[Federal Register Volume 62, Number 182 (Friday, September 19, 1997)]
[Rules and Regulations]
[Pages 49370-49395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24937]



[[Page 49369]]

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Part IV





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 159



Reporting Requirements For Risk/Benefit Information; Final Rule

Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / 
Rules and Regulations

[[Page 49370]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 159

[OPP-60010H; FRL-5739-1
RIN 2070-AB50


Reporting Requirements For Risk/Benefit Information

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.

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SUMMARY: This final rule codifies EPA's interpretation and enforcement 
policy regarding section 6(a)(2) of the Federal Insecticide, Fungicide 
and Rodenticide Act (FIFRA), which requires pesticide registrants to 
report information concerning unreasonable adverse effects of their 
products to EPA. The purpose of the rule is to clarify what 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). In comparison to previous EPA policy 
statements, some reporting requirements are expanded, and others 
reflect increased flexibility or exemptions for reporting specific 
types of information. When effective, this rule will supersede all 
previous policy statements pertaining to section 6(a)(2).
EFFECTIVE DATE:  This rule will become effective June 16, 1998.
FOR FURTHER INFORMATION CONTACT:  By mail: James V. Roelofs, Office of 
Pesticide Programs (7506C), U.S. Environmental Protection Agency, 401 M 
St., SW.,, Washington, DC 20460. Office location, telephone number and 
e-mail address: Crystal Mall #2, Rm. 1113, 1921 Jefferson Davis 
Highway, Arlington, VA, (703) 308-2964, e-mail: 
<a href="/cdn-cgi/l/email-protection#f78598929b989184d99d9e9ab79287969a969e9bd9928796d9909881"><span class="__cf_email__" data-cfemail="c8baa7ada4a7aebbe6a2a1a588adb8a9a5a9a1a4e6adb8a9e6afa7be">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Electronic Availability:

Internet

    Electronic copies of this document and various support documents 
are available from the EPA Home Page at the Federal Register-
Environmental Documents entry for this document under ``Rules and 
Regulations'' (http://www.epa.gov/fedrgstr/).

Fax on Demand

    Using a fax phone call 202-401-0527, select item 6301 for a copy of 
the Federal Register document, and select item 6051 for the Information 
Collect Request (ICR) form.
    This Federal Register document discusses the background of this 
final rule concerning the reporting of adverse effects information by 
pesticide registrants. It also addresses, in general terms, the main 
public comments on the provisions of the proposed rule published in the 
Federal Register of September 24, 1992 (57 FR 44290). In addition, on 
August 12, 1996, the Agency opened a comment period to receive comments 
on the burdens that would be imposed by the provisions of a draft final 
version of the rule (61 FR 41764)(FRL-5388-1). A draft version of the 
rule dated June 14, 1996 was made available to the public on request at 
that time. The comment period was subsequently extended twice, on 
September 20, 1996 (61 FR 49427)(FRL-5396-1) and October 25, 1996 (61 
FR 55259)(FRL-5640-7). This preamble provides EPA's final determination 
with respect to the provisions of the final rule, and provides 
information on the applicable statutory and regulatory review 
requirements. A more detailed section-by-section discussion of the 
public comments on the proposed rule, the related Information 
Collection Request (ICR), and the Agency's response thereto can be 
found in the public docket.
    This document is organized into 3 units. Unit I provides background 
on the relevant statutory provisions and the regulatory history of 
adverse effects reporting. Unit II contains a discussion of the final 
rule and EPA's response to the major comments submitted on the proposed 
rule. Unit III discusses compliance with the rulemaking requirements 
contained in FIFRA and other statutes and executive orders, followed by 
the regulatory text.

I. Background

 A. The Statute

    Section 6(a)(2) of FIFRA requires that, ``[i]f 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, the registrant shall submit such information to the 
Administrator.'' Section 6(a)(2) provides an important function by 
assuring that a previous Agency decision to register a pesticide 
remains a correct one, and that a registered pesticide can in fact be 
used without posing unreasonable adverse effects to human health and 
the environment. Other provisions of FIFRA allow the Agency to require 
pesticide registrants to develop and submit information the Agency 
believes it needs in order to evaluate the risks and benefits of 
pesticide products. Section 6(a)(2), however, provides that registrants 
must also inform the Agency of certain relevant information relating to 
their products, even though it was not specifically requested by EPA. 
It recognizes that registrants may come into the possession of 
important information that was not anticipated by the Agency, and that 
without the submission of such information by registrants, EPA would 
remain without it. Information reportable under this provision includes 
not only new information derived from scientific studies, but also 
reports of incidents of adverse effects resulting from the use of 
pesticide products. Thus, section 6(a)(2) serves to provide an 
important ongoing check on the correctness of the original decision to 
register a pesticide.
    As a general matter, pesticides may not be sold or distributed in 
the United States unless they are registered with the EPA (FIFRA 
section 3(a)). In order to obtain a pesticide registration, an 
applicant must provide EPA with data (or cite existing data) 
demonstrating that the proposed registration complies with the 
requirements for registration (FIFRA section 3(c)(1)(F)). The standard 
for determining whether an application should be granted is found in 
FIFRA section 3(c)(5), which provides that in order to grant a 
registration, EPA must find that a product's composition warrants the 
proposed claims for it; that the product's labeling and other material 
required to be submitted comply with FIFRA; that the product will 
perform its intended function without causing unreasonable adverse 
effects on the environment; and that, when used in accordance with 
widespread and commonly recognized practice, the product will not cause 
unreasonable adverse effects on the environment. FIFRA defines 
unreasonable adverse effects on the environment as ``any unreasonable 
risk to man or the environment, taking into account the economic, 
social, and environmental costs and benefits of the use of any 
pesticide.'' Thus, a critical aspect of determining whether or not a 
pesticide should be granted a registration is an evaluation of whether 
the benefits associated with the use of a pesticide exceed the risks 
associated with such use.
    The burden of demonstrating that a product meets the standards for 
registration rests at all times on the registrant or applicant for 
registration. See, e.g., Industrial Union Dept. v. American Petroleum 
Institute, 448 U.S. 607, 653 n. 61 (1980); Environmental Defense Fund 
v.  EPA, 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975). Section 6(a)(2) 
only imposes a reporting burden on persons who have registered

[[Page 49371]]

pesticides, and only requires reporting of information if that 
information is: (1) Additional; (2) factual; and (3) regards 
unreasonable adverse effects on the environment of the pesticide. These 
three factors were discussed extensively in the comments submitted on 
the proposed rule.

B. Previous Regulatory Interpretations of Section 6(a)(2)

    1. 1978 interpretive statement.  On August 23, 1978, EPA published 
in the Federal Register (43 FR 37611) its interpretation of the 
requirements imposed by section 6(a)(2). In that interpretive 
statement, EPA focused on the meaning of two of the three factors 
pertaining to whether information is reportable: what information is 
``regarding'' unreasonable adverse effects on the environment, and what 
information can be said to be ``factual.'' EPA went on to make clear 
that it believed information must be submitted under section 6(a)(2) if 
a registrant possesses the information, the information pertains to a 
pesticide for which the registrant holds a registration, and ``the 
information, if true, would be relevant to an Agency decision regarding 
the risks and benefits of the pesticide, i.e., an Agency decision 
regarding the registrability of the pesticide or regarding the proper 
terms and conditions of the registration of the pesticide.'' The 
statement went on to say that reportable information need only 
``pertain or relate to unreasonable adverse effects on the environment; 
it does not have to indicate, establish, or prove the existence of such 
effects.'' EPA made clear in the statement that a registrant need not 
determine that the information would result in a change in the terms 
and conditions of registration in order for information to be 
reportable, because the ultimate determination on such registration 
issues rests with EPA. If the information would be relevant to the 
Agency's decision-making on whether a pesticide should remain 
registered and, if so, under what terms and conditions, the information 
``regarded'' unreasonable adverse effects on the environment.
    In terms of the definition of ``factual,'' the Agency explained 
that there was no clear demonstration of congressional intent 
concerning the scope of the information, and that the Agency would 
therefore interpret the term based upon the function of section 6(a)(2) 
in the context of FIFRA's regulatory scheme. Since EPA routinely relies 
on expert opinion in order to make regulatory decisions, and since 
``Congress recognized that protection of the health of the public and 
the environment cannot wait until evidence of unreasonable adverse 
effects becomes conclusive or universally accepted,'' EPA determined 
that ``factual'' information should be interpreted broadly to include 
opinions if the opinions were not ``the unsolicited opinions of persons 
who are not employed or retained by the registrant to express the 
opinion and whose opinions would not be admissible under the Federal 
Rules of Evidence as `expert' opinion'' (Id. at 37613).
    2. 1979 policy statement. On July 12, 1979, EPA published in the 
Federal Register (44 FR 40716) a Statement of Enforcement Policy 
regarding registrants' obligations under section 6(a)(2). That 
statement did not curb the scope of section 6(a)(2) as enunciated in 
the 1978 interpretive statement, but instead indicated that certain 
information arguably pertinent to the evaluation of the risks and 
benefits of a pesticide ``are not currently needed by EPA in order to 
properly discharge its statutory responsibilities under FIFRA and thus 
need not be submitted by registrants.'' The Policy statement notified 
registrants of the types of information for which a registrant's 
failure to report might precipitate enforcement action by EPA. In other 
words, the policy statement announced as a matter of enforcement 
discretion that certain types of information need not be submitted by 
registrants notwithstanding the fact that the information fell within 
the scope of section 6(a)(2). EPA indicated that it would honor the 
exemptions from reporting contained in the policy statement until at 
least 30 days after a modification or revocation of the policy 
statement was published in the Federal Register. This final rule 
constitutes a revocation of that policy statement; the 1979 Policy 
Statement will cease to be Agency policy on June 16, 1998.
    3.  1985 interpretive rule.  On September 20, 1985, EPA published 
in the Federal Register (50 FR 38115) a Final Interpretive Rule and 
Statement of Policy concerning reporting obligations under section 
6(a)(2). The rule identified those types of information covered by 
section 6(a)(2) for which enforcement action would be brought if 
material were not submitted to the Agency, and exempted the reporting 
of other information covered by the statutory provision. It is not 
clear whether the Interpretive Rule ever became effective. The Federal 
Register Notice provided that EPA would publish in the Federal Register 
a notice announcing the effective date of the rule, but no subsequent 
notice was ever published. In light of the issuance of this new Final 
Rule, the issue of whether the 1985 Rule ever became effective need not 
be resolved.
    4. The 1992 proposed rule. On September 24, 1992, the Agency 
published in the Federal Register (57 FR 44290) a proposed rule 
relating to the submission of information pursuant to section 6(a)(2). 
The preamble to that rule discussed in detail the Agency's 
interpretation of section 6(a)(2) and the rationale for the provisions 
of the proposed rule. Many of those provisions have not changed 
significantly in this final rule. The Agency continues to endorse the 
substance of the preamble to the proposed rule. EPA has not always 
repeated in this preamble material addressed in the proposed rule; the 
discussion in that preamble should be consulted by anyone seeking 
additional background on the decisions reflected in this final rule. 
Throughout this preamble the term ``proposed rule'' refers to the 1992 
document.
    5.  The 1996 draft final rule. On August 12, 1996 the Agency opened 
a comment period to allow interested parties to comment on the 
Information Collection Request (ICR) and the potential burden that the 
provisions of the Agency's draft final rule would impose on 
registrants. The Agency made available a draft final version of the 
rule which reflected changes the Agency had made from the proposed rule 
on the basis of comments received and its own experience with section 
6(a)(2) information during the years since the proposed rule was 
published. The Agency received numerous written comments on the 
provisions of the ICR and the draft final rule, and also received oral 
comments from interested parties at two meetings held during the 
comment period. All comments received, as well as memoranda describing 
the meetings, and memoranda describing the Agency's response to 
comments are included in the public docket for this rule. The main 
issues which were raised and addressed by the Agency as a result of 
comments on the 1996 draft final rule are described in this preamble. 
Throughout this preamble, the term ``1996 draft'' refers to the draft 
version of the rule dated June 14, 1996, which was made available to 
the public on request through the Federal Register announcement of 
August 12, 1996.

C. Current Interpretation of Section 6(a)(2)

    In assessing the proper scope of section 6(a)(2), it is necessary 
to focus on the potential regulatory actions that the Agency can take 
under FIFRA in its continuing evaluation of whether a

[[Page 49372]]

 pesticide poses unreasonable adverse effects on the environment. The 
potential cancellation or suspension of a registration pursuant to 
section 6 is the most restrictive action EPA can take against a 
pesticide registration, and these were the regulatory activities most 
discussed by commenters on the proposed rule. While reportable 
information under section 6(a)(2) could conceivably result in 
cancellation or suspension action, this information could also be used 
by the Agency in other ways. The information could suggest the need for 
modifications to the terms and conditions of registration which could 
be necessitated by the balancing of the risks and benefits associated 
with a particular pesticide. It could also identify information gaps 
that could result in the request for additional information from 
registrants pursuant to section 3(c)(2)(B). Finally, it could identify 
to the Agency pesticides and issues that require closer examination by 
the Agency.
    The Agency thus takes a very broad view of the statutory scope of 
section 6(a)(2). Although EPA interprets the section as requiring the 
submission of potentially large amounts of information, the Agency is 
also sensitive to the burden this could put on both registrants and 
Agency reviewers. Accordingly, this final rule identifies the material 
that the Agency considers relevant to determining whether a registered 
pesticide continues to meet the standards of registration and wants to 
be submitted under section 6(a)(2), and essentially exempts from the 
reporting requirements information not covered by the Rule.
    This final rule establishes requirements on what information must 
be reported, when and how the information must be submitted to the 
Agency, and who has reporting obligations. The nature of the 
information that must be reported was the principal focus of most of 
the comments and takes up the bulk of the final rule. Most of this 
portion of the rule is considered by the Agency to be interpretive in 
nature and similar to the policy statements issued on section 6(a)(2) 
in the past. The primary sources of information covered by the rule are 
scientific studies, reports of incidents involving pesticides, and 
certain opinions, but other information could also be included if 
relevant to the risk/benefit balancing involved in the determination of 
whether a pesticide causes unreasonable adverse effects on the 
environment.
    A number of general comments argued the need for registrants to 
investigate and verify the validity of information before reporting. 
The Agency manifestly did not design this final rule to cover only 
information certified to be valid. Especially in the area of incident 
reporting, the Agency recognizes and accepts that many reports may 
prove not to be valid. Registrants are not obligated to investigate, 
analyze, or verify incidents before reporting to the Agency, and EPA 
accepts that a reporting registrant may well disagree with either the 
significance or validity of incident reports. Registrants are free to 
submit information challenging the validity of section 6(a)(2) 
information either at the time of, or after submission of the 
information to the Agency. In order to comply with the final rule, 
however, registrants must submit the required information promptly. 
Failure to submit information because of the incompleteness of ongoing 
investigations will be considered a violation of both this final rule 
and of FIFRA.
    Finally, EPA wants to serve notice that failure to comply with the 
requirements of section 6(a)(2), as reflected in this final rule, will 
be considered a violation of FIFRA sections 12(a)(2)(B)(ii) and 
12(a)(2)(N), and could result in actions for civil and/or criminal 
penalties under FIFRA section 14. Failure to comply with these 
requirements may also constitute grounds for cancellation under FIFRA 
section 6 of some or all of a registrant's pesticide registrations, 
both because such failure means that ``material required to be 
submitted does not comply with the provisions of [FIFRA]'' and because 
the Agency may conclude that the registrant has failed to carry its 
burden of demonstrating that the use of its pesticides do not pose 
unreasonable adverse effects on the environment. EPA does not intend to 
pursue cancellation every time section 6(a)(2) may have been violated, 
but egregious or repeated violations may warrant cancellation rather 
than, or in addition to, monetary fines.

 II. Section-By-Section Discussion

    Comments were received on virtually every provision of the 1992 
proposed rule, and on the 1996 draft version. As noted earlier, the 
Agency's detailed response to the comments are contained in documents 
available in the public docket for this rule. The discussion in this 
unit is limited to pointing out significant changes to the provisions 
of the 1992 proposed and 1996 draft rules, or to responding to comments 
that are, in the Agency's judgment, particularly important to clarify.

