Friday
August 21, 1992
Part
Environmental
Protection Agency
40 CFR Parts 156 and 170
Worker Protection Standard, Hazard
Information, Hand Labor Tasks on Cut
Flowers and Ferns Exception; Final Rule,
and Proposed Rules
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38102 Federal Register / Vol. 57, iSfo. 163 / Friday. August 21, 1992 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 156 and 170
[OPP-300164A; FRL-3774-6]
RIN 2070-AA49
Worker Protection Standard
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is issuing final revisions
to its regulations governing the
protection of workers from agricultural
pesticides. These revised regulations
expand the scope of the standard to
include not only workers performing
hand labor operations in fields treated
with pesticides, but employees in
forests, nurseries, and greenhouses, and
employees who handle (mix, load,
apply, etc.] pesticides for use in these
locations. The regulations expand
requirements for warnings about
applications, use of personal protective
equipment, and restrictions on entry to
treated areas, and add new provisions
for decontamination, emergency
assistance, contact with handlers of
highly toxic pesticides, and pesticide
safety training. Pesticide registrants are
required to add appropriate labeling
statements referencing these regulations
and specifying application restrictions,
restricted-entry intervals (REIs),
personal protective equipment (PPE],
and notification to workers of pesticide
applications. EPA has determined that
its present regulations are inadequate to
protect agricultural workers and
pesticide handlers who are
occupationally exposed to pesticides.
The revised regulations are intended to
reduce the risk of pesticide poisonings
and injuries among agricultural workers
and pesticide handlers through
implementation of appropriate exposure
reduction measures.
EFFECTIVE DATE: This rule will become
effective October 20,1992.
ADDRESSES: Comments should be
submitted in triplicate and addressed to
the Document Control Officer (H7506C),
Office of Pesticide Programs,
Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. All
comments should bear the document
control number OPP-300164A and will
be available for public inspection from
8:30 a.m. to 4 p.m., Monday through
Friday, at the Office of Pesticides
Program's Document Control Office, Rm.
1132, Crystal Mall #2,1921 Jefferson
Davis Highway, Arlington, VA 22202.
FOR FURTHER INFORMATION CONTACT: By
mail: James J. Boland, Acting Chief,
Occupational Safety Branch (H7506C),
Field Operations Division, Office of
Prevention, Pesticides and Toxic
Substances, Environmental Protection
Agency, 401 M St., SW., Washington, DC
20460. Office location and room number:
Rm. 1114, CM #2,1921 Jefferson Davis
Highway, Arlington, VA, (703) 305-7666.
SUPPLEMENTARY INFORMATION: This
Federal Register notice discusses the
background and events leading to this
final rule revising the Worker Protection
Standard; summarizes the public's
comments on the provisions of the
proposed rule (53 FR 25970, July 8,1988);
provides EPA's response to comments
and final determination with respect to
provisions of the revised standard;
dispusses implementation of the revised
standard by registrants, the Agency, the
States, and pesticide users; and provides
information on the applicable, statutory
and regulatory review requirements.
More detailed discussion of the public
comments and the Agency's response
are found in the Response to Public
Comments in the docket. The Agency is
interested in receiving additional
comments, data, and other evidence
concerning both the general prohibition
of routine hand labor tasks during a
restricted-entry interval and the
mechanism for granting exceptions to
that prohibition. Written comments,
data, or other evidence concerning these
topics should be submitted on or before
October 20,1992. Upon review of these
comments, EPA may modify this final
rule's restrictions upon entering an area
that remains under a restricted-entry
interval or the process by which the
exception requests are considered. As
ah aid to the reader, the following is an
outline of the contents of this document:
I. Background
A. Legal Authority
B. History of the Worker Protection
Standard
II. Organization and Summary of the Final
Rule
A. Organization of the Final Rule
B, Summary of the Worker Protection
Standard
G. Summary of Risk-Benefit Analysis
D. Minor Crop Statement
E. Compliance Dates
III. Provisions of the Final Rule
A. Restrictions Associated with
Applications
B. Entry Restrictions
C. Notice of Applications
P. Personal Protective Equipment (PPE)
E, Decontamination
F, Emergency Assistance
G. Pesticide Safety Training and
Information
H. Knowledge of Labeling Information
I. Other
IV. Labeling Statements
A. Background of Proposal
B. Reference Statement
C. Other Statements
V. Statutory Re
A. U.S. Department of Agriculture
B. Congressional Committees
C. FIFRA Scientific Advisory Panel
VI. Implementation
A. Agency Implementation Strategy
B. Registrant Compliance
C. EPA Communication and Training
Efforts
D. National Compliance Monitoring
Strategy
VII. Public Docket
VIII. Regulatory Requirements
A. Executive Order 12291
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
I. Background
A. Legal Authority
The Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) (7 U.S.C.
135) was enacted in 1947. Since then,
pesticide products have been subject to
Federal regulation under FIFRA. Today,
they are required to be registered with
EPA.
In 1972, FIFRA was amended by the
Federal Environmental Pesticide Control
Act (7 U.S.C. 136). The amendments
broadened Federal pesticide regulatory
authority by making it "unlawful for any
person to use any registered pesticide in
a manner inconsistent with its labeling"
(7 U.S.C. section 136j(a)(2)(G)), and they
provided civil and criminal penalties for
violations of FIFRA (7 U.S.C. 1361). The
amendments also authorized EPA to
provide regulations to carry out FIFRA
(7 U.S.C. 136w(a)). These new or revised
provisions augmented EPA's authority to
protect humans and the environment
from unreasonable adverse effects of
pesticides.
During the congressional
consideration of FIFRA amendments in
1972, it was emphasized that FIFRA was
to be implemented by EPA to protect
employees who might be exposed to
pesticides or their residues. The
legislative history of the 1972
amendments indicates an express intent
of Congress that farmers, farmworkers,
and others be afforded such protection
under FIFRA. The Senate Committee on
Agriculture and Forestry rejected the
need to include a specific provision in
FIFRA to protect farmworkers.
However, the Committee found
"protection of man and the
environment" to be a broad term
encompassing farmers, farmworkers,
and others who come into contact with
pesticides, and stated that:
The Committee believes there can be no
question.. .but.. .that the bill [The Federal
Environmental Pesticide Control Act of 1972
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(FEPCA)] requires the Administrator to
require that the labeling and classification of
pesticides be such as to protect farmers, farm
workers, and others coming in contact with
pesticides or pesticide residues. (S. Rep. No.
92-883, (Part II), 92nd Congress, 2nd Session
at 43-48 (1972) (Agriculture and Forestry),
U.S. Code Congressional and Administrative
News 1972. p. 4083).
B. History of the Worker Protection
Standard
In 1974, EPA promulgated the
regulations found at 40 CFR part 170
pursuant to its authority under FIFRA
(39 FR16888; May 10,1974). That part,
entitled "Worker Protection Standards
for Agricultural Pesticides," dealt only
with the pesticide-related occupational
safety and health of "farm workers
performing hand labor operations in
fields after ground (other than those
incorporated into the soil), aerial, or
other type of application of pesticides"
(40 CFR 170.1). Part 170 consisted of four
basic requirements: (1) A prohibition
against spraying workers and other
persons; (2) a general reentry interval
for all agricultural pesticides prohibiting
reentry into treated fields until the
sprays had dried or dusts had settled
and longer reentry intervals for 12
specific pesticides; (3) a requirement for
protective clothing for any worker who
had to reenter treated fields before the
specific reentry period had expired; and
(4) a requirement for "appropriate and
timely" warnings. Soil-incorporated
pesticides, mosquito abatement
treatments and related public pest
control programs, greenhouse
treatments, livestock and other animal
treatments, and treatments of golf
courses and similar nonagricultural
areas were exempted from coverage.
EPA's authority to promulgate such
requirements, including reentry interval
standards designed to limit workers'
occupational exposure to pesticides and
pesticide residues (such as those in part
170) is established, not only in the
legislative history but in the courts. See,
e.g., Organized Migrants in Community
Action v. Brennan (OMICA) 520 F.2d
1161 (B.C. Cir. 1975) and Public Citizen
Health Research Group, et al. v. Auchter
702 F.2d 1150 (B.C. Cir. 1983).
In OMICA the Court of Appeals stated: Our
own analysis of the statute [FIFRA] and its
legislative history confirms EPA's ample
statutory authority to issue field reentry
standards to protect farm workers. (520 F.2d
at 1185)... Even before FEPCA's enactment,
EPA and predecessor agencies construed the
labeling provisions of FIFRA to require field
reentry limitations for many pesticides. See
39 Fed. Reg. 16888 (1974). However, these
were merely informational until FEPCA made
them enforceable. See id. at 16889. It is clear
from an examination of the explanatory
statement accompanying EPA's proposed and
final rules that these standards (part 170)
were promulgated and implemented under
the labeling authority given EPA by FEPCA.
(520 F.2d at 1168).
In June 1980, EPA announced a Label
Improvement Program (LIP) under which
labels of pesticide products are
upgraded, improved, or revised to meet
current labeling standards. On March
29,1983, EPA issued a Farm Worker
Safety LIP (PR Notice 83-2) calling for
certain information to be placed on
labels of "all outdoor agricultural use
products which are applied to crops
whose culture requires hand labor." In
effect, PR 83-2 implemented 40 CFR part
170, promulgated 9 years before. PR 83-2
did not include mixing, loading, flagging,
or equipment operation because part 170
was limited to farmworkers engaged in
hand labor. Greenhouse treatments and
forestry uses were excluded for the
same reason. PR 83-2 defined the term
"hand labor tasks" to mean crop
production activities such as harvesting,
detasseling, thinning, weeding, topping,
planting, sucker removal, summer
pruning, moving irrigation equipment,
and other tasks performed in the field by
farmworkers who could have
substantial contact with pesticide-
treated surfaces such as plants and
plant parts.
An Agency review of 40 CFR part 170,
conducted in 1983, concluded that the
regulations were inadequate to protect
agricultural workers. The review
revealed concerns about enforceability
and coverage and cited continuing
reports of worker poisonings. In 1984,
EPA published an Advance Notice of
Proposed Rulemaking that announced
its decision to revise part 170 and
solicited public comment (49 FR 32605;
August 15,1984). Most comments
favored revising part 170, but they
expressed wide differences in opinion
about the revisions needed.
EPA subsequently initiated a process
of public participation known as
regulatory negotiation. An Advisory
Committee consisting of 25
representatives of farmworker unions,
health care providers, agricultural trade
associations, commercial pesticide
applicators, pesticide registrants, State
health and agriculture agencies, EPA,
and other Federal agencies was
constituted under the Federal Advisory
Committee Act (Pub. L. 92-463).
Negotiations began in November 1985.
In early 1986, after several meetings, the
representatives of the farmworker
unions ended their participation. As a
result, regulatory negotiation consensus
was not possible.
EPA issued a notice of proposed
rulemaking (NPRM) in the July 8,1988,
Federal Register. The proposed revisions
expanded the scope of part 170 to
include all employees performing tasks
related to the production of agricultural
plants on farms, in forests, nurseries,
and greenhouses, and handlers of
pesticides intended for use on
agricultural plants in these locations.
The NPRM also expanded requirements
for notification to workers about
applications, use of personal protective
equipment (PPE), and restrictions on
entry to treated areas, and proposed to ,
add new provisions for
decontamination, emergency medical
assistance, maintaining contact with
handlers of highly toxic pesticides,
cholinesterase monitoring, and training.
EPA also proposed to promulgate
labeling regulations to require
statements pertaining to general worker
protection, entry intervals, personal
protective equipment, and posting of
treated areas.
The proposed revisions were based on
five major concerns. First, the Agency
believed that data developed after 1974
on pesticide poisonings of workers
revealed the inadequacies and
shortcomings in the scope and
requirements of part 170. Many of these
data were placed into the record by EPA
and other parties to this rulemaking.
Second, the Agency stated that the
enforcement experiences of EPA and the
States over the years had led the
Agency to conclude that a clearer
exposition of liability and responsibility
provisions would lead to improved
worker protection. Third, the Agency
had determined that since the
reregistration program would not be
completed for some pesticides for
several years, measures were necessary
to protect workers in the interim. Fourth,
because EPA believed that protection
should be provided to other workers, it
proposed expanding coverage to
workers not covered by the present part
170. Finally, the Agency noted the
increased use of organophosphate and
carbamate pesticides since 1974. These
pesticides tend to be more acutely toxic
to humans than pesticides commonly
used in agriculture in the past.
Buring July and August of 1988, EPA
held more than 15 public meetings,
mostly in agricultural areas of the
country, to explain the proposed rules
and to answer questions (see 53 FR
25970; July 8,1988). The major meetings
were held in: Washington, BC; Casa
Grande, AZ; Fresno, CA; Greeley, CO;
Orlando, FL; Forest Park, GA; Caldwell,
IB; Bes Moines, IA; Augusta, ME;
Hagerstown, MB; Salisbury, MB;
Holyoke, MA; New Paltz, NY; Maumee,
OH; McAllen, TX; and Yakima, WA.
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In response to the notice of proposed
rulemaking, the Agency received 380
comments totaling more than 2,000
pages.
After a careful review and analysis of
the comments and data in the record,
the Agency is promulgating this final
rule revising 40 CFR part 170 (Worker
Protection Standard) and adding part
156, subpart K (Labeling Requirements
for Pesticides and Devices).
II. Organization and Summary of the
Final Rule
A, Organization of the Final Rule
Many comments stressed that the
proposal was confusing. EPA believes
that some of the confusion stemmed
from the format of the proposed
revisions. The proposed revisions
included requirements for workers at
four different use sites and addressed
many differing activities including hand-
labor activities, non-hand-labor
activities, early-entry activities, and
handling activities.
EPA has changed the format of the
final rule. The revisions to part 170 are
now in the form of two separate, more
self-contained standards—one for
pesticide handlers and one for workers
on all covered sites: Farms, forests,
greenhouses, and nurseries. This
organization will reduce confusion and
will make it easier for employers and
their employees to understand the
requirements, to comply with the
provisions, and to propose amendments
if data so warrant in the future.
B. Summary of the Worker Protection
Standard
The provisions in the revised Worker
Protection Standard are directed toward
the working conditions of two types of
employees: those who handle
agricultural pesticides (mix, load, apply,
clean or repair equipment, act as
flaggers, etc.) and those who perform
.tasks related to the cultivation and
harvesting of plants on farms or in
greenhouses, nurseries, or forests. There
are three types of provisions intended
to: (1) Eliminate or reduce exposure to
pesticides; (2) mitigate exposures that
occur; and (3) inform employees about
the hazards of pesticides. A summary of
these provisions is given here.
Discussions of these provisions and
summaries of the public's comments on
these provisions are contained in Unit
III of this preamble. More detailed
discussion of the public's comments can
be found in a document entitled
"Summary of the Public Comments and
the Agency's Response, Worker
Protection Standard" in the docket.
1. Provisions to eliminate or reduce
pesticide exposures. Exposure to
pesticides can be reduced by excluding
workers from areas treated with
pesticides, prohibiting handlers from
applying a pesticide in a way that will
expose workers or other persons, and
protecting handlers during handling
activities. Hence, the final rule contains
several provisions to achieve this
purpose such as application restrictions,
entry restrictions, use of personal
protective equipment, and notification to
workers of treated areas so they can
avoid inadvertent exposures.
SL. Application restrictions. Three
types of restrictions apply during
applications:
i. No pesticide may be applied in a
manner that will cause it to contact any
person except an appropriately trained
and equipped handler.
ii. No person, except an appropriately
trained and equipped handler, may be in
an area or, in some cases, near an area
being treated with pesticides.
iii. The employer must make sure that
any handler who is handling a pesticide
with a skull and crossbones symbol on
the label is monitored visually or by
voice at least every 2 hours. Handlers
using fumigants in greenhouses must be
in continuous visual or voice contact
with another handler.
b. Use of personal protective
equipment (PPE). Additional provisions
to minimize exposure are directed
toward the use of PPE. The appropriate
PPE based on the product's acute
toxicity by route of exposure (dermal,
ocular, or respiratory) will be specified
in the product labeling for the work
activity (handling or early entry).
i, Persons handling the pesticide must
wear the PPE specified for handlers oh
the labeling of the pesticide being used.
ii. Persons entering a treated area
before the expiration of a restricted-
entry interval (REI) who will contact
anything that has been treated must
wear PPE specified in the labeling for
early entry.
iii. When PPE is required by the
product labeling for the activity to be
performed, the employer must: (1)
Provide the PPE to each worker or
pesticide handler; (2) clean and maintain
the PPE correctly; (3) make sure that
each handler or worker wears and uses
the PPE correctly; (4) prevent workers or
handlers from wearing home or taking
hoine contaminated PPE; and (5) take
action to prevent heat stress, if the work
and the PPE might cause heat stress.
c. Entry restrictions. Access to
pesticide-treated areas is limited after
an application while the pesticide may
still present a hazard. EPA's current
practice is to set entry intervals (REIs)
based on data collected and evaluated
for this purpose, but many older
pesticides in agricultural use today may
not have been evaluated for entry
hazards. The collection and evaluation
of such data may take several years.
The final rule establishes REIs for all-
pesticide products which are used in the
production of agricultural plants and for
which REIs have not been set according
to current standards. Previously
established entry intervals will be
retained if they are based on entry data
that meet Agency guidelines. Any other
previously established entry interval is
considered to be "interim" and will be
retained only if it is longer than the REI
established by part 170.
In general, a 48-hour REI is
established for any product containing
an active ingredient that is in toxicity
category I (most acutely toxic category)
because of dermal toxicity or skin or eye
irritation. The REI is extended to 72
hours in arid areas if any such active
ingredient is an organophosphate and
the product is applied outdoors. A 24-
hour REI is established for any product
containing an active ingredient that is in
toxicity category II (moderately toxic)
because of dermal toxicity or skin or eye
irritation. A 12-hour interval is
established for all other products.
Workers are restricted from entering a
pesticide-treated area for the REI
specified on the product labeling. With
narrow exceptions, the time a worker
may be in areas under an REI is limited
and other safety measures are required.
The activities that may take place in an
area under an REI are limited to tasks
that do not require contact with treated
surfaces, short-term tasks that do not
require hand labor and tasks that may
be necessary in an emergency to save a
crop. In addition, affected persons or
organizations may request that the
Agency grant case-by-case exceptions
to the entry restrictions if they believe
their industries, crops, or crop practices
would bear an unreasonable economic
burden under such restrictions.
d. Notification of applications. To
help workers avoid inadvertent
exposures to pesticide-treated areas, the
Agency is requiring employers to inform
workers of where pesticides have been
applied on the agricultural
establishment. This notification may
take one or more forms:
i. All agricultural employees who may
come near a treated area must be
notified, either orally or by posting
treated areas with warning signs, of
pesticide applications and areas under
an REI on agricultural establishments.
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ii. For selected pesticide products for
which inadvertent early entry could be
especially hazardous, treated areas must
be posted with warning signs, and oral
warnings must be given to workers.
iii. For outdoor uses, there are no
notification requirements if workers will
not be within 1/4 mile of the treated
area during the application or before the
expiration of the PEL
iv. Treated areas must be posted for
all pesticide applications in greenhouses
if workers will be in the greenhouse
during the application or before the
expiration of the REI.
2. Provisions to mitigate exposure —
a. Decontamination. Employees
handling pesticides must be provided an
ample supply of water for washing
splashed or spilled pesticides off
themselves and for washing after the
pesticide-handling activity is complete.
Workers entering treated areas where,
within the last 30 days, a pesticide has
been applied or an REI has been in
effect, must be provided facilities for
washing.
b. Emergency assistance. Although
the Agency believes the precautions
such as observing application
restrictions and entry restrictions, using
PPE, and notifying workers of
applications will decrease the frequency
of acute pesticide poisoning or injury
incidents, medical emergencies
involving agricultural workers and
handlers may still arise. In such cases,
prompt medical treatment is necessary
to mitigate the extent of the injury or
poisoning. Hence, the rule contains
several duties related to emergency
care:
i. The name and location of the
nearest medical facility must be posted
at a central location.
ii. If an agricultural worker or handler
may have been poisoned or injured by a
pesticide, the employer must make
available transportation to a medical
care facility.
iii. The employer must provide to the
employee, or to medical personnel
treating the employee, information about
the pesticide(s) to which the worker or
handler may have been exposed.
3. Provisions to inform employees
about pesticide hazards. Since training
and information are essential
components of a successful occupational
risk-reduction strategy, the final rule
contains several requirements relating
to providing pesticide safety training
and information to employees. These are
requirements for: (1) Pesticide safety
training for all workers and handlers, (2)
use of a pesticide safety poster, (3)
access to labeling information, and (4)
access to information about what
pesticides have been used on the
establishment.
a. Training. All agricultural workers
must have basic pesticide safety
training. All handlers must have basic
pesticide safety training, training on the
handling of pesticides, and training on
the use of PPE.
A poster summarizing the elements of
basic pesticide safety must be posted at
a central location on the agricultural
establishment to reinforce the safety
training.
b. Access to product-specific
information. Pesticide handlers must
have knowledge of and access to the
information on the labeling of the
product they are using; early-entry
workers must have knowledge of the
information on the labeling. Employees
must have access for 30 days after the
application and any REI to a centrally
located listing of information about any
product used on any area on the
establishment.
C. Summary of Risk-Benefit Analysis
EPA estimates that at least tens of
thousands of acute illnesses and injuries
and a less certain number of delayed
onset illnesses occur annually to
agricultural employees as the result of
occupational exposures to pesticides
used in the production of agricultural
plants. These injuries and illnesses
continue to occur despite the protections
offered by the existing part 170 and by
product-specific regulation of pesticides.
Therefore, the Agency has determined
that occupational exposures of
agricultural employees to pesticides and
pesticide residues continue to cause
adverse effects in a broad range of
agricultural sectors and that it needs to
provide additional regulatory protection
for such workers.
EPA could, as an alternative to issuing
the pesticide product-specific aspects of
this regulation, delay action until the
development of additional product-
specific data and analyses permit a
product-specific solution. These data
and analyses, in large part, will be
generated through the ongoing
reregistration process, but, under the
present conditions, will not be
completed until the year 2002 at the
earliest.
EPA has chosen to issue a rule at this
time, because EPA cannot, through a
product-by-product review, quickly or
adequately reduce the incidence of
pesticide-related injuries and illnesses.
The Agency's workload precludes rapid
reevaluation of large numbers of
products, even if the needed data were
available now. Moreover, many of the
protections of this rule are not product-
specific. Instead, they establish general
protections, such as training,
notification, and decontamination, that
are also vital in protecting agricultural
employees from risks associated with
pesticide use.
The Agency believes that this rule will
reduce substantially the current illness
and injury incidents at modest cost to
agricultural employers, pesticide
handler employers, and registrants. The
rule requires: (1) Restrictions on entry
by agricultural employees into pesticide-
treated areas for, depending on pesticide
toxicity, 12 to 48 hours (72-hours in
certain limited circumstances) after
application, (2) the use of PPE for
persons handling agricultural pesticides
and for persons who must enter
pesticide-treated areas before the
expiration of the REI, (3) training for
agricultural employees about hazards
from exposures to pesticides, (4) that
information be provided to pesticide
handlers and early-entry workers, and
be available to other agricultural
employees, about the specific pesticides
to which they will be exposed, (5) that
water, soap, and towels be made
available to agricultural employees to
enable them to wash off pesticides and
pesticide residues routinely and after
emergency exposures, (6) that
emergency assistance be made available
to agricultural employees if a pesticide-
related illness or injury occurs or is
suspected, (7) that agricultural
employees, other than pesticide
handlers, be prohibited in areas being
treated with pesticides, and (8) that
agricultural employees be notified of
areas that are being treated or that
remain under an REI through oral
warnings or through warning signs
posted at the treated area, or, in the case
of some particularly hazardous
pesticides, through both oral and posted
warnings.
EPA, drawing on its expertise in
regulating pesticides, has determined
that these simple measures are likely to
reduce substantially the number of
pesticide-related illnesses and injuries
to agricultural employees. Both the
frequency of illness and injury incidents
under existing conditions and the
expected reduction in the number and
severity of these incidents due to
promulgation of this rule are difficult to
quantify. However, the Agency believes
that the reductions will be significant. In
its Regulatory Impact Analysis (RIA),
EPA has calculated an incremental first
year compliance cost of $94.3 million for
this rule and an annual incremental
compliance cost of $49.4 million in
subsequent years. The continuing
annual incremental cost of this rule
represents only one tenth of one percent
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of the total 1987 value of production for
all agricultural sectors subject to this
final rule. Assuming that the majority of
the current acute illness and injury
incidents in agricultural employees
caused by occupational exposures to
pesticides are prevented through
compliance with this new rule, there will
be significant benefits to agricultural
workers and pesticide handlers at a
modest cost. Furthermore, the Agency is
convinced that a substantial number of
additional incidents caused by delayed-
onset illnesses can be prevented through
compliance with this new rule. Such
expected avoidance of delayed-onset
illnesses in workers and handlers would
also reduce the costs attributable to
acute incidents avoided.
The Agency believes that, due to this
new agricultural worker protection rule,
the benefits in decreasing the number
and severity of pesticide-related
illnesses and injuries to agricultural
employees exceed the costs of the rule
to agricultural employers, pesticide
handler employers, and registrants.
Therefore, EPA hereby promulgates this
rule in the conviction that this •
mechanism is the best means of
reducing the unreasonable adverse
effects from pesticide-related illnesses
and injuries to agricultural employees in
the near term.
Some persons who commented on the
proposed worker protection rule
questioned the necessity for the rule in
specific sectors of agriculture and
requested exemptions for those sectors.
However, EPA believes that the record
of illness and injury incidents resulting
from occupational exposures of
agricultural employees to pesticides
used in the production of agricultural
plants and the undisputed inherent
acute and delayed-onset toxicity of
those agricultural pesticides supports
the Agency's conclusion that such
agricultural employees are subject to
unreasonable adverse effects from
pesticide use across the broad range of
agricultural sectors covered by this final
rule. Furthermore, no persuasive
evidence has been brought to the
Agency's attention which demonstrates
that any individual sector of agriculture
is not subject to unreasonable risks of
employee illness and injury. EPA is not
persuaded to delay promulgation of this
rule until data and analyses specific to
each agricultural sector and to each
pesticide are generated.
Under FIFRA, EPA is authorized to
promulgate regulations to mitigate
unreasonable adverse effects that may
result from exposures to pesticides. The
Occupational Safety and Health Act
(OSH Act) is similar in that the
Occupational Safety and Health
AdminisJpLtion (OSHA) is granted
authority to promulgate regulations to
mitigate "a significant risk." A recent
court decision that upheld the issuance
of OSHA's hazard communication rule (
29 CFR 1910.1200] was based solely on a
finding of generalized risk; the United
States Court of Appeals for the Third
Circuit stated:
This rulemaking proceeding produced a
performance-oriented information, disclosure
standard covering thousands of chemical
substances used in numerous industries. For
such a standard the significant risk
requirement must of necessity be satisfied by
a general finding concerning all potentially
covered industries. A requirement that the
Secretary assess risk to workers and need for
disclosure with respect to each substance in
each industry would effectively cripple
OSHA's performance of the duty imposed on
it... to protect all employees to the
maximum extent feasible ... [Associated
Builders and Contractors, Inc. v. Brock, 862
F.2d 63 at 68 (3d Cir. 1988)].
For the same reasons, EPA is
convinced that it is not required to make
a detailed risk finding with regard to
every pesticide product or to every
sector of agriculture before taking action
to protect all agricultural employees.
D. Minor Crop Statement
According to the Council for
Agricultural Science and Technology's
June 1982 report, PESTICIDES, Minor
Uses/Major Issues:
Vegetables, fruits, nuts, herbs,
ornamentals, trees, and turfgrass are often
referred to as minor crops because the
acreage and volume of production of any one
of the many crops in these groups are much
below that of corn, soybean, wheat, or any of
the other major field crops. Minor crops, as
well as major crops, must be protected from
insects, weeds, and diseases so as to be
economically produced. Specialized pest
control needs also exist for major crops in
certain situations. Pesticides developed for
use on minor crops and to meet the
specialized needs for major crops are
referred to as minor use pesticides.
The minor use crops are the ones this
Worker Protection Standard will impact
the most. Much of agricultural labor is
used on minor crops, and it is in the
production of these crops where the
greatest chance of pesticide exposure to
agricultural workers occurs.
E. Compliance Dates
To ensure that pesticide product
labeling bearing requirements of the
new standard does not find its way to
users before information on compliance
can be disseminated, the new labeling
may not be used until April 21,1993. At
that time, specified selected provisions
of the regulation will become
enforceable to support new instructions
to users on the labeling. After April 21,
1994, all agricultural pesticide products
sold or distributed by registrants must
bear the new labeling. After April 15,
1994, all provisions of the regulations
are enforceable when pesticides with
the revised labeling are used. After
October 23,1995, all agricultural
pesticide products sold or distributed by
anyone must bear the new labeling.
III. Provisions of the Final Rule
A. Restrictions Associated With
Applications
Present part 170 prohibits the
application of any pesticide in a way
that directly or through drift will contact
workers or other persons who are not
involved in the pesticide application. It
also requires unprotected persons to
vacate the area. The Agency proposed
to continue this provision with some
changes.
1. General restriction. The NPRM
proposed changes to the existing general
prohibition: "No owner or lessee shall
permit the application of a pesticide in
such a manner as to directly or through
drift expose workers or other persons
except those knowingly involved in the
application. The area must be vacated
by unprotected persons." The Agency
proposed to substitute the word
"contact" for the less precise term
"expose" and to clarify the requirement
that unprotected workers must vacate
the treated area during application by
modifying the language to: "No worker
shall be allowed or directed to enter or
remain in an area during the application
of any pesticide to the area, unless the
worker is a handler involved in the
application of the pesticide." Since these
regulations apply only to workers, all
references to "other persons" were
deleted in the proposal.
There were few comments on these
application restrictions. One comment
stated that workers should be permitted
to remain in the treated area during
application under some conditions. For
example, planting crews may need to be
in a field with the planter during an
application of a granular pesticide; field
crews may need to be in the same field
but may be distant from the area under
treatment; and workers should be able
to remain in a treated area if they are
upwind from the treatment or if an
"adequate barrier" or buffer zone
separates them from the application.
Some comments expressed concern for
protecting the public from agricultural
pesticide uses such as in retail
greenhouses, at "you-pick" farms, in
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38107
parks and recreational areas, along
roads and rights-of-way, and in schools.
In the final rule, the language from the
NPRM has been modified. Section
170.110 states that "during the
application of any pesticide ... the
agricultural employer shall not allow or
direct any person... to enter or to
remain in the treated area." The
exception found in the proposal for a
"worker [who] is a handler involved in
•the application" has been changed to an
exception for "an appropriately trained
and equipped handler." These changes
were made to make it clear that only
handlers trained and equipped as
required by this rule can be in an area
during application. Other workers, even
if protected, are not permitted to be in
the area.
The Agency has been persuaded by
the comments to reinsert the clause
"and other persons" into the section
prohibiting application in a way that
will contact workers (§ 170.210).
Pesticide applicators must refrain from
applying pesticides in areas where any
person is likely to be touched by the
chemical—either directly or from the
drift or fallout of the application. This
responsibility is irrespective of the
relationship of the handler to the person
in or near the treated area. This
provision is intended to protect workers
or other persons on agricultural
establishments in or near the treated
area even if those persons have no
reason or privilege to be in that location.
The prohibition is consistent with
present part 170, which declares that
applying pesticides directly on anyone,
whether a worker or any other person, is
a misuse and is subject to penalty.
2. Application restrictions in nurseries
and greenhouses. EPA proposed more
stringent application restrictions for
nurseries and greenhouses than the
general application restriction in present
part 170 or those proposed for farms and
forests. In greenhouses and nurseries,
production areas are often close
together. Plants requiring differing
pesticide treatments and hand labor
schedules may occupy the same bench
or bed. In the NPRM, the application
restrictions were discussed under the
heading of reentry restrictions, but
several comments requested
clarification of the proposed language.
Therefore, in the final rule, EPA is
separating the requirements into two
parts, restrictions associated with
applications and post-application entry
restrictions.
In greenhouses, employees often do
diverse tasks, including the application
of pesticides, close to other activities.
EPA recognized that exposure could
occur to workers in areas adjacent to
the treated area during some pesticide
applications and with some pesticide
formulations.
The Agency proposed specific
requirements for four different types of
applications in greenhouses:
a. The entire enclosed area of the
greenhouse must be vacated during the
application of a pesticide applied as a
fumigant, smoke, mist, aerosol, or fog, or
whose label requires a respiratory
protection device for applicators.
b. The pesticide-treated area plus 25
feet in all directions must be vacated for
any application other than those in
paragraph (a) above if there is no
ventilation in the enclosed area during
the application and the pesticide is
applied from a height of more than 12
inches from the planting medium, or is
applied using fine spray droplets or a
spray pressure greater than 40 psi.
c. The entire enclosed treated area hi
the greenhouse must be vacated during
application if ventilation occurs in the
enclosed treated area during the types
of application described in paragraph
(b) above.
d. Only the pesticide-treated area
must be vacated during application of
pesticides applied from a height of 12
inches or less and applied as a dry
formulation, or applied using coarse
spray droplets and spray pressure less
than 40 psi.
Nursery exposure situations are
similar to those in greenhouses, except
that nurseries: (1) Have lower inhalation
hazards, because they are not enclosed
structures, (2) do not have ventilation
systems that can be turned on and off at
will, but are constrained by the direction
and speed of the wind, and (3)
sometimes use aerial applications,
upward-directed, and very high pressure
(greater than 150 psi) sprays. The areas
with restricted worker entry during
applications in nurseries were defined
by the types of applications:
i. For soil-directed applications, the
restricted area is the treated area,
ii. For downward-directed
applications, the restricted area is the
treated area plus 25 feet downwind and
10 feet in other directions.
iii. For applications by aerial, upward-
directed, or high-pressure sprays, the
restricted area is the treated area plus
any moistened or dusted area.
Most comments concurred with the
proposed definitions of areas restricted
during applications for greenhouses and
nurseries. One comment stated that the
25-foot "barrier" zone was too small to
be protective. Another requested that
the 25-foot area restricted during
applications not apply to pesticides in
toxicity categories III and IV. One
comment requested that "soil-directed"
be redefined as pressure up to 60 psi if
water breakers are used.
A few comments requested
clarification of whether the specified 25-
foot area restricted during application
extended to areas beyond the
greenhouse or, in nurseries, extended off
the property.
The Agency agrees with the
recommendations that greenhouse and
nursery restrictions be clarified. The
restrictions in greenhouses have been
summarized in a table containing the
restrictions during applications and the
entry restrictions after application
(§ 170.110(c)). A similar table has been
.prepared for applications in nurseries
(§ 170.110(b)).
To provide a more useful description
of the area restricted during application
for employees in nurseries, the Agency
specifies .that an area of 100 feet in each
direction around the treated area must ,
be vacated during applications using
aerial, upward-directed, or 'high-pressure
sprays instead of "the area dusted or
misted"; EPA modified the area
restricted during application to 100 feet
beyond the treated area in nurseries
during fumigant, smoke, mist, fog, and
aerosol applications.
The prohibition against applying
pesticides in a way that will allow
contact with workers or other persons is
absolute. If an applicator has reason to
believe that workers (or other persons)
may be contacted by a pesticide during
a pesticide application in a greenhouse
or nursery, even if those workers (or
other persons) are in compliance with
the minimum distance requirements, the
application may not take place until
those workers (or other persons) leave
the area.
The Agency is not persuaded to
exempt pesticides in toxicity categories
III and IV from these provisions. The
intent is to reduce occupational
exposure to pesticides, regardless of
their acute toxicity. The Agency is
concerned also about possible subacute,
chronic, and reproductive or
developmental effects from pesticide
exposure.
The Agency concurs that, except for
fumigation when the entire greenhouse
and any adjacent structures that cannot
be sealed off from the treated area must
be vacated, subenclosures in the
greenhouse are permissible and these
subenclosures constitute the area that.
must be vacated during application. If
the treated area is enclosed, the 100- or
25-rfodt zones are not required. The
Agency's interpretation is that the 25-
foot or 100-foot areas restricted during
application do not extend beyond the
greenhouse, or beyond the property line
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of the nursery. However, the prohibition
against contacting workers or other
persons does extend beyond such
boundaries.
A few comments requested
clarification of "downwind" in a nursery
where wind currents tend to be
multidirectional over time. The Agency
concurs with this observation and has
determined that requiring a 25-foot area
beyond the treated area in all directions
will be more protective for workers.
3. Restrictions with fumigants.
Although some comments suggested that
the entry restrictions for fumigants were
adequate, some stated that the
restricted-entry area for a fumigant
should be defined as the "entire
enclosed structure" rather than the
"enclosed area" to differentiate between
an area enclosed by a temporary barrier
and the greenhouse itself.
Some comments requested that
"fumigant" be defined to distinguish it
from a mist or an aerosol. One comment
recommended prohibiting any early
entry into a greenhouse following
fumigation except to determine fumigant
concentration or to facilitate ventilation.
A comment requested that the
ventilation criteria for defining
dispersed vapors specify the minimum
number of required air exchanges
needed. Other comments stated that the
proposed ventilation criteria may not be
adequate for large production areas if
only small windows or fans are used
and recommended that replicated tests
be conducted using available ventilation
to determine the time necessary to
achieve the permissible exposure level
for a specific site.
In the final rule, the Agency defines a
fumigant as "any pesticide product that
is a vapor or gas, or forms a vapor or gas
on application, and whose method of
pesticidal action is through the gaseous
state." Final part 156 requires pesticide
registrants to identify fumigants on the
front panel of the label.
The Agency has determined that a
fumigant application is complete only
when (1) any exposure level listed on
the product labeling is reached, or (2) if
there is no labeling specified exposure
level, when one of the ventilation
criteria has been met. The fumigant
continues to disperse throughout the
treated area after its release. Persons
are exposed to the fumigant when they
enter fumigated areas to measure
ambient concentrations of fumigant or to
facilitate ventilation by manipulating
ventilation systems in greenhouses or by
removing tarpaulins or other coverings
from outdoor fumigation sites. These
persons, therefore, are handlers of the
fumigants. The Agency has changed the
definition of handlers to include such '
persons and has extended the
application prohibition for fumigants in
greenhouses to include the time needed
to reach the exposure level listed in the
labeling or to meet one of the ventilation
criteria. During this time, only handlers
who have the protections mandated on
the labeling and who meet the other
requirements in part 170 may enter the
treated area. These handlers may enter
the treated area only to measure the
fumigant level, remove coverings, or
operate the ventilation system.
The gaseous nature of fumigants
requires that the entire structure,
including any adjacent structure that
cannot be sealed off from the treated
area, be vacated during application.
Temporary barriers such as curtains or
shields are not designed to be air-tight
and therefore would not prevent
exposure to persons in areas adjacent to
those barriers. EPA has reworded the
application restrictions for fumigant
applications in greenhouses to specify
that the entire greenhouse plus any
adjacent structure that cannot be sealed
off from the treated area, not just the
"entire enclosed area," is the treated
area and therefore is restricted.
The Agency concurs that a specific
number of complete air exchanges
should be specified as constituting
sufficient ventilation following a
fumigant application (or other airborne
application) in a greenhouse. The
Agency has concluded that 10 is the
minimum number of air exchanges
needed. (If each air exchange removed
only 50 percent of the pesticide, 10
exchanges should leave approximately
1/1,024 of the original volume of
pesticide.) In proposing the ventilation
criteria for "vapors dispersed," EPA
used the limited data available and
consulted with authorities in greenhouse
pesticide application processes to
establish appropriate and reasonably
conservative criteria for protecting
workers from inhalation exposure
following fumigation in greenhouses.
Several comments noted that many
greenhouses are acres large and that
workers should be allowed to work in
one end of the greenhouse while a
spraying application is conducted in the
cither end of the greenhouse as long as
any mechanical ventilation draws the
drift away from the workers.
: The restriction on ventilation was
intended to protect workers from
airborne vapors, spray, and dusts.
Without ventilation, the transport of the
pesticide off-site would be minimal and
presumably would move in all directions
equally. With ventilation (passive or
active), air movement in any direction is
possible. The amount of drift is
dependent on such factors as the size
and weight of droplets or particles, the
pressure of spray, the distance from
application equipment to treated
surface, and the force and direction of
the ventilation. Even "passive"
ventilation involves factors such as size
of vents, the location of vents, and the
outdoor wind currents. The Agency is
not persuaded that it is possible to
predict the direction or distance that
sprays or dusts might drift for all
ventilation systems used by the
greenhouse industry; therefore, it will
continue to prohibit workers from
remaining in an area surrounding the
application. The dimensions of the area
depend upon the type of formulation and
the type of application. EPA agrees that
after application is completed, the
sprays and dusts will settle out of the air
and no longer pose an exposure hazard
to adjacent workers. Workers may enter
•the greenhouse after application to work
anywhere except in the treated area as
defined by Table 2 in § 170.110(c)(4).
In the NPRM, EPA listed criteria for
determining when vapors have
dispersed after the application of a
fumigant. Some comments requested
clarification and guidance on when
vapors are considered dispersed
following application of nonfumigant
pesticides that require the use of a
respirator during application or that are
applied as smoke, mist, fog, or aerosol.
The Agency has modified the
application restrictions for pesticides
that are applied as fumigants, smokes,
mists, aerosols, or fogs, and for
applications that require the use of a
respiratory protection device, to include
ventilation criteria that must be met
before workers are allowed to return to
work anywhere in the enclosed area, or,
in the case of fumigant applications,
anywhere in the entire greenhouse plus
any adjacent structure that cannot be
sealed off from the treated area.
B. Entry Restrictions
The Agency long has recognized the
value of limiting agricultural workers'
exposure to pesticides through the use of
REIs. Present part 170 established that
no worker without the prescribed
protective clothing should be allowed to
enter a treated area to perform a hand
labor task until the expiration of an REI.
In the NPRM, EPA did not change this
basic requirement, but did extend the
scope of this proscription to include any
farm, forest, nursery, or greenhouse
workers who contact pesticide residues
on treated surfaces or in soil, water, or
air, not just those who are performing
hand labor tasks. The NPRM required
that other protections, such as PPE,
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training, and decontamination facilities,
be provided to early-entry workers.
1. Restricted-entry intervals. Present
part 170 established a generic
"minimum" REI for pesticides used on
agricultural sites covered by that part,
and it set specific REIs of either 24 or 48
hours for 12 pesticides. Other REIs have
been established during the registration,
reregistration, and special review
processes. Some of these intervals are
"permanent" (based on adequate entry
data as required by 40 CFR part 158 or a
waiver of data submission); others are
interim intervals (not based on part 158
entry data) pending the generation of
adequate data.
Under existing Agency policy, the
establishment of REIs has been limited
to pesticides used on agricultural crops
where workers perform "hand labor
operations," involving "substantial
contact with treated surfaces." Workers
may have contact with treated surfaces
from activities such as moving irrigation
pipes and scouting, tasks usually not
considered as "hand labor" tasks. The
shift from routine preventive pesticide
applications to the increasing use of pest
control on an as-needed basis has
resulted in the need for more frequent
post-application entry by crop advisors,
such as integrated pest management
(IPM) scouts, professional pest
management consultants, and growers,
to determine the status of insect, mite,
disease, and weed pests at each stage of
crop development. The amount of
contact with treated surfaces in these
activities depends on variables such as
the height and density of the crop, the
nature of the activity, the surface that
contains the pesticide residue, and
whether residues are dry or wet.
Adverse effects on workers may result
from a combination of the toxicity of the
pesticide and the amount of exposure.
Even small amounts of highly toxic
pesticides can cause poisoning.
For these reasons, the Agency decided
that any activity that results in contact
with anything that has been treated with
the pesticide to which the REI applies
may be harmful to workers. Thus, the
Agency proposed that REIs apply to all
pesticide products used on agricultural
plants as defined by this part, regardless
of type of worker activities associated
with particular agricultural plants.
In proposing to revise part 170, the
Agency did not contemplate a change to
the part 158 process for establishing
permanent REIs. Rather, the proposed
revision to part 170 represents a change
in current Agency policy of setting
interim REIs which apply until
permanent REIs are established on .the
basis of part 158 entry data.
Therefore, part 156 retains all
permanent REIs set by EPA on the basis
of adequate data. It also retains all
previously established interim intervals
that are longer than those that would be
established pursuant to this rulemaking
in part 156. These longer REIs have been
based, in general, on either delayed
(chronic) effects or other exposure
hazards such as persistence, post-
application chemical transformations, or
potential .for severe skin sensitization.
2. Length of restricted-entry intervals.
In the NPRM, the Agency proposed to
retain the existing minimum REI of
"until sprays have dried, and dusts have
settled" for most pesticide applications
and to modify it by adding the phrase
"or vapors have dispersed" to protect
workers immediately after applications
of fumigants, mists, fogs, aerosols, or
smokes. It also proposed specific REIs of
48 hours for pesticides that contain
organophosphates or AT-methyl
carbamates in toxicity category I, and 24
hours for pesticides that contain
organophosphates or //-methyl
carbamates in toxicity category II and
for other active ingredients in toxicity
category I. The Agency considered other
options that reflect varying acute
toxicities.
The comments on this issue focused
on the length of the proposed intervals
and the bases for selecting the REIs.
a. Minimum restricted-entry intervals.
Several comments endorsed the concept
of "sprays dried, dusts settled, vapors
dispersed" as a minimum REI. Some
comments requested the Agency to
establish a minimum REI of 24 hours for
all pesticides; others explicitly opposed
a 24-hour minimum REI for all
pesticides. Another comment suggested
that there be no restricted-entry period
less than 12 hours.
., One comment stated that enforcement
of "sprays have dried, dusts have
settled, or vapors have dispersed"
would be difficult. Others stated that
determining when "sprays have dried,
dusts have settled, or vapors have
dispersed" is not feasible in some
greenhouses because in propagation and
misting situations it is difficult to
ascertain if sprays have dried because
foliage is kept constantly wet.
The Agency agrees that in some
circumstances it is difficult to determine
when the sprays have dried, the dusts
have settled, or the vapors have
dispersed; judgment is required to
assess when such an REI has expired.
The rates at which sprays dry, dusts
settle, or vapors disperse depend on
factors such as temperature, humidity,
rainfall, irrigation, dew deposition,
wind, crop density, height, leaf
configuration, amount of sunshine, and
type of pesticide formulation used. Parts
of a treated area may be dry while
others are not dry. In dense crops, such
as mature corn, the foliage in the center
of the stand may be wet while the
foliage in the outer areas, where a
supervisor is most likely to check, may
be dry. Rewetting of foliage because of
rain, irrigation, or dew may cause
confusion and uncertainty about
whether the sprays have dried. Wind
may make it difficult to determine
whether dusts have settled.
Many comments requested the
Agency to establish minimum REIs to
protect against possible unknown
chronic or delayed health effects. These
comments expressed concern that
because product-specific health-effect
evaluations take the Agency a long time
to conduct, agricultural workers
continue to be exposed to chemicals
whose potential for causing birth
defects, cancer, genetic mutations, and
other systemic damage has not been
tested. They recommended that the
Agency consider the potential chronic
and other delayed health effects and
establish longer REIs.
The Agency has decided to establish a
minimum REI of 12 hours for all
pesticide applications to replace the
"sprays have dried, dusts have settled,
vapors have dispersed" requirement.
This will provide a margin of safety
against occupational exposure to all
pesticides and eliminate the need for
pesticide users to judge how long
workers should be kept out of an area.
The disruption to agriculture, and thus
the cost, should be minimal; pesticides
could be applied in the evening, and
worker entry would be allowed the
following morning. This REI of 12 hours
could be modified through the
reregistration (or registration) process
on a case-by-case basis most often
involving submission of full entry data
(part 158).-
The Agency will continue to establish
REIs on a case-by-case basis for
products where nonacute health effects
are a concern.
b. Specific restricted-entry intervals.
Although most comments supported the
REIs proposed and many stated that in
most circumstances agriculture would
be able to comply, one comment stated
that REIs longer than the minimum
should be reserved for compounds
whose toxicity characteristics or
exposure history indicated a need for
longer intervals.
Some comments supported a 48-hour
REI for all active ingredients in toxicity
category I and a 24-hour REI for all
those in toxicity category II. Other
comments requested that REIs not
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exceed days-to-harvest intervals or
noted that 48 hours is the maximum
feasible REI under current crop
production methods. Many comments
supported 72-, 48-, and 24-hour REIs for
pesticides in toxicity categories I, II, and
III, respectively. Others specifically
opposed a 72/48/24-hour scheme or
stated that the REIs proposed should be
determined on a case-by-case basis
when data indicate a need.
The Agency's proposal was based on
California data showing that, from 1976
to 1985, 90 percent of the systemic
poisonings caused by active ingredients
in toxicity category I and 70 percent
caused by active ingredients in toxicity
category II involved either
organophosphates or Af-methyl
carbamates. These data suggest a
relationship between the classes of
chemicals used and poisonings.
However, a few comments stated that
the apparent relationship between
chemical class and poisoning in the data
is not unexpected; because of the types
of crops grown in California, it is likely
that 90 percent of the products in
toxicity category I and 70 percent of the
products in toxicity category II applied
were anticholinesterase compounds.
Many respondents objected to the
distinction made between
organophosphate and AT-methyl
carbamate pesticides and other
pesticides in the same toxicity category,
stating that the subdivision of toxicity
categories I and II by chemical family is
not defensible scientifically. These
comments asserted that it would be
more appropriate to use acute toxicity
data as the basis for generic REIs, and
to include all compounds in a toxicity
category. In contrast, some comments
requested that only organophosphate
and Af-methyl carbamate pesticides
have REIs.
After reevaluating this issue, the
Agency agrees that chemical class
should not be a criterion for establishing
REIs. The Agency expects that
chemicals in the same toxicity category
will pose similar risks of adverse effects
from acute toxicity; thus, no distinction
should be made among the chemical
classes within a toxicity category. The
Agency has changed the specific REIs.
In the final rule, all pesticides in toxicity
category II have REIs of 24 hours, and
all pesticides in toxicity category I have
REIs of 48 hours. All other pesticides
(those in toxicity categories III and IV)
are subject to the 12-hour minimum REI.
Studies have shown that some
organophosphates transform into more
toxic products in arid conditions. The
Agency has been persuaded that, in
areas receiving rainfall of less than 25
inches per annum, organophosphates
that are in toxicity category I and that
are used outdoors should have an REI of
72 hours. Acceptable sources of
statistics on average annual rainfall for
an area are nearby weather bureaus,
such as one located at a local airport or
one affiliated with the National
Oceanographic and Atmospheric
Administration (NOAA).
The Agency proposed that REIs be
biased on the acute toxicity of the
technical grade of the active ingredient.
Some comments requested that inert
ingredients be considered in setting
REIs.
• The Agency believes that the inert
ingredients in pesticide products
generally are not of a nature, or do not
remain in treated areas long enough, to
present hazards for reentering workers.
Accordingly, REIs will be based on the
possible hazards of residues of active
ingredients. The Agency is reexamining
the hazards of inert ingredients through
a separate process.
:The Agency proposed setting intervals
based on the highest toxicity category
indicated by available data on acute
dermal toxicity or skin and eye irritation
potential, determined by the criteria of
40 CFR 156.10(h)(l) of this chapter. If no
dermal toxicity data are available, oral
toxicity data would be used to set REIs.
: Workers may have dermal, oral, and
respiratory exposure to pesticides; for
wprkers entering treated fields, the
predominant route of exposure is
dermal. The Agency considered using
only dermal toxicity to establish REIs,
but the potential for eye and skin
irritation and for respiratory exposure
may be significantly large in some entry
situations. Cases of eye or skin irritation
are four times as common as those of
systemic poisonings among reentering
workers.
Inhalation exposure is a hazard in
enclosed areas, such as greenhouses,
especially after applications of
fumigants or pesticides with high vapor
pressure; it is less important as a hazard
for entry into treated areas outdoors,
except during removal of barriers, such
as tarpaulins, after application of a
ftimigant. Oral toxicity data are the most
widely available data on pesticides, but
(jral exposure in agriculture is related to
the worker's personal habits, such as
riot washing hands and face before
eating, drinking, or smoking.
