Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26473

Dated: April 29, 1998

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

corrected as follows:

PART 180—[CORRECTED]

1. The authority citation for part 180

continues to read as follows:

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

2. By correcting § 180.527, to read as

follows:

§ 180.527 N-(4-fluorophenyl)-N-(1-

methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-

thiadiazol-2-yl]oxy]acetamide; tolerances

for residues.

(a) General. (1) Time-limited

tolerances are established for combined

residues of the herbicide, N-(4-

fluorophenyl)-N-(1-methylethyl)-2-[[5-

(trifluoromethyl)-1,3,4-thiadiazol-2-

yl]oxy]acetamide and its metabolites

containing the 4-fluoro-N-methylethyl

benzenamine moiety in or on the

following raw agricultural commodities:

CommodityParts per

million

Expiration/Revocation Date

Corn, field,

forage .. 0.4 4/30/03

Corn, field,

grain ..... 0.05 4/30/03

Corn, field,

stover ... 0.4 4/30/03

Soybean

seed ..... 0.1 4/30/03

(2) Residues in these commodities not

in excess of the established tolerance

resulting from the use described in

paragraph (a) of this section remaining

after expiration of the time-limited

tolerance will not be considered to be

actionable if the herbicide is applied

during the term of and in accordance

with the provisions of the above

regulation.

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 98–12490 Filed 5–12–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300661; FRL–5790–8]

RIN 2070–AB78

Bromoxynil; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for bromoxynil and DBHA in

or on cotton. In addition, this regulation

establishes tolerances for bromoxynil

and DBHA in or on meat, meat by

products, and fat of cattle, hogs, horses,

goats, and sheep. Further, this

regulation establishes tolerances for

bromoxynil and DBHA in milk, eggs,

and poultry meat, meat by-products,

and fat. Rhone-Poulenc Ag Company

requested the tolerances for cotton

under the Federal Food, Drug, and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996 (Pub. L.

104-170).

DATES: This regulation is effective May

13, 1998. Objections and requests for

hearings must be received by EPA on or

before July 13, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300661],

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–

300661], 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. 119, 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–

300661]. 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: Jim Tompkins, 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, 703-305-5697, e-mail:

tompkins.jim@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 26, 1997

(62 FR 63170) (FRL–5755–6), EPA,

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(e)

announcing the filing of a pesticide

petition (PP) 3F4233 for tolerance by

Rhone-Poulenc Ag Company. This

notice included a summary of the

petition prepared by Rhone-Poulenc Ag

Company, the registrant. Comments in

response to the notice of filing were

received from public interest groups,

individual concerned citizens,

agricultural extension agents,

representatives of State agencies,

individual growers, and industry

groups. The issues raised were the same

issues raised in response to the

proposed rule (May 2, 1997, 62 FR

24065) (FRL–5617–5) for the

bromoxynil tolerance that expired on

January 1, 1998. Many of the comments

are addressed in this document.

Responses to other significant

comments are presented in Unit III. of

the final rule for last year’s tolerance

(June 18, 1997, 62 FR 33019) (FRL–

5724–9) or in a Response to Comments

document that has been included in the

docket for that action.

The petition requested that 40 CFR

180.324 be amended by establishing

tolerances for residues of the herbicide

bromoxynil plus its metabolite DBHA

(3,5-dibromo-4-hydroxybenzoic acid)

resulting from the application of

octanoic and heptanoic acid esters of

bromoxynil to cotton: undelinted

cottonseed at 7 parts per million (ppm),

cotton gin byproducts at 50 ppm, and

cotton hulls at 21 ppm. (Active

ingredient codes are 35302 for the

octanoic acid ester, and 128920 for the

heptanoic acid ester. CAS Reg. Nos. are
26474 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

1689-99-2 for the octanoic acid ester,

and 56634-95-8 for the heptanoic acid

ester.) The tolerances established in this

final rule differ from these tolerances

proposed by the registrant as the result

of the review of residue data for

bromoxynil and DBHA in cotton

commodities submitted by the registrant

after the petition was filed. In addition,

the petition requested that the

maximum allowable cotton acreage that

can be treated annually with

bromoxynil be increased from 400,000

acres to 1.3 million acres.

In the Federal Register of May 24,

1995 (60 FR 27414) (FRL–4953–9), EPA

established a time-limited tolerance

under section 408 of the FFDCA, 21

U.S.C. 346a, for residues of the

herbicide bromoxynil, (3,5-dibromo-4-

hydroxybenzonitrile) on cottonseed.

