know to whom to complain and 62% feared losing their jobs if they were
to complain.
    In general, agricultural producer organizations did not object to
the proposed changes for providing emergency medical information but
two commenters were concerned about spurious reporting of alleged
violations resulting from inclusion of the state or tribal regulatory
agency in the pesticide safety information. Two commenters interpreted
the proposal as requiring injured workers to contact state or tribal
agencies responsible for enforcement for emergency medical attention. A
grower organization pointed out that the nearest operating medical
facility might change depending on the time of day and wondered if they
needed to list hours of operation and addresses of all emergency
medical care facilities in the area where the employer operates.
    One commenter suggested the safety poster should always be in a
standardized format and requested that EPA not allow the information to
be displayed in several different formats.
    EPA Response. EPA has concluded that there was general support for
the proposed requirement regarding the content of the safety
information display. EPA has delayed implementation of the final
requirements for two years after

publication of the final rule to allow time for display material to be
updated, printed and distributed. However, EPA encourages employers to
implement the new requirements prior to that date by allowing employers
the option to use the new safety information content.
    In response to concerns about the placement of the medical facility
information and the inclusion of regulatory agency information in the
display, EPA has revised the regulatory text to clarify that the
contact information about the medical facility must be clearly
identified as the emergency medical contact information on the display.
Displaying the regulatory agency information is important for the
ability of workers and handlers to report possible violations, and in
those states where it is already required, it does not appear to have
generated spurious reporting of alleged violations. EPA appreciates
that some states may already require employers to make such medical and
regulatory information available and where state requirements meet or
exceed the federal requirement, they do not need to be duplicated.
However, EPA has added this requirement to the WPS to ensure the
information is available to workers and handlers in all states.
    EPA is finalizing the proposed requirement to identify a nearby
operating emergency medical care facility to simplify the requirement
in situations where the nearest operating emergency medical facility
varies with the location of workers and handlers.
    EPA disagrees with the comment requesting that the information be
displayed in a standardized format. As long as the information is
provided in a way that workers and handlers can understand, EPA sees no
need to mandate a specific format.

B. Location of Pesticide Safety Information Display

    1. Current rule and proposal. The existing rule requires
agricultural and handler employers to display the pesticide safety
poster at a central location on the establishment. EPA proposed to
require that agricultural employers display the pesticide safety
information at locations where decontamination supplies must be
provided, in addition to the existing requirement to display it at a
central location.
    2. Final rule. In the final rule, EPA has amended the proposal to
require that in addition to displaying pesticide safety information at
a central location, employers must also display it at permanent
decontamination supply locations and where decontamination supplies are
provided in quantities to meet the needs of 11 or more workers or
handlers. The final regulatory text for this requirement is available
at 40 CFR 170.311(a)(5).
    3. Comments and responses.
    Comments. Farmworker advocacy organizations and public health
organizations supported requiring display of pesticide safety
information where decontamination supplies are provided for easy access
to safety information for farm workers and families at strategic
locations. They asserted that this would improve the ability of
farmworkers and their families to stay healthy. They maintained that
due to language barriers, immigration status, and fear of retaliation,
farmworkers are often reluctant to ask their employers for information.
Three individual farmworkers also commented on the proposed rule and
echoed concerns expressed by farmworker advocacy groups and public
health organizations. The commenters requested clear information in
Spanish and English at a central location with easy access that
includes telephone numbers, places to go for help, and hospitals in the
area. They stated that it was important that employers give farmworkers
the necessary information about the pesticide application without
workers having to ask for information. About half of the grower
organizations commenting had no objection to the additional mandate on
employers and agreed that the additional reminders at decontamination
sites have potential benefits.
    The remaining grower organizations believed that the proposed
requirement would pose a significant burden. One commenter stated that
duplicating the pesticide safety information at multiple sites
throughout an agricultural organization did not equate to a better
training program and believed this requirement would likely result in
additional fines for noncompliance without raising safety awareness.
Some pointed out that workers are bused in for a day in the field and
irrigators are sent to different areas by phone; none of these
congregate at a central location.
    Many states opposed displaying the pesticide safety information at
decontamination sites. Because of the mobile nature of many
decontamination sites, such as the back of a pickup truck, some noted
the proposed requirement would be burdensome. One indicated that it
would be difficult for a grower owning fields across multiple counties
to keep the pesticide safety information accurate. They generally
supported displaying the pesticide safety information at permanent
decontamination sites and base of operation mix/load sites. Several
states asked for clarification about what types of decontamination
sites would be required to display the pesticide safety information and
suggested that portable toilet facilities and plumbed wash sites would
be more appropriate locations.
    Others mentioned the lack of protection from the weather of the
pesticide safety information at OSHA-required restroom facilities and
the lack of access to this information when the vehicles carrying
decontamination supplies are locked up at night. Two states recommended
different sizes for the pesticides safety information. One state
suggested that pesticide safety information displays be no larger than
11 x 17 inches and laminated to withstand at least one year's worth of
weather conditions for use at decontamination sites; this state also
recommended resizing the existing pesticide safety information to 8.5 x
11 inches or less and made of durable card stock or plastic for the
agricultural workers to take home.
    EPA Response. EPA agrees with the commenters who supported
requiring safety information displays at a central location and
anywhere decontamination supplies must be provided because the
information is a useful reminder of the hygienic safety principles from
their training. However, EPA was persuaded by arguments that the burden
to display the information at mobile decontamination sites could be
substantial, based on concerns for their ability to display the
information so that it could be easily seen by workers, such as by
posting it on a vertical surface. The final rule requires employers to
display the information at the central display and all permanent sites,
including a lavatory or bathroom, where decontamination supplies are
provided to meet the requirements of the rule. However, for other
locations where decontamination supplies must be provided, the
pesticide information display is required only when the supplies are
provided for 11 or more workers or handlers. This aligns with OSHA's
field sanitation standard that requires toilet facilities for 11 or
more workers. EPA notes that employers may use these portable toilet
facilities or permanent wash sites to display the information, as
recommended by some states.
    EPA does not agree with the contention that requiring the pesticide
safety information display at multiple locations would result in fines
for noncompliance, without greatly benefiting the employee. The
pesticide safety information display reinforces the

hygienic training principles from the safety training, and when coupled
with access to decontamination supplies, offers a hands-on opportunity
for workers and handlers to adopt these practices. Additionally,
information about medical facilities available to workers where they
may be exposed to pesticides may help them take steps to respond to an
emergency.
    EPA appreciates the comments regarding display size and options for
lamination. The final rule does not establish a specific size for the
information or require it to be laminated. However, the final rule
requires the information to be legible at all times while it is
displayed, and EPA expects that employers will opt for the optimal size
and protection from the elements for their specific needs. Because the
final rule limits the type of decontamination sites covered by this
requirement and includes flexibility for identifying the regulatory
agency and a nearby operating emergency medical care facility, it is
possible but unlikely that some growers with larger establishments may
need to provide different specific contact information about the
regulatory agency and/or the medical facility, depending on the area
where workers or handlers are working.
    Commenters suggested the information be available in English and
Spanish. EPA notes that the requirement is for the information to be
provided in a manner that the workers and handlers can understand,
which may include making it available in English and Spanish, or in
other languages as appropriate.
    EPA plans to develop and make available to agricultural and handler
employers posters bearing the pesticide safety information, in a
bilingual and pictorial format and with space for employers to add the
required regulatory agency and medical facility information. As
discussed in the proposed rule, the information does not have to be
displayed as a poster as long as the display includes the required
information and meets the requirements of the section.

C. Costs and Benefits

    1. Costs. EPA estimates the cost of requiring additional pesticide
safety information displays at permanent sites with decontamination
supplies and at other locations where there are 11 or more workers or
handlers and of requiring contact information on the display to be
updated to be $390,000 annually, or about $1 annually per establishment
per year.
    2. Benefits. Workers and handlers will benefit from having access
to information about basic pesticide safety at locations they are
likely to visit. In addition, workers and handlers will benefit from
having accurate information about nearby medical facilities and how to
contact the state regulatory agency if necessary. EPA finds the costs
from this requirement are reasonable when compared to the benefits of
reminding employees about basic pesticide safety and hygienic practices
at the sites where they routinely wash.

XIII. Decontamination

A. Clarify the Quantity of Water Required for Decontamination

    1. Current rule and proposal. The existing rule requires employers
to provide ``enough water for routine washing and emergency eye flush''
when workers are performing activities in areas where a pesticide was
applied and the REI has expired. For early-entry workers, the existing
WPS requires employers to provide ``a sufficient amount of water'' for
decontamination. The existing WPS requires employers to provide
handlers with ``enough water for routine washing, for emergency eye
flushing and for washing the entire body in case of an emergency.'' EPA
proposed to require specific quantities of water for workers, early-
entry workers and handlers based on its 1993 guidance, ``How to Comply
with the Worker Protection Standard for Agricultural Pesticides; What
Employers Need to Know.'' In the guidance, EPA recommended one gallon
of water per worker for routine decontamination, three gallons of water
for early-entry workers for decontamination and three gallons of water
per handler for routine handwashing and potential emergency
decontamination.
    EPA requested comment on the proposed quantities of water and the
use of waterless cleansing agents in place of soap, water, and single-
use towels. EPA also requested information on the efficacy of waterless
cleansing agents for removing pesticide residues.
    2. Final rule. EPA has finalized the proposed decontamination water
requirements. EPA has also clarified that employers must make the
required quantities of water and other decontamination supplies
available at the beginning of the work period. The final rule does not
allow waterless cleansing agents to be used in place of water, soap,
and single-use towels. The final regulatory text for these requirements
is available at 40 CFR 170.411(b), 170.509(b) and 170.605(h).
    3. Comments and responses.
    Comments. A majority of commenters supported the proposal to
require one gallon of water per worker for routine decontamination,
three gallons of water for early-entry workers for decontamination and
three gallons of water per handler for routine washing and emergency
decontamination but many requested clarification of the time frame
associated with the supply; they wondered if the prescribed amounts
were the maximum quantity per site or per number of workers, the
minimum amount at the beginning of the day or at all times during the
work period. Six commenters were in favor of replacing soap and water
with a waterless cleansing agent. One commenter noted such a
substitution would be effective for workers but not handlers; another
suggested that these agents might be less bulky than the existing
required supplies. One commenter provided information on a specific
waterless cleansing agent.
    EPA Response. EPA notes that the proposed quantities of water for
decontamination are intended for agricultural settings that are not
subject to the field standards of OSHA and the American National
Standards Institute (ANSI). Based on comments, EPA has clarified the
final rule to require that the specified amount of supplies be
available at the beginning of the work period and that they are to be
calculated per worker and per handler. The final rule does not require
the replenishment of used supplies until the beginning of the next work
period. The information supplied by commenters was insufficient to
convince EPA to replace water, soap, and single-use towels with a
waterless cleansing agent. The one waterless cleansing agent discussed
in the comments had limited use since the information indicated it
could be used to remove only one family of pesticides; workers and
handlers are likely to encounter residues from various families of
pesticides.

