Attachment C 

Pesticide Registration Notice 98-3 

Guidance on Final FIFRA 6(a)(2) Regulations for Pesticide Product Registrants 

(w/ Attachment) 

(available electronically at http://www.epa.gov/opppmsdl/PR Notices/pr98-3.pd0 
April 3, 1998 

PESTICIDE REGISTRATION NOTICE 98-3 

NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, DISTRIBUTORS 

AND REGISTRANTS OF PESTICIDE PRODUCTS 

ATTENTION: 

SUBJECT: 

Persons Responsible for Federal Registration of Pesticides 

Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide 

Product Registrants 

I. BACKGROUND 

On September 19, 1997, EPA published in the Federal Register the final rule codifying 

EPA's interpretation and enforcement policy regarding section 6(a)(2) of the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report 

information concerning unreasonable adverse effects of their products to EPA (62 FR 49370). 

The purpose of the rule is to clarify what information to submit, how and when to submit it, as 

well as which failures to report information, or delays in reporting, will be regarded by EPA as 

violations ofFIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 

12(a)(2)(N). In comparison to previous EPA policy statements, some reporting requirements 

have been expanded, and others reflect increased flexibility or exemptions for reporting specific 

types of information. This rule will become effective June 16, 1998, and will supersede all 

previous policy statements pertaining to section 6(a)(2). EPA is working with registrants in 

anticipation of the rule's effective date to prepare them for implementing the new FIFRA 6(a)(2) 

regulations smoothly and effectively. 

II. PURPOSE 

The purpose of this PR notice is to announce the availability of the attached document 

which will provide registrants comprehensive guidance on implementating the new regulations. 

The Agency has addressed in depth questions and issues raised by registrants and other parties 

subsequent to the publication of the final rule. The guidance in this document has been 

organized alphabetically by subject area, and a table of contents has been provided for ease of 

reference. 
III. FOR FURTHER INFORMATION 

Registrants may contact Kathryn Bouve for information or questions concerning this PR 

notice and attached guidance document at: Office of Pesticide Programs (7502C), U.S. 

Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. Office location, 

telephone number and e-mail address: Crystal Mall #2, Rm. 224, 1921 Jefferson Davis Highway, 

Arlington, VA, (703) 305-5032, e-mail: Bouve.Kate@epamail.epa.gov. 

Stephen L. Johnson 

Deputy Director 

Office of Pesticide Programs 

Environmental Protection Agency 
Attachment to PR Notice 98-3 

Attachment to PR Notice 98-3 

Guidance on Final FIFRA 6(a)(2) Regulations 

for Pesticide Product Registrants 

April 3, 1998 

I&EPAI 

Environmental Protection Agency 

Office of Pesticide Programs 
Attachment to PR Notice 98-3 

Guidance on Final FIFRA 6(a)(2) Regulations 

TABLE OF CONTENTS 

(alphabetical by topic) 

I. Introduction......................................................................................................... 1 

II. Agents: Definition and Reporting Responsibilities............................................... 1 

III. Aggregate Reporting............................................................................................ 3 

IV. Attorney-Client and Attorney Work-Product Privileges-- Waiver Requests........ 6 

V. Authorization to Waive or Modify Reporting Requirements................................ 6 

VI. Causation and Delayed Effects............................................................................ 7 

VII. Expert Opinion Information................................................................................. 8 

VIII. Exposure Type and Severity Categories............................................................... 9 

IX. Extraterritorial Adverse Effect Information......................................................... 13 

X. Information Involving Chemicals Similar to Registered Chemicals..................... 14 

XI. Implementing Rule Before the Effective Date...................................................... 14 

XII. Minimum Information Reportable....................................................................... 14 

XIII. Plant Damage Incident Exemptions..................................................................... 15 

XIV. Previously-Submitted Information....................................................................... 16 

XV. Reportable Injuries and Property Damage............................................................ 17 

XVI. Responsibilities ofNon-Pesticide-Division Employees........................................ 17 

XVII. Submission Due Date.......................................................................................... 18 

XVIII. Technical Corrections to Regulations................................................................... 18 

XIX. Voluntary Incident Reporting Forms.................................................................... 19 
Attachment to PR Notice 98-3 

I. INTRODUCTION 

On September 19, 1997, EPA published in the Federal Register the final rule codifying 

EPA's interpretation and enforcement policy regarding section 6(a)(2) of the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report 

information concerning unreasonable adverse effects of their products to EPA. The purpose of 

the rule is to clarify what information to submit, how and when to submit it, as well as which 

failures to report information, or delays in reporting, will be regarded by EPA as violations of 

FIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). In 

comparison to previous EPA policy statements, some reporting requirements have been 

expanded, and others reflect increased flexibility or exemptions for reporting specific types of 

information. This rule will become effective June 16, 1998, and will supersede all previous 

policy statements pertaining to .section 6( a)(2). 

EPA is working with registrants in anticipation of the rule's effective date to prepare 

them for implementing the new FIFRA 6(a)(2) regulations smoothly and effectively. The 

purpose of this document is to provide registrants comprehensive guidance on implementing the 

new regulations. The Agency has addressed in depth questions and issues raised by registrants 

and other parties subsequent to the publication of the final rule. The guidance in this document 

has been organized alphabetically by subject area, and a table of contents has been provided for 

ease of reference. 

For further information, contact Kate Bouve, Office of Pesticide Programs (7502C), U.S. 

Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. Office location, 

telephone number and e-mail address: Crystal Mall #2, Rm. 224, 1921 Jefferson Davis 

Highway, Arlington, VA, (703) 305-5032, e-mail: Bouve.Kate@epamail.epa.gov. 

