INTRODUCTION
Regulation of Marketed Pesticides
In most countries, before a pesticide product can be marketed
and used to manage a pest problem, the product must be registered
with a government agency responsible for regulating the sale,
distribution and use of pesticide products. Initially, registration
of pesticide products was required to protect the consumer from
fraudulent claims and limited attention was given to the impact
of the product on consumer safety or the environment. As awareness
of the potential impact of pesticides on the user, the consumer,
and the environment developed, the registration of a pesticide
products became the predominant method for regulating the use
of a pesticide products.
As requirements for registration of pesticide products expanded,
the product label became the bottom line of the registration process.
Every specific statement on the label had to be supported by evidence
that no adverse effect would be caused to man or the environment
if the product was used according to instructions specified on
the product label.
Regulation of Pesticide Applicators
Although a pesticide product may be approved to control a specific
pest problem on a given host crop or site, problems may still
occur if the applicator does not follow the instructions specified
on the label or fails to use sound judgment when exceptional situations
occur. As a result, it has been recognized over time that distribution
and use of some pesticide products need to be restricted to applicators
or users having the training or expertise to use the pesticide
product in a manner that no adverse harm will occur to man or
the environment.
Regulating applicators of pesticide products includes two steps:
(1) pesticide products designated for restricted use must be labeled
accordingly during registration process, and (2) a system of pesticide
applicator training and certification must be implemented to insure
that only trained applicators are granted a license to purchase
and use pesticide products labeled for restricted use.
Variability in Government Regulation of Pesticides
The pesticide market is global, corporations market their pesticide
products throughout the world, and treated products are exported
and imported across international boundaries. Since pesticide
regulations differ from one country to another, guidelines on
pesticide regulations are provided by an International Code of
Conduct on the Distribution and Use of Pesticides adopted delegates
of the United Nations Food and Agriculture Organization (FAO)
conference in 1985.
THE FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT
Federal regulation of pesticides in the United States began with
the Insecticide Act passed in 1910. After world war II,
which lead to the development of many new pesticides, the first
version of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) was passed in 1947. From 1910 to 1972, when FIFRA
was revised, the responsibility for regulating pesticides was
the domain of the United States Department of Agriculture (USDA).
In the sixties, public awareness over environmental issues including
pesticide use resulted in the creation of a new federal agency,
namely the Environmental Protection Agency (EPA) and a
major revision of FIFRA regulations, which transferred the responsibility
for regulation pesticides at the federal level from USDA to EPA.
Prior to 1972, the emphasis of FIFRA regulations was on the safety
and efficacy of pesticides in agriculture production. After the
passage of the amended FIFRA, the focus of FIFRA regulations shifted
to reduction of risks to mankind and the environment.
The amended FIFRA in 1972 changed the process for registering
a pesticide with the addition of new requirements to enable evaluation
of risks and environmental impacts associated with pesticides.
Responsibility for providing the data to support registration
shifted from the government to the manufacturer, and the EPA developed
a system for auditing independent institutions that generated
the data required for registration. A significant development
of the 1972 revision of FIFRA was the classification of pesticide
products for restricted or general use. Restricted use pesticide
products were considered a risk to the applicator or the environment
if applied without some level of training, and thereafter only
could be applied by certified applicators. Given the need for
a system of applicator certification, the USDA with its links
to state land-grant institutions assumed the responsibility for
training pesticide applicators who in turn were certified by state
government agencies having responsibility for enforcement of pesticide
regulations.
In 1988, the FIFRA regulations were amended again with an emphasis
on reregistration of pesticide products that been initially registered
prior to 1984. In addition, the 1988 FIFRA amendments established
a new system of registration fees and set new guidelines for pesticide
containers and disposal.
REGISTRATION OF PESTICIDES - FIFRA SECTION 3
"... no person in any State may distribute or sell to
any person any pesticide that is not registered under this Act
(FIFRA). To the extent necessary to prevent unreasonable adverse
effects on the environment, the (EPA) Administrator may by regulation
limit the distribution, sale, or use in any State of any pesticide
that is not registered under this Act ......"
The above statement is included in the initial paragraph of Section
3 of the FIFRA Act which summarizes the legal procedures that
the Environmental Protection Agency (EPA) and parties applying
for registration of a pesticide must follow to register a pesticide.
As a result, the process of obtaining a registration to market
a pesticide product is commonly referred to as a FIFRA Section
3 registration.
EPA publishes extensive guidelines on information required to
support registration of a pesticide. The basic categories of data
requirements for registration of a pesticide product include the
following:
1. Product Chemistry: This includes a full range of chemical
parameters describing the physical components of the pesticide
product.
2. Residue Chemistry: This data enables estimation of exposure
of the general population to pesticide residues in food and establishment
of tolerances for residues in food and feed.
3. Environmental Fate: This data enables assessment of
pesticide toxicity to man via exposure to residues remaining after
application. Required studies focus on degradation, metabolism,
mobility, dissipation and accumulation.
4. Toxicology: This data enables assessment of hazards
to humans and animals based on a variety of acute, subchronic
and chronic toxicity tests, plus tests to assess mutagenicity
and pesticide metabolism.
