# AttachmentB

Final Regulation for FIFRA Section 6(a)(2) Reports Codified as 40 CFRpart 159

(available electronicallyat http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ccfr&sid=c132624ebd03eaaI

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Title40: Protection of Environment
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### PART 159-STATEMENTSOF POLICIES AND INTERPRETATIONS

Section Contents 

### Subparts A-C [Reserved] Subpart D-Reporting Requirements for Risk/Benefit Information 

### § 159.152 

### What the law requires of registrants. 

### § 159.153 

### Definitions. 

### § 159.155 

### When information must be submitted. 

### § 159.156 

### How information must be submitted. 

### § 159.158 

### What information must be submitted. 

### § 159.159 

### Information obtained before promulgation of the rule. 

### § 159.160 

### Obligations of former registrants. 

### § 159.165 

### Toxicological and ecological studies. 

### § 159.167 

### Discontinued studies. 

### § 159.170 

### Human epidemiological and exposure studies. 

### § 159.178 

### Information on pesticides in or on food, feed or water. 

### § 159.179 

### Metabolites, degradates, contaminants, and impurities. 

### § 159.184 

### Toxic or adverse effect incident reports. 

### § 159.188 

### Failure of performance information. 

### § 159.195 

### Reporting of other information.



### Authority: 7 

### U.S.C. 136-136y. 

### Source: 63 

### FA 49388, 

### Sept. 19, 1997, 

### unless otherwise noted. Subparts A-C [Reserved] 

### liltop Subpart D-Reporting Requirementsfor Risk/Benefit Information 

### liltop § 159.152 Whatthe law requires of registrants.



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### IIJtop (a) Section 6(a)(2) ofthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) states: "If at any time afterthe registration ofa pesticide the registrant hasadditional 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 ofan application for registration, anyfactual information ofwhich he is aware regarding unreasonable adverse effects ofthe pesticide on humans orthe environment, which would be required to be reported under section 6(a)(2) if the product were registered. (c) Compliance with this partwill satisfy a registrant's obligations to submit additional information pursuantto section 6(a)(2) and will satisfy an applicant's obligation to submit additional information pursuantto §152.50(f)(3) ofthis chapter. 

### § 159.153 Definitions. 

### IIJtop (a) Forthe 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 onlyto this part: Establishedlevelmeans a tolerance, temporary tolerance, food additive regulation, action level, or other limitation on pesticide residues imposed by law, regulation, orother authority. Formal Reviewmeans Special Review, Rebuttable Presumption Against Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA section 6(b) cancellation proceeding, whether completed or not. Hospitalization means admission fortreatment to a hospital, clinic orother health care facility. Treatment as an out-patient is not considered to be hospitalization. Maximum contaminantlevel (MCL) means the maximum permissible level, established by EPA, for a contaminant in water which is delivered to any user ofa public water system. Non-targetorganism means any organism for which pesticidal control was either not intended or not legally permitted by application ofa pesticide. Pesticide means a pesticide product which is orwas registered by EPA, and each active ingredient, inert ingredient, impurity, metabolite, contaminant or degradate contained in, or derived from, such pesticide product. Qualifiedexpertmeans 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 tothe subject matter on which he or she renders a conclusion or opinion. Under Rule 702 ofthe 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 registrantsto 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. Registrantincludes any person who holds, or ever held, a registration for a pesticide product issued under FIFRA section 3 or 24(c). J. "5'-" "-' VJ. J.7



## http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=cl32624ebd03eaale75bb9baacc3... 7/14/2006Similarspecies means two or more species belonging to the same general taxonomic groups: The general taxonomic groupsfor purposes ofthis 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. Waterreference /eve meansthe level specified in paragraph (1) or (2) ofthis definition, whichever is lower. (1) Ten percent ofthe maximum contaminant level (MCL) established by EPA, or if no MCL has been established by EPA, 10 percent ofthe 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 ofthe pesticide. (2) The ambientwater quality criteria for the protection ofaquatic life, established by EPA pursuant to section 304(a) ofthe Clean WaterAct. [62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998] 

