The Food Quality Protection Act + EPA's Pesticide Adverse Effects Reporting Rule = New Data and Better Pesticide Risk Decisions

James Handley

Editors' Summary: With the enactment of the Food Quality Protection Act of 1996 (FQPA) amending both FIFRA and the Federal Food, Drug, and Cosmetic Act, EPA must perform a broad reassessment of pesticide risks and benefits, using more and better data than required previously. In response to this mandate, EPA recently promulgated an adverse effects reporting rule that will take effect on June 16, 1998. The new rule should provide EPA with an opportunity to obtain valuable data for performing the FQPA-mandated reassessment. This Article traces the events leading to the enactment of the FQPA, and discusses its broad reassessment requirements. The Article then reviews the substance of the new EPA adverse effects rule, including its pesticide registration requirements and reporting requirements. The Article further discusses enforcement of the new rule, and incentives for registrant compliance, such as EPA's Audit Policy and potential tort liability. To conclude, the author opines that the new rule provides EPA with a valuable window on the "real world" of pesticide adverse effects information.

Mr. Handley is an attorney in the Toxics and Pesticides Enforcement Division of the U.S. Environmental Protection Agency's (EPA's) Office of Enforcement and Compliance Assurance. The views expressed are solely his and do not necessarily reflect the views or policies of EPA or the U.S. government. Mr. Handley holds an LL.M. (with highest honors) in environmental law from George Washington University, a J.D. from the University of Houston, and a Bachelor of Chemical Engineering degree from the University of Delaware.

[28 ELR 10241]

Congress' 1996 enactment of the Food Quality Protection Act (FQPA)¹ will require that the U.S. Environmental Protection Agency (EPA) do a broad reassessment of pesticide risks and benefits, using a more complete and realistic analytical framework, taking into account cumulative effects of pesticides with common modes of toxicity, and taking special account of the effects of pesticides on infants and children. In registering pesticides, EPA relies heavily on laboratory data submitted by parties seeking to register pesticides. To perform its pesticide reassessment tasks under the FQPA, EPA will need more and better data on pesticide risks, including both laboratory and epidemiological studies performed after pesticides are registered, and information on incidents documenting adverse effects caused by pesticides in the real world, as opposed to the laboratory where conditions are controlled by the registrants. In a separate development, EPA recently promulgated a rule specifying requirements for pesticide registrants to report information about pesticide adverse effects. The rule provides a strategic opportunity for EPA to obtain valuable data that it will need in carrying out the task that Congress has set before it in the FQPA. This Article first traces the developments that prompted the enactment of the FQPA and delineates the important changes made by the FQPA. The Article next describes EPA's new rule governing reporting of pesticide adverse effects and how adverse effects information will support EPA's efforts to reassess pesticide risks. The Article concludes with a discussion of the incentives for registrants of pesticides to comply with the rule, including EPA's Audit Policy, and potential tort liability of registrants that fail to report pesticide adverse effects.

Events Leading to the Enactment of the FQPA

U.S. pesticide regulation began with the Federal Insecticide Act of 1910,² which was essentially a consumer protection statute for farmers, prohibiting fraudulent pesticide claims. In response to a burgeoning agricultural chemical industry spawned during World War II, the law was superseded in 1947 by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),³ requiring registration and labelling of pesticides [28 ELR 10242] sold in interstate commerce and providing the U.S. Department of Agriculture (USDA) with the authority to seize misbranded pesticides. In 1964, two years after publication of Silent Spring,⁴ in which biologist and nature writer Rachel Carson thrust into public consciousness the grave dangers of pesticides to humans and wildlife (particularly birds) and their widespread overuse, Congress provided authority for the Secretary of the USDA to refuse a new pesticide registration or to cancel an existing one in order to address an imminent hazard to the public. Responsibility for pesticide registration was transferred to EPA when it was created in 1970.⁵ The current standard, requiring that pesticides not be registered if they cause "unreasonable adverse effects," was added when Congress amended FIFRA in 1972. Although Congress has amended FIFRA in significant ways since 1972,⁶ this standard for registration has been retained.⁷

Prompted by the 1992 Ninth Circuit Court of Appeals decision in Les v. Reilly,⁸ and the results of a 1993 National Academy of Sciences (NAS) Board on Agriculture study, Pesticides in the Diets of Infants and Children,⁹ Congress enacted the FQPA, amending both FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA).¹⁰ The Reilly decision rejected EPA's regulatory attempt¹¹ to reconcile "the Delaney paradox." The Delaney paradox refers to the apparently conflicting provisions of FFDCA § 408(2),¹² requiring the Administrator to "promulgate regulations establishing food tolerances in or on raw agricultural commodities of poisonous or deleterious pesticide chemicals … to the extent necessary to protect public health … ,"¹³ and the "Delaney Clause" prohibiting the presence of any food additive in processed foods "if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal."¹⁴ The NAS report urged EPA and the Food and Drug Administration (FDA) to learn more about the health effects of pesticides, about pesticide residues found in foods, and about which foods children eat, to determine their dietary exposures to pesticides.¹⁵

The FQPA Mandates Broad Review of Pesticide Food Tolerances and Exemptions and Pesticide Registration

The FQPA¹⁶ resolved the "Delaney paradox" by expressly excluding pesticide residues in both raw agricultural commodities and processed foods from the definition of "food additive," thus exempting them from the Delaney prohibition and making them subject to the tolerance-setting procedure.¹⁷ The FQPA also restructured EPA's framework for pesticide residue tolerance-setting by providing that the Administrator may establish or leave in place a tolerance or exemption only if the Administrator determines that it is "safe," which is defined as "a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information."¹⁸ A pesticide that does not meet this standard because of nonthreshold effects (generally, carcinogenic effects) may still be assigned a tolerance if it protects consumers from a risk greater than risk from dietary exposure to the pesticide, or the use of the pesticide is "necessary to avoid disruption of domestic production of an adequate, wholesome and economical food supply," but the tolerance for pesticides with nonthreshold effects must be set so the risk does not exceed 10 times the yearly or twice the lifetime risk that would meet the safety standard and also must meet a [28 ELR 10243] separate standard for infants and children.¹⁹ The FFDCA mandates that, in setting tolerances or exemptions for pesticide residues, the Agency consider

cumulative effects of [pesticide] residues and other substances that have a common mode of toxicity[,] … aggregate levels of exposure of consumers (and major identifiable subgroups of consumers)[,] … variability of the sensitivities of the major identifiable subgroups of consumers[,] … whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen or other endocrine effects[,] … and safety factors … generally recognized as appropriate for the use of animal experimentation data.²⁰

Furthermore, the Act specifically requires EPA to consider the unique susceptibilities and exposures of infants and children:

in establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the Administrator … shall assess the risk … based on … consumption patterns among infants and children that are likely to result in disproportionately high consumption of food containing or bearing such residue[,] … information concerning the special susceptibility of infants and children to the pesticide residues[,] including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals; and … cumulative effects on infants and children of such residues and other substances that have a common mode of toxicity.²¹

The Act sets a three-tiered timetable for EPA to review all pesticide tolerances and exemptions within 10 years, giving priority to those that appear to pose the greatest risk.²² The result of entire classes of pesticides with common modes of toxicity will be reviewed by EPA, with the most dangerous being reviewed first.²³

