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24 ELR 10507 | Environmental Law Reporter | copyright © 1994 | All rights reserved A Practitioner's Guide to the Federal Insecticide, Fungicide, and Rodenticide Act: Part IILinda J. Fisher, Peter L. Winik, Carolyne R. Hathaway, Ann Claassen, and Jeffrey Holmstead Editors' Summary: This is the second of a three-part series explaining pesticide regulation. This installment discusses requirements for registration of pesticide producers, producer recordkeeping, end user requirements including those related to restricted use pesticides, enforcement authority, and EPA rulemaking and judicial review. The previous installment, which appeared in last month's issue, 24 ELR 10449, examined federal jurisdiction over pesticides, labeling and packaging requirements, pesticide registration, and related regulatory authorities. The third installment will cover storage, transportation, and disposal; import and export; state authority; data reporting; residue tolerances; biotechnology regulation; and emerging issues. Linda J. Fisher, former Assistant Administrator of EPA for Prevention, Pesticides, and Toxic Substances, is Environmental Counsel at the Washington, D.C., office of the national law firm of Latham & Watkins. Peter L. Winik is a partner and Carolyne R. Hathaway and Jeffrey Holmstead are senior associates with that firm. Ann Claassen is a senior associate with the firm of Weinberg, Bergeson & Neuman in Washington, D.C. The authors acknowledge contributions to the manuscript from Mark E. Newell, partner, and Donna J. Williams, Christopher J. Peters, Chad Johnson, and Jeffrey L. Hallos, associates, of Latham & Watkins. The authors also thank reviewers James V. Aidala Jr. and William L. Jordan for their thoughtful comments on the manuscript. FIFRA § 7 requires producers of pesticides to register their establishments and to file annual reports with EPA.1 FIFRA defines "establishment" broadly to include not only those sites that produce the final pesticide product but also [24 ELR 10508] sites producing any active ingredient.2 This requirement extends to foreign producers sending their pesticides to the United States as well as to domestic producers exporting pesticides.3 Also, producers that own several pesticide plants must register each site, despite the fact that all are under the single corporation's auspices.4 Initial registration is not particularly onerous. Before the site can produce any pesticide products, the producer must submit an application for registration.5 Application forms are available at any EPA regional office. A company need only provide EPA with its name and address, the ownership structure, e.g., corporation, partnership, etc., and the name and address of each site to be registered.6 EPA will then issue an "establishment registration number" for the site.7 Within 30 days after registering with EPA, the producer must also file a pesticide report. The report must state the types and amounts of pesticides or active ingredients that the producer is currently producing, that the producer has produced during thepast year, and that the producer has sold or distributed during the past year.8 Every year a producer must file another report by March 1st with the same information, even if the producer has no pesticide production to report.9 Under FIFRA § 8, all producers of pesticides who are required to register with EPA must also maintain records of the following: * EPA registration number and batch identification information. * Brand names and quantities of products including devices produced. * All ingredients used in producing pesticides. * Pesticide shipment and transfer information. * Guarantees that the producer has given. * Records of any relevant tests conducted on human beings. * Pesticide research data and summaries.10 The list above provides the general framework of the FIFRA bookkeeping requirements. Pesticide producers should consult the relevant regulation before deciding whether to retain specific records. The clear implication of FIFRA § 8 and the regulations is that when in doubt, a registrant should keep the documents. However, FIFRA excludes a few documents from the bookkeeping mandates. For instance, FIFRA does not require producers to maintain financial data, sales data other than shipment data, pricing data, personnel data, and research data (other than data relating to registered pesticides).11 The producer or other relevant party must allow an EPA employee or representative to inspect and copy these records upon a proper request.12 Any individual seeking access to such records must present appropriate credentials and a written statement giving the reason for the inspection, including a statement as to whether the inspector suspects a violation of the law.13 EPA can also gain access to documents held by independent testing facilities or laboratories that perform tests for the producer.14 Inspectors must commence and complete their work with reasonable promptness.15 EPA uses inspection as a central part of its FIFRA enforcement strategy for manufacturers and distributors. These persons should take care to keep their books and records up to date and in strict compliance with FIFRA mandates. FIFRA imposes three basic categories of requirements upon end users of pesticides: (1) requirements that apply to pesticides bearing FIFRA-mandated labels; (2) special requirements for pesticides that EPA classifies for restricted use; and (3) worker protection requirements for agricultural pesticides. FIFRA does not prevent an end user from using an unregistered, unlabeled product against pests. For example, if someone used water from a garden hose to dislodge pests from a plant or took this publication and physically used it to destroy or repel a passing pest, the actions would not violate FIFRA. Before using an unregistered pesticide, though, particularly a toxic chemical, the user should consider the consequences under other laws. For example, an unregistered product cannot claim the exemption from reporting of releases that the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) provides for registered pesticides.16 Should the use cause harm, the lack [24 ELR 10509] of registration might lend support to a claim of negligence in a subsequent tort action. Also, a person using an unregistered pesticide should be sure to be only a user. If the use is for the benefit of another, the person applying the pesticide could be acting as a seller or distributor of the pesticide, in violation of the FIFRA registration requirements.17 As discussed above, labels are key to FIFRA regulation of the actual use of pesticides.18 All registered pesticides and some unregistered products must bear FIFRA labels.19 It is illegal to "detach, alter, deface, or destroy, in whole or in part, any labeling required" under FIFRA.20 Labels give directions for pesticide use. The directions cover more than application; they also cover mixing (if necessary), storage, and disposal.21 For purposes of worker protection, label directions may cover a long list of more peripheral activities, from arranging for application, to restricting entry to treated areas, to transporting opened containers of pesticide.22 It is illegal to "use any registered pesticide in a manner inconsistent with its labeling."23 This is true even if the misuse is unintentional.24 If a person knowingly uses a pesticide, any misuse may be criminal, even if the person has no specific intent to ignore restrictions in the labeling.25 FIFRA treats several types of uses as consistent with the labeling even if not expressly mentioned in it.26 For example, unless the labeling specifies otherwise, a user may apply a pesticide at a dosage, concentration, or frequency less than that listed on the labeling; may use an application method not described in the labeling; may mix pesticides with fertilizer; or may use the pesticide against a target pest not specified on the labeling (if the pesticide is applied to a crop, animal, or site that is specified).27 In forestry and agriculture applications, the user may apply a pesticide in a more concentrated form than the label directs, unless EPA regulations or advisory opinions specifically require minimum dilutions.28 Note that this exception does not allow using an overall larger dose of the pesticide on a given site; it only allows applying the pesticide in a less dilute form. FIFRA actually gives EPA general authority to authorize uses not described on the label as long as EPA determines that the uses are consistent with FIFRA's purposes.29 Also, more specifically, FIFRA states that an experimental use permit (EUP),30 emergency exemption,31 or state registration32 may authorize uses not on the label.33 Each of these, however, may generate its own label or label amendments that will specify allowable uses.34 Any use of a product subject to an EUP must conform to the permit as well as the label.35 As mentioned earlier in this Article, EPA may decide to classify a registered pesticide for restricted use.36 Restricted use pesticides (RUPs) are ones that pose a serious risk of causing human injury or environmental harm despite the normal labeling restrictions, packaging requirements, and other FIFRA precautions.37 To provide additional protection, usually only certified applicators or people under their direct supervision may use RUPs.38 "Direct supervision" will sometimes require the certified applicator to be physically present when the pesticide is