This tolerance expired on April 1, 1997.

The tolerance was established in

response to a petition filed by the

Rhone-Poulenc AG Company, P.O. Box

12014, 2 T.W. Alexander Drive,

Research Triangle Park, NC 27709.

In the Federal Register of May 2, 1997

(62 FR 24065), EPA issued a proposed

rule for establishment of tolerances on

cotton commodities and poultry, eggs,

and milk, and revision of tolerances on

other livestock. In the Federal Register

of June 18, 1997 (62 FR 33019), EPA

issued a final rule for establishment of

tolerances on cotton commodities and

poultry, eggs, and milk, and revision of

tolerances on other livestock. The

tolerances for the cotton commodities

expired on January 1, 1998.

I. Risk Assessment and Statutory

Findings

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. . . .’’

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 the pesticide

residues from treated food and

contaminated drinking water is

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

the Food Quality Protection Act of 1996

(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 three

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
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26475

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.

II. 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 bromoxynil and to make a

determination on aggregate exposure,

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

tolerances for bromoxynil and DBHA on

undelinted cottonseed at 1.5 ppm;

cotton gin byproducts at 7.0 ppm; and

cotton hulls at 5.0 ppm; in or on cattle,

hogs, horses, goats, and sheep at 0.5

ppm in meat, 3.5 ppm in meat byproducts (mbyp), and 1.0 ppm in fat; at

0.1 ppm in milk; at 0.05 ppm in eggs;

at 0.05 ppm in poultry meat and fat; and

at 0.3 ppm in poultry mbyp. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerances 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 bromoxynil are

discussed in the proposed rule (May 2,

1997, 62 FR 24065).

B. Toxicological Endpoints

The toxicological endpoints for

bromoxynil are discussed in Unit IV.

‘‘Dose Response Assessment’’ of the

proposed rule for last year’s tolerance

(May 2, 1997, 62 FR 24065).

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.324) for the residues of

bromoxynil, in or on a variety of raw

agricultural commodities. Tolerances for

the residues of bromoxynil, resulting

from the application of octanoic and

heptanoic acid esters of bromoxynil to

cotton, have been established in or on

cattle, hogs, horses, goats, and sheep at

0.5 ppm in meat, 3.0 ppm in mbyp, and

1.0 ppm in fat. Tolerances for residues

of bromoxynil, resulting from the

application of octanoic and heptanoic

acid esters of bromoxynil to cotton have

been established at 0.1 ppm in milk; and

at 0.05 ppm in eggs; at 0.05 ppm in

poultry meat, mbyp, and fat. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

bromoxynil 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. A revised

acute dietary risk assessment was

conducted for bromoxynil. This revised

acute dietary assessment differs from

the assessment used for last year’s

tolerance as follows: (a) The results of

a new cotton residue study were used to

determine anticipated bromoxynil

residues; (b) a probabilistic assessment

submitted by the registrant was used.

The acute assessment used a NOEL of 4

milligram/kilograms body weight/day

(mg/kg bw/day) based on developmental

effects with the population subgroup of

concern being females ≥13 years old and

a NOEL of 8 mg/kg bw/day based on

systemic effects for all populations

except females ≥13 years old. The acute

analysis estimates the distribution of

single-day exposures for the overall U.S.

population and certain subgroups. The

MOE is a measure of how closely the

exposure comes to the NOEL and is

calculated as a ratio of the NOEL to the

exposure. The calculated MOE for acute

risk of bromoxynil for the general U. S.

Population is >58,000 and for females

≥13 years old is >24,000. For the most

exposed subgroups, the calculated MOE

for acute risk of bromoxynil is >32,000

for non-nursing infants, >36,000 for all

infants, and >35,000 for children 1-6

years old. These figures are above the

required MOE of 1,000 for females ≥13

years old and 100 for the general

population and all other population

subgroups, indicating that the potential

for an adverse effect from a single day

exposure is unlikely. The level of

concern for the general U.S. population

and all population subgroups except for

females ≥13 years is based on

interspecies extrapolation (10x) and

intraspecies variability (10x). For

females ≥13 years, an added factor of

10x is used pursuant to section

408(b)(2)(C) (See Unit II.E.b. of this

document).

ii. Chronic exposure and risk. For

chronic exposure to bromoxynil, the

reference dose (0.015 mg/kg/day) is

based upon a NOEL/LOEL of 1.5 mg/kg/

day, from a 1-year canine study, with

additional uncertainty factors applied
26476 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

for intra- (10x) and interspecies (10x)

variability.

