Pesticide Registration (PR) Notice 98-3: Guidance on Final FIFRA Section 6(a)(2) Regulations for Pesticide Product Registrants

EPA 730-N-98-003
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF.
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
April 3,1998

PESTICIDE REGISTRATION NOTICE 98-3

NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, DISTRIBUTORS
AND REGISTRANTS OF PESTICIDE PRODUCTS
i . • ' ' -
ATTENTION: Persons Responsible for Federal Registration of Pesticides

SUBJECT: 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 of FIFRA section 600(2), actionable under FBFRA sections 12(aX2)(B)(ii) and
12(aX2)(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.

n. 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.
R*cyctedtt«cycUbte . Pitted wth Vegetable OB Based tote on 100% Ftecycted Paper (-40% Posteonsumef)

-------
III. FOR FURTHER INFORMATION

Registrants may contact Kathryn Bouve for infonnation or questions concerning this PR
notice and attached guidance document at: Office of Pesticide Programs (7502C) US
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

-------
Attachment to PR Notice 98-3
Attachment to PR Notice 98-3
, . . -^

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

Aprils, 1998
&EPA
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
' •;-• •• • • .. i
H. Agents: Definition and Reporting Responsibilities ......... i
ffl. Aggregate Reporting _
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
VII. Expert Opinion Information
s ' • . ' "" "•• .•••• 8
Vm. Exposure Type and Severity Categories.....
DC Extraterritorial Adverse Effect Information.. 13
X. Information Involving Chemicals Similar toRegistered Chemicals 14
XL Implementing Rule Before the Effective Date. .......... 14
Xn. Minimum Information Reportable.........
Plant Damage Incident Exemptions.; ,
XIV. Previously-Submitted Information ,'£
15
XV. Reportable Injuries and Property Damage '.
XVI. Responsibilities of Non-Pesticide-Division Employees..... .... 17
XVn. Submission Due Date.
• " ** -" 18
XVEL Technical Corrections to Regulations
XTX. Voluntary Incident Reporting Forms 19
-------
-------
Attachment to PR Notice 98-3

I. INTRODUCTION
On September.19, 1997, EPA published in the Federal R.pi.t.r th. Sn.i -u ^-^
EPA s interpretation and enforcement policy regarding section 6(a)(2) of the Federal Insecticide
Tungicide and Rodenhcide 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(aK2). •

EPA is working wim registrants m anticipation of me.mle'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.

n. 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 of the relationship between the
agent and the registrant. Facts that will weigh in the determination of whether someone is
actmg 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
toe registrant has requested that me activity be conducted; me nature of me con
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.
i
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
adjusters, 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 wduld prefer
-------
Attachment to PR Notice 98-3
by
This
distributors deliver reportable bfc
registrants to report) and not to EPA; the Agency strongly
information from registrants themselves rather than from their supe
also makes sense from the perspective of good product stewardship, «ncc
presumably want to be aware of adverse effects associated with products
Note Aat where supplemental distributors choose to submit information to
directly to EPA the tune for reporting will continue to be calculated from
information is first received by the supplemental distributor. °™

HI. AGGREGATE REPORTING

The regulations establish /different requirements for reporting timeframes and for content
of incident reports depending on the defined severity categorT(see
Types and Seventy rat^ri^). The chart that follows summarized L
by others
rather*™
a the
time that the
ASAP - NLT 15
Days
Accum. 1 Month
Submit 1 Month Later
Accum. 3 Months
Submit 2 Months Later
Provide detailed
information for each
incident
Provide detailed information
for each incident
Aggregate and submit count of
incidents and effects for each
product or AI
Human Deaths
Human -Major
Moderate
Human-Minor
Unknown, etc.
Major-Wildlife
Plant
Water
Property Damage
All Domestic Animals
All other categories for -
Wildlife
Plant
Water
Property Damage
re^laH ^^ registrants to report minor or common incidents as defined in the
regulations as an aggregate count of incidents and effects for each product. The Age^ywiU
reject submissions of minor/common incidents if the summaries are not provided ^s is
necessary because theAgency expects the volume of incident reporting to incre^e afti L final
regulations become effective. To cope with this increase and mdntain focus onTe molt
-------
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
fcicident 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 factors 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. Asa
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
-------
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.
Number of Incidents and Adverse Effects Reported by Exposure Type and Severity Category
Reporting Period January - March 1998

Reg No/
Active
Ingredient
112233-1
H 2233-1 3
Active Ingred. X

total -
Incidents
30
47
7
H -D

Humtn-
Minor Effects
7
4
1
H - E

Human-
Unknown,
Unspecified, or
Delayed Effects
4
10
0
D-A

Domestic
Animal -
Death
1
0'
0 ,
D-B

Domestic
Animal-
Major Effects
4
9
2
D-C.D.E
Domestic
Animal-
Moderate,
• Minor,Unknown
or Unspecified
17
37
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. ,
i ' - S

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 1 0 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 Vm.
Exposure Types and Severity Categories for
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.
-------
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.
Tgghnjca] Correction? ft 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 work-
product 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 that, the information be formally provided to the Agency at
some time in the future.