II. AGENTS: DEFINITION AND REPORTING RESPONSIBILITIES 

Many registrants have raised questions about the role of registrant agents in the 

regulatory program. Whether a person can be considered an agent of a registrant in a given set of 

circumstances will depend heavily upon the specific facts of that set of circumstances. For the 

purposes of section 6(a)(2), EPA will generally look to the nature ofthe relationship between the 

"agent" and the registrant. Facts that will weigh in the determination of whether someone is 

acting as an agent will include whether the activity conducted is being conducted for the benefit 

of the registrant; whether the registrant is paying (directly or indirectly) for the activity; whether 

the registrant has requested that the activity be conducted; the nature of the contractual or 

financial relationship between the registrant and the person; etc. While the Agency will be 

guided to some extent by common law principles of agency in determining whether a person is 

acting as an agent for a registrant, EPA wants to make quite clear that if an "independent 

contractor" is doing pesticide-related work for, and at the behest of, a pesticide registrant, the 
Attachment to PR Notice 98-3 

Agency considers the independent contractor an "agent" for purposes of section 6( a )(2) 

reporting. 

The question of whether a retailer or wholesaler is an agent in any particular situation 

will also depend upon all the specific facts of the situation. As noted in the Preamble to the 

Final Rule (62 Federal Register at 49374), a distributor (retailer or wholesaler) that sells a wide 

variety of pesticide products produced by many different registrants would generally not be 

considered an agent of a registrant. On the other hand, a distributor that exclusively (or nearly 

exclusively) distributes or sells a particular registrant's products would generally be considered 

an agent of a registrant. The Agency may, however, consider additional factors, including 

whether the distributor has done anything (made statements, published advertisements, etc.) to 

lead users to believe that the distributor is acting for the registrant or would be an appropriate 

place for users to report incidents regarding particular chemicals, as well as the exact nature of 

the relationship between the registrant and the distributor. In any particular case, all the facts of 

the particular situation will be used to determine whether a distributor is acting as an agent of a 

registrant. 

Information that comes into the possession of an agent while the agent is acting for or on 

behalf of a registrant will be presumed to be possessed by the registrant for purposes of section 

6(a)(2) if either the agent is expected to perform duties related to the development, testing, sale, 

or registration of a pesticide, or the agent could be reasonably expected to come into possession 

of otherwise reportable information. Examples of agents that could be reasonably expected to 

come into possession of otherwise reportable information include, but are not limited to, poison 

control centers under contract with a registrant; regulatory consultants; attorneys involved in 

product liability litigation on behalf of a registrant; investigative personnel, such as claims 

adjustors, field investigators, or laboratories acting either directly on behalf of a registrant or on 

behalf of a company or law firm acting for the registrant; etc. Because the registrant is deemed 

to possess information when certain of its agents possess the information, the registrant may be 

held liable for failure to submit reportable information in the possession of the agent, whether or 

not the information is reported to the registrant by the agent. 

Supplemental distributors as defined in 40 CFR section 152.132 will be subject to 

enforcement action if reportable information in their possession is not submitted to the Agency 

in a timely manner. Section 152.132 makes clear that both supplemental distributors and 

registrants are liable for violations pertaining to the distributor product. The supplemental 

distributor accepts this responsibility when agreeing to become a supplemental distributor under 

that regulation. If a supplemental distributor has reportable information concerning the 

distributor product and that information is not provided to the Agency in a timely manner (as 

specified for the particular type of information in the rule) the Agency believes it has the 

authority to proceed with enforcement action against both the underlying registrant and the 

supplemental distributor~ 

Nevertheless, the Agency would like to minimize duplicative reporting and would prefer 

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Attachment to PR Notice 98-3 

that all reportable information be submitted by the underlying registrant rather than by numerous 

supplemental distributors acting for that registrant. Therefore, EPA requests that supplemental 

distributors deliver reportable information to the underlying registrants (in sufficient time for 

registrants to report) and not to EPA; the Agency strongly prefers receiving reportable 

information from registrants themselves rather than from their supplemental distributors. This 

also makes sense from the perspective of good product stewardship, since registrants would 

presumably want to be aware of adverse effects associated with products distributed by others. 

Note that where supplemental distributors choose to submit information to registrants rather than 

directly to EPA, the time for reporting will continue to be calculated from the time that the 

information is first received by the supplemental distributor. 

III. AGGREGATE REPORTING 

The regulations establish different requirements for reporting timeframes and for content 

of incident reports depending on the defined severity categories (see Section VIII. Exposure 

Types and Severity Categories). The chart that follows summarized the requirements. 

ASAP- NLT 15 Accum. 1 Month Accum. 3 Months 

Days Submit 1 Month Later Submit 2 Months Later 

Provide detailed Provide detailed information Aggregate and submit count of 

information for each for each incident incidents and effects for each 

incident product or AI 

Human Deaths Human -Major Human - Minor 

Moderate Unknown, etc. 

Major - Wildlife All Domestic Animals 

Plant 

Water All other categories for -

Property Damage Wildlife 

Plant 

Water 

Property Damage 

The regulations require registrants to report minor. or common incidents as defined in the 

regulations as an aggregate count of incidents and effects for each product. The Agency will 

reject submissions of minor/common incidents if the summaries are not provided. This is 

necessary because the Agency expects the volume of incident reporting to increase after the final 

regulations become effective. To cope with this increase and maintain focus on the most 

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Attachment to PR Notice 98-3 

significant incidents, the Agency developed the aggregate summary format. It speeds the 

incident screening process and facilitates loading the basic information into the Agency's 

Incident Data System. Summarizing the information and taking a broad view of the data helps 

EPA identify patterns of concern regarding products or active ingredients. It is assumed that this 

approach benefits the registrant, as well. 

Some registrants have expressed concern regarding the reliability of incident reports and 

the degree to which the Agency would be influenced by aggregate summaries. It should be 

noted that staff members in EPA's Office of Pesticide Programs (OPP) have many years of 

experience processing and analyzing incident data, and are well aware of the vagaries of incident 

reports, such as the frequent lack of specific details, uncertainties of causality, the sometimes 

erroneous assumptions of reporters, etc. The Agency is also aware that large numbers of 

incident reports may simply reflect a large product sales volume or the existence of toll-free 800 

numbers on product labels, making incident reporting easier. OPP staff members are also aware 

that the Agency may receive multiple reports of the same incident from various sources, which 

may inflate the number of incident reports for a particular product or chemical. While these can 

usually be sorted out for individually reported incidents, they cannot be detected in the aggregate 

reports. EPA takes these fac~ors into account when reviewing aggregate data to determine if the 

incident reports present patterns of concern. Furthermore, EPA makes this clear in its responses 

to people who request incident data in order that they not draw inappropriate conclusions from 

the data. 

