## 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.pd0April 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 ofPesticides 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) ofthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which requires pesticide registrants to report information concerning unreasonable adverse effects oftheirproducts to EPA (62 FR49370). The purpose ofthe 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 byEPA as violations ofFIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). In comparisonto previous EPA policy statements, some reporting requirements have been expanded, and others reflect increased flexibility or exemptions for reporting specific types ofinformation. 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 ofthe rule's effective date to prepare them for implementing the new FIFRA 6(a)(2) regulations smoothly and effectively. II. PURPOSE The purpose ofthis PRnotice is to announce the availability ofthe attached document which will provide registrants comprehensive guidance on implementating the new regulations. The Agency has addressed in depth questions and issues raisedbyregistrants and otherparties subsequentto the publication ofthe final rule. The guidance in this document has been organized alphabetically by subject area, and a table ofcontents has beenprovided for ease of reference.

### III. FOR FURTHER INFORMATION Registrants may contact Kathryn Bouve for information orquestions concerning this PR notice and attached guidance document at: Office ofPesticide 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 ofPesticide Programs Environmental Protection AgencyAttachment to PR Notice 98-3



### Attachmentto PRNotice 98-3



### Guidance on FinalFIFRA 6(a)(2) Regulations for Pesticide ProductRegistrants April 3, 1998



# I&EPAI

EnvironmentalProtection Agency Office ofPesticide ProgramsAttachment 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 AttorneyWork-Product Privileges-- Waiver Requests........ 6 V. Authorization to Waive orModify 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 Similarto 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.................................................................... 19Attachment to PR Notice 98-3 I. 

### INTRODUCTION On September 19, 1997, EPApublished in the Federal Register the final rule codifying EPA's interpretation and enforcement policyregarding section 6(a)(2) ofthe Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which requires pesticideregistrants to report information concerning unreasonable adverse effects oftheirproducts 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, ordelays in reporting, will beregarded 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 EPApolicy statements, somereporting requirements havebeen expanded, and others reflect increased flexibility orexemptions 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 ofthe rule's effective date to prepare them for implementing the new FIFRA 6(a)(2) regulations smoothly and effectively. The purpose ofthis document is to provide registrants comprehensive guidance on implementing the new regulations. The Agency has addressed in depth questions and issues raised byregistrants and otherparties subsequent to the publication ofthe final rule. The guidance in this document has beenorganized alphabetically by subject area, and a table ofcontents has beenprovided for ease ofreference. Forfurther information, contact Kate Bouve, Office ofPesticide 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 ofregistrant agents inthe regulatory program. Whether a person canbe considered an agent ofa registrant in a given set of circumstances will depend heavily upon the specific facts ofthat setofcircumstances. Forthe purposes ofsection 6(a)(2), EPA will generally look to the nature oftherelationship between the "agent" and the registrant. Facts that will weigh in the determination ofwhether someone is acting as an agent will include whetherthe activity conducted is being conducted for the benefit ofthe registrant; whetherthe registrant is paying (directly orindirectly) for the activity; whether the registrant has requested that the activitybe conducted; the nature ofthe contractual or financial relationship betweenthe registrant and the person; etc. While the Agency will be guided to some extentby common law principles ofagency in determining whether a person is acting as an agent for a registrant, EPA wants to make quite clear that ifan "independent contractor" is doing pesticide-related work for, and at the behest of, a pesticide registrant, theAttachment to PR Notice 98-3 Agency considers the independent contractor an "agent" for purposes ofsection 6(a)(2) reporting. The question ofwhether a retailer orwholesaler is an agent in anyparticular situation will also depend upon all the specific facts ofthe situation. As noted in the Preamble to the Final Rule (62 Federal Register at 49374), a distributor (retailer orwholesaler) that sells a wide variety ofpesticide products produced bymany different registrants would generally notbe considered an agent ofa registrant. Onthe otherhand, a distributorthat exclusively (ornearly exclusively) distributes or sells a particular registrant's products would generally be considered an agent ofa registrant. TheAgency may, however, consider additional factors, including whether the distributorhas done anything (made statements, published advertisements, etc.) to lead users to believe that the distributor is acting for the registrant orwould 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 beused to determine whether a distributor is acting as an agent ofa registrant. Information that comes into the possession ofan agent while the agent is acting for oron behalfofa registrant will bepresumed to be possessedbythe registrant for purposes ofsection 6(a)(2) ifeitherthe agent is expected to perform duties relatedto the development, testing, sale, orregistration ofa pesticide, orthe agent couldbe reasonably expected to come into possession ofotherwisereportable information. Examples ofagents that couldbe reasonably expected to come into possession ofotherwise 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 behalfofa registrant; investigative personnel, such as claims adjustors, field investigators, orlaboratories acting either directly on behalfofa registrant oron behalfofa company orlaw firm acting for the registrant; etc. Because the registrant is deemed to possess information when certain ofits agents possess the information, the registrant maybe held liable for failure to submitreportable information in the possession ofthe agent, whether or not the information is reported to the registrant bythe agent. Supplemental distributors as defined in 40 CFR section 152.132 will be subject to enforcement action ifreportable information intheirpossession is not submitted to the Agency in a timely manner. Section 152.132 makes clearthat both supplemental distributors and registrants are liable for violations pertaining to the distributorproduct. The supplemental distributor accepts this responsibility when agreeing to become a supplemental distributorunder that regulation. Ifa supplemental distributorhas reportable information concerning the distributorproduct and that information is notprovided to the Agency in a timely manner (as specified for the particular type ofinformation 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 2Attachment to PR Notice 98-3 that all reportable information be submitted by the underlying registrant ratherthan bynumerous supplemental distributors acting for that registrant. Therefore, EPA requests that supplemental distributors deliverreportable information to the underlying registrants (in sufficient time for registrants to report) and not to EPA; the Agency stronglyprefers receiving reportable information from registrants themselves rather than from their supplemental distributors. This also makes sense from the perspective ofgood product stewardship, since registrants would presumably want to be aware ofadverse effects associated with products distributed by others. Notethat 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 ofincidentreports 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. 1Month Accum. 3 Months Days Submit 1Month 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 orAI 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.orcommon incidents as defined in the regulations as an aggregate count ofincidents and effects for each product. The Agency will reject submissions ofminor/common incidents ifthe summaries are not provided. This is necessary because the Agency expects the volume ofincident reporting to increase afterthe final regulations become effective. To cope with this increase and maintain focus onthe most