### § 159.155 When information must be submitted. liJtop (a) The following reportable information must be received by EPA not laterthan the 30th calendar day afterthe 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 ofa pesticide in or on food orfeed 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 ofa 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 ofthis part, a registrant possesses or knows of information atthe time any officer, employee, agent, or other person acting for the registrant first comes into possession of, or knows of, such information; provided that, such person performs any activities for the registrant related to the development, testing, sale or registration ofa pesticide orthe person could be reasonably expected to come into possession of information otherwise reportable underthis part. In the case of information known to or possessed by an agent orother person acting for the registrant, a registrant is responsible for such information only ifthe agent orother person acquired such information while acting forthe registrant. [63 FR 33582, June 19, 1998]



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§ 159.156 How information must be submitted. 

### li1top
A submission under FIFRA section 6(a)(2) must be delivered to the Office of Pesticide Programs' Document Processing Desk atthe appropriate address as set forth in 40 CFR 150.17(a) or (b). (a} Include a cover letterwhich contains the information requested in paragraphs (d) and (e) ofthis section, and a prominent statement that the information is being submitted in accordance with FIFAA section 6(a)(2). (b) Contain the name ofthe submitter, registrant name and registration number, date oftransmittal to EPA, thetype ofstudy or incident being reported under §§159.165 through 159.195, and a statement of why the information is considered reportable underthis part. (c) Identifythe substance tested orotherwise covered bythe 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 ofthis chapter. (f) Ifthe information is part of a larger package being submitted in orderto 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 underthis part. · (g) If a claim ofconfidentiality is made under FIFAA 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 ofthis chapter regarding the identification and segregation of information claimed to be confidential. (h) Ifa submission includes a study subject to the flagging requirements of §158.34 of this chapter, comply with the requirements of that section, and, ifthe 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 (MAID), cite the MAID. (2) Ifthe previous submission was an incident report to which no MAID numberwas assigned, cite the date ofthe initial submission of the incident information or report. [63 FA 49388, Sept. 19, 1997, as amended at69 FA 39864, July 1, 2004; 71 FA 35545, June 21, 2006] 

### § 159.158 What information must be submitted. 

### li1top (a} 

### General. Information which is reportable underthis part must be submitted ifthe registrant possesses or receives the information, and the information is relevant to the assessment ofthe risks or benefits of one or more specific pesticide registrations currently or formerly held bythe registrant. Information relevant tothe assessment ofthe risks or benefits also includes conclusion(s) or opinion(s) rendered by a person who meets any ofthe following: (1) Whowas employed or retained (directly or indirectly) by the registrant, and was likely to receive such information. 

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(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)

**Exception~(1)** 

### Clearlyerroneous information. Information need not be submitted if before that date on which the registrant must submit such information if all ofthe following conditions are met: (i) The registrant discoversthat any analysis, conclusion, or opinion was predicated on datathat were erroneously generated, recorded, ortransmitted, oron computational errors. (ii) Every author ofeach such analysis, conclusion, oropinion, or as many authors as can be contacted through the use of reasonable diligence, has acknowledged in writing thatthe analysis, conclusion, or opinion was improper and has either corrected the original analysis, conclusion, oropinion accordingly, or provided an explanation as to why it cannot be corrected. (iii) As a result ofthe 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 thatthe original analysis, conclusion oropinion has no scientific validity. (2) 

### Previouslysubmittedinformation. 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, orother occurrence is contained completely in one ofthe following: (i) Documents officially logged in bythe EPA Office of Pesticide Programs. (ii) EPA publications, EPA hearing records, or publications cited in EPA Federal Register notices. (iii) Any other documentswhich are contained in the official files and records ofthe EPA Office of Pesticide Programs

