44552 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1904

Recording and Reporting Occupational

Injuries and Illnesses; Office of

Management and Budget Control

Numbers Under the Paperwork

Reduction Act

AGENCY: Occupational Safety and Health

Administration, Department of Labor.

ACTION: Final rule.

SUMMARY: The Occupational Safety and

Health Administration (OSHA) is

adding a new section to its regulation

for recording and reporting of

occupational injuries and illnesses (29

CFR part 1904). The new section will be

used to consolidate and display all of

the control numbers assigned by the

Office of Management and Budget

(OMB) for ‘‘approved’’ information

collection requirements in Part 1904.

None of the requirements are new; they

have been promulgated by OSHA at

various times over the past 25 years.

The display of OMB control numbers is

required under the implementing rules

and regulations of OMB and under the

Paperwork Reduction Act of 1995

DATE: Effective August 22, 1997.

FOR FURTHER INFORMATION CONTACT:

Mr. Stephen A. Newell, Office of

Statistics, U.S. Department of Labor,

Occupational Safety and Health

Administration, Room N3507; 200

Constitution Avenue, NW, Washington,

DC 20210 (202–219–6463, FAX 202–

219–5161).

SUPPLEMENTARY INFORMATION:

I. Background

OSHA has a number of provisions

within its regulation for recording and

reporting occupational injuries,

illnesses and deaths that require

employers to collect or prepare

information. These types of provisions

are broadly classified as ‘‘information

collection requirements.’’ All

information collection requirements are

subject to review and approval by OMB

on not more than a three-year cycle. It

should be noted that OHSA cannot

impose a penalty on employers for

violating collection of information

(recordkeeping, reporting, etc.)

requirements if the agency has failed to

obtain OMB approval of the

requirement. When OMB approves

collection of information requirements,

it issues a ‘‘control number’’ for the

collection of information provision. All

agencies are required to display [show

to the public] the OMB control numbers

so the public will know that OMB has

given the agency approval to require the

information [report, record,

documentation, form, etc.] to be

collected. In the past, OSHA has

displayed the relevant OMB control

numbers of the injury and illness

recordkeeping requirements by printing

them at the end of each section in part

1904 to which they were pertained.

However, to enable the public to easily

and readily identify all of the collection

of information requirements, OSHA is

dedicating one section in part 1904

(1904.30) to list the sections with

information collection requirements and

show the appropriate OMB control

numbers. As a result of this new format,

the parenthetical notes and approval/

control numbers now printed at the end

of the individual sections of Part 1904

can be removed.

None of the specific requirements to

collect and provide information is new.

The control numbers listed in this

document were assigned previously by

OMB; but not necessarily published in

the regulations. This document makes

no substantive change to the current

OMB information collection budget or

to any regulatory provision.

II. Exemption From Notice and

Comment Procedures

This action is a rule of agency

procedure and practice and is not

subject to the rulemaking requirements

of the Administrative Procedures Act. 5

U.S.C. § 553(b)(A). It does not affect the

substantive requirements or coverage of

the regulations themselves.

Furthermore, this document does not

modify or revoke existing rights or

obligations, nor does it establish new

ones. With this action, the Agency is

only providing information. OSHA,

therefore, finds that notice and public

procedure are impracticable and

unnecessary within the meaning of 5

U.S.C. 553(b)(3)(B).

III. Exemption From Delayed Effective

Date Requirement

Under 5 U.S.C. 553, OSHA finds that

there is good cause for making this

Document effective upon publication in

the Federal Register. This display of

control numbers simply provides

additional information on the existing

regulatory burden without increasing

that burden.

List of Subjects in 29 CFR Part 1904

Reporting and recordkeeping

requirements.

Accordingly, pursuant to sections 8

and 24 of the Occupational Safety and

Health Act of 1970 (29 U.S.C. 657, 673),

Secretary of Labor’s Order No. 1–90 (55

FR 9033), and 5 U.S.C. 553, 29 CFR Part

1904 is hereby amended as set forth

below.

