6486 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations

Hackensack River, at Jersey City then up

to an additional half hour delay in

opening is permitted. After the signal to

open is given, the opening may be

delayed no more than ten minutes.

From 7:15 a.m. to 9 a.m. and from 4:30

p.m. to 6:50 p.m., Monday through

Friday except federal holidays, the draw

need not open.

(h) The draw of the Route 280 (Stickel

Memorial) Bridge, mile 5.8, at Harrison,

shall open on signal if at least eight

hours notice is given. In an emergency,

the draw shall open as soon as possible

but not more than two hours after the

opening request.

(i) The draw of the Clay Street Bridge,

mile 6.0, at Harrison, shall open on

signal; except that notice must be given

before 2:30 a.m. for openings between 3

a.m. and 8:30 a.m. and before 2:30 p.m.

for openings between 4:30 p.m. and 7

p.m.

(j) The draw of the Route 7 (Rutgers

Street) Bridge, mile 6.9, at Belleville,

shall open on signal if at least four

hours notice is given.

(k) The draw of the NJTRO (West

Arlington) Bridge, mile 8.0, at Kearney,

shall open on signal from 7 a.m. to 11

p.m. if at least eight hours notice is

given. After the signal to open is given,

the opening may be delayed no more

than ten minutes. From 11 p.m. to 7

a.m., the draw need not be opened.

(l) The draw of the Avondale Bridge,

mile 10.7, at Lyndhurst, shall open on

signal; except that notice must be given

before 2:30 a.m. for openings between 3

a.m. and 8:30 a.m. and before 2:30 p.m.

for openings between 4:30 p.m. and 7

p.m.

(m) The draw of the NJTRO Bridge,

mile 11.7, at Lyndhurst, shall open on

signal from 8 a.m. to 4 p.m. if at least

six hours notice is given. After the

signal to open is given, the opening may

be delayed no more than ten minutes.

From 4 p.m. to 8 a.m., the draw need

not be opened.

(n) The draw of the Route 3 Bridge,

mile 11.8, at Rutherford, shall open on

signal if at least six hours notice is

given.

(o) The draw of the Douglas O. Mead

(Union Avenue) Bridge, mile 13.2, at

Rutherford, shall open on signal; except

that:

(1) From 4 p.m. to 8 a.m., the draw

shall open if at least eight hours notice

is given; and

(2) On Christmas and New Year’s Day,

the draw shall open if notice is given

prior to 4 p.m. the day prior.

(p) The draw of the following bridges

need not be opened for the passage of

vessels:

(1) Gregory Avenue Bridge, mile 14.0,

at Wallington.

(2) Second Street Bridge, mile 14.7, at

Wallington.

(3) West Eighth Street Bridge, mile

15.3, at Garfield.

Dated: January 28, 1997.

J.L. Linnon,

Rear Admiral, U.S. Coast Guard, Commander,

First Coast Guard District.

[FR Doc. 97–3484 Filed 2–11–97; 8:45 am]

BILLING CODE 4910–14–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300452; FRL–5585–1]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the insecticide bifenthrin in

or on the raw agricultural commodities

broccoli and cauliflower in connection

with EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of

bifenthrin on broccoli and cauliflower

in California. This regulation establishes

a maximum permissible level for

residues of bifenthrin in these foods

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

Federal Food, Drug and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. These tolerances

will expire and be revoked

automatically without further action by

EPA on January 31, 1998.

DATES: This regulation becomes

effective February 12, 1997. This

regulation expires and is revoked

automatically without further action by

EPA on January 31, 1998. Objections

and requests for hearings must be

received by EPA on April 14, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300452],

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 document control number, [OPP–

300452], should be submitted to: Public

Response and Program Resources

Branch, Field Operations 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 number [OPP–300452]. 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: Margarita Collantes, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Sixth Floor, Crystal Station #1, 2800

Jefferson Davis Highway, Arlington, VA

22202, (703) 308–8347, e-mail:

collantes.margarita@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

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 insecticide bifenthrin, (2-

methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-

chloro-3,3,3,-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate in or

on broccoli at 0.1 parts per million

(ppm) and cauliflower at 0.05 ppm.

