Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Rules and Regulations 7941

List of Subjects in 40 CFR Part 70

Environmental protection,

Administrative practice and procedure,

Air pollution control, Intergovernmental

relations, Operating permits, and

Reporting and recordkeeping

requirements.

Dated: February 5, 1997.

John P. DeVillars,

Regional Administrator, Region I.

Part 70, title 40 of the Code of Federal

Regulations is amended as follows:

PART 70—[AMENDED]

1. The authority citation for Part 70

continues to read as follows:

Authority: 42 U.S.C. 7401, et seq.

2. Appendix A to Part 70 is amended

by adding the entry for Maine in

alphabetical order to read as follows:

Appendix A to Part 70—Approval Status of

State and Local Operating Permits Programs

* * * * *

Maine

(a) Department of Environmental

Protection: submitted on October 23, 1995;

source category-limited interim approval

effective on March 24, 1997; source categorylimited interim approval expires March 22,

1999.

(b) [Reserved]

* * * * *

[FR Doc. 97–4327 Filed 2–20–97; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300449; FRL–5583–4]

RIN 2070-AB78

Benoxacor; Time-Limited Tolerances

for Residues

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of 4-(dichloroacetyl)-3,4-

dihydro-3-methyl-2H-1,4-benzoxazine

(benoxacor) when used as an inert

ingredient (safener) in pesticide

formulations containing metolachlor in

or on raw agricultural commodities for

which tolerances have been established

for metolachlor. This regulation is being

issued in response to a petition for the

establishment of a tolerance for residues

of benoxacor requested by Ciba-Geigy

Corp.

EFFECTIVE DATE: This regulation

becomes effective February 14, 1997 and

expires on February 14, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP-300449],

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, [OPP300449], 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 Hwy., Arlington,

VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

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 [OPP300449]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed on-line at many

Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Kerry B. Leifer, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Sixth

Floor, Crystal Station #1, 2800 Crystal

Drive Jefferson Davis Hwy., Arlington,

VA, (703)-308-8811, e-mail: leifer.kerry

@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, at

the request of Ciba, Crop Protection,

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e), is establishing

tolerances for residues of the inert

ingredient (safener) 4-(dichloroacetyl)-

3,4-dihydro-3-methyl-2H-1,4-

benzoxazine (benoxacor) at 0.01 part per

million (ppm) in or on raw agricultural

commodities for which tolerances have

been established for metolachlor. These

tolerances will expire on February 14,

1998. A notice of filing of a tolerance

petition, including the petitioner’s

summary of the information, data and

arguments in support of their petition

was published in the Federal Register

on November 5, 1996 (61 FR 56954).

There were no comments or requests

for referral to an advisory committee

received in response to the notice of

filing.

I. Background and Statutory Authority

A time-limited tolerance was

established for benoxacor when used as

an inert ingredient (safener) in pesticide

formulations containing metolachlor in

or on raw agricultural commodities for

which tolerances have been established

for metolachlor and published in the

Federal Register on June 30, 1992 (57

FR 29031). The time-limited tolerance

expired on December 1, 1996. This timelimited tolerance was established to

allow for the submission and Agency

review of chronic toxicity/oncogenicity

data on benoxacor. The requisite

chronic toxicity/oncogenicity studies in

the rat and mouse were submitted by

the petitioner; however, the Agency’s

review of the data is not yet complete.

In order to allow the for the continued

use of benoxacor as a safener in

formulations of metolachlor while the

EPA continues its review of the

submitted oncogenicity data, the

petitioner has requested that the timelimited tolerance be extended until such

time as the Agency is able to make a

definitive determination as to the safety

of the tolerance.

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.