Signed in Washington, D.C., this 5th day of

August, 1997.

Gregory R. Watchman,

Acting Assistant Secretary of Labor.

PART 1904—[AMENDED]

1. The authority citation for Part 1904

continues to read as follows:

Authority: Secs. 8, 24, Occupational Safety

and Health Act of 1970 (29 U.S.C. 657, 673),

Secretary of Labor’s Order No. 12–71 (36 FR

8754), 8–76 (41 FR 25059), 9–83 (48 FR

35736), 1–90 (55 FR 9033) or 6–96 (62 FR

111), as applicable.

Section 1904.7, 1904.8 and 1904.17

are also issued under 5 U.S.C. 553.

2. Section 1904.30 is added to read as

follows:

§ 1904.30 OMB control numbers under the

Paperwork Reduction Act

The following sections each contain a

collection of information requirement

which has been approved by the Office

of Management and Budget under the

control number listed.

29 CFR citation OMB control No.

1904.2 ....................................... 1218–0176

1904.4–7 ................................... 1218–0176

1904.8 ....................................... 1218–0007

1904.17 ..................................... 1218–0214

1904.21 ..................................... 1220–0045

3. Remove the parenthetical note

relating to the OMB control number that

appears at the end of each of the

following sections: 1904.2; 1904.4;

1904.5; 1904.6; 1904.15; 1904.21.

[FR Doc. 97–22380 Filed 8–21–97; 8:45 am]

BILLING CODE 4510–26–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300527; FRL–5736–9]

RIN 2070–AB78

Pyridate; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of pyridate in or on chickpeas

. This action is in response to EPA’s

granting of an emergency exemption
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44553

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

chickpeas. This regulation establishes a

maximum permissible level for residues

of pyridate in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on December

31, 1998.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300527],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300527], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300527]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308-9367, e-mail:

ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for combined residues of the

herbicide pyridate (O- (6-chloro-3-

phenyl-4-pyridazinyl)-S-octylcarbonothioate), the metabolite 6-

chloro-3-phenyl-pyridazine-4-ol and

conjugates of 6-chloro-3-phenylpyridazine-ol, expressed as pyridate, in

or on chickpeas at 0.1 part per million

(ppm). This tolerance will expire and is

revoked on December 31, 1998. EPA

will publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Pyridate

on Chickpeas and FFDCA Tolerances

The applicants state that chickpea

growers in the irrigated region of central

Washington and north-central Oregon

face an immediate crisis with broadleaf

weeds infesting their chickpea crop. The

problem occurred when there was a

period of unusually cool, wet weather

after planting in late March to midApril, causing a delay in both crop and

weed emergence. This delay, coupled

with the breakdown in the preemergence herbicide used, created a

condition where broadleaf weeds were

competing on an equal basis with the

chickpea crop. Chickpeas are poor

competitors with broadleaf weeds. The

applicants state that the pre-emergence

herbicides that were used (Sonalan and

Prowl) have a shorter period of soil

activity than the most effective preemergence herbicide available (Pursuit).

However, because crop rotation

includes potatoes, Pursuit could not be

used.

Because there are no post-emergence

herbicides that are currently registered

for use on chickpeas to control broadleaf

weeds, the applicants assert that left

uncontrolled, the broadleaf weed

infestation could reduce crop yields by

50 to 60%. EPA has authorized under

FIFRA section 18 the use of pyridate on
44554 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

chickpeas for control of broadleaf weeds

in Washington and Oregon. After having

reviewed the submission, EPA concurs

that emergency conditions exist for

these states.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

pyridate in or on chickpeas. In doing so,

EPA considered the new safety standard

in FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

under FFDCA section 408(l)(6) would be

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on December 31,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on chickpeas

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

EPA will take action to revoke this

tolerance earlier if any experience with,

scientific data on, or other relevant

information on this pesticide indicate

that the residues are not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether pyridate meets EPA’s

registration requirements for use on

chickpeas or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

pyridate by a State for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

any States other than Washington and

Oregon to use this pesticide on this crop

under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for pyridate,

contact the Agency’s Registration

Division at the address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute’’, ‘‘short-term’’, ‘‘intermediate

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44555

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children 1-6 years old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of pyridate and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for a

time-limited tolerance for combined

residues of pyridate on chickpeas at 0.1

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by pyridate are

discussed below.

