56102 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(l)(6), such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 21, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.438, by adding paragraph

(b) to read as follows:

§ 180.438 Lambda-cyhalothrin tolerance

for residues.

* * * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for combined residues of the insecticide

lambda-cyhalothrin (a 1:1 mixture of

(S)-α-cyano-3-phenoxybenzyl-(Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

(R)-α-cyano-3-phenoxybenzyl-(Z)-

(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-

dimethylcyclopropanecarboxylate and

its epimer a 1:1 mixture of (S)-α-cyano3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-

chloro-3,3,3-trifluoroprop-1-enyl)-2,2-

dimethylcyclo-propanecarboxylate and

(R)-α-cyano-3-phenoxybenzyl (Z)-

(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2-dimethylcyclopropanecarboxylate in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the dates specified in the

following table.

Commodity Parts per million Expiration/Revocation Date

barley bran 0.2 8/30/98

barley grain 0.05 8/30/98

barley hay 2 8/30/98

barley straw 2 8/30/98

canola seed 0.1 8/30/98

sugarcane 0.03 8/30/98

* * * * *

[FR Doc. 97–28655 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300564; FRL–5749–2]

RIN 2070–AB78

Ferric Phosphate; Establishment of an

Exemption from the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of ferric

phosphate, when used as a molluscicide

in or on all food commodities. W.

Neudorff GmbH KG submitted a petition

to EPA under the Federal Food, Drug

and Cosmetic Act (FFDCA) as amended

by the Food Quality Protection Act

(FQPA) of 1996 requesting the

exemption from the requirement of a

tolerance. This regulation eliminates the

need to establish a maximum

permissible level for residues of this

molluscicide in or on all food

commodities.

DATES: This regulation is effective on

October 29, 1997. Objections and

requests for hearings must be received

by December 29, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300564],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300564], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56103

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 be submitted electronically by

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

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300564]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Sheryl K. Reilly, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460,

Office location, telephone number, and

e-mail address: CS1 Rm. 5–W31, 2800

Crystal Drive, Arlington, VA, 703–308–

8265, e-mail:

reilly.sheryl@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: W.

Neudorff GmbH KG, c/o Walter G.

Telarek, PC, 1008 Riva Ridge Drive,

Great Falls, VA, has requested in

pesticide petition PP 7F4804 the

establishment of an exemption from the

requirement of a tolerance for residues

of the molluscicide iron (ferric)

phosphate. A notice of filing (FRL–

5721–6) was published in the Federal

Register (62 FR 32331–32336) on June

13, 1997, and the notice announced that

the comment period would end on July

13, 1997; no comments were received.

This exemption from the requirement

of a tolerance will permit the marketing

of raw agricultural commodities when

treated in accordance with EPA Reg No.

67702–3, which is being issued under

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended

(Pub. L. 95–396, 92 Stat. 819; 7 U.S.C.

136).

The data submitted in the petition

and all other relevant material have

been evaluated. The following is a

summary of EPA’s findings regarding

this petition.

I. Product Identity

NEU 1165M Slug and Snail Bait (EPA

file symbol No. 067702–G) is the first

pesticide product containing the active

ingredient ferric phosphate (FePO4,

CAS# 11045–86–0). The product

contains the active ingredient at a

concentration of 1% incorporated into a

solid matrix, which is odorless, and has

a white-to-buff color.

II. Risk Assessment and Statutory

Findings

New section 408(c)(2)(A)(i) of FFDCA

allows EPA to establish an exemption

from the requirement of 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(c)(2)(ii) defines ‘‘safe’’ to

mean that ‘‘there is a reasonable

certainty that no harm will result from

aggregate exposure to the pesticide

chemical residue, including all

anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(c)(2)(B) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue***.’’ EPA performs a number of

analyses to determine the risks from

aggregate exposure to pesticide residues.

First, EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

III. Toxicological Profile

Consistent with section 408(b)(2)(D)

of FFDCA, EPA has reviewed the

scientific data and other relevant

information in support of this action

and considered its validity,

completeness, reliability, and

relationship to human risk. EPA has

also considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children.