A DRES chronic exposure analysis

was conducted using anticipated

residue levels for all registered

commodities and livestock, and percent

crop treated information to estimate

dietary exposure for the general

population and several population

subgroups. The chronic analysis showed

that for chronic effects other than

cancer, for all population subgroups,

less than 1% of the reference dose was

consumed.

When EPA establishes, modifies, or

leaves in effect a tolerance, section

408(b)(2)(E) authorizes EPA to use

available data and information on the

anticipated residue levels of pesticide

residues in food and the actual levels of

pesticide chemicals that have been

measured in food. If EPA relies on such

information, EPA must require that data

be provided five years after the

tolerance is established, modified, or

left in effect, demonstrating that the

levels in food are not above the levels

anticipated. As required by section

408(b)(2)(E), EPA will issue a data callin for information relating to anticipated

residues to be submitted no later than

five years from the date of issuance of

this tolerance.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings: (a)

That the data used are reliable and

provide a valid basis to show what

percentage of the food derived from

such crop is likely to contain such

pesticide residue; (b) that the exposure

estimate does not underestimate

exposure for any significant

subpopulation group; and (c) if data are

available on pesticide use and food

consumption in a particular area, the

exposure estimate does not understate

exposure for the population in such

area. In addition, the Agency must

provide for periodic evaluation of any

estimates used. To provide for the

periodic evaluation of the estimate of

percent crop treated as required by the

section 408(b)(2)(F), EPA may require

registrants to submit data on percent

crop treated.

The Agency used percent crop treated

(PCT) information as follows. A routine

chronic dietary exposure analysis for

bromoxynil was based on 10% of the

cotton crop treated, 10% of all cereal

grain crops (wheat, corn, oats, barley,

rye, sorghum) treated, 62% of the onion

crop treated, 100% of the garlic crop

treated, and 71% of peppermint and

spearmint crop treated. PCT of 10% for

cotton was based on the petitioner’s

request that the Agency permit up to 1.3

million acres of cotton to be treated

annually with bromoxynil, which

amounts to 10% of the cotton crop

grown in the U.S. The registration of

bromoxynil will restrict treatment of

bromoxynil on cotton to no more than

1.3 million acres during 1998.

The Agency believes that the three

conditions listed above have been met.

With respect to (a), EPA finds that the

PCT information described above for

bromoxynil used on cotton is reliable

and has a valid basis. The registration of

bromoxynil will restrict treatment of

bromoxynil on cotton to no more than

1.3 million acres during 1998. Before

the petitioner can increase the treatment

of greater than 1.3 million acres of

cotton per year, permission from the

Agency must be obtained. For crops

other than cotton, the Agency has

utilized the latest statistical data from

RFF (Resources For The Future), Doane,

and the U.S. Department of Agriculture

(USDA), the best available sources for

such information. As to (b) and (c),

regional consumption information and

consumption information for significant

subpopulations is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant

subpopulation group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available information on the

consumption of food bearing

bromoxynil in a particular area.

The cancer risk from all food sources

is 1.5 in a million if 10% of the cotton

is treated. These risk estimates are based

on anticipated residues and percent

crop treated information.

2. From drinking water. Based on the

chemical characteristics and monitoring

data, bromoxynil residues are not

expected to be found in ground water.

For the action last year (June 18, 1997,

62 FR 33019), an analysis of surface

water based on cotton use was

conducted using the PRZM-EXAMS

computer model (Pesticide Root Zone

Model Version 2.3 plus Exposure

Analysis Modeling System Version

2.94). The maximum or peak estimated

concentration for bromoxynil was 12.3

parts per billion (ppb) and the

maximum estimated long-term mean

was 0.24 ppb (based on modeling using

36 years of weather data). These values

represent what might be expected in a

small water body near a cotton field

highly prone to runoff. The maximum

peak estimated concentration for

bromoxynil from the model correlates

with the highest value detected in the

U.S. Geological Survey (USGS)

