Attachment B

Environmental Protection Agency

§ 159.153

SOURCE: 63 FR 49388, Sept. 19, 1997, unless
otherwise noted.

Subparts A–C [Reserved]
Subpart D—Reporting Requirements for Risk/Benefit Information
§ 159.152 What the law requires of registrants.
(a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) states: ‘‘If at any time
after the registration of a pesticide the
registrant has additional factual information regarding unreasonable adverse
effects on the environment of the pesticide, he shall submit such information to the Administrator.’’
(b) Section 152.50(f)(3) of this chapter
requires applicants to submit, as part
of an application for registration, any
factual information of which he is
aware regarding unreasonable adverse
effects of the pesticide on humans or
the environment, which would be required to be reported under section
6(a)(2) if the product were registered.
(c) Compliance with this part will
satisfy a registrant’s obligations to
submit additional information pursuant to section 6(a)(2) and will satisfy an
applicant’s obligation to submit additional
information
pursuant
to
§ 152.50(f)(3) of this chapter.

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§ 159.153

Definitions.

(a) For the purposes of reporting information pursuant to FIFRA section
6(a)(2), the definitions set forth in
FIFRA section 2 and in 40 CFR part 152
apply to this part unless superseded by
a definition in paragraph (b) of this
section.
(b) For purposes of reporting information pursuant to FIFRA section
6(a)(2), the following definitions apply
only to this subpart:
Established level means a tolerance,
temporary tolerance, food additive regulation, action level, or other limitation on pesticide residues imposed by
law, regulation, or other authority.
Formal Review means Special Review,
Rebuttable Presumption Against Registration (RPAR), FIFRA section 6(c)
suspension proceeding, or FIFRA sec-

tion 6(b) cancellation proceeding,
whether completed or not.
Hospitalization means admission for
treatment to a hospital, clinic or other
health care facility. Treatment as an
out-patient is not considered to be hospitalization.
Maximum contaminant level (MCL)
means the maximum permissible level,
established by EPA, for a contaminant
in water which is delivered to any user
of a public water system.
Non-target organism means any organism for which pesticidal control was
either not intended or not legally permitted by application of a pesticide.
Pesticide means a pesticide product
which is or was registered by EPA, and
each active ingredient, inert ingredient, impurity, metabolite, contaminant or degradate contained in, or derived from, such pesticide product.
Qualified expert means one who, by
virtue of his or her knowledge, skill,
experience, training, or education,
could be qualified by a court as an expert to testify on issues related to the
subject matter on which he or she renders a conclusion or opinion. Under
Rule 702 of the Federal Rules of Evidence, a person may be qualified as an
expert on a particular matter by virtue
of ‘‘knowledge, skill, experience, training, or education.’’ In general, EPA
wants registrants to report information when a person has relevant expert
credentials, e.g., a medical doctor giving a medical opinion, a plant pathologist giving an opinion on plant pathology, etc.
Registrant includes any person who
holds, or ever held, a registration for a
pesticide product issued under FIFRA
section 3 or 24(c).
Similar species means two or more
species belonging to the same general
taxonomic groups: The general taxonomic groups for purposes of this requirement are: mammals, birds, reptiles, amphibians, fish, aquatic invertebrates, insects, arachnids, aquatic
plants (including macrophyte, floating,
and submerged plants), and terrestrial
(all non-aquatic) plants.
Water reference level means the level
specified in paragraph (1) or (2) of this
definition, whichever is lower.
(1) Ten percent of the maximum contaminant level (MCL) established by

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§ 159.155

40 CFR Ch. I (7–1–16 Edition)

EPA, or if no MCL has been established
by EPA, 10 percent of the most recent
draft or final long-term health advisory level (HAL) established by EPA,
or if EPA has not published or proposed
an MCL or HAL, the lowest detectable
amount of the pesticide.
(2) The ambient water quality criteria for the protection of aquatic life,
established by EPA pursuant to section
304(a) of the Clean Water Act.