The Act requires EPA to develop by August 3, 1998, a screening program to determine whether substances including pesticides have endocrine-disrupting effects and requires that the program be implemented a year later followed by public comment and scientific peer review.²⁴ For data on endocrine effects, as with the data on which EPA relies to make registration decisions, the Act places EPA in a position of relying heavily on laboratory testing by pesticide registrants and provides for suspension of the sale and distribution of a pesticide if a registrant fails to provide data on endocrine effects ordered by EPA.²⁵ The Act amended FIFRA to provide an expedited review process for safer pesticides (i.e., those expected to reduce pesticide risks to human health or nontarget organisms, or reduce the potential for contamination of groundwater or surface water or other valued environmental resources, or broaden the adoption and availability of effectiveness of integrated pest management strategies).²⁶ It also requires EPA to revise and expedite its procedure for review of antimicrobial pesticides,²⁷ and requires EPA to develop a procedure to re-review all pesticide registrations on a 15-year cycle.²⁸

[28 ELR 10244]

In order for EPA to reassess the risks of pesticides as envisioned in the FQPA, which includes examining cumulative effects of pesticides with common modes of toxicity, endocrine effects, and effects on children, EPA will need an accurate and complete picture of the health effects of the pesticides it must review. The more data available to EPA and the better the quality of that data, the more likely EPA will be to spot trends and patterns in health and environmental effects that can inform its regulatory decisionmaking.²⁹ Adverse effects data are an important part of a complete picture. Although individual incident reports are obviously anecdotal and may be of limited value in isolation, cumulatively they shed light on real-world situations and trends that laboratory data may not reveal.³⁰ Similarly, scientific studies done by pesticide registrants or others after registration help fill in and correct the preliminary information submitted by registrants that the Agency relied on to make initial registration decisions.³¹

The FIFRA § 6(a)(2) Rule

On September 19, 1997, EPA promulgated the longdelayed³² FIFRA § 6(a)(2) rule, titled Reporting Requirements for Risk/Benefit Information.³³ The rule is a statement of EPA policy regarding reporting of "adverse effects" information by pesticide registrants as required by FIFRA § 6(a)(2).³⁴ This provision of FIFRA requires that, "if at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, the registrant shall submit such information to the Administrator."³⁵ In registering a pesticide, EPA must determine, based on data submitted by registrants,³⁶ that the benefits exceed the risks for a particular use of the pesticide.³⁷ FIFRA defines the term "unreasonable adverse effects on the environment" as "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide," reflecting this risk/benefit balancing.³⁸

FIFRA § 6(a)(2) allows EPA to continuously update the information that it initially relied on in registering a pesticide, supplementing it with information from real-life exposure incidents and studies that were not available at the time of registration decision. This allows EPA to verify that a registered pesticide is being used without unreasonable adverse effects on human health and the environment,³⁹ to reassess whether registration is warranted, or to make adjustments to the conditions of registration, for example concerning labelling or restricted uses, if necessary to avoid or minimize adverse effects.⁴⁰ Moreover, because pesticide registration is almost always based entirely on animal laboratory data generated by registrants, adverse effects incident reports can function as an empirical check on the studies that formed the basis for registration.⁴¹

The 1997 rule is a refinement and consolidation of several existing policies that EPA has relied on to inform registrants of what information about adverse effects they are required to report, when it is to be reported, and in what form.⁴² In attempting to strike a balance between EPA's need for information and the burden on pesticide registrants of reporting that information, EPA recognized that adverse effects information has varying degrees of urgency and the rule sets the reporting obligations accordingly. More serious incidents, such as those involving a human death, must be reported, in [28 ELR 10245] detail,⁴³ within 15 days after the registrant learns of the incident.⁴⁴ Information about less severe effects may be accumulated and reported in summary fashion.⁴⁵ Information about scientific studies must be reported within 30 days.⁴⁶

For purposes of adverse effects reporting, the rule defines a "pesticide" as a "pesticide product which is or was⁴⁷ registered by EPA, and each active ingredient, inert ingredient, impurity, metabolite, contaminant or degradate contained in or derived from a pesticide product."⁴⁸ Thus, the reporting of adverse effects is not limited to the effects of the registered active ingredient per se, but includes adverse effects of the product as a whole, regardless of what constituent caused the adverse effects.⁴⁹ This is consistent with the broad statutory definitions of "adverse effects"⁵⁰ and of "pesticide,"⁵¹ as well as with EPA's pesticide risk assessment and food tolerance-setting process, which must include consideration of the risks posed by contaminants, metabolites, and impurities.⁵² Furthermore, Congress mandated in the FQPA that EPA factor in endocrine effects, which can be caused by degradates and metabolites of pesticides.⁵³

The rule requires employees or agents of registrants to report adverse effect information,⁵⁴ except that "any employee or agent who is not expected to perform any activities related to the development, testing, sale or registration of a pesticide and who could not reasonably be expected to come into possession of information that is otherwise reportable" is not required to report.⁵⁵ This proviso recognizes that some employees and agents who have nothing to do with the pesticide aspect of a registrant's business, and are not in a position to receive adverse effects information, should not be expected to recognize and report information to their supervisors.⁵⁶ On the other hand, the rule may require registrants to inform employees and agents of their obligations if they are in a position to receive adverse effects information or are involved in the pesticide-related aspects of a registrant's business, or both. For instance, retailers and distributors who sell the registrant's pesticide products and are closely identified with the registrant are expected to report.⁵⁷

Supplemental distributors⁵⁸ are considered agents of the registrants for purposes of FIFRA and both may be held liable for FIFRA violations,⁵⁹ including failure to report adverse [28 ELR 10246] effects information.⁶⁰ Attorneys for registrants may come into possession of adverse effects information, for instance, in conducting the defense of claims against the registrant. The rule treats attorneys as agents of registrants for reporting purposes⁶¹ and specifically requires reporting of claims and lawsuit-related incident data, even where the registrant disputes the validity of the claimed effect.⁶² Similarly, the rule requires reporting of expert opinions concerning adverse effects, even where the registrant disagrees with or has not validated the opinion.⁶³

Similar to EPA's prior policy statements,⁶⁴ the rule requires reporting of incidents involving adverse effects on humans or other nontarget organisms if (1) the registrant is aware or has been informed that a person or non-target organism may have been exposed to a pesticide; (2) the registrant is aware or has been informed that the person or nontarget organism has or may in the future suffer a toxic or adverse effect; and (3) the registrant has or could obtain information concerning (a) whether the incident occurred, (b) the pesticide product involved, and (c) the name of a person to contact regarding the incident.⁶⁵ The rule provides certain limited exceptions to the reporting requirements, most notably "where the registrant is aware of facts which clearly establish that the reported toxic effect did not or will not occur."⁶⁶ The new rule eliminates the 1979 policy's provision that required reporting of incidents only where the opinion of a qualified expert or the existence of a series of similar incidents supported the inference of a cause and effect link between the reported exposure and the reported effect.⁶⁷ This [28 ELR 10247] provision had been intended to screen out spurious incident reports, but it proved cumbersome in operation. The new rule also has dropped the recordkeeping requirements of the former policies, largely because the need to keep records to determine the existence of a series has been eliminated and because the Agency is confident that registrants will retain whatever records they deem necessary to prove compliance with the rule.⁶⁸