### 3Attachmentto 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 ofthe data helps EPA identify patterns ofconcernregarding products or active ingredients. Itis assumed that this approach benefits the registrant, as well. Some registrants have expressed concern regarding the reliability ofincident reports and the degree to which the Agency would be influenced by aggregate summaries. It shouldbe noted that staffmembers in EPA's Office ofPesticide Programs (OPP) have many years of experienceprocessing and analyzing incident data, and are well aware ofthe vagaries ofincident reports, such as the frequent lack ofspecific details, uncertainties ofcausality, the sometimes erroneous assumptions ofreporters, etc. The Agency is also aware that large numbers of incidentreports may simplyreflect a large product sales volume orthe existence oftoll-free 800 numbers onproduct labels, making incident reporting easier. OPP staffmembers are also aware that the Agency may receive multiple reports ofthe same incident from various sources, which may inflate the number ofincident reports for a particularproduct orchemical. 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 whenreviewing aggregate data to determine ifthe incident reports presentpatterns ofconcern. Furthermore, EPA makes this clearin its responses to people who request incident data in orderthat they not draw inappropriate conclusions from the data. An overview ofthe incident data simply identifies where there might beproblems and serves as the first step in a process ofgathering more information about the products or chemicals. Ifthe aggregate report appears to indicate a problem, the product managers - current orformer

- are consulted on theirknowledge ofthe 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 ofthe incidents. As a consequence, the registrant may need to develop additional data on the issue ornegotiate risk reduction measures, ifappropriate. 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 onhow to aggregate minor and common incident reports. Generally, two facts are reported: the number ofincidents and the number of

4Attachment to PR Notice 98-3 adverse effects that occurred as the result ofthe incidents. What follows is guidance on how to count incidents and effects, and present them to the Agency. The examples are hypothetical.

Reg No/ Numberoflncidents and Adverse Effects Reported by Exposure Type and SeverityCategory 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 ofeffects may exceed the total number ofincidents. That is demonstrated in the chart above. Ifa single incident affects multiple individuals in one exposure type and severity category, it is reported as one effect for that exposure type/severity combination. Forexample, ifone incident results in the death of5 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 ofexposure type and severity category. For example, ifone incident results in the death of2 domestic animals, major effects in 10 domestic animals, and minor effects to 2 humans, it counts as 1in D-A, 1in D-B, and 1 in H-D. Ifone 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. Ifa single incident results in majoreffects in one human, the death ofone 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 1in D-C.

