[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR159.184]

[Page 145-150]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 159_STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents
 
      Subpart D_Reporting Requirements for Risk/Benefit Information
 
Sec. 159.184  Toxic or adverse effect incident reports.

    (a) General. Information about incidents affecting humans or other 
non-target organisms must be submitted if the following three conditions 
are met:
    (1) The registrant is aware, or has been informed that a person or 
non-target organism may have been exposed to a pesticide.
    (2) The registrant is aware, or has been informed that the person or 
non-target organism suffered a toxic or adverse effect, or may suffer a 
delayed or chronic adverse effect in the future.
    (3) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (b) Exceptions. Information regarding an incident need not be 
submitted if any of the following conditions are met:
    (1) The registrant is aware of facts which clearly establish that 
the reported toxic effect, or reported exposure, did not or will not 
occur.
    (2) The registrant has been notified in writing by the Agency that 
the reporting requirement has been waived

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for this incident or category of incidents, and the registrant has not 
been notified in writing by the Agency that the waiver is rescinded.
    (3) It concerns a toxic effect to non-target plants, which were at 
the use site at the time the pesticide was applied, if the label 
provides adequate notice of such a risk.
    (4) It concerns non-lethal phytotoxicity to the treated crop if the 
label provides an adequate notice of such a risk.
    (5) It concerns a toxic effect to pests not specified on the label, 
provided that such pests are similar to pests specified on the label.
    (6) It concerns minor skin or eye irritation effects warned of on 
the label of a product which is registered for use in residential use 
sites, and the effects occurred as a result of use in a residential 
site.
    (c) Required information on individual incidents. To the extent that 
the registrant has any of the information listed in paragraphs (c)(1) 
through (c)(4) of this section, the registrant must supply the 
information on each pesticide incident that meets the requirements 
outlined in paragraph (a) of this section. If the registrant acquires 
additional information concerning an incident previously reported to the 
Agency under this part, such information shall be reported if it meets 
the criteria set forth in paragraph (f) of this section. In the future, 
the Agency may by notice specify a format for such submissions. The 
Administrative, Pesticide, Circumstance and Exposure Type(s) of 
information must be reported for individual incidents, except where the 
provisions of paragraph (e) of this section allow for aggregated summary 
forms of reporting, or if EPA in the future grants permission in writing 
for alternative reporting formats. The registrant must also provide one 
or more Exposure Type and Severity categories and their designations for 
each incident as set forth in paragraph (c)(5) of this section, 
depending on the applicability of the criteria listed below. The 
criteria listed should be used in assigning a category. For example, an 
incident which allegedly caused serious but non-fatal effects to human 
beings and domestic animals might be designated ``H-B: D-B.'' When a 
single incident involves multiple pesticides, the registrant need only 
report on their specific product. However, if a single incident involves 
more than one type of non-target organism--for example, both humans and 
domestic animals are involved--all appropriate available information 
dealing with each of the victims must also be reported. The 
informational items below are grouped by sections for ease in reporting 
pesticide incidents.
    (1) Administrative. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Name of reporter, address, and telephone number.
    (ii) Name, address, and telephone number of contact person (if 
different than reporter).
    (iii) Incident report status (e.g., new or update); if update, 
include the date of original submission.
    (iv) Date registrant became aware of the incident.
    (v) Date of incident (if appropriate, list start and end dates).
    (vi) Location of incident (city, county and state).
    (vii) Is incident part of a larger study.
    (viii) Source if different from reporting registrant.
    (2) Pesticide. Pesticide incident reports must be submitted for each 
pesticide that may have contributed to the incident, if the registrant 
possesses or receives any of the following information, and the incident 
meets the minimum requirements set forth in paragraph (a) of this 
section:
    (i) Product name.
    (ii) Active ingredient(s).
    (iii) EPA Registration Number.
    (iv) Diluted for use, or concentrate.
    (v) Formulation, if known.
    (3) Circumstance. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Evidence the label directions were not followed (e.g., yes, no, 
unknown).

[[Page 147]]