5. Reentry Protection: This data enables assessment of
hazard to workers reentering areas treated with pesticides and
determination of reentry intervals.
6. Spray Drift: This data enables evaluation of pesticide
spray drift and development of exposure estimates affecting nontarget
organisms (including humans, plants, wildlife, etc.) in general.
7. Nontarget Organisms: This data enables assessment of
hazards to nontarget organisms including birds, mammals, fish,
terrestrial and aquatic invertebrates, and plants. Both short
and long range studies may be required.
8. Product Performance: This data establishes the effectiveness
of the pesticide product to prevent unnecessary use of ineffective
products.
9. Biochemical & Microbial Pesticides: In addition,
special data requirements apply to biochemical and microbial pesticides.
In addition to initial data required for obtaining a Section 3
registration, the EPA may also require additional data to maintain
an existing registration. This action is clearly defined in Section
3 of FIFRA by the following statement:
"If the (EPA) Administrator determines that additional
data are required to maintain in effect registration of a pesticide,
the Administrator shall notify all existing registrants of the
pesticide to which the determination relates ..."
An application for registration of a pesticide is approved when
the EPA determines that the following criteria have been achieved:
1. The composition of the product warrant proposed claims.
2. Labeling of the material complies with the FIFRA Act.
3. The pesticide will perform its function without unreasonable
adverse effects on the environment.
4. When used in a manner anticipated, the pesticide will not cause
unreasonable adverse effects on the environment.
The official information medium for reporting all actions related
to pesticide registrations is the Federal Register. As
a result, all interested parties concerned with pesticide registrations
or related actions may monitor registrants' requests or EPA's
decisions and react accordingly.
Classification of Pesticides
"As a part of the registration of a pesticide the Administrator
shall classify it as being for general use or for restricted use."
A key decision made by EPA during the registration process is
whether a pesticide will be classified for general or restricted
use. A general use classification applies to pesticides
that will not generally cause unreasonable adverse effect on the
environment. A restricted use classification applies to
pesticides that may generally cause, without additional regulatory
restrictions, unreasonable adverse effects on the environment,
including injury to the applicator. Pesticides assigned a restricted
classification may be applied only by or under the direct supervision
of a certified applicator. As a result, the classification of
a pesticide has a significant impact on the eventual marketing
of the product. It is important to note that the classification
of a pesticide applies to the labeled formulation (or labeled
use) of a pesticide and not necessarily to the active ingredient
of the pesticide product.
FIFRA, FFDCA and TOLERANCES
Pesticide residues on agricultural commodities are regulated by
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
and by the Federal Food, Drug and Cosmetic Act (FFDCA).
FIFRA forbids the use of a pesticide is a manner inconsistent
with its label and denies registration of pesticides that may
have unreasonable adverse effects to man or the environment. Thus,
FIFRA regulates pesticide residues by regulating pesticide use.
FFDCA prohibits distribution of agricultural commodities that
contain levels of pesticides beyond a maximum tolerance
level, which is a legal maximum residue concentration allowed
in food or feed. If residues of a given pesticide are found to
exceed the established tolerance level, or no tolerance has been
established, a crop may be considered adulterated and may be seized
by the Food and Drug Administration (FDA), the United
States Department of Agriculture (USDA), or a state enforcement
agency.
Tolerances are set by EPA under the authority of FFDCA. Section
408 of FFDCA sets standards of risk and benefits assessment
for establishing residues in raw agricultural commodities (RACs).
Section 409 of FFDCA sets standards for residues in processed
foods. In the case of processed foods, the so-called Delaney
Clause bans any cancer causing additive. Thus, a risk/benefit
analysis in determining a pesticide tolerance on the use of a
potential cancer-causing pesticide on processed food is not possible
where a pesticide is demonstrated to be a potential cancer-causing
agent. As advances in chemical residue detection and medical technology
progress, the inconsistency of setting tolerances on raw and processed
food commodities has become a major issue in pesticide regulations.
EXPERIMENTAL USE PERMITS AND SPECIAL EXEMPTIONS
FIFRA SECTIONS 5, 18, 24c & 2(ee)
A number of special situations are defined under the law to permit
the use of a pesticide in a situation not covered by approved
label. Such special situations may apply to (1) development of
a new pesticide where field data is needed prior to completion
of the registration process, (2) application of a pesticide to
control a pest problem that is not specifically defined, and (3)
application of a pesticide under emergency situations where no
alternative pesticides are available to meet the need that exists.
Experimental Use Permits - FIFRA Section 5
"Any person may apply to the EPA for an experimental use
permit (EUP) for a pesticide..... The Administrator (EPA) may
issue an experimental use permit only if the Administrator determines
that the applicant needs such a permit in order to accumulate
information necessary to register a pesticide under section 3
of this Act."
At some point in time, the development of a new pesticide having
an active ingredient not previously registered must be evaluated
in the field to obtain residue data and evaluate the efficacy
of the product. Thus, it is necessary to apply the experimental
product in the field before a Section 3 registration has been
approved and possibly before a tolerance level has been established
for the active ingredient, since the tolerance level may also
be based on data gathered from experimental field trials.