An overview of the incident data simply identifies where there might be problems and 

serves as the first step in a process of gathering more information about the products or 

chemicals. If the aggregate report appears to indicate a problem, the product managers - current 

or former - are consulted on their knowledge of the product, such as its use, sales volume, risk 

issues considered during the application process, etc. The product manager will then contact the 

registrant to request additional information or further analysis of the incidents. As a 

consequence, the registrant may need to develop additional data on the issue or negotiate risk 

reduction measures, if appropriate. 

Registrants are free to submit supplemental information about incident reports, 

explaining circumstances such as mis-use, unusual use conditions, or interpreting the data's 

significance. When OPP receives incident submissions, the entire submission -- the aggregate 

summary and any explanatory information -- is filmed for archival purposes and future 

reference. The entire package is forwarded to the Incident Data Officers in the OPP science 

divisions, who then screen the incidents for significance. 

Registrants have requested additional guidance on how to aggregate minor and common 

incident reports. Generally, two facts are reported: the number of incidents and the number of 

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Attachment to PR Notice 98-3 

adverse effects that occurred as the result of the incidents. What follows is guidance on how to 

count incidents and effects, and present them to the Agency. The examples are hypothetical. 

Reg No/ 

Number oflncidents and Adverse Effects Reported by Exposure Type and Severity Category 

Reporting Period January- March 1998 

H-D H-E D-A D-B D-C,D,E 

Domestic 

Human- AnimalUnknown, Domestic Domestic Moderate, 

Active Total Human- Unspecified, or Animal- Animal- Minor, Unknown 

Ingredient Incidents Minor Effects Delayed Effects Death Major Effects or Unspecified 

112233-1 30 7 4 I 4 17 

112233-13 47 4 10 0 9 37 

Active lngred. X 7 I 0 0 2 4 

A single incident can result in effects to multiple exposure types and severity categories, 

so the total number of effects may exceed the total number of incidents. That is demonstrated in 

the chart above. 

If a single incident affects multiple individuals in one exposure type and severity 

category, it is reported as one effect for that exposure type/severity combination. For example, 

if one incident results in the death of 5 domestic animals, it counts as 1 in D-A. 

A single incident may involve multiple exposure types and severity categories, and it is 

counted once for each combination of exposure type and severity category. For example, if one 

incident results in the death of 2 domestic animals, major effects in 10 domestic animals, and 

minor effects to 2 humans, it counts as 1 in D-A, 1 in D-B, and 1 in H-D. 

If one individual experiences multiple effects that would be classified as major, 

moderate, and minor, the most severe category only (major) is assigned. Again, see Section 

VIII. Exposure Types and Severity Categories for expanded definitions. 

If a single incident results in major effects in one human, the death of one domestic 

animal, and moderate effects in 3 domestic animals, the human incident is reported individually. 

The other effects are aggregated and reported in the quarterly summary. They would count as 1 

in D-A and 1 in D-C. 

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Attachment to PR Notice 98-3 

The new Rule does not specify reporting time frames for some reportable items. These 

will be addressed through technical corrections to the regulations. Please see Section XVIII. 

Technical Corrections to Regulations, on page 18 of this document, for a discussion of proposed 

technical corrections. 

IV. ATTORNEY -CLIENT AND ATTORNEY WORK-PRODUCT PRIVILEGES--

WAIVER REQUESTS 

Some registrants requested clarification of the Agency's position on exempting from 

reporting requirements of 6(a)(2) material covered by the attorney-client and attorney workproduct privileges. The Preamble to the Final Rule (62 Fed. Reg. at 49377) states that, "The 

Agency has no intention to broadly exempt information covered by the attorney work-product 

doctrine." However, the Preamble also states that the Agency will consider granting a waiver 

request where it can be shown that: 1) the information is entitled to some privilege; 2) that 

providing the information to the Agency would substantially prejudice a registrant; and 3) that 

the information would not be particularly helpful to an analysis of a product's registration status. 

The Agency expects that it will likely be in a better position to amplify these criteria when and if 

it has considered some actual requests for waivers. 

Any request will be considered in the context of the particular facts involved. A 

registrant requesting a waiver should address all three of the criteria identified in the Preamble. 

It is likely that the third criterion will be particularly important to the Agency's deliberations. It 

is unlikely that the Agency will grant a waiver request unless the Agency knows, in some detail, 

what information is covered by the request and has determined that the information would not be 

particularly helpful to the Agency in fulfilling its regulatory responsibilities. 

Until the Agency has more experience with waiver requests, registrants wishing to 

submit such requests are encouraged to first discuss the request with relevant Agency officials. 

In particular circumstances, the Agency may also place appropriate conditions on waivers, 

including but not limited to, requiring thatthe information be formally provided to the Agency 

at some time in the future. 

All waiver requests must be addressed to the 6(a)(2) Officer in the Office of Pesticide 

Programs. Unless the Agency states otherwise in the future, a registrant may rely on any written 

grant of a waiver request signed by the 6(a)(2) Officer or any attorney in the Office of General 

Counsel. 

V. AUTHORIZATION TO WAIVE OR MODIFY REPORTING REQUIREMENTS 

As in the case of waivers concerning attorney-client or attorney work product privilege, 

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Attachment to PR Notice 98-3 

requests for waivers or modifications of reporting requirements must be addressed to the 6(a)(2) 

Officer. Unless the Agency states otherwise in the future, a registrant may rely on any written 

grant of a waiver request signed by the 6(a)(2) Officer or any attorney in the Office of General 

Counsel. 

VI. CAUSATION AND DELAYED EFFECTS 

One of the key differences between the regulations and earlier guidance (the 1979 

Enforcement Policy) concerns the issue of causation: In the past, an incident was reportable if 

the registrant inferred that a link existed between the effect and exposure or if similar incidents 

occurred three or more times. Under the new regulations, neither an inference nor a pattern 

needs to be established before reporting an incident. Ifbasic information is available-- an 

effect, an exposure, the identity of the pesticide, location where the incident occurred and a 

person to contact -- the incident is reportable. 