1, The Agency has determined that
entering areas while inhalation
exposure remains a hazard is not safe or
practical for persons other than
appropriately trained and equipped
pesticide handlers. Therefore, EPA has
modified the entry restrictions in
greenhouses to permit only handlers to
enter greenhouses until air
concentration levels or ventilation
criteria have been met following
applications of airborne pesticides or
pesticides that require a respirator
during application. The Agency also has
modified the definition of "handler" to
include persons who must enter areas
treated with soil fumigants to adjust or
remove soil coverings, such as
tarpaulins.
A few comments recommended that
use patterns and mode of action be
considered in setting REIs. Another
recommended that the persistence of the
residues should be considered in setting
REIs since some injuries, such as eye
injuries or birth defects, are unrelated to
the acute toxicity of the chemical.
Basing REIs on particular use
patterns, on the mode of action, or on a
particular use's potential for exposure is
not feasible because of variations in
potential exposure related to crop,
cultural practices, and application
techniques. These considerations are
appropriate for establishing permanent
REIs on a case-by-case basis such as
through the reregistration process.
c. Establishing entry restrictions in
the future. The REIs established through
this final rule are intended to remain in
effect until the reregistration process dt
other comprehensive EPA review
process makes definitive REI
determinations. In most circumstances,
the Agency expects that any1 REI
established as the result of the later
Agency review would prohibit early
entry to perform routine hand labor
tasks. However, such REIs would be
based on a risk-benefit judgment that
takes into account the prohibition
against routine early entry to perform
hand labor tasks.
The Agency expects to establish
appropriate entry restrictions on the
basis of several types of data. These
may include, as applicable, data on how
the residue degradation rate and
dislodgeability (amount readily
transferable from a surface to persons
contacting that surface) are influenced
by pesticide formulation type;
temperature; humidity; soil type; rainfall,
dew, and irrigation practices; sunlight;
crop type, height, and density; specific
production practices, or worker activity
and length of exposure. When feasible,
the Agency may establish product-
specific REIs that vary depending on
one or more of these parameters. For
example, the Agency may establish
longer REIs for timed-release
formulations, which are designed to
release the active ingredient over an
extended time period. The Agency may
determine that, for some tasks, shorter
REIs are warranted for "low crops" than
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38111
for tree crops and other "high crops,"
such as corn, because workers' exposure
levels would be expected to be lower.
The Agency may also determine that in
areas with characteristically hot, arid
conditions and certain soil types, longer
REIs are warranted for certain active
ingredients because of slower
degradation, higher transferability, and
transformation of the active into more
toxic forms. The Agency may also
impose longer REIs for some active
ingredients in areas with heavy dew or
frequent light rain because those actives
are either activated by moisture or
transformed by moisture into more toxic
forms. On the other hand, if adequate
data exist, the Agency may decide that
it is feasible to allow a reduction in REIs
when a specified amount of rain has
fallen or over-the-top irrigation has been
applied to the treated area.
Another type of product-specific
restricted-entry determination might
include situations where data indicate
that worker contact with the treated
surfaces could be acceptably reduced
through the use of minimal PPE or
mechanical devices that physically
separate the worker from the treated
surfaces. Such determinations might, for
example, allow early entry following
soil-directed applications if the worker
is wearing chemical-resistant footwear
and is performing tasks that do not
involve skin contact with the soil
surface. Another possible restricted
entry adjustment would be to prohibit
all routine hand labor tasks for a
specified time period, such as 1 or 2
days, and then to allow certain hand
labor tasks during the remaining
restricted-entry period if certain
(perhaps minimal) PPE is worn and
other precautions are taken. Still
another possible restricted-entry
adjustment might allow early entry
(with or without minimal PPE) if
devices, such as mechanical detasselers
or roguers, are used that minimize
worker exposure to treated surfaces.
The final rule does contain an exception
that allows early entry for activities that
involve no contact with anything that
has been treated with the pesticide to
which the REI applies, including, but not
limited to, soil, water, air, or surfaces of
plants in the treated area.
Unfortunately, it is unlikely that such
product-specific decisions will be
routine, because of their complexity.
Conveying such exceptions and
restrictions to users in a simple,
intelligible manner is difficult. The
necessary labeling would be unduly
complex. The Agency projects that such
adjustments will be most likely in those
situations where data indicate that a
relatively lengthy REI is necessary
under average conditions to adequately
reduce risk, but where such a lengthy
REI may make the pesticide's use
infeasible for certain crops for which
hand labor is necessary within tight
timeframes after application. Under
these circumstances, the Agency will
consider alternatives to the prohibition
of routine hand labor tasks throughout
the REI. In any such deliberations,
however, EPA will also consider
whether workers can be adequately
protected under a more complex set of
entry requirements.
For the longer run, because of the-
many factors that affect worker
exposure to pesticide residues, the
Agency is exploring alternative methods
of establishing REIs and alternatives to
REIs. One possible approach involves
on-site determination as to whether
residues have degraded (or are ,
otherwise unavailable) to a degree
deemed acceptable for workers to safely
enter to perform hand labor tasks
involving contact with treated surfaces.
One promising technique involves
immunoassay-based detection.
Immunoassay techniques could provide
rapid, simple, and cost-effective
methods for determining actual foliar or
soil residue levels under field
conditions. It is expected that
inexpensive kits can be developed that
will yield results in a short period of
time, thus enabling site-specific
determination as to whether residues
have decreased to an Agency-
established acceptable level for worker
entry. This technology would also
provide an effective means of signaling
to the agricultural employer when
residues remain sufficiently high so as to
make worker entry unreasonably risky,
even if the REI had expired.
EPA has determined that more
research is required to develop
immunoassay and other site-specific
monitoring systems for field residues.
However, the research data to date
indicate that an immunoassay-based
system probably could be developed.
Immunoassay devices use antibodies as
receptors to sample the environment of
the exposed surface (persons, foliage,
soil, etc). Specific antibodies to many
pesticides of concern already have been
developed and evaluated, but specific
antibodies for other priority compounds
need to be identified.
The Agency strongly encourages the
rapid development-of practical and
reliable techniques of this kind and
welcomes further information on
ongoing research and the opportunity to
cooperate with developers on the •
necessary research. To support the goal
of improving such technology, the
Agency also intends to consider
requiring the development of such
detection methods for the registration or
continued registration of selected
pesticides. Furthermore, as product-
specific reentry data are generated and
analyzed, EPA will investigate the
feasibility of adding information on the
pesticide labeling that indicates the
acceptable residue levels on the specific
surfaces of concern for that product.
Such information might encourage more
rapid development and marketing of
site-specific test kits.
3. Entry before a restricted-entry
interval expires—a. Entry for other than
hand labor tasks. Present part 170
allows workers to enter a treated area
without PPE before the expiration of the
REI if they are not performing hand
labor tasks. The Agency proposed to
modify this requirement by allowing
entry into pesticide-treated areas before
the expiration of the REI without
protective measures only when there is
no contact with pesticide residues on
treated surfaces or in soil, water, or air.
Pesticides would be considered to be in
the air, for example, in a greenhouse or
other enclosed area before the exposure
level listed on the labeling has been
reached or one of the ventilation criteria
established by § 170.110(c)(3) or in the
labeling has been met. Examples of "no
contact" activities listed in the proposal
included:
i. Operating a closed vehicle equipped
with a properly functioning positive-
pressure filtration system.
ii. Performing tasks that do not
involve contact with the soil subsurface
after a soil-incorporated or soil-injected
pesticide application.
iii. Performing tasks that do not
involve hand contact with the soil,
planting media, or plants after a soil-
directed or basal-directed application
while wearing chemical-resistant
footwear.
iv. Operating an open vehicle when
the crop is not tall enough to brush
against the worker or when pesticide
residues could not drop from trees and
other plants onto the worker.
v. Walking or riding through a
pesticide-treated area on an aisle, a
road, or a path, if the pesticide is
applied or is directed in a way that
would not cause residues to drop on the
worker and if the worker cannot brush
against treated plants or trees.
Many comments opposed any early-
entry activities. It is not clear whether
some were against early entry in
situations where there would be no
contact with pesticide residues.
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules
The Agency recognizes the need to
allow workers access to adjacent
benches or adjacent plants in
greenhouses and nurseries to carry out
other plant production tasks. In the
proposed regulation, the Agency
intended to allow workers to pass
through treated areas (walk around
benches, down aisles, etc.) after the
sprays and dusts had settled from the
air, if no contact with the treated surface
would result. The Agency considered
that walking down an aisle would result
in "no contact" after sprays and dusts
have settled if the worker was wearing
shoes with chemical-resistant soles,
even if the spray or dust has been
applied over a large area and the aisle
has received some deposit. Although the
"sprays and dusts have settled"
provision has been deleted, the Agency
believes that walking through a
pesticide-treated area on an aisle or
path would constitute "no contact" as
long as residues cannot drop on the
worker or the worker does not brush
against treated surfaces.
The Agency does not intend that
workers wearing PPE would be
considered to have "no contact."
Therefore, the example listed in the
NPRM: "Performing tasks that do not
involve hand contact with the soil,
planting media, or plants after a soil-
directed or basal-directed application
while wearing chemical-resistant
footwear" is not applicable to the final
rule. The following are examples of
situations that may be considered no
contact after sprays, dusts, and vapors
have settled out of the air:
(a) The worker is wearing footwear
and is walking in aisles or on roads,
footpaths, or other pathways through the
treated areas where the plants or other
treated surfaces cannot brush against
the worker and cannot drop or drip
pesticides onto the worker.
(b) The worker is in an open-cab
vehicle in a treated area where the
plants or other treated surfaces cannot
brush against the worker and cannot
drop or drip pesticides onto the worker.
(c) After a pesticide is correctly
incorporated or injected into the soil, the
worker is performing tasks that do not
involve touching or disrupting the soil
subsurface.
(d) The worker is in an enclosed cab
on a truck, tractor, or other vehicle.
The Agency will permit entry to a
treated area when the worker will have
"no contact" with the treated surfaces.
b. Entry for short-term tasks. EPA
proposed to allow worker entry into
treated areas after sprays have dried or
dusts have settled, but before the REI
has expired, to perform any activity, if
the workers are provided appropriate
PPE, training, and decontamination
facilities. The Agency anticipated that
agricultural producers seldom would
require workers to enter treated areas
before the REI has expired because of
theiincreased risk to the workers, the
cost of providing PPE, and the problems
of heat-related illnesses. It is expected
that most agricultural management
practices can be carried out after the
REI expires; thus, few workers would
need these protective measures.
A few comments supported the
proposal that early entry be permitted
with the use of PPE or stated that
roiitine hand labor should be allowed if
the worker is wearing the PPE required
by !EPA. Many comments opposed early
entry even with the use of PPE. One
comment noted that a requirement for
the use of PPE by field workers is not
practical and is not likely to be adhered
to in many situations. A comment stated
that the REI should be sufficiently long
so that at its expiration there are no
further concerns or restrictions on either
the field activities or the clothing worn
into the field.
Information gathered by the Agency
during the process that led to the NPRM
and comments that the Agency received
in response to the NPRM have
convinced EPA that entry during an REI
to perform routine hand labor tasks is
rarely necessary, especially when the
REI is 72 hours or less. The Agency
noted in the NPRM that:
The Agency anticipates that agricultural
producers will seldom require workers to
reenter treated areas before the reentry
interval has expired, because of the increased
risk to the workers; the cost of providing PPE,
decontamination water, and training; and the
problems related to heat-induced illnesses.
Since most agricultural management
practices can be carried out after the reentry
interval expires, few workers will need these
protective measures.
Furthermore, comments received in
response to the NPRM questioned the
feasibility of workers wearing PPE while
performing hand labor tasks under
normal agricultural field conditions. The
Agency has studied the issue of PPE for
agricultural field workers who are
performing routine hand labor tasks and
has concluded that routine use of PPE,
such as chemical-resistant gloves,
footwear, and headgear, two layers of
clothing, and protective eyewear, for
such field workers is, in general, not
only impractical, but also may be risk-
itjducing due to heat stress concerns.
The Agency has determined that hired
agricultural workers, especially
harvesters, have a disincentive to wear
PPE; because they frequently are paid at
a; piece rate, they have little tolerance
for anything that hinders their speed
arid efficiency. The Agency concludes
that it is likely that the PPE would be
removed or would be worn incorrectly if
it were required routinely in most hand
labor situations. Many comments also
observed that routine early entry during
the REI was rarely necessary.
After consideration of the comments
and the available data, the Agency has
concluded that, under most
circumstances, allowing routine entry
for unlimited time to areas under an REI,
even with PPE, decontamination, and
training, will not reduce adequately the
risk of agricultural workers' exposure to
pesticides, and that the economic
benefits associated with such routine
early entry do not justify the risks
associated with such early entry.
Consequently, the Agency is convinced
that routine hand labor tasks should not
be allowed before the expiration of the
REI, except in rare circumstances based
on case-by-case consideration.
, In this final rule, the Agency has
therefore prohibited most entry during
the REI to perform routine hand labor
tasks. The Agency will allow necessary
short-term activities, such as operating
irrigation equipment, in areas remaining
under an REI if: (1) There is no entry for
the first 4 hours after application and
thereafter until any exposure level listed
on the labeling has been reached or any
ventilation criteria established by
§ 170.110(c)(3) or in the labeling has
been met; (2) no hand labor tasks are
performed; (3) the time in treated areas
does not exceed 1 hour in any 24-hour
period for a worker; (4) the required PPE
is provided, cleaned, and maintained for
the worker; (5) the required
decontamination and change areas are
provided; and (6) the required safety
training and labeling-specific safety
information have been furnished.
As stated in the NPRM, the Agency
considers the risk of exposure for early-
entry workers to be comparable, in
some situations, to the risk for pesticide
handlers. Sometimes, early-entry
workers may receive greater exposure
than that encountered by an applicator
of the pesticide. The Agency believes
that there should be no entry to freshly
treated areas for any reason until the
dusts or sprays have settled and some
drying or volatilization of the
formulation has taken place; thus it has
prohibited entry to treated areas for the
first 4 hours after application. After 4
hours have elapsed, 1 hour should be
sufficient time to do necessary "short-
term" tasks, which the Agency is aware
must be done, and should minimize
worker exposure.
c. Exceptions to the prohibition on
routine early entry. Although the
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38113
Agency has determined, in general, not
to allow routine early entry even with
the use of PPE, the Agency did receive
information during the comment period
from the cut flower and cut fern industry
about the economic hardships that
would result in that particular industry if
routine hand labor activities were
prohibited during REIs. In that industry,
it appears that the risk-benefit balance
might militate in favor of allowing some
hand labor activity during the REI.
While no information was submitted
during the comment period
demonstrating that other industries
might suffer a significant adverse
economic effect if routine early entry
during REIs were disallowed, it is
certainly possible that other industries,
crops, or crop practices may be
significantly affected by the prohibition
of such routine early entry.
The Agency has, therefore, adopted
an exception process that would allow
interested persons to demonstrate to the
Agency that, in a particular industry,
crop, or crop practice, an exception
should be granted to the general
prohibition on routine early entry.
Persons wishing to obtain an exception
to the early-entry restrictions would
submit a request for such an exception
to the Agency.
The Agency encourages persons who
wish to submit such requests to submit
the requests as a group or association of
affected parties, rather than as
individuals. EPA expects that the most
efficient and effective request process
would ensue when a group or
association of growers and/or workers
with common interests present a single,
consolidated request for an exception.
Such a group request would both permit
a more efficient review process and lend
weight to the case that the exception
was necessary to alleviate typical
conditions in the commodity or crop-
practice situation for which the
exception is being requested and was
not a highly-specific localized situation.
Requests for exceptions that are limited
to a narrow geographic area, such as a
single agricultural establishment, must
be accompanied by persuasive evidence
that such a narrow geographic scope is
appropriate.
The Agency also notes that all of the
information pertinent to the specific
exception must be submitted with the
exception request. The rule states what
types of crops and crop production
practices might qualify for such an
exception and what information must be
supplied to the Agency in order for an
exception to be considered. If a request
for an exception is submitted to the
Agency without all of the required
information, the Agency shall return the
request to the submitter. When a request
for an exception that contains all of the
required information is submitted to
EPA, the Agency will publish a notice in
the Federal Register stating that an
exception is being considered,
describing the nature of the exception,
and allowing at least 30 days for
interested parties to comment. The
Agency will also send a copy of such
exception requests to USDA at that
time. EPA expects to cooperate with
USDA in obtaining information
necessary for analysis of the exception
requests.
If such an exception is approved, the
Agency will publish.a notice describing
the exception and the reasons for it in
the Federal Register. The final rule also
provides a means for the Agency to
withdraw exceptions if the Agency
receives poisoning information or other
data that indicate that the health risks
imposed by the early-entry exception
are unacceptable or if the Agency
receives other information that indicates
that the exception is no longer
necessary or prudent.
EPA will endeavor to review any
requests for exceptions expeditiously.
As stated above, requests from -
registrants or groups/organizations are
likely to yield the most efficient review
process. Also, the more specific the
request, the more readily the Agency
can evaluate the full range of impacts.
The Agency will consider the economic
urgency of the request and the timing of
the pest concern, crop, or production
practice for which the exception is being
requested. To expedite the exception
process, EPA intends to establish a
formal exception-review procedure that
remains outside of the usual registration
and reregistration processes. A special
organizational unit would be designated
as responsible for receiving and
processing exception requests, including
establishing a mechanism for receiving
comments, reviewing all submitted
information, and facilitating the
decision-making process among the
Agency technical experts. EPA believes
that this unique strategy will greatly
expedite the exception process and
allow the Agency to address exceptions
in a timely, manner. With this process,
EPA will endeavor to respond in a
timely manner when receiving requests
for exceptions that contain all of the
required information and will attempt to
respond with special urgency to
exception requests that are particularly
crucial due to unexpected pest problems
or crop-season timing.
The final rule provides that persons
requesting an exception may assume
that the exception has been denied if
EPA has not published its decision
whether to grant the exception within 9
months from the comment-closure date
specified in the Federal Register notice
in which the Agency announced that it
would consider the exception, unless the
Agency has taken action to extend its
review period for a specified time
interval due to the complexity of the
exception request or to the number of
exception requests concurrently under
Agency review.
While exception requests may be filed
immediately, the Agency is also
interested in receiving additional
comments and information on both the
general prohibition of routine early entry
for-the performance of hand labor tasks
during REIs and the mechanism and
criteria for granting exceptions to that
general prohibition. EPA is therefore
providing an additional 60-day period
during which written comments, data,
and other evidence concerning these
specific topics may be submitted to the
Agency for consideration. Upon review
of these comments, EPA may modify
this final rule where appropriate. This
additional comment period should allow
for possible refinement of this rule
without delaying its implementation and
without delaying the consideration of
exceptions that may prove to be
necessary.
Comments that EPA has already
received from the cut flower and cut
fern industry have convinced EPA that
this industry, at least, probably
warrants such an exception.. The
decision that such an exception is
probably warranted is based on a
balance of the risks and benefits that
would result from such an exception
(see proposed exception to rule
published elsewhere in this issue of the
Federal Register). The Agency is
unaware of any specific information
indicating that crops or industries other
than the cut flower and cut fern industry
would qualify for such an exception, but
the exception process adopted in this
final rule provides interested persons an
opportunity to submit relevant
information to the Agency if they
believe additional exceptions are
warranted.
A:Entry for agricultural emergencies.
Several comments suggested that early
entry.be allowed for emergencies on a
case-by-case basis. If there are
situations in which workers need to
enter an area before the expiration of an
REI, growers should be able to obtain
permission, in advance, from the EPA or
the State lead agency.
The Agency recognizes there may be a
need for workers to enter a treated area
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38114 Federal Register / Vol. 57,'No. 163 / Friday. August 21, 1992 / Rules and Regulations^
before the expiration of an REI to
perform tasks, including hand labor
tasks, in agricultural emergencies. The
Agency regards an agricultural
emergency as a sudden occurrence or
set of circumstances that the employer
could not have anticipated and over
which the employer has no control,
requiring entry into a treated area, when
no alternative practices would prevent
or mitigate a substantial economic loss.
A substantial economic loss means-a
loss in profitability greater than'that
which would be expected on the basis of
experience and fluctuations of crop
yields in previous years. Only losses
caused by the emergency conditions
specific to the affected site and
geographic area are considered. The
contribution of mismanagement cannot
be considered hi determining the loss.
Such emergencies might consist of
unexpected and severe .adverse
weather, such as frost, high winds,
tornado,, or hurricane, or an unexpected
and severe pest outbreak immediately
before harvest on a time-sensitive crop
such as .the soft fruits, soft vegetables, or
floral crops. If an emergency is
anticipated through a weather forecast,
pest outbreak bulletin, or other means, it
is not acceptable to proceed with a
pesticide application after becoming
aware of an impending emergency and
then require workers, due to the
emergency, to enter the treated area
before the REI has expired.
The Agency has modified the early-
entry restrictions to permit entry to
areas under REIs in agricultural
emergencies if a State, Tribal, or Federal
agency having jurisdiction declares that
the circumstances for an agricultural
emergency exist and the employer
determines that the agricultural
establishment is subject to the
emergency. Entry is permitted if: (1)
There is no entry for the first 4 hours
after application and no entry thereafter
until any exposure level listed on the
labeling has been reached or any
ventilation criteria established by
§ 170.110(c)(3) or in the labeling has
been met, (2) the required PPE is
provided; cleaned, and maintained for
the worker, (3) the required
decontamination and change areas are
provided, (4) the required general
training and label-specific information
has been furnished, and (5) only tasks
related to mitigating the emergency are
performed.
C. Notice of Applications
The Agency proposed that workers on
an agricultural establishment be notified
of pesticide applications and areas
remaining under an REI. An exception
was proposed for farms, forests, and
nurseries—no notification would be
necessary if, from the start of
application until the end of the REI, the
worker would not enter, work in, remain
im, or pass through, on foot or in an open
vehicle, the pesticide-treated area or
a.ny neighboring areas, including
growing areas and labor camps that are
contiguous or separated only by a
roadway from the treated area. A
similar exception proposed for
greenhouses stated that no notification
would be required if, from the start of
application until the end of the REI, the
worker would not enter, work in, remain
in, or pass through the greenhouse.
These exceptions were designed to limit
the notification requirement to those
occasions where the most potential for
eiccidental worker exposure exists and
where notification would prove most
useful. Notification would not be
required when pesticides are applied at
times when no workers are employed by
the establishment or when pesticides
are applied to (or an REI is in effect at)
distant areas of the establishment where
no work activities are occurring.
Some comments supported these
exceptions; some requested that the
exceptions be dropped and that workers
be notified of any pesticide-treated area
on the property, because crews may
enter treated areas by mistake. One
comment wanted to have information
provided to workers about pesticides
used in areas contiguous to the area
where they will be working. Another
noted that since only a small percentage
of farms require hand labor for
cultivation or harvesting, it seems
impractical to post fields when the only
pjie who would be entering is the farmer
who caused the field to be treated.
A few comments requested a
definition of the word "neighboring,"
and some stated that "neighboring
ikreas" should be defined as property
controlled and/or owned by the
employer.
After careful consideration, the
Agency has decided to retain but
reword the exception to notification on
farms and in nurseries and forests. The
term "neighboring area" has been
deleted; the final rule requires
notification if workers may be within I/
4 mile of the treated area's perimeter.
This distance was chosen for several
reasons. First, data .from studies show
that residue drift from a treated area is
itiegligible beyond 1/4 mile. Second, the
Agency believes that 1/4 mile is the
farthest distance that workers would be
likely to digress from their path or work
site for rest or meal breaks. Although
the Agency believes that a prudent
owner/opera tor of an agricultural
establishment will inform adjacent
property owners/operators of pesticide
applications at their mutual borders,
EPA has determined that such a
requirement is beyond the scope of this
rule. The exception to notification in
greenhouses has not been changed.
The Agency has added an additional
notification exception that applies to all
agricultural establishments. Notice (oral
or treated area posting] need not be
given to a worker if the worker (1)
applied or supervised the application of
the pesticide for which the notice would
be given and (2) the worker is already
aware of the information that would be
otherwise conveyed in an oral warning.
This exception exempts establishments
from having to orally warn or post
warning signs at treated areas for an
already-informed applicator of the
pesticide. This exception would be
especially important if the pesticide
applicator is the only worker on the
establishment for whom notification
would otherwise be required.
1. Oral notification. The Agency
proposed that workers be given daily
oral warnings about pesticide-treated
areas on farms and in forests, except as
noted above. The warnings would
consist of: (1) The location and
description of the treated area, (2) the
time during which entry is restricted,
and (3] instructions not to enter the
treated area until the REI has expired.
The warnings would be required to be
given in a manner the worker can
understand.
Several comments supported the
requirement for mandatory oral
warnings on farms and forests because
large numbers of agricultural workers
would not be able to read material
printed in English.
Some respondents felt that oral
warnings should be required only on the
first work day for any worker or when
there is a change in the spraying
schedules because daily warnings may
cause workers to ignore the repetitive
message. Some comments stated that
oral warnings would be unworkable in
some agricultural operations because
employees may report to work from
different locations at different times of
the day, e.g., coming from on-farm
camps or local housing or being bused
from cities or other farms.
Other comments objected to
mandatory oral warnings and requested
that employers be given a choice of
using oral warnings or posting warning
signs. One respondent suggested issuing
cards containing information about
spraying to workers in lieu of oral
warnings.
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Some comments stated that oral
warnings are more effective if they
include information such as the name of
the product or active ingredient, the
location of labeling, and/or safety
information for the product and the REI.
• Most comments supported a
requirement that oral warnings be
communicated in a language the worker
can understand. However, a few noted
that it would be difficult for growers to
find persons who could provide
translations into all the languages that
might be needed.
The Agency has been persuaded that
farm and forestry operations should
have the choice of notifying workers
orally or by posting signs at the treated
area. EPA is convinced that for highly
diversified farms where different crops
would be grown close together or for
large agricultural operations where
many workers are employed, oral
warnings may be impractical and may
not be as protective as posting signs at
the treated area. However, the Agency
believes that most farm and forestry
employers will opt to warn employees
orally. Signs that employers post must
meet the same criteria as the signs for
the mandatory treated-area posting.
The Agency also has been persuaded
to eliminate the requirement that oral
notification be given daily. Instead,
employers are required to notify
workers before the worker's first
opportunity for exposure to any treated
area. Regardless of whether the
employer uses oral notification or
posting, the Agency is requiring that
application-specific and restricted-entry-
specific information be posted at a
central location accessible to all
workers. This information will remind
workers of areas where pesticides are
being applied or where an REI is in
effect. EPA is convinced that additional
information about the pesticide
application can be conveyed more
effectively through these centrally
located notice areas than through oral
notification. Providing information about
applications on printed cards is not a
practical alternative to oral notification
because of language problems and the
cost of duplicating the information.
2. Posting pesticide-treated areas.
Besides oral warnings, the Agency
proposed to require the posting of
warning signs in areas of farms and
forests treated with pesticides having
REIs greater than 48 hours, except when
no workers would be in the area, as
discussed above. The Agency also
considered other posting options, such
as for pesticides with REIs more than 24
hours.
Some comments supported the
proposed posting requirements, but
some stated that posting must be
supplemented with oral notification,
particularly on large farms and in
forests where posting may be difficult.
Many comments advocated daily oral
notification supplemented with
mandatory posting so that persons
working near the area or moving through
the area are aware of the application
and can avoid contact.
Some comments stated that areas
treated with pesticides having REIs
exceeding 24 hours should be posted
because posting is an unequivocal way
of communicating to workers their right
and duty not to enter a treated field.
Some comments said that posting for
all pesticides with an REI of greater than
24 hours would be more consistent with
the purpose of the proposed rule than
posting only for intervals greater than 48
hours. The latter, they said, would
exempt nearly all pesticide applications
from posting. They stated that oral
warnings alone are inadequate for
warning workers of the hazards of entry
from products in toxicity categories I
and II and suggested the requirement
might be met by posting a map showing
treated areas.
Other comments opposed any
mandatory field posting requirement.
One stated that workers could be
notified by a centrally located
information board.
The Agency has reviewed the
comments on mandatory field posting
and has decided to modify these
requirements. The Agency has defined
at least two objectives for posting of
treated areas: (1) Warning of areas
treated with pesticides that are so toxic
that incidental exposure, i.e., contact
from brushing against the treated
surfaces, could cause an acute illness or
injury and (2) warning of areas treated
with pesticides for which a short
exposure could have the potential for a
delayed effect, such as developmental
toxicity. The final rule requires posting
for all pesticides that contain active
ingredients that are classified as toxicity
category I because of acute dermal
toxicity or skin irritation potential. On a
case-by-case basis, the Agency also may
require posting for other pesticides that
the Agency deems may produce adverse
health effects from a short-term
exposure.
The Agency will require that oral
notification also be given to workers
when posting is required so that a
second tier of warning is provided for
these pesticides. Pesticides meeting
these criteria will have a statement in
their labeling that the treated area must
be posted and workers must be notified
orally.
The Agency proposed that "When
several contiguous areas are to be
treated with pesticides on a rotating or
sequential basis, the entire area may be
posted." This would allow posting of a
larger area than the treated area when a
continuous spraying operation treats
alternative rows or areas, rather than
the entire area, on a sequential basis.
Since posting of individual rows in this
case would be difficult and expensive,
the Agency would allow the entire area
to be posted. However, no part of this
entire area may be entered while signs
are posted, except under the conditions
specified in the regulation for early
entry. The Agency has retained this
provision in the final rule.
3. Warning sign. The Agency
proposed a standard warning sign
containing a stern-faced person with an
upheld hand containing the words
"DANGER - PESTICIDES - KEEP OUT."
Although the sign proposed by the
Agency received some support, many
comments requested modifications to
the symbol or the wording. There were
suggestions that the sign should contain
the skull and crossbones or should use
some international symbol.
After consideration of the comments,
EPA remains opposed to the use of the
skull and crossbones symbol for the
reasons stated in the NPRM and
because posting may be required by the
Agency not only for the most acutely
toxic pesticides but also for some
pesticides in other toxicity categories.
Acute toxicity is only one factor in
determining what areas should be
posted; posting will be required by the
Agency on a case-by-case basis during
registration, reregistration, or special
review for pesticides presenting other
types of risks. Furthermore, farm, forest,
and nursery establishments may choose
to post all pesticide applications, and
greenhouse establishments must post all
pesticide applications.
The Agency did not find an
appropriate international symbol that it
believed conveyed the desired message.
The Agency has not been persuaded
that the basic design of the sign should
be changed. The Agency is convinced
that mandatory worker training will
promote worker recognition and
understanding of the sign proposed in
the NPRM.
Some comments expressed concern
that the words "Pesticides" and/or
"Danger" make the sign too negative;
others recommended that pesticide
signal words such as "DANGER" or
"CAUTION" be reserved for use with
specific materials that carry relevant
toxicity classifications. Some suggested
that to use the word "DANGER" or the
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38116 Federal Register / Vol. 57, No. 163 / Friday. August 21. 1992 / Rules and Regulations
skull and crossbones symbol on posting
signs would be misleading and weaken
the meaning of these signals where
materials in toxicity categories III or IV
might be involved.
Some comments requested that the
signs be in as many languages as
necessary to reflect the composition of
the work force; others requested that
additional information be required on
the signs, such as the name of the
pesticide, the date and time applied, and
where toxicity information may be
obtained.
The Agency is persuaded to change
the wording of the treated area warning
sign. The words "DANGER/PELIGRO,"
"PESTICIDES/ PESTICIDAS " and
"KEEP OUT/NO ENTRE" will be
required. The Agency realizes that
Spanish/English signs cannot be read by
all workers, but it is impractical to
require printing in all the languages used
by workers.
The Agency believes that removal of
the words "Pesticides" and "Danger"
from the signs would defeat the purpose
of the signs. Changing the wording to
reflect the signal word for the pesticide
used would require the employer to
have several sets of signs, which would
be burdensome. The objective of posting
is to keep workers out of an area under
treatment, not to inform them of the type
or degree of hazard.
Because the Agency believes that a
generic treated-area sign is the most
practical, economical, and reasonable
choice, it will not require application-
specific information to be listed on the
sign. Such information may be added to
the sign if the information does not
interfere with the other components of
the sign. Application-specific
information will be required at the
centrally located notification area.
The Agency proposed that warning
signs be visible from all usual points of
worker entry to the pesticide-treated
areas, including each access road, each
border with any labor camp adjacent to
the pesticide-treated area, and each foot
path and other walking route that enters
the pesticide-treated area. When there
were no usual points of worker entry,
signs were to be posted in the corners of
the pesticide-treated area or in any
other location affording maximum
visibility.
Several comments requested that
posting also be used to protect other
persons, such as persons who live in
houses or labor camps adjacent to the
fields and persons who may be passing
by fields. Some comments advocated
posting at specified distances along the
perimeter of treated areas in addition to
the usual points of access; others noted
the difficulty in posting all entries to
forested areas.
The Agency believes that "at the
usual points of entry" is the most
reasonable requirement for placement of
the signs. Posting at specified intervals
aiding the perimeter is unnecessary and
burdensome. Labor camps within or
adjacent to treated areas must be posted
when posting is required for the treated
area. Posting a warning sign at a central
location is an inadequate replacement
for the posting of treated areas.
Although posting may be difficult for
forestry operations, the Agency believes
it is feasible to post at locations that
may be considered usual points of
access, such as at the place where
logging roads enter a treated area.
The Agency also recognizes the
concerns expressed about warning
persons other than workers. While the
intent of the rule is to protect •'•
agricultural workers, the requirement for
posting treated areas will provide
warning to other people who might enter
the treated area inadvertently. The
Agency intends to consider additional
actions to deal with exposures not
coyered by these regulations. These
include non-agricultural exposures,
agricultural exposures excluded from
theise regulations, and exposures to the
public.
4. Notice of applications in
greenhouses and nurseries. In
greenhouses and nurseries, the Agency
proposed mandatory posting of all
entry-restricted areas instead of oral
notification, unless there are no workers
in the area.
Some comments supported the
requirement as proposed, stating that
the requirement to post pesticide-treated
areas seems fair in lieu of oral warnings.
Others objected to the requirement
because nurseries were singled out for
more restrictive posting requirements
than forests or farms.
The Agency has considered the
various comments and has decided to
retain the mandatory posting
requirement for pesticide applications in
greenhouses, but to change the
requirement for nurseries. Although
some nurseries are much like
greenhouses with many crops grown in
small areas, others more closely
resemble farms. Therefore, the Agency
is persuaded that nursery employers,
like farm employers, should be
permitted to choose between oral
notification and posting pesticide-
treated areas except when mandatory
posting and oral notification are
required by the labeling.
D. Personal Protective Equipment (PPE)
The predominant route of pesticide
exposure in outdoor agricultural work,is
through the skin. Therefore, any barrier
that can be placed between the
employee and the chemical to reduce
contact with the skin reduces the risk of
pesticide poisoning. EPA concluded, in
the proposal, that except for enclosed
cockpits and enclosed cabs with
positive-pressure filtration systems, the
only other practical barrier available to
pesticide applicators is PPE. For mixers
and loaders, closed systems and
technological advances in containers
and packaging, such as water-soluble
bags, have potential, but work is needed
to perfect these approaches. The NPRM
stated that PPE was the most
practicable approach to reducing
occupational exposure to agricultural
pesticides.
The proposal required the use of PPE
appropriate to the pesticide and the
work activity. The proposal also
required employers to provide, clean,
and maintain such equipment.
Several comments stated that PPE
should be the last resort for protection
and that engineering controls should be
explored first. Some studies of desirable
methods of protection have concluded
that PPE ranks below removal of
employees from areas where they may
be exposed, system design, and
mechanical protection. Some comments
stated that the proposed rule dismisses
mechanical techniques of reducing or
eliminating exposure as being
unavailable or of limited utility and that
this is in sharp contrast with other
regulatory proposals developed by EPA
and other Federal agencies which "force
technology" by providing a lead time for
nonmechanical solutions and then
requiring the application of the "best
available technology."
Unlike industrial environments, which
are more controlled and confined,
agricultural settings do not lend
themselves as easily to engineering
controls. The Agency is aware of the
emergence of engineering controls
suitable for agricultural situations and is
considering the adoption of such
controls on a product-specific basis
during the registration, reregistration,
and Special Review processes. Until
adequate engineering controls are
developed and tested, PPE will remain
the primary means of mitigating
exposure for agricultural pesticide
handlers. The elimination of routine
early entry for hand labor activities may
"force" the development of engineering
controls, such as mechanical harvesters,
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38117
weeders, and primers, in crops where
the timing of such tasks is critical.
Some comments requested that closed
system mixing and loading and enclosed
cab application be required for all
toxicity category I pesticides to reduce
employee injuries.
Some comments agreed with the
proposed reduction of PPE requirements
during use of closed mixing/loading
systems. However, another comment
requested that EPA not reduce PPE
requirements for closed system mixing/
loading. It stated that pesticides are
highly corrosive and that the Agency
has no program to inspect and certify
such systems. The comment asserted
that the efficacy of closed systems has
been impaired by the failure of the
Agency or the manufacturers to
establish uniform specifications for
container openings.
One comment stated that the
regulation should contain incentives to
develop low-risk transfer and cleaning
options. Requiring the use of chemical-
resistant gloves and aprons to transfer
granules in a closed system will cause
applicators to stay with more dangerous,
but cheaper, conventional systems.
Similarly, if self-cleaning mechanisms
are provided for pesticide equipment,
PPE requirements should be reduced.
Several comments requested that
engineering controls such as wiper
wands, low-pressure nozzles, and
stream emitters be rewarded with
reduced PPE requirements.
EPA considered requiring closed
systems for mixing and loading all
highly toxic pesticide concentrates. The
Agency has decided to encourage the
use of such systems by reducing the
amount of PPE required when closed
systems or enclosed cabs are used for
mixing, loading, applying, or other
handling activities, but it will not require
the use of such systems. The Agency
agrees that for closed systems to be
most effective in reducing exposure, the
kinds and types of equipment used in
such systems and the maintenance of
such equipment must be standardized.
Such a program is beyond the scope of
part 170 as proposed; the Agency is
investigating several types of
engineering controls and may require
the use of such controls in the future.
The Agency also agrees that "rewards"
such as a reduction of PPE requirements
are incentives for handlers to use
engineering controls, but eliminating all
PPE requirements during the use of
closed systems does not seem to be
prudent. A number of accidents are
reported despite the use of closed
systems.
One respondent requested that EPA
require state-of-the art protective
clothing for employees where
appropriate; another was concerned that
the Agency not establish excessively
rigid requirements that would
discourage use of improved knowledge
or technology.
EPA intends to remain attentive to the
development of innovative PPE and to
adjust the PPE requirements as
appropriate.
1. Personal protective equipment
(PPE) for early-entry workers. The
Agency proposed minimum PPE
requirements, based on the acute
toxicity of the active ingredient, for the
protection of workers who enter treated
areas before the expiration of an REI.
Several comments stated that early-
entry PPE should be the same as the PPE
required for handlers, presumably
including respiratory protection.
Another stated the Agency should have
a better rationale for excluding
inhalation toxicity as a hazard for
workers entering fields after dusts have
settled, sprays have dried, or vapors
have dispersed.
The Agency intends to eliminate
workers' respiratory exposure during
application (which is defined as
continuing until the pesticide is no
longer being dispersed] by prohibiting
workers from being in or near the
treated area. The Agency has concluded
that respiratory protection is not needed
during the permitted entry after
application.
Many comments recommended that
no early entry be allowed, because
workers will not use the PPE if the
weather is too hot or will risk heat
stress if they do wear the equipment. A
few comments objected to PPE other
than normal work attire for early-entry
workers by expressing the belief that, in
most cases, long-sleeved work shirts
and long work pants provide adequate
protection.
Several comments expressed dismay
that no minimum PPE was established
for early-entry workers in areas treated
with pesticides in toxicity categories III
and IV and recommended that early-
entry PPE for these pesticides should be
normal work attire plus chemical-
resistant gloves because many of these
chemicals are skin irritants. Others
requested that coveralls and chemical-
resistant gloves be the minimum PPE for
early entry after all pesticide
applications.
In the NPRM, there was a generic REI
for pesticides in toxicity categories III
and IV of, "until sprays have dried, dusts
have settled, or vapors have dispersed."
Since the proposal contained a complete
ban on hand labor activities during that
period, there was no need to specify PPE
for early entry for pesticides in toxicity
categories III and IV.
In the final rule, the Agency has
established a 12-hour REI in lieu of the
generic "until sprays have dried, dusts
have settled, or vapors have dispersed"
and specifies minimum PPE for early
entry for all pesticides.
The prohibition on most early-entry
activities in the final version of part 170
has eliminated the need for most uses of
early-entry PPE. For those exceptional
circumstances when early entry is
permitted, the Agency has decided to
require early-entry workers to wear the
PPE required for an applicator of the
pesticide (with the exception of
respiratory protection) for pesticides in
toxicity categories I and II. The Agency
has specified that the minimum attire for
early entry for pesticides in toxicity
categories III and IV will be coveralls,
waterproof or chemical-resistant gloves,
socks, and shoes. This minimum attire is
based on the Agency's desire to have
the body protection (coveralls) provided,
cleaned, and maintained for the worker
and on the Agency's belief that some
early-entry workers may receive greater
exposure to pesticides through residues
in the treated area than handlers may
receive during application. The Agency
reserves the right to establish different
PPE requirements for early-entry
activities on a case-by-case basis if
evidence supports such action.
The Agency does not believe that
requiring PPE or "normal work attire"
after the expiration of the REI is
warranted. Where data indicate that
such protection is needed, the Agency
will establish such a requirement;
however, it is more likely that the REI
would be extended until the PPE would
no longer be needed.
2. Personal protective equipment
(PPE) for pesticide handlers. Ideally,
each pesticide product labeling should
list specific PPE reflecting the
formulation, anticipated exposure level,
and toxicity of the product. These
determinations are made or are refined
as products are registered or
reregistered. However, the Agency
acknowledges that many pesticide
labels require PPE for handlers that is
inadequate by the Agency's present
standards. The Agency proposed to
establish PPE requirements until
appropriate product-specific
requirements can be established.
Registrants would be required to list the
requirements on the labeling for each
pesticide product. In this final rule, the
Agency is establishing, through parts 156
and 170, minimum requirements for PPE
for handlers of all agricultural pesticides
in various exposure situations.
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38118 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
Handlers, such as those mixing,
loading, and applying pesticides and
those involved in flagging, repairing,
adjusting, changing, or cleaning
equipment face potentially dangerous
levels of exposure to pesticides unless
adequate protection is used. The risk of
exposure is especially high for handlers
who perform all these tasks and for
persons, such as commercial pesticide
handlers, who perform these tasks
frequently.
Results of numerous studies indicate
that more than 97 percent of the
pesticide to which the body is exposed
during handling (especially during spray
applications) is deposited on the skin.
The hands and forearms account for the
highest percentage of total dermal
exposure. For ground applicators,
mixers, and loaders, respiratory
exposure constitutes a small percentage
of total exposure in outdoor handling
operations unless highly volatile
formulations are involved. Respiratory
exposure cannot be ignored in outdoor
applications, however, since nearly 100
percent of any pesticide that enters
through the lungs and gastrointestinal
tract is absorbed. When pesticides are
used in enclosed structures, the risk of
respiratory exposure is greater than
when pesticides are used outdoors.
a. Basis for the requirements. The
Agency considered whether the toxicity
category of the formulated product was
the appropriate basis for the PPE
requirements for pesticide handlers.
When the formulated pesticide product
is diluted by the user, the resulting
solution may be less toxic than the
concentrated formulated product. When
EPA establishes product-specific PPE
requirements during registration or
reregistration, it uses any available
registrant-supplied data on the acute
toxicity of the diluted product to
determine the appropriate PPE for
exposure to the diluted product. The
Agency proposed to base the
requirements on the toxicology of the
formulated product. By submitting data
on the toxicity of the diluted pesticide
product, however, registrants could
reduce the PPE requirements for
handlers, except for mixers and loaders
who would be exposed to concentrates.
The Agency proposed that handlers of
pesticides that are hi toxicity category
III or IV because of acute dermal or skin
irritation potential be required to wear
"normal work attire" (long-sleeved shirt,
long pants, shoes, and socks). For
pesticides that are hi toxicity category
III because of dermal toxicity or skin
irritation potential, handlers also would
be required to wear chemical-resistant
gloves. For pesticides that are in toxicity
category III or IV because of inhalation
toxicity or eye irritation potential, the
Agency proposed no minimum PPE
requirements, but reserved the option of
requiring PPE for those hazards on a
product-specific basis as warranted by
evidence.
Most comments supported the
Agency's proposal to base PPE
requirements on the toxicity of the
formulated product and the Agency's
use of a table to determine the
appropriate attire for a pesticide
product.
Some comments recommended that
PPE for applicators be based on the
toxicity of the dilute product; another
requested that PPE be based on the type
of formulation as well as the acute
toxicity. One comment stated that
toxicity should not be the sole
determinant of PPE and that use pattern
and mode of action must be considered.
.This regulation allows registrants that
have data on the toxicity of the dilute
product to use that data in establishing
tlys PPE requirements for handlers
exposed to the diluted product.
However, basing PPE on the type of
formulation, the use pattern, or the mode
of, action is best accomplished on a
product-specific basis during the case-
by-case review of a product. Therefore,
the Agency will not consider these
factors in establishing the generic PPE
requirements for pesticide handlers in
part 156.
b. Types of personal protective
equipment (PPE) required—i. Body
protection. In the current regulations,
"protective clothing" is defined as "at
least a hat or other suitable head
covering, a long-sleeved shirt and long-
legged trousers or a coverall-type
garment (all of closely woven fabric
covering the body, including arms and
legs), shoes and socks." The Agency
now deems this clothing inadequate to
protect either handlers or workers
entering treated areas before the
expiration of the REI.
In the NPRM, the Agency proposed
minimum PPE requirements that would
vary according to: (1) The acute toxicity
of the pesticide, (2) the type of employee
activity, (3) route of exposure, and (4)
the presence of engineering controls.
Under the proposal, all handlers and
early-entry workers exposed to
pesticides in toxicity category I or II
because of either dermal toxicity or skin
irritation potential would be required to
we;ar a protective suit over normal work
attire.
Some comments requested that
chemical-resistant protective suits be
required for handling all pesticides in
toxicity categories I and II, especially
for airblast applications. One comment
requested a change in the definition of
"protective suit" to include suits made
of nonwoven materials.
The Agency has changed the term
"protective suit" to "coverall" and
changed the definition. "Coverall"
means any loose-fitting one- or two-
piece garment that covers, at a
minimum, the entire body except the
feet, hands, and head.
The Agency considered requiring the
use of a chemical-resistant protective
suit when handling pesticides in toxicity
category I (acute dermal), but was
persuaded that two layers of clothing
provide adequate protection. To
minimize dermal exposure to pesticides,
protective garments must be worn to
cover any body area(s) of concern.
Cotton or cotton and polyester, i.e.,
woven fabrics, are preferred for work
clothing because they are more
comfortable to wear, and they can be
washed. Appropriate protective
coverings, such as coveralls, can reduce
the exposure to pesticide users' trunk
area, arms, and legs by 99 percent. One
study concluded that the use of
rubberized clothing did not provide
more protection than the regular work
clothing (consisting of cotton shirts and
trousers worn under long-sleeved
coveralls). The final rule, however,
allows users to wear a chemical-
resistant protective suit as an
alternative to the two layers of clothing.
The development of various types of
disposable chemical-resistant garments
made of nonwoven materials, such as
Tyvek (spunbonded olefinic fibers),
gives pesticide users a wide choice of
protective materials.
Most comments on the requirement to
wear a protective coverall over another
layer of clothing asked the Agency to
reconsider; objections centered on the
problems of heat-related illness and
discomfort associated with wearing two
layers of clothing in the summer months.
One comment stated that if a protective
suit is worn and becomes contaminated,
it can be discarded and replaced with a
clean suit on site, whereas if the normal
work attire becomes contaminated, the
worker may have to return home in
contaminated clothing.
Numerous comments stated that the
more uncomfortable protective clothing
becomes, the more likely it is that
employees will avoid wearing the
protective clothing or the more likely
they will not complain to the
appropriate authority about the lack of
protective clothing in the event the
employer fails to furnish such clothing.
Another comment stated that, in an
emergency, stripping the coverall off
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Federal Register / Vol. 57. No. 163 / Friday, August 21. 1992 / Rules and Regulations.^ 38119
quickly, washing, and putting on the
extra coverall that is required to be kept
at the decontamination site would be
more protective than a false sense of
security brought by two layers of
clothing.
Some comments stated that
convincing handlers to wear a coverall
and chemical-resistant gloves would be
a major breakthrough in PPE and that a
requirement for two layers of protection
might discourage any compliance.
The Agency considered the comments
on the requirement for handlers and
early-entry workers to wear a long-
sleeved shirt and long pants under a
coverall in activities involving
pesticides that are in toxicity category I
or II because of dermal toxicity or skin
irritation potential. A review of the
literature revealed several studies
supporting the concept of layering as an
effective protective system; the
protection afforded by protective
clothing is proportional to the thickness
and the closeness of the weave.
The Agency recognizes that the use of
PPE in hot, humid working conditions
may lead to heat stress and discomfort.
But the alternative of requiring the use
of a single-layered chemical-resistant
suit would not solve these problems.
The Agency does not consider a coverall
without an additional layer of clothing
to be protective for pesticides with an
acute dermal toxicity value in toxicity
category I or II. The Agency does
recognize, however, that pesticides in
toxicity category I present a greater
hazard and risk than those in toxicity
category II. Therefore, the Agency will
require either a chemical-resistant
protective suit or a coverall worn over a
long-sleeved shirt and long pants when
handling pesticides classified as toxicity
category I for dermal toxicity or skin
irritation. For handling pesticides
classified in toxicity category II for
dermal toxicity or skin irritation, a
chemical-resistant protective suit or
coveralls worn over a layer of clothing
that covers the trunk area (e.g., T-shirts
and shorts) is specified.
Many comments agreed with the
proposed PPE requirements for "normal
work attire," which was defined as long
pants, a long-sleeved shirt, shoes, and
socks, for handlers of pesticides in
toxicity categories III and IV. But
several other comments requested that
more than "normal work attire" be
required for handlers of pesticides in
toxicity categories III and IV.
The Agency has considered the
comments regarding the PPE required
for handling pesticides in toxicity
categories III and IV and has
determined that the PPE proposed is
adequate to protect handlers of these
pesticides. The Agency has written the
PPE requirements to create an incentive
for users to choose less acutely toxic
pesticides whenever possible.
Several comments requested EPA to
clarify that its intent was to establish
"normal work attire" for pesticide-
handling activities and not for all work
on agricultural establishments.
To eliminate the confusion, the phrase
"normal work attire" is not used in the
final rule. PPE and other clothing
required for handling the pesticide will
be specified on pesticide labeling.
ii. Hand protection. Dermal exposure
of the hands and forearms is the most
significant route of pesticide exposure
for hand laborers, applicators, mixers,
loaders, and other persons who are
exposed occupationally to agricultural
pesticides and their residues. It has been
estimated that chemical-resistant gloves
can reduce hand exposure by as much
as 98 percent.
The Agency proposed to require
chemical-resistant gloves for all early-
entry and pesticide handling situations
involving pesticides that are in toxicity
categories I, II, or III because of dermal
toxicity or skin irritation potential. [No
gloves were required for early-entry or
pesticide handling situations for
pesticides in toxicity category IV).
Leather gloves, uncoated cloth gloves,
and fingerless gloves are not acceptable,
because liquid and particulate
pesticides can penetrate them. The
Agency considered an exception for
early-entry workers handling roses,
because sturdy, flexible glove materials
such as leather will withstand the wear
and tear from thorns while providing
sufficient dexterity.
Few comments discussed glove
materials. The greenhouse industry
asked to be permitted to wear leather
gloves while working with roses and
other thorny plants.
