[Federal Register Volume 62, Number 192 (Friday, October 3, 1997)]
[Proposed Rules]
[Pages 51994-52002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26321]
[[Page 51993]]
_______________________________________________________________________
Part III
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 170
Pesticide Worker Protection Standard; Administrative Exception for Cut-
Rose Hand Harvesting; Administrative Decision; Proposed Rule
Exception Decisions to Early Entry Prohibition, Worker Protection
Standard; Technical Amendment; Final Rule
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 /
Proposed Rules
[[Page 51994]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 170
[OPP-250121; FRL-5599-2]
RIN 2070-AC95
Pesticide Worker Protection Standard; Administrative Exception
for Cut-Rose Hand Harvesting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Administrative Exception Decision.
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SUMMARY: With this document, EPA is announcing it has granted a limited
administrative exception to the 1992 Worker Protection Standard (WPS)
restrictions on early entry into pesticide-treated areas allowing
workers to hand harvest roses during restricted entry intervals. Under
Sec. 170.112 (e) of the WPS, EPA may establish exceptions to the
provision prohibiting early entry to perform routine hand-labor tasks.
EPA is granting the exception because if the rose harvests are delayed,
significant economic loss will occur; and, if the terms of this
exception are followed, the contact with pesticide-treated surfaces
will be minimal. The exception allows workers to enter for three hours
per 24-hour period during a restricted entry interval. Thus, EPA
granted this exception because it believes the benefits of this
exception outweigh any resulting risks. The exception took effect on
December 18, 1996, and expires on October 4, 1999.
EFFECTIVE DATE: This document is effective October 3, 1997.
FOR FURTHER INFORMATION CONTACT: Sara Ager, 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, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA, (703) 305-7666, e-mail: ager.sara@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: This Notice is issued under the authority of
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 the risks of pesticide exposure to
human health and the environment and the benefits of pesticide use to
society and the economy. Elsewhere in this issue of the Federal
Register, EPA is amending Sec. 170.112 of the WPS to include reference
to this administrative exception and its effective date.
I. Background
A. 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 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
application, use of personal protective equipment (PPE), restricted
entry intervals (REI) following pesticide application, decontamination
supplies, 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 an REI. Hand labor is defined by the
WPS 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 when entry into
the treated area is restricted as specified on the pesticide product
label.
C. WPS Exceptions to Early Entry Restrictions
Currently, the WPS only permits 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 the ``no
contact'' and ``short-term task'' exceptions, workers performing 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 provision prohibiting early entry to perform routine
hand-labor tasks. EPA grants or denies a request for an exception based
on a risk-benefit analysis as required by FIFRA. On June 10, 1994 (59
FR 30265) (FRL-4779-8), EPA granted an exception that allowed, under
specified conditions, early entry into pesticide-treated areas in
greenhouses to harvest cut roses. This exception expired on June 10,
1996. On May 3, 1995 (60 FR 21955, FRL-4950-4) (60 FR 21960, FRL-4950-
5), two additional exceptions were granted that allow early entry to
perform irrigation and limited contact tasks under specified
conditions.
D. Summary of Roses Inc.'s Petition
Roses Inc., a rose grower association, approached the Agency in the
spring of 1996 and expressed a need for continuing the WPS cut-rose
exception. According to Roses Inc., an early-entry exception to allow
the harvest of cut roses twice a day is necessary for cut-rose growers
to avoid the loss of significant portions of their crop.
Roses Inc. explained that commercial quality standards demand that
roses be cosmetically perfect and at a bloom stage where the bud is
just beginning to open. To meet such standards, Roses Inc. noted that
pesticides must be used to control insects and disease, and harvesting
must occur at least twice daily to capture flowers at the appropriate
bloom stage. Roses Inc. asserted that cut roses that do not meet these
standards have no economic value. Roses Inc. also asserted that the
required twice daily harvest is not possible on days when pesticides
with an REI greater than 4 hours have been applied, since the WPS
early-entry restrictions eliminate the possibility of a second harvest
and may, depending on the REI, eliminate both harvests for the second
day.
After consulting with the rose industry and gathering information
to complete the exception request, EPA determined that the request met
the requirements of Sec. 170.112(e)(1) and published a notice in the
Federal Register on October 30, 1996 (61 FR 56100) (FRL-5571-8). The
notice acknowledged receipt of Roses Inc.'s request, described terms
proposed by the cut-rose industry, and provided a 30-day comment
period. After considering the information obtained through public
dialogue and written comments, EPA granted a limited administrative
exception. In December 1996, EPA sent a letter to cut-rose growers
outlining the terms of this new exception. This action documents the
contents of the December letter.
E. Roses Inc.'s Proposed Terms
Roses Inc.'s request for an exception asked for continuance of the
terms of
[[Page 51995]]
the 1994 exception and an increase of the early entry exposure period
from 3 to 8 hours in a 24-hour period just prior to major floral
holidays. Specifically, Roses Inc. proposed the following terms:
1. For all products registered for use on roses, early entry to
harvest roses by hand is allowed, under the following conditions:
a. The time in the treated area during an REI does not exceed 3
hours in any 24-hour period, (except as provided in (b)).
b. For 2 weeks before major floral holidays, the time in the
treated area must not exceed 8 hours in any 24-hour period.
c. No entry is allowed for the first 4 hours and until after
inhalation/ventilation criteria on the label has been reached.
d. The early entry personal protective equipment (PPE) specified on
the product label must be used by workers.
e. The agricultural employer must properly maintain PPE.
f. The agricultural employer must take steps to prevent heat
stress.
g. The worker must read the label or be informed of labeling
requirements related to safe use.
h. Pesticide application specific information must be provided.
i. A pesticide safety poster must be displayed.
j. Decontamination supplies must be provided.
k. Workers must be WPS-trained.
l. Workers must be notified orally and information posted regarding
the exception.
