[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Notices]
[Pages 49841-49845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24003]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30108; FRL-4974-4]


Denial of Administrative Exception Request to Worker Protection 
Standard Early-Entry Prohibition for Hand Harvest of Cantaloupe and 
Squash in Chlorothalonil-Treated Fields

AGENCY: Environmental Protection Agency (EPA).

ACTION: Denial of administrative exception.

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SUMMARY: EPA is denying the State of Delaware's exception request for 
early entry into chlorothalonil-treated fields to allow hand labor 
harvesting of cantaloupes and squash 24 hours after application. In 
this decision, EPA is also denying an exception to Florida, Illinois, 
Indiana, Iowa, Maryland, Michigan, Ohio, Pennsylvania, Tennessee, and 
Virginia, for all crops that were requested during the public comment 
period for Delaware's proposal. Under Sec. 170.112(e) of the Worker 
Protection Standards (WPS), EPA may establish additional exceptions to 
the WPS provision of prohibiting early entry to perform routine hand 
labor tasks. The Agency grants or denies a request for an exception 
based on a risk-benefit analysis. Chlorothalonil, a wettable granular 
fungicide, has eye and skin irritation concerns and other kidney 
effects. It has also been classified a probable human carcinogen. In 
consideration of increased risks associated with performing early entry 
hand labor tasks on chlorothalonil-treated crops, and incomplete 
economic benefits information, the Agency has determined that the risks 
outweigh the benefits of allowing early entry into chlorothalonil-
treated fields for hand harvest activities.

FOR FURTHER INFORMATION CONTACT: Sara Ager or Ameesha Mehta, Office of 
Pesticide Programs (7506C), Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location, telephone number, and e-
mail address: Rm. 1121, 1921 Jefferson Davis Highway, Crystal Mall #2, 
Arlington, VA, (703-305-7371), e-mail: [email protected]. or 
[email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 49842]]


I. Background

A. Worker Protection Standard

    On August 21, 1992 (57 FR 38102), EPA issued a final rule revising 
the Worker Protection Standard (WPS) for agricultural pesticides (40 
CFR part 170). The WPS became fully implemented on January 1, 1995. The 
1992 WPS expanded the scope of the original WPS to include not only 
workers performing hand labor operations in fields treated with 
pesticides, but also workers in or on farms, forests, nurseries, and 
greenhouses, as well as handlers who mix, load, apply, or otherwise 
handle pesticides for use at these locations in the production of 
agricultural commodities. The WPS contains requirements for training, 
notification of pesticide applications, use of personal protective 
equipment (PPE), restricted entry intervals (REIs), decontamination, 
and emergency medical assistance.

B. WPS Early-Entry Restrictions

    The 1992 WPS includes provisions under Sec. 170.112 prohibiting 
agricultural workers from entering a pesticide-treated area to perform 
routine hand labor tasks during a REI. The WPS defines hand labor as 
any agricultural activity performed by hand or with hand tools that 
causes a worker to have substantial contact with treated surfaces (such 
as plants or soil) that may contain pesticide residues. The REI is the 
time after the end of a pesticide application during which entry into 
the treated area is restricted.

C. WPS Exceptions to Early-Entry Restrictions

    The WPS currently contains exceptions to the general prohibition 
against worker entry during the REI for the following purposes: (a) 
Entry resulting in no contact with treated surfaces; (b) entry allowing 
short-term tasks (less than 1 hour) to be performed with PPE and other 
protections; and, (c) entry to perform tasks associated with 
agricultural emergencies. Under these exceptions, workers engaging in 
early-entry work are not permitted to engage in hand labor.
    Under Sec. 170.112(e) of the WPS, EPA may establish additional 
exceptions to the Standard's provision of prohibiting early entry to 
perform routine hand labor tasks. EPA will grant or deny a request for 
an exception based on a risk-benefit analysis. On June 10, 1994 (59 FR 
30265), EPA granted an exception which allows, under specified 
conditions, early entry into pesticide-treated areas in greenhouses to 
harvest cut roses. In the Federal Register of May 3, 1995 (60 FR 
21953), two additional exceptions have been granted which allow early-
entry to perform irrigation and limited contact tasks under specified 
conditions.