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[62 FR 49388, Sept. 19, 1997, as amended at 63
FR 33582, June 19, 1998; 73 FR 75596, Dec. 12,
2008]

§ 159.155 When information must be
submitted.
(a) The following reportable information must be received by EPA not later
than the 30th calendar day after the
registrant first possesses or knows of
the information:
(1) Scientific studies described in
§ 159.165.
(2) Information about discontinued
studies described in § 159.167.
(3) Human epidemiological and exposure studies described in § 159.170.
(4) Detection of a pesticide in or on
food or feed described in § 159.178(a).
(5)
Detection
of
metabolites,
degradates, contaminates, impurities
described in § 159.179.
(6) Failure of performance studies described in § 159.188(a)(2), (b)(2), and (c).
(7) Other information described in
§ 159.195.
(b) Reportable information concerning detections of pesticides in
water described in § 159.178(b), adverse
effects
incidents
described
in
§ 159.184(a), and efficacy failure incidents described in § 159.188(a)(1) and
(b)(1) must be reported according to the
time frames set forth in § 159.184(d).
(c) EPA may, in its discretion, notify
a registrant in writing of a different reporting period that will apply to specific types of reportable information or
eliminate reporting requirements entirely. Such notification supersedes
otherwise applicable reporting requirements set forth in this part.
(d) For purposes of this part, a registrant possesses or knows of information at the time any officer, employee,
agent, or other person acting for the
registrant first comes into possession
of, or knows of, such information; pro-

vided that, such person performs any
activities for the registrant related to
the development, testing, sale or registration of a pesticide or the person
could be reasonably expected to come
into possession of information otherwise reportable under this part. In the
case of information known to or possessed by an agent or other person acting for the registrant, a registrant is
responsible for such information only if
the agent or other person acquired
such information while acting for the
registrant.
[63 FR 33582, June 19, 1998]

§ 159.156 How
submitted.

information

must

A submission under FIFRA section
6(a)(2) must be delivered to the Office
of Pesticide Programs’ Document Processing Desk at the appropriate address
as set forth in 40 CFR 150.17(a) or (b).
(a) Include a cover letter which contains the information requested in
paragraphs (d) and (e) of this section,
and a prominent statement that the information is being submitted in accordance with FIFRA section 6(a)(2).
(b) Contain the name of the submitter, registrant name and registration number, date of transmittal to
EPA, the type of study or incident
being reported under §§ 159.165 through
159.195, and a statement of why the information is considered reportable
under this part.
(c) Identify the substance tested or
otherwise covered by the information
(including, if known, the EPA registration number(s) to which the information pertains, and if known, the CAS
Registry Number).
(d) In reporting incidents, provide the
data listed in § 159.184, to the extent
such information is available.
(e) In submitting scientific studies,
follow the procedures set forth in
§ 158.32 or § 161.32 of this chapter, as applicable.
(f) If the information is part of a
larger package being submitted in
order to comply with another provision
of FIFRA (e.g., sections 3(c)(2)(B),
4(e)(1)(E)), identify in the transmittal
the individual studies being submitted
under this part.

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Environmental Protection Agency

§ 159.158

(g) If a claim of confidentiality is
made under FIFRA section 10 for information relating to any part of a study
or incident report contained in the submission, follow the procedures set forth
in § 158.33 or § 161.33 of this chapter, as
applicable regarding the identification
and segregation of information claimed
to be confidential.
(h) If a submission includes a study
subject to the flagging requirements of
§ 158.34 or § 161.34 of this chapter, as applicable, comply with the requirements
of that section, and, if the flagging
statement is positive, identify it as
6(a)(2) information in the transmittal.
(i) If a submission is a follow-up to an
earlier study or incident report submitted to EPA, the transmittal must
state that fact, and must cite the earlier submission, as follows:
(1) If the earlier submission was a
study to which EPA assigned a Master
Record Identifier number (MRID), cite
the MRID.
(2) If the previous submission was an
incident report to which no MRID
number was assigned, cite the date of
the initial submission of the incident
information or report.
[63 FR 49388, Sept. 19, 1997, as amended at 69
FR 39864, July 1, 2004; 71 FR 35545, June 21,
2006; 72 FR 61028, Oct. 26, 2007]

