66014 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

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: November 25, 1997.

Peter Caulkins,

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 180.416, is amended as

follows:

i. By designating the existing text as

paragraph (a) and adding a heading.

ii. By adding a new paragraph (b).

iii. By adding and reserving new

paragraphs (c) and (d) with headings to

read as follows.

§180.416 Ethalfluralin; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the residues of the herbicide

ethalfluralin, in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire on the dates

specified in the following table.

Commodity Parts per million Expiration/revocation date

Canola, seed ....................................................................................... 0.05 10/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–32933 Filed 12–16–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300573; FRL 5753–6]

RIN 2070–AB78

Primisulfuron-methyl; Pesticide

Tolerances for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

primisulfuron-methyl in or on bluegrass

grown for seed. 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 bluegrass grown for

seed. This regulation establishes a

maximum permissible level for residues

of primisulfuron-methyl 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 October

31, 1998.

DATES: This regulation is effective

December 17, 1997. Objections and

requests for hearings must be received

by EPA on or before February 17, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300573],

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–

300573], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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 5.1/6.1 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–

300573]. 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: Pat Cimino, 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) 308–9357; e-mail:

cimino.pat@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 residues of the herbicide

primisulfuron-methyl, in or on

bluegrass grown for seed at 0.10 parts

per million (ppm). This tolerance will

expire and is revoked on October 31,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66015

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

Primisulfuron-methyl on Bluegrass

Grown for Seed and FFDCA Tolerances

The applicant asserts that recent

growing conditions and curtailment of

burning, a cultural weed control

method, by the federal, state, and/or

county Clean Air Act requirements have

created unacceptable levels of weedy

grasses proliferating in Kentucky

bluegrass fields. There are no effective

registered pesticides or alternative

control practices available which will

provide adequate control of the weeds.

EPA has authorized under FIFRA

section 18 the use of primisulfuronmethyl on bluegrass grown for seed for

control of quackgrass, windgrass,

downey brome, wild oat, and other

weeds in Washington and Idaho. 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

primisulfuron-methyl in or on bluegrass

grown for seed. 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 October 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 bluegrass

grown for seed 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 primisulfuron-methyl meets

EPA’s registration requirements for use

on bluegrass grown for seed 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 primisulfuron-methyl 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 Idaho

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 primisulfuron-methyl,

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
66016 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

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 percent

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

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

non-nursing infants <1 year 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 primisulfuron-methyl and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for a time-limited tolerance

for residues of primisulfuron-methyl on

bluegrass grown for seed at 0.10 ppm.

EPA’s assessment of the dietary
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66017

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 primisulfuronmethyl are discussed below.

1. Acute toxicity. For acute dietary

risk assessment, the Agency used a

NOEL of 100 mg/kg/day, based on

delayed or absent ossification effects in

fetuses at the LEL of 500 mg/kg/day,

from the oral developmental study in

rats. This risk assessment will evaluate

acute dietary risk to the population

subgroup of concern, females 13+ years

of age.

2. Chronic toxicity. EPA has

established the RfD for primisulfuronmethyl at 0.006 milligrams/kilogram/

day (mg/kg/day). This RfD is based on

an 80–week mouse feeding study with

a LOEL of 1.7 mg/kg/day based on

increased absolute and relative liver

weights. An uncertainty factor of 300

was used because a NOEL was not

achieved.

3. Carcinogenicity. Primisulfuronmethyl has been classified as a Group D

chemical incomplete evidence based on

liver tumors in mice.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.452) for the residues of

primisulfuron-methyl, in or on the raw

agricultural commodities fresh corn and

corn forage and fodder. Tolerances are

also established on cattle, goat, hog,

horse, sheep, and poultry commodities

as well as milk and eggs. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

primisulfuron-methyl as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The acute

dietary food only risk assessment used

tolerance level residues for all

commodities with primisulfuron-methyl

tolerances. Therefore, the resulting

exposure estimates should be viewed as

conservative; further refinement using

anticipated residues and/or Monte Carlo

and percent of crop-treated would result

in lower dietary exposure estimates.

