Harold R. Willson
Department of Entomology
The Ohio State University
Columbus, OH 43210
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 Rodentcide 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:
- Product Chemistry: This includes a full range of chemical parameters describing the physical components of the pesticide product.
- 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.
- 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.
- 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.
- Reentry Protection: This data enables assessment of hazard to workers reentering areas treated with pesticides and determination of reentry intervals.
- 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.
- 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.
- Product Performance: This data establishes the effectiveness of the pesticide product to prevent unnecessary use of ineffective products.
- 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:
- The composition of the product warrant proposed claims.
- Labeling of the material complies with the FIFRA Act.
- The pesticide will perform its function without unreasonable adverse effects on the environment.
- 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:
- 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.
- 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.
- 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.
- 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.
"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.
Re-Registration - 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.
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
- 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.
- 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.
- 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.