24 ELR 10629 | Environmental Law Reporter | copyright © 1994 | All rights reserved

A Practitioner's Guide to the Federal Insecticide, Fungicide, and Rodenticide Act: Part III

Linda J. Fisher, Peter L. Winik, Carolyne R. Hathaway, Ann Claassen, and Jeffrey Holmstead

Editors' Summary: This is the third and final installment in ELR's series on federal pesticide law. This month's Article discusses proposed rules for storage, disposal, transportation, and recall; export and import laws; federal limits to state authority; requirements for reporting new health and safety data; regulation of pesticide residues in food under the Federal Food, Drug, and Cosmetic Act; EPA research and environmental monitoring authority; biotechnology issues; and some pending policy questions.

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, Jeffrey L. Hallos, and Gregory Slater, associates, and Amy Padden, 1994 summer associate, of Latham & Watkins. The authors also thank reviewers James V. Aidala Jr. and William L. Jordan for their thoughtful comments on the manuscript.

[24 ELR 10630]

A. Overview

The FIFRA Amendments of 1988 clarified EPA's authority to regulate the storage, transportation, and disposal of pesticides -- including suspended or canceled pesticides -- and their containers and rinsates.1 These amendments also authorized EPA, for the first time, to order the recall of suspended or canceled pesticides.

Now, pursuant to FIFRA §§ 3 and 6, the Administrator may require that:

(A) the registrant or applicant for registration of a pesticide submit or cite data or information regarding methods for the safe storage and disposal of excess quantities of the pesticide to support the registration or continued registration of a pesticide;

(B) the labeling of a pesticide contain requirements and procedures for the transportation, storage, and disposal of the pesticide, any container of the pesticide, any rinsate containing the pesticide, or any other material used to contain or collect excess or spilled quantities of the pesticide; and

(C) the registrant of a pesticide provide evidence of sufficient financial and other resources to carry out a recall plan under FIFRA § 19(b), and provide for the disposition of the pesticide, in the event of suspension and cancellation of the pesticide.2

In addition, the Administrator may, by regulation, or as part of an order issued under FIFRA § 6, or an amendment to such an order, issue requirements and procedures for the storage, transportation, and disposal of suspended or canceled pesticides, including their containers and rinsates.3 (No requirement or procedure, however, may require the recall of existing stocks of the pesticide except as provided in FIFRA § 19(b).4 )

EPA has not promulgated regulations in this area subsequent to the 1988 Amendments. Consequently, procedures EPA recommended in 1974 remain in effect.5 The current regulations provide recommended procedures for the disposal and storage of pesticides, pesticide containers, residues, and pesticide-related wastes.6 The regulations also require EPA to accept for safe disposal suspended and canceled pesticides, and detail the components of this acceptance program.7 These regulations will [24 ELR 10631] remain in effect, with a few key changes, after the proposed rules are finalized.8

EPA is revising the current regulations through a series of rulemakings.9 The goal of these rulemakings is to provide minimum, reasonable federal standards in two major categories: Requirements that apply to all pesticides, and additional requirements for pesticides recalled under § 19.10

B. Proposed Rules

EPA has planned three regulatory phases to address these topics. Phase 1 includes specific requirements for recalled pesticides. These cover the basic recall procedure, storage and disposal plans, and indemnification. Phases 2 and 3 apply to all pesticides. Phase 2 covers container design, containment structures for commercial operations, and labeling. Phase 3 covers storage, management of excess pesticides, containment structures for noncommercial operations, and transportation.

EPA has issued proposed rules for Phase 111 and for Phase 2.12 The Phase 1 rule should be promulgated in final form sometime in December 1994.13

1. Phase 1: Specific Requirements for EPA-Recalled Pesticides

[] Recalls. The proposed rule addresses both voluntary and mandatory recalls. For voluntary recalls, EPA proposed a rule prescribing the basic elements of a voluntary recall plan. Similarly, EPA proposed that mandatory recalls be accomplished through generic rulemaking, rather than pesticide product-specific rulemaking at the time of each cancellation order. According to EPA, these options would allow the regulated community to know with greater certainty what the Agency would require in a recall. In addition to the basics on how to conduct a recall, the proposed rule specifies transportation, storage, management options, and recordkeeping requirements once a recall has begun.14

[] Storage and Disposal Plans. The proposed rule clearly defines the criteria that registrants must include in an acceptable storage and disposal plan. It also describes the procedures, documentation requirements, reimbursement schedule, and updating requirements registrants must follow to be reimbursed for storage costs after they have submitted an acceptable storage and disposal plan to the Agency.15

[] Indemnification. The proposed rule establishes procedures for EPA indemnification of owners of suspended and canceled pesticides. In addition, the proposal tracks the statutory requirements for eligibility, amount of indemnification, and reimbursement by the seller.16

2. Phase 2: Requirements for All Pesticides

[] Containers. The proposed rules on containers treat nonrefillable and refillable containers separately and focus on performance standards rather than specific design standards. For nonrefillable containers, the proposed rules set container design standards, residue removal performance standards, and certification and recordkeeping requirements. For refillable containers, the proposed rules provide minimum design and construction standards for the containers, as well as refilling requirements for both registrants and refillers.17

[] Containment Structures (Commercial). The proposed rules set criteria for the design, maintenance, and operation of containment structures. These criteria apply to facilities of agricultural pesticide refilling establishments and custom blenders, and to facilities of businesses that apply agricultural pesticides for compensation.18

3. Phase 3: Further Requirements for All Pesticides

In Phase 3, EPA will address data requirements, additional containment concerns, and storage, disposal, and transportation of registered pesticides.19 EPA has not yet determined whether Phase 3 will be governed by regulations, guidance documents, or other mechanisms. If EPA develops regulations, they may require pesticide storage areas engaged in long-term storage of large quantities of pesticides to meet minimum standards for security, construction, fire protection, spill prevention and cleanup, and container management and inspection. In addition, the regulations may require existing facilities to ensure protection of water supplies immediately and new facilities to meet minimum siting and construction requirements. Lastly, EPA may issue regulations that require pesticide labels to include statements on disposal methods, residue removal, and handling procedures.

C. Pesticide Container Regulations

1. Pesticide Container Study

FIFRA § 19 requires EPA to conduct a study of options to encourage or require: "(i) the return, refill, and reuse of pesticide containers; (ii) the development and use of pesticide formulations that facilitate the removal of pesticide residues from containers; and (iii) the use of bulk storage facilities to reduce the number of pesticide containers requiring disposal."20 EPA submitted this report in May [24 ELR 10632] 1992.21 The report examines the current state of refillable and nonrefillable pesticide container use, as well as the current regulations covering the containers. Based on the information collected, the report provides numerous options for each of the three areas listed above. In addition, the report establishes three long-term goals for EPA's pesticide container management strategy: (1) encourage the pesticide industry to consider the pesticide formulation and its container as a single entity; (2) provide leadership in the area of pesticide containers, encourage further cooperation and dialogue, and monitor pesticide container trends; and (3) encourage the development and use of pesticide containers in a way that reduces risks to human health and the environment with the least possible cost and burden on the public.

2. Pesticide Container Design

Pursuant to FIFRA § 19(e), EPA was supposed to promulgate regulations no later than December 24, 1991, for the design of pesticide containers "that will promote the safe storage and disposal of pesticides."22 EPA published proposed rules on February 11, 1994, for nonrefillable and refillable containers.23 These rules put the burden on the registrant to ensure that the container design requirements are met. Registrants must certify that the container requirements have been met, and must maintain specified records on their nonrefillable and refillable containers.

The proposed rules prohibit registrants from distributing or selling a pesticide in a nonrefillable container that does not meet general performance standards for container integrity and dispensing capability. In addition, nonrefillable containers must have standardized closures and permanent markings indicating the pesticide and the material from which the container is constructed.24

The proposed rules also prohibit registrants from distributing or selling pesticides in a refillable container that does not meet certain design standards. These standards include: (1) permanent markings to allow for container identification; (2) minibulk container integrity standards, including a drop test; (3) integrity standards for bulk containers; and (4) vent, gauge, and shutoff valve requirements for bulk containers.25

3. Nonrefillable Container Residue Removal

Similarly, pursuant to FIFRA § 19(f), EPA was supposed to promulgate regulations no later than December 24, 1991, prescribing procedures and standards for the removal of pesticides from containers prior to disposal.26 EPA published its proposed rules on February 11, 1994.27

The proposed rules set a residue removal standard for one type of container/formulation combination: Rigid containers with dilutable pesticides. The rules set a laboratory performance standard, under which 99.9999 percent of each active ingredient must be removed using a specified methodology. Registrants must certify compliance and maintain records indicating that their containers satisfy the standard. EPA ultimately intends to set similar requirements for other container/formulation categories.28

FIFRA § 19(f)(2) sets December 24, 1993, as the deadline for state programs to ensure compliance with the pesticide residue removal procedures described above.29 However, since EPA has not yet published final rules, EPA published a policy statement providing for interim approval of state programs.30 Nothing in FIFRA § 19(f) or the proposed rules affects the authorities or requirements concerning pesticide containers under the Solid Waste Disposal Act.31

4. Refilling Responsibilities and Procedures

The proposed rules place refilling responsibilities on both the registrant and the refiller. The registrant is responsible for ensuring that there is a written contract with the refiller and that the pesticide's composition has not changed in the refilling process. To assist the refiller, the registrant must develop and furnish information regarding the proper refilling procedure, acceptable containers, and the product's label and labeling.

The refiller is responsible for maintaining the integrity of the pesticide when it is packaged into refillable containers. Accordingly, the refiller must follow a number of specified procedures, including a visual inspection of the container and removal of any residues prior to refilling.32

5. Containment Structures

The proposed rules require, subject to a limited number of exceptions, containment structures for facilities containing stationary bulk containers or a pesticide dispensing area used for agricultural pesticides. In addition, the proposed rules set design and operating standards for these containment structures.

All containment structures must meet general performance standards for materials used, design and construction, and operation. The proposed rules set specific requirements applicable to liquid bulk containers, stationary dry bulk containers, and pesticide dispensing areas. In addition, owners or operators must inspect and maintain the containment structures and maintain records.33

D. Recall and Idemnification

1. Recall

If EPA has suspended and canceled the registration of a pesticide under FIFRA § 6, and if EPA finds that recall of [24 ELR 10633] the pesticide is necessary to protect health or the environment, EPA must order a recall of the pesticide.34 If, after determining that a recall is necessary, EPA finds that voluntary recall by the registrant and others in the chain of distribution may be as safe and effective as a mandatory recall, EPA must request the registrant of the pesticide to submit, within 60 days of the request, a plan for the voluntary recall of the pesticide. According to the proposed rule, the plan must include the following components: (1) identification of persons responsible for the recall; (2) identification of potential holders of the pesticide; (3) information to be obtained from the holders; (4) information to be provided for the holders; (5) the means of transportation; (6) the storage facilities where the pesticides will be stored; (7) a guarantee that EPA will be notified if the pesticides are moved; (8) management options; (9) a recall schedule; (10) alternatives to elements of the plan; and (11) any special conditions warranting additional attention.35

If such a plan is requested and submitted, EPA must approve the plan and order the registrant to conduct the recall in accordance with the plan unless EPA determines, after an informal hearing, that the plan is inadequate to protect health or the environment.36 Once a voluntary recall has begun, the proposed rule requires registrants to keep records on the recall and to report, in writing, at least quarterly to EPA regarding the progress of the recall.37

If, after determining that a recall is necessary, EPA does not request a plan for the voluntary recall of the pesticide, or finds such a plan to be inadequate, EPA must issue a regulation that prescribes a plan for the recall of the pesticide.38 Such regulation may apply to any person who is or was a registrant, distributor, or seller of the pesticide, or any successor in interest to such a person.39

Under the proposed rule, which creates the model for all mandatory recalls, primary responsibility for the recall remains with the registrant. The registrant must develop and coordinate the recall plan, as well as provide for storage and transportation of the pesticide at no cost to the holders. However, all other persons in the distribution chain must assist in the implementation of the plan by taking responsibility for the collection, including transportation and storage, of pesticides from their customers. In this way, the recalled pesticide can pass back up the distribution chain to the registrant. In addition, the proposed rule would require all recallers to maintain records and make specified reports to EPA.40

A registrant is eligible for reimbursement for storage costs incurred as a result of a recall for a pesticide whose registration EPA has suspended and canceled. If such a registrant desires the reimbursement, it must, as soon as practicable after the suspension of the registration of the pesticide, submit to EPA a plan for the storage and disposal of the pesticide that meets criteria established by regulation.41 Under the proposed rule, EPA will use the following criteria to determine if a plan is acceptable: (1) whether the plan assures storage in accordance with applicable law; (2) whether the plan discusses all available management options and evaluates their feasibility, costs, and risks and benefits; (3) whether the plan includes information specified in the rule, including responsible parties, a description of the pesticide, and the storage facilities to be used; and (4) whether the plan is signed by the registrant.42

Within a reasonable time after the registrant incurs and pays such storage costs, EPA must reimburse the registrant, on request, for:

100 percent of the costs incurred by the registrant after the date of submission of [such] plan … or the date of the cancellation of the registration of the pesticide, whichever is later, but before the approval date of the plan by the Administrator;

… 50 percent of the costs incurred by the registrant during the 1-year period beginning on the date of the approval of the plan by the Administrator or the date of cancellation of the registration of the pesticide, whichever is later;

… 25 percent of the costs incurred by the registrant during the period beginning on the first day on the 5th year following the date of the approval of the plan by the Administrator or the date of cancellation of the registration of the pesticide, whichever is later, and ending on the date that a disposal permit for the pesticide is issued by a State or an alternative plan for disposal of the pesticide in accordance with an applicable law has been developed.43

FIFRA does not require EPA to reimburse the registrant for: (1) costs incurred before submitting the storage and disposal plan described above; or (2) costs incurred during the three-year period beginning on the 366th day following EPA approval of the plan or the date of cancellation of the registration of the pesticide, whichever is later.44

The proposed rule details the procedures for registrants to follow for submitting reimbursement claims. Registrants must provide adequate documentation to prove their claim, must certify the truth of the information provided, and must accept that any payment made is full satisfaction and final settlement of the claim. Registrants requesting reimbursement for 25 percent of their costs incurred after the first day of the fifth year must provide additional information.45

In addition to the statutory recall requirements, EPA has adopted a policy of initiating formal or informal recalls where a product is "potentially hazardous when used as directed, ineffective for the purposes claimed, or violative in nature."46 Because FIFRA does not expressly authorize [24 ELR 10634] this program, the effectiveness of formal and informal recalls is contingent on the cooperation of the company involved. EPA does not have to suspend or cancel a product before deciding that requesting a formal or informal recall is appropriate, but EPA will only initiate a formal or informal recall where the evidence clearly supports the need for such action. A formal recall (often accompanied by a civil penalty action) is used for more serious problems and involves EPA oversight and monitoring. An informal recall is conducted entirely by the company without EPA oversight, and is used when the potential hazard is small.

2. Indemnification

In 1988, the FIFRA amendments greatly restricted who could receive indemnification, essentially requiring a congressional line item appropriation for indemnification. In general, registrants, wholesalers, dealers, and distributors must reimburse purchasers for unused pesticides unless they gave notice at the time of distribution that the pesticide was not eligible for reimbursement. The one exception is that end users, and certain dealers and distributors who could not get reimbursed due to their seller's insolvency, may receive indemnification.47

The proposed rule details the eligibility requirements for indemnification and limits indemnification to the fair market value of the pesticide in the eligible party's possession immediately before suspension. Owners must mitigate any losses caused by suspension and cancellation orders. The rule also details the procedures for submission and review of indemnification claims.48

X. Imports and Exports

A. FIFRA Export Requirements

A pesticide intended solely for export to a foreign country is exempt from most FIFRA requirements if prepared or packaged according to the specifications of the foreign purchaser.49 The pesticide does not even have to be registered if the foreign purchaser signs a statement acknowledging that it cannot sell the pesticide in the United States.50 However, regardless of registration, the pesticide must meet nearly all the labeling requirements of FIFRA,51 including some special requirements that apply only to pesticides for export. The producer also is subject to provisions of FIFRA that require registration of the pesticide producing establishment and impose certain recordkeeping requirements.52

EPA's main policy guidance on exports is contained in the Code of Federal Regulations.53 The guidance discusses principally requirements for labeling, which apply to both registered and unregistered pesticides,54 and for purchaser acknowledgement statements, which apply to unregistered pesticides.55

1. Definition of Registered Pesticide

A registered pesticide is one that has a current FIFRA § 3 registration and that bears the labeling that FIFRA requires for distribution in the United States.56 However, export regulations treat some closely related products as if they had registrations. For example, the color and fragrance of the exported product may be different from that sold in the United States, within certain constraints.57

For the purposes of the purchaser acknowledgement rules only, EPA will treat a pesticide as if it were registered even though the exporter has decreased the percentage of an active ingredient by adding a List 4 inert ingredient (one generally regarded as posing minimal risk).58 Current regulations require such an altered pesticide to bear a label indicating that it is not registered for use in the United States, though the label may explain why it is not registered.59 EPA intends to exempt these pesticides from that labeling requirement in a future rulemaking. In the meantime, it will not enforce the requirement against such pesticides.60

Also for the purposes of the purchaser acknowledgement rules, EPA will consider a product to be registered even though it has minor differences in packaging from the actually registered product, e.g., size, net contents, "provided [24 ELR 10635] no change in use directions or requirement for child-resistant packaging would be necessary for the product to be registered for use in the United States."61 EPA will also allow certain minor labeling changes, such as use of metric units, revisions of nonmandatory statements, and addition of language to explain the meaning of a use classification.62 If these changes are of the sort that EPA would allow registrants to make on a domestic product without EPA approval, the modified product's label does not need to declare that the product is unregistered in the United States.63

2. Labeling

All pesticide exports, registered and nonregistered (including pesticides intended for research and development), must bear labeling that satisfies EPA regulations. The regulations require the labels to include:64

* an establishment registration number;65

* the name and address of the producer or registrant, or the person for whom the pesticide was produced;

* the net weight or measure;

* for pesticides classified for restricted uses,66 the statement "Restricted Use Pesticide";

* warning or caution statements about health and environmental hazards;67

* where highly toxic, the skull and crossbones, the word "Poison," and a statement of practical treatment;

* when the product is not registered in the United States, the statement "Not Registered for Use in the United States of America"; and

* the ingredient statement.