The Agency has determined that
multiple-use cotton gloves and cotton-
lined gloves are not acceptable for use
in pesticide handling or early entry
because they are difficult to
decontaminate after usel If suitable
puncture-resistant and chemical-
resistant gloves are not obtainable, the
Agency will allow the use of leather
gloves for working in thorny plants, with
two restrictions: (1) Chemical-resistant
glove liners must be worn, and (2)
leather gloves that have been worn once
for protection from pesticide exposure
shall thereafter be worn only with
chemical-resistant liners.
A few comments stated that either the
pesticide registrant or EPA should give
more specific guidance on how to
determine which glove materials are
chemical-resistant to specific pesticide
formulations.
The Agency concurs and has
developed a guidance package for
pesticide users on the selection, use, and
maintenance of chemical-resistant
gloves. The final rule requires
registrants to specify in the product
labeling the appropriate type of gloves
to be used with the product. EPA will
continue to cooperate with the
American Society for Testing and
Materials to develop testing criteria for
chemical resistance in gloves and to
sponsor research into the chemical
resistance of various glove materials.
hi. Foot protection. The feet may be
exposed to pesticides from spills,
splashes, or downward sprays, and from
walking through vegetation after
application while sprays are still wet.
The Agency proposed to require
chemical-resistant footgear for handlers
and workers entering areas treated with
pesticides in toxicity category I or II
(dermal/skin irritation).
A few comments stated that wearing
chemical-resistant footwear can be
uncomfortable and may cause a foot
disease similar to trench foot. Many
comments urged the Agency to
reconsider the requirement for chemical-
resistant footwear in forests, stating that
leather boots are worn for traction on
rocks and debris, protection from pests
and snakes, and for durability. The
comments stated that the safety hazards
of working in this environment increase
if chemical-resistant boots or boot
covers are required.
Because of the problems inherent in
decontaminating non-chemical-resistant
footwear, the Agency will continue to
require the use of chemical-resistant
footwear for pesticides in toxicity
categories I and II (dermal toxicity or
skin irritation). However, the Agency is
persuaded by the comments that for
physical safety, pesticide handlers and
early-entry workers in rough terrain
should be permitted to wear leather
boots if chemical-resistant boots of
sufficient traction and durability are not
obtainable.
iv. Eye protection. The eyes and face
may be exposed whenever there is a
chemical splash or a high level of mists,
vapors", or dusts during mixing, loading,
and applying pesticides or whenever
residues are dislodged from foliar
surfaces above the head of the worker.
The Agency proposed to require the use
of goggles or a face shield by all
handlers and early-entry workers
exposed to pesticides with toxicity
category I or II eye irritation potential.
Goggles or a face shield also would be
required during mixing and loading
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38120 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
using pressurized closed systems
because of the high risk of exposure and
serious eye injury if the system ruptured.
Many comments pointed out that
goggles and face shields are
uncomfortable during prolonged use in
hot weather and that there should be
some provision for employees who wear
eyeglasses. Others commented that for
most pesticides and use circumstances,
several styles of eye protection provide
near goggle-level protection at greatly
increased levels of wearer comfort and
with less tendency to fog.
The Agency is persuaded that safety
glasses with protective shields at the
eyebrows and temples provide adequate
eye protection in most pesticide
handling and early-entry situations.
Because they are more acceptable than
goggles to employees, they would be
more likely to be used. The regulation,
therefore, has been modified to require
the use of "protective eyewear" in
handler and early-entry situations
involving pesticides in toxicity
categories I and II for eye irritation. .
When "protective eyewear" is required,
the employer shall provide goggles, a
face shield, or safety glasses with side
shields and brow guards.
For products in toxicity category I for
eye irritation, the Agency may, on a
case-by-case basis, require the labeling
to include a requirement for the use of
goggles or a face shield.
v. Respiratory protection. The Agency
proposed to require handlers and other
workers who enter treated areas before
vapors have dispersed to wear
respiratory protection devices approved
by the National Institute for
Occupational Safety and Health
(NIOSH) and the Mine Safety and
Health Administration (MSHA), if the
pesticide is in toxicity category I or II for
inhalation toxicity. The Agency did not
propose to require respiratory protection
for handlers of pesticides with
inhalation toxicity classified in toxicity
category III or IV or for workers entering
treated areas after pesticide vapors
have dispersed.
Several comments pointed out that
although several types of respirators
have NIOSH/MSHA approval for
protection against pesticides, NIOSH
does not test respirators for individual
pesticides. Therefore, requiring "a
NIOSH- or MSHA-approved respirator"
does not assure the use of the most
appropriate respirator for a specific
pesticide. The comments also noted that
the NIOSH instructions that accompany
air-purifying respirators refer the user to
the pesticide label for limitations of use.
Some comments urged the Agency to
require pesticide manufacturers to
provide respirator instructions in the
ptoduct labeling.
' Most comments urged the Agency to
require respirator fit-testing before a
respirator is used and a physician's
approval that the handler's physical
condition will permit him/her to use a
respirator safely. One comment stated
that the use of forced air respirators
would eliminate some of the fitness and
fit testing problems.
: Several comments suggested that the
selection, use and maintenance of
respirators be consistent with the
program described in the OSHA
standards (29 CFR 1910.134] and/or that
the specific recommendations be
provided in the Agency's rule.
The Agency agrees with the comments
regarding the need for a comprehensive
respirator use program encompassing
selection, correct use, and appropriate
maintenance of respirators. EPA has
(developed a guidance document on the
use of respirators in agriculture. The
language in the final rule offers some
guidance on changing filters, cartridges
land canisters in the absence of direction
ifrom the manufacturer; part 156 requires
the registrant to specify what type of
ifespirator should be used with a product
that requires respiratory protection for
handling.
c. Exceptions to personal protective
equipment (PPE) requirements. The
Agency has retained the requirements
proposed for aerial applicators. Pilots in
enclosed cockpits will not be required to
wear PPE. Pilots in open cockpits must
wear the PPE required for a ground
applicator of the product in use, except
that chemical-resistant footwear is not
required, and a helmet with visor may
be used in lieu of a hat and protective
eyewear. Pilots in both types of
equipment must wear the protective
gloves required by the labeling when
entering or exiting a plane whose
exterior is contaminated by pesticide
residues.
;: The Agency proposed that pesticide
handlers in the enclosed cabs of ground
vehicles should be exempt from PPE
requirements. If the enclosed cab did not
contain a properly functioning gas- or
vapor-removing ventilation system, any
labeling requirement for a respirator
would be in effect, but all other PPE
would be waived. Fully enclosed cabs
without air filtration have been shown
to reduce dermal (but not respiratory)
exposure substantially for airblast
applicators. The Agency was concerned,
ihowever, that heat buildup in
unventilated enclosed cabs might lead
.applicators to open windows for
comfort, which would negate the benefit
of the enclosed cab. The Agency
specifically sought comment on this
issue. The Agency also was concerned
about the possibility of handlers leaving
the enclosed cab in the treated area,
becoming contaminated, and then
returning to the enclosed cab. Therefore,
EPA proposed that all PPE required for a
ground applicator of the pesticide must
be available for use any time the
handler leaves the cab in the treated
area.
Most comments expressed concern
that applicators in cabs without
ventilation will open the window on a
warm day, thus negating the cab's
protection.
Many suggested that full PPE should
be required for operators in an enclosed
cab without ventilation. One comment
noted that there is no way to eliminate
the need for handlers to leave the cab in
the treated area; since protective
clothing must be worn, employers will
use this as an excuse for not providing
protective cabs. An equipment
manufacturer commented that their
studies have shown that contaminated
clothing (gloves on the steering wheel or
dash, etc.) is a major source of chemical
contamination inside cab enclosures.
The Agency acknowledges the
potential for defeat of the enclosed cab's
protection by opening windows or by
contaminating the interior of the cab
with clothing or equipment containing
pesticide residues. However, EPA
supports the use of engineering controls
in lieu of PPE where feasible; an
enclosed cab used correctly is
protective. The Agency is aware that
pesticide applications in many regions
of the country take place where
discomfort from heat is not a factor,
even in enclosed cabs. The Agency is
aware also of many situations where the
applicator is not the mixer or loader or
the person who repairs or adjusts the
application equipment, and therefore
would not be required to change into or
out of PPE for these activities. Under
these conditions, it would be
inappropriate to require PPE in the
enclosed cabs. Therefore, the Agency
continues to waive the PPE
requirements, with the exception of any
respirator requirement, for applicators in
enclosed cabs. If the windows of the cab
are opened at any time during the
application or the enclosure is otherwise
breached, the cab is no longer
considered enclosed, and applicators
would be required to wear the PPE
required on the pesticide labeling for
applicators of the product.
Users must wear PPE when leaving
the cab only if they will contact
pesticide-treated surfaces in the treated
area. They may leave the cab for a rest
stop or other reason (other than
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Federal Register / Vol. 57. No. 163 / Friday, August 21. 1992 / Rules and Regulations 38121
handling pesticides] without wearing
PPE if they will not be in contact with
pesticide-treated surfaces in the treated
area. The applicator may leave the cab
and walk away from the just-treated
area without PPE.
The Agency is concerned that the
interior of the enclosed cab may be
contaminated from pesticide-
contaminated clothing worn or taken
into the cab. Therefore, the Agency
changed the language of the rule to
prohibit such an action. Once PPE is
worn in the treated area, it may not be
worn into or taken into the cab.
A few comments concurred with the
Agency's proposal to waive the use of
all PPE, including respirator, if the
enclosed cab has a properly functioning,
positive-pressure ventilation system that
removes vapors from the air. The
Agency based its proposal on studies
indicating that positive-pressure,
charcoal- filtered ventilation systems on
enclosed cabs can remove more than 99
percent of pesticide vapors and sprays
during air intake. Other comments
stated that enclosed cabs were
unproven as protection for airborne
hazards and that data are needed that
demonstrate the effectiveness of the
protection offered by an enclosed cab.
The Agency believes that incentives
should be used to encourage the use of
engineering controls instead of PPE
when such technology exists. In the final
rule, persons occupying an enclosed cab
that has a properly functioning
ventilation system, which is used and
maintained in accordance with that
manufacturer's written operating
instructions and which is declared in
writing by the manufacturer or by a
government agency to provide
respiratory protection equivalent to or
greater than the respirator required by
the pesticide labeling, may substitute a
long-sleeved shirt, long pants, shoes and
socks for labeling-specified PPE.
d. Duties relating to personal
protective equipment (PPE). The Agency
proposed that all PPE required by the
pesticide product labeling for a
particular work activity be provided to
handlers and early-entry workers and
that the employer clean and maintain
such equipment.
In the final rule, EPA has modified the
language to clarify who is responsible
for fulfilling the various requirements
and provisions. This section now
specifically states that the employer
shall provide the appropriate PPE in
clean and operating condition. This
provision does not prohibit handlers
who own PPE, such as a respirator, from
using that equipment. The employer,
however, would be required to assure
that such equipment is cleaned and
maintained. The employees would not
be allowed to wear home or to take
home the equipment unless it had been
cleaned first.
A few comments indicated
uncertainty about who would provide
"normal work attire" (long-sleeved
shirts, long pants, shoes, and socks)
when it is required by the labeling and
whether it is considered to be PPE. The
Agency does not include normal work
attire in the definition of PPE; therefore,
it is not part of the employer's
responsibility to provide or maintain
this attire.
The Agency perceives the appropriate
decontamination of PPE as a major area
of concern. Significant levels of some
pesticides can remain in clothing or
equipment if it is not laundered correctly
or if prescribed decontamination
procedures are not followed. Surveys of
pesticide users, especially agricultural
workers, indicate that a large
percentage do not follow any
precautionary procedures when cleaning
contaminated clothing and equipment. If
PPE is reused without cleaning or
laundering, the protective effect may be
reduced or eliminated. Therefore, the
Agency has determined that it is
appropriate for the employer to assure
that PPE is cleaned and maintained
properly before it is reused.
The proposal required that after each
use all PPE be washed thoroughly, with
detergent and hot water or be cleaned
according to the manufacturer's
instructions and that it either be dried
thoroughly before being stored or be
placed in a well-ventilated place to dry.
The Agency also proposed that PPE be
stored away from pesticide-
contaminated places and be stored
separately from personal clothing to
avoid contamination of either clean PPE
or clean personal clothing.
A few readers interpreted the
proposal as requiring laundry facilities
on-site (on the farm, forest, or nursery,
or in the greenhouse). It does not.
Several comments said EPA did not
provide sufficient guidance for the
implementation of the proposed cleaning
and maintenance provisions. Two
comments questioned appropriate
decontamination for chemical-resistant
protective clothing and equipment;
fabric clothing can be laundered daily,
but chemical-resistant suits are
expensive and are damaged by constant
laundering in hot water. One was
concerned that conventional washing of
chemical-resistant suits may result in
low-level contamination of the inside
surfaces that might not occur otherwise.
It suggested modifying the language to
state that chemical-resistant suits, hats,
boots, and gloves need not be washed or
cleaned daily, but must be kept in a
condition of cleanliness consistent with
employee safety.
Several comments questioned the
conditions under which the employee
may be permitted to wear or to take
home "normal work attire" that has
become contaminated. To prevent these
situations, some comments advocated
that the employer should be responsible
fbrcleaning and maintaining "normal
work attire," i.e., long-sleeved shirts,
long pants, shoes, and socks worn
during handling or early-entry activities
when it is specified on the labeling.
Several comments from the forestry
industry asserted that it was awkward
to clean and maintain PPE in typical
forestry situations. Some of these
requested that PPE and laundry
requirements be eliminated for
pesticides in toxicity categories III and
IV and for diluted pesticides in toxicity
categories I and II.
The Agency has studied the comments
on this issue. As stated above, normal
work attire is not considered to be PPE;
thus, the employer has no responsibility
to provide it. However, EPA is
concerned about employees' •wearing or
taking home pesticide-contaminated
clothing or equipment, regardless of
whether the clothing is provided by the
employer or by the employee. The
Agency, therefore, is inclined to require
that employers clean and maintain any
attire an employee wears while handling
pesticides or performing early-entry
tasks. However, such an option was not
discussed in the NPRM, and the
economic impact of such a requirement
has not been assessed. The Agency
must study the costs and logistics
involved in such a requirement and may
publish a proposal on this issue for
public comment at a later time. Although
it would be prudent for employers to
clean and to maintain pesticide-
contaminated work clothing for their
employees, it is not a requirement of this
final rule.
If a pesticide used in forestry requires
the use of PPE, such equipment must be
cleaned and maintained by the
employer. This cleaning and
maintenance need not be done on the
employer's premises or immediately
following use. EPA left flexibility in the
requirement to allow for employers to
collect contaminated PPE and to clean it
at their convenience at a location of
choice. Therefore, forestry employers
could provide their handlers (and early-
entry workers) with a clean set of PPE
for each day of handling activities and
provide a chemical-resistant container
that could be securely fastened, such as
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38122 Federal Register / Vol. 57, No. 163 / Friday. August 21, 1992 / Rules and Regulations
a sturdy plastic bag, for storing the
contaminated PPE until it is cleaned.
EPA's directive to wash PPE in hot
water and detergent is the alternative
when there are no directions from the
manufacturer on how to clean and
maintain equipment. The goal is to
remove pesticide residues as completely
as possible so that the equipment is
clean the next time it is used. Evidence
indicates that non-chemical-resistant
clothing and equipment, as well as many
chemical-resistant items, should be
cleaned in hot water and a heavy-duty
detergent to remove pesticide residues
most efficiently. If manufacturers of
chemical-resistant gloves, boots, or
protective suits indicate another method
of cleaning and maintaining the
equipment, it must be followed.
EPA proposed that persons
responsible for cleaning the PPE would
be informed that the equipment might be
contaminated with pesticides. Only a
few comments were received on this
issue. One comment requested that any
person cleaning the PPE be required to
provide written verification that he has
been warned of the hazards.
EPA concurs with the sense of the
comment and has rewritten the rule to
require the employer to inform persons
who clean or launder PPE or other
pesticide-contaminated items of the
possibility that such items may be
contaminated with pesticides and of the
potentially harmful effects from
exposure to pesticides. The employer
must also inform these persons of the
appropriate procedure(s) for handling
and cleaning such items.
Some comments requested more
specific guidance as to who would be
responsible for inspecting the PPE
before each day of use. A few suggested
that the inspector be a certified
applicator; others suggested that
training on the appropriate inspection of
PPE would be beneficial.
It is the employer's responsibility to
assure that the PPE is maintained
properly, and this includes inspecting
the PPE for damage and other defects.
This may be done by the employer, by a
designated supervisor, or by the
employees if they have been instructed
in the care and cleaning of PPE. The
Agency believes that it is not practical
in many agricultural situations to
require a certified applicator to inspect
all PPE before each day of use.
EPA concurs that information on
procedures for inspecting PPE would be
useful. The Agency has developed a
guidance brochure on the maintenance
and inspection of PPE such as protective
eyewear, gloves, protective footwear,
chemical-resistant protective suits, hats
or hoods, and coveralls.
;e. Heat-related illness (heat stress).
Although chemical-resistant suits are
not part of the minimum PPE proposed
by this regulation, they are required by
the labeling for a few pesticides. The
NPRM prohibited tasks requiring
chemical-resistant suits where a
combination of temperature, humidity,
and time required to complete a task
might be expected to cause heat-induced
illness. The onset of these illnesses
depends on a variety of factors, and
EPA expressed the belief in the NPRM
that users could be expected to
anticipate when work activities might
result in heat stress.
Many comments expressed concern
about the risk of heat stress in
agriculture with respect to the use of
FPE when handling pesticides in warm
climates, stating that guidance and
training were central to enabling
employers and employees to prevent
heat-related disorders. Nearly every
comment disagreed with EPA's
assumption that the employer could
ascertain when heat-related illness was
a .risk and asked EPA to give guidance
about the conditions that would warrant
limiting work due to heat stress
concerns.
Some comments stated that it is
inappropriate and unfair to ask
employers to make decisions about
heat-induced illness, a complicated and
potentially life-threatening condition;
farmers and ranchers have no training in
health care. The comments stated that
the employee should be trained to
recognize the early signs and symptoms
of heat-induced illness and be permitted
to take work breaks, remove chemical-
resistant suits (in a clean area), seek
medical attention, or take other
reasonable measures to alleviate those
symptoms.
A few comments requested that PPE
not be used or that the protective suit be
permitted to be unzipped during
applications when the applicator was
upwind of the spray. Some comments
stated that environmental conditions in
some States or regions make wearing
any PPE a problem because of extreme
heat or humidity.
;'. A few comments requested that
Hpecific temperature and humidity
guidelines be established.
The National Institute for
Occupational Safety and Health offered
some recommendations for reducing
heat stress when PPE is required.
. EPA has determined that heat-related
illness is a potential problem with the
use of many types of PPE. Therefore, the
Agency has modified the language in the
rule to state that the employer should
use appropriate precautions to prevent
heat-related illness (§ 170.240(g)}. EPA
has developed a guidance document that
addresses recognition, prevention, and
treatment of heat stress under
agricultural working conditions. This
document can be used by employers to
determine suitable measures for
preventing heat-related illness, as
required by the rule.
EPA also believes that training
handlers and early-entry workers to
recognize the early warning signs and
symptoms and to implement appropriate
first-aid measures for heat-related
illness will help to minimize the risk of
such illnesses. Thus, EPA has modified
the requirements for the training
programs for handlers and the
instructions for early-entry workers to
include information about heat-related
illness.
The establishment of specific
temperature and humidity limits was
determined to be inappropriate, because
they are only two of several factors that
contribute to the onset of heat-related
illness. The Agency is persuaded that
employers may be able to complete
necessary pesticide handling activities,
even in very warm weather, by
acclimating handlers and early-entry
workers, providing plenty of drinking
water, modifying work schedules and
work/rest cycles, and using portable
cooling devices.
E. Decontamination
The Agency proposed that water,
soap, and single-use towels be available
during any work activity where there is
potential employee contact with
concentrated or diluted pesticides or
with surfaces that have been treated
with pesticides.
For pesticide handlers and early-entry
workers, decontamination facilities
would be required at all times since
these activities have the greatest risk of
exposure. For persons working in
treated areas after the REI has expired,
the Agency proposed to limit the
requirement to activities in areas that
have been treated during the current
growing season.
Many comments questioned the need
for decontamination facilities during an
entire crop cycle, stating that a time
should be specified.
The Agency believes that there is a
need for decontamination facilities after
the end of the REI. The Agency
recognizes, however, that some
pesticides may have been applied long
before workers enter the area. EPA
agrees with the comments that
suggested that the proposed requirement
might be excessive, and it sought to
determine what might be a reasonable
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time during which decontamination
facilities should be available.
Knaak, Iwata, and Maddy, in a 1989
investigation of a series of pesticide
poisoning incidents that occurred after
the expiration of an REI, found that the
median time from application in these
incidents was 29 days. The Agency has
studied more recent data regarding the
incidence of multiple-case systemic
illnesses of agricultural field workers
from exposure to residues of
organophosphates in California. Among
the 44 incidents for which data were
provided, the mean length of time from
application to poisoning was 20 days,
with a median of 16 days. The range
was from less than 1 day to 66 days,
although this latter figure was an outlier
and did not appear to be well
substantiated. Excluding parathion (no
longer registered for most crops) and
this outlier, the longest period between
application and reentry poisoning was
39 days. The Agency believes that
poisoning incidents that occur more than
30 days beyond the REI probably stem
from a miscalculation in establishing the
REI that is listed on the labeling.
As part of the Pesticide Hazard
Assessment Project funded by EPA in
1985, a computer model was developed
to estimate how long hazardous residues
might persist. For one of the pesticides
studied the hazard was predicted to
remain for 30 days after the REI had
expired. The Agency is seeking to
corroborate and refine this model. In the
meantime, the Agency believes it should
institute a safety factor in the Worker
Protection Standard to compensate for
this potential variability.
In response to the comments, the
Agency has modified the language in the
final rule to require decontamination
facilities for workers entering a treated
area for which an REI is hi effect and for
workers entering a treated area within
30 days after the expiration of the REI.
The NPRM also stated that the water
shall be potable, in adequate supply, at
a temperature that will not injure the
eyes, and reasonably accessible to each
worker's place of work.
There were many comments about the
proposed rule's reference to potable
water. Those supporting the requirement
for potable water said that OSHA
requirements for field sanitation already
require potable water in the fields.
Comments from representatives of the
forestry industry pointed out that
potable water might not be available to
forestry workers working in areas with
no vehicular access.
Those opposing the requirement for
potable water stated that farm wells are
not required to meet the Safe Drinking
Water Act requirements, so it is
unreasonable to expect water supplied
from a farm to meet this standard for
quality. In their comments on the draft
final rule, under FIFRA section 25(a), the
U.S. Department of Agriculture (USDA)
stated that the decontamination
provisions of the draft final rule would
be unreasonably burdensome to
employers because of the requirement
for potable water for handwashing
purposes. They stated that the standard
for potable water is higher than
necessary for washing purposes and
that clean water should be sufficient.
Clean water, they suggested, would be
readily available from farm and.
irrigation wells, whereas potable water
may not be. USDA believes that
changing the decontamination
provisions to permit the use of clean
water would greatly reduce the burden
and expense to farm employers without
significantly reducing worker protection.
They suggested that an appropriate
standard might be the regional or local
standard for water safe for swimming.
As stated in the NPRM, the Agency
proposed the standard of "potable" for
the quality of water for two primary
reasons:
(1) "OSHA's Field Sanitation Standard (29
CFR 1928.110) requires potable water in the
fields for hand laborers, intended not only for
washing but also for drinking purposes. Even
though EPA's proposed requirement was
intended to provide water only for washing,
in practice the water may be used by workers
for drinking as well."
(2) "[O]nly 'potable' water can be defined
in such a way that noncompliance can be
clearly ascertained."
At the time of the proposal, EPA
believed that since OSHA uses the
potable water standard for its Field
Sanitation Standard, it would be easier
for employers to comply with one water
standard than with two. However, EPA
was reminded by commenters that
approximately 89 percent of agricultural
establishments are not currently
covered by OSHA's Field Sanitation
Standard and that EPA should be
responsive to-the burden to employers
on those establishments.
EPA has been persuaded by the
comments that a standard of "potable"
may impose a substantial burden to
agricultural employers, without a
concomitant benefit to workers. EPA
believes the goal of this requirement
should be to ensure that workers and
handlers will be provided with water
that will not cause" illness or injury when
it contacts their skin or eyes and will
not cause illness or injury if they should
happen to swallow it. Thus, the Agency
has been persuaded to eliminate the
requirement for "potable" water and
instead has required the provision of
water that meets the stated performance
standards. This will permit employers to
equip decontamination sites with water
which is used for drinking on the
agricultural establishment, but which
may not meet the standard of potability
in the Notice of Proposed Rulemaking.
In reexamining the options, EPA
considered establishing the quality
standard of "clean" water defined as
water safe for swimming. However, the
Agency was unable to ascertain how
agricultural employers would be able to
apply such a standard. In adopting a
standard of water quality different from
a potability standard, EPA remains
concerned that in practice, some
workers may drink the water, especially
if no alternative source of drinking
water were available in the field.
Moreover, the Agency has concluded
that water must be of a quality safe for
drinking because (1) workers and
handlers may accidentally swallow
water in the process of washing/flushing
their faces or eyes, and (2) workers and
handlers may mistake wash water for
drinking water. EPA believes that
placarding water to indicate that it is
not for drinking purposes would be a
difficult and unwieldy requirement given
the range of languages and degree of
illiteracy among workers. EPA concurs
with OSHA's stance in the preamble to
the Field Sanitation Standard that they
"would like to eliminate the use of signs
in several languages to identify different
classes of water quality in the same
workplace and the errors that occur
when water supplies are confused."
The Agency believes that defining
decontamination/eyeflush water, in
part, as water that "will not cause
illness or injury if swallowed" will allow
enforcement officials to ascertain
noncompliance. EPA expects that the
water used for drinking purposes on the
agricultural or handler establishment
will usually be the source of water for
washing and eyeflushing. EPA notes that
those establishments currently
complying with the requirement for
providing potable handwashing water to
workers under OSHA's Field Sanitation
Standard would also be in compliance
with the EPA requirement for
decontamination water if the same
water were used. It is important to note,
however, that EPA is not exercising any
statutory authority in this rulemaking to
address the general sanitation hazards
addressed by the OSHA Field
Sanitation Standard.
The Agency recognizes the difficulty
in providing decontamination sites for
employees working in areas with no
vehicular access and is modifying the
decontamination requirements for
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38124 Federal Register / Vol. 57. :No. 163 / Friday. August 21, 1992 / Rules and Regulations
activities performed more than 1/4 mile
from the nearest place of vehicular '
access. For these remote work sites, the
required decontamination site may be
located at the nearest place of vehicular
access, instead of within 1/4 mile of
each worker or handler. Workers and
handlers may use clean water from
springs, streams, lakes, or other sources
for routine and emergency
decontamination at the remote work
site, if such water is more accessible '
than the decontamination Water located
at the nearest place of vehicular access.
The Agency has concluded that, in such
circumstances, the risks from the use of
water of uncertain quality are likely to
be less than the risks from delay in
removing pesticides or pesticide
residues from the skin or eyes.
Some comments stated that
"reasonably accessible" needs
definition. Numerous comments
suggested that decontamination sites
should be no greater than 1/4 mile from
employees. Others noted that the
restricted-entry area is where
contamination may occur, that
decontamination sites should be made
available there, and that water in a tank
is protected in a treatment area.
The Agency believes that the
language of this requirement should be
consistent with the language of the
OSHA Field Sanitation Standard
requiring that the decontamination site
must be reasonably accessible, not to
exceed 1/4 mile or approximately a 5-
minute walk from each worker's place of
work. As a result, the rule has been
revised to include a specific distance
requirement of 1/4 mile. For agricultural
workers, the decontamination site must
not be in an area under an REI. For
early-entry activities, the
decontamination site may be in the area
where the employees are working. For
application activities, the
decontamination site may be in the area
being treated if the soap, single-use
towels, and clean change of clothing are
in enclosed containers and the water is
running tap water or is enclosed in a
container.
The Agency proposed that an eyeflush
dispenser be provided during handling
and early-entry situations involving a
product that is a severe eye irritant, i.e.,
toxicity category I or II for eye irritation,
signified to the user by a requirement for
protective eyewear on the labeling. The
dispenser would be immediately
available for emergency use, e.g., it
would be carried by the handler or on
the handler's vehicle. The Agency
solicited comment on whether the
dispenser needs to be available during
all activities or only certain ones,
whether each employee should carry a
dispenser, and whether carrying a 1-pint
dispenser on one's person represents
undue weight burden.
The comments supported the
requirement for requiring eyeflush
dispensers for mixers and loaders.
Eieveral comments stated that eyeflush
equipment should be available for all
employees, but that not all workers need
to carry eyeflush dispensers; only
handlers have such a need. Again,
language such as "otherwise
immediately accessible" was thought to
be vague. One comment included a copy
of an OSHA Field Directive that
cautions about the possibility of
contamination of eyeflush water by
acanthamoebae. Some comments
suggested that if a pesticide is a hazard
to eyes, it is best if each person carries a
dispenser, but if that is not possible, a
full pint for each 2 or 3 persons should
be made available. Several comments
noted that eyeflush containers carried
by employees may be contaminated by
pesticides.
. The Agency is concerned that the
language of the proposed rule may have
led to some misconception about what
water may be used for flushing the eyes
in case of emergency. The
decontamination water that must be
provided for routine washing and
emergency whole-body cleansing must
not cause illness or injury when it
contacts the eyes. Therefore, the Agency
has added "emergency eyeflushing" as
one of the basic functions to be met by
that water. EPA wants to make clear
that while special eyeflush dispensers
may be used, any source of water that
meets the standards for
decontamination in the final rulemaking
is acceptable for flushing the eyes. In
appropriate instances, the language of
the rule has been altered to change the
requirement from "eyeflush dispenser"
to "eyeflush water." In addition, these
requirements have been combined in
this final rulemaking to avoid confusion.
In response to comments about
'iyorkers and handlers who need more
immediate access to eyeflush
equipment, the Agency requires that the
emergency eyeflush water shall be
carried by the handler or early-entry
worker, or shall be on the vehicle or
iaircraft which the handler or early-entry
worker is using, or shall be otherwise
immediately accessible. Again, EPA
wants to make clear that this water does
not necessarily have to be in a
dispenser. Any nearby source of
adequate amounts of water meeting the
definition of decontamination water
satisfies this requirement.
The Agency is persuaded of the
importance of protecting against
bacterial and other types of
contamination of the water used for
washing and eyeflushing. Therefore, the
final rule will require employers to
assure that "at all times when the water
is available" to workers and handlers, it
will remain of a quality and temperature
that will not cause illness or injury when
it contacts the skin or eyes or if it is
swallowed. The agricultural employer
and handler employer will be
responsible for making sure that the
water is replaced and the container is
cleaned often enough to prevent
bacterial or other contamination that
could cause illness or injury to
employees using the water for washing
or eyeflushing. In most circumstances
this would mean replacing water in
containers at least daily and regular
cleaning of those containers.
F. Emergency Assistance
EPA proposed that all employees be
informed of the name, address, and
telephone number of the nearest
physician, clinic, or hospital equipped to
provide medical care in a pesticide
poisoning or injury emergency. This
information was to be displayed in a
prominent location on the agricultural
establishment at all times.
In pesticide poisonings or injury
emergencies, the victims may be unable
to transport themselves to the nearest
medical facility. Therefore, EPA
proposed that prompt transportation to
an appropriate medical facility be made
available when there is reason to
believe that a worker or a handler has
been poisoned or injured by a pesticide.
In a possible pesticide poisoning or
injury, the most effective medical care
can be provided only through a correct
diagnosis and prompt administration of
the appropriate antidote or treatment. A
doctor must know the name of the
product or active ingredient to which the
worker or handler has been exposed to
ascertain the appropriate treatment.
Thus, EPA proposed that in an
emergency, workers and handlers be
provided, if available, the product name,
registration number, active ingredient(s),
and first aid or antidote information and
other information about the use of the
pesticide and possible exposure to the
worker or the handler. This information
is available to pesticide users from the
labeling of the product or from their
knowledge of the product; the
requirement to provide information did
not require that the user maintain
records or keep pesticide labels or
containers.
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Federal Register / Vol. 57, No. 163 / -Friday, August 21, 1992 / Rules and Regulations 38125
In their comments on the draft final
rule, under FIFRA section 25(a), the
USDA stated that EPA needed to clarify
when the employer is responsible for
making available to the worker prompt
transportation to an appropriate
emergency facility. USDA stated that
they interpret this provision to be
applicable only while the employee is
on the employer's property. EPA agrees
and has clarified in the rule that the
agricultural employer must provide such
transportation when a worker is on the
employer's establishment, including in
any labor camp located on the
establishment. The Agency has similarly
clarified in the final rule that the handler
employer must provide emergency
transportation when a handler is at the
place of employment or at the handling
site.
The Agency found no other
information among the few comments
on this requirement to cause it to
reconsider other aspects of the
requirement; they remain in the final
rule essentially as proposed.
G. Pesticide Safety Training and
Information
Based on the conviction that training
and information are essential
components of a successful risk-
reduction strategy, the NPRM proposed
several requirements related to
providing pesticide safety training to
handlers and information to workers: (1)
General pesticide safety information for
workers through a poster to be
displayed in the work place, (2)
pesticide safety training for handlers
and early-entry workers, (3) labeling-
specific information to handlers, and (4)
labeling-specific information to workers
on request.
1. General pesticide safety
information—a. Poster. The Agency
proposed to require that general
pesticide safety information be
displayed on a poster in a prominent
location on each agricultural
establishment during the growing
season. The poster would contain
statements concerning pesticide hazards
and recommended safety practices, the
location of emergency medical care
facilities, a sample of the warning signs
used for posting treated areas, and
statements concerning the rights and
duties of employers, supervisors, and
workers. All information would appear
in English; if some workers read only
another language, the poster either
would be translated into that language
or contain a statement in that language
recommending that the workers have
someone explain the information to
them. Workers would be informed of the
location of the information and would
be allowed reasonable access to it.
The Agency considered whether other
methods of communicating this
information to workers, such as oral
instructions or a training program given
either by employers or by other
providers, would be more effective than
a poster, and asked for comment on this
issue.
Most comments favored a requirement
for a pesticide safety poster. There were
specific criticisms focused on the
proposed content of the poster. Some
comments stated that the language was
too forceful; others criticized the
language for not being emphatic enough.
Some comments requested that the
poster have definitions of the signal
words used on labeling.
There were several comments
concerning the location of the poster.
One suggested that more than one
poster be displayed per establishment;
another recommended that pesticide
users distribute information sheets to
their workers to avoid intimidation and
retaliation should workers attempt to
study the information presented on a
poster.
Some comments pointed to the
difficulty of posting information at forest
work sites and requested flexibility to
post at the crew headquarters or
assignment area.
The final rule maintains the
requirement for agricultural employers
and handler employers (other than
employers on commercial pesticide
handling establishments) to display
pesticide safety information in a poster
format at a central location, with some
modification of the proposed
requirement. Although the final rule also
requires that workers and handlers
receive oral or audiovisual training in
pesticide safety, the Agency believes
that, at least for workers who are
literate, a pesticide safety poster will
serve as an important reinforcement and
reminder of the information learned in
the training program. A poster also will
provide a convenient place in the
workplace to make note of specific
emergency medical information, i.e.
telephone numbers and addresses.
The Agency concurs with many of the
comments concerning linguistic
complexity, emphasis, and other aspects
of the proposed pesticide safety poster.
It has decided that the exact wording
and format do not belong in part 170
because changes may be needed as EPA
and others gain new information about
pesticide safety. In lieu of requiring the
employer to display specified items of
information, EPA is requiring that
general topics be covered in simple,
emphatic language. EPA intends to
publish a poster designed to address
many of the concerns raised in the
comments and intended to meet the part
170 requirement. Employers may use the
EPA poster or a poster of similar content
that meets the requirements of part 170.
The Agency will make such a poster
available through numerous distribution
sources and will encourage other
organizations to produce similar posters.
The final rule permits employers of
forestry workers or handlers to display
the poster at a place other than the
forest work site, as long as it is
reasonably convenient for workers or
handlers and they are informed of the
location. EPA does not believe that it is
necessary for employers to distribute
this information to workers or handlers
in written form. EPA believes that the
requirement as worded makes it clear
that only one poster need be displayed
per agricultural establishment,"even if
there are several work sites, e.g., more
than one greenhouse or field,;as long as
each employee has access to it. EPA has
made no changes to the employer's
duties to maintain the poster in legible
condition and update the emergency
medical care information as necessary.
EPA has been convinced by comments
that requiring the items of information
on the poster to be translated is
impractical. Since the purpose of the
poster in the final rule is to reinforce
worker or handler training, which must
be given in a manner the worker or
handler can understand, the requirement
for translation has been dropped.
b. Training for agricultural workers.
The Agency's request for comment on
the most appropriate method for
conveying basic pesticide safety
information to workers stimulated many
responses. The comments strongly
supported some combination of oral,
audiovisual, and written training in
pesticide safety for all agricultural
workers who may be exposed to
pesticides or pesticide residues.
Comments favoring training for all
workers came not only from worker
advocates such as unions and legal and
health service providers, but also from
universities, chemical companies, State
lead agencies and other State agencies,
growers, and grower organizations. A
Farm Bureau chapter stated that it
supported a one-time instruction given
for employees, i.e. at harvest or at time
of employment.
The comments stated that employers
need to convey safety information to all
workers orally because workers cannot
or will not read written materials; oral
instruction and training are the most
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38126 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
effective means to communicate
information.
The few comments opposing training
for workers were concerned about the
logistics of doing the training, but did
not oppose the concept of such training.
In their comments on the draft final rule,
under FIFRA section 25(a), the United
States Department of Agriculture stated
a concern about requiring training for
agricultural workers before their first
work period. They state: "In effect, the
training provision will require that an
employer provide training at the
beginning of the season, and then, each
time an additional worker or
replacement worker is hired.... Given
the extremely high variability and
turnover within labor intensive
agricultural work groups (1,000 percent
is not uncommon], this procedure ...
would frequently result in virtually
continuous training of small groups of
new hires by each employer."
The Agency believes that providing
information about ways to avoid or to
mitigate occupational exposure to
pesticides will reduce pesticide-related
illnesses and injuries among agricultural
workers significantly, and it has been
convinced by the public comments that
training as well as displaying a poster
will better convey this information. A
poster may be effective in conveying a
simple message, but training more
effectively conveys larger amounts of
information. Reliance on a poster also
presents problems relating to language,
literacy, and accessibility. Many
agricultural workers go directly to the
work site, rather than to a central
location; these workers would have
neither the opportunity nor the incentive
to examine a poster. For workers not
literate either in English or their native
language, adding a paragraph to the
poster in any language advising them to
have the poster explained to them
would do little good. From the
comments, EPA has concluded that an
oral or audiovisual training program is
an essential complement to a poster in
communicating pesticide safety
information to workers, and therefore
such a requirement is a necessary
component of worker protection
standards.
Although training each worker
involves more employer effort than
displaying a poster, the Agency has
determined that the burden will not be
significant. In their comments, many
employers noted that they train their
workers in pesticide safety, either
because they feel it is important, or
because they believe they are subject to
the OSHA Hazard Communication
regulations.
', EPA has developed videotape and
silide-tape training programs in English
and in Spanish. The Agency intends to
update these materials to correspond to
the requirements of the final rule. These
updated materials may be used by
employers, the Cooperative Extension
Service, State agencies, health care
providers, and others; employers may
obtain and use the training materials
themselves or make arrangements to
have workers trained by others.
; The final rule has been modified to
include a training requirement for
workers. The modified rule requires
agricultural employers to assure that
before the 6th day that any worker
enters any areas on the agricultural
establishment where, within the last 30
days, a pesticide has been applied or an
REI has been in effect, the worker
receives pesticide safety training. For
the first 5 years after the effective date
of the rule, however, the rule allows
employers up to the 16th day that any
worker enters any areas on the
agricultural establishment where, within
the last 30 days, a pesticide has been
applied or an REI has been in effect, to
assure that the worker receives
pesticide safety training. The Agency's
intent is that workers receive training as
soon as is practicable in each work
situation, but not necessarily before
their first exposure. In most instances,
the Agency believes that whenever
permanent employees and crews of
Employees are hired, the training could
take place before the new-hires' first
exposure period.
The longer time period (approximately
3 work-weeks for the first 5 years and
approximately 1 work-week thereafter)
allows agricultural employers more
flexibility in arranging for training of
workers they employ. Such flexibility
will be most useful for establishments
Where there is frequent turnover in the
workforce, such as with large crews of
seasonal labor, or where one or more of
the workers do not understand either
English or Spanish and a person who
can translate the training to such
workers must be located. After the 5-
year period, most of the existing
agricultural workforce already should be
trained and only workers new to
agriculture will need to be trained. In
addition, by the end of the 5-year
period, agricultural employers should
have access to training materials and
translators in the necessary languages.
Therefore, beginning 5 years from the
effective date of the revised final WPS,
workers must be trained before their
sixth day of entrance to areas where,
within the last 30 days, a pesticide has
been applied or an REI has been in
effect.
The 6th (or 16th, as applicable) day of
entry is not limited to a growing season
or calendar year. It is the 6th (or 16th)
day of exposure beginning when a
worker enters areas on the agricultural
establishment following a treatment
with a pesticide to which the Worker
Protection Standard applies. To avoid
keeping track of such workers' days of
exposure, two options are available to
the agricultural employers. First, they
can make sure that all workers are
trained before their first exposure in
such areas. Second, they can hire only
those workers who have already
received training and who possess a
valid training certificate.
The Agency is also attempting to
mitigate repetitive training by
establishing a relatively lengthy (about
20 months) lead time before the training
provisions of the final rule are
enforceable. This lead time will allow a
substantial number of workers to be
trained in the interim. Once a large
percentage of workers have been
trained, the concern about repetitive
training diminishes, because many new
hires already will have received
training.
The risks from pesticide residues
decrease as the time increases between
application and entry into treated areas.
The Agency recognizes that in some
circumstances or under some conditions
residues might remain as long as 30 days
after the end of an REI. Workers who
enter the areas after that time have little
to gain from the use of exposure-
mitigation techniques. As a result, a
grower who applies a preplant herbicide
in March and uses no other pesticide
treatments during the growing season
would not be obliged to train workers
who are hired to harvest the crop in
October. Therefore, the Agency has
chosen to require training for workers
who enter an area where, within the last
30 days, a pesticide has been applied or
an REI has been in effect.
All early-entry workers must be
trained before they are allowed to enter
an area before the REI has expired.
Workers must receive training before
they are allowed to enter treated areas
before the expiration of an REI to
perform tasks permitted under § 170.112
and involving contact with anything that
has been treated with the pesticide,
including, but not limited to, soil, water,
or surfaces of plants, because EPA
believes that their risk of exposure is
higher than that for workers entering
after the expiration of the REI.
Workers and early-entry workers
must be given the specified training in
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Federal Register / Vol. 57. No. 163 / Friday. August 21, 1992 / Rules and Regulations
38127
pesticide safety, unless they: (1) Satisfy
the training requirement for pesticide
handlers under this regulation, (2)
satisfy the training requirement under
part 171 of this chapter, or (3) are
currently certified private or commercial
pesticide applicators.
The training program must be
presented in a manner the worker can
understand, using nontechnical terms.
The general pesticide information must
be presented either orally using written
materials, or audiovisually. As a
minimum, the person conducting the
training must have been trained as a
pesticide handler under part 170.
The training may be presented using a
translator or through sign language, if
the employer assures that the worker
can understand the information being
presented. The fact that an employer
does not normally provide training in
the particular language of a job
applicant, or that translation services
are not readily available, does not
absolve an employer of his training
responsibilities under the WPS.
Employers who provide training under
the WPS should be cognizant that a
refusal to hire an applicant who is
unable to understand the language or
languages in which the employer usually
provides training may constitute
discrimination on the basis of national
origin. Discrimination on the basis of
national origin is actionable under Title
VII of the Civil Rights Act of 1964 or
under the Immigration Reform and
Control Act of 1986 (IRCA). There is
also a possibility that the failure of an
employer to provide training in any
language and, instead to consistently
require current training certificates from
applicants for those jobs whose
activities require WPS training, could
thereby be causing a disparate impact
which could, under some circumstances,
be interpreted as constituting
discrimination based on national origin.
Employers desiring information
regarding their responsibilities under
Title VII of the Civil Rights Act of 1964
or the anti-discrimination provisions of
the IRCA may contact the Equal
Employment Opportunity Commission
or the Special Counsel for Immigration
Related Unfair Employment Practices of
the U.S. Department of Justice,
respectively.
The training programs for workers
must include the same basic information
as those for handlers, except for topics
that are relevant only to handlers. For
example, worker training need not
include information related to the format
and meaning of pesticide labeling or to
transportation, storage, and disposal of
pesticides. Worker training must include
information about the worker protection
requirements of part 170 such as
application and entry restrictions, the
posting of warning signs and the design
of the warning sign, oral warnings, the
availability of specific information on
applications, and protection against
retaliatory acts. This will ensure that
workers know what protection they
should be receiving so they can
encourage compliance with part 170.
The final rule requires that workers be
retrained at 5-year intervals, measured
from the end of the month in which the
training is completed. The Agency
believes that such renewal of WPS
worker training will be adequate to
convey the basic pesticide safety
precepts to workers and to provide
timely updates and reinforcement,
without undue burden. The presence of
the required pesticide safety poster in
the workplace will serve as a reminder
of pesticide safety practices for workers
whose training may have occurred some
time in the past.
In their comments on the draft final
rule, under FIFRA section 25(a), USDA
expressed concern about the absence of
a formal mechanism to avoid repetitive
training of each new hire on each
agricultural establishment and
welcomed the opportunity to work with
EPA to develop such a verification
program. A change to the rule was
made. The rule now states that if the
agricultural employer determines that a
worker possesses an EPA-approved
WPS training certificate and has no
reason to believe it is invalid, that
determination shall meet the
requirements of assuring that the worker
has been trained. The revised final rule
requires trainers to assure that
appropriate WPS training has been
given to a worker before the training
certificate is issued.
EPA expects that a wide variety of
groups would be qualified to conduct
WPS training and issue EPA-approved
training certificates, including grower or
commodity organizations, pesticide
dealers, worker advocacy or interest
groups, or others.
The use of an EPA-approved WPS
training certificate is optional. The
Agency encourages those trainers who,
.voluntarily, would like to maintain
records or issue cards to workers to do
so.
EPA and USDA intend to establish a
joint task force to develop and
implement a mechanism for verification
of training. The task force would seek to
reduce the amount of duplication in
training and to establish a voluntary
system of training verification. Once the
mechanism for verification of training
has been determined, the Agency will
issue guidance regarding the specific
nature of the verification system. Such
guidance is expected to include the
following topics: (1) Criteria that the
Agency will use for determining which
persons or agencies will distribute the
training certificates to prospective
trainers; (2) description, format, and
content of the training certificate; (3)
mechanism for ascertaining the
expiration of the training certificate; (4)
content of the certification statement
that prospective trainers would have to
sign in order to receive the training
certificates.
2. Training for handlers. The Agency
proposed that general pesticide safety
training would be required for all
persons who are employed to handle
pesticides intended for use on
agricultural crops on farms or in forests,
nurseries, or greenhouses. This
requirement would be waived if the
handler were certified as a private or
commercial applicator. Each handler
was to be instructed by a trainer who
met certain minimum qualifications. The
training program also had to meet
minimum standards.
Many comments noted that EPA's
handler training was similar to the
training in chemical hazards required by
OSHA's Hazard Communication
Standard and questioned whether both
requirements were necessary. There
was concern that the apparent
duplication of OSHA's Hazard
Communication Standard may cause
confusion for the growers and regulatory
agencies.
EPA acknowledges that there may be
some confusion regarding the:
relationship between the training
required by the OSHA Hazard
Communication Standard and by this
standard and is working with OSHA to
define more clearly the roles of the two
agencies in hazard communication for
pesticides users. For additional
information on this topic, see EPA's
proposed amendment to 40 CFR part 170
published elsewhere in this issue of the
Federal Register.
Most comments on the training
requirements for handlers supported the
concept of such training. However, a
few comments opposed any training
requirement for pesticide handlers
because they thought private applicator
certification for all persons who handle
agricultural pesticides would be
burdensome and impractical.,
EPA does not intend to require private
applicator certification for all who
handle agricultural pesticides, but the
Agency does believe it is important that
all persons who handle agricultural
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pesticides have training in basic
pesticide safety.
Some comments that strongly
supported the concept of handler
training had reservations or criticisms
regarding specific provisions of the
training requirements.
A few comments stated that being
certified should not exempt handlers
from being trained under part 170, noting
that the proposed handler training
requirements exceed the private
applicator certification requirements in
some States.
The Agency acknowledges that there
may be variation among the States in
the content and effectiveness of
certification programs. EPA is revising
the certification regulations (40 CFR part
171) to upgrade the national "core"
requirements for certification of private
and commercial applicators. When the
revisions to part 171 are promulgated, all
State certification programs for pesticide
applicators will be required to contain
the components of the upgraded
national "core" requirements. The
Agency is confident that all State
certification programs then will meet or
exceed the minimum requirements for
training of pesticide handlers contained
in part 170.
Several comments said that training
should be specific to the task being
performed, not general pesticide safety
training and that, like labeling, training
should fit the toxicity of the substance.
EPA is not persuaded that job- or
product-specific instruction by
supervisors is an effective substitute for
basic pesticide safety training. The
Agency is convinced that pesticide
handlers will be more willing to observe
job specific safety instructions and to
cooperate in hazard reduction
provisions, such as using PPE, if they are
informed of the reasons for such
provisions. Therefore, this final rule
retains the requirement for general
pesticide safety training for all pesticide
handlers.
Some respondents questioned where
to find information required for the
training program, especially regarding
spill cleanup and chronic health effects.
EPA intends that the training
programs for pesticide handlers stress
basic principles of safe pesticide '
handling. Pesticide-specific information
is required to be furnished to each
handler before each handling task. EPA
intended that the information on health
effects should focus on types of possible
health effects, such as acute and chronic
effects, delayed effects, and
sensitization (allergic effects], that may
be associated with pesticide exposure,
not on product-specific effects.
Information in the training program
regarding pesticide spill cleanup would
be limited to the generally accepted
three-step procedure of containment,
removal, and disposal. Information on
how to dispose of a specific spilled
material will not be included in the
general training program. Any handler
assigned to clean up a spill would need
to have any information on the pesticide
labeling regarding spill cleanup
procedures, precautions, or
requirements specific to that product. If
no specific information is listed on the
pesticide labeling, the employer has no
requirement under this part to seek out
additional spill-specific information or
instructions.
The Agency is supportive of those
who want to train handlers beyond the
minimum requirements in part 170 and
encourages such initiatives. EPA is
developing a new regulation regarding
the appropriate procedures for disposal
of pesticides and pesticide containers.
When the rule is promulgated, the
information is expected to be
incorporated into pesticide labeling and
can be conveyed to the handler on a
product-specific basis.
: The handler also must be informed of •
any pesticide-specific warnings or
information regarding any health effects
listed on the labeling of the pesticide
being handled.
, One comment questioned the
relevancy of environmental information
in worker protection training. The
Agency believes such training is
relevant to worker protection. Many
environmental concerns are applicable
riot only to the organisms in the
environment, but also to workers and
other persons who may be in that
environment. Ground and surface water
warnings, for example, are designed to
protect not only aquatic organisms, but
also workers and other persons who
may be using the water for drinking,
cooking, bathing, etc. The Agency notes
that FIFRA defines "environment" as
including "water, air, land, and all
plants and man and other animals living
therein, and the interrelationships which
exist among these."
' A number of comments suggested that
handlers receive instruction concerning
the part 170 handler protection
requirements so they can assist in
protecting themselves and be aware of
noncompliance. One comment said that
the training should cover the anti-
retaliation provisions of the regulation
and employees's rights to file
icomplaints.
, EPA agrees with these comments and
ihas added such a subsection to the
Draining requirements.
In § 170.230, EPA has made some
modifications to the content of the
training program in addition to those
discussed above. The topics have been
reordered, and some have been
combined. Several subsections have
been rewritten to improve their clarity.
