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Reporting Requirements For Risk/Benefit Information
Support Documents
[Federal Register: September 19, 1997 (Volume 62, Number 182)]
[Rules and Regulations]
[Page 49369-49395]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se97-22]
[[Page 49370]]
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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:
roelofs.jim@epamail.epa.gov.
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 farmer.sandy@epamail.epa.gov. 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 (LD50), median lethal
concentration (LC50) or irritation indices, are not
reportable under this part unless the results indicate a more
restrictive toxicity category for labeling under the criteria of 40 CFR
156.10(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 (LD50), median lethal concentration
(LC50), or median effective concentration (EC50).
(2) At lower levels in a chronic study than previous studies with
similar species.
(3) In a study with a previously untested species the results
indicate the chronic no observed effect level (NOEL) is 10 percent or
less of the lowest LC50 or LD50 for a similar species.
(4) For plants when tested at the maximum label application rate or
less, if:
(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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