In general, under the new regulations, the agency considers incident reports to be simply 

allegations of adverse effects caused by exposure to a pesticide. Some incidents are wellinvestigated and reported in such as way as to establish a strong link between the adverse effect 

and the exposure. On the other hand, many other reports do not include enough facts to clearly 

demonstrate causation and registrants are not required under FIFRA 6(a)(2) to investigate the 

incident to gather additional information. Submission of an incident report by a registrant is not 

considered to be an admission of causation. 

Even incidents in which the reported adverse effects are not consistent with animal 

testing are reportable. For example, if an allegation is made that exposure to a particular 

chemical resulted in respiratory system effects, and the registrant is aware, based on scientific 

data, that the chemical does not cause respiratory system effects, the allegation must still be 

reported. Incident reports serve as a check on animal and other testing done in support of the 

registration application. Real world use of the product can cause adverse effects for a whole 

host of reasons such as species differences, product stability changes, or synergistic effects from 

different inert ingredients. Please note that a registrant may provide information to interpret 

incident patterns, describe special circumstances such as misuse, or explain why the effect could 

not have been caused by exposure to the pesticide. This information will be reviewed along with 

the incident reports. 

Exceptions to incident reporting include those situations in which the registrant has facts 

that clearly establish that the adverse effect did not or will not occur, or that exposure to a 

pesticide did not occur. Such facts may involve errors by the reporter. For example, a registrant 

may be told that a container of pesticide was dumped into a pond and all water fowl in and 

around the pond died. The reporter may later report that the container held gasoline, not a 

7 
Attachment to PR Notice 98-3 

pesticide. Therefore, there was no exposure to a pesticide, and the incident is not reportable. 

Factual errors involving toxic effects could be illustrated by the following example: A 

greenhouse worker claims he was sick and missed a day's work after he was exposed to a 

pesticide. However, it was learned that the worker went to a baseball game and lied about being 

sick. This would not be reportable. 

The provision in the regulations that requires submission of incident reports in which the 

person or non-target organism may suffer a delayed or chronic adverse effect in the future is 

worth special attention. These are cases in which there is no acute adverse effect, but exposure 

has occurred, and the reporter expresses concern about possible effects in the future. The 

primary purpose of this provision is to provide the agency with information about exposures to 

chemicals which were regulated in ways to ensure that exposure would be very low. 

It has been suggested that the agency list specific chemicals that may cause delayed or 

chronic effects and limit 'may suffer' incidents to those associated with the listed chemicals. 

The agency will not provide such lists. As registrants are aware, these lists are difficult to 

define, may exclude effects that could be significant, and are likely to change over time. While 

occurrence of a delayed effect may be extremely unlikely, the registrant cannot absolutely rule 

out the possibility. It is probably less burdensome for registrants to simply submit the allegation 

of chronic or delayed effects to the agency. The Agency may reconsider this requirement in the 

future. It should be noted that these reports apply to humans only, are to be summarized 

quarterly, and reported in severity category H-E (symptoms unknown, unspecified or are alleged 

to be of a delayed or chronic nature that may appear in the future). 

Finally, while EPA does not require registrants to report evidence that known exposures 

have not resulted in symptoms, the Agency is interested in receiving this information because of 

its usefulness in establishing a No Observed Effect Level for the pesticide in humans and 

different species of animals. Additionally, the reporting of exposures which do not lead to 

adverse effects provides a measure of a product's safety. 

VII. EXPERT OPINION INFORMATION 

Conclusions or opinions of experts must be submitted under FIFRA 6(a)(2) if the 

registrant possesses the information and either I) the information is otherwise reportable under 

one of the substantive provisions of the rule; or 2) the registrant knows, or should reasonably 

know, that the information, alone or in conjunction with other information, might raise concerns 

about the continued registration of a pesticide or about the appropriate terms and conditions of 

registration of a pesticide. As a general matter, the Agency frequently relies on the "weight of 

evidence" in making pesticide regulatory decisions, and it considers expert opinion that tends to 

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Attachment to PR Notice 98-3 

confirm or validate otherwise reportable information. In this context, expert opinions can play 

an important role in Agency decision-making. 

Examples of reportable expert opinions include, but are not limited to: investigator 

opinions concluding that exposure to a pesticide may have caused a particular adverse effect; 

scientific opinions that test data demonstrate that a pesticide causes a particular adverse effect; 

expert conclusions that a pesticide is likely to migrate into groundwater; expert opinions that a 

pesticide shares a common mechanism of toxicity with another chemical (an issue relevant to 

food tolerances under section 408 of the FFDCA as amended in 1996 by the Food Quality 

Protection Act); expert opinions reflecting that the aggregate risks posed by a pesticide may be 

higher than previously believed (another issue addressed in section 408 of the FFDCA as 

amended by the Food Quality Protection Act); expert opinions related to increased resistance to 

a particular pesticide; etc. In any particular case, if a registrant has questions concerning 

whether the Agency considers an expert opinion reportable under section 6(a)(2), the registrant 

is encouraged to either submit the opinion or contact the 6(a)(2) Officer in the Office of 

Pesticide Programs. 

VIII. EXPOSURE TYPE AND SEVERITY CATEGORIES 

The 6(a)(2) regulations define the severity categories assigned to each incident. In an 

effort to provide additional guidance on the assignment of severity categories, the Agency has 

expanded the definitions for humans and domestic animals. The severity category definitions for 

humans were derived from standard definitions used by the American Association of Poison 

· Control Centers. The examples of severity categories for domestic animals were prepared in 

consultation with the National Animal Poison Control Center/American Society for Prevention 

of Cruelty to Animals. 

In cases where multiple symptoms occur in an individual that result from an exposure 

incident, the most severe symptom should determine the severity category. For example, if an 

animal has repeated grand mal seizures, vomiting, diarrhea and salivation, the "major" category 

(D-B) should be used, since seizures are the most severe symptom. 