A. Section 159.153-- Definitions

    This section provides a number of definitions applicable to the 
final rule. Three definitions in particular were subject to a number of 
comments. Each is addressed in turn.
    Pesticide. The definition of pesticide in the proposed rule 
included ``each active ingredient, inert ingredient, impurity, 
metabolite, or degradate contained in, or derived from, a pesticide 
product which is or was registered.'' The 1996 draft added the word 
``contaminant'' to this definition. A number of commenters argued that 
this definition is excessively broad, impractical, and in violation of 
FIFRA (which defines the term pesticide more narrowly). The Agency has 
considered the comments, and determined to retain the definition of 
``pesticide'' contained in the 1996 draft.
    The focus of the statutory definition of ``pesticide'' is to define 
what products must be registered. The definition is one of intent-- 
essentially any product must be registered if it claims to control 
pests. This is distinctly different from the question of what 
information about those products has to be submitted to EPA in order to 
make the risk and benefit determinations required to establish or 
maintain registrations. So long as the use of the pesticide results in 
an adverse effect, it is irrelevant for purposes of whether the 
information must be submitted whether the effect isactually caused by 
an active ingredient, an inert ingredient, or a metabolite, degradate, 
impurity, or contaminant. In short, neither the statutory definition of 
``pesticide,'' nor the statutory definition of ``unreasonable adverse 
effects'' makes any reference to the constituent parts of a pesticide 
product. It is clearly the intent of the statute that the Agency judge 
whether the use of the product as a whole poses unreasonable adverse 
effects, regardless of what constituent part of the product may cause 
such effects. In practice, a number of pesticide risk assessments have 
been based in whole or in part on the risks posed by contaminants and 
impurities, such as dioxins in certain herbicides, or metabolites such 
as ethylene thiourea (ETU) in the EBDC fungicides. Moreover, a 
significant number of tolerances (maximum legal residue levels for 
pesticides on food or feed commodities) include metabolites as part of 
the tolerance expression established by regulation.
    Thus, the Agency does not believe it can be seriously argued that 
adverse information about the inert ingredients, metabolites or 
contaminants in a

[[Page 49373]]

pesticide product is outside the statutory scope of what must be 
reported under section 6(a)(2), or that it is inconsistent in any way 
with the statutory definition of a pesticide. Moreover, this 
interpretation is consistent with section 10(d) of FIFRA, which clearly 
contemplates that the Agency may require registrants to submit, for the 
purpose of registering pesticide products, information on a product's 
``separate ingredients, impurities, or degradation products'' as well 
as information on the product itself.
    EPA recognizes that this definition of pesticide may pose a problem 
for registrants who do not know the identity of inert ingredients in 
their products, or for large organizations where the applicability of 
inert ingredients, metabolites, or degradates to particular pesticide 
products may not be appreciated by those individuals who obtain adverse 
information concerning an inert, metabolite, or degradate. In any 
particular enforcement action that might arise under section 6(a)(2), 
EPA will consider these factors, as well as the steps a registrant has 
taken to assure that adverse effects information on both pesticide 
products and particular chemicals or metabolites is referred to the 
appropriate personnel in the company.
    Registrant. The definition of ``registrant'' in the proposed rule 
included any person who ``holds or ever held'' a pesticide 
registration. A number of commenters have challenged the authority of 
the Agency to apply the requirements of section 6(a)(2) to persons that 
held, but no longer hold, pesticide registrations. Some commenters 
argued that former registrants should be excused from reporting 
obligations after a set period of time (e.g., 3 or 5 years). Other 
commenters suggested that EPA extend the definition to include persons 
given emergency exemptions pursuant to section 18 of FIFRA.
    EPA has changed the definition of ``registrant'' from both the 
proposed rule and the 1996 draft to clarify that the definition 
includes agents acting for a registrant, but does not include persons 
who could not reasonably be expected to receive reportable information. 
The Agency did not change the definition insofar as it applies to 
former registrants, although certain exemptions have now been 
established to limit the time period of reporting requirements on 
former registrants, along the lines suggested by various commenters 
(see further discussion of Sec. 150.160 in Unit G of this preamble.). 
EPA explained in the preamble to the proposed rule its belief that 
section 6(a)(2) could be interpreted to put a continuing burden on 
registrants after a product registration is canceled or transferred. In 
the case of a transferred registration, for example, the pesticide 
product may continue to be widely used. Even in the case of canceled 
products, existing stocks may continue to be sold or used for a long 
period of time. Thus, the Agency's responsibilities with respect to 
whether sale or use of a pesticide should be permitted and, if so, 
under what conditions, do not necessarily end when a registration is 
sold or canceled. A former registrant may continue to receive 
information about its former products from consumer complaints or 
information about accidents well after a product is canceled or 
transferred. Since this information can affect continued Agency 
decision-making with respect to the once-registered product, EPA 
believes relevant information in the hands of former registrants must 
be provided to the Agency for a reasonable period of time. In its 1996 
draft, EPA did not include a cutoff for reporting by former 
registrants, but has now decided to accept a cutoff of reporting 
responsibilities at 5 years after cancellation or transfer of a 
registration for most information, and shorter requirements under 
certain circumstances.
    In order to minimize the burden on former registrants somewhat, the 
Agency added a new Sec. 159.160 to the proposed rule, providing that 
for registrants who have left the pesticide business, i.e., hold no 
active pesticide product registrations, adverse information associated 
with their formerly held registrations need only be reported for 1 year 
after they cease to hold any active registration. Similarly, for a 
person who continues to hold active pesticide registrations, and may 
therefore be likely to continue to receive adverse information even 
about formerly registered products, this rule provides that information 
need not be reported if it is associated only with inert ingredients, 
contaminants, impurities, metabolites, or degradates contained in 
formerly registered products and is obtained more than 1 year after the 
registrant first ceases to hold the registration. Former registrants 
will still be required to report adverse information involving the 
formerly-registered pesticide product itself, as well as information 
involving any of the active ingredients contained in the formerly-
registered product, for up to 5 years. If all registrations containing 
the active ingredient have been canceled, no reports need to be made 
concerning products containing the ingredient 3 years after the last 
registration containing the ingredient was canceled.
    Finally, the Agency has added two new provisions to this section 
that were not contained in the proposed rule or the 1996 draft. One of 
these new provisions (Sec. 159.160(b)(4)) is necessary to accommodate 
the 1996 amendments to FIFRA under the Food Quality Protection Act 
(Pub. L. 104-170) which removed liquid chemical sterilants from the 
FIFRA statutory definition of ``pesticide.'' These products are no 
longer regulated under FIFRA, and former registrants of these products 
have no obligations for reporting information about them to EPA under 
this part. The second new provision is that information arising from 
litigation is not subject to the other time limitations of this 
section, except for products and active ingredients which are wholly 
canceled or no longer defined as pesticides. EPA is excepting 
information developed or obtained during the course of litigation from 
the 5-year cut-off for several reasons. Litigation can produce 
information that can be helpful to the Agency and that is rarely 
obtained by EPA, such as testimony of expert witnesses, and in-depth 
examination of the causes of an incident. A time limit is 
inappropriate, because litigation-related information may take a long 
time to surface because of the nature of litigation schedules. Finally, 
it would not appear to be particularly burdensome to track information 
developed during the course of litigation, since the information would 
be coming from limited, discrete sources, and companies presumably are 
aware of the conduct of litigation to which they are a party.
    As to expanding the scope of coverage to holders of exemptions 
issued pursuant to section 18, the Agency does not believe that such 
holders are ``registrants'' within the meaning of FIFRA, and they are 
thus outside the statutory scope of section 6(a)(2). The Agency does 
have the authority to include adverse information reporting 
requirements as part of a section 18 exemption, and the Agency already 
considers this issue as part of its review of requests for such 
exemptions.
    The Agency believes that supplemental distributors operating 
pursuant to 40 CFR 152.132 are agents acting for a registrant, and are 
already covered by section 6(a)(2). Failure of a supplemental 
distributor to report adverse effects information otherwise covered by 
this Final Rule can result in enforcement action against both the 
supplemental distributor and the parent

[[Page 49374]]

 registrant. Regarding agents, the Agency has always considered 
registrants responsible for the actions of their agents. Clarifying 
language has been added to the regulatory text to emphasize that 
registrants will be held liable for the actions of their agents. The 
new language also makes it clear that for the purposes of reporting 
under this rule, the Agency considers an agent of the registrant to be 
a person who is likely to receive information about the effects of 
pesticides, and who is acting for the registrant at the time the 
information is received. Such agents could include consultants, 
contract laboratory researchers, attorneys, investigators, and others. 
However, the Agency does not consider every direct or indirect employee 
of a registrant as likely to receive such information. Financial and 
personnel workers, or even workers in a pesticide manufacturing plant, 
for example, would not be dealing with pesticide effects information 
nor would they normally be in contact with product users or other 
persons who are likely to report pesticide effects information. As a 
general matter, the issue of whether a retailer or distributor of 
pesticides is an agent of a registrant will depend upon the nature of 
the relationship between the retailer/distributor and the registrant. A 
retailer or distributor that sells a wide variety of pesticide products 
produced by many different registrants would generally not be 
considered an agent of any of the registrants. On the other hand, a 
retailer or distributor that exclusively (or nearly exclusively) 
distributes or sells a particular registrant's products would generally 
be considered an agent of that particular registrant.
    Water reference level. The water reference level is the level at or 
above which the Agency wants to be informed of a pesticide's presence 
in surface water or groundwater. The proposed rule defined water 
reference level as 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, 10 percent of the most recent draft or 
final long-term Health Advisory Level (HAL) if there is no MCL, or the 
lowest detectable amount if there is neither an MCL nor an HAL. 
Commenters that raised objections to the water reference level argued 
that the level would result in excessive reporting to the Agency. 
Commenters suggested that the reference level be set at the MCL or HAL 
itself rather than at a fraction of the level; the same commenters 
generally observed that since pesticides for which there is neither an 
MCL nor an HAL pose less of a concern, the reference level for those 
should not be set at so low a level as the level of detection.
    The terms of this final rule are substantially similar to those of 
the proposed rule and the 1996 draft. Given the persistence of some 
pesticides and the sketchy nature of the monitoring of pesticides in 
surface water and groundwater, the Agency does not believe it 
appropriate to set the reference level at the MCL or HAL. EPA believes 
an earlier warning of potential problems with pesticides in water is 
appropriate and has therefore determined to retain the reference level 
at 10 percent of the HAL or MCL. The Agency has also decided to retain 
the level of detection as the reference level for pesticides that have 
not been assigned an MCL or HAL. EPA believes that, until it has 
sufficient information about the likelihood of a pesticide making its 
way into water, it should receive information about detections in water 
at the earliest possible stage. However, the Agency did modify this 
provision so that the default requirement to report ``the lowest 
detectable amount'' when there is no MCL or HAL for a compound does not 
apply to metabolites, degradates, contaminants or impurities. 
Detections in water of these components of a pesticide need only be 
reported when the Agency has identified a specific level of concern in 
water. Furthermore, this final rule provides that detections below the 
MCL or HAL do not need to be reported as individual incidents, but are 
to be reported in aggregated form as described below in relation to 
incident reporting under Sec. 159.184.
    EPA did make one other significant change in the final rule's 
definition of water reference level. The MCL and HAL levels are based 
on human toxicity triggers; neither level takes into account the 
toxicity of pesticides to other life forms. In order to be consistent 
with other Agency policies related to the protection of water quality, 
the Agency added to the definition of ``water reference level'' the 
Ambient Water Quality Criteria for the Protection of Aquatic Life, 
established under the authority of section 304(a) of the Clean Water 
Act. If EPA has established such criteria for a specific pesticide, and 
that level is lower than 10 percent of the MCL or HAL, then the water 
quality criterion is the reportable reference level. For a compound 
which is detected in water, the Agency believes the reporting level 
should be whichever threshold is the most protective of the 
environment, whether that is the MCL-based trigger derived from 
estimated toxicity to humans, or water quality criteria derived from 
estimated risk to aquatic life. Water Quality Criteria documents for 
over 100 individual compounds, including some pesticides, are published 
by the Agency and are available from the National Technical Information 
Service (NTIS) in Springfield, Virginia (telephone 703-487-4650).

B. Section 159.155--When Information Must Be Submitted

    The proposed rule and the 1996 draft both required that reportable 
information be submitted to the Agency within 30 calendar days of the 
registrant's first becoming aware of the information. A registrant 
would be considered aware of information when any officer, employee, 
agent, or other person acting for or employed by the registrant, and 
considered likely to receive relevant information, first comes into 
possession of, or knows of, such information.
    In this final rule, the Agency is retaining the requirement that 
information about studies be reported within 30 days. With regard to 
information concerning incidents, however, the Agency has agreed with 
many of the commenters that the time frames for reporting should be 
differentiated based on the relative severity of the incidents being 
reported. Accordingly, this final rule has adopted a set of reporting 
schedules (in Sec. 159.184(d)) based on severity ratings which are 
consistent with those suggested by many commenters. Specifically, 
incident information involving human fatalities must be reported within 
15 days. Information regarding allegations of serious human illness or 
fatalities to wildlife, serious plant damage, serious property damage, 
or water contamination above MCLs or HALs, may be accumulated for 30 
days, and reported within 30 days after each accumulation period. All 
other incident information may be accumulated for 90 days and submitted 
within 60 days after each accumulation period. The Agency believes that 
this system will alleviate many of the concerns expressed by commenters 
that incident information could not be properly characterized or 
efficiently reported if the 30-day time limit were applied to all 
individual incidents. This system distinguishes between relatively more 
serious and relatively less serious incidents in a way that will enable 
EPA to receive and recognize more quickly information about more 
serious incidents. In addition, the Agency has decided that for the 
less serious categories of incidents, individual reports do not

[[Page 49375]]

need to be submitted. Instead, the Agency will require aggregated 
statistical reports-- counts of the number and type of incidents, 
listed by product or active ingredient. This will enable EPA to review 
possible patterns of incidents and require registrants to submit 
further detailed information on these incidents only if it seems useful 
to do so.
    Section 159.155(a) also provides that the Agency, with written 
notification to the registrants, can establish a different reporting 
period for specific types of reportable information or eliminate the 
reporting requirement altogether. The Agency believes that this 
provision will allow the Agency to more easily address those situations 
where the Agency determines that it does not need all the information 
otherwise required to be submitted by this rule, or that there is a 
different approach for a particular situation which can help to reduce 
the reporting burden on registrants while still providing the Agency 
with the information it needs. The Agency encourages registrants to 
continue to forward any ideas on ways to reduce the burden of reporting 
under section 6(a)(2).
    A number of commenters objected to the provision that a registrant 
would be deemed to possess information if any person acting for or 
employed by the registrant possesses or knows of the information. 
Instead, these commenters suggested that it would be more appropriate 
for the Agency to retain the standard contained in the 1985 
Interpretive Rule, which provided that a registrant possesses or knows 
of information only when the information is possessed or known of by a 
person acting for or employed by the registrant who is ``capable of 
appreciating the significance of such information.''
    The Agency does not agree with these comments and has retained the 
requirement as proposed, except for adding language to emphasize that 
an employee or agent must be ``likely to receive'' reportable 
information, and that they must be acting for the registrant at the 
time they receive it. The Agency is concerned that the ``capable of 
appreciating'' standard would lead to disputes over whether a 
particular individual is or is not capable of appreciating the 
significance of information in any particular instance. A registrant 
should take steps to assure that the results of studies performed by 
the registrant or at the registrant's request are reported promptly to 
someone responsible for assuring compliance with section 6(a)(2). 
Similarly, EPA believes that most registrants probably already have 
particular individuals designated to receive and/or respond to consumer 
complaints. The Agency does not believe it is unfair to place upon 
registrants the burden of assuring that such complaints are routed to 
people who understand the reporting requirements of section 6(a)(2).
    The Agency recognizes that even when a registrant has established a 
reasonable system for tracking reportable information, information may 
nonetheless be received by individuals working for that registrant who 
neither appreciate its significance nor pass it on to personnel who 
would. The Agency anticipates that its enforcement response to such 
situations will likely depend upon the identity of the person receiving 
the information and the steps taken to assure compliance with section 
6(a)(2). For example, if a person submits reportable information to an 
employee of a pesticide registrant that could reasonably be expected to 
receive the information, such as a sales representative who regularly 
meets pesticide users, dealers and crop consultants, or a person who 
takes phone calls from the public, the Agency believes that such an 
employee should be expected to transmit the information to the 
appropriate personnel working for the registrant, and the Agency would 
likely take enforcement action for failure to report such information 
within the appropriate time period. On the other hand, EPA recognizes 
that many employees of a company would not be expected to receive 
relevant information. For example, the Agency would not regard as 
reportable information received by employees in such activities as food 
services, maintenance, finances and accounting, or personnel. Similarly 
most employees involved in manufacturing would not be expected to 
receive reportable information, with the exception of industrial 
hygienists or safety officers specifically employed to monitor worker 
health effects.
    An example of information that is not reportable is when a 
registrant hires a scientist to conduct toxicity studies on a 
particular pesticide, and that scientist has previously worked at a 
university where he performed research on the toxic properties of the 
pesticide in question. The scientist's previous work was not performed 
for the registrant; he was not their agent at the time the previous 
work was done; the previous work does not become reportable under 
section 6(a)(2) (assuming that the work would otherwise be reportable) 
just because the scientist is hired by the registrant to perform a new 
study. As another example, a consultant is hired by Registrant B to 
help with the registration of a pesticide (to give general advice, and 
to review and conduct studies). The consultant previously worked for 
Registrant A to help with a special review. During the course of the 
earlier work, the consultant reviewed comparative toxicity studies 
involving a number of pesticides, including Registrant B's. The 
consultant was not an agent of Registrant B when this study was 
performed, and Registrant B has no section 6(a)(2) reporting 
obligations with respect to that study (unless the consultant provides 
it to Registrant B at any time, in which case it is reportable because 
the registrant (rather than the agent) possesses the information).