.. (iv) Any documents officially logged in bythe EPA Office of Pollution Prevention and Toxics underthe provisions ofsection 8(e) ofthe Toxic Substances Control Act, provided that ifthe information pertains to a chemical compound which, subsequenttothe submission ofdata under section 8(e), becomesthe subject ofan application for registration as a pesticide active ingredient, information is submitted to 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 underthis part need not be submitted if it fits into either ofthe 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, ifthe abstract in question clearly identified the active ingredient orthe registered pesticide(s) to which the information pertains. Otherwise reportable information received by or known to the registrant prior to publication ofan 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 ofthe following Federal agencies: Centersfor Disease Control and Prevention, Consumer Products Safety Commission, Department of Agriculture, Department ofthe 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, orfunded by the registrantwhich mayalso appear in forthcoming Government reports or publications must be reported and may not be withheld pending publication. (4) 

### Information concerning formerinerts, contaminants orimpurities. Notwithstanding any other provisions ofthis part, a registrant need not report information concerning a chemical compound that was at one time an inert ingredient or a contaminant or impurity ofa pesticide product, and would otherwise be reportable underthis part, if both ofthe following conditions are met: (i) The compound has been eliminated from its registered product dueto changes in manufacturing 

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processes, product formulation or by other means. (ii) The registrant has informed the appropriate product manager in the Office of Pesticide Programs in writing ofthe presence previously ofthe inert, contaminant or impurity in the product 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 ofthe rule. 

### liltop (a) Notwithstanding any other provision ofthis part, information held by registrants on August 17, 1998 which has not been previously submitted to the Agency, butwhich is reportable underthe terms ofthis part, must be submitted tothe Agency if it meets any ofthe following criteria: (1) Information is otherwise reportable under §159.184, and pertains to an incidentthat is alleged to have occurred on or afterJanuary 1, 1994, and to have involved any ofthe following: (i) A fatality or hospitalization of a human being. (ii) 

### Afatality ofa domestic animal. (iii) A fatality or fatalities to fish or wildlife, ifthe incident meetsthe criteria for the exposure type and severity category designation "W-A" set forth in §159.184(c)(5)(iii). (2) Submission ofthe information is requested bythe Agency pursuant to §159.195(c). (b) Ifa registrant possesses information required to be submitted by paragraph (a)(1) ofthis section, the registrant must submit on or before June 16, 1999 in accordance with §159.156(c), (d), and (e) an inventory ofthe incidentsthat meetthe requirements of paragraphs (a){1) ofthis section. Such an inventory must include the separate numberof incidentsthat meet the requirements of paragraphs (a)(1) (i), {a){1 )(ii), and (a)(1)(iii) ofthis 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) ofthis 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] 

### § 159.160 Obligations offormer registrants. 

### l1ltop (a) General. A former registrant is obliged to continue to submit information concerning the registration ofa pesticide product previously held bythe registrant and otherwise reportable underthe provisions of this part for a period of5 years afterthe registration ofthe pesticide product has been canceled or transferred to another registrant, with the exceptions provided by paragraph {b) ofthis section. (b) Exceptions. Notwithstanding the provisions of paragraph (a) ofthis section, a former registrant is not obligated to report information pursuanttothis part if any of the following conditions are applicable: (1) The information is first obtained bythe person morethan 1year afterthe date on which the person ceased to hold the registration ofthe product to which the information pertains, and the person holds no active pesticide registrations, orfor some other reason cannot reasonably be expected to receive information concerning the formerly registered product. 

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(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 1year afterthe date upon which the person ceased to hold the registration of the product. (3) The information is associated with an active ingredient ora 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 ofthe 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 (7 U.S.C. section 136(u)). (c) Information arising from litigation. Notwithstanding any other provisions ofthis section, a former registrant is obliged to submit information otherwise reportable underthis part concerning formerlyregistered pesticide products which arises in the course of litigation concerning the effects ofsuch products, regardless ofwhen the information is first acquired, provided that neither ofthe provisions of paragraphs (b)(3) or (b)(4) ofthis 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 productto which the information pertained. [62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998] 