used.39 Any use of the RUP must be in accordance with these or any other restrictions that EPA creates.40 The end user should easily be able to identify whether a product is a RUP. The label of each RUP for sale to end users must clearly indicate its classification and the restrictions that apply.41 All advertising for the product must mention its restricted classification.42 If the pesticide requires a certified applicator, the seller ordinarily will only sell it to a certified applicator or someone the seller knows is buying it for a certified applicator.43 For general reference, EPA regulations contain a list of RUPs requiring certified applicators.44 1. Becoming a Certified Applicator State and county agricultural extension services or EPA regional offices can usually answer specific questions about who certifies applicators, what information applicators need to know, and who offers training toward certification. Given that, here is some general information about applicator certification. The federal government may allow qualified states or Indian tribes to certify applicators.45 All but one or two states have federally approved certification programs.46 In states and tribal areas without approved programs, the federal government certifies applicators.47 In any case, the standards and procedures for certification are similar, since the state and tribal programs must meet minimum federal standards.48 There are two kinds of certified applicators. A private applicator is one who uses or supervises use of RUPs in the production of agricultural commodities, i.e., in farming, on the applicator's or the applicator's employer's land (owned or rented), or without compensation (other than the exchange of personal services between farmers) on the land of another.49 FIFRA considers all other RUP applicators to be commercial applicators.50 Private applicators have a little easier time winning certification than commercial applicators. Typically, private applicators win certification after passing a written or oral test, or sometimes after successfully completing a course or self-study program in pesticide application.51 An applicator must show "a practical knowledge of the pest problems and pest control practices associated with his agricultural operations; proper storage, use, handling, and disposal of the pesticides and containers; and his related legal responsibility."52 Applicators must show that they can identify common pests and pest-caused damage; read and understand labels and be able to follow label instructions and warnings; recognize situations that pose a danger of environmental contamination; and recognize pesticide poisoning symptoms and know how to respond.53 If an applicator cannot read, the person may take an oral test of practical knowledge with special questions about use of the specific pesticide that the person wants to use. The resulting certification will apply only to that pesticide.54 Commercial applicators must show a more detailed base of practical knowledge than private applicators.55 In addition, they must show practical knowledge of the problems specific to their particular field of work.56 For example, people who wish to apply RUPs inside houses and other structures must show knowledge of how to avoid food contamination and undue exposure to potentially sensitive pets and human occupants.57 Applicators who wish to be able to supervise uncertified applicators must show knowledge of state and federal supervisory requirements.58 The test for commercial applicators is usually written, but it may include performance testing.59 A certification is only valid for the particular state or tribal area for which it is issued. The certifying authorities may have reciprocity arrangements with other jurisdictions.60 These allow certified applicators to gain certification in the new jurisdiction without being retested. A certification is usually valid for a limited period; for example, federal private certifications expire after four years and commercial certifications after three.61 States must have provisions to ensure that certified applicators keep up with developing knowledge in the area;62 often those provisions require applicators to take continuing education courses or to be retested to keep their certification. Certifying authorities may deny, suspend, modify, or revoke a certification for cause.63 A suspension is an immediate action, effective for a limited time, though a revocation or modification may follow.64 For federal certifications, denials, revocations, and modifications take effect only after opportunity for a hearing.65 After a denial or revocation, a person seeking certification may have to take additional steps to acquire or reacquire it, or may be temporarily barred from certification.66 Generally, EPA's policy is to "deny, suspend, modify, or revoke a federal certification only in response to serious [24 ELR 10511] violations or against persons with a history of noncompliance."67 Such noncompliance may include misuse of a pesticide, violation of recordkeeping requirements, or other FIFRA violations,68 any of which may also make the applicator liable for civil penalties or other sanctions. As might be expected, EPA will tailor the sanction to the violation, seeking stronger sanctions against more serious or recurring violations.69 The 1990 Farm Bill requires all registered applicators to keep detailed records of each application of a RUP.70 Previously, only commercial applicators had to keep records; FIFRA had no requirements for private applicators.71 The Agriculture Marketing Service has promulgated recordkeeping rules under the new authority.72 The rules require certified applicators to keep records of the products, amounts, locations, applicator names, and other details of each application.73 Applicators must keep the records for two years and must allow appropriate officials to inspect and copy the records.74 Health care providers too must have access to the records when necessary to provide medical treatment.75 Applicators are excused from complying with the federal regulations if they are complying with comparable state regulations.76 Commercial applicators must give a copy of their records to the person for whom they have applied the RUPs.77 These requirements are not part of FIFRA and so have their own provisions for penalties and administrative review.78 EPA's FIFRA regulations still require state and federal certification programs to include recordkeeping requirements that apply to self-employed commercial applicators, firms employing commercial applicators, and persons who contract to have RUPs applied to property owned or operated by another.79 Though the new Farm Bill requirements sometimes duplicate or exceed the old FIFRA requirements, the Farm Bill left intact EPA authority to promulgate recordkeeping requirements.80 Note too that a violation of EPA regulations is a violation of FIFRA81 and may carry different penalties; though the sizes of fines for applicators under the two laws are comparable, enforcers may also seek criminal penalties or revocation of the applicator's certification under FIFRA.82 Certified applicators should be aware that FIFRA creates requirements for retail dealers of RUPs. These can affect certified applicators in two ways: They may be asked to cooperate with a dealer to help fulfill recordkeeping and reporting requirements, or they may inadvertently become a dealer by delivering a RUP to another person for use. The requirements discussed in this section apply only to those few states where the federal government runs the applicator certification program. Applicators and dealers in other states should check with state authorities about requirements. A restricted use pesticide retail dealer is defined as "any person who makes available for use any restricted use pesticide, or who offers to make available for use any such pesticide."83 The term "make available for use" is defined as "to distribute, sell, ship, deliver for shipment, or receive and (having so received) deliver, to any person. However, the term excludes transactions solely between persons who are pesticide producers, registrants, wholesalers, or retail sellers, acting only in those capacities."84 Also, when a pest control company applies a registered pesticide and does not leave unapplied pesticide with the client, FIFRA does not consider the service to be distributing or selling pesticides.85 Each restricted use pesticide dealer in a state where EPA conducts the applicator certification program must report to the appropriate EPA regional office the business name under which the dealer operates and the name and address of each of his or her dealerships, no later than 60 days after the person first becomes a dealer. Also, the dealer must revise the initial report to reflect any name changes, additions, or deletions of dealerships, within 10 days of such changes.86 Each dealer must meet recordkeeping requirements. When making restricted use pesticides available to a certified applicator, the dealer must record the applicator's name and address, various information from the applicator's document of certification, the name and amount of pesticide delivered, and the date.87 For a sale to an uncertified person, the dealer must determine the name of the certified applicator who will use the pesticide. Then the [24 ELR 10512] dealer must record the information that would be required for a sale to that applicator plus the name and address of the actual buyer.88 