C. Section 159.156--How Information Must Be Reported

    This section establishes guidelines for how reportable information 
must be submitted to the Agency. A number of minor modifications were 
made in order to clarify the procedures for identifying and submitting 
information pursuant to section 6(a)(2). The most significant comments 
on this section concern summaries and issues involving confidentiality 
of information.
    1. Paragraph (f). The requirement in Sec. 159.156(f) to summarize 
information concerning a study or incident is one that received a great 
deal of comment, and one that the Agency has modified from the proposed 
rule. Commenters raised a number of objections to the proposed 
requirement that registrants summarize ``all known information'' 
concerning a study or incident on numerous grounds, including that the 
requirement exceeded the Agency's statutory authority, that it would be 
unreasonably burdensome, that it would result in the submission of 
excessive, extraneous, and unreliable information (especially with 
regard to incidents), that it could be construed as an admission by a 
registrant that the information contained in a report (particularly an 
incident report) is correct, and that it could adversely affect the 
ability of a registrant to obtain information that might be considered 
proprietary, privileged, or confidential by someone because such 
information would have to be turned over to EPA.
    The Agency has retained a requirement to summarize information, but 
in the final rule is providing significant additional guidance on what 
information needs to be included, and what does not need to be 
included, in such summaries. It will enable the Agency to quickly 
ascertain the nature of the information being reported and

[[Page 49376]]

therefore more quickly and responsibly fulfill its responsibilities 
under FIFRA.
    The Agency does not believe that a summary ought to be construed as 
an admission by a registrant that the information reported to a 
registrant and contained in the summary is true and correct. The 
standard for reportability is not whether the registrant believes a 
report submitted to it is factual and accurate. The report itself will 
not automatically be taken by the Agency as an admission by a 
registrant that it concedes the correctness of information contained in 
an allegation. Registrants are free to provide with their submissions 
any information they deem appropriate which may qualify or contest a 
reported allegation of adverse effects.
    As to the suggestion that the proposed rule might hamper 
registrants' ability to obtain information from individuals, the Agency 
has little way of knowing whether individuals might not cooperate with 
registrants or provide them with much information they currently 
provide if those individuals know that the information might be passed 
on to EPA. EPA's treatment of any information would be governed by 
FIFRA section 10 (which involves treatment of Confidential Business 
Information (CBI) under FIFRA) and by the Freedom of Information Act 
(FOIA). If the information is not protected under section 10, and if it 
is not protected from release under FOIA, EPA would be obligated to 
make it available to members of the public upon request. On the other 
hand, FOIA does allow agencies to withhold from release medical files 
and similar material the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy, and EPA fully intends to 
protect such information from release. Section 159.156(i) of the 
regulatory text refers submitters to the already existing procedures 
for segregating material deemed confidential under FIFRA section 10.
    The Agency does not believe it would be appropriate, as some 
commenters suggested, to delegate to registrants the determination of 
whether the information in any particular case is so significant that 
it should be provided to the Agency. As the United States District 
Court for the District of Columbia found in the case of CSMA v. EPA, 
484 F.Supp. 513 (1980), this determination belongs to EPA rather than 
to the regulated community. Under the circumstances, EPA cannot allow 
registrants to withhold otherwise reportable information on the grounds 
that persons who submitted it to the registrant might prefer that it 
not be transmitted to EPA.
    In regard to summaries themselves, EPA agrees that the proposed 
rule was too vague and could have lead to reporting of excessive or 
extraneous information. The Agency also is sensitive to the need to 
provide registrants with more guidance on what and how to summarize.
    The new Sec. 159.156(f) makes the following changes. First, it 
refers only to incident reporting, and not laboratory studies. Studies 
are already subject to requirements that they be identified as section 
6(a)(2) information, both by the terms of this rule at Sec. 159.156, 
and by the existing ``flagging'' criteria for certain toxicity studies 
at 40 CFR 158.34. This will generally be sufficient for an initial 
determination of whether the study warrants an expedited scientific 
review. Thus, a further requirement for summarization is unnecessary. 
This is clearly not the case for incident information.
    Incident information may come to a registrant in many different 
forms, ranging from consumer complaints by telephone, to detailed 
investigative reports developed in connection with a lawsuit. After 
considering all comments on this issue, the Agency has decided to 
identify the specific items of factual information that would best 
enable EPA to evaluate quickly and accurately the nature and 
seriousness of the incident being reported. These data elements vary by 
type of incident, and are listed in the revised Sec. 159.184, which 
deals with incident reporting. The revised Sec. 159.156(f) simply 
refers the registrant to Sec. 159.184.
    It must be stressed that the information identified in Sec. 159.184 
constitutes the optimal set of information the Agency would like to 
have regarding different types of incidents. If a registrant does not 
possess certain information, there is no obligation to commence an 
investigation or to otherwise generate or obtain information. 
Registrants need only include in summaries those pieces of information 
which are both requested in this final rule and which they possess. The 
1996 draft provided that if a registrant came into possession of an 
additional piece of information that would have been included in the 
original summary, the registrant would have to submit the additional 
information in a second summary within 30 days of receipt, and 
reference the earlier submission. In response to comments, the Agency 
now believes that this provision was unnecessarily burdensome. 
Accordingly, this final rule (in Sec. 159.184(f)) provides that the 
obligation to submit follow-up information depends in part on the 
severity of the incident. Thus, any additional information concerning a 
human fatality needs to be submitted. Follow-up information also needs 
to be submitted in cases where the information expands on previously 
reported circumstantial information about a serious human illness or 
injury (exposure-severity category H-B) or the most serious level of 
incidents (``A'' level) for any of the non-human exposure categories. 
Finally, information needs to be submitted if it alters a previously 
reported moderate or minor severity rating to the H-A or H-B level for 
humans or the A level for any other exposure type, as defined by the 
criteria of Sec. 159.184 (c)(5). The Agency retains the authority under 
Sec. 159.195(b) to require more detailed information about any incident 
or group of incidents if it seems useful to do so.
    2. Paragraph (i). In the proposed rule, confidentiality was dealt 
with in paragraph (g). As a general matter, the confidentiality of 
information submitted pursuant to the final rule is governed by section 
10 of FIFRA. Any claim that material submitted pursuant to FIFRA 
section 6(a)(2) is entitled to confidentiality for reasons related to 
trade secrets or CBI must be viewed in light of FIFRA section 10. 
Section 10(d) provides that certain information, including ``any 
information concerning the effects of [a] pesticide on any organism or 
the behavior of such pesticide in the environment, including but not 
limited to, data on safety to fish and wildlife, humans and other 
mammals, plants, animals, and soil'' shall be available for disclosure 
to the public. Section 10 thus makes clear that information concerning 
the effects of a pesticide on humans or the environment cannot be 
withheld from the public on grounds of trade secrecy or business 
confidentiality.
    The Agency expects that most material submitted under section 
6(a)(2) will continue to be of the type that is not entitled to 
confidentiality and must be made available to the public pursuant to 
section 10(d). Accordingly, the final rule includes a provision 
requiring that, if registrants consider any portion of a section 
6(a)(2) submittal to be confidential, they specify the portion for 
which confidentiality is desired; they explain why such portion is 
entitled to confidentiality under the applicable provisions of FIFRA 
section 10; and they provide a ``sanitized'' version of the submittal 
that can be publicly released with the confidential information 
omitted. The sanitization process is identical to that codified in

[[Page 49377]]

40 CFR 158.33, and which has applied for years to data submitted to the 
Agency by pesticide registrants. The new paragraph (i) refers 
registrants to Sec. 158.33 for the appropriate procedures to handle 
confidentiality claims.
    To clarify this issue, the Agency is preparing a notice in the form 
of a class determination to registrants. The notice will inform 
registrants that the Agency will not honor routine business 
confidentiality claims for material submitted pursuant to section 
6(a)(2) and covered by the disclosure provision of section 10(d).
    Some commenters suggested that the Agency exempt from the reporting 
requirements of section 6(a)(2) material covered by the attorney-client 
or attorney work-product privileges. The Agency has no intention to 
broadly exempt information covered by the attorney work-product 
doctrine. Exempting attorney work-product from section 6(a)(2) 
reporting would make the reportability of investigative work hinge on 
whether the work was generated at the suggestion of an attorney or of a 
non-attorney associated with a registrant. The Agency does not believe 
there is any valid policy reason to exempt from section 6(a)(2) 
reporting valuable information merely because it was developed at the 
suggestion of an attorney.
    Although the Agency does not know what useful information, if any, 
might be covered by the attorney-client privilege, the same logic 
applies as to the work-product doctrine. EPA does not believe it should 
make registration decisions based upon incomplete information in order 
to avoid the possibility of affecting registrants' positions in 
litigation.
    The commenters raising this issue did not argue that information 
covered by the attorney work-product doctrine or the attorney-client 
privilege is outside the statutory scope of section 6(a)(2). Instead, 
these commenters suggested that the Agency as a matter of policy craft 
an exemption for such material from the statutory reporting 
requirements. This the Agency declines to do. However, a registrant is 
always free to notify the Agency of its possession of potentially 
privileged information which falls under the scope of section 6(a)(2) 
and request that the Agency not require the submission of certain 
specified information in a particular case. EPA does not commit to 
granting such requests, but neither does it rule out the possibility of 
exempting otherwise submittable information in particular circumstances 
where it can be shown that the information is entitled to some 
privilege, that providing it to the Agency would substantially 
prejudice a registrant, and that the information would not be helpful 
to an analysis of a product's registration status. No such request will 
be honored unless it is made in writing and sent or delivered to one of 
the addresses listed in Sec. 159.156, and has been granted in writing 
by a responsible Agency official.
    Although it was not raised by any of the commenters, the Agency 
considered amending this section (Sec. 159.156), to allow registrants 
to submit information to the Agency through the use of regular first 
class mail and electronic transmission. It is important to point out 
that the regulation already allows the Agency to easily and quickly 
specify alternate methods for submissions at anytime in the future 
through the issuance of a Pesticide Registration Notice (PR-Notice).
    The Agency did not specify the use of regular first class mail as 
an acceptable method for section 6(a)(2) submissions, because providing 
verification of the mailing by the registrant and receipt by the Agency 
provides important protections to both the registrant and the Agency. 
It eliminates the possibility of debate over whether an item was 
actually submitted, and by informing registrants whether an item 
actually was received, it enables registrants to resubmit materials in 
a timely manner if a document is not in fact received by the Agency. In 
addition, the Agency believes that the additional cost is insignificant 
for sending it return receipt, certified or registered mail, which is 
only likely to add between $1.10 and $4.85 to the cost of that mailing, 
with other options, i.e., priority mail or express mail, only costing 
between $2.25 and $10.00.
    As for including electronic transmission as an acceptable method 
for section 6(a)(2) submissions, the Agency is working hard to 
establish the necessary framework and policies that will enable EPA to 
accept electronic submissions of information collections, including 
those under FIFRA. However, the Agency is still in the process of 
addressing the major issues associated with allowing electronic 
submissions in general (including the establishment of a system that 
also ensures the protection of any CBI, provides a reasonable degree of 
data integrity to ensure that information contents are not scrambled or 
misread by the system, and ensures that registrants receive their 
desired proof of delivery and receipt, etc. Needless to say, the Agency 
is very committed to the use of electronic transmission as an 
acceptable mechanism for submitting information to the Agency, and as 
soon as the issues are resolved, electronic submission will be an 
option for submissions under section 6(a)(2).

D. Section 159.157--Recordkeeping Requirements

    The proposed rule provided for 5 years of record retention for most 
types of information submitted to comply with the rule, but 10 years 
retention for certain information, such as information alleging adverse 
effects to one or two human beings. These retention periods were 
intended, in part, to enable registrants to determine whether 
information on certain incidents, which would not have been reportable 
by itself, would turn out in time to be part of a series of three 
similar incidents, and would thus have become reportable under the 
provisions of the proposed rule. Since the ``series of three'' concept 
has been dropped from this rule, the different record keeping 
requirements no longer have any purpose, and are deleted from all 
sections of this rule where they were previously mentioned. The 
question remains whether any record keeping should be required. The 
proposed rule provided that a copy of any submission to the Agency, and 
proof of delivery to the Agency, be retained for 5 years. The Agency 
considers all information derived from a reportable incident to fall 
within the scope of section 6(a)(2), but believes that if summaries are 
provided, additional information will rarely be needed. The Agency also 
believes that most registrants will retain records of adverse 
information reported to them for their own needs, and the Agency 
recommends that they do so. The Agency has concluded, however, that 
there is little value to EPA in having registrants retain copies of 
their submissions, and therefore has eliminated this requirement 
entirely.

E. Section 159.158--What Information Must be Submitted

    This section provides guidance on what particular types of 
information must be submitted. The proposed rule contained four 
paragraphs. For clarity, the Agency has restructured Sec. 159.158 into 
only two paragraphs; paragraph (a) identifies the general requirements 
formerly contained in paragraphs (a) and (b) in the proposed rule, and 
the new paragraph (b) describes the exceptions to reporting 
requirements formerly contained in paragraphs (c) and (d) in the 
proposed rule. The most significant issue for the general reporting 
requirements of paragraph (a) concerns opinion information.
    A number of commenters objected that opinion information is not 
factual

[[Page 49378]]

information, and thus is not subject to the reporting requirements of 
section 6(a)(2). As support for this objection, they cite the case of 
CSMA v. EPA, supra, in which the court opined that opinion information 
was not subject to reporting under section 6(a)(2).
    EPA has determined to retain the proposed provision without change 
in the final rule. As stated in the preamble to the proposed rule, the 
Agency does not believe that the issue of opinion information was 
properly before the District Court in the CSMA case or was any part of 
the holding or basis for the decision in the case. The Agency also 
believes that, if the issue were presented to a court today, certain 
types of opinion information would be found within the scope of section 
6(a)(2).
    As noted in the preamble to the proposed rule, the Agency is 
frequently obliged to make decisions in at least partial reliance on 
expert opinion. Indeed, often the Agency must resolve scientific issues 
under a ``weight of evidence'' approach, because the state of science 
makes a more definitive resolution impossible. For example, a 
conclusion as to whether a particular growth seen in a sacrificed test 
animal is a benign or malignant growth is not a matter of uncontestable 
fact, but rather, is the expression of an informed judgment by a 
trained professional (i.e., an expert opinion). Such expert opinions 
often serve as the basis for subsequent decisions about whether a 
chemical might pose a cancer risk to humans. These conclusions are 
based on a combination of observations and expert opinions; experts can 
and do disagree, and no conclusion can be considered indisputable fact. 
Yet such opinions play an important role in whether a pesticide should 
be registered and under what conditions. Indeed, studies submitted by 
registrants or applicants for registration frequently contain the 
conclusions and opinions of experts concerning the results and import 
of those studies. Where those conclusions and opinions suggest that a 
pesticide may pose a significant risk or a risk greater than previously 
presumed, the Agency believes those conclusions and opinions must be 
reported to the Agency pursuant to section 6(a)(2).
    In order to be reportable, an opinion must meet two criteria. 
First, the opinion must relate to information that is relevant to the 
risk/benefit balance applicable to a particular registered pesticide. 
Second, the opinion must be from either an employee or agent of the 
registrant; a person from whom the registrant requested the opinion; or 
a person who could be considered an expert with regard to the matter on 
which the opinion was uttered. The Agency believes opinions from these 
categories of people are more likely to have credibility and/or warrant 
further investigation than are opinions from people not falling into 
these categories.
    In terms of whether a conclusion or opinion can be said to have 
been rendered by an expert, previous publications of the Agency have 
suggested that registrants should be guided by whether the individual 
rendering the conclusion or opinion would, by virtue of his or her 
knowledge, skill, experience, training, or education, be qualified as 
an expert under Rule 702 of the Federal Rules of Evidence to testify to 
the opinions or conclusions on the subject at issue.
    The Agency considers trained professionals to be experts in their 
trained field for purposes of section 6(a)(2) reporting. If a medical 
doctor expresses a conclusion or opinion on a person's medical 
condition and the causes of that condition, the conclusion or opinion 
must be reported, regardless of whether the registrant believes the 
information to be valid or correct, or whether the registrant believes 
the expert performed an appropriate investigation upon which to base 
the conclusion or opinion. It must be left to the Agency to evaluate 
the validity of the conclusion or opinion and determine the appropriate 
response to the information.
    Finally, this discussion of expert opinion does not mean that the 
Agency intends to exclude reports of adverse effects in cases where an 
average person would reasonably suspect that pesticide exposure was a 
likely cause. For example, where someone develops tremors shortly after 
using a pesticide, common sense would suggest a link between pesticide 
exposure and the effect. Such an event would be reportable, even if it 
were not brought to the attention of a trained professional.
    The Agency believes that information that does not directly involve 
the registered pesticide may nonetheless be reportable under section 
6(a)(2). For example, if a registrant of a chemical in a particular 
class receives a study using two other chemicals in the same class (for 
which the registrant does not hold any registrations), and the study 
shows that the other two have a similar, reportable feature, if the 
registrant concludes that the registered pesticide might have the same 
reportable feature, this information must be submitted under section 
6(a)(2), even though the study did not directly involve the registered 
pesticide itself. The appropriate test is whether the information is 
relevant to a registered pesticide rather than whether the information 
is derived from a study or use of the registered pesticide.
    In addition, the Agency believes that the registrant is responsible 
for submitting any reportable information in his possession or control, 
including any reportable information that the registrant may receive. 
In other words, registrants are obligated to submit otherwise 
reportable information which they receive electronically or orally; 
information need not be submitted to a registrant in writing in order 
for the information to be reportable.
    Section 159.158(b) establishes categories of information that the 
Agency will exempt from reporting under section 6(a)(2): Information 
that is clearly erroneous; information that has previously been 
submitted to the Agency; and published books or articles. The 
provisions covering clearly erroneous information are unchanged from 
the proposed rule and the 1996 draft. With regard to previously 
submitted information, the Agency has added a new paragraph (b)(2)(iv) 
to Sec. 159.158, which expands the criteria for what constitutes 
``previously submitted information'' to include information submitted 
to EPA's Office of Pollution Prevention and Toxics under the provisions 
of section 8(e) of the Toxic Substances Control Act (TSCA). Without 
this change, information on chemicals already submitted under TSCA 
section 8(e) would also have to be submitted under section 6(a)(2) if 
the chemical was any constituent part of a pesticide product. As many 
commenters noted, the manufacturers of chemicals that have a variety of 
uses, including, but not limited to inert ingredients of pesticide 
products, are likely to have submitted adverse effects information 
under TSCA section 8(e), and may not be pesticide registrants, while 
pesticide registrants may be unaware of such submissions. The Agency 
agrees with commenters that the Office of Pesticide Programs can 
identify and obtain TSCA section 8(e) submissions concerning pesticide 
inert ingredients. In the event, however, that a chemical becomes the 
subject of an application to be registered as a new active ingredient, 
this new provision does reference the existing requirement of 40 CFR 
152.50(f)(3) that an applicant for registration must submit the same 
information that would be required under section 6(a)(2) for a 
registered product.
    Many commenters noted that the proposed rule would have required 
the submission of published information, while the 1985 Interpretive 
Rule exempted from the reporting