These tolerances will expire and be

revoked automatically without further

action by EPA on January 31, 1998.

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
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 6487

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 were discussed in detail

in the final rule establishing a tolerance

for an emergency exemption for use of

propiconazole on sorghum (61 FR

58135, November 13, 1996)(FRL–5572–

9).

New section 408(b)(2)(A)(i) 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, 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) 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. Section 408(l)(6)

also requires EPA to promulgate

regulations by August 3, 1997,

governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemptions for

Bifenthrin on Broccoli and Cauliflower

and FFDCA Tolerances

The California Department of

Pesticide Regulations requested a

specific exemption for use of bifenthrin

on broccoli, cabbage, cauliflower,

rapini, leaf lettuce and head lettuce to

control the silverleaf whitefly.

California indicates that it still does not

have material that will provide them

with satisfactory late season control of

the silverleaf whitefly. The registrant

(Bayer Inc.) for the registered alternative

product imidacloprid Admire/Provado

does not want growers to use

imidacloprid throughout the growing

season in order to eliminate any

potential that the silverleaf whitefly

may develop a resistant gene to

imidacloprid. When used as a

combination, Imidacloprid and

bifenthrin allowed the growers to

maintain the ability to grow a

marketable crop in 1993 and 1994.

Without the use of bifenthrin, the

Applicant claims that growers will

suffer significant economic loss this

growing season.

Upon review of the economic data

submitted for this application, the

expected net revenue for cabbage, head

and leaf lettuce, each fall inside the

range of the respective historical

variations, implying that no significant

economic loss would occur. However,

the net revenue for cauliflower and

broccoli fall outside of the historical

range of variations of net revenue and

are therefore expected to result in

significant economic losses and an

urgent non-routine situation.

As part of its assessment of these

applications for emergency exemptions,

EPA assessed the potential risks

presented by residues of bifenthrin on

broccoli and cauliflower. In doing so,

EPA considered the new safety standard

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

decided to grant the section 18

exemptions only after concluding that

the necessary tolerances under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. These tolerances for

bifenthrin will permit the marketing of

broccoli and cauliflower, treated in

accordance with the provisions of the

section 18 emergency exemptions.

Consistent with the need to move

quickly on the emergency exemptions

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment under

section 408(e) as provided in section

408(l)(6). Although these tolerances will

expire and be revoked automatically

without further action by EPA on

January 31, 1998, under FFDCA section

408(l)(5), residues of bifenthrin not in

excess of the amount specified in the

tolerances remaining in or on broccoli

and cauliflower after that date will not

be unlawful, provided the pesticide is

applied during the term of, and in

accordance with all the conditions of,

the emergency exemptions. EPA will

take action to revoke these tolerances

earlier if any experience with, scientific

data on, or other relevant information

on this pesticide indicate that the

residues are not safe.

EPA has not made any decisions

about whether bifenthrin meets the

requirements for registration under

FIFRA section 3 for use on broccoli or

cauliflower or whether a permanent

tolerance for bifenthrin for these crops

would be appropriate. This action by

EPA does not serve as a basis for

registration of bifenthrin by a State for

special local needs under FIFRA section

24(c). Nor does this action serve as the

basis for any States other than those

listed above to use this product 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 exemptions for bifenthrin,

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
6488 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

For many of these 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 percent

or less of the RfD) is generally

considered by EPA to pose no

appreciable risk.

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 Margin of Exposure

(MOE) calculation based on the

appropriate NOEL) may be carried out

based on the nature of the carcinogenic

response and the Agency’s knowledge of

its mode of action.

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, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. 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. 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 percent 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.

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.