### § 159.165 Toxicological and ecological studies. 

# III top Adverse effects information must be submitted as follows: (a) Toxicologicalstudies. (1) The results ofa study ofthe toxicity ofa pesticide to humans orother nontarget domestic organisms if, relative to all previously submitted studies, they show an adverse effect under any ofthe following conditions: (i) That is in a different organ ortissue ofthe test organism. (ii) At a lowerdosage, or after a shorter exposure period, or after a shorter latency period. (iii) At a higher incidence or frequency. (iv) In a differentspecies, strain, sex, orgeneration oftest organism. (v) By a different route ofexposure. (2) Acute oral, acute dermal, acute inhalation orskin 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 underthis part unlessthe results indicate a more restrictive toxicity category for labeling underthe criteria of 40 CFR 156.1O(h). (b) Ecologicalstudies. The results of a study ofthe toxicity of a pesticide toterrestrial or aquatic wildlife or plants if, relative to all previously submitted studies, they show an adverse effect under any ofthe following conditions: (1) At levels 50 percent or more lowerthan previous acute toxicity studies with similarspecies, including determinations ofthe median lethal dose (LD50), median lethal concentration (LC50), or median effective concentration (EC50). (2) At lower levels in a chronic study than previous studies with similar species. 

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(3) In a study with a previously untested species the results indicatethe chronic no observed effect level (NOEL) is 10 percent or less of the lowest LC50 or LD50 for a similar species. (4) For plantswhen tested atthe maximum label application rate or less, ifeither ofthe following conditions is met: (i) More than 25 percent ofterrestrial plants show adverse effects on plant life cycle functions and growth such as germination, emergence, plant vigor, reproduction and yields. (ii) Morethan 50 percent ofaquatic 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 anytoxic effect (even ifcorroborative of information already known tothe Agency), must be submitted ifthe pesticide is or has been the subject ofa Formal Review based on that effect within 5 years of the time the results are received. Within 30 calendar days ofthe publication ofa Notice of Commencement of a Formal Review in the Federal Register, all information which has become reportable due tothe commencement ofthe Formal Review must be submitted. (d) Incomplete studies. Information from an incomplete study ofthe toxicity to any organism ofa registered pesticide product orany of its ingredients, impurities, metabolites, ordegradation products which would otherwise be reportable under paragraphs (a), (b) or (c) ofthis section must be submitted if the information meets any one of the folowing three sets ofcriteria: (1) Short-term studies. A study using a test regimine 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 ofthe final analysis not longerthan 90 calendar daysfollowing completion oftesting has elapsed. (v) Comparable information concerning the results ofa completed study would be reportable. (2) Long-term studies. A study using a test regimine 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 ofcompletion offinal analysis (not longerthat 1year 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 oranalysis of results is notyet complete but in which serious adverse effects have already been observed which may reasonably be attributed to exposure tothe substances tested, because the effects observed in exposed organisms differfrom effects observed in control organisms, are atypical in view of historical experience with the organism tested, or otherwise support a reasonable inference ofcausation, and 30 days have passed from the date the registrant first has the information. 

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

### § 159.167 Discontinued studies.
IIJtop The fact that a study has been discontinued before the planned termination must be reported to EPA, with the reason fortermination, if submission of information concerning the study is, or would have been, required underthis part. 

### § 159.170 Human epidemiological and exposure studies. IIJtop Information must be submitted which concerns any study that a person described in §159.158(a) has concluded, or might reasonably conclude, showsthat a correlation may exist between exposure to a pesticide and observed adverse effects in humans. Information must also be submitted which concerns exposure monitoring studies that indicate higher levels of risk or exposure than would be expected based on previously available reports, data, orexposure estimates. Such information must be submitted regardless ofwhetherthe registrant considers any observed correlation or association to be significant. 