B. Eliminate the Substitution of Natural Waters for Decontamination
Supplies

    1. Current rule and proposal. For sites where worker or handler
activities are farther than one-quarter mile from the nearest vehicular
access, the existing rule permits employers to allow workers and
handlers to use clean water from springs, streams, lakes or other
sources (``natural waters'' for the purposes of this section) for
decontamination, if such water is more accessible than the employer-
provided water. The employer must ensure any water used for
decontamination, including natural waters, is of a quality and
temperature that will not cause illness or injury. EPA

proposed to eliminate the provision that allows employers to permit
workers and handlers to substitute natural waters for the required
decontamination supplies at remote sites. For remote sites, the
proposal would have maintained the existing requirement for employers
to provide all decontamination supplies (soap, single-use towels, clean
change of clothing and water) at the nearest point of vehicular access.
However, the existing regulation does not permit substitution of waters
from natural sources for the decontamination water at the point of
nearest vehicular access, and EPA's proposed change mischaracterized
the existing requirements.
    2. Final rule. In the final rule, EPA has removed from the
regulatory text the provision that allows employers to permit workers
and handlers to use clean water from springs, streams, lakes or other
sources if that water is more accessible in remote locations where the
decontamination supplies are farther than one-quarter mile from where
workers and handlers are working. EPA is taking this approach to remove
confusion about the employer's responsibilities. The employer must
always provide the decontamination supplies in quantities outlined in
the regulation. When workers or handlers are performing tasks at remote
sites more than one-quarter mile from the nearest point of vehicular
access, employers must provide all required decontamination supplies
(soap, single-use towels, and water, plus clean change of clothing if
required) at the nearest point of vehicular access. Under the final
rule, employers are required to make the decontamination supplies
available as close as possible to the remote site (as determined by how
close a vehicle can get) and employers do not have to check or confirm
that water from springs, streams, lakes or other sources at remote
sites meets the standard of being of a quality and temperature that
will not cause illness or injury. EPA has amended the training
requirements to cover the proper use of natural waters at remote sites
by workers and handlers. EPA believes that workers and handlers in
these remote areas should primarily rely on the decontamination water
that is provided by the employer for routine washing and emergency
decontamination because the quality of the natural waters at the remote
site is unknown. In case of an overexposure, such as a spill, contact
from drift, or direct spray, workers and handlers should always use the
emergency decontamination supplies if they are more readily available.
However, training will emphasize that workers or handlers should rinse
immediately using the nearest source of clean water to mitigate the
exposure, and to use the nearest source of clean water, including
springs, streams, lakes or other sources, if more readily available
than the decontamination supplies. Workers and handlers will be advised
through training that as soon as possible they should decontaminate
thoroughly with the soap, water and towels provided by the employer
and, if available, change into clean clothes. EPA plans to modify
training materials to incorporate this information. The final
regulatory text for worker and handler decontamination is available at
40 CFR 170.411(b)(1), 170.509(b)(1), and 170.605(h)-(j).
    3. Comments and responses.
    Comments. Many commenters supported not using natural waters to
replace the required decontamination supplies. Two states, a farmworker
advocacy organization, and a grower organization supported the need for
employees to access the nearest clean water in case of an exposure.
Some farmworker advocacy organizations expressed concern that the
quality of the natural waters might be questionable and not the best
choice for decontamination.
    Finally, one farm bureau commenter stated that large scale planting
activities can place workers more than one-quarter mile from vehicular
access, and retaining the existing requirement is more reasonable than
expecting workers to carry washing water with them.
    EPA Response. EPA maintains its position that the employer-provided
decontamination supplies, provided within one-quarter mile of the
workers and handlers--or in remote areas, at the nearest point of
vehicular access to worker and handler work sites--are the appropriate
supplies for routine washing and emergency decontamination. The
employer must ensure this water meets the minimum criteria for quality.
However, EPA agrees with commenters that prompt washing in clean water
is an important step in reducing overexposure, for example, from a
spill, contact from drift, or direct spray. EPA has identified acute
incidents that would have been mitigated if the exposed worker or
handler had decontaminated promptly. EPA is concerned that the existing
requirements for employers to ensure the quality of natural waters
prior to its use and for them to permit its use will prevent workers
and handlers from using these waters to decontaminate in case of an
emergency. Ensuring the quality of all natural waters on their
establishment could be burdensome for employers, and as a result they
might not evaluate the quality or permit the use of natural waters.
    To ensure that workers and handlers needing emergency
decontamination can use water that is more accessible than the
decontamination water provided by the employer, the employer no longer
must predetermine that the quality of the water meets the criteria or
permit their employees access. The rule permits the use of natural
waters for emergency decontamination, but does not require it. Workers
and handlers seeking to mitigate an emergency exposure will be informed
in their training to use the nearest clean water to immediately rinse
off if such water is more readily available than the employer-provided
decontamination supplies, and then go to where the employer-provided
supplies are to fully decontaminate. EPA believes the benefits of using
natural clean waters to decontaminate immediately in an emergency
pesticide exposure situation outweighs the potential risks of making
workers or handlers wait until they can use supplied decontamination
water that has been evaluated for quality but may be less available to
immediately address the exposure. EPA thinks that washing in natural
waters in any agricultural area is unlikely to pose risks comparable to
a significant direct pesticide exposure.

C. Requirements for Ocular Decontamination in Case of Exposed Pesticide
Handlers

    1. Current rule and proposal. The existing rule requires employers
to provide ``enough'' water to handlers for routine and emergency
washing and emergency eye flushing. For handlers who use products that
require eye protection, employers must provide each handler with at
least one pint of water that they can carry for use in the event of an
ocular pesticide exposure. EPA proposed to require employers to provide
clean, running water at permanent (i.e., plumbed and not portable)
mixing and loading sites for handlers to use in the event of an ocular
pesticide exposure when using a pesticide with labeling that requires
eye protection.
    2. Final rule. Under the final rule, employers must provide water
for ocular decontamination either through a system capable of
delivering 0.4 gallons/minute for at least 15 minutes or from six
gallons of water able to flow gently for about 15 minutes. This water
must be available at all mixing and loading sites where handlers are
mixing or loading a product that requires eye

protection or when closed systems, operating under pressure, are in
use. The final rule amends the existing requirement for employers to
provide at least one pint of water per handler in portable containers
that are immediately available to handlers applying the pesticide,
rather than to all handlers mixing, loading and applying pesticides, if
the pesticide labeling requires protective eyewear. The final
regulatory text for these requirements is available at 40 CFR
170.509(d).
    The term ``potable'' in the preamble and regulatory text for the
proposed rule was a typographical error and has been corrected to
``portable'' in the final rule.
    3. Comments and responses.
    Comments. There was general support for this proposal. Many
commenters urged EPA to adopt or coordinate with American National
Standards Institute (ANSI) standard Z358.1-2009 and/or the OSHA
requirements, 29 CFR 1928.110, as several states have done. Many
requested a definition of ``permanent mixing and loading site'' and ``a
system capable.'' Some qualified their support based on the inclusion
of ``nurse rigs,'' ``nurse tanks'' and ``gravity-fed tanks'' in the
final rule. Commenters also explained that much of the mixing and
loading is done in the field rather than at a site with running water.
Other commenters wondered if the water for decontamination needed to be
potable.
    EPA Response. The OSHA standard at 29 CFR 1910.151(c) specifies
that ``. . . where the eyes or body of any person may be exposed to
injurious corrosive materials, suitable facilities for quick drenching
or flushing of the eyes and body shall be provided . . .''. The ANSI
standard provides specifications for two types of eyewash stations,
plumbed and gravity-fed. The specifications describe a system with a
precise rate of flow (0.4 gallons/minute for 15 minutes), that can
activate in 1 second or less and does not require the user to control
the flow of water. While the OSHA and ANSI standards are very
protective, EPA believes that the final rule requirements provide
handlers with mitigation appropriate to pesticide exposure in
agricultural settings at significantly lower costs than the ANSI
standards. Based on the comments, EPA realized that there might have
been some confusion regarding the nature of permanent mixing and
loading sites, the plumbing associated with non-permanent mixing and
loading sites, and the quality of the water required. In the final
rule, EPA decided to apply the requirements to all mixing and loading
sites where pesticides whose labeling requires protective eyewear are
handled because the risk to handlers who mix and load these products is
the same, regardless of where they perform the tasks. Rather than
specify what types of water tanks or eye wash systems would comply with
the requirement, EPA opted for flexibility. The final rule allows
employers to provide either at least 6 gallons of water in containers
suitable for providing a gentle eye flush for about 15 minutes, or a
system capable of delivering gently running water at a rate of 0.4
gallons per minute for at least 15 minutes to satisfy the requirement.
One emergency eyewash system is required at a mixing/loading site when
a handler is mixing or loading a product whose labeling requires
protective eyewear for handlers, regardless of how many handlers are
mixing or loading at that site. The final retains the existing
requirement for water to be of ``a quality and temperature that will
not cause illness or injury.''

D. Showers for Handler Decontamination

    1. Current rule and proposal. The existing rule establishes
specific requirements for routine and emergency handler decontamination
supplies, but these requirements do not include shower facilities. EPA
considered but did not propose a requirement for handler employers to
provide shower facilities.
    2. Final rule. EPA has not included in the final rule a requirement
for employers to provide shower facilities for handlers.
    3. Comments and responses.
    Comments. Many commenters supported the proposal for not providing
shower facilities for handlers while others requested that EPA require
employers to provide shower facilities for handlers. Those against
adding the shower requirement noted the provision would not necessarily
guarantee use in order to reduce take-home or handler exposure. Those
supporting a requirement for shower facilities indicated that handlers
would use them if they were provided. Both groups, however, agreed that
better training and adequate information on reducing take-home
exposure, as suggested by EPA, would be a better approach.
    EPA Response. EPA agrees that additional training for handlers and
clarified decontamination provisions such as the provision of at least
3 gallons of water per handler for routine and emergency washing,
available at the beginning of the day, would help reduce take-home
exposure without requiring shower facilities. The estimate of the cost
of installing showers as provided in the proposal, combined with the
lack of confidence that most handlers would routinely use showers if
provided, led to the conclusion that a shower requirement would be
unlikely to reduce risks to an extent commensurate with the costs.

E. Costs and Benefits

    1. Costs. EPA estimates the total cost of the revisions to the
decontamination requirements to be approximately $412,000 annually, or
about $1 per establishment per year, CPHEs $21 per establishment per
year.
    EPA does not believe there will be any cost associated with
deleting the provision allowing employers to direct workers and
handlers to use natural waters in addition to the decontamination
supplies required by the rule. The final rule still allows workers and
handlers to use clean, natural waters, but removes employers'
obligation to ensure that the water is of a temperature and quality
that will not cause harm.
    Because EPA is not imposing a requirement for employers to provide
shower facilities for handlers, there is no estimated cost. Refer to
the Economic Analysis of the proposed rule for details regarding the
estimated cost of requiring showers for handlers (Ref. 14).
    2. Benefits. EPA expects that workers and handlers will benefit
from having access to sufficient supplies for routine washing and
decontamination. In addition, handlers will benefit by having
sufficient water available to rinse their eyes in the event of an
accident while mixing or loading certain pesticides. Employers will
benefit from certainty about the amount of water that they must supply
and when that water must be available.

XIV. Emergency Assistance

A. Current Rule and Proposal

    The existing WPS requires employers of workers or handlers,
including those handlers employed by the agricultural establishment or
those working for a pesticide handling establishment, to provide prompt
transportation to an emergency medical facility to employees who have
been poisoned or injured by exposure to pesticides used on the
establishment. Emergency medical assistance under the existing rule
consists of the prompt provision of transportation to an emergency
medical facility for the worker or handler and the provision of
obtainable information about the exposure, including information about
the product(s) that may have been used, to emergency

medical personnel or the exposed employee.
    EPA proposed to require agricultural and handler employers to
provide emergency medical assistance within 30 minutes after learning
that an employee may have been poisoned or injured by exposure to
pesticides as a result of his or her employment, replacing the current
standard of ``prompt.'' The proposed change was intended to ensure that
the potentially injured party would be on route to a medical facility
within 30 minutes.
    EPA also proposed that the employer provide a copy of the pesticide
label, or specific information from the label, along with the SDS and
circumstances of the pesticide use and potential exposure, to employees
potentially injured by exposure to pesticides and to treating medical
personnel.