1. Chronic toxicity. EPA has

established the RfD for pyridate at 0.11

milligrams/kilogram/day (mg/kg/day).

This RfD is based on a two year chronic

feeding study in rats with a NOEL of

10.8 mg/kg/day and an uncertainty

factor of 100 based on body weight

depression in the males at the lowest

effect level (LEL) of 67.5 mg/kg/day. The

3-generation reproduction study was

considered co-critical with a NOEL of

10.8 mg/kg/day and an lowest observed

effect level (LOEL) of 67.5 mg/kg/day.

Depressed maternal and pup body

weight gains were observed at the LOEL.

2. Carcinogenicity. Pyridate has not

been to the Office of Pesticide Program’s

Cancer Peer Review Committee.

However, mouse and rat oncogenicity

studies indicate that pyridate was

negative in both species for carcinogenic

effects.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.462) for the combined residues

of pyridate (O- (6-chloro-3-phenyl-4-

pyridazinyl)-S-octyl-carbonothioate),

the metabolite 6-chloro-3-phenylpyridazine-4-ol and conjugates of 6-

chloro-3-phenyl-pyridazine-ol,

expressed as pyridate, in or on a variety

of raw agricultural commodities

including cabbage, corn (grain, fodder,

forage, silage) and peanuts (nutmeats,

hulls), all at 0.03 ppm. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

pyridate as follows:

Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made very

conservative assumptions -- 100% of

chickpeas and all other commodities

having pyridate tolerances will contain

residues and those residues would be at

the level of the tolerance -- which result

in an overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

The existing pyridate tolerances

(published, pending, and including the

necessary Section 18 tolerance(s)) result

in a Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

U.S. population at <1.0%; nursing

infants at <1.0%; non-nursing infants

(<1 year old) at <1.0%; children (1-6

years old) at <1.0%; and, children (7-12

years old) at <1.0%

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. Based on

information available to the Agency,

pyridate is not persistent and not

mobile. There is no established

Maximum Contaminant Level for

residues of (pyridate) in drinking water.

No health advisory levels for pyridate in

drinking water have been established.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related
44556 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause pyridate to exceed the RfD

if the tolerance being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

pyridate in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure.

Pyridate is not registered for any

residential uses at this time. Therefore,

no non-dietary, non-occupational

exposure is anticipated.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

pyridate has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

pyridate does not appear to produce a

toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that pyridate has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. An acute aggregate risk

is not required for pyridate as no acute

toxicity endpoint has been identified.

There are also no non-dietary nonoccupational exposures. The Agency

acknowledges the potential for exposure

to pyridate in drinking water, but does

not expect that exposure would result in

an aggregate (margin of exposure) MOE

(food plus water) that would exceed the

Agency’s level of concern for acute

dietary exposure.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions, and taking into account

the completeness and reliability of the

toxicity data, EPA has concluded that

aggregate exposure to pyridate from

food will utilize <1.0% of the RfD for

the U.S. population. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to pyridate in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from chronic aggregate exposure

to pyridate residues.

D. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

pyridate, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a three-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

b. Developmental toxicity studies. In

the developmental study in rats, the

maternal (systemic) NOEL was 165 mg/

kg/day, based on mortality and

decreased body weight at the LOEL of

400 mg/kg/day. The developmental

(fetal) NOEL was 165 mg/kg/day, based

on increased incidence of missing and/

or unossified sternabrae and decreased
Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations 44557

fetal body weight at the LOEL of 400

mg/kg/day.