FIFRA § 2(q)(1)(E) requires that all statements on a pesticide label be "in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use."68 Consequently, the Agency's policy requires the last four items referred to above to appear in English, in the language of the purchaser's country, and if different (and known or reasonably ascertainable), in the language of the country of final destination.69

The label normally required for registered pesticides will have some, but not necessarily all, of the required information for export. The exporter can provide the additional information through supplemental labeling.70 Conversely, the exporter may be able to redesign a domestic product label to meet the labeling requirements of the importing country and place any additional information that U.S. registration requires on supplementary labeling, which the importer could detach prior to final distribution.71

3. Foreign Purchaser Acknowledgment Statements

Pesticides intended for export that are not registered for use in the United States are subject to the foreign purchaser acknowledgement statement requirements of FIFRA § 17(a)(2).72 For the purposes of this requirement, "purchaser" means the foreign recipient of the pesticide even if it is being exported as part of a noncommercial transaction.73 Before exporting an unregistered pesticide, the exporter must obtain from the foreign purchaser an acknowledgement that includes the following information:74

* the name, address, and EPA identification number, if applicable, of the exporter;

* the name and address of the foreign purchaser;

* the identity of the product and the product's active ingredients;

* if known or reasonably ascertainable, the country or countries of final destination of the export shipment;

* a statement that indicates that the purchaser understands that the product is not registered for use in the United States and cannot be sold in the United States; and

* the foreign purchaser's signature and date of signature.

After receiving the signed acknowledgment from the foreign purchaser, the pesticide producer may export the product.

The exporter must provide EPA with the foreign purchaser acknowledgement statement and a certified statement that export did not take place until it received the signed acknowledgement. The exporter must send these to EPA within seven working days of receiving the acknowledgement or by the date of export, whichever is sooner.75 The exporter must submit purchaser acknowledgment statements on a per-shipment basis unless it elects to report annually. In that case, it must submit a purchaser acknowledgment statement prior to the first shipment in each calendar year of each unregistered pesticide to a particular purchaser in a foreign country and then submit to EPA an annual summary of all shipments of that product to that purchaser.76

[24 ELR 10636]

When exporters submit this information, they may seek to claim portions of it as confidential business information to prevent EPA disclosure. However, EPA will not grant confidential business information status to the names of the producer, the country of destination, the name of the product, or the active ingredient77 (though exporters of research and development pesticides may submit a code for this last item, as described below).

EPA transmits a copy of the foreign purchaser's acknowledgement statement to an appropriate official of the importing country.78 Foreign officials also receive notice from EPA should a pesticide product be subject to cancellation or suspension.79

4. Research and Development Products

A person who exports an unregistered product solely for limited use in research and development (R&D) need not obtain a purchaser acknowledgment statement.80 Additionally, EPA has stated that it will not enforce labeling requirements against the majority of such exports.81 An unregistered R&D pesticide qualifies for these exemptions if the testing:

* would not involve land uses of more than 10 acres (4.05 hectares), or be used on or affect food or feed crops which are intended for consumption;

* would not involve aquatic uses of more than 1 acre (0.405 hectares), or any aquatic uses which involve water used for irrigation, drinking or recreation, or be used on or affect plants or animals taken for food or feed from such waters; and

* would not involve tests on animals intended for food or feed.82

The exporter must substantiate the claim that the product meets these criteria by maintaining records regarding the purchaser and the quantity and purpose of each shipment.83

EPA regulations allow exporters to encode the statement of ingredients on the label (and on the purchaser acknowledgement statement, if required) to protect the confidentiality of the formulas of R&D pesticides.84 An exporter using coded names will have to keep records explaining the codes.85 If the exporter files a purchaser acknowledgement using codes, the exporter must submit the actual names of the ingredients to EPA, with confidentiality claims.86

B. FIFRA Import Requirements

FIFRA § 17(c) assigns responsibility for monitoring imports of pesticides to the Secretary of the Treasury, working together with the Administrator of EPA.87 The Customs Service enforces the import restrictions.88

1. What May Be Imported

The Customs Service will allow imports of pesticides only if they are registered under FIFRA.89 Customs will allow imports of unregistered pesticide devices, but they must not bear any labeling or graphics that would be misleading.90

2. Notice of Arrival

Prior to arrival of a pesticide shipment, the importer must submit to EPA a Notice of Arrival of Pesticides and Devices, using EPA Form 3540-1.91 However, if the importer does not intend to use or distribute the product as a pesticide, and the product is not on EPA's Abbreviated List of Pesticides, the importer does not need to submit a Notice of Arrival.92

EPA completes the Notice of Arrival form by adding a direction to Customs to do one of the following:

* release the shipment;

* refuse delivery of the shipment; or

* detain the shipment pending EPA's examination to determine whether the shipment complies with FIFRA.

EPA then returns the Notice of Arrival to the importer.93

3. Arrival and Disposition of the Shipment

Upon arrival of the shipment of pesticide, the importer presents Customs with the completed Notice of Arrival.94 If the importer does not have a completed Notice of Arrival, Customs detains the shipment until the importer presents such notice or EPA orders some other disposition of the shipment.95 The initial detention period is 30 days, but the Customs District Director may extend it for another 30 days for good cause. If, at the end of the detention period, the importer has presented no Notice of Arrival and EPA has given no order, Customs treats the shipment as a prohibited importation and will destroy the shipment unless the consignee arranges for export within 90 days.96

Upon presentation of the Notice of Arrival, Customs follows EPA's directions on the form.97 If the form instructs [24 ELR 10637] Customs to release the shipment, Customs will release the shipment to the consignee.98 If the form instructs Customs to refuse delivery, Customs will destroy the shipment unless the consignee arranges for export within 90 days.99

If the form instructs Customs to detain the shipment for examination, Customs will retain it at the importer's expense.100 EPA may then examine the shipment or may instruct Customs to deliver to EPA samples of the pesticide and samples of the labels, circulars, and advertising pertaining to the merchandise.101

Prior to EPA's determination of whether the shipment complies with FIFRA, Customs may release the shipment to the consignee under bond. The consignee may not use or dispose of the shipment until EPA makes a determination.102

If EPA determines that the shipment complies with FIFRA, it notifies Customs, which then releases the shipment.103 If EPA determines the shipment does not comply with FIFRA, it notifies the consignee.104 The consignee then has up to 20 days to submit written material or to appear before EPA, showing cause why the shipment should not be refused entry. If, after considering such evidence, EPA still believes the shipment should be refused, it notifies Customs, which then ensures exportation or destruction of the shipment.

XI. Relationship With States

FIFRA gives the federal government extensive authority to regulate pesticide use and distribution. As discussed elsewhere in this Article, FIFRA contemplates roles for the states in enforcement and in certifying applicators.105 However, FIFRA § 24106 also carves out a role for states in setting standards for pesticides. Essentially, the section gives states the authority to regulate the use of pesticides more strictly than the federal government, while denying states the power to regulate the labeling of such pesticides either more or less strictly than the federal government. Section 24 also permits states to register pesticides for special local needs. This Article discusses each of these provisions below.

A. FIFRA Preemption Framework

The Supremacy Clause of the U.S. Constitution107 establishes the dominance of federal law over the states. Interpreting that clause, the Supreme Court has delineated when federal law preempts state law. First, Congress may explicitly preempt all state law in a particular field.108 Also, federal law will by default preempt state law where compliance with both would be impossible.109 Finally, state law must yield where it would provide an obstacle to the goals of federal law.110 Still, courts will begin with the presumption that Congress did not intend to preempt state law.111 Working within this general framework, § 24 provides a specific example of the difficulties in determining exactly where the boundaries of federal preemption of state law lie.

FIFRA § 24(a) and (b) set forth the governing principles for state involvement in the regulation of pesticides. Subsection (a) provides that states may regulate the sale or use of registered pesticides in a more restrictive manner than the federal government, but they may not reduce the requirements placed on the use of such pesticides.112 In other words, federal regulations of the use or sale of pesticides are a floor above which states are free to add more strict regulations. However, subsection (b) provides that states may neither reduce nor increase FIFRA labeling and packaging requirements.113 Instead, federal regulations of the labeling or packaging provide a firm standard from which states may not deviate.

B. Use or Sale Versus Labeling Regulation

Because § 24 sets up a significant dichotomy -- between the power of states to increase the requirements for pesticide use or sale compared to their lack of power to deviate from federal regulations governing labeling or packaging -- an important issue is how to distinguish a "use" regulation from a "labeling" restriction. Several cases have explored this issue in the context of state laws requiring pesticide users or sellers to post warning notices or provide other warnings separate from those on the federally approved labeling.

In D-Con Co. v. Allenby,114 the court heard a dispute over a California law that required notice to consumers of certain risks of pesticide use. The plaintiff argued that FIFRA preempted the state-imposed requirements because they amounted to a labeling regulation at variance with the federal regulations. FIFRA defines "labeling" as "all labels and other written, printed, or graphic matter … accompanying the pesticide or device at any time; or … to which reference is made on the label or in literature accompanying the pesticide or device."115

The language "all … written … matter … accompanying the pesticide … at any time" suggests that "labeling" is all-encompassing. However, the court in D-Con held that FIFRA did not preempt the state law because the law did not specifically mandate that sellers provide notice by means of pesticide labels. The law allowed for notice by posted warnings and other means, none of which would have altered the federal labeling requirements, according to the court.116

In a subsequent case challenging the same California law, the Ninth Circuit agreed with this narrow interpretation of [24 ELR 10638] labeling, explaining that, despite the wording of the statute, "FIFRA's definition of labeling cannot encompass every type of written material accompanying the pesticide at any time. If this were true, then price stickers affixed to shelves, sheets indicating that a product is on sale, and even the logo on the exterminator's hat would all constitute impermissible labeling."117 Therefore, the court placed the state law under the rubric of a "use" restriction and accordingly declined to find it preempted by federal law.

The Second Circuit also found limits to the definition of "labeling" in upholding a New York law.118 New York enacted regulations that required commercial pesticide applicators to perform several tasks, such as giving the prospective purchaser a notification "cover sheet" with warnings and safety information. Also, applicators had to post signs on the perimeter of the affected property instructing persons not to enter the area for 24 hours. Finally, in some instances, the law required applicators to notify the public in newspapers of prospective use over large tracts of land.

In holding that these requirements were not "labeling" requirements but rather permissible sale and use regulations, the Second Circuit stated, "[b]ecause the notification materials are present in some spatial and temporal proximity to the applied pesticide, it is asserted they 'accompany' it. But this definition is rather strained. 'Labeling' is better understood by its relationship, rather than its proximity, to the product."119 The court drew a distinction between state regulations designed to protect "end users" ("labeling requirements" and thus preempted) and state regulations designed to protect either those who contract to have pesticides applied or members of the public who may be exposed to the chemicals as a result of their application to public areas ("sale and use regulations" and thus not preempted).

Specifically, the Second Circuit found that:

FIFRA "labeling" is designed to be read and followed by the end user. Generally, it is conceived as being attached to the immediate container of the product in such a way that it can be expected to remain affixed during the period of use.…

By contrast, the target audience of the New York notification program is those innocent members of the general public who may unwittingly happen upon an area where strong poisons are present as well as those who contract to have pesticides applied. The mere proximity of the warning, for example, notices posted around an enclosed field or copies of the EPA's labeling information provided to the contracting parties, does not transform the admonition into "labeling" within the meaning of FIFRA § 2(p).120

The court supported its decision by examining the purpose underlying FIFRA's prohibition of additional state labeling, i.e., to preserve the force of the information contained in the FIFRA label. According to the court, the regulations at issue, rather than "impair the integrity of the FIFRA label," would actually "serve to further the purpose of the statute by enlisting state aid to prevent 'unreasonable adverse effects [of pesticide use] on the environment.'"121

C. Use or Sale Regulation and State Registration

As the above cases illustrate, FIFRA § 24(a) clearly allows states to place additional requirements on persons selling or using pesticides. What happens when these requirements amount to a state registration program more restrictive than the federal program?

In National Agricultural Chemicals Ass'n v. Rominger,122 plaintiffs argued that FIFRA preempted a requirement in California's registration program for restricted use pesticides that registrants submit data beyond what the federal program requires. According to the plaintiffs, Congress intended FIFRA's § 3 data requirements to serve as a uniform national standard. Also, they argued that the California requirements imposed an unreasonable burden on the interstate commerce in pesticides. In effect, they saw constitutional limits on the authority FIFRA § 24(a) could grant states to affect interstate commerce.

The court concluded that FIFRA does not preempt the "state's power to require that prior to distribution of pesticides within the state the manufacturer and/or distributor supply data additional to that required to be supplied to EPA."123 The court decided that Congress intended to grant to the states broad power to regulate pesticides for the protection of their citizenry. Congress' authority to authorize states to take actions affecting interstate commerce is well-established, and "the state's exercise of that power does not represent an … impermissible burden on interstate commerce."124 Other courts have cited Rominger in support of the proposition that states have broad authority to regulate pesticide sale and use.125

D. Regulation by Local Governments

Section 24(a) permits states to place requirements in addition to federal restrictions on pesticide use, but the issue remains whether local governments may do the same. Nothing in FIFRA § 24(a) specifically addresses the role, if any, that local governments may play in restricting the use of pesticides. Indeed, § 24 never mentions local governments. Congress titled the section "Authority of States" and used "State" or "States" consistently throughout the section.

Nevertheless, there has been considerable debate over whether § 24(a) impliedly reserves a role for local governments in the regulation of pesticides. Until 1991, the [24 ELR 10639] majority of lower courts when confronted with this issue found that the legislative history of FIFRA and the statute by its own terms show Congress' intent was not to allow local governments a role in the regulation of pesticide use.126

In Wisconsin Public Intervenor v. Mortier,127 the Supreme Court reached the opposite result and held that local governments do have a role to play in the regulation of pesticide use. In Mortier, the town of Casey, Wisconsin, had adopted an ordinance that required a permit for the application of any pesticide to public lands, or to private lands subject to public use, or for the aerial application of any pesticide to private lands. The town granted Mortier a permit, but the permit precluded any aerial spraying and restricted the lands on which ground spraying would be allowed.

The Supreme Court concluded that "FIFRA does not preempt the town's ordinance either explicitly, implicitly, or by virtue of an actual conflict."128 The court based its decision in Mortier on the idea that while FIFRA's legislative history demonstrates "an unwillingness by Congress to grant political subdivisions [i.e., local governments] regulatory authority, it does not demonstrate an intent to prevent the States from delegating such authority to its subdivisions, and still less does it show a desire to prohibit local regulation altogether."129 Thus, the Court made a distinction between local government pesticide regulations enacted pursuant to delegated state authority and the same substantive local government regulations enacted sua sponte. The former are blessed, the latter are apparently prohibited.

Still, Mortier leaves several questions unanswered. For instance, what must a local government show to prove its state has delegated it FIFRA power?130 Is an implicit delegation of authority enough? Does silence amount to a delegation of authority to regulate pesticide use? Another unresolved issue is whether state statutes regulating pesticide sale or use can preempt local regulation.131 In the end, the Mortier decision may have created more debate than it quieted in ruling that local governments can also participate in the regulation of pesticide use under § 24(a).

E. State Tort Claims

As discussed above, § 24(b) preempts state labeling requirements that are inconsistent with federal standards for pesticides. State legislation that attempts to alter pesticide labeling requirements will be void according to § 24(b). Still, the question remains whether FIFRA preempts state tort claims that would have the effect of changing pesticide labels. This issue has been the subject of heated debate in the federal courts.

Until recently, Ferebee v. Chevron Chemical Co.132 had been the leading case on this topic. The plaintiff in Ferebee was the widow of a worker at the U.S. Department of Agriculture's (USDA's) Research Center in Beltsville, Maryland. The decedent, Richard Ferebee, contracted pulmonary fibrosis as the result of long-term skin exposure to paraquat, a herbicide manufactured by Chevron. Ferebee's widow argued that Chevron's failure to put an adequate warning on the pesticide label caused the injury. The jury returned a verdict in favor of the plaintiff and Chevron appealed.

On appeal, Chevron argued, among other things, that EPA approval of the paraquat label under FIFRA bound the jury to find that the label was adequate and that FIFRA preempted the plaintiff's state-law claim based on inadequate labeling. In rejecting both arguments, the D.C. Circuit stated:

Chevron's argument misunderstands the nature of the determination made by EPA and misconceives the relation between federal and state law. The fact that EPA has determined that Chevron's label is adequate for purposes of FIFRA does not compel the jury to find that the label is also adequate for purposes of state tort law as well. The purposes of FIFRA and those of state tort law may be quite distinct. FIFRA aims at ensuring that, from a cost-benefit point of view, paraquat as labelled does not produce "unreasonable adverse effects on the environment." State tort law, in contrast, may have broader compensatory goals; conceivably, a label may be inadequate under state law if that label, while sufficient under a cost-benefit standard, nonetheless fails to warn against a significant risk.133

The court held that Congress did not intend to preempt state damage actions but merely intended to preclude the states from directly ordering changes in EPA-approved labels. The court found that compliance with both state and federal law was "possible" because a manufacturer could either continue to use the EPA-approved label and pay damages or petition the EPA to allow the label to be made more comprehensive. Moreover, rather than find that state damages actions stand as an obstacle to the accomplishment of FIFRA's purposes, the court indicated that in some circumstances, tort recovery actually will promote legitimate regulatory aims by exposing new dangers associated with pesticides. The court surmised that successful state damages actions might lead manufacturers to petition the EPA to allow more detailed labeling of their products.