### § 159.178 Information on pesticides in or on food, feed or water. IIJtop (a) Foodandfeed. Information must be submitted if it shows that the pesticide is present in oron food or feed at a level in excess ofestablished levels, except that information on excess residues resulting solely from studies conducted under authority of FIFAA section 5 or under othercontrolled research studies conducted to test a pesticide product need not be submitted, provided that the treated crop is not marketed as a food orfeed 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 ofthe following instances: (i) Waters ofthe United States, as defined in §122.2 ofthis chapter, except paragraph (d) of§122.2. (ii) Ground water. (iii) Finished drinking water. (2) Ifthe lowest detectable amount ofthe pesticide is reported, the detection limit must also be reported. (3) Information need not be submitted regarding the detection of a pesticide in waters ofthe United States orfinished drinking water ifthe 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 ofthe pesticide. (4) Information need not be submitted concerning detections of pesticides in waters ofthe United States, grounq water orfinished drinking water ifthe substance detected is an inert ingredient, ora metabolite, degradate, contaminant or impurity ofa pesticide product, unless EPA has established or proposed a maximum contaminant level (MCL) or health advisory level (HAL) for that substance, or has estimated a health advisory level based on an established reference dose (AfD) for that substance, and notified registrants ofthat 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). 

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

### § 159.179 Metabolites, degradates, contaminants, and impurities. liJtop (a) Metabolites anddegradates. Information which shows the existence ofany metabolite ordegradate of a pesticide product must be submitted if either ofthe following conditions is met: (1) The metabolite ordegradate may occur or be present under conditions of use ofthe pesticide product, and the existence ofthe metabolite ordegradate or the association ofthe metabolite or degradate with the pesticide product has not been previously reported to EPA. (2) The metabolite ordegradate has been previously reported, but it is detected at levels higherthan any previously reported; and eitherofthe following conditions is met: (i) Any person described in §159.158(a) has concluded that the metabolite or degradate may pose a toxicological orecological risk based on any one or more ofthe following: (A) The physical or chemical properties ofthe metabolite or degradate. (B) Data regarding structurally analogous chemicals. (C) Data regarding chemical reactivity ofthe 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 ordegradate, or analogous chemicals, may have any experimentally determined half-life greaterthan 3 weeks as shown from laboratory aerobic soil metabolism studies orfield dissipation studies, or may have any experimentally determined resistance to hydrolytic degradation, or photolytic degradation on soil or in water, underany conditions, resulting in degradation of less than 10 percent in a 30-day period. (b) Contaminants andimpurities. The presence in any pesticide product of a contaminant or impurity not previously identified by the registrant as part ofthe pesticide product's approved composition must be reported pursuantto this part ifthe contaminant or impurity is present in the product in any ofthe following quantities: (1) Quantities greaterthan 0.1 percent byweight (1,000 parts per million). (2) Quantities that EPA considers, and so informs registrants, to be oftoxicological significance. (3) Quantitiesthatthe registrant considersto 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) Quantitiesthat 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] 

### § 159.184 Toxic or adverse effect incident reports. 

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liJtop (a) General. Information about incidents affecting humans or other non-target organisms must be submitted ifthe 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 informedthat the person or non-target organism suffered a toxic oradverse effect, or may suffer a delayed orchronic adverse effect in the future. (3) The registrant has orcould 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 ofthe following conditions are met: (1) The registrant is aware offacts which clearly establish thatthe reported toxic effect, or reported exposure, did not orwill not occur. (2) The registrant has been notified in writing bythe Agency that the reporting requirement has been waived for this incident orcategory of incidents, and the registrant has not been notified in writing by the Agency thatthe waiver is rescinded. (3) It concerns a toxic effectto non-target plants, which were at the use site atthe time the pesticide was applied, ifthe label provides adequate notice of such a risk. (4) It concerns non-lethal phytotoxicity tothe treated crop ifthe label provides an adequate notice of such a risk. (5) It concerns a toxic effectto pests not specified on the label, provided that such pests are similarto 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) Requiredinformation on individualincidents. Tothe extent that the registrant has any ofthe information listed in paragraphs (c)(1) through (c)(4) ofthis section, the registrant must supply the information on each pesticide incidentthat meetsthe requirements outlined in paragraph (a) ofthis section. Ifthe registrant acquires additional information concerning an incident previously reported tothe Agency underthis part, such information shall be reported if it meetsthe criteria set forth in paragraph (f) ofthis 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, exceptwhere the provisions of paragraph (e) ofthis 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 designationsfor each incident as set forth in paragraph (c)(5) ofthis section, depending on the applicability ofthe criteria listed below. The criteria listed should be used in assigning a category. For example, an incidentwhich 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, ifa single incident involves more than one type of non-target organism-forexample, both humans and domestic animals are involved-all appropriate available information dealing with each ofthe 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 ifthe registrant possesses or receives any ofthe following information, and the incident meetsthe minimum requirements set forth in paragraph (a) ofthis section: (i) Name of reporter, address, and telephone number. 