Since the acute dietary effect is based on

delayed or absent ossification effects in

fetuses, the subgroup of concern is

females 13+ years of age. For females

13+ years of age, an MOE value of

71,000 was calculated using the highend exposure value of 0.0014 mg/kg/

day.

ii. Chronic exposure and risk. Because

there are no human food items

associated with bluegrass and existing

meat/milk/poultry/egg tolerances are

adequate to cover secondary residues, a

new chronic Dietary Risk Evaluation

System (DRES) run was not performed

for this section 18 request. The latest

chronic DRES run was performed in

conjunction with the registration of

primisulfuron-methyl on corn. The

chronic dietary exposure estimates were

not refined using anticipated residues

and percent crop treated data. The

existing primisulfuron-methyl

tolerances result in a Theoretical

Maximum Residue Contribution

(TMRC) that is equivalent to the

following percentages of the RfD:

Subpopulation TMRCfood

Value(mg/kg/day) % RfD

U.S. Population ........................................................................................................................................................ 0.000571 10%

Nursing Infants ......................................................................................................................................................... 0.000484 8%

Non-Nursing Infants < 1 year old ............................................................................................................................ 0.001732 29%

Children 1–6 years old ............................................................................................................................................. 0.001327 22%

Children 7–12 years old ........................................................................................................................................... 0.000876 15%

Hispanics .................................................................................................................................................................. 0.000723 12%

Non-Hispanic Others ................................................................................................................................................ 0.000644 11%

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,

primisulfuron-methyl is moderately

persistent and highly mobile. There is

no established Maximum Concentration

Level for residues of primisulfuronmethyl in drinking water. No health

advisory levels for primisulfuronmethyl in drinking water have been

established. Based on ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, Sept 1992), primisulfuronmethyl has not been analyzed for in

water.

3. 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

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 primisulfuron-methyl 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 primisulfuron-methyl 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.

4. From non-dietary exposure.

Primisulfuron-methyl is not registered

for uses that would be expected to result
66018 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

in indoor or outdoor residential

exposure.

5. 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

primisulfuron-methyl 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, primisulfuronmethyl 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 primisulfuron-methyl has

a common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The acute aggregate risk

assessment takes into account exposure

from dietary food and water only. As

noted earlier, the MOE for females 13+

years of age was calculated to be 71,000.

Therefore, EPA does not have an acute

aggregate risk concern.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions described above, and

taking into account the completeness

and reliability of the toxicity data, EPA

has calculated that dietary exposure to

primisulfuron-methyl from food will

utilize 10% of the RfD for the U.S.

population. The Agency 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 primisulfuron-methyl 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 primisulfuron-methyl residues.

D. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

primisulfuron-methyl, EPA considered

data from developmental toxicity

studies in the rat and rabbit and a twogeneration 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.

ii. Developmental toxicity studies.

From the rat developmental study, the

maternal (systemic) NOEL was less than

100 mg/kg/day, based on decreased

weight gain during dosing at the LOEL

of 100 mg/kg/day. The developmental

(fetal) NOEL was 100 mg/kg/day, based

on delayed or absent ossification at the

LOEL of 500 mg/kg/day.

From the rabbit developmental study,

the maternal (systemic) NOEL was 10

mg/kg/day, based on abortions,

decreased weight gain and loose stool at

the LOEL of 300 mg/kg/day. The

developmental (fetal) NOEL was 600

mg/kg/day highest dose tested.

iii. Reproductive toxicity study. From

the rat reproductive study, the parental

(systemic) NOEL was 50 mg/kg/day,

based on decreased weight gain at the

LOEL of 250 mg/kg/day. The

developmental (pup) NOEL was 50 mg/

kg/day, based on decreased pup body

weight findings at the LOEL of 250 mg/

kg/day. The reproductive NOEL was 50

mg/kg/day, based on decrease in

testicular/spermatic function at the

LOEL of 250 mg/kg/day.

iv. Pre- and post-natal sensitivity. In

rats, although the developmental and

maternal NOELs and LOELs were at the

same dose levels, the finding of

developmental effects [absent

ossification] required that an acute

dietary risk assessment be performed for

females 13+ years of age. The calculated

MOE of 71,000 demonstrated that acute

pre-natal developmental risks were

below EPA’s level of concern. There

were no pre-natal developmental

concerns in rabbits, since the

developmental NOEL was greater than

600 mg/kg/day (HDT).

Similarly, there were no post-natal rat

reproductive study findings that
Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations 66019

required additional safety factors, since

the maternal and pup NOEL and LOEL

of 50 and 250 mg/kg/day, respectively,

occurred at the same dose levels and

both adult and pup animals had similar

toxic effects (decreased weight gain).

v. Conclusion. The pre- and post-natal

toxicology data base for primisulfuronmethyl is complete with respect to

current toxicological data requirements.

The Agency 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. Acute risk. The finding of

developmental effects in the rat study

absent ossification required that an

acute dietary risk assessment be

performed for females 13+ years of age.

The calculated MOE of 71,000

demonstrated that acute pre-natal

developmental risks were below EPA’s

level of concern.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to

primisulfuron-methyl from food will

utilize from 8% of the RfD for nursing

infants up to 29% of the RfD for nonnursing infants < 1 year old. 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.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in corn and

animals is adequately understood. The

residue of concern is the parent

compound only, as specified in 40 CFR

180.452.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(HPLC) has been submitted for inclusion

in PAM Vol. II to enforce the tolerance

expression. Method I of PAM II (Method

AG–499A) has been validated on corn

commodities and Method II (Method

AG–506) has been validated on

livestock commodities. Method A of

PAM II is a confirmation method for

plant commodities.

C. Magnitude of Residues

Residues of primisulfuron-methyl are

not expected to exceed 0.10 ppm in/on

bluegrass hay as a result of this section

18 use. A time-limited tolerance will be

established at this level. Secondary

residues in animal commodities are not

expected to exceed existing tolerances

as a result of this section 18 use.

D. International Residue Limits

No Codex (MRLs) have been

established for residues of

primisulfuron-methyl on grasses.

VI. Conclusion

Therefore, the tolerance is established

for residues of primisulfuron-methyl in

bluegrass grown for seed at 0.10 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 February 17,

1998, 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

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–300573] (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 (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, 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.

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(l)(6). 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
66020 Federal Register / Vol. 62, No. 242 / Wednesday, December 17, 1997 / Rules and Regulations

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: November 18, 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 180.452, is amended as

follows:

i. By designating the existing text as

paragraph (a) and adding a heading.

ii. By adding new paragraph (b).

iii. By adding and reserving new

paragraphs (c) and (d) with headings to

read as follows.

§180.452 Primisulfuron-methyl; tolerances

for residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide

primisulfuron-methyl in connection

with use of the pesticide under section

18 emergency exemptions granted by

EPA. These tolerances will expire and

are revoked on the dates specified in the

following table.

Commodity Parts per million Expiration/revocation date

Bluegrass hay ...................................................................................... 0.10 10/31/1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–32937 Filed 12–16–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300503A; FRL–5753–1]

RIN 2070–AB78

Revocation of Tolerances for

Commodities No Longer Regulated for

Pesticide Residues and Other Actions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule revokes tolerances

for pesticide residues in or on livestock

feed commodities that have been

deleted from the list of significant

livestock feed commodities in Table I of

Pesticide Assessment Guideline

860.1000. In implementing the Federal

Food, Drug, and Cosmetic Act (FFDCA),

EPA does not require data on or set

individual tolerance levels for minor,

non-significant livestock animal

commodities. As explained in this

document, EPA considers residues in

minor, non-significant livestock feed

commodities to be covered by the

tolerances for the pesticide on the

principal commodities of a crop.

DATES: This final rule becomes effective

January 16, 1998. Written objections and

requests for hearing must be received by

February 17, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300503A],

may 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 should be

identified by the document control

number and submitted to: Public

Information and Records Integrity

Branch, Information Resources and

Services (7506C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. In person, bring copy of

objections and hearing requests to: Rm.

1132, CM #2, 1921 Jefferson Davis Hwy.,

Arlington, VA 22202.

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