Several courts subsequently followed the D.C. Circuit's [24 ELR 10640] lead in finding that FIFRA does not preempt state court actions.134 In Ciba-Geigy Corp. v. Alter,135 the plaintiff sustained injury to his corn crop allegedly as the result of his use of Dual 8E, a herbicide manufactured by Ciba-Geigy. Ciba-Geigy argued that FIFRA preempted the plaintiff's claims to the extent that they were based on inadequate labeling. The Supreme Court of Arkansas disagreed, concluding that FIFRA neither expressly nor impliedly preempts state common-law tort claims for inadequate labeling.

The court criticized the Ferebee rationale that a manufacturer can comply with both federal and state law by continuing to use the EPA-approved label and paying damages to successful plaintiffs, noting that "[a] manufacturer who has to pay damages under state law is obviously not complying with the state law but is being held liable for not complying."136 Nevertheless, according to the Arkansas Supreme Court, "Ferebee … was correct … in concluding that after a jury determines a pesticide label to be inadequate the manufacturer can simply petition the EPA to allow the label to be made more comprehensive. By doing so, the manufacturer would be in compliance with state tort law and with EPA regulations."137 The court went on to reject Ciba-Geigy's argument that allowing state damage actions in cases such as this would conflict with the congressional purpose of uniform labeling.

A counter movement began when the court in Fitzgerald v. Mallinckrodt, Inc.138 held that FIFRA preempts conflicting state common law. In that case, the plaintiff, a maintenance worker at a golf course, was injured after an accidental exposure to a mercury-based fungicide. He claimed that had the warning labels been prepared differently he would not have been injured in the same manner. The Fitzgerald court acknowledged the holding in Ferebee, but rejected it, opting instead to follow the reasoning of the First Circuit in Palmer v. Liggett Group, Inc.,139 a preemption case involving cigarette labeling. The Fitzgerald court adopted the following language from Palmer:

The preemption clause of the Act expressly prohibits "state law" not merely "statutory law" from imposing any "requirement or prohibition" different from the Act's warning label.… If a manufacturer's warning that complies with the Act is found inadequate under a state tort theory, the damages awarded and verdict rendered against it can be viewed as state regulation: the decision effectively compels the manufacturer to alter its warning to conform to different state law requirements as "promulgated" by a jury's findings.… This challenge to the federal warning label's sufficiency -- and the confusion it would engender -- surely contravenes the Act's policy of uniform labeling.140

The Fitzgerald court found this reasoning persuasive and stated, "[w]here the Federal Government has preempted any state regulation, there can be no recovery in tort. Allowing recovery under state tort law where Congress has preempted state law would effectively authorize the state to do through the back door exactly what it cannot do through the front."141

The Eleventh Circuit followed the reasoning of Fitzgerald in Papas v. Upjohn Co. (Papas I),142 the first decision on the preemption issue in a product labeling case by a U.S. Circuit of Court of Appeals since Ferebee. The plaintiff in Papas was a kennel worker at a humane society. He claimed that he had become ill as a result of his exposure to pesticides used to rid dogs of fleas. He brought breach of warranty, negligence, and strict liability claims all based on failure to warn of alleged adverse health affects in the product labeling.143 The trial court granted a motion for partial summary judgment on the labeling claims, and the Eleventh Circuit affirmed.

The court found that FIFRA preempted all state tort law claims based on defective label warnings. The court stated:

We conclude that FIFRA impliedly preempts state common law tort actions based on labeling claims in several ways. First, having considered FIFRA's express prohibition of state labeling requirements in addition to those required under FIFRA, 7 U.S.C.A Section 136(v)(b), and having examined the labelling regulations adopted pursuant to FIFRA … we hold that the federal government has occupied the entire field of labeling regulation, leaving no room for the states to supplement federal law, even by means of state common law tort actions.

We also hold that jury awards of damages in such tort actions would result in direct conflict with federal law.144

After the Eleventh Circuit decided Papas in favor of an implied FIFRA preemption of state tort actions, the Supreme Court issued its ruling in Cipollone v. Liggett Group, Inc.145 [24 ELR 10641] Although Cipollone did not focus on FIFRA's preemption debate, its holding is relevant to this issue. In Cipollone, the Supreme Court held that the Federal Cigarette Labeling and Advertising Act146 preempted the plaintiff's state common-law failure-to-warn claims. The Court ruled that federal law must preempt a state tort action awarding damages for failure to warn or label adequately because the tort action has the same effect as positive state legislation.147 The case equated potential state tort damages with state legislation that requires producers to label their products in a manner inconsistent with the federal regulations.

After Cipollone, the Supreme Court remanded Papas back to the Eleventh Circuit for reconsideration in light of Cipollone. In Papas v. Upjohn Co. (Papas II),148 the Eleventh Circuit applied the rationale of Cipollone to rule that FIFRA explicitly preempts state tort actions based on failure to warn or label adequately. Thus, FIFRA preempts all negligence, strict liability, and breach of implied warranty claims, "to the extent they are based on inadequate labeling."149

Although Ferebee held that FIFRA does not preempt state tort actions, a fair reading of Cipollone and Papas II would indicate that they have weakened Ferebee considerably. In light of these recent decisions, § 24 probably should be understood to preempt both statutory and common law which could have the effect of altering federal labeling or packaging standards.

F. Special Local Needs Registrations

Under FIFRA § 24, a state may not permit the use or distribution of pesticides prohibited by EPA. However, for those pesticides that are already federally registered, § 24(c) allows states to register such pesticides for additional uses to meet special local needs.150 A state may also register new formulations, mixtures, or packagings of federally registered pesticides.151 A special-local-needs registration has the same effect as a FIFRA § 3 registration for all purposes of FIFRA, except that it authorizes distribution and use only within the registering state.152

EPA regulations set out standards and procedures for state special-local-needs registration.153 The state must have a special local need for the pesticide, a need that no other sufficiently available registered pesticide can meet.154 If the state registration will allow use on food or feed, the pesticide must have an EPA-set pesticide residue tolerance or exemption.155 If the pesticide is unavailable because EPA acted to restrict a use, a state may not permit that use unless EPA has superseded its restriction.156 States may not register new active ingredients or other products for use in pesticide manufacturing, nor register new uses for products registered only for use in manufacturing other pesticide products.157

EPA's general standards for state registration parallel the federal standards. Registrants must submit an application that includes information about the product, the manufacturer, and proposed labeling.158 If the registration is for a new product, for a use pattern of an existing product not similar to a federally registered use, or for a product that has had part of its registration denied, disapproved, canceled, or suspended, then the state must make a determination whether the use of the product will cause unreasonable adverse effects.159 For products intended for public health uses, such as disinfectants, the state must determine whether the product is effective.160 Product labeling and packaging must meet FIFRA standards, and the regulations may require the product to bear a restricted use classification.161

States must notify EPA of local needs registrations, and EPA may disapprove a registration for cause.162 Normally, EPA must issue its disapproval within 90 days of registration, unless the state is late in notifying EPA of the registration.163 The disapproval will specify an effective date.164 If a registration poses an imminent hazard or could result in an unpermitted pesticide residue on food or feed, EPA may disapprove it at any time.165 Given sufficient cause, EPA may also suspend a state's entire authority to grant local needs registrations.166

These § 24(c) regulations only cover situations where the state wishes to be more permissive than the federal government to meet special local needs. EPA does not have similar regulatory control or disapproval power where the state wishes to regulate the sale or use of a pesticide more stringently than the federal government.

XII. Section 6(a)(2) -- Reporting Requirements

A. Statutory Provision and EPA Guidance

After EPA registers a pesticide, if the registrant learns any new information regarding unreasonable adverse effects on the environment from the pesticide, FIFRA § 6(a)(2) requires the registrant to report the information to EPA.167 Refusing or failing to do so is a violation of FIFRA.168

[24 ELR 10642]

On several occasions EPA has attempted to clarify which failures or delays in reporting under § 6(a)(2) are considered to be actionable violations of FIFRA. This guidance includes:

* a 1978 memorandum of interpretation;169

* a 1979 enforcement policy;170

* a 1985 interpretive rule;171

* two 1988 data-flagging rules;172

* a 1992 notice to registrants;173 and

* a 1992 proposed rule.174

Though EPA promulgated the 1985 rule in a final version, the Agency never set an effective date and the rule remains "as general guidance on Section 6(a)(2) policy."175 EPA expects to publish a final version of the 1992 proposed rule in late 1994.176 Once EPA issues a final rule, it will serve as a comprehensive guide to § 6(a)(2) obligations. The following sections discuss these EPA guidance documents more fully.

1. 1978 Memorandum of Interpretation

In 1978, EPA issued a memorandum of EPA's General Counsel setting forth the "Agency Interpretation of Requirements Imposed on Registrants by Section 6(a)(2) of FIFRA."177 This memorandum established EPA's expansive interpretation of the statutory language of § 6(a)(2) and broad view of what constitutes "factual information regarding unreasonable adverse effects."178 The memorandum states that "any information on either risks or benefits relevant either to the terms or conditions of registration or to the question whether the pesticide should be registered at all is information 'regarding unreasonable adverse effects' which must be submitted if the other requirements of Section 6(a)(2) are satisifed."179 Moreover, the memorandum described "factual" information as "information which, either by itself or in conjunction with other information, might, be relevant and probative in regulatory decisionmaking."180 EPA excluded as not sufficiently factual "only the unsolicited opinions of persons who are not employed or retained by the registrant to express the opinion and whose opinion would not be admissible under the Federal Rules of Evidence as 'expert' opinion."181 The memorandum also provided several examples of information that the Agency does and does not consider to be reportable under § 6(a)(2).182 The memorandum explained that in the case of information "not essential to the Agency's function," EPA may exercise enforcement discretion and not hold failure to submit that information to be an actionable violation of FIFRA.183

2. 1979 Enforcement Policy

In July 1979, EPA published an enforcement policy describing the circumstances in which EPA would exercise its "enforcement discretion" to regard as "unactionable" the failure to report information that § 6(a)(2) otherwise requires.184 EPA indicated that it did not intend its enforcement policy to alter or amend the broad interpretation, set forth in the 1978 memorandum, of the requirements imposed on registrants under § 6(a)(2). Rather, the enforcement policy identifies "particular types of information which, though arguably pertinent to an evaluation of risks and benefits and otherwise reportable under Section 6(a)(2), are not currently needed byEPA in order to properly discharge its statutory responsibilities under FIFRA, and thus need not be submitted by registrants."185 In these cases, the "failure to submit information to EPA will not be treated as an actionable violation of Section 6(a)(2)."186

The enforcement policy attempts to explain when EPA will consider actionable the failure to submit data from any toxicological study, incomplete toxicological study, epidemiological study, efficacy study, incident involving toxic or adverse effects, incident involving failure of efficacy, or other matter.187

[] Toxicological Studies. EPA indicated that new toxicological information is unlikely to affect a pesticide's registration status unless it suggests that reliance on information previously submitted may have resulted in an underestimation of risk or that the prior information was otherwise inaccurate, misleading, or incomplete. Thus, registrants need not submit information that is essentially corroborative. However, registrants must submit any toxicological data that indicate that a pesticide may [24 ELR 10643] present different or greater hazards than previously recognized.188 Registrants must report toxicological studies on a registered pesticide product or any of its ingredients, impurities, metabolites, or degradation products if the substance tested:

* was associated with a toxic or adverse effect of a kind or an organ or tissue type not observed in any study previously reported to EPA;

* was associated with a toxic or adverse effect at a lower dosage or after a shorter exposure or latency period than in any study concerning the effect previously reported to EPA;

* was associated with a more severe, more frequent or higher incidence of a toxic or adverse effect than in any study concerning the effect previously reported to EPA;

* was associated with a toxic or adverse effect in a different species, sex, strain, or generation of test organisms than in any study of the effect previously reported to EPA;

* was associated with a toxic or adverse effect involving a rate or medium of exposure not associated with the effect in any study previously reported to EPA if humans or other non-target organisms "could conceivably" be exposed to the substance by that route or medium;

* appears to produce a toxic or adverse effect by a pharmacokinetic, metabolic, or biological mechanism different from that postulated or proposed for that effect in any study of the substance previously reported to EPA; or

* was associated with any toxic or adverse effect if the test substance is a pesticide or ingredient, impurity, metabolite, or degradation product of a pesticide that is the subject of a reregistration, generic standard, special review (formerly called a Rebuttable Presumption Against Registration or RPAR), suspension, or cancellation proceeding.189

The enforcement policy further provides that registrants must submit reportable information on a completed toxicological study to EPA within 30 days of receiving it. A registrant need not submit the information if the original basis for reporting was predicated on erroneous study data; every author whose analysis, conclusions, or opinions served as the basis for reporting has acknowledged in writing that his work was in error and corrected it accordingly; and as a result of such corrections, reporting is no longer required.190

[] Incomplete Toxicological Studies. EPA stated that it would not be useful to require the submission of preliminary or incomplete toxicological studies on a routine basis. Nonetheless, the registrant may not defeat the reporting requirements by indefinitely deferring completion of the analysis. Thus, once the registrant has completed all testing and a preliminary data analysis or gross pathological evaluation, EPA requires reporting after a reasonable period even if the registrant has not completed the final analysis. EPA's guidelines indicate that such a reasonable period may not exceed 90 days from the completion of testing for acute effects or other studies utilizing a testing regimen lasting 90 days or less, or one year from the completion of a chronic effects or other study lasting more than 90 days.191 The guidelines also require reporting of incomplete or preliminary studies when the registrant observes serious adverse effects in the test animals that may reasonably be attributed to exposure to the test substance because they differ from the effects observed in the controls, they are not typical of historical experience with the test organisms, or they otherwise support a reasonable inference of causation.192

[] Epidemiological Studies. EPA's enforcement policy requires registrants to report any completed epidemiological study or portion of such a study if it involves a correlation or association between a pesticide (or its ingredients, impurities, metabolites, or degradation products) and a reportable adverse effect in humans, regardless of whether the registrant considers the correlation or association to be significant.193

[] Efficacy Studies. EPA generally does not consider efficacy studies to be reportable. Efficacy studies are reportable only if they demonstrate that the pesticide may not perform as claimed to control organisms that may pose a risk to human health or if they suggest a deficiency or reduction in the efficacy claimed for a pesticide that is the subject of a special review, suspension, or cancellation proceeding.194

[] Incidents Involving Toxic or Adverse Effects. EPA recognized that "information concerning incidents in which toxic or adverse effects are attributed to pesticide exposure varies considerably in specificity and accuracy."195 EPA attempted to establish criteria that enable registrants to distinguish "demonstrably inaccurate" incident reports, which need not be submitted, from incident reports that provide "unique and valuable information on the hazards and environmental impacts associated with actual use and practice … which cannot be readily derived from laboratory data alone."196 EPA established criteria for determining the reportability of human incidents, incidents involving other nontarget organisms, and series of incidents. These criteria include the following elements: "(1) a report of a toxic or adverse effect, (2) a report of pesticide exposure, (3) an opportunity for investigation of the accuracy of the reports, and (4) a basis for an inference that the toxic effect and the pesticide exposure were related."197

[] Incidents Involving the Failure of Efficacy. EPA noted that the efficacy of pesticide products "can usually be adequately tested by the dictates of a competitive marketplace."198 Thus, registrants generally need not send EPA reports that a pesticide failed to perform as claimed. The exceptions concern products whose failure could directly harm human health. [24 ELR 10644] Registrants must report a single incident of failure to perform as claimed only if it involves use against organisms that "unless controlled, may pose an immediate hazard to human life."199 Registrants must report a series or pattern of the same type of efficacy failures if it involves any use to control organisms "which may pose a risk to human health."200

[] Other Information. In general, EPA indicated that it will not bring an enforcement action for failure to report information other than the several types just described. EPA will enforce the reporting requirement, however, if the registrant knows (or reasonably should know) that EPA would regard the information alone or in conjunction with other information "as raising serious questions about the continued registrability of one or more of the registrant's pesticide products, or about the proper terms and conditions of registration of any such product."201

[] Previously Reported Information. Section 6(a)(2) only requires the submission of "additional" information regarding unreasonable adverse effects to EPA.202 Thus, the registrant need not submit documents previously submitted to EPA or information otherwise readily accessible to EPA. EPA considers information to have been previously reported if it is contained in:

* documents that the registrant previously submitted to EPA;

* scientific articles or publications abstracted in Biological Abstracts, Chemical Abstracts, Index Medicus, or Pesticide Abstracts if the abstract clearly identifies the registered pesticide or active ingredient to which the information pertains;

* EPA publications, EPA hearing records or publications cited in EPA Federal Register notices;

* reports or publications that specified federal agencies make available to the public; or

* any other documents in the official files of EPA's Office of Pesticide Programs.203

3. 1985 Interpretive Rule

In 1985, EPA issued a "Final Interpretive Rule and Statement of Policy" that was intended to codify the Agency's "existing interpretation of what information FIFRA Section 6(a)(2) requires to be reported to EPA," as reflected in the 1978 memorandum and the 1979 enforcement policy.204 EPA's 1985 interpretive rule amended the prior enforcement policy by specifying circumstances in which registrants must report information on pesticide residues in food, feed, groundwater, or elsewhere in the environment.205 The 1985 rule also modified the 1979 enforcement policy by requiring registrants to submit most § 6(a)(2) information to EPA within 15 working days.206

Because of comments EPA received after publishing the rule, EPA never announced an effective date for it.207 Neither has EPA formally withdrawn it. The rule stands as general guidance on EPA's enforcement policy.208

4. 1988 Rules and 1992 Notice to Registrants

In 1988, EPA promulgated two rules requiring registrants to flag data on toxic effects in submissions to EPA. One rule addressed data submitted in connection with registration-related proceedings209 and one specifically addressed § 6(a)(2) data.210 In 1992, EPA sent out a notice clarifying there flagging requirements.211

Basically, the § 6(a)(2) data regulation requires registrants to identify submissions clearly as § 6(a)(2) data.212 The 1992 notice further explains that registrants must send the data to specific addresses at EPA headquarters,213 must include a transmittal letter highlighting the fact that it is a § 6(a)(2) submission, and must not mix § 6(a)(2) data with other required material.214 Further, registrants should consider any data that requires flagging under EPA's 1988 registration data rule215 to also be subject to § 6(a)(2) and submit copies accordingly.216 To encourage prompt reporting, EPA will not consists that § 6(a)(2) reports meet the format requirements for registration data.217 Also, if a registrant wishes to claim that data are confidential business information, the registrant must include the claim with the original data submission.218 EPA will presume that § 6(a)(2) submissions are health and safety data automatically subject to public release under FIFRA § 10(d)(1) unless the registrant can show that the data fall under one of the exceptions listed in that provision.219

5. 1992 Proposed Rule

Based on its review of comments submitted on the 1985 interpretive rule, EPA concluded that further clarification of the § 6(a)(2) reporting guidelines was appropriate.220 Thus, in September 1992, EPA issued a proposed rule in another attempt to codify its "interpretation regarding which failures to report information or delays in reporting" will be considered to be actionable violations of § 6(a)(2).221 The proposed rule, when effective, is to supersede the 1985 interpretive rule and all of the prior EPA policy statements concerning § 6(a)(2).222 The 1992 proposed rule, while generally consistent with EPA's prior reporting guidelines, modeifies and clarifies the earlier guidance in several important respects.