2. Exception has no expiration or, at minimum, expires in 5 years.
These proposed terms and conditions were the same as those imposed
with the 1994 exception with the addition of a longer early-entry time
prior to major floral holidays and an extended effective period.
According to Roses Inc., there are five major floral holidays resulting
in peak production periods. The holidays are Valentine's Day
(February), Easter (April), Mother's Day (May), Sweetest Day (October)
and Christmas (December).
After discussions with the Agency, Roses Inc. proposed a refinement
of the terms of their request. In addition to the terms above, Roses
Inc. proposed the following:
1. For products with a 12-hour REI on the label, allow early entry
to harvest roses under the following conditions:
a. The time in the treated area for each worker may not exceed 4
hours in any 12-hour REI period;
b. Conditions (b) through (l) above.
2. For products with an REI of 24 hours or more, allow early entry
to harvest roses under the following conditions:
a. Must meet all the early-entry conditions for the 12-hour REI
pesticide products listed above.
b. During the first 12 hours of the REI period, early-entry workers
would be required to wear additional PPE consisting of a canvas or
similar arm sleeve protectors, and a waterproof apron that protects the
upper torso and reaches to approximately knee level.
II. Summary of Comments Received and Major Issues
EPA received more than 50 comments on the proposed cut-rose
exception. Comments were received from approximately 38 individual cut-
rose growers, 9 agricultural associations, 3 government agencies, 3
academicians and 2 farmworker advocacy groups. More than 20 statements
were also received from employees of cut-rose growers. Some of these
statements were included with certain growers' submittals. A summary of
the major issues and EPA's response is provided below.
A. Economic Need for the Exception
The cut-rose market depends on the production of high-quality,
unblemished roses to achieve consumer acceptance and thus compete with
foreign producers. Since roses are an aesthetic commodity,
imperfections such as pest damage are not tolerated. Market demands
establish the high quality standards that rose growers must meet. The
wholesale flower market demands a cosmetically perfect rose that is
free of insects, pest damage and blemishes. Perfection for cut-roses
requires the buds to have the same size, shape, and degree of maturity.
To meet the market's standards, cut-rose growers stated they need
to control pests and diseases as a vital element in providing a
consistent quality product to their customers. According to survey data
collected by Roses Inc., growers treat roses with pesticides an average
of 6.4 times per month. Comments from growers on the frequency of
pesticide applications supports Roses Inc.'s estimate.
Growers and Roses Inc. also commented that the timing of harvest is
also critical in providing the market with roses at the same degree of
maturity. According to growers and Roses Inc., there is a short window
of opportunity to harvest the flower once it reaches this peak stage.
The rose industry also asserts the need to harvest frequently is due to
the physiology of the rose flower. Roses cut too soon do not open or
fully blossom whereas roses cut late are too full and have a shorter
shelf-life. Depending on the season and variety, the window for
harvesting a high quality rose once it reaches its peak is about 2 to 6
hours, according to public comments from Roses Inc. and cut-rose
growers.
The essential constraint imposed by the WPS on cut-rose production
is the REI. This is due to the need to harvest roses at least twice per
day under current practice to achieve maximum yield, quality and price.
REI's for most of the available pesticides range from 12 to 48 hours.
Therefore, the REI may interfere with the ability to harvest when
pesticide treatment is also needed, resulting in a negative impact on
the industry.
The methods available to cut-rose growers for producing roses and
controlling pests are essentially the same as when the original
exception was granted. Currently, spraying is performed in the late
morning when several pests are most active and when moisture produced
by spray equipment will dry rapidly. Late morning spraying would
usually prevent afternoon harvest(s) due to the length of most REIs.
Hypothetically, spraying could be performed after the last harvest of
the day, with reentry into the greenhouse after the 12-hour REI of most
pesticides expired the following morning. However, growers and
scientists do not agree on this issue. Most of the growers and several
scientists expressed concern that late day spraying would prolong leaf
wetness due to slower drying late in the day. Higher levels of moisture
are believed to increase disease and phytotoxicity. Several growers
said that the prevalence of diseases increased when late day spraying
was performed. Other growers and scientists believed that late day
spraying could be acceptable. Late day spraying would not eliminate the
need for an exception covering 24- and 48-hour REI pesticides.
Many growers noted that they are presently using integrated pest
management (IPM). Growers mentioned using heating, cooling,
ventilating, lighting, nutrition, greenhouse structures alteration and
methods of pruning, cutting, and handling of their crops. Even with
their screened greenhouses and computer environmental controls, growers
contend that they still need pesticides. Growers also stated that
chemical rotation is used to control pests and reduce the rate of pest
and disease resistance to chemicals. When pest and disease resistance
to chemicals increases, the need to treat also increases.
[[Page 51996]]
The original WPS exception (59 FR 30265) notes that ``EPA is
granting a two-year exception to provide rose growers time to adjust
pesticide spray schedules, find early-entry alternatives, and develop
technology.'' A condition of approval of the original exception to the
cut-rose industry was the expectation that progress would be made
toward obviating the need for another exception. Several organizations
representing farm workers commented that the lack of adequate effort
toward eliminating the need for the exception argues against renewing
the exception. Some individual growers have commented that they have
attempted to reduce the need for the exception by testing biological
controls, such as predatory mites, and changing cultural methods.
Several growers and Roses Inc. commented that newer, shorter REI
pesticides are not sufficiently effective. Farm worker advocacy
organizations wrote that the cut-rose industry did not use the 2 years
of the 1992 WPS cut-rose exception to develop safer practices.