B. Final Rule

    EPA has retained the existing requirement for providing
transportation and information promptly. The final rule clarifies that
these requirements apply only to current or recently employed workers,
and that emergency assistance must be provided if there is reason to
believe that a worker or handler has been potentially exposed to
pesticides or shows symptoms of pesticide exposure.
    EPA has amended the requirement for the information that the
employer must provide related to emergency assistance. The final rule
requires the employer to provide to treating medical personnel a copy
of the SDS, product name, EPA registration number and active ingredient
for each pesticide product to which the person may have been exposed,
as well as the circumstances of application or use of the pesticide on
the agricultural establishment and the circumstances that could have
resulted in exposure to the pesticide. This is a slight change to the
existing rule which makes the information available to the worker or
handler. In this final rule, the worker or handler has access to the
information through the hazard communications requirement. This
provision deals specifically with meeting the needs for medical
assistance, and requires that the information be provided to the
medical personnel.
    EPA has clarified in the final rule that the provision of the
emergency assistance requirement for transportation and information
applies only to currently employed workers seeking emergency medical
assistance or recently employed workers within 72 hours after their
employment for acute exposures occurring on the agricultural
establishment.
    The final regulatory text for these requirements is available at 40
CFR 170.309(f) and 170.313(k).
    Readiness is among the most important factors in an employer's
ability to promptly carry out the emergency assistance requirements.
EPA strongly encourages employers to develop an emergency response plan
and to address in such a plan details related to the emergency medical
assistance requirements of the WPS. EPA also encourages employers to
periodically test, evaluate and, if necessary, update the plan. EPA
will develop a sample plan to help employers prepare for possible
pesticide-related emergencies. Employers can also find additional
information concerning the development and implementation of an
emergency preparedness program at the U.S. Department of Homeland
Security's Web site, http://www.ready.gov/business/.
    Although EPA believes that it is important for employers to develop
emergency response plans, EPA has not made this a requirement of the
final rule. EPA recognizes that pesticide exposure is just one of many
hazards that should be addressed in an emergency response plan, and
that EPA has very little information about the extent of emergency
planning in the agricultural community. Accordingly, EPA has decided
that it would be unwise to address this issue in the WPS without the
benefit of a more robust dialogue with all stakeholders.

C. Comments and Responses

    Comments. Many private citizens and farmworker advocacy
organizations, some pesticide state regulatory agencies and several
public health organizations supported the proposal to require
agricultural employers and handler employers to provide emergency
medical assistance within 30 minutes after learning that an employee
may have been poisoned or injured by exposure to pesticides as a result
of his or her employment, replacing the current standard of ``prompt.''
They stated that the clarification of time for the provision of
transportation and information would improve the safety of farmworkers.
    The Progressive Congressional Caucus, many farmworker advocacy
organizations and public health organizations expressed concern that
the proposed emergency response time of 30 minutes is too long and
recommended that it should be further reduced. Commenters reasoned that
pesticide poisoning can be fatal or result in long-term effects if not
quickly treated.
    On the other hand, many commenters, mostly growers and farm
bureaus, and some states and agricultural producer organizations
expressed opposition to the proposal and favored retaining ``prompt ''
to allow more flexibility due to geographical constraints. The Small
Business Administration's Office of Advocacy stated that small farms
that are farther away from medical facilities would not be able to
obtain emergency transportation within the timeframe. Those with few
employees and limited transportation options would be overburdened in
attempting to comply with a 30 minute timeframe.
    Commenters representing many states, several agricultural
industries, many growers and farm bureaus, and the Small Business
Administration's Office of Advocacy recommended that emergency response
requirements should apply only to current employees seeking emergency
medical assistance for acute incidents.
    Additional comments from states and their organizations recommended
that the agriculture emergency requirement address only acute exposures
to current employees of the establishment. They raised concerns for the
potential for former employees or those with exposures in the past to
request emergency assistance. One commenter stated that allowing any
person who was ever employed by the establishment the ability to demand
emergency assistance could cause problems with compliance and
enforcement. Some of these organizations requested clarification of the
term ``emergency medical facility.''
    Commenters also recommended that the requirement allow, similar to
OSHA, trained first aid providers on the establishment to provide care,
which could enable more timely treatment.
    Commenters noted that requiring the employer to provide the label
to employees potentially injured by exposure to pesticides and to
treating medical personnel could lead to further exposure, if the
employee takes an open container of pesticides bearing the label.
Further, commenters suggested that the information outlined in the
proposal could be obtained from sources other than the label.
    EPA Response. EPA was convinced by the concerns raised by members
of the agricultural community that geographical constraints, in some
cases, would make the 30 minute response timeframe for transportation
difficult or impossible to meet. Agricultural establishments can be
very large and are

often distant from population centers. Remote locations, including
those in forestry, are common; and the distance to an emergency medical
facility or to an ambulance service can be significant.
    The final rule requires employers to comply with the emergency
assistance requirements by promptly making transportation available to
an emergency medical facility for potentially injured employees and
providing the SDS, specific product information, and information about
the exposure to the treating medical personnel. Because the information
about the pesticide may be critical to effectively manage the illness,
EPA decided to focus the requirement to ensure that treating medical
personnel receive the information. The agricultural employer must
provide that information in a way that is reasonably expected to be
accessible to the treating medical personnel. The requirement does not
preclude the employer providing the information to injured employees
and does not prevent injured employees from requesting this
information. This requirement will allow continued flexibility for
employers and encourage timely medical treatment for potentially
injured employees.
    In deciding to retain the requirement for prompt provision of
transportation, EPA also took into consideration OSHA's standard for
the provision of transportation to persons in construction, which
requires ``Proper equipment for prompt transportation of the injured
person to a physician or hospital.'' 29 CFR 1926.50(e).
    EPA agrees with the recommendation to clarify that the requirement
applies only to current or recently employed workers seeking emergency
medical assistance for acute exposures occurred at the agricultural
establishment, and has revised the final rule accordingly.
    EPA notes that for some cases of suspected pesticide injury, the
attention of a trained first aid provider can mitigate the injury. Such
treatment would not negate the obligations of the employer to provide
transportation promptly to an injured employee, or to provide
information about the pesticide and exposure to medical personnel, but
is encouraged. Allowing a competent first aid provider to administer
timely treatment to an injured employee could offset complications from
longer exposures.
    EPA agrees with comments that a requirement to provide the label in
the event of an emergency could be burdensome and place employees at
risk for additional exposure if the label is attached to an open
container of pesticides. EPA has not included the proposed requirement
to provide the label or information from the label; rather, the final
rule requires the employer to provide the necessary information, but
does not specify the source of the information. EPA has removed from
the list of specific pieces of information the employer must provide
information about antidote, first aid, and recommended treatment
because the SDS contains this information. EPA notes that the
information about the product and the SDS will be available as part of
the pesticide application and hazard information.
    In response to the requests for clarification of what qualifies as
an emergency medical facility, EPA notes that a hospital, clinic, or
infirmary offering emergency health services qualifies.
    Finally, the employer must provide information about the pesticide
and the exposure to the treating medical personnel.

D. Costs and Benefits

    There are no incremental costs associated with the decision to
retain the requirement of prompt provision of transportation in the
existing rule. The cost associated with the SDS were included in the
costs for the pesticide application and hazard information. There are
significant benefits to reducing damage from pesticide exposure by
prompt medical attention.

XV. Personal Protective Equipment

A. Respirators: Fit Testing, Training and Medical Evaluation

    1. Current rule and proposal. The existing regulation requires
handler employers to ensure that each handler's respirator fits
correctly. However, the existing rule does not provide specific details
on ensuring that a respirator fits properly, nor does it require
employers to conduct medical evaluations of the handler's fitness for
respirator use, provide training on the proper use of respirators, or
retain fit test records.
    EPA proposed to require handler employers to comply with the
respirator fit testing, training, and medical evaluation requirements
set by OSHA at 29 CFR 1910.134 whenever a respirator other than a dust
or mist filtering mask is required by the labeling. EPA did not propose
any new requirements for filtering facepiece respirators (OSHA's term
for dust or mist filtering masks). The OSHA standard includes a
specific standard for fitting a user for respirator use, training on
recognizing when the respirator seal may be broken, and what steps to
take to properly use and maintain respirators. OSHA also requires
respirator users to be medically evaluated to ensure the respirator use
does not cause undue stress on their bodies. EPA proposed to require
that employers comply with the OSHA requirements for fit testing,
training, and medical evaluation by cross-referencing 29 CFR 1910.134,
in order to avoid creating a duplicative regulation and to ensure that
if technology advances lead OSHA to amend its standard, the change
would automatically apply to pesticide uses subject to the WPS as well.
EPA also proposed to require handler employers to maintain records of
the fit test, training, and medical evaluation for two years.
    2. Final rule. EPA has retained the proposed elements in the final
rule, with some changes and clarifications. Specifically, the final
rule cross references and requires compliance with the OSHA standards
for fit testing, training, and medical evaluation when a respirator is
required by the labeling. The final rule expands from the proposal the
types of respirators covered by the requirement to include filtering
facepiece respirators. The final rule also adds an additional item to
the list of conditions that would trigger replacement of the gas- or
vapor-removing canisters or cartridges.
    In the final rule, EPA has retained the proposed requirement for
handler employers to maintain records of the fit testing, medical
evaluation, and training. The final rule clarifies that the required
training is limited to the care and use of respirators, 29 CFR
1910.134(k)(1)(i)-(vi), and does not include the training on the
general requirements (i.e., 29 CFR 1930.134(k)(1)(vii)).
    The final regulatory text for these requirements is available at 40
CFR 170.507(b)(10) and 170.507(d)(7).
    3. Comments and responses.
    Comments. EPA received many comments in favor of requiring handler
employers to comply with the respirator fit testing, training, and
medical evaluation requirements established in the OSHA standard. Many
farmworker advocacy organizations and some PPE manufacturers asserted
that EPA should also apply the proposed standards for fit testing,
training, and medical monitoring to users of filtering facepiece
respirators in addition to the other respirator types (e.g., tight
fitting elastomeric facepieces). Commenters suggested that filtering
facepiece respirators are widely used and covered by OSHA's respirator
requirements, and that their exclusion would result in inadequate
protection for many pesticide handlers. OSHA defines a filtering
facepiece as ``a negative