[[Page 49379]]

 requirements any information contained completely in ``any scientific 
article or publication which has been abstracted in Biological 
Abstracts, Chemical Abstracts, Index Medicus, or Pesticides Abstracts'' 
if the abstract clearly identified the active ingredient or registered 
pesticide to which the information pertains. The 1996 draft would have 
required submission of scientific articles or published literature 
(including those abstracted in the identified abstracts) only if that 
information pertained to epidemiological studies and incident reports. 
In response to comments, the Agency has decided to exempt all published 
articles abstracted in recognized data bases of scientific and medical 
literature, including articles concerning epidemiological studies and 
incidents. The Agency believes that conducting its own literature 
searches will generally be sufficient to identify useful published 
information. However, in the event that a registrant does become aware 
of published information concerning one of their pesticide products 
that would be otherwise reportable under this part, and the material 
does not appear to be abstracted in any recognized and generally 
available data base, the information would be reportable.

F. Section 159.159--Information Obtained Before Promulgation of the 
Rule

    The Agency added this new section to the 1996 draft in order to 
address the issue of reporting previously-obtained information raised 
by a number of commenters. The proposed rule did not address this 
issue. If the final rule were silent on the issue, then under the terms 
of the rule as originally proposed, any previously unsubmitted 
information which became reportable under the final rule would have to 
be submitted within 30 days. Such a requirement would probably not be 
feasible for registrants or EPA. The Agency has decided to limit the 
scope of reporting previously-obtained information in a number of ways.
    The 1996 draft would have required that studies reportable under 
Secs. 159.165, 159.170, 159.179, or 159.188, would be limited to 
reporting of studies completed within 5 years of the effective date of 
this rule. It should be understood that registrants are already 
required to comply with the obligation to report toxicology studies, 
failure of performance for health-related products, and other 
information required by previous Agency policy statements and guidance 
concerning section 6(a)(2) information. The Agency now believes that 
other data call-in activities are likely to have brought in previously 
unreported studies likely to be of use to the Agency, and is therefore 
eliminating this requirement to submit previously obtained studies.
    It is important to note that nothing in this final rule relieves 
any registrant of liability for failure to report information that 
should have been submitted under previous statements of the section 
6(a)(2) policy. However, any registrant who submits previously 
reportable information pursuant to Sec. 159.159 should note that the 
Agency's Enforcement Response Policy for FIFRA addresses the Agency's 
policy for responding to registrants who self-confess violations. 
Substantial penalty reductions may also be available to registrants who 
submit previously reportable information under the Agency's Incentives 
for Self-Policing: Discovery, Disclosure, Correction and Prevention of 
Violations Final Policy Statement, 60 FR 66708 (December 22, 1995) 
(``Self-Disclosure Policy'')(FRL-5400-1). The Self-Disclosure Policy 
has several important goals, including encouraging greater compliance 
with the laws and regulations which protect human health and the 
environment through self-policing, discovery, disclosure, correction 
and prevention of violations. If specific criteria are met, reductions 
in gravity-based penalties up to 100% are available under the Self-
Disclosure Policy. Registrants are advised that the criteria in the 
Self-Disclosure Policy are strictly applied. In particular, registrants 
should note that the Self-Disclosure Policy requires notification to 
EPA of the possible violation within 10 days of discovery.
    In addition, the Agency's Final Policy on Compliance Incentives for 
Small Businesses, which became effective June 10, 1996, provides small 
businesses with incentives to participate in on-site compliance 
assistance programs and to conduct environmental audits. Under this 
policy, EPA will eliminate civil penalties provided that the small 
business satisfies all of the following four criteria:
    (1) The small business has made a good faith effort to comply with 
applicable environmental requirements (through on-site assistance 
programs or voluntary audits and disclosures).
    (2) The small business was not subject to any enforcement actions 
for the current violation and has not been subject to two or more 
enforcement actions for environmental violations in the past 5 years.
    (3) The small business corrects the violation and remedies any 
associated harm within 6 months of discovery (an additional 6 months 
may be granted if pollution prevention technologies are being used).
    (4) The violation has not caused and does not have the potential to 
cause serious harm to public health, safety or the environment, it does 
not have the potential to present imminent and substantial endangerment 
to public health or the environment, and it does not involve criminal 
conduct.
    To further limit the burden of reporting previously obtained 
information, the final Sec. 159.159(a)(1) provides only for reporting 
of incident information obtained since January 1, 1994, and that such 
required incident reporting be limited to human hospitalizations or 
fatalities, and domestic animal or non-target wildlife fatalities only, 
since these categories of incident information are more likely to 
warrant regulatory action by EPA.
    Section 159.159 further eases the burden of reporting previously 
held information by providing a full year for registrants to respond, 
and by also providing that registrants shall submit an inventory of 
reportable material, rather than submitting individual incident 
reports. This will enable the Agency to selectively decide when to ask 
for more detailed submissions if it seems likely that information 
valuable for regulatory decision-making can be retrieved. As described 
in Sec. 159.159(b)(2), an inventory is a listing of the number and kind 
of incidents associated with a particular ingredient or product, using 
the exposure type and severity categories set forth in the rule in 
Sec. 159.184(c)(5).

G. Section 159.160--Exceptions Relating to Former Registrants

    This new section was added to the 1996 draft to clarify that former 
registrants are not obligated to report adverse information on their 
formerly-registered products more than 1 year after they cease to hold 
the registration, provided that they hold no active pesticide 
registrations. A former registrant who has entirely left the pesticide 
business is considered less likely to receive reportable information 
than an active registrant, and it would be a greater burden on such 
companies to keep a reporting system in place. In this final rule the 
obligations of former registrants have been further limited in several 
ways. For a person who continues to hold one or more active pesticide 
registrations, information need not be reported if it is associated 
with inert ingredients, contaminants, impurities, metabolites, or 
degradates contained in formerly-registered products more than 1 year 
after the

[[Page 49380]]

registrant first ceases to hold the registration. Former registrants 
who still hold one or more active registrations will still be required 
to report adverse information involving the formerly-registered 
pesticide product itself, as well as information involving any of the 
active ingredients contained in the formerly-registered product, for a 
period of 5 years after they cease to hold the registration, but not 
indefinitely, as the 1996 draft would have required. Finally, a 
provision has been added to require that information arising from 
litigation is reportable regardless of the time elapsed after the 
registrant ceases to hold the registration (except in the case of 
wholly canceled active ingredients). The Agency believes this would not 
be unduly burdensome, since the former-registrant would clearly be 
aware of receiving the information through the litigation process, and 
it pertains only to pesticide chemicals that have recently been or are 
still being actively marketed, for which EPA has an on-going interest 
in receiving reportable information.

 H. Section 159.165--Toxicological and Ecological Studies

    This section identifies the parameters for reporting information 
from toxicological and ecological studies. The proposed rule dealt with 
toxicological and ecological studies together, and provided that the 
results of an incomplete or complete study of the toxicity of a 
pesticide to any human or non-target organism be reported if it showed 
a toxic effect, when compared to a previously submitted, valid study:
    (1) In a different organ or tissue of the test organism.
    (2) At a lower dosage, or after a shorter exposure period, or after 
a shorter latency period.
    (3) At a higher incidence or frequency.
    (4) In a different species, strain, sex, or generation of test 
organism.
    (5) By a different route or medium of exposure.
    (6) Through a different pharmacokinetic, metabolic, or biological 
mechanism.
    Many commenters argued that EPA should only require the submission 
of studies that show significantly greater or different toxic effects 
than previously submitted studies. In particular, they suggested that 
the Agency not require studies showing a similar toxic effect in the 
same species of test organism. Commenters also suggested that the 
Agency not require the submission of acute toxicity studies unless the 
information would result in a change in toxicity category of the 
chemical. Some commenters alleged that the registrants of generic 
products--those no longer protected by patents and manufactured by more 
than one company--would not necessarily know whether a particular test 
result was new or more serious than previously reported information, 
thus making compliance difficult.
    In response to some of these comments, the Agency has made a number 
of changes in the final rule. The most significant revision is that EPA 
has established separate standards for studies designed to determine 
the toxicity of pesticides to humans (revised Sec. 159.165(a)), and for 
studies designed to determine the toxicity of pesticides to non-target 
plants and wildlife (new Sec. 159.165(b)). The requirements for 
submission of toxicological studies are not substantially changed. 
However, as suggested by some commenters, this final rule exempts 
reporting of acute toxicity studies if the results would not lead to a 
more restrictive toxicity category for labeling as provided in 40 CFR 
156.10(h).
    The Agency has made greater changes in the requirements for 
submission of ecological studies. The proposed rule simply referred to 
``non-target organisms'' and applied the same standards as for studies 
relating to potential human toxicity. The new Sec. 159.165(b) specifies 
what the Agency wants in the areas of acute toxicity, chronic toxicity, 
and phytotoxicity. The Agency believes these revisions will give much 
clearer guidance to registrants, and result in submissions most likely 
to be of value to Agency decision-making. The Agency has also provided 
some flexibility in relation to acute toxicity studies using the same 
or similar species.
    In relation to incomplete studies, a number of commenters noted 
that the 1996 draft did not provide any guidance concerning reporting 
information from incomplete studies. In this final rule, the Agency has 
expanded Sec. 159.165(d) to clarify the situations in which results of 
an incomplete study need to be reported. The language of this paragraph 
is essentially the same as the Agency used in its 1985 interpretive 
rule. These provisions are designed to ensure that severe adverse 
effects appearing in test organisms before the completion of a study 
are reportable, and also that results must be reported before the final 
analysis of a study is completed, if enough time has elapsed since the 
end of actual testing that a final analysis could have been completed.
    The Agency does not agree that manufacturers of generic chemicals 
are at any unreasonable disadvantage in complying with the rule. The 
requirement to report new or more serious effects has been in place 
since 1979, and is not changed by this rule. If a registrant is in any 
doubt about the significance of a study result, they can ask EPA to 
provide the Data Evaluation Reviews (DERs) for their chemical. DERs are 
summaries of reviews of studies submitted to EPA in support of 
pesticide chemical registrations. These documents are available on 
request to the public, and provide EPA's conclusions about study 
results, including such numerical parameters as No Observed Effect 
Levels (NOELs) which can be used to determine whether a new study is 
showing a more serious effect than previously reported information. 
There is no significant burden to registrants to obtain these 
documents.

I. Section 159.170--Human Epidemiological and Exposure Studies

    The proposed rule required that registrants submit any information 
concerning any study upon which a person described in Sec. 159.158(b) 
has concluded, or an expert 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, whether or not the registrant considers any observed 
correlation to be significant. This provision is largely unchanged. The 
final rule slightly modifies the description of exposure monitoring 
studies; such studies are reportable if they indicate exposure which is 
higher than indicated by previously available reports, data, or 
exposure estimates.

J. Section 159.178--Information about Pesticides on Food or Feed, or in 
Water

    The proposed rule would have required the reporting of information 
by registrants relating to the presence of pesticides in food or feed 
if the level of pesticide detected in the food or feed was in excess of 
an established tolerance, food additive regulation, or action level 
with the exception of information regarding residues resulting solely 
from studies conducted under authority of FIFRA section 5 (experimental 
use permits). In response to comments, the Agency has expanded this 
exemption to make clear that controlled studies designed to test a 
pesticide product are generally exempt from this requirement provided 
that treated crops bearing excess residue levels as a result of 
experimental applications are not marketed as food or feed.
    Information concerning the presence of pesticides in water would 
have to have been reported if the presence of the

[[Page 49381]]

pesticide in most surface waters, groundwater, or drinking water 
exceeded the water reference level. These provisions are essentially 
unchanged in the final rule. However, the 1996 draft and this final 
rule include a provision that detections of metabolites, degradates, 
contaminants or impurities in water need not be reported unless EPA has 
identified a specific reference point, such as a draft or final MCL or 
HAL, or has estimated an HAL based on an established Reference Dose, 
and notified registrants of that estimated HAL.
    A number of commenters thought that the rule as proposed and the 
1996 draft version would result in an excessive number of reports of 
questionable value, particularly of detections in water. The Agency 
recognizes that there may be a large number of detects of pesticides in 
water, and that the value of each incremental report may be small. The 
Agency also recognizes that there may be duplicate reports of the same 
detect submitted by different registrants. The Agency has established 
water reference levels that are designed to provide EPA with an early 
warning that a pesticide may be present in water before that presence 
has reached impermissible levels. However, in response to comments, and 
in order to assure that the information received is as useful as 
possible to the Agency, EPA is requiring in this final rule, that 
detections below MCLs or HALs be aggregated into quarterly statistical 
summaries to help reduce the burden of reporting for registrants.
    In response to comments received, the Agency would like to clarify 
its position on reporting residues of inerts, metabolites, degradates, 
impurities, or contaminants on food or feed commodities. This issue 
hinges on whether the presence of the residue on food or in feed would 
require a tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA). Under the FFDCA, food is considered adulterated if chemical 
residues are detected on the food unless the chemical residues are 
covered by a tolerance, or the chemical has been specifically exempted 
from needing a tolerance, or the chemical is generally considered safe. 
At 40 CFR 180.2, EPA identified a number of chemicals considered 
``safe'' under the meaning of section 408 of the FFDCA, and has also 
exempted (40 CFR 180.1001) a number of substances from the requirements 
of a tolerance.