Growers commented that they use heating and venting or horizontal
air flow or, less commonly, high-intensity lighting, to reduce humidity
and free moisture to control disease. Some growers have installed
screens over vents to reduce infestation from insects such as thrips
and aphids. Roses Inc., asserted that as a small industry under severe
foreign competition, it has not had the resources to pursue
alternatives to the exception as aggressively as desired. Roses Inc.
expressed disappointment that few newer and safer chemicals with short
REIs and more biological control methods have not been developed as
rapidly as hoped.
According to Roses Inc., the cut-rose industry uses approximately
28 essential chemicals to control many pests. Powdery mildew, botrytis,
and downy mildew are the three most significant diseases. Thrips,
aphids, white flies, and two-spotted spider mites are the most
important insect and mite pests. Roses Inc. and growers commented
numerous times that all currently available pesticides are essential to
produce domestically-grown cut-roses. Annual spray schedules were
supplied by several growers and these document the use of a variety of
pesticides.
In many cases several different chemicals, often with different
REIs, are available to control each pest. Growers and a consultant for
Roses Inc. argued that this variety of pesticides is necessary for
several reasons, especially for pest resistance management. These
commenters noted that pest resistance has already become a problem with
several pesticides now available, including pyrethroids, abamectin and
iprodione. Additional reasons given for requiring different chemicals
were: price, relative efficacy, low phytotoxicity, efficacy against
multiple pests, mode of application, and speed of achieving control.
While several reasons were provided regarding chemical usefulness,
insufficient information comparing the merits of chemicals used to
control the same pests was presented, especially when the chemicals had
differing REIs. This deficiency should be remedied if another renewal
is requested. However, despite presenting less than the desired amount
of comparative information regarding pesticides, the Agency believes
that there is still a need for the exception no matter which individual
pesticides may be used. Regardless of the justification of the
necessity of any particular pesticide, clearly the cut-rose industry
cannot currently rely only on 4-hour REI pesticides, changes in
cultural practices or drastic reductions of the number of pesticide
applications. Therefore, even if several individual pesticides were
determined unessential, growers would still be faced with applying
mostly longer REI pesticides at frequencies similar to the present.
Roses Inc. and several growers raised concerns about the impact of
foreign imports on the U.S. cut-rose market and industry. Imported cut-
roses reached 66% of the U.S. market, with the largest percent being
shipped from Columbia and Ecuador. U.S. growers are concerned about the
regulatory limitations they operate under relative to their foreign
competitors. Foreign producers have access to stronger and more
effective pesticides that are no longer registered in the United
States. Imported roses enter the United States free of pesticide-
related restrictions. U.S. growers indicated that these factors give
foreign producers a comparative advantage over them.
U.S. rose growers stated that they must achieve high quality
standards for lower prices to compete with foreign imports in the U.S.
rose market. Prices for cut roses have decreased by 3% to 6% between
1992 and 1995. The average annual wholesale prices for hybrid-tea roses
in different geographic regions range between 17 and 68 cents per stem,
with the U.S. average at 33 cents per stem. Prices peak 1 to 2 weeks
prior to major floral holidays, like Valentines Day, and may reach over
$1.00 per stem.
Growers stated that to survive economically, they need to harvest
two and sometimes three times a day. A few growers noted occasional
exceptions only harvesting once on Sundays or holidays, like Christmas
and New Years. According to rose growers who cut twice a day, the first
cut yields 40% to 70% of the daily harvest, with the second cut
yielding the remaining 30% to 60%. For those cutting three times a day,
the first cut yields 40 to 70%, the second cut 10 to 30%, and the last
cut up to 45% of the daily harvest. These percentages seem to vary
considerably by geographic region and season. The amount of flowers
that mature in the afternoon increases as temperatures and light
intensity increases.
Growers indicated without an exception that they lose a minimum of
the afternoon harvest(s) when they need to treat with a pesticide(s).
If a grower applies a pesticide that has a 12-hour REI after the
morning harvest, they will miss a minimum of the afternoon harvest(s).
Growers would lose 1 to 2 full days of harvest with an application of a
pesticide that has a 24- or 48-hour REI, respectively.
Based on the information collected and provided by growers, losses
of 7% to 14% may occur if EPA did not grant the exception. Roses Inc.
and many growers estimated losses between 7% to 14% of the annual
harvest. Others estimated losses to be 10% to 30% a year. Losses in
revenue could range between $8 and $16 million annually, assuming
losses of 7% to 14%. Growers with a higher frequency of pesticide
applications and/or applications of pesticides with 24- or 48-hour REIs
will have greater loss estimates.
Secondary markets for roses do exist; however, the prices are
significantly lower than those for prime roses. Street vendors selling
cut-roses may be considered the secondary market. According to growers,
prices for the secondary market range between 8 and 14 cents per stem
and up to 30 cents in one area. These prices are 50% to 75% lower than
the prime market price and lower than some growers production costs per
stem.
A grower's decision to sell roses to the secondary market will
depend on their variable production costs. If the unit price is lower
than the costs to produce the cut rose, it is not economical for the
grower to sell to the secondary markets. This may vary by grower
depending on the time of year. For example, a grower may sell flowers
to the secondary markets during the summer because their fuel
expenditures may be low thus reducing their overall production costs.
Based on the production costs and budget data available, some rose
growers will not be able to sustain additional losses even with the
exception to the WPS REI requirements.
[[Page 51997]]
Budget information was obtained from a few growers and a March 1995
report by the U.S. International Trade Commission (ITC) Report. The ITC
collected detailed budget data for 1991 through 1993 and part of 1994.
According to the ITC data, almost half of the growers incurred net
losses in 1991 and 1992 and two-thirds of the growers incurred net
losses in 1993. It is difficult to determine from this data if the same
growers incurred losses year after year.