Because it is illegal to supply a RUP for use by uncertified applicants,89 dealers ordinarily take great care in documenting such sales. Buyers should not be surprised to be asked to produce identification and copies of certifications. A noncertified buyer should be able to produce the original certification of the applicator or alternatively a photocopy of the certification plus evidence of an agreement or authorization to purchase for the applicator.90 Dealers must maintain their records for two years91 and must make them available to EPA for inspection.92 C. Worker Protection Requirements In 1992, after extensive study and solicitation of comments, EPA promulgated broad new worker protection regulations and parallel regulations requiring worker protection information on labels.93 As discussed below, these bind employers of workers who might handle or be exposed to pesticides in agricultural settings. In response to concerns about the ability of farmers and agribusiness to comply, Congress has delayed until January 1995, the effective date of some worker protection requirements, however employers must honor most of the specific worker protection requirements currently found on labels.94 EPA regulations require worker protection labeling provisions on all pesticides produced after April 1994 that have instructions for use in circumstances where worker protection requirements apply.95 However, distributors and retailers may still sell pesticides with older labels until October 1995.96 The standard in effect in a particular case will depend on the regulations, the congressional time extension, and the actual label on the pesticides used.97 Two kinds of employers are subject to worker protection requirements. One kind are agricultural employers, defined as: any person who hires or contracts for the services of workers, for any type of compensation, to perform activities related to the production of agricultural plants, or any person who is an owner of or is responsible for the management or condition of an agricultural establishment [i.e. a farm, forest, nursery, or greenhouse] that uses such workers.98 The other kind are handler employers, defined as "any person who is self-employed as a handler or who employs any handler, for any type of compensation."99 The definition of handler is lengthy, but essentially covers any person employed to handle, apply, or assist in the handling or application of pesticides in any manner, excepting persons handling emptied and cleaned pesticide containers.100 Despite this broad definition, the worker protection standards for handlers only apply when a pesticide is "handled for use on an agricultural establishment."101 2. General Duties and Enforcement The regulations impose certain general duties upon subject employers. Employers are responsible for seeing that each worker or handler receives the protections required by the rules; that pesticides are used in a manner consistent with their labeling; that supervisors have information and directions sufficient to assure that each worker and handler receives the required protections; and that each supervisor will assure compliance with the regulations by each worker or handler.102 Employers may not take retaliatory action against workers or handlers for attempts to comply with the regulations, or any action "having the effect of preventing or discouraging any worker or handler from complying or attempting to comply" with any requirement of the regulations.103 EPA bases enforcement of these standards on the FIFRA requirement that no one may use a registered pesticide in a manner inconsistent with its labeling104 and the FIFRA provision that holds employers responsible for acts or omissions of officers, agents, and employees.105 For purposes of enforcement of worker protection requirements, EPA considers use to include preapplication activities, application, postapplication activities, and "other pesticide-related activities."106 3. Standards for Workers EPA has designed the worker standards to protect agricultural workers who might be exposed to a pesticide while or after it is applied. The standards cover such topics as limiting worker presence during pesticide application,107 limiting entry into treated areas,108 giving notice and other information to workers about applications,109 training and certifying workers in pesticide safety practices,110 posting safety information,111 providing for decontamination of exposed workers,112 and giving emergency assistance to poisoned or injured workers.113 The agricultural employer is also responsible for making sure that employers of pesticide handlers coming on to a site are aware of any entry restrictions for treated areas.114 The worker protection standards apply whenever using any pesticide on an agricultural establishment in the production of agricultural plants, i.e., any plant grown or maintained for commercial or research purposes, with certain exceptions enumerated in EPA's regulations.115 The list of exceptions serves partly to clarify what "production of agricultural plants" actually includes. It does not include wide area, government-sponsored pest control efforts; applications to animals; applications to noncommercial plants such as plants in a home, home vegetable gardens, ornamental gardens, shade trees, or windbreaks; application to structures, rights-of-way, pastures, or rangeland; or application to already harvested crops or timber.116 The exemptions also remove some kinds of pesticide uses not likely to pose widespread incidental risks to workers, such as direct injection of pesticides, use on vertebrate pests, use in traps, or research use of unregistered pesticides.117 In addition, some of the worker protection requirements do not apply to employers themselves or members of employers' immediate families working at their own establishment.118 Employers may wish to provide these safeguards to family anyway, especially if they are already providing them to other workers. This Article does not include a detailed description of the worker protection standards. Employers should consult both the pesticide label and EPA regulations to determine exactly what worker protection standards apply.119 The regulations include exemptions to requirements on the label, provisions that expand upon label requirements, and provisions that apply independent of the labeling. As examples, the label may prohibit entry into a treated area for a specified interval. The regulations allow entry during that period despite the label, including entry to handle emergencies, if workers and employers follow listed precautions.120 Or, the label may require the employer to give oral notice to workers of each application. The regulations explain what constitutes adequate oral warning for those pesticides.121 And, regardless of what the labeling says about notice, the regulations include quite detailed requirements about posting warning signs that apply to almost all pesticide applications in greenhouses, and to almost all other agricultural applications if the employer has not given oral notice.122 EPA has designed the handler standards to protect those people in agricultural settings who might have contact with a pesticide while preparing it, applying it, or doing related tasks. The standards cover such topics as taking safety measures during application,123 posting safety information for handlers at the application site,124 training and certifying handlers,125 making sure handlers understand necessary safety information on the label or specific to the site,126 making sure equipment is safe and used safely,127 posting basic safety and medical assistance information,128 ensuring that handlers use proper protective equipment,129 providing for decontamination of exposed handlers,130 and giving emergency assistance to poisoned or injured workers.131 Handler employers are also responsible for informing employers of agricultural workers about applications, entry restrictions, notice requirements, and any product-specific information on the pesticide label concerning worker protection.132 The standards apply whenever handlers use pesticides on a farm, forest, nursery, or greenhouse, with specific exceptions.133 The list of exceptions is almost identical to the list for the worker standards, however there is no exception for pesticides injected directly into plants.134 The standards also include an exemption for the handler employer and members [24 ELR 10514] of the employer's immediate family identical to the exemption for agricultural employers and their families.135 As with the worker standards, employers should consult both the pesticide label and the regulations to make sure they are aware of all applicable requirements for handler protection. EPA has also published guides for pesticide handlers and agricultural workers.136 Like most federal environmental laws, FIFRA offers EPA a full range of enforcement options, from administrative warnings to criminal sanctions. It allows EPA to delegate enforcement authority to the states or Indian tribes,137 and many states have cooperative agreements with EPA giving them the lead in performing inspections and conducting other enforcement actions.138 However, FIFRA differs from most pollution control laws in that it has no citizen enforcement provision and creates no cause of action for citizens to invoke against violators.139 This part of this Article surveys EPA's general enforcement authority and policies under FIFRA. Other parts of this