The persistance of symptoms or the development of delayed symptoms should be 

considered when classifying severity. For example, human cases may report developing 

common symptoms like headaches, general weakness, memory and concentration problems, 

depression, irritability, muscular aches and pains, or shortness ofbreath. If these symptoms last 

for just a few days and are minimally troublesome (do not require treatment) then they would be 

classified as minor (H-D). However, if symptoms persist for one month or longer they would be 

classified as moderate (H-C). Symptoms persisting for two or more months that significantly 

alter daily activities would be classified as major (H-B). 

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Attachment to PR Notice 98-3 

If exposure to the pesticide is reported to lead to the development of unusual sensitivity 

to pesticides, other chemicals, or to odors (sometimes alleged as hypersensitivity or multiple 

chemical sensitivity), efforts should be made to collect information about specific symptoms 

such as headaches or shortness of breath. If symptoms persist for two or more months, and 

significantly alter daily activities then such a case would be classified as major. If symptoms 

persist for less than two months, the incident would be classified according to the appropriate 

definition. 

H-A - Human Death 

§159.814 (5)(i)(A): "Ifthe person died." 

It is reported that the person died as a result of exposure or as a direct complication of 

exposure to the pesticide. 

H-B - Human -Major 

§159.184 (5)(i)(B): "Iftheperson alleged or exhibited symptoms which may have been lifethreatening. or resulted in adverse reproductive effects or in residual disability." 

Life-threatening effects include, but are not limited to, intracranial hemorrhage, repeated 

seizures, grand mal seizures, coma, clinical evidence of renal failure, respiratory depression or 

bronchoconstriction requiring immediate treatment, cardiovascular instability, cardiac arrest, 

respiratory arrest, or patients who require mechanical ventilation. In general, life threatening 

effects are any condition which ifuntreated would likely lead to death. 

Adverse reproductive effects include, but are not limited to, premature or low weight 

birth, spontaneous abortion, miscarriage, or stillbirth; birth defects, including mental retardation; 

and infertility in men or women. 

Residual disability is any adverse effect which lasts for months or years after the initial 

poisoning and limits a major activity, e.g., require continuous health care, time off work, or 

modification of daily activities. Examples include delayed neuropathy, renal damage requiring 

dialysis, permanent change in vision, development of chronic respiratory disease such as asthma. 

H-C - Human Moderate 

159.184 (5)(i)(C): "If the person alleged or exhibited symptoms more pronounced. more 

prolonged. or of a more systemic nature than minor symptoms. Usually some form oftreatment 

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Attachment to PR Notice 98-3 

of the person would have been indicated. Symptoms were not life threatening and the person 

has returned to his/her pre-exposure state of health with no additonal residual disability." 

Effects include, but are not limited to, a corneal abrasion, blurred vision with pinpoint 

pupils, high fever, disorientation (confusion, hallucinations), isolated brief seizures, profuse 

sweating, drooling, gastro-intestinal symptoms leading to dehydration, caustic injury to mouth 

or esophagus, severe muscle weakness, incoordination, tremor, or hives. More prolonged 

effects are those that last one month or longer, such as a persistent skin rash. 

H-D - Human Minor 

159.184 (5)(i)(D): "If the person alleged or exhibited some symptoms. but they were minimally 

traumatic. The symptoms resolved rapidly and usually involved skin. eye. or respiratory 

irritation." 

Effects include, but are not limited to, skin rash, itching, conjunctivitis (red, tearing 

eyes), drowsiness, transient cough, headache, joint pain, agitation, restlessness, or mild gastrointestinal symptoms such as self-limited diarrhea, stomach cramps, or nausea. These effects are 

reported to have lasted less than one month. 

H-E - Symptoms Unknown, Unspecified or May Appear in Future 

159.184 (5)(i)(E): "If symptoms are unknown. unspecified or are alleged to be of a delayed or 

chronic nature that may appear in the future." 

A person reporting an incident to a registrant may report exposure and allege an adverse 

effect. Specific symptoms, however, may be unknown or unspecified. If exposure is reported, 

no acute adverse effect is alleged, but the reporter informs the registrant they may suffer delayed 

or chronic effects, the incident is reportable as H-E. 

Although not required by the regulation, the agency would be interested in documented 

cases of measured exposure that do not result in symptoms. If a documented exposure occurred 

and, based on other available evidence, was likely to lead to an adverse effect, then a report 

would be filed under this category. This category can be used for reporting evidence that known 

exposures have not resulted in symptoms. This information is useful in establishing a No 

Observed Effect Level for the pesticide. Additionally, the reporting of exposures which do not 

lead to adverse effects provides a measure of a product's safety. 

The category could be used when a major contamination has occurred that could 

foreseeably lead to an adverse effect. An example is the application inside a home of a highly 

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Attachment to PR Notice 98-3 

toxic organophosphate such as methyl parathion. It would be useful to report such incidents to 

the Agency to ensure that proper enforcement action is taken to prevent mis-use in the future. 

D-A -Domestic Animal Death 

159.184 (5)(ii)(A): "If the domestic animal died or was euthanized." 

It was reported that the animal died or was euthanized as a result of exposure or as a 

direct complication of exposure to the pesticide. 

D-B - Domestic Animal Major 

§ 159.184 (5)(ii)(B): "If the domestic animal exhibited or was alleged to have exhibited 

symptoms which may have been life-threatening or resulted in residual disability." 

Life-threatening effects include, but are not limited to, massive or internal hemorrhage, 

loss of consciousness, grand mal seizures, paralysis, cardio-respiratory depression and 

bronchoconstriction requiring immediate treatment. In general, life-threatening effects are any 

condition which, if untreated, would likely lead to death. Residual disability includes adverse 

effects which last for an extended period of time after the initial poisoning and may affect the 

life span for the animal. An example of an adverse effect which may last for an extended period 

of time is the case of a cat that developed severe weakness lasting for weeks to months after 

organophosphate exposure. An example of a residual disability that may affect the life span of 

an animal is the case of a dog which recovered from cholecalciferol rodenticide ingestion but is 

left with decreased renal function. 

D-C - Domestic Animal Moderate 

§ 159.184 (5){ii)(C): "If the domestic animal exhibited or was alleged to have exhibited 

symptoms which are more pronounced. more prolonged or a more systemic nature than minor 

symptoms. Usually some form of treatment would have been indicated to treat the animal. 

Symptoms were not life-threatening and the animal has returned to its pre-exposure state of 

health with no additional residual disability." 

Effects include, but are not limited to, corneal abrasion, difficulty breathing, 

hyperthermia, isolated focal seizures, gastrointestinal symptoms leading to dehydration, caustic 

injury to mouth or esophagus, severe muscle weakness, incoordination, tremors and hives. More 

prolonged effects are those that last one month or longer, such as a persistent skin rash. 

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Attachment to PR Notice 98-3 

D-D - Domestic Animal Minor 

§159.184 (5)Cii)CD): "Ifthe domestic animal was alleged to have exhibited symptoms. but they 

were minimally bothersome. The symptoms resolved rapidly and usually involved skin. eye or 

respiratory irritation." 

Effects include, but are not limited to, excessive salivation, skin rash, itching, 

conjunctivitis, lethargy, transient cough, mild gastrointestinal symptoms of a short duration and 

minor behavioral changes such as agitation and hyperactivity. 

D-E- Symptoms Unknown, Unspecified or May Appear in Future 

§ 159.184 (5)(ii)(E): "If symptoms are unknown or not specified." 

If a documented exposure occurred and, based on other available evidence, was likely to 

lead to an adverse effect, then a report would be filed under this category. This category can be 

used for reporting evidence that known exposures have not resulted in symptoms. This 

information is useful in establishing a No Observed Effect Level for the pesticide in different 

species of animals. Additionally, the reporting of exposures which do not lead to adverse effects 

provides a measure of a product's safety. 

IX. EXTRATERRITORIAL ADVERSE EFFECT INFORMATION 

Information derived from studies or incidents occurring outside the United States is 

reportable if the information is relevant to a pesticide registration held by the registrant 

possessing the information and if the information is otherwise reportable under section 6(a)(2). 

In any particular case, the reportability of a study or incident may be affected by the differences, 

if any, between the formulation of product involved in the foreign information and the 

formulation of products registered in the United States, as well as other study or incident 

conditions which may or may not be relevant to conditions in the United States (soil type, crop 

sites, directions and conditions of use). All submissions to EPA must be in English; untranslated 

foreign language documents will not be accepted. 

Until the Agency gains greater experience in determining what otherwise reportable 

information associated with studies or incidents occurring outside the United States is not helpful 

in making regulatory decisions concerning pesticides registered in this country, the Agency will 

consider all such information to be reportable unless an expert concludes that differences 

between the formulation of product involved in the foreign information and product registered in 

the United States make the information irrelevant to the product registered in the United States. 

In any particular case, a registrant can inquire from the 6(a)(2) Officer whether particular 

information should be reported. After the Agency has gained more experience evaluating 

information associated with foreign studies or incidents, the Agency may revise this guidance. 

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Attachment to PR Notice 98-3 

X. INFORMATION INVOLVING CHEMICALS SIMILAR TO REGISTERED 

CHEMICALS 

Information involving a chemical different from any contained in a registrant's registered 

pesticides is nonetheless reportable by that registrant if the registrant knows or should know that 

the information is relevant to the registered pesticide and is otherwise reportable under section 

6(a)(2). Examples of types of information that a registrant should know are relevant to its 

registered product include, but are not limited to, a study of a chemical in the same class as the 

registered pesticide where the study suggests (or the registrant knows that an expert concludes) 

that it applies to all chemicals in the class; certain toxicity information relating to a chemical 

which the Agency or an expert has concluded shares a common mechanism of toxicity with the 

registrant's registered pesticide; etc. In any particular case, the determining factor is likely to be 

the nature of the information available to the registrant suggesting that the otherwise reportable 

information is relevant to the registrant's registered product. 

XI. IMPLEMENTING RULE BEFORE THE EFFECTIVE DATE 

Although the regulations were published in the Federal Register on September 19, 1997, 

they do not become effective until June 16, 1998. Some registrants may wish to implement 

some or all of the rule before its effective date. Registrants should contact the Agency in writing 

and specify the portions of the rule they would like to implement before the effective date. Such 

a request should not be considered granted unless and until granted in writing by a responsible 

Agency official. As a general matter, the Agency expects to be in a position to grant such 

requests expeditiously and certainly does not want to discourage any registrant from 

implementing the new rule before its effective date. 

XII. MINIMUM INFORMATION REPORT ABLE 

The regulations specify minimum information that must be available in order to make the 

incident reportable. Those information elements are: an exposure may have occurred; an 

adverse effect has occurred or a delayed or chronic adverse effect may occur in the future; the 

pesticide can be identified (product name, product registration number, or active ingredient); the 

location where the incident occurred; and a person to contact for more information about the 

incident. It should be noted that reportable information may arise from newspaper articles. 

Identification of the pesticide is critical to the Agency's ability to take regulatory action 

to address risk. If the person reporting an incident does not provide sufficient information for 

the registrant to be able either to identify the product involved by name and/or registration 

number, or to identify the active ingredient used in the product, the incident is not reportable. 

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Attachment to PR Notice 98-3 

It should be noted that an active ingredient can be identified even though a specific 

product can not be identified. The active ingredient can be identified through analyzing water or 

an animal carcass, or through the general knowledge of the user. For example, someone may 

report that he knows he put diazinon on the lawn, but threw away the packaging so he cannot 

report the name of the product. 

In other cases, the person reporting the incident to the registrant reports the name of a 

product, but does not know the product registration number. Often, the registrant can determine 

the product in question because the registrant sells only one product by that name. Alternatively, 

the registrant can at least identify the active ingredient because all products using that name 

contain the same active ingredient. In other cases, however, the reported product 'name' is so 

general that a specific product or active ingredient cannot be identified. For example, the 

reporter says he used an Ortho product in the garden and experienced nausea and dizziness. The 

Ortho product line includes many different products containing many different active 

ingredients. In this example, the incident would not be reportable. 