A battery of acute toxicity studies

place NEU 1165M Slug and Snail Bait

in the following Toxicity Categories:

Acute Oral (Toxicity Category IV); Acute

Dermal (Toxicity Category IV; Primary

Eye Irritation (Toxicity Category III); and

Primary Dermal Irritation (Toxicity

Category IV). (MRIDs 440427–04,–05,

–06, and –07)

Data waivers were requested for acute

inhalation toxicity, dermal sensitization,

genotoxicity, reproductive and

developmental toxicity, subchronic (90–

day) oral toxicity, and chronic toxicity.

The waivers were accepted based on the

long history of use of iron and iron salts

by humans without any indication of

deleterious effects, and on the

following:

The toxicity of ferric phosphate is

low; ferric phosphate occurs naturally

as a mineral, and is added to food, such

as bread, for nutritional fortification.

Iron is an essential nutrient for humans

and all other vertebrates; the average

human diet contains 10–15 mg of iron

a day. Ferric phosphate is also

sometimes used as a fertilizer. In

addition, iron is found in abundance in

nature; the low water-solubility of ferric

phosphate limits its absorption across

the intestinal epithelium.

IV. Residue Chemistry

A waiver was requested and granted

for magnitude of the residue anticipated

at the time of harvest and method used

to determine the residue data

requirements based on ferric

phosphate’s (1) low toxicity, (2) natural

occurrence, (3) abundance in the

environment, (4) widespread use as

human nutrient and dietary

supplements and in infant formula, (5)

status at FDA as ‘‘generally recognized

as safe’’ (GRAS), and (6) data available

in the open literature.

V. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 directs EPA to

consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures. The primary

non-food sources of exposure the

Agency considers include drinking

water or groundwater, and exposure

through pesticide use in gardens, lawns,

or buildings (residential and other

indoor uses).

1. Dietary exposure. Dietary exposure

of ferric phosphate via food or water

exists due to its use as a nutritional

supplement and its ubiquitous presence

in nature. Residues from use of the

biochemical pesticide, ferric phosphate,

will not significantly add to the current

dietary exposures.

2. Non-dietary, non-occupational

exposure. Increased non-dietary

exposure of ferric phosphate via noncommercial greenhouse, home lawn and

garden or ornamental use will be

minimal. Exposure by the inhalation

route would be non-existent because
56104 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations

ferric phosphate is not volatile and the

formulation of the product is a solid

matrix of non-respirable size. In

summary, the potential aggregate

exposure, derived from non-dietary and

non-occupational exposure should be

minimal.

VI. Cumulative Effects

Ferric phosphate has a very low

toxicity to humans. Because of its low

toxicity, low rate of application, and use

patterns, the Agency believes that there

is no reason to expect any cumulative

effects from ferric phosphate and other

substances.

VII. Endocrine Disruptors

The Agency has no information to

suggest that ferric phosphate has any

effect on the immune and endocrine

systems. The Agency is not requiring

information on the endocrine effects of

this biochemical pesticide at this time;

Congress has allowed 3 years after

August 3, 1996, for the Agency to

implement a screening program with

respect to endocrine effects.

Nevertheless, the above discussion on

exposure from all sources combined

with the low toxicity of ferric phosphate

would indicate such testing would not

be necessary.

VIII. Safety Determination for U.S.

Population, Infants and Children

Based on the information discussed

above, EPA concludes that there is

reasonable certainty that no harm will

result from aggregate exposure to the

U.S. population, including infants and

children, to residues of ferric phosphate.

This includes all anticipated dietary

exposures and all other exposures for

which there is reliable information. The

Agency has arrived at this conclusion

because, as discussed above, the toxicity

of ferric phosphate to mammals is very

low and under reasonably foreseeable

circumstances it does not pose a risk.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (safety) for infants and

children in the case of threshold effects

to account for pre- and post-natal

toxicity and the completeness of the

database, unless EPA determines that a

different margin of exposure (safety)

will be safe for infants and children.

Margins of exposure (safety) are often

referred to as uncertainty (safety)

factors. In this instance, the Agency

believes there is reliable data to support

the conclusion that ferric phosphate is

practically non-toxic to mammals,

including infants and children, and,

thus, there are no threshold effects, and

EPA has not used a margin of exposure

(safety) approach to assess the safety of

ferric phosphate. As a result, the

provision requiring an additional

margin of exposure (safety) does not

apply.