    (ii) How exposed (e.g., spill, drift, equipment failure, container 
failure, mislabeling, runoff, etc.).
    (iii) Situation (e.g., household use, mixing/loading, application, 
reentry, disposal, transportation, other (describe)).
    (iv) Use site (e.g., home, yard, commercial turf, agricultural 
(specify crop), industrial, building/office, school, nursery, 
greenhouse, pond/lake/stream, well, forest/woods, other.
    (v) Applicator certified (yes, no, unknown).
    (vi) A brief description of the circumstances of the incident.
    (4) Other incident specific information. Pesticide incident reports 
must be submitted if the registrant possesses or receives any of the 
following information, and the incident meets the minimum requirements 
set forth in paragraph (a) of this section:
    (i) If the incident involves humans:
    (A) Route of exposure (skin, eye, respiratory, oral).
    (B) List signs/symptoms/adverse effects.
    (C) If laboratory tests were performed, list name of test(s) and 
results.
    (D) If available, submit laboratory report(s).
    (E) Time between exposure and onset of symptoms.
    (F) Was adverse effect the result of suicide/homicide or attempted 
suicide/homicide.
    (G) Type of medical care sought, (e.g., none, Poison Control Center, 
hospital emergency department, hospital inpatient, private physician, 
clinic, other).
    (H) Demographics (sex, age, occupation).
    (I) If female, pregnant?
    (J) Exposure data: amount of pesticide; duration of exposure; weight 
of victim.
    (K) Was exposure occupational; days lost due to illness.
    (L) Was protective clothing worn (specify).
    (ii) If domestic animal:
    (A) Type of animal (e.g., livestock, poultry, bird, fish, household 
pet e.g., dog/cat etc.).
    (B) List signs/symptoms/adverse effects.
    (C) Breed/species (name and number affected, per adverse effect).
    (D) Route of exposure (e.g., skin, eye, respiratory, oral).
    (E) Time between exposure and onset of symptoms.
    (F) If laboratory test(s) performed, list name of tests and results.
    (G) If available, submit laboratory report(s).
    (iii) If fish, wildlife, plants or other non-target organisms:
    (A) List species affected, and number of individuals per species.
    (B) List symptoms or adverse effects.
    (C) Magnitude of the effect (e.g., miles of streams, square area of 
terrestrial habitat).
    (D) Pesticide application rate, intended use site (e.g., corn, 
turf), and method of application.
    (E) Description of the habitat and the circumstances under which the 
incident occurred.
    (F) If plant, type of plant life (i.e., crop, forest, orchard, home 
garden, ornamental, forage).
    (G) Formulation of pesticide if not indicated by brand name 
(granular, flowable).
    (H) Distance from treatment site.
    (I) If laboratory test(s) performed, list name of test(s) and 
results.
    (J) If available, submit laboratory report(s).
    (iv) If surface water:
    (A) If raw water samples, water bodies sampled and approximate 
locations in each water body.
    (B) If raw water samples, proximity of sampling locations to 
drinking water supply intakes and identities of systems supplied.
    (C) If finished water samples, water supply systems sampled.
    (D) If finished water samples, percent surface water source by 
specific surface water sources to water supply system(s).
    (E) Sample type (grab, composite).
    (F) Sampling times/frequency.
    (G) Pesticides and degredates analyzed for, the detection limits, 
and the amount detected.
    (H) Method of analysis.
    (v) If ground water:
    (A) Pesticides and degredates analyzed for, the analytical method 
used,

[[Page 148]]

the detection limits, and the amount detected.
    (B) Sample date.
    (C) Amount pesticide applied (lbs-ai/acre).
    (D) Date of last application.
    (E) Depth to water.
    (F) Latitude/longitude.
    (G) Soil series and texture (sand/silt/clay).
    (H) Frequency of applications per year.
    (I) Aquifer description (confined/unconfined).
    (J) Method of application.
    (K) Years pesticide used.
    (L) Well use and well identifier.
    (M) Screened interval.
    (N) Annual cumulative rainfall (inches).
    (O) Maximum rainfall and date.
    (P) Cumulative irrigation (inches).
    (Q) Hydrologic group.
    (R) Hydraulic conductivity.
    (S) pH.
    (T) Organic matter or organic carbon (percent).
    (vi) If property damage.
    (A) Provide description.
    (B) [Reserved]
    (5) Exposure types and severity category designations--(i) Humans. 
If an effect involves a human, provide the appropriate 2-letter exposure 
types and severity categories and their designations, based upon the 
following categories:
    (A) H-A: If the person died.
    (B) H-B: If the person alleged or exhibited symptoms which may have 
been life-threatening, or resulted in adverse reproductive effects or in 
residual disability.
    (C) H-C: If the person alleged or exhibited symptoms more 
pronounced, more prolonged or of a more systemic nature than minor 
symptoms. Usually some form of treatment 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 additional 
residual disability.
    (D) H-D: If the person alleged or exhibited some symptoms, but they 
were minimally traumatic. The symptoms resolved rapidly and usually 
involve skin, eye or respiratory irritation.
    (E) H-E: If symptoms are unknown, unspecified or are alleged to be 
of a delayed or chronic nature that may appear in the future.
    (ii) Domestic animals. If an effect involves a domestic animal, 
provide the appropriate 2-letter notation based upon the following 
categories:
    (A) D-A: If the domestic animal died or was euthanized.
    (B) D-B: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which may have been life-threatening or resulted in 
residual disability.
    (C) D-C: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which are more pronounced, more prolonged or of a 
more systemic nature than minor symptoms. Usually some form of treatment 
would have been indicated to treat the animal. Symptoms were not life 
threatening and the animal has returned to its pre-exposure state of 
health with no additional residual disability.
    (D) D-D: If the domestic animal was alleged to have exhibited 
symptoms, but they were minimally bothersome. The symptoms resolved 
rapidly and usually involve skin, eye or respirator irritation.
    (E) D-E: If symptoms are unknown or not specified.
    (iii) Fish or wildlife. If an alleged effect involves fish or 
wildlife, label the incident W-A if any of the following criteria are 
met, or W-B if none of the criteria are met:
    (A) Involves any incident caused by a pesticide currently in Formal 
Review forecological concerns.
    (B) Fish: Affected 1,000 or more individuals of a schooling species 
or 50 or more individuals of a non-schooling species.
    (C) Birds: Affected 200 or more individuals of a flocking species, 
or 50 or moreindividuals of a songbird species, or 5 or more individuals 
of a predatory species.
    (D) Mammals, reptiles, amphibians: Affected 50 or more individuals 
of a relatively common or herding species or 5 or more individuals of a 
rare or solitary species.
    (E) Involves effects to, or illegal pesticide treatment (misuse) of 
a substantial tract of habitat (greater than or