5Attachment 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, onpage 18 ofthis document, for a discussion ofproposed technical corrections. 

### IV. ATTORNEY-CLIENT AND ATTORNEY WORK-PRODUCT PRIVILEGES-- WAIVER REQUESTS Some registrants requested clarification ofthe Agency's position on exempting from reporting requirements of6(a)(2) material coveredbythe attorney-client and attorney workproductprivileges. The Preamble to the Final Rule (62 Fed. Reg. at 49377) states that, "The Agencyhas no intention to broadly exempt information coveredbythe attorney work-product doctrine." However, the Preamble also states that the Agency will consider granting a waiver request where it can be shownthat: 1) the information is entitledto some privilege; 2) that providing the information to the Agency would substantiallyprejudice a registrant; and 3) that the information would not beparticularly helpful to an analysis ofa product's registration status. TheAgency expects that it will likelybe in a betterposition to amplify these criteria when and if it has considered some actual requests for waivers. Any request will be considered in the context oftheparticular facts involved. A registrant requesting a waiver should address all three ofthe criteria identified in the Preamble. Itis likely that the third criterion will be particularly important to the Agency's deliberations. It is unlikelythat the Agency will grant a waiverrequest unless the Agency knows, in some detail, what information is coveredbythe request and has determined that the information would notbe particularlyhelpful 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 waiverrequests must be addressed to the 6(a)(2) Officerin the Office ofPesticide Programs. Unless the Agency states otherwise in the future, a registrant mayrely on any written grant ofa waiver request signedbythe 6(a)(2) Officer or any attorney in the Office ofGeneral Counsel. 

### V. AUTHORIZATION TO WAIVE ORMODIFY REPORTING REQUIREMENTS As in the case ofwaivers concerning attorney-client or attorney workproductprivilege,

6Attachment to PR Notice 98-3 requests for waivers ormodifications ofreporting requirements must be addressed to the 6(a)(2) Officer. Unless the Agency states otherwise in the future, a registrant mayrely on any written grant ofa waiverrequest signed bythe 6(a)(2) Officeror any attorney in the Office ofGeneral Counsel. 

### VI. CAUSATION AND DELAYED EFFECTS One ofthe key differences betweenthe regulations and earlierguidance (the 1979 Enforcement Policy) concerns the issue ofcausation: In the past, an incident was reportable if theregistrant inferred that a link existed between the effect and exposure or ifsimilar incidents occurred three ormore times. Underthe new regulations, neither an inference nor a pattern needs to be establishedbefore reporting an incident. Ifbasic information is available-- an effect, an exposure, the identity ofthe pesticide, location where the incident occurred and a person to contact

-- the incident is reportable. In general, underthe new regulations, the agency considers incident reports to be simply allegations ofadverse effects causedby 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. Onthe otherhand, many otherreports do not include enough facts to clearly demonstrate causation andregistrants are not requiredunder FIFRA 6(a)(2) to investigate the incident to gather additional information. Submission ofan incident report by a registrant is not considered to be an admission ofcausation. Even incidents in which the reported adverse effects are not consistent with animal testing are reportable. Forexample, ifan allegation is made that exposure to a particular chemical resulted inrespiratory system effects, and the registrant is aware, based on scientific data, that the chemical does not cause respiratory system effects, the allegationmust still be reported. Incident reports serve as a checkon animal and othertesting done in support ofthe registration application. Real world use ofthe product can cause adverse effects for a whole host ofreasons such as species differences, product stability changes, or synergistic effects from different inert ingredients. Please note that a registrant mayprovide information to interpret incident patterns, describe special circumstances such as misuse, orexplain whythe effect could not have been causedby exposure to thepesticide. This information will bereviewed 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 orwill not occur, orthat exposure to a pesticide did not occur. Such facts may involve errors bythe reporter. For example, a registrant maybe told that a container ofpesticide was dumped into a pond and all water fowl in and around the pond died. The reportermay laterreport that the containerheld gasoline, not a

