropriate respirator, or with engineering controls, such as closed mixing/loading
systems and enclosed cabs/cockpits, calculated MOEs are still lower than 100.
For workers entering a treated site, restricted entry intervals (REIs) are calculated using
a similar MOE approach to determine the minimum length of time required after application
before workers or others are allowed to enter to perform routine hand labor activities.
In addition, the Agency closely examines occupational cancer risks and seeks ways to
reduce cancer risks to the extent required to protect worker health, taking into account both the
estimated risks and the benefits of the pesticide.
D. Types of Worker Risk Mitigation Measures
Mitigation measures that will be considered to reduce risk to workers may include
additional PPE (e.g., 2 layers of clothing, chemical resistant gloves, footwear, headgear,
apron, and/or appropriate respirator), closed mixing and loading systems, enclosed cabs,
enclosed cockpits,.reduced application rates, reduced frequency of applications, mechanical
harvesting and longer REIs. In addition, depending on toxicity and potential exposure, EPA
may reclassify some pesticides as Restricted Use Pesticides (RUPs).
Technologies have been developed and are available to greatly reduce exposure to both
handlers and workers. Many registrants are already providing their products hi bulk and mini-
bulk recyclable containers, water soluble packages, gel packs, less "dusty" granular
formulations and systems which are engineered to greatly reduce workers' contact with the
particular pesticide. In some cases, selection of the most appropriate system is chemical or use
specific and will depend on formulation type, application method and cost considerations. The
Agency recognizes and welcomes innovative approaches that may be developed to suit specific
needs and encourages registrants to consult with EPA on specific mitigation approaches.
Additionally, under EPA funding, Cornell University is working to put together a
catalog of engineering controls including information on the following: closed transfer
systems, returnable/refillable containers, carbon cab filters, chemical induction bowls,
diaphragm check valves, hydraulic boom folding, nozzles/holders, injection devices, and tank
rinsing devices. This study is currently targeted for completion in late 2001.
For the purposes of occupational risk mitigation described in this notice, EPA
anticipates that many occupational scenarios will require the use of some type of engineering
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control. Depending on the magnitude of the risk and the severity of the potential effects
associated with exposure to a pesticide, different levels of mitigation may be necessary. In
some cases, where the risk warrants, specific technologies or methods may be required.
Examples of possible technologies that may be required in a given case are: dry coupling
systems for loading operations, enclosed cabs that meet specific performance standards (such
as the American Society of Agricultural Engineers (ASAE) standard) to protect persons
applying the pesticide, and specific chemigation methods such as drip irrigation, or subsurface
placement equipment. The Agency is aware of standards that have been developed and are
being developed by the ASAE, such as an enclosed cab standard, and an closed system
standard (still in development). Enclosed cabs, certified by the manufacturer as meeting the
ASAE standard S-525, would generally meet EPA's request that use be restricted to enclosed
cab applications. However, other types of engineering controls may also be adequate to
address risk.
In order to illustrate what the Agency envisions by the term "engineering controls",
several examples of varying degrees of protection are given below. These items are not
intended to suggest that a registrant will be required to incorporate all types of engineering
controls simultaneously, but rather that these systems are currently known to the Agency as
options for risk mitigation.
1. Contained/Closed Mixing and Loading Systems
One engineering control available for mixing and loading pesticides is a closed system.
By closed system EPA means a system designed by the manufacturer to enclose the pesticide to
prevent it from contacting individuals while it is being handled. Under the WPS, when a closed
mixing and loading system is used correctly and maintained according to the manufacturers
operating instructions, handlers may reduce some of the personal protective equipment listed
on the pesticide labeling for mixing and loading activities.
a. Mechanical Transfer System. One type of closed system for liquid
formulations is a mechanical transfer system that consists of a probe that is inserted into the
pesticide container and seals tightly to the pesticide container to prevent liquid (but not
necessarily any vapor) from contacting handlers or other people. The pesticide is either
transferred directly from its container to a spray tank, or the container is connected directly to
the spray system. Mixers and loaders using this closed system are permitted to wear reduced
PPE. A mechanical transfer system usually does not meet the definition of a closed system
under the WPS unless inhalation exposure is not a concern; however it is considered an
engineering control which greatly reduces dermal exposure.
b. Dry Disconnect System. A dry-disconnect system does not meet the
definition of a closed system under WPS unless it is part of a mechanical closed system. Dry
disconnect systems are considered to be an engineering control that reduces potential worker
exposure by reducing leakage of liquid when pipes or hoses are uncoupled from equipment or
from other pipes or hoses. Dry-disconnect systems involve fittings designed by the
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manufacturer to minimize pesticide leakage at each hose disconnect point. These systems are
often used in conjunction with mechanical transfer systems.
c. Water-soluble Packaging. Water-soluble packaging is considered to
be an engineering.control that reduces exposure during the handling of a pesticide. Under the
WPS, individuals handling a product while it is enclosed in intact water-soluble packets are
permitted to wear reduced PPE.