Thus, as a new product approaches the stage for experimental field
testing, an EUP must be obtained from the EPA to gather information
required for a Section 3 registration. In the process of granting
an EUP, the EPA will define the terms under which the experimental
material may be applied in regard to such parameters as area and
habitats or subjects to be treated, time period allowed, and types
of treatments to be applied. If a tolerance has not been established
for the product under evaluation, then the EPA will establish
a temporary tolerance level before issuing the EUP.
Exemption of Federal and State Agencies - FIFRA Section 18
Occasionally, a situation develops where a pesticide product may
have to be applied to correct a significant pest problem and a
Section 3 registration applicable to the given condition is lacking.
Such a situation is addressed in FIFRA Section 18 with the following
statement:
"The Administrator (EPA) may, at his discretion, exempt
any Federal or State agency from any provision of this Act if
it determines that emergency conditions exist which require such
exemption. The Administrator (EPA), in determining whether or
not such emergency conditions exist, shall consult with the Secretary
of Agriculture and the Governor of any State concerned if they
request such determination."
Revised rules clarifying conditions and procedures applicable
to Section 18 regulations were published in 1985 and 1986 in the
Federal Register. Four types of emergency exemptions defined included
the following:
1. Specific exemption: A specific exemption may be authorized
in an emergency condition to avert (a) a significant economic
loss, or (b) a significant risk to (i) endangered species, (ii)
threatened species, (iii) beneficial organisms, or (iv) the environment.
2. Quarantine exemption: A quarantine exemption may be
authorized in an emergency to control the introduction or spread
of any pest new or not known to be widely prevalent.
3. Public health exemption: A public health exemption may
be authorized in an emergency to control a pest that will cause
a significant risk to human health.
4. Crisis exemption: A crisis exemption may be utilized
in an emergency when time from discovery of emergency to the time
when pesticide use is needed is insufficient to allow for authorization
or a specific, quarantine, or public health exemption.
Authority of States - FIFRA Section 24c
When a pesticide is registered for given use on a given commodity
and a need exists for an additional use on the same commodity,
a state may provide a registration for the additional use of the
product which was not included in EPA's Section 3 registration.
In practice, a state label under this section is generally referred
to as a Section 24c label given the following statement
found in FIFRA Section 24:
"A State may regulate the sale or use of any federally
registered pesticide or device in the State, but only if and to
the extent the regulation does not permit any sale or use prohibited
by this Act. ....... A State may provide registration for additional
uses of federally registered pesticides formulated for distribution
and use within that State to meet special local needs in accord
with the purposes of this Act and if registration for such use
has not previously been denied, disapproved, or canceled by the
(EPA) Administrator."
The existence of a Section 3 registrations and tolerance for a
given use of a product is a critical requirement for granting
of a Section 24c by a state. If a special need does exist for
a product and no tolerance exists, then the only process for providing
an exemption would be to apply for a specific exemption under
Section 18, which could only be granted by EPA, who could establish
a temporary tolerance. In an emergency situation, a state could
declare crisis exemption under Section 18, but such action would
only be taken if the action could be defended under the same requirements
of a specific exemption.
FIFRA Sec. 2(ee) To Use Any Pesticide in a Manner Inconsistent
With Its Labeling
"The term 'to use any pesticide in a manner inconsistent
with its labeling" means to use any registered pesticide
in a manner not permitted by the labeling, except that the term
shall not include (1) applying a pesticide at any dosage, concentration,
or frequency less than that specified on the labeling specifically
prohibits deviation from the specified dosage, concentration,
or frequency, (2) applying a pesticide against any target pest
not specified on the labeling if the application is to the crop,
animal, or site specified on the labeling after the Administrator
has determined that the use of the pesticide against other pests
would cause an unreasonable adverse effect on the environment,"
..... etc
.
The exemptions covered in a FIFRA Section 2(ee) clarify
interpretations of a label that are considered legal from the
standpoint that the approved time and place of use has not been
altered from that stated on the label. The most common use of
the Section 2(ee) is the use of a product to control a pest not
given on a label in the same manner that one would apply the product
for a pest listed on the label. In such a situation, the use would
not be altered as it would have been under a Section 24c.
The term of "Section 2(ee)" derives it's name from the
fact that the definition is found in the initial definition Section
2 of FIFRA and the (ee) refers to the alphabetical sequence of
the definition in the listings.
Implementation of a Section 2(ee) often includes a formal letter
to the State regulatory agency from the registrant if the manufacturer
desires to support the use. In addition, it is commonly recognized
that any knowledgeable authority (such as state extension specialist
may recommend a product for control of a pest when a Section 2(ee)
is applicable.
REVIEW & SUSPENSION - FIFRA Section 6
"If it appears to the Administrator (EPA) that a pesticide
or its labeling or other material required to be submitted does
not comply with the provisions of this Act (FIFRA) or, when used
in accordance with widespread and commonly recognized practice,
generally causes unreasonable adverse effects on the environment,
the Administrator may issue a notice of intent either - (1) to
cancel its registration or to change its classification together
with reasons for his action, or (2) to hold a hearing to determine
whether or not its registration should be canceled or its classification
changed."
(FIFRA Section 6b)
"If the Administrator (EPA) determines that action is
necessary to prevent an imminent hazard during the time required
for cancellation or change in classification proceedings, he may,
by order, suspend the registration of a pesticide immediately."