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
7942 Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Rules and Regulations

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 408(b)(2)(D) specifies

factors EPA is to consider in

establishing a tolerance. Section

408(b)(3) requires EPA to determine that

there is a practical method for detecting

and measuring levels of the pesticide

chemical residue in or on food and that

the tolerance be set at a level at or above

the limit of detection of the designated

method. Section 408(b)(4) requires EPA

to determine whether a maximum

residue level has been established for

the pesticide chemical by the Codex

Alimentarius Commission. If so, and

EPA does not propose to adopt that

level, EPA must publish for public

comment a notice explaining the

reasons for departing from the Codex

level. Section 408 governs EPA’s

establishment of exemptions from the

requirement for a tolerance using the

same safety standard as section

408(B)(2)(A) and incorporating the

provisions of section 408(b)(2)(C) and

(D). Section 408(d) allows for the filing

of a petition proposing the issuance of

a regulation establishing, modifying, or

revoking a tolerance or tolerance

exemption for a pesticide chemical

residue in or on a food.

II. 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 effects 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 a reasonable

certainty of no harm.

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

calculations 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.

III. 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. A

time-limited tolerance was established

for benoxacor when used as an inert

ingredient (safener) in pesticide

formulations containing metolachlor in

or on raw agricultural commodities for

which tolerances have been established

for metolachlor and published in the

Federal Register on June 30, 1992. The

time-limited tolerance expired on

December 1, 1996.

EPA has reassessed the toxicology

data base for benoxacor including new

reproductive, chronic and

carcinogenicity studies provided by the

petitioner as part of this action to extend

the time-limited tolerances for

benoxacor. EPA has sufficient data to

assess the hazards of benoxacor and to

make a determination on aggregate

exposure, consistent with section

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

for residues of benoxacor at 0.01 ppm in

or on raw agricultural commodities for

which tolerances have been established

for metolachlor. 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 has

established the RfD for benoxacor at

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

This RfD is based on a 2–year feeding

study in rats with a NOEL of 0.4 mg/kg/

day and an uncertainty factor of 100.

The uncertainty factor of 100 was

applied to account for inter-species

extrapolation (10) and intra-species

variability (10). Increased nonneoplastic lesions of the stomach

(including epithelial hyperplasia) and

liver (including centrilobular

enlargement and hepatocyte vacuolation

in males) were the effects observed at

the lowest effect level (LEL) of 2.0 mg/

kg/day.

2. Acute toxicity. Based on the

available acute toxicity data, EPA has
Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Rules and Regulations 7943

determined that benoxacor does not

pose any acute dietary or nondietary

risks.

3. Carcinogenicity. Based upon

findings of a carcinogenic effect in the

nonglandular stomach of rats and mice,

benoxacor has been referred to the

Office of Pesticide Program’s Health

Effects Division Cancer Peer Review

Committee for classification as to its

carcinogenicity. It is scheduled for

review and classification in February

1997. The Agency has determined that,

for the purposes of this time-limited

tolerance and until such time as the

Peer Review Committee makes a

determination regarding the nature of

the carcinogenic response and mode of

action of benoxacor, a risk assessment of

benoxacor utilizing the RfD derived

from the chronic toxicity data is

appropriate due to the nature of the

tumor (forestomach) and the low

incidence of tumors at the high dose

level of 41 mg/kg/day.

B. Aggregate Exposure

For the purpose of assessing chronic

dietary exposure from benoxacor, EPA

considered the proposed benoxacor

tolerance of 0.01 ppm and the raw

agricultural commodities for which

tolerances have been established for

metolachlor. There are no other

established U.S. tolerances for

benoxacor, and there are no other

registered uses for benoxacor on food or

feed crops in the United States. In

conducting this exposure assessment,

EPA assumed tolerance level residues

and 100 percent crop treated, resulting

in a large overestimate of dietary

exposure and protective of any chronic

dietary exposure scenario.

Other potential sources of exposure of

the general population to residues of

pesticide chemicals are residues in

drinking water and exposure from nonoccupational sources. There is no

established Maximum Concentration

Level for residues of benoxacor in

drinking water and no health advisory

levels for benoxacor in drinking water

have been established.