The cost and budget data received from growers showed similar
results. Some growers showed profits and others showed net losses.
Growers with net losses explained that, over the last year or two, they
had implemented changes in cultural practices or made significant
capital expenditures, like screens for vents and light systems for the
greenhouses. It is difficult to fully interpret the budget data without
a broader sample and access to more details.
A large number of rose growers could potentially be effected
without the exception to the WPS. The U.S. cut-rose industry is
comprised of 175 growers and up to 200 growers when all small growers
are included. California growers constitute about 46% of the number of
growers and produce at least 65% of the U.S. total production. About
two-thirds of all U.S. growers would be considered small. The impact of
losses incurred will depend on the efficiency within a greenhouse
operation, the pest pressure in each greenhouse, and the ability to
adjust spray schedules and the timing of harvest. Growers with few
resources, including small growers are likely to be effected the most.
Smaller growers may have more limited resources for capital
improvements to help reduce pest pressure or install lights as quickly
as larger operations. Most likely, larger operations have invested in
upgrading their greenhouses with more efficient equipment and
facilities. On the other hand, small growers may have more flexibility
than really large operations to adjust harvest and spray schedules.
B. Risk To Workers
Commenters noted that the large number and high volume of chemicals
used, as well as the high frequency of applications that is typical in
rose production indicate potential for high worker exposure and high
worker risk. These comments stated that many of the chemicals listed in
the Roses Inc., exception request are acutely toxic, or have been shown
to cause a variety of delayed effects in laboratory animals, including
cancer, reproductive and developmental effects, neurotoxicity, and
endocrine disruption.
Commenters also expressed a belief that rose harvesters are better
protected than other agricultural workers. They cited several
characteristics of the rose greenhouse to indicate a relative degree of
safety. Such characteristics include a stable, skilled work force that
tends to be well-trained and receptive to safety training. Also cited
is the tendency for rose harvesters to be paid either on an hourly or
salary basis rather than a piece rate. This, it is argued, indicates a
probability that workers will adhere to safe work practices making use
of protective equipment and other safety measures which might be
foregone if such measures could slow their work, thus reducing their
pay. Some comments also noted that in the greenhouse environment,
workers generally have easy access to water for drinking and
decontamination, and that in the relatively confined space of a
greenhouse, workers are easier to monitor for compliance with safety
rules.
Others observed that certain characteristics of the greenhouse
environment suggests an increased level of worker risk. Both growers
and worker advocates cite the problem of heat and humidity in
greenhouses which increases risk of heat-related illness and
discourages workers from wearing protective clothing and equipment
because it may be uncomfortable. EPA shares the concerns about the risk
of heat stress in greenhouses. EPA also notes that, while greenhouse
environments tend to be warm and humid, the environment is
controllable.
Numerous comments from rose growers indicated excellent safety
records for their employees, and many said neither they nor their
employees had ever experienced pesticide related injuries or illnesses.
Comments from a county agricultural commissioner in California cited a
draft report by the Worker Health and Safety Branch of the California
Department of Pesticide Regulation. The draft report summarizes cases
reported to the California Pesticide Illness Surveillance Program, and
covers poisoning incident data for greenhouses and outdoor nursery
operations for the years 1990 through 1994. According to this draft
report, only three cases of pesticide-related illness, rated as
possibly or probably related to pesticide exposure, were indicated as
specific to rose growing operations; none of these incidents involved
hospitalization, and one involved the worker missing 5 days of work.
(EPA notes that some incidents appearing on the draft report cite only
``ornamentals'' or do not indicate the crop involved.) These commenters
further state that while in other parts of the country many pesticide
incidents go unreported, in California, for several reasons, it is rare
for incidents to go unreported. The reasons given include California's
extensive regulatory program, the general level of public awareness
about pesticide use, and requirements placed on the medical care
industry to report all suspected pesticide-related cases. This
commenter asserts that acute pesticide poisonings, at least in
California, are less likely to be overlooked than in the past. EPA
believes that incident reporting is higher in California that in other
parts of the country, but does not believe that it is rare for cases to
go unreported.
Worker advocates argued that, while the reported number of
pesticide-related incidents may be small, many incidents still go
unreported. Even the California Incident Reporting System, these
commenters argue, documents only a small fraction of the actual
incidents that occur because: (1) Many farmworkers cannot afford to
take a day off work to seek medical treatment, so they continue working
despite symptoms of acute poisoning; (2) many farmworkers lack the
financial means to secure medical care, or lack transportation to get
to a medical provider; and (3) often farmworkers and medical providers
do not recognize or report symptoms of pesticide exposure. Several
commenters also expressed concern over delayed effects that are
difficult to link to pesticides because the exposure does not result in
immediate symptoms, and therefore does not get reported. Such effects
may include cancer, reproductive and developmental effects,
neurotoxicity, and endocrine system disruption. The Association of
Farmworker Opportunity Programs states that incidents are under
reported since the symptoms of pesticide poisoning often mimic the
symptoms of colds and flu.
Commenters expressed disbelief that repeated or prolonged pesticide
exposures could lead to such delayed effects. Some noted that family
members and friends who have worked in the rose industry for a number
of years continue to enjoy good health. Others criticized the Agency's
concern for effects resulting from repeated low-dose exposures as
``conjectural and speculative theorizing,'' and suggested that the
Agency should assume the burden of proof that such effects are real
before placing entry restrictions on the industry.
One grower mentioned that none of his retirees filed claims for
effects
[[Page 51998]]
suffered from long-term use. Another grower wrote that in 50 years of
operation they have never had a case of poisoning or a case of someone
getting sick from applying pesticides. One grower mentioned that his
employees were more likely to have an increased exposure to toxic
chemicals while they were pursuing their hobbies than while harvesting
roses.