XIII. PLANT DAMAGE INCIDENT EXEMPTIONS 

The regulations exempt registrants from reporting certain incidents of plant damage and 

registrants have asked EPA to clarify those exemptions. These exemptions are related to 

pesticide product labels, which can include warnings of possible damage to plants related to use. 

The warning may apply to the treated crop as well as non-target plants. 

The label may warn that the treated crop could be damaged if the product is not used 

according to the label instructions. The misdirected application of a broad-spectrum herbicide 

such as glyphosate or paraquat can result in damage to the treated crop. For example, an apple 

orchard may be sprayed to control weeds beneath the trees. If the spray is misdirected and is 

taken up by the apple trees, the pesticide can cause damage, such as reduced yield. Since the 

label warns of that risk, however, that incident would not be reportable. The regulations exempt 

reporting of non-lethal damage to the treated crop if the label warns of that effect. However, if 

non-lethal damage to the treated crop occurs and there is no label warning, that incident would 

be reportable. It may indicate the need to require an additional label warning. If there is lethal 

damage to the treated crop-- with or without a label warning-- the incident is reportable. 

Labels may also warn of the possibility of damage to non-target plants at the use site. 

For example, 2,4-D may be applied to wheat, but in addition to killing the weeds (pests) listed 

on the label, it kills volunteer com or sorghum present in the wheat field. Com and sorghum are 

neither the listed pests nor the treated crop. But if the label warns of this possibility, the incident 

is not reportable. 

If, however, a pesticide moves by way of primary drift, secondary surface runoff, or 

secondary aerial movement from the treatment site to untreated areas and plant injury occurs, the 

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Attachment to PR Notice 98-3 

plant injury is reportable to the Agency. Primary spray drift is the off-target movement of 

pesticide spray from the treatment site to untreated areas at the time of pesticide application. 

Secondary surface runoff is pesticide movement in surface water or sediment from the treatment 

site to untreated sites days, weeks, or months after the initial pesticide application. Secondary 

aerial movement is the off-target movement of a pesticide via volatilization, co-distillation, 

evapo-transpiration, and/or wind blown soil particles from the treatment site days, week, or 

months after the initial pesticide application. Some environmental and climatic factors that may 

affect pesticide movement off-target include wind, temperature and temperature inversions, 

humidity, and irrigation/rainfall patterns, in addition to soil-related factors such as soil type, soil 

slope, and soil conservation. These variable conditions cannot be fully anticipated at the time of 

registration. Examples of reportable incidents may be injury to crops that are irrigated with 

groundwater that is contaminated with a persistent herbicide or injury to plants following a 

rainfall. Receiving incident reports of plant damage is essential to refining use directions in 

order to prevent damage in the future. 

XIV. PREVIOUSLY-SUBMITTED INFORMATION 

If a registrant knows that adverse effects information concerning their registered product 

has already been submitted to the Agency by another party in a timely manner, it does not have 

to report the information. The burden is on the registrant, however, to ensure that the 

information was, indeed, submitted by another party. 

A related issue is the submission of additional information about a specific 6(a)(2) 

submission provided to the Agency at an earlier time. Registrants are obligated to submit 

additional information as a follow-up to previously submitted data or incident reports. In the 

case of incident reports, the following types of information should be submitted: 

• any of the required information specified in the regulations about a human death; 

• the identification of the pesticide, circumstance information, or a laboratory report for 

major human incidents (H-B) or fatalities of wildlife (W-A) (Note: Since fatalities of 

domestic animals are aggregated and reported statistically, the registrant may hold the 

additional information until the Agency requests it be submitted.); 

• any information that would result in re-categorizing the incident into any of the 

following: human death (H-A), human major (H-B), domestic animal death (D-A) or the 

"A" level (the most serious category) for any other exposure or incident type (fish or 

wildlife, plants, water contamination, or property damage). 

This additional information should be provided by the registrant making the initial report 

if that registrant obtains the information. If another party made the initial submission, but a 

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Attachment to PR Notice 98-3 

registrant obtains the additional information about their product, the registrant is obligated to 

submit the information to the agency. 

XV. REPORTABLE INJURIES AND PROPERTY DAMAGE 

Some incidents appear to be unrelated to the pesticidal characteristics of the product. For 

example, an incident in which someone's leg is broken as a result of a pesticide container falling 

off a forklift would not be reportable. On the other hand, if a pesticide container explodes, 

lacerates someone's face, but no poisoning symptoms occur, the incident would be reportable. 

The adverse effect was due to factors related to the chemistry or characteristics of the pesticide 

product. Odor complaints need not be reported if the only complaint is the offensive nature of 

the odor. On the other hand, if someone reports that a product has a bad odor and that the odor 

made the person nauseous and gave them a headache, the incident is reportable. The registrant 

cannot be sure that the nausea and headache are not poisoning effects. 

Regarding property damage, §159.184(a) does limit reporting of incidents to situations in 

which a person or non target organism suffered a toxic or adverse effect or may suffer a delayed 

or chronic adverse effect in the future. The Agency takes the position, however, that an incident 

that results in property damage that could have caused direct human injury, such as fire or 

explosion, or an incident that requires substantial clean-up or renders a structure uninhabitable, 

would be reportable under §159.195. Under §159.195, information is reportable if it raises 

concerns about the continued registration of a product or about the appropriate terms and 

conditions of registration of a product. For example, an acutely toxic pesticide is stored in a 

house and the product leaks from the container as a result of faulty packaging. The house is so 

contaminated with the pesticide that the people living in the house are evacuated and the 

property is condemned. That incident would be reportable under § 159.195. 

XVI. RESPONSIBILITIES OF NON-PESTICIDE DIVISION EMPLOYEES 

The definition of "registrant" provides a two part test for excluding an employee of a 

registrant from an obligation to report adverse effects information. An employee who is not 

expected to perform any activities related to the development, testing, sale, or registration of a 

pesticide (as defined in the rule) and who could not reasonably be expected to come into 

possession of information that is otherwise reportable is not obligated to report that information. 