[]Who Must Report. Section 6(a)(2) applies to a "registrant" "at any time after the registration of a pesticide."223 In EPA's proposed definitions, the term registrant includes "any person who has ever held a registration for a pesticide product under FIFRA."224 EPA noted that § 6(a)(2) does not apply directly to applicants for a pesticide registration. However, the EPA regulations pertaining to registration applications require applicants to furnish with their application "any factual information … regarding unreasonable adverse effects of the pesticide on man or the environment which would be required to be reported under FIFRA Section 6(a)(2) if the product were registered."225

[]Information That Must Be Reported. Section 6(a)(2) applies to information that the registrant "has."226 The proposed rule makes it clear that such information may include information that the registrant or any "officer, employee, agent or other person acting for the registrant" either "possesses or knows."227

[]Factual Information. Section 6(a)(2) applies specifically to "factual" information.228 EPA reaffirmed its position, discussed at length in the 1979 memorandum, that the term "factual information" includes "any observed or verifiable information as well as information asserted to be correct, such as expert opinion."229 A registrant must submit opinion information that is otherwise reportable if it was expressed by a person: "(1) Who was employed or retained … by the registrant; (2) From whom the registrant requested the opinion(s) or conclusion(s); (3) Who, by virtue of knowledge, skill, experience, training, or education could be considered to be an expert."230 As in the earlier guidance, registrants need not report clearly erroneous studies withdrawn and corrected by every author, but they must report the corrected study if it qualifies by itself.231

[]Additional Information. Under § 6(a)(2) only "additional" information must be submitted to EPA.232 EPA noted that "'additional"' information refers to information not already submitted by the registrant to the Agency."233 EPA has proposed to limit the exclusion for previously submitted information to cases where the registrant is aware that all of the information is contained in "(1) documents officially logged in by EPA, (2) EPA publications, EPA hearing records, or publications cited in EPA Federal Register notices; or (3) any other documents in the official files and records of EPA'a Office of Pesticide Programs."234 This proposal eliminates the exemption for certain information contained in other federal agency publications or the scientific literature. 235 EPA has stated that it does not intend this change to require registrants to "conduct literature searches or gather information from outside their organization."236 However, if the registrant is or becomes aware of reportable information that was previously exempt, the registrant would have to submit that information under § 6(a)(2). 237

[]When Must Information Be Submitted. EPA has proposed to require that registrants submit information "within 30 calendar days after any officer, employee or agent of the registrant possesses or knows of the information."238

[]Reportable Studies, Incidents, Data, and Other Information. The 1992 proposed rule attempts to further refine and clarify the studies, incidents, and other information that registrants must report under § 6(a)(2). The proposal establishes criteria for the reporting of the results of complete or incomplete toxicological and ecological studies;239 discontinued studies;240 human epidemiological and exposure studies;241 information concerning pesticide residues in food or feed, surface water, ground water, and drinking water;242 information regarding new metabolites, degradants, or impurities;243 incidents of toxic or adverse effects casually related to exposure to the pesticide;244 studies or incidents regarding the failure of performance or efficacy;245 and other information that the registrant knows (or should know) has the potential to raise questions regarding the continued registrability of a pesticide product or about the terms or conditions of registration.246

[]Recordkeeping. The proposed rule requires registrants to keep copies of research data for as long as the pesticide remains registered, and copies of § 6(a)(2) reports for five to 10 years, depending on content.247

[24 ELR 10646]

B. Relationship to TSCA § 8(e)

Section 6(a)(2) applies only to registrants after the registration of a pesticide. However, the analogous substantial risk reporting requirements of § 8(e) of the Toxic Substances Control Act (TSCA)248 may require the submission of similar information at an earlier stage in the development and testing of potential pesticides. TSCA excludes "pesticides" that are manufactured, processed, or distributed solely for use as pesticides from the definition of "chemical substance" and thus from the jurisdiction of the Act.249 EPA, however, has narrowly interpreted the definition of "pesticide" and narrowly applied the pesticide exemption from TSCA.

EPA has taken the position that research and development pesticides are chemical substances subject to TSCA (including the reporting requirements of TSCA § 8(e)) "until their manufacturers or importers demonstrate an intent to create a pesticide by submitting an application for an experimental use permit … or an application for registration under … FIFRA."250 Companies engaging in pesticide research, development, and testing must therefore consider the potential reportability under TSCA § 8(e) of studies and other information regarding the toxic and other adverse effects that may be associated with their developmental pesticides.

XIII. Pesticide Residue Tolerances

A. Statutory Background

In addition to implementing the requirements of FIFRA, EPA is also responsible, under the Federal Food,Drug, and Cosmetic Act (FFDCA),251 for regulating pesticide residues in foods and animal feed. Although FIFRA and the FFDCA are not technically interdependent, EPA will not register a pesticide under FIFRA until the applicant has obtained the necessary tolerances or exemptions under the FFDCA.252 A tolerance is the maximum level of a pesticide residue (usually expressed in parts per million, or ppm) that may be present on food or animal feed. In general, EPA will register a pesticide for use on food or animal feed only if (1) EPA has established a tolerance for the pesticide and, when it is applied in accordance with its EPA-approved label, any residue from the pesticide will fall within the tolerance limit; (2) EPA has exempted the pesticide from the requirement for a tolerance; or (3) the pesticide is generally recognized as safe (GRAS) within the meaning of the FFDCA.

EPA establishes two types of pesticide tolerances under the FFDCA. Under § 408,253 the Agency sets tolerances for residues on raw agricultural commodities, including fresh fruits and vegetables, grains, milk, and meats.254 Under § 409,255 it sets tolerances for pesticide residues in processed foods.256 (Technically, a residue limitation on processed food is a food additive regulation, but people generally call it a tolerance.) As a matter of practice, EPA must set a tolerance that is low enough to protect public health yet high enough to allow for residues that are likely to remain when the pesticide is used in accordance with its FIFRA labeling instructions, which the Agency also must approve.

FFDCA § 408 requires the Agency to consider "relevant" factors in setting a tolerance, including (1) the need for an adequate, wholesome, and economical food supply; (2) the overall impact on consumers from the pesticide considering exposure from all sources and exposure to related poisonous substances; and (3) the usefulness of the pesticide.257 Thus, as with FIFRA, the FFDCA requires the Agency to weigh both the risks and the benefits of a pesticide in making its regulatory decisions.258

B. Raw Agricultural Commodities

Although the FFDCA regulatory structure is relatively straightforward, the statutory language that creates this structure is not. Section 301 of the Act prohibits the shipment in interstate commerce of "adulterated" food.259 Under § 402(a)(2)(B), a food is considered to be adulterated "if it is a raw agricultural commodity and it bears or contains a pesticide which is unsafe within the meaning of section 408(a)."260 Section 408(a), in turn, provides that if a pesticide does not qualify as GRAS, it is "unsafe" (and consequently, that a food containing that pesticide is "adulterated") unless one of the following conditions is met: (1) EPA has established a tolerance for the pesticide on a particular commodity and the pesticide residue is within that tolerance; or (2) with respect to a particular commodity, EPA has exempted the pesticide fromthe requirement for a tolerance.261

There are two points to remember about § 408 that are not entirely self-evident from the statutory language. First, before EPA will register a product for use on food or feed, EPA must accept as GRAS or grant a tolerance or an exemption for each of a product's active and inert ingredients.262 Under the Act, EPA establishes tolerances for specific [24 ELR 10647] chemicals (including their metabolites), not for a product. Second, according to a definition in FFDCA § 201, an ingredient may qualify as GRAS based on either (1) a record of safe use prior to 1958 (when the FFDCA underwent a major modification) or (2) evidence of widespread agreement in the scientific community about its safety.263 EPA regulations include a list of GRAS chemicals, and EPA will respond to written requests to determine whether other chemicals are GRAS.264

1. Section 408 Procedures

Section 408 and its accompanying regulations provide detailed procedures for the establishment of pesticide tolerances for raw agricultural commodities.265 EPA may establish a tolerance or an exemption (1) in response to a petition submitted by any person that holds or has applied for a pesticide registration under FIFRA; (2) in response to a request by any other interested person; or (3) on its own initiative.266 EPA most commonly sets a tolerance in response to a petition from a pesticide manufacturer, and the procedures that apply in that case are somewhat different than those that apply in the other two situations.

Once a person files a petition for the establishment of a tolerance or an exemption, the Agency must issue a Federal Register notice of the filing within 30 days.267 After reviewing the petition, the Agency must either establish a tolerance (which may be set at zero) or grant an exemption from the tolerance requirements.268

As an intermediate step, the Agency has the option (as does the petitioner) of referring the petition to an advisory committee for its recommendation.269 This option, however, is rarely used. Advisory committees must make a recommendation to EPA within 60 to 90 days.270 After that time, the Agency may proceed to issue a final regulation and is not bound by the recommendation of the advisory committee.271

In theory, absent a referral to an advisory committee, the Agency is required to act on the petition within 90 days.272 In practice, though, EPA review usually takes at least one year and often much longer.273

If the Agency wishes to establish a tolerance or an exemption on its own initiative, or upon the request of a third party, it must publish a proposed regulation and allow a public comment period of at least 30 days before issuing a final regulation establishing the tolerance or exemption.274 However, any person that holds (or has applied for) a FIFRA registration that would be affected by the proposal may refer the proposed tolerance to an advisory committee for independent study.275 The process and deadlines for committee and agency action are then the same as described two paragraphs above.276

Any person adversely affected by a final tolerance or exemption may file written objections with the Agency within 30 days after it is issued.277 If a person other than the petitioner files the objections, then EPA must give the petitioner the opportunity to respond to them in writing.278 If the objection raises factual issues (as opposed to legal or policy issues), then the Agency will hold a public hearing.279 Although a final tolerance or exemption is generally subject to judicial review,280 a person that has not submitted written objections to the Agency may not challenge a final tolerance or exemption in court.281

Note that EPA imposes significant fees on persons requesting almost any administrative action under § 408.282 That includes persons seeking a tolerance or exemption, requesting an advisory group review, filing objections, or causing the Agency to submit a record for judicial review. EPA will consider requests to waive fees when the applicant is acting in the public interest or when the fee would work an unreasonable hardship.283

2. Temporary Tolerances and Emergency Exemptions

A pesticide producer may wish to obtain a temporary tolerance for an experimental product or for a use that EPA has not approved. Such a tolerance allows the sale or use of products that federal enforcers would otherwise consider adulterated under the FFDCA. Under FFDCA § 408(j), EPA may set a temporary tolerance upon its own initiative or at the request of a person that has obtained an EUP under FIFRA.284 EPA has some flexibility in determining the amount of data that an applicant must submit with a request for a temporary tolerance. Therefore, before compiling data to support a request for a temporary tolerance, an applicant should consult with the Agency.285

FIFRA § 18 allows EPA to grant federal and state agencies emergency exemptions from FIFRA, which allow them to use pesticides in ways not covered in a registration to address [24 ELR 10648] public health, quarantine, and similar crises.286 EPA considers possible food residues in issuing these exemptions,287 but ordinarily does not set or change the tolerance for the pesticide. In such circumstances, federal enforcers generally invoke their discretion to overlook these anticipated but technically illegal residues on food.

3. Exemptions From the Requirement for a Tolerance

Under FFDCA § 408(c), EPA may exempt any pesticidal chemical from the necessity of a tolerance when a tolerance is not necessary to protect the public health.288 In general, the procedures for issuing such an exemption are the same as those required for establishing a permanent tolerance.

In some cases, however, the requirements for exempting inert ingredients in pesticide formulations may be somewhat less stringent.289 As with temporary tolerances, however, an applicant would be well-advised to consult with the Agency before compiling the data to support an exemption for an inert ingredient.

C. Processed Foods

FFDCA § 201(s) broadly defines a "food additive" as any substance that directly or indirectly becomes "a component of or otherwise affect[s] the characteristics of any food."290 The definition explicitly excludes pesticide residues on raw agricultural commodities and "a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity."291 Significantly, however, it does not exclude pesticide residues that may remain in processed foods. Therefore, the FFDCA regulates pesticide residues in processed foods as food additives under § 409.292

These so-called pesticidal food additives may reach processed food through several avenues. In some cases, processors or packers intentionally apply fumigants, insecticides, or other pesticides to foods. In other cases, pesticidal chemicals migrate to foods from containers or processing equipment. In many cases, however, the pesticide residue simply remains from the raw agricultural commodity.

With respect to this latter category, FFDCA § 402(a)(2) adds an important proviso. Under this section, there is no need for a separate tolerance under § 409 if the pesticide residue in the processed food "has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity."293 However, if processing has the effect of concentrating a pesticide residue so that it exceeds the § 408 tolerance for the raw commodity, then the pesticide becomes an "unsafe" food additive.294 In this case, the processed food is "adulterated" under the FFDCA unless EPA has established a separate tolerance (technically, a food additive regulation) under § 409.

1. Section 409 Procedures

The procedures for establishing a tolerance under § 409 are similar to those under § 408.295 Under § 409, however, any person may file a petition to request the issuance of a tolerance, while under § 408, third parties may only request EPA to issue tolerances and EPA may deal with those third-party requests with somewhat more discretion than with a petition from a FIFRA registrant or applicant.296 As under § 408, EPA must publish a notice in the Federal Register within 30 days after a § 409 petition is filed.297 After reviewing the petition (along with any public comments received) the Agency must either issue a regulation establishing a tolerance or deny the petition.298

EPA may also set a tolerance on its own initiative.299 In that case, the Agency must publish a proposed tolerance and allow for a public comment period of at least 30 days before issuing a final tolerance.

As under § 408, any person may file written objections to a tolerance established under § 409 within 30 days after the final tolerance is issued, and EPA is required to make a formal ruling on such objections.300 The filing of such objections is a prerequisite for seeking judicial review of a tolerance under the FFDCA.301

2. The Delaney Clause

The so-called Delaney Clause prohibits EPA from establishing a tolerance (technically, a food additive regulation) [24 ELR 10649] in processed foods for a substance that has been found "to induce cancer in man or animal."302 It is important to note that the Delaney Clause only applies to food additives regulated under § 409. It does not apply to pesticide residues on raw agricultural products. These are regulated only under § 408, which explicitly requires the Agency to balance risks and benefits.303 Also, it does not apply to pesticide residues in processed food if they do not "concentrate" above the § 408 tolerance.304

There is now widespread agreement in the scientific community that the Delaney Clause, which was enacted almost 40 years ago, is at odds with a rational policy for regulating cancer risks. In a 1982 policy statement, the Food and Drug Administration (FDA) noted that technological advances have made it possible to detect trace amounts of chemicals that pose extremely small cancer risks. As a result, the FDA stated, the Delaney Clause would likely ban an increasing number of beneficial substances that are safe in small amounts.305

In 1987, the National Academy of Sciences (NAS) issued a report that also was critical of the regulatory framework created by the Delaney Clause.306 In response to the NAS report, EPA announced that it would adopt a de minimis interpretation of the Delaney Clause.307 The Agency explained that under this approach, it would approve a pesticide and issue a § 409 tolerance as long as the pesticide would pose only a de minimis or negligible risk. Although the regulated community welcomed this approach, several environmental organizations immediately challenged it in court. As a result of this challenge, the Ninth Circuit struck down the de minimis policy, concluding that it was "contrary to the provisions of the Delaney Clause prohibiting food additives that induce cancer."308

Over the last several years, there have been a number of unsuccessful legislative efforts to repeal or revise the Delaney Clause. These efforts have failed primarily because of a disagreement about the proper statutory framework for addressing cancer risks. Several environmental groups have insisted on a bright-line test that would ban any food additive that poses a lifetime cancer risk of more than one in one million. Advocates on the other side of the debate point out that Americans routinely choose to face risks that are much higher than one in one million, and advance an approach that would allow a somewhat greater degree of risk for certain food additives that are beneficial in maintaining an adequate and economical food supply.

As discussed below in Part XVI, the Clinton Administration is preparing a proposal that it hopes will break the impasse on this issue. However, it is too soon to predict with any certainty the eventual outcome of the legislative process or the final shape of any legislation.

XIV. EPA Research and Monitoring

FIFRA § 20309 directs EPA to carry out its own pesticide research and monitoring in addition to what EPA requires of registrants. EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) and Office of Research and Development (ORD) jointly carry out these functions.

In particular, under FIFRA § 20 EPA must undertake research, including research by grant or contract with other federal agencies, universities, or others, as may be necessary to carry out the purposes of FIFRA, and EPA must conduct research into integrated pest management in coordination with the Secretary of Agriculture.310 EPA also must take care to ensure that such research does not duplicate research being undertaken by any other federal agency.311

The ORD conducts the research, and the OPPTS uses the findings to promulgate guidelines for pesticide use. Currently, the main focuses of this research are spray drift and exposure assessment. Research on spray drift primarily involves agricultural pesticides. Private industry is funding this work.