Scientific studies as well as incidents showing adverse effects must be reported under the rule if they provide new information about adverse effects, for instance where they indicate adverse effects at lower concentrations or dosages than previously reported.⁶⁹ Toxicological studies, ecological studies,⁷⁰ and epidemiological studies are all reportable if they provide new information.⁷¹ The rule specifically requires reporting of certain incomplete and discontinued studies.⁷² The rule also requires reporting of information showing that the pesticide is present in food, feed, or water in excess of established levels.⁷³ For antimicrobial pesticides, the rule requires reporting of incidents or studies relating to failure of performance that could endanger public health.⁷⁴ In addition to the enumerated types of reportable information, the rule contains a "catchall" to cover other information relevant to the continued registration or conditions of registration of a pesticidal product.⁷⁵ The rule, which goes into effect on June 16, 1998, expressly does not relieve registrants of their current reporting obligations under EPA's prior policy statements,⁷⁶ and the preamble notes that EPA's Audit (self-disclosure) Policy applies to late reporting of FIFRA § 6(a)(2) information.⁷⁷

Enforcement of the § 6(a)(2) Rule

FIFRA § 14⁷⁸ provides for penalties of $ 5,500⁷⁹ per violation of FIFRA. Both failure⁸⁰ and refusal⁸¹ to submit reports required by FIFRA are violations. In addition to civil penalties, [28 ELR 10248] the § 6(a)(2) rule specifically mentions criminal penalties⁸² and cancellation of a pesticide's registration under FIFRA § 6 as possible responses to egregious or repeated violations.⁸³

EPA's Audit Policy⁸⁴ provides incentives for self-disclosure of environmental violations, including violations of the FIFRA § 6(a)(2) rule. The policy provides for elimination of all gravity-based penalties (as distinct from penalties to recover economic benefit of noncompliance which are not eliminated under the policy) where each of its nine criteria is satisfied. Where the violation is discovered and reported but not as part of a systematic audit (as required by the policy's criterion number one), the policy provides for 75 percent penalty reductions. The policy's nine criteria⁸⁵ are: (1) systematic discovery;⁸⁶ (2) voluntary discovery;⁸⁷ (3) disclosure within 10 days after the violation is discovered;⁸⁸ (4) discovery or disclosure independent of government or third-party plaintiff;⁸⁹ (5) correction and remediation;⁹⁰ (6) prevention of recurrence;⁹¹ (7) no violations of the same type at the same facility within the past three years, and the violation is not part of a pattern of federal, state, or local violations by the facility's parent organization (if any) within the last five years;⁹² (8) no serious actual harm or imminent and substantial endangerment was caused by the violation;⁹³ and (9) cooperation in providing all information requested by EPA.⁹⁴

Aside from voluntary reporting, EPA has a number of ways to assure that adverse effects information is reported. EPA may search court records and case filings to gather information about litigation-related incidents,⁹⁵ and it may contact poison control centers and hospitals for data about adverse effects incidents. Furthermore, EPA has some reasonable indications about which registrants are conscientiously reporting and which are not. Often there are several registrants with similar products and use patterns whose adverse effects reporting can be compared.⁹⁶ FIFRA provides EPA with clear authority to inspect and search pesticide records,⁹⁷ but its authority to inspect for adverse effects data is [28 ELR 10249] less clear.⁹⁸ When registrants refuse access, EPA's authority to cancel registrations⁹⁹ is probably a more potent deterrent to noncompliance than civil penalties. Thus, effective enforcement will require a close working relationship between the Office of Enforcement and Compliance Assurance (OECA) and the Office of Pesticide Programs (OPP).¹⁰⁰

In the past the OECA has relied on a carrot and stick approach to enforcement. To provide a "carrot," it has initiated "cap" programs that limit or "cap" the penalty liability of violators who self-disclose violations and come into compliance. The OECA concluded such a cap program in 1996-1997 to obtain unreported information under the Toxic Substances Control Act (TSCA) § 8(e) program, (analogous to the FIFRA § 6(a)(2) program) followed by a "stick"—targeted enforcement against nonparticipants. The Audit Policy has arguably already provided the "carrot"; it is difficult to imagine how the Agency could create more incentives for reporting § 6(a)(2) information than to eliminate penalties for qualifying registrants. In choosing targets for the "stick," EPA should focus on quickly obtaining the data that is most needed immediately: adverse effects information on the high-risk pesticides that it has identified for early review under the FQPA.¹⁰¹

FIFRA Preemption May Be Lost by Registrants Who Fail to Report Adverse Effects Information

In addition to the deterrent effect of an enforcement action for failure to report adverse effects information, registrants face another potential incentive to report promptly to EPA: they may lose FIFRA preemption defenses in tort suits if they have not fully disclosed adverse effects of their products to EPA. In defending personal injury and property damage suits by private parties, pesticide manufacturers have invoked FIFRA's preemption provisions to assert that having obtained registration and having included EPA-approved labelling on their products shields them from liability under state tort law for defective products and failure to warn.¹⁰² In essence, they argue that, in complying with EPA's requirements under FIFRA,¹⁰³ they have done all that is required of them.¹⁰⁴

Some courts have held that where the pesticide is registered and includes the EPA-approved label, the manufacturer cannot be held liable for failure to adequately warn of the dangers of its products.¹⁰⁵ The rationale for FIFRA preemption is essentially that because of EPA's expertise and access to the relevant scientific information, it is in the best position to make determinations about the risks and benefits of pesticide products. Therefore, the argument goes, state courts and their juries should not be allowed to second-guess EPA's risk/benefit determination, possibly imposing more stringent requirements on registrants without the benefit of EPA's expertise or scientific data. This argument loses force where EPA has not been provided with relevant information that it should have had in making a determination about registration or where EPA has not been provided with information about adverse effects developed after registration that might cause EPA to reassess its decisions on registration, labelling, or uses of a pesticide.¹⁰⁶ Where the registrant has itself withheld information from EPA, the argument for preemption becomes untenable; EPA no longer can be expected to make fully informed determinations when the registrant has withheld information.¹⁰⁷ Furthermore, the registrant should not be allowed to profit from its concealment, especially where such concealment involved fraud.¹⁰⁸

Conclusion

The FQPA is a major advance in the way EPA reviews pesticide registrations and food tolerances. The Act [28 ELR 10250] mandates that EPA review all pesticide tolerances within a decade and, in so doing, consider the cumulative effects of whole classes of pesticides with common modes of toxicity, take special account of the exposures and susceptibilities of children, and consider in its decisionmaking the endocrine-disrupting effects of pesticides. This will represent a broader and more comprehensive review than has ever been previously conducted. To carry out this mandate effectively, EPA will need to look closely at all the relevant scientific studies and include in its analysis information about pesticide adverse effects from both scientific studies and incident reports. In the culmination of a process started long before the enactment of FQPA, last year EPA released its final rule on the reporting of pesticide adverse effects information. The rule provides EPA with a valuable window on the "real world" of pesticide adverse effects information that should help inform it in carrying out the reviews mandated by the FQPA. Through its Audit Policy, EPA has given pesticide registrants strong incentives to report previously unreported information and should aggressively enforce the rule when it takes effect this June, with a particular focus on obtaining data on the high-risk pesticides that the OPP has identified for early review.