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§ 159.158 What information must be
submitted.
(a) General. Information which is reportable under this part must be submitted if the registrant possesses or receives the information, and the information is relevant to the assessment of
the risks or benefits of one or more
specific pesticide registrations currently or formerly held by the registrant. Information relevant to the assessment of the risks or benefits also
includes conclusion(s) or opinion(s)
rendered by a person who meets any of
the following:
(1) Who was employed or retained (directly or indirectly) by the registrant,
and was likely to receive such information.
(2) From whom the registrant requested the opinion(s) or conclusion(s)
in question.
(3) Who is a qualified expert as described in § 159.153(b).

(b) Exceptions—(1) Clearly erroneous
information. Information need not be
submitted if before that date on which
the registrant must submit such information if all of the following conditions are met:
(i) The registrant discovers that any
analysis, conclusion, or opinion was
predicated on data that were erroneously generated, recorded, or transmitted, or on computational errors.
(ii) Every author of each such analysis, conclusion, or opinion, or as many
authors as can be contacted through
the use of reasonable diligence, has acknowledged in writing that the analysis, conclusion, or opinion was improper and has either corrected the
original analysis, conclusion, or opinion accordingly, or provided an explanation as to why it cannot be corrected.
(iii) As a result of the correction, the
information is no longer required to be
reported under FIFRA section 6(a)(2),
or if no correction was possible, the authors agree that the original analysis,
conclusion or opinion has no scientific
validity.
(2) Previously submitted information.
Information regarding an incident,
study, or other occurrence need not be
submitted if before the date on which
the registrant must submit such information, the registrant is aware that
the reportable information concerning
that incident, study, or other occurrence is contained completely in one of
the following:
(i) Documents officially logged in by
the EPA Office of Pesticide Programs.
(ii) EPA publications, EPA hearing
records, or publications cited in EPA
FEDERAL REGISTER notices.
(iii) Any other documents which are
contained in the official files and
records of the EPA Office of Pesticide
Programs.
(iv) Any documents officially logged
in by the EPA Office of Pollution Prevention and Toxics under the provisions of section 8(e) of the Toxic Substances Control Act, provided that if
the information pertains to a chemical
compound which, subsequent to the
submission of data under section 8(e),
becomes the subject of an application
for registration as a pesticide active
ingredient, information is submitted to

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§ 159.159

40 CFR Ch. I (7–1–16 Edition)

the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
(3) Publications. A published article or
report containing information otherwise reportable under this part need
not be submitted if it fits into either of
the following categories:
(i) Any scientific article or publication which has been abstracted in a
recognized database of scientific and
medical literature, such as Medline,
ENBASE, Toxline or Index Medicus, if
the abstract in question clearly identified the active ingredient or the registered pesticide(s) to which the information pertains. Otherwise reportable
information received by or known to
the registrant prior to publication of
an abstract concerning the information
must be reported and may not be withheld pending such publication.
(ii) Reports or publications which
have been made available to the public
by any of the following Federal agencies: Centers for Disease Control and
Prevention, Consumer Products Safety
Commission, Department of Agriculture, Department of the Interior,
Food and Drug Administration or any
other agency or institute affiliated
with the Department of Health and
Human Services. Otherwise reportable
information concerning research which
was performed, sponsored, or funded by
the registrant which may also appear
in forthcoming Government reports or
publications must be reported and may
not be withheld pending publication.
(4) Information concerning former
inerts, contaminants or impurities. Notwithstanding any other provisions of
this part, a registrant need not report
information concerning a chemical
compound that was at one time an
inert ingredient or a contaminant or
impurity of a pesticide product, and
would otherwise be reportable under
this part, if both of the following conditions are met:
(i) The compound has been eliminated from its registered product due
to changes in manufacturing processes,
product formulation or by other
means.
(ii) The registrant has informed the
appropriate product manager in the Office of Pesticide Programs in writing of
the presence previously of the inert,
contaminant or impurity in the prod-

uct and its subsequent elimination
from the product.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998]