In its work on exposure assessment, the ORD is placing particular emphasis on the residential environment and the effects of pesticides on children. ORD has targeted three areas of research to assist in its assessment of exposure to pesticides used around the home: Surface residues, lawn care chemicals (in particular how they are tracked), and activity patterns of persons in and around residences. EPA invited discussion of this research strategy at a public workshop in December 1992, and then adopted the strategy in 1993. An independent journal recently published some preliminary results from this research.312 Researchers also presented findings from this program at a meeting of the International Society of Exposure Analysis (ISEA) held in September 1994. In addition, the ORD plans to publish, on behalf of EPA, a comprehensive report in 1996 that would include all research findings to date.

The OPPTS uses the ORD's research in developing guidelines for registrants. For example, based on the ORD's research, the OPPTS will develop and include a new guideline on postapplication exposure assessment in the residential environment. EPA will add this guideline to the subdivision K guidelines regarding reentry protection data requirements.313 The OPPTS plans to issue an interim guideline sometime in 1995 and a final guideline in 1996.

Under FIFRA § 20, EPA must also formulate and periodically revise, in cooperation with other federal, state, or [24 ELR 10650] local agencies, a national plan for monitoring pesticides.314 The Agency must undertake monitoring of air, soil, water, man, plants, animals, and other parts of the environment as may be necessary to implement FIFRA and the national pesticide monitoring plan.315 EPA must establish procedures for monitoring man, animals, and their environment for incidental pesticide exposure, including ways to measure incidental human and environmental pesticide pollution and its long-term trends, and ways to identify the sources of contamination and their relationship to human and environmental effects.316 The Agency must carry out these activities in cooperation with other federal, state, and local agencies.317

In practice, EPA has developed several national monitoring plans, which vary in scope and purpose. For example, the ORD is developing a National Human Exposure Assessment Survey (NHEXAS). This plan, still in its pilot stage, will involve the monitoring of 30 selected chemicals on a national basis. Six of the chemicals are pesticides. Researchers presented a series of papers on the pilot studies at the ISEA meeting. These papers should be available in print in early 1995.

In addition, the Office of Monitoring is implementing the Environmental Monitoring Assessment Program (EMAP), which looks at how ecosystems are affected by, among other things, chemical substances. EMAP is split up into different areas such as wetlands, coastal areas, and so forth. EPA does not base either EMAP or NHEXAS specifically on FIFRA § 20 authority, but both programs contribute to fulfilling EPA's § 20 duties.

There are also smaller, but nevertheless national, monitoring efforts done by or at the direction of EPA. For instance, EPA has previously imposed monitoring requirements on chemical manufacturing companies that produce certain chemicals, for example, tributyl tin pesticide. The Agency also has, through the ORD, engaged in narrow monitoring projects in controlled settings for various regulatory purposes, e.g., to support new registration, support reregistration, or address a specific problem that has been identified in the review process.

XV. Regulation of Pesticides Produced Through Biotechnology

FIFRA § 2(u) broadly defines pesticide as "(1) any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, and (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant."318 Because the definition does not depend on the nature of a substance or how it is made, EPA has taken the position that it covers not only traditional chemical pesticides, but also a growing category of substances known as biological pesticides. Although this category still represents only a small fraction of the pesticides used in this country, about one-half of new registration submissions over the last few years have been for biological pesticides. EPA officials believe that this trend is likely to continue.

EPA classifies three distinct types of products as biological pesticides:

* Microbial pesticides: This subcategory covers both microorganisms (including bacteria, fungi, algae, and protozoa) and viruses that are used for pesticidal purposes.

* Biochemical pesticides: There is little formal guidance to distinguish biochemical from traditional chemical pesticides, and the distinction is not always entirely clear. In general, however, a material must be of natural origin (i.e., produced by a plant or animal) and must operate through a non-toxic mechanism in order to be classified as a biochemical.

* Plant pesticides: As defined by EPA, plant pesticides are "pesticidal substances that are produced in the plant and the genetic material necessary for the production of those substances."319 They do not include plant-produced pesticides extracted from plants for use elsewhere.320 Thus, the plant itself contains a substance that kills, injures, repels, or in any way mitigates the target pest. Most importantly, this subcategory includes pesticidal substances that are introduced into a plant through genetic engineering.

In EPA's view, the potential risks of biological pesticides "are generally expected to be lower than those for chemical pesticides."321 The Agency believes that as compared to traditional chemical pesticides, biologics generally have greater specificity to the target pest, more targeted and lower toxicity, and limited persistence in the environment. For these reasons, the Agency has tried to encourage their development. It has developed a reduced set of data requirements for microbial and biochemical pesticides,322 and has said that it will review registration applications for these products on an expedited basis. It appears that the Agency intends to adopt a similar approach for plant pesticides.323

Notwithstanding EPA's interest in promoting biological pesticides, the regulatory framework for these products is somewhat complex. The Agency has developed (or in the case of plant pesticides, is in the process of developing) separate regulatory requirements for each of the three subcategories of biologics. In addition, it has created separate requirements for microbial and biochemical pesticides that have been genetically modified or are nonindigenous. Therefore, a biochemical pesticide produced through recombinant DNA (rDNA) or similar techniques would be treated differently than the same substance produced through traditional means.

[24 ELR 10651]

A. Biochemical and Microbial Pesticides

As with chemical pesticides, the development of biological pesticides involves a number of steps, ultimately culminating in a registration under FIFRA § 3.324 Initial development and testing begins in the laboratory and then usually moves to the greenhouse. Next, the developer typically conducts limited outdoor testing in order to evaluate pesticidal activity under actual use conditions. After these initial stages, further testing involves the use of larger outdoor test plots, often in different parts of the country. Both the initial and later testing produce data that are necessary for registration.

Except for nonindigenous or genetically engineered microorganisms, which are discussed below, the regulatory requirements during the early development stages are no different for biological pesticides than they are for chemical pesticides. There is usually no EPA oversight until tests are conducted on at least 10 acres of land or one surface-acre of water. Once either of these thresholds has been reached, EPA requires an experimental use permit (EUP) for all types of pesticides, regardless of whether they are biological or traditional chemical pesticides.325

The first potential difference in the regulatory treatment of biological pesticides arise at the EUP stage, where EPA may require somewhat different containment safeguards for certain types of microbial pesticides. The most important difference arises when the developer is ready to submit an application for registration, inasmuch as the Agency has developed different data requirements for biochemical and microbial pesticides than for traditional chemical pesticides.

The formal data requirements for biological pesticides are discussed below. However, because biologically based materials are usually complex and difficult to standardize or interpret, EPA has made it clear that companies should consult with the Agency before preparing an application for a microbial or biochemical pesticide. A preapplication conference with Agency scientists is not only desirable, but essential for determining the data requirements and testing protocols that will be necessary for registration. After a person submits an application, the review process may include an on-going dialogue with the Agency about interpretation of test results. Even then, the process often ends in a conditional registration with additional testing requirements.

Not surprisingly, EPA developed the data requirements for biological pesticides by modifying the set of data required for chemical pesticides. In general, the requirements for biological materials are less onerous because the Agency assumes that they pose less risk than chemical pesticides. Unfortunately, however, because the data requirements are based on preexisting protocols that were developed for chemical pesticides, they often do not fit well with the biological material under consideration.

EPA published its original guidelines for registration of microbial and biochemical pesticides in October 1982.326 These guidelines (generally known as the Subdivision M Guidelines) included an early set of data requirements, but the requirements continued to evolve. Two years later, after criticism from its Science Advisory Panel, the Agency adopted regulations containing a somewhat different set of data requirements.327 Although the guidelines still remain in effect, the regulations obviously take precedence where there are inconsistencies.

The most serious contradiction between the guidelines and the regulations involves toxicology testing for biochemical pesticides. The guidelines did not require subchronic studies for biochemical pesticides unless acute toxicity or mutagenicity tests indicated that such testing was necessary. The regulations, however, do require subchronic studies unless EPA expressly grants a waiver. When EPA adopted the regulations, this requirement substantially increased the cost of registering nontoxic biochemical pesticides, and for several years there were virtually no applications to register such materials. Today, however, the Agency generally waives the subchronic toxicity testing requirement and there is renewed interest in biochemical pesticides.

Since EPA promulgated the regulations in 1984, the Agency has substantially revised the guidelines for registering microbial (and particularly viral) pesticides.328 Although these new guidelines are also called Subdivision M, they contain no requirements for biochemical pesticides and do not entirely supersede the original guidelines. In order to find the requirements for biochemical pesticides, one must refer to the original Subdivision M, where the current requirements for biochemical pesticides are intermixed with the requirements that used to apply to microbial pesticides.

The Subdivision M Guidelines divide the data requirements into eight separate areas:

* product analysis,

* toxicology,

* residue chemistry,

* hazard to nontarget organisms (ecological effects),

* environmental fate and expression,

* product performance,

* experimental use permit data, and

* label development.

Significantly, the guidelines provide for a tiered testing scheme in four of the areas: Toxicology, residue chemistry, hazard to nontarget organisms, and environmental fate and [24 ELR 10652] expression. Under this tiered approach, if Tier I tests do not give rise to any concern, i.e., the tests results are negative, then the guidelines require no further testing. If any Tier I test is positive, however, then the applicant must proceed with relevant testing under other tiers, as specified in the guidelines.

B. Nonindigenous and Genetically Modified Microorganisms

Since the mid-1980s, there has been substantial controversy over the regulation of genetically modified microorganisms. Anti-biotechnology and environmental groups have sought strict regulation for genetically modified products, focusing primarily on those developed with rDNA techniques. Industry groups, joined by many scientists and university researchers, have insisted that there is nothing inherently risky about rDNA. They argue that the government should base regulatory decisions on the potential risk from a product, not on the process that created it.

Until late 1994, the Agency's approach to regulating genetically engineered biological pesticides was based on a 1986 policy statement, the Reagan Administration's Coordinated Framework for Regulation of Biotechnology Products.329 The Coordinated Framework included policy statements on biotechnology by EPA, the Food and Drug Administration, the USDA, the Occupational Health and Safety Administration, and the National Institutes of Health. In September 1994, however, after several years of interagency discussions, EPA issued a final rule to relax the FIFRA requirements established under the Coordinated Framework.330

1. The 1986 Coordinated Framework Policy Statement

As noted above, EPA has generally exempted companies performing small-scale field tests (those conducted on less than 10 acres of land or one surface-acre of water) from the EUP requirement. Under the 1986 policy statement, however, this exemption did not apply to genetically engineered microbial pesticides and nonindigenous naturally occurring microorganisms.331 In the policy statement, the Agency took the position that because microorganisms have the ability to reproduce, a small-scale field test for these materials poses essentially the same degree of risk as a large-scale field test.

Rather than requiring an EUP for small-scale testing of these organisms, however, the policy statement required the developer to submit a notification to the Agency before conducting any type of field test. Based on the information provided in the notification, the Agency decided whether to require an EUP. Under the policy statement, the data required in the notification varied depending on whether the microorganism was classified as high risk or low risk. The high risk category consisted of (1) intergeneric microorganisms, i.e, organisms produced from two different genera; (2) microorganisms derived from source organisms that are pathogens; and (3) nonindigenous naturally occurring organisms. Microorganisms falling within the high risk category were subject to a higher level of scrutiny referred to as Level II review. Other microorganisms covered by the policy statement were generally subject only to Level I review.

2. The FIFRA Biotechnology Rule

The 1986 policy statement generated much controversy, especially from researchers and scientists who argued that it unfairly singled out rDNA for more stringent regulatory oversight. They acknowledged that rDNAtechniques have the potential to produce products that may pose an environmental risk, but pointed out that traditional breeding methods (a less sophisticated form of biotechnology) have the same potential. In their view, it is the product -- not the process -- that EPA should regulate. If anything, they argued, rDNA is a safer process. Traditional breeding techniques often introduce unintended traits into a new plant or organism, while rDNA -- a more precise technique -- allows researchers to be more certain about the traits that they transfer to a new organism. (Indeed, Agency staff acknowledge that of the more than 75 microorganisms reviewed under the 1986 policy statement, none have raised significant risk concerns.)

In response to these arguments, the Agency proposed, in January 1993, a rule designed to replace the regulatory regime established under the 1986 policy statement.332 In the preamble to the rule, the Agency stated:

the scope of coverage for this rule should be reduced, from that articulated in 1986, to focus only on those microbial pesticides for which the Agency has risk concerns or where the Agency lacks sufficient information or knowledge to conclude that their use at small-scale is unlikely to cause unreasonable adverse effects.333

The proposal sought comment on two different options for the scope of the notification requirement. Under either of them, naturally occurring nonindigenous microorganisms would no longer be covered. Both options also would have reduced the scope of coverage for genetically modified organisms. EPA's designated preferred option focused, as did the 1986 policy statement, on microorganisms that have been modified by rDNA or similar techniques. However, it would have covered only those "microbial pesticides whose pesticidal properties have been imparted or enhanced."334

EPA's alternative option was more explicitly risk-based. It would have required notification for "microbial pesticides for which specific pesticidal activities have been created or increased by deliberated processes or techniques," unless the organism was "unlikely to pose a greater risk in the test site environment" than the organism from which it was derived.335 This option would not have focused on rDNA [24 ELR 10653] or similar techniques, but would have covered modifications by any deliberate process or technique. However, because it would have allowed the researcher to consider natural containment barriers in the test site environment and other factors that would affect the risk of the field test, it would have resulted in a much narrower scope for the rule. Notwithstanding the narrower scope of the alternative option, most industry commenters supported the Agency's preferred option because it drew a clear line between microbial pesticides that were covered by the notification requirement and those that were not.

In September 1994, EPA issued a final FIFRA biotechnology rule that replaced the regulatory regime established under the 1986 policy statement.336 The rule incorporates, with minor changes to the proposed language, the Agency's preferred option for the scope of the notification requirement. Thus, the notification requirement applies to "[m]icrobial pesticides whose pesticidal properties have been imparted or enhanced by the introduction of genetic material that has been deliberately modified."337 Although this approach may still subject many low-risk microbial pesticides to EPA oversight, it will significantly reduce the burden on companies and researchers that are developing genetically engineered pesticides.

There are additional provisions in the final rule that further reduce the scope of the notification requirement from that of the 1986 policy statement. Although EPA had proposed to exempt all naturally occurring nonindigenous microorganisms from the notification requirement, the final rule exempts such organisms only if they have been reviewed by USDA.338 It appears, however, that virtually all such organisms are subject to USDA oversight, and will, therefore, be exempted from notification under FIFRA.339 The final rule also exempts from the notification requirement microorganisms modified solely by the rearrangement or deletion of nucleotide sequences within a single genome.340 In addition, the rule clarifies that notification is not required for testing conducted in a facility with adequate containment and inactivation controls.341

The data requirements for a notification will be codified at 40 C.F.R. § 172.48, and are substantially the same as those required for high-risk organisms under the 1986 policy statement. The final rule states that EPA will review each notification within 90 days, but also prohibits an applicant from proceeding with a proposed test until it has received a notice of approval from EPA.342 After reviewing the information in the notification, EPA may respond in one of five ways. The Agency may:

* require additional information from the applicant to assess the test adequately;

* approve the proposed test;

* approve the proposed test with conditions;

* require an EUP for the test; or

* disapprove the proposed test because of the potential for unreasonable adverse effects.343

Under the final rule, Agency disapproval of a proposed test is considered the equivalent of denial of an EUP, and the test applicant may pursue the same remedies that are available to an EUP applicant.344

C. Plant Pesticides

One of the most promising recent advances in agricultural technology involves the use of rDNA to introduce pesticidal properties into plants themselves. Thus, it will soon be possible for a farmer to purchase plants that repel or protect themselves from many common pests. This technique may substantially reduce or even eliminate the need to use chemical pesticides on these plants. This would not only reduce costs to farmers (in terms of both the cost of chemical pesticides and the cost of labor needed to apply them) but is also likely to reduce the risks associated with exposure to chemical pesticides.

Several companies have developed and plan soon to market corn, potato, and cotton plants that contain an insect control protein derived from the common soil bacterium Bacillus thuringiensis (Bt), which is effective at controlling several common pests.345 Large-scale field tests indicate that these plants will not require the application of additional pesticides to control the target pests.

To define the regulatory requirements for such plants more precisely, the Agency is drafting a series of proposed rules and a statement of policy.346 The drafts make it clear that EPA does not intend to assert jurisdiction over the plants themselves, but simply over the pesticidal substances produced by the plants and the genetic material coding for and controlling those substances.347 Even though the Agency claims jurisdiction over these substances, it intends to exempt most of them from regulation.348

Specifically, EPA has identified three classes of plant pesticides that it intends to exempt under FIFRA. The first consists of plant pesticides derived from closely related plants.349 The second consists of plant pesticides that work through nontoxic mechanisms. These mechanisms include altering plant structures to make the plant less susceptible to pests, altering plant biochemistry to make it less susceptible to toxins from the pest, or altering the plant's nutritional value to the pest to make it less attractive.350 The third consists of coat proteins from plant viruses. Introducing [24 ELR 10654] genetic codes for these proteins into the plant's genome tends to promote resistance to the virus.351

At the same time, it appears that EPA will propose to exempt three classes of plant pesticides from the requirement for food tolerances under the FFDCA. The first consists of pesticidal substances whose use would not result in significantly different dietary exposures than those that people have historically encountered.352 The second consists of nucleic acids, the building blocks of the genetic code, which are ubiquitous in food.353 The third consists of plant virus protein coats, which have long been present in foods and are not known to cause disease in animals.354

The Office of Management and Budget is currently reviewing drafts of the policy and proposed rules. They should appear in the Federal Register during the last half of 1994.355

XVI. Reforms and Initiatives

A. Current Legislative Proposals

There has been considerable congressional interest in reform of both FIFRA and the FFDCA. For the past four years, various proposals have been put before the Congress for consideration; all have failed to move successfully through the legislative process.