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(ii) Name, address, and telephone number of contact person (if differentthan reporter). (iii) Incident report status (e.g., new or update); if update, include the date oforiginal submission. (iv) Date registrant became aware ofthe 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 ifdifferentfrom reporting registrant. (2) Pesticide. Pesticide incident reports must be submitted for each pesticide that may have contributed tothe incident, ifthe registrant possesses or receives any ofthe following information, and the incident meetsthe 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 ifthe registrant possesses or receives any ofthe following information, andthe incident meets the minimum requirements set forth in paragraph (a) of this section: (i) Evidence the label directions were notfollowed (e.g., yes, no, unknown). (ii) How exposed (e.g., spill, drift, equipmentfailure, 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 (specifycrop), 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 ofthe incident. (4) Otherincidentspecific information. Pesticide incident reports must be submitted ifthe registrant possesses or receives any ofthe following information, and the incident meetsthe minimum requirements set forth in paragraph (a) ofthis section: (i) Ifthe incident involves humans: (A) Route ofexposure (skin, eye, respiratory, oral). (B) List signs/symptoms/adverse effects. 

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(C) If laboratory tests were performed, list name oftest(s) and results. (D) If available, submit laboratory report(s). (E) Time between exposure and onset ofsymptoms. (F) Was adverse effect the result ofsuicide/homicide orattempted 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 ofexposure; weight ofvictim. (K) Was exposure occupational; days lost due to illness. (L) Was protective clothing worn (specify). (ii) If domestic animal: (A) Type ofanimal (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 ofexposure (e.g., skin, eye, respiratory, oral). (E) Time between exposure and onset ofsymptoms. (F) If laboratorytest(s) performed, list name oftests 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 ofthe effect (e.g., miles ofstreams, square area ofterrestrial habitat). (D) Pesticide application rate, intended use site (e.g., corn, turf), and method of application. (E) Description ofthe habitat and the circumstances underwhich 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. 

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(I) If laboratorytest(s) performed, list name oftest(s) and results. (J) Ifavailable, submit laboratory report(s). (iv) Ifsurface water: (A) If raw water samples, water bodies sampled and approximate locations in each water body. (B) If raw water samples, proximity of sampling locationsto drinking water supply intakes and identities ofsystems supplied. (C) If finished water samples, water supply systems sampled. (D) If finished water samples, percent surface water source by specific surface watersources 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 ofanalysis. (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 ofapplications peryear. (I) Aquifer description (confined/unconfined). (J) Method ofapplication. (K) Years pesticide used. (L) Well use and well identifier. (M) Screened interval. (N) Annual cumulative rainfall (inches). (0) Maximum rainfall and date. 

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(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 andseveritycategorydesignations--(i) Humans. Ifan 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: Ifthe person died. (B) H-B: Ifthe 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 orexhibited symptoms more pronounced, more prolonged or ofa more systemic nature than minor symptoms. Usually some form oftreatment ofthe person would have been Indicated. Symptomswere not life threatening and the person has returned to his/herpre-exposure state of health with no additional residual disability. (D) H-D: Ifthe person alleged orexhibited some symptoms, but they were minimallytraumatic. The symptoms resolved rapidly and usually involve skin, eye or respiratory irritation. (E) H-E: Ifsymptoms are unknown, unspecified or are alleged to be of a delayed orchronic nature that may appear in the future. (ii) 

### Domesticanimals. Ifan effect involves a domestic animal, provide the appropriate 2-letter notation based upon the following categories: (A) D-A: Ifthe domestic animal died orwas euthanized. (B) D-B: Ifthe domestic animal exhibited or was alleged to have exhibited symptoms which may have been life-threatening or resulted in residual disability. (C) D-C: Ifthe domestic animal exhibited orwas alleged to have exhibited symptoms which are more pronounced, more prolonged orofa more systemic nature than minor·symptoms. Usually some form of treatment would have been indicatedtotreatthe animal. Symptomswere not life threatening and the animal has returned to its pre-exposure state of health with no additional residual disability. (D) D-D: Ifthe 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 orwildlife. If an alleged effect involvesfish orwildlife, label the incident W-A ifany ofthe following criteria are met, orW-B if none ofthe criteria are met: (A) Involves any incident caused by a pesticide currently in Formal Review forecological concerns. 