7Attachment 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 illustratedbythe following example: A greenhouse worker claims he was sick and missed a day'swork after he was exposed to a pesticide. However, it was learned that the worker went to a baseball game and lied aboutbeing sick. This would not be reportable. Theprovision in the regulations thatrequires submission ofincident reports in which the person ornon-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 ofthis 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. Ithas 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 overtime. While occurrence ofa delayed effect maybe extremely unlikely, the registrant cannot absolutely rule outthe possibility. It is probably less burdensome for registrants to simply submit the allegation ofchronic or delayed effects to the agency. The Agency may reconsider this requirement in the future. It should benoted that these reports apply to humans only, are to be summarized quarterly, and reported in severity category H-E (symptoms unknown, unspecified orare alleged to be ofa delayed orchronic 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 thepesticide in humans and different species ofanimals. Additionally, the reporting ofexposures which do not lead to adverse effects provides a measure ofa product's safety. 

### VII. EXPERT OPINION INFORMATION Conclusions or opinions ofexperts mustbe submittedunderFIFRA 6(a)(2) ifthe registrant possesses the information and either I) the information is otherwise reportable under one ofthe substantive provisions ofthe rule; or2) the registrant knows, or should reasonably know, that the information, alone or in conjunction with other information, might raise concerns about the continued registration ofa pesticide orabout the appropriate terms and conditions of registration ofa pesticide. As a general matter, the Agency frequently relies on the "weight of evidence" in making pesticideregulatory decisions, and it considers expert opinion that tends to

8Attachment to PR Notice 98-3 confirm orvalidate otherwise reportable information. In this context, expert opinions canplay an important role in Agency decision-making. Examples ofreportable 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 oftoxicity with another chemical (an issue relevant to food tolerances under section 408 ofthe FFDCA as amended in 1996 by the Food Quality Protection Act); expert opinions reflecting that the aggregate risks posedby a pesticide may be higherthan previouslybelieved (another issue addressed in section 408 ofthe FFDCA as amendedby the Food Quality Protection Act); expert opinions related to increased resistance to a particularpesticide; etc. In any particularcase, ifa registranthas questions concerning whetherthe 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 ofseverity categories, the Agency has expanded the definitions for humans and domestic animals. The severity category definitions for humans were derived from standard definitions usedbythe AmericanAssociation ofPoison

·Control Centers. The examples ofseverity categories for domestic animals were prepared in consultation with the National Animal Poison Control Center/American Society for Prevention ofCruelty 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, ifan animal has repeated grand mal seizures, vomiting, diarrhea and salivation, the "major" category (D-B) shouldbe used, since seizures are the most severe symptom. Thepersistance ofsymptoms orthe development ofdelayed symptoms should be consideredwhen 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. Ifthese symptoms last forjust a few days and are minimally troublesome (do not require treatment) then they would be classified as minor (H-D). However, ifsymptoms persist for one month orlongerthey would be classified as moderate (H-C). Symptoms persisting for two or more months that significantly alter daily activities wouldbe classified as major (H-B).

9Attachment to PR Notice 98-3 Ifexposure to the pesticide is reported to leadto the development ofunusual sensitivity to pesticides, other chemicals, orto odors (sometimes alleged as hypersensitivity ormultiple chemical sensitivity), efforts shouldbe made to collect information about specific symptoms such as headaches or shortness ofbreath. Ifsymptoms persist for two ormore months, and significantly alterdaily activities then such a case would be classified as major. Ifsymptoms 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): "Iftheperson died." It is reported that the person died as a result ofexposure or as a direct complication of exposure to the pesticide. H-B

- Human -Major §159.184 (5)(i)(B): "Ifthepersonalleged orexhibited symptoms which mayhave been lifethreatening. orresulted in adverse reproductive effects orinresidual disability." Life-threatening effects include, but are not limited to, intracranial hemorrhage, repeated seizures, grand mal seizures, coma, clinical evidence ofrenal failure, respiratory depression or bronchoconstriction requiring immediate treatment, cardiovascular instability, cardiac arrest, respiratory arrest, orpatients who require mechanical ventilation. In general, life threatening effects are any condition which ifuntreatedwould likely leadto death. Adverse reproductive effects include, but are not limited to, premature orlow weight birth, spontaneous abortion, miscarriage, or stillbirth; birth defects, including mental retardation; and infertility in men orwomen. Residual disability is any adverse effect which lasts for months oryears after the initial poisoning and limits a major activity, e.g., require continuous health care, time offwork, or modification ofdaily activities. Examples include delayed neuropathy, renal damage requiring dialysis, permanent change in vision, development ofchronic respiratory disease such as asthma. H-C