§ 159.159 Information obtained before
promulgation of the rule.
(a) Notwithstanding any other provision of this part, information held by
registrants on August 17, 1998 which
has not been previously submitted to
the Agency, but which is reportable
under the terms of this part, must be
submitted to the Agency if it meets
any of the following criteria:
(1) Information is otherwise reportable under § 159.184, and pertains to an
incident that is alleged to have occurred on or after January 1, 1994, and
to have involved any of the following:
(i) A fatality or hospitalization of a
human being.
(ii) A fatality of a domestic animal.
(iii) A fatality or fatalities to fish or
wildlife, if the incident meets the criteria for the exposure type and severity
category designation ‘‘W-A’’ set forth
in § 159.184(c)(5)(iii).
(2) Submission of the information is
requested by the Agency pursuant to
§ 159.195(c).
(b) If a registrant possesses information required to be submitted by paragraph (a)(1) of this section, the registrant must submit on or before June
16, 1999 in accordance with § 159.156(c),
(d), and (e) an inventory of the incidents that meet the requirements of
paragraphs (a)(1) of this section. Such
an inventory must include the separate
number of incidents that meet the requirements of paragraphs (a)(1)(i),
(a)(1)(ii), and (a)(1)(iii) of this section,
and for each type of incident, the total
numbers of fatalities or hospitalizations involved.
(c) If a registrant possesses information required to be submitted by paragraph (a)(2) of this section, the information must be submitted in accordance with any schedule contained in
the Agency’s request for the information.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998, as amended at 63 FR 41193, Aug. 3,
1998]

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Environmental Protection Agency

§ 159.165

§ 159.160 Obligations of former registrants.
(a) General. A former registrant is
obliged to continue to submit information concerning the registration of a
pesticide product previously held by
the registrant and otherwise reportable
under the provisions of this part for a
period of 5 years after the registration
of the pesticide product has been canceled or transferred to another registrant, with the exceptions provided
by paragraph (b) of this section.
(b) Exceptions. Notwithstanding the
provisions of paragraph (a) of this section, a former registrant is not obligated to report information pursuant
to this part if any of the following conditions are applicable:
(1) The information is first obtained
by the person more than 1 year after
the date on which the person ceased to
hold the registration of the product to
which the information pertains, and
the person holds no active pesticide
registrations, or for some other reason
cannot reasonably be expected to receive information concerning the formerly registered product.
(2) The information is associated
solely with an inert ingredient, contaminant, impurity, metabolite, or
degradate contained in a product, and
the information is first obtained by the
person more than 1 year after the date
upon which the person ceased to hold
the registration of the product.
(3) The information is associated
with an active ingredient or a formerly
registered product, and the active ingredient or every active ingredient
contained in the formerly registered
product has not been contained in any
pesticide product registered in the
United States for any part of the 3–
year period preceding the date on
which the person first obtained the information.
(4) The information pertains solely to
a formerly registered product that no
longer meets the definition of ‘‘pesticide’’ in section 2(u) of FIFRA.
(c) Information arising from litigation.
Notwithstanding any other provisions
of this section, a former registrant is
obliged to submit information otherwise reportable under this part concerning formerly-registered pesticide
products which arises in the course of

litigation concerning the effects of
such products, regardless of when the
information is first acquired, provided
that neither of the provisions of paragraphs (b)(3) or (b)(4) of this section are
met. Such information shall be submitted in the same manner and according to the same schedules as it would
have to be submitted by a current registrant of a pesticide product to which
the information pertained.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998, as amended at 73 FR 75596, Dec. 12,
2008]

