51994 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules

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.

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 § 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

§ 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 § 170.112 prohibiting agricultural

workers from entering a pesticidetreated area to perform routine handlabor 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 earlyentry work are not permitted to engage

in hand labor.

Under § 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 cutrose 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 § 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
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules 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, cutrose 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.
51996 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules

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.
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules 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
51998 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules

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 cutrose 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
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules 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 cutrose 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 labelspecific 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
52000 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules

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

(§ 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 § 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 § 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

§ 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 § 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 § 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 earlyentry 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 § 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
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules 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 oppdocket@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
52002 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Proposed Rules

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