Legislative reform packages generally focus on several primary areas: Reform of the Delaney Clause356 and the tolerance setting process;357 streamlining the cancellation and suspension processes for removing dangerous pesticides from the market;358 enhancing the enforcement provisions;359 limiting the term of the registration;360 providing restrictions on the export of banned or unregistered pesticides;361 and improving recordkeeping or data-collection authorities.362

1. Reform of the Delaney Clause and the Tolerance Setting Process

As discussed above in Part XIII of this Article, the regulatory standard for setting tolerances under FFDCA § 408363 for pesticide residues found in raw agricultural products differs from that of § 409364 for residues in processed foods. All legislative reform packages call for amending the FFDCA to provide for a single consistent negligible risk standard to be applied to residues in both raw and processed foods. The debate is how to define the concept of negligible risk as it applies to carcinogens, as well as threshold health effects.

Some legislative proposals also prescribe the dietary exposure assumptions that EPA must use under FIFRA as it evaluates the risk posed to consumers from each pesticide. These assumptions are important because they drive the risk assessment, and therefore, the decision that EPA will make as to the safety of the pesticide being evaluated. For example, one legislative proposal incorporates an additional 10-fold margin-of-safety factor for dietary exposure to pesticides among infants and children.365

Equally controversial is the role that benefits should play in the decision to allow a pesticide to enter or remain on the market. Under FIFRA, EPA is directed to take the benefits to society of use of the pesticide into account and to balance those benefits against the health and environmental risks posed by it. Under FFDCA § 408, regulators can also take societal benefits into account. Regulators can take these benefits into account under § 409, but not for those pesticides that are carcinogenic and concentrate in processed foods. Legislative approaches differ as to whether or not regulators should take benefits into account under either § 408 or § 409, and if so, how to define those benefits, to whom the benefits should enure, e.g., to consumers or to growers, and whether they should justify keeping a pesticide that exceeds the negligible risk standard on the market.

2. Streamlining Cancellation and Suspension Provisions

Most legislative packages call for reform of the process by which pesticide registrations can be canceled or suspended under FIFRA.366 For cancellations, many proposals call for an informal rulemaking process with notice and comment to replace the hearing with cross-examination before an administrative law judge.367

Reforms of the suspension provisions include eliminating the requirement that a notice of cancellation be filed [24 ELR 10655] at the same time that a suspension action is taken and providing instead up to a six-month interval between the two actions; and eliminating the right of the registrant to a hearing and substituting a petition procedure with prompt judicial review.368

3. Enforcement

The enforcement provisions of the FFDCA and FIFRA are noticeably weaker than other environmental laws. Some legislative reform packages include language that enhances inspection, recordkeeping, laboratory audit authorities, and increases penalty authorities. Some legislative packages include citizen suit and whistleblower provisions similar to those found in other environmental laws.369

4. Export Restrictions

Congress has shown considerable interest in restricting the ability of pesticide manufacturers to export pesticides that have been banned for health or environmental reasons.370 Additionally, some in Congress would like to ban the export of pesticides manufactured in the United States that have never been registered under FIFRA or received a food tolerance under the FFDCA. Reformers argue that without such restrictions, unsafe pesticides return to the United States as residues on imported foods, completing a "circle of poison." However, one proposal would require EPA to allow the exportation of a pesticide that is otherwise banned in the United States if (a) the Administrator finds that the prohibition of the pesticide is not based on an adverse human health effect, and (b) the importing country informs the Administrator in writing that it is aware that all or virtually all of the uses of the pesticide are prohibited in the United States.371

5. Registration Terms

Some legislative proposals would amend FIFRA to provide for a review of all health and safety data on a pesticide at certain time intervals, for example, every 12 years, and to require a renewal of the registration and tolerances by EPA at the same time. Registrants failing to supply the necessary data in a timely fashion, and obtain such a review and approval would be subject to suspension or cancellation.372

6. Improved Recordkeeping and Data Collection

Many legislative proposals call for growers to keep records on their application of all (or some) pesticides.373

B. Current Regulatory Proposals

Two of the more interesting pending pesticide regulatory proposals involve the Agency's Endangered Species Protection Program and its Pesticide and Groundwater Strategy. Both of these programs have undergone considerable evolution over the last several years, and are nearing finalization.

1. Endangered Species Protection Program

In the 1988 reauthorization of the Endangered Species Act (ESA),374 Congress directed EPA to work with the USDA and the Fish and Wildlife Service (FWS) to develop a program to protect federally listed species from potentially harmful exposure to pesticides. To comply with the ESA, EPA's Office of Pesticide Programs published a proposal in July 1989 that discussed a program to protect listed species from potentially harmful exposure to pesticides. EPA plans to issue a final Endangered Species Protection Program through administrative rulemaking sometime in 1994.375

Under EPA's program, EPA, the FWS, and the USDA rank listed species according to sensitivity to pesticides and likelihood of exposure. The program seeks to initially protect those species that are most sensitive to pesticides. EPA identifies which pesticides may affect the species and then consults with the FWS. EPA is currently waiting for the results of its first consultation with the FWS on 32 species. If the FWS determines that the identified pesticides may harm a listed species, the FWS will issue a Biological Opinion which specifies reasonable and prudent actions for EPA to implement to protect the endangered species.

EPA will implement the program primarily by requiring certain label statements instructing users to comply with use limitations developed jointly by EPA and the FWS. EPA has not yet written final versions of these statements. EPA and the FWS will issue use limitations on a county-by-county basis, in county bulletins, wherever a listed species may be exposed to pesticides.376

2. Pesticides and Groundwater Strategy

In 1991, EPA developed a Pesticides Groundwater Strategy, which describes the policies, management programs, and regulatory approaches that EPA will use to protect the nation's groundwater resources from the risk of contamination by pesticides. A central goal of EPA's strategy is to provide the states with an opportunity to manage the use of pesticides in ways that protect groundwater resources.

Accordingly, in December 1993, EPA issued a document entitled Guidance for Pesticides and Ground Water State Management Plans.377 This guidance, with its two appendices,378 [24 ELR 10656] establishes the components of State Management Plans (SMPs), and provides approaches and methods to assist states in developing and implementing SMPs.

There are two kinds of SMPs -- generic SMPs (which establish SMP components in general terms) and Pesticide SMPs (which address specific pesticides). EPA plans to publish a proposed rule setting forth the components of a Pesticide SMP and specifying pesticides for which a Pesticide SMP will be required. EPA will invoke the SMP approach for a specific chemical if: (1) the Agency concludes that the pesticide may cause unreasonable adverse effects to human health or the environment where effective local management measures are lacking; and (2) the Agency determines that labeling and restricted use classification measures provide insufficient protection of groundwater resource, but national cancellation would not be necessary if states assume management of the pesticide to effectively address the contamination risk. If the SMP approach for a specific chemical is invoked, the legal sale and use of the pesticide would be confined to states with an approved Pesticide SMP.

XVII. Conclusion

Over the past several decades, pesticides have become an integral part of all of our lives. The agricultural sector is heavily dependent upon them as it produces an affordable and abundant food supply for this nation and much of the world. But the uses of pesticides extend far beyond agriculture and are greatly varied, ranging from hospitals that use chemicals to sterilize medical devices, to pulp and paper mills for the control of microorganisms, to our own homes and gardens for pest control, and much more.

Yet, even as the uses of pesticides continues to grow, so does the public's concern about their safety. FIFRA, which began as a law designed to protect the farmer from ineffective products and advertising fraud, has evolved over time to one that protects human health and the environment from the risks posed by pesticides.379 Public concern about pesticides in the food supply and in the environment, and grower concern over consumer preference has forced many changes in the industry. Pesticide manufacturers are investing in research for new, safer pesticides. Biotechnology offers the promise of pest control without the use of synthetic chemicals. Growers are reinventing the way they grow crops to use chemicals more judiciously, if at all. And the role of organic farming in the agricultural economy has developed a strong foothold, as consumer demand for organic produce grows.

Perhaps more profoundly, EPA's regulatory jurisdiction under FIFRA and the FFDCA was once thought of only in terms of individual pesticide registrations. Today, EPA plays a significantly greater role in shaping agriculture policies and practices in this country. Its regulatory decisions now incorporate policies of reduced risk, reduced use, integrated pest management, and pollution prevention, all of which affect the marketing and use of various pesticides.

As this new role for EPA continues to expand, the challenges presented to the regulatory agency, the chemical industry, and agriculture will be significant. Practitioners in particular will need to keep abreast of how the aforementioned policies are implemented, and how they affect pesticide regulatory decisions. Because of the impact on the pesticide industry, it will become increasingly important for the successful pesticide registrants to work cooperatively with the agricultural community, consumer and environmental groups, and regulatory agencies to shape the implementation of these policies and their relationship to product registrants.

1. Pub. L. No. 100-532, Title IV, §§ 401-403, Title VIII, § 801(q)(1)(D), 102 Stat. 2654, 2669, 2672, 2683 (1988) (codified as 7 U.S.C. § 136q, ELR STAT. FIFRA § 19). EPA previously claimed authority to regulate these aspects of pesticide use as part of its general authority to regulate pesticide labeling.

2. 7 U.S.C. § 136q(a)(1), ELR STAT. FIFRA § 19(a)(1).

3. Id. § 136q(a)(2), (3), ELR STAT. FIFRA § 19(a)(2),(3). Regulations governing storage, transportation, and disposal of canceled or suspended pesticides, as well as regulations governing recalls, are not subject to FIFRA § 25(a)(4) mandatory congressional review. See id. § 136q(d)(2), ELR STAT. FIFRA § 19(d)(2).

4. Id. § 136q(b)(6), ELR STAT. FIFRA § 19(b)(6).

5. See 40 C.F.R. pt. 165 (1993).

6. See id. §§ 165.7-.11.

7. See id. §§ 165.3-.6.

8. The most important changes to the current regulations involve the acceptance program, which ended with the 1988 FIFRA Amendments. While the regulations for the program will remain in effect, they will only cover pesticides suspended and canceled before December 24, 1988. In addition, the current sections will be renumbered once the proposed regulations are final. For a description of the changes to the existing regulations see 58 Fed. Reg. 26856, 26872 (May 5, 1993); 59 Fed. Reg. 6712, 6778-80 (Feb. 11, 1994).

9. See 54 Fed. Reg. 18076, 18083-86 (Apr. 26, 1989).

10. See EPA, EXECUTIVE SUMMARY FOR PROPOSED 40 C.F.R. PART 165 (Apr. 15, 1992).

11. See 58 Fed. Reg. at 26856 (to be codified at 40 C.F.R. pt. 165).

12. See 59 Fed. Reg. at 6712 (to be codified at 40 C.F.R. pts. 156 & 165).

13. See Unified Regulatory Agenda, Item 3704, 59 Fed. Reg. 21062 (Apr. 25, 1994).

14. See 58 Fed. Reg. at 26856, 26872-78 (to be codified at 40 C.F.R. §§ 165.160-.198).

15. See id. at 26878-82 (to be codified at 40 C.F.R. §§ 165.200-.218).

16. See id. at 26882-84 (to be codified at 40 C.F.R. §§ 165.220-.236).

17. See 59 Fed. Reg. at 6712, 6780-87 (to be codified at 40 C.F.R. §§ 165.100-.139).

18. See id. at 6787-89 (to be codified at 40 C.F.R. §§ 165.140-.157).

19. See id. at 6712, 6713 (Feb. 11, 1994).

20. 7 U.S.C. § 136q(g)(1)(A), EPA STAT. FIFRA § 19(g)(1)(A).

21. See EPA, PESTICIDE CONTAINERS: A REPORT TO CONGRESS (May 1992) (EPA 540/09-91-116).

22. 7 U.S.C. § 136q(e)(1)(A), ELR STAT. FIFRA § 19(e)(1)(A).

23. 59 Fed. Reg. at 6712, 6780-87 (to be codified at 40 C.F.R. §§ 165.100-.139).

24. Id. at 6780 (to be codified at 40 C.F.R. § 165.102).

25. Id. at 6783-85 (to be codified at 40 C.F.R. §§ 165.124-.128).

26. 7 U.S.C. § 136q(f)(1)(A), ELR STAT. FIFRA § 19(f)(1)(A).

27. 59 Fed. Reg. at 6780-82 (to be codified at 40 C.F.R. §§ 165.104-.114).

28. Id.

29. 7 U.S.C. § 136q(f)(2), ELR STAT. FIFRA § 19(f)(2).

30. 58 Fed. Reg. 43994 (Aug. 18, 1993).

31. 7 U.S.C. § 136q(f)(3), ELR STAT. FIFRA § 19(f)(3). The Solid Waste Disposal Act, also called the Resource Conservation and Recovery Act, appears at 42 U.S.C. §§ 6901-6992k, ELR STAT. RCRA §§ 1001-11012.

32. See 59 Fed. Reg. at 6712, 6784-87 (to be codified at 40 C.F.R. §§ 165.129-.136).

33. See id. at 6787-89 (to be codified at 40 C.F.R. §§ 165.140-.157).

34. 7 U.S.C. § 136q(b)(1), ELR STAT. FIFRA § 19(b)(1).

35. See 58 Fed. Reg. at 26856, 26872-74 (to be codified at 40 C.F.R. §§ 165.160-.167).

36. 7 U.S.C. § 136q(b)(2), ELR STAT. FIFRA § 19(b)(2).

37. See 58 Fed. Reg. at 26875 (to be codified at 40 C.F.R. §§ 165.172-.174).

38. A recall plan must include: (1) the level and the distribution change to which the recall is to extend, and a schedule for recall; and (2) the means to be used to verify the effectiveness of the recall. See 7 U.S.C. § 136q(b)(5), ELR STAT. FIFRA § 19(b)(5).

39. Id. § 136q(b)(3), ELR STAT. FIFRA § 19(b)(3).

40. See 58 Fed. Reg. at 26875-78 (to be codified at 40 C.F.R. §§ 165.180-.196).

41. 7 U.S.C. § 136q(c)(1), ELR STAT. FIFRA § 19(c)(1).

42. See 58 Fed. Reg. at 26879 (to be codified at 40 C.F.R. § 165.207).

43. 7 U.S.C. § 136q(c)(2)(B), (C), (E), ELR STAT. FIFRA § 19(c)(2)(B), (C), (E).

44. Id. § 136q(c)(2)(A), (D), ELR STAT. FIFRA § 19(c)(2)(A), (D).

45. See 58 Fed. Reg. at 26879-82 (to be codified at 40 C.F.R. §§ 165.208-.218).

46. OFFICE OF COMPLIANCE MONITORING, OFFICE OF PESTICIDES AND TOXIC SUBSTANCES, EPA, ENFORCEMENT RESPONSE POLICY FOR THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) (July 2, 1990).

47. For more detail on indemnification, see supra Part IV.H.4.

48. See 58 Fed. Reg. at 26882-84 (to be codified at 40 C.F.R. §§ 165.220-.236).

49. 7 U.S.C. § 136o(a)(1); ELR STAT. FIFRA § 17(a)(1).

50. Id. § 136o(a)(2), ELR STAT. FIFRA § 17(a)(2).

51. Id. § 136o(a)(1), ELR STAT. FIFRA § 17(a)(1). Label requirements that do not apply to unregistered export products include directions for use of the product (id. § 136(q)(1)(F), ELR STAT. FIFRA § 2(q)(1)(F)); name, brand, or trademark (id. § 136(q)(2)(C)(ii), ELR STAT. FIFRA § 2(q)(2)(C)(ii)); and the registration number (id. § 136(q)(2)(C)(iv), ELR STAT. FIFRA § 2(q)(2)(C)(iv)).

52. Id. § 136o(a)(1), ELR STAT. FIFRA § 17(a)(1). The requirements are in id. §§ 136e, 136f, ELR STAT. FIFRA §§ 7, 8. This Article discusses those requirements in Part V, supra.

53. 40 C.F.R. pt. 168 (1993) (originally published at 58 Fed. Reg. 9062 (Feb. 18, 1993), superseding earlier versions of pt. 168). EPA has also produced a series of brief guidances addressing questions about the regulations. These include OFFICE OF COMPLIANCE MONITORING (OCM) & OFFICE OF PESTICIDE PROGRAMS (OPP), EPA, FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) PESTICIDES EXPORT POLICY INTERPRETIVE GUIDANCE, ISSUE: MULTILINGUAL LABELING (Apr. 8, 1993) [hereinafter EPA GUIDANCE I]; OCM & OPP, EPA, FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) PESTICIDES EXPORT POLICY QUESTIONS AND ANSWERS, ISSUES: SUPPLEMENTAL LABELING; EFFECTIVE DATE; REGISTRATION STATUS FOR LABELING PURPOSES; FOREIGN PURCHASER ACKNOWLEDGEMENT STATEMENTS; CONFIDENTIALITY (May 27, 1993) [hereinafter EPA GUIDANCE II; OCM & OPP, EPA, FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) PESTICIDES EXPORT POLICY QUESTIONS AND ANSWERS, ISSUES: RESEARCH AND DEVELOPMENT PESTICIDES; ACTIVE INGREDIENT CONCENTRATIONS (Aug. 31, 1993) ]hereinafter EPA GUIDANCE III[.

54. 40 C.F.R. § 168.65 (1993).

55. Id. § 168.75.

56. Id. §§ 168.65(b)(1)(3)(A), .75(b). See also EPA GUIDANCE II, supra note 53, question 8. For a discussion of pesticide registration, see supra Part IV.

57. 40 C.F.R. §§ 168.65(b)(1)(iii)(A)(2), .75(b)(4) (1993). Specifically, the chemical causing the color or fragrance change must be on EPA's list of generally safe chemicals exempt from the food tolerance requirements. (Printed in id. § 180.1001.) The chemical must not be on EPA's "List 1" of inert ingredients presenting toxicological concerns. The fragrance change must not cause the pesticide product to have a food-like fragrance. And the exporter's records must show the complete formula of the pesticide.