(FIFRA Section 6c)
Cancellation vs. Suspension
When questions are raised regarding the status of a current Section
3 registration of a pesticide, the EPA may choose to issue a cancellation
or suspension notice regarding the registration status of the
pesticide in question. The cancellation of a pesticide
registration is generally a slow process following a series of
notices and hearings. Furthermore, when a pesticide's registration
is canceled, the remaining stock of the labeled pesticide may
be used for a given time period depending on terms given in the
cancellation notice. In contrast, the suspension of a registration
of a pesticide is immediate, and use of remaining stocks of the
labeled pesticide are terminated immediately.
A significant portion of the legal terminology included in Section
6 applies to timeframes and procedures regarding notification
of registrants and response actions that may lead to either judicial
reviews, public hearings or scientific review. Since the process
of cancellation may take months or years before a final decision
is enacted, the suspension process is employed when immediate
termination of a pesticide's use is considered essential. However,
when suspension actions are taken on a registration, the registrant
is still given an opportunity to request an expedited hearing.
Reporting of Adverse Effects
"If at any time after registration of a pesticide the
registrant has additional factual information regarding unreasonable
adverse effects on the environment of the pesticide, he shall
submit such information to the Administrator." (FIFRA
Section 6a-2)
The requirement that a registrant must report any adverse environmental
effect of a pesticide places registrants in a position of sometimes
having to report field observations that may have negative implications
on the continued marketing of their product. The industry generally
follows a policy of responsible reporting to demonstrate product
stewardship and prevent liabilities that may result from concealment
of information linked to an adverse impact of a product.
Voluntary Cancellation
"A registrant at any time may request that any of its
pesticide registrations be canceled or amended to delete on or
more uses."
(FIFRA Section 6f)
When the economic or public defense of a pesticide product exceeds
the value of maintaining a given registration of the product,
a registrant may choose to voluntary cancel or amend the registration
in question. Such a situation often results when a product serving
a limited market is linked to a case generating adverse publicity.
Canceled & Suspended Pesticides in Storage
"Any producer, exporter, registrant, applicant for registration,
holder of experimental use permit, commercial applicator, or any
person distributing or selling any pesticide, who possesses any
pesticide which has had its registration canceled or suspended
shall notify the Administrator (EPA) and appropriate State and
local officials of (1) such possession, (2) the quantity of such
pesticide such person possesses, and (3) place at this such pesticide
is stored." (FIFRA Section 6g)
When a pesticide registration is canceled or suspended, a problem
exists regarding the continued use of product. In the case of
products having a canceled registration, the timeframe is often
extended over a period of time to enable reasonable consumption
of the product in question. In the case of a suspended registration,
the product may need to be retrieved to prevent additional use
of the product.
REREGISTRATION - FIFRA Section 4
In October of 1988, the FIFRA Amendments of 1988 were signed into
law with most of the provisions becoming effective on December
24, 1988. These amendments accelerated the reregistration process
for previously registered pesticides and authorized the collection
of fees to support reregistrations activities. In addition, the
law altered EPA's responsibilities and funding requirements for
storage and disposal of suspended and canceled pesticides and
the indemnification to holders of canceled pesticides.
The original FIFRA law was enacted in 1947, amended in 1964 and
again in 1972. Over time registration requirements became more
stringent as technology for pesticide evaluation changed. Section
4.0 of the FIFRA law required that pesticide products be reviewed
for reregistration and that EPA issue "Registration Standards",
which include (1) a comprehensive review of all available data
on an existing chemical, (2) a list of additional data needed
for full registration, and (3) the EPA's current regulatory position
for a given chemical.
The 1988 amendments identified 5 phases in the reregistration
process which included the following:
Phase 1. EPA was required to publish lists (starting March 1989)
of pesticide active ingredients subject to reregistration and
obtain a response from registrants that they intend to seek registration.
Phase 2. Registrants are required to respond to EPA (within 3
months after EPA publishes each list) regarding their intent to
seek reregistration, identify studies required to satisfy EPA's
current data requirements, agree to fill data gaps, and pay a
portion of the registration fee.
Phase 3. Registrants are required to summarized and reformat key
existing studies to facilitate EPA review and pay a final reregistration
fee. This phase is to be completed within 2 years after passage
of the 1988 amendments.
Phase 4. EPA is required to complete its review of the submissions
made by registrants under Phases 2 and 3, identify data gaps,
and issue requirements for registrants to fill data gaps. This
phase is scheduled for a periods of 2 to 4 years after passage
of the 1988 amendments
Phase 5. EPA is required to conduct a thorough, comprehensive
examination of all data submitted in support of pesticide reregistration
and either reregister a pesticide or take appropriate action.
This phase will occur over a span between 3 to 9 years following
the enactment of the 1988 amendments. However, progress achieved
to date on the reregistration process is backlogged and the process
is likely to extend beyond the year 2000.
