159.159—Information obtained before promulgation of the rule.
(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.
(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to FIFRA section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 CFR part 152 apply to this part unless superseded by a definition in paragraph (b) of this section.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 section 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 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.
Code of Federal Regulations
(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:
(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; provided 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.
Code of Federal Regulations
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.
(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.
Code of Federal Regulations
(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.
(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:
(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 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 product and its subsequent elimination from the product.
Code of Federal Regulations
(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:
(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).
(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.