EPA agrees that the likelihood of pesticide-related incidents going
unreported in California is much lower than in other states where
systems for reporting incidents are not in place, and where the
regulatory framework providing for workers' health and safety may not
be as developed. Nevertheless, EPA believes it is difficult to
conclude, based on incident data, that reentry protections such as REIs
are less important to the health and safety of rose harvesters than to
other farmworkers. While the number of rose workers reported to have
experienced pesticide-related illness or injury in California appears
to be small, it may not be an accurate gauge for rose workers
nationally, and does not account for size of the rose work force
relative to the size of the general agricultural work force. Employers'
Reports of Occupational Injuries, compiled by the California Department
of Industrial Relations (1981 - 1990) indicate that workers in
horticultural specialty crops, which include roses, had a slightly
higher rate of pesticide poisoning (0.53 poisonings per 1,000 workers
per year) than that for all agricultural workers (0.46 poisonings per
1,000 workers per year).
Regarding delayed effects, EPA acknowledges that several rose
production chemicals identified by Roses Inc., have been shown in
laboratory animals to cause the variety of effects cited by worker
advocates in their comments. However, EPA does not have sufficient data
to determine whether the potential level of exposure to rose harvesters
corresponds to levels of concern identified in the toxicological
studies that demonstrated these effects. More importantly, EPA has
generic concern for workers working in areas shortly after pesticide
applications have been completed when pesticide residue levels are at
their highest and the potential for worker exposure is greatest. Such
concern is heightened when many different chemicals are used and
cultural practices dictate frequent or prolonged reentry, as is the
case with rose harvesting. Finally, EPA agrees that such delayed
effects would rarely, if ever, be captured in pesticide incident
reports.
Worker risk can be decreased by reducing exposure during periods
when pesticide residues are at the highest levels, by limiting the time
workers are exposed, and by limiting the workers' direct contact with
treated surfaces. EPA believes that the early-entry requirements set
out in this exception acceptably reduces worker contact with pesticide-
treated surfaces. Worker contact will be limited by not allowing entry
for the first 4 hours following application and until inhalation and
ventilation criteria on the label has been met; by limiting the
duration of the contact to 3 hours and by requiring PPE to protect
workers from treated surfaces.
C. Personal Protective Equipment (PPE)
Some growers wrote that safety has always been important to them.
One cut-rose grower wrote that they have not had serious problems with
pesticide exposure in the history of their organization because of
their stringent training program and serious attitude toward worker
protection. An employee wrote that each worker has and uses their own
safety equipment including full protective gear. One harvester stated
that the PPE used during the REI was both comfortable and protective.
One grower mentioned that, except for the respirators, the PPE
equipment does not appear to unduly stress the staff. Another grower
explained that his employees were agreeable to the use of special
gloves, sleeves and aprons; however, they were opposed to the use of
full protective suits, respirators, boots, gloves and face shields. One
cut-rose grower wrote that he tried to have workers use coveralls, but
everyone complained about the heat. Another grower mentioned that the
employees complain about the PPE being uncomfortable in the heat of the
summer; however, he writes that he allows plenty of water breaks.
A grower mentioned that his employees preferred leather gloves
rather than rubber gloves because of comfort and perspiration in
chemical resistant gloves. In a public dialogue with rose harvesters,
one harvester mentioned that his hands were raw after using chemical
resistant gloves.
Several growers and harvesters mentioned that they had complete
laundry and shower facilities. One grower with laundry and shower
facilities stated he assigns an individual to launder the PPE.
EPA believes that PPE, along with other provisions of this
exception, will reduce worker exposure to pesticide residues and thus
will reduce the risk.
D. Time Allowed in the Treated Area
Several growers' comments supported the Roses Inc. request that the
time allowed in treated areas be expanded from 3 hours per worker per
day to 4 or 8 hours per worker per day. Other growers commented that by
rotating staff and using pesticides with 12-hour REIs or less, less
than 3 hours per worker per day was sufficient to maintain normal
harvest levels.
EPA notes that the shorter the workers' time in the treated area,
the less potential exposure the worker will experience. By limiting
early-entry rose harvesters to 3 hours per worker per day, EPA believes
potential harvester exposure and resulting potential risk will be
considerably less than would be expected if workers' time in treated
areas is expanded to 4 or 8 hours.
E. Expiration Date
Roses Inc. requested the Agency to grant an exception for 5 years
or indefinitely. Some commenters stated that the exception should be
longer than 2 years because it would not be enough time to establish
new methods that could be successfully implemented. One grower stated
that the exception should be granted for 5 years.
Several growers suggested granting the exception permanently until
compelling data shows that the issue needs to be revisited. One grower
mentioned the exception should be granted for an unlimited amount of
time and remove the use of the exception from any grower that has a
series of problems or multiple violations.
EPA expects the cut-rose industry to work towards eliminating the
need for this exception. Therefore, this exception will expire on
October 4, 1999. Although the technology may not exist in 2 years to
completely eliminate the need for a cut-rose exception, the Agency will
want to review the advances made in greenhouse technology and cultural
cut-rose practices. In addition, EPA will take into account the
conclusions from the NIOSH's study on PPE effectiveness and any
relevant toxicological data that may be available at that time. If
another exception request is received, EPA will need to make
considerations based on all additional information that may be
available at that time.
III. EPA's Exception Decision
In the WPS, EPA prohibited, in general, early entry for hand labor,
such as harvesting because EPA concluded that entry during a
restricted-entry interval to perform routine hand-labor tasks is rarely
necessary, that PPE for
[[Page 51999]]
workers is not always practical because workers may remove it or use it
incorrectly, and that the PPE itself may generate heat stress. In this
case, EPA believes that the risks for rose harvesters will be mitigated
by the limited time harvesters are allowed in the treated area, the use
of PPE and the short period of time that it will be worn, accessible
decontamination facilities, and provision of label-specific information
to harvesters and basic pesticide safety information.