The reregistration process was expected to cost about $250 million
and approximately 50% of the cost is expected to come from the
leverage of new fees. The pesticide industry must now pay for
the reregistration process through two kinds of fees: (1) a reregistration
fee for each active ingredient, and (2) an annual fee for registration
maintenance. The impact of the reregistration action on pesticide
product registration was significant. EPA had canceled nearly
20,000 pesticide registrations for failure to pay the annual registration
maintenance fee due March 1, 1989. Many of the cancellations represented
a general cleaning out of obsolete registrations of which many
had reported no production since 1985.
PESTICIDE APPLICATOR CERTIFICATION
Congress amended the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) in 1972 to correct problems associated with the misuse
of pesticides. Included in the amendments were two regulatory
provisions that required certification of applicators of pesticides.
These provisions were (1) that EPA must classify all pesticide
products for either "general" or "restricted"
use and (2) that "restricted use" pesticides may be
used only by, or under direct supervision of, certified applicators
or under regulatory restrictions required by EPA. At the time
the provisions regarding certification of applicators were made,
Congress specified that the provisions be fully implemented by
October, 1976.
The amended FIFRA established two types of certified applicators,
commercial and private. A commercial applicator was designated
as a person who uses or supervises the use of restricted use pesticides
on the property of another party in return for compensation. In
contrast a private applicator was designated as a person
who uses or supervises the use of a restricted use pesticide to
produce an agricultural commodity on property owned or rented
by him (or her) or his (or her) employer. A private applicator
could also apply a pesticide to a second party's property if no
compensation was exchanged or if the service was performed as
a trade of services between producers of agricultural commodities.
In 1974, EPA published standards for certification of applicators
of restricted use pesticides in the Federal Register. The responsibility
for training and certification of applicators was assigned to
the States providing that plans for certification of applicators
by individual States were approved by EPA. Since States could
select to implement plans of applicator certification exceeding
the basic standards established by EPA, programs of applicator
certification differed from State to State. Some States implemented
the minimal standards recommended by EPA and other States implemented
programs having higher standards.
Certification Standards
The initial EPA standards for applicator certification established
10 occupational categories for commercial applicators. States
had the option of establishing additional categories, subdividing
the categories, or deleting categories if local conditions warranted
such actions.
Federal guidelines declared that competence of commercial applicators
in the use and handling of pesticides would be determined by written
examinations. Determination of competence by performance testing
would be allowed when appropriate. General standards prescribed
for all categories of certified commercial applicators required
demonstration of competence on the following subjects: (1) label
and labeling; (2) pesticide safety; (3) environmental effects;
(4) knowledge about pests; (5) knowledge about pesticides; (6)
equipment use; (7) application techniques, and (8) State and Federal
laws and regulations. In addition, commercial applicators were
to demonstrate a practical knowledge regarding their specific
category of certification.
The federal guidelines required that private applicators demonstrate
a practical knowledge of pest problems and pest control operations
including storage, use, handling and disposal of pesticides and
containers plus related legal responsibilities. Verification of
a private applicator's competence was declared the responsibility
of the responsible state agency. The use of written, oral or equivalent
testing procedures was to be determined by the states. However,
a private applicator was required to demonstrate an ability to
comprehend a pesticide label and associated labeling. (Note: The
use of written examination to determine competence and a capability
to read pesticide labels were not required of private applicators.)
Non-certified persons were allowed to apply restricted use pesticides
under the supervision of certified commercial or private applicators.
The physical presence of the certified applicators was not required
assuming that guidance for pesticide application was given and
provisions had been made for contacting the certified applicator
if a need developed. However, a pesticide label could require
the presence of the certified applicator when application was
to be made by a non-certified applicator.
Revision of Standards for Applicator Certification
In the fall of 1990, new guidelines on certification of pesticide
applicators were published in the Federal Register. The new rules
proposed a number of changes, which included the following:
(a) Establishment of private applicator categories and additional
commercial applicator categories.
(b) Revision of general and specific standards of competency including
elimination of the non-reader provision permitted in earlier guidelines.
(c) Establishment of levels of supervision of non-certified applicators
by certified applicators.
(d) Proposed record keeping on training provided noncertified
applicators using restricted use pesticides under the supervision
of certified commercial applicators.
(e) That certified applicators be recertified every 5 years.
WORKER PROTECTION STANDARD FOR AGRICULTURAL PESTICIDES
The Worker Protection Standard (WPS) is a regulation issued
in 1992 by the EPA to protect agricultural workers from pesticide
exposure. Employers of agricultural workers who must comply with
WPS include (1) managers or owners of farms, forests, nurseries,
or greenhouses, (2) labor contractors for farms, forest, nurseries,
or greenhouses, and (3) custom pesticide applicators or crop consultants
hired by farm, forest, nursery, or greenhouse operators. Agricultural
employees to be protected by WPS are defined under two categories,
namely: (1) workers, who perform tasks related to production
of agricultural plants such as harvesting, weeding or watering,
and (2) pesticide handlers, who perform tasks related to
the application of pesticides such as mixing pesticides, applying
pesticides, loading open pesticide containers, servicing pesticide
application equipment, or entering a treated area during any restricted-entry
interval.
Pesticide uses covered by WPS include any pesticide product which
exhibits the following statement in the Directions for Use section
of the pesticide label:
"Agricultural Use Requirements
Use this product only in accordance with its labeling and with
the Worker Protection Standard, 40 CFR Part 170. 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 about personal protective equipment,
notification of workers, and restricted-entry intervals."