monitoring data, 12.2 ppb, which has

been corrected for an analytical recovery

rate of 50%. For this action, the Agency

has reevaluated the concentrations of

bromoxynil in surface water to be used

to assess risk associated with drinking

water. EPA reviewed USGS national

monitoring data and determined which

of these sites were likely to have

bromoxynil use. To estimate a

reasonable high end exposure, EPA

focussed on the calculated time

weighted annual mean concentrations of

bromoxynil at each of 11 USGS

monitoring sites, which the EPA views

as located in watersheds likely to have

bromoxynil use. (These values were not

corrected for the analytical recovery rate

of 50%.) These time weighted annual

mean concentrations ranged from 0.011

ppb to 0.18 ppb, with 10 out of the 11

sites with time weighted annual mean

concentrations below 0.05 ppb. Six of

the 10 sites had time weighted annual

mean concentrations at or below 0.014

ppb. The highest annual time-weighted

mean (0.18 ppb) was located in a

relatively small watershed

(approximately 100 square miles) and a

relatively small water body, and the

calculated annual mean value at this

site was significantly influenced by the

presence of a single high value (the

highest value found in all of the

available monitoring data). Based on

this information, EPA believes that 0.05

ppb is a reasonable high end estimate

for purposes of estimating drinking

water exposure. However, EPA is

imposing surface water monitoring

requirements as a condition of

registration to allow use of more precise

estimates in the future.

i. Acute exposure and risk. Acute

drinking water exposure was calculated

by multiplying the estimated

concentration of bromoxynil in surface

water (12.3 ppb) by the estimated water

consumption (2 liters for adults, 1 liter

for children) and then dividing by body

weight (70 kg for males, 60 kg for

females, and 10 kg for children). Acute

drinking water exposure is calculated to

be 3.5 x 10-4 mg/kg/day for adult males

and females, and 1.2 x 10-4 mg/kg/day

for children. The MOE for drinking

water for all three population subgroups

is >10,000.

ii. Chronic exposure and risk. Chronic

drinking water risk was calculated in

the same way as acute risk, except that
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26477

the estimated mean concentrations of

0.24 ppb, 0.05 ppb, and 0.01 ppb were

used. At 0.24 ppb, the highest of these

concentrations, chronic drinking water

exposure is calculated to be 2 x 10-5 mg/

kg/day for children, 7 x 10-6 mg/kg/day

for males, and 8 x 10-6 mg/kg/day for

females. All of these exposures are <1%

of the RfD of 0.015 mg/kg/day. The

cancer risk (calculated based on a 70-

year lifetime) is calculated to be 8 x 10-7

at a chronic water exposure

concentration of 0.24 ppb, 2 x 10-7 at a

concentration of 0.05 ppb, and 3 x 10-8

at a concentration of 0.01 ppb. The

Agency has determined that a

concentration of 0.05 ppb for

bromoxynil is a reasonable high end of

exposure for bromoxynil in surface

water; therefore, the cancer risk from

exposure to bromoxynil in drinking

water is calculated at 2 x 10-7.

EPA believes the estimates of

bromoxynil exposure in water derived

from the PRZM-EXAMS model,

particularly the estimates pertaining to

chronic exposure, are significantly

overstated for several reasons. The

PRZM-EXAMS model was designed to

estimate exposure for ecological risk

assessments and thus uses a scenario of

a body of water approximating the size

of a 1 hectare (2.5 acres) pond. This

tends to overstate chronic drinking

water exposure levels for the following

reasons. First, surface water source

drinking water generally comes from

bodies of water that are substantially

larger than a 1 hectare (2.5 acres) pond.

Second, the modeled scenario also

assumes that essentially the whole basin

receives an application of the pesticide.

Yet, in virtually all cases, basins large

enough to support a drinking water

facility will contain a substantial

fraction of the area which does not

receive the pesticide. Third, there is

often at least some flow (in a river) or

turn over (in a reservoir or lake) of the

water so the persistence of the pesticide

near the drinking water facility is

usually overestimated. Fourth, even

assuming a reservoir is directly adjacent

to an agricultural field, the agricultural

field may not be used to grow a crop on

which the pesticide in question is

registered for use. Fifth, the PRZMEXAMS modeled scenario does not take

into account reductions in residueloading due to applications of less than

the maximum application rate or no

treatment of the crop at all (percent crop

treated data).

3. From non-dietary exposure.

Bromoxynil is currently not registered

for use on any residential non-food

sites.

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

bromoxynil 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,

bromoxynil 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 bromoxynil has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The MOE for all dietary

sources (food plus water) is >16,000 for

the entire U.S. population, >11,000 for

females ≥13 years old, and >5,000 for

children 1-6 years old. These MOEs are

greater than the levels of concern of

1,000 for females ≥13 years and 100 for

all other population groups.

Accordingly, EPA concludes that there

is a reasonable certainty that no harm

will result to the general population and

major identifiable population subgroups

from aggregate acute exposure to

bromoxynil.