Bifenthrin is already registered by EPA

for numerous food and feed uses, as

well as residential use (ornamentals,

houseplants, turf, pets and inside

domestic dwellings). At this time, EPA

is not in possession of a registration

application for bifenthrin on broccoli or

cauliflower. However, a petition

tolerance for these uses is expected in

1997. Based on information submitted

to the Agency thus far, EPA has

sufficient data to assess the hazards of

bifenthrin and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for the time-limited

tolerances for residues of bifenthrin on

broccoli at 0.1 ppm and cauliflower at

0.05 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing these tolerances

follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, EPA’s

Office of Pesticide Programs (OPP) has

established the RfD for bifenthrin at

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

The RfD for bifenthrin is based on a 1–

year feeding study in dogs with a NOEL

of 1.5 mg/kg/day and an uncertainty

factor of 100. Intermittent tremors was

the effect observed at the Lowest Effect

Level (LEL) of 3 mg/kg/day.

2. Acute toxicity. Based on available

acute toxicity data, OPP has determined

that the NOEL of 1 mg/kg/day from the

oral developmental toxicity study in rats

should be used to assess risk. The

maternal effects observed at the LEL of

2 mg/kg/day was based on tremors from

day 7 to 17 of dosing. This acute dietary

endpoint will determine acute dietary

risks to all subgroups of the population.

3. Short-term toxicity. OPP has

determined that a short- and

intermediate-term risk assessment is

appropriate for occupational and

residential routes of exposure. OPP

recommends that the same NOEL of 1

mg/kg/day, taken from the above acute

rat developmental oral toxicity study be

used for these MOE residential

calculations. A dermal penetration of 20

percent (similar to other pyrethroids)

should be employed for worker MOE

calculations. OPP did not identify an

inhalation exposure intermediate-term

hazard.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), the Carcinogenicity

Peer Review Committee (CPRC) has

classified bifenthrin as a Group C

chemical, possible human carcinogen,

based on urinary bladder tumors in

mice, but did not recommended

assignment of a Q1*, instead

recommended the RfD approach. Based

on CPRC’s recommendation that the RfD

approach be used to assess dietary

cancer risk, a quantitative dietary risk

assessment was not performed. Human

health risk concerns due to long-term

consumption of bifenthrin residues are

adequately addressed by DRES chronic

exposure analysis using the RfD.

B. Aggregate Exposure

Tolerances for residues of bifenthrin

in or on food/feed commodities are

currently expressed in terms of the

combined residues of the insecticide

bifenthrin [2-methyl[1,1′-biphenyl]-3-

yl)methyl-3-(2-chloro-3,3,3,-trifluoro-1-

propenyl)-2,2-

dimethylcyclopropanecarboxylate (40

CFR 180.442(b)) expressed in or on

certain raw agricultural commodities

ranging from 0.05 ppm in eggs to 10.0

ppm in dried hops.

For the purpose of assessing chronic

dietary exposure from bifenthrin, EPA

assumed tolerance level residues and

100 percent of crop treated refinements

to estimate the TMRC from all the

established existing food uses of

bifenthrin. There are no livestock feed

items associated with this section 18
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 6489

request, so no additional livestock

dietary burden will result from this

section 18 registration. Therefore, no

secondary residues in meat, milk,

poultry, and eggs are expected as a

result of this use and existing meat, milk

and poultry tolerances are adequate.

For the purpose of assessing acute

dietary exposure from bifenthrin, EPA

assumed anticipated residue data for

most of the established existing food

uses of bifenthrin. Although no

livestock feed items are associated with

this section 18 use, additional

refinement of the acute milk residue

values were performed for this section

18 in order to further define the acute

risk estimate.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking water

and exposure from non-occupational

(non-dietary) sources. Based on the

available studies used in EPA’s

assessment of environmental risk,

bifenthrin appears to be moderately

persistent and not mobile. There are no

established Maximum Concentration

Level for residues of bifenthrin in

drinking water. No health advisory

levels for bifenthrin in drinking water

have been established. The ‘‘Pesticides

In Groundwater Database’’ (EPA 734–

12–92–001, Sept. 1992), indicates that

bifenthrin has not been monitored.