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equal to 10 acres, terrestrial or aquatic).
    (F) Involves a major spill or discharge (greater than or equal to 
5,000 gallons) of a pesticide.
    (G) Involves adverse effects caused by a pesticide, to federally 
listed endangered or threatened species.
    (iv) Plants. If an alleged effect involves damage to plants, label 
the incident P-A if the following criterion is met, or P-B if the 
criterion is not met:
    (A) The effect is alleged to have occurred on more than 45 percent 
of the acreage exposed to the pesticide.
    (B) [Reserved]
    (v) Other non-target organisms. If an alleged effect involves damage 
to non-target organisms other than fish, wildlife or plants (for 
example, beneficial insects), label the incident ONT.
    (vi) Water contamination. If a pesticide is alleged to have been 
detected in groundwater, surface water or finished drinking water, label 
the incident in accordance with the following criteria:
    (A) G-A: If the pesticide was detected at levels greater than the 
maximum contaminant level (MCL) or health advisory level (HAL) or an 
applicable criterion for ambient water quality.
    (B) G-B: If the pesticide was detected at levels greater than 10 
percent of the MCL, HAL or a criterion for ambient water quality but 
does not exceed the MCL or other applicable level.
    (C) G-C: If the pesticide was detected at levels less than 10 
percent of the MCL, HAL, or other applicable level, or there is no 
established level of concern.
    (vii) Property damage. If an incident involves alleged property 
damage the applicable term(s) shall be included along with any other 
applicable effect category label; for example, ``H-B: property damage.'' 
Label the incident in accordance with the following criteria:
    (A) PD-A: The product is alleged to have caused damage in a manner 
that could have caused direct human injury, such as fire or explosion.
    (B) PD-B: The product is alleged to have caused damage in excess of 
$5,000.
    (C) PD-C: Any allegation of property damage that does not meet the 
criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including 
cases in which the level of damages is not specified.
    (d) Time requirements for submitting incident information. 
Information concerning incidents reportable under this section must be 
submitted within the time frames listed for different exposure and 
severity categories, as follows:
    (1) For allegations involving human fatality (H-A), registrants must 
submit the required information, to the extent it is available, no later 
than 15 days after learning of an allegation.
    (2) Information concerning incidents which meet the criteria for the 
following exposure and severity category labels described in paragraph 
(c)(5) of this section, reports of detections of pesticides in water, 
and efficacy failure incidents may be described in Sec. 159.188(a)(1) 
and (b)(1), may be accumulated for a 30-day period, and submitted to the 
Agency within 30 days after the end of each 30-day accumulation period 
for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; 
Property Damage, PD-A.
    (3) Incidents or reports of detections of pesticides in water 
meeting all other exposure and severity label categories, information 
may be accumulated by registrants for 90 days and submitted within 60 
days after the end of each 90-day accumulation period.
    (e) Aggregated reports. For incidents that are reportable under the 
schedule requirements of paragraph (d)(3) of this section, in lieu of 
individual reports containing the information listed in paragraphs 
(c)(1) through (c)(4) of this section, registrants must provide an 
aggregated report listing:
    (1) The time period covered by the report.
    (2) For each exposure and severity label category, a count of the 
number of incidents, listed by product registration number (if known) or 
active ingredient.
    (3) A count of domestic animal incidents in categories, other than 
D-A or D-B, which can be added together and reported as a single number.
    (f) Reporting additional information. If, after the submission of an 
incident report to the Agency, a registrant acquires additional 
information concerning that incident, the information

[[Page 150]]

should be submitted within the same time frame as applied to the 
original incident report, if any of the following conditions apply:
    (1) The information concerns an alleged human fatality (H-A), and 
the information consists of any of the elements listed in paragraphs 
(c)(1) through (c)(4) of this section.
    (2) The information concerns an incident originally reported as 
alleging a major human illness or injury (H-B), or fatality to a 
domestic animal (D-A), or wildlife (W-A), and the additional information 
consists of pesticide or circumstance information listed in paragraphs 
(c)(2) or (c)(3) of this section, or is a laboratory report concerning 
persons or animals involved in the incident.
    (3) The information concerns any incident not originally reported 
with one of the exposure and severity labels H-A, or H-B for human 
incidents, or at the ``A'' level of severity for any other exposure or 
incident type, and the new information would result in labeling the 
incident H-A or H-B for a human incident, or at the ``A'' level of 
severity for any other exposure or incident type listed in paragraph 
(c)(5) of this section.

[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]