Since it is a violation of Federal law to use a pesticide product
in a manner that is inconsistent with the label, any use of a
pesticide product with a label that includes WPS implies compliance
by the applicators and responsible employers.
A number of agricultural uses of pesticides are not covered by
WPS such as the application of pesticides to pastures, rangelands,
livestock, parks, and home gardens. Applications of pesticides
in government sponsored public pest control programs and research
applications of unregistered pesticides are also not covered by
WPS.
STATE ENFORCEMENT OF PESTICIDE REGULATIONS
Under FIFRA and other federal regulations governing pesticide
use, state agencies are authorized to (1) implement enforcement
of federal regulations, and (2) assume responsibility for training
and monitoring pesticide applicators. In addition, state agencies
enforce state laws regulating the sale and distribution of pesticides.
Most state pesticide registration laws are limited to the collections
of a fees to allow the sale of a pesticide products in the state
assuming it has obtained an approved label under federal registration
standards. In some states, pesticide laws may exceed the minimum
standards prescribed under federal law, and additional review
of pesticide products are required before use in the state is
approved. In the case of pesticide applicator certification, some
states implement minimum standards required by EPA and other states
implement standards of certification exceeding federal standards.
In California, a unique system of pesticide laws regulates the
use of state designated restricted use pesticides. In this system,
site specific permits must be obtained to apply restricted pesticides
and recommendations for such treatments can only be made by licensed
pest control advisors.
In summary, the implementation and enforcement of pesticide regulations
may differ from one state to another despite the fact that all
states are basically enforcing their interpretation of the federal
regulations established under FIFRA.
PESTICIDE ISSUES AND RELATED LEGISLATION
Although pesticide registrations and application in the United
States are primarily regulated under FIFRA and to some extent
FFDCA, a number of other laws influence the use, storage, and
transport of pesticide products. The following section briefly
highlight a few current pesticide issues and related legislation.
Pesticides and Water Quality
Water quality is an issue of public concern, and attention is
often focused on the presence of agricultural chemicals, especially
pesticides, in private and public water supplies. In 1972, Congress
enacted the Clean Water Act, which focused attention on
point source and non-point sources of pollution including pollution
by pesticides.
Another federal law related to pesticides is the Safe Drinking
Water Act, which was initiated in 1972 and amended in 1974
and 1986. A key feature of the drinking water legislation was
the establishment of drinking water standards called maximum
containment levels (MCL) for polluting chemicals including
a number of pesticides. In brief, public water systems may not
deliver water if a given chemical pollutant exceeds the MCL, and
states must monitor and control activities that introduce pollutants
into a source of drinking water.
Currently states are developing State Management Plans (SMP),
to address cases of pesticide pollution of water supplies. The
development of such plans are being enacted under EPA guidelines
and justified under FIFRA Sections 3 and 6, which relate to pesticide
registration and suspension respectively.
Pesticide and Food Quality
The presence of pesticides in food is a common public issue, especially
if the pesticide is identified as a potential carcinogen. Since
the Delaney clause of FFDCA legislation passed in 1958 prohibits
the presence of any potential cancer causing pesticide in processed
food and modern technology enables detection of trace amounts
of pesticide residues in food products, detection of pesticides
identified as potential carcinogens in food products at negligible
risk levels raises legal questions.
A policy of negligible-risk evolved over time and strict interpretation
of the out-dated Delaney clause was not applied to cases where
the risk of cancer was estimated at below one in a million. However,
a court decision in 1992 declared that the Delaney clause must
be enforced and a chain of judicial and legislative actions have
occurred since the court decision to establish new policies on
pesticides in food. As of late 1995, a number of legislative bills
had been proposed, but the replacement of the Delaney clause with
a legal policy of negligible risk had not yet been achieved.
Pesticides, Wildlife and Endangered Species
The potential impact of pesticides on wildlife was established
in the 60s and 70s during the years of extensive use of DDT and
other persistent pesticides. Today, the use of pesticides having
a potential for bioaccumulation in the environment have been eliminated.
In addition, new pesticide products are subjected to a battery
of eco-toxicological tests to detect adverse risks to wildlife.
In 1973, Congress passed the Endangered Species Act (ESA),
which provided protection for threatened and endangered animal
and plant species. The ESA required all Federal agencies to ensure
that authorized actions should not jeopardize the existence of
threatened or endangered species. Since EPA under FIFRA registers
pesticides, which may impact endangered species, compliance with
ESA is required.
Right to Know Laws and Pesticides
SARA is an acronym that stands for Superfund Amendment
and Reauthorization Act, a federal act enacted in 1986. Title
III of SARA is called the "Emergency Planning and Community
Right-to-Know Act", which gives communities the right to
obtain information about hazardous chemicals that may affect their
community and facilitate preparation to deal with potential chemical
emergencies. If a pesticide product is regarded as an extremely
hazardous substance (EHS) and is stored locally at a level
exceeding a threshold planning quantity (TPQ) defined under
SARA, then a prescribed process must be followed to inform local
officials responsible for emergency planning. In addition, if
an EHS material is released (e.g. spilled) in excess of a reportable
quantity (RQ), the release must be reported.