Based on the available data and

percentage of the RfD which is occupied

(maximum of 55 percent for nonnursing infants with no anticipated

residue or percent crop treated

refinement), OPP does not anticipate

that addition of risk from drinking water

to the dietary burden would result in a

TMRC that exceeds 100 percent of the

RfD. Therefore, OPP concludes that

potential bifenthrin residues in drinking

water are not likely to pose a human

health concern.

There are residential uses of

bifenthrin and EPA acknowledges that

there may be short- and intermediateterm non-occupational exposure

scenarios. OPP has identified a toxicity

endpoint for an intermediate-term

residential risk assessment. However, no

acceptable reliable exposure data to

assess these potential risks are available

at this time. Given the time-limited

nature of this request, the need to make

emergency exemption decisions

quickly, and the significant scientific

uncertainty at this time about how to

aggregate non-occupational exposure

with dietary exposure, the Agency will

make its safety determination for this

tolerance based on those factors which

it can reasonably integrate into a risk

assessment.

At this time, the Agency has not made

a determination that bifenthrin and

other substances that may have a

common mode of toxicity would have

cumulative effects. Given the timelimited nature of this request, the need

to make emergency exemption decisions

quickly, and the significant scientific

uncertainty at this time about how to

define common mode of toxicity, the

Agency will make its safety

determination for this tolerance based

on those factors which it can reasonably

integrate into a risk assessment. For

purposes of this tolerance only, the

Agency is considering only the potential

risks of bifenthrin in its aggregate

exposure.

C. Safety Determinations for U.S.

Population

EPA has concluded that chronic

dietary exposure to bifenthrin will

utilize 23 percent of the RfD for the U.S.

population. As mentioned before, EPA

does not expect that chronic exposure

from drinking water would result in an

aggregate exposure which would exceed

100 percent of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to bifenthrin residues. For the

acute population subgroup of concern,

children (1 to 6 years old), the

calculated MOE value is 50. MOE values

under 100 exceed the Agency’s level of

concern for acute dietary exposure.

Though the acute dietary risk

assessment assumes anticipated

residues for most commodities and is a

relatively refined estimate of exposure,

OPP expects that further refinement of

the acute dietary risk assessment for

children (1 to 6 years old) using the

Monte Carlo model would result in an

acceptable MOE. Use of the Monte Carlo

methodology would allow incorporation

of the range of expected residues for

each commodity being evaluated,

instead of point estimates, as well as

consideration of percent crop treated

refinements in the acute exposure

analysis. Currently, 100 percent crop

treated is assumed for every commodity

evaluated in the analysis; this results in

over estimation of acute dietary

exposure from bifenthrin.

D. Determination of Safety for Infants

and Children.

In assessing the potential for

additional sensitivity of infants and

children to residues of bifenthrin, EPA

considered pre- and post-natal toxicity

data in rabbits and rats. EPA notes that

the developmental toxicity NOEL of 8.0

mg/kg/day highest dose tesed (HDT)

demonstrates that there is no

developmental (prenatal) effects in

fetuses exposed to bifenthrin in rabbits.

The developmental toxicity NOEL of 2.0

mg/kg/day HDT in rats indicated a

slight increase in litters with

hydroureter (distended ureter). In the

absence of a dose-related finding of

hydroureter in the rat developmental

study and in the presence of similar

incidences in the recent historical

control data, the marginal findings of

hydroureter in rat fetuses at 2.0 mg/kg/

day [in the presence of maternal

toxicity] is not considered a significant

developmental finding nor is it

considered to provide sufficient

evidence of a special dietary risk (either

acute or chronic) for infants and

children which would require an

additional safety factor.

In the 2–generation reproductive

toxicity study in the rat, parental

toxicity occurred as decreased body

weight at 5.0 mg/kg/day with a NOEL of

3.0 mg/kg/day. There were no

developmental [pup] or reproductive

effects up to 5.0 mg/kg/day HDT.