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(B) Fish: Affected 1,000 or more individuals ofa schooling species or50 or more individuals of a nonschooling species. (C) Birds: Affected 200 or more individuals ofa flocking species, or 50 or moreindividuals of a songbird species, or 5 or more individuals ofa predatory species. (D) Mammals, reptiles, amphibians: Affected 50 or more individuals of a relatively common or herding species or 5 or more individuals ofa rare orsolitary species. (E) Involves effects to, or illegal pesticide treatment (misuse) of a substantial tract of habitat (greater than orequal to 1 0 acres, terrestrial oraquatic). (F) Involves a major spill or discharge (greater than orequal to 5,000 gallons) ofa pesticide. (G) Involves adverse effects caused by a pesticide, tofederally listed endangered orthreatened species. (iv) Plants. If an alleged effect involves damage to plants, label the incident P-A ifthe following criterion is met, or P-B ifthe criterion is not met: (A) The effect is alleged to have occurred on more than 45 percent ofthe acreage exposed to the pesticide. (B) [Reserved] (v) Othernon-targetorganisms. If an alleged effect involves damage to non-target organisms otherthan fish, wildlife or plants (for example, beneficial insects), label the incident ONT. (vi) Watercontamination. If a pesticide is alleged to have been detected in groundwater, surface water orfinished drinking water, label the incident in accordance with the following criteria: (A) G-A: If the pesticide was detected at levels greaterthan the maximum contaminant level (MCL) or health advisory level (HAL) oran applicable criterion for ambient water quality. (B) G-B: If the pesticide was detected at levels greaterthan 10 percent ofthe MCL, HAL or a criterion for ambient water quality but does not exceed the MCL or other applicable level. (C) G-C: Ifthe pesticide was detected at levels less than 10 percent ofthe MCL, HAL, orother applicable level, orthere is no established level ofconcern. (vii) Propertydamage. 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 mannerthat could have caused direct human injury, such asfire orexplosion. (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 meetthe criteria of paragraphs (c)(5)(viO(A) or (B) ofthis section, including cases in which the level of damages is not specified. (d) Time requirements forsubmitting incidentinformation. Information concerning incidents reportable underthis 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, tothe extent it is available, no laterthan 15 days after learning of an allegation. 

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(2) Information concerning incidents which meetthe criteria for the following exposure and severity category labels described in paragraph (c)(5) ofthis section, reports ofdetections of pesticides in water, and efficacy failure incidents may be described in §159.188(a)(1) and (b)(1), may be accumulated for a 3D-day period, and submitted tothe Agency within 30 days afterthe end of each 3D-day accumulation period for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; Property Damage, PO-A. (3) Incidents or reports ofdetections 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 afterthe end ofeach 90-day accumulation period. (e) Aggregatedreports. For incidentsthat are reportable underthe 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 ofthe number of incidents, listed by product registration number (if known) oractive ingredient. (3) A count ofdomestic animal incidents in categories, otherthan D-A or D-B, which can be added together and reported as a single number. (f) Reportingadditionalinformation. If, afterthe submission ofan incident reporttothe 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, ifany ofthe following conditions apply: (1) The information concerns an alleged human fatality (H-A), and the information consists ofany ofthe elements listed in paragraphs (c){1) through (c)(4) ofthis section. (2) The information concerns an incident originally reported as alleging a major human illness or injury (H-B), orfatality to a domestic animal (0-A), or wildlife (W-A), and the additional information consists of pesticide or circumstance information listed in paragraphs (c){2) or (c)(3) ofthis section, or is a laboratory report concerning persons oranimals involved in the incident. (3) The information concerns any incident notoriginally reported with one ofthe exposure and severity labels H-A, or H-B for human incidents, or atthe "A" level ofseverity 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 incidenttype listed in paragraph (c)(5) ofthis section. [62 FA 49388, Sept. 19, 1997; 63 FA 33583, June 19, 1998] 