Article discuss more specialized enforcement and enforcement-like tools. Part IV discusses various tools to terminate or limit pesticide registrations. Those actions are not enforcement, strictly speaking, since EPA may take them for reasons other than a violation of the Act. Part VI discusses actions to limit an applicator's certification in response to a violation. And Part IX discusses EPA's authority to order recall of canceled or suspended pesticides. Section 12 of FIFRA lists unlawful acts and omissions.140 It is not necessarily a comprehensive listing; as FIFRA § 14 states, a violation of any provision of FIFRA could subject a person to penalties.141 However, § 12 refers to, clarifies, elaborates on, or includes most if not all of the provisions of FIFRA that EPA or the states are likely to enforce. In addition, it sets out defenses for some violations. Section 12(a)(1) lists six violations associated with the sale and distribution of pesticides, all subject to affirmative defenses.142 Under this paragraph, it is a violation to sell or distribute the following: (1) an unregistered pesticide or any pesticide whose registration has been canceled or suspended, unless EPA has authorized sale or distribution; (2) a registered pesticide with claims, e.g., description or advertising, that differ substantially from claims made in connection with its registration; (3) a registered pesticide with a composition that differs from that described in the registration statement; (4) a pesticide that has not been colored or discolored as EPA requires;143 (5) a pesticide that is adulterated or misbranded; or (6) a device that is misbranded. Section 12(b) lists five defenses for these violations.144 The first two excuse basically innocent parties: A person relying in good faith on the guarantee of a registrant or domestic supplier (in which case, the guarantor is liable for any penalties) or a shipper, if the shipper allows enforcement authorities to copy any records regarding the pesticide or device. The third excuses public officials performing their official duties. The fourth and fifth exempt persons acting under an EUP or otherwise distributing or selling the pesticide only for research purposes. Section 12(a)(2) lists 19 violations not subject to these defenses. Many of the entries on the list simply incorporate by reference requirements stated elsewhere in FIFRA, however they sometimes add important shadings and so bear careful reading. For example, one clause makes it unlawful for any person to refuse to submit reports required in FIFRA §§ 5, 6, 7, 8, 11, or 19, while another clause makes it unlawful for any registrant, wholesaler, dealer, or retailer to fail to file any report required in any part of FIFRA.145 Some of the requirements of § 12(a)(2) act as keystones of regulatory programs found in other parts of the Act. For example, while other sections of FIFRA regulate the contents of labels and EUPs, § 12(a)(2) makes it is unlawful to detach, alter, deface, or destroy any labeling; to use a pesticide in a manner inconsistent with its labeling; or to use a pesticide under an EUP contrary to the terms of the permit.146 Many of the requirements deal with data. It is unlawful to refuse to maintain required records; to refuse to allow inspection and copying of records where FIFRA requires it; to reveal improperly or use to personal advantage confidential information; to knowingly falsify applications for registration or EUPs, data required of establishments under § 7, required records, required reports, or information marked and submitted to EPA as confidential; to falsify any information related to pesticide testing; or to submit data known to be false in support of a registration.147 Some of the requirements are independent of other sections of FIFRA. For example, § 12(a)(2)(P) makes it unlawful [24 ELR 10515] to test pesticides on human beings unless they are fully informed and voluntary participants in the test.148 In short, to understand violations and defenses under FIFRA, one must begin by carefully reading both § 12 and the substantive regulatory sections. Not surprisingly, sometimes one must then go to the associated regulations, case law, and policy documents to understand the requirements fully. It also bears noting that, if an employee, officer, or agent violates FIFRA, the employer or principal also is liable.149 For example, if a pesticide advisor employed by a dealer violates the Act, the dealer is also liable.150 If a business violates FIFRA and then goes through a corporate reorganization or buyout, liability may also attach to the successor corporation, though not to the successor corporation's officers or to the employees of the original business if they were otherwise uninvolved with the violation.151 EPA has largely delegated pesticide enforcement under FIFRA to the states, which typically assign their pesticide programs to their agriculture departments. To fund enforcement, the departments receive federal money through cooperative agreements with EPA as well as state money. EPA maintains oversight and control of the state enforcement programs through the terms and conditions of the cooperative agreements.152 Though EPA and the states negotiate cooperative agreements individually, EPA insists that each agreement reflect national priorities for inspection and enforcement. Through the cooperative agreement, EPA and the state will agree that the state will undertake a set number of inspections of various categories of covered persons including registrants, dealers, commercial applicators, growers, and laboratories. The inspections may vary in their focus from year to year to reflect concerns about worker safety, groundwater requirements, suspended and canceled pesticides, false advertising, compliance with good laboratory practices, or other matters. The inspections can vary in scope or form. They may include books and records searches, label inspections, use practices inspections, reviews of advertising or product claims, or products sampling. State employees perform most inspections. The inspections may be routine random inspections or may be conducted in response to a tip received at the federal, state, or local level. After the inspection, the state department of agriculture may commence an enforcement action if one is warranted. Although EPA does not have the authority to overfile a federal enforcement action, as contemplated under many other federal environmental statutes,153 the state may request EPA's involvement if the matter is significant or if the state needs federal assistance. In appropriate cases, the states may turn the enforcement authority back to EPA. FIFRA provides EPA with a number of general enforcement mechanisms for responding to violations of the Act. These include notices of warning; civil administrative penalties; stop sale, use, or removal orders; seizures; injunctions; and criminal sanctions. EPA discusses these and some more specialized enforcement options in its FIFRA Enforcement Response Policy (ERP) guidance.154 A notice of warning is the least formal of EPA's enforcement devices. EPA typically issues one only for relatively minor violations of FIFRA. Section 14(a)(4) authorizes EPA to issue a warning, in lieu of a civil penalty, in cases where the violation occurred despite the exercise of due care or did not cause significant health or environmental harm.155 Section 14(a)(2) requires that a written warning be issued to private applicators and uncertified end users prior to the assessment of any civil penalties for subsequent FIFRA violations.156 Section 9(c)(3) also permits EPA to issue warning notices for minor violations where this course of action adequately serves the public interest.157 EPA's FIFRA ERP discusses the circumstances in which notices of warning are appropriate.158 The FIFRA ERP establishes "Gravity Adjustment Criteria" to be applied in determining the severity of a violation. These criteria assign numerical values to the toxicity of the pesticide; the extent and severity of actual or potential harm to human health; the extent and severity of actual or potential environmental harm; and the compliance history and degree of culpability.159 If, based on these criteria, EPA determines that a violation is minor, EPA may issue a notice of warning. EPA may also issue notices of warning for some first-time recordkeeping or late-reporting violations.160 EPA uses administrative enforcement proceedings to assess civil penalties in response to most violations of FIFRA. In 1992, EPA initiated 286 civil penalty proceedings under FIFRA, assessing total penalties of $ 1,098,549.161 The largest FIFRA civil penalty in 1992 was $ 300,000.162 The average penalty was $ 6,172, up from $ 3,350 in 1991.163 Section 14(a) establishes civil penalties for violations of FIFRA. Registrants, commercial applicators, wholesalers, [24 ELR 10516] dealers, retailers, or other distributors who violate any provision of FIFRA are subject to civil penalties of not more than $ 5,000 for each violation.164 Applicators not described in § 14(a)(1), including private applicators, who hold or apply registered pesticides only to provide a pest control service without delivering any unapplied pesticide to any person, are subject to penalties of $ 500 for the first violation of FIFRA and $ 1,000 for subsequent violations.165 EPA has indicated that applicators who hold or apply unregistered pesticides are considered to be "distributors" of the pesticide subject to the