2. Chronic risk. Using the exposure

assumptions described above, EPA has

concluded that aggregate exposure to

bromoxynil from food and drinking

water will utilize <1% of the RfD for the

U.S. population. EPA has also

concluded that aggregate exposure to

bromoxynil will utilize <1% of the RfD

for the most highly exposed

subpopulation, children 1-6 years old

(discussed below). 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.

Accordingly, EPA concludes that there

is a reasonable certainty that no harm

will result to the general population and

major identifiable population subgroups

from aggregate chronic exposure to

bromoxynil.

D. Aggregate Cancer Risk for U.S.

Population

The aggregate cancer risk for the U.S.

population calculated for use of

bromoxynil is 1.7 x 10-6. EPA believes

that a risk estimate of this level

generally represents a negligible risk, as

EPA has traditionally applied that

concept. EPA has commonly referred to

a negligible risk as one that is at or

below 1 in 1 million (1 x 10-6).

Quantitative cancer risk assessment is

not a precise science. There are a

significant number of uncertainties in

both the toxicology used to derive the

cancer potency of a substance and in the

data used to measure and calculate

exposure. Thus, EPA generally does not

attach great significance to numerical

estimates that differ by approximately a

factor of 2. Therefore, EPA considers the
26478 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

carcinogenic risk from bromoxynil to be

negligible within the meaning of that

standard as it has been traditionally

applied by EPA. Accordingly, EPA

concludes that there is a reasonable

certainty that no harm will result to the

general population and major

identifiable population subgroups from

aggregate exposure to bromoxynil.

Specific risks to infants and children

other than cancer are discussed below.

E. 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

bromoxynil, EPA considered all

available developmental and

reproductive toxicity data. A total of 12

developmental and 3 reproductive

toxicity studies were available for

review. These include oral prenatal

developmental toxicity studies (four in

rats, two in rabbits, and one in mice

with the phenol; one in rats with the

octanoate), dermal prenatal

developmental toxicity studies (one

each in rats and rabbits with both the

phenol and the octanoate), and dietary

two-generation reproduction studies in

rats (two with the phenol; one with the

octanoate). The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from maternal pesticide

exposure gestation. 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 uncertainty

factor (usually 100 for combined interand 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. Analysis. Developmental toxicity

was observed, following in utero

exposure to bromoxynil, in multiple

studies, by two routes of exposure, and

in three species. The induction of

supernumerary ribs was shown to be the

most sensitive indicator of

developmental toxicity in fetal rats,

mice, and (in certain studies) rabbits. In

EPA’s 1997 tolerance action concerning

bromoxynil (62 FR 33019, June 18, 1997

), EPA concluded that the children’s

safety factor was not necessary to

protect the safety of infants and

children. That decision rested on the

view that, given the large number of

studies available on bromoxynil, EPA

had a high degree of certainty regarding

the level at which effects would occur

in experimental animals. Since that

action, EPA revisited the children’s

safety factor decision and concluded

that the safety factor should be retained.

This revised decision is based on EPA’s

conclusion that the standard 100-fold

safety factor may not be adequate to

protect the safety of infants and children

given the clear showing of increased

susceptibility of fetuses, the steep dose

response curve, and the demonstrated

severe developmental effects at doses

above the LOEL. Nevertheless, EPA’s

decision at this time remains tentative

due to the fact that EPA has only

recently sought external science review

of its approach to the children’s safety

factor and also instituted an internal

reexamination process. Given the

toxicological factors noted above, EPA is

unwilling to make safety determinations

regarding this pesticide without using

the additional tenfold safety factor.

EPA believes that the population of

concern for which the safety factor

should be retained is the developing

fetus and the endpoint of concern is

supernumerary ribs. This endpoint, a

developmental anomaly, results from in

utero exposure. Although some systems

in infants and children continue

developing, it is unlikely that

supernumerary ribs, even though

observed across multiple species, would

result from postnatal exposure. Since

the acute dietary endpoint for females

≥13 years old is based on developmental

effects, it was determined that the 10-

fold safety factor should be applied to

the acute risk assessment for females

≥13 years old (the population subgroup

that is relevant to in utero exposure), but

is not needed for children and infants.

A 10-fold factor safety factor applied to

females ≥13 years old will provide

additional protection for infants and

children and ensure a reasonable

certainty of no harm to this sensitive

subpopulation.

2. Acute risk. The MOE of >5,000 for

children 1-6 years old, the most highly

exposed subpopulation, is greater than

the level of concern of 100. For females

≥13 years old, the population subgroup

that is most relevant to the development

of in utero exposure, the MOE of 11,000

is greater than the level of concern of

1000. Therefore acute risk for children

does not trigger any concerns.