- Human Moderate 159.184 (5)(i)(C): "Ifthe person alleged orexhibited symptoms more pronounced. more prolonged. orofa more systemic nature than minor symptoms. Usually some form oftreatment

10Attachment to PR Notice 98-3 ofthe person would have been indicated. Symptoms were not life threatening and the person has returned to his/herpre-exposure state ofhealth 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 briefseizures, profuse sweating, drooling, gastro-intestinal symptoms leading to dehydration, caustic injury to mouth or esophagus, severe muscle weakness, incoordination, tremor, orhives. More prolonged effects are those that last one month orlonger, such as a persistent skin rash. H-D

- Human Minor 159.184 (5)(i)(D): "Ifthe person alleged orexhibited some symptoms. butthey were minimally traumatic. The symptoms resolved rapidly and usually involved skin. eye. orrespiratory irritation." Effects include, but are not limited to, skin rash, itching, conjunctivitis (red, tearing eyes), drowsiness, transient cough, headache,jointpain, agitation, restlessness, ormild gastrointestinal symptoms such as self-limited diarrhea, stomach cramps, ornausea. These effects are reported to have lasted less than one month. H-E

- Symptoms Unknown, Unspecified orMayAppear in Future 159.184 (5)(i)(E): "Ifsymptoms are unknown. unspecified or are alleged to be ofa delayed or chronic nature that may appear in the future." A personreporting an incident to a registrant may report exposure and allege an adverse effect. Specific symptoms, however, may beunknown orunspecified. Ifexposure is reported, no acute adverse effect is alleged, butthe reporter informs the registrant they may suffer delayed orchronic effects, the incident is reportable as H-E. Although not requiredbythe regulation, the agency would be interested in documented cases ofmeasured exposure that do not result in symptoms. Ifa documented exposure occurred and, based on other available evidence, was likely to lead to an adverse effect, then a report would be filed underthis category. This category canbe 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 ofexposures which do not lead to adverse effects provides a measure ofa product's safety. The category couldbe used when a major contaminationhas occurred that could foreseeably lead to an adverse effect. An example is the application inside a home ofa highly

11Attachment to PR Notice 98-3 toxic organophosphate such as methyl parathion. Itwould 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 -DomesticAnimalDeath 159.184 (5)(ii)(A): "Ifthe domestic animal died or was euthanized." It was reported that the animal died or was euthanized as a result ofexposure oras a direct complication ofexposure to the pesticide. D-B

- DomesticAnimalMajor §159.184 (5)(ii)(B): "Ifthe domestic animal exhibited orwas alleged to have exhibited symptoms which may have been life-threatening orresulted in residual disability." Life-threatening effects include, but are not limited to, massive orinternal hemorrhage, loss ofconsciousness, grand mal seizures, paralysis, cardio-respiratory depression and bronchoconstriction requiring immediate treatment. In general, life-threatening effects are any condition which, ifuntreated, would likely lead to death. Residual disability includes adverse effects which last for an extended period oftime afterthe initial poisoning and may affect the life span for the animal. An example ofan adverse effect which may last for an extended period oftime is the case ofa cat that developed severe weakness lasting for weeks to months after organophosphate exposure. An example ofa residual disability that may affect the life span of an animal is the case ofa dog which recovered from cholecalciferolrodenticide ingestion but is left with decreased renal function. D-C

- DomesticAnimalModerate § 159.184 (5){ii)(C): "Ifthe domestic animal exhibited orwas alleged to have exhibited symptoms which are more pronounced. moreprolonged or a more systemic nature than minor symptoms. Usually some form oftreatment 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, difficultybreathing, 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 orlonger, such as a persistent skin rash.



### 12Attachment to PR Notice 98-3 D-D

- DomesticAnimalMinor §159.184 (5)Cii)CD): "Ifthe domestic animal was alleged to have exhibited symptoms. but they were minimallybothersome. The symptomsresolved rapidly and usually involved skin. eye or respiratory irritation." Effects include, but are not limited to, excessive salivation, skinrash, itching, conjunctivitis, lethargy, transient cough, mild gastrointestinal symptoms ofa short duration and minorbehavioral changes such as agitation and hyperactivity. D-E- Symptoms Unknown, UnspecifiedorMayAppear in Future §159.184 (5)(ii)(E): "Ifsymptoms are unknown ornot specified." Ifa documented exposure occurred and, based on other available evidence, was likely to lead to an adverse effect, then a report would be filed underthis category. This category canbe 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 ofanimals. Additionally, the reporting ofexposures which do not lead to adverse effects provides a measure ofa product's safety. 