1. Pub. L. No. 75-717, 110 Stat. 1513 (codified at 21 U.S.C. §§ 301-391).

2. Federal Insecticide Act of 1910, ch. 191, 36 Stat. 331, repealed by Federal Insecticide, Fungicide, and Rodenticide Act of 1947, Pub. L. No. 80-104, 61 Stat. 163.

3. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-31.

4. RACHEL CARSON, SILENT SPRING (1962). The best-selling, and perhaps the best-known, environmental book ever published, created an immediate public relations problem for the agricultural chemicals industry; the wisdom and safety of widespread pesticide use had not previously been seriously questioned. See DAN FAGIN & MARIANNE LAVELLE, TOXIC DECEPTION 174-75 (1995).

5. Reorg. Plan No. 3 of 1970, § 2(a)(8), reprinted in 5 U.S.C. app. at 1343-44 (1988), and in 84 Stat. 2086 (1970).

6. In 1975, Congress sought to assure that EPA consider the agricultural effects of its registration and regulatory decisions by adding a requirement that EPA give the Secretary of Agriculture advance notice of proposed regulations, and creating a Science Advisory Panel to review such proposals. In 1978, Congress authorized EPA to issue conditional registrations before receiving the data necessary for registration, and in 1988 Congress attempted to expedite, and provide a fee-based funding structure for, EPA's review of existing pesticides, which had fallen far behind the mandates of the 1972 law. See Linda J. Fisher et al., A Practitioner's Guide to the Federal Insecticide, Fungicide, and Rodenticide Act: Part I, 24 ELR 10449, 10451-52 (Aug. 1994).

7. See 7 U.S.C. § 136a(c)(5), ELR STAT. FIFRA § 3(c)(5), which provides that to grant registration, EPA must find that a product's composition warrants the proposed claims for it, that the label complies with FIFRA, that it will perform its intended function without unreasonable adverse effects on the environment, and that when used in accordance with widespread and commonly recognized practice it will not cause unreasonable adverse effects on the environment (the latter requirement is an acknowledgement that the label requirements are not always followed in common practice and requires EPA to take account of how pesticides are actually used). The term "unreasonable adverse effects on the environment" is defined as "any unreasonable risk to man or the environment, taking into account the economic, social and environmental costs and benefits of the use of any pesticide." Id. § 136(bb), ELR STAT. FIFRA § 2(bb).

8. See 968 F.2d 985, 22 ELR 21303 (9th Cir. 1992). As described below, the decision forced EPA to cancel tolerances for pesticides that show up on processed food. Thus, the decision mobilized both industry and public interest groups to press for a legislative fix.

9. See NATIONAL RESEARCH COUNCIL, NATIONAL ACADEMY OF SCIENCES, PESTICIDES IN THE DIETS OF INFANTS AND CHILDREN (1993).

10. 21 U.S.C. §§ 321-350b, FFDCA §§ 201-412.

11. See Regulation of Pesticides in Food: Addressing the Delaney Paradox: Policy Statement, 53 Fed. Reg. 41104 (Oct. 19, 1988).

12. See 21 U.S.C. § 346a, FFDCA § 408 (known as the "Miller Amendment"); Amendment of July 22, 1954, Pub. L. No. 83-518, 68 Stat. 511 (1954).

13. See 21 U.S.C. § 346a(b), FFDCA § 408(b).

14. Id. § 348(c)(3)(A). FFDCA § 409(c)(3)(A) (Food Additives Amendment of 1958, Pub. L. No. 85-929, § 4, 72 Stat 1785 (1958)). The Delaney Clause was named for Rep. James J. Delaney (D-N.Y.), who championed the cause of "pure foods." See James S. Turner, Delaney Lives! Reports of Delaney's Death Are Greatly Exaggerated, 28 ELR 10003 (Jan. 1998) (wherein Turner argues persuasively that the "paradox" was more perceived than real because the FFDCA allowed pesticides to "flow through" raw agricultural commodities to processed foods as long as the levels did not exceed the tolerances allowed on the raw commodities).

15. See EPA Summary and Explanation of Major Issues in Food Quality Protection Act of 1996, 26 Chem. Reg. Rep. (BNA) 737 (Aug. 16, 1996).

16. For a clear and concise description of the FQPA and its impacts, see Impact of the Food Quality Protection Act of 1996, 3 ENVTL. LAW. 478 (1997).

17. As amended, FFDCA § 201(s) now states, "the term 'food additive' … does not include—(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical …." 21 U.S.C. § 321(s), FFDCA § 201(s).

18. Id. §§ 346a(b)(2), (c)(2), FFDCA §§ 408(b)(2), (c)(2).

19. Id. § 346a(b)(2)(B)(ii)-(iv), FFDCA § 408(b)(2)(B)(ii)-(iv).

20. Id. § 346a(b)(2)(D), FFDCA § 408(b)(2)(D).

21. Id. § 346a(b)(2)(C), FFDCA § 408(b)(2)(C). The standard for infants and children requires EPA to use an additional tenfold margin of safety when assessing threshold risks unless, on the basis of reliable data, the Administrator concludes a different margin will be safe for infants and children. See id. EPA has already invoked the exception in setting tolerances for vinclozolin, a pesticide used on snap beans and other crops, prompting criticism by public interest groups who view this as evidence that EPA is abrogating its new powers. See Environmental Agency Under Fire on Safety Rules, N.Y. TIMES, Dec. 29, 1997, at A16.

22. FFDCA § 408(q) states,

the Administrator shall review tolerances and exemptions for pesticide chemical residues … as expeditiously as practicable, assuring that—(A) 33 percent … are reviewed within 3 years of [the date of enactment of the FQPA]; (B) 66 percent … within 6 years … [;] and (C) 100 percent … within 10 years …. In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption meets the requirements ["no harm from aggregate exposure" standard] of subsections (b)(2) or (c)(2) … and [if the tolerance or exemption does not meet the standard] shall … issue a regulation … to modify or revoke the tolerance or exemption …. The Administrator shall give priority to the review of tolerances or exemptions that appear to pose the greatest risk to public health.

21 U.S.C. § 346a(q), FFDCA § 408(q).

23. EPA's Office of Pesticide Programs (OPP) is currently reviewing the registrations of many organophosphate pesticides under the FQPA's mandates. According to Jeffrey Morris of the OPP's Special Review branch, "organophosphates could live and die together" as a group because they display a common mechanism of toxicity, which when considered in combination pose a significant risk to human health. Organophosphates Now Facing Tolerance Reassessment, PESTICIDE REP., Dec. 19, 1997, at 2 [hereinafter PESTICIDE REP.]. Adverse effects associated with organophosphates include cholinesterase inhibition, tearing of eyes, numbness, muscle twitching, effects on memory and concentration, tremors, gastrointestinal cramps, convulsions, induced delayed neuropathy, depression of respiratory centers, and death. See id. at 3.