higher applicable penalties. Other private applicators and persons not described above who violate the requirements of FIFRA are subject to penalties of $ 1,000 for violations subsequent to the receipt of a written warning or citation for any prior FIFRA violation.166 EPA's ERP provides that civil penalties are the appropriate enforcement mechanism for most violations of FIFRA. EPA will seek civil penalties for violations that (1) present an actual or potential risk of human or environmental harm or impede EPA's ability to fulfill the goals of the Act; and (2) were committed as a result of ordinary negligence, inadvertence, or mistake; (3) by either (a) a registrant, commercial applicator, "for hire" applicator, wholesaler, dealer, retailer, or distributor or (b) a private applicator or other person not listed above who has received a prior written warning or citation for a violation of FIFRA.167 In determining the amount of the penalty to be assessed,FIFRA requires EPA to consider the appropriateness of the penalty to the size of the business, the effect on the violator's ability to continue in business, and the gravity of the violations.168 EPA may not assess penalties without notice and an opportunity for a hearing on the alleged violation in the county, parish, or city in which the person resides.169 EPA's ERP establishes a five-stage process for applying the statutory criteria to determine the civil penalty amount. These steps include: (1) determination of the gravity or level of the violation; (2) determination of the size category of the business; (3) application of the civil penalty matrices to determine the base penalty amount associated with the level of the violation and the size of the business; (4) adjustment of the base penalty downward or upward in light of gravity adjustment criteria, including the toxicity of the pesticide, the actual or potential harm to human health or the environment, the compliance history of the violator, and the violator's level of culpability; and (5) consideration of the violator's ability to pay the adjusted penalty amount and continue in business. The ERP provides additional penalty reductions for violations voluntarily disclosed to EPA within 30 to 60 days of their discovery, for demonstrations of the respondent's attitude or good faith, and for special or extraordinary circumstances.170 EPA will assess separate civil penalties, up to the statutory maximum, for each independent violation of FIFRA. EPA has explained that "[a] violation is independent if it results from an act (or failure to act) which is not the result of any other charge for which a civil penalty is to be assessed, or if the elements of proof for the violations are different."171 "Dependent" violations do not result in separate civil penalties.172 Thus, each individual sale or application of a product is a separate, independent offense, for which EPA may assess penalties up to the statutory maximum. On the other hand, multiple misbrandings on a single product label are dependent offenses, which EPA will treat as a single violation.173 EPA may, however, assess a separate penalty each time a person sells or distributes the misbranded product.174 3. Stop Sale, Use, or Removal Orders Section 13(a) authorizes EPA to issue a stop sale, use, or removal order to any person who owns, controls, or has custody of a pesticide or device that, there is reason to believe on the basis of inspection or tests, is in violation of any provision of FIFRA, has been or is intended to be distributed or sold in violation of FIFRA, or has a canceled or suspended registration. After receipt of the order, a person cannot sell, use, or remove the pesticide except in accordance with the order.175 Violation of an order is itself a violation of FIFRA.176 EPA has found that the stop sale, use, or removal order is an efficient and effective enforcement tool. EPA may issue such orders based only on a reasonable belief of a FIFRA violation. They are easier to prepare and issue than a seizure, and they apply to all of the products owned or in the custody or control of the person that receives the order and may extend to products coming into the person's control in the future. The orders provide a great deal of enforcement flexibility and can easily be adopted to particular factual circumstances.177 EPA's ERP requires the issuance of a stop sale, use, or removal order for: * Pesticides for which there is reason to believe that there is a potential hazard to man or the environment because (1) they are not registered or are so over-formulated, under-formulated or adulterated as to present a serious health hazard; or, (2) they are packaged in improper or damaged containers, or are so inadequately labeled, as to make safe or effective use unlikely or impossible. * Pesticides or devices with labeling that is materially misleading or fraudulent, and if followed by a user, is likely to cause a life-endangering health hazard or serious adverse environmental effects.… * Pesticides or hazardous devices that are in violation of [FIFRA] and are the subject of a recall, but which the responsible party refuses to remove, is recalcitrant in removing or is unable to remove from the channels of trade. * Pesticides or hazardous devices that are in violation of [FIFRA] and for which a civil penalty has been issued but which have not been brought into compliance. * Pesticides that have been suspended under FIFRA Section 6.178 EPA may issue a stop sale, use, or removal order for less grave situations than those just listed -- for example, for continued or repeated minor violations or where several minor violations appear on a label. Where EPA suspects a violation of FIFRA has already occurred, EPA will assesses civil penalties along with the order.179 Any administrative hearing on the penalties can then also explore the facts underlying the order. FIFRA § 13(b) authorizes EPA to initiate in rem condemnation proceedings in federal district court against certain pesticides and devices.180 Once the court grants EPA's condemnation request, FIFRA § 9(b)(3) authorizes EPA to obtain and execute a warrant to seize the violating pesticide or device.181 The first prerequisite for seizure is commerce-related. EPA may seek seizure of a pesticide or device "that is being transported or, having been transported, remains unsold or in original unbroken packages, or that is sold or offered for sale in any State, or that is imported from a foreign country."182 The second prerequisite is FIFRA-related. EPA may seek seizure of a pesticide if it is adulterated or misbranded, unregistered, inadequately labeled, inadequately colored or discolored, or the subject of claims or directions for use that differ in substance from those made with its registration.183 EPA may seek seizure of a device if it is misbranded.184 EPA may also seek seizure of pesticides or devices that cause unreasonable adverse environmental effects even when used in accordance with FIFRA and the products' labeling.185 The circumstances in which FIFRA authorizes EPA to initiate a seizure generally overlap with those in which EPA may issue a stop sale, use, or removal order. Because an order is quicker and easier to obtain than a seizure and often provides a greater degree of flexibility, EPA will generally initiate a seizure only in circumstances where an order would be inadequate or ineffective.186 FIFRA § 16(c) gives the federal district courts jurisdiction to enforce FIFRA and to prevent and restrain violations.187 EPA may therefore seek a permanent injunction, preliminary injunction, or temporary restraining order to ensure compliance with the Act. EPA is unlikely to seek such extraordinary relief absent compelling circumstances. To obtain a permanent injunction, EPA must demonstrate to the court that other administrative or judicial remedies are inadequate to restrain the violation or prevent unreasonable risk to public health or the environment; that enforcers have diligently pursued all other appropriate administrative remedies yet the violation continues; or that irreparable injury, loss, or damage will result unless a court grants injunctive relief. To obtain a preliminary injunction or temporary restraining order, EPA must also establish that immediate and irreparable injury will result absent such interim relief and that, based on the facts presented, EPA will likely prevail in a trial on the merits of the case.188 Nonetheless, EPA's ERP indicates that situations may justify seeking injunctive relief. It gives as examples situations where a civil remedy or penalty would not effectively address a violation of a § 6 cancellation or suspension order, or where the Agency has already taken administrative enforcement action but a violation continues.189 Section 14(b) establishes criminal penalties for knowing violations of FIFRA.190 At least one court has concluded that a knowing violation is one where the defendant has a general intent to take an action that happens to be unlawful, as opposed to specific intent to take an action that FIFRA proscribes. So, for example, a prosecutor needs to prove that a defendant knew it was applying a pesticide in a particular manner, but not that defendant knew that the manner was inconsistentwith the pesticide's labeling.191 Potential criminal penalties under FIFRA vary depending on the violator and the violation. Registrants, applicants for registration, or producers are subject to fines of $ 50,000, imprisonment for up to one year, or