Review of the environmental fate data

submitted by the petitioner indicates

that benoxacor is mobile and hydrolyzes

slowly at low pH’s, but rapidly degrades

in the soil (half-life of 49 days under

aerobic conditions and 70 days

anaerobically). Although the Agency

does not have available data to perform

a drinking water assessment at this time,

exposure to residues of benoxacor in

drinking water is not expected to result

in unacceptable aggregate risk. This

conclusion is based on the low

application rate, the lack of significant

acute oral toxicity, and the low

percentage of the RfD occupied by

dietary exposure, as well as an

assessment of other pesticide chemicals

which shows that except for highly

mobile, persistent and acutely toxic

chemicals, a significant contribution to

aggregate risk to drinking water is

unlikely.

EPA has evaluated the estimated nonoccupational exposure to benoxacor. All

metolachlor products to which

benoxacor is added as a safener are

commercial agricultural products not

registered for residential use. The

potential for non-occupational exposure

to benoxacor by the general population

is therefore unlikely except for the

potential residues in food crops

discussed above.

Section 408(b)(2)(D)(v) of FFDCA

requires that, when considering whether

to establish, modify, or revoke a

tolerance or tolerance exemption, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide

chemical’s residues and ‘‘other

substances that have a common

mechanism of toxicity.’’ While the

Agency has some information in its files

that may turn out to be helpful in

eventually determining whether a

pesticide chemical shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the capability to fully resolve the

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

pesticide chemicals. The Agency hopes

that the results of this pilot process will

enable the Agency to apply common

mechanism issues to its pesticide risk

assessments. At present, however, the

Agency does not know how to apply the

information in its files concerning

common mechanism issues to risk

assessments. Therefore, the Agency

believes that in most cases there is no

‘‘available information’’ concerning

common mechanism that can be applied

to tolerance decisions. ‘‘Available

information’’ as used in this context

includes both the toxicity data, as well

as policies and methodologies for

conducting cumulative risk

assessments. In most cases, although

data may be available, policies and

methodologies have not been developed

to permit their use. When the Agency

has determined that a particular

pesticide chemical may share a

significant common mechanism with

other chemicals, a tolerance decision

may be affected by common mechanism

issues. Conversely, when the Agency

has determined that a pesticide

chemical does not share a common

mechanism of toxicity with other

chemicals, the tolerance decision will

state this and provide supporting

information. Where the Agency cannot

determine whether a common

mechanism of toxicity is operating

because of lack of available information,

a tolerance decision will be based upon

the best available and useful

information for the individual chemical,

and a risk assessment will be performed

for the individual chemical assuming

that no common mechanism of toxicity

exists.

In the case of benoxacor, EPA has not

yet determined whether to include this

chemical in a cumulative risk

assessment. This tolerance decision

therefore does not take into account

common mechanism issues. The Agency

will reexamine the tolerances for

benoxacor during the tolerance

reassessment process or when the timelimited tolerance approaches expiration.

C. Determination of Safety for U.S.

Population

1. Chronic risk. Based on the

completeness and reliability of the

toxicity data, EPA has concluded that

dietary exposure to benoxacor will

utilize 4.8 percent of the RfD for the

U.S. population. EPA generally has no

concern for exposures below 100

percent of the RfD. Acceptable, reliable

data are not available to quantitatively

assess risk from drinking water.

However, EPA concludes that there is a

reasonable certainty that no harm to the

U.S. population will result from

aggregate exposure to benoxacor

residues.

2. Acute risk. Due to the minimal

acute toxicity of benoxacor, there are no

concerns for acute dietary, occupational,

and non-occupational exposures to

benoxacor.