### IX. EXTRATERRITORIAL ADVERSE EFFECT INFORMATION Information derived from studies orincidents occurring outside the United States is reportable ifthe information is relevant to a pesticide registration heldbythe registrant possessing the information and ifthe information is otherwise reportable under section 6(a)(2). In any particular case, the reportability ofa study orincident maybe affected by the differences, ifany, between the formulation ofproduct involved in the foreign information and the formulation ofproducts registered in the United States, as well as other study or incident conditions which may ormay notbe relevant to conditions inthe United States (soil type, crop sites, directions and conditions ofuse). All submissions to EPAmustbe inEnglish; untranslated foreign language documents will not be accepted. Until the Agency gains greater experience in determining what otherwise reportable information associated with studies orincidents 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 bereportableunless an expert concludes that differences between the formulation ofproductinvolved in the foreign information and product registered in the United States makethe information irrelevant to the product registered in the United States. In anyparticular case, a registrant can inquire from the 6(a)(2) Officerwhetherparticular information shouldbereported. Afterthe Agency has gained more experience evaluating information associated with foreign studies orincidents, the Agency may revise this guidance.

13Attachment to PR Notice 98-3 

### X. INFORMATION INVOLVING CHEMICALS SIMILARTOREGISTERED CHEMICALS Information involving a chemical different from any contained in a registrant's registered pesticides is nonetheless reportablebythat registrant ifthe registrant knows or should know that the information is relevant to the registered pesticide and is otherwise reportable under section 6(a)(2). Examples oftypes ofinformation that a registrant should know are relevant to its registered product include, but are not limited to, a study ofa 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 oran experthas concluded shares a common mechanism oftoxicity with the registrant's registered pesticide; etc. In any particularcase, the determining factor is likely to be the nature ofthe information available to the registrant suggesting that the otherwise reportable information is relevant to the registrant's registered product. 

### XI. IMPLEMENTINGRULE BEFORE THE EFFECTIVE DATE Although the regulations were published in the Federal Register on September 19, 1997, they do notbecome effective until June 16, 1998. Some registrants may wish to implement some orall ofthe rule before its effective date. Registrants should contact the Agency in writing and specify the portions ofthe rule they would like to implementbefore 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 aposition 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 REPORTABLE The regulations specify minimum information that mustbe available in order to make the incident reportable. Those information elements are: an exposure may have occurred; an adverse effect has occurred ora delayed orchronic adverse effect may occurin the future; the pesticide can be identified (product name, product registration number, or active ingredient); the location where the incident occurred; and aperson to contact for more information about the incident. It should benoted that reportable information may arise from newspaper articles. Identification ofthe pesticide is critical to the Agency's ability to take regulatory action to address risk. Ifthe personreporting an incident does not provide sufficient information for the registrant to be able eitherto identify the product involved by name and/or registration number, orto identify the active ingredient used in the product, the incident is not reportable.

14Attachment 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 ofthe user. For example, someone may report that he knows heput diazinon on the lawn, but threw away the packaging so he cannot report the name ofthe product. In othercases, the person reporting the incident to the registrant reports the name ofa product, but does not know theproduct registration number. Often, the registrant can determine the product in questionbecause the registrant sells only one productby that name. Alternatively, the registrant can at least identify the active ingredientbecause 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 ofplant damage and registrants have asked EPA to clarify those exemptions. These exemptions are related to pesticide product labels, which can include warnings ofpossible damage to plants related to use. The warning may apply to the treated crop as well as non-targetplants. The label maywarn that the treated crop could be damaged ifthe product is not used according to the label instructions. The misdirected application ofa broad-spectrum herbicide such as glyphosate orparaquat can result in damage to the treated crop. For example, an apple orchard may be sprayed to control weeds beneath the trees. Ifthe spray is misdirected and is taken up by the apple trees, the pesticide can cause damage, such as reduced yield. Since the label warns ofthat risk, however, that incident would not be reportable. The regulations exempt reporting ofnon-lethal damage to the treated crop ifthe label warns ofthat 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. Ifthere is lethal damage to the treated crop-- with orwithout a label warning-- the incident is reportable. Labels may also warn ofthe possibility ofdamage 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 comor sorghum present in the wheat field. Com and sorghum are neither the listed pests nor the treated crop. But ifthe label warns ofthis possibility, the incident is not reportable. If, however, a pesticide moves by way ofprimary drift, secondary surface runoff, or secondary aerial movement from the treatment site to untreated areas and plant injury occurs, the