However, to provide greater certainty about the potential risk to
early-entry rose harvesters, EPA has provided funding to the National
Institute of Occupational Safety and Health (NIOSH) to conduct and
evaluate the effectiveness of PPE at mitigating residue exposure. EPA
believes it is essential to examine the effectiveness of PPE to
mitigate worker exposure and intends to consider the results of NIOSH
research, as well as any additional data generated in responding to
future exception requests. Therefore, if the rose industry believes
that there may be a continuing need for an exception for rose
harvesting, EPA strongly encourages that they pursue data demonstrating
the effectiveness of risk reduction measures, such as PPE, in addition
to the EPA-funded NIOSH research.
While the rose industry has begun to explore alternatives to early
entry, such as adjusting spray schedules, trying engineering controls,
and other safe alternatives, EPA believes a more systematic approach is
necessary to progress toward eliminating the need for an exception. EPA
also believes that certain alternate practices have promise for
eventually reducing or eliminating the need for early entry for rose
harvesting in greenhouses. Therefore, EPA strongly recommends that the
cut-rose industry pursue data development and research on such
alternatives, and pilot test those alternatives which appear to be most
promising.
A. EPA's Risk Assessment
Post-application worker exposure is a function of time, activity,
and pesticide residue levels. Risk increases with longer periods of
exposure, high levels of contact with treated surfaces and when contact
occurs while pesticide residue levels are at their highest. Worker risk
can be reduced by limiting exposure during periods when pesticide
residues are at the highest levels, by limiting the time workers are
exposed, and by limiting the workers' direct contact with treated
surfaces.
During peak production periods when rose bushes have been
cultivated for maximum production, rose harvesters can have
considerable contact with foliage during harvesting activities. Since
cut-rose harvesting typically occurs twice per day, 6 or 7 days per
week, rose harvesters are likely to have repeated exposure to the
pesticide residues present in greenhouses. The high frequency of
pesticide applications to roses, combined with the relatively slow
expected breakdown of pesticides applied in greenhouses, indicate that
pesticide residues will be present during rose harvesting activities.
If harvesting takes place while foliage is still wet, or when residues
have not dried due to irrigation, dew, high humidity or condensation,
transfer of pesticide residues from foliage to the rose harvesters will
be higher, resulting in an increase in risk. This exception requires
that harvesting not take place until 4 hours after application and
after all inhalation and ventilation criteria on the label has been
met. This combined with the cut-rose growers need to reduce dew, high
humidity, and condensation in the greenhouses for optimum roses should
decrease harvesting taking place while foliage is wet.
Toxicological endpoints for repeated pesticide exposures tend to be
lower than for single and short-term exposures. Several chemicals used
on roses have been shown to produce adverse effects in laboratory
animals. EPA does not have sufficient data to determine whether the
potential level of exposure to rose harvesters corresponds to the
levels of concern identified in the toxicological studies that
demonstrated these effects. Given that exposure to pesticides used in
cut-rose cultivation has the potential to cause adverse effects, a way
to reduce that risk is to reduce the exposure. A worker's exposure can
be decreased with shorter periods of exposure, less contact with
treated surfaces and with reduced pesticide residue levels.
EPA has designed this exception to reduce the risk associated with
increased exposure during early entry while balancing the benefits of
giving cut-rose growers flexibility to perform necessary harvesting
tasks. EPA is maintaining the 3-hour maximum time allowed in the
treated area within a 24-hour period rather than allow unlimited entry
during the period prior to major floral holidays as Roses, Inc.
requested. The Agency concludes that this is sufficient time to harvest
and combined with the other protections required under this exception,
EPA believes the benefits of a limited 3-hour entry period outweigh the
risks of exposure in that period.
EPA believes that risk for rose harvesters will be mitigated by
limiting time harvesters are allowed in the treated area, the use of
PPE, the availability of decontamination supplies, and the provision of
label-specific information to harvesters and basic pesticide safety
information.
EPA believes that the early-entry requirements set out in this
exception acceptably reduces worker contact with pesticide-treated
surfaces. Worker contact will be limited by not allowing entry for the
first 4 hours following application and until inhalation and
ventilation criteria on the label has been met; by limiting the
duration of the contact to 3 hours and by requiring PPE to protect
workers from treated surfaces.
The following additional factors or terms contributed to EPA's
decision: (1) Early entry PPE could be comfortably worn for 3 hours;
(2) use of unattached absorbent glove liners make it much more likely
that harvesters will wear the required chemical resistant gloves or
liners underneath the optional leather gloves; (3) there is
approximately only 200 greenhouse cut-rose growers, facilitating
communication and compliance monitoring activity between the rose
industry and EPA; (4) the scale of greenhouse operations and limited
number of harvesters per greenhouse should allow employers to more
easily ensure that workers wear the PPE; (5) cut-rose growers using
this exception will be required to report any incidents which
harvesters believe are the result of pesticide exposure occurring
during early-entry harvesting under the conditions of this exception;
(6) running water, and in some cases showers, for decontamination and
heat-stress alleviation are more accessible in greenhouse operations
than in field settings; and (7) the exception will be in effect for
less than 3 years before reevaluation. EPA therefore believes that
early entry with PPE is feasible and provides adequate reduction of
risks to rose harvesters.