Therefore, there is no evidence of

special post-natal sensitivity to infants

and children in the rat reproduction

study. This finding suggests that postnatal development in pups is not more

sensitive and that infants and children

may not have a greater sensitivity to

bifenthrin than adult animals.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of

bifenthrin ranges from 14 percent for

nursing infants to 55 percent for nonnursing infants (<1 year old). However,

this calculation assumes tolerance level

residues for all commodities and is

therefore an over-estimate of dietary

risk. Refinement of the dietary risk

assessment by using anticipated residue

data would reduce dietary exposure. As

mentioned before, the addition of

potential exposure from bifenthrin

residues in drinking water is not

expected to result in an exposure which

would exceed the RfD. EPA therefore

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to bifenthrin.

As mentioned above, dietary cancer

concerns for infants and children are

adequately addressed by the chronic

exposure analysis using the RfD.

FFDCA section 408 provides that EPA

shall apply an additional safety factor

for infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the data base unless EPA concludes

based on reliable data that said

additional safety factor is unnecessary.

Should an additional uncertainty factor

be deemed appropriate, when
6490 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations

considered in conjunction with a

refined exposure estimate, it is unlikely

that the dietary risk will exceed 100

percent of the RfD. Therefore, EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to bifenthrin residues.

V. Other Considerations

The metabolism of bifenthrin in

plants and animals is adequately

understood for the purposes of this

tolerance. There are no Codex maximum

residue levels established for residues of

bifenthrin on brassica vegetables and

lettuce. Adequate methods for purposes

of data collection and enforcement of

tolerance for bifenthrin residues are

available. Method P–2132M (MRID#

416585–01), which was validated on

celery, should be adequate for analysis

of brassica vegetables and lettuce.

VI. Conclusion

Therefore, a tolerance in connection

with the FIFRA section 18 emergency

exemptions is established for residues of

bifenthrin on broccoli at 0.1 ppm and

cauliflower at 0.05 ppm. These

tolerances will expire and be

automatically revoked without further

action by EPA on January 31, 1998.

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 April 14, 1997,

file written objections to any aspect of

this regulation (including the automatic

revocation provision) 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

A record has been established for this

rulemaking under docket control

number [OPP–300452]. A public version

of this record, 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 Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. 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

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget. In addition,

this action does not impose any

enforceable duty or contain any

unfunded mandate as described in the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

1994).

Pursuant to the requirements of the

Regulatory Flexibility Act (5 U.S.C.

601–612), the Administrator has

determined that regulations establishing

new tolerances or raising tolerance

levels or establishing exemptions from

tolerance requirements do not have a

significant economic impact on a

substantial number of small entities. A

certification statement to this effect was

published in the Federal Register of

May 4, 1981 (46 FR 24950).

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), EPA 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 the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 30, 1997.

Penelope A. Fenner-Crisp,

Acting Director, 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.
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Rules and Regulations 6491

2. In 180.442, by adding a new

paragraph (c) to read as follows:

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(c) A time-limited tolerance is

established for residues of the combined

residues of the insecticide bifenthrin [2-

methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-

chloro-3,3,3,-trifluoro-1-propenyl)-2,2-

dimethylcyclopropanecarboxylate in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. These tolerances are

specified in the following table. These

tolerances will expire and be

automatically revoked on the date

specified in the table without further

action by EPA.

Commodity Parts per million Expiration/Revocation

Date

Broccoli ............................................................................................................................................... 0.1 January 31, 1998

Cauliflower .......................................................................................................................................... 0.05 January 31, 1998

[FR Doc. 97–3380 Filed 2–11–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 76

[MM Docket No. 92–266; FCC 96–491]

Cable Television Consumer Protection

and Competition Act of 1992

AGENCY: Federal Communications

Commission.

ACTION: Final Rule.

SUMMARY: In this Memorandum Opinion

and Order, we adopt rule changes

responsive to the decision of the court

in Time Warner Entertainment Co. v.