both. Commercial applicators of restricted use pesticides and persons who distribute or sell pesticides or devices are subject to fines of $ 25,000, imprisonment for up to one year, or both. Courts may find private applicators guilty of a misdemeanor and order fines of up to $ 1,000, imprisonment for up to 30 days, or both. Persons who, with intent to defraud, use or reveal information relative to formulas of products acquired under pesticide registration requirements are subject to fines of up to $ 10,000, imprisonment for three years, or both.192 Under the Alternative Fines Act, a court may increase criminal fines under FIFRA substantially if a violation results in death.193 Criminal conduct under FIFRA may also violate other federal criminal laws.194 For example, knowing submission of false information in connection with a registration might involve conspiracy or fraud.195 Unlawful disposal of a pesticide [24 ELR 10518] might constitute a criminal violation of the Resource Recovery and Conservation Act196 or, if the disposal were into surface water, the Federal Water Pollution Control Act.197 Also, persons who do not directly violate FIFRA but who aid or abet a criminal violation may themselves face prosecution.198 VIII. EPA Authority, Administrative Procedure, and Judicial Review FIFRA grants EPA general authority to prescribe regulations to carry out the provisions of the Act.199 In addition, there are separate grants of rulemaking authority throughout FIFRA to support and govern particular rulemakings.200 FIFRA rulemakings, like most federal agency rulemakings, are subject to the procedural requirements of the Administrative Procedure Act,201 which include giving public notice of rulemakings and opportunity to comment. However, FIFRA requires EPA to give special notice and opportunity to comment to the Secretary of Agriculture, the Congress, and a Scientific Advisory Panel (SAP).202 At least 60 days prior to signing any proposed regulation for publication in the Federal Register, EPA must send copies of the proposal to the Secretary of Agriculture, the SAP, and the agriculture committees of the House and Senate.203 EPA must also publish the notification to the Secretary in the Federal Register.204 If the Secretary or the SAP respond with comments within 30 days, EPA must publish the comments with the proposed regulation.205 If EPA gets no response after 30 days, EPA may go ahead and publish the proposed rule notwithstanding the 60-day advance notice requirement.206 EPA may also waive or modify the time requirements with the Secretary and the SAP's consent.207 The SAP is the same group that comments and advises on suspensions and cancellations of pesticide registrations, discussed earlier in Part IV.H of this Article. It also comments on EPA's scientific analyses and helps provide peer review for scientific studies. The National Institutes of Health and the National Science Foundation nominate the members of the SAP, but EPA selects them after publishing the nominees' names in the Federal Register. EPA routinely invites public comment on the nominees.208 Pursuant to the requirements of § 10 of the Federal Advisory Committee Act,209 the SAP or its sub-panels hold open meetings from time to time to address specific issues before them. Notice of these meeting appears in the Federal Register, usually with an invitation for the public to submit written comments; the SAP may grant requests from the public to offer oral comments at a meeting if time allows. FIFRA § 25(c) authorizes EPA to make six particular kinds of rules only after notice and opportunity for hearing.210 Under this subsection, EPA may declare injurious plants or animals to be pests (except for man and for microorganisms living on or in living man or other living animals). This authority goes to defining the jurisdictional scope of FIFRA.211 EPA may determine pesticides to be highly toxic to man, which goes to labeling requirements.212 EPA may establish standards for protective packaging.213 EPA may specify which classes of devices are subject to misbranding and establishment registration and recordkeeping requirements.214 EPA may require pesticides to be colored or discolored if necessary for the protection of health and the environment.215 And EPA may determine and establish suitable names to be used for chemicals in the ingredient statement that appears on labels.216 FIFRA expressly grants EPA general discretion to solicit interested individuals or groups to offer views orally or in writing on any proposed rules and other actions under the Act.217 If EPA holds a public hearing to solicit views, whether the hearing is discretionary or mandatory, it must give timely notice in the Federal Register.218 FIFRA imposes intragovernmental notice and comment requirements on final rules that are generally parallel to the requirements for proposed rules. At least 30 days prior to signing any final regulation for publication in the Federal Register, EPA must send copies of the proposal to the Secretary of Agriculture, the SAP, and the agriculture committees of the House and Senate.219 EPA must also publish the notification to the Secretary in the Federal Register.220 If the Secretary or the SAP respond with comments within [24 ELR 10519] 15 days, EPA must publish them with the final regulation, along with EPA's response.221 If EPA gets no response after 15 days, EPA may go ahead and publish the proposed rule notwithstanding the 30-day advance notice requirement.222 EPA may also waive or modify the time requirements with the Secretary and the SAP's consent.223 When EPA promulgates the final rule, it must send a copy to the Secretary of the Senate and the Clerk of the House; the rule may not go into effect until 60 days after EPA transmits it to these officials.224 3. General Substantive Standards In its grant of general rulemaking authority, FIFRA requires EPA to "take into account the difference in concept and usage between various classes of pesticides and differences in environmental risk and the appropriate data for evaluating such risk between agricultural and nonagricultural pesticides."225 EPA must also analyze the effect of the regulation on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy. The publication of the final rule in the Federal Register must include the analysis of these effects.226 As a general rule, federal district courts may review final actions of the Administrator "not committed to the discretion of the Administrator by law."227 Examples of such actions include refusing to cancel or suspend a registration or to change a classification (if EPA does so without a public hearing);228 ordering label revisions;229 or exempting federal or state agencies from registration requirements.230 FIFRA does not expressly set forth a standard of review for these types of actions. At least one court, however, has concluded that such actions are reviewable for abuse of discretion.231 With respect to any order that EPA issues following a public hearing,232 any person who will be adversely affected by such order and who had been a party to the proceeding may obtain judicial review in a United States court of appeals.233 The person should file a petition for review in the circuit in which such person resides or has a place of business, within 60 days after the entry of such order.234 The clerk of the court must send a copy of the petition forthwith to the Administrator or any officer designated by the Administrator for that purpose, and the Administrator must then file in the court the record of the proceedings on which the Administrator based the order.235 Upon the filing of such petition, the court has exclusive jurisdiction to affirm or set aside the order complained of in whole or in part.236 The court must consider all evidence of record.237 The court must sustain the order if it is supported by substantial evidence when considered on the record as a whole.238 1. 7 U.S.C. § 136e, ELR STAT. FIFRA § 7; 40 C.F.R. § 167.20 (1993). But note that sites where pesticides are mixed to a customer's specifications (custom blenders) are excluded from the registration requirement under limited circumstances. 40 C.F.R. § 167.20(a)(1) (1993). 2. 40 C.F.R. § 167.3 (1993). 3. Id. 4. Id. At least two other types of establishments must also be registered. Sites that produce a pesticide for use under an experimental use permit and those establishments producing products for a Special Local needs registration must also be registered. Id. § 167.20(a)(3). 5. Id. § 167.20(c). 6. Id. § 167.20(b). 7. Id. § 167.20(d). 8. Id. § 167.85(b). 9. Id. § 167.85(d). 10. 7 U.S.C. § 136f(a), ELR STAT. FIFRA § 8(a); 40 C.F.R. § 169.2 (1993). 11. Id. § 136f(a), ELR STAT. FIFRA § 8(a). 12. Id. § 136f(b), ELR STAT. FIFRA § 8(b); 40 C.F.R. § 169.3 (1993). 13. 7 U.S.C. § 136f(b), ELR STAT. FIFRA § 8(b). 14. 40 C.F.R. § 169.3(a) (1993). 15. 7 U.S.C. § 136f(b), ELR STAT. FIFRA § 8(b). 16. 42 U.S.C. § 9603(e), ELR STAT. CERCLA § 103(e). The Toxic Substances Control Act (TSCA) has a similar provision, but it does not explicitly require that a chemical be registered under FIFRA in order to be exempt from TSCA. See 15 U.S.C. § 2601(2)(B)(i), ELR STAT. TSCA § 3(2)(B)(i) (a "chemical substance" within the meaning of TSCA does not include "any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide"). However, except for under certain circumstances, EPA will not consider a pesticide to be exempt from TSCA's research and development requirements until the pesticide's manufacturers or importers submit either an application for an experimental use permit or an application for registration under FIFRA. 