B. Economic Analysis
Through written comments and public dialogue, the cut-rose industry
has made a case that entry during the REI to harvest cut roses is
necessary, and that prohibiting such entry could have a substantial
adverse economic impact on growers of these commodities. Based on
written statements received from the rose industry, on information
gained during public meetings and greenhouse tours, as well as on EPA's
knowledge of rose production, EPA finds that the benefits of early
entry are substantial. The rose industry has provided sufficient
[[Page 52000]]
information demonstrating that routine entry during an REI to harvest
roses twice daily is still necessary and that prohibiting such entry
could have a substantial economic impact on cut-rose growers.
Depending on the product applied, the associated REI, and the time
of year, growers could lose 25-50% of their daily revenues on the days
pesticides are applied. EPA believes that the cut-rose industry cannot
absorb this loss without significant repercussions. Additionally, since
the exception is subject to conditions designed to mitigate risk to
early-entry workers, EPA believes that early entry under the terms of
this exception will not pose unreasonable risks to rose harvesters.
IV. Terms of the Exception
Use of this exception is conditioned on the following requirements:
A. Completed Conditions and Certification Statement
Agricultural employers must read and send a completed Conditions
and Certification Statement to the EPA before using this exception
(Forms may be obtained by writing, calling, faxing or e-mailing Sara
Ager at the address and telephone number listed in FOR FURTHER
INFORMATION CONTACT.).
B. Compliance with Requirements
Agricultural employers must fully comply with the early-entry
requirements of this exception:
1. No entry for first 4 hours after application and until after any
inhalation and ventilation criteria specified on the label has been
reached (Sec. 170.112(c)(3)).
2. Workers may enter a treated area during an REI to perform only
hand harvesting of greenhouse grown roses (exception to
Sec. 170.112(c)(1)).
3. A worker's time in the treated area during an REI for hand
harvesting shall not exceed 3 hours within any 24-hour period
(exception to Sec. 170.112(c)(2)).
4. Workers must read the label or be informed in a language the
worker understands of labeling requirements related to safe use.
5. The agricultural employer shall notify workers before entering a
treated area, either orally or in writing, in a language the workers
understand, that the establishment is using this exception to allow
workers to enter treated areas before the REI expires, to hand harvest
roses.
6. Agricultural employers must provide, properly maintain, and
ensure workers wear the early entry PPE listed on the label in
accordance with Sec. 170.112(c)(4)-(c)(9). When chemical resistant
gloves are required on the label, workers have the option of wearing
the leather gloves over the required chemical resistant gloves. In
accordance with Sec. 170.112(c)(4)(vii), once leather gloves have been
worn for early-entry use, thereafter they shall be worn only with
chemical-resistant liners and they shall not be worn for any other use.
In addition, unattached, absorbent glove liners may be worn
underneath the chemical resistant gloves or liners, provided the
unattached, absorbent liners are completely covered by the chemical
resistant liner or glove (exception to Sec. 170.112(c)(4)(vii)).
Absorbent liners must be disposed of after each day of use in early-
entry harvesting.
7. All other applicable provisions of the Worker Protection
Standard (40 CFR part 170) also remain in effect.
C. Reporting Incidents
Agricultural employers using this exception are required to report
any incidents that harvesters believe are the result of pesticide
exposure occurring during early entry harvesting under this exception.
The agricultural employer shall notify EPA (address provided under FOR
FURTHER INFORMATION CONTACT) within 5 consecutive days of any incident
believed to be the result of exposure to pesticides or pesticide
residues that occurred during early-entry harvesting performed under
the conditions of this exception.
In addition, there may be no findings of unacceptable levels of
risk by EPA, resulting from NIOSH's investigations, from other risk
studies, or from incident reporting and investigation. If the Agency
receives information that shows the health risks posed by early entry
to areas treated with pesticides registered for use on cut-roses are
unacceptable, it reserves the right to not allow specific chemicals to
be used in conjunction with this exception. EPA reserves the right to
withdraw or revise the scope and conditions of this exception at any
time, in accordance with Sec. 170.112(e)(6).
V. Reevaluation of the Cut-rose Exception
This exception will expire on October 4, 1999. In the interim, EPA
is expecting the cut-rose industry to actively pursue alternate
cultural methods that will eliminate the need for this exception. EPA
also expects that with the research, Roses Inc. and other industry
trade groups will sponsor outreach education with cut-rose producers
explaining the exception, the need for strict compliance with its terms
and explain the risk concerns presented by pesticide use and worker
entry during REIs.
The cut-rose industry was not able to make adequate progress over
the 2 years that the original exception was in place to eliminate the
need for renewal. The effort of individual growers to attempt to use
alternatives to long REI chemicals has not been sufficient to obviate
the need for a new exception. Some alternative measures that appear
promising initially may have serious shortcomings when examined more
closely. For example, spraying after the last harvest was generally
claimed to be unacceptable for a number of reasons, including several
given above. However, little documentation was presented concerning
these shortcomings, and there was no evidence given regarding their
impact. Some of these shortcomings, while generally accepted, remain
hypothetical or anecdotal.
In addition, not all growers had the same experience when using
alternatives. Several growers commented that they used late day
spraying successfully, at least since the original exception expired in
June 1996. It is also possible that hypothetical expectations of
failure may not be borne out by experience or experiment. For example,
while several scientists and growers were concerned that insects that
are more active early in the day would not be effectively controlled by
late spraying, two growers commented that they sprayed late for thrips.
It is important to demonstrate not only the existence of some noted
shortcomings, but also to measure their impact. It is possible that
where these problems exist, their magnitude and/or frequency of
occurrence is sufficiently small to be acceptable to growers. Perhaps
more importantly, where real and significant problems are found, it may
be possible to ameliorate their effects. The specific conditions in
which problems of applying alternatives arise may be identified, giving
growers more confidence in using them at other times.