A subsection has been added requiring
instruction in the recognition and
avoidance of heat-related illness
associated with the use of PPE.
The Agency's proposal to require a
trainer to be a certified private or
commercial applicator or to be
designated by a State or Federal agency
as a trainer of certified applicators
received considerable attention.
Some comments objected to
permitting certified applicators,
especially private applicators, to run
training programs. Being certified has no
bearing on competency to train others in
pesticide safety, they maintained, and
this provision may lead to unqualified
persons providing training. Comments
also said that trainers should be
required to attend a continuing
education course on how to instruct
pesticide handlers.
A number of comments requested that
other people who meet EPA
requirements be permitted to run
training programs for handlers or that
the trainer should not be required to be
a certified applicator. They pointed out
that many agricultural professionals
could do such training, such as county
cooperative extension agents, university
professors, consultants, and properly
trained supervisory personnel.
Several respondents stated that a
trainer was not necessary at all;
employees handling pesticides could be
given written information on pesticides
to meet training requirements, if the
handler is able to read. Another
comment said that States should
determine how training will be done.
The Agency continues to believe that
the physical presence of a person to run
the program and to respond to the
questions of participants is critical to
the success of the training. EPA will
require the presence of a trainer since
many of those needing training may
have little formal education and may not
be able to read and comprehend written
materials without help. The Agency is
aware that some States have developed
successful training programs for
certified applicators that do not require
the presence of a trainer. EPA will allow
States to adopt training programs that
are more comprehensive than the
Federal program. If any State wishes to
establish an autotutorial program
accompanied by some measurement of
understanding, EPA will review the
program to determine whether it is as
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comprehensive as the program required
by this regulation.
After considering these comments, the
Agency has decided that the most
relevant trainer qualification is previous
training in pesticide use and safety.
Certified applicators, whether private or
commercial, would have some
knowledge and experience in pesticide
handling; with the assistance of written
and audiovisual materials they should
be able to respond to most questions on
this topic. The Agency believes that
most agricultural establishments either
employ a certified applicator or contract
for the services of a certified applicator
in the course of business. Therefore, the
Agency does not expect that a large
number of people will need to obtain
certification to act as trainers under this
part. The Agency also does not envision
or promote the idea that agricultural
employers will use the certification
system as an alternative to this handler
training requirement.
A person designated as a qualified
trainer of certified applicators or
pesticide handlers by a State, Tribal, or
Federal agency having jurisdiction is
eligible to be a trainer under part 170.
EPA is also persuaded by the comments
that stated that a trainer could be a
person who has completed a train-the-
trainer or continuing education course.
In the final rule, the Agency has
modified the trainer qualification
requirement to specify that a person
who has completed a pesticide safety
train-the-trainer course is eligible to be a
trainer of handlers under this part.
EPA did not propose to require
verification of training, because it was
concerned that this could be considered
a requirement for private certified
applicator recordkeeping—a
requirement specifically prohibited by
FIFRA section 11.
Some comments expressed the view
that section 11 of FIFRA prohibits the
Agency from issuing regulations
requiring recordkeeping by private
applicators.
A number of comments urged some
type of training verification with
mandatory recordkeeping. Some
suggested cards be issued to trained
handlers; others suggested that the
trainer be required to maintain records
of training program participants. Many
comments were concerned about the
lack of recordkeeping requirements.
They stated that without verification of
training, violations will occur,
enforcement will be difficult, and
employees will be trained more than
once.
Some comments argued that
requirements to keep records of worker
training would not be prohibited by
FIFRA section 11, claiming that a
requirement for persons acting as
trainers to keep records of trainees
would not be the imposition of a
recordkeeping requirement on a private
applicator who voluntarily chose to act
as a trainer.
Several comments suggested
eliminating private applicators as
trainers since they cannot be required to
keep records and suggested that only
certified commercial applicators should
be eligible to conduct this training
because they could be required to keep
records.
EPA did not propose recordkeeping
requirements in the proposed rule
because of possible concerns that such
recordkeeping might be inconsistent
with section 11 of FIFRA. The Agency
has concluded that section 11 does not
prohibit the Agency from requiring
trainers, including trainers who happen
to be private applicators, to keep
records verifying any training they give .
under part 170. Because the Agency did
not propose a recordkeeping
requirement for trainers in the proposed
rule, however, EPA is not adopting any
such requirements in the final rule. If
experience under the final rule indicates
that recordkeeping would be warranted,
EPA will revisit this issue.
Although the training provision may
be difficult to enforce in some cases
without written verification, the Agency
will seek enforcement of the provision
and expects that the compliance rate
will be high enough that significant risk
reduction will be accomplished.
In their comments on the draft final
rule, under FIFRA section 25(a), USDA
expressed concern about the absence of
a formal mechanism to avoid repetitive
training of each new hire on each
agricultural establishment and
welcomed the opportunity to work with
EPA to develop such a verification
program. A change to the rule was
made. The rule now states that if the
handler employer determines that a
handler possesses an EPA-approved
WPS training certificate and has no
reason to believe it is invalid, that
determination shall meet the
requirements of assuring that the
handler has been trained. The revised
final rule requires trainers to assure that
appropriate Worker Protection Standard
training has been given to a handler
before the training certificate is issued.
As described under the section about
worker training, EPA and USDA intend
to establish a joint task force to develop
and implement a mechanism for
verification of training. The task force
would seek to reduce the amount of
duplication in training and to establish a
voluntary system of training verification.
The use of an EPA-approved WPS
training certificate is optional. The
Agency encourages those trainers who,
voluntarily, would like to maintain
records or issue cards to handlers to do
so.
Some respondents misinterpreted the
proposed rule's silence on the issue of
frequency of handler training to indicate
that retraining before each handling
episode was necessary; others assumed
that training was required either
annually or upon initial employment
each year.
Numerous comments raised questions
such as when and how often training
should be done. Some suggested it
should be a one-time instruction
conducted at the beginning of the
growing season or at the time of
employment; others wanted to see
training required annually or more often.
The Agency did not specify in the
NPRM how often pesticide safety
training must be conducted. However,
the final rule requires training for
handlers to be renewed at least once
every 5 years, measured from the end of
the month in which the training is
completed. The Agency believes that
such renewal of WPS handler training
will be adequate to convey the basic
pesticide safety precepts to handlers
and to provide timely updates and
reinforcement, without undue:burden.
Mandatory annual retraining of the
same employees presenting general
information that typically does not
change over the course of a year would
be a burden on employers.
EPA intends to develop model training
programs that will facilitate compliance .
with part 170. The Agency's plans in this
respect are discussed in more detail in
Unit VI of this preamble. Although the
Agency expects that most pesticide
safety training will be conducted using
materials developed by EPA, it does not
believe that this must be the only source
of training materials. On the other hand,
some assurance of the adequacy of
privately developed materials is
desirable. The final rule specifies the
minimum content for such materials
(§ 170.230].
H. Knowledge of Labeling Information
1. Access to labeling. The Agency
proposed that any information from the
labeling of any pesticide that is being
used be provided upon request to the
handler. This requirement was intended
to provide handlers with product-
specific pesticide safety information that
will increase their ability to protect
themselves and others.
Some comments stated that product-
specific information is important but
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38130 Federal Register / Vol. 57', No. 163 / Friday, August 21, 1992 / Rules and Regulations
that handlers may be too intimidated to
request the information from the
supervisor or employers.
, Some comments suggested that the
Agency delete the access-to-labeling
provisions because the OSHA Hazard
Communication Standard has been
expanded to include agricultural
employees. One recommended that the
rule be changed to allow growers to
retain either the pesticide label or the
Material Safety Data Sheet (MSDS).
EPA has amended this section
(§ 170.232) to address these concerns.
Handlers must read or must be informed
of, in a manner that they can
understand, all labeling requirements
related to the safe use of the pesticide
such as signal words, human hazard
precautions, PPE requirements, first aid
instructions, and any additional
precautions relating to the handling
activity. In addition, the handler must
have access to the labeling at all times
during the handling activity in case a
question arises about the use
requirements. This does not mean that
multiple copies must be made and
carried with each handler, but that the
product container itself or a copy of the
labeling must be available in a place
where it may be consulted if necessary.
The Agency believes that almost all
respondents supported its intended goal,
which was to assure that all handlers,
including those working in an assisting
or nonsupervisory capacity, are aware
of the product-specific instructions for
the pesticide being handled. If handlers
are not aware of labeling requirements,
it is more likely the product will not be
used in accordance with labeling, a
violation of FIFRA. In this regard, a
MSDS is not an adequate substitute for
product labeling. Although an MSDS
may contain useful information about
the safe handling and storage of the
material and the risks associated with
exposure to the material, it will not
address all the enforceable use
requirements on the pesticide labeling.
The Agency considers that giving
instructions in the relevant labeling
requirements would assure this
awareness and that reading the labeling
also would be adequate. EPA agrees
that handlers may be intimidated from
requesting the labeling, and that even if
a request is made, the labeling may not
be read or understood.
2. Labeling information for early-
entry workers. The Agency did not
propose that early-entry workers have
access to labeling information.
Some comments noted that early-
entry workers would need product-
specific information to have knowledge
of the specific hazards associated with
their early-entry assignment and that it
would be appropriate for early entry
workers to have access to the labeling.
EPA agrees that it is essential for
workers who enter a treated area before
the expiration of an REI to have job and
product-specific instructions in pesticide
safety. Therefore, the Agency has added
language under the entry restrictions in
the subpart on agricultural workers. This
language provides that before being
allowed to enter a treated area during
the REI, the workers either must read
the product labeling or must be informed
in a manner that they can understand of
all labeling requirements related to
human hazards or precautions, first aid,
symptoms of poisoning, PPE specified
for early-entry, and any other labeling
requirements related to safe use.
3. Product-specific information for
workers. The Agency proposed to
require that product-specific information
be provided to workers, on request, for
all treated areas subject to notification,
beginning on the day the pesticide is to
be applied and continuing at least until
ithe expiration of the REI. The required
information included: (1) The specific
location and description of the area
treated or to be treated, (2) the brand
name, active ingredients, and EPA
registration number of the pesticide
used, and (3} the restricted-entry
interval. In the NPRM, the Agency
stated that it considered requiring this
information to be displayed at a central
location, such as a notice board, or to be
written on warning signs.
Few comments were opposed to
providing this information. Most were
critical of the requirement as written,
however, and recommended posting the
information at a central location.
Numerous comments were opposed to
any requirement that compels workers
to request information, because workers
are too intimidated to request
information from the employer, fearing
that such a request could jeopardize
their jobs.
• The Agency is convinced that workers
must have unhampered access to
product-specific information about the
pesticides to which they are exposed
occupationally. The Agency was
persuaded by the comments that some
agricultural workers may be intimidated
and that oral communication of this
information may be complex and
inconvenient. The Agency has amended
this section to require employers to list
the product-specific information in a
central place on the agricultural
establishment and to allow workers
unimpeded access to this information.
The information must include: (1) The
location and description of the treated
area, (2) the product name, (3) the EPA
registration number, (4) the active
ingredient(s) of the pesticide, (5) the
time and date the pesticide was applied,
and (6] the REI for the pesticide.
While the Agency acknowledges the
similarity between this requirement and
requirements of OSHA's Hazard
Communication Standard, EPA will not
require that an MSDS or similar fact
sheet be made available, because such a
requirement was not proposed in the
NPRM. EPA and OSHA are committed
to cooperating, within the constraints of
their respective statutes, to minimize
confusion and to avoid duplication of
the requirements of the two agencies.
EPA has prepared a notice of
proposed rulemaking to amend the WPS
that requests comments on the
feasibility and utility of requiring that
MSDSs or fact sheets be made available
to agricultural employees. This NPRM is
being published in this issue of the . ,
Federal Register.
I. Other
1, Cholinesterase monitoring. EPA
proposed that commercial pesticide
handlers exposed to toxicity category I
or II organophosphate pesticides for 3
consecutive days or for any S days in a
21-day period be monitored for
cholinesterase inhibition. The Agency
solicited and received comments on: (1)
The types of employees to be monitored
and, in particular, whether the
requirement should be extended to
private handlers, [2] the length of
exposure (whether a more sensitive
"trigger" with fewer days exposure
would be more appropriate), and (3) the
difficulties, costs, and advantages of
day-based and symptom-based triggers.
Although some comments stated that
only commercial handlers had sufficient
exposure to warrant monitoring, many
comments stated that private pesticide
handlers also may have sufficient
exposures to warrant cholinesterase
monitoring and that this requirement
should apply to all handlers. Some
comments stated that applying the
requirement only to commercial
handlers creates a double standard for
protection that is not supportable.
Several comments supported the
inclusion of all agricultural employees in
a medical monitoring requirement
because the cholinesterase monitoring
requirement of the proposal afforded no
protection for early-entry workers or
other workers. Other comments stated
that a medical monitoring program for
all employees would be unnecessary
and impractical.
A few comments stated that
cholinesterase monitoring was
unnecessary because of all the other
requirements being initiated with part
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170. Some suggested that cholinesterase
monitoring be an option rather than a
requirement; voluntarily implemented
programs probably would be more
successful than imposed programs.
Most respondents supported the
Agency's proposed "trigger" of 3
consecutive days or any 6 days of
exposure in a 21-day period. Some,
however, stated that while a day-based
trigger may be of use in detecting
adverse health effects over time, it is of
limited use in addressing accident
situations or brief overexposure; a
symptom-based trigger is too ill defined
for use as a regulatory tool and could be
confusing to both the employer and the
supervising physician as to its
applicability. One comment stated that a
trigger based on hours (rather than
days) of exposure would be a more
rational way of including the highly
exposed. Some comments suggested
alternative triggers. A few reviewers
stated that the Agency had given no
rationale for the trigger chosen and
asked how it had been determined. One
suggested that determining the ideal
trigger would have to wait until more
data were available. Some comments
suggested eliminating a trigger and
requiring the testing on a preset
schedule.
Many comments, both those for and
those against a cholinesterase
monitoring requirement, expressed
concern about the recordkeeping that
would be necessary to implement a
monitoring program and to follow
migratory and seasonal workers.
Some comments opposed monitoring
because of the cost. Two comments
included estimates that monitoring
would cost $70 per test or $200 to $400
per employee over the growing season,
exclusive of the costs of recordkeeping
and additional physician fees. Others
noted that lost work time and cost of
transporting handlers to a physician's
office where the test could be performed
would be a burden to employers. In
some remote rural areas, the testing
would necessitate long-distance travel
to the nearest qualified physician. One
comment warned that the expense of the
test and the time off work probably
would result in this regulation being
ignored. In contrast, another comment
stated that the reduced medical
disability costs among handlers would
easily outweigh the costs of
implementing a monitoring program.
Numerous comments expressed
concerns regarding the validity and the
reliability of cholinesterase testing
methods, the availability of qualified
laboratories to support a cholinesterase
monitoring program, and the sufficiency
of most physicians' knowledge about the
toxicity of pesticides and ability to
interpret the results of cholinesterase
tests properly.
The Agency is concerned about many
of the problems of cholinesterase
monitoring, including the difficulty in
finding knowledgeable physicians to set
up monitoring programs and qualified
laboratories to perform the analyses.
The comments noted that a quality
control program for laboratories would
be needed nationwide if a monitoring
program were to be successful. EPA is
not prepared to establish such a
program nationwide at this time.
The Agency believes that despite the
practical difficulties associated with a
nationwide program, the monitoring of
employee exposure is a prudent
occupational health practice and
encourages employers wishing to
operate such programs. To facilitate
voluntary programs, the Agency has
required that pesticides that contain
cholinesterase-inhibiting compounds be
identified as such in the labeling of the
product. The Agency also is interested
in cooperating in research or
evaluations that might be done on new
or existing exposure monitoring
programs.
The Agency is concerned, however,
that even reliable blood-level
cholinesterase monitoring often would
not prevent pesticide poisoning
incidents. Blood samples are taken at
intervals—weekly, biweekly, or
monthly—during the exposure season;
the handler may accumulate enough
exposure between samples to become
ill. In addition, the delay between
sampling and the evaluation of the test
results is such that most handlers will
receive more exposure before the test
results are known. Before such a
monitoring system can indicate that
handlers should be removed from
further exposure to cholinesterase-
inhibiting pesticides because their blood
cholinesterase levels are dangerously
low, the handlers may have received
enough additional exposure to
precipitate acute poisoning.
EPA is troubled by the reactive nature
of available cholinesterase monitoring
methods. The Agency would prefer to
explore methods of monitoring
exposures to cholinesterase-inhibiting
pesticides, and perhaps to other
pesticides, which'are more likely to be
preventive. One promising approach
involves immunoassay-based detection.
Immunoassay techniques could provide
rapid, simple, and cost-effective
monitoring methods for exposure
monitoring systems under field
conditions. It is expected that
inexpensive kits can be developed that
will yield quantitative results in less
than 30 minutes, thus enabling more
frequent monitoring and rapid response
if unacceptable exposure is indicated.
This technology could provide an
effective means of signaling to the
pesticide handler when exposure is
unacceptably high.
EPA has determined that more
research is required to develop
immunoassay monitoring systems for
pesticide handlers. However, the
research data to date indicate that an
immunoassay-based personal
monitoring exposure system probably
could be developed. Immunoassay
devices use antibodies as receptors to
sample the environment of the exposed
persons. Specific antibodies tb many
pesticides of concern already have been
developed and evaluated, but specific
antibodies for other priority compounds
need to be identified. Ideally, a sampling
system would be developed to
incorporate all of the compounds of ',
concern. The Agency strongly
encourages the rapid development of
practical and reliable techniques of this
kind and welcomes further information
on ongoing research and the opportunity
to cooperate with developers,on the
necessary research. To support the goal
of improving exposure monitoring
technology, the Agency also intends to
consider requiring the development of
such detection methods for the
registration or continued registration of
selected pesticides.
In conclusion, although a blood-level
cholinesterase monitoring program may
be prudent for some handlers, EPA has •
determined that imposing a nationwide
requirement for such monitoring is not
justified at this time. The Agency is not
convinced that such a program would
provide benefits commensurate with the
costs entailed. The Agency intends to
pursue the development of more
effective exposure monitoring systems,
such as the immunoassay-based system
discussed above.
EPA intends to reconsider the need
for and the appropriate form of exposure
monitoring for pesticide handlers after
this final Worker Protection Standard
has been implemented. This will give
the Agency the opportunity to evaluate
more thoroughly the ongoing research in
this area and the results of new or
existing exposure monitoring programs.
The Agency expects to issue a proposed
rule in this area in about 3 years.
2. Relationship between OSHA's
Hazard Communication Standard and
EPA's Worker Protection Standard. The
proposed revisions to the Worker
Protection Standard (WPS) were
published July 8,1988; the following
month, August 8,1988, the Occupational
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38132 Federal Register / Vol. 57', No. 163 / Friday, August 21, 1992 / Rules and Regulations
Safety and Health Administration
(OSHA) published a notice of proposed
rulemaking which would modify its
Hazard Communication Standard
(HCS). In the preamble to these
proposed modifications, OSHA states
that the HCS would apply to workers
who are exposed to pesticide residues
after application.
EPA received numerous comments
that pointed to the potential overlap of
some requirements of the WPS with
those of the HCS. Those who wrote
were concerned that the requirements of
the two standards might duplicate each
other or might be conflicting. A few
were concerned about possible conflicts
with similar State laws. All want to see
EPA and OSHA resolve any potential
conflict before their respective
regulations are made final.
Some respondents felt that OSHA
should have responsibility for defining
hazard communication in agriculture;
more felt that EPA should have the
responsibility where pesticides are used.
Some asked that the access-to-labeling
provisions of the WPS be deleted
because of the OSHA regulation calling
for access to MSDSs.
Some growers claimed they should be
exempt from the WPS because they are
covered by OSHA. Worker
representatives want EPA to require
training for all workers, as the HCS
does.
EPA has made a commitment to work
with OSHA within the constraints of
each Agency's statutes to minimize
confusion and to avoid duplication
between the requirements of each
Agency. Section 4(b)(l) of the
Occupational Safety and Health Act
precludes OSHA from regulating
working conditions or hazards with
respect to which other Federal agencies
exercise statutory authority to prescribe
or to enforce standards or regulations
affecting occupational safety or health
(29 U.S.C. 653(4)(b)(l)}. In part 170,
however, EPA has exercised statutory
authority only with regard to
agricultural working conditions or
hazards that are related to pesticides.
The Occupational Safety and Health Act
and its regulations may apply to other
agricultural working conditions or
hazards and to nonagricultural working
conditions (e.g., office work) that may
take place on agricultural
establishments. Among the regulations
that may be applicable to nonpesticide
working conditions in agriculture are the
Hazard Communication Standard (29
CFR 1928.21) and the Field Sanitation
Standard (29 CFR 1928.110). Since the
OSHA Field Sanitation Standard
addresses general sanitary hazards,
rather than pesticide hazards, EPA
believes its applicability is not affected
by part 170.
IV. Labeling Statements
'A. Background of Proposal
• The Agency noted in the NPRM that
for part 170 to be enforceable under the
misuse provision of FIFRA section
i2(a)(2)(G), its requirements must be
incorporated onto pesticide labels or
labeling. Rather than require that the
regulations be printed in their entirety
on each product, EPA proposed that part
170 be incorporated by means of a
reference statement. In addition to the
reference statement, those requirements
Of part 170 that were product specific,
such as personal protective equipment
and restricted-entry intervals, and
product-specific information necessary
for compliance with part 170, such as
whether the product is a fumigant,
would appear as statements on labeling.
Requirements applicable to all products,
such as providing decontamination
1 Vvater, would not appear as statements
; on labeling.
The NPRM proposed that the required
worker protection labeling statements
be consolidated for the convenience of
registrants in a new subpart K of part
156, "Labeling Requirements for
Pesticides and Devices." The Agency
proposed specific regulatory text and
labeling statements for part 156, and
solicited comment on the labeling
'aspects of the Worker Protection
• :Standard. The Agency also discussed
!how it would implement these labeling
.changes as part of its pesticide
registration program.
B. Reference Statement
'• The comments were divided evenly in
uopposing or supporting the proposal to
'reference part 170 on the label rather
"than including the full text of all
requirements in labeling. Comments that
opposed the proposal to reference part
170 gave reasons such as: (1) The
problem of availability of the specific
; requirements of the regulation should it
not be incorporated in pesticide labeling
in its entirety, (2) the need for
information at the use site, and (3) the
undermining of the "read the label" and
. the "label is the law" message that users
have been trained to follow. They
; suggested that noncompliance is more
likely for requirements that are not on
the label. Several comments stressed the
! need for wide dissemination of the
requisite information. Two comments
suggested that users should not be
referred to part 170 but to Agency-
; generated guides, instructional
; materials, or popularized versions of the
regulations.
The Agency acknowledges the need
for pesticide users to have access to full
information about the legal requirements
for use of a pesticide. It also notes that
in many cases the quantity of
information on pesticide labeling is
considerable. Confusion in
understanding labeling statements may
result in noncompliance as surely as
difficulty in obtaining the information
may result in noncompliance. The
Agency intends to develop and to make
available, through its outreach activities
and with the assistance of the
Cooperative Extension Service, State
pesticide-regulating agencies, and the
traditional networks of communication
with the agricultural community such as
commodity organizations and industry
associations, information to assist users
in understanding and complying with
part 170. EPA believes that such
information will minimize the need for
users to seek out the Code of Federal
Regulations (CFR) to understand their
duties. The Agency intends to complete
the development of basic training
materials prior to implementing part 170.
The Agency considered requiring
registrants to distribute a copy of part
170 with each sale of agricultural
pesticides, but concluded that such
requirement would result in waste
through duplication. However, the
Agency encourages any efforts
registrants choose to make to
communicate part 170 requirements to
users. The Agency has retained its
approach in the final rule of referencing
part 170 on the label, but has changed
the language in the reference statement
for the purposes of brevity and clarity.
C. Other Statements
Other changes have been made to
part 156 in response to comments. The
proposed wording of the labeling
statements for restricted-entry intervals,
notification, and personal protective
equipment have been shortened.
One comment suggested that the
signal word be required to appear in
Spanish for products in toxicity
categories III and IV as well as on
products in toxicity categories I and II.
The Agency believes that for the most
toxic products, where there is a
significant risk of serious injury by
accidental exposure, it is reasonable to
require translation of a limited amount
of critical information, such as the signal
word, into Spanish because it is the
primary language for many agricultural
workers in the United States. Extending
this translation requirement to
additional products, information, or
languages would add verbiage to
already crowded product labels without
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38133
increasing the likelihood of avoiding
additional pesticide poisonings. EPA
permits a product to bear labeling in
languages other than English, but it will
not require translation as part of the
final rule.
A number of changes to worker
protection statements have been made
in the final rule in response to
comments. These changes have focused
on risk mitigation measures such as the
entry restrictions, notification about
treated areas, and use of personal
protective equipment by handlers and
other workers entering treated areas
prior to the expiration of a restricted-
entry interval. The restricted-entry
statements are to be placed in the
"Directions For Use" section of the
pesticide labeling under the subheading
of "Agricultural Use Requirements" to
consolidate most worker protection
statements in one place.
No comments were received in
reference to the proposed notification
statements. Several changes to the
notification section have been made in
the final rule. The wording of the
statement was changed to "notify
workers of the application by warning
them orally and posting warning signs at
entrances to treated areas" rather than
merely "subject to posting" to
distinguish the statement from other
general requirements of part 170 which
involve the display of written materials.
The subsection related to location of the
statement on the labeling has been
modified to require that the notification
requirement be in the Agricultural Use
Requirements section of the labeling
with the other required worker
protection statements.
No comments were received on the
proposed personal protective equipment
statements. In the final rule the Agency
has made a number of administrative
and technical changes to these sections.
These are reflected in changes in the
terminology used in the table for the
protective equipment requirements for
handling activities in 40 CFR 156.212(e).
For example, the term "coveralls" has
been used instead of "protective suit"
and "protective eyewear" has been used
instead of "goggles or face shield."
Two differences between the
proposed and the final rule relate to PPE
labeling statements. Wherever possible
throughout the PPE section, the Agency
has taken the approach of specifying the
exact wording of PPE labeling
statements and specifying which
products are subject to the statement.
The goals of this approach are to reduce
the burden on registrants in interpreting
part 158 in the process of revising
product labeling and to reduce the need
for registrants to consult with EPA about
PPE labeling language.
Another difference between the
proposed and the final rule is the way in
which information about acceptable
types of PPE is conveyed to users.
Specific types of glove materials will be
recommended on the labeling, and
specific types of respirators will be
required on the pesticide labeling.
Where protection of a certain body area
is called for, e.g., eye protection, the
labeling will not list all acceptable kinds
of protective eyewear. Instead, the
labeling statement will list "protective
eyewear," and users will refer to the
standardized definition of acceptable
kinds of PPE for eye protection in 40
CFR 170.240 (the section of the
pesticide-handling subpart which covers
PPE), in the EPA-prepared guidance
brochure on protective eyewear, or in
other new EPA training materials
dealing with PPE. Through these
definitions and through handler training
programs, users should become
accustomed to the criteria for
acceptable types of PPE, and EPA
believes this will reduce labeling
verbiage related to PPE.
EPA has made every effort to
minimize the additional labeling
language necessitated by the revisions
to part 170 and to eliminate excess
verbiage. At the same time, EPA
recognizes that use restrictions can
ordinarily be enforced only through
labeling statements. EPA's approach,
therefore, has been to put users on
notice, via the labeling, of the
regulations with which they must
comply.
One comment suggested requiring the
identification of the toxicity category on
product labels. Signal words are
intended to convey the relative acute
toxicity of products in a manner users
can understand easily. Since users may
not be aware of the criteria on which
toxicity categories are based, the
Agency believes that the toxicity
category would not be useful on labeling
and that the signal word is sufficient.
In the final rule, EPA has specified the
location, or alternative locations, for all
required statements. The final rule
allows that statements be consolidated,
to the extent possible, for the
convenience of the reader and that
statements be at the beginning of the
directions for use to emphasize their
importance.
V. Statutory Review
A. U.S. Department of Agriculture
As required by FIFRA section 25(a), a
copy of this final rule was provided to
the Secretary of Agriculture on June 7,
1991. On March 27,1992, the Secretary
provided written comments on this final
rule. The Secretary offered many
comments that led EPA to revise the
final rule, its cost estimates, and its
approach to implementation of the final
rule. Following is a summary of the
principal comments by the Secretary,
together with the Agency's responses.
The full texts of the Secretary's
comments and EPA's responses are
contained in the docket for this rule.
Comment #1: USDA expressed
concern about the impact of restricted-
entry intervals (REIs) that exceed 72
hours.
Response: USDA's concern is due to
two aspects of the draft final rule: (a) A
requirement that registrants must retain
existing REIs that are longer than those
that would be established through the
Worker Protection Standard, and (b) a
redefinition of "restricted-entry
interval" — instead of allowing early
entry if minimal protective clothing is
worn, the rule now prohibits all early
entry to perform hand labor tasks,
except for a few narrow exceptions.
Therefore, this rule might subject users
to considerable costs that were not
contemplated when these longer REIs
were set. EPA believes that USDA has a
valid concern regarding longer REIs
established before the promulgation of
this rule.
EPA has ascertained that REIs exceed
72 hours for only a few currently
registered active ingredients—usually
for only a few uses of each. EPA is
reviewing such uses for each of the few
active ingredients in light of current
information. The review is based on the
availability of reentry data, poisoning
incidents, or other evidence that could
help determine: (a) Whether routine
early entry to perform hand labor tasks
must be prohibited for the entire REI to
mitigate risk to hand laborers, or (b)
whether early entry for hand laborers
with personal protective equipment
(PPE) and other protections could be
permitted on pesticide labeling as an
appropriate temporary mechanism to
respond to USDA's concerns about
disruptions and costs to growers who
are using pesticides with REIs longer
than 72 hours, or (c) whether another
product-specific strategy should be
adopted.
EPA will notify registrants of this
review process and will request that
registrants notify EPA of longer REIs
that may have been overlooked in the
Agency's search. With cooperation from
affected registrants, EPA expects to
complete, the review process in time for
those registrants to alter their labeling
within the,time allotted in this rule.
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38134 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
Comment #2: Activities that entail
only slight contact with treated surfaces
should be subject to a reduced standard,
and provision should be made to permit
necessary agricultural worker activities
with the use of PPE, particularly when
REIs exceed 72 hours.
Response: The final rule contains an
exception that allows early entry for
activities that involve no contact with
anything that has been treated with the
pesticide to which the REI applies,
including, but not limited to, soil, water,
air, or surfaces of plants in the treated
area. However, when contact with
treated surfaces will occur, EPA is
unable to predict on a generic basis
which activities, crops, and situations
will involve only "slight" contact. This
can be determined only through data
review, usually as part of the
registration or reregistration process.
See preamble discussion in Unit III—
establishing entry restrictions in the
future.
During the formal comment period for
this rulemaking, EPA received many
comments from the cut flower and cut
fern industry about the economic
hardship that prohibiting routine hand
labor during REIs would cause their
industry. The Agency did not receive
comments from other industries or
commodity organizations that indicated
that they would sustain such a hardship
and the Agency has no information
indicating that any crops or industries
other than the cut flower and cut fern
industry would be significantly affected
by the entry restrictions imposed by this
final rule. However, there may be other
industries, crops, or crop practices that
would bear an unreasonable economic
burden under such restrictions'.
Therefore, the final rule allows the
Agency to grant exceptions to the entry
restrictions on a case-by-case basis.
Comment #3: USDA believes it is
imperative that EPA clarify whether the
prohibition on early entry to perform
hand labor tasks applies to State-
established REIs.
Response: States determine the
restrictions that apply to State-
established REIs. The final rule's
restrictions on entry apply solely to REIs
that appear on federally approved
pesticide product labeling. On some
occasions, registrants request the
addition of a State-established REI to
their federally approved product
labeling. If EPA approves such an
addition, a decision will be made on a
case-by-case basis as to whether to
prohibit routine early entry to perform
hand labor tasks during the entire State-
established REI. EPA may chose to
create an exception on individual
product labeling to allow, after the
expiration of the EPA-mandated REI,
early entry to perform routine hand
labor tasks with certain limited PPE and
work clothing.
Comment #4: USDA supports the
concept of providing training to workers
who may be exposed to potentially
dangerous pesticides.
Response: None required.
Comment #5: USDA expressed
concern that the manner in which
training is required is unreasonably
burdensome.
' Response: USDA's concern is that if
EPA requires training before each
worker is potentially exposed, then
training one or more times daily could
be required of employers with frequent
! employee turnover, as is common in
some hand labor crews. Such training
might have to be conducted on the spot,
.such as at the side of the field, and
would likely be less beneficial to the
worker and onerous to the employer.
EPA will continue to require that early
entry workers must be trained before
entering areas and contacting treated
surfaces while an REI is in effect,
because their risks are expected to be
higher. EPA has made a change,
however, in the training requirement for
non-early-entry workers. The modified
•rule continues to require training for all
agricultural workers. However, in
general, the modified rule requires
!; agricultural employers to assure that
:when any worker enters any areas on
the agricultural establishment where,
within the last 30 days, a pesticide has
been applied or an REI has been in
effect, the worker receives pesticide
safety training before their 6th day of
entry into such treated areas on any
particular agricultural establishment.
However, for the first 5 years after the
effective date of the rule, workers must
be trained before their 16th day of entry
into such treated areas on any particular
agricultural establishment.
i; Finally, it should be noted that EPA
deliberately established a relatively
lengthy [about 20 months) lead time
•: before the training provisions of the
: final rule would be enforceable. This
lead time was established, in part, so
that a substantial number of workers
could be trained in the interim. Once a
'' large percentage of workers have been
trained, the concern about repetitive
training diminishes, because many new
! hires already will have received
training.
This issue does not pertain to
handlers' for whom risks are expected
• to be higher—the rule requires that
handlers receive training before they
handle pesticides.
Comment #6: USDA expressed
concern about the absence of a formal
mechanism to avoid repetitive training
of each new hire on each agricultural
establishment. USDA welcomes the
opportunity to work with EPA to
develop such a verification program.
Response: Two changes to the final
rule were made. The rule now requires
training for workers or handlers to be
renewed at least once every 5 years. In
addition, the rule now states that if the
agricultural employer determines that a
worker possesses an EPA-approved
Worker Protection Standard training
. certificate that the employer has no
reason to believe is invalid, that
determination shall meet the
requirements of assuring that the worker
has been trained. The revised final rule
requires trainers to assure that
appropriate Worker Protection Standard
training has been given to a worker
before the training certificate is issued.
Comment #7: Additional funding will
be required if EPA anticipates that
USDA will meet some of the training
requirements of this rule.
Response: EPA has not assumed that
USDA will be the vehicle to meet the
training requirements. The Agency
believes that employers will train most
workers and handlers. In addition, EPA
will promote training by other interested
persons and organizations by
conducting train-the-trainer courses and
by developing suitable training
materials and making them available for
trainers' use. However, EPA seeks to
work closely with USDA in the
development of Worker Protection
Standard training materials, including
materials designed to train workers and
pesticide handlers and materials
targeted at aiding growers in learning
how to comply with the revised rule.
EPA also seeks to cooperate with USDA
in the development and implementation
of the training verification system and
other projects designed to inform the
regulated audience about the revised
rule and how to comply with it.
Comment #8: Making agricultural
producers responsible for employees'
own safety actions is unrealistic.
Response: While compliance is
primarily a duty of employers under the
final rule, enforcement officials have
authority to consider the facts of the
case before making a determination of
whether a violation has occurred. The
Agency agrees, for example, that it
would be unfair for employers who
expend considerable efforts to assure
compliance to be treated in the same
manner as less conscientious employers
who tolerate or encourage
noncompliance. However, the Agency
believes that it is more appropriate not
to intrude by regulation into this area.-
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Federal Register / Vol. 57. No. 163 / Friday, August 21, 1992 /Rules and Regulations 38135
Enforcement officials have traditionally
based their compliance decisions on the
facts of an individual case.
Comment #9: USDA questions the
requirement that a listing of all
pesticides applied must be displayed in
a central location until 30 days after the
REI has expired.
Response: The NPRM, which
proposed that the information be
provided to workers upon request,
generated many comments. The majority
of the commenters, including worker
organizations, State agencies, and a
land-grant university, recommended that
the information be provided to workers
through posting. The National
Agricultural Chemicals Association
recommended a requirement that the
information be provided with each oral
warning. Some commenters cited
worker intimidation as the reason for
opposing the proposal that information
be supplied upon request. Others cited
the potential difficulties that employers
would have in complying with
individual oral requests for such
information. EPA was persuaded by the
comments to require the posting of this
information at a central place. On that
basis, in turn, EPA was persuaded to
drop the proposed daily oral warnings
and require one-time oral warnings
instead. EPA believes that most
employers would find daily oral
warnings more onerous than a one-time
posting in a central location.
Comment #10: The rule needs to
clarify when the employer is responsible
for making available to the worker
prompt transportation to an appropriate
emergency facility. USDA interprets this
to be applicable only while the
employee is on the employer's property.
Response: EPA has clarified in the
final rule that the agricultural employer
must provide such transportation when
a worker is on the employer's property,
including in any labor camp located on
the property. The Agency has similarly
clarified in the final rule that the handler
employer must provide emergency
transportation when a handler is at the
place of employment or at the handling
site.
Comment #11: The decontamination
provisions are unreasonably
burdensome to employers because of the
requirement for potable water for
handwashing purposes.
Response: A change to the final rule
was made. EPA replaced the
requirement for potable water with a
requirement for water that is of a quality
and temperature that will not cause
illness or injury when it contacts the
skin or eyes or if it is swallowed.
Evidence indicates that the drinking
water on many agricultural
establishments has not been test for
potability. EPA continues to require
water of such quality that, if accidently
swallowed, would not cause illness or
injury, because it is concerned that
workers will accidently use
decontamination water for drinking
purposes. In addition, the Agency-
recognizes that water used to wash the
face may accidently enter the mouth.
EPA believes that this is a simple
standard that will be easy for employers
to understand and comply with.
Comment #12: The cost for eyeflush
dispensers should be accounted for.
Response: USDA's comments on the
cost analysis of eyeflush dispensers led,
in part, to EPA's reexamination of the
requirement. The language of the rule
has been altered to change the
requirement from "eyeflush dispenser"
to "eyeflush water," and the
requirements for decontamination water
and eyeflush water have been combined
in the rule to avoid confusion. In
addition, the requirement for weekly
replacement of nonsterile eyeflush
water has been deleted and a
performance standard has been added
that requires employers to ensure that
the decontamination and eyeflush water
remains "of a quality and temperature
that will not cause illness or injury when
it contacts the skin or eyes or if it is
swallowed."
Eyeflush dispensers are no longer
specifically required at decontamination
sites; instead, eyeflush water is
required. For example, eyeflush water
may be the water in a carboy containing
the decontamination water or may be
running water from a tap. While special
eyeflush dispensers may be used, any
source of water that meets the
standards for decontamination in the
final rulemaking is .acceptable for
flushing the eyes. Eyeflush dispensers
would be required only when handlers
or early-entry workers must carry,
eyeflush water. This would occur only
when handlers or early-entry workers
are required by the pesticide labeling to
wear protective eyewear and when they
do not have decontamination water
otherwise immediately accessible to
them, such as running water nearby or a
carboy on a vehicle they are using.
Comment #13: USDA questions
whether it is reasonable to require
decontamination facilities and training
for a period of 30 days after the
expiration of the REI.
Response: EPA reconsidered the 30-
day time period due to comments from
both USDA and Congress, and remains
convinced that pesticide safety training
and access to decontamination water
are necessary for a considerable time
after the REI expires. (Congress
requested a time'period longer than 30
days.] The final rule continues to require
that worker training and
decontamination water be provided for
30 days after the expiration of the REI.
The 30-day period was an attempt to
limit and better define the sometimes
open-ended time period in the NPRM
that was "any surface that has been
treated with a pesticide during the
agricultural crop production cycle in
which the task occurs." (NPRM
§ 170.38(a)) In addition, it is important to
note that this final rule is establishing
minimum REIs. These REIs are intended
as temporary safeguards until product-
specific reviews are conducted. At that
time, the Agency anticipates that longer
REIs will be established on some of the
products, based on restricted-entry-
related incidents or on entry data.
On the other hand, even permanent
product-specific REIs are based on
"average" conditions. They do not and
cannot take into account differences due
to temperature and humidity; rainfall,
dew, and irrigation practices; degree of
sunlight; crop type, height, and density;
region-specific production practices; or
worker activity and length of exposure.
Evidence indicates the importance of
washing pesticides off as soon as
possible after an exposure to mitigate
adverse effects. Retaining
decontamination requirements for a
period of 30 days after the expiration of
an REI minimizes the chances that
workers will be harmed by residues,
decreases their chronic exposures to
pesticides, and lessens the risk of
delayed effects that may be
unrecognized at present. Studies also
indicate the value of training in any
program to reduce risk and increase
safety.
EPA has concluded that providing
workers with pesticide safety training
and supplying them with water, soap,
and towels for routine washing for a
period of 30 days after the expiration of
an REI is a prudent and inexpensive
measure to protect them from a variety
. of opportunities for exposure to
pesticides.
Comment #14: EPA should establish
regional climate-based restricted-entry
intervals, and the need for
decontamination provisions and safety
training should be based on the
pesticide persistence expected in a
particular region.
Response: When EPA establishes
product-specific REIs all available data
for the product are considered. All such
REIs must be set on a case-by-case
basis, after detailed review of the
properties and uses of the pesticide.
Such a detailed review is not possible in
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Federal Register / Vol. 57,;No. 163 / Friday. August 21, 1992 / Rules and Regulations
a regulation of the scope of the Worker
Protection Standard. Part 170
establishes only "interim" REIs to
strengthen deficient existing protections
until a more thorough review can be
performed.
As discussed in response to Comment
#13, restricted-entry intervals will, for
the most part, be based on "average"
conditions. Even in the ideal situation,
where entry is based on on-site field
tests, situations will arise where
workers will be exposed to
unacceptable levels of residues. These
situations include being contacted by
drift from nearby applications, mistakes
in warnings about areas not yet safe to
enter, "hot spots" within treated areas
from spills, or application mistakes, etc.
In addition, the establishment of a
residue level that is "safe" for entry
involves, at this time, only an analysis
of exposure to a specific product on a
specific occasion, and is often based
only upon acute toxicity data. The
Agency is also concerned about acute
and delayed health effect risks from the
cumulative effect of multiple exposures
to a single product and multiple •
exposures to multiple products. Since
the opportunities for exposure are so
variable, training employees once every
5 years and providing decontamination
facilities for a period of 30 days after the
restricted-entry interval seem to be
prudent, low-cost measures that can
reduce the pesticide-related illnesses
and injuries that may stem from such
exposures.
Comment #15: USDA takes exception
to the term "decontamination facilities"
after the expiration of the REI when the
risk of pesticide exposure is negligible
and suggests "personal hygiene
facilities" or simply "handwashing
facilities."
Response: EPA will continue to call
the provision "decontamination
facilities," because the term best
describes the purpose of providing soap,
towels, arid water to pesticide handlers,
early-entry workers, and agricultural
workers working in areas that have
recently been treated with pesticides.
The Agency does not consider the risk
of pesticide exposure to be negligible for
these employees.
Comment #16: USDA is concerned
that regulation beyond the harvest
interval could be misinterpreted in a
manner that would generate
unwarranted food safety concerns.
Response: Preharvest intervals and
entry restrictions are based on different
criteria. Entry restrictions are based on
the expected skin or eye exposure that
workers might receive during an entire
workday from exposure to residues on
foliage, fruit, other plant parts, and in or
on the soil, water, or air. Preharvest
intervals are based on the expected
dietary intake of the edible portion of
the crop based on amounts consumed.
The Agency has concluded that field
workers often will have a far greater
opportunity for exposure than the
consumers of the crop they pick. Finally,
the uncertainties associated with any
REI have already been discussed. This
uncertainty has led EPA to require
prudent, but economical, worker
protections after the REI has expired.
;: Comment #17: In informal discussions
between EPA and USDA about this final
rale, USDA expressed concern about
limiting the access of crop consultants
iand IPM scouts to treated areas
Immediately following pesticide
iapplications and during REIs.
Response: EPA has changed the final
rule to allow persons who are
performing duties as crop advisors to
have access to treated areas without a
time limitation. A crop advisor is
defined as any person who is assessing
pest numbers or damage, pesticide
distribution, or the status or
requirements of agricultural plants. The
term does not include any person who is
performing hand labor tasks. EPA was
unwilling to exempt crop advisors from
all of the protections provided by this
rule, but has defined them as pesticide
handlers if they enter an area during a
pesticide application or REI. As
pesticide handlers, they must receive
such protections as handler training
(unless already certified applicators),
PPE and the availability of
decontamination facilities. However,
since crop advisors who are employed
by commercial establishments (rather
than directly for the agricultural
establishment) are not workers covered
by part 170 protections, their presence in
a treated area after the expiration of the
REI will not trigger notification
requirements, such as oral warnings,
treated area posting, or posting of
application-specific information, and the
operator of the establishment need not
supply them with decontamination sites.
The Agency bases this change on its
conclusion that crop advisors are likely
to be particularly well-informed about
pesticide risks and how to protect
themselves.
: Comment #18: USDA raised concerns
about the Regulatory Impact Analysis.
Response: In light of USDA's
'• concerns, EPA reexamined the
Regulatory Impact Analysis for this final
'rule. The Agency used USDA-provided
'data and data from other sources to
update and refine the analyses for the
Various requirements of the rule. The full
text of EPA's responses to USDA's
concerns is contained in the docket and
in EPA's revised Regulatory Impact
Analysis for this rule.
B. Congressional Committees
As required by FIFRA section 25(a), a
copy of this final rule was provided to
the Committee on Agriculture, Nutrition,
and Forestry of the U.S. Senate and the
Committee on Agriculture of the U.S.
House of Representatives. Comments
were provided by Senator Patrick Leahy
and Representative Charlie Rose.
Following is a summary of each
comment by Senator Leahy and
Representative Rose, together with the
Agency's response.
Comment #1: Supports covering
greenhouse, nursery, and forestry
workers.
Response: None required.
Comment #2: Supports prohibiting
routine hand labor activities prior to the
expiration of the applicable restricted-
entry interval.
Response: None required.
Comment #3: Supports covering all
farms regardless of size.
Response: None required.
Comment #4: Supports training for
workers as well as handlers.
Response: None required.
Comment #5: All field workers should
be given crop sheets.
Response: The Agency agrees that
workers should have access to
information about the hazards of the
specific pesticides to which they may be
exposed during their work activities.
Crop sheets provide workers with
hazard information for all the pesticides
that may be applied to the crops they
are working with. The Agency is
establishing a system whereby
information on the specific pesticide(s)
actually used on a crop will be posted at
a central location to which workers will
have access. The Agency is also
proposing to make MSDSs or
comparable pesticide-specific fact
sheets available to workers. The
information posted at the central
, location, coupled with MSDS-type
information, will allow workers to
determine the hazards of the specific
pesticides they may be exposed to
during their work activities.
Comment #6: The training for workers
and handlers should include information
on the workers' rights and the growers'
responsibilities.
Response: The Agency agrees that
workers and handlers should be aware
of the protections they are entitled to
under the Worker Protection Standard.
The Agency has incorporated such a
provision into the training requirements
for workers and handlers.
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Federal Register / Vol. 57. No. 163 / Friday, August 21, 1992 / Rules and Regulations 38137
Comment #7: All worker and handler
training should be ongoing and updated
as needed.
Response: The Agency supports the
concept of ongoing training and the
updating of information as needed. A
change to the final rule was made. The
final rule now requires training for
workers or handlers to be renewed at
least once every 5 years, measured from
the end of the month in which the
training is completed. The Agency
believes that such renewal of WPS
training will be adequate to convey the
basic pesticide safety precepts to
handlers and to provide timely updates
and reinforcement, without undue
burden.
This final rule requires the continual
presence of a pesticide safety poster to
serve as ongoing reinforcement of
training for workers and handlers on
agricultural establishments. The final
rule also requires employers to update
as necessary the information about the
location of the nearest emergency
medical facility. In addition, updated
information about specific pesticides to
which the workers may be exposed will
be provided to workers as specified
under the notification provisions.
Comment #8: Supports establishing a
minimum restricted-entry interval (REI)
for all pesticides and setting REIs for
toxicity category I and II pesticides
without distinguishing those of a specific
chemical class.
Response: None required.
Comment #9: In all dry areas, all
toxicity category I pesticides should
have a 72-hour restricted-entry interval.
Response: During the ongoing
reregistration of pesticides, the Agency
is requiring registrants to supply data
about foliar and soil dissipation rates on
products for which this information is
relevant. When the Agency has the
necessary data, it will establish product-
specific REIs based on the product, and,
as applicable, on the crops or sites
where it is used, cultural practices,
varying climatic conditions, and
application techniques. At present, the
Agency has data to indicate that some
organophosphates transform into more
toxic products in arid conditions. There
are no data to indicate that other
chemical classes of pesticides undergo
similar transformations. Without data to
support a longer REI for chemical
families other than organophosphates,
the Agency has extended the REI to 72
hours for organophosphate pesticides
only. The transformation of
organophosphates into more toxic
products is related to the lack of
moisture in the soil and conditions of
very low humidity. These conditions are
generally found only in areas where
rainfall is consistently below 25 inches a
year. The Agency believes that defining
arid-like conditions, such as a
combination of percent humidity, days
without measurable dew or rainfall, and
percent soil moisture, is unsuitable for
establishing these "interim" REIs.
Comment #10: Generic REIs should be
established on the basis of the highest
acute toxicity rating, whether dermal or
oral. (Methomyl poisoning incidents in
California cited as basis.]
Response: Studies of fieldworker
exposures indicate that the predominant
exposures in outdoor situations are to
the skin and eyes. Except in those few
situations where fieldworkers have
eaten fruits or vegetables before the
preharvest interval has expired, the
Agency is unaware of validated
fieldworker poisoning incidents where
the primary route of exposure was oral.
The worker training materials being
developed by the Agency include
specific warnings not to eat fruits and -
vegetables unless a supervisor indicates
that it is safe to do so. In this final rule,
the Agency intends to establish REIs
based on three parameters: dermal
toxicity, skin irritation potential, and
eye irritation potential. If dermal
toxicity data are unavailable, the oral
toxicity data will be used. For example,
under this strategy, methomyl would be
assigned a 48-hour REI because it is a
toxicity category I eye irritant.
With respect to the methomyl
incidents cited by Congress, preliminary
reports indicate that, under special
environmental conditions, methomyl
dissipation is not following the
predicted pattern and rate. EPA will
adjust REIs for methomyl to reflect these
special environmental conditions, if
there are indications that the incidents
were not unique. The Agency is
unaware of data or conclusions by
experts that the oral LD5o is a more
accurate assessment of the actual
hazard to workers than dermal LD60,
either in these methomyl incidents or in
other fieldworker poisoning incidents.
Comment #11: Continue protections
for workers for a minimum of 60 days
after the expiration of the restricted-
entry interval.
Response: EPA reconsidered the 30-
day time period due to comments from
both USDA and Congress. The Agency
has studied more recent data regarding
the incidence of multiple-case systemic
illnesses of agricultural field workers
from exposure to residues of
organophosphates in California. Among
the 44 incidents for which data were
provided, the mean length of time from
application to poisoning was 20 days,
with a median of 16 days. The range
was from less than 1 day to 66 days,
although this latter figure was an outlier
and did not appear to be well
substantiated. Excluding parathion (no
longer registered for most crops) and
this outlier, the longest period between
application and reentry poisoning was
39 days. The Agency believes that
poisoning incidents that occur more than
30 days beyond the REI probably stem
from a miscalculation in establishing the
REI that is listed on the labeling.
Therefore, EPA decided to continue to
require that decontamination water be
provided for 30 days after the expiration
of the REI. See EPA's response to
USDA's Comment #13 for a more
complete discussion.
Comment #12: Moving or repair of
irrigation equipment should be
designated as a hand labor task, since
workers performing such tasks are likely
to come in contact with treated surfaces.