pressure particulate respirator with a filter as an integral part of
the facepiece or with the entire facepiece composed of the filtering
medium'' in 29 CFR 1910.134(b).
    Furthermore, many farmworker advocacy organizations stated that EPA
should require compliance with all elements of 29 CFR 1910.134, rather
than the proposal to just include fit testing, training, and medical
evaluation. Specifically, they urged EPA to adopt OSHA's requirements
for employers to develop a respiratory protection program (29 CFR
1910.134(c)) and conduct a workplace hazard evaluation (29 CFR
1910.134(d)(1)(iii)).
    Nearly all commenters expressed support for a general requirement
related to proper respirator care and use, such as appears in the
existing rule. However, many pesticide manufacturers and their
associations, state farm bureaus and agricultural producer
organizations questioned the feasibility of the proposed requirement
for medical evaluations because locating qualified physicians
practicing in rural areas would be difficult. Other farm bureaus noted
that the OSHA standard applies to general industries, shipyards, marine
terminals, longshoring and construction, and it would not likely be
easily adopted in agricultural settings. Some commenters, including the
Small Business Administration's Office of Advocacy, also asserted that
EPA's cost estimates associated with the medical evaluations and fit
testing were too low.
    Some commenters, including a state farm bureau, raised concerns
that EPA's reference to OSHA's regulations could give OSHA legal
grounds to pursue oversight of certain small farming operations,
contrary to provisions of existing law.
    EPA Response. In the final rule, EPA has required that employers
comply with the respirator fit testing, training, and medical
evaluation requirements described in the proposed rule when the use of
respirators is required by the labeling. The final rule also expands
its coverage to include filtering facepiece respirators (referred to as
dust/mist filtering respirators in the proposal). EPA included
filtering facepiece respirators in the final rule to ensure that
handlers required to use any type of respirator are adequately
protected. Filtering facepiece respirators need to be fit tested and
used properly to provide the intended protection. In addition, this
will ensure that respirators used under the WPS provide the same level
of protection as comparable respirators used under OSHA's respiratory
protection requirements.
    EPA acknowledges that, if the final rule were to require handler
employers to comply with the OSHA requirement to adopt a worksite-
specific respiratory protection program, such a requirement would
address in detail the selection, cleaning, storing, repair and
replacement of respirators, as well as worksite-specific procedures
when respirator use is required. EPA has decided not to expand the
final rule to include the OSHA requirement to adopt a worksite-specific
respiratory protection program because specific respirator requirements
are described on EPA-approved, product-specific pesticide labeling.
These product-specific respirator requirements are based on the acute
inhalation toxicity of the end-use product or a comprehensive risk
assessment informed by incident data, or on extensive pesticide active
ingredient toxicology data, exposure science and epidemiology data (if
available), or on both. Therefore, requiring a general worksite-
specific respiratory protection program would duplicate the analysis
underlying product-specific respirator requirements included on
pesticide labeling.
    EPA acknowledges that implementing respirator fit testing,
training, and medical evaluation in agriculture will place additional
burden on agricultural employers. However, the proper fit and use of
respirators is essential in order to realize the protections
respirators are intended to provide. EPA's pesticide risk assessment
process relies on National Institute for Occupational Safety and Health
(NIOSH) protection factors (i.e., respirators used according to OSHA's
standards) when deciding whether handler inhalation exposure can be
mitigated by respirator use. If the handler inhalation exposure can be
mitigated by a particular type of respirator, EPA may require the use
of that respirator on the pesticide label, among other risk mitigation
measures. Without the protection provided by the respirators identified
on the label, use of those pesticides would cause unreasonable adverse
effects on the pesticide user, i.e., the handler.
    EPA is aware of several states, including California, Oregon and
Washington, that have successfully incorporated all aspects of the OSHA
standard for respirators in agriculture, demonstrating the feasibility
of applying OSHA's requirements in agriculture. North Carolina has
incorporated many innovative ways to facilitate the medical evaluation
and fit testing process, and helped farmers (including handler
employers) locate reputable sources for online services for fit testing
and medical evaluation, and sources for NIOSH-approved respirators,
filters, and cartridges. EPA plans to work with stakeholders such as
state regulatory agencies, universities, and others to provide outreach
assistance such as training programs and written materials and to
encourage the dissemination of information about fit testing and
medical evaluation resources.
    EPA has reviewed and revised its cost estimates for fit testing,
training and medical evaluation. The cost estimate assumes that farms
would designate one handler to be fit tested so the incremental costs
for the filtering facepiece respirators reflects the need to fit test
and train on multiple types of respirators. The increased costs also
reflects the cost of the on-line medical evaluation, which replaces the
estimated time of a medical technician reviewing the evaluation, and
the cost of the employer's time to arrange (if off-site) or oversee (if
on-farm) the evaluation and fit test, which was previously omitted. EPA
has also updated wages, price of materials and services such as the
cost of the medical evaluation and the fit test materials. Details of
the revised estimate are available in the Economic Analysis for this
final rule (Ref. 1).
    EPA recognizes that some handlers may not be able to use a tight-
fitting respirator. EPA notes that the purpose of the medical
evaluation is to ensure handlers are able to tolerate the physical
burden caused by the use of respirators. Many medical conditions, such
as cardiovascular diseases and the reduced pulmonary function caused by
smoking, could impede the ability of the handler to wear a respirator
without adverse health impacts. The medical evaluation should identify
these potential issues and disqualify the handler from using a tight-
fitting respirator. Tight fitting respirators include filtering
facepiece respirators, full and half face elastomeric respirators and
tight fitting powered air purifying respirators (PAPR). However, for
these handlers, loose-fitting PAPRs are an option for respiratory
protection because they do not require medical evaluations or fit
testing. EPA notes that many handler employers may be able to rely on
online services where medical evaluations can be performed by relying
on medical questionnaires. The employee would complete the medical
questionnaire, which would be provided to the licensed medical
professional for review. If the employee is cleared by the review, he
or she is approved to wear a respirator. If the employee is not cleared
through the review of the questionnaire, the employer may send the
employee for further medical review

or the employer may identify a different employee to handle the
pesticide.
    EPA does not believe that including in the WPS a requirement that
employers must perform respirator fit testing, training, and medical
evaluation in accordance with OSHA's requirements by cross-reference to
29 CFR 1910.134 affects the scope of OSHA's jurisdiction. This final
rule changes only the FIFRA WPS, which is implemented and enforced by
EPA, the States and Tribes, and not by OSHA.
    However, in consideration of the commenters who asked that EPA
require compliance with all elements of OSHA requirements at 29 CFR
1910.134, the Agency re-evaluated other elements of that regulation. As
part of that re-evaluation, EPA identified an inconsistency between the
Agency's proposal and OSHA's requirements concerning a change schedule
for the replacement of the gas- or vapor-removing canisters or
cartridges. Specifically, OSHA requirements address change schedules
that utilize NIOSH end-of-service-life indicator designations (29 CFR
1910.134(d)(3)(iii)(B)(2)). To ensure respirator protections are of
greater consistency across industries, EPA has added the OSHA
requirement that triggers the replacement of the gas- or vapor-removing
canisters or cartridges to the list of conditions in the final rule at
Sec.  170.507(d)(7) through an incorporation by reference.
    4. Costs and benefits. EPA estimates the cost to employers of
complying with the WPS respirator requirements that cross-reference the
OSHA standard would be $10.6 million annually, or about $43 per year,
on average, for agricultural establishments with handlers and about $8
for commercial pesticide handling establishments per year. On family-
owned farms that use pesticides and do not hire labor, the estimated
annual cost of the respirator requirements is approximately $9 per
establishment per year. As explained previously, the estimated cost
increased in the final rule because the cost analysis was revised to
account for handlers to be fit tested and trained to use multiple types
of respirators, the cost of an on-line medical evaluation, and the
employer's time to arrange for the fit testing, evaluation and
training. EPA assumes that about 30 percent of handlers working on 60
percent of farms that employ handlers will be fit tested in any year;
the average cost per farm reflects this assumption. The cost to
commercial pesticide handling establishments only reflects the cost of
recordkeeping because EPA assumes that they already comply with OSHA's
respirator requirements because they engage in activities outside of
the scope of the WPS that are covered by OSHA. The cost estimates for
agricultural establishments are very conservative because of broad
assumptions regarding the number of handlers and farms affected, and
the fact that some establishment owners are already required to comply
with OSHA requirements related to respirator use for other reasons.
    EPA cannot quantify the benefits associated with this specific
requirement. However, ensuring that handlers can safely use respirators
and that those respirators fit properly will increase the protections
offered by respirators to the levels presumed in EPA's pesticide
registration decisions. This should lead to a reduction in occupational
pesticide-related illnesses. In comparison to these expected benefits
of proper respirator use and reduced illnesses, the costs associated
with the final rule requirements appear to be reasonable.

B. Chemical-Resistant PPE

    1. Current rule and proposal. The definition for ``chemical
resistant'' in the existing WPS is a ``material that allows no
measurable movement of the pesticide being used through the material
during use.'' Prior to the proposed rule, EPA received many comments
from stakeholders suggesting that there was no way for agricultural
employers, handlers, early-entry workers, pesticide educators and
inspection personnel to ensure the PPE being used was ``chemical
resistant.'' EPA proposed requiring employers to provide PPE defined by
its manufacturer as chemical resistant.
    2. Final rule. EPA has rejected the proposed change. The final rule
retains the existing definition of chemical resistance. The final
regulatory text for this requirement is available at in 40 CFR
170.507(b)(1).
    3. Comments and responses.
    Comments. While several commenters representing states and academia
supported the idea of PPE manufacturers defining chemical resistant in
principle, many also questioned the feasibility of such an approach.
Specifically, the commenters questioned whether manufacturers can
reliably label PPE as chemical resistant in a permanent manner that
would be easy for enforcement personnel to check during inspections.
Several other commenters from pesticide manufacturers and PPE
manufacturers suggested such claims may not be able to be made for the
wide range of pesticide formulations and active ingredients. One PPE
manufacturer asserted that the existing definition was purposefully
worded to ensure worker protection and that EPA's proposal over-
simplifies a very complex and critical issue. Many other commenters
reiterated this latter comment regarding over-simplification of the
process for developing chemical resistant PPE.
    EPA Response. EPA recognizes the many comments highlighting the
challenging issues involved with having PPE being defined as chemical
resistant by the equipment manufacturer, who does not know the
ingredients in every pesticide product. EPA agrees with commenters that
the proposed approach would create more problems than it would resolve.
Therefore, the final rule retains the existing chemical resistant
definition.
    4. Costs and benefits. Because EPA is retaining the current
definition of chemical resistant, there are no estimated costs.

C. Contaminated PPE

    1. Current rule and proposal. The existing WPS requires employers
to ensure that PPE is cleaned before each day of reuse. If the article
cannot be properly cleaned, the employer must dispose of it in
accordance with applicable Federal, State, and local regulations. EPA
proposed to add a requirement for employers to render unusable
contaminated PPE that cannot be properly cleaned before it is disposed.
    2. Final rule. In the final rule, the employer must ensure that
contaminated PPE is made unusable as apparel or disposed of in such a
way that it is unavailable for further use. EPA has also included in
the final rule a requirement for the person who cleans, disposes, or
otherwise handles the contaminated PPE to wear the gloves required for
mixing and loading the pesticide that contaminated the PPE. The final
regulatory text for this requirement is available at 40 CFR
170.507(d)(2).
    3. Comments and responses.
    Comments. Prior to the proposed rulemaking, state pesticide
regulatory agencies expressed concern that unless proper measures are
taken, contaminated PPE might be reused either as PPE or simply as a
garment, placing the person wearing it at risk from pesticide exposure.
In support of the proposal, one public health organization commented
that rendering contaminated garments unusable would prevent adverse
health effects. A state noted that the proposal was an effective method
to reduce the potential for access to contaminated PPE. One grower

organization noted that the potential for exposure exists when
individuals cut or render contaminated PPE unusable, and suggested a
requirement to seal the contaminated PPE in a disposal container and to
dispose of the container in an appropriate manner.
    In contrast, some grower organizations stated that the current
requirement is adequate and EPA should not adopt the proposal. Some
farm bureaus opposed the proposal and thought the concern for
individuals gaining access to contaminated PPE was well meaning yet
hypothetical. Some of these commenters suggested it could lead to
confusing violation scenarios, specifically from the interpretation of
``render unusable.''
    EPA Response. The final rule clarifies that the requirement is to
make the PPE ``unusable as apparel.'' EPA agrees that access to
contaminated PPE might be prevented by sealing it in a container and
entrusting it to a waste disposal system that effectively prevents
diversion of waste, and that such an approach would reduce pesticide
exposure to the person handling the contaminated article relative to
many methods of rendering the PPE unusable. EPA has included in the
final rule a provision allowing the PPE to be ``made unavailable for
further use'' as an alternative to the proposed requirement to render
the contaminated PPE unusable. To reduce the potential exposure to a
person handling contaminated PPE, the final rule requires that a person
must wear gloves while handling PPE covered by 40 CFR 170.507(d)(2).
    EPA disagrees with comments from farm bureaus suggesting that there
is little likelihood of persons accessing contaminated PPE. As
mentioned in the preamble to the proposed rulemaking, state pesticide
regulatory agencies have raised concerns for the potential reuse of
contaminated PPE to EPA. EPA relies on state pesticide regulatory
agencies to raise issues with implementation of the existing WPS that
arise when they conduct inspections of WPS establishments. EPA has
chosen to amend the existing rule in response to the input provided by
the States.
    4. Costs and benefits. EPA has estimated that the cost of rendering
the PPE unusable or unavailable is negligible. Although the benefits
cannot be quantified, contact with contaminated PPE may result in
significant exposure, especially if worn repeatedly. The negligible
cost of this requirement compared to the benefit from ensuring that
contaminated PPE cannot continue to cause exposure is reasonable.

XVI. Decision Not To Require Monitoring of Handler Exposure to
Cholinesterase-Inhibiting Pesticides

A. Current Rule and Proposal

    The existing WPS does not have a requirement to monitor
cholinesterase (ChE) levels in workers or handlers. In the proposal,
EPA invited comment on whether to require routine ChE monitoring of
handlers. However, because EPA's initial judgement was that the
benefits of routine ChE monitoring would not justify the cost, EPA did
not propose to add a requirement for routine monitoring of ChE
inhibition in handlers.

B. Final Rule

    The final rule does not include a requirement for routine ChE
monitoring for handlers.