Conversely, persons who could reasonably be expected to come into possession of information 

on the toxicity of chemicals, even if they work outside the area of pesticides, should be informed 

of their obligation to report the information under FIFRA 6(a)(2), as well as their obligation to 

report information under section 8(e) of the Toxic Substances Control Act (TSCA) as described 

in Part 2 of the March 16, 1978 Policy Statement ( 43 FR 11111 ). 

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Attachment to PR Notice 98-3 

XVII. SUBMISSION DUE DATE 

§ 159.156 of the rule specifies the time frames for submitting reportable information. 

The rule provides that the submission may either be mailed by certified or registered mail, be 

delivered in person or by courier service, or delivered by such other methods as the Agency 

deems appropriate. Registrants should note that the EPA Office of Pesticide Programs considers 

the date a document is pin-punched as the official document receipt date. In the case of a 

document delivered to OPP by courier, the pin-punch date is the same date the document was 

received in EPA. However, in the case of a document delivered by the U.S. Postal Service by 

certified or registered mail, there is usually a time lag of at least two working days between the 

date the a submission is received in the general EPA mail center and the date it is delivered to 

OPP and pin-punched. Therefore, registrants should take this time lag into account, in addition 

to the USPS delivery lag time, when opting to send 6(a)(2) reporting documents via the U.S. 

Postal Service so that the document can be pin-punched by OPP within specified reporting 

timeframes. It should be noted that certified mail green cards or registered or certified mail 

receipt logs indicate only that a package from some party was received -- it is not proof of the 

contents ofthe package. The best documentation ofreceipt of6(a)(2) submissions is the pinpunched document itself. 

XVIII. TECHNICAL CORRECTIONS TO THE REGULATIONS 

The Agency plans to publish technical corrections to the regulations in the Federal 

Register. The corrections will address errors in the regulations published on September 19, 

1997. As such they are not subject to notice and comment. The corrections will be of four 

types: 

A) Reporting Time Frame Corrections 

Most of the corrections ensure that time frames for submitting all types of adverse effects 

information are clearly established. In the Proposed Rule the time frame for reporting all 

information was 30 days. In response to comments the Agency decided to allow for different 

reporting schedules for different types of information. As a result, however, the final regulations 

erroneously failed to establish time frames for the submission of certain types of information. 

The time frame technical corrections will specify that: 

• The following types of information must be received by EPA no later than the 30th 

calendar day after the registrant first possesses or knows of the information: pesticides in 

food or feed above the tolerance level or if no tolerance has been established; pesticides 

in water above the MCL or HAL; metabolites, degradates, contaminants, and impurities; 

efficacy failure studies for public health products; substantiated incidents of pest 

resistance; and other information described in §159.195. 

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Attachment to PR Notice 98-3 

• Incidents of efficacy failure of public health products may be accumulated for 1 month 

and submitted by the end of the month following the accumulation period. 

In the discussion of§ 159.178- Information about Pesticides in Food, Feed or Water, the 

preamble to the final regulations states that information about detections of pesticides in water 

below the MCL or HAL but otherwise reportable must be aggregated into quarterly statistical 

summaries as described in §159.184(d)(3) and (e). Corrections will be made to the regulations 

to specify that detections of pesticides in water described in§ 159.178(b) below the MCL or 

HAL, but otherwise reportable may be accumulated for 3 months and submitted by the end of 

the second month following the accumulation period. 

B) Required Information about Pesticide Detections in Food, Feed or Water 

Other technical corrections ensure that useful information is submitted to the Agency. 

Although these information items are implied, the technical corrections will specify that: 

• Required information about detections of pesticides in food, feed, or water described in 

§ 159.178 will be that specified in the list of reportable information required for incidents 

(§159.184(c))- administrative, pesticide, circumstance, and appropriate incident specific 

information. For detections in food or feed, the appropriate incident specific information 

would be sample type, sampling times/frequency, pesticides analyzed for, amount found, 

detection limits, and method of analysis. For detections of pesticides in surface water, 

the required information would be the incident-specific list for surface water 

(§ 159.184(c)( 4)(iv)). For detections of pesticides in ground water, the required 

information would be the incident specific list for ground water ( § 159 .184( c)( 4 )( v) ). 

• Required information about detections of pesticides in food, feed, or water will include 

the amount of pesticide detected. This will be added to §159.184(c)(4)(iv) and (v). 

C) Corrections of Typographical and Cross Referencing Errors 

Other technical·corrections to the regulations will include corrections of typographical 

errors and minor cross referencing errors. 

D) Definition of Registrant 

The definition of registrant in § 159.153 will be changed to comport with the statutory 

definition of registrant. Other language in the current definition will be moved to 159.155(b). 

XIX. VOLUNTARY INCIDENT REPORTING FORMS 

As a service to its members, the Chemical Producers and Distributors Association 

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Attachment to PR Notice 98-3 

(CPDA) has formed a work group to design standardized forms for capturing and submitting 

individual incident reports and aggregate reports. OPP staff are participating in this effort. The 

individual incident form is designed to capture the basic information about the incident in order 

to determine if it is reportable (exposure, adverse effect, contact person, pesticide identification, 

and where it occurred). In addition, it will foster the process by which registrants categorize 

each incident by exposure type and severity category and determine how much information is to 

be reported and when to submit the reports. An aggregate report format is also being designed. 

Detailed instructions accompany both forms. This will support aggregate reporting of 

appropriate categories of exposure types and severity as specified in the regulations. Use of the 

form will be voluntary. The form will be distributed to interested parties by CPDA. 

The Agency is committed to electronic submission of incident reports but not at the 

present time. Both the regulated community and the Agency need to gain experience in 

implementation of the new regulations and meeting the data management challenges they 

present. For example, the voluntary form may well need fine-tuning over time. In addition, 

OPP is working on other electronic submission efforts to gain valuable experience that can be 

applied to electronic reporting of incidents, as well as other types of information. OPP will 

work closely with registrants before embarking on electronic submission efforts. 

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