FCC, 56 F.3d 151 (D.C. Cir. 1995). In its

decision, the court considered rules

adopted by the Commission to

implement rate regulation and related

provisions of the Cable Television

Consumer Protection and Competition

Act of 1992 (‘‘1992 Cable Act’’). The

rules were largely affirmed by the court.

In five discrete areas, however, the court

reversed the Commission’s

implementing decisions and rules. The

order is intended to conform the rules

to the court’s decision.

DATES: The amendments to 47 CFR

Sections 76.905 and 76.921 shall

become effective March 14, 1997, and

the amendments to 47 CFR Sections

76.922 and 76.913 will become effective

upon approval by the Office of

Management and Budget of the

information collection requirements, but

no sooner than March 14, 1997. The

Commission will publish a document at

a later date establishing this effective

date. Written comments by the public

on the modified information collections

are due April 14, 1997.

ADDRESSES: A copy of any comments on

the information collections contained

herein should be submitted to Dorothy

Conway, Federal Communications

Commission, Room 234, 1919 M Street,

N.W., Washington, DC 20554, or via the

Internet to dconway@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information concerning this

rulemaking contact Meryl S. Icove or

Hugh Boyle, Cable Services Bureau,

(202) 418–7200. For additional

information concerning the information

collections contained in this rulemaking

contact Dorothy Conway at (202) 418–

0217, or via the Internet at

dconway@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Memorandum Opinion

and Order in MM Docket No. 96–266,

FCC 96–491, adopted December 23,

1996 and released December 31, 1996.

The complete text of this Order is

available for inspection and copying

during normal business hours in the

FCC Reference Center (room 239), 1919

M Street, NW., Washington, DC, and

also may be purchased from the

Commission’s copy contractor,

International Transcription Services,

Inc. (‘‘ITS Inc.’’) at (202) 857–3800, 2100

M Street, NW., Suite 140, Washington,

DC 20017.

PAPERWORK REDUCTION ACT: This

rulemaking contains modified

information collections. The

Commission, as part of its continuing

effort to reduce paperwork burdens,

invites the general public to comment

on the information collections

contained in this rulemaking, as

required by the Paperwork Reduction

Act of 1995. Public comments are due

April 14, 1997. Comments should

address: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the Commission, including

whether the information shall have

practical utility; (b) the accuracy of the

Commission’s burden estimates; (c)

ways to enhance the quality, utility, and

clarity of the information collected; and

(d) ways to minimize the burden of the

collection of information on the

respondents, including the use of

automated collection techniques or

other forms of information technology.

OMB Approval Number: 3060–0561

Title: Section 76.913 Assumption of

jurisdiction by the Commission.

Type of Review: Revision of existing

collection.

Respondents: State, local and tribal

governments.

Number of Respondents: 50.

Estimated Time Per Response: 8

hours.

Total Annual Burden: 400 hours.

Estimated costs per respondent: $500.

Postage and stationery costs are

estimated at an average of $10 per

petition. 50 petitions × $10 = $500.

Needs and Uses: 76.913 permits local

franchising authorities (‘‘LFAs’’) that are

unable to meet certification standards to

petition the Commission to regulate the

rates for basic cable service and

associated equipment of their respective

franchisees. The Commission has

amended its rules as follows: If the local

franchising authority lacks the resources

to administer rate regulation, its petition

no longer must be accompanied by a

demonstration that franchise fees are

insufficient to fund any additional

activities required to administer basic

service rate regulation. Elimination of

this requirement constitutes a modified

information collection; all other

requirements remain intact.

The information in the petitions is

used by Commission staff to identify

situations where it should exercise

jurisdiction over basic service and

equipment rates in place of a local

franchising authority. If the information

were not collected, the basic cable rates

of some franchise areas not subject to

effective competition would remain

unregulated in contravention of the

goals of the 1992 Cable Act.

OMB Approval Number: 3060–0607.

Title: Section 76.922 Rates for Basic

Service Tiers and Cable Programming

Tiers.

Type of Review: Revision of existing

collection.