On several issues regarding alternate practices and the need for
all currently available chemicals, many growers and the consultant for
Roses Inc., commented that due to variations in growing conditions and
pests among different growers, even in the same region, generalizations
could not be made about the adequacy of alternate practices. By
extension, attempts to implement these alternate practices in the
entire industry would seriously harm some growers. While there is
undoubtedly some validity in arguments about variability, such general
arguments are, by nature, practically unverifiable. Therefore, better
[[Page 52001]]
documentation of the impacts of using alternate practices will be
necessary in the future.
In light of the cut-rose industry's claimed lack of adequate
resources to conduct necessary studies of alternatives and because of
the inability to answer some basic background questions necessary for
the thorough evaluation of the need for an exception, the Agency will
work with the cut-rose industry and scientists knowledgeable about cut-
rose production over the next 2 years to gather necessary information
and perform research in areas that may move the industry from the need
for further exceptions. Therefore, in the next 2 years, the industry,
should show continuing progress in documenting and demonstrating, but
not limited to, the following:
1. Adequate justification for including all current pesticides, in
the exception especially 24- and 48-hour REI pesticides.
a. There is more than one chemical of a given class or mode of
action, that controls the same pest or spectrum of pests, the industry
should justify the need for maintaining all such chemicals in the
exception, i.e. describe the advantages and disadvantages of each
chemical.
b. Advantages of specific chemicals, such as price or efficacy
differences, should be quantified. Part A should be completed within
the first year of the exception so that part B may be presented to the
Agency by August 1998.
2. Due to the large number of pests and chemicals required by the
industry, the Agency does not believe that registration of new, safer
chemicals or biological control agents in the next 2 years will be
sufficient to replace many of the longer REI chemicals currently used.
Therefore, efforts to eliminate the need for another exception should
focus on practices that allow avoidance of the REI of existing
chemicals, including:
a. Systematic research of spraying at times that minimize the need
for an exception, in particular spraying after the last daily harvest.
Such research should include measurement of the impact of late day
spraying on pest damage and phytotoxicity. Attempts should be made to
ameliorate problems encountered with implementation of altered spray
schedules.
b. Exploration of techniques that allow early harvesting of roses,
which may eliminate or reduce the need for harvesting several times per
day.
Roses Inc. and several growers requested a longer term for the
current exception. Several growers also commented that 2 years is an
unrealistically short time period to research and implement new methods
of pest control or production. It is therefore critical that clear and
measurable objectives and goals are established early and that these
goals and objectives, and progress in meeting them, are regularly
reported to the Agency. The cut-rose industry should work closely with
the Agency and researchers to accomplish these goals. Success or
difficulty in accomplishing such benchmarks may then be used should
another exception be desired.
EPA is interested in working with the rose industry to identify
specific research efforts, identify competitive grant funds that may be
available to support such research, discuss protocols and time frames
for initiating and completing studies, and incorporating practices at
the individual grower establishment. However, establishing research
goals, objectives, time lines, and measurements is fundamentally the
responsibility of the cut-rose industry. Sara Ager in the Certification
and Occupational Safety Branch will continue to be the lead Agency
contact for the rose industry. The Agency is willing to meet with the
rose industry to discuss implementation of the exception, review any
findings from the NIOSH risk investigations, and review the industry's
progress in reducing the need for early entry and this exception.
VI. Public Docket
A record has been established for this administrative decision
under docket number ``OPP-250121.'' A public version of this record,
including printed, paper versions of electronic comments, that does not
include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Crystal Mall #2, Office of
Pesticide Programs, Environmental Protection Agency, 1921 Jefferson
Davis Highway, Arlington, VA. Electronic comments can be sent directly
to EPA at opp-docket@epamail.epa.gov.
VII. Regulatory Assessment Requirements
This document is an adjudication of eligibility for an exception to
certain requirements of the Worker Protection Standard, 40 CFR part
170. As such it is not a regulation or rule and therefore is not
subject to review by the Office of Management and Budget (OMB) under
Executive Order 12866 entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993), the Regulatory Flexibility Act, 5 U.S.C.
section 601, et seq., or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). It does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4). It also does not require any prior
consultation as specified by Executive Order 12875, entitled Enhancing
the Intergovernmental Partnership (58 FR 58093, October 28, 1993) or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
The information collection requirements associated with this
exception have been approved by OMB pursuant to the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. under OMB control number 2070-00148
(EPA ICR No. 1759). An Agency may not conduct or sponsor, and a person
is not required to respond to a collection of information subject to
OMB approval under the PRA, unless it has been approved by OMB and
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations, after initial display in the preamble of the
final action or rule, are listed in 40 CFR part 9 and appear on any
related collection instrument.
The total public burden related to the information collection
activities in this exception are estimated to be 600 burden hours, with
the average burden for each cut rose grower estimated to be 3 burden
hours. For analysis purposes, ``burden'' includes the total time,
effort, or financial resource expended by persons to generate,
maintain, retain, or disclose or provide information to or for the
Agency. As defined by the PRA, ``burden'' means the total time, effort,
or financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal agency.
This includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
Send comments on the accuracy of the burden estimates, and any
suggested
[[Page 52002]]
methods for minimizing respondent burden, including through the use of
automated collection techniques, to the Director, OPPE Regulatory
Information Division, U.S. Environmental Protection Agency (Mail Code
2137), 401 M St., SW., Washington, DC 20460, with a copy to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th St., NW., Washington, DC 20503, marked ``Attention: Desk
Officer for EPA.'' Please remember to include the OMB control number in
any correspondence.
List of Subjects in Part 170
Environmental protection, Administrative practice and procedure,
Labeling, Occupational safety and health, Pesticides and pests.
Dated: September 29, 1997.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 97-26321 Filed 10-2-97; 8:45 am]
BILLING CODE 6560-50-F