§ 159.165 Toxicological and ecological
studies.
Adverse effects information must be
submitted as follows:
(a) Toxicological studies. (1) The results of a study of the toxicity of a pesticide to humans or other non-target
domestic organisms if, relative to all
previously submitted studies, they
show an adverse effect under any of the
following conditions:
(i) That is in a different organ or tissue of the test organism.
(ii) At a lower dosage, or after a
shorter exposure period, or after a
shorter latency period.
(iii) At a higher incidence or frequency.
(iv) In a different species, strain, sex,
or generation of test organism.
(v) By a different route of exposure.
(2) Acute oral, acute dermal, acute
inhalation or skin and eye irritation
studies in which the only change in
toxicity is a numerical decrease in the
median lethal dose (LD50), median lethal concentration (LC50) or irritation
indices, are not reportable under this
part unless the results indicate a more
restrictive toxicity category for labeling under the criteria of 40 CFR 156.62.
(b) Ecological studies. The results of a
study of the toxicity of a pesticide to
terrestrial or aquatic wildlife or plants
if, relative to all previously submitted
studies, they show an adverse effect
under any of the following conditions:
(1) At levels 50 percent or more lower
than previous acute toxicity studies
with similar species, including determinations of the median lethal dose
(LD50), median lethal concentration
(LC50), or median effective concentration (EC50).

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§ 159.167

40 CFR Ch. I (7–1–16 Edition)

(2) At lower levels in a chronic study
than previous studies with similar species.
(3) In a study with a previously untested species the results indicate the
chronic no observed effect level (NOEL)
is 10 percent or less of the lowest LC50
or LD50 for a similar species.
(4) For plants when tested at the
maximum label application rate or
less, if either of the following conditions is met:
(i) More than 25 percent of terrestrial
plants show adverse effects on plant
life cycle functions and growth such as
germination, emergence, plant vigor,
reproduction and yields.
(ii) More than 50 percent of aquatic
plants show adverse effects on plant
life cycle functions and growth such as
germination, emergence, plant vigor,
reproduction and yields.
(c) Results from a study that demonstrates any toxic effect (even if corroborative of information already
known to the Agency), must be submitted if the pesticide is or has been
the subject of a Formal Review based
on that effect within 5 years of the
time the results are received. Within 30
calendar days of the publication of a
Notice of Commencement of a Formal
Review in the FEDERAL REGISTER, all
information which has become reportable due to the commencement of the
Formal Review must be submitted.
(d) Incomplete studies. Information
from an incomplete study of the toxicity to any organism of a registered
pesticide product or any of its ingredients, impurities, metabolites, or degradation products which would otherwise be reportable under paragraphs
(a), (b) or (c) of this section must be
submitted if the information meets any
one of the folowing three sets of criteria:
(1) Short-term studies. A study using a
test regimen lasting 90 calendar days
or less, and all of the following conditions are met:
(i) All testing has been completed.
(ii) A preliminary data analysis or
gross pathological analysis has been
conducted.
(iii) Final analysis has not been completed.
(iv) A reasonable period for completion of the final analysis not longer

than 90 calendar days following completion of testing has elapsed.
(v) Comparable information concerning the results of a completed
study would be reportable.
(2) Long-term studies. A study using a
test regimen lasting more than 90 calendar days, and all of the following
conditions are met:
(i) All testing has been completed.
(ii) A preliminary data analysis or
gross pathological analysis has been
conducted.
(iii) Final analysis has not been completed.
(iv) A reasonable period of completion of final analysis (not longer that 1
year following completion of testing)
has elapsed.
(v) Comparable information concerning the results of a completed
study would be reportable.
(3) Serious adverse effects. Any study
in which testing or analysis of results
is not yet complete but in which serious adverse effects have already been
observed which may reasonably be attributed to exposure to the substances
tested, because the effects observed in
exposed organisms differ from effects
observed in control organisms, are
atypical in view of historical experience with the organism tested, or otherwise support a reasonable inference
of causation, and 30 days have passed
from the date the registrant first has
the information.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998; 73 FR 75597, Dec. 12, 2008]