15Attachment 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 ofpesticide application. Secondary surface runoffis pesticide movement in surface water orsediment from the treatment site to untreated sites days, weeks, or months after the initial pesticide application. Secondary aerial movement is the off-target movement ofa pesticide via volatilization, co-distillation, evapo-transpiration, and/or windblown soil particles from the treatment site days, week, or months after the initial pesticide application. Some environmental and climatic factors that may affectpesticide 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 ofreportable incidents may be injuryto crops that are irrigated with groundwaterthat is contaminated with apersistent herbicide orinjury to plants following a rainfall. Receiving incident reports ofplant damage is essential to refining use directions in order to prevent damage in the future. XIV. PREVIOUSLY-SUBMITTED INFORMATION Ifa registrant knows that adverse effects information concerning theirregistered product has already been submitted to the Agency by anotherparty in a timely manner, it does not have to report the information. The burden is onthe registrant, however, to ensure that the information was, indeed, submittedbyanotherparty. A related issue is the submission ofadditional information about a specific 6(a)(2) submissionprovided to the Agency at an earlier time. Registrants are obligated to submit additional information as a follow-up to previously submitted data orincident reports. In the case ofincident reports, the following types ofinformation should be submitted:

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

• the identification ofthepesticide, circumstance information, ora laboratory report for major human incidents (H-B) orfatalities ofwildlife (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 ofthe following: human death (H-A), human major (H-B), domestic animal death (D-A) orthe "A" level (the most serious category) for any other exposure or incident type (fish or wildlife, plants, water contamination, orproperty damage). This additional information should be provided bythe registrant making the initial report ifthat registrant obtains the information. Ifanotherparty made the initial submission, but a

16Attachment to PR Notice 98-3 registrant obtains the additional information about theirproduct, the registrant is obligated to submitthe information to the agency. 

### XV. REPORTABLE INJURIES AND PROPERTYDAMAGE Some incidents appear to beunrelated to the pesticidal characteristics ofthe product. For example, an incident in which someone's leg is broken as a result ofa pesticide container falling offa forklift would not be reportable. Onthe otherhand, ifa pesticide container explodes, lacerates someone's face, butno poisoning symptoms occur, the incident wouldbereportable. The adverse effect was due to factors related to the chemistry orcharacteristics ofthe pesticide product. Odor complaints need not bereported ifthe only complaint is the offensive nature of the odor. On the otherhand, ifsomeonereports that a producthas a badodor and that the odor madethe person nauseous and gave them a headache, the incident is reportable. The registrant cannotbe sure that the nausea and headache are notpoisoning effects. Regarding property damage, §159.184(a) does limit reporting ofincidents to situations in which a person ornon target organism suffered a toxic or adverse effect ormay suffer a delayed orchronic adverse effect in the future. The Agency takes theposition, however, that an incident that results inproperty damage that could have causeddirect human injury, such as fire or explosion, or an incident that requires substantial clean-up orrenders a structure uninhabitable, wouldbereportable under §159.195. Under §159.195, information is reportable ifit raises concerns about the continuedregistration ofa product or about the appropriate terms and conditions ofregistration ofa product. Forexample, an acutely toxic pesticide is stored in a house and the product leaks from the container as a result offaulty 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 Thedefinition of"registrant" provides a two part test for excluding an employee ofa 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, orregistration ofa pesticide (as defined in the rule) and who could not reasonably be expected to come into possession ofinformation that is otherwise reportable is not obligated to report that information. Conversely, persons who couldreasonably be expected to come intopossession ofinformation on the toxicity ofchemicals, even ifthey work outside the area ofpesticides, shouldbe informed oftheir obligation to report the information under FIFRA 6(a)(2), as well as their obligation to report information under section 8(e) ofthe Toxic Substances Control Act (TSCA) as described in Part 2 ofthe March 16, 1978 Policy Statement (43 FR 11111).