K. Section 159.179-- Metabolites, Degradates, Contaminants, and 
Impurities

    The purpose of the section is to ensure that the Agency is informed 
when registrants learn of toxicologically significant new breakdown 
products or when they learn of higher levels of contamination than were 
previously known to be associated with their pesticide products. In 
response to comments, the provisions of this section in this final rule 
have been modified to better reflect the Agency's intention that this 
provision be consistent with the Agency's policy on cross-contamination 
(PR Notice 96-8, October 31, 1996) and the requirements governing when 
impurities must be identified in a product's composition (see, e.g., 40 
CFR 158.155, 158.167 and 158.175). In PR-Notice 96-8, EPA set out the 
Agency's interpretation of the term ``toxicologically significant'' as 
it applies to contaminants in pesticide products that are also 
pesticide active ingredients (Ais). That PR-Notice provides risk-based 
concentration levels of such contaminants that will generally be 
considered toxicologically significant. The concentrations are defined 
according to the type of the pesticide that is contaminated and the 
pesticide category of the contaminant. As provided by this regulation, 
registrants must report to EPA any contaminant exceeding the 
toxicologically significant levels using the procedures for reporting 
such contamination that were established in the PR-Notice.
    In general, the cited regulations in part 158 and the cross-
contamination policy serve to assure that all batches of a given 
pesticide product meet certain standards of uniformity and that the 
Agency has information about all the significant components of a 
product's composition. At the same time, these regulations and policies 
recognize that it could be either impossible or prohibitively expensive 
to manufacture a pesticide product without any detectable impurities in 
it. The Agency therefore allows the presence of certain impurities in 
pesticide products below various levels without requiring that the 
registrant include information about the impurities in its formula or 
elsewhere in its application, and without considering the product 
containing such impurities to be inconsistent with the composition of 
the registered product. Section 159.179 provides that registrants do 
not have to notify EPA pursuant to section 6(a)(2) of the presence of 
any impurities or contaminants that would not have to be discussed in 
an application for registration or where the Agency has concluded that 
the presence of the contaminant does not render a product's composition 
inconsistent with the composition accepted by the Agency as part of the 
product's registration. However, where the presence of an impurity or 
contaminant would have to have been identified in the application 
materials or if the presence exceeds the levels allowed in the cross-
contamination policy (or any similar policy issued by the Agency in 
writing), registrants are required under Sec. 159.179 to report the 
presence of the contaminant or impurity to EPA.
    The Agency notes that impurities which are not also pesticide 
active ingredients that occur during manufacture of a pesticide are 
already subject to certain reporting requirements under the provisions 
of 40 CFR 158.167 and/or 158.175. For purposes of reporting under the 
present rule, any detection of a manufacturing impurity at levels 
greater than the expected level reported to the Agency pursuant to 
Sec. 158.167 or greater than a certified limit established pursuant to 
Sec. 158.175 must be reported as section 6(a)(2) information.

L. Section 159.184--Toxic or Adverse Effect Incident Reports

    One of the most important routes by which adverse effects 
information can come to the attention of the Agency is through toxic or 
adverse effect incident reports. Many of the Agency's registration 
decisions are predictive in nature. In contrast, incident reports can 
provide the Agency with information depicting the practical impacts of 
pesticide use, including real-world effects of pesticide use. The 
Agency considers incident reporting to be a vital component of section 
6(a)(2).
    The 1992 proposed rule version of Sec. 159.184 imposed different 
reporting requirements for single incidents as opposed to a series of 
incidents involving three or more organisms. Incidents involving a 
single person or non-target organism were only reportable if the 
registrant (or other qualified person) had concluded that a causal 
relationship might exist between exposure to the pesticide and the 
toxic effect, or if the alleged effect were previously unreported or 
more severe than previously reported effects. If the ``three or more'' 
trigger was met, an incident or incidents had to be reported without 
regard to whether the registrant had concluded that a causal 
relationship existed between exposure and the effect or whether the 
toxic effect had previously been reported to the Agency.

[[Page 49382]]

    The proposed Sec. 159.184 was the subject of a large number of 
comments challenging the provision alternatively as too broad as well 
as too narrow. The Agency reconsidered Sec. 159.184 in the light of 
recent experience, as well as the comments received on both the 1992 
and 1996 versions, and has determined that the threshold for reporting 
incident information needed to be changed in a number of ways and that 
registrants could benefit from more specific guidance in this preamble.
    The provision for reporting incident information in this final rule 
requires the reporting of any single incident involving humans or 
nontarget organisms if:
    1. The registrant has been informed that a person or non-target 
organism may have been exposed to a pesticide.
    2. The registrant has been informed that the person or nontarget 
organism has suffered or may suffer (or may have suffered) a toxic 
effect.
    3. The registrant has a certain minimum level of information 
enabling them to pursue further information on the incident if they 
wish, such as the identity of the product involved, the location where 
the incident occurred, and the name of a person to contact concerning 
the incident.
    This third provision was added in response to comments on the 1996 
draft, and is designed to eliminate completely anonymous or very 
incomplete reports that can not be deemed meaningful by either 
registrants or EPA.
    Individual incidents otherwise meeting the general standard need 
not be reported if they meet any of six criteria for exemption. Most of 
these exemptions concern effects which are already warned of on the 
label. The most significant exemption, in EPA's view, is to allow an 
exemption for reporting of skin or eye irritation effects warned of on 
the label of a product which is registered for use in residential use 
sites, and the incident was alleged to occur in a residential use site. 
Many commenters suggested this exemption. EPA's reason for accepting 
this suggestion is that the burden of reporting the information and for 
EPA to process it probably outweighs its value. There may be numerous 
allegations of such effects because of the high volume of products 
involved, but such incidents are relatively minor in terms of health 
effects significance. Moreover, such reports are nearly impossible to 
verify, and are not likely to lead to regulatory action in the absence 
of clear and specific evidence that the labeling or packaging of the 
product in question is inadequate to protect the public.
    This rationale, however, does not support including non-residential 
use sites in this exemption, i.e., uses in institutional, industrial, 
and agricultural settings. In contrast to homeowners, the customer base 
for non-residential uses is likely to be familiar with pesticide 
hazards and the importance of the label directions, and in many cases, 
the users are actually trained in their use. Thus, if it is determined 
that a significant number of adverse effects continues to occur in this 
group regardless of label warnings, the Agency might well require 
changes to the terms and conditions of registration (such as requiring 
different warning statements, application methods, or the use of 
personal protective equipment) to respond to the situation. The Agency 
will reexamine the application of reporting requirements to non-
residential products for minor effects warned about on the label in 3 
years. If EPA determines that this information is no longer needed for 
some or all non-residential situations, the Agency will notify 
registrants accordingly pursuant to Sec. 159.155(a).
    In this final rule, the Agency has eliminated the distinction 
between single incidents and a series of incidents. The Agency also 
eliminated the requirement, for single incidents, that the registrant 
or an employee, consultant, or expert, must have determined that the 
reported effect may have resulted from the reported exposure. These 
changes were made partly in response to comments received, and partly 
because the Agency determined that much valuable information was not 
submitted to the Agency while the higher threshold embodied in previous 
policies was in effect.
    Under the 1996 draft, incidents would have been reported whenever a 
registrant was informed that a human or other organism had been exposed 
to a pesticide and the registrant had been informed either that the 
human or other organism had thereafter suffered an adverse effect or 
that the exposure that occurred was unexpected and an adverse effect 
may have occurred thereafter or may occur in the future.
    In this final rule, the term ``unexpected exposure'' has been 
eliminated. Many commenters felt that it was too ambiguous, and also 
that it was unfair to require reporting of ``unexpected exposures'' in 
situations in which no specific symptoms or adverse effects were 
alleged, since this would not be evidence of an adverse effect. In 
EPA's view, there are two separate issues here. With regard to 
``unexpected exposures'', EPA is willing to eliminate this language as 
a criterion for routine reporting requirements under this final rule, 
on the grounds that it is ambiguous, and in most cases would not result 
in useful information being submitted. However, the Agency wishes to 
make it very clear that on some occasions it may have an interest in 
``unexpected exposure'' information, and may require it to be submitted 
as section 6(a)(2) information at its discretion. For example, in 
regulating certain highly toxic pesticides EPA has required such 
measures as special protective clothing for applicators, restricted 
reentry intervals for treated fields, the use of closed mixing and 
loading systems, closed cabs for applicators or flaggers, and related 
measures, all designed to minimize the likelihood of exposure. Since 
one of the purposes of section 6(a)(2) is to obtain information that 
will show whether previous registration decisions are effectively 
protecting health and the environment, the Agency believes that 
information about ``unexpected exposures,'' even when these exposures 
are the subject of label warnings, is within the purview of section 
6(a)(2). In those circumstances where the Agency considers it important 
to receive information concerning unexpected exposures, EPA will notify 
registrants that such information must be submitted pursuant to 
Sec. 159.195(b).
    The second issue raised by commenters concerns whether specific 
symptoms have been reported. Some commenters felt that in the absence 
of concrete evidence of adverse effects to exposed individuals there is 
no basis for a report under section 6(a)(2). In essence, these 
commenters are objecting to the reporting criteria of 
Sec. 159.184(a)(2) that the registrant has been informed that a person 
``may have suffered or may suffer'' an adverse effect. The Agency 
disagrees with these comments. The standard for reporting an incident 
is that there be both an allegation of exposure and an allegation of 
possible harm. This does not mean that the exposed person must be 
visibly ill for an incident to be reportable. Many pesticides are 
associated with health risks which are not necessarily those of acute 
toxicity. Exposure to certain pesticides may pose risks of birth 
defects, reproductive disorders, chronic nerve, liver, thyroid, heart, 
or other organ damage, or cancer. Any of these effects would be a 
legitimate cause of concern to exposed individuals, and none of them 
would necessarily be visible or apparent in the short term. 
Accordingly, the Agency rejects the

[[Page 49383]]

argument that only overt evidence of adverse effects is reportable.
    The Agency recognizes that the lower threshold for reporting of 
incidents contained in this final rule might result in the submission 
of information which is not sufficiently reliable or detailed to 
warrant regulatory action. On the other hand, such information might 
well provide the Agency with advance warning of potential problems and 
could identify issues that warrant increased review and investigation. 
The Agency is aware of a number of instances in the past in which 
information that could well have resulted in regulatory action or 
investigation was not reported under previous policy determinations on 
incident reporting under section 6(a)(2). These include instances in 
which litigation involving allegations of adverse effects caused by 
pesticide products has not been promptly reported by registrants 
pursuant to section 6(a)(2).
    Registrants should be aware that the Agency considers information 
related to a lawsuit involving an allegation of adverse effects due to 
a pesticide to be clearly reportable under the terms of the final rule, 
unless the registrant is aware of facts which establish that the 
alleged exposure and effect did not or will not occur. The Agency 
expects to be informed of incident information in a timely manner, 
regardless of whether the registrant agrees with the substance of the 
incident report.
    In addition to changing the threshold for reporting incident 
information, the Agency has identified in this section of the final 
rule the information elements that must be included in incident reports 
if the information is available to the registrant. For the convenience 
of both registrants and Agency reviewers, EPA hopes to develop new and 
more efficient ways to submit this type of information, such as direct 
electronic submission of data. The Agency has elected to delay the 
effective date of this final rule to 9 months after publication 
primarily in order to work with all interested parties to seek the 
least burdensome and most efficient ways to implement reporting 
requirements. Until alternative reporting methods are adopted, the 
Agency urges registrants to use the simple list format set out in the 
final rule.
    As noted earlier, registrants are not obligated to investigate 
incidents in order to acquire information to satisfy any particular 
data element. If a registrant lacks information, it does not need to be 
provided. In its 1996 draft, the phrasing of the rule text appeared to 
require that if, after an initial report is made, a registrant acquired 
information related to any element previously unreported, the 
information should be reported and reference the earlier submission. 
Many commenters on the 1996 draft noted that this provision could 
result in numerous submissions of minor factual information of little 
use to the Agency. EPA agrees, and has accepted commenters' suggestions 
to modify this final rule to provide that follow-up information need 
only be submitted when it pertains to human fatalities, materially 
alters the circumstance information concerning serious human injuries/
illnesses or wildlife fatalities, or alters previously reported low 
severity levels up to the ``A'' or ``B'' level of severity for human 
incidents, or the ``A'' level for all other incidents, as defined by 
the exposure type and severity labeling criteria set out in the rule 
text at Sec. 159.184(c)(5).
    Unless directed otherwise by the Agency, registrants are not 
obligated to provide the Agency with any additional information on an 
incident other than what is summarized in providing the relevant data 
elements. The Agency may ask for additional information in the 
registrant's possession pursuant to Sec. 159.195, but in the absence of 
such a request, providing the information called for in the data 
elements is all that a registrant must do in submitting incident 
information under section 6(a)(2).
    Finally, the rule requires the registrant to assign an ``exposure 
type and severity label'' to each incident. These labels categorize 
what was exposed (i.e., humans, domestic animals, fish or wildlife, 
plants, or involves contamination of water), and the severity of the 
alleged incident. The assignment of a label will not be interpreted by 
the Agency as agreement by the registrant with the substance of any 
incident reported, nor will it be interpreted as registrant agreement 
with the particular rating assigned. The purposes of the ratings are 
for registrants to determine reporting requirements and time frames and 
for the Agency to quickly categorize the nature and scope of the 
adverse effect being alleged.
    The Agency offers the following response to the significant 
comments received on the issue of incident reporting:

    A large number of commenters argued that the proposed rule would 
result in the submission of much information of dubious value that 
would overwhelm Agency review resources. The Agency shares the 
commenters' concern that section 6(a)(2) information be properly 
managed and that significant submissions not be overwhelmed. The Agency 
does not believe (as many of the commenters seem to imply) that the 
appropriate response is to exempt most incident information from 
reporting requirements. Instead, the Agency has liberalized the time 
frames for reporting, and instituted aggregated statistical reporting 
for incidents of a relatively less serious nature, in order to make the 
incoming information easier to manage for both registrants and the 
Agency. The Agency also hopes to develop more sophisticated and 
efficient methods such as electronic submission. EPA also expects to 
use the authority in Sec. 159.155 to reduce the number of certain types 
of repetitive reports.
    A few commenters argued that a requirement to report 
unsubstantiated and uninvestigated incidents is unreasonable, 
excessively burdensome, and excessively expensive. Many registrants, 
however, routinely receive incident reports or consumer complaints and 
already have procedures for gathering and evaluating such reports. 
Keeping the Agency informed of these reports should not impose a 
significant additional burden, particularly since less severe incidents 
can be reported as aggregated counts and not as individual reports.
    The Agency appreciates that the threshold for reporting incidents 
is far less than conclusive assurance that a reported toxic effect was 
caused by reported pesticide exposure, and expects that its regulatory 
decisions will be based upon an appropriate evaluation of all the 
relevant information available to the Agency. The Agency understands 
that with the elimination of the provision that called for registrant 
judgment as to whether there is a cause and effect relationship between 
reported exposure and a reported toxic effect, registrants are being 
directed to report information with which they may disagree. Regulatory 
decisions will take into account the quality and reliability of any 
information received. The Agency neither presumes the validity of 
incident reports nor views such reports as admissions against interest 
by the submitter.
    A number of commenters suggested that the reporting criteria be 
narrowed so that only additional or new unreasonable adverse effects 
are reported to the Agency, and that registrants should not be required 
to report incidents involving effects anticipated or warned about on 
pesticide labels. To the extent that the commenters are suggesting that 
additional reports of previously

[[Page 49384]]

understood effects ought not to be reported, the Agency strongly 
disagrees. The frequency of occurrence of an adverse effect is 
extremely important information to pesticide decision-making. The 
Agency also generally disagrees that incidents involving effects warned 
about on labels should not be reported. Such incidents can provide 
important information about the adequacy of label warnings and whether 
additional steps need to be taken to provide the desired protection. 
However, the Agency recognizes that minor skin or eye irritation 
effects warned of on the label of home-use products are not likely to 
be the source of reports warranting regulatory action, and will exempt 
this category of incidents from routine reporting requirements at this 
time.
    Similarly, the Agency has a responsibility to consider misuse of 
pesticides as a factor in determining whether a product is adequately 
labeled, or should be registered at all. If misuse incidents involving 
non-target organisms were exempted, as the proposed rule would have 
provided, potentially significant information for recognizing problem 
pesticides could be lost. Therefore the Agency has eliminated that 
proposed exemption.
    One commenter suggested that the rule include a provision exempting 
from reporting incidents involving non-labeled pests. The Agency 
agrees, and has added such a provision in the final rule. Incidents 
involving toxic effects to non-labeled pests that are similar in kind 
to pests on the label (e.g., insects or weeds) need not be reported. 
However, if an event involves a toxic effect to an unrelated species 
(e.g., an insecticide kills birds or mammals, even if regarded as 
pests) the incident must be reported.