3. Chronic risk. Using the exposure

assumptions described above, EPA has

concluded that aggregate exposure to

bromoxynil from food will utilize <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. Therefore, the Agency

concludes that there is a reasonable

certainty of no harm to infants and

children as a result of chronic dietary

exposure to bromoxynil.

III. Other Considerations

A. Metabolism In Plants and Animals

The nature (metabolism) of

bromoxynil residues in plants and

livestock is adequately understood for

the purposes of these tolerances. In all

the plant and animal (poultry and

ruminants) metabolism studies

submitted, the residues of concern were

parent bromoxynil and the metabolite

DBHA. The tolerances for cotton

commodities and livestock are

expressed in terms of bromoxynil and

DBHA.

Pending receipt of additional

metabolism data for DBHA in livestock,

the Agency has assumed that DBHA is

of equal toxicity to the parent and

translates proportionately to the parent

for livestock commodities. The Agency

believes these assumptions are

adequately protective for purposes of

these tolerances.

B. Analytical Enforcement Methodology

Adequate analytical methodology is

available for data collection and

tolerance enforcement for bromoxynil

per se in plants. Method I in PAM, Vol.

II, is a GLC/MCD that has undergone a

successful EPA method validation on

wheat grain. This method involves

alkaline hydrolysis in methanolic KOH

to convert residues to bromoxynil,

cleanup by liquid-liquid partitioning,

methylation using diazomethane,

further cleanup on a Florisil column,

and determination by GLC/MCD.

Method Ia is the same method, but uses

GC/ECD for determination of

methylated bromoxynil.
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26479

The analytical method ‘‘Bromoxynil:

Method of Analysis for Bromoxynil and

its Metabolite, 3,5-Dibromo-4-

hydroxybenzoic Acid in Cottonseed,

Gin Trash, and Seed Processed

Fractions using GC-MSD.’’ (Method

RES9603) has been the subject of an

Independent Laboratory Validation

(ILV) and an Agency Petition Method

Validation (PMV). The method

validation data are being reviewed by

the Agency; approval of the method for

enforcement purposes is anticipated.

Method A is a GC/MCD or ECD

method for the analysis of bromoxynil

per se in livestock tissues and is

essentially the same as Method I.

Method B is a GC/ECD method that is

also similar to Method I, with

modifications to the cleanup

procedures. A method for DBHA in

animal commodities has been

developed and is currently in the

process of review and validation by the

Agency.

C. Magnitude of Residues

In the petition for these tolerances,

the registrant requested that 40 CFR

180.324 be amended by establishing

tolerances for residues of the herbicide

bromoxynil and its metabolite DBHA on

cotton at 7 ppm for undelinted

cottonseed, 50 ppm for cotton gin

byproducts, and 21 ppm for cotton

hulls. These proposed tolerances are the

same as those issued in the June 18,

1997 final rule (62 FR 33019).

Immediately prior to establishing these

tolerances, the registrant reduced the

maximum label rate as a result of

Agency risk concerns. The tolerances

were determined by extrapolating from

residue studies conducted at the former

maximum label rate (4.5 lb ai/A).

Following the submission of the

tolerance petition, the registrant

submitted residue data for bromoxynil

and DBHA in cotton commodities at the

revised maximum application rate of 3

applications at 0.5 lb ai/A each for a

total of 1.5 lb ai/A. These data show that

bromoxynil and DBHA residues in

cotton commodities are lower than the

values determined for the June 18, 1997

final rule. Based on the new residue

data, tolerances for bromoxynil and

DBHA in cotton commodities are being

changed to 7.0 ppm in cotton gin

byproducts, 5.0 ppm in cotton hulls,

and 1.5 ppm in undelinted cottonseed.

In the June 18, 1997 final rule,

tolerances for livestock commodities

(including milk and eggs) were

expressed as bromoxynil per se only;

the Agency concluded that

measurement of bromoxynil per se in

livestock commodities could serve as a

marker to indicate the amount of DBHA

present in livestock. After further

consideration, the Agency has

determined that measurement of

bromoxynil per se in livestock is not

adequate to determine the amount of

DBHA present. Therefore, in this action,

tolerances are expressed as bromoxynil

and DBHA instead of only as

bromoxynil per se in livestock.

Tolerances for ruminant commodities

(meat, fat, and meat by products) were

recalculated since issuing the June 18,

1997 final rule due to new information.