Response: EPA concurs that moving
and repairing irrigation equipment may
cause workers to contact treated
surfaces. However, the Agency believes
that this contact will be short-term and
mostly nonsubstantial. The Agency
realizes that moving, adjusting, or
repairing irrigation equipment may be
necessary while an area remains under
a REI. The Agency has, however, placed
strict limitations on early entry to
perform such tasks. These include: (1)
No entry for the first 4 hours after an
application, (2) a limit of 1 hour per
worker per day for performing such
early entry tasks, (3) PPE provided,
cleaned, and maintained for the
workers, (4) special instructions
provided, including information about
the hazards of the pesticide(s) to which
the workers will be exposed, and (5)
special decontamination and change
area provisions.
Comment #13: A responsible agency
should determine whether or not an
emergency actually exists before early
entry due to an agricultural emergency
is permitted.
Response: The Agency intends that
early entry due to an agricultural
emergency be an extremely rare
circumstance. Therefore, this final rule
requires two separate determinations
that an emergency exists: (1) A
responsible agency must declare that
circumstances exist that might cause an
agricultural emergency on an
establishment. For example, a State,
Tribal, or Federal agency having
jurisdiction over the establishment
would have to declare that a potentially
crop-damaging drought, hail storm, high
winds, hurricane, tornado, freeze, or
frost has occurred (or is predicted to
occur) in the area where the agricultural
establishment is located. (2) In addition,
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38138 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
the agricultural employers must declare:
(a] That they could not have anticipated
the circumstances that led to the
emergency when they applied the
pesticide, (b) that they had no control
over the circumstances that led to the
emergency, (c) that no practices other
than early entry will prevent or mitigate
a substantial economic loss involving
the crop in that treated area, and (d)
that the loss of profit without early entry
will be greater than that which would be
expected on the basis of experience and
the fluctuations of crop yields in
previous years. EPA believes that these
rigorous determinations will preclude
widespread or improper use of the
emergency provisions.
Comment #14: Strongly object to the
exemption for cut flower and cut fern
workers for early entry. Congress notes
that California prohibits early entry for
hand labor without apparent deleterious
effect on the cut flower industry.
Response: A change to the final rule
has been made. The Agency has
adopted an exception process that
would allow interested persons to
demonstrate to the Agency that, in a
particular industry, an exception should
be granted to the general prohibition on
routine early entry. Persons wishing to
obtain an exception to the early-entry
restrictions would submit a request for
such an exception to the Agency.
Comments that EPA has already
received from the cut flower and cut
fern industry have convinced EPA that
this industry, at least, probably
warrants such an exception. The
decision that such an exception is
probably warranted is based on a
balancing of the risks and benefits that
would result from such an exception
(see proposed exception to rule
published elsewhere in this issue of the
Federal Register). However, the Agency
is interested in a full range of comments
and information on this proposed
exception and has provided 30 days for
interested parties to comment. The
Agency particularly welcomes
comments supported by information,
such as evidence demonstrating whether
the risks to workers would be
acceptable, whether the use of personal
protective equipment in these
circumstances would be feasible, and
whether there are feasible alternative
practices that would make routine early
entry unnecessary. The Agency also
would welcome any additional
information concerning the likely
economic impact on this industry of a
prohibition of routine hand labor tasks
during the restricted-entry intervals.
While EPA has concluded that it
would be difficult to ensure worker
safety during widespread and routine
early entry, narrow exceptions, such as
this one, can receive adequate
management attention to help ensure
compliance when such early entry is
critical to a crop.
The Agency notes that although
California law prohibits all early entry
work involving hand labor, California
does not currently impose REIs beyond
"sprays have dried/dusts have settled"
for many of the pesticides used by the
cut flower and cut fern industry. In
addition, California has established only
4 24-hour REI for toxicity category I
pesticides, with longer REIs for specific
organophosphate and AT-methyl
carbamate pesticides. This final rule is
establishing a minimum 12-hour REI for
iall pesticides plus a 24-hour REI for all
tpxicity category II (dermal and ocular
routes) pesticides and a 48-hour REI for
all toxicity category I (dermal and
ocular routes) pesticides. Thus, while
California prohibits early entry, its entry
standards for this industry are generally
less stringent than those of EPA's final
rule. The economic impact of complying
with EPA's REIs is likely to be higher
than compliance with California's entry
limitations, unless an exception is
provided.
Comment #15: Urge a requirement for
cholinesterase monitoring of all
commercial and private pesticide
handlers who may handle
organophosphate or AT-methyl
carbamate pesticides.
i. Response: The Agency believes that
monitoring of employee exposure is a
prudent occupational health practice.
However, as explained in the preamble
(Unit III.I), EPA is concerned about
many of the problems of cholinesterase
monitoring.
1 EPA intends to reconsider the need
lor and the appropriate form of exposure
monitoring for pesticide handlers after
this final rule is implemented. This will
give the Agency the opportunity to
evaluate more thoroughly the ongoing
research in this area and the results of
'new or existing exposure monitoring
^programs. The Agency expects to issue a
proposed rule in this area in about 3
years.
r Comment #16: Cholinesterase testing
:bf field workers should be required in
(poisoning incidents involving
(organophosphate or AT-methyl
carbamate pesticides.
Response: EPA presumes that treating
medical personnel would prescribe such
testing when appropriate and that
prudent employers would encourage
such diagnostic tests. However, the
focus of this rule is prevention of
poisoning incidents for persons
occupationally exposed to agricultural
pesticides. It does not address diagnosis
or treatment of pesticide illnesses or
injuries. Diagnostic testing was not
proposed in the NPRM and the Agency
deems such a requirement beyond the
scope of this rule.
Comment #17: Supports evacuation of
greenhouse workers during fumigation
application and restricted-entry periods.
Response: None required.
Comment #18: Supports mandatory
posting of treated areas in greenhouses.
Response: None required.
Comment #19: Unrealistic to expect
that unprotected workers could reenter
treated areas in greenhouses and
nurseries without exposure to pesticide-
treated surfaces.
Response: The Agency is convinced
that there are situations in which
workers may reenter many areas in
nurseries and greenhouses without
contacting treated surfaces, and has
chosen to permit such entry. An
example of such entry is when workers
are wearing footwear and are walking
through the aisles of treated areas
where the plants or other treated
surfaces cannot brush against the
worker and cannot drop or drip
pesticides onto the worker. Under the
final rule, worker entry into treated
areas is prohibited when contact would
take place.
Comment #20: Concerned about the
adequacy of the ventilation and buffer
zone criteria established for
greenhouses and nurseries and urge
further study of the effectiveness of the
standards in practice.
Response: The Agency is interested in
cooperating in research or evaluations
that might be done on this aspect of the
regulation and has held some
preliminary discussions as to the best
design of such a research project.
Comment #21: Not requiring
notification for workers who are not
expected to come within 1/4 mile of a
treated area is inappropriate.
Response: EPA acknowledges that
workers frequently are required to move
throughout the field or nursery to
accomplish their assigned tasks. This
final rule requires employers to notify
workers of any pesticide application on
the establishment unless the employer
makes sure that the worker will not be
in the treated area and will not walk
within 1/4 mile of the treated area. As a
practical matter, if workers move
throughout an establishment, their
employer must notify them of all treated
areas on the establishment remaining
under an REI. The exception to the
notification requirement is intended to
be in effect only when pesticides are
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38139
applied at times when workers are not
present on the property or when
pesticides are applied to distant areas of
the establishment where no work
activities are occurring. Some farms,
nurseries, and forests are vast or
noncontiguous; requiring workers to be
notified of areas greatly distant from
their place of work would be pointless
and counterproductive.
Comment #22: Concern about EPA's
rejection of the skull and crossbones
symbol for the restricted-entry sign.
Response: The Agency acknowledges
that the skull and crossbones is a far
more recognized symbol for "highly
toxic" or "very poisonous" than any
other pictorial representation. For
precisely that reason, FIFRA requires
the skull and crossbones symbol on the
labels of pesticides that are highly toxic
orally, dermally, or through inhalation.
EPA prohibits the use of the skull and
crossbones symbol on any other
pesticide label. The Agency has
consistently taught pesticide users that
the skull and crossbones is the symbol
for the most highly toxic pesticides, i.e.
those where only a few drops by mouth
could be fatal.
For this reason, the Agency is
convinced that the skull and crossbones
is not appropriate for notifying workers
of areas remaining under an REI. While
some of these areas may have been
treated with highly toxic pesticides,
other areas may have been treated with
moderately or slightly toxic pesticides.
Rather than diluting the impact of the
skull and crossbones symbol, EPA has
chosen to create a new symbol for
restricted entry.
The Agency is taking several steps to
assure recognition and acceptance of
the new symbol: (1) The symbol is
mandatory nationwide. States and
industries currently using other signs
and symbols must use the EPA-
mandated sign. (2) Mandatory worker
training programs must explain the
symbol to workers. (3) The EPA-
mandated pesticide safety poster will
serve as a reminder to workers by
depicting the restricted-entry sign and
its meaning.
Comment #23: The implementation
time frames are too long. All regulations
should be mandatory within 8 months.
Response: Implementation and
enforcement of the revised Rule depends
on the misuse provision of FIFRA
section 12(a)(2)(G) that states it is
unlawful "to use any registered
pesticide in a manner inconsistent with
its labeling." Thus, the provisions of the
Worker Protection Standard must be in
the labeling or must be linked to
pesticide product labeling as directions
for use before they can be implemented
or enforced. Although the Agency
strongly believes that the protective
measures of this final rule should
become effective as soon as practicable,
it has concluded that a phased and
orderly schedule of relabeling,
information dissemination and training,
and enforcement is needed to facilitate
both registrant compliance with the new
labeling requirements and user
understanding and compliance with the
worker protection standard.
Therefore, the Agency will require
that no revised labels appear in the
marketplace for approximately the first
8 months after promulgation so the
Agency will have an opportunity to
explain the requirements to users.
Thereafter, product-specific
requirements will be enforceable when
they appear on labeling. Twenty months
is the latest tune that labeling may be
revised by the registrants. EPA expects
many labeling revisions will occur
earlier than the 20-month deadline.
Comment #24: The regulatory
protections ignore chronic health risks.
Response: The Agency is concerned
about minimizing both acute and
chronic health risks. Several provisions
of this final rule are designed, at least in
part, to reduce chronic health risks.
These include: (1) Incorporating
information about chronic risks and how
to avoid them into the mandatory
worker and handler training programs,
(2) providing decontamination sites for
30 days beyond the expiration of the
REI, (3) establishing a minimum REI of
12 hours for all pesticides, and (4)
establishing for all handlers and early-
entry workers minimum PPE and work
clothing requirements designed to
minimize dermal exposure to all
pesticides, regardless of their acute
toxicity. EPA believes that these
protections against acute risks, if
adhered to consistently over time, will
protect against chronic risks as well, by
reducing exposures that may give rise to
chronic effects. On the other hand, the
Agency has concluded that more
stringent pesticide-specific protections
[such as REIs or PPE) based on chronic
health risks should more appropriately
be set after case-by-case review.
Comment #25: No buffer zones are
required to protect workers in the field
from drift.
Response: The Agency recognizes that
drift from nearby applications is a
common cause of exposure for
agricultural workers. This final rule
specifically requires that both the
pesticide handler and the handler's
employer must make sure that the
pesticide is not applied so as to contact,
either directly or through drift, any
worker or other person, other than an
appropriately trained and equipped
handler. EPA considers this protection
so crucial that it is the one situation
where a generic requirement from the
Standard is listed on each pesticide
product label.
Comment #26: Toxicological concerns
about inert ingredients are ignored.
Response: The Agency is concerned
about minimizing risks to workers and
handlers of any chemicals of
toxicological concern, whether they are
active or inert ingredients. In
establishing PPE requirements for
handlers and early-entry workers in the
final rule, the Agency considers the
toxicity of the formulated pesticide
product. The toxicity of the formulated
product encompasses the toxicological
characteristics of both the active
ingredient(s) and the inert ingredient(s).
In establishing REIs, however, the
Agency has determined that the
properties of the active ingredient(s) are
the main toxicological concern. Many of
the inert ingredients that might
otherwise pose a toxicological hazard
are volatile and will not remain on the
treated surface beyond the first few
hours. Similarly, EPA has chosen to
consider only the toxicity of the active
ingredient(s) in establishing REIs and in
determining which products must
contain a requirement for both oral
warnings and treated area posting.
In a process separate from this rule,
EPA is evaluating and, where
appropriate, reducing the risks posed by
inert ingredients. In addition, the
Agency will evaluate the risks of all
formulations, including their inert
ingredients,,during its accelerated
reregistration program, now underway.
The Agency has concluded that further
attention to inert ingredients in the final
rule is unnecessary.
C. FIFRA Scientific Advisory Panel
Pursuant to FIFRA section 25(d), a
copy of this final rule was provided to
the FIFRA Scientific Advisory Panel
(SAP). The SAP waived review of the
final rule.
VI. Implementation
A. Agency Implementation Strategy
I. Phased implementation. The
Agency is establishing different
implementation dates for the
requirements in part 170 and the
changes required in pesticide labeling
found in part 156.
The first amended labeling under part
156 would be available to users no
sooner than April 21,1993. As pesticide
products with amended labeling are
used, EPA will begin to enforce the
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38140 Federal Register / Vol. 57, No. 163 / Friday. August 21, 1992 / Rules and Regulations
provisions of part 170 that are related to
the new specific requirements on '
pesticide product labeling for restricted- ;
entry intervals, personal protective 1:
equipment, and notification about '
treated areas.
After April 21,1994, all products i
covered by this rule must have amended
labeling when they are distributed or
sold by registrants. :
After April 15,1994, EPA will begin to ,;
enforce the remaining provisions of part
170.
Implementation and enforcement of
the revised Worker Protection Standard '•
depend upon the misuse provision of ''.
FIFRA section 12(a)(2)(G) that states it ;
is unlawful "to use any registered :
pesticide in a manner inconsistent with .
its labeling." Thus, the provisions of this
revised standard must be in the labeling :
or must be linked to pesticide product
labeling by reference before they can be ,
implemented or enforced.
Currently, changes in directions for |
use ordinarily are incorporated in their ,:
entirety into the labeling of each '.
affected pesticide product.
Implementation and enforcement of new .
directions for use occur when a
pesticide product with the changed
labeling is used. The Agency has
determined that implementation of the ;
Worker Protection Standard through this
mechanism would be difficult. Only
worker protection requirements that
vary from product to product will be :
placed on the pesticide product labeling ,
as specific directions for use. Part 170
requirements that do not vary among •:
affected products will not be repeated in
each product's labeling; the Agency will '
reference these standards on pesticide :
product labeling. '
Placing requirements related to the ::
directions for use in documents that are '•
referenced on the pesticide product ;
labeling, but which do not accompany '•.',
the product in commerce, is unusual.
Although the Agency believes the ;:
protective measures of the revised part
170 should become effective as soon as ;
possible, it has concluded that a phased
and orderly schedule of relabeling, i
information dissemination, and
enforcement is needed to facilitate both :
registrant compliance with the new [,
labeling requirements and user
understanding and compliance with the :
Worker Protection Standard. •
The requirements of the revised '-'.
Worker Protection Standard related to a!
product's potential hazard to users and
other persons will be on the label or in . •
the product labeling. A registrant of an ;
affected pesticide product will be ;;
required to specify: (1) A prohibition :
from applying the pesticide in a manner :
that contacts anyone except '
appropriately trained and equipped
handlers, (2] PPE for handling and early-
entry activities, (3) a restricted-entry
interval, and (4) when appropriate, that
workers be notified orally and by
posting of signs at the treated areas.
-- Although the concepts of not applying
pesticides when workers or other people
may be contacted, of using PPE to
handle pesticides, of restricting entry to
treated areas, and of notification about
pesticide-treated areas are familiar to
agricultural pesticide users, this
rulemaking modifies these requirements
in significant ways. Since these.product-
specific provisions are essential to the
safe use of a pesticide, the Agency is
unwilling to delay their implementation.
Consequently, all product-specific
requirements will be effective as soon as
they appear on pesticide product
labeling. However, the Agency will
require that no such labeling changes
appear in the marketplace until there
has been an opportunity to explain them
to users.
Other new requirements apply to all
pesticide products used in the
production of agricultural plants. These
include the requirements for training
handlers and agricultural workers, for
providing pesticide-specific information
to employees, and for providing
decontamination water and emergency
assistance for handlers and workers. It
is not practical to describe these
requirements fully in the product
labeling. Therefore, it will take time to
communicate these requirements to the
agricultural community and for that
community to implement them. As a
result, enforcement of the general
requirements will be delayed as
described below. (Unit VI.A.2.)
2. Implementation of part 170. EPA
will implement part 170 in two phases:
a. Accelerated implementation of
provisions supporting product-specific
labeling. Specific requirements related
to restricted-entry intervals and
notification about treated areas .are
being added or changed through this
revision of part 170.
To implement the requirements that
will be found on some product labeling
for restricted-entry intervals, and the
instructions to both orally warn and
post treated areas, sections of part 170
that concern these requirements and the
exceptions to these requirements must
be implemented quickly to prevent
unintended burden on the user during
the phase-in period of compliance with
this regulation. The sections of part 170
that will have accelerated
implementation, i.e. that will be
enforced as the associated statements
appear in pesticide labeling are:
i. Sections of part 170 related to entry
restriction. Section 170.112(a)(l) through
(a)(4) states the general restrictions on
worker entry to treated areas prior to
the expiration of an REI. Section
170.112[b) describes an exception to the
general restrictions and permits entry if
the worker will have no contact with
anything that has been treated with the
pesticide to which the REI applies.
Sections 170.112(c)(l) through (3)
describe the exemption for early entry
to perform short-term tasks and describe
the requirements for that exemption
which will be implemented on an
accelerated schedule. Sections
170.112(d)(l) through (2)(ii) plus
170.112(c)(3) that is referenced in
(d)(2)(iii) describe the exemption for
early entry due to an agricultural
emergency and describe the
requirements for that exemption which
will be implemented on an accelerated
schedule.
ii. Sections of part 170 related to
requirements about oral warnings and
posting of treated areas. Implementation
of the requirements to both orally warn
and post treated areas in the labeling
requires implementation of
§ 170.120(a)(3) and (b}(3), which tell the
employer the exceptions to the oral
warning and treated-area posting
requirements.
b. Implementation of part 170
provisions that are generic to all
pesticide uses. The enforcement of the
remaining or "generic" provisions (i.e.
those that apply to all pesticides uses) in
the final rule will begin April 15,1994.
The phased implementation dates for
part 170 are intended to allow time for
EPA and cooperating organizations to
develop, reproduce, and distribute the
training and instructional materials
necessary to encourage compliance. If
part 170 implementation were to be
triggered solely by the appearance of
revised labeling, some users would have
to comply with part 170 before
instructional materials were available to
assist them in doing so.
3. Implementation of part 156. The
Agency is establishing two separate
sale/distribution dates for registrants.
The first date regulates the earliest date
that a registrant is allowed to sell or
distribute a pesticide product with
labeling amended to include part 156
statements. This date is the effective
date of part 170 (which is 60 days after
publication of the final rule) plus 6
months. During this time the Agency will
execute an implementation outreach
program. The second date, 18 months
after the effective date of part 170, is the
time by which all affected pesticide
products sold or distributed by
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38141
registrants would be required to contain
the appropriate part 156 statements in
their labeling.
In the past, EPA has not placed
constraints on registrants as to how
soon pesticide products bearing Agency-
required changes to labeling could be
sold or distributed; the emphasis has
been on the maximum time registrants
would be allowed for changing labeling.
However, in the implementation of the
Worker Protection Standard, registrants
will not be allowed to sell or distribute
pesticide products with labeling
amended to include part 156 label-
specific requirements or the generic part
170 reference statement prior to an
established date. This constraint is to
prevent pesticide labeling with the new
worker protection statements pursuant
to this final rule from becoming
available to users before EPA and
cooperating organizations can
disseminate the information necessary
to tell users how to comply with the
requirements. Otherwise, users could
face the dilemma of being required to
comply with provisions without the
necessary information on how to do so.
-A summary of the implementation
schedule is given in the following Table
1:
Table 1.—Implementation Time Table
Table 1.—Implementation Time Table—
Continued
Time
Publication In
the Federal
Register of
part 170 and
part 156
(notice to
registrants of
mandatory
labeling
changes).
60 days alter
publication.
Part 156
Activities
Inform
regfstrants of
required label
changes (LIP
or PR notice).
Effective date.
Part 170
Activities
Initiate outreach
to regulated
community to
inform
affected
parties about
the rule,
particularly
the
accelerated
provisions,
i.e. the
requirements
in the
labeling for
restricted-
entry
intervals.
treated area
posting and
oral
notification to
workers, and
use of
personal
protective
equipment.
Effective date,
including the
process for
requesting
exceptions to
restricted-
entry
intervals.
Time
6 months after
effective date
of part 156
and part 170.
April 15, 1994.
18 months after
part 156 and
part 170
effective date
(12 months
after earliest
sale or
distribution
date for
registrants).
36 months after
part 156 and
part 170
effective
date.
Part 156
Activities
Earliest date
that products
with
amended
labeling may
be sold or
distributed by
registrants.
All pesticide
products sold
or distributed
by registrants
must bear
labeling
referencing
part 170 and
other part
156 labeling
statements.
Pesticide
products
sold/
distributed by
any person
must bear
amended
labeling.
Part 170
Activities
Start
compliance
efforts on
new product-
specific
requirements
on labeling
(accelerated
provisions of
part 170).
Start
enforcement
of part 170
"generic"
provisions
whenever a
pesticide
product with
amended
labeling is
used.
B. Registrant Compliance
A large number of products will be
affected by the new requirements, and
an orderly relabeling process is
necessary to avoid confusion, to ensure
clear and appropriate labeling to guide
users, and to facilitate registrant
compliance. Thus, the Agency has
included in this preamble instructions to
registrants and compliance deadlines for
changes to pesticide labeling required
by the new subpart K, part 156 ("Worker
Protection Statements"). The Agency
has tried to make the new labeling
requirements as self-explanatory as
possible to reduce the need for
registrant inquiries.
1. Applicability of part 156, subpart K
statements. This section provides
guidance to registrants in determining
which of their products may be affected
by the new part 156 subpart K, whether
existing worker protection statements
should be retained, and how new part
156 subpart K labeling statements
should be determined.
a. Scope. Products affected by part 156
subpart K are, with some exceptions,
those products registered for use in the
production of agricultural plants (40 CFR
156.200(b)). The scope of agricultural
pesticides for purposes of subpart K is
broad and refers to any product
registered for use in the production of
agricultural plants on farms, or in
forests, nurseries, or greenhouses; these
terms are defined in 40 CFR 170.3. Part
156, subpart K applies to products that
may be applied directly to agricultural
plants or to growing areas. Any such
product must bear the subpart K
statements, except as noted below.
Several types of products that may be
registered for application on farms, or in
forests, nurseries, or greenhouses need
not bear the subpart K statements.
These are defined by the exceptions to
the handler applicability section of part
170 (40 CFR 170.202(b)). If a product has
both exempted uses and covered uses,
the subpart K statements must appear
on labeling.
Under subpart K, a reference
statement on the label will direct users
to part 170, which contains more specific
requirements than those listed in the
labeling.
b. Existing statements. Various types
of worker protection statements
currently appear, in the labeling of many
agricultural products. Most of these
statements will be modified or will be
replaced by the new subpart K
requirements. Several comments on the
proposed rule requested clarification of
the relationship between subpart K and
PR Notice 83-2, which called for certain
worker protection statements, based on
part 170, to be placed on agricultural
product labels. EPA is revoking PR
Notice 83-2 effective as of April 21,1993,
and registrants of products subject to PR
Notice 83-2 must modify their labeling
according to subpart K requirements.
Some products within the scope of
subpart K were not subject to PR Notice
83-2, including products registered for
uses in forests and in greenhouses, for
use on nursery ornamentals, and for use
on crops whose culture does not involve
commonly recognized hand labor tasks.
In addition to PR Notice 83-2
statements, some products currently
bear statements pertaining to REIs and
PPE that were required through
registration or a Registration Standard
or Special Review decision on an active
ingredient contained in the product. The
status of existing REI and PPE
statements will be governed by the
relevant subpart K sections on these
topics (40 CFR 156.208 and 156.212). The
Agency will issue a PR Notice to
registrants with detailed guidelines on
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38142 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992! / Rules and Regulations
how to evaluate existing labeling
,' statements and on what new labeling
1 statements to adopt.
c. New statements. Four types of
worker protection statements may apply
to products covered by the new subpart
K: General statements, REI statements,
worker notification statements, and PPE
statements.
i. General. All products must carry a
standard reference statement alerting
the user that the product must be used
according to part 170 (40 CFR
156.206(b)). A standard statement
prohibiting users from allowing a
pesticide to contact nonhandlers
directly or through drift also must
appear on all products (40 CFR
156.206(a)). A different version of this
statement was required by PR Notice
83-2; that version must be replaced by
the revised version. Products required to
use either DANGER or WARNING as
signal words (toxicity category I or II
products) also must use the Spanish
signal word PELIGRO or AVISO on the
label, and a'phrase in Spanish
instructing the reader to have the label
explained before using the product (40
CFR 156.206(e)).
If the product contains an active
ingredient that is an organophosphate or
an Af-methyl carbamate, this information
must be in the labeling either as part of
the product name or in the Statement of
Practical Treatment (First Aid) section
of the labeling (40 CFR 156.206(c)(l)).
This information is required in the
labeling to aid employers who want to
provide cholinesterase monitoring
programs for their employees.
If the product is a fumigant, its status
as a fumigant must be conveyed as part
of the product-name or product-type
information, placed close to the product
name (40 CFR 156.206(c)(2)).
ii. Restricted entry. Products covered
by subpart K must have a standard REI
statement. Fumigants will retain their
current entry restrictions, but the
statements must be converted to the
format of the subpart K restricted-entry
statements (40 CFR 156.208(d)}. The
standard restricted-entry statement (40
CFR 156.208(a)) includes the restricted-
entry interval (determined by 40 CFR
156.208(c),(d),(e), or (f)).
Some existing labeling bears entry-
restriction statements. In determining
the appropriate subpart K restricted-
entry interval (REI), three situations are
possible:
First, a product that has a product-
specific REI based on foliar or soil
dissipation data for the product (or for
each active ingredient in the product)
that have been submitted to and
accepted by EPA, must retain this REI
(40 CFR 156.208(e)).
The second situation involves
products that have an REI that is not
product-specific. Here the existing REI
must be compared to the REI that would
apply using the criteria in 40 CFR
156.208(c); the longer of the two REIs
would be the restricted-entry interval.
Third, a product that has no REI (this
would include products prohibiting entry
"until sprays have dried or dusts have
settled" and other products) must use
the criteria of 40 CFR 156.208(c) to
determine the appropriate REI unless all
data required to set a product-specific
interval are submitted to and accepted
by EPA and a specific REI is approved.
Under the criteria of 40 CFR
156.208(c), REIs are determined by
comparing available acute toxicity data
for the active ingredients in a product.
Registrants must use any obtainable
results of toxicity testing (i.e., toxicity
' category) for the three relevant routes of
, exposure (dermal toxicity, skin irritation
effects, and eye irritation effects) for
each active ingredient in the product. If
necessary, formulators should seek
verification of toxicity category
information from their suppliers. In
\ some circumstances, acute oral toxicity
or the toxicity of a registered technical
1 product may be used. Among the acute
toxicity data used in the comparison, the
most toxic toxicity category determines
the REI: 48 hours for toxicity category I,
24 hours for toxicity category II, or 12
hours for toxicity category III and
toxicity category IV (40 CFR 156.208(c)).
When no acute toxicity data are
available for one or more of the active
ingredients, registrants must use the
toxicity category of the formulated
product indicated by the signal word in
the comparison.
When the REI has been determined,
the appropriate number of hours is
inserted into the restricted-entry
statement of 40 CFR 156.208(b), unless
, the REI varies crop by crop.
If a product contains a toxicity
category I active ingredient that is a
cholinesterase-inhibiting
organophosphate ester, a statement
must be added requiring a 72-hour REI
when the product is applied outdoors in
an area where the average annual
rainfall is less than 25 inches a year (40
CFR 156.208(c)(2)(i)).
EPA reserves the right to modify any
subpart K restricted-entry interval for a
product in the future. For example, this
. may occur either at the beginning or end
of a Special Review for an active
• ingredient in the product (40 CFR
156.204(a)) or on evaluation of foliar or
soil dissipation data, or other relevant
data, showing that a different REI is
warranted (40 CFR 156.204(b)).
Registrants, or others, may undertake to
develop, at their discretion, foliar
dissipation or other exposure data that
would lead to the establishment of a
product-specific REI; until that time, an
interim REI will apply to the product.
iii. Notification to workers. Each
product in toxicity category I for acute
dermal toxicity or skin irritation
potential, other products designated by
EPA, and each fumigant that may be
.,used in greenhouses must carry a
standard statement indicating that
workers must be given notification of
the application both orally and by
posting of treated areas (40 CFR
156.210). A definition of a fumigant
appears in 40 CFR 156.203.
iv. Personal protective equipment
(PPE) and work clothing. All products
must bear statements specifying
minimum PPE or work clothing as
determined by subpart K. Appropriate
PPE or work clothing is required by
subpart K for all handling activities (40
CFR 156.212) and activities in treated
areas before the expiration of an REI.
If a product has PPE or work clothing
statements on the labeling, the registrant
must compare these existing statements
with the requirements of subpart K, and
use the more protective or more specific
item of PPE or work clothing for each
area of the body to be protected. If
product labeling prohibits the wearing of
gloves or boots, such a prohibition must
be retained on labeling as it is worded.
The format of all PPE and work clothing
statements should be that described in
subpart K, even if a more protective or
more specific item is being retained. The
following are examples of comparisons
of degree of protection or specificity
between PPE items in subpart K and PPE
items now on product labeling:
(1) A coverall is more protective than
a long-sleeved shirt and long pants.
(2) A chemical-resistant (or
liquidproof, waterproof, rubber, etc.)
suit, rain gear or rain suit is more
protective than a coverall or long-
sleeved shirt and long pants.
(3) Chemical-resistant gloves are more
protective than cotton, cloth, paper, or
leather gloves.
(4) Chemical-resistant footwear is
more protective than shoes and socks.
(5) Air-supplied or self-contained
respirators are more protective than
other classes or types of respirators.
(6) A cartridge or canister respirator is
more protective than a dust/mist mask
or dust/mist respirator.
As indicated below, certain words
and phrases on existing labeling must be
replaced by terms described in subpart
K.
Unless the registrant has data that
indicate a particular type of material(s)
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Federal Register / Vol. 57, No. 163 / Friday, August 21. 1992 / Rules and Regulations ; 38143
is more chemically resistant to a
particular pesticide product or a
particular type of pesticide products, the
labeling statements for the use of gloves
in subpart K must be followed.
"Chemical resistant" must be used
instead of such terms as "liquidproof,"
"rubber," "natural rubber," "vinyl,"
"synthetic rubber," "impervious,"
"neoprene," "plastic," "impermeable,"
or "nonporous." The term "waterproof
must be used in place of "water-
resistant" or other terms if the pesticide
is used dry or as an aqueous solution.
Unless the registrant has data
indicating that the NIOSH/MSHA
approval number prefix listed in subpart
K is inappropriate for a particular
pesticide product or a particular type of
pesticide product, NIOSH/MSHA
approval number prefixes indicated in
subpart K shall be substituted for the
general phrase "NIOSH/MSHA
approved" in respirator statements on
existing labeling. For a dust/mist mask,
the NIOSH/MSHA approval number
prefix is "TC-21C." For a cartridge
respirator, the NIOSH/MSHA approval
number prefix is "TC-23C." For a
canister respirator, the NIOSH/MSHA
approval number is prefix "TC-14G." For
a supplied-air respirator, the NIOSH/
MSHA approval number prefix is "TC-
19C." For a self-contained breathing
apparatus (SCBA), the NIOSH/MSHA
approval number prefix is TC-13F."
To determine the appropriate PPE
requirements for handling activities, the
table in 40 CFR 156.212{e) is used in
conjunction with the acute toxicity data
on the formulated product for each route
of exposure listed in the table.
Registrants must determine the toxicity
category of the formulated product for
acute dermal toxicity, skin irritation
potential, eye irritation potential, and
acute inhalation toxicity. If the acute
toxicity data for dermal or inhalation
exposure are not available, the acute
oral toxicity may be used as a surrogate.
(If acute toxicity data for any of these
routes of exposure are not available, the
toxicity category of the formulated
product as a whole must be used as a
substitute for each such route of
exposure.) Given the toxicity category
for each route of exposure, the table
gives the appropriate item or items of
PPE or work clothing necessary to
protect that part of the body. All such
items taken together comprise the basic
"outfit" to be worn by the handler. This
"outfit," in the form of a list of PPE and
work clothing items, is inserted into a
standardized handler PPE statement [40
CFR 156.212(d)(3)).
In addition to the basic handler outfit
statement, statements related to
exposure pattern are required for
products in toxicity categories I and II
(40 CFR 156.212(1)). For products that
must be mixed or loade,d, there must be
a statement requiring the use of a
chemical-resistant apron unless there is
a requirement for a chemical-resistant
suit (40 CFR 156.212(i)(l)). If overhead
exposure is possible during handling,
there must be a statement requiring the
use of a wide-brimmed hat or a
chemical-resistant hood (40 CFR
156.212(i)(2)). If equipment is used to
mix, load, or apply the product, there
must be a statement requiring the use of
a chemical-resistant apron for persons
who clean or repair equipment unless
there is a requirement for a chemical-
resistant suit (40 CFR 156.212(i)(3)).
If a product is sold as a concentrate
and diluted for application, registrants
may submit to the Agency or cite
additional acute toxicity data on the .
diluted product. The PPE requirements
for all handlers except mixer/loaders
would then be based upon the data on
the product as diluted for application.
The appropriate PPE and work
clothing requirements for' early-entry
activities are the same as for
applicators, except no respiratory
protection device would be needed for
early entry to pesticide-treated areas. In
addition, the minimum PPE for early-
entry activities consists of coveralls,
chemical-resistant (or waterproof)
gloves, shoes, and socks.
The Agency reserves the right to
modify the subpart K requirements for
PPE and work clothing for a product at
some future time. This might occur at the
beginning or end of a Special Review, or
on review of data showing that different
requirements are warranted.
d. Labeling format—i. Language and
location of labeling. Specific language
for worker protection labeling
statements has been employed in
subpart K to facilitate registrant
compliance and to eliminate
unnecessary variation among
agricultural product labeling.
Each section of subpart K describing a
required worker protection statement
specifies a location on labeling for that
statement. Most worker protection
statements are required to be grouped
near the beginning of the Directions for
Use section of the product labeling
under the heading Agricultural Use
Requirements. General statements such
as the reference to part 170 would
appear first. The only statements
required to appear elsewhere on
labeling are the Spanish signal word and
explanatory statement, which must
appear close to the English signal word;
the identification of the type of product
(organophosphate or Af-methyl
carbamate), which must be associated
with the product name or in the
Statement of Practical Treatment (First
Aid) section; identification of a
fumigant, which must appear as part of
or close to the product name; and the
PPE statements, which must appear in
the Hazards to Humans (and Domestic
Animals) section of the labeling. At the
discretion of the registrant, any existing
worker protection statements that are
not superseded or modified by subpart K
may be relocated under this overall
worker protection heading, unless this
would reduce existing protection
associated with nonagricultural uses.
ii. New or amended product labeling.
As of April 21,1993, labeling submitted
with applications for new or amended
registration must comply with subpart K.
The Agency will review and approve
labeling for new products under normal
Agency procedures.
iii. Existing products. Registrants of
products that are registered as of the
effective date of subpart K and:that fall
within the scope of subpart K must
revise their product labeling to comply
with the new requirements in one of the
following ways:
(1) Subpart K labeling followed
exactly. The Agency is specifying
precise wording and exact requirements
for worker protection labeling so that
registrants of existing products will be
able to revise product labeling more
easily within the timeframes
established. If a registrant certifies that
the Worker Protection Standard PR
Notice wording is followed exactly for a
specific product, no Agency approval is
required. The registrant must submit the
following:
(A) An Application for Amended
Registration (EPA Form 8570-1): Under
"Subject of Amendment" in section II of
the application, the registrant must
identify the subject of the amendment as
"WORKER PROTECTION
CERTIFICATION" and include a
certification statement such as, "All
products being sold or distributed after
April 21,1994, will be in compliance
with the labeling requirements of 40 CFR
part 156, subpart K."
(B) A copy of the product's revised
labeling (draft or final) with the changes
highlighted, preferably with a felt-tipped
marker. The Agency may choose to
review this labeling as a check on the
correctness of the registrant's
compliance with subpart K.
(2) Subpart K labeling not followed
exactly. If a registrant wishes to use
wording different from that required by
the Worker Protection Standard PR
Notice, an amended registration must be
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38144 Federal Register / Vol. 57. No. 163 / Friday, August 21, 1992 / Rules and Regulations
approved. The registrant must submit
the following:
(A) An Application for Amended
Registration (EPA Form 8570-1). Under
"Subject of Amendment" in section II of
the application, the registrant must
identify the subject of the amendment as
"WORKER PROTECTION LABELING
AMENDMENT" and include a statement
such as, "The applicant requests the
Agency to review proposed revised
labeling text that differs from 40 CFR
part 156, subpart K."
(B) Five copies of the product's
proposed draft labeling with the changes
highlighted, preferably with a felt-tipped
marker.
EPA encourages registrants seeking
amendments under section 3(b) to
submit their applications as soon as
possible after the effective date of this
regulation. EPA cannot assure that these
amendments to registration will be
approved in time to incorporate the
revised language on the labeling by the
deadlines. As stated above, the Agency
intends that the standard and
implementing labeling statements be put
in place as quickly as possible. Thus, it
is unlikely that EPA will grant an
extension of time merely because a
special labeling amendment has been
proposed. This policy does not preclude
registrants from requesting special
amendments to registration; registrants,
however, are required to meet
applicable deadlines for labeling
changes regardless of the status of any
special amendment to registration.
iv. Where to send amended
application. Applications for amended
registration and other labeling must be
submitted to the address listed in the
Worker Protection Standard PR Notice
and must be received on or before April
21,1994. After this date, no product may
be distributed or sold by the registrant
(or a supplemental registrant) unless it is
in compliance with the new subpart K.
After October 23,1995, all products
distributed or sold by any person must
bear labeling statements in compliance
with the new subpart K.
v. Earliest distribution or sale.
Finally, it should be noted that no
product with the subpart K labeling
statements may be distributed or sold
by a registrant prior to April 21,1993,
even though the registrant may submit
certification and EPA may approve new
or amended products with subpart K
labeling prior to that date.
vi. Failure to comply. If the items
listed above, such as a certification
statement, and, if applicable, the final
printed labeling are not submitted on or
before the date specified above, the
Agency may issue a "Notice of Intent to
Cancel" under FIFRA section 6(b). If,
after a certification is reviewed, the
Agency determines that the registrant
has incorrectly labeled the product, the
product may be deemed to be
misbranded in violation of FIFRA
section 12(a)(l)(E) or the Agency may
issue a "Notice of Intent to Cancel"
under FIFRA section 6(b).
C. EPA Communication and Training
Efforts
EPA has been engaged in the
promotion of pesticide safety in
agriculture for many years. In the course
of this program, the Agency has
developed working relationships with
other Federal, State, and private
organizations with similar objectives: It
has sponsored the production and
distribution of many types of pesticide
safety materials. With the promulgation
of the revised Worker Protection
Standard, the Agency intends to develop
appropriate materials to inform
pesticide users and agricultural workers
of the new requirements and to facilitate
compliance.
! • 1. Product labeling. The labeling of
each agricultural pesticide product
subject to part 170 will indicate, by
means of a reference statement, that the
product must be used according to these
regulations. Requirements that vary
from product to product, such as
restricted-entry intervals and personal
protective equipment, will appear as
specific labeling statements, while
requirements that do not vary among
products, such as provision of
decontamination sites, will not be
repeated in each product's labeling.
' 2. Development of materials. To assist
agricultural employers and pesticide
users in complying with the revised
Worker Protection Standard, the Agency
intends to develop or to cooperate in the
development of new educational
materials and to revise some existing
educational materials. These materials
may be used by agricultural employers,
migrant health clinics, Cooperative
Extension offices, unions, commodity
organizations, and similar groups.
a. Compliance materials. In addition
to the promulgation of part 170 standard,
the Agency intends to develop
compliance guides and audiovisual
compliance programs for agricultural
employers and handler employers.
These guides and programs will
summarize and explain the regulations
and will assist agricultural employers
and handler employers to understand
their responsibilities under part 170.
•, b. Training programs for handlers and
workers. Existing written and
audiovisual training programs on
pesticide safety are expected to be
revised as one spurce of assistance to
agricultural employers and handler
employers in training their employees in
pesticide safety. The training programs
also may be used by others such as
migrant health clinics, State agencies,
and worker organizations to train
agricultural workers and handlers. The
training programs that are planned are
handbooks, slides/tapes and videos in
English and Spanish. They will be
designed to meet the pesticide safety
training requirements of the new part
170.
c. Pesticide safety poster. A bilingual
pesticide safety poster for agricultural
workers, entitled "Be Safe With
Pesticides/Use Pesticidas Con
Cuidado," has been developed by the
Agency and has been distributed widely
with the assistance of cooperating
organizations. EPA plans to revise the
poster and intends that display of this
revised poster will fulfill the pesticide
safety poster requirement of part 170.
d. Guidelines on the selection and use
of personal protective equipment (PPE).
Numerous comments from the public
addressed the need for more information
and guidance on the selection, use, and
maintenance of PPE, including the
avoidance of heat stress. The Agency
has developed informational materials
to provide guidance to pesticide users
on these topics. The Agency also
intends to develop guidance documents
on cholinesterase monitoring to assist
employers who have or want to have
such a program.
3. Liaison with other agencies and
organizations. In the past, EPA has had
the assistance of a number of
governmental agencies, farmworker
service organizations, and trade
associations in communicating with the
agricultural community. The Agency will
continue to work with these groups to
inform affected persons of their rights
and responsibilities under the revised
standard, to assist in the reproduction
and distribution of educational
materials developed by the Agency and
to encourage compliance on the part of
their members and clients.
D. National Compliance Monitoring
Strategy
The Agency's approach to
enforcement of the Worker Protection
Standard will be based on development
of a National Compliance Monitoring
Strategy for worker protection.
Pesticide use enforcement under
FIFRA is dependent upon two broad
authorities, the authority to regulate the
distribution and sale of pesticides and
the authority to require that registered
pesticides be used according to their
labeling. In most States, enforcement is
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38145
by State regulatory agencies through
Cooperative Enforcement Agreements
with EPA. EPA intends to assure
enforcement of part 170 primarily
through these agreements. The National
Compliance Monitoring Strategy will be
developed in partnership with the State
regulatory agencies and will guide all
enforcement activities related to this
regulation.
To achieve maximum compliance, the
Agency plans a major communication
effort to inform the regulated community
of the new requirements. The registrant
of a pesticide product subject to part 170
will be governed by the timeframes for
product relabeling laid out above. Once
a relabeled product is used, it must be
used in accordance with its labeling or
the user will be in violation of FIFRA
section 12(a)(2)(G). The product will
bear a reference statement notifying the
user that the product must be used in
accordance with part 170.
The relationship between State and
Federal entities in the enforcement of
pesticide use regulations is governed by
FIFRA section 26(a). With the exception
of Nebraska, Wyoming, and (in part]
Colorado, all States have primary use
enforcement authority and have entered
into Cooperative Enforcement
Agreements with EPA. EPA regional
offices annually negotiate the terms of
these agreements with State regulatory
agencies. Starting in fiscal year 1990,
these agreements have included a
specific section on worker protection
enforcement activities. EPA expects that
individual State compliance monitoring
strategies will be developed once the
National Compliance Monitoring
Strategy is completed. These strategies
will describe inspection and complaint
response schemes and compliance
communication activities to be
conducted in each State. Development
of interagency coordination agreements
among various State agencies concerned
with pesticide use and worker safety
may be part of each State's strategy.
EPA also anticipates that registrant
compliance with worker-protection-
related registration requirements will be
monitored through activities agreed
upon under Cooperative Enforcement
Agreements.
Toward the accomplishment of these
goals, money has been allocated to the
States in EPA's budget for fiscal years
1990,1991, and 1992 for the development
of worker protection programs and
related compliance activities. In States
where Cooperative Enforcement
Agreements are not in place, EPA
regional inspectors will conduct
compliance monitoring programs based
on the National Compliance Monitoring
Strategy for this regulation.
VII. Public Docket
Documents relied upon by the Agency
in the development of this final rule,
including public comments submitted on
the proposed rule, have been given the
document control number OPP-300164A
and are available for public inspection
from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays, at the
Office of Pesticide Programs' Document
Control Office, Rm. 1132, CM #2,1921
Jefferson Davis Highway, Arlington, VA.
VIII. Regulatory Requirements
A. Executive Order 12291
Under Executive Order 12291, a
Regulatory Impact Analysis (RIA] has
been developed and has been submitted
to the Office of Management and Budget
(OMB]. This document is available for
public inspection at the address given at
the beginning of this Notice. A summary
of.the document follows.
EPA believes that the benefits that
will accrue to agricultural workers and
handlers from implementation of the
WPS include the reduction in lost time
from the workforce, reduced medical
expenses, and increased well-being and
productivity through being less affected
by pesticide poisoning. These and any
related benefits cannot be adequately
quantified with available data. The
Agency is convinced that the benefits to
society from avoided incidents of acute,
allergic, and delayed adverse effects
from occupational exposures to
agricultural-plant pesticides exceed the
costs attributable to this final rule.
The final rule would serve to protect a
labor force of 3.9 million exposed either
directly or indirectly to pesticides as a
result of their occupations on farms, in
forests, in nurseries, in greenhouses, or
in commercial pesticide-handling
operations. This work force includes 1.4
million hired workers and handlers on
farms, 92,000 hired workers and
handlers in nurseries and greenhouses,
and 10,000 hired workers and handlers
in forests. There are also 38,000
commercial handlers who handle
agricultural-plant pesticides. In addition,
2.36 million agricultural-establishment
operators and unpaid workers
(presumably family members] handle
agricultural-plant pesticides or perform
tasks related to the production of
agricultural plants on farms, nurseries,
and greenhouses.
EPA estimates that the incremental
costs of this final rule will be about $95
million in the first year and about $50
million annually thereafter. To facilitate
comparison with other regulations, EPA
has also calculated the incremental
costs by annualizing them over 10 years
at several illustrative interest rates.
Using 3% and 10%, the annualized costs
of this final rule would be about $54 and
$56 million per year respectively. The
annual cost of the rule is therefore
expected to be $50 to $60 million dollars,
while the estimated annual benefits of
this final rule include avoiding 8,000 to
16,000 physician-diagnosed
(nonhospitalized] acute and allergic
pesticide poisoning incidents, avoiding
about 300 hospitalized acute and allergic
pesticide poisoning incidents,'and
avoiding potentially important numbers
of cancer cases, serious developmental
defects, stillbirths, persistent neurotoxic
effects, and nondiagnosed acute and
allergic poisoning incidents. '
B. Regulatory Flexibility Act
This final rule has been reviewed
under the Regulatory Flexibility Act of
1980 (Pub. L. 96-354; 94 Stat. 1164; 5
U.S.C. 601-612] for its impact on small
businesses. The results of that review
have been incorporated into the
Regulatory Impact Analysis and are
discussed in more detail in that
document (available for public
inspection at the address listed at the
beginning of this Notice]. A summary
follows.
• The revised final rule exempts owners
of agricultural establishments and
members of their immediate family from
the provisions pertaining to safety
training and information,
decontamination facilities, notification
of pesticide treatments, and emergency
assistance. EPA presumes that owners
and family members will provide
themselves and each other with these
protections, and has chosen not to
regulate such behavior. This decision
represents a significant exemption for
small entities, since about 45 percent
(251,000 of 560,000] of the agricultural
establishments within the scope of the
WPS do not hire labor and are,
therefore, exempt from all but a few of
the final rule's requirements.
As a result, the analysis reveals that
agricultural establishments without
hired labor will bear a low cost-burden
as compared to agricultural
establishments with hired labor. The
incremental continuing annual costs
averaged across all establishments
without hired labor are about $15 per
establishment, whereas the costs
averaged across all hired-labor
agricultural establishments are about
$140 per establishment per year. Non-
hired-labor feed and grain farms, which
make up the largest crop segment, will
incur incremental continuing annual
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Federal Register / Vol. 57, No. 163 / Friday. August 21, 1992 / Rules and Regulations
costs averaging about $10 per farm.
Hired-labor feed and grain farms will
incur incremental continuing annual
costs averaging about $55 per farm.
None of the provisions of the
regulation provide a direct efficiency of
size to establishments with many
employees. Most of the provisions are
totally or mostly variable (per worker)
costs. However,, two provisions that
contain some fixed (per establishment)
cost elements are training and
notification. Even these provisions are
not directly efficiency-of-size cost
factors, due to: (1) The diverse and
sporadic nature of pesticide-use and
labor-use practices, and (2) the
exceptions and options in the rule that
allow employers to select the most cost-
effective option for their particular
circumstance.
The variability in the cost-factors due
to these exceptions and options is
difficult to quantify. Therefore, the
analysis of the impact on 1-worker
agricultural establishments versus the
impact on 10-worker agricultural
establishments is a "worst-case"
analysis that assumes that all costs of
training and notification are fixed rather
than variable. This results hi an
overestimate of the impact of this rule to
1-worker agricultural establishments.
However, even with the overestimate,
results indicate that the burden is not
unreasonably higher for such small
establishments. The average
incremental continuing annual cost due
to all provisions for a feed and grain
farm with one hired employee is about
$25 (or $25 per employee). For a feed
and grain farm with 10 hired employees,
it is about $115 per year (or $10 per
employee). For vegetable/fruit/nut
establishments with one hired
employee, the average incremental
continuing annual cost for all provisions
is about $95 per establishment (or $95
per employee). The cost is about $650 (or
$65 per employee) for a vegetable/fruit/
nut establishment with 10 hired
employees.
The Agency has determined that the
burden on small agricultural businesses
does not outweigh the risk to handlers
and workers employed in those
businesses, and that further exemptions
from the regulation for small businesses
would not be warranted.
C. Paperwork Reduction Act
The information collection
requirements contained in this rule have
been approved by the Office of
Management and Budget (OMB) under
the provisions of the Paperwork
Reduction Act, 44 U.S.'C. 3501 etseq.,
and have been assigned OMB Control
Number 2070-0060.
The reporting burden for registrants is
lestimated to average 5.9 hours per
product, including time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing the collection of information.
Send comments regarding this burden
estimate or any other aspect of this
collection of information, including
suggestions for reducing this burden, to
Chief, Information Policy Branch, PM-
223, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460
and to the Office of Management and
Budget, Washington, DC 20503, marked .
"Attention: Desk Officer for EPA."
List of Subjects hi 40 CFR Parts 156 and
170
Environmental protection, Labeling,
Pesticides and pests, Intergovernmental
relations, Occupational safety and
health, Reporting and recordkeeping
requirements.
Dated: August 13, 1992.
'William K. Reilly,
Administrator.
Therefore, chapter I of Title 40 is
amended in subchapter E, to read as
follows:
PART 156— LABELING
REQUIREMENTS FOR PESTICIDES
AND DEVICES
•'• 1. In part 156:
! a. The authority citation for part 156
continues to read as follows:
Authority: 7 U.S.C. 136-136y.
b. Section 156.10 is designated as
subpart A, and the subpart heading is
added, § 156.10 is amended by revising
paragraph (i)(2)(viii), and subparts B
through J are added and reserved, to
read as follows:
Subpart A— General Provisions
§ 156.10 Labeling requirements.
,(2)* * *
(viii) Worker protection statements
meeting the requirements of subpart K
of this part.
*• * * * *
c. New subpart K, consisting of
§ § 156.200, 156.203, 156.204, 156.206,
156.208, 156.210, and 156.212, is added, to
read as follows:
Subpart K— Worker Protection Statements
Sec.
156.200 Scope and applicability.
156.203 Definitions.
156.204 Modification and waiver of
requirements.
156.206 General statements.
156.208 Restricted-entry statements.
Sec.
156.210 Notification-to-workers statements.
156.212 Personal protective equipment
statements.
Subpart K—Worker Protection
Statements
§ 156.200 Scope and applicability.
(a) Scope. (1) This subpart prescribes
statements that must be placed on the
pesticide label and in pesticide labeling.
These statements incorporate by
reference the Worker Protection
Standard, part 170 of this chapter. The
requirements addressed in these
statements are designed to reduce the
risk of illness or injury resulting from
workers' and pesticide handlers'
occupational exposures to pesticides
used in the production of agricultural
plants on agricultural establishments as
defined in § 170.3 of this chapter. These
statements refer to specific workplace
practices designed to reduce or
eliminate exposure and to respond to
emergencies that may arise from the
exposures that may occur.
(2) This subpart prescribes interim
requirements that must be placed on the
pesticide label and in pesticide labeling.
These interim requirements pertain to
restricted-entry intervals, personal
protective equipment, and notification.
On a case-by-case basis, these interim
requirements will be reviewed and may
be revised during reregistration or other
agency review processes.
(b) Applicability. (1) The requirements
of this subpart apply to each pesticide
product that bears directions for use in
the production of any agricultural plant
on any agricultural establishment as
defined in § 170.3 of this chapter, or
whose labeling reasonably permits such
use.
(2) The requirements of this subpart
do not apply to a product that bears
directions solely for uses excepted by
§ 170.202(b) of this chapter.
(c) Effective dates. (1) The effective
date of this subpart is October 20,1992.
(2) No pesticide product bearing
labeling amended and revised as
required by this subpart shall be
distributed or sold by a registrant prior
to April 21,1993.
(3) No product to which this subpart
applies shall be distributed or sold
without amended labeling by any
registrant after April 21,1994.
(4) No product to which this subpart
applies shall be distributed or sold
without amended labeling by any person
after October 23,1995.
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Federal Register / Vol. 57, No. 163 / Friday. August 21, 1992 / Rules and Regulations 38147
§156.203 Definitions.
Terms in this subpart have the same
meanings as they do in the Federal
Insecticide, Fungicide, and Rodenticide
Act, as amended. In addition, the
following terms, as used in this subpart,
shall have the meanings stated below:
Fumigant means any pesticide
product that is a vapor or gas or forms a
vapor or gas on application and whose
method of pesticidal action is through
the gaseous state.
Restricted-entry interval means the
time after the end of a pesticide
application during which entry to the
treated area is restricted.
§ 156.204 Modification and waiver of
requirements.
(a) Modification on Special Review. If
the Agency concludes in accordance
with § 154.25(c) of this chapter that a
pesticide should be placed in Special
Review because the pesticide meets or
exceeds the criteria for human health
effects of § 154.7(a)(lK2) or (6) of this
chapter, the Agency may modify the
personal protective equipment required
for handlers or early-entry workers or
both, the restricted-entry intervals, or
the notification to workers requirements.
(b) Other modifications. The Agency,
pursuant to this subpart and authorities
granted in FIFRA sections 3, 6, and 12,
may, on its initiative or based on data
submitted by any person, modify or
waive the requirements of this subpart,
or permit or require alternative labeling
statements. Supporting data may be
either data required by Subdivisions U
or K of the Pesticide Assessment
Guidelines or data from medical,
epidemiological, or health effects
studies. The Pesticide Assessment
Guidelines contain the standards for
conducting acceptable tests, guidance
on evaluation and reporting of data,
definition of terms, further guidance on
when data are required, and examples
of acceptable protocols. They are
available through the National
Technical Information Service, 5285 Port
Royal Rd., Springfield, VA 22161. A
registrant who wishes to modify any of
the statements required in § § 156.206,
156.208,156.210, or 156.212 must submit
an application for amended registration
unless specifically directed otherwise by
the Agency.
§ 156.206 Genera! statements.
(a) Application restrictions. Each
product shall bear the statement: "Do
not apply this product in a way that will
contact workers or other persons, either
directly or through drift. Only protected
handlers may be in the area during
application." This statement shall be
near the beginning of the DIRECTIONS
FOR USE section of the labeling under
the heading AGRICULTURAL USE
REQUIREMENTS.
(b) 40 CFR Part 170 reference
statement. (1) Each product shall bear
the reference statement: "Use this
product only in accordance with its
labeling and with the Worker Protection
Standard, 40 CFR part 170." This
statement shall be placed on the product
label under the heading
AGRICULTURAL USE
REQUIREMENTS.
(2) Each product shall bear the
statement: "This standard contains
requirements for the protection of
agricultural workers on farms, forests,
nurseries, and greenhouses, and
handlers of agricultural pesticides. It
contains requirements for training,
decontamination, notification, and
emergency assistance. It also contains
specific instructions and exceptions
pertaining to the statements on this
label [in this labeling] about [use any of
the following that are applicable]
personal protective equipment,
restricted-entry interval, and
notification to workers." These
statements shall be placed immediately
following the reference statement
required by paragraph (b)(l) of this
section, or they shall be placed in the
supplemental product labeling under the
heading AGRICULTURAL USE
REQUIREMENTS.
(3] If the statements in paragraph
(b)(2) of this section are included in
supplemental labeling rather than on the
label of the pesticide container, the
container label must contain this
statement immediately following the
statement required in paragraph (b)(l) of
this section: "Refer to supplemental
labeling entitled AGRICULTURAL USE
REQUIREMENTS in the DIRECTIONS
FOR USE section of the labeling for
information about this standard."
(4] If the statements in paragraph
(b)(2) of this section are included in
supplemental labeling, they must be
preceded immediately by the statement
in paragraph (b](l) of this section under
the heading AGRICULTURAL USE
REQUIREMENTS in the labeling.
(c) Product-type identification. (1) If
the product contains an
organophosphate (i.e., an
organophosphorus ester that inhibits
cholinesterase) or an TV-methyl
carbamate (i.e., an TV-methyl carbamic
acid ester that inhibits cholinesterase),
the label shall so state. The statement
shall be associated with the product
name or product-type identification or
shall be in the STATEMENT OF
PRACTICAL TREATMENT or FIRST
AID section of the label.
(2) If the product is a fumigant, the
label shall so state. The identification
shall appear:
(i) As part of the product name; or
(ii) Close to the product name, as part
of the product-type identification or as a
separate phrase or sentence;
(d) State restrictions. Each product
shall bear the statement: "For any
requirements specific to your State,
consult the agency in your State
responsible for pesticide regulation."
This statement shall be under the
heading AGRICULTURAL USE
REQUIREMENTS in the labeling.
(e) Spanish warning statements. If the
product is classified as toxicity category
I or toxicity category II according to the
criteria in § 156.10(h)(l), the. signal word
shall appear in Spanish in addition to
English followed by the statement, "Si
Usted no entiende la etiqueta, busque a
alguien para que se la explique a Usted
en detalle. (If you do not understand the
label, find some one to explain it to you
in detail.)" The Spanish signal word
"PELIGRO" shall be used for products in
toxicity category I, and the Spanish
signal word "AVISO" shall be used for
products in toxicity category II. These
statements shall appear on the label
close to the English signal word.
(Approved by the Office of Management and
Budget under control number 2070-0060.)
§ 156.208 Restricted-entry statements.
(a) Requirement. Each product with a
restricted-entry interval shall bear the
following statement: "Do not enter or
allow worker entry into treated areas
during the restricted-entry interval
(REI)." This statement shall be under the
heading AGRICULTURAL USE
REQUIREMENTS in the labeling.
(b) Location of specific restricted-
entry interval statements. (1) If a
product has one specific restricted-entry
interval applicable to all registered uses
of the product on agricultural plants, the
restricted-entry interval for the product
shall appear as a continuation of the
statement required in paragraph (a) of
this section and shall appear as follows:
"of X hours" or "of X days" or "until the
acceptable exposure level of X ppm or
mg/m3 is reached."
(2) If different restricted-entry
intervals have been established for
some crops or some uses of a product,
the restricted-entry statement in
paragraph (b)(l) of this section shall be
associated on the labeling of the product
with the directions for use for each crop
each use to which it applies,
immediately preceded or immediately
followed by the words "Restricted-entry
interval" (or the letters "REI").
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Federal Register /Vol. 57. No. 163 / Friday, August 21. 1992 / Rules and Regulations
(c) Restricted-entry interval bqsed on
toxicity of active ingredient—(1)
Determination of toxicity category. A
restricted-entry interval shall be
established based on the acute toxicity
of the active ingredients in the product.
For the purpose of setting the restricted-
entry interval, the toxicity category of
each active ingredient in the product
shall be determined by comparing the
obtainable data on the acute dermal
toxicity, eye irritation effects, and skin
irritation effects of the ingredient to the
criteria of § 156.10(h)(l). The most toxic
of the applicable toxicity categories that
are obtainable for each active ingredient
shall be used to determine the
restricted-entry interval for that product.
If no acute dermal toxicity data are
obtainable, data on acute oral toxicity
also shall be considered in this
comparison. If no applicable acute
toxicity data are obtainable on the
active ingredient, the toxicity category
corresponding to the signal word of any
registered manufacturing-use product
that is the source of the active ingredient
in the end-use product shall be used. If
no acute toxicity data are obtainable on
the active ingredients and no toxicity
category of a registered manufacturing-
use product is obtainable, the toxicity
category of the end-use product
(corresponding to the signal word on its
labeling) shall be used.
(2) Restricted-entry interval for sole
active ingredient products, (i) If the
product contains only one active
ingredient and it is in toxicity category I
by the criteria in paragraph (c)(l) of this
section, the restricted-entry interval
shall be 48 hours. If, in addition, the
active ingredient is an
organophosphorus ester that inhibits
cholinesterase and that may be applied
outdoors in an area where the average
annual rainfall for the application site is
less than 25 inches per year, the
following statement shall be added to
the restricted-entry interval statement:
"(72 hours in outdoor areas where
average annual rainfall is less than 25
inches a year)."
(ii) If the product contains only one
active ingredient and it is in toxicity
category II by the criteria in paragraph
(c)(l) of this section, the restricted-entry
interval shall be 24 hours.
(iii) If the product contains only active
ingredients that are in toxicity category
III or IV by the criteria in paragraph
(c)(l) of this section, the restricted-entry
interval shall be 12 hours.
(3) Restricted-entry interval for
multiple active ingredient products. If
the product contains more than one
active ingredient, the restricted-entry
interval (including any associated
statement concerning use in arid areas
under paragraph (c)(2)(i) of this section)
shall be based on the active ingredient
that requires the longest restricted-entry
interval as determined by the criteria in
this section.
(d) Exception for fumigants. The
criteria for determining restricted-entry
intervals in paragraph (c) of this section
shall not apply to any product that is a
fumigant. For fumigants, any existing
restricted-entry interval (hours, days, or
acceptable exposure level) shall be
retained. Entry restrictions for fumigants
have been or shall be established on a
case-by-case basis at the time of
registration, reregistration, or other
Agency review process.
: (e) Existingproduct-specific
restricted-entry intervals. (1) A product-
specific restricted-entry interval, based
on data collected in accordance with
§ 158.390 of this chapter and Subdivision
K of the Pesticide Assessment
Guidelines, shall supersede any
restricted-entry interval applicable to
the product under paragraph (c) of this
section.
; (2) Product-specific restricted-entry
intervals established for pesticide
products or pesticide uses that are not
covered by part 170 of this chapter shall,
remain in effect and shall not be placed
under the heading AGRICULTURAL
USE REQUIREMENTS in the labeling.
, (f) Existing interim restricted-entry
' intervals, (i) An interim restricted-entry
interval established by the Agency
before the effective date of this subpart
will continue to apply unless a longer
restricted-entry interval is required by
paragraph (c) of this section.
(2) Existing interim restricted-entry
intervals established by the Agency for
pesticide products or pesticide uses not
covered by part 170 of this chapter shall
. remain in effect and shall not be placed
under the heading AGRICULTURAL
; USE REQUIREMENTS in the labeling.
(Approved by the Office of Management and
: Budget under control number 2070-0060.]
§ 156.210 Notification-to-workers
: statements.
(a) Requirement. Each product that
meets the requirements of paragraph (b)
of this section shall bear the posting and
oral notification statements prescribed
below. The statements shall be in the
DIRECTIONS FOR USE section of the
labeling under the heading
AGRICULTURAL USE
REQUIREMENTS.
(b) Notification to workers of
pesticide application. (1) Each product
that contains any active ingredient
classified as toxicity category I for
either acute dermal toxicity or skin
irritation potential under the criteria in
§ 156.10(h)(l) shall bear the statement:
"Notify workers of the application by
warning them orally and by posting
warning signs at entrances to treated
areas." If no acute dermal toxicity data
are obtainable, data on acute oral
toxicity of the active ingredient shall be
considered instead. If no data on acute
dermal toxicity, skin irritation potential,
or acute oral toxicity are obtainable on
the active ingredient, the toxicity
category corresponding to the signal
word of any registered manufacturing-
use product that is the source of the
active ingredient in the end-use product
shall be used. If none of the applicable
acute toxicity data are obtainable on the
active ingredient and no toxicity
category of the registered
manufacturing-use product is
obtainable, the toxicity category of the
end-use product corresponding to the
product's signal word shall be used.
(2) Each product that is a fumigant
.and is registered for use in a greenhouse
(or whose labeling allows use in a
greenhouse) shall bear the statement:
"For greenhouse applications, notify
workers of the application by warning
them orally and by posting warning
signs outside all entrances to the
greenhouse."
(Approved by the Office of Management and
Budget under control number 2070-0060.)
§ 156.212 Personal protective equipment
statements.
(a) Requirement. Each product shall
bear the personal protective equipment
statements prescribed in paragraphs (d)
through (j) of this section.
(b) Exceptions. (1) If personal
protective equipment were required for
a product before the effective date of
this subpart, the existing requirements
shall be retained on the labeling
wherever they are more specific or more
protective (as specified in EPA guidance
materials) than the requirements in the
table in paragraph (e) of this section.
(2) Any existing labeling statement
that prohibits the use of gloves or boots
overrides the corresponding requirement
in paragraph (e) of this section and must
be retained on the labeling.
(3) If the product labeling contains
uses that are not covered by part 170 of
this chapter, the registrant may adopt
the personal protective equipment
required in this section for those uses.
However, if the personal protective
equipment required in this section
would not be sufficiently protective or
would be onerously overprotective for
uses not covered by part 170 of this
chapter, the registrant must continue to
apply the existing personal protective
equipment requirements to those uses.
The labeling must indicate which
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38149
personal protective equipment
requirements apply to uses covered by
part 170 of this chapter and which
personal protective equipment
requirements apply to other uses.
(c) Location of personal protective
equipment statements—(1) Personal
protective equipment statements for
pesticide handlers. Personal protective
equipment statements for pesticide
handlers shall be in the HAZARDS TO
HUMANS (AND DOMESTIC
ANIMALS) section of the labeling. The
required statements may be combined to
avoid redundancy as long as the
requirements and conditions under
which they apply are identified.
(2) Personal protective equipment
statements for early-entry workers.
Personal protective equipment
statements for early-entry workers shall
be placed in the DIRECTIONS FOR USE
section of the labeling under the heading
AGRICULTURAL USE
REQUIREMENTS and immediately after
the restricted-entry statement required
in § 156.208(a).
(d) Personal protective equipment
statements for pesticide handlers. (1)
The table in paragraph (e) of this section
specifies minimum requirements for
personal protective equipment (as
defined in § 170.240 of this chapter) and
work clothing for pesticide handlers.
This personal protective equipment
requirement applies to any product that
presents a hazard through any route of
exposure identified in the table (acute .
dermal toxicity, skin irritation potential,
acute inhalation toxicity, and eye
irritation potential).
(2) The requirement for personal
protective equipment is based on the
acute toxicity category of the end-use
product for each route of exposure as
defined by § 156.10(h)(l). If data to
determine the acute dermal toxicity or
the acute inhalation toxicity are not
obtainable, the acute oral toxicity shall
be used as a surrogate to determine the
personal protective equipment
requirements for that route of exposure.
If data to determine the acute toxicity of
the product by a specific route of
exposure (including acute oral toxicity
in lieu of acute dermal or acute
inhalation toxicity) are not obtainable,
the toxicity category corresponding to
the signal word of the end-use product
shall be used to determine personal
protective equipment requirements for
that route of exposure. If the signal word
is "CAUTION," toxicity category III will
be used.
(3) The minimum personal protective
equipment and work clothing
requirements specified in this section
shall be included in a statement such as
the following: "Applicators and other
handlers must wear: (body protection
statement); (glove statement, if
applicable); (footwear statement, if
applicable); (protective eyewear
statement, if applicable); (respirator
statement, if applicable)." The format of
statements given in this paragraph is
optional, but it is recommended for
clarity.
(e) Summary of personal protective
equipment requirements. The following
Table 1 summarizes the personal
protective equipment requirements by
route of exposure and toxicity category:
TABLE 1.—MINIMUM PERSONAL PROTECTIVE EQUIPMENT (PPE) AND WORK CLOTHING FOR HANDLING ACTIVITIES
Route of Exposure
Dermal Toxicity or Skin Irritation
Potential1...
Inhalation Toxicity
Eyo Irritation Potential
Toxicity Category of End-Use Product
1
Coveralls worn over long-
sleeved shirt and long
pants
Socks
Chemical-resistant footwear
Chemical-resistant gloves2
Respiratory protection
device3
Protective eyewear
II
Coveralls worn over short-
sleeved shirt and short
pants
Socks
Chemical-resistant footwear
Chemical-resistant gloves2
Respiratory protection
device3
Protective eyewear
III
Long-sleeved shirt and long
pants
Socks
Shoes
Chemical-resistant gloves2
No minimum4
No minimum4
IV
Long-sleeved shirt and long
pants
Socks
Shoes
No minimum4
No minimum4
No minimum4
the more toxic (lower numbered) category.
1 It dermal toxicity and skin irritation potential are in different toxicity categories, protection shall be based on
* For labeling language for chemical-resistant gloves, see paragraph (f) of this section.
» For labeling language for respiratory protection device, see paragraphs (g) and (h) of this section.
* Although no minimum PPE is required by this section for this toxicity category and route of exposure, the Agency may require PPE on a product-specific basis.
(f) Chemical-resistant gloves labeling
statements for pesticide handlers. If the
table in paragraph (e) of this section
indicates that chemical-resistant gloves
are required, the glove statement shall
be as specified in paragraph (f)(2), (3),
(4), or (5) of this section.
(1) Exception. The registrant shall
specify a glove type other than that
selected through the criteria in
paragraphs (f)(2) through (5) of this
section if information available to the
registrant indicates that such a glove
type is more appropriate or more
protective than the glove type specified
in this section. The statement must
specify the particular types of chemical-
resistant glove (such as nitrile, butyl,
neoprene, and/or barrier-laminate).
(2) Solid formulations. For products
formulated and applied as solids or
formulated as solids and diluted solely
with water for application, the glove
statement shall specify: "waterproof
gloves."
(3) Aqueous-based formulations. For
products formulated and applied as a
water-based liquid or formulated as a
water-based liquid and diluted solely
with water for application, the glove
statement may specify: "waterproof
gloves" instead of the statement in
paragraph (f)(4) of this section.
(4) Other liquid formulations. For
products formulated or diluted with
liquids other than water, the glove
statement shall specify: "chemical-
resistant (such as nitrile or butyl)
gloves."
(5) Gaseous formulations and
applications. For products formulated or
applied as gases, any existing glove
statement established before the
effective date of this subpart, including
any glove prohibition statement, will
continue to apply. If no glove statement
or glove prohibition now exists, the
glove statement shall specify "chemical-
resistant (such as nitrile or butyl)
gloves."
(g) Existing respirator requirement for
pesticide handlers on product labeling—
(1) General requirement. If a statement
placed on a product's labeling before the
effective date of this subpart indicates
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38150 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
that respiratory protection is required,
that requirement for protection shall be
retained. The statement must specify, or
be amended to specify, one of the
following respirator types and the
appropriate MSHA/NIOSH approval
number prefix:
(i] Dust/mist filtering respirator with
MSHA/NIOSH/ approval number,prefix
TC-21C; or
(ii) Respirator with an organic-vapor-
removing cartridge and a prefilter
approved for pesticides with MSHA/
NIOSH approval number prefix TC-23C
or with a canister approved for
pesticides with MSHA/NIOSH approval
number prefix TC-14G; or
(in) Supplied-air respirator with
MSHA/NIOSH approval number prefix
TC-19C or self-contained breathing
apparatus (SCBA) with MSHA/NIOSH
approval number TC-13F.
(2) Respirator type already specified
on labeling. If the existing respiratory
protection requirement specifies a'
respirator type, it shall be retained. The
respirator statement must be revised, if
necessary, to conform to the wording in
paragraph (g)(l) of this section.
(3) Respirator type not already
specified on labeling. If the existing
respiratory protection requirement on
product labeling does not specify a
respirator type as listed in paragraph
(g)(l) of this section, the specific
respirator type shall be that required in
the criteria in paragraphs (g)(3)(ii)
through (vij of this section.
(i] Exception. The registrant shall
specify a different type of respiratory
protection device if information, such as
vapor pressure value, is available to the
registrant to indicate that the type of
respiratory protection device selected
through the criteria in paragraphs
(g)(3](ii) through (vi) of this section
would not be adequately protective, or
might increase risks to the user
unnecessarily.
(ii) Gases applied outdoors. For
products that are formulated or applied
as a gas (space and soil fumigants] and
that may be used outdoors, the
respiratory protection statement shall
be: "For handling activities outdoors,
use either a respirator with an organic-
vapor-removing cartridge with a
prefilter approved for pesticides
(MSHA/NIOSH approval number prefix
TC-23C), or a canister approved for
pesticides (MSHA/NIOSH approval
number prefix TC-14G)."
(iii) Gases used in enclosed areas. For
products that are formulated or applied
as a gas (space and soil fumigants) and
that may be used in greenhouses or
other enclosed areas, the respiratory
protection statement shall specify: "For
handling activities in enclosed areas,
use either a supplied-air respirator with
MSHA/NIOSH approval number prefix
TC-19C, or a self-contained breathing
apparatus (SCBA) with MSHA/NIOSH
approval number TC-13F."
(iv) Solids. For products that are
' formulated and applied as solids, the
: respiratory protection statement shall
; specify: "dust/mist filtering respirator
(MSHA/NIOSH approval number prefix
TC-21CJ."
(v) Liquids in toxicity category I. For
products that are formulated or applied
' as liquids, and, as formulated, have an
acute inhalation toxicity (or its surrogate
as specified in paragraph (d)(2) of this
section) in category I, the respiratory
; protection statement shall specify:
i "either a respirator with an organic-
•• vapor-removing cartridge with a
i prefilter approved for pesticides
(MSHA/NIOSH approval number prefix
TC-23C), or a canister approved for
pesticides (MSHA/NIOSH approval
number prefix 14G)."
(vi) Liquids in toxicity category II. For
products that are formulated or applied
as liquids, and, as formulated, have an
acute inhalation toxicity (or its surrogate
as specified in paragraph (d)(2) of this
section) in category II, the respiratory
protection statement shall specify: "For
, handling activities during (select uses
applicable to the product: airblast,
mistblower, pressure greater than 40
p.s.i. with fine droplets, smoke, mist, fog,
, aerosol or direct overhead) exposures,
wear either a respirator with an organic-
vapor-removing cartridge with a
prefilter approved for pesticides
(MSHA/NIOSH approval number prefix
TC-23C), or a canister approved for
pesticides (MSHA/NIOSH approval
number prefix 14G). For all other
i exposures, wear a dust/mist filtering
respirator (MSHA/NIOSH approval
: number prefix TC-21C)."
(h) New respirator requirement
established for pesticide handlers in
this part—(1) General requirement. If
the table in paragraph (e) of this section
; indicates a respiratory protection device
is required, and existing product
: labeling has no respiratory protection
; requirement, the registrant shall add a
respiratory protection statement that
.specifies a: "dust/mist filtering
respirator (MSHA/NIOSH approval
number prefix TC-21C)."
(2) Exception. The registrant shall
! specify a different type of respiratory
protection device if information, such as
vapor pressure value, is available to the
registrant to indicate that the type of
respiratory protection device required in
,• paragraph (h)(l) of this section would
not be adequately protective or might
increase risks to the user unnecessarily.
(i) Additional personal protective
equipment requirements for pesticide
handlers. In addition to the minimum
personal protective equipment and work
clothing requirements given in the table
in paragraph (e) of this section, the
labeling statement for any product in
toxicity category I or II on the basis of
dermal toxicity or skin irritation
potential (or their surrogate as specified
in paragraph (d)(2) of this section), shall
include the following personal
protective equipment instructions,
additions, or substitutions as applicable:
(1) If the product is not ready-to-use
and there is no existing requirement for
a chemical-resistant suit, the following
statement shall be included: "Mixers/
Loaders: add a chemical-resistant
apron."
(2) If the application of the product
may result in overhead exposure to any
handler (for example, applicator
exposure during airblast spraying of
orchards or flagger exposure during
aerial application), the following
statement shall be included: "Overhead
Exposure: wear chemical-resistant
headgear."
(3) If any type of equipment other than
the product container may be used to
mix, load, or apply the product, and
there is no requirement for a chemical-
resistant protective suit, the following
statement shall be included: "For
Cleaning Equipment: add a chemical-
resistant apron."
(j) Personal protective equipment for
early-entry workers. This paragraph
specifies minimum requirements for
personal protective equipment (as
defined in § 170.240 of this chapter) and
work clothing for early-entry workers.
(1) For all pesticide products, add the
statement: "For early entry to treated
areas that is permitted under the
Worker Protection Standard and that
involves contact with anything that has
been treated, such as plants, soil, or
water, wear: (list the body protection,
glove, footwear, protective eyewear, and
protective headgear, if applicable,
statements specified for applicators and
other handlers, but omit any respiratory
protection statement)."
(2) If the body protection statement in
the personal protective equipment
requirement for handlers specifies a
long-sleeved shirt and long pants,
"coveralls" must be specified in the
statement of personal protective
equipment for early-entry workers.
(3) If there is no statement requiring
gloves and no prohibition against gloves
for applicators and other handlers under
the heading HAZARDS TO HUMANS
(AND DOMESTIC ANIMALS) in the
labeling, add a requirement for
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38151
"waterproof gloves" in the statement of
personal protective equipment for early-
entry workers.
(Approved by the Office of Management and
Budget under control number 2070-0060.)
2. By revising part 170 to read as
follows:
PART 170—WORKER PROTECTION
STANDARD
Subpart A—General Provisions
Sec.
170.1 Scope and purpose.
170.3 Definitions.
170.5 Effective date and compliance dates.
170.7 General duties and prohibited actions.
170.9 Violations of this part.
Subpart B—Standard for Workers
Sec.
170.102 Applicability of this subpart.
170.110 Restrictions associated with
pesticide applications.
170.112 Entry restrictions.
170.120 Notice of applications.
170.122 Providing specific information about
applications.
170.124 Notice of applications to handler
employers.
170.130 Pesticide safety training.
170.135 Posted pesticide safety information.
170.150 Decontamination.
170.160 Emergency assistance.
Subpart C—Standard for Pesticide
Handlers
Sec.
170.202 Applicability of this subpart.
170.210 Restrictions during applications.
170.222 Providing specific information about
applications.
170.224 Notice of applications to
agricultural employers.
170.230 Pesticide safely training.
170.232 Knowledge of labeling and site-
specific information.
170.234 Safe operation of equipment.
170.235 Posted pesticide safety information.
170.240 Personal protective equipment.
170.250 Decontamination.
170.200 Emergency assistance.
Authority: 7 U.S.C. 136w.
Subpart A—General Provisions
§ 170.1 Scope and purpose.
This part contains a standard
designed to reduce the risks of illness or
injury resulting from workers' and
handlers' occupational exposures to
pesticides used in the production of
agricultural plants on farms or in
nurseries, greenhouses, and forests and
also from the accidental exposure of
workers and other persons to such
pesticides. It requires workplace
practices designed to reduce or
eliminate exposure to pesticides and
establishes procedures for responding to
exposure-related emergencies.
§170.3 Definitions.
Terms used in this part have the same
meanings they have in the Federal
Insecticide, Fungicide, and Rodenticide
Act, as amended. In addition, the
following terms, when used in this part,
shall have the following meanings:
Agricultural employer means any
person who hires or contracts for the
services of workers, for any type of
compensation, to perform activities
related to the production of agricultural
plants, or any person who is an owner of
or is responsible for the management or
condition of an agricultural
establishment that uses such workers.
Agricultural establishment means any
farm, forest, nursery, or greenhouse.
Agricultural plant means any plant
grown or maintained for commercial or
research purposes and includes, but is
not limited to, food, feed, and fiber
plants; trees; turfgrass; flowers, shrubs;
ornamentals; and seedlings.
Chemigation means the application of
pesticides through irrigation systems.
Commercial pesticide handling
establishment means any establishment,
other than an agricultural establishment,
that:
(1) Employs any person, including a
self-employed person, to apply on an
agricultural establishment, pesticides
used in the production of agricultural
plants.
(2) Employs any person, including a
self-employed person, to perform on an
agricultural establishment, tasks as a
crop advisor.
Crop advisor means any person who
is assessing pest numbers or damage,
pesticide distribution, or the status or
requirements of agricultural plants. The
term does not include any person who is
performing hand labor tasks.
Early entry means entry by a worker
into a treated area on the agricultural
establishment after a pesticide
application is complete, but before any
restricted-entry interval for the pesticide
has expired.
Farm means any operation, other than
a nursery or forest, engaged in the
outdoor production of agricultural
plants.
Forest means any operation engaged
in the outdoor production of any
agricultural plant to produce wood fiber .
or timber products.
Fumigant means any pesticide
product that is a vapor or gas, or forms a
vapor or gas on application, and whose
method of pesticidal action is through
the gaseous state.
Greenhouse means any operation
engaged in the production of agricultural
plants inside any structure or space that
is enclosed with nonporous covering
and that is of sufficient size to permit
worker entry. This term includes, but is
not limited to, polyhouses, mushroom
houses, rhubarb houses, and similar
structures. It does not include such
structures as malls, atriums,
conservatories, arboretums, or office
buildings where agricultural plants are
present primarily for aesthetic or
climatic modification.
Hand labor means any agricultural
activity performed by hand or with hand
tools that causes a worker to have
substantial contact with surfaces (such
as plants, plant parts, or soil) that may
contain pesticide residues. These
activities include, but are not limited to,
harvesting, detasseling, thinning,
weeding, topping, planting, sucker
removal, pruning, disbudding, roguing,
and packing produce into containers in
the field. Hand labor does not include
operating, moving, or repairing irrigation
or watering equipment or perfprming the
tasks of crop advisors.
Handler means any person, including
a self-employed person: ;
(1) Who is employed for any type of
compensation by an agricultural •
establishment or commercial pesticide
handling establishment to which subpart
C of this part applies and who is:
(i) Mixing, loading, transferring, or
applying pesticides.
(ii) Disposing of pesticides or
pesticide containers.
(iii] Handling opened containers of
pesticides.
(ivj Acting as a flagger.
(v) Cleaning, adjusting, handling, or
repairing the parts of mixing, loading, or
application equipment that may contain
pesticide residues.
(vi) Assisting with the application of
pesticides.
(vii) Entering a greenhouse or other
enclosed area after the application and
before the inhalation exposure level
listed in the labeling has been reached
or one of the ventilation criteria
established by this part ( § 170.110(c)(3))
or in the labeling has been met:
(A) To operate ventilation, equipment.
(B) To adjust or remove coverings
used in fumigation.
(C) To monitor air levels.
(viii) Entering a treated area outdoors
after application of any soil fumigant to
adjust or remove soil coverings such as
tarpaulins.
(ix) Performing tasks as a crop
advisor:
(A) During any pesticide application.
(B] Before the inhalation exposure
level listed in the labeling has been
reached or one of the ventilation criteria
established by this part (§ 170.110(c)(3))
or in the labeling has been met.
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38152 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
(C) During any restricted-entry
interval.
(2) The term does not include any
person who is only handling pesticide
containers that have been emptied or
cleaned according to pesticide product
labeling instructions or, in the absence
of such instructions, have been
subjected to triple-rinsing or its
equivalent.
Handler employer means any person
who is self-employed as a handler or
who employs any handler, for any type
of compensation.
Immediate family includes only
spouse, children, stepchildren, foster
children, parents, stepparents, foster
parents, brothers, and sisters.
Nursery means any operation engaged
in the outdoor production of any
agricultural plant to produce cut flowers
and ferns or plants that will be used in
their entirety in another location. Such
plants include, but are not limited to,
flowering and foliage plants or trees;
tree seedlings; live Christmas trees;
vegetable, fruit, and ornamental
transplants; and turfgrass produced for
sod.
Owner means any person who has a
present possessory interest (fee,
leasehold, rental, or other) in an
agricultural establishment covered by
this part. A person who has both leased
such agricultural establishment to
another person and granted that same
person the right and full authority to
manage and govern the use of such
agricultural establishment is not an
owner for purposes of this part.
Restricted-entry interval means the
time after the end of a pesticide
application during which entry into the
treated area is restricted.
Treated area means any area to
which a pesticide is being directed or
has been directed.
Worker means any person, including
a self-employed person, who is
employed for any type of compensation
and who is performing activities relating
to the production of agricultural plants
on an agricultural establishment to
which subpart B of this part applies.
While persons employed by a
commercial pesticide handling
establishment are performing tasks as
crop advisors, they are not workers
covered by the requirements of subpart
B of this part.
§ 170.5 Effective date and compliance
dates.
(a) Effective date. The effective date
for this part, including § 170.112(e), shall
be October 20,1992.
(b) Accelerated provisions. The
compliance date shall be April 21,1993,
for:
(1) Section 170.112(a) through (c)(3);
(2) Section 170.112(d)(l) through
, (3) The requirement of § 170.112(c)(3)
as referenced in § 170.112(d)(2)(iii);
(4) The requirement of § 170.112(c](3)
as referenced in § 170.112[e)(5);
.. (5) Section 170.120(a)(3); and
(B) Section 170.120(b)(3).
(c) All other provisions. The
compliance date for all other provisions
of this part shall be April 15, 1994.
§ 170.7 General duties and prohibited
actions.
: (a) General duties. The agricultural
lemployer or the handler employer, as
appropriate, shall:
[1] Assure that each worker subject to
subpart B of this part or each handler
subject to subpart C of this part receives
the protections required by this part.
I ! (2] Assure that any pesticide to which
subpart C of this part applies is used in
a manner consistent with the labeling of
the pesticide, including the requirements
of this part.
j (3) Provide, to each person who
supervises any worker or handler,
Information and directions sufficient to
assure that each worker or handler
^receives the protections required by this
part. Such information and directions
ghall specify which persons are
responsible for actions required to
jcomply with this part.
(4) Require each person who
'supervises any worker or handler to
assure compliance by the worker or
handler with the provisions of this part
and to assure that the worker or handler
receives the protections required by this
part.
, (b) Prohibited actions. The
agricultural employer or the handler
employer shall not take any retaliatory
action for attempts to comply with this
part or any action having the effect of
preventing or discouraging any worker
or handler from complying or attempting
to comply with any requirement of this
: part.
§ 1 70.9 Violations of this part.
: (a) Under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C.
136 et seq.) (FIFRA) section 12(a)(2)(G) it
is unlawful for any person "to use any
registered pesticide in a manner
inconsistent with its labeling." When
this part is referenced on a label, users
must comply with all of its requirements
except those that are inconsistent with
product-specific instructions on the
labeling. For the purposes of this part,
EPA interprets the term "use" to include:
(1) Preapplication activities, including,
but not limited to:
(i) Arranging for the application of the
pesticide;
(ii) Mixing and loading the pesticide;
and
(iii) Making necessary preparations
for the application of the pesticide,
including responsibilities related to
worker notification, training of handlers,
decontamination, use and care of
personal protective equipment,
emergency information, and heat stress
management.
(2) Application of the pesticide.
(3) Post-application activities
necessary to reduce the risks of illness
and injury resulting from handlers' and
workers' occupational exposures to
pesticide residues during the restricted-
entry interval plus 30 days. These
activities include, but are not limited to,
responsibilities related to worker
training, notification, and ,
decontamination.
(4) Other pesticide-related activities,
including, but not limited to, providing
emergency assistance, transporting or
storing pesticides that have been
opened, and disposing of excess
pesticides, spray mix, equipment wash
waters, pesticide containers, and other
pesticide-containing materials.
(b] A person who has a duty under
this part, as referenced on the pesticide
product label, and who fails to perform
that duty, violates FIFRA section
12{a)(2](G) and is subject to a civil
penalty under section 14. A person who
knowingly violates section 12(a)(2)(G) is
subject to section 14 criminal sanctions.
(c) FIFRA section 14(b)(4) provides
that a person is liable for a penalty
under FIFRA if another person
employed by or acting for that person
violates any provision of FIFRA. The
term "acting for" includes both
employment and contractual
relationships.
(d) The requirements of this part,
including the decontamination
requirements, shall not, for the purposes
of section 653(b)(l) of Title 29 of the U.S.
Code, be deemed to be the exercise of
statutory authority to prescribe or
enforce standards or regulations
affecting the general sanitary hazards
addressed by the OSHA Field
Sanitation Standard, 29 CFR 1928.110, or
other agricultural, nonpesticide hazards.
Subpart B—Standard for Workers
§ 170.102 Applicability of this subpart.
(a) Requirement. Except as provided
by paragraph (b) of this section, this
subpart applies when any pesticide
product is used on an agricultural
establishment in the production of
agricultural plants.
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(b) Exceptions. This subpart does not
apply when any pesticide is applied on
an agricultural establishment in the
following circumstances:
(1) For mosquito abatement,
Mediterranean fruit fly eradication, or
similar wide-area public pest control
programs sponsored by governmental
entities.
(2] On livestock or other animals, or in
or about animal premises.
(3) On plants grown for other than
commercial or research purposes, which
may include plants in habitations, home
fruit and vegetable gardens, and home
greenhouses.
(4) On plants that are in ornamental
gardens, parks, and public or private
lawns and grounds that are intended
only for aesthetic purposes or climatic
modification.
(5) By injection directly into
agricultural plants. Direct injection does
not include "hack and squirt," "frill and
spray," chemigation, soil-incorporation,
or soil-injection.
(6) In a manner not directly related to
the production of agricultural plants,
including, but not limited to, structural
pest control, control of vegetation along
rights-of-way and in other noncrop
areas, and pasture and rangeland use.
(7) For control of vertebrate pests.
(8) As attractants or repellents in
traps.
(9) On the harvested portions of
agricultural plants or on harvested
timber.
(10) For research uses of unregistered
pesticides.
(c) Exemptions. For the purposes of
this subpart, the owners of agricultural
establishments need not assure that the
protections in § 170.112(c)(5) through (9);
§ 170.112(c)(5) through (9) as referenced
in §§ 170.112(d)(2)(iii) and 170.112(e);
and §§ 170.120,170.122,170.130,170.135,
170.150, and 170.160 are provided to
themselves and members of their
immediate family while they are
performing tasks related to the
production of agricultural plants on their
own agricultural establishment.
However, they must provide any
protections required by these sections to
other workers and other persons who
are not members of their immediate
family and are encouraged to provide
the protections to themselves and
members of their families.
§ 170.110 Restrictions associated with
pesticide applications.
(a) Farms and forests. During the
application of any pesticide on a farm or
in a forest, the agricultural employer
shall not allow or direct any person,
other than an appropriately trained and
equipped handler, to enter or to remain
in the treated area.
(b] Nurseries. In a nursery, during any
pesticide application described in
column A of Table 1 of this paragraph,
the agricultural employer shall not allow
or direct any person, other than an
appropriately trained and equipped
handler, to enter or to remain in the area
specified in column B of Table 1 of this
paragraph. After the application is
completed, Until the end of any
restricted-entry interval, the entry-
restricted area is the treated area.
Table 1.—-Entry-Restricted Areas in Nurseries During Pesticide Applications
A. During Application of a Pesticide:
B. Workers are Prohibited in:
(1) (a) Applied:
(i) Aerially, or
(ii) In an upward direction, or
(i) Using a spray pressure greater than 150 psi, or
(b) Applied as a:
(i) Funrfgant, or
(ii) Smoke, or
(iii) Mist, or
(iv) Fog, or
(v) Aerosol.
(2)(a) Applied downward using:
(i) A height of greater than 12 inches from the planting medium, or
(ii) A fine spray, or
(iii) A spray pressure greater than 40 psi and less than 150 psi.
(b) Not as In 1 or 2(a) above but for which a respiratory protection device is required for
application by the product labeling.
(3) Applied otherwise.
Treated area plus 100 feet in all directions on the nursery
Treated are plus 25 feet in all directions on the nursery
Treated area
(c) Greenhouses. (1) When a pesticide
application described in column A of
Table 2 under paragraph (c)(4) of this
section takes place in a greenhouse, the
agricultural employer shall not allow or
direct any person, other than an
appropriately trained and equipped
handler, to enter or to remain in the area
specified in column B of Table 2 until
the time specified in column C of Table
2 has expired.
(2) After the time specified in column
C of Table 2 under paragraph (c)(4) of
this section has expired, until the
expiration of any restricted-entry
interval, the agricultural employer shall
not allow or direct any worker to enter
or to remain in the treated area as
specified in column D of Table 2 under
paragraph (c)(4) of this section, except
as provided in § 170.112.
(3] When column C of Table 2 under
paragraph (c)(4) of this section specifies
that ventilation criteria must be met,
ventilation shall continue until the air
concentration is measured to be equal to
or less than the inhalation exposure
level the labeling requires to be
achieved. If no inhalation exposure level
is listed on the labeling, ventilation shall
continue until after:
(i) Ten air exchanges are completed;
(ii) Two hours of ventilation using
fans or other mechanical ventilating
systems; or
(iii) Four hours of ventilation using
vents, windows or other passive
ventilation; or
(iv) Eleven hours with no ventilation
followed by 1 hour of mechanical
ventilation; or
(v) Eleven hours with no ventilation
followed by 2 hours of passive:
ventilation; or
(vi) Twenty-four hours with no
ventilation.
(4) The following Table 2 applies to
paragraphs (c)(l), (2), and (3) of this
section.
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38154 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
Table 2.—Greenhouse Entry Restrictions Associated With Pesticide Applications
A. When a Pesticide is Applied:
B. Workers are Prohibited in:
C. Until:
D. After the Expiration of Time in Column
C Until the Restricted-Entry Interval
Expires, the Entry-Restricted Area is:
(1) As a fumigant
(2) As a
(i) Smoke, or
(ii) Mist, or
(iii) Fog, or
(iv) Aerosol
(3) Not in 1 or 2 above, and for
which a respiratory protection'
device is required for applica-
tion by the product labeling
(4) Not in 1, 2, or 3 above, and:
(i) From a height of greater
than 12 in. from the planting
medium, or
(if) As a fine spray, or
(iii) Using a spray pressure
greater than 40 psi
(5) Otherwise
Entire greenhouse plus any adjacent
structure that cannot be sealed off
from the treated area
Entire enclosed area
Entire enclosed area
Treated area plus 25 feet in all directions
in the enclosed area
The ventilation criteria of paragraph
(c)(3) of this section are met
The ventilation criteria of paragraph
(c)(3) of this section are met
The ventilation criteria of paragraph
(c)(3) of this section are met
Application is complete
No entry restrictions after criteria in
column C are met
Entire enclosed area is the treated area
Treated area
Treated area
Treated area
Application is complete
Treated area
§ 170.112 Entry restrictions.
(a) General restrictions. (1) After the
application of any pesticide on an
agricultural establishment, the
agricultural employer shall not allow or
direct any worker to enter or to remain
in the treated area before the restricted-
entry interval specified on the pesticide
labeling has expired, except as provided
in this section.
(2) Entry-restricted areas in
greenhouses are specified in column D
in Table 2 under § 170.110(c)(4).
(3) When two or more pesticides are
applied at the same time, the restricted-
entry interval shall be the longest of the
applicable intervals.
(4) The agricultural employer shall
assure that any worker who enters a
treated area under a restricted-entry
interval as permitted by paragraphs (c),
(d), and (e) of this section uses the
personal protective equipment specified
in the product labeling for early-entry
workers and follows any other
requirements on the pesticide labeling
regarding early entry.
(b) Exception for activities with no
contact. A worker may enter a treated
area during a restricted-entry interval if
the agricultural employer assures that
both of the following are met: •
(1) The worker will have no contact
with anything that has been treated with
the pesticide to which the restricted-
entry interval applies, including, but not
limited to, soil, water, air, or surfaces of
plants; and
(2) No such entry is allowed until any
inhalation exposure level listed in the
labeling has been reached or any
ventilation criteria established by
§ 170.110(c)(3) or in the labeling have
been met.
(c) Exception for short-term activities.
A worker may enter a treated area
during a restricted-entry interval for
short-term activities if the agricultural
employer assures that the following
requirements are met:
(1) No hand labor activity is
performed.
(2) The time in treated areas under a
restricted-entry interval for any worker
does not exceed 1 hour in any 24-hour
period.
1 (3) No such entry is allowed for the
first 4 hours following the end of the
application, and no such entry is
allowed thereafter until any inhalation
exposure level listed in the labeling has
been reached or any ventilation criteria
established by § 170.110(c}(3] or in the
labeling have been met.
(4) The personal protective equipment
specified on the product labeling for
early entry is provided to the worker.
, .Such personal protective equipment
ishall conform to the following
standards:
(i) Personal protective equipment
(PPE) means devices and apparel that
are worn to protect the body from
contact with pesticides or pesticide
residues, including, but not limited to,
coveralls, chemical-resistant suits,
chemical-resistant gloves, chemical-
resistant footwear, respiratory
protection devices, chemical-resistant
.aprons, chemical-resistant headgear,
and protective eyewear.
(ii) Long-sleeved shirts, short-sleeved
shirts, long pants, short pants, shoes,
socks, and other items of work clothing
are not considered personal protective
equipment for the purposes of this
section and are not subject to the
requirements of this section, although
pesticide labeling may require that such
work clothing be worn during some
activities.
(iii) When "chemical-resistant"
personal protective equipment is
specified by the product labeling, it shall
be made of material that allows no
measurable movement of the pesticide
being used through the material during
use.
(iv) When "waterproof personal
protective equipment is specified by the
product labeling, it shall be made of
material that allows no measurable
movement of water or aqueous solutions
through the material during use.
(v) When a "chemical-resistant suit"
is specified by the product labeling, it
shall be a loose-fitting, one- or two-
piece, chemical-resistant garment that
covers, at a minimum, the entire body
except head, hands, and feet.
(vi) When "coveralls" are specified by
the product labeling, they shall be a
loose-fitting, one- or two-piece garment,
such as a cotton or cotton and polyester
coverall, that covers, at a minimum, the
entire body except head, hands, and
feet. The pesticide product labeling may
specify that the coveralls be worn over a
layer of clothing. If a chemical-resistant
suit is substituted for coveralls, it need
not be worn over a layer of clothing.
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations ^3J155
(vll) Gloves shall be of the type
specified by the product labeling. Gloves
or glove linings made of leather, cotton,
or other absorbent materials must not be
worn for early-entry activities unless
these materials are listed on the product
labeling as acceptable for such use. If
chemical-resistant gloves with sufficient
durability and suppleness are not
obtainable for tasks with roses or other
plants with sharp thorns, leather gloves
may be worn over chemical-resistant
liners. However, once leather gloves
have been worn for this use, thereafter
they shall be worn only with chemical-
resistant liners and they shall not be
worn for any other use.
(viii) When "chemical-resistant
footwear" is specified by the product
labeling, it shall be one of the following
types of footwear: chemical-resistant
shoes, chemical-resistant boots, or
chemical-resistant shoe coverings worn
over shoes or boots. If chemical-
resistant footwear with sufficient
durability and a tread appropriate for
wear in rough terrain is not obtainable
for workers, then leather boots may be
worn in such terrain.
(ix) When "protective eyewear" is
specified by the product labeling, it shall
be one of the following types of
eyewear: goggles; face shield; safety
glasses with front, brow, and temple
protection; or a full-face respirator.
(x) When "chemical-resistant
headgear" is specified by the product
labeling, it shall be either a chemical-
resistant hood or a chemical-resistant
hat with a wide brim.
(5) The agricultural employer shall
assure that the worker, before entering
the treated area, either has read the
product labeling or has been informed,
in a manner that the worker can
understand, of all labeling requirements
related to human hazards or
precautions, first aid, symptoms of
poisoning, personal protective
equipment specified for early entry, and
any other labeling requirements related
to safe use.
(6) The agricultural employer shall
assure that:
(i) Workers wear the personal
protective equipment correctly for its
intended purpose and use personal
protective equipment according to
manufacturer's instructions.
(ii) Before each day of use, all
personal protective equipment is
inspected for leaks, holes, tears, or worn
places, and any damaged equipment is
repaired or discarded.
(iii) Personal protective equipment
that cannot be cleaned properly is
disposed of in accordance with any
applicable Federal, State, and local
regulations.
(iv) All personal protective equipment
is cleaned according to manufacturer's
instructions or pesticide product
labeling instructions before each day of
reuse. In the absence of any such
instructions, it shall be washed
thoroughly in detergent and hot water.
(vj Before being stored, all clean
personal protective equipment is dried
thoroughly or is put in a well-ventilated
place to dry.
(vi) Personal protective equipment
contaminated with pesticides is kept
separately and washed separately from
any other clothing or laundry.
(vii) Any person who cleans or
launders personal protective equipment
is informed that such equipment may be
contaminated with pesticides, of the
potentially harmful effects of exposure
to pesticides, and of the correct way(s)
to handle and clean personal protective
equipment and to protect themselves
when handling equipment contaminated
with pesticides.
(viii) All clean personal protective
equipment is stored separately from
personal clothing and apart from ,
pesticide-contaminated areas.
(ix) Each worker is instructed how to
put on, use, and remove the personal
prbtective equipment and is informed
about the importance of washing
thoroughly after removing personal
protective equipment.
(x) Each worker is instructed in the
prevention, recognition, and first aid
treatment of heat-related illness.
(xi) Workers have a clean place(s)
away from pesticide-storage and
pesticide-use areas for storing personal
clothing not in use; putting on personal
protective equipment at the start of any
exposure period; and removing personal
protective equipment at the end of any
exposure period.
(7) When personal protective
equipment is required by the labeling of
any pesticide for early entry, the
agricultural employer shall assure that
no worker is allowed or directed to
perform the early-entry activity without
implementing, when appropriate,
measures to prevent heat-related illness.
(8) During any early-entry activity, the
agricultural employer shall provide a
decontamination site in accordance with
§ 170.150.
(9) The agricultural employer shall not
allow or direct any worker to wear
home or to take home personal
protective equipment contaminated with
pesticides.
(d) Exception for an agricultural
emergency. (1) An "agricultural
emergency" means a sudden occurrence
or set of circumstances which the
agricultural employer could not have
anticipated and over which the
agricultural employer has no control,
and which requires entry into a treated
area during a restricted-entry interval,
when no alternative practices would
prevent or mitigate a substantial
economic loss. A substantial economic
loss means a loss in profitability greater
than that which would be expected
based on the experience and
fluctuations of crop yields in previous
years. Only losses caused by the
agricultural emergency specific to the
affected site and geographic area are
considered. The contribution of
mismanagement cannot be considered
in determining the loss.
(2) A worker may enter a treated area
under a restricted-entry interval in an
agricultural emergency to perform tasks,
including hand labor tasks, necessary to
mitigate the effects of the agricultural
emergency, if the agricultural employer
assures that all the following criteria are
met:
(i) A State, Tribal, or Federal Agency
having jurisdiction declares the
existence of circumstances that could
cause an agricultural emergency on that
agricultural establishment.
(ii) The agricultural employer
determines the agricultural
establishment is subject to the
circumstances declared under, paragraph
(d)(2)(i) of this section that result in an
agricultural emergency meeting the
criteria of paragraph (d)(l) of this
section.
(iii) The requirements of paragraphs
(c)(3) through (9) of this section are met.
(e) Exception requiring Agency
approval. The Agency may, in
accordance with paragraphs (e)(l)
through (3) of this section, grant an
exception from the requirements of this
section. An exception may be •
withdrawn in accordance with
paragraph (e){6) of this section.
(1) Requesting an exception. A
request for an exception must be
submitted to the Director, Office of
Pesticide Programs (H-7501C),
Environmental Protection Agency, 401 M
Street, SW., Washington, DC 20460 and
must be accompanied by two copies of
the following information:
(i) The name, address, and telephone
number of the submitter.
(ii) The time period for which the
exception is requested.
(iii) A description of the crop(s) and
specific crop production task(s) for
which the exception is requested. Such a
description must include an explanation
as to the necessity of applying
pesticides of a type and at a frequency
such that the restricted-entry interval
would interfere with necessary and
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'38156 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
time-sensitive hand labor tasks for the
period for which the exception is sought.
(iv) A description of the geographic
area for which the exception is
requested. If the exception request is for
a limited geographic area, the
explanation must include a description
as to why the circumstances of exposure
or economic impact resulting from the
prohibition of routine hand labor tasks
during the restricted-entry interval are
unique to the geographic area named in
the exception.
(v) An explanation as to why, for each
requested crop-task combination,
alternative practices would not be
technically or financially viable. Such
alternative practices might include:
rescheduling the pesticide application or
hand labor activity; using a non-
chemical pest control alternative; using
an alternative to the hand labor tasks,
such as machine cultivation; or
substituting a pesticide with a shorter
restricted-entry interval. This
information should include estimates or
data on per acre revenue and cost of
production for the crop and area for
which the exception is requested. These
estimates or data should include: the
situation prior to implementation of this
final rule, the situation after
implementation of this final rule if the
exception is not granted, the situation
after implementation of this final rule if
the exception is granted, and specific
information on individual factors which
cause differences in revenues and costs
among the three situations.
(vi) A description or documentation of
the safety and feasibility of such an
exception, including, but not limited to,
the feasibility of performing the
necessary hand labor activity while
wearing the personal protective
equipment required for early entry for
the pesticide(s) expected to be applied,
the means of mitigating heat-related
illness concerns, the period of time
required daily per worker to perform the
hand labor activity, any suggested
methods of reducing the worker's
exposure, and any other mitigating
factors, such as the availability of
running water for routine and
emergency decontamination and
mechanical devices that would reduce
the workers' contact with the treated
surfaces. The information should include
the costs associated with early-entry,
such as decontamination facilities,
special information and training for the
workers, heat stress avoidance
procedures, and provision, inspection,
cleaning, and maintenance of personal
protective equipment. EPA will not grant
exceptions where the costs of early
entry equal or exceed the expected loss
in value of crop yield or quality.
(2) Notice of receipt, (i) When a
request for an exception is submitted to
the Agency along with all of the
information required in paragraph (e)(l)
of this section, the Agency shall issue a
notice in the Federal Register stating
that an exception is being considered,
describing the nature of the exception,
and allowing at least 30 days for
Interested parties to comment.
(ii) If a request for an exception is
submitted to the Agency without all of
the information required in paragraph
(e)(l) of this section, the Agency shall
return the request to the submitter.
(3) Exception decision. EPA will
publish in the Federal Register its
decision whether to grant the request for
exception. EPA will base its decision on
whether the benefits of the exception
outweigh the costs, including the value
of the health risks attributable to the
exception. If the exception is granted,
the notice will state the nature of and
reasons for the exception.
(4) Presumptive denial, (i) Except as
provided in paragraph (e)(4)(ii) of this
section, persons requesting an exception
may assume that the exception has been
denied if EPA has not issued its decision
whether to grant the exception within 9
months from the comment-closure date
specified in the Federal Register notice
in which the Agency announced, in
accordance with paragraph (e](2) of this
section, that it would consider the
exception.
i (ii) Persons requesting an exception
may not assume' that the request has
been denied as provided by paragraph
,(e)(4)(i) of this section if the Agency has
taken action to extend its review period
for a specified time interval due to the
complexity of the exception request or
to the number of exception requests
^concurrently under Agency review. EPA
shall state the reason(s) for the delay in
issuing a decision on the exception
'request. A notice of such an action may
be published in the Federal Register or
persons who requested the exception
may be directly notified of the action.
| (5) Agricultural employer duties.
When a worker enters a treated area
during a restricted-entry interval under
an exception granted under paragraph
(e) of this section, the agricultural
employer shall assure that the
requirements of paragraphs (c)(3)
through (9) of this section are met,
unless the notice granting the exception
specifically indicates otherwise.
(6) Withdrawing an exception. An
exception may be withdrawn by the
Agency at any time if the Agency
receives poisoning information or other
data that indicate that the health risks
imposed by this early-entry exception
are unacceptable or if the Agency
receives other information that indicates
that the exception is no longer
necessary or prudent. If the Agency
determines that an exception should be
withdrawn, it will publish a notice in the
Federal Register, stating the basis for its
determination. Affected parties would
then have 30 days to request a hearing
on the Agency's determination. The
exception, however, would be
discontinued as of the date specified by
EPA in the notice, which may include
any of the 30-day period and the time
required for any subsequent hearing
process. Thereafter the Agency will
decide whether to withdraw the
exception and will publish a notice in
the Federal Register stating its decision.
§ 170.120 Notice of applications.
(a) Notification to workers of
pesticide applications in greenhouses.
The agricultural employer shall notify
workers of any pesticide application in
the greenhouse in accordance with this
paragraph.
(1) All pesticide applications shall be
posted in accordance with paragraph (c)
of this section.
(2] If the pesticide product labeling
has a statement requiring both the
posting of treated areas and oral
notification to workers, the agricultural
employer shall also provide oral
notification of the application to the
worker in accordance with paragraph
(d) of this section.
(3) Notice need not be given to a
worker if the agricultural employer can
assure that one of the following is met:
(i) From the start of the application
until the end of the application and
during any restricted-entry interval, the
worker will not enter, work in, remain
in, or pass through the greenhouse; or
(ii) The worker applied (or supervised
the application of) the pesticide for
which the notice is intended and is
aware of all information required by
paragraphs (d)(l) through (3) of this
section.
(b) Notification to workers on farms,
in nurseries, or in forests of pesticide »-'
applications. The agricultural employer''
shall notify workers of any pesticide
application on the farm or in the nursery
or forest in accordance with this
paragraph.
(1) If the pesticide product labeling
has a statement requiring both the
posting of treated areas and oral
notification to workers, the agricultural
employer shall post signs in accordance
with paragraph (c) of this section and
shall provide oral notification of the
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Federal Register / Vol. 57, No. 163 / Friday, August 21. 1992 / Rules and Regulations 38157'
application to the worker in accordance
with paragraph (d) of this section.
(2) For any pesticide other than those
for which the labeling requires both
posting and oral notification of
applications, the agricultural employer
shall give notice of the application to the
worker either by the posting of warning
signs in accordance with paragraph (c)
of this section or orally in accordance
with paragraph (d) of this section, and
shall inform the workers as to which
method of notification is in effect.
(3) Notice need not be given to a
worker if the agricultural employer can
assure that one of the following is met:
(i) From the start of the application
until the end of the application and
during any restricted-entry interval, the
worker will not enter, work in, remain
in, or pass through on foot the treated
area or any area within 1/4 mile of the
treated area; or
(ii) The worker applied (or supervised
the application of) the pesticide for
which the notice is intended and is
aware of all information required by
(d)(l) through (3) of this section.
(c) Posted warning signs. The
agricultural employer shall post warning
signs in accordance with the following
criteria:
(1) The warning sign shall have a
background color that contrasts with
red. The words "DANGER" and
"PELIGRO," plus "PESTICIDES" and
"PESTICIDAS," shall be at the top of the
sign, and the words "KEEP OUT" and
"NO ENTRE" shall be at the bottom of
the sign. Letters for all words must be
clearly legible. A circle containing an
upraised hand on the left and a stern
face on the right must be near the center
of the sign. The inside of the circle must
be red, except that the hand and a large
portion of the face must be in a shade
that contrasts with red. The length of the
hand must be at least twice the height of
the smallest letters. The length of the
face must be only slightly smaller than
the hand. Additional information such
as the name of the pesticide and the
date of application may appear on the
warning sign if it does not detract from
the appearance of the sign or change the
meaning of the required information. A
black-and-white example of a warning
sign meeting these requirements, other
than the size requirements, follows:
BILLING CODE 6560-50-F
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38158 Federal Register / Vol. 57, No. 163 / Friday, August 21,1992 / Rules and Regulations
DANGER PELIGRO
PESTICIDES PESTKIDAS
KEEP OUT
NO ENTRE
BILLING CODE 6560-50-C
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(2) The sign shall be at least 14 inches
by 16 inches in size, and the letters shall
be at least 1 inch in height unless a
smaller sign and smaller letters are
necessary because the treated area is
too small to accommodate a sign of this
size. If a smaller sign is used, it must
meet the proportions and other
requirements described in paragraph
(c)(l) of this section.
(3) On farms and in forests and
nurseries, the signs shall be visible from
all usual points of worker entry to the
treated area, including at least each
access road, each border with any labor
camp adjacent to the treated area, and
each footpath and other walking route
that enters the treated area. When there
are no usual points of worker entry,
signs shall be posted in the corners of
the treated area or in any other location
affording maximum visibility.
(4) In greenhouses, the signs shall be
posted so they are visible from all usual
points of worker entry to the treated
area including each aisle or other
walking route that enters the treated
area. When there are no usual points of
worker entry to the treated area, signs
shall be posted in the corners of the
treated area or in any other location
affording maximum visibility.
(5) The signs shall:
(i) Be posted no sooner than 24 hours
before the scheduled application of the
pesticide.
(ii) Remain posted throughout the
application and any restricted-entry
interval.
(iii) Be removed within 3 days after
the end of the application and any
restricted-entry interval and before
agricultural-worker entry is permitted,
other than entry permitted by § 170.112.
(6) The signs shall remain visible and
legible during the time they are posted.
(7) When several contiguous areas are
to be treated with pesticides on a
rotating or sequential basis, the entire
area may be posted. Worker entry, other
than entry permitted by § 170.112, is
prohibited for the entire area while the
signs are posted.
(d) Oral warnings. The agricultural
employer shall provide oral warnings to
workers in a manner that the worker
can understand. If a worker will be on
the premises during the application, the
warning shall be given before the
application takes place. Otherwise, the
warning shall be given at the beginning
of the worker's first work period during
which the application is taking place or
the restricted-entry interval for the
pesticide is in effect. The warning shall
consist of:
(1) The location and description of the
treated area.
(2) The time during which entry is
restricted.
(3) Instructions not to enter the
treated area until the restricted-entry
interval has expired.
§ 170.122 Providing specific information
about applications.
When workers are on an agricultural
establishment and, within the last 30
days, a pesticide covered by this
subpart has been applied on the
establishment or a restricted-entry
interval has been in effect, the
agricultural employer shall display, in
accordance with this section, specific
information about the pesticide.
(a) Location, accessibility, and
legibility. The information shall be
displayed in the location specified for
the pesticide safety poster in
§ 170.135(d) and shall be accessible and
legible, as specified in § 170.135(e] and
ffi.
(b) Timing. (1) If warning signs are
posted for the treated area before an
application, the specific application
information for that application shall be
posted at the same time or earlier.
(2) The information shall be posted
before the application takes place, if
workers will be on the establishment
during application. Otherwise, the
information shall be posted at the
beginning of any worker's first work
period.
(3) The information shall continue to
be displayed for at least 30 days after
the end of the restricted-entry interval
(or, if there is no restricted-entry
interval, for at least 30 days after the
end of the application) or at least until
workers are no longer on the
establishment, whichever is earlier.
(c) Required information. The
information shall include:
(1) The location and description of the
treated area.
(2) The product name, EPA
registration number, and active
ingredient(s) of the pesticide.
(3) The time and date the pesticide is
to be applied.
(4) The restricted-entry interval for the
pesticide.
§ 170.124 Notice of applications to handler
employers.
Whenever handlers who are
employed by a commercial pesticide
handling establishment will be
performing pesticide handling tasks on
an agricultural establishment, the
agricultural employer shall provide to
the handler employer, or assure that the
handler employer is aware of, the
following information concerning any
areas on the agricultural establishment
that the handler may be in (or may walk
within 1/4 mile of) and that may be
treated with a pesticide or that may be
under a restricted-entry interval while
the handler will be on the agricultural
establishment:
(a) Specific location and description
of any such areas; and
(b) Restrictions on entering those
areas.
§ 170.130 Pesticide safety training.
(a) General requirement—(1)
Agricultural employer assurance. The
agricultural employer shall a'ssure that
each worker, required by this section to
be trained, has been trained according
to this section during the last 5 years,
counting from the end of the month in
which the training was completed.
(2) Requirement for workers
performing early-entry activities. Before
a worker enters a treated area on the
agricultural establishment during a
restricted-entry interval to perform
early-entry activities permitted by
§ 170.112 and contacts anything that has
been treated with the pesticide to which
the restricted-entry interval applies,
including but not limited to, soil, water,
or surfaces of plants, the agricultural
employer shall assure that the worker
has been trained.
(3) Requirement for other agricultural
workers—(i) Training before the 6th day
of entry. Except as provided in
paragraph (a)(2) of this section, before
the 6th day that a worker enters any
areas on the agricultural establishment
where, within the last 30 days a
pesticide to which this subpart applies
has been applied or a restricted-entry
interval for such pesticide has been in
effect, the agricultural employer shall
assure that the worker has been trained.
(ii) Exception for first 5-year period.
Until October 20,1997, and except as
provided in paragraph (a) (2) of this
section, before the 16th day that a
worker enters any areas on the
agricultural establishment where, within
the last 30 days a pesticide to which this
subpart applies has been applied or a
restricted-entry interval for such
pesticide has been in effect, the
agricultural employer shall assure that
the worker has been trained. After
October 20,1997, this exception no
longer applies.
(b) Exception. A worker who is a
currently certified as an applicator of
restricted-use pesticides under part 171
of this chapter or who satisfies the
training requirements of part:!71 of this
chapter or who satisfies the handler
training requirements under § 170.230(c)
need not be trained under this section.
(c) Training programs. (1) General
pesticide safety information shall be
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Federal Register / Vol. 57,, No. 163 / Friday, August 21, 1992 / Rules and Regulations
presented to workers either orally from
written materials or audiovisually. The
information must be presented in a
manner that the workers can understand
(such as through a translator) using
nontechnical terms. The presenter also
shall respond to workers' questions.
(2) The person who conducts the
training shall meet at least one of the
following criteria:
(i) Be currently certified as an
applicator of restricted-use pesticides
under part 171 of this chapter; or
(ii) Be currently designated as a
trainer of certified applicators or
pesticide handlers by a State, Federal,
or Tribal agency having jurisdiction; or
[iii) Have completed a pesticide safety
train-the-trainer program approved by a
State, Federal, or Tribal agency having
jurisdiction; or
(iv) Satisfy the training requirements
in part 171 of this chapter or in
§ 170.230(c).
(3) Any person who issues an EPA-
approved Worker Protection Standard
worker training certificate must assure
that the worker who receives the
training certificate has been trained in
accordance with (c)(4) of this section.
(4) The training materials shall
convey, at a minimum, the following
information:
(i) Where and in what form pesticides
may be encountered during work
activities.
(ii] Hazards of pesticides resulting
from toxicity and exposure, including
acute and chronic effects, delayed
effects, and sensitization.
(iii) Routes through which pesticides
can enter the body.
(iv) Signs and symptoms of common
types of pesticide poisoning.
(v) Emergency first aid for pesticide
injuries or poisonings.
(vi) How to obtain emergency medical
care.
(vii) Routine and emergency
decontamination procedures, including
emergency eyeflushing techniques.
(viii) Hazards from chemigation and
drift.
(ix) Hazards from pesticide residues
on clothing.
(x) Warnings about taking pesticides
or pesticide containers home.
(xi) Requirements of this subpart
designed to reduce the risks of illness or
injury resulting from workers'
occupational exposure to pesticides,
including application and entry
restrictions, the design of the warning
sign, posting of warning signs, oral
warnings, the availability of specific
information about applications, and the
protection against retaliatory acts.
(d) Verification of training. (1) Except
as provided in paragraph (d)(2) of this
section, if the agricultural employer
assures that a worker possesses an
EPA-approved Worker Protection
Standard worker training certificate,
then the requirements of paragraph (a)
of this section will have been met.
(2) If the agricultural employer is
iiware or has reason to know that an
EPA-approved Worker Protection
Standard worker training certificate has
not been issued in accordance with this
section, or has not been issued to the
worker bearing the certificate, or the
training was completed more than 5
years before the beginning of the current
month, a worker's possession of that
certificate does not meet the
requirements of paragraph (a) of this
section.
§ 170.135 Posted pesticide safety
information.
, (a) Requirement. When workers are
on an agricultural establishment and,
within the last 30 days, a pesticide
covered by this subpart has been
applied on the establishment or a
restricted-entry interval has been in
effect, the agricultural employer shall
display, in accordance with this section,
pesticide safety information.
(b) Pesticide safety poster. A safety
poster must be displayed that conveys,
at a .minimum, the following basic
pesticide safety concepts:
(1) Help keep pesticides from entering
your body. At a minimum, the following
points shall be conveyed:
(i) Avoid getting on your skin or into
your body any pesticides that may be on
plants and soil, in irrigation water, or
drifting from nearby applications.
(ii) Wash before eating, drinking,
using chewing gum or tobacco, or using
the toilet.
(iii) Wear work clothing that protects
the body from pesticide residues (long-
sleeved shirts, long pants, shoes and
socks, and a hat or scarf).
1 - (iv) Wash/shower with soap and
Water, shampoo hair, and put on clean
; plothes after work.
(v) Wash work clothes separately
from other clothes before wearing them
again.
. (vi) Wash immediately in the nearest
, clean water if pesticides are spilled or
sprayed on the body. As soon as
possible, shower, shampoo, and change
into clean clothes.
(vii) Follow directions about keeping
out of treated or restricted areas.
(2) There are Federal rules to protect
workers and handlers, including a
requirement for safety training.
(c) Emergency medical care
information. (1) The name, address, and
telephone number of the nearest
emergency medical care facility shall be
on the safety poster or displayed close
to the safety poster.
(2) The agricultural employer shall
inform workers promptly of any change
to the information on emergency
medical care facilities.
(d) Location. (1) The information shall
be displayed in a central location on the
farm or in the nursery or greenhouse
where it can be readily seen and read by
workers.
(2) The information shall be displayed
in a location in or near the forest in a
place where it can be readily seen and
read by workers and where workers are
likely to congregate or pass by, such as
at a decontamination site or an
equipment storage site.
(e) Accessibility. Workers shall be
informed of the location of the
information and shall be allowed access
to it.
(f) Legibility. The information shall
remain legible during the time it is
posted.
§ 170.150 Decontamination.
(a) Requirement. If any worker on an
agricultural establishment performs any
activity in an area where, within the last
30 days, a pesticide has been applied or
a restricted-entry interval has been in
effect and contacts anything that has
been treated with the pesticide,
including, but not limited to, soil, water,
or surfaces of plants, the agricultural
employer shall provide, in accordance
with this section, a decontamination site
for washing off pesticide residues.
(b) General conditions. (1) The
agricultural employer shall provide
workers with enough water for routine
washing and emergency eyeflushing. At
all times when the water is available to
workers, the employer shall assure that
it is of a quality and temperature that
will not cause illness or injury when it
contacts the skin or eyes or if it is
swallowed.
(2) When water stored in a tank is to
be used for mixing pesticides, it shall
not be used for decontamination or
eyeflushing, unless the tank is equipped
with properly functioning valves or
other mechanisms that prevent
movement of pesticides into the tank.
(3) The agricultural employer shall
provide soap and single-use towels at
each decontamination site in quantities
sufficient to meet workers' needs.
(4) To provide for emergency
eyeflushing, the agricultural employer
shall assure that at least 1 pint of water
is immediately available to each worker
who is performing early-entry activities
permitted by § 170.112 and for which the
pesticide labeling requires protective
eyewear. The eyeflush water shall be
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations 38161
carried by the early-entry worker, or
shall be on the vehicle the early-entry
worker is using, or shall be otherwise
immediately accessible.
(c) Location. (1) The decontamination
site shall be reasonably accessible to
and not more than 1/4 mile from where
workers are working.
(2) For worker activities performed
more than 1/4 mile from the nearest
place of vehicular access:
(i) The soap, single-use towels, and
water may be at the nearest place of
vehicular access.
(ii) The agricultural employer may
permit workers to use clean water from
springs, streams, lakes, or other sources
for decontamination at the remote work
site, if such water is more accessible
than the water at the decontamination
site located at the nearest place of
vehicular access.
(3) The decontamination site shall not
be in an area being treated with
pesticides.
(4) The decontamination site shall not
be in an area that is under a restricted-
entry interval, unless the workers for
whom the site is provided are
performing early-entry activities
permitted by § 170.112 and involving
contact with treated surfaces and the
decontamination site would otherwise
not be reasonably accessible to those
workers.
(d) Decontamination after early-entry
activities. At the end of any exposure
period for workers engaged in early-
entry activities permitted by § 170.112
and involving contact with anything that
has been treated with the pesticide to
which the restricted-entry interval
applies, including, but not limited to,
soil, water, air, or surfaces of plants, the
agricultural employer shall provide, at
the site where the workers remove
personal protective equipment, soap,
clean towels, and a sufficient amount of
water so that the workers may wash
thoroughly.
§ 170.160 Emergency assistance.
If there is reason to believe that a
person who is or has been employed on
an agricultural establishment to perform
tasks related to the production of
agricultural plants has been poisoned or
injured by exposure to pesticides used
on the agricultural establishment,
including, but not limited to, exposures
from application, splash, spill, drift, or
pesticide residues, the agricultural
employer shall:
(a) Make available to that person
prompt transportation from the
agricultural establishment, including any
labor camp on the agricultural
establishment, to an appropriate
emergency medical facility.
(b) Provide to that person or to
treating medical personnel, promptly
upon request, any obtainable
information on:
(1) Product name, EPA registration
number, and active ingredients of any
product to which that person might have
been exposed.
(2) Antidote, first aid, and other
medical information from the product
labeling.
(3) The circumstances of application
or use of the pesticide on the
agricultural establishment.
(4) The circumstances of exposure of
that person to the pesticide.
Subpart C—Standard for Pesticide
Handlers
§ 170.202 Applicability of this subpart.
(a) Requirement. Except as provided
by paragraph (b] of this section, this
subpart applies when any pesticide is
handled for use on an agricultural
establishment.
(b) Exceptions. This subpart does not
apply when any pesticide is handled for
use on an agricultural establishment in
the following circumstances:
[1] For mosquito abatement,
Mediterranean fruit fly eradication, or
similar wide-area public pest control
programs sponsored by governmental
entities.
(2) On livestock or other animals, or in
or about animal premises.
(3) On plants grown for other than
commercial or research purposes, which
may include plants in habitations, home
fruit and vegetable gardens, and home
greenhouses.
(4) On plants that are in ornamental
gardens, parks, and public or private
lawns and grounds and that are
intended only for aesthetic purposes or
climatic modification.
(5) In a manner not directly related to
the production of agricultural plants,
including, but not limited to, structural
pest control, control of vegetation along
rights-of-way and in other noncrop
areas, and pasture and rangeland use.
(6) For control of vertebrate pests.
(7) As attractants or repellents in
traps.
(8) On the harvested portions of
agricultural plants or on harvested I
timber.
(9) For research uses of unregistered
pesticides.
(c) Exemptions. For the purposes of
this subpart, owners of agricultural
establishments need not assure that the
protections in §§ 170.210(b) and (c),
170.222,170.230,170.232, 170.234, 170.235,
170.240(e) through (g), 170.250, and
170.260 are provided to themselves or to
members of their immediate family who
are performing handling tasks on their
own agricultural establishments.
However, they must provide any
protections required by these sections to
other handlers and other persons who
are not members of their immediate
family, and are encouraged to provide
the protections to themselves and
members of their families.
§ 170.210 Restrictions during applications.
(a] Contact with workers and other
persons. The handler employer and the
handler shall assure that no pesticide is
applied so as to contact, either directly
or through drift, any worker or other
person, other than an appropriately
trained and equipped handler.
(b) Handlers handling highly toxic
pesticides. The handler employer shall
assure that any handler who is
performing any handling activity with a
product that has the skull and
crossbones symbol on the front panel of
the label is monitored visually or by
voice communication at least every 2
hours.
(c) Fumigant applications in
greenhouses. The handler employer
shall assure:
(1) That any handler who handles a
fumigant in a greenhouse, including a
handler who enters the greenhouse
before the acceptable inhalation
exposure level or ventilation criteria
have been met to monitor air levels or to
initiate ventilation, maintains:
continuous visual or voice contact with
another handler.
(2) That the other handler has
immediate access to the personal
protective equipment required by the
fumigant labeling for handlers in the
event entry into the fumigated
greenhouse becomes necessary for
rescue.
§ 170.222 Providing specific information
about applications.
When handlers (except those
employed by a commercial pesticide
handling establishment) are on an
agricultural establishment and, within
the last 30 days, a pesticide covered by
this subpart has been applied on the
establishment or a restricted-entry
interval has been in effect, the handler
employer shall display, in accordance
with this section, specific information
about the pesticide.
(a) Location, accessibility, and
legibility. The information shall be
displayed in the same location specified
for the pesticide safety poster in
§ 170.235[d) of this part and shall be
accessible and legible, as specified in
§ 170.235(e) and (fj of this part.
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Federal Register / Vol. 57. No. 163 / Friday. August 21, 1992 /Rules and Regulation^
(b) Timing. (1) If warning signs are
posted for the treated area before an
application, the specific application
information for that application shall be
posted at the same time or earlier.
(2) The information shall be posted
before the application takes place, if
handlers [except those employed by a
commercial pesticide handling
establishment) will be on the
establishment during application.
Otherwise, the information shall be
posted at the beginning of any such
handler's first work period.
(3) The information shall continue to
be displayed for at least 30 days after
the end of the restricted-entry interval
(or, if there is no restricted-entry
interval, for at least 30 days after the
end of the application) or at least until
the handlers are no longer on the
establishment, whichever is earlier.
(c) Required information. The
information shall include:
(1) The location and description of the
treated area.
(2) The product name, EPA
registration number, and active
ingredient(s) of the pesticide.
(3) The time and date the pesticide is
to be applied.
(4) The restricted-entry interval for the
pesticide.
§ 170.224 Notice of applications to
agricultural employers.
Before the application of any pesticide
on or in an agricultural establishment,
the handler employer shall provide the
following information to any agricultural
employer for the establishment or shall
assure that any agricultural employer is
aware of:
(a) Specific location and description
of the treated area.
(b) Time and date of application.
(c) Product name, EPA registration
number, and active ingredient(s).
(d) Restricted-entry interval.
(e) Whether posting and oral
notification are required.
(f) Any other product-specific
requirements on the product labeling
concerning protection of workers or
other persons during or after
application.
§ 170.230 Pesticide safety training.
(a) Requirement. Before any handler
performs any handling task, the handler
employer shall assure that the handler
has been trained in accordance with this
section during the last 5 years, counting
from the end of the month in which the
training was completed.
(b) Exception. A handler who is
currently certified as an applicator of
restricted-use pesticides under part 171
of this chapter or who satisfies the
training requirements of part 171 of this
chapter need not be trained under this
section.
,(c) Training programs. (1) General
pesticide safety information shall be
presented to handlers either orally from
written materials or audiovisually. The
information must be presented in a
manner that the handlers can
understand (such as through a
translator). The presenter also shall
respond to handlers' questions.
(2) The person who conducts the
training shall meet at least one of the
following criteria: *'
(i) Be currently certified as an
applicator of restricted-use pesticides
under part 171 of this chapter; or
(ii) Be currently designated as a
trainer of certified applicators or
pesticide handlers by a State, Federal,
or Tribal agency having jurisdiction; or
(iii) Have completed a pesticide safety
'train-the-trainer program approved by a
State, Federal, or Tribal agency having
jurisdiction.
(3) Any person who issues an EPA-
approved Worker Protection Standard
handler training certificate must assure
that the handler who receives the
training certificate has been trained in
accordance with paragraph (c)(4) of this
section.
' (4) The pesticide safety training
materials must convey, at a minimum,
the following information:
'• (i) Format and meaning of information
contained on pesticide labels and in
labeling, including safety information
such as precautionary statements about
human health hazards.
(ii) Hazards of pesticides resulting
from toxicity and exposure, including
acute and chronic effects, delayed
effects, and sensitization.
(iii) Routes by which pesticides can
enter the body.
(iv) Signs and symptoms of common
types of pesticide poisoning.
(v) Emergency first aid for pesticide
injuries or poisonings.
'; (vi) How to obtain emergency medical
care.
(vii) Routine and emergency
decontamination procedures.
! (viii) Need for and appropriate use of
personal protective equipment.
(ix) Prevention, recognition, and first
aid treatment of heat-related illness.
(x) Safety requirements for handling,
.transporting, storing, and disposing of
pesticides, including general procedures
for spill cleanup.
(xi) Environmental concerns such as
drift, runoff, and wildlife hazards.
(xii) Warnings about taking pesticides
or pesticide containers home.
(xiii) Requirements of this subpart
1 that must be followed by handler
employers for the protection of handlers
and other persons, including the
prohibition against applying pesticides
in a manner that will cause contact with
workers or other persons, the
requirement to use personal protective
equipment, the provisions for training
and decontamination, and the protection
against retaliatory acts.
(d) Verification of training. (1) Except
as provided in paragraph (d)(2) of this
section, if the handler employer assures
that a handler possesses an EPA-
approved Worker Protection Standard
handler training certificate, then the
requirements of paragraph (a) of this
section will have been met.
(2) If the handler employer is aware or
has reason to know that an EPA-
approved Worker Protection Standard
handler training certificate has not been
issued in accordance with this section,
or has not been issued to the handler
bearing the certificate, or the handler
training was completed more than 5
years before the beginning of the current
month, a handler's possession of that
certificate does not meet the
requirements of paragraph (a) of this
section.
§ 170.232 Knowledge of labeling and site-
specific information.
(a) Knowledge of labeling
information. (1) The handler employer
shall assure that before the handler
performs any handling activity, the
handler either has read the product
labeling or has been informed in a
manner the handler can understand of
all labeling requirements related to safe
use of the pesticide, such as signal
words, human hazard precautions,
personal protective equipment
requirements, first aid instructions,
environmental precautions, and any
additional precautions pertaining to the
handling activity to be performed.
(2) The handler employer shall assure
that the handler has access to the
product labeling information during
handling activities.
(b) Knowledge of site-specific
information. Whenever a handler who is
employed by a commercial pesticide
handling establishment will be
performing pesticide handling tasks on
an agricultural establishment, the
handler employer shall assure that the
handler is aware of the following
information concerning any areas on the
agricultural establishment that the
handler may be in (or may walk within
1/4 mile of) and that may be treated
with a pesticide or that may be under a
restricted-entry interval while the
handler will be on the agricultural
establishment:
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Federal Register / Vol. 57. No. 163 / Friday, August 21. 1992 / Rules and Regulations '-. 38163
(1) Specific location and description of
any such areas; and
(2) Restrictions on entering those
areas.
§ 170.234 Safe operation of equipment.
fa) The handler employer shall assure
that before the handler uses any
equipment for mixing, loading,
transferring, or applying pesticides, the
handler is instructed in the safe
operation of such equipment, including,
when relevant, chemigation safety
requirements and drift avoidance.
(b) The handler employer shall assure
that, before each day of use, equipment
used for mixing, loading, transferring, or
applying pesticides is inspected for
leaks, clogging, and worn or damaged
parts, and any damaged equipment is
repaired or is replaced.
(c) Before allowing any person to
repair, clean, or adjust equipment that
has been used to mix, load, transfer, or
apply pesticides, the handler employer
shall assure that pesticide residues have
been removed from the equipment,
unless the person doing the cleaning,
repairing, or adjusting is a handler
employed by the agricultural or
commercial pesticide handling
establishment. If pesticide residue
removal is not feasible, the handler
employer shall assure that the person
who repairs, cleans, or adjusts such
equipment is informed:
(1) That such equipment may be
contaminated with pesticides.
(2) Of the potentially harmful effects
of exposure to pesticides.
(3) Of the correct way to handle such
equipment.
§ 170.235 Posted pesticide safety
Information.
(a) Requirement. When handlers
(except those employed by a
commercial pesticide handling
establishment) are on an agricultural
establishment and, within the last 30
days, a pesticide covered by this
subpart has been applied on the
establishment or a restricted-entry
interval has been in effect, the handler
employer shall display, in accordance
with this section, pesticide safety
information.
{b) Pesticide safety poster. A safety
poster must be displayed that conveys,
at a minimum, the following basic
pesticide safety concepts:
(1) Help keep pesticides from entering
your body. At a minimum, the following
points shall be conveyed:
(i) Avoid getting on your skin or into
your body any pesticides that may be on
plants and soil, in irrigation water, or
drifting from nearby applications.
(ii) Wash before eating, drinking,
using chewing gum or tobacco, or using
the toilet.
(iii) Wear work clothing that protects
the body from pesticide residues (long-
sleeved shirts, long pants, shoes and
socks, and a hat or scarf).
(iv) Wash/shower with soap and
water, shampoo hair, and put on clean
clothes after work.
(v) Wash work clothes separately
from other clothes before wearing them
again.
(vi) Wash immediately in the nearest
clean water if pesticides are spilled or
sprayed on the body. As soon as
possible, shower, shampoo, and change
into clean clothes.
[vii) Follow directions about keeping
out of treated or restricted areas.
(2) There are Federal rules to protect
workers and handlers including a
requirement for safety training.
(c) Emergency medical care
information. (1) The name, address, and
telephone number of the nearest
emergency medical care facility shall be
on the safety poster or displayed close
to the safety poster.
(2) The handler employer shall inform
handlers promptly of any change to the
information on emergency medical care
facilities.
(d) Location. (1) The information shall
be displayed in a central location on the
farm or in the nursery or greenhouse
where it can be readily seen and read by
handlers.
(2) The information shall be displayed
in a location in or near the forest in a
place where it can be readily seen and
read by handlers and where handlers
are likely to congregate or pass by, such
as at a decontamination site or an
equipment storage site.
(e) Accessibility. Handlers shall be
informed of the location of the
information and shall be allowed access
to it.
(f) Legibility. The information shall
remain legible during the time it is
posted.
§ 170.240 Personal protective equipment.
(a) Requirement. Any person who
performs tasks as a pesticide handler
shall use the clothing and personal
protective equipment specified on the
labeling for use of the product.
(b) Definition. (1) Personal protective
equipment (PPE) means devices and
apparel that are worn to protect the
body from contact with pesticides or
pesticide residues, including, but not
limited to, coveralls, chemical-resistant
suits, chemical-resistant gloves,
chemical-resistant footwear, respiratory
protection devices, chemical-resistant
aprons, chemical-resistant headgear,
and protective eyewear.
(2) Long-sleeved shirts, short-sleeved
shirts, long pants, short pants, shoes,
socks, and other items of work clothing
are not considered personal protective
equipment for the purposes of this
section and are not subject to the
requirements of this section, although
pesticide labeling may require that such
work clothing be worn during some
activities.
(c) Provision. When personal
protective equipment is specified by the
labeling of any pesticide for any
handling activity, the handler employer
shall provide the appropriate personal
protective equipment in clean and
operating condition to the handler.
(1) When "chemical-resistant"
personal protective equipment is
specified by the product labeling, it shall
be made of material that allows no
measurable movement of the pesticide
being used through the material during
use.
(2) When "waterproof personal
protective equipment is specified by the
product labeling, it shall be made of
material that allows no measurable
movement of water or aqueous solutions
through the material during use.
(3) When a "chemical-resistant suit"
is specified by the product labeling, it
shall be a loose-fitting, one- or two-piece
chemical-resistant garment that covers,
at a minimum, the entire body except
head, hands, and feet.
(4) When "coveralls" are specified by
the product labeling, they shall be a
loose-fitting, one- or two-piece garment,
such as a cotton or cotton and polyester
coverall, that covers, at a minimum, the
entire body except head, hands, and
feet. The pesticide product labeling may
specify that the coveralls be worn over
another layer of clothing.
(5) Gloves shall be of the type
specified by the product labeling. Gloves
or glove linings made of leather, cotton,
or other absorbent material shall not be
worn for handling activities unless such
materials are listed on the product
labeling as acceptable for such use.
(6) When "chemical-resistant
footwear" is specified by the product
labeling, one of the following types of
footwear must be worn:
(i) Chemical-resistant shoes.
(ii) Chemical-resistant boots;
(iii) Chemical-resistant shoe coverings
worn over shoes or boots.
(7) When "protective eyewear" is
specified by the product labeling, one of
the following types of eyewear must be
worn:
(i) Goggles. /
(ii) Face shield.
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$8164 Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Rules and Regulations
(iii) Safety glasses with front, brow,
and temple protection.
(iv) Full-face respirator.
(8) When a "chemical-resistant apron"
is specified by the product labeling, an
apron that covers the front of the body
from mid-chest to the knees shall be
worn.
(9] When a respirator is specified by
the product labeling, it shall be
appropriate for the pesticide product
used and for the activity to be
performed. The handler employer shall
assure that the respirator fits correctly.
(10) When "chemical-resistant
headgear" is specified by the product
labeling, it shall be either a chemical
resistant hood or a chemical-resistant
hat with a wide brim.
(d) Exceptions to personal protective
equipment specified on product
labeling—(1) Body protection, (i] A
chemical-resistant suit may be
substituted for "coveralls," and any
requirement for an additional layer of
clothing beneath is waived.
(ii) A chemical-resistant suit may be
substituted for "coveralls" and a
chemical-resistant apron.
(2) Boots. If chemical-resistant
footwear with sufficient durability and a
tread appropriate for wear in rough
terrain is not obtainable, then leather
boots may be worn in such terrain.
(3) Gloves. If chemical-resistant
gloves with sufficient durability and
suppleness are not obtainable, then
during handling activities with roses or
other plants with sharp thorns, leather
gloves may be worn over chemical-
resistant glove liners. However, once
leather gloves are worn for this use,
thereafter they shall be worn only with
chemical-resistant liners and they shall
not be worn for any other use.
(4) Closed systems. If handling tasks
are performed using properly
functioning systems that enclose the
pesticide to prevent it from contacting
handlers or other persons, and if such
systems are used and are maintained in
accordance with that manufacturer's
written operating instructions,
exceptions to labeling-specified
personal protective equipment for the
handling activity are permitted as
provided in paragraphs (d)(4)(i) and (ii)
of this section.
(i) Persons using a closed system to
mix or load pesticides with a signal
word of DANGER or WARNING may
substitute a long-sleeved shirt, long
pants, shoes, socks, chemical-resistant
apron, and any protective gloves
specified on the labeling for handlers for
the labeling-specified personal
protective equipment.
(ii) Persons using a closed system to
mix or load pesticides other than those
in paragraph (d)(4)(i) of this section or to
perform other hanoUing tasks may
substitute a long-sleeved shirt, long
pants, shoes, and socks for the labeling-
specified personal protective equipment.
(iii) Persons using a closed system
that operates under pressure shall wear
protective eyewear.
: (iv) Persons using a closed system
shall have all labeling-specified
personal protective equipment
immediately available for use in an
emergency.
(5) Enclosed cabs. If handling tasks
are performed from inside a cab that has
a nonporous barrier which totally
surrounds the occupants of the cab and
prevents contact with pesticides outside
of the cab, exceptions to personal
protective equipment specified on the
product labeling for that handling
activity are permitted as provided in
paragraphs (d)(5)(i) through (iv) of this
section.
(i) Persons occupying an enclosed cab
may substitute a long-sleeved shirt, long
pants, shoes, and socks for the labeling-
specified personal protective equipment.
If a respiratory protection device is
Specified on the pesticide product
labeling for the handling activity, it must
be worn.
(ii) Persons occupying an enclosed
;cab that has a properly functioning
Ventilation system which is used and
maintained in accordance with the
manufacturer's written operating
instructions and which is declared in
writing by the manufacturer or by a
governmental agency to provide
respiratory protection equivalent to or
greater than a dust/mist filtering
respirator may substitute a long-sleeved
shirt, long pants, shoes, and socks for
the labeling-specified personal
1 protective equipment. If a respiratory
protection device other than a dust/
mist-filtering respirator is specified on
the pesticide product labeling, it must be
worn.
(iii) Persons occupying an enclosed
•cab that has a properly functioning
ventilation system which is used and
maintained in accordance with the
manufacturer's written operating
instructions and which is declared in
writing by the manufacturer or by a
'governmental agency to provide
respiratory protection equivalent to or
greater than the vapor- or gas-removing
respirator specified on pesticide product
labeling may substitute a long-sleeved
shirt, long pants, shoes, and socks for
the labeling-specified personal
protective equipment. If an air-supplying
; respirator or a self-contained breathing
apparatus (SCBA) is specified on the
pesticide product labeling, it must be
worn.
(iv) Persons occupying an enclosed
cab shall have all labeling-specified
personal protective equipment
immediately available and stored in a
chemical-resistant container, such as a
plastic bag. They shall wear such
personal protective equipment if it is
necessary to exit the cab and contact
pesticide-treated surfaces in the treated
area. Once personal protective
equipment is worn in the treated area, it
must be removed before reentering the
cab,
(6) Aerial applications—(i) Use of
gloves. Chemical-resistant gloves shall
be worn when entering or leaving an
aircraft contaminated by pesticide
residues. In the cockpit, the gloves .shall
be kept in an enclosed container to
prevent contamination of the inside of
the cockpit.
(ii) Open cockpit. Persons occupying
an open cockpit shall use the personal
protective equipment specified in the
product labeling for use during
application, except that chemical-
resistant footwear need not be worn. A
helmet may be substituted for chemical-
resistant headgear. A visor may be
substituted for protective eyewear.
(iii) Enclosed cockpit. Persons
occupying an enclosed cockpit may
substitute a long-sleeved shirt, long
pants, shoes, and socks for labeling-
specified personal protective equipment.
(7) Crop advisors. Crop advisors
entering treated areas while a restricted-
entry interval is in effect may wear the
personal protective equipment specified
on the pesticide labeling for early-entry
activities instead of the personal
protective equipment specified on the
pesticide labeling for handling activities,
provided:
(i) Application has been completed for
at least 4 hours.
(ii) Any inhalation exposure level
listed in the labeling has been reached
or any ventilation criteria established by
§ 170.110(c)(3) or in the labeling have
been met.
(e) Use of personal protective
equipment. (I) The handler employer
shall assure that personal protective
equipment is used correctly for its
intended purpose and is used according
to the manufacturer's instructions.
(2) The handl* employer shall assure
that, before each day of use, all personal
protective equipment is inspected for
leaks, holes, tears, or worn places, and
any damaged equipment is repaired or
discarded.
(f) Cleaning and maintenance. (1) The
handler employer shall assure that all
personal protective equipment is
cleaned according to the manufacturer's
instructions or^pesticide product
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Federal Register / Vol. 57, No. 163 /Friday, August 21, 1992 / Rules and Regulations 38165
labeling instructions before each day of
reuse. In the absence of any such
instructions, it shall be washed
thoroughly in detergent and hot water.
(2) If any personal protective
equipment cannot be cleaned properly,
the handler employer shall dispose of
the personal protective equipment in
accordance with any applicable Federal,
State, and local regulations. Coveralls or
other absorbent materials that have
been drenched or heavily contaminated
with an undiluted pesticide that has the
signal word DANGER or WARNING on
the label shall be not be reused.
(3) The handler employer shall assure
that contaminated personal protective
equipment is kept separately and
washed separately from any other
clothing or laundry.
(4) The handler employer shall assure
that all clean personal protective
equipment shall be either dried
thoroughly before being stored or shall
be put in a well ventilated place to dry.
[5] The handler employer shall assure
that all personal protective equipment is
stored separately from personal clothing
and apart from pesticide-contaminated
areas.
(6) The handler employer shall assure
that when dust/mist filtering respirators
are used, the filters shall be replaced:
(i) When breathing resistance
becomes excessive.
(ii) When the filter element has
physical damage or tears.
(iii) According to manufacturer's
recommendations or pesticide product
labeling, whichever is more frequent.
(iv) In the absence of any other
instructions or indications of service life,
at the end of each day's work period.
(7) The handler employer shall assure
that when gas- or vapor-removing
respirators are used, the gas- or vapor-
removing canisters or cartridges shall be
replaced:
[i) At the first indication of odor, taste,
or irritation.
(ii) According to manufacturer's
recommendations or pesticide product
labeling, whichever is more frequent.
(Hi) In the absence of any other
instructions or indications of service life,
at the end of each day's work period.
(8) The handler employer shall inform
any person who cleans or launders
personal protective equipment:
(i) That such equipment may be
contaminated with pesticides.
(ii) Of the potentially harmful effects
of exposure to pesticides.
(iii) Of the correct way(s) to clean
personal protective equipment and to
protect themselves when handling such
equipment.
(9) The handler employer shall assure
that handlers have a clean place(s)
away from pesticide storage and
pesticide use areas where they may:
(i) Store personal clothing not in use.
(ii) Put on personal protective
equipment at the start of any exposure
period.
(iii) Remove personal protective
equipment at the end of any exposure
period.
(10) The handler employer shall not
allow or direct any handler to wear
home or to take home personal
protective equipment contaminated with
pesticides.
(g) Heat-related illness. When the use
of personal protective equipment is
specified by the labeling of any
pesticide for the handling activity, the
handler employer shall assure that no
handler is allowed or directed to
perform the handling activity unless
appropriate measures are taken, if
necessary, to prevent heat-related
illness.
§ 170.250 Decontamination.
(a) Requirement. During any handling
activity, the handler employer shall
provide for handlers, in accordance with
this section, a decontamination site for
washing off pesticides and pesticide
residues.
(b) General conditions, (i) The
handler employer shall provide handlers
with enough water for routine washing,
for emergency eyeflushing, and for
washing the entire body in case of an
emergency. At all times when the water
is available to handlers, the handler
employer shall assure that it is of a
quality and temperature that will not
cause illness or injury when it contacts
the skin or eyes or if it is swallowed.
(2) When water stored in a tank is to
be used for mixing pesticides, it shall
not be used for decontamination or eye
flushing, unless the tank is equipped
with properly functioning valves or
other mechanisms that prevent
movement of pesticides into the tank.
(3) The handler employer shall
provide soap and single-use towels at
each decontamination site in quantities
sufficient to meet handlers' needs.
(4) The handler employer shall
provide one clean change of clothing,
such as coveralls, at each
decontamination site for use in an
emergency.
(c) Location. The decontamination site
shall be reasonably accessible to and
not more than 1/4 mile from each
handler during the handling activity.
(1) Exception for mixing sites. For
mixing activities, the decontamination
site shall be at the mixing site.
(2) Exception for pilots. The
decontamination site for a pilot who is
applying pesticides aerially shall be in
the airplane or at the aircraft's loading
site.
(3) Exception for handling pesticides
in remote areas. When handling
activities are performed more than 1/4
mile from the nearest place of vehicular
access:
(i) The soap, single-use towels, clean
change of clothing, and water may be at
the nearest place of vehicular access.
(ii) The handler employer may permit
handlers to use clean water from
springs, streams, lakes, or other sources
for decontamination at the remote work
site, if such water is more accessible
than the water at the decontamination
site located at the nearest place of
vehicular access.
(4) Decontamination site in treated
areas. The decontamination site shall
not be in an area being treated with
pesticides or in an area under a
restricted-entry interval, unless:
(i) The decontamination site is in the
area where the handler is performing
handling activities;
(ii) The soap, single-use towels, and
clean change of clothing are in enclosed
containers; and
(iii) The water is running tap water or
is enclosed in a container.
(d) Emergency eyeflushing.To
provide for emergency eyeflushing, the
handler employer shall assure that at
least 1 pint of water is immediately
available to each handler who is
performing tasks for which the pesticide
labeling requires protective eyewear.
The eyeflush water shall be carried by
the handler, or shall be on the vehicle or
aircraft the handler is using, or shall be
otherwise immediately accessible.
(e) Decontamination after handling
activities. At the end of any exposure
period, the handler employer shall
provide at the site where handlers
remove personal protective equipment,
soap, clean towels, and a sufficient
amount of water so that the handlers
may wash thoroughly.
§ 170.260 Emergency assistance.
If there is reason to believe that a
person who is or has been employed by
an agricultural establishment or
commercial pesticide handling
establishment to perform pesticide
handling tasks has been poisoned or
injured by exposure to pesticides as a
result of that employment, including, but
not limited to, exposures from handling
tasks or from application, splash, spill,
drift, or pesticide residues, the handler
employer shall:
(a) Make available to that person
prompt transportation from the place of
employment or the handling site to an
appropriate emergency medical facility.
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Federal Register / Vol. 57, No. 163 / Friday. August 21, 1992 / Rules and Regulations
(b) Provide to that person or to
treating medical personnel, promptly
upon request, any obtainable
information on:
(1) Product name, EPA registration
number, and active ingredients of any
product to which that person might have
been exposed.
(2) Antidote, first aid, and other
medical information from the product
labeling.
(3) The circumstances of handling of
the pesticide.
(4) The circumstances of exposure of
that person to the pesticide.
[FR Doc. 92-20005 Filed 8-19-92; 10:31 am]
BILLING CODE 6560-50-F
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules 38167
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 170
[OPP-300164C; FRL-3793-1]
RIN 2070-AA49
Worker Protection Standard; Hazard
Information
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This proposed rule is a
companion to a final rule, published
elsewhere in this issue of the Federal
Register, which revises regulations
governing worker protection from
agricultural pesticides and their
residues. As a result of comments
received during this rulemaking, EPA is
proposing an additional modification to
its Worker Protection Standard to
provide information to covered workers
that is substantially equivalent to that
required under the Hazard
Communication Standard promulgated
by the Occupational Safety and Health
Administration (OSHA). This proposal
would add a requirement that specific
hazard information be made available to
agricultural workers and pesticide
handlers concerning the pesticides to
which they are exposed. This
information would be in the form of fact
sheets or Material Safety Data Sheets.
EPA believes this modification would
provide information to agricultural
workers equivalent to that provided to
other workers and would do much to
avoid confusion among pesticide users
as to their obligation for communicating
pesticide hazard information to workers.
DATES: Written comments, data, and
other evidence concerning the proposal
should be submitted on or before
October 20,1992.
ADDRESSES: Comments should be
submitted in triplicate and addressed to
the Document Control Officer (H7506C),
Office of Pesticide Programs,
Environmental Protection Agency, 401M
St., SW., Washington, DC 20460. All
comments should bear the document
control number, OPP-300164C, and will
be available for public inspection from
8:30 a.m. to 4 p.m., Monday through
Friday excluding legal holidays, at the
OPP Document Control Office, Rm. 1132,
CM #2,1921 Jefferson Davis Highway,
Arlington, VA.
FOR FURTHER INFORMATION CONTACT: By
mail: James J. Boland, Acting Chief,
Occupational Safety Branch (H7506C),
Office of Prevention, Pesticides, and
Toxic Substances, Environmental
Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location
and phone number: Rm. 1114, CM #2,
1921 Jefferson Davis Highway,
Arlington, VA, (703)-305-7666.
SUPPLEMENTARY INFORMATION: In 1974,
EPA promulgated the regulations found
at 40 CFR part 170, which dealt with
pesticide-related occupational safety
and health of workers performing hand
labor operations in fields during or after
application of pesticides. As the result
of changing conditions and an
awareness of the shortcomings of part
170, EPA proposed to revise its worker
protection regulations in 1988 (53 FR
25970; July 8,1988) ("the NPRM"). A
substantial number of comments were
received as the result of this proposal,
and the Agency is issuing the final rule
elsewhere in this issue of the Federal
Register. These revisions expand the
scope of part 170 beyond coverage of
workers performing hand labor
operations in fields treated with
pesticides to include a wider range of
occupational exposures to agricultural
pesticides. The regulations cover
workers in or on farms, forests,
nurseries, and greenhouses, as well as
workers who handle (mix, load, and
apply) pesticides at these locations. The
revisions expand requirements for
safety and health warnings about
applications, use of personal protective
equipment, and observation of entry
restrictions, and add new provisions for
training, decontamination, and
emergency medical assistance.