When hazardous chemicals including pesticides are reported to
local officials, copies of material safety data sheets
(MSDS) on the products must be submitted. The MSDS documentation
is available on most pesticide products and provides relevant
health and safety information on hazardous chemicals.
In addition to SARA III, many state and local governments have
passed right to know laws, especially in relation to the use of
pesticides on private and public lawns. Such laws generally require
commercial and municipal pesticide applicators to inform customers
and the public about treatments applied and to post notices on
properties under treatment.
Pesticides and International Trade
The expansion of free trade among nations has focused attention
on issues related to the export and import of pesticides and products
treated with pesticides, especially when the pesticide in question
is not registered for use within the United States. The export
and import of pesticides is addressed in Section 17 of FIFRA,
and labels of pesticide products exported but not registered for
use within the USA must include the statement "Not Registered
for Use in the United States of America". When food products
treated with such exported products are imported back into the
USA, the cycle is often termed the "circle of poison".
In practice, the frequency of imported food products having had
treatments in conflict with EPA registrations or FDA tolerances
is relatively low. In practice, the major problem is differences
in standards established by different countries, since the USA
has one system of standards and most countries of the world follow
an international standard established by the Codex Alimentarius
Commission (a joint commission under FAO and WHO agencies of the
United Nations). Thus, the primary challenge is harmonizing standards
applicable to pesticide residues allowed in treated food products.
Pesticides and Integrated Pest Management
"Integrated pest management (IPM) is a sustainable approach
which combines the use of biological, cultural, physical, and
chemical tactics in a way that minimizes economic, health, and
environmental risks."
Task Force for IPM, San Antonio, 1994
The adoption of the IPM approach in pest management programs has
been accepted as a policy which will reduce problems associated
with pesticides. In recent years, the USDA (U.S. Dept. of Agriculture)
and EPA have promoted an initiative to achieve a national goal
of IPM on 75% of crop acres by the year 2000. Although reference
to the adoption of IPM in FIFRA is limited to a reference on providing
instruction on IPM during pesticide applicator training (FIFRA
Section 11(c)), the IPM concept has recently been receiving greater
attention in recent pesticide regulation proposals such as the
EPA guidelines for State Management Plans on pesticides associated
with ground water pollution. In summary, the adoption and promotion
of IPM practices may be expected to receive greater attention
in future pesticide regulation or pesticide management programs.
Suggested References on Pesticide Management
General References:
...... 1991. EPA's Pesticide Programs. EPA 21T-1005. 25
pg.
Bohmont, Bert L. 1990. The Standard Pesticide User's Guide.
Prentice Hall, Inc. Englewood Cliffs, NJ
Buchholz, Rogene, A. 1993. Principles of Environmental Management,
The Greening of Business. Prentice Hall, Englewood Cliffs,
New Jersey. 433 pg.
Conner Jr., J. D., Ebner, L. S., Landfair, S. W., O'Conner III,
C. A., Weistein, K. W., and Jovanovich, A. P. 1991. Pesticide
Regulation Handbook, 3rd Ed., Executive Enterprises Publications
Co., Inc. New York. 540 pg.
FAO, 1990. International Code of Conduct on the Distribution
and Use of Pesticides. Food and Agriculture Organization of
the United Nations. Rome. 34 pg.
Greene, Jan. 1994. Pesticide Regulation Handbook - A Guide
for Users. Lewis Publishers. 155 pg.
Hotchkiss, B. E., J. W. Gillett, M. A. Kamrin, J. W. Witt, and
A. Craigmill. 1990. EXTOXNET - Extension Toxicology Network,
A Pesticide Information Project of Cooperative Extension Offices
of Cornell University, The University of Californi, Michigan State
University and Oregon State University. Distribution via Cornell
University.
Landy, M. K., M. J. Roberts, and S. R. Thomas. 1990. The Environmental
Protection Agency: Asking the Wrong Questions. Oxford University
Press, New York. 309 pg.
Lever, B. G. 1990. Crop Protection Chemicals. Ellis Horwood
Ltd. England. 192 pg.
Marco, G. J., R. M. Hollingworth, and W. Durham. 1987. Silent
Spring Revisited. American Chemical Society, Washington, DC.
214 pg.
Marco, G. J., R. M. Hollingworth, and J. R. Plimmer. 1991.
Regulation of Agrochemicals, A Driving Force in Their Evolution.
American Chemical Society, Washington, D.C. 188 pg.
Marer, Patrick J., Mary Louise Flint, and Michael W. Stimmann.
1988. The Safe and Effective Use of Pesticides. Univ. of Calif.
Statewide IPM Project, Div. of Agr. and Nat'l. Res. Pub. 3324.
387 pg.
National Research Council. 1989. Alternative Agriculture.
National Academy Press. 448 pg.
National Research Council. 1991. Sustainable Agriculture Research
and Education in the Field, A Proceedings. National Academy
Press. Washington, D.C. 437 pg.
Olexa, M. T., S. Kubar, T. Cunningham, and P. Meriwether. 1995.