§ 159.167 Discontinued studies.
The fact that a study has been discontinued before the planned termination must be reported to EPA, with
the reason for termination, if submission of information concerning the
study is, or would have been, required
under this part.
§ 159.170 Human epidemiological and
exposure studies.
Information must be submitted
which concerns any study that a person
described in § 159.158(a) has concluded,
or might reasonably conclude, shows
that a correlation may exist between
exposure to a pesticide and observed
adverse effects in humans. Information
must also be submitted which concerns

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Environmental Protection Agency

§ 159.179

exposure monitoring studies that indicate higher levels of risk or exposure
than would be expected based on previously available reports, data, or exposure estimates. Such information
must be submitted regardless of whether the registrant considers any observed correlation or association to be
significant.

taminant level (MCL) or health advisory level (HAL) for that substance, or
has estimated a health advisory level
based on an established reference dose
(RfD) for that substance, and notified
registrants of that level.
(5) Information to be submitted is the
same as that required in § 159.184(c)(1),
(2), (3), (4)(iv) and (v), and (5)(vi).

§ 159.178 Information on pesticides in
or on food, feed or water.
(a) Food and feed. Information must
be submitted if it shows that the pesticide is present in or on food or feed at
a level in excess of established levels,
except that information on excess residues resulting solely from studies conducted under authority of FIFRA section 5 or under other controlled research studies conducted to test a pesticide product need not be submitted,
provided that the treated crop is not
marketed as a food or feed commodity.
The information to be submitted is the
same as that required in § 159.184(c)(1),
(2), (3), and (4)(iv)(E), (F), (G), and (H).
(b) Water. (1) Information must be
submitted if it shows that a pesticide is
present above the water reference level
in any of the following instances:
(i) Waters of the United States, as defined in § 122.2 of this chapter, except
paragraph (d) of § 122.2.
(ii) Ground water.
(iii) Finished drinking water.
(2) If the lowest detectable amount of
the pesticide is reported, the detection
limit must also be reported.
(3) Information need not be submitted regarding the detection of a
pesticide in waters of the United States
or finished drinking water if the pesticide is registered for use in finished
drinking water or surface water and
the amount detected does not exceed
the amounts reported by a registrant
in its application for registration, as
resulting in those waters from legal applications of the pesticide.
(4) Information need not be submitted concerning detections of pesticides in waters of the United States,
ground water or finished drinking
water if the substance detected is an
inert ingredient, or a metabolite,
degradate, contaminant or impurity of
a pesticide product, unless EPA has established or proposed a maximum con-

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998]

§ 159.179 Metabolites, degradates, contaminants, and impurities.
(a) Metabolites and degradates. Information which shows the existence of
any metabolite or degradate of a pesticide product must be submitted if either of the following conditions is met:
(1) The metabolite or degradate may
occur or be present under conditions of
use of the pesticide product, and the
existence
of
the
metabolite
or
degradate or the association of the metabolite or degradate with the pesticide
product has not been previously reported to EPA.
(2) The metabolite or degradate has
been previously reported, but it is detected at levels higher than any previously reported; and either of the following conditions is met:
(i) Any person described in § 159.158(a)
has concluded that the metabolite or
degradate may pose a toxicological or
ecological risk based on any one or
more of the following:
(A) The physical or chemical properties of the metabolite or degradate.
(B) Data regarding structurally analogous chemicals.
(C) Data regarding chemical reactivity of the metabolite or degradate
and structurally analogous substances.
(D) Data on the metabolite or
degradate.
(ii) The registrant has concluded, or
has been advised by any person described in § 159.158(a) that the metabolite or degradate, or analogous chemicals, may have any experimentally determined half-life greater than 3 weeks
as shown from laboratory aerobic soil
metabolism studies or field dissipation
studies, or may have any experimentally determined resistance to
hydrolytic degradation, or photolytic
degradation on soil or in water, under