C. Comments and Responses

    Comments. In response to the proposal, several grower
organizations, state farm bureaus, crop consultants and their
organizations, and states and their organizations expressed support for
EPA's decision not to require a mandatory routine ChE monitoring
program as part of the WPS. Several commenters stated that the most
effective approach to prevent handler exposure to any pesticide product
is to address the potential for exposure in advance of use, rather than
after exposure has taken place. Many of these commenters agreed with
EPA's assessment in the proposal that EPA's worker risk assessments and
mitigation measures are sufficient to provide the necessary protection
from pesticide exposure during handling. One commenter also suggested
that requiring ChE monitoring may add to confusion and provide a false
sense of safety to workers, health care providers, and regulators
because it only measures exposure. These commenters suggested that the
best approach that can be taken to mitigate exposure would be to
address it through product-specific risk assessments supporting the
registration of pesticide products, robust handler training on specific
pesticides, and effective enforcement of label requirements.
    In addition, some of the commenters objected that ChE monitoring is
an invasive process, and that routine ChE monitoring would be extremely
time-consuming and costly and would provide information of questionable
value. One commenter stated that a proper ChE monitoring program would
require that a baseline be established for employees, and that it would
be highly unlikely that a baseline could be obtained for many workers
because of previous exposure to organophosphate insecticides, while
another commenter suggested that exposure to other common materials can
change the levels of ChE, especially in serum level measurements,
making it difficult to establish a baseline. Another commenter added
that the timing of meals, stress, physical activity, and changes in
body mass can cause ChE levels to fluctuate within an individual, and
that the baseline value should be taken on the day of handling a ChE-
inhibiting pesticide prior to exposure due to this intra-individual
variability. The commenter suggested that baselines established every 1
to 2 years, as currently recommended by Washington State and
California, respectively, would not provide meaningful information
concerning the degree of exposure due to these daily fluctuations.
    Conversely, several commenters, including some members of Congress,
the California Department of Public Health, Washington State's
Department of Health and Department of Labor and Industries, several
public health organizations, academics, and farmworker advocacy
organizations supported the idea of adopting a routine ChE monitoring
program as part of this rulemaking, particularly for handlers who use
ChE-inhibiting pesticides like organophosphates and N-methyl-carbamate
pesticides. Many of these commenters cited the existing ChE monitoring
programs in California and Washington State in their arguments for why
ChE monitoring should be expanded nationally.
    Some commenters stated that California and Washington have
longstanding medical monitoring programs with proven track records in
reducing exposure to, and illnesses from, highly neurotoxic chemicals.
These commenters stated that the successful implementation of these
monitoring programs has helped health professionals understand the
effects of these classes of pesticides and prevent poisoning by
identifying overexposure. Two commenters stated that Washington's
program is effective and protects workers as reflected by worksite
field evaluations of action level ChE depressions, which have
identified multiple pesticide WPS violations that are believed to
contribute to worker exposure. A couple of commenters stated that the
benefits realized by the state programs, which would expand nationally
if monitoring were to be required, include:
     Greater certainty about the frequency of pesticide
overexposure.

     Avoidance of serious pesticide illness.
     Improved compliance with the WPS.
     Identification of any existing PPE, work
practice, and engineering control requirements that are not sufficient
to protect pesticide handlers from exposure.
     Greater awareness of chemical and exposure
hazards.
    Some commenters cited Washington State's data that shows that the
percentage of overexposed participating handlers who required remedial
action fell from 20% when the program started in 2004 to 6% in 2013,
for a reduction of 70%. These commenters stated that Washington's
Department of Labor and Industries found that ChE monitoring helped
identify the causes of overexposure, which allowed for those causes to
be corrected by alerting employers and handlers to unsafe work
practices, conditions, or equipment. Additionally, a couple of
commenters stated that the percentages of handlers who actually reached
the removal level from handling ChE-inhibiting pesticides remained
consistently low after the implementation of the ChE monitoring
program, with the percentages being 3.8% in 2004, 0% in 2010 and 2011,
2.3% in 2012, and 4% in 2013. These commenters believed that the sharp
decline in the number of handlers needing remedial action, along with
the consistently low percentage of handlers who exceeded 20% below
their baseline (i.e., those who reach the evaluation level in the state
programs), shows that the program has been effective in reducing
exposure to OPs and carbamates, and that monitoring should be
implemented nationally so that all workers receive similar benefits.
    Some commenters in support of requiring ChE monitoring also
discussed the costs associated with ChE monitoring. They stated that
the cost of implementation should not deter EPA from requiring medical
monitoring on a national level. A few commenters stated that EPA's
estimate that the cost of ChE monitoring would average $53 per year per
agricultural establishment was a small cost when contrasted with the
70% reduction in overexposure according to Washington State's data. A
couple of commenters also stated that monitoring in California and
Washington has led to substantially fewer pesticide poisonings and
reduced use of these highly toxic pesticides, and can, in turn, reduce
long-term medical costs to farmworkers and the agricultural economy.
Some commenters stated that EPA's analysis did not include an
estimation of the medical expenses that were saved, the lost wages
prevented, and the pesticide-related illnesses avoided as a result of
early detection and intervention. As a result, the commenters believed
that the benefits of a national ChE monitoring program would more than
justify the costs given the severe effects of overexposure to ChE-
inhibiting pesticides.
    Other commenters supporting ChE monitoring stated that employees
who handle ChE-inhibiting chemicals in non-agricultural sectors
routinely receive the protection of medical monitoring. For example,
some commenters stated that OSHA requires medical monitoring for
workers who handle a wide range of toxic substances. They also stated
that USDA requires monitoring of its employees who may be exposed to
organophosphate or carbamate pesticides. These commenters stated that
these safeguards should be provided for all workers who handle these
pesticides, and therefore should be included in the final rule.
    EPA Response. After reviewing the comments, EPA continues to
believe that the expected benefits of a routine ChE monitoring program
for handlers are not sufficient to justify the costs. As stated in the
proposed rule, EPA believes that Washington State's efforts have
identified the primary reasons for ChE inhibition among pesticide
handlers. In many cases, ChE depression was caused by handlers not
following basic safety and hygiene procedures, e.g., not wearing the
label-required PPE and failing to wash before meals or bathroom breaks.
Additionally, several handlers who did wear respirators as required by
labeling had beards, which compromised the seal between the face and
the respirator and reduced the protection intended to be afforded by
the PPE. EPA believes that requiring expanded and more frequent handler
training, in combination with requirements for fit testing and training
on proper respirator use for handlers, addresses the primary reasons
for overexposure to ChE-inhibiting pesticides.
    The revised labeling with increased protections and new mitigation
measures resulting from the reregistration of organophosphates and
carbamates will also result in lowered handler exposure. Reregistration
has resulted in some uses of the most acutely toxic organophosphates
being phased out. For the remaining uses, EPA has imposed additional
PPE requirements, requirements for closed-system mixing and loading,
and reductions to rates of application and number of annual
applications permitted. As labels with updated PPE requirements for
handlers are seen and followed in the field, EPA expects to see reduced
numbers of overexposures. Additionally, the organophosphates and
carbamates that are still registered are being used less frequently and
being replaced by pesticides with lower risks, also reducing the
potential for overexposure.
    While EPA estimated the costs of a national, routine ChE monitoring
program to be at least $15.2 million annually, or about $53 per
agricultural establishment per year and $120 per commercial pesticide
handling establishment per year, this estimate does not include the
full costs that would be expected of a national ChE monitoring program.
As stated in the proposed rule, a national, routine ChE monitoring
program would likely include program components such as training,
recordkeeping, clinical testing, and field investigations, which were
not included in the estimated costs because the initial $15.2 million
estimate appeared by itself to be disproportionately high in comparison
to the expected benefits. Additionally, the estimated costs do not
include the states' costs to build infrastructure to support ChE
monitoring or to cover continued laboratory costs such as equipment
maintenance and administrative support. If EPA were to calculate these
additional costs, the estimated costs would be much higher than $15.2
million annually. Therefore, EPA stands by its assessment in the
proposed rule that the cost of implementing a national, routine ChE
monitoring program is not justified by its limited benefits.
    EPA believes that the increased handler protections being finalized
in this rulemaking, combined with the product-specific risk mitigation
measures, will appropriately address the elevated potential for ChE
inhibition in handlers. Moreover, the training and PPE elements of the
final rule will have the combined effect of providing important
protective benefits to all pesticide handlers through increased
knowledge of exposure risks and prevention strategies. This approach
will lead to a reduction of pesticide exposures because it prevents
handler exposure before it occurs.

D. Costs and Benefits

    Since EPA is not requiring routine ChE monitoring, there are no
costs associated with this decision.

XVII. Exemptions and Exceptions

A. Immediate Family

    1. Current rule and proposal. The WPS currently exempts the owners
of agricultural establishments from requirements to provide certain WPS
protections to themselves and their immediate family members. Owners
are required to comply with all applicable provisions of the WPS for
any worker or handler employed on the establishment who is not a member
of the owner's immediate family. The definition of ``immediate family''
in the existing rule includes only the owner's spouse, children,
stepchildren, foster children, parents, stepparents, foster parents,
brothers, and sisters. EPA proposed to expand the definition of
``immediate family'' to add father-in-law, mother-in-law, sons-in-law,
daughters-in-law, grandparents, grandchildren, brothers-in-law, and
sisters-in-law.
    Note, too, that the existing WPS definitions of workers and
handlers depend upon them being employed for compensation. Therefore,
any person performing worker or handler tasks who does not receive a
wage, salary or other compensation is not a worker or handler protected
by the WPS, regardless of familial relationship to the owner.
    EPA requested comment on but did not propose changes narrowing the
immediate family exemption in two ways: (1) Limiting it only to those
immediate family members of an owner of an agricultural establishment
who are at least 16 years old, and (2) eliminating the exemptions from
requirements regarding emergency assistance for workers and handlers
and regarding handler monitoring during fumigant application.
    As part of the proposal to establish a minimum age for pesticide
handlers and early-entry workers, EPA proposed to add an exemption from
the minimum age requirements to the immediate family exemption.
    2. Final rule. EPA has finalized the definition of ``immediate
family'' as limited to the owner's spouse, parents, stepparents, foster
parents, father-in-law, mother-in-law, children, stepchildren, foster
children, sons-in-law, daughters-in-law, grandparents, grandchildren,
brothers, sisters, brothers-in-law, sisters-in-law, aunts, uncles,
nieces, nephews, and first cousins. ``First cousin'' means the child of
a parent's sibling, i.e., the child of an aunt or uncle. The final
regulatory text for this definition is available at 40 CFR 170.305.
    EPA has amended the exemption from certain provisions of the WPS
for owners and members of their immediate families to include
exemptions from the minimum age requirements for handlers and early-
entry workers. The final regulatory text for this exemption is
available at 40 CFR 170.601(a)(1)(i) and 170.601(a)(1)(xii).
    EPA has clarified the final regulatory text related to the
exemption from certain provisions of the WPS for owners and members of
their immediate families. The exemption in the final rule will apply to
owners and members of their immediate family on any agricultural
establishment where a majority of the establishment is owned by one or
more members of the same immediate family. The final regulatory text
for this exemption is available at 40 CFR 170.601(a)(1).
    EPA has not included in the final rule any of the other changes to
the owner and immediate family exemption considered in the proposal.
    3. Comments and responses.
    Comments. Most of the commenters expressed general support for the
proposed expansion to the definition of immediate family and the
inclusion of an exemption from the minimum age requirement. Some
commenters asserted that the definition provides greater clarity about
who qualifies under the immediate family exemption and will assist both
the regulated community and state regulatory agencies in ensuring
compliance with the proposed rule.
    A few commenters requested that EPA expand the definition to
include cousins. Many commenters, including the Small Business
Administration's Office of Advocacy, requested that EPA expand the
definition further to include aunts, uncles, nieces, nephews, and
cousins. Commenters requesting further expansion of the definition
noted that an expansion of the family members considered immediate
family under the WPS would better reflect the reality of the family
farm in America. Commenters also requested that EPA further expand the
definition and exemption to recognize varying ownership patterns used
to assure the continued operation of the farm and the involvement of
siblings and their heirs. One commenter suggested that EPA align the
exemption with USDA's interpretation of farm ownership by family
members, which considers a ``family farm'' to be one where a majority
of the farm is owned by family members, rather than retaining EPA's
interpretation of the exemption as applying only on establishments that
are wholly owned by one or more members of the same immediate family.
    A few commenters requested that EPA delete the definition of
immediate family and eliminate the exemption. These commenters noted
that risks from pesticide exposure are the same for family and non-
family members, so all persons need the same level of protection
regardless of their familial relationship to the owner.
    EPA Response. EPA has further expanded the definition of immediate
family to also include aunts, uncles, nieces, nephews, and first
cousins (i.e., child of a parent's sibling, child of an aunt or uncle)
and is retaining the exemption in the WPS. EPA believes that the
proposed definition of ``immediate family'' represents an appropriate
accommodation to the social costs of the WPS to farm owners and members
of their immediate families relative to FIFRA's requirement to prevent
unreasonable adverse effects.
    EPA considered commenters' requests to expand the definition of
``immediate family.'' Commenters suggested that a definition that
includes cousins, or cousins, aunts, uncles, nieces and nephews would
better reflect the actual patterns of family-based farm ownership in
the United States. EPA agrees with commenters' suggestions that family-
based farm ownership may extend beyond relationships covered by EPA's
existing or proposed definition. EPA agrees with commenters' requests
to expand the definition to include aunts, uncles, nieces, nephews, and
first cousins. For clarity, EPA has chosen to define ``first cousin''
as the child of a parent's sibling, i.e., the child of an aunt or
uncle.
    EPA has clarified the applicability of the exemption in the final
rule in response to comments. The exemption in the final rule applies
to the owners and their immediate family members on any agricultural
establishment where a majority of the establishment is owned by one or
more members of the same immediate family. A ``majority of the
establishment'' means that more than 50 percent of the equity in the
establishment is owned by one or more members of the same immediate
family as defined in the WPS.
    EPA agrees that the risks associated with pesticide exposure do not
vary based on a person's relationship to the owner of the
establishment. However, EPA recognizes that family-owned farms need
flexibility and expects that those family members working on an
establishment covered by the immediate family exception would be
adequately prepared and supervised by family members. Although owners
and their immediate family members are exempted from certain provisions
of the WPS (e.g., providing pesticide safety training and specific
decontamination supplies for immediate family