24. FFDCA § 408(p) states,

Not later than 2 years after [the date of enactment of this section], the Administrator shall in consultation with the Secretary of Health and Human Services develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.

21 U.S.C. § 346a(p), FFDCA § 408(p). One impetus for this provision may have been a 1996 publication, which focused on the health and ecological havoc wreaked by the hormone-like effects of many pesticides. See THEO COLBURN, OUR STOLEN FUTURE; ARE WE THREATENING OUR FERTILITY, INTELLIGENCE AND SURVIVAL?—A SCIENTIFIC DETECTIVE STORY (1996).

25. FFDCA § 408(p)(5) states,

the Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under the subsection, to conduct testing in accordance with the screening program described in paragraph (1), and submit information obtained from the testing to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation of the information … If a registrant … fails to comply with an order [to conduct testing] the Administrator shall issue a notice of intent to suspend sale or distribution of the substance … If a person requests a hearing … the only matter for resolution at the hearing shall be whether the registrant has failed to comply with an order [to conduct testing].

21 U.S.C. § 346a(p)(5), FFDCA § 408(p)(5).

26. See 7 U.S.C. § 136a(c)(10), ELR STAT. FIFRA § 3(c)(10).

27. See id. § 136a(h)(3), ELR STAT. FIFRA § 3(h)(3).

28. See id. § 136a(g), ELR STAT. FIFRA § 3(g). Another noteworthy innovation of the FQPA is the "right to know" provision, which requires EPA (in consultation with the USDA and the U.S. Department of Health and Human Services) to publish an annual booklet to inform consumers about the risks and benefits of pesticides. The booklet must contain recommendations to consumers for reducing dietary exposures to chemical residues in foods consistent with a healthy diet. See 21 U.S.C. § 347(o), FFDCA § 408(o).

29. See U.S. GENERAL ACCOUNTING OFFICE, REP. NO. GAO/RCED-92-32, PESTICIDES, BETTER DATA CAN IMPROVE THE USEFULNESS OF EPA'S BENEFIT ASSESSMENTS (1991); U.S. GENERAL ACCOUNTING OFFICE, REP. NO. GAO/RCED-95-163, PESTICIDES—EPA'S EFFORTS TO COLLECT AND TAKE ACTION ON EXPOSURE INCIDENT DATA (1995).

30. For example, the author litigated an enforcement action against DowElanco in which over 200 incidents involving the organophosphate chlorpyrifos (trade named "Dursban") were disclosed in the course of the investigation. Ultimately, the company paid a penalty of $ 876,000 to settle a charge of failure to timely report these incidents. See In re DowElanco, FIFRA 95-H-18 (Aug. 17, 1995) (consent agreement). The reported human adverse effects included peripheral neuropathy (damage to the peripheral nervous system), multiple chemical sensitivity, dizziness, impaired vision, headaches, memory loss, nausea, numbness of hands and feet, burning eyes, vomiting, difficulty breathing, headache, stomach cramps, diarrhea, sinusitis, fatigue, memory loss, rash and swollen tongue, respiratory ailments, and birth defects; even deaths were alleged to have been caused by pesticide exposure.

31. Examining cumulative effects of pesticides, the Environmental Working Group (a public interest group) recently concluded that 1.1 million children under age five eat food each day that contains an unsafe dose of organophosphate pesticides. The group used a method developed by the NAS to assess the exposure of infants and children to organophosphates, government data on children's eating habits, and pesticide test results from 1991 to 1996 on nearly 82,000 samples. Dr. Lynn Goldman, EPA's Assistant Administrator for Pesticides and Toxic Substances characterized the study as "useful" as a "snapshot at one point in time." See Study Warns on Pesticide Levels in Food, WALL ST. J., Jan. 30, 1998, at A16.

32. The rule was originally proposed in 1992 (see 57 Fed. Reg. 44290 (Sept. 24, 1992)), and has been substantially revised in response to public comments and Office of Management and Budget review.

33. 62 Fed. Reg. 49370 (effective June 16, 1998).

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

35. Id.

36. See Data Requirements for Registration, 40 C.F.R. pt. 158 (1997).

37. See Fisher et al., supra note 6 and accompanying text.

38. 7 U.S.C. § 136(bb), ELR STAT. FIFRA § 2(bb).

39. Note that the absence of unreasonable adverse effects when a pesticide is in normal use is a condition of registration. FIFRA provides that a pesticide may only be registered if "when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment." 7 U.S.C. § 136a(c)(5)(D), ELR STAT. FIFRA § 3(c)(5)(D). The best way for EPA to learn of problems in actual use is through adverse effects reports.

40. After EPA's OPP obtained the adverse effects reports mentioned in supra note 30, it persuaded DowElanco to undertake risk reduction measures aimed at pest control operators; to voluntarily cancel its registration of Dursban for use in total release indoor foggers, direct application pet products, and paint additives; and to make label changes to inform consumers of the proper retreatment intervals for other uses where consumers were apparently overapplying pesticides causing increased risk without increased efficacy. The company also stated that it planned to phase in substitutes in the termiticide market. See PESTICIDE REP., supra note 23, at 6.

41. The author has heard representatives of pesticide registrants argue publicly that laboratory-generated animal data does not translate into human health effects. For instance, an observation that a chemical causes endocrine effects in animals is not a basis to conclude that similar effects are likely to occur in humans or even other animals. Thus, data on the unfortunate humans who suffer adverse effects may, in effect, be a case-specific refutation of that argument.

42. The preexisting guidance included a 1978 guidance document, 43 Fed. Reg. 37611 (Aug. 23, 1978); a 1979 enforcement policy, 44 Fed. Reg. 40716 (July 12, 1979); and a 1985 interpretive rule, 50 Fed. Reg. 38115 (Sept. 20, 1985) (codified at 40 C.F.R. pt. 153 subpt. D (1993)).

43. Reports of human fatalities must include available information about whether label directions were followed, how exposure occurred (e.g., spill, spray drift, equipment failure, container failure, mislabeling, runoff, etc.), route of exposure, (e.g., skin, eye, respiratory, oral), exposure situation (e.g., household, mixing/loading, application, reentry, disposal, transportation), use site, whether the applicator was certified, a brief description of the circumstances, whether laboratory tests were performed and any results, time between exposure and onset of symptoms, whether the exposure resulted from attempted suicide or homicide, medical care sought, demographic data about the victim, amount of pesticide to which the victim was exposed, whether the exposure was occupational, and whether protective clothing was used. See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. 49370, 49392 (§ 159.184(c)(4)(i)) (effective June 16, 1998).

44. See id. at 49394 (§ 159.184(d)).

45. At the other end of the spectrum, information concerning minor incidents, such as those involving less than $ 5,000 of property damage, may be accumulated for up to 90 days, summarized, and then submitted within 60 days. See id.

46. See id. at 49388 (§ 159.155(a)). The 30-day time for reporting studies is calculated from the date the registrant first possesses or knows about reportable information.

47. The rule requires reporting by both registrants and former registrants. See id. (§ 159.152). Former registrants must report for five years after the registration has been canceled or transferred to another registrant. The rule provides four narrow exceptions. Most notably: if the former registrant holds no active registrations, it must report only if the information was received less than one year after the date on which it ceased to hold the registration. See id. at 49390 (§ 159.160(a)(1)).

48. See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49388 (§ 159.152).

49. See id. at 49391 (§ 159.179), which specifies that new information concerning adverse effects of pesticide metabolites, degradates, contaminants, and impurities is reportable.

50. See 7 U.S.C. § 136(bb), ELR STAT. FIFRA § 2(bb).

51. A pesticide is defined in FIFRA as "(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for us as a plant regulator, defoliant, or desiccant … [but] shall not include … any … 'new animal drug' …." 7 U.S.C. § 136(u), ELR STAT. FIFRA § 2(u) (emphasis added).

52. The rule's preamble states,

in practice, a number of pesticide risk assessments have been based in whole or in part on the risks posed by contaminants and impurities such as dioxins in certain herbicides, or metabolites such as ethylene thiourea (ETU) in EBDC fungicides. Moreover, a significant number of tolerances (maximum legal residue levels for pesticides on food or feed commodities) include metabolites as part of the tolerance expression established by regulation.

Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49372.

53. See supra note 24 and accompanying text.

54. See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49373-74.

55. See id. at 49388 (§ 159.153) (emphasis added).

56. The preamble to the § 6(a)(2) rule states, "the definition [of registrant] includes agents acting for a registrant but does not include persons who could not reasonably be expected to receive reportable information." Id. at 49373. The preamble later states,

the Agency considers an agent of the registrant to be a person who is likely to receive information about the effects of pesticides, and who is acting for the registrant at the time the information is received … the Agency does not consider every direct or indirect employee as likely to receive such information.

Id. at 49474.

57. The preamble discussion states that

as a general matter, the issue of whether a retailer or distributor of pesticides is an agent of a registrant will depend upon the nature of the relationship between the retailer/distributor and the registrant … a retailer or distributor that exclusively (or nearly exclusively) sells a particular registrant's product would generally be considered an agent of that particular registrant.

Id. Neither the rule nor its preamble discuss the related situation where a subsidiary of a registrant comes into possession of adverse effects information but a similar analysis would seem applicable. Thus, whether the subsidiary is an agent for purposes of the rule would depend upon the particular relationship between the parent and subsidiary, and whether the subsidiary is performing functions relating to development, testing, sale, or registration of a pesticide or whether it could reasonably be expected to come into possession of adverse effects information. See id. at 49388 (§ 159.153).

58. Supplemental distributors are essentially entities through which a registrant may, after notice to EPA, distribute its registered product. The labelling on the supplementally distributed product must be identical to that required in the registration except for the product name and registration number (which reflects the identity of both the supplemental distributor and the registrant) and pesticidal claims may be deleted but not added. See Supplemental Distributors, 40 C.F.R. § 153.132 (1997).

59. See id.

60. See id; see also Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49373-74. EPA has been asked to consider a policy to encourage supplemental distributors to report adverse effects information to the registrants who would in turn report to EPA. This would reduce reporting burdens and decrease the potential for duplicative reporting of information by supplemental distributors and registrants. Note, however, that once information has been reported to EPA, it is not "additional" information in the terminology of FIFRA § 6(a)(2). Thus, if either the registrant or the supplemental distributor submits the required information, the reporting obligation for that information is satisfied. But where neither the supplemental distributor nor the registrant reports, EPA has taken enforcement action against both. See e.g., In re Pfizer, Inc., FIFRA 94-H-17 (Jan. 3, 1997) (settlement); In re AgrEvo Environmental Health, Inc., FIFRA 94-H-18 (Dec. 18, 1996) (consent agreement).

61. "EPA has declined to exempt attorney 'work-product' from the reporting requirements of the rule." See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49374.

Exempting attorney work-product … would make the report-ability of investigative work hinge on whether the work was generated at the suggestion of an attorney or of a non-attorney associated with a registrant. The Agency does not believe there is any valid policy reason to exempt valuable information from section 6(a)(2) reporting merely because it was developed at the suggestion of an attorney. Although the Agency does not know what useful information, if any, might be covered by the attorney-client privilege, the same logic applies …. [A] registrant is … free to request [in writing] that the Agency not require submission of certain specified information in a particular case ….

Id. at 48377.

62. See id. at 49383:

the Agency considers information related to a lawsuit involving an allegation of adverse effects due to a pesticide to be clearly reportable under the terms of the final rule unless the registrant is aware of facts which establish that the alleged exposure and effect did not or will not occur. The Agency expects to be informed of incident information regardless of whether the registrant agrees with the substance of the incident report.

63. Section 159.158 provides,

Information … must be submitted … if relevant to the assessment of the risks or benefits of one or more specific pesticide registrations currently or formerly held by the registrant [which] includes conclusion(s) or opinion(s) rendered by a person … employed or retained (directly or indirectly) by the registrant … from whom the registrant requested the opinion(s) or conclusion(s) in question [and] who is qualified as an expert as described in sec. 159.153(b).

Id. at 49389. Section 159.153(b) defines a "qualified expert," as

one who … could be qualified by a court as an expert to testify on issues related to the subject matter on which he or she renders a conclusion or opinion. Under Rule 702 of the Federal Rules of Evidence, a person may be qualified as an expert on a particular matter by virtue of his or her "knowledge, skill, experience training or education."

Id. at 49388. The U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 23 ELR 20979 (1993), replaced the long-standing Frye rule, which allowed admission of testimony "deduced from a well-recognized scientific principle or discovery … sufficiently established to have gained general acceptance" that would "assist the trier of facts," Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923), with a more stringent test based on Fed. R. Evid. 702. The court required instead that the testimony (1) pertain to valid scientific knowledge and (2) involve "reasoning or methodology that can properly be applied to the facts at issue." Daubert, 509 U.S. at 590-92, 23 ELR at 20982. For a discussion of the rule's applicability in pesticide cases, see Erin K.L. Mahaney, Assessing the Fitness of Novel Scientific Evidence in the Post-Daubert Era: Pesticide Exposure Cases as a Paradigm for Determining Admissibility, 26 ENVTL. L. 1096 (1996).

64. See supra notes 33-38 and accompanying text.

65. See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49392 (§ 159.184).

66. Id. The rule also exempts incidents "concerning non-lethal phytotoxicity to the treated crop if the label provides an adequate notice of such a risk." Id. This implies that EPA intends that lethal phytoxicity to the treated crop (such as the crop damage alleged in the cases against DuPont involving the fungicide Benlate) be reportable and also that incidents or studies involving the nonlethal phytoxicity not mentioned on the label are also reportable. (In addition, this type of incident might be reportable as "property damage" as described in § 159.184(c)(4)(vi).

Pursuant to FIFRA § 3(c)(5), EPA has, by regulation, waived data requirements pertaining to efficacy in the registration process. Presumably, efficacy against the target crop (the reason for applying an herbicide) is legally distinct from phytoxicity to the treated crop (which the rule recognizes as an adverse effect). EPA's OPP explained that EPA does not consider efficacy in registering most pesticides and argued that decisions preempting state-law damage claims on the basis that EPA had made a determination of efficacy or lack of phytotoxicity to the treated crop had misunderstood FIFRA and EPA's registration process. See Pesticide Registrant (PR) Notice 96-4 (June 3, 1996). Unfortunately, the notice blurred the distinction between phytotoxicity to the target (weed) and the treated crop. The new rule properly recognizes that lethal phytotoxicity to the treated crop is a reportable adverse effect that EPA might consider after registration even where it has not evaluated this effect in the registration process.