Water-soluble packaging is the only currently available type of engineering control for
use with wettable powder formulations. Some liquid pesticide formulations may also be
converted into gels and packaged into water-soluble packets (gel packs).
d. Prepackaged Granular Containers. Some technologies are
available for granular formulations, where the granules are packaged in a container that fastens
directly onto specially made application equipment. Once attached, the equipment opens the
container and meters out the granules. Under the WPS, such systems meet the definition of a
closed loading system and a closed application system, if the granules are soil incorporated, in
which case reduced PPE is permitted under that regulation.
2. Enclosed Cabs
a. Enclosed Cabs for Application and Flagging. The engineering
control available for handlers applying pesticides using motorized ground equipment or
flagging to support aerial applications is an enclosed cab. By enclosed cab, EPA means a cab
having a nonporous barrier .-that totally surrounds the occupants and prevents contact with
pesticides outside of the cab. By definition, all enclosed cabs protect against dermal exposure.
Some enclosed cabs also provide respiratory protection — they can be equipped with a
ventilation system that provides paniculate filtration equivalent to a NIOSH-approved dust/mist
respirator or that provides organic-vapor-removing and paniculate filtration equivalent to a
NIOSH-approved organic-vapor-removing respirator with a dust/mist prefilter. The
performance criteria for enclosed cabs are found in the WPS at 40 CFR Part 170.240(d)(5).
If the occupational risk assessment for such handlers indicates that dermal exposure is
the only exposure route of concern (i.e., inhalation risks are not a concern even when no
respirator is worn), then an enclosed cab providing only dermal protection is sufficiently
protective and will be required on the pesticide labeling. However, if the risk assessment
indicates that inhalation risks are a concern unless an appropriate respirator is worn, then the
pesticide labeling will indicate that the enclosed cab must provide respiratory protection
equivalent to the type of respirator required for the pesticide or that the handler must wear the
appropriate respirator while inside the enclosed cab. As noted hi section D above, depending
on the severity of inhalation risks, EPA may require that enclosed cabs meet performance
criteria beyond those specified in the WPS.
Under the WPS, handlers in any enclosed cab need not wear all of the label-required
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PPE designed for dermal protection (e.g., double layer body protection, or chemical-resistant
gloves, footwear, or headgear), provided such PPE is immediately available for use if the
handler exits the enclosed cab in the treated area and contacts treated surfaces. If the
manufacturer or a government agency declares that the enclosed cab provides respiratory
protection equivalent to the label-required respirator (and certain use and maintenance
conditions are met), handlers need not wear the respirator while in the enclosed cab.
However, the appropriate respirator must be immediately available for use if the handler exits
the, cab within the treated area.
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b. Enclosed Cockpits for Aerial Application. The engineering control
available for applying pesticides in aerial equipment is an enclosed cockpit. Under the WPS,
applicators in an enclosed cockpit may substitute long sleeve shirt, pants, shoes and socks for
label specified PPE.
3. Reentry
For individuals entering treated fields, depending on the magnitude of the risk and the
severity of the effect, the Agency would consider several different mitigation measures. REIs
longer than those currently specified on labels, as well as mechanical harvesting, where
possible, would be evaluated to reduce exposure to reentry workers. The Agency is aware of
many different efforts to mechanize harvesting and other tasks, and encourages continued
research in this area. Finally, the Agency may consider allowing exceptions to the REIs,
depending on the potential level of risk for time-critical reentry activities, and the data
available regarding the extent of these various activities.
E. Occupational Risk Management Approach for OPs
The following approach will generally be used by the Agency in making risk
management decisions for workers:
1. Based on the occupational assessments that have been conducted, EPA will first
determine whether or not existing uses have adequate MOEs based on available data and
current labeling. Worker risks for which the MOE is greater than the target MOE (typically
100) are not considered to be of concern. In such cases, the Agency generally will not pursue
additional risk reduction measures.
2. For uses with MOEs of concern (generally < 100) based on current labeling, EPA
will seek to reduce risks to workers to the greatest extent feasible with PPE and engineering
controls, as well as application modifications such as decreased application rates. Based on the
Agency's experience with the OP occupational risk assessments completed thus far, this
approach will likely include, at the minimum, the use of closed mixing and loading systems
and enclosed cab/cockpit equipment for pesticide applications for many outdoor agricultural
uses.