members), they are obligated to follow the pesticide labeling and other
WPS provisions that are established to protect workers and handlers
from risks associated with specific pesticides. For these reasons, EPA
has chosen not to eliminate the definition of immediate family or the
exemption from certain portions of the rule for the establishment owner
and members of his or her immediate family.
    Although owners of establishments and members of their immediate
family are exempt from some of the provisions of the rule, EPA expects
that they will voluntarily follow the provisions from which they are
exempt, or achieve equivalent risk mitigations through other means. EPA
encourages owners and family members to carefully study the WPS
requirements and assure themselves that they are not placing each other
at risk of unreasonable adverse effects.
    4. Costs and benefits. EPA estimates changing the definition of
immediate family and adding to the existing exemptions for owners and
members of their immediate family an exemption from the minimum age
requirements would not substantially change the cost of the final rule.

B. Crop Advisors and Employees

    1. Current rule and proposal. The existing rule exempts employers
from complying with certain handler requirements when the employee
performs crop advising tasks in a treated area under an REI and is a
certified or licensed crop advisor or directly supervised by a
certified or licensed crop advisor. A certified or licensed crop
advisor is one who has fulfilled the requirements of a program
acknowledged as appropriate in writing by EPA or a state or tribal
agency responsible for pesticide enforcement. The existing rule allows
a certified or licensed crop advisor to make specific determinations
regarding the appropriate PPE, decontamination and safe method of
conduct for those working under his or her direct supervision. A person
employed by a commercial pesticide handling establishment performing
crop advising tasks after expiration of an REI is not subject to any
provisions of the WPS. The rule also exempts employers from complying
with worker requirements such as providing decontamination supplies and
emergency assistance for certified or licensed crop advisors and for
persons they directly supervise.
    EPA proposed to eliminate the exemptions for employees directly
supervised by certified or licensed crop advisors. EPA also proposed to
eliminate the exemption from the worker decontamination and emergency
assistance provisions for certified or licensed crop advisors employed
as workers on agricultural establishments.
    2. Final Rule. EPA has eliminated both exemptions as proposed.
However, EPA has included in the final rule added flexibility in the
PPE requirements for crop advisors and their employees. Specifically,
EPA has added language to the final regulation that allows crop
advisors and their employees who perform crop advising tasks while an
REI is in effect to substitute the label-required handler PPE with
either the label-required PPE for early-entry activities or a standard
set of crop advisor PPE. The standard set of PPE for crop advising
tasks included in the final rule consists of coveralls, shoes plus
socks, chemical-resistant gloves made of any waterproof material and
eye protection if the labeling of the pesticide product applied
requires protective eyewear for handlers. The final regulatory text for
this requirement is available at 40 CFR 170.601(b) and 170.607(g).
    3. Comments and responses.
    Comments. In response to the proposal, crop consultant
associations, several states and other commenters objected to
eliminating the exemption currently in place for employees working
under the direct supervision of a certified or licensed crop advisor.
They asserted that certified and licensed crop advisors often exceed
the minimum safety training requirements when educating their employees
and those employees are aware of the risks associated with their work.
Some crop consultant associations and other commenters noted that they
are not aware of any case of endangerment or harm that has occurred to
any employee under the direct supervision of a certified or licensed
crop advisor.
    The crop advisor associations also expressed concern that EPA
underestimated the economic impact to crop advisors, and in turn to
farmers, of eliminating this exemption, citing specifically the
increased costs of additional PPE, the cost of work done by certified
or licensed crop advisors instead of by their employees, and the cost
of increased management time. Crop consultant associations and other
commenters contended that these increased costs could discourage
investment in integrated pest management (IPM) and result in increased
pesticide use that might put workers at increased risk of pesticide
exposure. Several states supported EPA's proposal to eliminate the crop
advisor exemption.
    EPA Response. After consideration of the comments submitted, EPA
has concluded that the burdens associated with eliminating the
exemption for employees of crop advisors are justified by the
additional protections provided to workers performing crop advising
tasks who are not certified or licensed crop advisors. EPA has retained
the exemption to the WPS for certified or licensed crop advisors
because these individuals are highly trained about pesticide risks and
how to protect themselves. EPA eliminated the exemption for crop
advisors' employees because pest scouting tasks may result in
substantial contact with a pesticide on treated surfaces in pesticide-
treated areas. The amount of contact with pesticides during scouting
depends on variables such as the height and density of the crop, the
nature of the activity, the surface that contains the pesticide
residue, and whether residues are dry or wet. While EPA recognizes that
the crop consulting industry has implemented a training program for
employees, the program is not required and can vary in content and
quality from employer to employer. Additionally, crop scouts and
assistant crop advisors are generally entry-level employees who may not
feel empowered to ask an employer for PPE or other protections and may
not understand the complex factors influencing risk well enough to take
appropriate protective measures for themselves.
    Incident monitoring programs do not capture illness data
specifically associated with crop advising tasks because cases are
categorized under a general ``field worker'' label. However, EPA's risk
assessments indicate that people doing crop advising tasks during an
REI are at risk of chronic, low-level pesticide exposure over time. PPE
requirements and availability of decontamination supplies during and
after an REI are fundamental to mitigating risks of concern for
workers. Allowing workers who are supervised by certified or licensed
crop advisors to conduct crop advising tasks without the same basic
protections provided for other workers would establish a lesser
standard of protection for similar types of work. EPA understands that
IPM programs require post-application entry and the timing is critical
to efficacy. By retaining the exemption for certified or licensed crop
advisors to conduct crop advising tasks during an REI and allowing
flexibility for employers to substitute the label required PPE for
handlers with either PPE for early-entry workers or a standard set of
PPE, the

increased costs noted in comments are reduced.
    4. Costs and Benefits. EPA estimates the cost of amending the
exemption for crop advisors would be negligible. EPA finds that the
incremental cost of employers providing decontamination supplies and
PPE for crop advisor employees are reasonable compared to the cost. EPA
is allowing flexibility in the choice of PPE for crop advisor employees
who must enter treated areas under an REI to accommodate entry into
multiple fields with the same attire. Benefits from reduced exposure to
pesticides as a result of requiring the standard protections for all
workers, including those supervised by certified or licensed crop
advisors, are reasonable when compared to their cost.

C. Closed Systems

    1. Current rule and proposal. The existing WPS permits exceptions
to the label-specified PPE when using a closed system for certain
pesticide handling activities. The existing rule does not adequately
describe the specific characteristics of an acceptable closed system.
EPA proposed to establish specific design criteria and operating
standards for closed systems based on California's existing standards
in the 1998 Closed Systems Director's Memo (http://www.cdpr.ca.gov/docs/whs/cac/cacwhs98-01.pdf).
    2. Final Rule. EPA has modified the proposed approach regarding
closed systems. Specifically, in the final rule EPA has adopted a broad
definition, a performance-based standard, and basic operating
standards. The operating standards require the handler employer to
ensure that written operating instructions for the closed system are
available, that the handler receives training on use of the closed
system, and that the system is maintained according to the written
instructions. Specific design criteria and recordkeeping requirements
that EPA proposed are not included in the final rule.
    The final rule retains the existing requirements for PPE when a
closed system is used: Labeling-mandated PPE must be immediately
available for use in an emergency and handlers must use protective
eyewear for closed systems that operate under pressure.
    The final regulatory text for the definition of closed systems is
available at 40 CFR 170.305. The final regulatory text for the closed
system exception is available at 40 CFR 170.607(d)(3).
    3. Comments and responses.
    Comments. Most comments that addressed closed systems supported the
goal of encouraging their use as an engineering control through a WPS
exception; however, very few individuals, states or organizations
supported the proposal as written. Several farmworker advocacy
organizations and public health organizations suggested that EPA
require closed systems for all Toxicity Category I pesticide products
rather than continuing the voluntary system. Comments from states and
grower and industry associations supported the existing voluntary,
performance-based system and objected to the proposed specific design
criteria, noting a number of weaknesses in the criteria. Specifically,
they noted that the pressure requirements were too prescriptive and
would not allow effective mixing, that the proposal did not address
water soluble packaging or lock and load systems used for dry
formulations, and that the complicated requirements would be a
deterrent to increased adoption of closed systems. A number of
commenters also noted that the design standards are too restrictive to
accommodate future innovation. States commented that assessing
compliance with the design standard would require extensive inspector
training and could result in technical violations without providing
additional handler protection.
    EPA Response. EPA considered the comments submitted and was
convinced that the prescriptive requirements in the proposal would be a
disincentive to the voluntary adoption of closed systems. In response,
EPA has finalized a closed system performance standard that will permit
flexibility for the system while meeting the protection goals.
    In response to comments advocating that EPA require closed systems
for all Toxicity Category I pesticides under the rulemaking, EPA
reminds the commenters that worker risk assessments and the risk
management processes establish the required protections that appear on
product labels. EPA identifies the basic protections, often PPE, to
protect handlers from risks of concern. If handler exposure during
mixing and loading is above the established level of concern, and if
PPE does not reduce exposure to below the level of concern, the
pesticide label may require a closed system for mixing and loading. EPA
has required the use of closed systems on some product labeling.
    EPA recognizes that the reduction in handler PPE alone is not
likely to be enough incentive for an employer to use closed systems.
However, EPA is convinced that on larger establishments, the efficiency
and comparative protection value of a closed system, combined with the
reduction in PPE that must be worn by the handler, may induce users to
adopt closed systems. Establishing requirements for such closed
systems--whether required or used voluntarily--is necessary to protect
handlers, who could be exposed to concentrated pesticides if they use
poorly designed or constructed closed systems.
    EPA agrees with the comments that a broad definition of ``closed
system'' will encourage industry innovation better than the proposed
prescriptive rule and will allow flexibility for employers to design
systems specific to their needs. A broad performance standard, along
with requirements concerning operating instructions, training and
maintenance, will enable employers, handlers and regulatory personnel
to determine whether a closed system qualifies for the exemption. The
operating standards will ensure that the closed systems are used as
intended and are adequately maintained.
    EPA notes that the California Department of Pesticide Regulation
(CDPR) no longer supports use of the prescriptive-based criteria upon
which EPA modeled the proposal outlined in the NRPM. In December 2014,
CDPR published proposed regulations outlining a simplified,
performance-based criteria for closed system design. California is the
only state with specific closed system standards, and has required
their use with certain chemicals since the 1970s. CDPR developed their
revised closed systems standard and discussed the proposal with
representatives from groups that will be directly affected including
agricultural producer organizations, manufacturers, applicators, and
growers, as well as at CDPR's Pesticide Registration and Evaluation
Committee and the Agricultural Pest Control Advisory Committee and Pest
Management Advisory Committee meetings. EPA considered CDPR's proposed
rule in the development of the final closed systems standard. EPA's
final closed system requirements were developed using CDPR's proposal
as a model and do not conflict with CDPR's proposed closed system
requirements.
    Section 170.607(d)(2)(i) establishes a performance standard for
closed systems. Specifically, a closed system must remove the pesticide
from its original container and transfer the pesticide product through
connecting hoses, pipes and couplings that are sufficiently tight to
prevent exposure of handlers to the pesticide product, except for the
negligible escape associated with normal operation of the