51 Fed. Reg. 15096, 15098 (Apr. 22, 1986). 17. See Villari v. Terminex Int'l, Inc., 692 F. Supp. 568 (E.D. Pa. 1988) (corporation applying pesticide as part of extermination service held to be a seller under FIFRA). Note that FIFRA, as amended in 1988, no longer considers a person applying pesticides as part of a pest control service to be distributing or selling the pesticides if the pesticides are registered. 7 U.S.C. § 136(gg), ELR STAT. FIFRA § 2(gg). 18. See supra Part III.A. 19. Id. 20. 7 U.S.C. § 136j(a)(2)(A), ELR STAT. FIFRA § 12(a)(2)(A). 21. 40 C.F.R. § 156.10(i)(2) (1993). 22. Id. § 170.9(a). 23. 7 U.S.C. § 136j(a)(2)(G), ELR STAT. FIFRA § 12(a)(2)(G). The phrase "inconsistent with its labeling" is defined as "not permitted by the labeling." Id. § 136(ee), ELR STAT. FIFRA § 2(ee). 24. See George's Pest Control Servs. v. U.S. Environmental Protection Agency, 572 F.2d 204, 8 ELR 20063 (9th Cir. 1977) (pest control service that sprayed insecticide in a meat market with the spray nozzle 8 to 12 inches from a wall rather than directly in cracks and crevices as provided for by the label violated FIFRA). But see Oregon Envtl. Council v. Kunzman, 714 F.2d 901, 905, 13 ELR 20901, 20903 (9th Cir. 1983) (direct aerial spraying in residential area did not "ignore" label's warning to "avoid" breathing of spray and contact with skin and eyes because appellee took sufficient precautions to comply with label restrictions). 25. 7 U.S.C. § 136l(b), ELR STAT. FIFRA § 14(b) (establishing criminal penalties for "knowing" violations); see United States v. Corbin Farm Serv., 444 F. Supp. 510, 8 ELR 20333 (E.D. Cal.), aff'd, 578 F.2d 259, 8 ELR 20615 (9th Cir. 1978) (to prove knowing violation of FIFRA, government must show intent to use pesticide but need not show intent to ignore labeling). 26. See 7 U.S.C. § 136(ee), ELR STAT. FIFRA § 2(ee). 27. Id. Since it is not a misuse to apply a pesticide to a pest not listed on the labeling, it similarly is not unlawful to recommend or advertise such a use. See Advocacy of Pesticide Uses Which Do Not Appear on Registered Pesticide Label; Statement of Policy, 46 Fed. Reg. 51745 (Oct. 22, 1981). Antimicrobial agents are an exception to this rule, since for such products efficacy claims not supported by data submitted with the registration may foster a false sense of security among health care professionals. See Advocacy of Pesticide Uses Which Do Not Appear on Registered Pesticide Labels; Amendment to the Statement of Policy, 51 Fed. Reg. 19174 (May 28, 1986); see also EPA Settles With Courtaulds Coatings, Inc. of Louisville, KY. for Violations of Pesticide Laws, PR Newswire (Dec. 27, 1993) (Courtaulds Coatings fined $ 38,640 for implying that products had antimicrobial properties). 28. 7 U.S.C. § 136(ee), ELR STAT. FIFRA § 2(ee). 29. Id. 30. See supra Part IV.F. 31. See supra Part II.B.2.c. 32. See infra Part XI.E. 33. 7 U.S.C. § 136(ee), ELR STAT. FIFRA § 2(ee). 34. See 40 C.F.R. §§ 172.6 (labeling requirements for EUPs), 166.7(a) (allowable use of labeling for emergency exemptions), 162.153(e) (labeling requirements for state registrations) (1993). 35. 7 U.S.C. § 136j(a)(2)(H), ELR STAT. FIFRA § 12(a)(2)(H). 36. See supra Parts III.A.1.d, IV.D.2.g. 37. See 40 C.F.R. §§ 152.170-.171 (1993). Note that EPA applies a cost-benefit test, weighing the costs of unrestricted use against the benefits of restriction. 38. 7 U.S.C. § 136a(d)(1)(C)(i), (ii), ELR STAT. FIFRA § 3(d)(1)(C)(i),(ii). 39. See 40 C.F.R. 171.6(a). The pesticide label may indicate whether the supervisor must be present; in any case, there are standards for supervision. See id.; see also id. § 171.2(a)(28). 40. 7 U.S.C. § 136j(a)(2)(F), ELR STAT. FIFRA § 12(a)(2)(F). 41. 40 C.F.R. §§ 152.166, 156.10(j) (1993). 42. Id. § 152.168. 43. See 7 U.S.C. § 136j(a)(2)(F), ELR STAT. FIFRA § 12(a)(2)(F). 44. 40 C.F.R. § 152.175 (1993). 45. 7 U.S.C. § 136i(a)(2), ELR STAT.FIFRA § 11(a)(2); for the standards and procedurs relating to submission of state and tribal plans, see 40 C.F.R. §§ 171.7-.8, -.10 (1993). 46. Personal communication, Assistant Administrator's Office, EPA Office of Pesticides and Toxic Substances (May 1994). 47. 7 U.S.C. § 136i(a)(1), ELR STAT. FIFRA § 11(a)(1); 40 C.F.R. § 171.11 (1993). 48. 40 C.F.R. § 171.7(e) (1993). 49. 7 U.S.C. § 136(e)(2), ELR STAT. FIFRA § 2(e)(2); 40 C.F.R. § 171.2(a)(20) (1993). 50. 7 U.S.C. § 136(e)(3), ELR STAT. FIFRA § 2(e)(3); 40 C.F.R. § 171.2(a)(9) (1993). 51. See 40 C.F.R. §§ 171.5(b), -.11(d) (1993). 52. Id. § 171.5(a). 53. Id. § 171.5(a)(1)-(5). 54. Id. §§ 171.5(b)(1), -.11(d)(1)(iv). 55. Id. §§ 171.4(b), -.11(c)(3). 56. Id. §§ 171.4(c), -.11(c)(3). 57. Id. § 171.4(c)(7). 58. Id. § 171.6(a). 59. Id. §§ 171.4(a), -.11(c)(4). 60. Id. §§ 171.8(e)(6), -.11(e). 61. Id. § 171.11(c)(4),(d)(2). 62. Id. § 171.8(a)(2). 63. See id. §§ 171.7(b)(1)(iii)(A), -.11(f). 64. Id. § 171.11(f)(1), (5). 65. Id. § 171.11(f)(1)-(4). 66. Id. § 171.11(2)(i)(B)-(D); OFFICE OF COMPLIANCE MONITORING, OFFICE OF PESTICIDES AND TOXIC SUBSTANCES, EPA, ENFORCEMENT RESPONSE POLICY FOR THE FEDERAL INSECTICIDE, FUNGICIDE, AND REODENTICIDE ACT ("FIFRA") 11 (July 2, 1990) (hereinafter FIFRA ERP). 67. FIFRA ERP, supra note 66, at 10. 68. See 40 C.F.R. §§ 171.7(b)(1)(iii)(A), (B), -.11(f) (1993). 69. For policy guidance concerning the size of penalties, see FIFRA ERP, supra note 66, at 11. 70. 7 U.S.C. § 136i-1(a) (Supp. V 1993). 71. See id. § 136i(d), ELR STAT. FIFRA § 11(d). 72. 7 C.F.R. pt. 110 (1994). Some confusion and uncertainty surround these rules. The Agriculture Marketing Service promulgated regulations in spring of 1993 to require recordkeeping. See 58 Fed. Reg. 19014 (Apr. 9, 1993). Then in summer of 1993, the Agriculture Marketing Service revised the order of part of 7 C.F.R. See 58 Fed. Reg. 42408 (Aug. 9, 1993). That revision "reserved" the freshly promulgated sections of pt. 110 for a "separate rulemaking." Apparently, the recordkeeping rulemaking and the general revision went on in parallel and ignored each other. Both versions of pt. 110 appear in the 1994 edition of the Code of Federal Regulations along with a note explaining that a future action will clarify the situation. Meanwhile, in response to a lawsuit and other questions raised about the regulations, the Agriculture Marketing Service has already proposed substantive amendments to the recordkeeping rules. 59 Fed. Reg. 16400 (Apr. 6, 1994). 73. 7 C.F.R. § 110.3(a) (1994). 74. Id. § 110.3(c), (e). 75. 7 U.S.C. § 136i-1(c) (Supp. V 1993); 7 C.F.R. § 110.5 (1994). 76. 7 C.F.R. § 110.3(g) (1994). 77. 7 U.S.C. § 136i-1(a)(2) (Supp. V 1993); 7 C.F.R. § 110.3(d) (1994). 78. 7 U.S.C. § 136i-1(d) (Supp. V 1993); 7 C.F.R. §§ 110.7-.8 (1994). 79. 40 C.F.R. §§ 171.7(b)(1)(iii)(E), -.11(c)(7). 80. See 7 U.S.C. § 136i(a), ELR STAT. FIFRA § 11(a). 81. Id. § 136j(a)(2)(B), (M), ELR STAT. FIFRA § 12(a)(2)(B), (M). 82. Compare 7 C.F.R. § 110.7 (1994) (civil penalties under Farm Bill) with 7 U.S.C. § 136l(a)(1)-(2), (b) (civil and criminal penalties under FIFRA) and 40 C.F.R. §§ 171.7(b)(1)(iii)(A), -.11(f) (provisions for suspending, revoking, or modifying certifications under FIFRA). 83. 40 C.F.R. § 171.2(b)(1) (1993). 84. Id. § 171.2(b)(2). 85. 7 U.S.C. § 136(gg), ELR STAT. FIFRA § 2(gg). 86. 40 C.F.R. § 171.11(g)(1) (1993). 87. Id. § 171.11(g)(2)(i). 88. Id. § 171.11(g)(ii). 89. 7 U.S.C. § 136j(a)(2)(F), ELR STAT. FIFRA § 12(a)(2)(F). 90. 40 C.F.R. § 171.11(g)(ii) (1993). 91. Id. § 171.11(g)(2)(i), (ii). 92. Id. § 171.11(g)(3). 93. 57 Fed. Reg. 38101 (Aug. 21, 1992) (codified as 40 C.F.R. pt. 170 (1993)). 94. See Pub. L. No. 103-231, 108 Stat. 333 (1994). This delay does not apply to "specific worker protection requirements that appear directly on the label or labeling of the pesticide product." Id. § 1, 108 Stat. at 333. 95. See id. §§ 156.200, -.212. 96. Id. § 156.200(c). 97. A FIFRA violation occurs only when pesticide is used "in a manner inconsistent with its labeling." 7 U.S.C. § 136j(a)(2)(G), ELR STAT. FIFRA § 12(a)(2)(G). Therefore, an employer would not be in violation of FIFRA for failing to comply with the new worker protection requirements if the pesticides used by the employer bore only the old labels and did not have the new workerprotection requirements. EPA, QUESTIONS & ANSWERS, THE WORKER PROTECTION STANDARD: 1994 LEGISLATIVE CHANGES (Apr. 1994) (whatever label, old or new, is on the product used by the employer, the employer must follow the instructions on that label); see also 57 Fed. Reg. 38102, 38140 (Aug. 21, 1992) ("the provisions of this standard [40 C.F.R. pt. 156, subpt. A] must be in the labeling or linked to the pesticide before they can be implemented or enforced."). If a product combines old and new labels, the more restrictive worker protection requirements must be followed. EPA, QUESTIONS & ANSWERS, THE WORKER PROTECTION STANDARD: 1994 LEGISLATIVE CHANGES (Apr. 1994). 98. 40 C.F.R. § 170.3 (1993). 99. Id. 100. Id. 101. Id. § 170.202(a). 102. Id. § 170.7(a). 103. Id. § 170.7(b). 104. See id. § 170.9(a) (citing 7 U.S.C. § 136j(a)(2)(G), ELR STAT. FIFRA § 12(a)(2)(G)). 105. See 40 C.F.R. § 170.9(c) (1993) (citing 7 U.S.C. § 136l(b)(4), ELR STAT. FIFRA § 14(b)(4)). 106. 40 C.F.R. § 170.9(a) (1993). 107. Id. § 170.110. 108. Id. § 170.112. 109. Id. §§ 170.120, -.122. 110. Id. § 170.130. 111. Id. § 170.135. 112. Id. § 170.150. 113. Id. § 170.160. 114. Id. § 170.124. 