D. Delaware's Petition for an Exception

    The State of Delaware petitioned the Agency, under Sec. 170.112(e), 
to allow early entry by workers into chlorothalonil-treated cantaloupe 
and squash fields to perform hand labor harvesting 24 hours after the 
spray application. Chlorothalonil is an agricultural fungicide used to 
control Downey mildew and other fungal diseases. The existing label REI 
is 48 hours. The pre-harvest interval (PHI) for melons and squash is 
zero days. The PHI is the time that must elapse, in days, from the last 
day of application to the first day that a crop can be harvested. 
Delaware's petition states that if growers cannot harvest daily they 
will suffer substantial economic losses. The time period requested was 
from July 1 through September 15, 1995.
    1. Need for early entry. According to the petition, cantaloupe and 
squash are under severe disease pressure from Downey mildew in 
Delaware, which if unchecked, can destroy the crop. Standard practice 
is to make preventive (prophylactic) applications of chlorothalonil 
every 7 days where Downy mildew is a problem. Delaware contends that 
considerable quantities of fruit could be damaged or lost during a 48-
hour REI, due to the inability to harvest mature crops. The 
alternatives to chlorothalonil are maneb or penncozeb, both of which 
have a PHI of 5 days. Chlorothalonil has a PHI of zero days, and 
therefore is used in order to accommodate daily harvesting for fresh 
market. Under the 48-hour REI, growers must wait 2 days to harvest. 
Under the requested early-entry exception, growers would only have to 
wait 24 hours after application to begin harvesting. Delaware contends 
that regardless of how a grower schedules sprays, there would be a 48-
hour REI following a spray application, and weather and crop maturity 
may require harvest during that time. According to Delaware, the 
average plot size is 1 acre and will require two to five workers 1 hour 
to harvest. Workers can harvest several fields over an 8-hour day. 
Machine harvesting of cantaloupe or squash is not currently feasible.
    2. Proposed terms of exception request. The State of Delaware 
proposed the following protective measures:
    (a) No harvesting would be performed until 24 hours after 
application.
    (b) Growers harvesting cantaloupe and squash between 24 and 48 
hours following the application of chlorothalonil would provide oral 
warnings to workers to avoid contacting their eyes with their hands and 
forearms or any clothing which may be in contact with the foliage 
during the harvest. They would give this warning at the start of each 
workday.
    (c) Workers would be given instructions at the beginning of the 
workday to wash their hands, forearms, and faces after every 2 hours or 
at the conclusion of a harvest period if less than 2 hours.
    (d) To accommodate the increased use of water at the field 
decontamination site, the grower would provide 3 gallons of water or 
have running water available, as opposed to the WPS recommendation of 1 
gallon of water per worker.
    The State of Delaware concludes that the costs of these measures 
are inconsequential when compared with the expected loss in the crop 
value.
    3. Economic impact. The exception request estimates that 450 acres 
of cantaloupe and squash production are potentially affected by the 
Downey mildew disease in Delaware. Based on Delaware's 1993 statistics, 
the revenue amount for cantaloupe is $2,250 per acre. The inability to 
harvest in time would result in decreased revenue per acre.

II. Summary of Comments Recieved and Major Issues

    EPA received numerous comments on the proposed exception. Comments 
were received from State agencies, grower groups, farm worker groups, 
EPA regions and individuals. A summary of the major issues and EPA's 
response are provided below.

A. Additional States

    During the public comment period, the following States petitioned 
to be included under Delaware's early-entry exception request: Florida, 
Illinois, Indiana, Iowa, Maryland, Michigan, Ohio, Pennsylvania, 
Tennessee, and Virginia. These States asked for the early-entry 
exception to be granted for several crops, including cantaloupes, 
cucumbers, cucurbits, snap beans, squash, stone fruits, and tomatoes. 
The State of Missouri commented that it did not want to be included 
under the exception, but suggested that a national exception be 
considered if these requests were scientifically valid and workers 
could be adequately protected.