58. Id. § 168.75(b)(4)(ii). This exception does not apply to pesticides used in public health settings where EPA requires efficacy data for registration. Id.

59. Id. § 168.65(b)(1)(iii).

60. EPA GUIDANCE III, supra note 53, question 8.

61. 40 C.F.R. § 168.75(b)(2)(i) (1993).

62. Id. § 168.75(b)(2)(ii), (3).

63. Id. § 168.65(b)(1)(iii)(A)(3).

64. Id. § 168.65(b).

65. For a discussion of establishment registration, see supra Part V.A.

66. For discussions of use classification, see supra Parts III.A.1.d (labeling), IV.D.2.g (registration), VI.B (use).

67. These may need to be worded differently from the statements on domestic labels (discussed supra in Part III.A.1.b). See 40 C.F.R. § 168.65(b)(1)(ii) (1993).

68. 7 U.S.C. § 136(q)(1)(E), ELR STAT. FIFRA § 2(q)(1)(E).

69. 40 C.F.R. § 168.65(b)(4) (1993). Note the possible exceptions for the ingredients statement given in id. § 168.65(b)(1)(iv). For additional guidance on multilingual labeling, see EPA GUIDANCE I, supra note53.

70. 40 C.F.R. § 168.65(c) (1993).

71. See EPA GUIDANCE II, supra note 53, question 1.

72. 7 U.S.C. § 136o(a)(2), ELR STAT. FIFRA § 17(a)(2). This provision of FIFRA does not require acknowledgement statements for pesticides with canceled registrations if EPA is permitting continued sale of existing stocks under id. § 136d(a)(1), ELR STAT. FIFRA § 6(a)(1). For answers to some common questions about the requirement, including more detailed guidance than presented here, see EPA GUIDANCE II, supra note 53, questions 10-15.

73. EPA GUIDANCE III, supra note 53, question 4.

74. 40 C.F.R. § 168.75(c)(1) (1993).

75. Id. § 168.75(c)(2).

76. Id.

77. EPA GUIDANCE II, supra note 53, questions 16-17.

78. 7 U.S.C. § 136o(a), ELR STAT. FIFRA § 17(a); 40 C.F.R. § 168.75(d) (1993).

79. 7 U.S.C. § 136o(b), ELR STAT. FIFRA § 17(b).

80. 40 C.F.R. § 168.75(b)(5) (1993).

81. EPA GUIDANCE III, supra note 53, question 1. If the pesticide is an R&D microbial subject to outdoor release notification requirements in the United States and exported for outdoor release, EPA will enforce the labeling requirements. Id.

82. 40 C.F.R. § 168.75(b)(5)(i) (1993).

83. Id. § 168.75(b)(5)(iii).

84. Id. §§ 168.65(b)(1)(iv), .75(c)(1)(iii)(C).

85. Id. § 168.85(a).

86. Id. § 168.75(c)(1)(iii)(C), (c)(2)(iii).

87. 7 U.S.C. § 136o(c), ELR STAT. FIFRA § 17(c).

88. See generally 19 C.F.R. §§ 12.100-.117 (1993).

89. Id. § 12.111.

90. Id.

91. Id. § 12.112. Importers may get EPA Form 3540-1 from any of the EPA regional offices or from the EPA Office of Compliance Monitoring (EN-342), 401 M St. NW, Washington, DC 20460.

92. 19 C.F.R. § 12.112(b) (1993).

93. See id. § 12.112(a).

94. Id. § 12.113(a).

95. Id. § 12.113(b).

96. Id. § 12.113(c).

97. Id. §§ 12.114, .115.

98. Id. § 12.114.

99. Id.

100. Id. § 12.115.

101. Id. § 12.116. Customs will notify the consignee in writing that it has taken samples for EPA. Id.

102. Id. § 12.115.

103. Id. § 12.117(a).

104. Id. § 12.117(b).

105. See supra Parts VI.B.1, VII.

106. 7 U.S.C. § 136v, ELR STAT. FIFRA § 24.

107. U.S. CONST. art. VI, cl. 2.

108. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 248, 14 ELR 20077, 20080 (1984).

109. Id.

110. Id.

111. Maryland v. Louisiana, 451 U.S. 725, 746 (1981).

112. 7 U.S.C. § 136v(a), ELR STAT. FIFRA § 24(a).

113. Id. § 136v(b), ELR STAT. FIFRA § 24(b).

114. 728 F. Supp. 605, 20 ELR 20629 (N.D. Cal. 1989).

115. 7 U.S.C. § 136(p), ELR STAT. FIFRA § 2(p).

116. D-Con, 728 F. Supp. at 606, 20 ELR at 20630.

117. Chemical Specialties Manufacturers Ass'n v. Allenby, 958 F.2d 941, 946, 22 ELR 20822, 20824 (9th Cir.), cert. denied, 113 S. Ct. 80 (1992).

118. New York State Pesticide Coalition, Inc. v. Jorling, 874 F.2d 115, 19 ELR 20859 (2d Cir. 1989).

119. Id. at 119, 19 ELR at 20860.

120. Id. at 119, 19 ELR at 20860-61 (citation omitted).

121. Id. at 119, 19 ELR at 20861 (quoting 7 U.S.C. § 136a(c)(5), ELR STAT. FIFRA § 3(c)(5)).

122. 500 F. Supp. 465 (E.D. Cal. 1980).

123. Id. at 468.

124. Id. at 471.

125. See, e.g., Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1541, 14 ELR 20556, 20562 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984); Florida Citrus Packers v. California, 549 F. Supp. 213, 216 (N.D. Cal. 1982).

126. Professional Lawn Care Ass'n v. Village of Milford, 909 F.2d 929, 20 ELR 21245 (6th Cir. 1990); Maryland Pest Control Ass'n v. Montgomery County, 646 F. Supp. 109, 17 ELR 20511 (D. Md. 1986), aff'd per curiam sub nom. Maryland Pest Control Ass'n v. Prince George's County, 822 F.2d 55, 18 ELR 20585 (4th Cir. 1987). But see, Coparr, Ltd. v. City of Boulder, 734 F. Supp. 363 (D. Colo. 1989), aff'd, 942 F.2d 724, 22 ELR 20071 (10th Cir. 1991); People v. County of Mendocino, 36 Cal. 3d 476, 204 Cal. Rptr. 897 (Cal. 1984).

127. 111 S. Ct. 2476, 21 ELR 21127 (1991).

128. Id. at 2482, 21 ELR at 21128.

129. Id. at 2484, 21 ELR at 21129.

130. Several states have delegated FIFRA authority to the local governments in their boundaries. Parties concerned with the overlay of local, state, and federal laws should consult the laws of the state with which they are dealing before assuming the relevant state has actually delegated such authority to their local governments.

131. The outcome of this issue may naturally vary from state to state. Compare Pesticide Public Policy Foundation v. Village of Wauconda, 622 F. Supp. 423 (N.D. Ill. 1985), on certification of questions to Ill. Supreme Court, 510 N.E.2d 858, 17 ELR 21174 (Ill.), aff'd per curiam, 826 F.2d 1068 (7th Cir. 1987) (state law preempts local regulation) with People ex. rel. Deukmejian v. County of Mendocino, 683 P.2d 1150, 14 ELR 20767 (Cal. 1984) (state law does not preempt local regulation).

132. 736 F.2d 1529, 14 ELR 20556 (D.C. Cir. 1984).

133. Id. at 1540, 14 ELR at 20561 (emphasis in original).

134. See, e.g., Ciba-Geigy Corp. v. Alter, 834 S.W.2d 136 (Ark. 1992). See also Thornton v. Fondren Green Apartments, 788 F. Supp. 928, 22 ELR 21526 (S.D. Tex. 1992) (FIFRA does not expressly or impliedly preempt Texas common law); Montana Pole & Treating Plant v. I.F. Laucks & Co., 775 F. Supp. 1339 (D. Mont. 1991) (FIFRA does not expressly or impliedly preempt state common-law remedies), aff'd on other grounds, 993 F.2d 676, 23 ELR 20843 (9th Cir. 1993); Riden v. ICI Americas, Inc., 763 F. Supp. 1500 (W.D. Mo. 1991) (FIFRA does not expressly or impliedly preempt state tort claims, nor do state common-law remedies conflict with the purposes of FIFRA); Evenson v. Osmose Wood Preserving, Inc., 760 F. Supp. 1345 (S.D. Ind. 1990) (FIFRA does not preempt state tort claims based on inadequate labeling of pesticides, adopting Ferebee); Stewart v. Ortho Consumer Products, 1990 U.S. Dist. LEXIS 3391 (E.D. La. 1990) (FIFRA does not preempt state tort claims because compliance with both state tort damage awards and the FIFRA section at issue is not impossible); Cox v. Velsicol Chemical Corp., 704 F. Supp. 85, 19 ELR 20936 (E.D. Pa. 1989) (Congress did not intend to immunize manufacturers from state tort claims based on inadequate warnings); Whitener v. Reilly Industries, 1989 U.S. Dist. LEXIS 17548 (S.D. Ill. 1989) (Congress has not specifically preempted state tort actions, nor would compliance with both the labeling requirements of FIFRA and state tort law be impossible; furthermore, state tort action would not stand as an obstacle to the accomplishment of the full purposes and objective of Congress); Roberts v. Dow Chemical Co., 702 F. Supp. 195 (N.D. Ill. 1988) (FIFRA does not preempt state tort claims because FIFRA regulations are not so comprehensive as to occupy the entire field); Wilson v. Chevron Chemical Co., 1986 WL 14925 (S.D.N.Y. 1986) (FIFRA does not preempt punitive damages awards).

135. 834 S.W.2d at 136.

136. Id. at 143.

137. Id.

138. 681 F. Supp. 404 (E.D. Mich. 1987).

139. 825 F.2d 620 (1st Cir. 1987).

140. 681 F. Supp. at 407 (quoting 825 F.2d at 627-28) (citation omitted) (emphasis added by Fitzgerald court).

141. Id.

142. 926 F.2d 1019, 21 ELR 20898 (11th Cir. 1991) (per curiam) (Papas I).

143. Id. at 1020, 21 ELR at 20898.

144. Id. at 1024-25, 21 ELR at 20900.

145. 112 S. Ct. 2608 (1992).

146. 15 U.S.C. §§ 1331-1341 (1988 & Supp. V 1993).

147. 112 S. Ct. at 2621.

148. 985 F.2d 516, 23 ELR 20613 (11th Cir. 1993) (per curiam) (Papas II).

149. Id. at 517, 520, 23 ELR at 20613, 20615.

150. 7 U.S.C. § 136v(c)(1), ELR STAT. FIFRA § 24(c)(1).

151. 40 C.F.R. § 162.152(b)(2) (1993).

152. 7 U.S.C. § 136v(c)(1), ELR STAT. FIFRA § 24(c)(1); 40 C.F.R. § 162.152(c)(1) (1993).

153. See 40 C.F.R. pt. 162 (1993).

154. Id. §§ 162.151(i), 162.152(a)(1), 162.153(b).

155. Id. § 162.152(a)(2); 7 U.S.C. § 136v(c)(3), ELR STAT. FIFRA § 24(c)(3). For a discussion of pesticide residue tolerances, see infra Part XIII.

156. 40 C.F.R. § 162.152(a)(3) (1993). For rules concerning state registration of new uses for pesticides with voluntarily or partially canceled registrations, see id. § 162.(b)(ii), (iii).

157. See id. § 162.152(b)(1)(iv), (2)(iii).

158. Id. § 162.153(a).

159. Id. § 162.153(c).

160. Id. § 162.153(d).

161. Id. § 162.153(e)-(g).

162. Id. §§ 162.153(h), 162.154.

163. 7 U.S.C. § 136v(c)(2), ELR STAT. FIFRA § 24(c)(2); 40 C.F.R. § 162.154(c) (1993).

164. 40 C.F.R. § 162.154(c) (1993).

165. 7 U.S.C. § 136v(c)(3), ELR STAT. FIFRA § 24(c)(3); 40 C.F.R. § 162.154(b) (1993).

166. 7 U.S.C. § 136v(c)(4), ELR STAT. FIFRA § 24(c)(4); 40 C.F.R. § 162.155 (1993).

167. 7 U.S.C. § 136d(a)(2), ELR STAT. FIFRA § 6(a)(2).

168. Id. § 136j(a)(2)(B)(ii), (N), ELR STAT. FIFRA § 12(a)(2)(B)(ii), (N).

169. Pesticide Registrant Reporting Requirements, Agency Interpretation of Requirements Imposed on Registrants by Section 6(a)(2) of FIFRA, 43 Fed. Reg. 37611 (Aug. 23, 1978).

170. Enforcement Policy Regarding Failure to Report Information Under Section 6(a)(2) of FIFRA, 44 Fed. Reg. 40716 (July 12, 1979).

171. Reporting Requirements for Risk/Benefit Information, Final Interpretive Rule and Statement of Policy, 50 Fed. Reg. 38115 (Sept. 20, 1985) (codified at 40 C.F.R. pt. 153 subpt. D (1993)).

172. Codified at 40 C.F.R. §§ 152.125, 158.34 (1993).

173. OFFICE OF PESTICIDE PROGRAMS, EPA, NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, AND REGISTRANTS OF PESTICIDE PRODUCTS (PR NOTICE 92-1) (Jan. 2, 1992) [hereinafter PR NOTICE 92-1].

174. Reporting Requirements for Risk/Benefit Information, Proposed Rule, 57 Fed. Reg. 44290 (Sept. 24, 1992).

175. PR NOTICE 92-1, supra note 173, at 4.

176. See Unified Regulatory Agenda, Item 3700, Reporting Requirements for Risk/Benefit Information (Revision), 59 Fed. Reg. 21061 (Apr. 25, 1994).

177. 43 Fed. Reg. 37611 (Aug. 23, 1978).

178. 7 U.S.C. § 136d(a)(2), ELR STAT. FIFRA § 6(a)(2).

179. 43 Fed. Reg. at 37613.

180. Id.

181. Id. (emphasis added). The court in Chemical Specialty Manufacturers Ass'n v. U.S. Environmental Protection Agency disagreed with EPA's conclusion that an expert's opinion is "factual" information that must be reported under § 6(a)(2). See 484 F. Supp. 513, 518, 10 ELR 20430, 20432 (D.D.C. 1980). In the preamble to its 1985 interpretive rule, EPA noted the court's conclusion that "expert opinion was not 'factual' in nature within the meaning of Section 6(a)(2)." However, EPA stated that "because the court's actual order held without qualification in favor of EPA …, EPA and the Department of Justice believe that EPA is free to take the position that expert opinion evidence … [is] covered by Section 6(a)(2) despite the dicta in CSMA, and EPA continues to take this position." 50 Fed. Reg. 38115-116 (Sept. 20, 1985).

182. 43 Fed. Reg. at 37614.

183. Id. at 37615.

184. 44 Fed. Reg. 40716 (July 12, 1979).

185. Id. at 40716.

186. Id.

187. Id. at 40717.

188. Id. at 40718.

189. Id. at 40717.

190. Id. at 40717-18.

191. Id. at 40718-19.

192. Id.

193. Id. at 40719.

194. Id.

195. Id. at 40720.

196. Id.

197. Id.

198. Id. at 40722; see also 44 Fed. Reg. 27932, 27938-40 (May 11, 1979).

199. 44 Fed. Reg. at 40721-22.

200. Id. at 40722.

201. Id.

202. 7 U.S.C. § 136d(a)(2), ELR STAT. FIFRA § 6(a)(2).

203. 44 Fed. Reg. at 40722.

204. 50 Fed. Reg. 38115 (Sept. 20, 1985).

205. Id. at 38119; see also 40 C.F.R. §§ 1253.73, .77 (1993) (dietary or environmental pesticide residue studies or incident reports).

206. 50 Fed. Reg. 38117; see also 40 C.F.R. §§ 153.64 (1993).

207. The rule appears in 40 C.F.R. pt. 153 subpt. D (1993). See effective date note at id.

208. Both PR Notice 92-1, supra note 173, and the 1992 proposed rule, 57 Fed. Reg. 44290 (Sept. 24, 1992), discuss the status of the 1985 interpretive rule.

209. 40 C.F.R. § 158.34 (1990).

210. Id. § 152.125.

211. PR Notice 92-1, supra notes 173.

212. 40 C.F.R. § 152.125 (1993).

213. By mail, to Document Processing Desk -- 6(a)(2), Office of Pesticide Programs -- H7504C, U.S. EPA, 401 M St., SW, Washington, DC 20460. In person or by courier, to Office of Pesticide Programs, Document Processing Desk -- 6(a)(2), Room 266A, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.

214. PR Notice 92-1, supra note 173, at 2.

215. 40 C.F.R. § 158.34 (1990).

216. PR Notice 92-1, supra note 173, at 2.

217. Id. The format requirements for registration data are in 40 C.F.R. § 158.32 (1993).

218. PR Notice 92-1, supra note 173, at 3.

219. Id. The statutory provision referred to is 7 U.S.C. § 136h(d)(1), ELR Stat. FIFRA § 10(d)(1).

220. 57 Fed. Reg. 44290, 44291 (Sept. 24, 1992).

221. Id. at 44290.

222. Id. at 44291.

223. 7 U.S.C. § 136(a)(2), ELR Stat. FIFRA § 6(a)(2).

224. 57 Fed. Reg. at 44292.

225. 40 C.F.R. § 152.50(f)(3) (1993); see also 57 Fed. Reg. at 44292.

226. 7 U.S.C. § 136(a)(2), ELR Stat. FIFRA § 6(a)(2).

227. 57 Fed. Reg. at 44293 (emphasis added).

228. 7 U.S.C. § 136(a)(2), ELR Stat. FIFRA § 6(a)(2).

229. 57 Fed. Reg. at 44291.