115. Id. § 170.102(a), (b). 116. Id. § 170.102(b)(1)-(4), (6), (9). 117. Id. § 170.102(b)(5), (7), (8), (10). 118. Id. § 170.102(c). 119. EPA has also published a comprehensive guide, entitled The Worker Protection Standard for Agricultural Pesticides: How To Comply -- What Employers Need to Know, that explains exactly what is required of employers under the new worker protection standards. The publication (publication number 055-000-00442-1) is available from the U.S. Government Printing Office, and can be ordered by calling (202) 783-3238. Note too that Pub. L. No. 103-231, 108 Stat. 333 (1994), has temporarily modified some of the regulatory requirements. The law expires on January 1, 1995. 120. 40 C.F.R. § 170.112 (1993). In fact, employers may ask EPA to approve a special exemption if they anticipate a technical or financial need to enter a treated area earlier than the label allows. Id. § 170.112(e). Note that until January 1995, the reentry standards in Pub. L. No. 103-231, § 2, 108 Stat. 333, 333 (1994) may control. 121. 40 C.F.R. § 170.120(d) (1993). 122. Id. § 170.120(a)-(c). 123. Id. § 170.210. 124. Id. § 170.222. 125. Id. § 170.230. 126. Id. § 170.232. 127. Id. § 170.234. 128. Id. § 170.235. 129. Id. § 170.240. 130. Id. § 170.250. 131. Id. § 170.260. 132. Id. § 170.224. 133. Id. § 170.202; see also id. § 170.3 (definition of agricultural establishment). 134. Id. § 170.202(b). Compare id. with id. § 170.102(b). 135. Id. § 170.202(c). Compare id. with id. § 170.102(c). 136. The guides, Protect Yourself From Pesticides -- Guide for Pesticide Handlers and Protect Yourself From Pesticides -- Guide for Agricultural Workers are both available from the U.S. Government Printing Office, by calling (202) 783-3238 (respective order numbers: 055-000-00467-6 and 055-000-00444-7). 137. 7 U.S.C. §§ 136u(a), 136w-1, 136w-2, ELR STAT. FIFRA §§ 23(a), 26, 27; see also 40 C.F.R. §§ 35.550-.605, -173 (1993) (federal cost sharing in state enforcement and applicator certification and training efforts, and procedures governing recision of state primary enforcement responsibility). 138. In such states, EPA may bring its own enforcement actions only in emergency situations or where EPA has referred the action to the state and the state has failed to begin enforcement within 30 days. 7 U.S.C. § 136w-2(a), (c), ELR STAT. FIFRA § 27(a), (c). Under separate delegation authority, almost all applicator certification programs are state-run and enforced. See supra Part VI.B.1. 139. Almond Hill School v. U.S. Dep't of Agric., 768 F.2d 1030, 15 ELR 20985 (9th Cir. 1985); Fiedler v. Clark, 714 F.2d 77 (9th Cir. 1983) (per curiam). 140. 7 U.S.C. § 136j, ELR STAT. FIFRA § 12. 141. Id. § 136l, ELR STAT. FIFRA § 14. 142. Id. § 136j(a)(1), ELR STAT. FIFRA § 12(a)(1). 143. Id. § 136w(c)(5), ELR STAT. FIFRA § 25(c)(5) authorizes EPA to require pesticides to be colored or discolored. The pesticides that currently may need to be colored or discolored are arsenicals and barium fluosilicate; sodium fluoride and sodium fluosilicate; and seed treatments. 40 C.F.R. §§ 153.140-.158 (1993). 144. 7 U.S.C. § 136j(b), ELR STAT. FIFRA § 12(b). 145. Id. § 136j(a)(2)(B)(ii), (N), ELR STAT. FIFRA § 12(a)(2)(B)(ii), (N). 146. Id. § 136j(a)(2)(A), (G), (H), ELR STAT. FIFRA § 12(a)(2)(A), (G), (H). 147. Id. § 136j(a)(2)(B), (D), (M), (Q), (R); ELR STAT. FIFRA § 12(a)(2)(B), (D), (M), (Q), (R). 148. Id. § 136j(a)(2)(P), ELR STAT. FIFRA § 12(a)(2)(P). 149. Id. § 136l(b)(4), ELR STAT. FIFRA § 14(b)(4). 150. See United States v. Corbin Farm Serv., 444 F. Supp. 510, 8 ELR 20333 (E.D. Cal.), aff'd, 578 F.2d 259 (9th Cir. 1978). 151. See Oner II, Inc. v. U.S. Environmental Protection Agency, 597 F.2d 184 (9th Cir. 1979). 152. See supra notes 1 and 2 and accompanying text. 153. Compare 33 U.S.C. § 1319(a), ELR STAT. FWPCA § 309(b), 42 U.S.C. § 6928(a), ELR STAT. RCRA § 3008(a) with 7 U.S.C. § 136w-2, ELR STAT. FIFRA § 27. 154. FIFRA ERP, supra note 66. 155. 7 U.S.C. § 136l(a)(4), ELR STAT. FIFRA § 14(a)(4). 156. Id. § 136l(a)(2), ELR STAT. FIFRA § 14(a)(2). 157. Id. § 136g(c)(3), ELR STAT. FIFRA § 9(c)(3). 158. FIFRA ERP, supra note 66, at 4-5. 159. Id. app. B-2. 160. Id. at 5. 161. EPA, NATIONAL PENALTY REPORT, OVERVIEW OF EPA FEDERAL PENALTY PRACTICES, FY 1992, at 6 (May 1993). 162. Id. at 18. 163. Id. at 12. 164. 7 U.S.C. § 136l(a)(1), ELR STAT. FIFRA § 14(a)(1). 165. Id. § 136l(a)(2), ELR STAT. FIFRA § 14(a)(2). 166. Id. 167. FIFRA ERP, supra note 66, at 10. 168. 7 U.S.C. § 136l(a)(4), ELR STAT. FIFRA § 14(a)(4). 169. Id. § 136l(a)(3), ELR STAT. FIFRA § 14(a)(3). 170. FIFRA ERP, supra note 66, at 17-22. 171. Id. at 25. 172. Id. 173. Id. at 26. 174. Id. 175. 7 U.S.C. § 136k(a), ELR STAT. FIFRA § 13(a). 176. Id. § 136j(a)(2)(I), ELR STAT. FIFRA § 12(a)(I). 177. FIFRA ERP, supra note 66, at 5. 178. Id. at 6. 179. Id. at 7. 180. 7 U.S.C. § 136k(b), ELR STAT. FIFRA § 13(b). 181. Id. § 136g(b)(3), ELR STAT. FIFRA § 9(b)(3). 182. Id. § 136k(b), ELR STAT. FIFRA § 13(b). 183. Id. § 136k(b)(1), ELR STAT. FIFRA § 13(b)(1). 184. Id. § 136k(b)(2), ELR STAT. § 13(b)(2). 185. Id. § 136k(b)(3), ELR STAT. FIFRA § 13(b)(3). 186. FIFRA ERP, supra note 66, at 5. 187. 7 U.S.C. § 136n(c), ELR STAT. FIFRA § 16(c). 188. See FIFRA ERP, supra note 66, at 8-9. 189. Id. at 9. 190. 7 U.S.C. § 136l(b)(1)-(3), ELR STAT. FIFRA § 14(b)(1)-(3). 191. United States v. Corbin Farm Serv., 444 F. Supp. 510, 8 ELR 20333 (E.D. Cal.), aff'd, 578 F.2d 259, 8 ELR 20615 (9th Cir. 1978). 192. 7 U.S.C. § 136(b)(1)-(3), ELR STAT. FIFRA § 14(b)(1)-(3). 193. 18 U.S.C. § 3571 (1988). 194. See FIFRA ERP, supra note 66, at 14. 195. See 18 U.S.C. §§ 371, 1000 (1988). 196. See 42 U.S.C. § 6928(d)-(f), ELR STAT. RCRA § 3008(d)-(f). 197. See 33 U.S.C. § 1319(c), ELR STAT. FWPCA § 309(c). 198. See 18 U.S.C. § 2 (1988) (federal aiding and abetting law); United States v. Corbin Farm Serv., 444 F. Supp. 510, 8 ELR 20333 (E.D. Cal.), aff'd, 578 F.2d 259, 8 ELR 20615 (9th Cir. 1978) (advisor who counseled unlawful use of pesticide could be considered to have aided or abetted). 199. 7 U.S.C. § 136w(a)(1), ELR STAT. FIFRA § 25(a)(1). 200. E.g., id. § 136a(c)(2)(C), ELR STAT. FIFRA § 3(c)(2)(C) (authority to prescribe simplified procedures for pesticide registration), id. § 136f(a), ELR STAT. FIFRA § 8(a) (authority to establish recordkeeping requirements for registrants and others), id. § 136w(b), ELR STAT. FIFRA § 25(b) (authority to exempt pesticides from FIFRA regulation). 201. 5 U.S.C. §§ 500-559, ELR STAT. ADMIN. PROC. §§ 500-559. 202. 7 U.S.C. §§ 136s(a), 136w(a)(2)-(4), ELR STAT. FIFRA §§ 21(a), 25(a)(2)-(4). 203. Id. § 136w(a)(2)(A), (a)(3), (d), ELR STAT. FIFRA § 25(a)(2)(A), (a)(3), (d). 204. Id. § 136w(a)(2)(D), ELR STAT. FIFRA § 25(a)(2)(D). 205. Id. § 136w(a)(2)(A), (d), ELR STAT. FIFRA § 25(a)(2)(A), (d). 206. Id. 207. Id. § 136w(a)(2)(C), (d), ELR STAT. FIFRA § 25(a)(2)(C), (d). 208. See, e.g., 58 Fed. Reg. 11229 (Feb. 24, 1993). 209. Pub. L. No. 92-463, 86 Stat. 770 (1972), reprinted in 5 U.S.C. app. at 1175 (1988). 210. 7 U.S.C. § 136w(c), ELR STAT. FIFRA § 25(c). 211. See supra Part II. 212. See 7 U.S.C. § 136(q)(2)(D), ELR STAT. FIFRA § 2(q)(2)(D); 40 C.F.R. § 156.10(h)(1)(i)(A), (iii)(A); supra Part III.A.1.b. 213. See 40 C.F.R. pt. 157; supra Part III.B. 214. See 40 C.F.R. § 153.240 (1993). 215. See id. §§ 153.140-.158. 216. See id. § 156.10(g)(3). 217. 7 U.S.C. § 136s(b), ELR STAT. FIFRA § 21(b). 218. Id. § 136s(c), ELR STAT. FIFRA § 21(c). 219. Id. § 136w(a)(2)(A), (a)(3), (d), ELR STAT. FIFRA § 25(a)(2)(A), (a)(3), (d). 220. Id. § 136w(a)(2)(D), ELR STAT. FIFRA § 25(a)(2)(D). 221. Id. § 136w(a)(2)(A), (d), ELR STAT. FIFRA § 25(a)(2)(A), (d). 222. Id. 223. Id. § 136w(a)(2)(C), (d), ELR STAT. FIFRA § 25(a)(2)(C), (d). 224. Id. § 136w(a)(4), ELR STAT. FIFRA § 25(a)(4). 225. Id. § 136w(a)(1), ELR STAT. FIFRA § 25(a)(1). 226. Id. § 136w(a)(2)(B), ELR STAT. FIFRA § 25(a)(2)(B). 227. Id. § 136n(a), ELR STAT. FIFRA § 16(a). 228. Id. 229. See Ciba-Geigy Corp. v. U.S. Environmental Protection Agency, 801 F.2d 430, 17 ELR 20072 (D.C. Cir. 1986) (involving a mailgram informing a registrant that EPA would view products shipped after a particular date without particular labeling changes as misbranded, and would consider appropriate enforcement action). 230. See Environmental Defense Fund v. Blum, 458 F. Supp. 650, 8 ELR 20748 (D.D.C. 1978). 231. See Environmental Defense Fund v. Ruckelshaus, 439 F.2d 584, 1 ELR 20059 (D.C. Cir. 1971). 232. "Public hearing" encompasses both formal and informal public hearings and is not limited to adjudicatory hearings, as defined by the Administrative Procedure Act. Louisiana v. Train, 392 F. Supp. 564, 568, 5 ELR 20367, 20368 (W.D. La. 1975). See also Environmental Defense Fund v. Costle, 631 F.2d 922, 10 ELR 20585 (D.C. Cir. 1980) (in determining whether proceedings before EPA are sufficient to qualify as public hearing resulting in "final order" to allow appellate court jurisdiction, it is availability of record for review, not holding of a quasijudicial hearing, that is jurisdictional touchstone), cert. denied, 449 U.S. 1112 (1980). 233. 7 U.S.C. § 136n(b), ELR STAT. FIFRA § 16(b). 234. Id. 235. 28 U.S.C. § 2112 (1988) governs filing of administrative records with the court. 236. 7 U.S.C. § 136n(b), ELR STAT. FIFRA § 16(b). 237. Id. 238. Id.; see also Environmental Defense Fund v. U.S. Environmental Protection Agency, 489 F.2d 1247, 1251, 4 ELR 20031, 20033 (D.C. Cir. 1973). 24 ELR 10507 | Environmental Law Reporter | copyright © 1994 | All rights reserved |