B. Economic Need for Exception

    The original exception request from the State of Delaware estimated 
450 acres of cantaloupe and squash 

[[Page 49843]]
production potentially affected by the Downey mildew disease. During 
the comment period, EPA provided Delaware and the other States with a 
list of questions requesting detailed information on the economics and 
exposure parameters of early entry during the 48-hour REI. During the 
comment period, the Agency received similar requests from 10 other 
States for cantaloupe, squash, and other crops. States provided 
differing information on economic impacts, length of harvest seasons 
and acreage treated, but all presented similar scenarios on the 
frequency of harvesting and chlorothalonil application.
    Under the most common scenario and depending on disease pressures, 
chlorothalonil is applied every 7 days for a period of several weeks 
and cantaloupe and squash are harvested daily from the treated acreage. 
Chlorothalonil has a zero day PHI, and with the former REI, the most 
that growers would have to delay the harvest would be 24 hours. 
According to Delaware and other States, a delay of more than 24 hours 
could cause the fruit to become overripe and, consequently, downgraded.
    EPA is aware that prices for crops are set by grade and market 
type, including fresh local markets and bulk processing. Cantaloupes 
are produced for a fresh market only, their price being determined by 
the size and quality of the fruit. Squash are graded according to size, 
width, and quality, and are produced for both fresh market and bulk 
processing. If the fruit is too ripe when harvested, it will be 
considered lower grade, and therefore not appropriate for fresh local 
market. The State of Ohio submitted information on revenue loss for 
cucumbers of approximately $100 per acre because of lower grading of 
fruit. Because there is not a market for lower grade cantaloupe, 
growers could potentially experience a loss in revenue for the 1 day a 
week they could not harvest. However, according to the Virginia 
Extension Service, if a good preventive spray schedule is maintained 
pre-harvest, then chlorothalonil application may not be necessary 
during the harvest period and losses in cantaloupe production due to 
the additional 24-hour delay in harvest may not occur. Virginia 
Extension Service also states that a 2 to 3-year crop rotation practice 
and the use of disease resistant varieties is important to delay onset 
of various disease infestations. Furthermore, disease pressures due to 
varying environmental conditions vary from year to year.
    Several States have claimed that significant economic loss may 
occur if growers must wait until the expiration of the 48-hour REI to 
harvest. However, no State submitted detailed information that allowed 
the Agency to quantify or complete a reliable qualitative assessment of 
the projected economic impacts due to the additional delay of 24 hours. 
During the comment period, the Agency provided a list of questions to 
States, which requested incremental yield losses for each 12-hour REI 
period. The information was requested to assess what yield losses 
occurred during a 12-hour, 24-hour, and a 48-hour delay in harvest. 
Additional information was elicited on 5-year historical net and gross 
revenues, production budgets, and marketing strategies on the crop of 
concern. This information would aid EPA in assessing if the significant 
losses in yield were a direct result of the longer 48-hour REI.
    Maryland estimated that a maximum of 10 to 15 percent loss of yield 
would be incurred for both cantaloupe and squash. Although Maryland did 
not provide any historical data on net and gross revenues to reliably 
quantify the projected economic impacts, Maryland did estimate that the 
yield loss was due to an additional 24-hour (1 day) delay in harvest 
each week which would result in a loss of \1/7\ (14 percent) of 
growers' total production. This yield loss may constitute a higher 
portion of grower income. Also, the State of Delaware estimated that 50 
to 75 percent of grower net revenue would be lost if the exception was 
not granted. However, also Delaware stated that these substantial 
losses in grower profit may not occur because growers may choose 
alternative cash crops to avoid risk.
    The Agency did not have historical data (3 to 5 years) on acreage, 
yields and prices; therefore, the Agency was not able to assess and 
confirm if yield losses would be due to an additional 24-hour delay in 
harvest or other factors. Furthermore, cost of production (growers' 
expenses) and marketing options (growers' revenue) are used to estimate 
grower profit. However, incomplete information was provided with 
regards to cost of productions, revenues, and marketing options (e.g., 
bulk processing, fresh market, and local market) to confirm if growers 
would experience 50 to 75 percent loss in profits. EPA realizes that 
States do not normally collect detailed economic information on minor 
crops, but the information is essential for EPA to base its decision on 
the required complete risk-benefit analysis. Further discussion of 
necessary economic information is contained in Unit IV. of this 
document.