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§ 159.184

40 CFR Ch. I (7–1–16 Edition)

any conditions, resulting in degradation of less than 10 percent in a 30-day
period.
(b) Contaminants and impurities. The
presence in any pesticide product of a
contaminant or impurity not previously identified by the registrant as
part of the pesticide product’s approved
composition must be reported pursuant
to this part if the contaminant or impurity is present in the product in any
of the following quantities:
(1) Quantities greater than 0.1 percent by weight (1,000 parts per million).
(2) Quantities that EPA considers,
and so informs registrants, to be of
toxicological significance.
(3) Quantities that the registrant
considers to be of toxicological significance.
(4) Quantities above a level for which
the registrant has information indicating that the presence of the contaminant or impurity may pose a risk
to health or the environment.
(5) Quantities that a person described
in § 159.158(a) has informed the registrant is likely to be of toxicological
significance.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June
19, 1998]

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§ 159.184 Toxic or adverse effect incident reports.
(a) General. Information about incidents affecting humans or other nontarget 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 nontarget 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 re-

ported 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
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 nontarget 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

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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).
(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:

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40 CFR Ch. I (7–1–16 Edition)

(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,
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

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Environmental Protection Agency

§ 159.184

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
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 nontarget 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.

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§ 159.188

40 CFR Ch. I (7–1–16 Edition)

(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
§ 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 re-

port to the Agency, a registrant acquires additional information concerning that incident, the information
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 HA, 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]

§ 159.188 Failure of performance information.
(a) Microorganisms that pose a risk to
human health. Information must be
submitted which concerns either incidents described in paragraph (a)(1) of
this section or a study described in
paragraph (a)(2) of this section:
(1) Information which concerns an incident which meets all of the following
conditions:
(i) The registrant has been informed
that a pesticide product may not have
performed as claimed against target
microorganisms.
(ii) The possible failures of the pesticide to perform as claimed involved
the use against microorganisms which
may pose a risk to human health.
(iii) The pesticide product’s use site
is other than residential.

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Environmental Protection Agency

§ 159.195

(iv) 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.
(2) A study which indicates that the
pesticide may not perform in accordance with one or more claims made by
the registrant regarding uses intended
for control of microorganisms tha may
pose a risk to human health, including
any of the public health antimicrobials
identified in part 161 of this chapter.
(b) Animals that pose a risk to human
health. For the purposes of this section,
any animal (including insects) poses a
risk to human health if it may cause
disease in humans, either directly or as
a disease vector; produce toxins that
are harmful to humans; or cause direct
physical harm to humans. Information
must be submitted which concerns either incidents described in paragraph
(b)(1) of this section or a study described in paragraph (b)(2) of this section.
(1) Information which concerns an incident which meets all of the following
conditions:
(i) The registrant has been informed
by municipal, State, or Federal public
health officials that a pesticide product may not have performed as claimed
against target animals.
(ii) The possible failures of the pesticide to perform as claimed involved
the use against animals that pose a
risk to human health.
(iii) 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.
(2) A study which indicates that the
pesticide may not perform in accordance with one or more claims by the
registrant regarding uses intended for
control of animals that pose a risk to
human health, including any of the
public health pesticides identified in
part 158 of this chapter.
(c) Development of pesticide resistance.
Information must be submitted concerning substantiation of any incident
of a pest having developed resistance to
any pesticide (both public health and
non-public health) that occurred under

conditions of use, application rates and
methods specified on the label if either
of the following conditions is met:
(1) The survival of the suspected pesticide-resistant pest was significantly
higher than that of a known susceptible pest when both the suspected resistant and susceptible pests were
treated with the pesticide under controlled conditions.
(2) Biochemical tests or DNA sequencing indicate that the pest is resistant to the pesticide.
[63 FR 49388, Sept. 19, 1997, as amended at 72
FR 61029, Oct. 26, 2007]