67. The 1979 policy, which remains in effect until June 16, 1998, provides that human incidents are required to be reported if either of these criteria apply:

(1) Human Incidents. The information concerns an incident in which:

(a) The registrant has been informed that some person suffered an adverse physiological or behavioral effect (other than local damage to or irritation of the skin of the type commonly associated with dermal exposure, when the label provides adequate notice of such a hazard);

(b) The registrant has been informed that the affected person may have been exposed to the pesticide, or to one or more of its ingredients;

(c)(i) The registrant has verified that the person did suffer an adverse effect and was exposed to the pesticide, or

(ii) The registrant has received sufficient information to enable investigation of whether or not the reported adverse effect and exposure occurred, a reasonable period of time for investigation has elapsed, and the registrant is not aware of facts which establish that the reported exposure did not occur; and

(d)(i) The registrant has concluded that the effect may have resulted from the exposure, or

(ii) The registrant has been advised by any individual whose opinion is reportable under Section 6(a)(2)—i.e., an employee, consultant, or qualified expert—that the effect may have resulted from the exposure, and is not aware of facts which conclusively establish that the reported adverse effect and reported exposure were unrelated.

(2) Incidents Involving Other Nontarget Organisms. The information concerns an incident in which:

(a) The registrant has been informed of an adverse effect on nontarget fish or wildlife, domestic animals, or plants;

(b) The registrant has been informed that the affected fish, … may have been exposed to the pesticide, or to one or more of its ingredients;

(c)(i) The registrant has verified that the reported adverse effect and expsoure did occur, or

(ii) The registrant has received sufficient information to enable investigation of whether or not the reported adverse effect and exposure occurred, … and the registrant is not aware of facts which establish that the … exposure did not occur; and

(d)(i) The registrant has concluded that the effect may have resulted from the exposure, or

(ii) The registrant … is not aware of facts which conclusively establish that the reported adverse effect and reported exposure were unrelated; and

(e)(i) The registrant cannot demonstrated [sic] that the pesticide exposure resulted from improper use, or

(ii) The labeling of the pesticide does not provide reasonable notice of the risk of adverse effects of the kind reported.

Enforcement Policy Regarding Failures to Report Information Under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act, 44 Fed. Reg. 40716, 40720 (July 12, 1979).

68. See Reporting requirements for Risk/Benefit Information, 62 Fed. Reg. at 49377 (§ 159.157) (the recordkeeping provision which was dropped from the final rule).

69. See id. at 49390 (§ 159.165).

70. See id.

71. See id. at 49391 (§ 159.170).

72. See id. (§ 159.165(d)(3)), which requires, inter alia, that registrants report "any study in which testing or analysis of results is not yet complete but in which serious adverse effects have already been observed which may reasonably be attributed to exposure to the substances tested …" Id: see also id. (§ 159.167), which requires "the fact that a study has been discontinued before the planned termination must be reported … if submission of information concerning the study is, or would have been, required under this part reportable." Id.

73. This is a new requirement. See Reporting Requirements of Risk/Benefit Information, 62 Fed. Reg. at 49391 (§ 159.178). Information must be submitted if it shows that the pesticide is present on food or feed at a level in excess of tolerances set pursuant to the FFDCA, in water above the water reference level in surface waters of the United States, groundwater, or finished drinking water. If the lowest detectable amount of pesticide is found, then the detection limit must be reported. Information concerning pesticide inert ingredients, metabolites, degradates or contaminants need not be reported unless EPA has established or proposed a maximum contaminant level, a health advisory level, or has estimated a health advisory level and notified registrants of that level.

74. See id. at 49394 (§ 159.188). The new rule has dropped the provision of the 1979 policy that required reporting of incidents involving efficacy failure only where the effect was either verified or could have been verified, or was part of a series or pattern of such failures. See Enforcement Policy Regarding Failures to Report Information Under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act, 44 Fed. Reg. 40716, 40721-22 (July 12, 1979). The new rule requires reporting of studies indicating that the "product may not perform against[infectious] micro-organisms in accordance with one or more of the [label] claims by the registrant …." See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49394-95 (§ 159.188(b)(2)).

75. See Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49395 (§ 159.195). As examples, the "catchall" lists situations such as previously unknown or unexpected bioaccumulations of pesticides, greater-than-anticipated drift of pesticides to nontarget areas, use of a pesticide that poses a greater risk than previously anticipated or promotes secondary pest infestations, or information that might tend to invalidate a study submitted to the Agency to support registration. See id.

76. See id. at 49390 (§ 159.159). Note that EPA requires reporting of incidents alleged to have occurred after January 1, 1994, that previously were not required to be reported if the incidents involve fatalities of humans, domestic animals and certain incidents involving deaths of fish or wildlife, but EPA has eliminated a proposal in the draft rule that would have required registrants to "look back" five years and report studies covered by the new rule that were not covered by prior policy statements. Id.

77. See id. at 49379.

78. See 7 U.S.C. § 1361, ELR STAT. FIFRA § 14.

79. Penalty amounts were increased 10 percent to $ 5,500 for each FIFRA violation. See Debt Collection Improvement Act of 1996, 31 U.S.C. § 3701 (amending Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. § 2461. The change has been implemented as a regulation at Civil Monetary Penalty Inflation Adjustment Rule, 61 Fed. Reg. 69360 (Dec. 31, 1996).

80. FIFRA § 12(a)(2) provides, "it shall be unlawful for any person—(N) who is a registrant, wholesaler, dealer, retailer, or other distributor to fail to file reports required by this subchapter …." 7 U.S.C. § 136j(a)(2), ELR STAT. FIFRA § 12(a)(2).

81. FIFRA § 12(a)(2) provides, "it shall be unlawful for any person—(B) to refuse to—(ii) submit any reports required by or under section 136c, 136d, 136e, 136f, 136i, or 136q …." Id.

82. "EPA wants to serve notice that failure to comply with the requirements of section 6(a)(2), as reflected in this final rule … could result … in criminal penalties under FIFRA section 14." Reporting Requirements for Risk/Benefit Information, 62 Fed. Reg. at 49372.

83. See id.

Failure to comply withthese requirements may also constitute grounds for cancellation under FIFRA section 6 of some or all of a registrant's pesticide registrations both because such failure means that "material required to be submitted does not comply with the provisions of [FIFRA]" and because the Agency may conclude that the registrant has failed to carry its burden of demonstrating that the use of its pesticides do not pose unreasonable adverse effects on the environment. EPA does not intend to pursue cancellation every time § 6(a)(2) may have been violated, but egregious or repeated violations may warrant cancellation rather than, or in addition to, monetary fines.

Id.

84. Incentives for Self-Policing, Discovery, Correction, and Prevention of Violations, Final Policy Statement, 60 Fed. Reg. 66708 (Dec. 22, 1995).