First, new residue data for bromoxynil

and DBHA in cotton commodities were

used to determine expected maximum

theoretical dietary exposure to

bromoxynil and DBHA via ingestion of

cotton commodities. Second, maximum

theoretical residues in livestock

commodities were recalculated based on

a revision in the dosing levels used in

livestock feeding studies. Doses were

previously calculated in terms of

bromoxynil octanoate; however, since

tolerances in RACs (raw agricultural

commodities) are for bromoxynil per se,

doses were recalculated as such.

Finally, changes were made to the

relative contributions of feed items in

the diet as a result of grazing restrictions

for grass, and information provided by

the registrant on the amount of cotton

gin trash in beef and dairy cattle diets.

These changes did not affect tolerances

for residues in milk, eggs, or meat and

fat of ruminants and poultry; however,

the tolerances for residues in meat byproducts increased to 3.5 ppm for

ruminants and to 0.3 ppm for poultry.

D. International Residue Limits

There are no established or proposed

Codex MRLs for bromoxynil residues.

E. Rotational Crop Restrictions

Required additional limited field

rotational crop studies have not been

submitted to the Agency; acceptable

studies previously submitted in support

of reregistration reflect a maximum

seasonal and single application rate of

0.5 lb ai/A, but the use on cotton

constitutes a maximum seasonal

application rate of 1.5 lb ai/A. Pending

receipt of these studies registered labels

must restrict rotation of cotton fields

treated at a rate of greater than 0.5 lb ai/

A/season to cotton.

IV. Conclusion

Therefore, tolerances are established

for bromoxynil and DBHA in undelinted

cottonseed at 1.5 ppm, cotton gin

byproducts at 7.0 ppm, and cotton hulls

at 5.0 ppm. In addition, this document

establishes tolerances for the residues of

bromoxynil and DBHA, resulting from

the application of octanoic and

heptanoic acid esters of bromoxynil to

cotton, in or on cattle, hogs, horses,

goats, and sheep to 0.5 ppm in meat, 3.5

ppm in mbyp, and 1.0 ppm in fat.

Further, this document establishes

tolerances for residues of bromoxynil

and DBHA, resulting from the

application of octanoic and heptanoic

acid esters of bromoxynil to cotton, at

0.1 ppm in milk; at 0.05 ppm in eggs;

at 0.05 ppm in poultry meat and fat; and

at 0.3 ppm in poultry mbyp.

V. 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 July 13, 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).
26480 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

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.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300661] (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 119 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

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.

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.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. 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 1985, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the tolerances 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.

VIII. 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: May 6, 1998.

James Jones,

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. In § 180.324, paragraph (a) is

revised to read as follows:

§ 180.324 Bromoxynil; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the herbicide

bromoxynil (3,5-dibromo-4-

hydroxybenzonitrile) resulting from

application of its octanoic and/or

heptanoic acid ester in or on the

following commodities:

Commodity Parts per million

Alfalfa, seeding ................. 0.1 ppm

Barley, grain ...................... 0.1 ppm

Barley, straw ..................... 0.1 ppm

Corn, fodder (dry) ............. 0.1 ppm

Corn, fodder (green) ......... 0.1 ppm

Corn, fodder, field (dry) ..... 0.1 ppm

Corn, fodder, field (green) 0.1 ppm

Corn, grain ........................ 0.1 ppm

Corn, grain, field ............... 0.1 ppm

Flaxseed ............................ 0.1 ppm

Flax straw .......................... 0.1 ppm

Garlic ................................. 0.1 ppm

Grass, canary, annual,

seed.

0.1 ppm

Grass, canary, annual,

straw.

0.1 ppm

Mint hay ............................ 0.1 ppm

Oats, forage, green ........... 0.1 ppm

Oats, grain ........................ 0.1 ppm

Oats, straw ........................ 0.1 ppm

Onions (dry bulb) .............. 0.1 ppm

Rye, forage, green ............ 0.1 ppm

Rye, grain .......................... 0.1 ppm

Rye, straw ......................... 0.1 ppm

Sorghum, fodder ............... 0.1 ppm

Sorghum, forage ............... 0.1 ppm

Sorghum, grain ................. 0.1 ppm

Wheat, forage, green ........ 0.1 ppm

Wheat, grain ...................... 0.1 ppm

Wheat, straw ..................... 0.1 ppm

(2) Tolerances are established for

residues of the herbicide bromoxynil

(3,5-dibromo-4-hydroxybenzonitrile)

and its metabolite 3,5-dibromo-4-

hydroxybenzoic acid (DBHA) resulting

from application of its octanoic and/or

heptanoic acid ester in or on the

following commodities:
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26481