M. Section 159.188--Failure of Performance Information

    Section 6(a)(2) requires the submission of information concerning 
unreasonable adverse effects on the environment. The term 
``unreasonable adverse effects'' is statutorily described as a risk/
benefit balance. Thus, although section 6(a)(2) reporting has primarily 
focused upon the risks posed by pesticide use, the statutory language 
includes within its scope information concerning the benefits of 
pesticide use.
     In its 1979 Policy Statement, the Agency announced that it would 
consider it an actionable violation of section 6(a)(2) to fail to 
report information that a pesticide may not have performed 
efficaciously when used against organisms which pose a potential threat 
to public health. At that time, the Agency essentially exempted from 
reporting all failure of efficacy information involving pesticides used 
against organisms that did not pose a potential threat to human health.
    The provision in the 1992 proposed rule involving the reporting of 
failure of performance information required that such information be 
reported in three circumstances:
    1. Information concerning incidents in which a pesticide allegedly 
failed to perform as claimed against target organisms which, if not 
controlled, might pose an immediate risk to human health and the 
registrant has been provided with sufficient information to investigate 
the allegation and was unable to establish that the reported failure of 
performance did not occur.
    2. Information concerning a series of three or more incidents 
occurring within 10 years involving allegations that the pesticide did 
not perform as claimed against target organisms which, if not 
controlled, might pose a risk to human health and the registrant has 
been provided with sufficient information to investigate the 
allegations and was unable to establish that the reported failures of 
performance did not occur; or information concerning studies 
demonstrating that the pesticide may not perform in accordance with any 
public health claims.
    3. Information concerning a series of three or more incidents 
occurring within 10 years involving allegations that a pesticide that 
has been the subject of a special review or cancellation or suspension 
proceeding pursuant to sections 6(b) or 6(c) of FIFRA failed to perform 
as claimed, or showed a reduction in efficacy, involving a use that was 
a subject of the special review or suspension or cancellation 
proceeding.
    The Agency received a large number of comments addressing this 
provision of the proposed rule. Some commenters objected to the scope 
of the provision because it did not require the submission of all 
efficacy failure information. Other commenters objected to the 
requirement to submit any failure of efficacy information. Many 
commenters objected to any requirement to submit consumer complaints 
that a product might not have worked as effectively as the consumer 
would have desired, especially in the context of household use 
products. A number of commenters asked for clarification of many of the 
provisions of the proposed rule, including the differentiation between 
uses that might pose an immediate risk to human health and uses which 
might only pose a risk to human health.
    The Agency has decided to restructure and clarify the provisions of 
this section in the final rule. The 1996 draft rule would have required 
the submission of information concerning failure of efficacy in the 
situations enumerated below. The revisions adopted by EPA in this final 
rule are noted in each case.
    1. Information concerning incidents involving the failure of a 
pesticide to perform as claimed against target microorganisms which, if 
uncontrolled, might pose a threat to human health if the pesticide's 
function is not a residential use and the registrant has or could 
obtain information concerning where the incident occurred, the 
pesticide or product involved, and the name of a person to contact 
regarding the incident; and information concerning any study indicating 
that a pesticide might not perform as claimed when used to control 
microorganisms that might pose a risk to human health, including any of 
the public health antimicrobials identified in 40 CFR part 158. This 
provision is retained in the final rule, except to note that certain 
liquid chemical sterilants that would have been covered by this 
provision have been removed from FIFRA jurisdiction by the Food Quality 
Protection Act of 1996 (Pub. L. 104-170).
    2. For pesticides used for the purpose of controlling animals 
(including insects) that might cause disease in humans (either directly 
or as disease vectors), produce toxins that are harmful to humans, or 
cause direct physical harm to humans, information must be submitted 
concerning incidents in which the registrant has been informed by a 
municipal, State, or Federal public health official that the product 
may not have performed as claimed and the registrant has or could 
obtain sufficient information concerning where the incident occurred, 
the pesticide or product involved, and the name of a person to contact 
regarding the incident; and information must be submitted concerning 
studies that indicate that the pesticide may not perform as claimed 
when used to control animals or insects that might pose a risk to human 
health. This provision has been retained without change from the 1996 
draft version of the rule.
    3. Under the 1996 draft, information would have to have been 
submitted concerning studies involving the failure of a pesticide to 
perform against a pest as claimed if the performance of the pesticide 
in the study was less than the

[[Page 49385]]

performance standard specified in the Pesticide Assessment Guidelines 
for Product Performance (Subdivision G) or, if no performance standard 
is specified or suggested in the Guidelines, if the performance of the 
pesticide was less than or equal to that of an untreated control, and 
the pesticide label does not warn the user that the pest control 
failure might occur when the pesticide is used under the conditions in 
which the failure occurred. In this final rule, this provision has been 
eliminated. Many commenters noted that ``failure of performance'' 
information would often arise from deliberate product testing studies, 
which would be irrelevant for regulatory purposes, since they do not 
reflect actual use conditions, or from consumer allegations, which 
would be very difficult to evaluate. The Agency agrees, and has 
eliminated this provision.
    4. The 1996 draft would have required submission of information 
concerning substantiation of any incident of pest resistance to any 
pesticide which occurs in actual use according to the label, whether or 
not the pesticide has any health-related uses. Under the 1996 draft, an 
incident of pest resistance would be considered substantiated if the 
survival of the suspected pesticide-resistant pest was significantly 
higher than that of a known susceptible pest when both the suspected 
resistant and susceptible pests were treated with the pesticide under 
the same conditions, or biochemical tests or DNA sequencing indicate 
that a pest has developed resistance to a pesticide. Under the 1996 
draft, incidents involving suspected pest resistance to a pesticide 
would have been reported if the incident occurred in the same state or 
in a state adjacent to a state where a substantiated incident or study 
has taken place and the incident involved the same pest as the 
substantiated incident.
    In this final rule, the Agency is retaining the requirement for 
information concerning substantiated incidents of pest resistance. It 
is clear to EPA that pest resistance is a very significant factor in 
determining the benefits of specific pesticides, and that such 
information may be critical to specific regulatory decisions that weigh 
the risks and benefits of pesticide products. However, the Agency does 
recognize that unsubstantiated allegations of resistance would be of 
questionable value and is willing to dispense with routine reporting of 
such allegations, since they would be difficult to use in decision 
making.
    Several commenters on the 1996 draft were concerned that there is 
no generally agreed upon standard for identifying a ``significantly 
higher'' survival rate for an allegedly resistant pest species, and 
that this may make it difficult for registrants to comply with the 
requirement to report ``substantiated incidents.'' The Agency believes 
that the concept of a ``significantly higher'' survival rate for 
suspected resistant pests is the correct place to begin to define a 
standard for substantiated incidents. The Agency acknowledges that this 
is an area of science where there is at present no clear cut standard. 
Accordingly, the Agency will work to develop guidance on this issue 
with input from all interested parties.
    The provision for submitting failure of performance of public 
health antimicrobial pesticides requires registrants to submit 
information concerning all incidents and all studies involving the 
possible failure of efficacy of any public health use of an 
antimicrobial pesticide unless the registrant cannot obtain minimal 
specified information regarding an incident or if the use involved in 
the efficacy failure is a residential use. EPA does not believe that 
residential uses are likely to be important public health uses, and it 
believes that the people most likely to be reporting such incidents 
(ordinary consumers instead of trained health professionals) have less 
expertise than those that are likely to be involved in reporting 
incidents involving non-residential uses.
    The Agency has eliminated the distinction between uses that might 
pose an immediate risk to human health and uses that might pose a risk 
to human health, and is requiring the submission of all reportable 
incidents rather than a series of three. In reviewing the Proposed 
Rule, the Agency discovered that it was ambiguous on the subject of 
whether studies involving efficacy failures of public health pesticides 
were reportable under section 6(a)(2). The final rule makes clear that 
any study indicating a lack of efficacy of a public health 
antimicrobial pesticide must be reported to the Agency, except for 
those chemicals which are liquid chemical sterilants no longer 
regulated as pesticides pursuant to the FIFRA amendments of 1996.
    The Agency established a separate provision for the reporting of 
incidents and studies involving non-antimicrobial public health 
pesticides. These pesticides include many insecticides, rodenticides, 
and other pesticides that control living organisms (other than 
microbial organisms) that pose a potential health risk to humans. 
Again, the Agency has eliminated the distinction between an immediate 
risk to public health and a risk to public health. All incidents 
meeting the provisions of this final rule must be reported. In order to 
avoid the submission of potentially less reliable reports, however, the 
Agency has decided to require the submission of incident allegations 
only if the allegation has been made by a government employee (at the 
Federal, State, or local level) involved in the public health field. 
For example, an incident involving efficacy failure of a mosquitocide 
reported by an employee of a mosquito control district would be 
reportable under this provision; a similar incident reported to a 
registrant by a private citizen would not be reportable. As with 
antimicrobial pesticides, any study indicating a lack of efficacy of a 
public health non-antimicrobial pesticide must be reported to the 
Agency.
    For uses of pesticides other than public health uses, the Agency is 
not requiring the reporting of information concerning incidents where a 
product is asserted not to have performed in accordance with label 
claims. In its 1996 draft, the Agency considered requiring the 
submission of studies that indicate that a pesticide's performance 
failed to meet the guidelines established by the Agency for product 
performance or, in the absence of a performance guideline, failed to 
achieve greater pest control than occurred without any pesticide use. 
However, in response to comments, the Agency now believes that most 
failure of performance information would be difficult to evaluate, and 
this type of information is not being required except in the case of 
substantiated incidents of pest resistance.
    The Agency has decided not to differentiate in this provision 
between pesticide uses that were once the subject of a special review 
or cancellation or suspension hearing and all other pesticide uses. If 
the Agency determines that it needs additional information concerning 
possible failure of performance of any pesticide, including one that 
was the subject of a special review or cancellation or suspension 
hearing, the Agency can request that information pursuant to 
Sec. 159.195 of this final rule. In addition, if the conclusion of a 
special review or cancellation or suspension hearing clearly provides 
(or provided) that the pesticide product was being allowed to remain on 
the market only because the product was significantly more effective 
than alternative products, registrants would be obligated to provide 
information calling into question the

[[Page 49386]]

continuing efficacy of the product under Sec. 159.195.
    Finally, the Agency has determined that substantiated information 
about pest resistance is another area where failure of performance 
information may assist the Agency in the performance of its regulatory 
role. The Agency is therefore requiring the submission of information 
concerning the occurrence of pest resistance under actual conditions of 
use, where such information meets a defined standard of reliability. 
The 1996 draft would also have required reporting of unsubstantiated 
allegations of pest resistance if they involved the same pest/crop 
combinations as substantiated incidents, and occurred in the same or 
adjacent states as substantiated incidents. However, the Agency now 
believes that this requirement would result in submissions that would 
be difficult to evaluate and of dubious value, and prefers to rely on 
controlled studies of pest resistance that are more likely to produce 
useful information. As noted above, EPA will work to develop guidance 
for the regulated community to define the level of results in a study 
that can be considered substantiation of resistance.
    Several commenters, noting that efficacy against pests is the 
primary benefit offered by pesticide products, argued that EPA has no 
authority to require information on efficacy failure (or any other lack 
of benefits information) under section 6(a)(2). To support this 
position, one commenter cited the District Court decision in the CSMA 
case. The Agency appreciates that the court in that case opined that 
benefits information was outside the scope of section 6(a)(2). However, 
the Agency believes that the court was clearly incorrect on this point. 
Section 2(bb) of FIFRA defines unreasonable adverse effects on the 
environment as including the consideration of information on benefits 
as well as risks. It is clear under FIFRA that a failure of efficacy of 
a product could tip the risk/benefit balance in favor of cancellation 
of a product or specific uses of a product. Under such circumstances, 
the Agency believes there is no question that failure of efficacy 
information falls within the statutory scope of material covered by 
section 6(a)(2).

N. Section 159.195--Reporting of Other Information

    The 1992 proposed rule required the submission of information not 
included within any of the other provisions of the rule if the 
registrant is not aware of facts which establish that the information 
is incorrect and the registrant knows, or should know, that if the 
information should prove to be correct, EPA would regard the 
information either alone or in conjunction with other information as 
having the potential to raise questions about the continued 
registration of a product or about the appropriate terms and conditions 
of registration of a product. Similar general provisions have been 
included in all previous Agency policy statements and interpretations 
of section 6(a)(2).
    In response to a comment, the Agency added one example to the types 
of information that must be reported under Sec. 159.195(a) of this 
final rule. Specifically, the Agency is making it clear that it 
considers any information which might tend to invalidate in any way a 
study submitted to the Agency to support a pesticide registration, to 
be reportable under section 6(a)(2).
    The Agency intends to take enforcement action pursuant to this 
provision only when it believes a registrant clearly should have known 
that information would have been considered important by the Agency in 
its evaluation of a pesticide product registration. If a registrant is 
aware that the registration decision for one of its products was based 
upon an assumption by the Agency that is called into question by some 
new piece of information, that information must be provided under this 
provision if it is not already reportable under some other provision of 
this final rule. In situations where a registrant is unsure how this 
provision applies to specific information, the Agency encourages the 
registrant to seek advice from EPA.
    The Agency on occasion may notify a registrant that it considers a 
particular type of information to be reportable pursuant to section 
6(a)(2). Such a notification to the registrant removes any question 
concerning whether the registrant should know that the Agency considers 
the information important. In order to eliminate any possible confusion 
on this point, EPA has added a specific provision spelling out a 
registrant's obligation when it is informed that the Agency desires the 
submission of specific information pursuant to section 6(a)(2).

III. Statutory Review Requirements

    In accordance with section 25 of FIFRA, a copy of the final rule 
was provided to the Secretary of the Department of Agriculture (USDA), 
the FIFRA Scientific Advisory Panel (SAP), the Committee on 
Agriculture, Nutrition and Forestry of the U.S. Senate, and the 
Committee on Agriculture of the U.S. House of Representatives. EPA did 
not receive any comments.

IV. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) determined that this rule was a ``significant regulatory 
action'' because there was a potential for it to raise novel legal or 
policy issues related to the implementation of a statutory mandate. The 
Agency determined that this final rule is unlikely to have a major 
economic impact on pesticide registrants, and no impact on any other 
sector of the economy, or on any other government entities, programs or 
policies. The aggregate annual impact on the private sector is 
estimated to be about $15.7 million in the first year, and about $8 
million annually thereafter. The basis for EPA's determination is 
contained in the Information Collection Request prepared for this rule 
(see Unit IV.D. below).
    In addition, the rule is consistent with the purposes of FIFRA, and 
does not conflict with any other statutory mandate or with the 
principles of the Executive Order. This action was submitted to OMB for 
review pursuant to this Executive Order, and any comments or changes 
made during that review have been documented in the public record.

B. Unfunded Mandates Reform Act and Executive Order 12875

    This final rule does not contain any ``Federal mandate'' that may 
result in expenditures of $100 million or more for State, local, and 
tribal governments, in the aggregate, or for the private sector in any 
1 year. Therefore, this action is not subject to the requirements of 
the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, or 
Executive Order 12875, entitled Enhancing the Intergovernmental 
Partnership (58 FR 58093, October 28, 1993).

 C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), the Agency hereby certifies that this action will 
not have a significant economic impact on a substantial number of small 
entities. This determination is based on the burden analysis included 
in the Information Collection Request discussed in Unit IV. D. below. 
In summary, EPA estimates that in the first year of implementation this 
regulation will impose a total cost of about $15.7 million and a total 
burden of 195,942 hours, which would decrease in year two to about $8 
million

[[Page 49387]]

and 83,172 burden hours annually for subsequent years. Since the 
estimated cost and burden is distributed among approximately 2,100 
pesticide registrants, the average per registrant cost and burden in 
the first year of implementation is estimated to be $7,461 and 93.31 
burden hours, decreasing in subsequent years to an annual cost of 
$3,870 and 39.61 burden hours. Naturally, this average estimate may not 
be reflective of an individual registrants costs and burdens, since the 
individual costs and burdens are directly related to such things as the 
number of products, the number of employees, and the number of incident 
reports or studies the individual registrant receives and therefore 
must provide to EPA. In addition, the basis for estimating the 
anticipated increase in cost and burden includes several assumptions 
that may have artificially inflated the estimates. The Agency will 
reevaulate these estimates in 3 years, when the Agency seeks an 
extension of the Information Collection Request.
    Our expectation, based on actual reporting under the existing 
requirements, is that the registrants with significant market share 
will most likely experience most of the burden. We therefore expect 
only a fraction of the registrants that are impacted to be small 
businesses, particularly with regard to the retroactive report 
provision, which requires registrants to provide information that is in 
their possession and not previously submitted to EPA with regard to a 
complaint involving fatalities or hospitalizations related to their 
pesticide which occurred during the last 3\1/2\ years. Registrants are 
only required to submit summaries and have up to an entire year to 
submit the information to EPA. The Agency does not believe that this 
requirement will have any significant adverse impacts on either small 
or large registrants, since allegations involving such serious adverse 
effects like fatalities or hospitalizations are relatively rare and are 
most likely to be easily recognizable by the registrants, given their 
own need to know this information.
    The Agency discussed this determination with the Chief Counsel for 
Advocacy of the Small Business Administration (SBA), during the OMB 
review under Executive Order 12866. A copy of the SBA comments, and 
EPA's response, has been placed in the docket for this rulemaking.

D. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501 et 
seq., the current information collection activities relating to section 
6(a)(2) are conducted under an Information Collection Request (EPA ICR 
No. 1204) approved by the Office of Management and Budget (OMB) under 
OMB Control No. 2070-0039. An amendment to this ICR to cover the 
information collection requirements contained in this final rule was 
submitted to OMB under the provisions of 5 CFR 1320.11. Comments 
addressing the Agency's costs and burden estimates in the proposed rule 
and in response to the Agency's request for additional comments last 
summer, were taken into consideration and are reflected in the final 
ICR, which was submitted and subsequently approved by OMB.
    The reporting burden for the first year of this collection of 
information includes an estimated 5.9 hours per submission of 
scientific studies, 2.3 hours per submission of incident reports, 9.3 
hours per registrant for reviewing their records for, and submitting to 
the Agency, any fatality and hospitalizations not previously submitted 
to the Agency, 0.3 hours per registrant for the potential need to track 
a submission in order to provide subsequent follow-up, and 4.8 hours 
per registrant for rule familiarization and training. The annual 
reporting burden for this collection of information in subsequent years 
is estimated to be 5.9 hours per submission of scientific studies, 2.3 
hours per submission of incident reports, 0.3 hours per registrant for 
the potential need to track a submission in order to provide subsequent 
follow-up, and 2.6 hours per registrant for continued training. These 
estimates include the time needed to review instructions; develop, 
acquire, install, and utilize technology and systems for the purposes 
of collecting, validating, and verifying information, and disclosing 
and providing information; adjust the existing ways to comply with any 
previously applicable instructions and requirements; train personnel to 
respond to a collection of information; search existing data sources; 
complete and review the collection of information; and transmit or 
otherwise disclose the information.
    No person is required to respond to a collection of information 
unless it displays a currently valid OMB control number. OMB control 
numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR 
chapter 15.
    A copy of the final ICR has been placed in the docket for this 
final rule and may also be obtained from Sandy Farmer, Regulatory 
Information Division, OPPE, U.S. Environmental Protection Agency 
(2137), 401 M St., SW., Washington, DC 20460, by calling (202) 260-
2740, or by e-mail to <a href="/cdn-cgi/l/email-protection#751314071810075b06141b110c3510051418141c195b1005145b121a03"><span class="__cf_email__" data-cfemail="076166756a627529746669637e476277666a666e6b2962776629606871">[email protected]</span></a>. If you should have 
any additional comments regarding the burden estimate or any other 
aspect of this collection of information, including suggestions for 
reducing this burden, increasing electronic submissions, etc.., please 
address them to the Director of the Regulatory Information Division at 
the address listed above for Sandy Farmer. Please be sure to include 
the EPA and OMB ICR number in any correspondence.

E. Executive Order 12898

    Pursuant to Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency has considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and minority communities and has determined that this final 
rule will not adversely affect environmental justice.

F. Executive Order 13045

    This final rule will not have an economic impact of $100 million or 
more and, therefore, does not require special considerations or OMB 
review under Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).

V. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

 List of Subjects in 40 CFR Part 159

    Environmental protection, Pesticides and pests, Policy statements, 
Reporting and recordkeeping requirements.

    Dated: September 11, 1997.

Carol M. Browner,

Administrator.
     Therefore, 40 CFR chapter I is amended as follows:
    1. By adding a new part 159 consisting of subparts A, B, and C, 
which are reserved, and subpart D to read as follows:

[[Page 49388]]

PART 159--STATEMENTS OF POLICIES AND INTERPRETATIONS

Subparts A--C [Reserved]
Subpart D--Reporting Requirements for Risk/Benefit Information
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.
159.158   What information must be submitted.
159.159   Information obtained before promulgation of the rule.
159.160   Exception relating to former registrants.
159.165   Toxicological and ecological studies.
159.167   Discontinued studies.
159.170   Human epidemiological and exposure studies.
159.178   Information on pesticides in or on food, feed, or water.
159.179   Metabolites, degradates, contaminants, and impurities.
159.184   Toxic or adverse effect incident reports.
159.188   Failure of performance information.
159.195   Reporting of other information.

    Authority: 7 U.S.C. 136-136y.


Subparts A--C [Reserved]

Subpart D--Reporting Requirements for Risk/Benefit Information


Sec. 159.152   What the law requires of registrants.

    (a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) states: ``If at any time after the registration 
of a pesticide the registrant has additional factual information 
regarding unreasonable adverse effects on the environment of the 
pesticide, he shall submit such information to the Administrator.''
    (b) Section 152.50(f)(3) of this chapter requires applicants to 
submit, as part of an application for registration, any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on humans or the environment, which would be required 
to be reported under section 6(a)(2) if the product were registered.
    (c) Compliance with this part will satisfy a registrant's 
obligations to submit additional information pursuant to section 
6(a)(2) and will satisfy an applicant's obligation to submit additional 
information pursuant to Sec. 152.50(f)(3) of this chapter.


Sec. 159.153   Definitions.

    (a) For the purposes of reporting information pursuant to FIFRA 
section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 
CFR part 152 apply to this part unless superseded by a definition in 
paragraph (b) of this section.
    (b) For purposes of reporting information pursuant to FIFRA section 
6(a)(2), the following definitions apply only to this part:
    Established level means a tolerance, temporary tolerance, food 
additive regulation, action level, or other limitation on pesticide 
residues imposed by law, regulation, or other authority.
    Formal Review means Special Review, Rebuttable Presumption Against 
Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA 
section 6(b) cancellation proceeding, whether completed or not.
    Hospitalization means admission for treatment to a hospital, clinic 
or other health care facility. Treatment as an out-patient is not 
considered to be hospitalization.
    Maximum contaminant level (MCL) means the maximum permissible 
level, established by EPA, for a contaminant in water which is 
delivered to any user of a public water system.
    Non-target organism means any organism for which pesticidal control 
was either not intended or not legally permitted by application of a 
pesticide.
    Pesticide means a pesticide product which is or was registered by 
EPA, and each active ingredient, inert ingredient, impurity, 
metabolite, contaminant or degradate contained in, or derived from, 
such pesticide product.
    Qualified expert means one who, by virtue of his or her knowledge, 
skill, experience, training, or education, could be qualified by a 
court as an expert to testify on issues related to the subject matter 
on which he or she renders a conclusion or opinion. Under Rule 702 of 
the Federal Rules of Evidence, a person may be qualified as an expert 
on a particular matter by virtue of ``knowledge, skill, experience, 
training, or education.'' In general, EPA wants registrants to report 
information when a person has relevant expert credentials, e.g., a 
medical doctor giving a medical opinion, a plant pathologist giving an 
opinion on plant pathology, etc.
    Registrant includes any person who holds, or ever held, a 
registration for a pesticide product issued under FIFRA section 3 or 
24(c), including any employee or agent of such a person; provided that 
any employee or agent who is not expected to perform any activities 
related to the development, testing, sale or registration of a 
pesticide, and who could not reasonably be expected to come into 
possession of information that is otherwise reportable under this part, 
shall not be considered a registrant for purposes of this part; and 
provided further that information possessed by an agent shall only be 
considered to be possessed by a registrant if the agent acquired such 
information while acting for the registrant.
    Similar species means two or more species belonging to the same 
general taxonomic groups: The general taxonomic groups for purposes of 
this requirement are: mammals, birds, reptiles, amphibians, fish, 
aquatic invertebrates, insects, arachnids, aquatic plants (including 
macrophyte, floating, and submerged plants), and terrestrial (all non-
aquatic) plants.
    Water reference leve means the level specified in paragraph (1) or 
(2) of this definition, whichever is lower.
    (1) Ten percent of the maximum contaminant level (MCL) established 
by EPA, or if no MCL has been established by EPA, 10 percent of the 
most recent draft or final long-term health advisory level (HAL) 
established by EPA, or if EPA has not published or proposed an MCL or 
HAL, the lowest detectable amount of the pesticide.
    (2) The ambient water quality criteria for the protection of 
aquatic life, established by EPA pursuant to section 304(a) of the 
Clean Water Act.


Sec. 159.155   When information must be submitted.

    (a) Reportable information concerning scientific studies must be 
received by EPA not later than the 30th calendar day after the 
registrant first possesses or knows of the reportable information. 
Reportable information concerning adverse effects incidents must be 
reported according to the schedules set forth in Sec. 159.184(d), which 
differentiates reporting times depending on the severity of the 
incident. EPA may, in its discretion, notify a registrant in writing of 
a different reporting period that will apply to specific types of 
reportable information or eliminate reporting requirements entirely. 
Such notification supersedes otherwise-applicable reporting 
requirements set forth in this part.
    (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 the registrant first comes into possession of, or knows of, 
such information.

[[Page 49389]]

Sec. 159.156   How information must be submitted.

    A submission under FIFRA section 6(a)(2) must be delivered as 
specified in either paragraph (a) or (b) of this section, and must meet 
the other requirements of this section:
    (a) Be mailed by certified or registered mail to the following 
address, or such other address as the Agency may subsequently specify 
in writing:

    Document Processing Desk--6(a)(2), Office of Pesticide 
Programs--7504C, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460.


    (b) Be delivered in person or by courier service or by such other 
methods as the Agency deems appropriate to the following address, or to 
such other address as the Agency may subsequently specify in writing: 
Document Processing Desk--6(a)(2), Office of Pesticide Programs, Room 
266A, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, 
Virginia 22202.
    (c) Include a cover letter which contains the information requested 
in paragraphs (d) and (e) of this section, and a prominent statement 
that the information is being submitted in accordance with FIFRA 
section 6(a)(2).
    (d) Contain the name of the submitter, registrant name and 
registration number, date of transmittal to EPA, the type of study or 
incident being reported under Secs. 159.165 through 159.195, and a 
statement of why the information is considered reportable under this 
part.
    (e) Identify the substance tested or otherwise covered by the 
information (including, if known, the EPA registration number(s) to 
which the information pertains, and if known, the CAS Registry Number).
    (f) In reporting incidents, provide the data listed in 
Sec. 159.184, to the extent such information is available.
    (g) In submitting scientific studies, follow the procedures set 
forth in Sec. 158.32 of this chapter.
    (h) If the information is part of a larger package being submitted 
in order to comply with another provision of FIFRA (e.g., sections 
3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual 
studies being submitted under this part.
    (i) If a claim of confidentiality is made under FIFRA section 10 
for information relating to any part of a study or incident report 
contained in the submission, follow the procedures set forth in 
Sec. 158.33 of this chapter regarding the identification and 
segregation of information claimed to be confidential.
    (j) If a submission includes a study subject to the flagging 
requirements of Sec. 158.34 of this chapter, comply with the 
requirements of that section, and, if the flagging statement is 
positive, identify it as 6(a)(2) information in the transmittal.
    (k) If a submission is a follow-up to an earlier study or incident 
report submitted to EPA, the transmittal must state that fact, and must 
cite the earlier submission, as follows:
    (1) If the earlier submission was a study to which EPA assigned a 
Master Record Identifier number (MRID), cite the MRID.
    (2) If the previous submission was an incident report to which no 
MRID number was assigned, cite the date of the initial submission of 
the incident information or report.


Sec. 159.158   What information must be submitted.

    (a) General. Information which is reportable under this part must 
be submitted if the registrant possesses or receives the information, 
and the information is relevant to the assessment of the risks or 
benefits of one or more specific pesticide registrations currently or 
formerly held by the registrant. Information relevant to the assessment 
of the risks or benefits also includes conclusion(s) or opinion(s) 
rendered by a person:
    (1) Who was employed or retained (directly or indirectly) by the 
registrant, and was likely to receive such information.
    (2) From whom the registrant requested the opinion(s) or 
conclusion(s) in question.
    (3) Who is a qualified expert as described in Sec. 159.153(b).
    (b)  Exceptions--(1) Clearly erroneous information. Information 
need not be submitted if before the date on which the registrant must 
submit such information all of the following conditions are met:
    (i) The registrant discovers that any analysis, conclusion, or 
opinion was predicated on data that were erroneously generated, 
recorded, or transmitted, or on computational errors.
    (ii) Every author of each such analysis, conclusion, or opinion, or 
as many authors as can be contacted through the use of reasonable 
diligence, has acknowledged in writing that the analysis, conclusion, 
or opinion was improper and has either corrected the original analysis, 
conclusion, or opinion accordingly, or provided an explanation as to 
why it cannot be corrected.
    (iii) As a result of the correction, the information is no longer 
required to be reported under FIFRA section 6(a)(2), or if no 
correction was possible, the authors agree that the original analysis, 
conclusion or opinion has no scientific validity.
    (2) Previously submitted information. Information regarding an 
incident, study, or other occurrence need not be submitted if before 
the date on which the registrant must submit such information, the 
registrant is aware that the reportable information concerning that 
incident, study, or other occurrence is contained completely in one of 
the following:
    (i) Documents officially logged in by the EPA Office of Pesticide 
Programs.
    (ii) EPA publications, EPA hearing records, or publications cited 
in EPA Federal Register notices.
    (iii) Any other documents which are contained in the official files 
and records of the EPA Office of Pesticide Programs.
    (iv) Any documents officially logged in by the EPA Office of 
Pollution Prevention and Toxics under the provisions of section 8(e) of 
the Toxic Substances Control Act, provided that if the information 
pertains to a chemical compound which, subsequent to the submission of 
data under section 8(e), becomes the subject of an application for 
registration as a pesticide active ingredient, information is submitted 
to the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
    (3) Publications. A published article or report containing 
information otherwise reportable under this part need not be submitted 
if it fits into either of the categories described in paragraphs 
(b)(3)(i) or (b)(3)(ii) of this section.
    (i) Any scientific article or publication which has been abstracted 
in a recognized database of scientific and medical literature, such as 
Medline, ENBASE, Toxline or Index Medicus, if the abstract in question 
clearly identified the active ingredient or the registered pesticide(s) 
to which the information pertains. Otherwise reportable information 
received by or known to the registrant prior to publication of an 
abstract concerning the information must be reported and may not be 
withheld pending such publication.
    (ii) Reports or publications which have been made available to the 
public by any of the following Federal agencies: Centers for Disease 
Control and Prevention, Consumer Products Safety Commission, Department 
of Agriculture, Department of the Interior, Food and Drug 
Administration or any other agency or institute affiliated with the 
Department of Health and Human Services. Otherwise reportable

[[Page 49390]]

information concerning research which was performed, sponsored, or 
funded by the registrant which may also appear in forthcoming 
Government reports or publications must be reported and may not be 
withheld pending publication.
    (4) Information concerning former inerts, contaminants or 
impurities.  Notwithstanding any other provisions of this part, a 
registrant need not report information concerning a chemical compound 
that was at one time an inert ingredient or a contaminant or impurity 
of a pesticide product, and would otherwise be reportable under this 
part, if:
    (i) The compound has been eliminated from its registered product 
due to changes in manufacturing processes, product formulation or by 
other means.
    (ii) The registrant has informed the appropriate product manager in 
the Office of Pesticide Programs in writing of the presence previously 
of the inert, contaminant or impurity in the product and its subsequent 
elimination from the product.


Sec. 159.159  Information obtained before promulgation of the rule.

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


Sec. 159.160   Obligations of former registrants.

    (a) General. A former registrant is obliged to continue to submit 
information concerning the registration of a pesticide product 
previously held by the registrant and otherwise reportable under the 
provisions of this part for a period of 5 years after the registration 
of the pesticide product has been canceled or transferred to another 
registrant, with the exceptions provided by paragraph (b) of this 
section.
    (b) Exceptions. Notwithstanding the provisions of paragraph (a) of 
this section, a former registrant is not obligated to report 
information pursuant to this part if any of the following conditions 
are applicable:
    (1) The information is first obtained by the person more than 1 
year after the date on which the person ceased to hold the registration 
of the product to which the information pertains, and the person holds 
no active pesticide registrations, or for some other reason cannot 
reasonably be expected to receive information concerning the formerly-
registered product.
    (2) The information is associated solely with an inert ingredient, 
contaminant, impurity, metabolite, or degradate contained in a product, 
and the information is first obtained by the person more than 1 year 
after the date upon which the person ceased to hold the registration of 
the product.
    (3) The information is associated with an active ingredient or a 
formerly-registered product, and the active ingredient or every active 
ingredient contained in the formerly-registered product has not been 
contained in any pesticide product registered in the United States for 
any part of the 3-year period preceding the date on which the person 
first obtained the information.
    (4) The information pertains solely to a formerly-registered 
product that no longer meets the definition of ``pesticide'' in section 
2(u) of FIFRA (7 U.S.C. section 136(u)).
    (c) Information arising from litigation. Notwithstanding any other 
provisions of this section, a former registrant is obliged to submit 
information otherwise reportable under this part concerning formerly-
registered pesticide products which arises in the course of litigation 
concerning the effects of such products, regardless of when the 
information is first acquired, provided that neither of the provisions 
of paragraphs (b)(3) or (b)(4) of this section are met. Such 
information shall be submitted in the same manner and according to the 
same schedules as it would have to be submitted by a current registrant 
of a pesticide product to which the information pertained.


Sec. 159.165  Toxicological and ecological studies.