§ 159.195 Reporting of other information.
(a) The registrant shall submit to the
Administrator information other than
that described in §§ 159.165 through
159.188 if the registrant knows, or reasonably should know, that if the information should prove to be correct, EPA
might regard the information alone or
in conjunction with other information
about the pesticide as raising concerns
about the continued registration of a
product or about the appropriate terms
and conditions of registration of a
product. Examples of the types of information which must be provided if
not already reportable under some
other provision of this part include but
are not limited to information showing:
(1) Previously unknown or unexpected bioaccumulation of a pesticide
by various life forms.
(2) Greater than anticipated drift of
pesticides to non-target areas.
(3) Use of a pesticide may pose any
greater risk than previously believed
or reported to the Agency.
(4) Use of a pesticide promotes or creates secondary pest infestations.
(5) Any information which might
tend to invalidate a study submitted to
the Agency to support a pesticide registration.
(b) A registrant is not obligated
under paragraph (a) of this section to
provide information to the Administrator if the registrant is aware of
facts which establish that otherwise reportable information is not correct.
(c) The registrant shall submit to the
Administrator information other than
that described in §§ 159.165 through

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159.188 if the registrant has been informed by EPA that such additional information has the potential to raise
questions about the continued registration of a product or about the appropriate terms and conditions of registration of a product.

Subpart G—Protocol for and Conduct of a
Study
160.120 Protocol.
160.130 Conduct of a study.
160.135 Physical and chemical characterization studies.

Subparts H–I [Reserved]

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

PART 160—GOOD LABORATORY
PRACTICE STANDARDS
Subpart A—General Provisions
Sec.
160.1 Scope and applicability.
160.3 Definitions.
160.10 Applicability to studies performed
under grants and contracts.
160.12 Statement of compliance or non-compliance.
160.15 Inspection of a testing facility.
160.17 Effects of non-compliance.

Subpart B—Organization and Personnel
160.29
160.31
160.33
160.35

Subpart J—Records and Reports
160.185 Reporting of study results.
160.190 Storage and retrieval of records and
data.
160.195 Retention of records.

Personnel.
Testing facility management.
Study director.
Quality assurance unit.

Subpart C—Facilities
160.41 General.
160.43 Test system care facilities.
160.45 Test system supply facilities.
160.47 Facilities for handling test, control,
and reference substances.
160.49 Laboratory operation areas.
160.51 Specimen and data storage facilities.

Subpart D—Equipment

AUTHORITY: 7 U.S.C. 136a, 136c, 136d, 136f,
136j, 136t, 136v, 136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.
SOURCE: 54 FR 34067, Aug. 17, 1989, unless
otherwise noted.

Subpart A—General Provisions
§ 160.1

Scope and applicability.

(a) This part prescribes good laboratory practices for conducting studies
that support or are intended to support
applications for research or marketing
permits for pesticide products regulated by the EPA. This part is intended
to assure the quality and integrity of
data submitted pursuant to sections 3,
4, 5, 8, 18 and 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act,
as amended, and section 408 or 409 of
the Federal Food, Drug and Cosmetic
Act.
(b) This part applies to any study described by paragraph (a) of this section
which any person conducts, initiates,
or supports on or after October 16, 1989.
[73 FR 75597, Dec. 12, 2008]

160.61 Equipment design.
160.63 Maintenance and calibration of equipment.

Subpart E—Testing Facilities Operation
160.81
160.83
160.90

Standard operating procedures.
Reagents and solutions.
Animal and other test system care.

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Subpart F—Test, Control, and Reference
Substances
160.105 Test, control, and reference substance characterization.
160.107 Test, control, and reference substance handling.
160.113 Mixtures of substances with carriers.

§ 160.3

Definitions.

As used in this part the following
terms shall have the meanings specified:
Application for research or marketing
permit means any of the following:
(1) An application for registration,
amended registration, or reregistration
of a pesticide product under FIFRA
sections 3, 4 or 24(c).
(2) An application for an experimental use permit under FIFRA section 5.
(3) An application for an exemption
under FIFRA section 18.

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