85. For a listing of the criteria and their explanations, see id. at 66711-12.

86. "Through (a) an environmental audit or (b) an objective documented, systematic procedure or practice reflecting the regulated entity's due diligence in preventing, detecting, and correcting violations." Id. at 66711.

87. "The violation [must be] discovered voluntarily, and not through a legally mandated monitoring or sampling requirement prescribed by statute, regulation, permit, judicial or administrative order, or consent agreement." Id. EPA has interpreted violations of reporting requirements, such as those of FIFRA § 6(a)(2), as eligible for gravity-based penalty reduction or elimination under the Audit Policy.

88. "The regulated entity must fully disclose the specific violation to EPA [in writing] within 10 days (or such shorter period provided by law) after it has discovered the violation has or may have occurred." Id.

89. Incident information reportable under FIFRA § 6(a)(2) often comes in the form of claims or litigation by private parties. The policy requires that the violation be "disclosed … prior to the filing of a complaint by a third party …." Id. Several interpretations are possible; one is that the policy would exclude late-reporting of all claims-related incidents. This would seem to defeat the aim of the policy to encourage self-disclosures. Another interpretation is that the filing of a complaint (for example seeking damages for property damage or personal injury) against a registrant is not a complaint by a third party for a violation of an environmental law per se, but rather a complaint about negligence, a defective product, etc. The exception would be where the third party alleged injury as a result of a registrant's FIFRA reporting violations, for instance, because the failure to report had interfered with preventative steps that EPA might have taken, such as canceling a registration or requiring additional warnings. Whether or not it satisfies criterion number four, unless reported within 10 days, litigation-related incident information may fail to meet criterion number three; the filing of a lawsuit and service of process would seem to establish when a registrant became aware of the alleged incident. The registrant's legal department certainly should be presumed to know its FIFRA § 6(a)(2) reporting requirements. See supra note 62 and accompanying text.

90. The regulated entity must correct the violation within 60 days. See Incentives for Self-Policing, Discovery, Correction, and Prevention of Violations, Final Policy Statement, 60 Fed. Reg. at 66711. In the case of FIFRA § 6(a)(2), this would imply reporting all previously unreported incidents and studies. The policy provides that EPA may grant extensions of this time if requested in writing before the 60-day time has expired. See id.

91. The regulated entity must agree in writing to take steps to prevent a recurrence, for instance by setting up a regular formal reporting system for incidents and studies. See id.

92. See id. This implies only "one bite at the audit policy." Each registrant will have only one chance to catch up on reporting; subsequent violations will be subject to the usual penalty guidelines.

93. See id. In FIFRA § 6(a)(2) cases, this implies that the late reporting did not delay or materially alter EPA's regulatory process. For instance, a registrant who reported a study that it had known about for two years indicating that a pesticide is so dangerous to human health that the agency might consider canceling its registration or registration for some uses, would probably not be eligible for penalty reduction under the Audit Policy.

94. See id. This means the registrant must assist EPA in investigating the disclosed violations or any other violations, and is similar to the criteria that EPA's FIFRA Enforcement Response Policy requires for penalty reduction.

In order to encourage voluntary disclosure of FIFRA violations, the Agency will offer a 40% reduction of the civil penalty if the disclosure was made: (1) by the violator promptly to EPA or States with cooperative enforcement agreements … ; (2) before the violation was discovered by EPA or a State; (3) before an inspection was scheduled by EPA or a State; and (4) the violator immediately takes all steps necessary to come into compliance, and steps requested by the Agency to mitigate the violation.

U.S. EPA, ENFORCEMENT RESPONSE POLICY FOR THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA) 26 (1990).

95. These searches may now be accomplished electronically, facilitating the detection of unreported incidents.

96. Note that once EPA contacts a registrant to investigate whether it is in compliance with its reporting obligations, penalty reductions under the Audit Policy are no longer available. This is because Audit Policy criterion number three requires that "the violation must be identified and disclosed by the regulated entity … prior to the commencement of an inspection or investigation or the issuance by [a federal, state, or local agency] of an information request." Incentives for Self-Policing, Discovery, Correction, and Prevention of Violations, Final Policy Statement, 60 Fed. Reg. at 66711.

97. See 7 U.S.C. § 136g, ELR STAT. FIFRA § 9.

98. The scope of EPA's inspection authority is tied to FIFRA § 8, which specifies which records registrants, distributors, and others must keep. The provision makes no direct reference to adverse effects information. This may suggest the need for a statutory fix. See id. § 136f, ELR STAT. FIFRA § 8.

99. See supra note 83 and accompanying text.

100. The two offices necessarily have different relationships with registrants. The OPP must work with registrants on scientific issues and relies heavily on their cooperation. The OECA has both compliance and enforcement functions, but to the extent it functions as an enforcement litigation office and communicates with registrants through their attorneys it must retain a more adversarial posture.

101. Organophosphates, carbamates, and organochlorides appear to be high priorities for review according to Assistant Administrator for Prevention, Pesticides and Toxic Substances, Lynn Goldman. See EPA Releases Schedule for Reassessing 10,000 Pesticide Tolerances, PESTICIDE AND TOXIC CHEM. NEWS, Aug. 6, 1997, at 3; see also supra note 22.

102. See Does FIFRA Label State Tort Claims for Inadequate Warning "Preempted"? Welchert v. American Cyanamid, Inc., 7 VILL. ENVTL. L. J. 313-37 (1996). For a discussion of recent FIFRA preemption cases, see No Cause for Relief: FIFRA's Preemptive Scope After Cippollone v. Liggett Group, Inc., 1995 ANN. SURV. OF AM. L. 565.

103. FIFRA § 24 provides,

Authority of States

(a) In general—A State may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent that regulation does not permit any sale or use prohibited by this subchapter.

(b) Uniformity—Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.

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

104. This defense is similar to the defense that cigarette manufacturers invoked in their personal injury suits. They argued that by providing the mandatory labels mandated by the cigarette law they had fulfilled their duty to warn. The argument fell flat, however, when it was discovered that cigarette manufacturers had fraudulently concealed information from the FDA and the public.

105. See, e.g., Welchert v. American Cyanamid, Inc., 59 F.3d 69 (8th Cir. 1995). Other courts have made a distinction, holding that preemption only applies to claims based on labelling (failure to warn or breach of warranty), but not to other negligence or defects that caused injury. See e.g., Burke v. Dow Chemical Co., 797 F. Supp. 1128, 23 ELR 20192 (E.D.N.Y. 1992); Worm v. American Cyanamid Co., 5 F.3d 744, 24 ELR 20120 (4th Cir. 1993).

106. See Roberson v. E.I. DuPont de Nemours & Co., 863 F. Supp. 929, 933, 25 ELR 20773, 20775 (W.D. Ark. 1994) (holding that "DuPont may be estopped from asserting FIFRA pre-emption to the extent that it withheld material facts from the agency, either at the time of registration or thereafter.").

107. See Romah v. Hygenic Sanitation Co., No. 01255, slip op. at 14 (Pa. Super. Nov. 12, 1997), wherein the court permitted the Romahs to pursue their products liability claim because Dow negligently or fraudulently concealed negative test results during the application process for Dursban 2E.

108. See id.