### § 159.188 Failure of performance information. lrJtop (a) Microorganisms thatpose a risk to human health. Information must be submitted which concerns either incidents described in paragraph (a)(1) ofthis section or a study described in paragraph (a)(2) of this section: (1) Information which concerns an incidentwhich meets all ofthe 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 asclaimed involved the use against microorganisms which may pose a risk to human health. (iii) The pesticide product's use site is otherthan residential. 

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(iv) The registrant has orcould obtain information concerning where the incident occurred, the pesticide or product involved, and the name ofa person to contact regarding the incident. (2) A studywhich indicatesthatthe pesticide may not perform in accordance with one or more claims made bythe registrant regarding uses intended for control of microorganismsthat may pose a risk to human health, including any ofthe public health antimicrobials identified in part 158 of this chapter. (b) Animals thatpose a risk to human health. Forthe purposes ofthis 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; producetoxins that are harmful to humans; or cause direct physical harm to humans. Information must be submittedwhich concerns either incidents described in paragraph (b)(1) ofthis section ora study described in paragraph (b)(2) ofthis section. (1) Information which concerns an incidentwhich meets all ofthe 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 againsttarget animals. (ii) The possible failures ofthe pesticide to perform as claimed involved the use against animalsthat pose a risk to human health. (iii) The registrant has orcould obtain information concerning where the incident occurred, the pesticide or product involved, and the name ofa person to contact regarding the incident. (2) A study which indicatesthatthe pesticide may not perform in accordance with one or more claims by the registrant regarding uses intended for control ofanimalsthat pose a risk to human health, including any ofthe public health pesticides identified in part 158ofthis chapter. (c) Developmentof pesticide resistance. Information must be submitted concerning substantiation ofany incident ofa pest having developed resistance to any pesticide (both public health and non-public health) that occurred underconditions of use, application rates and methods specified on the label if either ofthe following conditions is met: (1) The survival ofthe suspected pesticide-resistant pestwas significantly higherthan that ofa known susceptible pest when both the suspected resistant and susceptible pestswere treated with the pesticide undercontrolled conditions. (2) Biochemical tests or DNA sequencing indicate thatthe pest is resistanttothe pesticide. 

### § 159.195 Reporting of other information. 

### [i]top (a) The registrant shall submittothe Administrator information otherthan that described in 

### §§159.165 through 159.188 ifthe registrant knows, or reasonably should know, that ifthe information should prove to be correct, EPA might regard the information alone or in conjunction with other information aboutthe pesticide as raising concerns aboutthe continued registration of a product oraboutthe appropriate terms and conditions of registration of a product. Examples ofthe types of informationwhich must be provided if not already reportable under some other provision ofthis Part include butare not limitedto information showing: (1) Previously unknown or unexpected bioaccumulation ofa pesticide by various life forms. (2) Greaterthan anticipated drift of pesticidesto non-target areas. (3) Use of a pesticide may pose any greater risk than previously believed or reported to the Agency. (4) Use ofa pesticide promotes orcreates secondary pest infestations. 

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(5) Any information which mighttend to invalidate a study submittedtothe Agency to support a pesticide registration. (b) A registrant is not obligated under paragraph (a) ofthis section to provide information tothe Administrator ifthe registrant is aware offacts which establish that otherwise reportable information is notcorrect. (c) The registrant shall submitto the Administrator information otherthan that described in 

### §§159.165 through 159.188 ifthe registrant has been informed by EPA that such additional information hasthe potential to raise questions aboutthe continued registration ofa product or aboutthe appropriateterms and conditions of registration ofa product. [62 FA 49388, Sept. 19, 1997; 63 FA 33583, June 19, 1998] Browse Previous 

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