C. Risk to Workers

    Several commenters noted that 35 percent of the farm worker 
population is made up of women and children. Furthermore, children 
constitute a potentially sensitive population to the risks associated 
with pesticides. In comments received from the Delaware Rural 
Ministries, it was stated that a large number of the harvesters of 
cantaloupe in that State were farm or neighborhood children.
    Another commenter noted that growers are experiencing difficulty 
understanding why there is a need for a 48-hour REI when the PHI is 
zero days. The commenter also noted that growers do not understand the 
risk distinction between eating and harvesting chlorothalonil-treated 
vegetables. The residues that harvesters may contact are far greater 
than residues a consumer may contact from eating a treated vegetable. 
Harvesting activities may result in a substantial portion of the body 
being exposed to chlorothalonil residues found on the foliage. In some 
cases, harvesting activities may result in the same amount of pesticide 
exposure as those obtained during handler activities. Additionally, EPA 
limits the levels of pesticide residue by establishing tolerances on 
food crops. A tolerance is the legal limit of a pesticide residue 
allowed in or on a raw agricultural commodity and, in appropriate 
cases, on processed foods. Appropriately, EPA limits the levels of 
pesticide residues to workers by establishing REIs for all pesticides 
which have agricultural uses.

D. Potential Mitigation Options

    One commenter noted that the REI is the single most effective way 
to reduce the risk of farm worker pesticide poisonings and reliance on 
PPE is the least effective and least practical way to protect field 
workers. EPA agrees that PPE is less likely to mitigate the risks 
associated with this exception and may be impractical due to heat 
stress concerns. The Agency received further numerous comments 
questioning the feasibility and practicality of these requirements. For 
instance, many commenters, including the Florida Fruit and Vegetable 
Association and the Farmworker Justice Fund asserted that the PPE 
imposed by the label, especially the coveralls and goggles, are too 
cumbersome and would place an undue hardship on workers performing 
their tasks. One commenter noted that perspiration and dirt accumulate 
on the eyewear, thereby hindering the workers' vision. Additionally, 
the coveralls, when worn in hot, humid climates, 

[[Page 49844]]
cause worker discomfort and significantly increase the risk of heat-
related illnesses. The University of Florida remarked that in their 
State, the risk of heat stress was a far more real concern than the 
potential risk of exposure to chlorothalonil residues. Many commenters 
stated that the level of PPE had a direct effect on a worker's income 
since workers are paid according to the amount of produce that they 
harvest and burdensome PPE or heat illness decreases the worker's 
harvesting speed and efficiency. Consequently, many workers may be 
reluctant to wear the label-specified PPE. Hence, EPA primarily relied 
on administrative controls, such as reduction in application rates and 
limits in time allowed for harvesting in evaluating this exception 
request. At the present, engineering controls such as mechanical 
harvesting are not available for cantaloupe and squash production.
    The State of Michigan commented that on cantaloupes the average 
application rate for chlorothalonil is 1.47 pints/acre. Due to the 
limited efficacy and economic data submitted, the Agency was not able 
to assess and quantify the impacts to growers of reducing the 
application rate, the mean expected yield loss if growers use the next 
best practical means of controlling the pest, or the anticipated impact 
of not controlling the pest without the use of a pesticide.