17Attachment to PR Notice 98-3 

### XVII. SUBMISSIONDUE DATE §159.156 ofthe rule specifies the time frames for submitting reportable information. The rule provides that the submission may eitherbemailed by certified orregistered mail, be delivered in person orby courier service, ordelivered by such othermethods as the Agency deems appropriate. Registrants should note that the EPA Office ofPesticide Programs considers the date a document is pin-punched as the official document receipt date. In the case ofa document delivered to OPP bycourier, the pin-punch date is the same date the document was received in EPA. However, in the case ofa document deliveredbythe U.S. Postal Serviceby certified orregistered mail, there is usually a time lag ofat least two working days betweenthe date the a submission is received in the general EPA mail center and the date it is delivered to OPP andpin-punched. Therefore, registrants shouldtake 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-punchedby OPP within specifiedreporting timeframes. 

### It should be noted that certified mail green cards orregistered orcertified mail receipt logs indicate only that a package from some party was received

-- it is not proofofthe contents ofthepackage. The best documentation ofreceiptof6(a)(2) submissions is the pinpunched document itself. 

### XVIII. TECHNICAL CORRECTIONS TOTHE 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 offour types: 

### A) Reporting Time Frame Corrections Most ofthe corrections ensure that time frames for submitting all types ofadverse 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 ofinformation. As a result, however, the final regulations erroneously failed to establish time frames for the submission ofcertain types ofinformation. Thetime frame technical corrections will specify that:

• The following types ofinformation must be received by EPA no later than the 30th calendar day after the registrant first possesses orknows ofthe information: pesticides in food or feed above the tolerance level or ifno tolerance has been established; pesticides in water above the MCL or HAL; metabolites, degradates, contaminants, and impurities; efficacy failure studies for public healthproducts; substantiated incidents ofpest resistance; and other information described in §159.195.

18Attachment to PR Notice 98-3

• Incidents ofefficacy failure ofpublic health products may be accumulated for 1month and submitted bythe end ofthe month following the accumulation period. In the discussion of§159.178- Information about Pesticides in Food, Feed orWater, the preamble to the final regulations states that information about detections ofpesticides in water below the MCL orHAL 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 ofpesticides in water described in§159.178(b) below the MCL or HAL, but otherwise reportable may be accumulated for 3 months and submittedbythe end of the second month following the accumulationperiod. 

### B) Required Information aboutPesticide Detections in Food, Feed orWater Othertechnical 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 ofpesticides in food, feed, orwaterdescribed in §159.178 will be that specified in the list ofreportable 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 ofanalysis. Fordetections ofpesticides in surface water, the required information would be the incident-specific list for surface water (§ 159.184(c)(4)(iv)). Fordetections ofpesticides in ground water, the required information would bethe incident specific list for ground water ( §159.184(c)(4)(v)).

• Required information about detections ofpesticides in food, feed, orwaterwill include the amount ofpesticide detected. This will be added to §159.184(c)(4)(iv) and (v). 

### C) Corrections ofTypographical and Cross Referencing Errors Other technical·corrections to the regulations will include corrections oftypographical errors and minor cross referencing errors. 

### D) Definition ofRegistrant The definition ofregistrant in §159.153 will bechanged to comport with the statutory definition ofregistrant. Other language in the current definition will be moved to 159.155(b). 

### XIX. VOLUNTARY INCIDENT REPORTINGFORMS As a service to its members, the Chemical Producers and Distributors Association

19Attachment to PR Notice 98-3 (CPDA) has formed a work group to design standardized forms for capturing and submitting individual incidentreports and aggregate reports. OPP staffare participating in this effort. The individual incident form is designed to capture the basic information about the incident in order to determine ifit is reportable (exposure, adverse effect, contact person, pesticide identification, and where it occurred). In addition, it will foster the process bywhichregistrants categorize each incident by exposure type and severity category and determine how much information is to bereported and when to submit the reports. An aggregate report format is also being designed. Detailed instructions accompanyboth forms. This will support aggregate reporting of appropriate categories ofexposure types and severity as specified in the regulations. Use ofthe form will be voluntary. The form will bedistributed to interested parties by CPDA. The Agency is committed to electronic submission ofincident reports but not at the presenttime. Both the regulated community and the Agency need to gain experience in implementation ofthe new regulations and meeting the data management challenges they present. Forexample, the voluntary form may well need fine-tuning overtime. In addition, OPP is working on otherelectronic submission efforts to gain valuable experience that can be applied to electronic reporting ofincidents, as well as othertypes ofinformation. OPP will work closely with registrants before embarking on electronic submission efforts.

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