D. Determination of Safety for Infants

and Children

In assessing the potential for

additional sensitivity of infants and

children to residues of benoxacor, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a 2-generation reproduction study in

rats. The developmental toxicity studies

are designed to evaluate adverse effects

on the developing organism resulting

from pesticide chemical exposure

during prenatal development to one or

both parents. Reproductive toxicity

studies provide information relating to

effects from exposure to a pesticide

chemical on the reproductive capability

of mating animals and data on systemic

toxicity.
7944 Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Rules and Regulations

Based on current toxicological data

requirements, the data base for

benoxacor relative to pre- and post-natal

toxicity is complete. EPA notes

developmental toxicity NOELs of 100

mg/kg/day in rats and 12.5 mg/kg/day in

rabbits. Developmental toxicity was

observed in rats at 400 mg/kg/day; these

effects occurred in the presence of

maternal toxicity. In rabbits,

developmental alterations were noted at

the maternally toxic dose of 62.5 mg/kg/

day. The developmental NOELs are

more than 250- and 31-fold higher in the

rats and rabbits respectively, than the

NOEL of 0.4 mg/kg/day from the

chronic toxicity/oncogenicity study in

rats, which is the basis of the RfD.

In the 2–generation reproductive

toxicity study in rats, the reproductive

toxicity NOEL of 4.57 mg/kg/day was

greater than the parental (systemic)

toxicity NOEL (3.55 mg/kg/day in males

and 4.51 mg/kg/day in females. The

NOEL of 4.57 mg/kg/day for

reproductive (pup) toxicity was 11-fold

higher than the NOEL of 0.4 mg/kg/day

from the chronic toxicity/oncogenicity

study in rats,, which is the basis of the

RfD. The reproductive (pup) lowest

observed effect levels (LOEL) of 64 mg/

kg/day (first generation; F1) and 72.25

mg/kg/day (second generation; F2) are

based on decreased body weights on

lactation day 21. Because these

reproductive effects occurred in the

presence of parental (systemic) toxicity,

these data do not suggest an increased

post-natal sensitivity to children and

infants (i.e., that infants and children

might be more sensitive than adults) to

benoxacor exposure.

FFDCA section 408 provides that EPA

shall apply an additional uncertainty

(safety) factor for infants and children in

the case of threshold effects to account

for pre- and postnatal toxicity and the

completeness of the data base unless

EPA concludes that a different margin of

exposure (safety) is appropriate. EPA

believes that reliable data support using

standard uncertainty factors (usually

100x for combined inter- and

intraspecies variability) and not the

additional uncertainty factor when EPA

has a complete data base and when the

severity of the potential effect in infants

and children or the potency or unusual

toxic properties of a compound do not

raise concerns regarding the adequacy of

the traditional uncertainty factors.

Based on current toxicological data

requirements the data base for

benoxacor relative to pre- and postnatal

toxicity is complete. As mentioned

above, because both developmental and

reproductive effects occurred in the

presense of parental (systemic) toxicity,

these data do not suggest an increased

pre- or postnatal sensitivity of children

and infants to benoxacor exposure.

Therefore, EPA concludes, upon the

basis of reliable data that a 100-fold

uncertainty factor is adequate to protect

the safety of infants and children and an

additional safety factor is not warranted.

1. Chronic risk. Based on the TMRC

exposure estimates, EPA has concluded

that the percentage of the RfD that will

be utilized by dietary exposure to

residues of benoxacor ranges from 3.3

percent for pregnant females 13+ years

old, up to 20 percent for non-nursing

infants.

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

that a different margin of safety is

appropriate. Based on current

toxicological data requirements, the data

base for benoxacor relative to pre- and

post-natal toxicity is complete. As

mentioned above, because reproductive

effects occurred in the presence of

parental (systemic) toxicity, these data

do not suggest an increased post-natal

sensitivity of children and infants to

benoxacor exposure, and therefore an

additional safety factor was not applied.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to benoxacor residues.

2. Acute risk. Due to the minimal

acute toxicity of benoxacor, EPA

concludes that there is a reasonable

certainty of no harm for infants and

children resulting from acute dietary or

non-occupational exposures to

benoxacor.