All waiver requests must be addressed to the 6(aX2) Officer hi 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(aX2) 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,
-------
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. If basic 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 well-
investigated 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
-------
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 hi 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.

VH. EXPERT OPIMON INFORMATION

Conclusions or opinions of experts must be submitted under FTFRA 6(a)(2) if the
registrant possesses the information and either 1) 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 hi 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
-------
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 secftion 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 hi the Office of Pesticide
Programs. ,

Vm. EXPOSURE TYPE AND SEVERITY CATEGORIES

, The 6(aX2) 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 hi
consultation with the National Animal Poison Control Center/American Society for Prevention
of Cruelty to Animals.

In cases where multiple symptoms occur hi 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 of breath. 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).
-------
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

S159.814 (SViVA) : "If the 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 f5ViVB>: "If the person alleged or exhibited symptoms which mav have been Jife-
threatening. 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 if untreated 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
f '
I $9,184 (SXDfC): "If the person alleged or exhibited symptoms more pronoun^
Prolonged, or of a more systemic nature than min^r symptoms. Usually some form of tr
10
-------
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 (SVnfDV "If the person alleged or exhibited some symptoms, but they were minimally
traumatic. The symptoms resolved rapidly and usually involved skin, eve, or respiratory
irritation."

Effects include, but are not limited to, skin rash, itchingT conjunctivitis (red, tearing eyes),
drowsiness, transient cough, headache, joint pain, agitation, restlessness, or mild gastro-intestinal
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, Unspecifie d or May Appear in Future
159.184 (SViXE)' "If symptoms are unknown, unspecified or are alleged to be of a delayed or
chronic nature that may appear in the future." •
1 - - i ' . ' *" *
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 reportabie 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 naj 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
11
-------
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.
"If the domestic ?nima] died 9r was e
H "
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

§ 1 59. 1 84 f S ViiVBV "If the domestic animal exhibited or was alleperl in have exhihiteH
symptoms which mav have been life-threatening or resulted jn residual HiMhiftfy "

Life-threatening effects include, but are not limited to, massive or internal hemorrhage
loss of consciousness, grand mal seizures, paralysis, cardio-respiratory depression and
bronchoconstnction 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 ammal is the case of a dog which recovered from cholecalciferol rodenticide ingestion but is
left with decreased renal function.

D-C - Domestic Animal Moderate
.§139,1 ?4 fflfiWQ: "If the domestic animal exhibited nr was allied tn have exhibit
symptoms w
>re pronouncedT rno
form of treatment
!-threat
health with no additional residual disabilit
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, incoodination, tremors and hives More
prolonged effects are those that last one month or longer, such as a persistent skin rash
12
-------
Attachment to PR Notice 98-3 . ,
'•.•'.... i . . • '
. D-D - Domestic Animal Minor

§ 159.184 CSViiVD): "If the domestic animal was alleged to have exhibited symptoms, but thpy
were minimally bothersome. The symptoms resolved rapidly and usually involved skin, eyg nr
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 (5Vii¥F>: "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 npi 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.

DC. EXTRATERRITORIAL ADVENE EFFECT INFORMATION

Information derived fromstudies 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 of 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.

t
-.,.'•'• ' •• -13 ' ; ' .
-------
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.

XH. MINIMUM INFORMATION REPORTABLE

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.
14
-------
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 beidentified 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. ,

Xin. 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 freated crop could be damaged if the product is not used
according (o 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 corn or sorghum present in the wheat field. Corn 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

15 .'
-------
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(aX2)
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
16
-------
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 die 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 excludingan 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 FEFRA 6
-------
Attachment to PR Notice 98-3

XVII. SUBMISSION DUE DATE
^^
^
te date a docun™. is pin-punched as ft. official docum^°pt * i o • ,

tuneframes It should be noted that certified mall green cids
ma green csor o,
receipt logs mdicate only that a package fiom somfparty was rS !ft is no?Drotf of L

p^unSl^e^

XVIfl. TECHNICAL CORRECTIONS TO THE REGULATIONS
1997. Aseconoccanco^ent H.«1B« w

A) Reporting Time Frame Corrections
°f infonnation must be received by EPA no later than the 30th

resistance; and other information described in §159.195. •* aentsol,Pest
18
-------
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

bef ^ ^ rff ti(T StatCS *at information ab°* 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(dX3) and (e). Corrections will be maJe 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 '

A,u P^1^^31^^0^6^6*^86^
Although these information items are implied, the technical corrections will specify that:

* f^™^^
Y^O , fi^l j*? ?* * ^ ** Ust °f teP0*3*31* infonnation required for incidents
(§159.184(c)) - administrative, pesticide, circumstance, and appropriate incident specific

information. For detections in food or feed, the appropriate incident specific infonnation
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 Se
required information would be the incident-specific list for surface water
(§159.184(c)(4Xiv)). For detections of pesticides in ground water, the required
information would be the incident specific list for ground water (§159.184(cX4)(y)).

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
_ .. ^

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

, . ' • . • . i

• • • .• ' • • • • 19
-------
• • • ..-,.<•%
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.
20
-------