230. Id. at 44301 (proposed 40 C.F.R. § 159.158(b)

231. Id. (proposed 40 C.F.R. § 159.158(c)).

232. 7 U.S.C. § 136(a)(2), ELR Stat. FIFRA § 6(a)(2).

233. 57 Fed. Reg. at 44291.

234. Id. (proposed 40 C.F.R. § 159.158(d)).

235. Id. at 44293.

236. Id..

237. Id..

238. Id. at 44293, 44300 (proposed 40 C.F.R. § 159.155).

239. See id. at 44293-94, 44301 (proposed 40 C.F.R. § 159.165).

240. See id. at 44294, 44301 (proposed 40 C.F.R. § 159.165).

241. See id. (proposed 40 C.F.R. § 159.170).

242. See id. at 44294-96, 44301 (proposed 40 C.F.R. § 159.178).

243. See id. at 44296, 44302 (proposed 40 C.F.R. § 159.179).

244. See id. at 44296-98, 44302 (proposed 40 C.F.R. § 159.184).

245. See id. at 44298, 44302 (proposed 40 C.F.R. § 159.188).

246. See id. at 44298-99, 44303 (proposed 40 C.F.R. § 159.195).

247. Id. at 44293, 44300-01 (proposed 40 C.F.R. § 159.159).

248. 15 U.S.C. § 2607(e), ELR STAT. TSCA § 8(e).

249. Id. § 2602(2)(B)(ii), ELR STAT. TSCA § 3(2)(B)(ii).

250. EPA Revisions of PMN Regulations, Final Rule, 51 Fed. Reg. 15096, 15098 (Apr. 22, 1986).

251. 21 U.S.C.A. §§ 301-395 (West 1972 & Supp. 1994).

252. 40 C.F.R. § 152.112(g) (1993).

253. 21 U.S.C.A. § 346a (West 1972 & Supp. 1994)

254. FFDCA § 201(r), 21 U.S.C. § 321(r) (1988), defines a raw agricultural commodity as "any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing."

255. 21 U.S.C.A. § 348 (West 1972 & Supp. 1994).

256. The provision requiring processed food residues to meet tolerances is FFDCA § 402(a)(2)(C), 21 U.S.C.A. § 342(a)(2)(C) (West Supp. 1994). Under a so-called flow-through provision in that subparagraph, a tolerance set for a pesticide on raw agricultural commodities can serve for the processed commodity if the processing removes the residue "to the extent possible in good manufacturing practice." Id.

257. Id. § 408(b), 21 U.S.C. § 346a(b) (1988).

258. Although FFDCA requires such a risk/benefit analysis only under § 408, the Agency has stated that "EPA interprets section 409 to also allow EPA to consider benefits to food consumers in reaching its decisions unless the Delaney Clause applies." 53 Fed. Reg. 41104 (Oct. 19, 1988). This Article discusses the Delaney Clause infra in this Part.

259. 21 U.S.C.A. § 331 (West 1972 & Supp. 1994).

260. Id. § 342(a)(2)(B) (West Supp. 1994).

261. Id. § 346a(a) (West 1972 & Supp. 1994).

262. 40 C.F.R. § 152.112(g) (1993). As discussed below, if the applicant can show that a particular inert presents a low risk to the public health, EPA has developed a policy of waiving certain data requirements for receiving an exemption. See infra note 42 and accompanying text. A complete listing of materials currently exempted as being inert ingredients can be found in 40 C.F.R. § 180.1001(c) (covering ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest); § 180.1001(d) (covering ingredients in pesticide formulations applied to growing crops only); § 180.1001(e) (covering ingredients in pesticide formulations applied to animals).

263. FFDCA § 201(s), 21 U.S.C. § 321(s) (1988).

264. 40 C.F.R. § 180.2 (1993).

265. 21 U.S.C.A. § 346a (West 1972 & Supp. 1994); 40 C.F.R. pts. 178-80 (1993).

266. See FFDCA § 408(d)(1), (e), 21 U.S.C.A. § 346a(d)(1), (e) (West 1972 & Supp. 1994).

267. 40 C.F.R. § 180.7(d) (1993). The contents that are required in a petition for a tolerance or an exemption are set forth in id. § 180.7.

268. FFDCA § 408(d)(2), 21 U.S.C. § 346a(d)(2) (1988).

269. Id. § 408(d)(3).

270. Id. For details of advisory committee referral, appointment, and procedure, see 40 C.F.R. §§ 180.10-.12 (1993).

271. FFDCA § 408(d)(3), 21 U.S.C. § 346a(d)(3) (1988).

272. Id. § 408(d)(2).

273. A petitioner that insists on having a decision within the statutory time limit can expect to have the petition acted upon unfavorably. See 55 Fed. Reg. 41126, 41128 (Oct. 19, 1988).

274. FFDCA § 408(e), 21 U.S.C.A. § 346a(e) (West Supp. 1994).

275. Id.

276. See id.

277. Id. § 408(d)(5).

278. Id.

279. 40 C.F.R. § 178.32(b)(1) (1993).

280. FFDCA § 408(i), 21 U.S.C.A. § 346a(i) (West 1972 & Supp. 1994).

281. 40 C.F.R. § 180.30 (1993).

282. See id. § 180.33.

283. Id. § 180.33(m).

284. 21 U.S.C. § 346a(j) (1988). This Article discusses EUPs supra in Part IV.F.

285. See also 40 C.F.R. § 180.31 (1993) (procedures and standards for temporary tolerances).

286. 7 U.S.C. § 136p, ELR STAT. FIFRA § 18. This Article discusses emergency exemptions in more detail supra in Part II.B.2.c.

287. 40 C.F.R. § 166.25(a)(2) (1993).

288. 21 U.S.C. § 346a(c) (1988).

289. The general data requirements for inert ingredients are set forth at 52 Fed. Reg. 13305 (Apr. 22, 1987).

290. 21 U.S.C. § 321(s) (1988).

291. Id. § 321(s)(1), (2) (1988) (emphasis added).

292. Id. § 348 (1988). Note that FFDCA § 406, 21 U.S.C. § 346 (1988), authorizes EPA to set tolerances for "poisonous or deleterious substance[s]" "required in the production" of food and that "cannot be avoided by good manufacturing practice." This section may arguably serve as an alternative basis for regulating pesticide residues in processed foods.

FFDCA §§ 406 & 409 both grant authority to "the Secretary" (originally, the Secretary of Health, Education, and Welfare), however the executive reorganization creating EPA transferred that authority to the EPA Administrator. Reorganization Plan No. 3 of 1970, § 2(a)(4), reprinted in 5 U.S.C. app. at 1343, 1344 (1988) and 84 Stat. 2086 (1970).

293. 21 U.S.C.A. § 342(a)(2)(C) (West Supp. 1994).

294. EPA maintains a great deal of discretion in determining whether processing "concentrates" a pesticide residue. The specific methodology to be used in making such a determination depends upon the type of residue, the commodity being processed, and the actual process being used. For guidance on particular data-reporting requirements, see EPA, PESTICIDE ASSESSMENT GUIDELINES, SUBDIVISION O, RESIDUE CHEMISTRY, SERIES 171-4 (1982).

295. The regulations that set forth the procedural requirements under § 409 are in 40 C.F.R. pts. 177-79 (1993). Note that pts. 178 & 179 apply also to actions under § 408.

296. Compare FFDCA § 409(b), (c), 21 U.S.C. § 348(b), (c) (1988) with FFDCA § 408(d), (e), 21 U.S.C.A. 346a(d), (e) (West 1972 & Supp. 1994).

297. Id. § 409(b)(5), 21 U.S.C. § 348(b)(5) (1988); 40 C.F.R. § 177.88 (1993).

298. FFDCA § 409(c), 21 U.S.C. § 348(c) (1988).

299. Id. § 409(d).

300. Id. § 409(f); see also 40 C.F.R. pt. 178 (1993).

301. See Nader v. U.S. Environmental Protection Agency, 859 F.2d 747, 19 ELR 20246 (9th Cir. 1988), cert. denied, 490 U.S. 1034 (1989); see also FFDCA § 409(g), 21 U.S.C. § 348(g) (1988); 40 C.F.R. § 177.140 (1993).

302. FFDCA § 409(c)(3)(A), 21 U.S.C. § 348(c)(3)(A) (1988).

303. See id. § 408(b).

304. See id. § 402(a)(2)(C), 21 U.S.C.A. § 342(a)(2)(C) (West Supp. 1994), discussed supra in this Part.

305. 47 Fed. Reg. 14464 (Apr. 2, 1982).

306. NATIONAL RESEARCH COUNCIL, NAS, REGULATING PESTICIDES IN FOOD: THE DELANEY PARADOX (1987).

307. 53 Fed. Reg. 41104 (Oct. 19, 1988).

308. Les v. Reilly, 968 F.2d 985, 990, 22 ELR 21303, 21306 (9th Cir. 1992), cert. denied, 113 S. Ct. 1429 (1993).

309. 7 U.S.C. § 136r, ELR STAT. FIFRA § 20.

310. Id. § 136r(a), ELR STAT. FIFRA § 20(a). The procedures governing the award of grants for such research and similar research under other environmental statutes are outlined in 40 C.F.R. pt. 30 (1993). The results of EPA-funded research may be published as an EPA publication if the author complies with EPA's peer review process, or in an independent journal. Id. § 30.518. A grant recipient may retain title to an invention under this program, but EPA will require a royalty-free, irrevocable license to use the invention. Id. §§ 30.1102, .1130.

311. 7 U.S.C. § 136r(a), ELR STAT. FIFRA § 20(a).

312. See R. W. Whitmore et al., Non-Occupational Exposures to Pesticides for Residents of Two U.S. Cities, ARCHIVES OF ENVTL. CONTAMINATION & TOXICOLOGY, Jan. 1994, at 47-59; R. G. Lewis et al., Evaluation of Methods for Monitoring the Potential Exposure of Small Children to Pesticides in the Residential Environment, id. at 37-46.

313. See 40 C.F.R. § 158.390 (1993).

314. 7 U.S.C. § 136r(b), ELR STAT. FIFRA § 20(b).

315. Id. § 136r(c), ELR STAT. FIFRA § 20(c).

316. Id.

317. Id.

318. 7 U.S.C. § 136(u), ELR STAT. FIFRA § 2(u).

319. EPA, STATEMENT OF POLICY; PLANT-PESTICIDES SUBJECT TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT AND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT at 12 (Draft Dec. 20, 1993).

320. Id. at 9.

321. EPA, PROPOSAL TO CLARIFY THE REGULATORY STATUS OF PLANT-PESTICIDES at 3 (Draft Nov. 20, 1992) [hereinafter 1992 DRAFT PROPOSAL].

322. See 40 C.F.R. §§ 158.65, -.690, -.740 (1993).

323. 1992 DRAFT PROPOSAL, supra note 321, at 3.

324. For a discussion of FIFRA registration requirements, see supra Part IV.

325. For a certain class of biological pesticides, EPA recently expanded the acreage threshold for when an EUP is required from 10 acres to 250 acres. This higher cut-off applies to arthropod pheromone products in solid matrix dispensers used at a maximum rate of 150 grams of active ingredient per acre per year. See 59 Fed. Reg. 3681 (Jan. 26, 1994).

326. EPA, PESTICIDE ASSESSMENT GUIDELINES: SUBDIVISION M -- BIORATIONAL PESTICIDES (1982). These guidelines are available from the National Technical Information Service (NTIS) in Springfield, Virginia, as No. PB83-153965. When EPA published these guidelines, EPA used the term "biorational pesticides" to describe what are now referred to as "biochemical and microbial pesticides." EPA adopted the latter term in response to criticism of the term "biorational pesticides" by EPA's Science Advisory Panel.

327. See 49 Fed. Reg. 42881 (Oct. 24, 1984) (codified at 40 C.F.R. §§ 158.690 (biochemical pesticides), 158.740 (microbial pesticides)).

328. EPA, PESTICIDE ASSESSMENT GUIDELINES: SUBDIVISION M -- BIORATIONAL PESTICIDES (1989) (NTIS Doc. No. PB89-211676).

329. 51 Fed. Reg. 23320 (June 26, 1986).

330. 59 Fed. Reg. 45600 (Sept. 1, 1994).

331. EPA defines nonindigenous microorganisms as "naturally occurring microorganisms placed in environments where they are not native." 49 Fed. Reg. 50880, 50881 (Dec. 31, 1984). In practice, any organism that is native to the continental United States is not regulated as nonindigenous. The additional regulatory burden for nonindigenous microorganisms is onerous enough to justify a substantial research effort to show that the organism is in fact indigenous to the United States.

332. See 58 Fed. Reg. 5878 (Jan. 22, 1993).

333. Id. at 5880.

334. Id. at 5882.

335. Id.

336. 59 Fed. Reg. 45600 (Sept. 1, 1994).

337. Id. at 45612.

338. Id. at 45602.

339. Id.

340. Id.

341. Id.

342. Id. at 45614.

343. Id.

344. These remedies are specified at 40 C.F.R. § 172.10.

345. EPA has already registered several forms of Bt as microbial pesticides under FIFRA. These products do not qualify as plant pesticides, however, because they are not contained in the plants themselves but are applied (like traditional pesticides) to crops that already are in the field.

346. See EPA, STATEMENT OF POLICY; PLANT-PESTICIDES SUBJECT TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT AND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (Draft Dec. 20, 1993).

347. Id. at 12.

348. Id. at 7.

349. Id. at 24, 29-35.

350. Id. at 26-27, 35-37.

351. Id. at 27-28, 37-41.

352. Id. at 42-46, 47-52.

353. Id. at 46-47, 52-53.

354. Id. at 47, 52-53.

355. See Unified Regulatory Agenda, Item 3682, 59 Fed. Reg. 21056 (Apr. 25, 1994).

356. FFDCA § 409(c)(3)(A), 21 U.S.C. § 348(c)(3)(A) (1988). The Delaney Clause prohibits the presence of carcinogenic additives in processed foods. See supra Part XIII.C.2.

357. See, e.g., Pesticide Reform Act of 1994, S. 2084, 103d Cong., 2d Sess. § 3, 140 CONG. REC. S5301 (daily ed. May 5, 1994); Food Quality Protection Act of 1993, S. 1478, 103d Cong., 1st Sess. § 303, 139 CONG. REC. S12130 (daily ed. Sept. 21, 1993).

358. See, e.g., Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1994, S. 2050, 103d Cong., 2d Sess. §§ 4, 6, 140 CONG. REC. S4875 (daily ed. Apr. 26, 1994); Food Quality Protection Act of 1993, S. 1478, 103d Cong., 1st Sess. §§ 202, 204, 139 CONG. REC. S12130 (daily ed. Sept. 21, 1993).

359. See, e.g., Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1994, S. 2050, 103d Cong., 2d Sess. § 6, 140 CONG. REC. S4875 (daily ed. Apr. 26, 1994).

360. See, e.g., id. § 2.

361. See, e.g., id. § 3.

362. See, e.g., id. §§ 16, 17; Pesticide Food Safety Act of 1993, S. 331, 103d Cong., 1st Sess. § 102, 139 CONG. REC. S1418 (daily ed. Feb. 4, 1993).

363. 21 U.S.C.A. § 346a (West 1972 & Supp. 1994).

364. Id. § 348.

365. Pesticide Reform Act of 1994, S. 2084, 103d Cong., 2d Sess. § 3, 140 CONG. REC. S5301 (daily ed. May 5, 1994).

366. See supra note 352. For a discussion of current provisions for cancellation and suspension of registrations, see supra Parts IV.H, IX.

367. One recent legislative proposal allows EPA to reduce the risks associated with the use of a pesticide by issuing a notice to the registrant requiring changes in packaging, labeling, or the composition of the pesticide necessary to reduce such risks. Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1994, S. 2050, 103d Cong., 2d Sess. § 7, 140 CONG. REC. S4875 (daily ed. Apr. 26, 1994). This innovative procedure would allow EPA to bypass lengthy cancellation proceedings where the registrant is unwilling to comply with EPA's request that it change the use of its pesticide.

368. See, e.g., id. §§ 4, 6, 13.

369. See, e.g., id. §§ 17, 18.

370. See, e.g., id. § 3. For a discussion of the present regulation of pesticide exports, see supra Part X(A).

371. Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1994, S. 2050, 103d Cong., 2d Sess. § 3, 140 CONG. REC. S4875 (daily ed. Apr. 26, 1994).

372. See, e.g., id. § 2. For a discussion of registration and reregistration, see supra Part IV. Part XII discusses additional data reporting requirements.

373. See, e.g., id. §§ 16, 17, 140 CONG. REC. S4875 (daily ed. Apr. 26, 1994). For a discussion of current end-user requirements, see supra Part VI.

374. 16 U.S.C. §§ 1531-1544, ELR STAT. ESA §§ 2-18.

375. See Unified Regulatory Agenda, Item 3695, 59 Fed. Reg. 21060 (Apr. 25, 1994).

376. See generally EPA OPP, PROGRAM SUMMARY, ENDANGERED SPECIES PROTECTION PROGRAM (July 1994).

377. EPA, GUIDANCE FOR PESTICIDES AND GROUND WATER STATE MANAGEMENT PLANS (Dec. 1993) (EPA 735-B-93-005a) (available from ELR Document Service AD-152).

378. See EPA, GUIDANCE FOR PESTICIDES AND GROUND WATER STATE MANAGEMENT PLANS APPENDIX A: REVIEW, APPROVAL, AND EVALUATION OF STATE MANAGEMENT PLANS (Feb. 1994) (EPA 735-B-93-005b) (available from ELR Document Service AD-190); EPA, GUIDANCE FOR PESTICIDES AND GROUND WATER STATE MANAGEMENT PLANS APPENDIX B: ASSESSMENT, PREVENTION, MONITORING AND RESPONSE COMPONENTS OF STATE MANAGEMENT PLANS (Feb. 1994) (EPA 735-B-93-005c) (available from ELR DOCUMENT SERVICE AD-191.

379. See the discussion of the history of FIFRA in Part I supra.

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