system. This closed system performance standard is based on the
criteria for closed systems in section 6746(f)(1) of CDPR's proposed
regulations with a few changes, partly to accommodate the different
terminology in the two sets of regulations. Also, EPA adjusted the
requirement to apply to transferring any pesticide product rather than
a pesticide concentrate so the WPS criterion would apply to
transferring liquid formulations and dry formulations whereas
California's proposed requirements would only apply to liquid
formulations. Lastly, EPA added the phrase ``except for the negligible
escape associated with normal operation of the system'' to provide the
flexibility intended in the proposed rule. The existing WPS describes a
closed system as preventing the pesticide from contacting handlers or
other persons, which is a very high standard because it does not allow
any exposure. The phrase ``except for the negligible escape associated
with normal operation of the system'' is intended to account for the
expected or predictable small release of pesticides from existing
closed systems when hoses, pipes and couplings are disconnected. EPA
recognizes that there will often be a small amount of material in the
hoses, pipes and couplings to which the handler possibly could be
exposed. EPA has not quantified the maximum amount of pesticide escape
that is acceptable, but notes that it should be consistent with the
intent of a closed system, which is to prevent contact to the handlers
or other persons.
    EPA also adjusted the final regulatory text for closed systems to
address the comments about water soluble packaging. The regulatory text
in the final rule was revised to state clearly that the closed system
exception from PPE applies when intact, sealed water soluble packaging
is loaded into a mixing tank or system. The regulation also clarifies
that water soluble packaging is no longer a closed system if the
integrity of the packaging is compromised. This language in the final
rule incorporates EPA's current position about water soluble packaging
and closed systems, as established in the Interpretive Guidance on the
WPS: http://www.epa.gov/pesticides/safety/workers/wpsinterpolicy.htm.
    While the final rule includes only a performance standard, EPA
recognizes that it may be helpful to have guidance on how to construct
a system to meet that standard. As part of California's proposed
rulemaking, CDPR and the University of California, Davis (UC Davis)
developed plans for building a closed system to release along with the
proposal. The ``Overview of Closed Systems Components and User
Designs'' document includes lists of component parts (and costs) for
three levels of systems (basic, medium and high). The design plans
developed by CDPR and UC Davis will provide users with examples of
representative closed systems components so they can identify or
develop acceptable closed systems.
    4. Costs and benefits. EPA estimates the cost of the final closed
system requirements will be $2.1 million annually. EPA estimates that
cost per agricultural establishment will range from $5-$30 per year,
and the cost per commercial pesticide handling establishment will be
about $21 per year. EPA estimates that on family establishments, the
cost would range from $1-$30 per year. Many commenters from the
pesticide industry and grower associations stated that EPA
underestimated the costs of closed systems in the proposed rule partly
because existing closed systems would need to be upgraded to meet the
proposed standards. The changes to replace the proposed specific design
standards with a broad performance standard in the final rule address
these comments, because employers will be able to continue using most
existing closed systems with minimal adjustments. For details refer to
the Economic Analysis accompanying this rule (Ref. 1). In addition, EPA
notes that the WPS does not require use of closed systems, so
commenters who assumed many pesticide users would have to purchase
expensive closed systems were incorrect.
    EPA adjusted the closed system cost estimates from the proposed
rule in several ways to reflect changes in the final rule. The cost
estimate in the proposed rule assumed that some users of closed systems
would purchase new systems while others would revert to using PPE. In
light of the revised definition, the final cost estimate assumes that
most users would simply purchase an adapter to connect their existing
closed system to the pesticide container, which is the part that most
likely needs to be added to convert existing mechanical transfer
systems to be closed systems that meet EPA's criteria. These changes
and costs are based on the CDPR and UC Davis document ``Overview of
Closed Systems Components and User Designs,'' which includes lists of
component parts and their costs for three levels of systems. In
addition, the cost of developing operating instructions was added,
assuming that most closed systems are custom-made systems that would
require the employer to develop operating instructions, while the costs
of keeping records of maintenance was deleted. EPA reduced the
estimated number of farms using closed systems based on information
from the Agricultural Handler Exposure Task Force, which showed that
the limited number of pesticide users who use closed systems are
primarily larger establishments and commercial pesticide handling
establishments. Therefore, the estimated costs of the closed system
criteria decreased from the proposed rule to the final rule.
    Using closed systems is preferred to wearing PPE as an approach for
managing chemical exposure in the ``hierarchy of controls'' established
under standard industrial hygiene principles. Enclosing the chemical
and substantially reducing the potential for exposure at the source
reduces the potential for subsequent exposure to handlers, other
people, and the environment.

D. Aerial Applications--Eyewear Protection for Open Cockpits

    1. Current rule and proposal. Under the existing WPS, where
labeling requires eye protection, the requirement may be satisfied by
goggles, safety glasses with front, brow and temple protection, or a
full face respirator. The existing WPS allows aerial applicators
applying pesticides from open cockpit aircraft to substitute a visor
for label-required eye protection. Because the term ``visor'' can be
used to refer to the brim of a cap that provides only shade and offers
little eye protection from pesticide sprays, EPA proposed to clarify
the requirement by removing the term. EPA proposed to allow aerial
applicators to substitute for the label-required eyewear a helmet with
the face shield lowered, because this more clearly indicates EPA's
expectation of a clear visor that covers and adequately protects the
eyes.
    2. Final rule. In the final rule, EPA has removed the term
``visor.'' The final rule allows the substitution of a helmet with face
shield lowered for labeled protective eyewear for aerial applicators in
aircraft with open cockpits. The final regulatory text for this
requirement is available at 40 CFR 170.607(f)(2).
    3. Comments and responses.
    Comments. There were very few comments addressing this proposal.
One state suggested EPA consult with relevant aerial agencies
responsible for overseeing the use of open cockpits for making
pesticide applications to see if the proposal is feasible.
    An aerial applicators association asserted that aerial applications
of pesticides using open cockpit aircraft

are very rare and that EPA is solving a problem that does not exist.
They objected to handlers operating open cockpit aircraft being
required to wear the same PPE as handlers operating open cab ground
equipment. They did not highlight any specific issue with the helmet
and visor being lowered when protective eyewear are required.
    EPA Response. EPA acknowledges that while open cockpit aircraft may
be rare, available exposure data indicate that even pilots in enclosed
cab aircraft are exposed to the pesticides they apply. Ensuring that
the eye is protected from pesticides is required by the product
labeling. Helmets with face shields in the lowered position provide
acceptable eye protection, but many items referred to as ``visors''
offer no eye protection from pesticide sprays.
    4. Costs and benefits. This provision does not represent a
substantive change to the existing rule. EPA expects the cost to aerial
applicators to be negligible.

E. Aerial Applications--Use of Gloves

    1. Current rule and proposal. In the existing rule, aerial
applicators have the option of whether to wear chemical resistant
gloves to enter and exit the aircraft unless gloves are required by the
product labeling. In the proposal, EPA inadvertently inserted the
regulatory language that existed prior to the 2004 rule revision that
required pilots to wear chemical resistant gloves.
    2. Final rule. The final rule retains the exception in the existing
WPS that offers aerial applicators the option of wearing chemical-
resistant gloves when entering and exiting the aircraft, except when
the product labeling requires that chemical-resistant gloves be worn
when entering and exiting the aircraft. The final regulatory text for
this requirement is available at 40 CFR 170.607(f)(1).
    3. Comments and responses.
    Comments. Many applicators and their associations and pesticide
manufacturers noted this error. The commenters also asserted the use of
gloves presents a hazard to pilots who may fall when entering and
exiting the aircraft when wearing gloves. They also suggested
contamination from contact with the exterior of the aircraft is
minimized due to advances in application techniques (e.g., GPS) that
help pilots avoid flying through their spray.
    EPA Response. The final rule retains the exception in the existing
regulation that offers aerial applicators the option of wearing
chemical-resistant gloves when entering and exiting the aircraft,
except when the product labeling requires that chemical resistant
gloves be worn entering and exiting the aircraft.
    4. Costs and benefits. There is no cost associated with including
the existing exception in the final regulation.

F. Enclosed Cabs--Changes to Exceptions to PPE Requirements When
Applying Pesticides From Inside an Enclosed Cab

    1. Current rule and proposal. The existing WPS permits exceptions
to the labeling-specified PPE when handling tasks are performed from
inside an enclosed cab that meets the specifications defined in the
rule based on the dermal protection provided by the enclosed cab, which
prevents pesticides from contacting the body. The existing rule also
permits persons occupying an enclosed cab to forego certain labeling-
required respiratory protection if the cab has been certified by the
manufacturer to provide respiratory protection equivalent to the
handler respiratory protection required by the pesticide labeling.
    EPA proposed to eliminate the requirement for any labeling-
specified respiratory protection PPE when applying pesticides from
inside an enclosed cab. This would have allowed handlers to substitute
a long-sleeved shirt, long pants, shoes, and socks for the labeling-
specified PPE in all cases no matter what type of respiratory
protection PPE was required by the labeling.
    2. Final Rule. In the final rule, EPA requires handlers in enclosed
cabs to wear the labeling-specified respiratory protection except when
the only labeling-specified respiratory protection is a filtering
facepiece respirator (NIOSH approval number prefix TC-84A) or dust/mist
filtering respirator. In the final rule, handlers in enclosed cabs may
substitute a long-sleeved shirt, long pants, shoes and socks for the
labeling-specified PPE for skin and eye protection. If a filtering
facepiece respirator (NIOSH approval number prefix TC-84A) or dust/mist
filtering respirator is required by the pesticide product labeling for
applicators, then handlers do not need to wear the respirator inside
the enclosed cab if the enclosed cab has a properly functioning air
ventilation system that is used and maintained in accordance with the
manufacturer's written operating instructions. If any other type of
respirator is required by the pesticide labeling for applicators, then
the handler must wear the respirator inside the enclosed cab during
handling activities.
    EPA has retained other exceptions to PPE requirements for handlers
using enclosed cabs. Specifically, all of the PPE required by the
pesticide product labeling for applicators must be immediately
available to handlers in an enclosed cab and be stored in a sealed
container to prevent contamination. Handlers must wear the applicator
PPE if they exit the cab within a treated area during application or
when a REI is in effect. Once PPE has been worn in a treated area,
handlers must remove it before reentering the cab to prevent
contamination of the cab.
    The final regulatory text for the enclosed cab exception is
available at 40 CFR 170.607(e).
    3. Comments and responses.
    Comments. EPA did not receive any comments in opposition to the
proposed changes to the enclosed cab exception. One grower noted that
the enclosed cab exception is an excellent component of the proposal.
Another commenter noted that respirator use is infrequent since the
spraying operation takes place from inside an enclosed, climate-
controlled tractor cab.
    EPA Response. EPA considered the comments submitted and is
convinced that the enclosed cab exception should be retained since it
provides an important option to reduce potential pesticide exposure
through engineering controls rather than PPE, and such cabs can be an
important tool for addressing heat stress issues for handlers. Although
EPA considered a more expansive exception under its proposal, after
reevaluation of the potential exposure risks for handlers and the
protections afforded by enclosed cabs, EPA determined that enclosed
cabs may not universally provide respiratory protection necessary to
mitigate inhalation risks for any pesticide product that required
respiratory protection greater than a filtering facepiece respirator
(NIOSH approval number prefix TC-84A) or dust/mist filtering
respirator. EPA determined that enclosed cabs may not provide adequate
protection from inhalation exposure hazards when the inhalation
exposure risk arises from vapors or other non-particulate inhalation
hazards. Additionally, EPA has learned that there are no longer any
enclosed cab manufacturers certifying cabs to provide respiratory
protection and the American Society of Agricultural and Biological
Engineers has withdrawn their enclosed cab standard. Based on this
information, EPA has removed provisions under the enclosed cab
exception that permit persons occupying an enclosed cab to eliminate
certain labeling-required respiratory protection PPE if the cab has
been certified by the manufacturer to provide respiratory protection

equivalent to the respiratory protection required by the pesticide
labeling.
    4. Costs and benefits. EPA does not estimate that the change to the
exception to PPE requirements for handlers using a tractor with an
enclosed cab to apply pesticides will have a significant cost. Handlers
will benefit by using adequate respiratory protection when applying
pesticides from an enclosed cab.