    Adverse effects information must be submitted as follows:
    (a) Toxicological studies. (1) The results of a study of the 
toxicity of a pesticide to humans or other non-target domestic 
organisms if, relative to all previously submitted studies, they show 
an adverse effect under any of the following conditions:
    (i) That is in a different organ or tissue of the test organism.
    (ii) At a lower dosage, or after a shorter exposure period, or 
after a shorter latency period.
    (iii) At a higher incidence or frequency.
    (iv) In a different species, strain, sex, or generation of test 
organism.
    (v) By a different route of exposure.
    (2) Acute oral, acute dermal, acute inhalation or skin and eye 
irritation studies in which the only change in toxicity is a numerical 
decrease in the median lethal dose (LD<INF>50</INF>), median lethal 
concentration (LC<INF>50</INF>) or irritation indices, are not 
reportable under this part unless the results indicate a more 
restrictive toxicity category for labeling under the criteria of 40 CFR 
156.10(h).
    (b) Ecological studies. The results of a study of the toxicity of a 
pesticide to terrestrial or aquatic wildlife or plants if, relative to 
all previously submitted studies, they show an adverse effect under any 
of the following conditions:
    (1) At levels 50 percent or more lower than previous acute toxicity 
studies with similar species, including determinations of the median 
lethal dose (LD<INF>50</INF>), median lethal concentration 
(LC<INF>50</INF>), or median effective concentration (EC<INF>50</INF>).
    (2) At lower levels in a chronic study than previous studies with 
similar species.
    (3) In a study with a previously untested species the results 
indicate the chronic no observed effect level (NOEL) is 10 percent or 
less of the lowest LC<INF>50</INF> or LD<INF>50</INF> for a similar 
species.
    (4) For plants when tested at the maximum label application rate or 
less, if:
    (i) More than 25 percent of terrestrial plants show adverse effects 
on plant life

[[Page 49391]]

cycle functions and growth such as germination, emergence, plant vigor, 
reproduction and yields.
    (ii) More than 50 percent of aquatic plants show adverse effects on 
plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (c) Results from a study that demonstrates any toxic effect (even 
if corroborative of information already known to the Agency), must be 
submitted if the pesticide is or has been the subject of a Formal 
Review based on that effect within 5 years of the time the results are 
received. Within 30 calendar days of the publication of a Notice of 
Commencement of a Formal Review in the Federal Register, all 
information which has become reportable due to the commencement of the 
Formal Review must be submitted.
    (d) Incomplete studies. Information from an incomplete study of the 
toxicity to any organism of a registered pesticide product or any of 
its ingredients, impurities, metabolites, or degradation products which 
would otherwise be reportable under paragraphs (a), (b) or (c) of this 
section must be submitted if the information meets any one of the 
folowing three sets of criteria:
    (1) Short-term studies. A study using a test regimen lasting 90 
calendar days or less, and:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period for completion of the final analysis not 
longer than 90 calendar days following completion of testing has 
elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (2)  Long-term studies. A study using a test regimen lasting more 
than 90 calendar days, and:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period of completion of final analysis (not 
longer that 1 year following completion of testing) has elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (3) Serious adverse effects. Any study in which testing or analysis 
of results is not yet complete but in which serious adverse effects 
have already been observed which may reasonably be attributed to 
exposure to the substances tested, because the effects observed in 
exposed organisms differ from effects observed in control organisms, 
are atypical in view of historical experience with the organism tested, 
or otherwise support a reasonable inference of causation, and 30 days 
have passed from the date the registrant first has the information.


Sec. 159.167   Discontinued studies.

    The fact that a study has been discontinued before the planned 
termination must be reported to EPA, with the reason for termination, 
if submission of information concerning the study is, or would have 
been, required under this part.


Sec. 159.170   Human epidemiological and exposure studies.

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


Sec. 159.178   Information on pesticides in or on food, feed or water.

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


Sec. 159.179   Metabolites, degradates, contaminants, and impurities.

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

[[Page 49392]]

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.
    (b) Contaminants and impurities. The presence in any pesticide 
product of a contaminant or impurity not previously identified by the 
registrant as part of the pesticide product's approved composition must 
be reported pursuant to this part if the contaminant or impurity is 
present in the product in any of the following quantities:
    (1) Quantities greater than 0.1 percent by weight (1,000 parts per 
million).
    (2) Quantities that EPA considers, and so informs registrants, to 
be of toxicological significance.
    (3) Quantities that the registrant considers to be of toxicological 
significance.
    (4) Quantities above a level for which the registrant has 
information indicating that the presence of the contaminant or impurity 
may pose a risk to health or the environment.
    (5) Quantities that a person described in Sec. 159.158(a) has 
informed the registrant is likely to be of toxicological significance.


Sec. 159.184   Toxic or adverse effect incident reports.

    (a) General. Information about incidents affecting humans or other 
non-target organisms must be submitted if the following three 
conditions are met:
    (1) The registrant is aware, or has been informed that a person or 
non-target organism may have been exposed to a pesticide.
    (2) The registrant is aware, or has been informed that the person 
or non-target organism suffered a toxic or adverse effect, or may 
suffer a delayed or chronic adverse effect in the future.
    (3) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (b) Exceptions. Information regarding an incident need not be 
submitted if any of the following conditions are met:
    (1) The registrant is aware of facts which clearly establish that 
the reported toxic effect, or reported exposure, did not or will not 
occur.
    (2) The registrant has been notified in writing by the Agency that 
the reporting requirement has been waived for this incident or category 
of incidents, and the registrant has not been notified in writing by 
the Agency that the waiver is rescinded.
    (3) It concerns a toxic effect to non-target plants, which were at 
the use site at the time the pesticide was applied, if the label 
provides adequate notice of such a risk.
    (4) It concerns non-lethal phytotoxicity to the treated crop if the 
label provides an adequate notice of such a risk.
    (5) It concerns a toxic effect to pests not specified on the label, 
provided that such pests are similar to pests specified on the label.
    (6) It concerns minor skin or eye irritation effects warned of on 
the label of a product which is registered for use in residential use 
sites, and the effects occurred as a result of use in a residential 
site.
    (c) Required information on individual incidents.  To the extent 
that the registrant has any of the information listed in paragraphs 
(c)(1) through (c)(4) of this section, the registrant must supply the 
information on each pesticide incident that meets the requirements 
outlined in paragraph (a) of this section. If the registrant acquires 
additional information concerning an incident previously reported to 
the Agency under this part, such information shall be reported if it 
meets the criteria set forth in paragraph (f) of this section. In the 
future, the Agency may by notice specify a format for such submissions. 
The Administrative, Pesticide, Circumstance and Exposure Type(s) of 
information must be reported for individual incidents, except where the 
provisions of paragraph (e) of this section allow for aggregated 
summary forms of reporting, or if EPA in the future grants permission 
in writing for alternative reporting formats. The registrant must also 
provide one or more Exposure Type and Severity categories and their 
designations for each incident as set forth in paragraph (c)(5) of this 
section, depending on the applicability of the criteria listed below. 
The criteria listed should be used in assigning a category. For 
example, an incident which allegedly caused serious but non-fatal 
effects to human beings and domestic animals might be designated ``H-B: 
D-B.'' When a single incident involves multiple pesticides, the 
registrant need only report on their specific product. However, if a 
single incident involves more than one type of non-target organism -- 
for example, both humans and domestic animals are involved -- all 
appropriate available information dealing with each of the victims must 
also be reported. The informational items below are grouped by sections 
for ease in reporting pesticide incidents.
    (1) Administrative. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Name of reporter, address, and telephone number.
    (ii) Name, address, and telephone number of contact person (if 
different than reporter).
    (iii) Incident report status (e.g., new or update); if update, 
include the date of original submission.
    (iv) Date registrant became aware of the incident.
    (v) Date of incident (if appropriate, list start and end dates).
    (vi) Location of incident (city, county and state).
    (vii) Is incident part of a larger study.
    (viii) Source if different from reporting registrant.
    (2) Pesticide.  Pesticide incident reports must be submitted if the 
registrant possesses or receives any of the following information, and 
the incident meets the minimum requirements set forth in paragraph (a) 
of this section:
    (i) Product name.
    (ii) Active ingredient(s).
    (iii) EPA Registration Number.
    (iv) Diluted for use, or concentrate.
    (v) Formulation, if known.
    (vi) List the same information under paragraphs (c)(2)(i) through 
(c)(2)(v) for other pesticides that may have contributed to this 
incident.
    (3) Circumstance. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Evidence the label directions were not followed (e.g., yes, no, 
unknown).
    (ii) How exposed (e.g., spill, drift, equipment failure, container 
failure, mislabeling, runoff, etc.).
    (iii) Situation (e.g., household use, mixing/loading, application, 
reentry, disposal, transportation, other (describe)).
    (iv) Use site (e.g., home, yard, commercial turf, agricultural 
(specify crop), industrial, building/office, school, nursery, 
greenhouse, pond/lake/stream, well, forest/woods, other.
    (v) Applicator certified (yes, no, unknown).
    (vi) A brief description of the circumstances of the incident.
    (4) Other incident specific information. Pesticide incident reports 
must be submitted if the registrant possesses or receives any of the 
following information, and the incident meets the minimum requirements 
set forth in paragraph (a) of this section:

[[Page 49393]]

    (i) If the incident involves humans:
    (A) Route of exposure (skin, eye, respiratory, oral).
    (B) List signs/symptoms/adverse effects.
    (C) If laboratory tests were performed, list name of test(s) and 
results.
    (D) If available, submit laboratory report(s).
    (E) Time between exposure and onset of symptoms.
    (F) Was adverse effect the result of suicide/homicide or attempted 
suicide/homicide.
    (G) Type of medical care sought, (e.g., none, Poison Control 
Center, hospital emergency department, hospital inpatient, private 
physician, clinic, other).
    (H) Demographics (sex, age, occupation).
    (I) If female, pregnant?
    (J) Exposure data: amount of pesticide; duration of exposure; 
weight of victim.
    (K) Was exposure occupational; days lost due to illness.
    (L) Was protective clothing worn (specify).
    (ii) If domestic animal:
     (A) Type of animal (e.g., livestock, poultry, bird, fish, 
household pet e.g., dog/cat etc.).
    (B) List signs/symptoms/adverse effects.
    (C) Breed/species (name and number affected, per adverse effect).
    (D) Route of exposure (e.g., skin, eye, respiratory, oral).
    (E) Time between exposure and onset of symptoms.
    (F) If laboratory test(s) performed, list name of tests and 
results.
    (G) If available, submit laboratory report(s).
    (iii) If fish, wildlife, plants or other non-target organisms:
    (A) List species affected, and number of individuals per species.
    (B) List symptoms or adverse effects.
    (C) Magnitude of the effect (e.g., miles of streams, square area of 
terrestrial habitat).
    (D) Pesticide application rate, intended use site (e.g., corn, 
turf), and method of application.
    (E) Description of the habitat and the circumstances under which 
the incident occurred.
    (F) If plant, type of plant life (i.e., crop, forest, orchard, home 
garden, ornamental, forage).
    (G) Formulation of pesticide if not indicated by brand name 
(granular, flowable).
    (H) Distance from treatment site.
    (I) If laboratory test(s) performed, list name of test(s) and 
results.
    (J) If available, submit laboratory report(s).
    (iv) If surface water:
    (A) If raw water samples, water bodies sampled and approximate 
locations in each water body.
    (B) If raw water samples, proximity of sampling locations to 
drinking water supply intakes and identities of systems supplied.
    (C) If finished water samples, water supply systems sampled.
    (D) If finished water samples, percent surface water source by 
specific surface water sources to water supply system(s).
    (E) Sample type (grab, composite).
    (F) Sampling times/frequency.
    (G) Pesticides and degradates analyzed for and their detection 
limits.
    (H) Method of analysis.
    (v) If ground water:
    (A) Pesticide and degradates analyzed for and the analytical 
methods and detection limits.
    (B) Sample date.
    (C) Amount pesticide applied (lbs-ai/acre).
    (D) Date of last application.
    (E) Depth to water.
    (F) Latitude/longitude.
    (G) Soil series and texture (sand/silt/clay).
    (H) Frequency of applications per year.
    (I) Aquifer description (confined/unconfined).
    (J) Method of application.
    (K) Years pesticide used.
    (L) Well use and well identifier.
    (M) Screened interval.
    (N) Annual cumulative rainfall (inches).
    (O) Maximum rainfall and date.
    (P) Cumulative irrigation (inches).
    (Q) Hydrologic group.
    (R) Hydraulic conductivity.
    (S) pH.
    (T) Organic matter or organic carbon (percent).
    (vi) If property damage.
    (A) Provide description.
    (B) [Reserved]
    (5) Exposure types and severity category designations--(i) Humans. 
If an effect involves a human, provide the appropriate 2-letter 
exposure types and severity categories and their designations, based 
upon the following categories:
    (A) H-A: If the person died.
    (B) H-B: If the person alleged or exhibited symptoms which may have 
been life-threatening, or resulted in adverse reproductive effects or 
in residual disability.
    (C) H-C: If the person alleged or exhibited symptoms more 
pronounced, more prolonged or of a more systemic nature than minor 
symptoms. Usually some form of treatment of the person would have been 
Indicated. Symptoms were not life threatening and the person has 
returned to his/her pre-exposure state of health with no additional 
residual disability.
    (D) H-D: If the person alleged or exhibited some symptoms, but they 
were minimally traumatic. The symptoms resolved rapidly and usually 
involve skin, eye or respiratory irritation.
    (E) H-E: If symptoms are unknown, unspecified or are alleged to be 
of a delayed or chronic nature that may appear in the future.
    (ii) Domestic animals. If an effect involves a domestic animal, 
provide the appropriate 2-letter notation based upon the following 
categories:
    (A) D-A: If the domestic animal died or was euthanized.
    (B) D-B: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which may have been life-threatening or resulted in 
residual disability.
    (C) D-C: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which are more pronounced, more prolonged or of a 
more systemic nature than minor symptoms. Usually some form of 
treatment would have been indicated to treat the animal. Symptoms were 
not life threatening and the animal has returned to its pre-exposure 
state of health with no additional residual disability.
    (D) D-D: If the domestic animal was alleged to have exhibited 
symptoms, but they were minimally bothersome. The symptoms resolved 
rapidly and usually involve skin, eye or respirator irritation.
    (E) D-E: If symptoms are unknown or not specified.
    (iii) Fish or wildlife. If an alleged effect involves fish or 
wildlife, label the incident W-A if any of the criteria listed in 
paragraphs (c)(5)(iii)(A) through (c)(5)(iii)(G) of this section are 
met, or W-B if none of the criteria are met:
    (A) Involves any incident caused by a pesticide currently in Formal 
Review forecological concerns.
    (B) Fish: Affected 1,000 or more individuals of a schooling species 
or 50 or moreindividuals of a non-schooling species.
    (C) Birds: Affected 200 or more individuals of a flocking species, 
or 50 or moreindividuals of a songbird species, or 5 or more 
individuals of a predatory species.
    (D) Mammals, reptiles, amphibians: Affected 50 or more individuals 
of a relativelycommon or herding species or 5 or more individuals of a 
rare or solitary species.
    (E) Involves effects to, or illegal pesticide treatment (misuse) of 
a

[[Page 49394]]

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


Sec. 159.188   Failure of performance information.

    (a)  Microorganisms that pose a risk to human health.  Information 
must be submitted which concerns either incidents described in 
paragraph (a)(1) of this section or a study described in paragraph 
(a)(2) of this section:
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed that a pesticide product may 
not have performed as claimed against target microorganisms.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against microorganisms which may pose a risk to human 
health.
    (iii) The pesticide product's use site is other than residential.
    (iv) The registrant has or could obtain information concerning 
where the incident occurred, the pesticide or product involved, and the 
name of a person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims made by the registrant regarding 
uses intended for control of microorganisms that may pose a risk to 
human health, including any of the public health antimicrobials 
identified in part 158 of this chapter.
    (b)  Animals that pose a risk to human health. For the purposes of 
this section, any animal (including insects) poses a risk to human 
health if it may cause disease in humans, either directly or as a 
disease vector; produce toxins that are harmful to humans; or cause 
direct physical harm to humans. Information must be submitted which 
concerns either incidents described in paragraph (b)(1) of this section 
or a study described in paragraph (b)(2) of this section.
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed by municipal, State, or 
Federal public health officials that a pesticide product may not have 
performed as claimed against target animals.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against animals that pose a risk to human health.
    (iii) The registrant has or could obtain information concerning 
where the

[[Page 49395]]

incident occurred, the pesticide or product involved, and the name of a 
person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims by the registrant regarding uses 
intended for control of animals that pose a risk to human health, 
including any of the public health pesticides identified in part 158 of 
this chapter.
    (c) Development of pesticide resistance. Information must be 
submitted concerning substantiation of any incident of a pest having 
developed resistance to any pesticide (both public health and non-
public health) that occurred under conditions of use, application rates 
and methods specified on the label if either of the following 
conditions is met:
    (1) The survival of the suspected pesticide-resistant pest was 
significantly higher than that of a known susceptible pest when both 
the suspected resistant and susceptible pests were treated with the 
pesticide under controlled conditions.
    (2) Biochemical tests or DNA sequencing indicate that the pest is 
resistant to the pesticide.


Sec. 159.195   Reporting of other information.

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

[FR Doc. 97-24937 Filed 9-18-97; 8:45 am]
BILLING CODE 6560-50-F


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