Laws Governing Use and Impact of Agricultural Chemicals: An
Overview. Univ. of Florida Coop. Ext. Service Bull. 311. 94
pg.
Tweedy, B. G., H. J. Dishburger, L. G. Ballantine, and J. McCarthy.
1991. Pesticide Residues and Food Safety, A Harvest of Viewpoints.
American Chemical Society, Washington, DC. 360 pg.
Witt, Steven C. 1990. Bioltechnology, Microbes & the Environment.
Center Science Information. 219 pg.
Reregistration (FIFRA):
...... 1992. Pesticide Reregistration. EPA 700-K92-004.
16 pg.
...... 1993. Pesticide Reregistration Progress Report.
EPA 738-R-93-022. 27 pg.
Gray, Edward C. 1991. A Short History of Pesticide Reregistration.
Chapter 5 of Regulation of Agrochemicals. pg 45 - 54.
Leng, Marguerite L. 1991. Consequences of Reregistration on Existing
Pesticides. Chapter 4 of Regulation of Agrochemicals. pg
27 - 44.
Pesticide Assessment:
Curtis, Charles R. 1988. Agricultural Benefits Derived from
Pesticide Use: A Study of the Assessment Process. Ohio State
University. 148 pg.
Pesticide Applicator Certification:
EPA. 1990. Certification of Pesticide Applicators; Proposed Rules.
Federal Register 40 CFR Part 171.
Worker Protection Standard:
EPA. 1992. Worker Protection Standard, Hazard Information, Hand
Labor Tasks on Cut Flowers and Ferns Exception; Final Rule, and
Proposed Rules. Federal Register 40 CFR Parts 156 and 170.
EPA. 1993. The Worker Protection Standard for Agricultural
Pesticides -How to comply, What Employers Need to Know. EPA
735-B-93-001. 141 pg.
EPA. 1993. Protect Yourself from Pesticides - Guide for Agriculture
Workers. (in English and Spanish) EPA 735-B-93-002. 43 pg.
Pesticides and Water Quality:
Carsel, Robert F. and Charles N. Smith. 1987. Impact of Pesticides
on Ground Water Contamination. Chapter 5 of Silent Spring Revisited.
American Chemical Society, Washington, D.C. pg 71 - 83.
Nimmo, D. R., D. L. Coppage, Q. H. Pickering, and D. J. Hansen.
1987. Assessing the Toxicity of Pesticides to Aquatic Organisms.
Chapter 4 of Silent Spring Revisited. American Chemical
Society, Washington, D.C. pg 49 - 69.
Sailus, Martin. 1989. Pesticides and Groundwater, A Guide for
the Pesticide User. Northeast Regional Agriculture Engineering
Service, Cooperative Extension NRAES Bull. 34. 18 pg.
Pesticides and Wildlife:
........ 1988. The Controversy Over Pesticides and Endangered
Species: Two Points of View. EPA Journal 14(3):26-27.
Hall, Russell J. 1987. Impact of Pesticides on Bird Populations.
Chapter 6 of Silent Spring Revisited. American Chemical
Society, Washington, D.C. pg. 85 - 111.
Pesticides and Food:
........ 1990. Pesticides and Food Safety (issue emphasis). EPA
Journal Vol. 16 NO. 3. 56 pg.
........ 1993. The Keystone National Policy Dialogue on Food
Safety and Pesticides. Keystone Center, CO. 128 pg.
Garland, Anne Witte. 1989. For Our Kid's Sake - How to Protect
Your Child Against Pesticides in Food. Natural Resources Defense
Council. 87 pg.
Whitford, F., B. Miller, M. Jones and L. Bledsoe. 1994. Pesticides
and Wildlife: An Introduction to Testing, Registration, and Risk
Management. Purdue Pesticide Programs Bulletin 30. 39 pg.
International Pesticide Issues:
Freed, Virgil H. 1987. Pesticides: Global Use and Concerns. Chapter
9 of Silent Spring Revisited. American Chemical Society,
Washington, D.C. pg. 145 - 158.
Johnson, Edwin L. 1991. Pesticide Regulation in Developing Countries
of the Asia-Pacific Region. Chapter 6 of Regulation of Agrochemicals.
American Chemical Society Society, Washington, D.C. pg
55 - 72.
Thomas, Barry. 1991. Pesticide Registration in Europe. Chapter
7 of Regulation of Agrochemicals. American Chemical Society,
Washington, D.C. pg 73 - 79.
Periodicals and Annual Publications:
Crop Protection Chemical Reference. (Annual Publication)
John Wiley & Sons, New York and Chemical and Pharmaceutical
Pub. Corp. Paris. 2300+ pg.
Farm Chemicals Handbook. (Annual Publication) Meister Publishing
Co., Willoughby, OH
Insect Control Guide. (Annual Publication) Meister Pub.
Co., Willoughby, OH.
MSDS Reference for Crop Protection Chemicals. (Bi-annual
Publication) John Wiley & Sons, New York and Chemical and
Pharmaceutical Pub. Corp. Paris. 1400+ pg.
Pesticide & Toxic Chemical News. Weekly Publication
by Food Chemical News, Inc. Washington D.C.
Weed Control Manual. Annual Publication by Meister Pub.
Co., Willoughby, OH.
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