WPC 2J BNLZTimes Roman#|]:H]\  PCP"S^*8DSS888S^*8*.SSSSSSSSSS..^^^Jxooxf]xx8Axfxx]xo]fxxxxf8.8NS8JSJSJ8SS..S.SSSS8A.SSxSSJP!PZ8*888888888888S.xJxJxJxJxJooJfJfJfJfJ8.8.8.8.xSxSxSxSxSxSxSxSxSxSxJxSxSxSxS]SxJxJoJoJoJoJxSfJfJfJfJxSxSxSxSxSxS8S8S888SA8xSf.f8f8f.xSxSxSxSxSxo8o8o8]A]A]A]Af8f8xSxSxSxSxxSfJfJN:*LS8JSSSSS.4}}S2S}2JJS88SS]]8J2t^^\\^^ee*C^.wR)Ewn\1fy\r\S{v\rQMS PS 810QMPS810.PRS]\  PChhhhP2lH|LL Times RomanTimes Roman BoldTimes Roman ItalicTimes Roman Bold Italic"S^*A]SS888S_*8*.SSSSSSSSSS88___SoooxooxASofxxfxo]fxooff8.8_S8SSJSJ8S]..S.]SSSAA.]JoSJA:%:_8*888888888888S.oSoSoSoSoSxoJoJoJoJoJA.A.A.A.x]xSxSxSxSx]x]x]x]fJoSxSxSfJxSfSoSoSoJoJoJoJxSoJoJoJoJxSxSxSxSxS]ASASA8ASS8oSf.f8f8f.x]x]x]xSxSxoAoAoA]A]A]A]Af8f8x]x]x]x]ofJfAfAN:*SSASSSSSS,2}}S2}}S}2.SSS88SS]]8S2te_\\_eee*C_.wR)Ewn\1fy\r\`{v\r#|]"S^*8DSS888S^*8*.SSSSSSSSSS..^^^Jxooxf]xx8Axfxx]xo]fxxxxf8.8NS8JSJSJ8SS..S.SSSS8A.SSxSSJP!PZ8*888888888888S.xJxJxJxJxJooJfJfJfJfJ8.8.8.8.xSxSxSxSxSxSxSxSxSxSxJxSxSxSxS]SxJxJoJoJoJoJxSfJfJfJfJxSxSxSxSxSxS8S8S888SA8xSf.f8f8f.xSxSxSxSxSxo8o8o8]A]A]A]Af8f8xSxSxSxSxxSfJfJN:*LS8JSSSSS.4}}S2S}2JJS88SS]]8J2t^^\\^^ee*C^.wR)Ewn\1fy\r\S{v\r2 ZLXD L QMS PS 810QMPS810.PRS]\  PChhhhP"S^*8]SS888S_*8*.SSSSSSSSSS88___SxoxxofASoxfx]oxxxxo8.8aS8S]J]J8S].8].]S]]JA8]SxSSJB%BW8*888888888888].xSxSxSxSxSxxJoJoJoJoJA.A.A.A.x]SSSSx]x]x]x]xSxSSSxSxSf]xSxSxJxJxJxJx]oJoJoJoJSSSSS]A]A]A8A]S8]o.o8o8o.x]x]x]SSxxJxJxJ]A]A]A]Ao8o8x]x]x]x]xxSoJoJN:*ZS8SSSSSS27}}S2}}S}2.SSS88SS]]8S2t__\\__ee*C_.wR)Ewn\1fy\r\]{v\rNy.]8*:H]\  PCPNy.a8* _a4  p(AC<{,\8*-\*f9 xCXz-]8*0 ]9 xIC"S^*8FSS888Sq*8*.SSSSSSSSSS88qqqSffoxffxx8Jo]oxfxfS]xff]]A.AFS8SSJSJ.SS..J.xSSSSAA.SJoJJAC.CZ8*888888888888S.fSfSfSfSfSooJfJfJfJfJ8.8.8.8.oSxSxSxSxSxSxSxSxS]JfSxSxS]JxSfSfSfSoJoJoJoJxSfJfJfJfJxSxSxSxSxSxS8S8S888SJ8oJ].]8]8].oSoSoSxSxSofAfAfASASASASA]8]8xSxSxSxSo]J]A]AN:*WSASSSSSS.4}}S2S}2$]]S88SSSS8]2tqq\\qqee*Cq.wR)Ewn\1fy\r\S{v\r2  #]\  PC:HP#6 X01Í Í<X01Í Í 6  yO 6 -% September 24, 1992 6  yO  6  d  yO 3 Part VI 6  yO 6 '! Environmental Protection Agency 6  yO( 6  d  yO *% 40 CFR Parts 153 and 159  yO 6   Reporting Requirements for Risk/Benefit Information; Proposed Rule 6  zNh D(This reprint was prepared from the electronic file that accompanied the original signed documents 7transmitted to the Office of the Federal Register. This file was certified to be a true copy of the originals.) 6  yO  (This document appeared at 57 FR 44289 - 44304.) 6 0*(( 6  yO 6 XK yO @ Federal Register / Vol. 57, No. 186 / Thursday, September 24, 1991 / Proposed Rules d 6ԥ ENVIRONMENTAL PROTECTION AGENCY  yO  *% 40 CFR Parts 153 and 159 6  yO 6  [OPP - 60010C; FRL 4047 - 5]  yO I  Reporting Requirements for Risk/Benefit Information 6  yO 6  AGENCY: Environmental Protection Agency (EPA).  yO(  ACTION: Proposed rule. d  yOx  SUMMARY: EPA proposes to codify its interpretation regarding which failures to report information, or delays in reporting, will be regarded by EPA as violations of FIFRA section 6(a)(2), actionable under FIFRA sections 12(a)(2)(B)(ii) and 12(a)(2)(N). EPA's first enforcement policy regarding FIFRA section 6(a)(2) appeared in the  yO  Federal Register of July 12, 1979 (44 FR 40716). EPA took steps to amend and codify that policy by issuing a final  yO! rule and statement of policy which was published in the Federal Register of September 20, 1985 (50 FR 38115). That rule was not made effective by EPA because of comments received after it was published. Based on the comments, the Agency has revised the rule, and is now issuing a proposed rule which incorporates those revisions. The proposal revises the requirements for submission of information regarding pesticide ingredients, impurities, metabolites and degradates; it also contains changes intended to clarify the Agency's intent regarding whether and when to submit information pursuant to FIFRA section 6(a)(2). This rule is proposed under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.  yO'  DATES: Comments on this proposed rule will be accepted until November 23, 1992.'0*((Ԍ yO ԙ ADDRESSES: Submit written comments, bearing the identification number OPP-60010C, by mail to: Public Docket, Field Operations Division (H7506C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., SW., Washington DC 20460. In person deliver comments to: Public Docket Rm. 1132, CM # 2, 1921 Jefferson Davis Highway, Arlington, VA. Information submitted in any comment concerning the proposal may be claimed to be confidential by marking any or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice to the submitter. Comments will be available for public inspection in Room 1132 at the address given above, from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays.  yO  FOR FURTHER INFORMATION CONTACT: By mail: James V. Roelofs, and/or David Alexander, Office of Pesticide Programs (H7501C), U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Crystal Mall #2, Rm. 1115, 1921 Jefferson Davis Highway. Arlington, VA, (703) 305-7102.  yO  SUPPLEMENTARY INFORMATION:  {OH Electronic Availability: This document is available as an electronic file on The Federal Bulletin Board at 9 a.m.  yO on the date of publication in the Federal Register . By modem dial 202 - 512 - 1387 or call 202 - 512 - 1530 for disks or paper copies. This file is available in Postscript, Wordperfect 5.1 and ASCII. The 1985 rule was issued as a final interpretive rule as subpart D of 40 CFR part 153. This proposed rule is being issued for notice and comment as 40 CFR part 159, subpart D. This Supplementary Information is organized into five units. Unit I provides a brief history of the Agency's regulatory efforts regarding FIFRA section 6(a)(2). Unit II sets forth EPA's interpretation of section 6(a)(2) to provide a context for the proposed rule. Unit III provides a discussion of the basis for the proposed rule, and examples of how the rule is applied. Unit IV notes that this rule complies with section 25 of FIFRA, and that the FIFRA Scientific Advisory Panel waived review of the rule and the U.S. Department of Agriculture had no comments on the rule. Unit V demonstrates that promulgation of this rule complies with various regulatory review requirements, including Executive Order 12291, the Regulatory Flexibility Act, and the Paperwork Reduction Act. The last Unit is the text of the proposed rule. The proposed rule is organized as follows. General information appears in the earlier sections of the rule, and includes: the text of the relevant statutory requirements (159.152); definitions (159.153); provisions concerning when and how information must be submitted (159.155 - 159.156), and what information must be submitted (159.158). Sections 159.165 through 159.195 provide details on the specific types of information that give rise to reporting requirements. This rule is proposed pursuant to FIFRA section 25, 7 U.S.C. 136w. This proposal sets forth which ``reports'' must be submitted to satisfy the requirements of FIFRA section 12(a)(2)(B)(ii) and 12(a)(2)(N) insofar as they pertain to FIFRA section 6(a)(2). This rule does not require submission of all ``additional factual information'' which is within the scope of section 6(a)(2); it does describe that information for which EPA will hold registrants responsible  yO under FIFRA section 12. The July 12, 1979 Federal Register Notice contemplated later issuance of supplementary notices concerning types of information not specifically considered in the July 1979 Notice (See 44 FR 40717). This proposed rule should be considered such a supplementary notice. On January 2, 1992, the Agency issued a Notice to Manufacturers, Formulators, Producers and Registrants of Pesticide Products (PR Notice 92 - 1) to remind them of their statutory responsibilities under section 6(a)(2) and to provide general guidance. The PR Notice suggests that this proposed rule could be used as a guide to the Agency's 6(a)(2) policies. However, since this rule is not final, registrants are not obligated to meet reporting requirements which are being proposed for comment at this time. The requirements of the final rule may differ from the proposals due to information gained during the comment period.#0*%%Ԍ yO ԙ1 I. History 6  yO 6  Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136d(a)(2), 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.'' Section 6(a)(2) requires each registrant to submit any item of information in its possession which pertains to a pesticide product for which it holds or held a registration and which, if true, would be relevant to an evaluation of the risks and benefits of the pesticide product. Information consisting solely of certain unsolicited lay opinion or which has been previously submitted is an exception to this requirement. See the discussion in Unit II of this document and 159.158(b) and (d). On September 20, 1985, EPA issued a comprehensive codification of EPA's enforcement policy. In it, EPA codified its policy regarding the types of information EPA actually wants to have submitted under FIFRA section 6(a)(2). That codification amended the previous policy (44 FR 40716) by specifying that certain failures to submit information concerning pesticide residues in food, feed, ground water or elsewhere in the environment would be regarded as actionable violations of FIFRA section 6(a)(2). That codification also specified that most information had to be received by EPA within 15 working days of the time any officer, employee or other person acting for or employed by the registrant and capable of appreciating the significance of such information first comes into possession of, or knows, the information. The Agency invited comments on the September 20, 1985 rule and indicated that appropriate modifications to the rule would be considered on the basis of those comments. Comments and questions were received on many aspects of the rule from trade associations, public interest groups and individual registrants. Based on the Agency's review of the comments and questions it became apparent that clarification of the rule was appropriate. Accordingly, the rule proposed today, when effective, will supersede that rule and all previous policy statements pertaining to section 6(a)(2).  yO c II. General Interpretation Regarding the Type of Information That Must Be Submitted Under FIFRA /Section 6(a)(2) 6  yO 6  Section 6(a)(2) requires registrants to provide additional factual information to the Agency regarding unreasonable adverse effects on the environment of their pesticide products. The language of the statute limits the type of information to be submitted in three ways discussed here. First, it must be ``additional'' information. Second, it must be ``factual'' information. Third, it must be information ``regarding'' unreasonable adverse effects of the pesticide. Each of these three elements operates to reduce the required information from the total universe of ``all information.'' The first limiting factor is that the information be ``additional.'' The word ``additional'' must be read in the context of a statute that permits the Agency to require extensive information from an applicant before and after a registration is granted. Thus, ``additional'' information refers to information not already submitted by the registrant to the Agency.  {O  The second limiting factor, ``factual information,'' is not explained in the statute. In CSMA v. EPA, et. al., 484 F. Supp. 513 (D.D.C. 1980), the U. S. District Court for the District of Columbia offered its view that ``factual information,'' in the context of section 6(a)(2), did not include any opinion information, even expert opinion. This issue was not before the Court and because the Agency believes the Court's view is contrary to the weight of legal authority, the Agency has elected not to follow what it believes to be an incorrect reading of the statute. The Agency notes that, because it was not aggrieved by the District Court decision, it could not challenge the District Court's view of the scope of section 6(a)(2) in the Court of Appeals. In general, American courts have recognized that ``[t]he difference between so-called 'fact' and 'opinion' is not a difference between opposites or contrasting absolutes, but a mere difference in degree with no recognizable line#0*%%  {O to mark the boundary.'' (U.S. v. Pierson, 503 F. 2d 173, 176 (1974)). Formerly, the admissibility of evidence turned on the question of whether it was fact or opinion, but the courts now look to the value or utility of the evidence  {O rather than to its classification. (McCormick on Evidence, sec. 11 (1972); U.S. v. Pierson, cited above). Under sections 701 through 703 of the Federal Rules of Evidence, an expert's opinion and theories are admissible apart  {O$ from the information underlying the opinion (Rodriquez v. Olin Corp., 780 F.2d 491 (5th Cir. 1980), U.S. v.  {O Williams, 447 F.2d 1285 (5th Cir. 1971)).  yO  Consideration of this question was first set out in a 1978 opinion issued by EPA and published in the Federal  yO Register at 43 FR 3761, August 23, 1978. Key to that opinion was the meaning of ``factual information,'' which was discussed in terms of the likely function Congress intended this provision to serve. The opinion stated that under FIFRA section 6(a)(2) registrants must provide the Agency with information of the type it normally relies upon in making decisions under FIFRA. Thus, ``factual information'' was determined to include data from scientific studies, expert opinions and information about toxic or adverse incidents caused by the use of a pesticide. Additional guidance as to the meaning of ``factual information'' is provided by the commonly understood meaning of ``factual.'' Thus, the dictionary definition of factual includes ``something known with certainty,'' ``something asserted as certain,'' and ``something that has been objectively verified'' [American Heritage Dictionary of the American Language, Morris, Editor, Boston, 1976]. The common understanding of ``factual'' is that type of information which is more reliable than information which, for example, has not been verified, or is not known to be, or believed to be, certain. This definition would include more than just scientific data. It also contemplates any observed or verifiable information as well as information asserted to be correct, such as expert opinion. This reliability factor has been incorporated into these regulations. Only information which has a special degree of reliability is required to be submitted under these regulations. Thus, data developed in the course of a scientific study and reports of toxic or adverse effects can meet this standard of reliability because they are based on observations of tangible events. Expert opinion is also considered to be factual because the reliability of the opinions of experts is enhanced by their special training, knowledge and skill. In several instances where the boundary between factual and other types of information may be less clear, the Agency's proposed rule limits the scope of information which must be submitted by employing a test which takes into account the degree of reliability of information and EPA's need for it. Thus, an unsolicited report of a single toxic and adverse incident which is received by a registrant need not be submitted unless it concerns: (1) A toxic or adverse effect in a given species after exposure to a pesticide when that effect was not previously reported to the Agency, (2) a toxic or adverse effect in a given species after exposure to a pesticide when that effect is more severe than previously reported to the Agency, or (3) any toxic or adverse effects to humans or non-target organisms in which an expert or a person associated with the registrant concludes that there may be a causal connection between the use of the pesticide and the observed effect. Although reporting of other incidents could be required under the statute, the Agency has limited reporting of single incidents to meet the practical need of sorting out information which, if reported, would be of little value to the Agency in its decision making. The third limiting factor is the requirement that only information ``regarding'' unreasonable adverse effects of the pesticide need be submitted. ``Regarding'' in this context operates to require a causal connection between the use of the pesticide and the adverse effect. Here again, the statute and legislative history do not provide evidence regarding the strength or the proximity of the cause and effect. The strongest and closest link would result from a scientific study or risk assessment specifically designed to establish a causal link between the use of a pesticide and an adverse effect. A weaker and more distant link might result from an unsolicited report by a lay person of a single toxic and adverse incident in which the use of the pesticide and the toxic and adverse effect are separated in time or space and where observable connections between the two events are not reported. Although the causal connection in the latter case is adequate to meet the statutory standard, this situation is closer to the boundary between factual and other information. To avoid an extremely broad reporting requirement, the Agency's proposed rule does not require a single incident report to be submitted without an additional measure of either reliability or need. This measure is provided by the requirement found in the regulations, that the effect occur after exposure and be new,#0*%% more severe or that an expert or person associated with the registrant conclude that a causal connection between the use of the pesticide and the observed toxic and adverse effect may exist. This is the same requirement discussed above. It serves both to strengthen the factual reliability of information and is used here to establish both the need for the information and the causal link. (However, Unit III.D. discusses the requirement that records of such reports be retained for a specific period.) In a similar fashion, registrants are required to report a series of similar toxic and adverse incidents. As is the case with single incident reports, the causal link for some or all of the incidents which comprise a series may be weak. Although some of the reported incidents might meet neither the statutory standard nor the more rigorous standard regarding need or causality established by the proposed rule, every incident in the series must be reported. The series must be reported because a series of incidents contains an inherent factor which enhances the strength of the causal connection. The cumulative weight of several toxic and adverse incidents associated with use of the same pesticide provides both greater assurance of the existence of a causal link between use and the toxic and adverse effect than would result from a single incident report and a greater indication of need for the information on the part of the Agency. Thus, the requirement that there be expert opinion, intended to strengthen the causal link, or the requirement that there be known exposure followed by new or more severe effects, intended to demonstrate the Agency's need, are not needed for a report of a series of toxic and adverse incidents. When three or more organisms show toxic and adverse effects following exposure to a pesticide, it is more likely that a causal relationship exists than when only one organism is injured. Thus, when evidence indicates that many organisms can be injured, either at the same time or at different times, the Agency's concern is heightened.  yO &1 III. Basis of Policy and Examples 6  yO0 6  In this unit, EPA provides additional information and guidance concerning sections of the proposed rule. Examples of how the rule applies, and discussion of major changes from the 1985 rule are provided.  {M A. Who Must Submit Information Under FIFRA Section 6(a)(2)  {O  EPA believes all registrants are subject to FIFRA section 6(a)(2). Section 6(a)(2) imposes a requirement that a registrant submit certain information ``at any time after the registration of a pesticide.'' Although section 6(a)(2) does not directly address applicants, 40 CFR 152.50(f)(3) requires applicants for registration to submit with their applications any factual information regarding unreasonable adverse effects of the pesticide that would be required to be submitted by registrants under section 6(a)(2) if the product were registered. FIFRA section 2(y) defines registrant as any person ``. . . who has registered any pesticide pursuant to the provisions of [FIFRA].'' This statutory language suggests the term ``registrant'' should be viewed as including former holders of a registration. EPA also believes that the context of other statutory provisions where the term is used, as well as policy considerations, suggest that some obligations under FIFRA continue after a person has transferred a registration, or it has been canceled. First, FIFRA section 3(c)(2)(B), in giving the Administrator the authority to require the submission of data to support registration, speaks of ``existing registrants,'' thus suggesting that the term ``registrants'' may, in other contexts, apply to persons other than those who currently hold a registration. Second, although many obligations in FIFRA apply only to existing registrants, there are important policy reasons to subject former holders of registrations to the requirements of section 6(a)(2). These persons may obtain information that would be relevant to EPA's regulation of registrations currently held by other persons. A prior registrant may, for example, receive consumer complaints after it has sold a registration or it has been canceled. The registrant may also become involved in lawsuits regarding a product which has been transferred or canceled, or may obtain information as a result of distribution of a canceled pesticide outside of the United States, distribution by another registrant, or during the life of an existing stocks provision. Therefore, to remind registrants of their#0*%% continuing duty to comply with FIFRA section 6(a)(2), EPA defines ``registrant'' in 159.153(b) to include any person who has ever held a registration for a pesticide product under FIFRA sections 3 or 24. The policy that voluntary cancellation of a pesticide registration does not relieve the registrant of its duties under FIFRA section 6(a)(2) was announced in EPA's existing stocks policy at 56 FR 29367, June 26, 1991.  {M B. When to Submit Information Under FIFRA Section 6(a)(2)  {Ox  Section 6(a)(2) does not require investigation or other information-gathering efforts by registrants. Although time is provided to allow a basic investigation to be done by the registrant if he so chooses, nothing in this rule requires the conduct of an investigation. The time period for submission of incident reports begins when a registrant knows of the information. However, in order to assure that registrants have enough time to elevate information through their organizations, in 159.155(a) EPA is now proposing that information be submitted within 30 calendar days after any officer, employee, or agent of a registrant possesses or knows of the information. EPA solicits comment on whether a shorter, or longer, time period may be appropriate given EPA's need to analyze and act on information promptly, and a registrant's need to have adequate time to transmit data from a field office to headquarters, analyze it, and transmit it to EPA. If, in response to comment, EPA provides time in excess of 30 calendar days for registrants to submit information, EPA is hereby providing notice that it may establish dual time frames in which the most critical information would have to be submitted more promptly than other information. Therefore commenters who advocate establishment of a longer time frame are requested to specify which information can and should be submitted earlier, and why.  {M2 C. What Information to Submit Under Section 6(a)(2)  {O  Section 6(a)(2) does not require a registrant to gather information from outside its organization or to conduct investigations. FIFRA section 3(c)(2)(B) allows the Agency to impose such requirements. However, FIFRA section 14(b)(4) provides that an omission (such as a failure to report information) of any officer, agent, or other person acting for or employed by a registrant is to be regarded as the omission of the registrant. Therefore, although registrants have no duty to gather information from persons who have no obligation to them, registrants must develop a system for becoming aware of, and submitting, information known to their employees or agents. Section 159.158(a) makes clear that information may be reportable when the registrant possesses or knows of the information which pertains to a pesticide registered by the registrant. The requirement that information a registrant ``knows of'' is meant to require submission of relevant aurally or visually received information as well as written information. The provision that submittable information ``pertains to a pesticide registered to the registrant'' is meant to require submission of pertinent information regarding a registrant's pesticide, whether or not the information was actually generated with a pesticide produced by the registrant. Such submittable information may include generic studies and incidents involving competitors' products if they contain one or more ``pesticides'' in common, unless the information has previously been submitted. The term ``Pesticide'' is defined in 159.153(a)(3). Information possessed by, or known to, the registrant, such as relevant abstracts, must be submitted as well as information gained through voluntary investigations. In addition, 159.195 requires reporting of information other than the kinds specified in 159.165 through 159.188 if the registrant knows, or should know, that the information raises questions about the continued registrability or the terms and conditions of registration of a pesticide product. EPA wishes to clarify that, after EPA has informed a registrant, or a registrant's agent, that EPA considers such additional information to be pertinent to the question of whether the product's registrations should be canceled, suspended, or modified in some respect, the registrant or agent will undoubtedly be charged with actual knowledge that such questions have been raised. In 159.158(d), EPA has deleted the exceptions, formerly at 153.66(b)(2)(i)(B) and (D), from submitting#0*%% information contained in certain Federal or scholarly publications. This change does not require that registrants conduct literature searches or gather information from outside their organizations but if they are aware of it, they must submit appropriate information under section 6(a)(2). Submission of information which is wholly opinion information is limited. The limitation is contained in 159.158(b) and is discussed in Unit II. of this document.  {M D. How to Submit FIFRA Section 6(a)(2) Information  {O@  In order to bring important information to EPA's attention, 159.156(c) requires that information which is submitted under this rule include a prominent statement to that effect. In order to allow EPA to properly evaluate information submitted under this rule, 159.156(e) requires that all available information about a submittable event be provided, rather than only the information which makes the event submittable. This requirement includes all information that a registrant has or knows of as a result of an investigation. If a registrant knows of any additional information about an event or effect of concern that has been submitted, the additional information must also be submitted under 159.156(e) and the other provisions of this rule. For instance, if a series of incidents are reported under 159.184(c) or 159.188(b), a registrant must report any similar incident in accordance with the provisions of this rule. If a preliminary report of a toxicology study is submittable, the final report must also be submitted in accordance with the provisions of this rule. If a registrant knows of a follow-up, tiered, or other study regarding an effect which was the subject of a submission under this rule, information regarding that later study must be submitted in accordance with the provisions of this rule. In all of the above situations, a prominent reference in the later submission to the earlier submission and the fact that the earlier submission was submitted under FIFRA section 6(a)(2) will be sufficient to meet the requirements of 159.156(c) In order to permit EPA to enforce the requirements, under authority of FIFRA section 8(a), 159.157(a) requires registrants to retain a copy of each submission and proof of the time of the delivery to EPA for 5 years after delivery. Section 159.157(b) requires that information derived from any incident involving toxic effects to one or two individual humans, or involving one or two failures of efficacy of uses which were subject to a ``Formal Review'' (a Special Review proceeding--formerly called a Rebuttable Presumption Against Registration--under Part 154 of this chapter, or a cancellation or suspension proceeding under FIFRA section 6(b) or (c), respectively), or any information about organisms which may pose a risk to human health unless controlled be retained by the registrant and kept available for inspection for a period of 10 years from the date the registrant receives the information. Such information may become submittable under 159.184 or 159.188 during the 10 - year time period. Section 159.157(c) requires that information derived from any incident involving toxic effects to one or two individual non-target organisms be maintained and kept available for inspection for a period of 5 years from the date of the incident, unless the information need not be reported due to the exception in 159.184(c)(4). Such information may become submittable under 159.184(c) during the 5 - year time period. Section 159.157(d) reiterates the requirement in 40 CFR 169.2(k) requiring retention of research data for the life of the product. EPA may request access to any of these records during an inspection of a facility in which they are located.  {MB E. Submission of Toxicology Studies  {O  1. Basis of policy. The result of any study in which exposure to a pesticidal substance is associated with a toxic effect is clearly pertinent to evaluation of risk and is thus legally reportable under section 6(a)(2). However, unless an item of toxicological information provides new results as indicated in 159.165(a), or unless it suggests that reliance on material previously submitted to EPA may have resulted in underestimation of the level or degree of risk, or was otherwise inaccurate or incomplete, submission of such new information is not likely to affect the registration#0*%% status of products containing the substance tested. EPA ordinarily will not treat failure to submit toxicological information which is identical to previously submitted information as an actionable violation of section 6(a)(2); however in 159.165(a), the Agency insists on submission of any toxicological data which indicate that a pesticide may present different or greater risks than previously reported to EPA. When a particular pesticide is or was involved ``Formal Review,'' EPA's need for information is considerably greater. In such circumstances, the ultimate status of the pesticide depends on a comprehensive Agency reevaluation of the pesticide's risks and benefits, including an assessment of the reliability of previously submitted material and the extent to which it has been corroborated. Thus, if a particular substance is or was the subject of a Formal Review, EPA will treat failure to submit any toxicological information linking that substance with any toxic or adverse effect which was, or is, the subject of that proceeding as an actionable violation of section 6(a)(2), even if such information merely confirms or corroborates prior data. EPA does not now distinguish between reporting of results from complete, or incomplete toxicology studies. Information from either which shows a risk of a kind or degree not previously associated with the substance tested must be submitted within 30 calendar days after the information is known to the registrant, regardless of whether the study is complete. EPA has eliminated the requirement that toxicology studies be submitted solely because a product is in reregistration review.  {OH  2. Examples of how the rule will be applied. (a) A registrant conducts the first study of the acute effects of ingestion of a certain pesticide on rabbits. A prior acute study of the same pesticide using mice found that exposed mice experienced increased mortality due to liver damage. The registrant notes increased mortality of unknown origin in the exposed rabbits compared to control animals. The registrant may take a reasonable period, not exceeding 30 calendar days, for investigation of the significance and cause of the increased mortality. After that period has elapsed, failure to submit information concerning the study to EPA will be treated as an actionable violation of section 6(a)(2), regardless of whether or not the analysis is yet complete, because the information concerns a study in which toxic effects have been observed in a different species than previously reported. Of course, the registrant will always be entitled to supplement any initial submission with the results of subsequent analysis. (b) A foreign competitor of the registrant conducts a 2-year study of the effects of chronic exposure to a certain pesticide on rats. The pesticide is also in the registrant's pesticide product. Nine months after the study commences, the registrant learns at a meeting that study personnel observed that a large percentage of the exposed rats have developed ocular opacity of the type associated with formation of cataracts. None of the control rats exhibits a comparable abnormality. Though the test is incomplete and the evidence that the pesticide is inducing cataracts is not yet definitive, the ocular abnormalities seen in the rats may be attributable to exposure to the pesticide, and the observed effects must be reported to EPA within 30 calendar days of the date the registrant learned of the observation. Despite the fact that the registrant did not manufacture the actual pesticide tested, because the pesticide is also in the registrant's product, the information pertains to the registrant's pesticide and must be reported.  {M" F. Discontinued Studies  {O  Section 159.167 requires reporting of the reason(s) for cessation of a study whose results are reportable under this subpart within 30 days after work on the study stops, if testing is ceased before the time specified in the test protocol, or if work on analysis of results is ceased before completion. The requirement of 159.167 is designed to ensure that stopping work on a study will not serve to avoid submission requirements under this rule.  {M! G. Human Epidemiological and Exposure Studies  {O,#  Epidemiological studies can be indispensable sources of information on the critical issue of the risks associated with human exposure to pesticide products. Thus, it is important that EPA be able to examine independently the#0*%% relevance of any epidemiological information concerning pesticide exposure. The Agency will consider any failure to provide such information within 30 calendar days of receipt by the registrant to be an actionable violation of section 6(a)(2). Registrants may supplement any submission of epidemiological information with a statement describing any reservations they might have concerning the information's validity or significance but such information must be submitted under 159.170.  {M H. Submission of Information Concerning Pesticide Residues  {O@  1. Food or feed. Information on exposure is as important to assessment of the potential risk associated with use of a pesticide as data which indicate the toxicological effects of a pesticide. If monitoring or other information is available which is likely to allow EPA to better protect public health or assess environmental fate by refining exposure calculations, it is imperative that EPA receive that information. Data on ingredients, impurities, metabolites, or degradates are important to the Agency's efforts to verify or modify calculations of levels of exposure to these chemicals. The requirement to report information on active ingredients and their derivatives which are found in an amount above an established level on/in food or feed has been retained and expanded to require reporting of information on active and inert ingredients, impurities, metabolites and degradates which are found on/in food above established levels. EPA has announced in its Inert Ingredients in Pesticide Products Policy Statement, 52 FR 13305, April 22, 1987, pages 13307 - 13308, its policy of gathering exposure information for inert ingredients which may be of toxicological concern and issuing tolerances or exemptions from tolerance for inerts used on food. EPA is also gathering data on impurities which may be of concern. Accordingly, EPA sees no reason to distinguish in this rule between any components of pesticides with regard to reporting of residues on food or feed. Section 159.178(a) now requires reporting of information on any pesticide ingredient, impurity, metabolite or degradate found on or in food or feed above an established level. EPA establishes permissible levels of pesticides in food and feed by setting tolerances and promulgating food additive regulations under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA has added ``action levels'' set by the Food and Drug Administration (FDA) to the list in 159.153(b)(1) of levels of residues established for food and feed. If no levels have been established, information concerning any amounts of residue found on food or feed are required to be reported. If a pesticide has been exempted from the requirement of a tolerance, or is not subject to a tolerance, action level, or other established level and is known to be an innocuous part of the human diet, EPA has no interest in learning of any amounts of that substance in or on food or feed, unless that information would be relevant to a promulgated or issued requirement intended to allow conduct of a material-balance analysis to determine levels of exposure to amounts of substances which may be of concern. On the other hand registrants must provide EPA with any information which may show that residues resulting from pesticide use may exceed established levels, even if such excess levels may not reach the consumer. Therefore registrants must report information from studies showing that a single tested sample exceeds a tolerance, even if some tested composites in the same or a different study do not exceed the tolerance, and must report information from studies which show that the average tested sample of a composite exceeds a tolerance level. Recent information submitted to EPA demonstrated that residues of the pesticide aldicarb on individual samples of bananas exceeded tolerances, sometimes by large amounts, even though composite samples previously tested had never exceeded tolerance levels. EPA believes that it is critical that information on both individual samples and composite samples which may exceed tolerances or other established levels be submitted promptly so that EPA can assess the significance of the excess and the risk presented to public health and take any regulatory measures which may be needed. EPA will enforce this provision. This requirement is identical to the one included in 40 CFR 153.73 and 153.77, published on September 20, 1985, and EPA does not believe responsible parties could view this provision as excessively stringent. However, EPA solicits comment on this aspect of today's proposal and will give# 0*%% careful consideration to any comments. Section 159.178(a) clarifies that legal performance studies will not normally result in reportable information under this section. Specifically, information from legally conducted performance studies using application rates in excess of label rates will not normally constitute information reportable under this section. EPA strongly feels that the reporting requirements stated above will provide the Agency with meaningful information on potential adverse health or environmental effects that may result from there being unacceptable levels of pesticide active and inert ingredients, impurities, metabolites, and degradates in food or feed--even in cases where the tolerance exceedence is detected on only one sample. However, the Agency is interested in receiving substantive comment on whether the requirements as proposed will provide the best possible information on the magnitude of the potential risk and whether there may be other reporting requirements that would better accomplish this end.  {O  2. Surface water. Sections 159.178(b)(1) and (4) require that studies or incident reports be submitted if they concern a pesticide found in ``waters of the United States'' (i.e., virtually all surface waters) in amounts in excess of the ``Water Reference Level.'' The ``Water Reference Level'' is defined in 159.153 to be the limit of detection of a pesticide; or, alternatively, equal to 10 percent of the Maximum Contaminant Level (MCL), if one has been established by EPA, or if one has not, 10 percent of the most recent draft or final long-term Health Advisory Level (HAL). If EPA has not published or proposed an MCL or an HAL, the Water Reference Level would be the lowest detectable amount of the pesticide. EPA is proposing both of these definitions in the regulatory text because the Agency is aware of arguments in favor of each of these approaches. The Agency is soliciting comment on the best approach to defining a ``Water Reference Level'' for reporting adverse effects to the Agency. In the final rule there will be only one definition of Water Reference Level. In addition to comment on the approach, EPA solicits comment on whether reporting should be based on a single incident or a series of incidents. If EPA takes the position that any detection should be reported, the Agency does not mean to suggest that any level of these chemicals poses a significant risk to human health or the environment. However, such findings may lead the Agency to conclude that there is a need for further monitoring or for regulatory activity designed to lessen the likelihood that levels of concern will result in the future. In addition, any information concerning the levels of pesticide ingredients in surface water can enhance EPA's understanding of chemical characteristics and environmental conditions which may lead to unacceptable environmental contamination. Inclusion of the term ``waters of the United States,'' which is defined in 40 CFR 122.2, allows EPA to specify better where it anticipates a pesticide active ingredient, metabolite or degradate, which may cause unexpected avoidable harm, may be found. However, as used here, ``waters of the United States'' excludes 40 CFR 122.2(d) because that paragraph encompasses impoundments into which waste water with known industrial contaminants is released. If the Agency selects 10 percent of the MCL as the ``Water Reference Level,'' the regulatory text in 159.153 (Definitions) would be changed by substituting ``10 percent of the MCL'' for ``the limit of detection.''  {O  3. Ground water. Section 159.178(b)(2) requires that information from studies or incident reports be submitted if they concern a pesticide found in ground water at a level above the ``Water Reference Level.'' Under proposed 40 CFR 152.170(b)(3), 56 FR 22076, May 13, 1991, EPA proposed in pertinent part, to consider restricting the use of pesticides whose ingredients reach ground water three or more times in distinct locations. However, the Agency is proposing in 159.178 of this rule to require reporting single incidents of ground water contamination so that it receives information about individual incidents of ground water contamination known to different registrants. Submission of three or more such incidents from any source would be sufficient to allow EPA to consider a restricted use classification under proposed 152.170(b)(3). The ``Water Reference Level'' is defined in 159.153 to be the limit of detection of a pesticide; or, alternatively, equal to 10 percent of the Maximum Contaminant Level (MCL), if one has been established by EPA, or if one has not, 10 percent of the most recent draft or final long-term Health Advisory (HA) Level. If EPA has not published or proposed either an MCL or HA, the Water Reference Level would be the lowest detectable amount of the pesticide. EPA is proposing both of these definitions in the regulatory text because the Agency is aware of arguments in favor of each of these approaches. The Agency is soliciting comment on the best approach to defining a ``Water# 0*%% Reference Level'' for reporting adverse effects to the Agency. In the final rule there will be only one definition of Water Reference Level. In addition to comment on the approach, EPA solicits comment on whether reporting should be based on a single incident or a series of incidents.  {O   4. Drinking water. Section 159.178(b)(3) requires submission of information on studies or individual incidents regarding amounts of a pesticide found in finished drinking water above the ``Water Reference Level.'' Finished drinking water includes water which has gone through a community water supply and is ready for drinking, as well as ground water being used directly as a source of drinking water. The ``Water Reference Level'' is defined in 159.153 to be the limit of detection of a pesticide or 10 percent of MCL; or, alternatively, equal to 10 percent of the MCL, if one has been established by EPA, or if one has not, 10 percent of the most recent draft or final long-term Health Advisory (HA) Level. If EPA has not published or proposed either an MCL or HA, the Water Reference Level would be the lowest detectable amount of the pesticide. EPA is proposing both of these definitions in the regulatory text because the Agency is aware of arguments in favor of each of these approaches. The Agency is soliciting comment on the best approach to defining a ``Water Reference Level'' for reporting adverse effects to the Agency. In the final rule there will be only one definition of Water Reference Level. In addition to comment on the approach, EPA solicits comment on whether reporting should be based on a single incident or a series of incidents.  {O  5. Pesticides applied to water. Re-reporting of an additional detection of a pesticide at levels which a registrant, in his application for registration, reported can result from legal use in drinking water or waters of the United States is not required because these amounts are expected when the pesticide is used.  {M4 I. New Metabolites  {O  EPA has an interest in learning of the existence of new chemicals resulting from pesticide use so that EPA can determine the need for definitive data to assess whether those chemicals are of toxicological concern. Accordingly, EPA has added a new 159.179 to require submission of information regarding the existence of metabolites, degradates, or impurities which may result from use of pesticides, if the existence of those metabolites or degradates has never been reported to EPA and they may be persistent or of possible toxicological concern. The standards of persistence are those EPA proposes to use in proposed 40 CFR 152.170(b)(3), and are discussed at 56 FR 22076, May 12, 1991.  {M J. Submission of Information Regarding Toxic Incidents  {O  1. Section 159.158(a) interprets FIFRA section 6(a)(2) to require submission of information the registrant ``has'' when the information, if true, would be relevant, by itself or in conjunction with other information, to an Agency decision regarding the risks and benefits of the registrant's pesticide. All information concerning an incident which meets the requirements set forth in those sections is likely to be useful during EPA's evaluation of a pesticide. Accordingly, registrants are reminded that they must submit all information which they have concerning an incident reportable under 159.184 or 159.195 rather than only the information which triggers the requirement to report. At a minimum, EPA expects to receive copies of written reports of incidents which are provided to the registrant, and/or descriptions written by the registrant from information the registrant receives aurally or visually, which describe all known details of the incident, the effects alleged to have occurred, the results of investigations, how the registrant became aware of the incident, and the author of reports. Information concerning incidents in which toxic effects are attributed to pesticide exposure varies considerably in specificity and accuracy. Some reports received by registrants are so vague or implausible that they would be unlikely to provide a basis for administrative action. On the other hand, some incident reports may contain unique# 0*%% and valuable information on the risks and environmental impacts associated with actual use and practice which cannot be readily derived from laboratory data alone. Thus, the Agency has endeavored to select sets of criteria which will give practical assistance to each registrant in identifying those types of incident information which are currently needed by EPA in order to discharge properly its statutory responsibilities. Each set of criteria contains the following elements: A report of a toxic effect; a report of pesticide exposure; an opportunity for investigation of the accuracy of the reports; and some inference that the toxic effect and the pesticide exposure were related, balanced with EPA's need to consider the information. Incident information concerning a single incident of toxic effects generally has little current utility for regulatory purposes and need not be submitted to EPA under section 6(a)(2) unless the information is predicated on a conclusion, opinion, or reasonable inference that the reported effects were related to pesticide exposure. Under 159.184(a), failure to submit information regarding any single incident of a toxic effect to a single non-target organism will not be treated as a violation of section 6(a)(2) unless the registrant has concluded that the reported effect may have been caused by the reported pesticide exposure, or has been advised by any person described by  {O( 159.158(b) that a causal relationship may exist, or the information indicates that the effect succeeded exposure and is new or more severe than that previously reported to EPA. The Agency believes that an effect which is more severe than one previously reported is a matter of significant concern. However, this criterion requires a judgment as to whether the effect is truly greater than any previously reported. EPA solicits comment on whether this is an appropriate reporting criterion as stated, or whether there is a better way to identify data showing a greater magnitude of risk than previously known. Information concerning a single incident in which humans exposed to a pesticide have experienced toxic effects is extremely useful in evaluating the risks associated with pesticide use, and in deciding whether a method of applying the pesticide should be prohibited or the labeling should be changed. Receipt of incident information regarding toxic and adverse effects in humans is particularly important because of the difficulties associated with predicting human toxicity on the basis of animal data. Thus, under 159.184(a) and (b) EPA considers any failure to submit incident information concerning any single toxic effect in humans which includes the basic elements previously identified and which is otherwise reportable under section 6(a)(2) to be an actionable violation of FIFRA, regardless of the circumstances which resulted in the pesticide exposure. The exception that does not require registrants to submit data for an effect noted on the product label is based on the fact that sufficient data were available to EPA on that effect for the Agency to determine it necessary to require a warning statement on the product label. In contrast, under 159.184(b)(3) EPA will not treat failure to submit information on any single incident involving toxic effects on non-target organisms as an actionable violation of section 6(a)(2) if the registrant can demonstrate that the pesticide was used improperly and that the label provides reasonable notice of the risk of the specific toxic effects reported. Considering that phytotoxicity is known to occur even when a pesticide is used properly, an expansion of the misuse exception has been added so that a non-lethal incident (159.184(b)(2), or series of incidents (159.184(c)(4)), of phytotoxicity at the application site adequately warned against on the label need not be reported, even if the effect occurred as a result of legal use. In contrast to the requirements applicable to an incident involving a single organism, if a registrant has been informed of a series of incidents (i.e., incidents involving three or more organisms) in which the same kind of toxic effect has followed exposure to the same pesticide, a reasonable inference of a causal relationship may arise from the existence of the series or pattern itself, even in the absence of a specific conclusion or expert opinion to that effect. In such circumstances it would be superfluous to require that the registrant conclude or be advised that a causal relationship exists or that the effect is new or more severe. Therefore, registrants must report, under 159.184(c) any series or pattern of three or more incidents involving the same kind of toxic effect from the same pesticide. Moreover, even if a series or pattern consists of incidents which would otherwise not be reportable under this rule because each incident involves predictable effects on non-target organisms (other than humans) resulting# 0*%% from improper use, EPA will treat failure to report such information in an aggregate form as an actionable violation of section 6(a)(2). EPA needs this type of incident information because the existence of widespread or routine misuse of pesticide products may be a basis for changes in labeling, additional restrictions on use, or other regulatory action. EPA's position is that three or more discrete incidents comprise a series and thus establish a reasonable presumption of a causal, non-aberrational relationship between the use of a pesticide and the observed effect. In basing reporting requirements on a fixed number of incident occurrences, EPA is attempting to ensure that it receives vital and informative data, that registrants have decisive guidance on what to submit, and that registrants do not bear the legal responsibility of having to determine whether the relationship between the use of the pesticide and the observed effect is causal. EPA believes that a reporting trigger of three incidents is appropriate. However, the Agency is interested in receiving substantive comment on whether a different number of incidents, or an alternative approach that does not establish an investigation requirement, may be more appropriate to trigger reporting of multiple incidents. For ease of interpretation, EPA has now specified in 159.184(c) that incidents involving similar toxic effects to any three or more individual non-target animals or endangered or threatened plants, within a 5 year period, must be reported. For humans 159.184(c) specifies that information derived from any number of occurrences involving similar toxic effects affecting a total of three or more individual persons within a 10 year period must be reported. For non-endangered, non-threatened plants similar incidents involving any three or more plants on different days or in different locations within a 5 - year period must be reported. When any such incident is reportable, all additional occurrences of similar toxic and adverse effects known at the time must be reported, even if the additional effects would not have to be reported alone. Studies or incidents which arguably indicate failures of public health antimicrobials, products meant to control possible disease vectors, and products which have been subject to Special Review, are reportable under 159.188. Unit III. K. of this preamble discusses the reporting requirement and indicates the urgency with which EPA views the need to receive information about products designed to prevent public health problems.  {O  2. Examples of how the rule will be applied. (a) A registrant receives a report from an unidentified source indicating that an agricultural employee experienced respiratory difficulties after working in a field where a pesticide manufactured by the registrant had recently been applied. A few days later, the registrant discusses the alleged incident with a toxicologist, who states that, in his opinion, the reported respiratory symptoms could have been caused by exposure to the registrant's pesticide. This is the basis of a reportable toxic incident and the registrant then has 30 calendar days to investigate the incident (if the registrant chooses) and submit information to EPA. If the registrant discovers within that time frame facts which establish that the reported toxic and adverse effect or reported exposure did not occur, or which conclusively establish that the respiratory difficulties experienced by the exposed individual were unrelated to pesticide exposure, the incident need not be reported. Otherwise, information concerning the incident must be submitted to EPA and proof of submission must be retained for 5 years because the toxicologist is a qualified expert whose opinion is reportable under FIFRA section 6(a)(2). (b) A registrant receives a report from an agricultural extension agent indicating that two fish were killed in a creek adjacent to a field where a registrant's pesticide had recently been applied. After investigation, not exceeding 30 calendar days, the registrant concludes that the reported fish kill probably resulted from exposure to the registrant's pesticide. However, the registrant also discovers facts which establish that the pesticide was improperly applied by an individual who disregarded a statement on the label expressly warning that use resulting in contamination of surface waters could kill fish. This incident need not be reported under this section because fewer than three fish were affected. However the information must be retained for 5 years after the incident in compliance with 159.157(c). (c) The registrant has received reports of mortality in non-target birds feeding in or near fields where the registrant's pesticide has been applied. Though some of these reports were not specific enough to enable investigation of their accuracy, the registrant has identified specific investigable incidents affecting three or more birds in which it appears that birds died following use of the registrant's pesticide. However, the registrant has not determined# 0*%% whether or not the pesticide was responsible for the observed bird mortality, and no employee, consultant, or qualified expert has indicated that a causal relationship may exist. Nevertheless, the existence of the unexplained incidents in the organisms is sufficient to support a reasonable inference of a causal relationship between the toxic and adverse effects and excess residues, and failure to submit all information concerning any of the incidents will be considered an actionable violation of section 6(a)(2) if more than three birds were affected. (d)(i) A registrant receives a complaint from a user who says he experienced gastric disturbances after using a registrant's product. The user is no longer ill and did not visit a doctor or hospital and EPA has received reports of a similar character and severity previously. Absent additional information the incident need not be reported because neither the registrant, nor a qualified expert, has concluded that the incident may have resulted from exposure to the pesticide. However, the registrant must retain a record of this incident for 10 years, under 159.157(b). (ii) If the user visited a doctor, Poison Control Center, or hospital, expert opinion will often be part of the file. If the registrant concludes, or a qualified expert advises the registrant, that the effect may indeed have resulted from exposure, the incident must then be reported. (iii) If the user experiences other effects not previously reported to EPA in connection with the pesticide, or similar effects that are more severe than previously reported, the incident must then be reported unless the registrant can demonstrate that the pesticide was used improperly and that the label provides reasonable notice of the risk of the specific toxic effects reported. (iv) In the above examples, if the information is reported, a copy of the report and proof of delivery must be retained by the registrant for 5 years after delivery under 159.157(a). If it is not reported, the information must be retained for 10 years after the incident in compliance with 159.157(c). (e)(i) A registrant receives a report of a flagger who suffered eye irritation. A doctor's notes about which the registrant is aware indicate that the irritation may be due to exposure to the registrant's pesticide. However the product's label contains a warning statement about eye irritation and the registrant discovers within 30 calendar days of receipt of the report that the flagger failed to wear goggles as required by the label. The incident need not be reported because it involves a minor risk which is warned against on the label and is of a type excepted by 159.184(b)(1) but the information must be retained by the registrant for 10 years under 159.157(b). (ii) A registrant receives a report of a worker who reentered the field contrary to label directions who later suffered eye irritation. The information indicated that a doctor concluded that the irritation may have been due to exposure to residues of the registrant's product. The label warns against eye irritation and the registrant has information showing the worker failed to wear goggles required by the label. The incident need not be reported under 159.184(b)(1) but the information must be retained by the registrant for 10 years. (iii) Subsequent to the incident in Unit III.J.2.(d)(ii) above, the registrant receives one detailed report regarding two more reentry workers who suffered the same kind of effect in the same field at the same time as each other. The registrant has no new information regarding a doctor's diagnosis. The information from the new report regarding toxic and adverse effects suffered by two humans and the information regarding the previous one must be submitted to EPA within 30 calendar days of receipt of the latter report because, in total, the information now constitutes three incidents involving toxic and adverse effects to humans under 159.184(c). That section contains no exception regarding minor risks warned against on the label and the fact that two persons were injured at one time does not change the fact that, in total, three humans were affected. (iv) Another registrant receives a report of a reentry worker who suffered eye irritation. The information indicated that a doctor concluded that the irritation may be due to exposure to residues of the registrant's product. The label warns against eye irritation and also requires workers to wear goggles if they enter the field within 24 hours after application of the pesticide. The registrant has information indicating that the worker did not wear goggles. However the registrant investigates and finds that the worker entered the field 48 hours after application of the pesticide. Even though minor, the incident must be reported under 159.184(a). The effect does not qualify as an exception under 159.184(b)(1), because the risk of the effect suffered by the worker was not adequately warned against on the label. In each of the above examples, if the registrant had become aware of an incident involving a product manufactured by someone else, the reporting requirement would not change if the toxic and adverse effect may have$0*%% been due to an ingredient, metabolite or degradate in, or derived from, the registrant's product.  {M K. Submission of Efficacy Studies and Incidents  {O   In most instances, EPA will not treat the failure to submit information from studies concerning the efficacy of a pesticide as an actionable violation of section 6(a)(2) unless such information indicates that the pesticide may not perform as claimed when used to control organisms which pose a potential risk to human health. This standard is incorporated in 159.188(b)(2). The Agency will not treat any failure to submit incident information concerning failure of performance against organisms which may pose any risk to human health but do not pose an immediate risk to human health, (i.e., failure to control possible disease vectors) as an actionable violation of section 6(a)(2) unless such information concerns a series or pattern of three or more comparable failures of performance. In an instance where a reported failure of performance involved use against organisms which may pose an immediate risk to human life, EPA would consider any single reported incident of failure of performance to be relevant to regulatory action. Single incidents of failures of products which may pose an immediate risk to human health are reportable under 159.188(a), and a series of incidents of three or more similar failures in which a product failed to perform as claimed against organisms which may pose a risk to human health is reportable under 159.188(b)(1). Examples of organisms which could pose a risk, but perhaps not an immediate risk, to human health include disease vectors such as ticks. Organisms which could pose an immediate risk to human health include microorganisms, like hepatitis B virus, which themselves infect humans. Such organisms are controlled by ``public health antimicrobials.'' Public health antimicrobials are often registered for use in hospital settings to prevent the spread of life threatening diseases. It is imperative to the mission of the Agency that each incident concerning possible failure of a public health antimicrobial be reported to EPA without delay. EPA has noted that compliance with this requirement, which already appears in current policy statements, has been spotty in the recent past. If this critical requirement is violated, the Agency intends to pursue enforcement action and sanctions with vigor appropriate for regulatory requirements that, if violated, may have a direct and immediate impact on public health. In instances where use of a particular pesticide appears to involve substantial risks, EPA must evaluate the efficacy of the pesticide, in addition to the magnitude and value of its use and the feasibility of substitutes, before determining whether or not the risks associated with use of the pesticide are acceptable. Accordingly, whenever any use of a registered pesticide is or was the subject of a Formal Review as defined in 159.153(b)(2), EPA is interested in information which concerns any deficiency in or reduction below the claimed efficacy of the product for the use being reviewed. When users of pesticides conduct methodical investigations, such as comparative field trials, and provide registrants with the information concerning studies, or a series of incidents listed in 159.158(c)(1), the information regarding deficiencies in claimed efficacy is reliable enough to be considered by EPA and therefore must be reported. Information regarding such studies of products which are, or have been, the subject of Formal Review must be submitted to EPA.  {M L. Submission of Information Not Listed  {Oz  1. Discussion of basis for rule. Sections 159.165 through 159.188 establish policies concerning the types of information which have been the subject of most of the inquiries made and concerns expressed with regard to FIFRA section 6(a)(2). There are, however, other categories of information which may be reportable under FIFRA section 6(a)(2) and 159.158. Such reportable information includes, for example, information concerning soil, plant, and animal metabolism; bioaccumulation by various life forms, levels of exposure to applicators, farm workers, and other persons, drift of pesticides to non-target areas; and a variety of other information which might affect EPA decisions concerning the continued registrability of a product or the appropriate terms and conditions of registration. EPA has not attempted to establish with specificity, for each category of such additional information, which#0*%% failures to report information EPA will or will not treat as actionable violations of FIFRA section 6(a)(2). However, in order to provide some guidance to registrants, 159.195 sets forth a general rule covering all information not described by 159.165 through 159.188. In cases when the registrant should know that the information, alone or in conjunction with other information, raises questions about a greater than negligible risk or toxic or adverse effects in a species not previously reported to EPA, or more severe than previously reported to EPA, 159.156(a) allows registrants a reasonable period, never exceeding 30 calendar days, to verify or investigate apparently reportable information. If, during this period, the registrant learns of facts showing that the information is incorrect, the information need not be submitted and failure to report will not be considered an actionable violation of section 6(a)(2). Otherwise the information must be submitted and proof of delivery must be retained for 5 years. Information not submitted to EPA, solely because the registrant is aware of less than three similar adverse effects, must be retained for 10 years if the effects are to humans, and for 5 years if the effects are to non-target organisms. It should be noted again that whenever a registrant, including any employee or agent of a registrant or any person acting for a registrant, is notified by EPA that the Agency considers such additional information to be pertinent to the question of whether the product's registrations should be modified in any respect, the Agency considers such notification to constitute actual knowledge on the part of the registrant that the information is covered by 159.195.  {O  2. Examples. (a) The registrant receives verifiable reports that five cans of the registrant's product leaked 3 years after the registrant sold them. The registrant has no information regarding incidents of toxic and adverse effects caused by the leaks. Nonetheless, the registrant should know that such information about container failures may raise serious questions about the proper terms and conditions of registration of the product, due to the possibility of uncontrolled, unpredictable exposure to the product or its residues, as demonstrated by the series of incidents. Therefore the information would have to be submitted within 30 calendar days of the time the registrant possesses or knows of the information. However, if the registrant investigates, and, within the time permitted, discovers that three cans leaked because they were stored under conditions which were neither in accordance with the labelling or commonly recognized practice (such as the cans were damaged in a warehouse fire), the series of incidents need not be reported unless the registrant has knowledge that EPA is considering terms and conditions of registration to which such information would be relevant. (b)(i) A registrant has previously submitted a toxicological study and an exposure study concerning its product to the Agency. Based on those studies, a consultant to a test lab engaged by the registrant calculates the risk presented to applicators by the use of the registrant's product. Unless the registrant knows that a calculation suggesting greater risk has been reported to EPA previously, the consultant's conclusion and the basis for it must be submitted to EPA within 30 calendar days because the registrant should know EPA would regard this type of information as having the potential for raising questions about the terms and conditions of registration of the product. (ii) Within 30 calendar days an employee of the registrant concludes that the risk presented to applicators is much lower than the risk calculated by the consultant. The difference is due to use of a different assumption by the employee. However, the information consisting of the consultant's conclusion and its basis must be submitted because the registrant does not have facts establishing that use of the consultant's assumption is incorrect. (iii) Within 30 calendar days an employee of the registrant concludes that the risk presented to applicators is much lower than the risk calculated by the consultant. The difference is due to an arithmetic error in the consultant's calculation which the consultant corrects in writing. The consultant's original conclusion and calculation need not be submitted because the registrant is aware of facts establishing that the information is incorrect.  yO & IV. Statutory Review Requirements 6  yO! 6  In accordance with section 25 of FIFRA, this rule was provided to the U.S. Department of Agriculture (USDA), the Committee on Agriculture, Nutrition and Forestry of the Senate, the Committee on Agriculture of the House of Representatives, and the FIFRA Scientific Advisory Panel (SAP) for comment prior to publication. USDA had no comment and SAP waived review.#0*%%Ԍ yO ԙ& V. Regulatory Review Requirements 6  {M 6  A. Executive Order 12291  {O   Under Executive Order 12291, EPA must judge whether a rule is ``major'' and therefore subject to the requirement that a regulatory analysis be performed. A ``major'' rule is one which has an annual effect of $100 million or more, or results in a major increase in costs or prices, or has significant adverse effects on economic activities. The Agency concludes that this proposed rule does not meet the criteria for ``major'' because it imposes no requirements for data generation and will result in submission of certain existing information an estimated total of 120 times per year. This will result in an estimated total burden to all registrants of 5,380 person hours, excluding voluntary investigations performed by registrants, but including time spent analyzing those reports which would not be analyzed absent this rule. This proposed rule has been submitted to the Office of Management and Budget for review as required by Executive Order 12291.  {M B. Regulatory Flexibility Act  {O  As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), I hereby certify that this proposed rule will not have a significant economic impact on a substantial number of small entities. EPA has estimated that the regulation will impose a total cost of $564,000 on 2,500 pesticide registrants. Since only a fraction of these are small entities, the number of small entities affected and the cost imposed on them is substantially less than the total.  {Ml C. Paperwork Reduction Act  {O  The information collection requirements of this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An Information Collection Request (ICR) document has been prepared by EPA (ICR No. 1204) and a copy may be obtained from Sandy Farmer, Information Policy Branch, (PM-223) EPA, 401 M St., SW., Washington DC 20460, or by calling (202) 260-2740. Public reporting burden for this collection of information is estimated to average 25 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Chief, Information Policy Branch, PM-223, Environmental Protection Agency, 401 M St., SW., Washington DC 20460, and to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: EPA Desk Officer, Washington DC 20503. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposal.  yO  q  List of Subjects in 40 CFR Parts 153 and 159 6  yOF 6  Pesticides and pests, Policy statements, Reporting and recordkeeping requirements. Dated: September 10, 1992.  yO! .U F. Henry Habicht,  {Mf" 6 , Acting Administrator. 6  {O# 6  Therefore, it is proposed that 40 CFR chapter I be amended as follows:#0*%%Ԍ  yO -T PART 153--[AMENDED] 6  yOX 6  1. In part 153: a. The authority citation for part 153 continues to read as follows:  yO  Authority: 7 U.S.C. 136--136y.  yO@ & Subpart D--[Removed and Reserved] 6  yO 6  b. By removing subpart D, consisting of 153.61 through 153.79, and designating subpart D as ``[Reserved].'' 2. By adding new part 159 consisting of subparts A, B, and C, which are reserved, and subpart D to read as follows:  yO   PART 159--STATEMENTS OF POLICIES AND INTERPRETATIONS 6  yOH 6  Subparts A--C [Reserved]  yO  Subpart D--Reporting Requirements for Risk/Benefit Information  yO  Sec. 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. 159.157 Recordkeeping. 159.158 What information must be submitted. 159.165 Toxicological and ecological studies. 159.167 Discontinued studies. 159.170 Human epidemiological and exposure studies. 159.178 Information about pesticides in or on food or feed, or in water. 159.179 New metabolites, degradates, and contaminants. 159.184 Toxic or adverse effect incident reports. 159.188 Failure of performance information. 159.195 Reporting of other information.  yOX  Authority : 7 U.S.C. 136-136y.  yO *? Subparts A--C [Reserved] 6  yOx 6   Subpart D--Reporting Requirements for Risk/Benefit Information 6 6  yO 6  159.152 What the law requires of registrants.  yO`"  (a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) states that 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) Compliance with this part will satisfy a registrant's obligations to submit additional information pursuant to$0*%% section 6(a)(2).  yOX  159.153 Definitions.  yO  (a) The definitions set forth in FIFRA section 2 and in part 152 of this chapter apply to this part unless superseded by a definition in paragraph (b) of this section. (b) The following definitions apply to this part:  {O@  Established level means a tolerance, food additive regulation, action level, or other limitation on residues imposed by law, regulation, or other authority.  {O  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.  {Od  Pesticide means each active ingredient, inert ingredient, impurity, metabolite, or degradate contained in, or derived from, a pesticide product which is or was registered.  {O  Registrant includes any person who holds, or ever held, a registration for a pesticide product issued under FIFRA section 3 or 24(c).  {O  Water reference level means the limit of detection of a pesticide in water; or, alternatively, 10 percent of the Maximum Contaminant Level (MCL) if one has been established by EPA, or if one has not, 10 percent of the most recent draft or final long-term Health Advisory Level (HAL), or if EPA has not published or proposed an MCL or an HAL, the lowest detechable amount of the pesticide.  yO:  159.155 When information must be submitted.  yO  (a) EPA will consider information to be submitted on time if it is received by EPA not later than the 30th calendar day after the registrant first possesses or knows of the reportable information. (b) For purposes of this part a registrant possesses or knows of information at the time any officer, employee, agent, or other person acting for or employed by the registrant first comes into possession of, or knows of, such information.  yOB  159.156 How information must be submitted.  yO  A submission under FIFRA section 6(a)(2) must: (a) Be identical to, but be in addition to, copies sent in compliance with any other requirements. (b) Be addressed to: FIFRA 6(a)(2) Document Processing Desk, Program Management and Support Division (H-7504C), U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. (c) Contain the name of the submitter, the company name and number, the date of transmittal to EPA, and a prominent statement that the information is being submitted in accordance with FIFRA section 6(a)(2). (d) Identify the substance tested or otherwise covered by the information (including the EPA registration number(s) to which the information pertains, and if known, the CAS Registry Number). (e) Summarize all known information concerning the study or incident or other event being reported. (f) Assert any claims of confidentiality for information contained in the submission. (g) If submitted under another provision of FIFRA (e.g., sections 3(c)(2)(B), 4(e)(1)(E)), also comply with all applicable requirements and any additional guidelines for the submission of data under such provision. #0*%%Ԍ yO  159.157 Recordkeeping.  yO  Registrants shall maintain records of all the following for the time periods specified: (a) A copy of each submission under FIFRA section 6(a)(2) with proof of delivery to the address in 159.156(b) must be maintained and kept available for inspection for 5 years after the date of the submission. (b) The following information must be maintained and kept available for inspection for a period of 10 years from the date of the incident: (1) Information derived from any incident involving toxic effects to one or two humans (see 159.184(c)). (2) Information derived from any incident involving one or two failures of a pesticide to perform as claimed in use against organisms which, unless controlled, may pose a risk to human health (see 159.188(b)). (3) Information derived from any incident involving one or two failures of a pesticide to perform as claimed if such use is, or in the past has been, the subject of a Formal Review (see 159.188(c)). (c) Information derived from any incident involving toxic effects to one or two individual non-target organisms must be maintained and kept available for inspection for a period of 5 years from the date of the incident, unless the information need not be reported due to the exception in 159.184(c)(4) (see 159.184(c)). (d) Research data must be retained for the life of the pesticide product(s) to which it pertains, as per 40 CFR 169.2(k).  yO  159.158 What information must be submitted.  {Oh  (a) General. Information which is reportable under one or more of the sections from 159.165 to 159.195 must be submitted if the registrant, including any officer, employee, agent, or other person acting for the registrant possesses or knows of the information, and the information pertains to the registrant's pesticide, regardless of whether the information was generated from use or testing of the registrant's pesticide.  {O  (b) Opinion information. Information reportable under one or more of the sections from 159.165 to 159.195 must be submitted if the opinion which makes it reportable was expressed by a person: (1) Who was employed or retained (directly or indirectly) by the registrant. (2) From whom the registrant requested the opinion(s) or conclusion(s) in question. (3) Who, by virtue of his or her knowledge, skill, experience, training, or education could be considered to be an expert with regard to the matter on which he or she rendered the opinion.  {O<  (c) Clearly erroneous information. Information need not be submitted if before the date on which the registrant must submit such information: (1) The registrant discovers that any analysis, conclusion, or opinion was predicated on data that were erroneously generated, recorded, or transmitted, or on computational errors. (2) Every author(s) of each such analysis, conclusion, or opinion has acknowledged in writing that the analysis, conclusion, or opinion was improper because of the use of the erroneous data, and has corrected the original analysis, conclusion, or opinion accordingly. (3) As a result of the correction, the information is no longer required to be reported under FIFRA section 6(a)(2).  {O~  (d) 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 all information concerning that incident, study, or other occurrence is contained completely in: (1) Documents officially logged in by EPA.  yO!  (2) EPA publications, EPA hearing records, or publications cited in EPA Federal Register notices. (3) Any other documents which are contained in the official files and records of the EPA Office of Pesticide Programs. #0*%%Ԍ yO ԙ 159.165 Toxicological and ecological studies.  yO  (a) The results of an incomplete or complete study of the toxicity to any human or other non-target organism of a pesticide must be submitted if: (1) It shows a toxic effect in a different organ or tissue of the test organism than a previously submitted valid study. (2) It shows a toxic effect at a lower dosage, or after a shorter exposure period, or after a shorter latency period than a previously submitted valid study. (3) It shows a toxic effect at a higher incidence or frequency than a previously submitted valid study. (4) It shows a toxic effect in a different species, strain, sex, or generation of test organism than a previously submitted valid study. (5) It shows a toxic effect by a different route or medium of exposure than a previously submitted valid study. (6) It shows a toxic effect through a different pharmacokinetic, metabolic, or biological mechanism than a previously submitted valid study. (b) 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.  yO Within 30 calendar days of the publication of a Notice of Commencement of a Formal Review in the Federal  yOH Register , all information which has become reportable due to the commencement of the Formal Review must be submitted.  yOh  159.167 Discontinued studies.  yO  The fact that a study has been discontinued before the planned termination must be reported to EPA, with the reason for termination if known, if submission of information concerning the study is, or was, required under this subpart.  yO  159.170 Human epidemiological and exposure studies.  yOp  Information which concerns any study (or portion thereof) upon which a person described in 159.158(b) has concluded, or a person described in 159.158(b)(3) would conclude, that a positive correlation or association may exist between exposure to a pesticide and either a toxic effect in humans, or residues of the pesticide in human tissue or body fluid, must be submitted regardless of whether or not the registrant considers any observed correlation or association to be significant.  yO  159.178 Information about pesticides in or on food or feed, or in water.  {Ox  (a) Food and feed. Information must be submitted if it arguably shows that the pesticide is present 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 need not be submitted.  {O  (b) Water. Information must be submitted if it may show that a pesticide: (1) Is present in waters of the United States, (as defined at 40 CFR 122.2, except paragraph (d) of 122.2) above the ``Water Reference Level,'' as defined in 159.153. (2) Is present is groundwater above the ``Water Reference Level.'' (3) Is present in finished drinking water above the ``Water Reference Level.''#0*%%Ԍ (4) But information need not be submitted regarding the detection of a pesticide in waters of the United States or finished drinking water if it is registered for use in finished drinking water or surface water and the amount detected does not exceed those amounts reported by a registrant, in its application for registration, as resulting in those waters from legal applications of pesticides.  yO  159.179 New metabolites, degradates, and contaminants.  yO@  Information which shows the existence of any substance which appears to be a pesticide, as defined in this part, must be submitted if: (a) The substance may occur under conditions of use of the pesticide product; and (b) The existence of the substance or the association of the substance with the pesticide product has not previously been reported to EPA; and (c) Any of the following is true: (1) Any person described in 159.158(b) has determined that the substance may be of toxicological or ecological concern. (2) The registrant has concluded, or has been advised by any person described in 159.158(b), that the substance, or analogous chemicals, may have any experimentally determined halflife 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 any conditions, resulting in degradation of less than 10 percent in a 30-day period. (3) The registrant has concluded, or a reasonable person described in 159.158(b) person would conclude, that the substance may be of toxicological or ecological concern based on: (i) The physical or chemical properties of the new substance; and/or (ii) Data regarding analogous chemicals; and/or (iii) Data regarding chemical reactivity of the substance and analogous substances; and/or (iv) Data on the substance.  yO  159.184 Toxic or adverse effect incident reports.  {O8  (a) Information from incidents affecting one or two humans or non-target organisms. Information regarding a single toxic or adverse effect incident must be submitted if: (1) The registrant has been informed that a person or nontarget organism suffered a toxic effect. (2) The registrant has been informed that the affected person or non-target organism may have been exposed to a pesticide. (3) The registrant is not aware of facts which establish that the reported toxic effect, or reported exposure, did not occur. (4)(i) The registrant, or any person described in 159.158(b), has concluded that there may be a causal relationship between the toxic effect and exposure to its pesticide. (ii) The toxic or adverse effect occurred in a species in which that effect was not previously reported to the Agency. (iii) The toxic or adverse effect was more severe than that previously reported in that species.  {O!  (b) Exceptions. Information regarding a single toxic effect need not be submitted if: (1) It concerns an effect for which the label provides adequate notice of the risk of that effect in the affected type of organism. (2) It concerns a non-lethal toxic effect to non-target plants which were at the use site at the time the pesticide#0*%% was applied, if the label provides adequate notice of such a risk. (3) It concerns a toxic effect to organisms other than humans which was due to misuse of the pesticide.  {O  (c) Information on incidents affecting three or more humans or non-target organisms. This paragraph covers information derived from any number of occurrences involving similar toxic effects to any three or more individual non-target animals or endangered or threatened plants, or involving any three or more other plants on different days or in different locations, at any time within a 5-year period. For humans, this paragraph covers information derived from any number of occurrences involving similar toxic effects affecting a total of three or more individual persons at any time within a 10-year period. Covered information must be reported if the information meets the standards in paragraphs (c)(1) through (3) of this section and is not subject to the exclusion in paragraph (c)(4) of this section: (1) The registrant has been informed that the persons or non-target organisms suffered similar toxic effects. (2) The registrant has been informed that the affected persons or non-target organisms may have been exposed to a specific pesticide. (3) The registrant is not aware of facts which establish that the reported toxic effects, or reported exposures, did not occur, or establish that the reported exposures and reported similar effects were unrelated. (4) Notwithstanding paragraphs (c)(1), (2), and (3) of this section information pertaining solely to non-lethal toxic effects to non-target plants at the use-site at the time the pesticide was applied need not be submitted if warnings of the specific effect appear on the label of the registrant's product.  yO  159.188 Failure of performance information.  {Oj  (a) Immediate risk to human health. Information must be submitted which concerns an incident in which: (1) The registrant has been informed that a pesticide product did not perform as claimed against target organisms. (2) The failure of the pesticide to perform as claimed involved a use, such as a public health antimicrobial use, against organisms of any character which, unless controlled, may pose an immediate risk to human health. (3) The registrant has received sufficient information to conduct an investigation of the incident and has not established that the reported failure of performance did not occur.  {O  (b) Risk to human health. 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) A series or pattern of three or more similar incidents in which: (i) The registrant has been informed that a pesticide product did not perform as claimed against target organisms. (ii) The registrant has received sufficient information to conduct an investigation of three or more incidents and has not established that the failures of performance occurred less than three times. (iii) The failures of the pesticide to perform as claimed involved the use against organisms such as possible disease vectors which, unless controlled, may pose a risk to human health. (iv) The three or more incidents occurred within 10 years of each other. (2) A study which demonstrates that the pesticide may not perform in accordance with any claim by the registrant regarding uses intended for control of organisms that may pose a risk to human health, including any of the public health antimicrobial or other uses identified in 158.640 of this chapter.  {O~  (c) Products subject to formal review. Information must be submitted if it shows any deficiency or reduction in the claimed efficacy of a registered pesticide, if such use is, or in the past has been, the subject of a formal review and it concerns any study or an incident described in paragraph (c)(1) of this section. (1)(i) The registrant has been informed of three or more similar failures to perform as claimed against target organisms. (ii) For at least three individual incidents the registrant has received sufficient information to conduct an investigation and has failed within 30 days of the third incident to establish that the reported failures of performance occurred less than three times.#0*%%Ԍ (iii) The three or more incidents occurred within a 10 year period.  yO  (2) Within 30 calendar days of the publication of a Notice of Commencement of a Formal Review in the Federal  yO Register , all information under this section which has become reportable due to the commencement of the formal review must be submitted.  yO  159.195 Reporting of other information.  yO@  (a) If the registrant knows of information other than that discussed in other sections of subpart D of this part, the registrant shall submit such information to the Administrator if: (1) The registrant is not aware of facts which establish that the information is incorrect. (2) The registrant knows, or reasonably should know, that if the information should prove to be correct, EPA would regard the information alone or in conjunction with other information about the pesticide, as having the potential to raise questions about the continued registrability of a product or about the appropriate terms and conditions of registration of a product. (3) Examples of reportable information include but are not limited to: bioaccumulation by various life forms, levels of exposure to applicators, farm workers, and other persons, drift of pesticides to non-target areas, calculations showing possible unreasonable risk, and a variety of other information which might affect EPA decisions concerning the continued registrability of a product or the appropriate terms and conditions of registration. (b) [Reserved] [FR Doc. 92 - 22782 Filed 9 - 23 - 92; 8:45 am]  yO0  BILLING CODE 6560 - 50 - F