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3. Where engineering controls are not feasible due to logistical constraints, for
example, greenhouse applications, EPA intends to seek maximum feasible PPE which may
include 2 layers of clothing, chemical resistant gloves, footwear, headgear, apron, and
respirators, where appropriate. EPA may also seek modifications to use patterns, and
modifications in application equipment or formulation systems.
4. Due to the availability of mechanical flaggers and Global Positioning Systems, the
industry is moving away from the use of human flaggers. The Agency may seek to prohibit
the use of human flaggers or restrict the use of human flaggers to enclosed cabs where the risk
assessment warrants mitigation for these workers.
5. For harvesters and other workers reentering treated fields, if MOEs based on
existing REIs are inadequate, EPA will likely seek to extend REIs in order to provide greater
protection to these reentry personnel, or require changes in use patterns to reduce residues
following applications.
6. In situations where the MOEs are inadequate and risks continue to exceed benefits
even after consideration of maximum PPE, engineering controls and modifications to the use
pattern, the Agency will consider cancellation of the use. For example, certain application
methods such as hand-held equipment (backpack sprayers, handwands and knapsacks), may
have risks that exceed benefits even after consideration of PPE, engineering controls or
modified use patterns.
In managing risk, EPA must take into account the economic, social, and environmental
costs and benefits of the pesticide's use. The approach outlined in this notice allows for -
consideration of a wide range of factors in making risk management decisions for worker risks.
These factors may include, in addition to calculated MOEs, consideration of pesticide exposure
incident data, the nature and severity of adverse effects," uncertainties in the risk assessment,
the cost, availability and relative risk of alternatives, and the importance of the chemical in
EPM or public health programs.
EPA employs a wide range of data hi assessing the risks and benefits of pesticides and
hi making regulatory decisions. Among these data are a variety of use-related information,
such as how each pesticide is applied, where and when it is used, how much is actually used,
and what it controls. Use-related data cover the extent of pesticide use across different sites
and geographic regions, typical use patterns, use profiles for specific pesticides, and the role of
pesticides in pest management systems. The Agency considers this use-related data hi
developing appropriate risk mitigation and risk management decisions.
F. Label Amendments
Changes to OP pesticide labels resulting from worker risk mitigation measures will be
accomplished as part of reregistration. Registrants may choose to amend their registrations to
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incorporate worker risk mitigation measures prior to the issuance of the interim RED or
tolerance decision. Before submitting label changes, registrants are strongly encouraged to
consult with the EPA Chemical Review Manager responsible for the review of the specific
chemical. Registrants may submit EPA Form No. 8570-1 Application for Pesticide
Registration/Amendment and five copies of the revised label for EPA approval. Send this
application to:
Document Processing Desk (AMEND)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave.
Washington, DC 20460-0001
G. Implementation and Timing
As of September 28, 2000, 36 OPs have entered the risk management phase (Phase 5)
of the Public Participation Process (developed as part of TRAC). It is during Phase 5 that the
Agency will develop, in consultation witia registrants and other stakeholders, integrated risk
management strategies for each chemical to address all the risks identified in the revised
assessments.
It is the Agency's expectation that risk mitigation established during Phase 5 of the
TRAC process would be implemented as soon as possible, generally for the growing season
following the publication of the interim RED document. Sale under previously approved -
labeling and existing stocks will be developed on a case-by-case basis and will be articulated
once the individual chemical specific assessment is completed.
ED. For Further Information
A. Related Documents and How to Access Them
Preliminary and revised risk assessment for the OPs are available on EPA's web page
(http://www.epa.gov/pesticides/op) and from the Office of Pesticide Program's (OPP) Public
Docket. The OPP Docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA. Other documents related to the TRAC process and the schedule for
completing the public participation process for the OPs are also available on EPA's web page.
EPA encourages registrants and other interested parties to review the OP risk
assessments currently available at the EPA web site or through the OPP Public Docket to
determine which worker situations are likely to require mitigation and which products may be
affected.
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B. Contact
Any questions regarding this notice or the Agency's approach for managing worker risks
for the OPs should be directed to: Kathleen Meier, Reregistration Branch II, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs, US EPA, Ariel Rios Building,
1200 Pennsylvania Ave NW, Washington DC 20460; phone: (703) 308-8017; Fax: (703) 3 08-
8041; e-mail: meier.kathleen@epa.gov.
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'?%.
Marcia E. Mulkeyf Director
Office of Pesticide Programs
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