Commodity Parts per million

Cattle, fat ........................... 1 ppm

Cattle, mbyp ...................... 3.5 ppm

Cattle, meat ....................... 0.5 ppm

Cotton gin byproducts ....... 7.0 ppm

Cotton, hulls ...................... 5.0 ppm

Cotton, undelinted seed .... 1.5 ppm

Eggs .................................. 0.05 ppm

Goats, fat .......................... 1 ppm

Goats, mbyp ...................... 3.5 ppm

Goats, meat ...................... 0.5 ppm

Hogs, fat ............................ 1 ppm

Hogs, mbyp ....................... 3.5 ppm

Hogs, meat ........................ 0.5 ppm

Horses, fat ......................... 1 ppm

Horses, mbyp .................... 3.5 ppm

Horses, meat ..................... 0.5 ppm

Milk .................................... 0.1 ppm

Poultry, fat ......................... 0.05 ppm

Poultry, mbyp .................... 0.3 ppm

Poultry, meat ..................... 0.05 ppm

Sheep, fat .......................... 1 ppm

Sheep, mbyp ..................... 3.5 ppm

Sheep, meat ...................... 0.5 ppm

* * * * *

[FR Doc. 98–12639 Filed 5–8–98; 9:42 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300660; FRL–5790–5]

RIN 2070–AB78

Diflubenzuron; Temporary Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

temporary tolerance for residues of the

insecticide diflubenzuron (N-[[4-

chlorophenyl)amino]-carbonyl]-2,6-

difluorobenzamide) and metabolites

convertible to p-chloroaniline expressed

as diflubenzuron on rice grain at 0.01

ppm. Uniroyal Chemical Company, Inc.

submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act of 1996

requesting this temporary tolerance in

association with an Experimental Use

Permit (EUP) under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA).

DATES: This regulation is effective May

13, 1998. Objections and requests for

hearings must be received by EPA on or

before July 13, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300660],

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–

300660], 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–

300660]. 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: Paul Schroeder, 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) 305-6602, e-mail:

schroeder.paul@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of February 25, 1998

(63 FR 9528) (FRL–5775–3), EPA issued

a notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(e) announcing

the filing of a pesticide petition (PP

6G4771) from Uniroyal Chemical

Company, Inc., Bethany, CT proposing

to amend 40 CFR part 180 by

establishing a tolerance for residues of

the insect growth regulator,

diflubenzuron and metabolites

convertible to p-chloroaniline,

expressed as diflubenzuron in or on rice

at 0.02 parts per million (ppm) and rice

straw at 0.8 ppm. The notice included

a summary of the petition prepared by

Uniroyal Chemical Company, Inc., the

registrant. In the Federal Register of

March 9, 1998 (63 FR 11445) (FRL–

5777-8), a clarification of the notice of

filing was published explaining that

Uniroyal had submitted two petitions,

6G4771, for the establishment of a

temporary tolerance in or on rice at 0.01

ppm in association with a 3,000 acre

EUP, and 8F4925, to amend 40 CFR

180.377 to include a tolerance for

residues of the insect growth regulator,

diflubenzuron and metabolites

convertible to p-chloroaniline,

expressed as diflubenzuron in or on rice

at 0.02 parts per million (ppm) and rice

straw at 0.8 ppm. There were no

comments received in response to the

notice of filing or the clarification.

I. Risk Assessment and Statutory

Findings

EPA establishes maximum legal levels

(tolerances) for pesticide residues on

food under section 408 of FFDCA. EPA

performs a number of analyses to

determine the risk from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the Final Rule

on Bifenthrin Pesticide Tolerances (62

FR 62961, November 26, 1997) (FRL–

5754–7).

II. 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 residues of the insecticide

diflubenzuron (N-[[4-

chlorophenyl)amino]-carbonyl]-2,6-

difluorobenzamide) and metabolites

convertible to p-chloroaniline expressed

as diflubenzuron on rice grain at 0.01,

and to make a determination on

aggregate exposure, consistent with

section 408(b)(2), for a tolerance for

residues of the insecticide

diflubenzuron (N-[[4-

chlorophenyl)amino]-carbonyl]-2,6-

difluorobenzamide) and metabolites

convertible to p-chloroaniline expressed

as diflubenzuron on rice grain at 0.01.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.