As a result of the rulemaking revising
part 170, EPA received many comments
expressing concern about possible
overlap or conflict between part 170
requirements and any requirements that
might also be placed upon the regulated
community by OSHA. Some comments
expressed the opinion that part 170
should provide agricultural employees
information about the chemicals to
which they are exposed equivalent to
the requirements of the OSHA Hazard
Communication Standard. The Agency
has reviewed the record underlying this
rulemaking and believes that the revised
part 170 provides protection at least the
equivalent of the Hazard
Communication Standard, with one
exception. OSHA requires that hazard-
specific information be made available
to workers in the form of Material
Safety Data Sheets (MSDSs). Based on
the comments in the record, EPA agrees
with the need for providing hazard.
specific information to workers exposed
to those hazards. EPA proposes to
require that employees be given access
to pesticide-specific information in the
form of fact sheets approved by EPA or
State agencies concerning specific
pesticides; alternatively, this
requirement would be met if employees
were given access to MSDSs for the
pesticides to which they are exposed.
I. Relationship Between EPA's Worker
Protection Standard and OSHA's
Hazard Communication Standard
OSHA's Hazard Communication
Standard (HCS) (29 CFR 1910.1200)
requires employers to train employees in
the nature, detection, and avoidance of
chemical hazards in the workplace;
maintain MSDSs for all hazardous
chemicals and provide them on request;
and label chemical containers. The HCS
was promulgated in 1983 to cover
manufacturing workers; in 1987, it was
extended to cover all workers, including
agricultural workers (52 FR 31852;
August 24,1987) (29 CFR 1928.21).
Although the NPRM for EPA's Worker
Protection Standard (WPS) discussed
the relationship between the proposed
decontamination requirements and
OSHA's Field Sanitation Standard (29
CFR 1928.110), it did not address the
relationship between part 170 and the
HCS. Nevertheless, the Agency received
a considerable number of public
comments on this issue in response to
the NPRM. Comments came primarily
from grower groups, the Cooperative
Extension Service, worker
representatives, and State lead agencies.
Comments noted that the HCS recently
had become applicable to agricultural
employers and contained requirements,
such as training and notification, that
appeared to be similar to measures in
EPA's proposal. Comments claimed
either that the two regulations were
duplicative or they were inconsistent.
One comment pointed to inconsistencies
between some MSDSs and the
corresponding pesticide labels in the
hazard information they provide. Many
growers believed that there could be
confusion in dealing with more than one
"oversight agency," unnecessary
compliance costs, and extra paperwork
burdens. One comment stated that, by
including agriculture in its HCS, OSHA
was "interfering" with EPA's pesticide
program.
The comments proposed varying
solutions to the perceived
inconsistencies. The majority, stated that
EPA and OSHA should hold discussions
to clarify the "regulatory boundaries"
between the two agencies, noting that
confusion among the public, :
enforcement difficulties, and litigation
are likely if the relationship is not
clarified. One comment suggested a
Memorandum of Understanding
between EPA and OSHA. Two
comments requested that EPA delay
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38168
Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules
implementation of part 170 until an
agreement with OSHA was reached.
Many comments stated that OSHA
should "stay out," and that only EPA
should regulate hazard communication
in agriculture. In support of this view,
comments stated that the Cooperative
Extension Service "traditionally works
well" with EPA; that EPA has a history
of putting resources and priority in its
pesticide program; that the revised part
170 would include adequate hazard
communication for agricultural workers;
that the HCS is primarily a standard for
manufacturing while part 170 is
"specifically designed" for the
agricultural setting; that OSHA
enforcement is limited to larger farms
because of a current appropriations
rider; that Congress intended FIFRA to
regulate pesticide-hazardous materials;
that OSHA has no Indian reservation
enforcement policy; and that labels are
a "better source of information" than the
MSDS. One comment stated that only
one agency should regulate, without
stating which one. Another suggested
that OSHA adopt EPA's proposed
regulations as hazard communication
requirements for the agricultural sector.
One comment stated that EPA should
"yield" to the HCS and "fill in
elsewhere" as necessary, while another
felt that OSHA should cover all aspects
of worker safety. Several comments
proposed a specific division of
regulatory authority between the
agencies, under which the EPA would
cover workers at agricultural pesticide
use sites, including both handlers and
workers who are exposed to residues,
while OSHA would cover
"downstream" nonagricultural workers,
those exposures to residues other than
at agricultural use sites.
While pesticide users anticipated
confusion over which rules they should
follow, some State agencies were
concerned about the division of
responsibility for programs and
enforcement at the State government
level. The situation would be
complicated because a given State could
be participating in an EPA State Plan, an
OSHA State Plan, both, or neither. One
State agency asked for either a formal
jurisdictional division at the Federal
level which each State would be
required to implement, or an alternative
"flexible approach" allowing
cooperation among pesticide lead
agencies and occupational safety and
health agencies in each State. One
comment stated that regardless of which
agency issued regulations, enforcement
would be "complaint-driven" rather
than based on inspections, and was
concerned that EPA did not have an
OSHA-type complainant protection
system.
Comments from the Texas
Department of Agriculture (TDA), the
lead agency in that State for pesticides,
identified the difficulty that a given
situation may present. In 1988, the State
passed an Agricultural Worker Hazard
Communication Act pursuant to which
TOA developed training programs and
promulgated implementing regulations,
actions consistent with the Federal-
State relationship set forth by FIFRA
section 24. Because Texas does not have
an approved OSHA State Plan, under
the OSHAct the Federal HCS is
applicable in that State, and any similar
State regulations are preempted.
Because of the similarity between the
new Texas law and the Federal HCS,
isome persons in that State have
suggested that the Texas law and
regulations may be preempted by the
HCS. TDA has urged both OSHA and
EPA to clarify their jurisdictional
relationship in a manner that would
permit TDA to implement its programs
and enforce its regulations without the
present ambiguity.
During the public comment period on
BPA's NPRM for the Worker Protection
Standard, OSHA held a public hearing
and requested public comment on
several issues associated with the HCS
(53 FR 29822; August 8,1988), including
the question of possible preemption of
the HCS by EPA's pesticide regulations.
EPA has reviewed the relevant
comments in OSHA's HCS rulemaking
docket and was represented at the
hearing. Substantially the same
concerns were raised in comments on
the two rulemakings, and similar
.solutions were proposed. A number of
organizations submitted written
comments to both agencies.
EPA submitted its written comments
to the OSHA Hazard Communication
iStandard docket. The Agency
acknowledged that both agencies had
attempted to regulate occupational
pesticide exposure under their
respective statutes, and pointed out that
iSignificant public concern existed over
the recent actions of both agencies in
this area. EPA identified problems with
the view of jurisdictional issues
expressed by OSHA in its Federal
.Register notice, as related to some
aspects of EPA's pesticide program, the
implications of the proposed revisions to
part 170, the question of preemption, and
possible alternative approaches. EPA
concluded that "[gjiven the shared
regulatory purpose, the similarity of the
proposed requirements, and the
justifiable public concern over
tegulatory duplication, EPA believes
that the time is ripe for the two agencies
to address, in as concrete a fashion as
possible, the issues raised by their
mutual jurisdiction" (OPP Docket
300164-C373).
In late 1988, the two agencies formed
a working group to address these issues.
The United States Department of
Agriculture requested and was granted
permission to participate because of its
close involvement in matters related to
the use of agricultural pesticides. The
working group met several times. After
reviewing drafts of the final Worker
Protection Standard and this NPRM,
OSHA's view is that EPA's final rule,
when promulgated and enforced, will
address essentially the same
information transmittal issues covered
by the HCS. OSHA also concluded that
when this NPRM is promulgated, EPA
will have approximately the same
requirements as the HCS. In view of this
similarity, OSHA will defer to EPA and
will not enforce the HCS with regard to
employees exposed to pesticides who
are covered by the Worker Protection
Standard. However, OSHA will
continue to enforce the HCS for other
hazardous chemicals to which
employees are exposed in agriculture.
EPA fully supports OSHA's efforts to
assure that persons exposed to chemical
hazards are provided with information
about those hazards; EPA pursues
similar goals in its pesticide program. At
the same time, EPA acknowledges the
various public concerns expressed by
growers, workers, States and others
regarding the relationship between the
revised part 170 and OSHA's HCS. EPA
does not intend to require actions on the
part of the regulated public that either
duplicate or conflict with another
agency's requirements intended to
accomplish essentially the same
purpose. FIFRA encourages cooperation
between EPA and other Federal
agencies and flexibility between Federal
and State levels in the implementation
of pesticide programs, as long as the
overall goal of protection is met. EPA
also supports such flexibility and
cooperation among various agencies in a
given State. In light of the differences
among State pesticide and occupational
health and safety programs, a single
approach at the Federal level may not fit
particular cases at the State level.
EPA has elected to proceed with the
final Worker Protection Standard
published elsewhere in this issue of the
Federal Register, believing it is
unreasonable to delay issuance of all
part 170 protective measures, including
those unrelated to hazard
communication. The Agency is
proposing in this document to amend
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Federal
/ Vol.57, No. 163 /Friday, August 21, 1992 / Proposed Rules
38169
part 170, as soon as practicable
following public notice and comment, to
provide pesticide hazard communication
for agricultural workers and pesticide
handlers on agricultural sites that is at
least the equivalent of OSHA's hazard
communication provisions. EPA believes
that its newly revised Worker Protection
Standard, with modifications, would
provide an appropriate vehicle for
ensuring the communication of pesticide
hazard information in the agricultural
workplace, for a number of reasons.
First, EPA's final rule already includes
a number of provisions that appear to
accomplish a similar purpose as some of
OSHA's hazard communication
requirements. These include pesticide
safety training for handlers and workers
(§§ 170.130 and 170.230); display of a
pesticide safety poster (§ 170.135);
notification of the presence of pesticides
in the workplace, including posted or
oral warnings and the pesticide name
and location of treated areas displayed
at a central location (§§ 170.120,170.122,
170.222); and access to and knowledge
of pesticide labeling information by
handlers (§ 170.232). The principal
difference between OSHA's hazard
communication program and EPA's
current worker protection program is the
right to written information about the
specific hazards of pesticides present in
the workplace, in the form of MSDSs.
Second, EPA's hazard communication
requirements would be tailored to fit the
context of agricultural-pesticide use,
rather than being generic standards for
all occupational sectors as is the case
with OSHA's Hazard Communication
Standard.
Third, incorporation of a full
agricultural hazard communication
program into part 170 would do much to
alleviate confusion and concern in the
regulated community over possible
conflicts and duplication between the
agencies.
Fourth, direct EPA involvement in
agricultural pesticide hazard
communication could assist States such
as Texas that desire to implement their
own State-specific hazard
communication program in agriculture.
Under FIFRA, more stringent State
regulations are permissible. Under the
OSHAct, however, more stringent State
regulations may be permitted, but in
States without approved OSHA State
plans, State regulations are preempted.
EPA does not propose to incorporate
OSHA's hazard communication program
word for word, primarily because the
Agency believes that its part 170
requirements are more suited to the
agricultural workplace.
Therefore, EPA proposes to modify
part 170 in only one respect to meet the
objectives of OSHA's HCS. Specifically,
EPA proposes to include a requirement
to make available written pesticide-
specific hazard information on request
to pesticide handlers and to workers
potentially exposed to pesticide
residues. The Agency proposes to add
new §§ 170.133 and 170.233, entitled
"Hazard Information," to subpart B,
Standard for Agricultural Workers, and
subpart C, Standard for Pesticide
Handlers, respectively. The proposed
pesticide-specific hazard information
requirement has been adapted from
OSHA's MSDS requirement (29 CFR
1910.1200(g)) and specifies the type and
form of written information (MSDS or
fact sheet) and the obligation to obtain,
to maintain, and to make available the
information to handlers and workers.
Some commenters stated that the
typical MSDS is not written with the
agricultural workplace in mind and
contains information that is either
difficult to understand or irrelevant to
agricultural workers. In response, the
Agency has proposed that an alternative
form of hazard information also be
acceptable, i.e., a fact sheet that
contains specific types of relevant
information. These fact sheets would be
either prepared by or approved by a
Federal or State agency. One advantage
of fact sheets is that they might be
designed to communicate product-
specific risk and hazard-reduction
information to agricultural workers and
pesticide handlers through the use of
nontechnical and often comparative
terms. The proposed fact sheets allow
the development of one fact sheet for a
pesticide, i.e., malathion or 2,4-D. The
Agency welcomes comments as to
whether the fact sheets should be
narrower in focus, such as requiring
different fact sheets for different
formulations of the same active
ingredient.
The Agency is considering a range of
options concerning the forrfpft and
content of the fact sheets. Cfcie option is
to require all the information currently
required in an MSDS. Another option is
to require that the fact sheet contain
only the MSDS information that would
be most useful to agricultural workers
and pesticide handlers, allowing them to
obtain other information from an MSDS,
which also would be made accessible.
Still another option is to refer users to
the pesticide product labeling for certain
information, such as personal protective
equipment requirements and restricted-
entry intervals and to require that both
the labeling and the fact sheet be made
accessible to agricultural workers and
pesticide handlers. The Agency seeks
comment as to the appropriate format
and content of the fact sheets.
The content being proposed for the
fact sheets would encourage the use of
nontechnical language and eliminate the
requirement for some.highly technical
data that might be of little use to
agricultural workers and pesticide
handlers. The Agency is inclined to
minimize the technical specificity of the
information in favor of language more
easily interpreted by agricultural
workers and pesticide handlers.
Specifically, the Agency is considering
requiring that technical information be
expressed through the use of
comparative terms. The Agency seeks
information and assistance from
interested parties as to how this might
best be accomplished and seeks specific
comments as to what range of numeric
values for each quantitative property of
the pesticide would be appropriate for
each comparative term. In the case of
vapor pressure, for example, what
ranges of vapor pressure values should
be characterized as highly volatile,
moderately volatile, slightly volatile, or
relatively nonvolatile?
Other physical characteristics that
might be best expressed in comparative
terms include flammability, explosivity,
solubility, stability (or shelf life), and, in
some instances, compatibility. However,
this latter characteristic could be
specifically described either by listing
products the pesticide is known to be
compatible with or .by listing Iproducts
the pesticide is known to be
incompatible with.
At least two possible chart-style
presentations might be appropriate for
fact sheets. One is the National Fire
Protection Association Hazard Rating
chart, which could be used to describe
the fire hazards. These ratings are keyed
to a numeric scale from 0 to 4 as follows:
0 = least, 1 = slight, 2 = moderate, 3 =
high, and 4 = severe hazard. Health
hazard, fire hazard, and reactivity
hazard are rated. Another chart that
might be appropriate for adaptation is
the SARA Title III Hazard Classification
chart, which uses a "yes/no" key to
indicate whether the chemical presents
an immediate (acute) health, delayed
(chronic) health, fire, sudden release of
pressure, or reactivity hazard; The
Agency solicits comment on chart-style
presentations in general and on the
utility of .these two specific examples.
The Agency is inclined to require
simple, standardized phrases to describe
the toxicological characteristics of the
chemicals. The usual technical
terminology, for example: "Toxicology:
Acute Exposure: Skin - Rabbit, 2.0 mg/
kg" may not communicate interpretable
information to most people, including
most agricultural workers and pesticide
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Federal Register / Vol. 57. No. 163 / Friday. August 21, 1992 / Proposed Rules
handlers. The Agency believes that
standard descriptive phrases should be
limited to three or four per adverse
effect, such as: (1) Skin or eye irritants
could be classified as: severe irritant,
moderate irritant, slight irritant, or
relatively non-irritating; (2) Systemic
toxicity through swallowing, through
inhaling, or through absorption through
the skin could be classified as: highly
toxic, moderately toxic, slightly toxic, or
relatively nontoxic; (3) Sensitization
potential could be classified as: severe
sensitizer, moderate sensitizer, slight
sensitizer, or relatively nonsensitizing.
These simple terms could be easily
learned by agricultural workers and
pesticide handlers who are
occupationally exposed to pesticides.
The Agency is also considering whether
to associate a "signal word," i.e.,
danger, warning, caution, with each of
these routes of entry in addition to the
comparative phrase. For example:
"Warning—moderately toxic if
swallowed; Caution—slightly irritating
to the eyes," etc. The LDso or LCso or
other quantitative values could also
appear on the fact sheet, but standard
descriptive terms would be mandatory.
The Agency is also inclined to require
that fact sheets express delayed-onset
toxicity concerns in a comparative
manner and to require that the fact sheet
simply state whether any government
agency or recognized medical
organization has listed the pesticide or
any of its ingredients as a potential
carcinogen, rather than list each agency
or organization separately. In any case,
EPA is inclined to require that fact
sheets incorporate simplified language
for these effects, such as: tumor-causing
in lieu of oncogenic; birth-defect-causing
in lieu of teratogenic; injury to fetus in
lieu of embryotoxic or fetotoxic; injury
to pregnant females in lieu of maternally
toxic; injury to genes or chromosomes in
lieu of genotoxic or mutagenic; injury to
brain and nervous system in lieu of
neurotoxic; immune system injury in lieu
of immunosuppression; and heart/lung
injury in lieu of cardiopulmonary
impairment.
Information on the fact sheet that is
directed specifically to medical
personnel, such as antidotes or
appropriate medical amelioration
procedures, could retain the precise
medical terminology. However, for the
sections on symptoms of overexposure,
medical conditions aggravated by
exposure, and emergency and first aid
procedures for each applicable route of
exposure, the Agency is inclined to
require the use of simplified language.
For example, the following terms might
be substituted for the more precise
medical terminology: tears in lieu of
lacrimation; rash or reddening in lieu of
erythema; cracking in lieu of fissuring;
peeling or scaling in lieu of
desquamation; unconsciousness or
stupor in lieu of narcosis; swelling in
lieu of edema; tissue damage in lieu of
necrosis; giddiness, headache, dizziness,
and blurred vision in lieu of central
nervous system depression; slow heart
rate in lieu of bradycardia; rapid heart
rate in lieu of tachycardia; high blood
pressure in lieu of hypertension; low
blood pressure in lieu of hypotension;
low body temperature in lieu of
hypothermia; cramps, diarrhea, nausea
or vomiting in lieu of gastrointestinal
irritation; loss of appetite in lieu of
anorexia; muscle pains in lieu of
myalgia; bluish skin color in lieu of
cyanosis; yellowish skin color in lieu of
jaundice; lack of coordination in lieu of
ataxia; shortness of breath or difficulty
breathing in lieu of dyspnea; rapid
breathing in lieu of tachypnea; muscle
spasms in lieu of tetany or myotonia;
pinpoint pupil in lieu of miosis; runny
nose in lieu of rhinorrhea; blood in feces
in lieu of melena; blood in urine in lieu
of hematuria; irritated stomach in lieu of
gastritis; drooling or excess saliva in lieu
of salivation; abnormality or irregularity
in lieu of anomaly; poisoning in lieu of
tqxification; and plenty or large in lieu
of copious. The Agency solicits,
comments on this approach and
suggestions as to possible changes in
these proposed substitutes as well as
suggestions as to similar terms that
might be simplified.
The Agency is considering allowing
the fact sheets to indicate which
exposure-reduction measures have been
established for the product, without
specifying the details of those measures.
The fact sheet would then indicate how
the pesticide handlers or agricultural
workers should assess whether those
exposure-reduction measures have been
met. For example, the fact sheet would
indicate that a restricted-entry interval
has been set for the product and that
workers should not enter the area
immediately after application and until
the supervisor indicates that the
restricted-entry period has expired. If
another type of exposure limitation has
been established for the product, such
as an OSHA Permissible Exposure Limit
(PEL], the fact sheet might state that a
standard had been established for
exposures to the product through
inhalation and direct that enclosed
treatment areas should be tested before
workers reenter those areas. If
ventilation criteria or other criteria have
been established for such enclosed
treatment areas, these should be listed
in the fact sheet. For example, the fact
sheet might state: "Stay out of enclosed
treatment areas until they have been
mechanically ventilated for at least 2
hours or until a test indicates that the
levels of pesticide product in the air are
no longer hazardous."
The Agency is also inclined to require
that any environmental effects listed on
the fact sheets be .expressed in simple,
standardized comparative phrases. The
existing terminology on some MSDSs,
for example: "48-hr ECso Daphnia
Magna: 22 mg/1," may not communicate
interpretable information to the
audience targeted by the fact sheet. As
an alternative, EPA suggests the use of
the same language as for systemic
toxicity to humans, i.e., highly toxic,
moderately toxic, slightly toxic, or
relatively nontoxic. The environmental
categories could include, as appropriate,
an indication of the relative toxicity of
the pesticide to fish, other aquatic
organisms, birds, mammals, bees,
reptiles and amphibians, and
invertebrate organisms.
If personal protective equipment,
engineering controls, and other special
workplace practices are actually listed
on the fact sheet rather than referenced
by the fact sheet to the labeling or
MSDS, the Agency is inclined to require
standardization of terminology in
describing such requirements and
practices. This requirement would be
designed to reduce confusion that may
be caused by fact sheets that appear to
be inconsistent with the requirements on
pesticide labeling. For example, the
following terms might be required: (1)
Personal protective equipment in lieu of
protective clothing or protective clothing
and equipment; (2) coverall in lieu of full
body suit or protective clothing; (3)
chemical-resistant in lieu of chemical-
impervious or impermeable; (4]
specifying one or more protective types
of chemical-resistant materials, such as
neoprene, natural rubber, butyl rubber,
PVC, nitrile, plastic laminate, etc; (5)
specifying "waterproof only when any
plastic or rubber is resistant to the
chemical; (6] protective eyewear, such
as goggles, face shield or safety glasses
in lieu of other eyewear terms; (6]
protective footwear, such as boots, shoe
covers or shoes in lieu of other footwear
terms; (8) dust/mist respirator in lieu of
dust respirator or mask; and (9)
specifying a type of respirator—either
dust/mist, vapor-removing, or supplied
air—in lieu of respirator, organic-vapor
respirator, air-purifying respirator, or
pesticide respirator.
In addition, the Agency is inclined to
require a standardized format for the
presentation of such requirements and
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules i 38171
practices, such as: (1) Body: [specify:
"coverall" or "chemical-resistant
protective suit" or "long-sleeved shirt
and long pants" and/or "chemical-
resistant apron" as applicable]; (2)
Hands: [specify type of glove material or
use "waterproof to indicate any plastic
or rubber will suffice]; (3) Feet: [specify
type of footwear material or use
"waterproof to indicate that any plastic
or rubber material will suffice]; (4) Eyes:
[specify "protective eyewear" or a
particular type of eyewear, such as
goggles]; (5) Lungs: [specify "dust/mist
respirator" or "vapor-removing
respirator approved for pesticides or
organic vapors" or "air-supplied
respirator"].
The Agency seeks comment as to
appropriate standardized language for
describing various engineering controls,
such as closed systems, enclosed cabs,
and enclosed cockpits and for
describing various workplace practice
recommendations or requirements, such
as cleaning and maintenance of
personal protective equipment, washing
hands and face frequently, etc.
The Agency solicits comment as to the
appropriate means of conveying
information about spill cleanup
procedures and about disposal methods
for excess pesticide and for pesticide
containers. Such technical, product-
specific information might be more
appropriate for pesticide labeling or
MSDSs than for fact sheets. On the
other hand, unless pesticide labeling or
MSDSs were also accessible to pesticide
handlers and agricultural workers, at
least some of this information would
seem appropriate for fact sheets to
avoid unacceptable risk of exposure in
an emergency.
The Agency also solicits comment as
to whether providing the pesticide
product labeling should be an
acceptable alternative or supplement to
providing an MSDS or fact sheet. The
Agency has several concerns about such
an option. The pesticide product
labeling may be unavailable to most
agricultural workers. The labeling is
often affixed to the product container
and thus located in a pesticide storage
area. The labeling may be contaminated
or rendered partially unreadable during
use of the container under normal field
conditions. Furthermore, the Agency is
concerned about information that is
routinely included in MSDSs but that is
not on the pesticide product labeling,
such as information about delayed-onset
adverse health effects and spill or leak
cleanup procedures. However, the
pesticide product labeling is a logical
source of hazard information about the
product and could be produced
separately from the container, which
would make it more accessible. Another
option is to require that both the
labeling or MSDS and a fact sheet be
made available. The Agency seeks
comment as to whether pesticide
labeling should be an acceptable
alternative to MSDSs or fact sheets in
the agricultural workplace or whether a
fact sheet plus the pesticide labeling or
MSDS should be required.
The Agency is also considering
requiring or allowing the use of
pictogram symbols on fact sheets to
graphically convey crucial health and
safety information to workers
occupationally exposed to pesticides.
The use of pictograms is a widely
accepted and efficient means of
conveying information to people.
Workers/handlers exposed
occupationally to agricultural pesticides
have a wide range of language skills.
Many workers/handlers speak and read
a language other than English; others
speak English, but cannot read it; still
others speak and read English, but are
unable to interpret the technical data
being presented to them in the fact
sheets. While some workers/handlers
may have little difficulty deciphering
highly technical terms, the Agency
believes they constitute a small fraction
of the workforce currently encompassed
by the Worker Protection Standard.
Considerable study has been given to
the use of easily understood
international symbols for traffic control.
While less study has been undertaken to
develop such symbols for hazard
communication such an approach could
prove beneficial. For example, a
pictogram could depict a drop of
chemical on the skin of a hand or
forearm with the words (or an
additional symbol) in the upper corner
of the pictogram indicating whether the
chemical is slightly toxic, moderately
toxic, or highly toxic by the dermal
route. Some of these pictograms have
already been developed or proposed;
others would have to be created. The
Agency solicits comments on the option
of requiring or allowing pictograms on
fact sheets and solicits examples of
pictograms that might be appropriate.
The Agency is concerned that State or
Federal agencies choosing to produce or
to approve fact sheets should develop
and employ specific standards for
content and completeness under the
general criteria in the rule. The Agency
invites comment on the option of
requiring that authority to approve fact
sheets be contingent upon EPA approval
and periodic reapproval of a plan by the
organization proposing to operate such a
process. Such a plan would describe the
criteria for approval, including topics to
be covered, method of presentation,
acceptable sources of information, and
requirements for updating of fact sheets
as new information becomes available.
The Agency believes that the
economic impact of this proposal on
agricultural entities will be negligible.
Agricultural employers already are
subject to OSHA's Hazard
Communication Standard and must
provide MSDSs on request. The fact
sheet alternative may reduce this
existing burden by creating a regulatory
option that may be easier for employers
to meet and that may benefit handlers
and workers by providing hazard
information in a more understandable
form. Agricultural employers also will
derive benefits from the consolidation of
certain Federal hazard communication
requirements under one agency, which
will facilitate understanding and
compliance. -
The Agency believes that its proposal,
when implemented, would address the
public's concern about the relationship
between OSHA's Hazard
Communication Standard and EPA's
Worker Protection Standard in a way
that could be anticipated to reduce
confusion among agricultural employers
and ensure adequate communication of
pesticide hazards to agricultural
handlers and workers. EPA solicits
comment on any aspect of the matters
discussed in this proposal.
II. Statutory Review
A. U.S. Department of Agriculture
As required by FIFRA section 25(a), a
copy of this Notice of Proposed
Rulemaking and the final rule (40 CFR
Part 170) were provided to the Secretary
of Agriculture on June 7,1991. On March
27,1992, the Secretary provided written
comments. The Secretary had comments
concerning hazard communication in
connection with provisions in the
Worker Protection Standard; however,
none of those comments applied
specifically to this NPRM.
B. Congressional Committees
As required by FIFRA section 25(a), a
copy of the final rule was provided to
the committee on Agriculture, Nutrition,
and Forestry of the U.S. Senate and the
Committee on Agriculture of the U.S.
House of Representatives. Comments
were provided by Senator Patrick Leahy
and Representative Charlie Rose.
Following is a summary of each
comment .by Senator Leahy and
Representative Rose, together with the
Agency's response.
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules
Comment #1: Farmworkers, like all
other workers, should have access to
MSDSs as well as the product label.
Response: EPA agrees that workers
should have access to MSDSs or fact
sheets containing similar information
about the hazards of specific pesticides.
The Agency also notes that the Worker
Protection Standard requires employers
to provide information from pesticide
labels to workers assigned to perform
early entry activities and to persons
assigned to handle pesticides. In
addition, label-specific information must
be provided to workers and handlers in
the event of an occupationally caused
pesticide-related illness or injury.
Comment #2: EPA should also require
growers to provide their workers with
crop sheets.
Response: The Agency agrees that
workers should have access to
information about the hazards of the
specific pesticides they may be exposed
to during their work activities. The
purpose of this Notice of Proposed
Rulemaking is to establish a mechanism
for effectively and efficiently conveying
information about pesticide hazards to
workers and handlers. The Agency
anticipates diverse suggestions and
views during the comment period as to
the best means of conveying product-
specific information to agricultural
employees.
C. Scientific Advisory Panel
Pursuant to FIFRA section 25(d), a
copy of this proposed rule was provided
to the FIFRA Scientific Advisory Panel
(SAP). A waiver of review was
requested; the waiver was granted.
III. Regulatory Assessment
Requirements
A. Executive Order 12291
Under Executive Order 12291, EPA is
required to judge whether a rule should
be classified as major or non-major for
purposes of review by the Office of
Management and Budget (OMB).
According to E.0.12291, major rules are
rules that are likely to result in:
(1) An annual effect on the economy
of $100 million or more; or
(2) A major increase in the costs or
prices for consumers, individual
industries, Federal, State or local
governmental agencies, or geographic
regions; or,
(3) Significant adverse effects on
competition, employment, investment,
productivity, innovation, or in the ability
of U.S. based enterprises to compete
with foreign-based enterprises in
domestic or export markets.
This proposed rule would not be a
major rule because it does not meet any
of the above criteria. This proposed rule
has been submitted to the Office of
Management and Budget (OMB) for
review as required by E.0.12291.
B. Regulatory Flexibility Act
This proposed rule has been reviewed
under the Regulatory Flexibility Act of
1980 (Pub. L. 96-354; 94 Stat. 1164; 5
U.S.C. 601-612) for its impact on small
businesses.
The Agency has determined that the
burden on small agricultural businesses
does not outweigh the risk to handlers
and workers employed in those
businesses, and an exemption from the
requirements in this rule amendment for
small businesses would not be
warranted. The burden to employers is
that of holding for 30 days and making
available to their employees upon
request informational documents that
are available to the employers at no
charge.
C. Paperwork Reduction Act
'• The Agency has determined that there
are no information collection burdens
under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq.,
associated with the requirements of this
proposed rule.
List of Subjects in 40 CFR Part 170
' I Environmental protection, Pesticides
land pests, Intergovernmental relations,
Occupational safety and health,
Reporting and recordkeeping
requirements.
Dated: August 13,1992.
William K. Reffly,
Administrator.
:,. Therefore, it is proposed that part 170
as revised elsewhere in this issue of the
Federal Register, be amended as.
follows:
PART 170—[AMENDED]
;; 1. The authority citation for part 170
continues to read as follows:
Authority: 7 U.S.C. 136w.
2. By amending § 170.3 by adding and
alphabetically inserting the following
.definition to read as follows:
§ 170.3 Definitions.
* ' * * * *
Material Safety Data Sheet means an
information document as defined by 29
CFR 1910.1200(g).
•'• 3. By adding new § 170.133 to subpart
B, to read as follows:
§ 170.133 Hazard information.
(a) Requirement. The agricultural
employer shall make available hazard
information concerning a pesticide, in
accordance with this section, to any
worker who enters a pesticide treated
area on an agricultural establishment
where, within the last 30 days a
pesticide has been applied or a
restricted-entry interval has been in
effect, or to any worker who may be
exposed to the pesticide during its
normal conditions of use or in a
foreseeable emergency.
(b) Format of information. Hazard
information shall be in one of the
following forms:
(1) A Material Safety Data Sheet for
the product, or for each active and inert
ingredient listed on the label of the
product.
(2) A fact sheet that has been
prepared or approved by a State or
Federal agency for the pesticide. If the
chemical ingredients of two or more
pesticides are substantially similar, but
the specific composition varies and the
products present similar hazards, one
fact sheet may suffice for these similar
products.
(c) Content of fact sheets. Each fact
sheet shall contain information,
expressed in nontechnical terms, except
for items specifically targeted towards
medical personnel, such as antidotes or
emergency treatment. The information
shall include:
(1) Typical brand name(s) of the
pesticide, and the chemical name and
common name of the pesticide.
(2) Information on the physical
characteristics of the pesticide, such as:
(i) Color, state (solid, liquid, or gas),
odor, and comparative volatility.
(ii) Comparative flammability and
explosivity.
(iii) Comparative shelf-life stability,
comparative or actual compatibility or
incompatibility to possible tank-mix
products, and comparative likelihood of
decomposing into hazardous
components.
(3) Information on the comparative
toxicity of the pesticide:
(i) The comparative acute toxicity for
the pesticide when swallowed, inhaled,
or absorbed through the skin, expressed
in terms of the relative category (highly
toxic, moderately toxic, slightly toxic or
relatively nontoxic) and corresponding
signal word, basing the category and
signal word on the criteria of § 156.10(h)
of this chapter.
(ii) The comparative skinlrritation
potential and eye irritation potential for
the pesticide expressed in terms of the
relative category (severely, moderately,
or slightly irritating or relatively
nonirritating to skin and/or eyes) and
corresponding signal word, basing the
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules | 38173
category and signal word on the criteria
of § 158.10{h) of this chapter.
(iii) The comparative sensitization
category for the pesticide expressed in
terms of the relative category [highly,
moderately, or slightly likely or
relatively unlikely to cause allergic or
sensitivity reactions in some
individuals).
(iv) Symptoms of overexposure.
(v) Any chronic or delayed health
effects, including tumors, malignancy or
cancer, changes in the genes or
chromosomes, birth defects, illness or
death (miscarriage or stillbirth) to a
fetus, infertility or sterility in men or
women, blood disorders, nerve or brain
disorders, skin disorders, liver and
kidney disorders, and/or lung and
respiratory disorders.
(vi) Whether the pesticide has been
found to be a potential cancer-causing
agent by a government agency or
recognized medical organization. The
sources that must be considered include
the latest editions of the National
Toxicology Program Annual Report on
Carcinogens (NTP), the International
Agency for Research on Cancer
Monographs (IARC), the Occupational
Safety and Health Administration
(OSHA), and EPA.
(vii) Medical conditions that may be
aggravated by exposure to the product.
(viii) Emergency and first aid
procedures for each applicable route of
exposure, i.e., oral, dermal, inhalation,
and eye.
(ix) Information for physicians on the
antidote, if any, and other applicable
information for medical treatment.
(x) The types of exposure limits that
have been established for the pesticide.
The exposure limits that must be
investigated include the OSHA
Permissible Exposure Limit (PEL) and
the EPA restricted-entry interval (REI).
Any other known and applicable
exposure limit used or recommended by
the manufacturer, formulator, importer
or a governmental agency must also be
noted. All listed limits must be
accompanied by a reference source to
permit more detailed information to be
obtained.
(4) Information on any special
protection needed in handling the
product such as use of personal
protective equipment, engineering
controls, and workplace practices for
the pesticide:
(i) Situations where personal
protective equipment or engineering
controls should be used.
(ii) Body protection, including the type
of clothing to be worn during exposures,
such as mixing/loading, cleaning of
equipment, and other handling
situations.
(iii) Hand and foot protection needed,
including specific material, if known,
that is chemical-resistant to the
pesticide or typical carrier solvent.
(iv) Eye protection.
(v) Respiratory protection, including,
if known, the specific respirator type
(dust/mist filtering, vapor/gas-removing,
or air-supplied) and the Mine Safety and
Health Administration/National
Institute for Occupational Safety and
Health (MSHA/NIOSH) approval
number prefix assigned to equipment
that is protective for the pesticide for
exposures outdoors and in enclosed
areas.
(vi) Recommendations for ventilating
enclosed areas, if appropriate.
(vii) Any other personal protective
equipment that would be appropriate for
specific exposure situations.
(viii) Recommended engineering
controls, such as closed systems,
enclosed cockpits, or enclosed cabs.
(ix) Other special protection
information or special workplace
practices.
(5) Information on spill or leak
cleanup procedures and disposal
methods for excess chemical and for
containers.
(6) The date the fact sheet was
prepared or revised to its present form.
(7) The telephone number of the
National Pesticide Telecommunications
Network and the name, address, and
telephone number of the manufacturer,
formulator, importer, or responsible
party, if known, who could provide
additional information about the
formulated product or the active/inert
ingredient and about appropriate
emergency procedures.
(8) If relevant information for any
given category on the fact sheet is not
obtainable, the category shall be marked
to so indicate.
(d) Accuracy of information on the
fact sheet and updates. (1) The entity
preparing the fact sheet shall ensure that
the information recorded accurately
reflects the scientific evidence used in
making the hazard determination or
shall ensure that the information
recorded accurately reflects the
information published on the
manufacturer's Material Safety Data
Sheet or the pesticide registrant's
product labeling.
(2) If the entity preparing the fact
sheet becomes aware of any significant
information regarding its hazards or
those of its formulations or the inert
ingredients, one of the following actions
is required:
(i) The new information shall be
added to the fact sheet within 3 months.
(ii) If the pesticide is not being
produced or imported currently, the
information shall be added to the fact
sheet before the formulated product is
introduced or reintroduced into the
workplace.
(e) Obtaining information. If a fact
sheet or Material Safety Data Sheet for
the formulated product or for each label-
listed active and inert ingredient in the
formulated product is not available at
the time the product is purchased, the
agricultural employer shall take
appropriate and timely steps to obtain
the Material Safety Data Sheet or fact
sheet from the distributor, the
manufacturer, a State or Federal agency,
or another distribution source.
(f) Maintaining information. The
agricultural employer shall maintain the
information specified in paragraph (a) of
this section at an appropriate central
location, accessible to workers during
working hours and readily obtainable in
an emergency.
(g) Providing information. The
agricultural employer shall provide a
written copy of the information specified
in paragraph (b) of this section, within a
reasonable amount of time, oh the
request of the worker, a representative
of the worker, or medical personnel
treating the worker.
4. By adding new § 170.233 |to subpart
C, .to read as follows:
§ 170.233 Hazard information.;
(a) Requirement. The handler
employer shall provide hazard
information concerning a pesticide, in
accordance with this section, to any
handler of a pesticide that is being
handled or that has been handled within"
the past 30 days or to any handler who
may be exposed to the pesticide during
its normal conditions.of use or in a
foreseeable emergency.
'(b) Format of information. Hazard
information shall be in either one of the
following forms:
(1) A Material Safety Data Sheet for
the product, or for each active and inert
ingredient listed on the label of the
product.
(2) A fact sheet that has been
prepared or approved by a State or
Federal agency for the pesticide. If the
chemical ingredients of two or more
pesticides are substantially similar, but
the specific composition varies and the
products present similar hazards, one
fact sheet may suffice for these similar
products.
(c) Content of fact sheets. Each fact
sheet shall contain information,
expressed in nontechnical terms, except
for items specifically targeted towards
medical personnel, such as antidotes or
emergency treatment. The information
shall include:
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38174
Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules
(1) Typical brand name(s) of the
pesticide, and the chemical name and
common name of the pesticide.
(2) Information on the physical
characteristics of the pesticide, such as:
(i) Color, state (solid, liquid, or gas),
odor, and comparative volatility.
(ii) Comparative flammability and
explosivity.
(iii) Comparative shelf-life stability,
comparative or actual compatibility or
Incompatibility to possible tank-mix
products, and comparative likelihood of
decomposing into hazardous
components.
(3) Information on the comparative
toxicity of the pesticide:
(i) The comparative acute toxicity for
the pesticide when swallowed, inhaled,
or absorbed through the skin, expressed
in terms of the relative category (highly
toxic, moderately toxic, slightly toxic, or
relatively nontoxic) and corresponding
signal word, basing the category and
signal word on the criteria of § 156.10(h)
of this chapter.
(ii) The comparative skin irritation
potential and eye irritation potential for
the pesticide expressed in terms of the
relative category (severely, moderately,
or slightly irritating or relatively
nonirritating to skin and/or eyes) and
corresponding signal word, basing the
category and signal word on the criteria
of § 156.10(h) of this chapter.
(iii) The comparative sensitization
category for the pesticide expressed in
terms of the relative category (highly,
moderately, or slightly likely or
relatively unlikely to cause allergic or
sensitivity reactions in some
individuals).
(iv) Symptoms of overexposure.
(v) Any chronic or delayed health
effects, including tumors, malignancy, or
cancer, changes in the genes or
chromosomes, birth defects, illness or
death (miscarriage or stillbirth) to a
fetus, infertility or sterility in men or
women, blood disorders, nerve or brain
disorders, skin disorders, liver and
kidney disorders, and/or lung and
respiratory disorders.
(vi) Whether the pesticide has been
found to be a potential cancer causing
agent by a government agency or
recognized medical organization. The
•sources that must be considered include
the latest editions of the National
Toxicology Program Annual Report on
Carcinogens (NTP), the International
Agency for Research on Cancer ,
Monographs (IARC), the Occupational
Safety and Health Administration
(OSHA), and EPA.
(vii) Medical conditions that may be
aggravated by exposure to the product.
(viii) Emergency and first aid
procedures for each applicable route of
exposure, i.e., oral, dermal, inhalation,
and eye.
• (ix) Information for physicians on the
antidote, if any, and other applicable
information for medical treatment.
(x) The types of exposure limits that
have been established for the pesticide.
The exposure limits that must be
investigated include the OSHA
Permissible Exposure Limit (PEL) and
the EPA restricted-entry interval (REI).
Any other known and applicable
exposure limit used or recommended by
the manufacturer, formulator, importer
or a governmental agency must also be
noted. All listed limits must be
accompanied by a reference source to
permit more detailed information to be
obtained.
'.; (4) Information on any special
protection needed in handling the
product such as use of personal
protective equipment, engineering
controls, and workplace practices for
the pesticide:
, (i) Situations where personal
protective equipment or engineering
controls should be used.
i (ii) Body protection, including the type
of clothing to be worn during exposures,
such as mixing/loading, cleaning of
equipment, and other handling
situations.
(iii) Hand and foot protection needed,
including specific material, if known,
that is chemical-resistant to the
pesticide or typical carrier solvent.
(iv) Eye protection.
;; (v) Respiratory protection, including,
if known, the specific respirator type
(dust/mist filtering, vapor/gas-removing,
or air-supplied) and the Mine Safety and
Health Administration/National
Institute for Occupational Safety and
Health (MSHA/NIOSH) approval
number prefix assigned to equipment
that is protective for the pesticide for
exposures outdoors and in enclosed
areas.
(vi) Recommendations for ventilating
enclosed areas, if appropriate.
(vii) Any other personal protective
equipment that would be appropriate for
specific exposure situations.
(viii) Recommended engineering
controls, such as closed systems,
enclosed cockpits, or enclosed cabs.
' (ix) Other special protection
'information or special workplace
practices.
i (5) Information on spill or leak
cleanup procedures and disposal
methods for excess chemical and for
containers.
(6) The date the fact sheet was
prepared or revised to its present form.
1 (7) The telephone number of the
^National Pesticide Telecommunications
Network and the name, address, and
telephone number of the manufacturer,
formulator, importer, or responsible
party, if known, who could provide
additional information about the
formulated product or the active/inert
ingredient and about appropriate
emergency procedures.
(8) If relevant information for any
given category on the fact sheet is not
obtainable, the category shall be marked
to so indicate.
(d) Accuracy of information on the
fact sheet and updates. (1) The entity
preparing the fact sheet shall ensure that
,the information recorded accurately
reflects the scientific evidence used in ',
making the hazard determination or
shall ensure that the information
recorded accurately reflects the
information published on the
manufacturer's Material Safety Data
Sheet or the pesticide registrant's
product labeling.
(2) If the entity preparing the fact
sheet becomes aware of any significant
information regarding its hazards or
those of its formulations or the inert
ingredients, one of the following actions
is required:
(i) The new information shall be
added to the fact sheet within 3 months.
(ii) If the pesticide is not being
produced or imported currently, the
information shall be added to the fact
sheet before the formulated product is
introduced or reintroduced into the
workplace.
(e) Obtaining information. If a fact
sheet or Material Safety Data Sheet for
the formulated product or for each label-
listed active and inert ingredient in the
formulated product is not available at
the time the product is purchased, the
handler employer shall take appropriate
and timely steps to obtain the Material
Safety Data Sheet or fact sheet from the
distributor, the manufacturer, a State or
Federal agency, or another distribution
source.
(f) Maintaining information. The
handler employer shall maintain the
information specified in paragraph (a) of
this section at an appropriate central
location, accessible to handlers during
working hours and readily obtainable in
an emergency.-
(g) Providing information. The handler
employer shall provide a written copy of
the information specified in paragraph
(b) of this section, within a reasonable
amount of time, on the request of the
handler, a representative of the handler,
or medical personnel treating the
handler.
[FR Doc. 92-20006 Filed 8-19-92; 10:31 am]
BILLING CODE 6560-50-F
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Federal Register / Vol. 57. No: 163 / Friday, August 21, 1992 / Proposed Rules 38175
40 CFR Part 170
[OPP-300164E; FRL-4160-7]
Exception to Worker Protection
Standard Early Entry Prohibition for
Hand Labor Tasks Performed on Cut
Flowers and Cut Ferns
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed exception to rule;
request for comment.
SUMMARY: EPA is considering an
exception to the Worker Protection
Standard, published elsewhere in this
issue of the Federal Register, that would
allow, under specified conditions, early
entry to perform routine hand labor
tasks on cut flowers and cut ferns.
DATES: Comments, data, or evidence
should be submitted on or before
September 21,1992.
ADDRESSES: Comments should be
submitted in triplicate and addressed to
the Document Control Officer (H7506CJ,
Office of Pesticide Programs,
Environmental Protection Agency, 401M
St., SW., Washington, DC 20460.
All comments should bear the
document control number OPP-300164E
and will be available for public
inspection from 8:30 a.m. to 4 p.m.,
Monday through Friday, at the OPP
Document Control Office, Rm. 1132,
Crystal Mall #2,1921 Jefferson Davis
Highway, Arlington, VA.
FOR FURTHER INFORMATION CONTACT:
James J. Boland, Acting Chief,
Occupational Safety Branch (H7506C),
Environmental Protection Agency, 401M
St., SW., Washington, DC 20460, (7031
305-7666.
SUPPLEMENTARY INFORMATION:
I. Background
Section 170.112(eK2) of the Worker
Protection Standard (40 CFR part 170),
which is published elsewhere in this
issue of the Federal Register, provides a
mechanism for considering exceptions
to the provision in the Standard
prohibiting early entry to perform
routine hand labor tasks. Information
that the Agency received from the cut
flower and cut fern industry during the
comment period for the Notice of
Proposed Rulemaking for 40 CFR parts
158 and 170, the Worker Protection
Standard for agricultural pesticides, has
persuaded EPA that there could be
substantial economic repercussions if
routine hand labor tasks were
prohibited during the restricted-entry
interval. The Agency has reviewed the
information received on the subject and
is inclined to grant an exception to such
a prohibition for this industry, because,
in light of the economic benefits and
new conditions of entry that would be
imposed, the Agency believes it is likely
that early entry would not pose
unreasonable risks to workers in this
industry.
II. Evidence
Rose growers (and other cut flower
growers) opposed the proposed
restricted-entry intervals because of the
economic burden that would result to
their industry. Several comments
emphasized the need to cut the roses
twice a day, 365 days a year. The
comments stated that roses are sprayed
on a weekly or biweekly basis and that
not cutting flowers 26 to 50 days a year
would be economically disastrous. One
grower estimated that a 1 to 2-day
restricted-entry interval would cause at
least a 10- to 15-percent crop loss.
Roses.^Inc., estimated the crop loss
would represent 14 percent of annual
sales or, on average, a loss of more than
$35,000 per year per acre.
Several comments suggested that
reentry for tending floral crops be
allowed after sprays dry, in normal
work attire, for not more than 3 hours
per worker per day. Others requested
that entry to treated areas be allowed
for not more than 1 hour in 24 hours per
worker so that flowers could be tended.
III. Agency's Preliminary Findings
The Agency believes that the cut
flower and cut fern industry must have
frequent access to harvest and tend to
this time-sensitive crop. However, the
Agency has no basis for reducing or
eliminating restricted-entry intervals on
these crops. EPA is not aware of any
substitute practice that could be used to
avoid the economic burden to the
industry. The Agency believes that the
projected economic costs due to a
prohibition of early entry to perform
hand labor tasks are higher than the
costs of sending workers in during the
restricted-entry interval and providing
them with the required early entry
protections, including decontamination
facilities, specific information, heat-
stress avoidance, and providing,
cleaning, and maintaining the personal
protective equipment.
To avoid excessive economic burden
to the cut flower industry, the Agency is
inclined to allow early entry, under
certain conditions, to perform hand
labor tasks on cut flowers or cut ferns,
such as harvesting, pruning, disbudding,
and watering. The Agency believes that,
in this situation, the use of personal
protective equipment, accompanied by a
limitation on worker-exposure time,
accessible decontamination facilities,
label-specific and general pesticide
safety instruction, and, often, shade and
mechanical cooling devices, will reduce.
the risk of excessive pesticide exposure
for these workers. The Agency expects
this exception would have no
geographic or time limitations, because
these crops are throughout the country
and EPA has no basis to believe a time
limitation is appropriate. The following
additional factors also influenced the
Agency's tentative conclusion: (1)
Personal protective equipment would be
worn for only limited periods of time
because the tasks to be performed are of
short duration; (2) the tasks to be
performed could be accomplished in a
reasonably efficient manner while
wearing personal protective equipment,
including coveralls, chemical-resistant
gloves (possibly underneath leather
gloves), chemical-resistant footwear and
headgear, and safety glasses; (3) the
accessibility, usual in this industry, of
running water for decontamination and
heat stress alleviation; and (4) the
availability, also usual in this industry,
of shade, fans, or other mechanical
ventilation to provide some cooling. The
Agency is therefore persuaded that early
entry with personal protective
equipment is feasible and likely to
provide adequate reduction of risks to
the workers in the cut flower and cut
fern industry.
IV. Proposed Terms of Exception
Under the exception to § 170.112(a)(l)
of the Worker Protection Standard that
the Agency is considering, workers
could carry out hand labor tasks
associated with the cultivation and
harvesting of cut flowers and cut ferns if
the requirements of § 170.112(c)(3)
through (c)(9) are met, i.e., (1) No entry
takes place for the first 4 hours after the
application and, thereafter, until any
exposure level listed on the labeling has
been reached or any ventilation criteria
established by the Worker Protection
Standard or in the labeling has been
met; (2) the personal protective
equipment required for early entry is
provided, cleaned, and maintained for
the worker; (3) the required
decontamination and change areas are
provided; (4) the required basic training
and label-specific information have
been furnished; and (5) measures to
prevent heat-related illness are
implemented, when appropriate. In
addition, for this specific exception for
cut flowers and cut ferns the time in
treated areas for each worker could not
exceed 3 hours in any 24-hour period.
V. Comments Solicited
The Agency is interested in a full
range of comments and information on
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Federal Register / Vol. 57, No. 163 / Friday, August 21, 1992 / Proposed Rules
this proposed exception and grants 30
days for interested parties to comment.
The Agency particularly welcomes
comments supported by information,
such as evidence demonstrating whether
the risks to workers would be
acceptable, whether the use of personal
protective equipment in these
circumstances would be feasible, and
whether there are feasible alternative
practices that would make routine early
entry unnecessary. The Agency also
would welcome any additional
information concerning the likely
economic impact on this industry of a
prohibition of routine hand labor tasks
during the restricted-entry intervals.
Dated: August 13,1992.
William K. Reilly,
Administrator.
[FR Doc. 92-20007 Filed 8-19-92; 10:31 am]
BILLING CODE 6560-50-F
•&U.S. GOVERNMENT PRINTING OFFICE: 1994 - 515-003/01001
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