III. EPA's Exception Decision

A. EPA's Risk Assessment

    Chlorothalonil has acute concerns such as eye and skin irritation. 
Chlorothalonil exposure also results in adverse kidney effects which 
appear to be precursors to kidney cancer. EPA has classified 
chlorothalonil as a probable human (Category B2) carcinogen. EPA 
has conducted a preliminary risk assessment utilizing a chlorothalonil 
dislodgeable foliar residue study on cucumbers. This study was 
submitted by the registrant to determine an active ingredient based 
REI. Data indicate that field residues from the high rate of 
application persist for longer than the REI and would result in 
unacceptable risks to harvesters.
    Based on the exposure information provided by commenters, EPA 
conducted its preliminary risk assessment using the following 
assumptions: an 8-hour workday; 70 kg body weight of an adult male; and 
the appropriate dermal absorption rate for chlorothalonil. Therefore, 
EPA assumed that only a small percentage of the total residues are 
absorbed through the skin. EPA then calculated the margin of exposure 
(MOE) to estimate the potential harmful kidney effects to workers who 
were exposed to chlorothalonil on a seasonal basis. The MOE is a 
numerical value that characterizes the degree of safety related to a 
toxic chemical. EPA's policy for acceptable chlorothalonil exposure is 
an MOE of 100 or greater. A value of 100 or more provides an acceptable 
margin of safety to protect workers from potential health risks. For 
subchronic dermal exposure (between 1 week and several months of 
harvesting), a no-observed-effect-level (NOEL) of 1.5 mg/kg/day was 
determined from a subchronic study in rats. The NOEL refers to the dose 
rate of chemical at which there are no statistically or biologically 
significant increases in adverse effects in laboratory animals. The 
MOEs for chlorothalonil were calculated by dividing the NOEL of 1.5 mg/
kg/day, by the harvesters' daily exposure (mg/kg/day), and resulted in 
values significantly less than 100. The exposure resulting from hand 
labor activities would place male workers at an unacceptably high risk 
of developing harmful kidney effects. Risks to children and women would 
be higher.
    After consideration of all the comments on potential and feasible 
mitigation techniques, and EPA's preliminary risk assessment, the only 
mitigation option that would result in MOEs of 100 or greater was a 
significant reduction in the maximum allowable application rate. This 
would mean that the maximum application rate would have to be reduced 
from 4.0 pts/acre (2.09 lbs ai/acre) to 1.5 pts/acre (0.78 lbs ai/
acre).
    EPA is further evaluating data necessary to complete its RED for 
chlorothalonil. The RED is scheduled for completion this year and an 
increase to the REI may occur with the current maximum label 
application rate. Upon completion of the RED, EPA will be in a better 
position to make an accurate determination of worker risks from 
chlorothalonil for all crops.

B. Economic Analysis

    The State of Delaware and the other States requesting this 
exception have not made a case, based on the submitted data, that entry 
during the REI to harvest cantaloupes and squash is necessary, and that 
prohibiting such entry could have a substantial adverse economic impact 
on growers of these commodities. Incomplete information was submitted 
in areas such as cost of production, 3 to 5-year historical data on 
acreage yields and prices, and potential marketing options (e.g., bulk 
processing, fresh market, and local market). Based on the submitted 
information, EPA is not able to quantify or complete a reliable 
qualitative assessment of the projected economic impacts, yield loss 
and grower profit associated with loss of harvest days. Therefore, EPA 
could not conclude that cantaloupe and squash growers would suffer a 
substantial adverse economic impact if early-entry harvesting is not 
permitted.

C. Delaware Decision

    EPA has evaluated the available information on the risks and 
benefits of granting this exception. Based on its complete review of a 
preliminary risk assessment, the submitted economic information and the 
potential mitigation options, EPA has determined that the risks of the 
exception outweigh the benefits, and has decided to deny the State of 
Delaware's exception request.

D. Additional States Decision

    EPA also received requests for the exception from other States for 
crops other than cantaloupe and squash, including, cucumbers, 
cucurbits, muskmelons, snap beans, stone fruits, and tomatoes. EPA is 
also denying requests from additional States based on the results of 
the assessment conducted for workers harvesting chlorothalonil-treated 
squash and cantaloupes in Delaware.

IV. Guidance on Supporting Information for Exception Requests

    For similar, but non-WPS, exemption requests such as a section 18 
exemption, under 40 CFR 166.22, States are also required to provide 
detailed economic information. Data used to assess significant economic 
loss includes, at minimum:
    (a) Historical (5-year) net and gross revenues for the crops, 
including cost of production budgets.
    (b) Estimated gross revenues without the proposed pesticide based 
on the mean expected yield loss if growers use the next best practical 
means of controlling (rather than on worst-case maximum yield 
reductions if no alternative control measure is used).
    (c) The anticipated impact of not controlling the pest.
    EPA is in the process of developing guidance to clarify 
Sec. 170.112(e) required information that must be submitted by a 
petitioner requesting an early-entry exception. The Agency is aware 
that many States do not collect historical yield and revenue 
information on minor crops. The Agency is further aware that 
substantial time would be needed to acquire that information. 
Therefore, EPA will provide guidance on the type, 

[[Page 49845]]
quality, and degree of specificity of the information that must be 
submitted by States and commodity groups. It is expected that with 
experience gained in implementing the WPS, and with the 1995 season to 
pursue alternative production and marketing practices, the need for 
early entry will decrease.

List of Subjects

    Environmental protection, Occupational safety and health, and 
Pesticides and pests.

    Dated: September 19, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 95-24003 Filed 9-26-95; 8:45 am]
BILLING CODE 6560-50-F