XVIII. General Revisions

A. Label vs. Labeling

    1. Current rule and proposal. FIFRA defines the label as ``the
written, printed, or graphic matter on, or attached to, the pesticide
or device or any of its containers or wrappers.'' 7 U.S.C. 136(p)(1)
For reasons of space and user convenience, detailed use instructions
and precautions often appear in labeling provided with the pesticide
product upon sale. As defined in FIFRA, ``labeling'' includes ``all
labels and all other written, printed, or graphic matter accompanying
the pesticide or device at any time; or to which reference is made on
the label or in literature accompanying the pesticide or device . . .''
7 U.S.C. 136(p)(2).
    Labeling may include booklets distributed with the product when
such documentation is too long to be included on the label that is
securely attached to the container. For example, some products have
labeling that is 60 or more pages long. FIFRA and EPA regulations
require certain information to appear on the label--on or attached to
the pesticide container. Other information necessary to use the product
safely, such as directions for use, may be included in a booklet
distributed with, but not securely attached to, the container (40 CFR
156.10(i)(1)(ii)); this information could also be available on the
Internet if the producer has decided to provide web-distributed
labeling for the product (Ref. 21). In either format, the information
would be considered labeling. Labeling sometimes includes enforceable
references to other documents that do not physically accompany the
container, such as the WPS.
    The existing rule discusses employers' responsibilities related to
pesticide labels and labeling in several places. The existing rule
requires agricultural and handler employers to ensure that pesticides
are used in a manner consistent with the labeling. When the emergency
assistance provisions of the WPS are triggered, the existing rule
requires employers to provide information from the product labeling to
affected workers, handlers, and/or treating medical personnel. Handlers
must receive training on the format and meaning of information
contained on pesticide labels and in labeling. Finally, employers must
ensure that handlers have either read or have been informed in a manner
they understand of all labeling requirements related to safe use of the
pesticide, and that the handler has access to the product labeling
during handling activities.
    Although the proposal reorganized the rule, some of the
requirements for the existing rule outlined in the previous paragraph
remained essentially unchanged in the proposed rule, e.g., agricultural
and handler employers' responsibility to ensure that pesticides are
used in a manner consistent with the labeling. The proposal included a
requirement for employers to maintain copies of the pesticide labeling
for each pesticide used on the establishment for 2 years from the date
of application. The proposal also would have required the employer to
provide a copy of the label and the product's SDS when the emergency
assistance provisions are triggered, rather than to provide information
from the pesticide labeling.
    2. Final rule. Where the proposed rule would have required the
employer to provide a copy of the pesticide label, or specific
information from the labeling, and the SDS under the emergency
assistance provisions, the final rule only requires the employer to
provide the SDS and specific information, which can be obtained from
the pesticide application and hazard information display, rather than
the label or labeling. See Unit XIV. for other comments, EPA's
responses and the final regulatory text related to emergency
assistance. The final rule eliminates the proposed requirement for
employers to maintain copies of the labeling, rather than the label,
for each product bearing a WPS requirement on the labeling, and
replaces it with a requirement for the employer to retain specific
information about the product used and the application, as well as the
SDS. See Unit VII. for other comments, EPA's responses and the final
regulatory text related to this requirement.
    For handler training requirements, EPA has amended the language in
the final rule to delete the word ``all'' related to labeling. The
final rule requires handlers to receive training on following the
portions of the labeling applicable to the safe use of the pesticide
and on the format and meaning of information contained on pesticide
labels and in labeling applicable to the safe use of the pesticide. The
final regulatory text for these provisions is available at 40 CFR
170.501(c)(3)(iii)-(iv).
    For labeling and application-specific information the employer must
provide to the handler, EPA has amended the final rule to require the
employer to provide the handler with information on all portions of the
labeling applicable to the safe use of the pesticide, rather than on
all labeling requirements. The final regulatory text for this provision
is available at 40 CFR 170.503(a).
    3. Comments and responses.
    Comments. Commenters raised issues with EPA's use of the term
``labeling'' in the proposed rule. Commenters raised specific concerns
with the use of the broader ``labeling'' in various requirements
instead of limiting those requirements to just the label. These
concerns arose in regard to agricultural and commercial pesticide
handler employer duties, emergency assistance, hazard communication,
and handler training and establishment-specific information.
    Some commenters generally disagreed with EPA's use of ``labeling''
and requested that EPA use ``label'' instead throughout the rule. They
asserted that labeling is too broad and that labeling includes
materials not attached to the container, such as advertisements,
brochures and pamphlets. Commenters assert that the broadness of
``labeling'' applied to requirements to provide or retain this
information could result in a requirement on employers to track down
many ancillary pieces of information for a complete record, or to face
a technical violation for failure to retain all elements of the
labeling.
    Under the agricultural and commercial pesticide handler employer
duties, at 40 CFR 170.9(a) and 170.13(a) of the proposal, commenters
said that EPA's use of labeling was too broad. They asserted that
employers' liability should be only to comply with the WPS rather than
with the label or all relevant labeling because making the employer
responsible for complying with all labeling exceeds the scope and
intent of the WPS. They also noted that certified applicators, those
competent to use pesticides according to the labeling instructions and
who make the actual applications, should be required to comply with the
labeling, but that the agricultural employer should not.
    In regard to emergency assistance, commenters requested that EPA
delete the reference to labeling and replace it with a requirement to
provide the label and EPA registration number of the product.
Commenters note that this requirement would be sufficient to provide
appropriate information for emergencies.

    Commenters also requested that in the section on pesticide
application and hazard information, EPA delete the requirement for the
employer to maintain copies of the labeling for all WPS-labeled
pesticides used on the establishment, and instead to require the
employer to maintain a copy of the label and EPA-registration number.
Again, commenters noted that such a requirement would likely result in
technical violations without providing benefit to workers or handlers.
    In the sections on handler training and establishment-specific
information, commenters took issue with requirements to train handlers
on all labeling and to ensure that for specific applications handlers
have read the labeling or have been informed of all labeling
requirements. Commenters noted that a requirement for handlers to be
trained on all labeling requirements, rather than those pertinent to
their specific tasks, would be overly broad and unnecessary. Commenters
requested that EPA replace ``labeling'' with ``label'' in these
sections.
    EPA Response. EPA disagrees with commenters' request to replace
``labeling'' with ``label'' throughout the regulation because the
broader term is appropriate in many provisions of the WPS. The FIFRA
scheme for managing the risks of pesticide products rests primarily on
mandatory use directions and precautionary statements approved by EPA
in the registration process and communicated to users through labels
and labeling. Although in the case of lower risk products intended for
general consumer use, this information typically fits on the label,
this is not the case for many agricultural and commercial-use
pesticides.
    Labeling does not include advertisements, pamphlets or brochures
unless they accompany the product when sold or are referenced on the
labeling. For instance, EPA has indicated that documents such as
marketing brochures used to sell the product and to provide information
to customers and is not labeling as defined by FIFRA section 2(p).
(http://www.epa.gov/pesticides/regulating/labels/labels_faq/lr_faq_10.html) If a document of this type does not accompany the
product when sold and there is no reference to the bulletin on the
product label, it is not ``labeling.'' Note though, that non-labeling
documentation related to a product must not have claims that differ
from the product label. 7 U.S.C. 136j(a)(1)(B).
    Because mandatory use directions often appear in the labeling of
agricultural pesticides, rather than the label, some provisions of the
WPS appropriately use the word ``labeling.'' Where the word
``labeling'' appears in the WPS, employers are responsible for
following or providing labeling as defined in FIFRA. This does not
require employers to find, retain, or provide advertisements, pamphlets
or marketing brochures that do not meet the definition of ``labeling.''
    For example, it is appropriate that agricultural and handler
employers' duties under the final rule include ensuring compliance with
``labeling'' rather than just the label. The existing regulation has
the same requirement under general duties and prohibited actions. 40
CFR 170.7(a)(2). The labeling may include directions for use or other
information essential to the safe and effective application of the
pesticide, or specific information related to WPS protections, such as
the REI. For these reasons, EPA has decided not to replace ``labeling''
with ``label'' throughout the final rule as suggested by the
commenters.
    Furthermore, the obligation of certified applicators (or any other
person legally applying a pesticide) to follow the labeling does not
negate the obligation of agricultural and handler employers to comply
with the labeling. Requirements related to the WPS are found both in
the regulation (e.g., training, application-specific information) and
on specific product labeling (e.g., directions for use, REI, PPE). In
addition, other non-WPS elements of the labeling, such as application
rates and maximum number of applications to a crop, are relevant to
protecting workers and handlers from occupational exposure to
pesticides. When employers choose to use a pesticide that references
the WPS on the labeling on their establishment (either as the
applicator or by directing another person to apply the pesticide on
their behalf), they are obligated to ensure that all requirements of
the labeling are followed, not only those related to the WPS, to ensure
that workers and handlers are adequately protected.
    However, EPA agrees that certain WPS requirements could be limited
to the information on the label or specific information from the label,
and has specified ``label'' instead of ``labeling'' or specific
information from the label where appropriate. For example, EPA agrees
with commenters that employers need not provide all labeling in the
event of the emergency. In the current rule, EPA lists specific
information that must be provided to a potentially injured worker or
handler, or to treating medical personnel: Product name, EPA
registration number, active ingredients, antidote, and first aid and
medical treatment information. Since all of this information is
required on the label (40 CFR 156.10(a)(1)), the final rule allows the
employer to provide a copy of the label or this specific information
from the label, in addition to providing a copy of the SDS, when
emergency assistance is required.
    EPA also agrees with commenters' request to eliminate the
requirement for employers to maintain copies of the labeling for all
pesticides with a WPS reference statement used on the establishment.
EPA agrees that if workers, handlers, or other persons need information
on a specific product that was used on the establishment, such
information can be obtained using the EPA registration number and
product name. In response to comments received, EPA has replaced the
proposal with a requirement for the employer to retain only the EPA
registration number, active ingredient(s), product name, and other
application-specific information for such products, in addition to the
SDS.
    Similarly, EPA agrees that requiring handler employers to ensure
that handlers have been trained generally on, and for specific
applications have read or been informed of all labeling requirements
may be unnecessary if they are only using a product for a single type
of application. The labeling could include directions for use covering
multiple application methods and multiple crop sites, which may be of