49370 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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.

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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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
49372 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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 § 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 § 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 formerlyregistered 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 (§ 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 indepth 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
49374 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 § 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 MCLbased 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

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

§ 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
49376 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 § 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 § 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 § 159.184, which deals

with incident reporting. The revised

§ 159.156(f) simply refers the registrant

to § 159.184.

It must be stressed that the

information identified in § 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 § 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 HB level for humans or the A level for any

other exposure type, as defined by the

criteria of § 159.184 (c)(5). The Agency

retains the authority under § 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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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

§ 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 § 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 (§ 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 § 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
49378 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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

§ 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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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 previouslyobtained information in a number of

ways.

The 1996 draft would have required

that studies reportable under

§§ 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 § 159.159

should note that the Agency’s

Enforcement Response Policy for FIFRA

addresses the Agency’s policy for

responding to registrants who selfconfess 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 SelfDisclosure Policy. Registrants are

advised that the criteria in the SelfDisclosure 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 § 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

§ 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 § 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 formerlyregistered 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
49380 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 formerlyregistered 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 formerregistrant 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

§ 159.165(a)), and for studies designed

to determine the toxicity of pesticides to

non-target plants and wildlife (new

§ 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

§ 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 § 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 § 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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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 PRNotice 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 crosscontamination policy (or any similar

policy issued by the Agency in writing),

registrants are required under § 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

§ 158.167 or greater than a certified limit

established pursuant to § 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

§ 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.
49382 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

The proposed § 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 § 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 nonresidential 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 nonresidential situations, the Agency will

notify registrants accordingly pursuant

to § 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 § 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

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

§ 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 § 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
49384 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 decisionmaking. 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 nonlabeled 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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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 pesticideresistant 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 nonantimicrobial 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 § 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
49386 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

continuing efficacy of the product under

§ 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

§ 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
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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 31⁄2 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:
49388 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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

§ 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

§ 152.50(f)(3) of this chapter.

§ 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 outpatient 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.

§ 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 § 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 otherwiseapplicable 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.
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 49389

§ 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 §§ 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 § 159.184, to the extent

such information is available.

(g) In submitting scientific studies,

follow the procedures set forth in

§ 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 § 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

§ 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.

§ 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 § 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
49390 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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.

§ 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 § 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 § 159.184(c)(5)(iii).

(2) Submission of the information is

requested by the Agency pursuant to

§ 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

§ 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.

§ 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 formerlyregistered 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 formerlyregistered 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.

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

§ 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.

§ 159.170 Human epidemiological and

exposure studies.

Information must be submitted which

concerns any study that a person

described in § 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.

§ 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 § 122.2 of this chapter, except

paragraph (d) of § 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.

§ 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

§ 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 § 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
49392 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 § 159.158(a) has informed the

registrant is likely to be of toxicological

significance.

§ 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 nontarget organism may have been exposed

to a pesticide.

(2) The registrant is aware, or has

been informed that the person or nontarget 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 nontarget 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 nonfatal 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:
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 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
49394 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 nontarget 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, WA; 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.

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

§ 159.195 Reporting of other information.

(a) The registrant shall submit to the

Administrator information other than

that described in §§ 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 §§ 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