IX. Other Considerations

1. Analytical method. The Agency

proposes to establish an exemption from

the requirement of a tolerance without

any numerical limitation; therefore, the

Agency has concluded that an analytical

method is not required for enforcement

purposes for ferric phosphate residues.

2. Codex maximum residue level.

There are no CODEX tolerances nor

international tolerance exemptions for

ferric phosphate at this time.

X. Conclusion

Based on the information discussed

above, EPA establishes an exemption

from the requirement of a tolerance

pursuant to FFDCA section 408(j)(3) for

ferric phosphate.

This exemption from the requirement

of a tolerance will be revoked if any

experience with or scientific data on

this pesticide indicate that the tolerance

is not safe.

XI. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

exemption regulation issued by EPA

under new section 408(e) as was

provided in the old section 408.

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 adversely affected by this

regulation may, on or before December

29, 1997, file written objections to the

regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (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 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

issue(s) 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.

XII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300564] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which
Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Rules and Regulations 56105

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

XIII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the tolerance

requirement under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629), February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since tolerance

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

XIV. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives and the

Comptroller General of the General

Accounting Office prior to publication

of the rule in today’s Federal Register.

This is not a major rule as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 21, 1997.

Stephen L. Johnson,

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. Section 180.1191 is added to

subpart D to read as follows:

§ 180.1191 Ferric phosphate; exemption

from the requirement of a tolerance.

An exemption from the requirement

of a tolerance is established for residues

of the biochemical pesticide, ferric

phosphate (FePO4, CAS No. 11045–86–

0) in or on all food commodities.

[FR Doc. 97–28657 Filed 10–28–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–5914–3]

National Oil and Hazardous

Substances Contingency Plan;

National Priorities List Update

AGENCY: Environmental Protection

Agency.

ACTION: Notice of deletion of the Bowers

Landfill Superfund Site from the

National Priorities List (NPL).

SUMMARY: The Environmental Protection

Agency (EPA) announces the deletion of

the Bowers Landfill Superfund Site in

Ohio from the National Priorities List

(NPL). The NPL is Appendix B of 40

CFR part 300 which is the National Oil

and Hazardous Substances Contingency

Plan (NCP), which EPA promulgated

pursuant to section 105 of the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (CERCLA), as amended.

This action is being taken by EPA and

the State of Ohio, because it has been

determined that Responsible Parties

have implemented all appropriate

response actions required. Moreover,

EPA and the State of Ohio have

determined that remedial actions

conducted at the site to date remain

protective of public health, welfare, and

the environment.

EFFECTIVE DATE: October 29, 1997.

FOR FURTHER INFORMATION CONTACT:

David Wilson (312) 886–1476 (SR–6J),

Remedial Project Manager or Gladys

Beard at (312) 886–7253, Associate

Remedial Project Manager, Superfund

Division, U.S. EPA—Region V, 77 West

Jackson Blvd., Chicago, IL 60604.

Information on the site is available at

the local information repository located

at: Pickaway County Public Library, 165

E. Main Street, Circleville, OH 43113.

Requests for comprehensive copies of

documents should be directed formally

to the Regional Docket Office. The

contact for the Regional Docket Office is

Jan Pfundheller (H–7J), U.S. EPA,

Region V, 77 W. Jackson Blvd., Chicago,

IL 60604, (312) 353–5821.

SUPPLEMENTARY INFORMATION: The site to

be deleted from the NPL is: Bowers

Landfill Superfund Site located in

Pickaway County, Ohio. A Notice of

Intent to Delete for this site was

published September 10, 1997 (62 FR

47619). The closing date for comments

on the Notice of Intent to Delete was

October 9, 1997. EPA received no

comments and therefore no

Responsiveness Summary was prepared.

The EPA identifies sites which appear

to present a significant risk to public

health, welfare, or the environment and

it maintains the NPL as the list of those

sites. Sites on the NPL may be the

subject of Hazardous Substance

Response Trust Fund (Fund-) financed

remedial actions. Any site deleted from

the NPL remains eligible for Fundfinanced remedial actions in the

unlikely event that conditions at the site

warrant such action. Section

300.425(e)(3) of the NCP states that

Fund-financed actions may be taken at

sites deleted from the NPL in the

unlikely event that conditions at the site

warrant such action. Deletion of a site

from the NPL does not affect responsible

party liability or impede agency efforts

to recover costs associated with

response efforts.

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous