[Federal Register Volume 61, Number 111 (Friday, June 7, 1996)]
[Notices]
[Pages 29096-29099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14449]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30112; FRL-5373-8]


Chlorothalonil; Request for Exception to Worker Protection 
Standard's Prohibition of Early Entry Into Pesticide-Treated Areas to 
Harvest Muskmelons by Hand

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of receipt of petition for an exception; request 
for comment.

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SUMMARY: EPA's Worker Protection Standard (WPS) permits the Agency to 
grant exceptions to restrictions on worker entry into pesticide-treated 
areas. This permission is found in 40 CFR 170.112(e). The State of 
Indiana has petitioned the Agency to allow workers to enter into 
muskmelon fields that have been treated with chlorothalonil, to engage 
in hand harvesting before the 48-hour restricted entry interval (REI) 
has expired. An REI is the amount of time that must expire after a 
pesticide application before workers are allowed to enter the treated 
area. The request covers the period of June 15 through August 30, 1996, 
the general range of time when muskmelons are harvested. This Notice 
acknowledges receipt of Indiana's petition and invites comments from 
the public on the substance of the petition.

DATES: Comments, data, or evidence should be submitted on or before 
July 8, 1996.

ADDRESSES: The Agency invites any interested person to submit written 
comments identified by docket number ``OPP-30112'' to: By mail: Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring comments to: Rm. 1132, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: <a href="/cdn-cgi/l/email-protection#39564949145d565a525c4d795c495854585055175c4958175e564f"><span class="__cf_email__" data-cfemail="472837376a2328242c2233072237262a262e2b6922372669202831">[email protected]</span></a>. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number ``OPP-30112.'' No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic comments on this 
document may be filed online at many Federal Depository Libraries.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice. All written comments will be available for 
public inspection in Rm. 1132 at the Virginia address given above from 
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Joshua First, Field Operations 
Division, 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-
7437), e-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="d8beb1aaabacf6b2b7abb0adb998bda8b9b5b9b1b4f6bda8b9">[email protected]</a> gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Authority

    This Notice is issued under the authority of 40 CFR 170.112, 
authorized by section 25(a) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136w(a). Under FIFRA, EPA is 
authorized to mitigate unreasonable adverse effects that may result 
from exposure to pesticides, taking into account risks of pesticide 
exposure to human health and the environment and the benefits of 
pesticide use to society and the economy.

B. The Worker Protection Standard

    Introduced in 1974, the Worker Protection Standard (WPS) is 
intended to reduce the risk of pesticide poisonings and injuries among 
agricultural workers who are exposed to pesticide residues, and to 
reduce the risk of pesticide poisonings and injuries

[[Page 29097]]

among pesticide handlers who may face more hazardous levels of 
exposure. Updated in 1992, the WPS scope now includes workers 
performing hand labor operations in fields treated with pesticides, 
workers in or on farms, forests, nurseries, and greenhouses, and 
pesticide handlers who mix, load, apply, or otherwise handle 
pesticides. The WPS contains requirements for pesticide safety 
training, notification of pesticide applications, use of personal 
protective equipment (PPE), restricted entry intervals following 
pesticide application, decontamination supplies, and emergency medical 
assistance.

C. Early Entry Exceptions

    In general, Sec. 170.112 of the WPS prohibits agricultural workers 
from entering a pesticide-treated area during a restricted entry 
interval (REI). REIs are specified on the pesticide product label and 
typically range from 12 to 72 hours. Product-specific longer REIs have 
been set for a few pesticides.
    The WPS contains the following exceptions to the general 
prohibition against worker entry into treated areas during the REI:
    (1) Entry resulting in no contact with treated surfaces.
    (2) Entry allowing short-term tasks (less than 1 hour) to be 
performed by workers wearing PPE and meeting other conditions.
    (3) Entry to perform tasks associated with agricultural 
emergencies.
    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. Before implementing such changes, 
however, EPA is required to provide a 30-day public comment period. EPA 
will grant or deny a request for an exception based on a risk-benefit 
analysis. This analysis is required by 40 CFR 170.112(e)(3), and takes 
into account both the added risks and the benefits from allowing early 
entry to perform hand labor tasks.
    Under 40 CFR 170.112(b) and (c), workers engaging in early entry 
work are not permitted to engage in hand labor, which results in 
substantial contact with pesticide-treated surfaces, and under 
Sec. 170.112(d) and (e), workers are explicitly allowed to engage in 
hand labor. 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.
    On June 10, 1994 (59 FR 30265), EPA granted an exception which 
allows, under specific conditions, early entry into pesticide-treated 
areas in greenhouses to harvest roses by hand cutting. In the Federal 
Register of May 3, 1995 (60 FR 21953) (FRL-4950-9), two additional 
exceptions were granted which allow early-entry to perform irrigation 
and limited contact tasks under specified conditions.
    On September 27, 1995 (60 FR 49841) (FRL-4974-4), EPA denied the 
State of Delaware an exception to the 48-hour REI for chlorothalonil 
that had been submitted in a petition. The petition had requested an 
exception for the purpose of allowing workers early entry (a 12-hour 
REI) into treated areas to hand harvest cantaloupes and squash. An 
additional 10 States submitted similar requests during the 30-day 
public comment period after EPA published notice of its receipt of 
Delaware's petition, and EPA denied those requests as well.

D. Basic Information about Chlorothalonil

    Chlorothalonil is a wettable granular fungicide used to control 
powdery mildew, downey mildew, and Alternaria leaf blight diseases, 
among others. Under the WPS, the REI has been set at 48 hours, an 
increase from 12 hours. The pre-harvest interval (PHI) for melons and 
squash is 0 days. The PHI is the period that must elapse, in days, from 
the last day of application to the first day that a crop can be 
harvested. Chlorothalonil is in acute Toxicity Category I for primary 
eye irritation and has been classified as a probable human carcinogen 
(Category B<INF>2). Chlorothalonil poses risks of severe eye irritation 
and delayed health effects (kidney effects). Currently EPA is working 
on a Reregistration Eligibility Document (RED) for chlorothalonil. A 
RED is a document that combines all scientific and economic information 
about a pesticide and which is used for determining whether or not a 
pesticide should be reregistered. The chlorothalonil RED is scheduled 
for completion this year.

II. Summary of Indiana's Petition

    The State of Indiana has petitioned the Agency under 
Sec. 170.112(e) to allow early entry by workers into chlorothalonil-
treated muskmelon fields to perform hand labor harvesting immediately 
after application of the fungicide. The current REI for chlorothalonil 
is 48 hours. Indiana's petition states that muskmelon growers will 
suffer substantial economic losses if they cannot harvest their crop on 
a daily basis. The time period for the exception requested is from June 
15 through August 30, 1996.

A. Need for Early Entry

    According to the request, Indiana-grown muskmelons are under strong 
disease pressure from Alternaria leaf blight, anthracnose, bacterial 
wilt, gummy stem blight, and powdery mildew. According to Indiana, if 
unchecked, these diseases can destroy the crop and result in serious 
reductions in muskmelon yield and quality.
    Indiana states that muskmelons ripen quickly, and must therefore be 
harvested daily to avoid the fruit becoming over-ripe. Indiana contends 
that considerable amounts of fruit could be damaged or lost during the 
48-hour REI, and even during a 24-hour REI, due to the inability to 
harvest mature crops daily. Indiana states that over-ripe muskmelons 
are not harvested; their connection to the vine is cut; and they are 
simply left in the field. Moreover, Indiana contends that if left on 
their vines, mature (over-ripe) muskmelons act as ``suckers,'' 
depriving less mature melons on the vine of nutrients necessary for 
their growth. Indiana estimated that a 7 percent crop loss would result 
from over-ripe fruit being left on the vine for 48 hours, and that a 2 
percent loss would result from a 24-hour delay of harvest. It is also 
claimed that these over-ripe melons interfere with the production of 
female flowers, which are necessary for producing new fruit.
    Indiana said that additional labor costs may be incurred to remove 
over-ripe fruit, posing a second set of costs to growers beyond costs 
associated with direct losses in sales.
    Indiana states that fungicides applied after the first melon 
harvest result in greater muskmelon yields and a longer production 
period of fruit graded as United States Department of Agriculture 
(USDA) #1 quality. Powdery mildew is controlled primarily with ``timely 
applications'' of systemic fungicides, such as triadimefon and benomyl. 
Bacterial wilt is controlled through managing cucumber beetle 
populations, which spread the disease. Alternaria leaf blight, 
anthracnose, and gummy stem blight must be controlled with repeated 
applications of fungicides. Indiana says that, of the available 
appropriate fungicides for these three diseases, only chlorothalonil 
can be used during harvest, because muskmelons are harvested daily and 
chlorothalonil has a 0-day PHI. Indiana states that cultural controls 
for Alternaria leaf blight are not readily available and are not very 
effective in any case. Where powdery mildew is a problem, 
chlorothalonil is usually applied as necessary.

[[Page 29098]]

    The alternative to chlorothalonil on muskmelons is mancozeb, which 
has a PHI of 5 days and is therefore not considered to be a practical 
alternative during the harvest. Indiana's petition implies that 
rescheduling chlorothalonil applications during the conventional 7-day 
spray schedule would not be practical because regardless of how a 
grower reschedules applications, there would be a 48-hour REI following 
a spray application; weather and crop maturity would most likely 
require harvest during that time.
    According to Indiana, the average melon field size is 20 to 40 
acres. Large fields are 250 acres. Other States have previously said 
that two to five workers are required to harvest for 1 hour per field, 
and that workers would harvest several fields over an 8-hour day. 
Machine harvesting of cantaloupe or squash is not possible. The State 
of Indiana says that it is open to suggestions from the Agency for any 
means to mitigate eye hazards to harvest crews posed by chlorothalonil. 
Indiana does not believe that workers should be required to wear any 
additional PPE, because EPA has stated that it believes that workers 
will not wear it (because of heat stress).

B. Proposed Terms of Exception

    The State of Indiana has proposed the following terms:
    1. Harvesting would be performed immediately after application.
    2. All Indiana muskmelon growers would be required to use the 
MELCAST disease warning system (described below), and only apply 
chlorothalonil according to MELCAST times of predicted need. Indiana 
states that the MELCAST system is part of an integrated pest management 
program that results in two to four fewer annual chlorothalonil 
applications than the conventional 7-day program.
    3. Limitations on current use patterns (and thereby lowering 
potential risk) by reducing the application rate and reducing the 
number of applications. The maximum chlorothalonil application rate 
would be 0.78 pounds of active ingredient per acre (lbs ai/acre), as 
opposed to the maximum rate of 1.5 lbs ai/acre. This lower rate would 
begin 2 days prior to the beginning of the melon harvest and continuing 
through the harvest.
    4. Growers would be subject to unannounced inspections by the 
Office of Indiana State Chemist to ensure compliance, especially with 
the lower application rate of 0.78 pounds of active ingredient.
    MELCAST is a computerized, weather-based disease advisory system 
that helps growers determine when the most appropriate times are for 
applying only essential fungicides. The Purdue Cooperative Extension 
Service has shown that using MELCAST will result in two to four fewer 
fungicide applications without increasing risk of crop losses. MELCAST 
can be used with Alternaria leaf blight, anthracnose, and gummy stem 
blight. It is assumed that the State of Indiana believes that the costs 
of these measures are less than the expected costs associated with crop 
losses without the exception being granted.

C. Economic Impacts

    The State of Indiana has claimed that a significant economic loss 
may occur if the 48-hour REI remains in effect. Indiana has said that 
the daily harvest of muskmelons is essential to maximize crop 
production. Indiana projects that, with a 0-day REI, a muskmelon crop 
that yields 4,500 melons per acre over a 4-week harvest period (picked 
every day) results in a net return of $2,000 per day. With a 24-hour 
REI, Indiana calculates that the net return will be $1,440 per acre, an 
income reduction of 28 percent. With the current 48-hour REI, Indiana 
has projected a net return of $810 per acre, a 59 percent reduction 
from the best-case scenario of $2,000 per acre. Indiana states that the 
vast majority of Indiana muskmelon growers derive their incomes from 
farms that are 40 acres or less. For these farmers, whose incomes are 
claimed to be between $30,000 and $40,000, a 28 percent or 59 percent 
reduction in income could seriously affect their ability to make a 
living from growing muskmelons.
    The following are the most significant points that EPA needs to 
address before an economic analysis can be completed. First, the 
applicant did not estimate the loss of fruit to disease if 
chlorothalonil is not used at all. Such an estimate would also include 
the reduced costs of not using chlorothalonil. Because the applicant 
has projected the costs of adhering to the 48-hour REI to be quite 
high, it is possible that not using chlorothalonil at all could be 
preferable in some situations.
    Second, it is unclear to EPA how cutting over-ripe muskmelons 
(``sucker fruit'') from fruit-producing vines is considered an 
additional labor cost. EPA believes that it is labor that would have 
occurred in any case, and that picking fewer melons actually requires 
less labor. If the activity is claimed as an additional cost resulting 
from unproductive labor, the applicant has not clarified or explained 
that. Moreover, the applicant has not explained how a delay in harvest 
of 1 day will result in all of the fruit that would have been harvested 
being over-ripe; nor has the applicant explained how over-ripe melons 
are automatically economically valueless.
    Third, the applicant did not consider the relative savings in 
reduced usage of chlorothalonil due to implementing MELCAST, and 
assumed one application per week in projecting yield reductions. The 
use of the MELCAST system reportedly should reduce chlorothalonil 
applications to be, on average, less frequent than once every 7 days.
    Finally, better explanation and documentation of the basis and 
methodology for estimating the stated quantitative yield loss estimates 
of 2 percent and 7 percent for the 24-hour REI and the 48-hour REI are 
needed.

D. Potential Risks

    Prior to the introduction of WPS-based interim REIs, 
chlorothalonil's REI was 12 hours; its current REI is 48 hours. Based 
on new data received through its reregistration program, EPA is now 
reviewing the length of chlorothalonil's REI. At the current standard 
application rate (for muskmelons) of 1.5 lbs ai/acre, chlorothalonil 
appears to pose risks to most workers, risks that could be mitigated by 
a longer REI.
    EPA has conducted several preliminary qualitative assessments, 
based on different assumptions, to evaluate the potential carcinogenic 
and toxicity risks from exposure to chlorothalonil. When chlorothalonil 
treatment begins before the harvest season at 1.5 lbs ai/acre, and then 
drops in rate to 0.78 lbs ai/acre during the harvest season (as Indiana 
is proposing), the risk is substantially reduced from the current 
treatment schedule. The REI for this application schedule would be 24 
hours. However, because chlorothalonil has a half-life of 3.5 days, the 
residue remaining after the application at the rate of 1.5 lbs ai/acre, 
coupled with the subsequent rate of 0.78 lb ai/acre, will still leave 
residues that pose risks of some concern to workers, if they entered 
the treated site immediately after application.
    It appears that still lower potential risk could be attained by 
reducing the chlorothalonil application to 0.78 lb ai/acre for the 
entire growing and harvesting season. Lowest risk seems to be posed by 
use of alternative fungicides prior to harvest with chlorothalonil 
application at the reduced rate starting just prior to the harvest 
period in order to accommodate the PHI of the alternatives.

[[Page 29099]]

    EPA's assessment of worker risk from re-entry may be affected by 
additional information about foliar dislodgable residue, especially 
about chlorothalonil residue levels between applications, and other 
information.

III. Comments and Information Solicited

    The Agency is interested in receiving comments on this proposed 
exception. In particular, the Agency welcomes comments supported by 
data or additional information about muskmelons, about the potential 
risks associated with granting this exception request, about cultural 
practices, and about the potential economic impacts.
    This would include evidence demonstrating whether or not the risks 
to workers would be acceptable given Indiana's proposed terms, and an 
REI of 0 hours. It would also include evidence about whether or not 
REIs of 4, 12, or 24 hours are appropriate given varying application 
schedules and the substitution of alternative fungicides during the 
growing season. An REI of 4 hours has not been proposed, and EPA 
maintains concerns about the potential worker risks associated with a 
4-hour REI, but EPA nevertheless is soliciting comments on it. An 
alternative but similar application schedule using another fungicide 
(mancozeb) during the growing season may warrant an REI of 12 hours, 
and an application schedule similar to that proposed by Indiana might 
result in an REI of 24 hours.
    The Agency is also interested in evidence about whether or not the 
use of PPE, engineering controls, or any additional decontamination 
procedures or safety training would be useful should the exception be 
granted. The Agency is interested in obtaining data on how heat stress 
from PPE can be mitigated, and if there are any reports of poisoning 
incidents involving harvesters being exposed to chlorothalonil.
    The Agency also would like information about cultural practices and 
economic impacts, such as an appropriate time limit on activities 
performed during the REI; this would include information about the 
affect the WPS had on the 1995 melon season. Comments on feasible 
alternative fungicides or integrated pest management practices that 
would make early entry for hand harvesting unnecessary, and their 
associated costs, are also solicited. The Agency welcomes any 
additional information concerning the economic impact on Indiana's 
muskmelon industry (such as crop yield and/or price) resulting from 
continuing to prohibit hand harvesting during chlorothalonil's 48-hour 
REI on muskmelons. Also solicited is additional information on the 
average life of muskmelon fruit, uses for over-ripe fruit, uses for 
canned muskmelon fruit and juice, and the stages of maturity that are 
required for different markets.

IV. Public Record

    Interested persons are invited to submit written comments on this 
action. Comments must bear a notation indicating the docket control 
number [OPP-30112].
     A record has been established for this action under docket number 
``OPP-30112'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:

    <a href="/cdn-cgi/l/email-protection#335c43431e575c50585647735643525e525a5f1d5643521d545c45"><span class="__cf_email__" data-cfemail="f29d8282df969d91999786b29782939f939b9edc978293dc959d84">[email protected]</span></a>

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for the proposal as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.

List of Subjects

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

    Dated: May 31, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 96-14449 Filed 6-06-96; 8:45 am]
BILLING CODE 6560-50-F

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