IV. Other Considerations

The nature of the residue in plants

and animals is adequately understood

for this tolerance. There are no Codex

maximum residue levels established for

residues of benoxacor on commodities

for which a tolerance for metolachlor

exist. Adequate enforcement

methodology, GC/NPD, is available to

enforce the tolerance expression. An

analytical methodology for the

determination of benoxacor and its

metabolites in plant and animal

commodities (Ciba Analytical Method

AG536(C)) is available from: By mail,

Calvin Furlow, Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Crystal Mall #2,

Rm 1128, 1921 Jefferson Davis Hwy.,

Arlington, VA.

V. Conclusion

Therefore, time-limited tolerances are

established for residues of benoxacor

when used as an inert ingredient

(safener) in pesticide formulations

containing metolachlor in or on raw

agricultural commodities for which

tolerances have been established for

metolachlor. These tolerances will

expire on February 14, 1998.

VI. 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 the new

section 408(d) 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 its

current procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by April 22, 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 requester’s

contentions on such issues, and a

summary of any evidence relied upon

by the requester (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

requester would, if established, resolve

one or more of such issues in favor of

the requester, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requester would be adequate to justify

the action requested (40 CFR 178.32).
Federal Register / Vol. 62, No. 35 / Friday, February 21, 1997 / Rules and Regulations 7945

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.

VII. Public Docket

A record has been established for this

rulemaking under docket number [OPP300449]. 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. EPA has also established

a special record for post-FQPA

tolerances which contains documents of

general applicability. This record can be

found in the same location.

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.

VIII. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to review by the Office of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under section 3(f), the order defines ‘‘a

significant regulatory action’’ as an

action that is likely to result in a rule:

(1) Having an annual effect on the

economy of $100 million or more, or

adversely and materially affecting a

sector of the economy, productivity,

competition, jobs, the environment,

public health or safety, or State, local or

tribal governments or communities (also

referred to as ‘‘economically

significant’’); (2) creating serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially altering

the budgetary impacts of entitlement,

grants, user fees, or loan programs or the

rights and obligations thereof; or (4)

raising novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Pursuant to the terms of this Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

the Unfunded Mandates Reform Act of

1995 (Pub. L. 104–4), or require prior

consultation 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 tolerances established on the

basis of a petition under section 408(d)

of FFDCA do not require issuance of a

proposed rule, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

enactment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence the RFA is inapplicable.

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

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 14, 1997.

Peter Caulkins,

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. By revising § 180.460 to read as

follows:

§ 180.460 Benoxacor; tolerances for

residues.

Tolerances are established for

residues of the inert ingredient (safener)

benoxacor (4-(dichloroacetyl)-3,4-

dihydro-3-methyl-2H-1,4-benzoxazine)

when used in pesticide formulations

containing metolachlor in or on raw

agricultural commodities for which

tolerances have been established for

metolachlor. These tolerances expire on

February 14, 1998.

[FR Doc. 97–4495 Filed 2–20–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 410 and 415

[BPD–852–CN]

RIN 0938–AH40

Medicare Program; Revisions to

Payment Policies and Five-Year

Review of and Adjustments to the

Relative Value Units Under the

Physician Fee Schedule for Calendar

Year 1997; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correction of final rule with

comment period.

SUMMARY: This document corrects

technical errors that appeared in the

final rule with comment period

published in the Federal Register on

November 22, 1996 entitled ‘‘Medicare

Program; Revisions to Payment Policies

and Five-Year Review of and

Adjustments to the Relative Value Units

Under the Physician Fee Schedule for

Calendar Year 1997.’’

EFFECTIVE DATE: January 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Stanley Weintraub, (410) 786–4498.

SUPPLEMENTARY INFORMATION:

Background

In the Federal Register Document

dated November 22, 1996, there were a

number of technical errors. In

Addendum B, beginning on page 59595,

we inadvertently printed incorrect

information for certain codes. The

corrections appear in this document

under the heading ‘‘Correction of

Errors.’’