In the developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 300 mg/kg/day, based on body

weight depression at the LOEL of 600

mg/kg/day. The developmental (pup)

NOEL was 600 mg/kg/day, the highest

dose tested.

c. Reproductive toxicity study. In the

3-generation reproductive toxicity study

in rats, the maternal (systemic) NOEL

was 10.8 mg/kg/day, based on body

weight depression at the LOEL of 67.5

mg/kg/day. The developmental/

reproductive (pup) NOEL was 10.8 mg/

kg/day, based on body weight loss at the

LOEL of 67.5 mg/kg/day.

d. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for pyridate

is complete with respect to current data

requirements. There are no pre- or postnatal toxicity concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 3-generation rat

reproductive toxicity study. Based on

the developmental and reproductive

toxicity studies discussed above, there

does not appear to be an extra

sensitivity for pre- or post-natal effects.

e. Conclusion. EPA concludes that

reliable data support use of the standard

100-fold margin of exposure/uncertainty

factor and that an additional margin/

factor is not needed to protect infants

and children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to pyridate from

food will utilize less than 1% of the RfD

for infants and children. EPA generally

has no concern for exposures below

100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to pyridate in drinking

water and from non-dietary, nonoccupational exposure, EPA does not

expect the aggregate exposure to exceed

100% of the RfD. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to pyridate

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the pyridate residue in

plants and ruminants is adequately

understood. The total toxic residue

consists of pyridate (O- (-chloro-3-

phenyl-4-pyridazinyl) -S-octylcarbonothioate), its metabolite 6-chloro3-phenyl-pyridazine-4-ol (aka CL9673),

and conjugates of that metabolite, all

expressed as pyridate. .

B. Analytical Enforcement Methodology

A total residue method using UV—

HPLC is available for residue data

gathering and enforcement purposes.

The method has been adequately

validated by recovery data, has passed

a successful method trial, and has been

forwarded to FDA for publication in

PAM-II. The limit of quantitation is 0.03

ppm..

C. Magnitude of Residues

Residues of pyridate, its metabolite 6-

chloro-3-phenyl-pyridazine-4-ol and

conjugates of that metabolite all

expressed as pyridate are not expected

to exceed 0.1 ppm in/on chickpeas.

Secondary residues are not expected in

animal commodities as no feed items

are associated with this Section 18 use.

D. International Residue Limits

There are no CODEX, Mexican, or

Canadian MRLs established for pyridate

in/on chickpeas.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of pyridate (O-

(6-chloro-3-phenyl-4-pyridazinyl)-Soctyl-carbonothioate), the metabolite 6-

chloro-3-phenyl-pyridazine-4-ol and

conjugates of 6-chloro-3-phenylpyridazine-ol, expressed as pyridate in/

on chickpeas at 0.1 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by October 21, 1997,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300527] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.
44558 Federal Register / Vol. 62, No. 163 / Friday, August 22, 1997 / Rules and Regulations

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d). The Office

of Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. 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 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 12, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

2. Section 180.462 is amended to read

as follows:

a. By designating the existing text as

paragraph (a) and adding a heading.

b. By adding paragraph (b).

c. By adding the headings and

reserving paragraphs (c) and (d).

Section 180.462, as amended, reads as

follows:

§ 180.462 Pyridate; tolerances for

residues.

(a) General . * * *

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for the residue of the herbicide pyridate

in connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. This tolerance will

expire and is revoked on the date

specified in the following table:

Commodity Parts per

million

Expiration/

revocation

date

Chickpeas ......... 0.1 12/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–22373 Filed 8–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300533; FRL–5738–6]

RIN 2070–AB78

Sethoxydim; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety in or on horseradish. This action

is in response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on horseradish in Illinois.

This regulation establishes a maximum

permissible level for residues of

sethoxydim in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on September

30, 1998.

DATES: This regulation is effective

August 22, 1997. Objections and

requests for hearings must be received

by EPA on or before October 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300533],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300533], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing