11360 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Rules and Regulations

104 58 FR 51735 (October 4, 1993), section 1(a) at

51735. 105RIA at pp. 313–326.

API argues these other programs offer a

larger potential for overall reduction in

NOX emissions. The figure of $25,000 to

$45,000 per ton of NOX reduced

developed in the OTAG process ascribes

all the costs of RFG to NOX control,

including costs incurred to reduce

toxics and VOCs, and to meet the

various content requirements. If VOC

and NOX reductions are valued equally,

as OTAG has done, the incremental cost

per ton of NOX removed falls by more

than a factor of four to under $7,000 per

ton, and the average cost falls to $3,000

to $4,000 per ton. That incremental cost

is higher than projected by EPA for the

Phase II RFG NOX standard because it

assumes that all the gasoline in the 37

state OTAG region, over 90 percent of

the gasoline sold in the U.S. outside of

California, would be included in the

RFG program. Costs rise rather than fall

as volume of RFG produced increases

because less efficient refineries would

be drawn into producing RFG.

Moreover, EPA’s $5,000 per ton cost

estimate for the Phase II RFG NOX

standard applies to the final increment

of emission reduction pursued under

the program, while API compares this

incremental cost to average costs of

other control programs. Average costs

are always less than incremental costs;

if Phase II RFG costs are evaluated on

an average-cost basis, the cost per ton

for RFG areas falls to between $2,000

and $3,000.

Based on the evidence presented, EPA

concludes that some stationary source

NOX controls are more cost-effective

than the Phase II RFG NOX standard,

and some are not. The fact that some

stationary source NOX controls are more

cost-effective does not vitiate the costeffectiveness of the Phase II RFG NOX

standard. EPA cited stationary source

costs both above and below the cost of

Phase II RFG NOX standard in the RFG

rulemaking. EPA does not find that it

understated the relative costeffectiveness of stationary source NOX

controls.

API argues that stationary sources

offer more potential for reducing air

pollution. API argues that EPA should

sequence NOX controls and target major

stationary sources first, since stationary

source NOX control is more costeffective and can be targeted

geographically to avoid controls where

controls are not needed. Other NOX

controls should not be considered until

major stationary source controls are

employed and evaluated, according to

API.

As discussed previously, some

stationary source NOX controls are more

cost-effective than the Phase II RFG NOX

standard, and some are not. However,

OTAG has projected that, in 2007,

mobile sources will still contribute 42

percent of all NOX after implementation

of 1990 CAAA controls for mobile and

stationary sources. These measures

include the retrofit of reasonably

available control technology on existing

major stationary sources of NOX and

implementation of enhanced inspection

and maintenance programs under Title

I; new emission standards for new

motor vehicles and nonroad engines,

and the RFG program under Title II; and

controls on certain coal-fired electric

power plants under Title IV. Given the

challenges facing so many areas in

identifying and implementing programs

that will lead to attainment of the ozone

standard, and the need for additional

NOX controls, EPA believes that NOX

reductions in urban areas where mobile

sources are concentrated, as part of a

region-wide NOX reductions, are still

essential to achieve ozone attainment. In

addition, OTAG modeling demonstrates

that even with unrealistically large NOX

reductions, such as an 80 percent

reduction in elevated NOX plus a 60

percent reduction in low level NOX,

without VOC reductions, attainment

still would not be reached throughout

the OTAG region. EPA believes that

both stationary source and mobile

source controls will be necessary for

many areas to reach attainment.

3. Executive Order 12866

API argues that the Phase II RFG NOX

emission reduction standard does not

satisfy the provisions of Executive Order

12866. API argues that the Phase II RFG

NOX standard is not compelled by

statute or necessary to interpret the

statute, or made necessary by public

need, or the most cost-effective NOX

control to achieve the regulatory

objective.

EPA believes the Phase II RFG NOX

reduction standard meets the

substantive requirements of the

Executive Order 12866. Although the

Phase II RFG NOX standard is not

required by statute, it is ‘‘made

necessary by compelling public

need’’ 104 and is a cost-effective

standard. As discussed earlier, the

authority EPA used to establish the

standard, section 211(c)(1)(A), allows

EPA to regulate fuels or fuel additives

if their emission products cause or

contribute to air pollution that may

reasonably be anticipated to endanger

public health or welfare. EPA used this

authority based on scientific evidence

regarding the benefits of NOX control

and the cost-effectiveness of NOX

reductions. The preceding discussion

indicates that EPA’s RFG rulemaking

properly complied with Executive Order

12866.

V. Conclusion

A detailed discussion of the

determination of the need for, scientific

justification for, and cost-effectiveness

of NOX control is presented in the RIA

for the final rule.105 EPA’s review here

of the air quality benefits and costeffectiveness of the Phase II RFG NOX

reduction standard does not show that

the prior rulemaking determinations

supporting this standard were

inappropriate. After considering API’s

petition, public comment, and other

relevant information available to EPA,

API’s petition for reconsideration of the

Phase II RFG NOX emission reduction

standard is denied.

Dated: February 28, 1997.

Mary D. Nichols,

Assistant Administrator, Office of Air and

Radiation.

[FR Doc. 97–6217 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300458; FRL–5593–1]

RIN 2070–AB78

Clopyralid; Pesticide Tolerance for

Emergency Exemption

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

the herbicide clopyralid in or on the raw

agricultural commodity cranberries in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

clopyralid on cranberries in the states of

Massachusetts, Oregon, and

Washington. This regulation establishes

maximum permissible levels for

residues of clopyralid in this food. The

tolerance will expire July 31, 1998.

DATES: This regulation becomes

effective March 12, 1997. This

regulation expire on July 31, 1998.

Objections and requests for hearings

must be received by EPA on or before

May 12, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300458],

must be submitted to: Hearing Clerk

(1900), Environmental Protection
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Rules and Regulations 11361

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–

300458], must also 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 Highway,

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–

300458]. 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: Libby Pemberton, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail: Sixth Floor, Crystal

Station #1, 2800 Jefferson Davis

Highway, Arlington, VA 22202. (703)

308–8326, e-mail:

pemberton.libby@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of clopyralid on

cranberries at 2 parts per million (ppm).

This tolerance will expire on July 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 FFDCA, 21 U.S.C. 301

et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 CFR 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

Clopyralid on Cranberries and FFDCA

Tolerances

EPA has authorized use under FIFRA

section 18 of clopyralid on cranberries

for control of various weeds.

Cancellations of the most effective

registered alternatives have left growers

with few tools to control weeds in a

crop which cannot be cultivated. Over

time, since control has been less than

adequate, the problems have gotten

steadily worse, resulting in nearepidemic levels of herbaceous perennial

weeds over the past few years on many

cranberry farms. The projected yield

loss on the affected acres would cause

those growers to suffer a significant

economic loss.

As part of its assessment of these

specific exemptions, EPA assessed the

potential risks presented by residues of

clopyralid on cranberries. In doing so,

EPA considered the new safety standard

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

decided that the necessary tolerance

under FFDCA section 408(l)(6) would

clearly be consistent with the new safety

standard and with FIFRA section 18.

This tolerance for residues of clopyralid

will permit the marketing of cranberries

treated in accordance with the

provisions of the section 18 emergency

exemptions. Consistent with the need to

move quickly on these emergency

exemptions in order to address an

urgent non-routine situation and to

ensure that the resulting food is safe and

lawful, EPA is issuing this tolerance

without notice and opportunity for

public comment under section 408(e) as
11362 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Rules and Regulations

provided in section 408(l)(6). Although

this tolerance will expire on July 31,

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

residues of clopyralid not in excess of

the amount specified in this tolerance

remaining in or on cranberries 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 this tolerance 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 clopyralid meets the

requirements for registration under

FIFRA section 3 for use on cranberries

or whether a permanent tolerance for

clopyralid for cranberries would be

appropriate. This action by EPA does

not serve as a basis for registration of

clopyralid 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 Massachusetts,

Oregon, and Washington 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

clopyralid, contact the Agency’s

Registration Division at the address

provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

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 acceptable by EPA.

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

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.

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.

Clopyralid is already registered by EPA

for outdoor Christmas tree plantations,

grasses grown for seed, fallow cropland,

non-cropland and other non-food uses,

as well as several food use registrations.

EPA believes it has sufficient data to

assess the hazards of clopyralid and to

make a determination on aggregate

exposure, consistent with section

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

for residues of clopyralid in or on

cranberries at 2 ppm. EPA’s assessment

of the dietary exposures and risks

associated with establishing this

tolerance follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, the

EPA’s Office of Pesticide Programs

(OPP) has established the RfD for

clopyralid at 0.5 milligrams/kilogram/

day (mg/kg/day). The RfD was

established based on an NOEL of 50 mg/

kg/day from a 2–year rat feeding study.

Effects observed at the lowest effect

level (LEL) were decreased mean body

weights in females. An uncertainty

factor of 100 was used.

2. Acute toxicity. No toxicology

studies were identified by OPP which

demonstrated the need for an acute

dietary risk assessment.

3. Short-term non-dietary inhalation

and dermal toxicity. Based on available

data indicating that there was no

evidence of toxicity by the dermal or

inhalation routes, worker exposure risks

were not calculated.

4. Carcinogenicity. No evidence of

carcinogenicity was seen in mice or in

rats fed clopyralid for 24 months.

B. Aggregate Exposure

Tolerances are established for

residues of clopyralid (3,6-dichloro-2-

pyridinecarboxylic acid) in or on several

raw agricultural commodities (40 CFR

180.431(a) and (b)).

For the purpose of assessing chronic

dietary exposure from clopyralid, EPA

assumed tolerance level residues and

100% of crop treated for the proposed

and existing food uses of clopyralid.
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Rules and Regulations 11363

These conservative assumptions result

in overestimation of human dietary

exposures.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking water

and exposure from non-occupational

sources. There is no entry for clopyralid

in the ‘‘Pesticides in Groundwater Data

Base’’ (EPA 734–12–92–001, September

1992). There is no established

Maximum Concentration Level (MCL)

for residues of clopyralid in drinking

water. No drinking water health

advisory levels have been established

for clopyralid.

The Agency does not have available

data to perform a quantitative drinking

water risk assessment for clopyralid at

this time. Previous experience with

persistent and mobile pesticides for

which there have been available data to

perform quantitative risk assessments

have demonstrated that drinking water

exposure is typically a small percentage

of the total exposure. This observation

holds even for pesticides detected in

wells and drinking water at levels

nearing or exceeding established MCLs.

Based on this experience and the OPP’s

best scientific judgement, EPA

concludes that it is not likely that the

potential exposure from residues of

clopyralid in drinking water added to

the current dietary exposure will result

in an exposure which exceeds the RfD.

Clopyralid is registered for uses, such

as lawns, that could result in nonoccupational exposure and EPA

acknowledges that there may be short-

, intermediate-, and long-term nonoccupational, non-dietary exposure

scenarios. At this time, the Agency has

insufficient information to assess the

potential risks from such exposure.

However, available data for clopyralid

indicate no evidence of toxicity by the

dermal or inhalation routes. 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 clopyralid and

other substances that may have a

common mode of toxicity would have

cumulative effects. Clopyralid is a

member of the pyridinoxy class of

herbicides. Other members of this class

include fluroxypyr, tricolpyr, and

picloram. 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

define common mode of toxicity EPA

will make its safety determination for

these tolerances based on those factors

which can reasonably integrate into a

risk assessment. For purposes of this

tolerance only, the Agency is

considering only the potential risks of

clopyralid in its aggregate exposure.

C. Safety Determinations For U.S.

Population

Taking into account the completeness

and reliability of the toxicity data, EPA

has concluded that dietary exposure to

clopyralid from published tolerances

will utilize 1.65 percent of the RfD for

the U.S. population. EPA does not

anticipate that the potential exposure

from residues of clopyralid in drinking

water added to the current dietary

exposure will result in a chronic

exposure which would exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

clopyralid residues.

D. Determination of Safety for Infants

and Children

Based on current toxicological data

requirements, the data base for

clopyralid relative to pre- and post-natal

toxicity is complete. EPA notes that the

developmental toxicity NOELs of >250

mg/kg/day, the highest dose tested

(HDT) in both rats and rabbits

demonstrate that there is no

developmental (prenatal) toxicity

present for clopyralid. EPA further notes

that the developmental NOELs are 5–

fold higher in both rats and rabbits,

respectively, than the NOEL of 50 mg/

kg/day from the 2–year feeding study in

rats, which is the basis for the RfD.

In the two-generation reproductive

toxicity study in rats, the pup toxicity

NOEL of 1,500 mg/kg/day, the HDT, was

greater than the parental (systemic)

toxicity NOEL of 500 mg/kg/day. This

finding suggests that post-natal

development in pups is not more

sensitive and that infants and children

may not be more sensitive to clopyralid

than adult animals. The pup NOEL is

30–fold higher than the RfD NOEL of 50

mg/kg/day. This information, together

with the uncertainty factor of 100

utilized to calculate the RfD for

clopyralid, is considered adequate

protection for infants and children with

respect to prenatal and postnatal

development against dietary exposure to

clopyralid residues. EPA believes that

the data base of clopyralid is sufficiently

complete regarding infants and children

and that effects seen in that data are not

such to suggest a 100–fold uncertainty

factor will be inadequate. Therefore,

EPA has determined that an additional

10–fold safety factor is not appropriate

and that the 100–fold uncertainty factor

will be safe for infants and children.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of

clopyralid ranges from 1.07% for

nursing infants (<1 year old) up to

3.72% for children 1 to 6 years old.

However, this calculation assumes

tolerance level residues for all

commodities and is therefore an overestimate of dietary risk. Refinement of

the dietary risk assessment by using

anticipated residue data would reduce

dietary exposure. The addition of

potential exposure from clopyralid

residues in drinking water is not

expected to result in an exposure which

would exceed the RfD.

V. Other Considerations

The metabolism of clopyralid in

plants and animals is adequately

understood for the purposes of this

tolerance. There are no Codex maximum

residue levels established for residues of

clopyralid on cranberries. The residue

of concern is clopyralid (3,6-dichloro-2-

pyridinecarboxylic acid). Adequate

methods for purposes of data collection

and enforcement of tolerances for

clopyralid are available. A method for

determining clopyralid residues is

described in PAM, Vol. II.

VI. Conclusion

Therefore, tolerances in connection

with the FIFRA section 18 emergency

exemptions are established for residues

of clopyralid in cranberries at 2 ppm.

This tolerance will expire on July 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 May 12, 1997,

file written objections to any aspect of

this regulation (including the automatic

revocation provision) and may also
11364 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Rules and Regulations

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

A record has been established for this

rulemaking under docket number [OPP–

300458]. 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.

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, 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

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).

Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply.

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: February 27, 1997.

Peter Caulkins,

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.

2. In § 180.431, by adding a new

paragraph (c) to read as follows:

§ 180.431 Clopyralid; tolerances for

residues.

* * * * *

(c) Section 18 emergency exemptions.

A time-limited tolerance is established

for residues of the herbicide clopyralid

(3,6-dichloro-2-pyridinecarboxylic acid)

in connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerance is

specified in the following table. The

tolerance expires on the date specified

in the table.

Commodity Parts per

million

Expiration

Date

Cranberries ........ 2 July 31, 1998

[FR Doc. 97–5875 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 76

[CS Docket No. 96–60; FCC 97–27]

Cable Television Leased Commercial

Access

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission has adopted

a Second Report and Order and Second

Order on Reconsideration of the First

Report and Order (‘‘Order’’) regarding

implementation of the leased

commercial access provisions of the

1992 Cable Act. The Order addressed

comments and petitions for

reconsideration filed in response to the

Order on Reconsideration of the First

Report and Order and Further Notice of

Proposed Rulemaking in CS Docket 96–

60, FCC 96–122 (released March 29,

1996) (subparts referred to separately as

‘‘Reconsideration Order’’ and ‘‘Further

NPRM’’). The Order: revised the

maximum rate formulas for use of full-